How we approach the treatment of patients with high-risk neuroblastoma with naxitamab: experience from the Hospital Sant Joan de Déu in Barcelona, Spain.

Naxitamab [humanized 3f8 (hu3F8)] is a humanized monoclonal antibody (mAb) targeting the disialoganglioside GD2. It was approved in 2020 by the United States Food and Drug Administration (FDA) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for treatment of pediatric and adult patients with relapsed/refractory high-risk neuroblastoma, limited to the bone or bone marrow (BM). The team at Sant Joan de Déu Children's Hospital in Barcelona, Spain, have been using naxitamab to treat neuroblastoma under clinical trial protocols [e.g. Trial 201, and hu3F8, irinotecan, temozolomide, and sargramostim (GM-CSF) (HITS) study] and compassionate use since 2017. The team has experience with two primary regimens: naxitamab with GM-CSF only, or naxitamab in combination with irinotecan, temozolomide, and GM-CSF (chemoimmunotherapy). This article aims to provide a practical overview of the team's experience with naxitamab to date, including preparing the treatment room and selecting the team. Adverse event management, including the use of ketamine to manage pain during anti-GD2 mAb infusions, is also discussed. We hope this will provide practical information for other health care providers considering offering this treatment.

Non-destructive Near Infrared Spectroscopy for the labelling of frozen Iberian pork loins.

Iberian pigs fed on acorns and pasture were slaughtered from January until March of 2018 and 2019. The meat from those Iberian pigs is a seasonal food that only can be found fresh, at the marketplace, during a limit period of the year. Selling frozen-thawed meat is a legal practice, but consumers must be informed about it on the product label. However, to declare as fresh meat, meat previously frozen, is one of the most frequent meat frauds. The present study compares the performance of two rather different Near Infrared Spectroscopy instruments, based on Fourier Transform and Linear Variable Filter technologies, for the in-situ detection of fresh and frozen-thawed acorns-fed Iberian pig loins using Partial Least Discriminant Analysis (PLS-DA). The performance of the models developed for both instruments offered a very high discriminant ability. Furthermore, the models showed consistent results and interpretation when were evaluated with several scalars and graphical methods.

Short Communication: The potential of portable near infrared spectroscopy for assuring quality and authenticity in the food chain, using Iberian hams as an example.

This communication assesses the use of a portable near infrared (NIR) instrument to measure quantitative (fatty acid profile) properties and qualitative ('Premium' and 'Non-premium') categories of individual Iberian pork carcasses at the slaughterhouse. Acorn-fed Iberian pigs have more unsaturated fats than pigs fed conventional compound feed. Recent advances in miniaturisation have led to a number of handheld NIR devices being developed, allowing processing decisions to be made earlier, significantly reducing time and costs. The most common methods used for assessing quality and authenticity of Iberian hams are analysis of the fatty acid composition of subcutaneous fat using gas chromatography and DNA analysis. In this study, NIR calibrations for fatty acids and classification as premium or non-premium ham, based on carcass fat measured in situ, were developed using a portable NIR spectrometer. The accuracy of the quantitative equations was evaluated through the standard error of cross validation or standard error of prediction of 0.84 for palmitic acid (C16:0), 0.94 for stearic acid (C18:0), 1.47 for oleic acid (C18:1) and 0.58 for linoleic acid (C18:2). Qualitative calibrations provided acceptable results, with up to 98% of samples (n = 234) correctly classified with probabilities ⩾0.9. Results indicated a portable NIR instrument has the potential to be used to measure quality and authenticity of Iberian pork carcasses.

Anthropometrical study of the human glenoid in a normal Spanish population. / Estudio antropométrico de la glena humana en una población española normal.

OBJECTIVE: To evaluate the size of the glenoid in a southern Spanish population, to compare it with previous results from other populations and determine the size of the implants that are marketed for shoulder arthroplasty. MATERIAL AND METHODS: Between January 2015 and December 2017, an anthropometrical study of the human glenoid was performed using computed axial tomography scans (CT) of 154 patients over 30 years old. The glenoid dimensions were analysed 3-dimensionally using 2mm interval thicknesses, determining the average height and width of the glenoid. The upper point of the glenoid geometry was determined as the supraglenoid tubercle of the ovoid glenoid surface, where the long head of the biceps tendon is thought to originate. The lower point was then positioned at the furthest point from the upper point on the glenoid contour. Anterior and posterior points were determined such that the 3-dimensional anterior-posterior distance was maximized on the plane perpendicular to the upper-lower axis. Sex differences and correlations between sides and among the respective parameters in the glenohumeral dimensions were also evaluated. RESULTS: The glenoid had an average height of 28.78mm and width of 20.27mm. The values were significantly different between the men and the women, being greater in the men. The glenoid size is well correlated with the patient's size. Direct correlations exist between the glenoid height and width and the glenoid size and the patient's height. The available metaglenoids currently on the market are no bigger than 25-24mm. CONCLUSION: In comparison, the southern Spanish population have a glenoid size similar to the Caucasian population, but smaller than that of the American population. The data shown could be useful to improve the design of shoulder prostheses for the southern Spanish population.

Fourier transform near-infrared spectroscopy coupled to a long fibre optic head for the quality control of IBERIAN pork loins: Intact versus minced.

Conventional chemical analyses of meat products are time-consuming, expensive and destructive. The advantages of NIR spectroscopy are its speed, portability, suitability for both at-line and on-line analysis, low cost and the possibility of simultaneously measuring many different parameters in a large number of samples. The purpose of this study was to develop and validate calibrations for the prediction of moisture, protein and fat in Iberian pig pork loins using an FT-NIR instrument coupled to a 5-m fibre optic sensor head. The best equations obtained for intact loin in both modes of analysis (full and optimal spectral range) displayed Standard Error of Cross-Validation (RMSECV) of 1.06% and 1.09% and Determination Coefficient of Cross-Validation (RCV2) of 0.69 and 0.77 for fat: RMSECV of 0.87% and 0.77% and RCV2 of 0.67 and 0.73 for moisture; while for protein, the RMSECV values were 0.51% and 0.49% and the RCV2 values were 0.66 and 0.70.

Superior capsular reconstruction of irreparable rotator cuff tear using autologous hamstring graft. / Reconstrucción de la cápsula superior en las roturas irreparables del manguito mediante injerto autógeno de isquiotibiales.

OBJECTIVE: The aim of this study was to investigate the clinical results and radiographic findings after superior capsular reconstruction (SCR) of postero-superior symptomatic irreparable rotator cuff tears (PSIRCT) using a new SCR technique using autologous hamstring graft MATERIAL AND METHODS: From 2014 to 2016, 8 shoulders of 8 patients (mean age 59.6 years) with PSIRCT underwent SCR using autologous hamstring graft. Physical examination, X-ray and MRI were performed before the surgery and 12 months after it. A descriptive analysis was performed of the variables, and the non-parametric test of signs comparing the measurements taken before the operation and 12 months after it. RESULTS: We found an improvement in the Constant test from 49 before the SCR to 77.25 one year after the operation. The mean active flexion significantly increased from 99.3° to 142.5°. The mean preoperative AH distance increased from 5.25 (range from 3 to 7) before surgery to 8.18 (range from 6 to 10.5) after the SCR. There were no tears of the graft during follow-up. CONCLUSION: SCR with a hamstring graft improves the function of the shoulder in PSIRCT, and is an alternative technique for treating these injuries without closing the door to other types of surgery.

Outcomes of rotator cuff augmentation surgery with autologous fascia lata. / Resultados de la cirugía de refuerzo del manguito rotador con fascia lata autógena.

OBJECTIVE: To evaluate whether augmentation grafts using autologous fascia lata improve functional results for rotator cuff repairs and reduce the retear rate compared to those without augmentation. MATERIAL AND METHODS: This is a prospective evaluation comprising 20 patients with a complete symptomatic rotator cuff tear. The operations were carried out from a superior approach performing a total cuff repair, for 10 patients we used a suture augmented with an autologous graft taken from their own fascia lata while unaugmented sutures were used for the other 10 patients. The follow-up period lasted for one year post-intervention. We measured variables for tear type, functionality and pain, both baseline and at 6 and 12-month follow ups. We evaluated retear incidence in each group as well as each group's pain and functionality response. RESULTS: The improved pain levels in the non-graft group evolved gradually over time. Conversely, in the group with the augmentation grafts, average Constant-Murley shoulder outcome scores at six months were already above 10 and were maintained at 12 months. One retear occurred in the graft group and 2 in the group without grafts, thus presenting no significant differences. There were no significant changes in pain and function values at the one year follow up in either group. CONCLUSION: Our preliminary results regarding rotator cuff augmentation surgery with autologous fascia lata showed a significant improvement in pain levels after 6 months compared to the patients with no augmentation, who required 12 months to reach the same values. After a year of follow up, there were no differences between the mean Constant and pain scores in either intervention group The number of retears in the non-graft group was greater than that in the group with grafts although the difference was not significant.

Coronal patellar osteotomy of the external facet combined with the release of the lateral retinaculum improves the clinical outcomes of isolated lateral release in lateral knee compartment syndrome. / La osteotomía patelar coronal de la faceta externa asociada a liberación del retináculo lateral mejora los resultados clínicos de la liberación lateral aislada en el síndrome de compresión lateral de rótula.

OBJECTIVE: To describe a novel coronal osteotomy of the external facet of the patella, and to evaluate if the outcomes of the treatment of lateral knee compartment syndrome (LKCS) with this osteotomy, combined with the release of the external lateral retinaculum, are better than the isolated lateral retinacular release. MATERIAL AND METHODS: A prospective study with a 2 year follow up that included 70 patients diagnosed with LKCS, distributed into 2 groups. The first group included 50 patients on whom the lateral retinacular release combined with osteotomy was performed, and a second group on whom an isolated retinacular release was performed. Measurements were made using the Werner functional scale before the surgery and at 3, 12, and 24 months follow-up. RESULTS: There were significant differences in the overall functional state between the two groups after the surgery (better in the osteotomy group at all the intervals, P<.05). The improvement, which was progressive up to 12 months, was slightly less at 24 months, although the values were still better than the pre-surgical ones in both groups. Pain was the variable that showed most improvement. The patients with LKCS with degenerative signs showed a benefit in all cases. CONCLUSION: The results demonstrate that the described patellar osteotomy technique, combined with lateral retinacular release, significantly improves the pain and the functional scale score of patients with LKCS after 2 years of follow-up, to a greater extent than isolated lateral retinacular release, including those in which there was evidence of degenerative signs.

Selection and evaluation of micro-organisms for biocontrol of Verticillium dahliae in olive.

AIMS: To identify potential biological control agents against Verticillium wilt in olive through a mass screening approach. METHOD AND RESULTS: A total of 47 strains and nine mixtures of micro-organisms were evaluated against Verticillium dahliae in a three stage screening: (i) in vitro, by the effect on the mycelial growth and spore germination of the pathogen; (ii) in natural infested soil, by the effect on the reduction of microsclerotia of the pathogen; (iii) in planta, by the effect on the infection of olive plants under controlled conditions. Various fungal and bacterial strains and mixtures inhibited the pathogen and showed consistent biocontrol activity against Verticillium wilt of olive. CONCLUSION: The screening has resulted in promising fungi and bacteria strains with antagonistic activity against Verticillium, such as two non-pathogenic Fusarium oxysporum, one Phoma sp., one Pseudomonas fluorescens and two mixtures of micro-organisms that may possess multiple modes of action. SIGNIFICANCE AND IMPACT OF THE STUDY: This study provides a practical basis for the potential use of selected strains as biocontrol agents for the protection of olive plants against V. dahliae infection. In addition, our study presented an effective method to evaluate antagonistic micro-organisms of V. dahliae in olive.

Enhanced production of microsclerotia in recalcitrant Verticillium dahliae isolates and its use for inoculation of olive plants.

AIMS: The optimization of a simple protocol for the mass production of viable microsclerotia (MS) of Verticillium spp., even for recalcitrant isolates, to the inoculation of olive cuttings. METHOD AND RESULTS: Four Verticillium spp. isolates were characterized by growth rate and morphology. Then, the production ability and the viability of MS over time were assessed in seven solid culture media and five aqueous media. The best culture medium, according to the quantity and the quality (size) of the MS produced, was the alkaline-modified sodium polipectate (AMSP) aqueous medium. The MS viability was higher in peat moss substrates. Finally, the MS obtained in this work were infective causing 100% incidence of Verticillium wilt (VW) disease in inoculated olive plants. CONCLUSION: This study demonstrates that the modified sodium polipectate medium amended with 0·1% agar is the most suitable for the production of MS of Verticillium dahliae isolates that have lost the ability to produce MS in standard culture media. SIGNIFICANCE AND IMPACT OF THE STUDY: Mass production of MS for artificial infestation of soil is critical to the study of epidemiological and control aspects of the VW. To overcome the failure in the production of MS in recalcitrant isolates, a culture media was optimized and a successful plant inoculation experiment was carried out with artificial MS.

Prediction of fatty acids content in pig adipose tissue by near infrared spectroscopy: at-line versus in-situ analysis.

A handheld micro-electro-mechanical system (MEMS) based spectrometer working in the near infrared region (NIR) (1600-2400nm) was evaluated for in-situ and non-destructive prediction of main fatty acids in Iberian pig (IP) carcasses. 110 IP carcasses were measured. Performance of the instrument was compared with at-line high-resolution NIRS monochromators working in two analysis modes: melted fat samples (transflectance cups) and intact adipose tissues (interactance fiber optic). Standard Error of Prediction (SEP) values obtained on the MEMS-NIRS device were: 0.68% (stearic), 1.30% (oleic), 0.55% (linoleic) and 1% (palmitic), explaining a variability of 83%, 84%, 81% and 78%, respectively. As expected, this represented a loss of predictive capability in comparison to at-line models, even with the same spectral characteristics as on the handheld device. However, the estimated total errors were at the same level for gas chromatography and NIRS analysis. This indicates that the MEMS-NIRS in-situ analysis of each individual carcass provides a cost-effective and real-time quality control system with suitable accuracy.

Data pre-processing to improve the mining of large feed databases.

The information stored in animal feed databases is highly variable, in terms of both provenance and quality; therefore, data pre-processing is essential to ensure reliable results. Yet, pre-processing at best tends to be unsystematic; at worst, it may even be wholly ignored. This paper sought to develop a systematic approach to the various stages involved in pre-processing to improve feed database outputs. The database used contained analytical and nutritional data on roughly 20 000 alfalfa samples. A range of techniques were examined for integrating data from different sources, for detecting duplicates and, particularly, for detecting outliers. Special attention was paid to the comparison of univariate and multivariate solutions. Major issues relating to the heterogeneous nature of data contained in this database were explored, the observed outliers were characterized and ad hoc routines were designed for error control. Finally, a heuristic diagram was designed to systematize the various aspects involved in the detection and management of outliers and errors.

Handling of missing data to improve the mining of large feed databases.

Feed databases often have missing data. Despite their potentially major effect on data analysis (e.g., as a source of biased results and loss of statistical power), database managers and nutrition researchers have paid little attention to missing data. This study evaluated various methods of handling missing data using mining outputs from a database containing data on chemical composition and nutritive value for 18,864 alfalfa samples. A complete reference dataset was obtained comprising the 2,303 cases with no missing data for the attributes CP, crude fiber (CF), NDF, ADF and ADL. This dataset was used to simulate 2 types of missing data (at random and not at random), each with 2 loss intensities (33 and 66%), thus yielding a total of 4 incomplete datasets. Missing data from these datasets were handled using 2 deletion methods and 4 imputation methods, and outputs in terms of the identification and typing of alfalfa (using ANOVA and descriptive statistics) and of correlations between attributes (using regressions) were compared with outputs from the complete dataset. Imputation methods, particularly model-based versions, were found to perform better than deletion methods in terms of maximizing information use and minimizing bias although the extent of differences between methods depended on the type of missing data. The best approximation to the uncertainty value was provided by multiple imputation methods. It was concluded that the choice of the most suitable method for handling missing data depended both on the type of missing data and on the purpose of data analysis.

Authentication of organic feed by near-infrared spectroscopy combined with chemometrics: a feasibility study.

Organic products tend to retail at a higher price than their conventional counterparts, which makes them susceptible to fraud. In this study we evaluate the application of near-infrared spectroscopy (NIRS) as a rapid, cost-effective method to verify the organic identity of feed for laying hens. For this purpose a total of 36 organic and 60 conventional feed samples from The Netherlands were measured by NIRS. A binary classification model (organic vs conventional feed) was developed using partial least squares discriminant analysis. Models were developed using five different data preprocessing techniques, which were externally validated by a stratified random resampling strategy using 1000 realizations. Spectral regions related to the protein and fat content were among the most important ones for the classification model. The models based on data preprocessed using direct orthogonal signal correction (DOSC), standard normal variate (SNV), and first and second derivatives provided the most successful results in terms of median sensitivity (0.91 in external validation) and median specificity (1.00 for external validation of SNV models and 0.94 for DOSC and first and second derivative models). A previously developed model, which was based on fatty acid fingerprinting of the same set of feed samples, provided a higher sensitivity (1.00). This shows that the NIRS-based approach provides a rapid and low-cost screening tool, whereas the fatty acid fingerprinting model can be used for further confirmation of the organic identity of feed samples for laying hens. These methods provide additional assurance to the administrative controls currently conducted in the organic feed sector.

In-situ Iberian pig carcass classification using a micro-electro-mechanical system (MEMS)-based near infrared (NIR) spectrometer.

Iberian pig (IP) products are gourmet foods highly appreciated at international markets, reaching high prices, because of its exquisite flavors. At present, there aren't practical and affordable analytical methods which can authenticate every single piece put on the market. This paper reports on the performance of a handheld micro-electro-mechanical system (MEMS)-based spectrometer (1600-2400nm) for authentication-classification of individual IP carcasses into different commercial categories. Performance (accuracy and instrumental design) of the instrument was compared with that of high-resolution NIRS monochromators (400-2500nm). A total of 300 carcasses of IPs raised under different feeding regimes ("Acorn", "Recebo" and "Feed") were analyzed in three modes (intact fat in the carcass, skin-free subcutaneous fat samples and melted fat samples). The best classification results for the MEMS instrument were: 93.9% "Acorn" carcasses correctly classified, 96.4% "Feed" and 60.6% "Recebo", respectively. Evaluation of model performance confirmed the suitability of the handheld device for individual, fast, non-destructive, low-cost analysis of IP carcasses on the slaughterhouse line.

Building a metadata framework for sharing feed information in Spain.

Information about the nutritional aspects and uses of feed is of widespread interest, hence systematic efforts of laboratories to obtain it. The way this information is currently being handled leaves something to be desired, underscoring the need to use computerized systems and statistical techniques that allow the management of large volumes of heterogeneous information. This project seeks to develop a structure that will facilitate the exchange and exploitation of information on feeds produced in Spain. To this end, metadata and data mining techniques have been adopted by the Feed Information Service at the University of Cordoba. The structure has been designed to work on the basis of a server-client architecture, in which information is stored on local software (Califa) by its own creators so that it can subsequently be incorporated into a database server where it can be accessed online. Various aspects of the structure are described in this paper: organization (participants and data shared), format (physical features), logistics (data description), quality (reliability of information), legality (correct use of data), and financing (revenue and expenditure). An indication is given of the amount of information accumulated to date, now exceeding 200,000 numerical data and associated metadata, arranged in several thematic databases. The activities carried out highlight the heterogeneous nature of the information produced, as well as the large number of errors and ambiguities that slip through the normal filters and reach the end-user of the data.

Multivariate near-infrared reflection spectroscopy strategies for ensuring correct labeling at feed bagging in the animal feed industry.

A key concern in animal feed factories is guaranteeing the correct labeling of compound feeds. Therefore, due to incorrect labeling, there is an urgent need for new control methods on the claims that can be made. In this study, this question has been tackled with different multivariate classification algorithms based on the near-infrared spectral fingerprint obtained from a given compound feed analyzed in its original physical market presentation form (i.e., cubes, coarse meals, pellets). The objective of this paper is the evaluation of different methods for establishing a separation among 24 feed types. Two linear methods, soft independent modeling of class analogy (SIMCA) and partial least squares (PLS) with two approaches to classification (PLSD and PLS-LDA); and one nonlinear method, support vector machines (SVM), were studied. The database used had the following structure: a first division was made between granules and meals; within these two groups, there was a second division according to three animal species to which the feed was marketed (bovine, ovine, and porcine); within each species there was a third division according to the age or physiological status of the animal (i.e., lactating dairy cattle, starters, etc.). Given the database structure, all the methods were evaluated following two strategies: (1) development of a model composed of the nine classification models corresponding to the structure of the data; and (2) development of a unique model that discriminates among the 24 classes of different feeds. With both strategies the lowest percentage of misclassified samples was achieved with the SVM method (3.96% with strategy 1 and 2.31% with strategy 2). Among the linear methods evaluated, SIMCA yielded the best results, with a percentage of 8.47% misclassified samples with strategy 1 and 4.05% misclassified samples with strategy 2. The results in this study show the ability of near-infrared spectroscopy to make acceptable classifications of feed types based only on spectral information, with differences in performance depending on the multivariate algorithm used.

A feasibility study on the use of near-infrared spectroscopy for prediction of the fatty acid profile in live Iberian pigs and carcasses.

This work reports on the development and optimisation of NIRS technology for fat characterization both in live pigs and in carcasses in the slaughterhouse; use of this technology would enable implementation of a real-time traceability and control system based on non-destructive sensors. A total of 52 Iberian pig fat samples were analysed using a LabSpec(®)Pro A108310 spectrophotometer (Analytical Spectral Device Inc.), with a high-intensity fiber-optic contact probe. Spectra were collected in five analysis modes: from the live animal, from the carcass in the slaughterhouse, from a subcutaneous fat sample with skin, from a skin-free subcutaneous fat sample and from a transverse section. Calibrations were developed for the prediction of the four main fatty acids in Iberian pig fat, obtaining for palmitic acid SECV values of 1.24% for in vivo analysis and 0.82% for carcass analysis, for stearic acid 0.67% and 0.94%, for oleic acid 1.42% and 1.48% and for linoleic 0.36% and 0.55%, respectively. The calibrations accounted for between 60% and 74% of the variation recorded in live animals, and between 31% and 87% of variation in carcasses. These results confirm the feasibility of NIRS technology for the on-site inspection and control of Iberian pig, both in the field and in the slaughterhouse.