bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and validation of a novel predictive model and web calculator for evaluating transfusion risk after spinal fusion for spinal tuberculosis: a retrospective cohort study
Authors: Dong Shengtao , Li Wenle , Tang Zhi-Ri , Wang Haosheng , Pei Hao , Yuan Bo 
Published: September 2021

Abstract
Objectives
The incidence and adverse events of postoperative blood transfusion in spinal tuberculosis (TB) have attracted increasing attention. Our purpose was to develop a prediction model to evaluate blood transfusion risk after spinal fusion (SF) for spinal TB.

Methods
Nomogram and machine learning algorithms, support vector machine (SVM), decision tree (DT), multilayer perceptron (MLP), Naive Bayesian (NB), k-nearest neighbors (K-NN) and random forest (RF), were constructed to identified predictors of blood transfusion from all spinal TB cases treated by SF in our department between May 2010 and April 2020. The prediction performance of the models was evaluated by 10-fold cross-validation. We calculated the average AUC and the maximum AUC, then demonstrated the ROC curve with maximum AUC.

Results
The collected cohort ultimately was consisted of 152 patients, where 56 required allogeneic blood transfusions. The predictors were surgical duration, preoperative Hb, preoperative ABL, preoperative MCHC, number of fused vertebrae, IBL, and anticoagulant history. We obtained the average AUC of nomogram (0.75), SVM (0.62), k-NM (0.65), DT (0.56), NB (0.74), MLP (0.56) and RF (0.72). An interactive web calculator based on this model has been provided (https://drwenleli.shinyapps.io/STTapp/).

Conclusions
We confirmed seven independent risk factors affecting blood transfusion and diagramed them with the nomogram and web calculator.
Preventing calcium and vitamin D deficiencies following weight loss and metabolic surgery
Authors: Suthakaran Reshi , Indigahawela Imeshi , Mori Krinal , Lim Kiat , Aly Ahmad 
Published: September 2021

Abstract
Introduction
Uncertain nutritional outcomes following common metabolic surgical techniques are concerning given the long-term potential for postoperative metabolic bone disease. This study aims to investigate the variations in serum calcium, vitamin D, and parathyroid hormone (PTH) levels following Roux-en-Y Gastric bypass (RYBP) and Sleeve Gastrectomy (SG).

Methods
A retrospective analysis of 370 patients who underwent metabolic surgery at a single-centre group practice in Melbourne, Australia, over 2 years.

Results
Patients underwent SG (n = 281) or RYGP (n = 89), with 75% and 87% of the cohort being female, respectively. Postoperative mean serum calcium levels and median serum vitamin D levels improved significantly by 24 months within both cohorts. Serum PTH levels within the RYBP group were significantly higher than the SG group across all time points. PTH levels significantly fell from 5.7 (IQR 4.2–7.4) to 5.00 (4.1–6.5) pmol/L by 24 months following SG. However, PTH levels following RYBP remained stable at 24 months, from 6.1 (IQR 4.7–8.7) to 6.4 (4.9–8.1) pmol/L. Furthermore, we failed to notice a significant improvement in PTH levels following RYBP among those with higher PTH levels preoperatively.

Conclusion
Higher PTH levels following RYBP, compared to SG, may imply we are undertreating patients who are inherently subjected to a greater degree of malabsorption and underlying nutritional deficiencies. This finding calls for a tailored supplementation protocol, particularly for those with high preoperative PTH levels undergoing RYBP, to prevent deficiencies.
Adverse events in thyroid surgery: observational study in three surgical units with high volume/year
Authors: Del Rio Paolo , Carcoforo Paolo , Medas Fabio , Bonati Elena , Loderer Tommaso , Koleva Radica Margherita , Calò Piergiorgio 
Published: September 2021

Abstract
Background
Thyroid surgery, performed for benign or malignant pathologies, is one of the most frequently performed procedures and its frequency has even been increasing in recent years. Postoperative bleeding, recurrent laryngeal nerve (RLN) palsy, associated to dysphonia, dysphagia, dyspnea, and hypoparathyroidism represent the most fearful and common complications. We conducted a multicenter, observational study of retrospectively collected data in three high-volume referral centers, enrolling all patients undergone to thyroid surgery between January 2016 and December 2017 in Parma University Hospital, Cagliari University Hospital and Ferrara University Hospital.

Materials
Patients were divided into five groups, differentiated thyroid carcinoma, medullary thyroid carcinoma, non-toxic benign pathology, hyperfunctioning benign pathology and NIFTP (Non-invasive Follicular Thyroid neoplasm with Papillary-like nuclear features). A follow up at 7 and 30 days was executed, evaluating the onset of paresthesia, dysphonia and dysphagia. A 6-month follow-up was conducted in cases of early complications.

Results
Totally, 1252 patients were eligible for the study: 907 female and 345 male, with a female to male ratio of 2.6:1 and an average age of 53.428. Total thyroidectomy was performed in 1022 cases, lobectomy in 230. After 6 months we recorded paresthesia in 0.5%, dysphonia in 1.8% and dysphagia in 0.5%.

Conclusion
Our study confirms once again that a share of morbidity escapes the possibilities of prediction and control by the operator, depending on patient anamnestic, pathological or anatomical factors.
Active-site engineering of ω-transaminase from Ochrobactrum anthropi for preparation of L-2-aminobutyric acid
Authors: Zhang Zhiwei , Liu Yang , Zhao Jing , Li Wenqiang , Hu Ruiwen , Li Xia , Li Aitao , Wang Yaping , Ma Lixin 
Published: September 2021

Abstract
Background
The unnatural amino acid, L-2-aminobutyric acid (L-ABA) is an essential chiral building block for various pharmaceutical drugs, such as the antiepileptic drug levetiracetam and the antituberculosis drug ethambutol. The present study aims at obtaining variants of ω-transaminase from Ochrobactrum anthropi (OATA) with high catalytic activity to α-ketobutyric acid through protein engineering.

Results
Based on the docking model using α-ketobutyric acid as the ligand, 6 amino acid residues, consisting of Y20, L57, W58, G229, A230 and M419, were chosen for saturation mutagenesis. The results indicated that L57C, M419I, and A230S substitutions demonstrated the highest elevation of enzymatic activity among 114 variants. Subsequently, double substitutions combining L57C and M419I caused a further increase of the catalytic efficiency to 3.2-fold. This variant was applied for threonine deaminase/OATA coupled reaction in a 50-mL reaction system with 300 mM L-threonine as the substrate. The reaction was finished in 12 h and the conversion efficiency of L-threonine into L-ABA was 94%. The purity of L-ABA is 75%, > 99% ee. The yield of L-ABA was 1.15 g.

Conclusion
This study provides a basis for further engineering of ω-transaminase for producing chiral amines from keto acids substrates.
A novel heterozygous mutation of CHD7 gene in a Chinese patient with Kallmann syndrome: a case report
Authors: Xu Weiwei , Zhou Weibin , Lin Haiyang , Ye Dan , Chen Guoping , Dong Fengqin , Shen Jianguo 
Published: September 2021

Abstract
Background
Variants of chromodomain helicase DNA binding protein 7 (CHD7) gene are commonly associated with Kallmann syndrome (KS) and account for 5–6% of idiopathic hypogonadotropic hypogonadism (IHH) cases. Here we report a novel mutation of CHD7 gene in a patient with KS, which may contribute to the better understanding of KS.

Case presentation
A 29-year-old male patient with KS and a chief complaint of delayed puberty for 13 years (Tanner B Stage< 4) was admitted to the Department of Endocrinology of the First Affiliated Hospital of Zhejiang University (Hangzhou, China) in September 2019. Dual-energy X-ray absorptiometry (DEXA) showed low bone density in both lumbar spine (L1 ~ L5 mean Z-score − 3.0) and femoral neck (Z-score − 2.7). Dynamic contrast-enhanced magnetic resonance imaging (MRI) of pituitary and contrast-enhanced computed tomography (CT) showed no abnormal findings. Ophthalmological evaluation showed that his both eyes showed exotropia, and no sight loss was noted. Heterozygous c.1619G > T mutation of TCD7 gene (p.G4856V) was detected, whereas none of his family members had this mutation. Human chorionic gonadotropin (HCG) and human menopausal gonadotropin (HMG) were injected for three times/week to treat idiopathic hypogonadotropic hypogonadism (IHH). After several months of therapy, the patient’s health condition improved. His testicles became larger, and his secondary sexual characteristics improved after treatment.

Conclusion
Exploration of the novel splice-site mutation of CHD7 may further our current understanding of KS.
Diné (Navajo) female perspectives on mother–daughter communication and cultural assets around the transition to womanhood: a cross-sectional survey
Authors: Richards Jennifer , Chambers Rachel Strom , Begay Jaime Lynn , Jackson Kendrea , Tingey Lauren , Patel Hima , Carvajal Scott , Carroll Stephanie Russo , Teufel-Shone Nicolette , Barlow Allison 
Published: September 2021

AbstractBackgroundThe inclusion of protective factors (“assets”) are increasingly supported in developing culturally grounded interventions for American Indian (AI) populations. This study sought to explore AI women’s cultural assets, perspectives, and teachings to inform the development of a culturally grounded, intergenerational intervention to prevent substance abuse and teenage pregnancy among AI females.MethodsAdult self-identified AI women (N = 201) who reside on the Navajo Nation completed a cross-sectional survey between May and October 2018. The 21-question survey explored health communication around the transition to womanhood, cultural assets, perceptions of mother–daughter reproductive health communication, and intervention health topics. Univariate descriptive analyses, chi squared, and fisher’s exact tests were conducted.ResultsRespondents ranged in age from 18 to 82 years, with a mean age of 44 ± 15.5 years. Women self-identified as mothers (95; 48%), aunts (59; 30%), older sisters (55; 28%), grandmothers (37; 19%), and/or all of the aforementioned (50; 25%). 66% (N = 95) of women admired their mother/grandmother most during puberty; 29% (N = 58) of women were 10–11 years old when someone first spoke to them about menarche; and 86% (N=172) felt their culture was a source of strength. 70% (N = 139) would have liked to learn more about reproductive health when they were a teenager; 67% (N = 134) felt Diné mothers are able to provide reproductive health education; 51% (N = 101) reported having a rite of passage event, with younger women desiring an event significantly more than older women. Responses also indicate a disruption of cultural practices due to government assimilation policies, as well as the support of male relatives during puberty.ConclusionsResults informed intervention content and delivery, including target age group, expanded caregiver eligibility criteria, lesson delivery structure and format, and protective cultural teachings. Other implications include the development of a complementary fatherhood and/or family-based intervention to prevent Native girls’ substance use and teen pregnancy.
Assessment of medical students’ clinical performance using high-fidelity simulation: comparison of peer and instructor assessment
Authors: Yu Ji Hye , Lee Mi Jin , Kim Soon Sun , Yang Min Jae , Cho Hyo Jung , Noh Choong Kyun , Lee Gil Ho , Lee Su Kyung , Song Mi Ryoung , Lee Jang Hoon , Kim Miran , Jung Yun Jung 
Published: September 2021

Abstract
Background
High-fidelity simulators are highly useful in assessing clinical competency; they enable reliable and valid evaluation. Recently, the importance of peer assessment has been highlighted in healthcare education, and studies using peer assessment in healthcare, such as medicine, nursing, dentistry, and pharmacy, have examined the value of peer assessment. This study aimed to analyze inter-rater reliability between peers and instructors and examine differences in scores between peers and instructors in the assessment of high-fidelity-simulation-based clinical performance by medical students.

Methods
This study analyzed the results of two clinical performance assessments of 34 groups of fifth-year students at Ajou University School of Medicine in 2020. This study utilized a modified Queen’s Simulation Assessment Tool to measure four categories: primary assessment, diagnostic actions, therapeutic actions, and communication. In order to estimate inter-rater reliability, this study calculated the intraclass correlation coefficient and used the Bland and Altman method to analyze agreement between raters. A t-test was conducted to analyze the differences in evaluation scores between colleagues and faculty members. Group differences in assessment scores between peers and instructors were analyzed using the independent t-test.

Results
Overall inter-rater reliability of clinical performance assessments was high. In addition, there were no significant differences in overall assessment scores between peers and instructors in the areas of primary assessment, diagnostic actions, therapeutic actions, and communication.

Conclusions
The results indicated that peer assessment can be used as a reliable assessment method compared to instructor assessment when evaluating clinical competency using high-fidelity simulators. Efforts should be made to enable medical students to actively participate in the evaluation process as fellow assessors in high-fidelity-simulation-based assessment of clinical performance in situations similar to real clinical settings.
Biomedical engineering and ethics: reflections on medical devices and PPE during the first wave of COVID-19
Authors: Maccaro Alessia , Piaggio Davide , Dodaro Concetta Anna , Pecchia Leandro 
Published: September 2021

AbstractIn March 2019, the World Health Organization (WHO) declared that humanity was entering a global pandemic phase. This unforeseen situation caught everyone unprepared and had a major impact on several professional categories that found themselves facing important ethical dilemmas. The article revolves around the category of biomedical and clinical engineers, which were among those most involved in dealing with and finding solutions to the pandemic. In hindsight, the major issues brought to the attention of biomedical engineers have raised important ethical implications, such as the allocation of resources, the responsibilities of science and the inadequacy and non-universality of the norms and regulations on biomedical devices and personal protective equipment. These issues, analyzed one year after the first wave of the pandemic, come together in the appeal for responsibility for thought, action and, sometimes, even silence. This highlights the importance of interdisciplinarity and the definitive collapse of the Cartesian fragmentation of knowledge, calling for the creation of more fora, where this kind of discussions can be promoted.
Neonatologists’ decision-making for resuscitation and non-resuscitation of extremely preterm infants: ethical principles, challenges, and strategies—a qualitative study
Authors: Cavolo Alice , de Casterlé Bernadette Dierckx , Naulaers Gunnar , Gastmans Chris 
Published: September 2021

AbstractBackgroundDeciding whether to resuscitate extremely preterm infants (EPIs) is clinically and ethically problematic. The aim of the study was to understand neonatologists’ clinical–ethical decision-making for resuscitation of EPIs.MethodsWe conducted a qualitative study in Belgium, following a constructivist account of the Grounded Theory. We conducted 20 in-depth, face-to-face, semi-structured interviews with neonatologists. Data analysis followed the qualitative analysis guide of Leuven.ResultsThe main principles guiding participants’ decision-making were EPIs’ best interest and respect for parents’ autonomy. Participants agreed that justice as resource allocation should not be considered in resuscitation decision-making. The main ethical challenge for participants was dealing with the conflict between EPIs’ best interest and respect for parents’ autonomy. This conflict was most prominent when parents and clinicians disagreed about births within the gray zone (24–25 weeks). Participants’ coping strategies included setting limits on extent of EPI care provided and rigidly following established guidelines. However, these strategies were not always feasible or successful. Although rare, these situations often led to long-lasting moral distress.ConclusionsParticipants’ clinical–ethical reasoning for resuscitation of EPIs can be mainly characterized as an attempt to balance EPIs’ best interest and respect for parents’ autonomy. This approach could explain why neonatologists considered conflicts between these principles as their main ethical challenge and why lack of resolution increases the risk of moral distress. Therefore, more research is needed to better understand moral distress in EPI resuscitation decisions.Clinical Trial Registration: The study received ethical approval from the ethics committee of UZ/KU Leuven (S62867). Confidentiality of personal information and anonymity was guaranteed in accordance with the General Data Protection Regulation of 25 May 2018.
Patient involvement at the managerial level: the effectiveness of a patient and family advisory council at a regional cancer centre in Sweden
Authors: Fredriksson Mio , Modigh Anton 
Published: September 2021

Abstract
Background
In cancer care as well as other types of treatment and care, little is known about the contribution of Patient and Family Advisory Councils (PFACs) operating at the managerial level in healthcare organizations. The aim of the study was to investigate the effectiveness of a Swedish PFAC operating at the managerial level at one of Sweden’s six regional cancer centres.

Methods
This was a qualitative, single-case study based on interviews with PFAC participants and meeting minutes from PFAC meetings. These were analysed using a modified version of a framework developed by Abelson et al. to design and evaluate collective involvement processes in the healthcare sector: (i) representation; (ii) information; (iii) process or procedures and (iv) outcomes and decisions.

Results
The descriptive representation was good regarding geographical location and cancer diagnosis. Information from the regional cancer centre was an important part of the meeting agenda. The procedures encouraged everyone to speak up, and the participants saw the representatives from the regional cancer centre as allies against the hospitals and regions, raising some questions about the PFAC's independence. Regarding outcomes, most participants did not know to what extent their work had led to any improvements in cancer care. However, they still regarded the council as effective, as issues the participants raised were listened to by the representatives from the regional cancer centre and ‘taken further’ in the healthcare organization.

Conclusions
The participants were satisfied with being listened to, but they found it difficult to know whether their work had led to improvements, in part because they did not know enough about how the healthcare organization worked above the care-provision level. This was a hurdle to achieving change. The study suggests it is more difficult for patients and next of kin to participate at the managerial level, compared to the care-provision level in healthcare systems, where they could potentially influence important aspects of cancer care and policy, since it is at these levels strategic decisions about priorities in cancer care and service configurations are made. This indicates that there is a particular need for guidance and support for patient and public involvement to work successfully at this level, which may include relevant education and training in system knowledge.
An in vivo pharmacokinetic study of metformin microparticles as an oral sustained release formulation in rabbits
Authors: Bouriche Sihem , Alonso-García Angela , Cárceles-Rodríguez Carlos M. , Rezgui Farouk , Fernández-Varón Emilio 
Published: September 2021

AbstractBackgroundMetformin hydrochloride is a biguanide derivative that has been widely used to treat type 2 diabetes in humans. In veterinary medicine, metformin has shown increasing potential for diabetes treatment in different species, such as equids, dogs, cats and rabbits. It is highly hydrophilic, with incomplete gastrointestinal absorption and very large variability in absolute bioavailability between species, ranging from 4% in equids to 60% in humans. Metformin also shows a short half-life of approximately 2 h in dogs, cats, horses and humans. The objectives of this study were to evaluate a poly (lactic acid) (PLA) metformin microparticle formulation to test in rabbits and conduct a pharmacokinetics study of intravenous (SIV) and oral solution (SPO) metformin administration and oral PLA microparticle (SPLA) administration to rabbits to evaluate the improvement in the metformin pharmacokinetics profile.ResultsMetformin-loaded PLA microparticles were characterized by a spherical shape and high encapsulation efficiency. The results from Fourier transform infrared (FTIR) spectroscopy suggested the presence of interactions between metformin and PLA. X-Ray diffraction (XRD) analysis corroborated the results from the differential scanning calorimetry (DSC) studies, showing that metformin is present in an amorphous state within the microparticles. Physicochemical characterization suggested that PLA and metformin hydrochloride interacted within the microparticles via hydrogen bonding interactions. The pharmacokinetic study in rabbits showed sustained-release characteristics from the prepared microparticles with a delay in the time needed to reach the maximum concentration (Tmax), decreased Cmaxand bioavailability, and increased mean residence time (MRT) and half-life compared to the pure drug solution.ConclusionsMetformin-loaded PLA microparticles showed optimal and beneficial properties in terms of their physicochemical characteristics, making them suitable for use in an in vivo pharmacokinetic study. The pharmacokinetic parameters of the metformin microparticles from the in vivo study showed a shorter Tmax, longer MRT and half-life, decreased Cmaxand the prolonged/sustained release expected for metformin. However, the unexpected decrease in bioavailability of metformin from the microparticles with respect to the oral solution should be evaluated for microparticle and dose design in future works, especially before being tested in other animal species in veterinary medicine.