bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in “Boao Lecheng Pilot Zone”
Authors: Li Jiahe , Liu Lichang , Cao Haijun , Yang Mei , Sun Xin 
Published: January 2023

AbstractThis article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulatory approval in China by utilizing RWE generated in a free trade pilot zone “Boao Lecheng” in Hainan Province. In 2020, the National Medical Products Administration (NMPA) issued a draft guideline on the “Use of real-world data to support clinical evaluation for medical devices”, suggesting that RWE derived from RWD could support clinical evaluation throughout the life cycle of a medical device. Meanwhile, the Chinese government has allowed qualified RWD collected in Boao Lecheng to support registration application of innovative medical devices and drugs in China. These medical devices and drugs should have been approved abroad, but not in China yet, and met urgent and unmet medical needs in China. The article also presents the successful story of an innovative Glaucoma drainage tube as the first medical device approved in China using RWE generated in Boao Lecheng in 2020. Although we are witnessing an increased interest in RWE, a few challenges remain, e.g., limited data accessibility and data sharing, concerns on data quality, etc. Collaborations among relevant stakeholders in the RWE research are vital to address the challenges.
Multi-inflammatory syndrome in children (MIS-C) associated with COVID-19: a nursing perspective experience report from a high-income tertiary paediatric hospital context
Authors: Hjelmgren Henrik , Andersson Karin , Widegren Jessica , Bergman Erika , Vermé Anna , Mördrup Karina , Öhlander Marcus , Bartholdson Cecilia 
Published: January 2023

Abstract
Background
In the midst of the COVID-19 coronavirus pandemic, a new disease that affects children has arisen called multisystem inflammatory syndrome in children (MIS-C). Several research articles focusing on its medical aspects have been published, but very few have focused on nursing care. The aim of this study was therefore to describe the nursing status of children suffering from MIS-C and the experiences of registered nurses (RNs) in caring for these children in paediatric hospital inpatient care.

Methods
The study design includes both quantitative nursing clinical record data and qualitative interview data. Quantitative data from the clinical records were analysed using descriptive statistics. Qualitative data analysis of the interviews was conducted using both deductive and inductive approaches with content analysis.

Results
In total, 47 clinical records from children with MIS-C were investigated during January–March 2021. The mean age of the children was 8.8 years. Boys were more affected than girls. Challenges in children’s nursing status were related to circulation (fever and swelling), nutrition (great thirst and loss of appetite), pain, and psychosocial situations. When caring for children with MIS-C, nurses experienced “frustration over uncertainty of care”, “children’s illbeing” and “unavoidable procedures”.

Conclusion
This study contributes knowledge to the ongoing nursing care of children suffering from MIS-C. The results show many different areas of nursing focus, which challenges nurses and other disciplines within paediatric hospital care. One important factor when caring for these children was the use of a central venous line early in the care process, which improved the quality of care. Moreover, the care of children suffering from MIS-C demands resources and time from healthcare professionals, especially RNs, to meet caring needs and reduce illbeing.
Prevalence and genotype distribution of human papillomavirus infections in Beijing, China between 2016 and 2020
Authors: Zhang Wei , Guo Nan , Li Baoping , Shang E , Wang Jinxia , Zhang Mei , Yang Ximing 
Published: January 2023

Abstract
Background
Certain types of human papillomavirus (HPV) induce long-lasting infections that cause cervical cancer. This study evaluated the prevalence of HPV infections and the distribution of their genotypes among clinic patients and healthy women in Beijing, China.

Methods
Cervical specimens were collected from 12,100 patients and 1176 subjects who underwent physical examinations at Dongzhimen Hospital, Beijing University of Chinese Medicine, between March 2016 and September 2020. HPV genotyping was performed using commercial kits designed to detect 15 high-risk and 2 low-risk HPV genotypes.

Results
There was a higher overall prevalence of HPV among the clinic patients (21.0%) than among the healthy women (11.9%). The most common HPV genotypes among the patients were: HPV-52 (5.4%), HPV-16 (3.4%), HPV-58 (3.2%), HPV-51 (2.6%), HPV-39 (2.0%), HPV-56 (2.0%), and HPV-66 (2.0%). Among the healthy women: HPV-52 (3.0%), HPV-51 (1.8%), HPV-58 (1.6%), HPV-66 (1.5%), HPV-16 (1.2%), HPV-56 (1.2%), and HPV-18 (1.1%). Multiple HPVs were detected in 29.1% of the gynecological outpatients and in 23.6% of the women receiving physical examinations. The most common pairs of HPV types detected were HPV-52 and HPV-16 in the clinic patients, and HPV-52 and HPV-56 in the healthy women. Age-specific HPV positivity and peak prevalence were observed among the individuals in both groups for women aged less than 25 years and those between 61 and 65 years of age.

Conclusions
Our results provide current estimates of HPV prevalence and genotypes in the Beijing region. The epidemiological characteristics observed also provide a reference for the development of cervical cancer screening strategies and selection of HPV vaccine antigen targets for this region. A comparison of these HPV prevalence data with those from other regions suggests that regional vaccines may be an important direction for future research.
Effects of the experience of breastfeeding-friendly practices and breastfeeding intention and self-efficacy on breastfeeding behavior: a cohort study in Taiwan
Authors: Wang Yu-Wen , Chang Ying-Ju 
Published: January 2023

Abstract
Background
Approximately 80% of births in Taiwan occurred in Baby-Friendly accredited facilities, although the trend of exclusively breastfeeding infants until 6 months of age has stagnated in the last ten years. To guide breastfeeding promotion interventions during postnatal stays and encourage mothers to continue breastfeeding for the first 6 months, factors associated with breastfeeding behaviors to 6 months post-delivery must be investigated. This study explored the relationships among breastfeeding intention, experience of breastfeeding-friendly practices, breastfeeding self-efficacy, and breastfeeding behavior at four and 6 months after childbirth.

Methods
In this longitudinal cohort study, women who gave birth to healthy newborns at two Baby-Friendly hospitals in Taiwan and who had initiated breastfeeding were recruited two to 4 days after giving birth. Data were collected three to 5 days after childbirth during hospitalization and at one, two, four, and 6 months after childbirth using a self-developed questionnaire to measure breastfeeding intention and the experience of breastfeeding-friendly practices, and the traditional Chinese version of the Breastfeeding Self-Efficacy Scale-Short Form to measure self-efficacy.

Results
A total of 155 women completed the questionnaires five times within 6 months. The determinants of exclusive breastfeeding at 4 months and any breastfeeding at 6 months were the intention to breastfeed for over 6 months; a higher score for the experience of breastfeeding-friendly practices; and a higher level of breastfeeding self-efficacy during that period. The experience of breastfeeding-friendly practices during hospitalization did not predict breastfeeding behavior at 4 and 6 months. Intending to breastfeed for less than 4 months and lower breastfeeding self-efficacy during the hospital stay were both associated with shorter breastfeeding durations of less than 6 months after childbirth.

Conclusions
Longer intended duration of breastfeeding, sustaining breastfeeding-friendly practices after discharge, and maintenance of a higher level of breastfeeding self-efficacy were the determinants of breastfeeding at 4 and 6 months. Healthcare professionals in Taiwan must support breastfeeding-friendly practices and consider interactive interventions to promote continued breastfeeding at different stages during the first 6 months after childbirth on the basis of the mother’s breastfeeding plan and breastfeeding self-efficacy during their postnatal hospitalization.
Arthroscopic treatment of unstable scaphoid fracture and nonunion with two headless compression screws and distal radius bone graft
Authors: Cheng Cong , Jiang Zongyuan , Sun Haoran , Hu Jiaping , Ouyang Yanggang 
Published: January 2023

Abstract
Background
The treatment of unstable scaphoid fracture and nonunion remains a challenging problem for hand surgeons. Minimally invasive treatment has become the preferred method of treatment.

Purpose
This study introduces the arthroscopic technique with two headless compression screws (HCS) fixation and distal radius bone grafting for the treatment of unstable scaphoid fracture and nonunion, aiming to evaluate its clinical and radiological outcomes.

Methods
It was a retrospective study. From January 2019 to February 2021, a total of 23 patients were included in the current study. Among them, 13 patients with unstable scaphoid fracture underwent arthroscopic treatment with two HCS; 10 patients with scaphoid nonunion underwent arthroscopic treatment with two HCS and a distal radius bone graft. The range of motion of the wrist, visual analog scale (VAS), grip strength, the Modified Mayo Wrist Score (MMWS), the Patient-Rated Wrist Evaluation (PRWE) score, and the Disability of the Arm, Shoulder and Hand (DASH) score were collected at preoperatively and the final follow-up. A computed tomography scan of the wrist was performed on each patient to analyze for union and postoperative osteoarthritis during the follow-up period.

Results
Significant improvement was only observed in wrist extension. Clinical outcomes including grip strength, VAS pain score, MMWS, PRWE score, and DASH score were significantly improved at the final follow-up. In the subgroup analysis, both patients stabilized with either two HCS or a distal radius bone graft and two HCS have improved clinical outcomes after surgery, respectively. All patients achieved union. No screw fixation failure occurred, and no other postoperative complication was observed in any of the patients.

Conclusions
The arthroscopic technique with two-HCS fixation and distal radius bone grafting is a reliable and effective technique for the treatment of unstable scaphoid fracture and nonunion, providing satisfactory union rates and clinical outcomes.
The pressure field as a methodology for fluid management and red cell preservation during cardiac surgery
Authors: Woodford Stephen F. , Butlin Mark , Wei Bai , Chao Wei , Avolio Alberto 
Published: January 2023

Abstract
Purpose
Anemia and red cell transfusion contribute to morbidity and mortality of surgery. The concept of patient blood management to mitigate preoperative anemia, optimize coagulation, conserve red cells intraoperatively and accept lower post-operative transfusion thresholds has recently gained widespread acceptance across a range of surgical disciplines. Fluid administration is likely to contribute significantly to perioperative anemia and red-cell transfusion requirements, yet a robust basis for managing fluid administration in this context has not been articulated. There is an urgent need for this.

Methods
We developed ‘the pressure field method’ as a novel approach to guiding the administration of fluid and drugs to optimize tissue perfusion. The pressure field method was used for the intraoperative management of 67 patients undergoing semi-elective cardiac surgery. We compared intraoperative anemia and transfusion requirements in this cohort with a conventional group of 413 patients undergoing cardiac surgery.

Results
In the pressure field group, no patients required transfusion whereas in the conventional group, 16% required transfusion during bypass and these patients received an average of 2.4 units of packed red cells (P < 0.0001). The average decrease in hemoglobin in the pressure field group was only 13 g/L, whereas in the conventional group it was 52 g/L (P < 0.0001). 80% of the pressure field group received no intravenous fluid during cardiac surgery, and the average intraoperative fluid load was 115 mL.

Conclusion
The pressure field method appears to reduce transfusion requirements due to decreased intraoperative fluid loading.
27 years of experience with the Fontan procedure: characteristics and clinical outcomes of children in a tertiary referral hospital
Authors: Polat Ahmet Bülent , Ertürk Murat , Uzunhan Ozan , Karademir Nur , Öztarhan Kazım 
Published: January 2023

Abstract
Background
The Fontan operation has improved the survival of children born with congenital heart disease with single ventricle physiology. The most widely adopted variations of the Fontan procedure are the extracardiac conduit, the lateral tunnel ve the intra/extracardiac conduit with fenestration. Despite advances in the treatment and prevention of early and late complications that may develop after Fontan surgery, morbidity still remains an important problem.

Methods
304 patients who underwent Fontan surgery in our center between 1995 and 2022 were included in our study. The complications that developed in patients who underwent primary Fontan or lateral tunnel surgery and extracardiac conduit Fontan application were compared.

Results
Classic Fontan surgery and lateral tunnel surgery were performed in 26 of the patients, and extracardiac Fontan surgery was performed in 278 patients. 218 of 304 cases were patients with single ventricular pathology. 86 cases were patients with two ventricular morphologies but complex cardiac pathology. Fenestration was performed in only 6 patients, other patients did not require fenestration. The mean follow-up period of our patients was 12 years (3 months–27 years). When the complications between Fontan procedures were compared in our study, it was found that the length of hospital stay and mortality were statistically significantly reduced in patients who underwent extracardiac Fontan surgery. There was no significant difference in terms of complications that can be seen after Fontan surgery and the length of stay in the intensive care unit.

Conclusion
Fontan complex is a palliative surgery for children with complex heart disease. Palliative surgical operations aimed at the preparation of the Fontan circulation lead to the preparation of the pulmonary vascular bed and the preservation of ventricular function. The techniques applied in Fontan surgery affect the early and long-term complications and the survival of the patients. In our study, when we examined the patients who extracardiac conduit Fontan procedure for the non-cardiac route, we found that mortality and morbidity were minimal.
Cell-type-specific translational control of spatial working memory by the cap-binding protein 4EHP
Authors: Wiebe Shane , Huang Ziying , Ladak Reese Jalal , Skalecka Agnieszka , Cagnetta Roberta , Lacaille Jean-Claude , Aguilar-Valles Argel , Sonenberg Nahum 
Published: January 2023

AbstractThe consolidation of learned information into long-lasting memories requires the strengthening of synaptic connections through de novo protein synthesis. Translation initiation factors play a cardinal role in gating the production of new proteins thereby regulating memory formation. Both positive and negative regulators of translation play a critical role in learning and memory consolidation. The eukaryotic initiation factor 4E (eIF4E) homologous protein (4EHP, encoded by the gene Eif4e2) is a pivotal negative regulator of translation but its role in learning and memory is unknown. To address this gap in knowledge, we generated excitatory (glutamatergic: CaMKIIα-positive) and inhibitory (GABAergic: GAD65-positive) conditional knockout mice for 4EHP, which were analyzed in various behavioral memory tasks. Knockout of 4EHP in Camk2a-expressing neurons (4EHP-cKOexc) did not impact long-term memory in either contextual fear conditioning or Morris water maze tasks. Similarly, long-term contextual fear memory was not altered in Gad2-directed 4EHP knockout mice (4EHP-cKOinh). However, when subjected to a short-term T-maze working memory task, both mouse models exhibited impaired cognition. We therefore tested the hypothesis that de novo protein synthesis plays a direct role in working memory. We discovered that phosphorylation of ribosomal protein S6, a measure of mTORC1 activity, is dramatically reduced in the CA1 hippocampus of 4EHP-cKOexc mice. Consistently, genetic reduction of mTORC1 activity in either excitatory or inhibitory neurons was sufficient to impair working memory. Taken together, these findings indicate that translational control by 4EHP and mTORC1 in both excitatory and inhibitory neurons are necessary for working memory.
Faecal metabarcoding provides improved detection and taxonomic resolution for non-invasive monitoring of gastrointestinal nematode parasites in wild moose populations
Authors: Davey Marie L. , Kamenova Stefaniya , Fossøy Frode , Solberg Erling J. , Davidson Rebecca , Mysterud Atle , Rolandsen Christer M. 
Published: January 2023

Abstract
Background
Although wild ungulate populations are heavily monitored throughout Europe, we understand little of how parasites affect population dynamics, and there is no systematic, long-term monitoring of parasite diversity and parasite loads. Such monitoring is in part hampered by a lack of time- and cost-effective assay methodologies with high sensitivity and good taxonomic resolution. DNA metabarcoding has been successfully used to characterize the parasitic nemabiome with high taxonomic resolution in a variety of wild and domestic hosts. However, in order to implement this technique in large-scale, potentially non-invasive monitoring of gastrointestinal parasitic nematodes (GIN), protocol optimization is required to maximize biodiversity detection, whilst maintaining time- and cost-effectiveness.

Methods
Faecal samples were collected from a wild moose population and GIN communities were characterized and quantified using both parasitological techniques (egg and larva counting) and DNA metabarcoding of the ITS2 region of rDNA. Three different isolation methods were compared that differed in the volume of starting material and cell lysis method.

Results
Similar nematode faunas were recovered from all samples using both parasitological and metabarcoding methods, and the approaches were largely congruent. However, metabarcoding assays showed better taxonomic resolution and slightly higher sensitivity than egg and larvae counts. The metabarcoding was not strictly quantitative, but the proportion of target nematode sequences recovered was correlated with the parasitologically determined parasite load. Species detection rates in the metabarcoding assays were maximized using a DNA isolation method that included mechanical cell disruption and maximized the starting material volume.

Conclusions
DNA metabarcoding is a promising technique for the non-invasive, large-scale monitoring of parasitic GINs in wild ungulate populations, owing to its high taxonomic resolution, increased assay sensitivity, and time- and cost-effectiveness. Although metabarcoding is not a strictly quantitative method, it may nonetheless be possible to create a management- and conservation-relevant index for the host parasite load from this data. To optimize the detection rates and time- and cost-effectiveness of metabarcoding assays, we recommend choosing a DNA isolation method that involves mechanical cell disruption and maximizes the starting material volume.

Graphical Abstract
Adverse cardiovascular, limb, and renal outcomes in patients with diabetes after peripheral artery disease revascularization treated with sodium glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors
Authors: Lee Hsin-Fu , Chuang Chi , Li Pei-Ru , Yeh Yung-Hsin , Chan Yi-Hsin , See Lai-Chu 
Published: January 2023

Abstract
Aims
The effectiveness and limb safety of sodium glucose co-transporter 2 inhibitors (SGLT2i) for patients with type-2 diabetes (T2D) who have received peripheral artery disease (PAD) revascularization are unknown.

Methods and results
In this nationwide retrospective cohort study, we identified a total of 2,455 and 8,695 patients with T2D who had undergone PAD revascularization and received first prescriptions for SGLT2i and dipeptidyl peptidase-4 inhibitors (DPP4i), respectively, between May 1, 2016, and December 31, 2019. We used 1:1 propensity score matching (PSM) to balance covariates between the two study groups. Patients were followed up from the drug index date until the occurrence of specified outcomes, death, discontinuation of the index drug, or the end of the study period, whichever occurred first. After PSM, we observed that compared with DPP4i, SGLT2i were associated with comparable risks of ischemic stroke, acute myocardial infarction, and heart failure hospitalization but were associated with a lower risk of cardiac death (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.40–0.90]; p = 0.0126). Regarding major limb outcomes, SGLT2i were associated with comparable risks of repeated revascularization and lower limb amputation compared with DPP4i. SGLT2i were associated with a lower risk of composite renal outcomes (HR: 0.40; 95% CI: 0.27–0.59; p < 0.0001) compared with DPP4i.

Conclusion
In a real-world study of patients with T2D who had undergone PAD revascularization, SGLT2i were associated with lower risks of cardiac death and composite renal outcomes but not associated with increased risks of adverse limb events compared with DPP4i.
New algorithms demonstrate untargeted detection of chemically meaningful changing units and formula assignment for HRMS data of polymeric mixtures in the open-source constellation web application
Authors: Letourneau Dane R. , August Dennis D. , Volmer Dietrich A. 
Published: January 2023

AbstractThe field of high-resolution mass spectrometry (HRMS) and ancillary hyphenated techniques comprise a rapidly expanding and evolving area. As popularity of HRMS instruments grows, there is a concurrent need for tools and solutions to simplify and automate the processing of the large and complex datasets that result from these analyses. Constellation is one such of these tools, developed by our group over the last two years to perform unsupervised trend detection for repeating, polymeric units in HRMS data of complex mixtures such as natural organic matter, oil, or lignin. In this work, we develop two new unsupervised algorithms for finding chemically-meaningful changing units in HRMS data, and incorporate a molecular-formula-finding algorithm from the open-source CoreMS software package, both demonstrated here in the Constellation software environment. These algorithms are evaluated on a collection of open-source HRMS datasets containing polymeric analytes (PEG 400 and NIST standard reference material 1950, both metabolites in human plasma, as well as a swab extract containing polymers), and are able to successfully identify all known changing units in the data, including assigning the correct formulas. Through these new developments, we are excited to add to a growing body of open-source software specialized in extracting useful information from complex datasets without the high costs, technical knowledge, and processor-demand typically associated with such tools.