bluuebunny/crossref_metadata_2025_split huggingface dataset:
Design, implementation, and management of an international medical device registry
Authors: Mauch Herbert , Kaur Jasmin , Irwin Colin , Wyss Josie 
Published: November 2021

Abstract
Background
Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success.

Methods
We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants.

Results
We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries.

Conclusions
Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine.

Trial registration
ClinicalTrials.gov NCT02004353. 9th December 2013.
Salt stress improves thermotolerance and high-temperature bioethanol production of multi-stress-tolerant Pichia kudriavzevii by stimulating intracellular metabolism and inhibiting oxidative damage
Authors: Li Chunsheng , Liu Qiuying , Wang Yueqi , Yang Xianqing , Chen Shengjun , Zhao Yongqiang , Wu Yanyan , Li Laihao 
Published: November 2021

Abstract
Background
High-temperature bioethanol production benefits from yeast thermotolerance. Salt stress could induce obvious cross-protection against heat stress of Pichia kudriavzevii, contributing to the improvement of its thermotolerance and bioethanol fermentation. However, the underlying mechanisms of the cross-protection remain poorly understood.

Results
Salt stress showed obvious cross-protection for thermotolerance and high-temperature ethanol production of P. kudriavzevii observed by biomass, cell morphology and bioethanol production capacity. The biomass and ethanol production of P. kudriavzevii at 45 °C were, respectively, improved by 2.6 and 3.9 times by 300 mmol/L NaCl. Metabolic network map showed that salt stress obviously improved the key enzymes and intermediates in carbohydrate metabolism, contributing to the synthesis of bioethanol, ATP, amino acids, nucleotides, and unsaturated fatty acids, as well as subsequent intracellular metabolisms. The increasing trehalose, glycerol, HSPs, and ergosterol helped maintain the normal function of cell components. Heat stress induced serious oxidative stress that the ROS-positive cell rate and dead cell rate, respectively, rose from 0.5% and 2.4% to 28.2% and 69.2%, with the incubation temperature increasing from 30 to 45 °C. The heat-induced ROS outburst, oxidative damage, and cell death were obviously inhibited by salt stress, especially the dead cell rate which fell to only 20.3% at 300 mmol/L NaCl. The inhibiting oxidative damage mainly resulted from the abundant synthesis of GSH and GST, which, respectively, increased by 4.8 and 76.1 times after addition of 300 mmol/L NaCl. The improved bioethanol production was not only due to the improved thermotolerance, but resulted from the up-regulated alcohol dehydrogenases and down-regulated aldehyde dehydrogenases by salt stress.

Conclusion
The results provide a first insight into the mechanisms of the improved thermotolerance and high-temperature bioethanol production of P. kudriavzevii by salt stress, and provide important information to construct genetic engineering yeasts for high-temperature bioethanol production.

Graphical Abstract
Directed evolution and secretory expression of xylose isomerase for improved utilisation of xylose in Saccharomyces cerevisiae
Authors: Bae Jung-Hoon , Kim Mi-Jin , Sung Bong Hyun , Jin Yong-Su , Sohn Jung-Hoon 
Published: November 2021

Abstract
Background
Xylose contained in lignocellulosic biomass is an attractive carbon substrate for economically viable conversion to bioethanol. Extensive research has been conducted on xylose fermentation using recombinant Saccharomyces cerevisiae expressing xylose isomerase (XI) and xylose reductase/xylitol dehydrogenase (XR/XDH) pathways along with the introduction of a xylose transporter and amplification of the downstream pathway. However, the low utilization of xylose in the presence of glucose, due to the varying preference for cellular uptake, is a lingering challenge. Studies so far have mainly focused on xylose utilization inside the cells, but there have been little trials on the conversion of xylose to xylulose by cell before uptake. We hypothesized that the extracellular conversion of xylose to xylulose before uptake would facilitate better utilization of xylose even in the presence of glucose. To verify this, XI from Piromyces sp. was engineered and hyper-secreted in S. cerevisiae for the extracellular conversion of xylose to xylulose.

Results
The optimal pH of XI was lowered from 7.0 to 5.0 by directed evolution to ensure its high activity under the acidic conditions used for yeast fermentation, and hyper-secretion of an engineered XI-76 mutant (E56A and I252M) was accomplished by employing target protein-specific translational fusion partners. The purified XI-76 showed twofold higher activity than that of the wild type at pH 5. The secretory expression of XI-76 in the previously developed xylose utilizing yeast strain, SR8 increased xylose consumption and ethanol production by approximately 7–20% and 15–20% in xylose fermentation and glucose and xylose co-fermentation, respectively.

Conclusions
Isomerisation of xylose to xylulose before uptake using extracellular XI was found to be effective in xylose fermentation or glucose/xylose co-fermentation. This suggested that glucose competed less with xylulose than with xylose for uptake by the cell. Consequently, the engineered XI secretion system constructed in this study can pave the way for simultaneous utilization of C5/C6 sugars from the sustainable lignocellulosic biomass.
Self-generated peroxyacetic acid in phosphoric acid plus hydrogen peroxide pretreatment mediated lignocellulose deconstruction and delignification
Authors: Tian Dong , Chen Yiyi , Shen Fei , Luo Maoyuan , Huang Mei , Hu Jinguang , Zhang Yanzong , Deng Shihuai , Zhao Li 
Published: November 2021

Abstract
Background
Peroxyacetic acid involved chemical pretreatment is effective in lignocellulose deconstruction and oxidation. However, these peroxyacetic acid are usually artificially added. Our previous work has shown that the newly developed PHP pretreatment (phosphoric acid plus hydrogen peroxide) is promising in lignocellulose biomass fractionation through an aggressive oxidation process, while the information about the synergistic effect between H3PO4 and H2O2 is quite lack, especially whether some strong oxidant intermediates is existed. In this work, we reported the PHP pretreatment system could self-generate peroxyacetic acid oxidant, which mediated the overall lignocellulose deconstruction, and hemicellulose/lignin degradation.

Results
The PHP pretreatment profile on wheat straw and corn stalk were investigated. The pathways/mechanisms of peroxyacetic acid mediated-PHP pretreatment were elucidated through tracing the structural changes of each component. Results showed that hemicellulose was almost completely solubilized and removed, corresponding to about 87.0% cellulose recovery with high digestibility. Rather high degrees of delignification of 83.5% and 90.0% were achieved for wheat straw and corn stalk, respectively, with the aid of peroxyacetic acid oxidation. A clearly positive correlation was found between the concentration of peroxyacetic acid and the extent of lignocellulose deconstruction. Peroxyacetic acid was mainly self-generated through H2O2 oxidation of acetic acid that was produced from hemicellulose deacetylation and lignin degradation. The self-generated peroxyacetic acid then further contributed to lignocellulose deconstruction and delignification.

Conclusions
The synergistic effect of H3PO4 and H2O2 in the PHP solvent system could efficiently deconstruct wheat straw and corn stalk lignocellulose through an oxidation-mediated process. The main function of H3PO4 was to deconstruct biomass recalcitrance and degrade hemicellulose through acid hydrolysis, while the function of H2O2 was to facilitate the formation of peroxyacetic acid. Peroxyacetic acid with stronger oxidation ability was generated through the reaction between H2O2 and acetic acid, which was released from xylan and lignin oxidation/degradation. This work elucidated the generation and function of peroxyacetic acid in the PHP pretreatment system, and also provide useful information to tailor peroxide-involved pretreatment routes, especially at acidic conditions.

Graphical abstract
Inferior vena cava thrombosis as a possible cause of nephrotic-range proteinuria: two case reports
Authors: Apostolova Yana , Mehier Patricia , Qanadli Salah D. , Pruijm Menno 
Published: November 2021

Abstract
Background
Nephrotic-range proteinuria is a common reason for nephrological consultation in clinical practice. The differential diagnosis is wide, and generally focuses on different forms of glomerulonephritis, but other causes should not be overlooked, as illustrated in this article.

Case presentations
We report two female patients with nephrotic-range proteinuria. In the first case, a 46 year old Caucasian patient who suffered from extreme obesity (Body mass index (BMI) 77 kg/m2), acute kidney injury and nephrotic-range proteinuria were discovered during an emergency consultation for acute abdominal pain. The second patient (aged 52, also Caucasian) developed stage 4 chronic kidney disease and nephrotic proteinuria (protein/creatinine ratio 1821 g/mol) after accidental rupture of the inferior vena cava during a gastric bypass operation. On split-urine collection, both had a much higher degree of proteinuria during the day than during the night, compatible with orthostatic proteinuria. At further work-up, inferior vena cava thrombosis was diagnosed in both patients, whereas renal veins were patent.

Discussion
After simple anticoagulation in the first case, and anticoagulation plus endovascular recanalization in the second, there was almost complete resolution of the orthostatic proteinuria and a strong improvement of the estimated glomerular filtration rate in both patients. These cases highlight that nephrotic-range proteinuria can be linked to inferior vena cava thrombosis, and that a split-urine collection may also be very useful in the diagnostic work-up of proteinuria in adults.
Irreversible electroporation for pancreatic cancer using intraprocedural cone-beam computed tomography fusion navigation: a case report
Authors: Rao Sriram , Bui Thanh-Lan , Sasani Ali , Sadeghi Ben , Macherla Anvesh , Houshyar Roozbeh , Abi-Jaoudeh Nadine 
Published: November 2021

AbstractBackgroundPatients diagnosed with locally advanced pancreatic cancer are usually not eligible for surgical resection because of significant vascular involvement. Stereotactic body radiation therapy and chemotherapy are the treatments recommended by the National Comprehensive Cancer Network criteria. For patients who do not respond to or tolerate stereotactic body radiation therapy and/or chemotherapy, a new option is irreversible electroporation. Irreversible electroporation is a nonthermal minimally invasive ablation technique that uses electrical pulses to induce apoptosis of tumor cells without damage to the extracellular matrix, thus preserving ducts and vessels. Irreversible electroporation requires very precise needle placement, which has limited its ubiquitous use. Intraprocedural cone-beam computed tomography with navigation can be fused with previous imaging to provide real-time tumor navigation capabilities during the procedure to allow for more accurate needle placement and treatment. Here, we present a patient who underwent percutaneous irreversible electroporation with intraprocedural cone-beam computed tomography fusion guidance to treat his pancreatic cancer.Case presentationThe patient, an 88-year-old White male, initially presented with abdominal pain, and was ultimately diagnosed with locally advanced pancreatic cancer. He has an excellent performance status and no other comorbidities. He was started on chemotherapy and radiation therapy, with good response. However, continued vascular involvement of the tumors precluded him from safe surgical resection. The patient underwent irreversible electroporation with intraprocedural cone-beam computed tomography fusion navigation. The primary lesion demonstrates no residual tumor, and the soft tissue involvement of the adjacent vasculature has stabilized.ConclusionsAlthough not curative on its own, irreversible electroporation holds promise as a treatment option for patients with locally advanced pancreatic cancer to increase downsizing to curative surgery or increase quality of life. Cone-beam computed tomography navigation can improve irreversible electroporation by providing guidance during needle guidance. Image fusion with previous advanced imaging can improve lesion visualization and targeting, thereby improving the effectiveness of irreversible electroporation.
New Delhi metallo-β-lactamase-1 among Escherichia coli strains isolated from leukemia patients in Iran: two case reports
Authors: Roshani Mahdane , Goodarzi Alireza , Dehbashi Sanaz , Afrasiabi Farhad , Goudarzi Hossein , Hashemi Ali , Arabestani Mohammad Reza 
Published: November 2021

Abstract
Background
Escherichia coli has appeared as an important opportunistic pathogen responsible for nosocomial infections in patients with immunodeficiency, particularly in leukemia patients. New Delhi metallo-beta-lactamase is an enzyme originally found in Enterobacteriaceae.

Case presentation
In this study, 80 isolates of Escherichia coli and Klebsiella pneumoniae were collected over the course of 2 years from two medical centers in Tehran, Iran. Production of carbapenemase was detected in the isolates using modified Hodge test. New Delhi metallo-beta-lactamase-1 genes were detected by polymerase chain reaction amplification with specific primers. Two New Delhi metallo-beta-lactamase-1-producing Escherichia coli strains were isolated from two Iranian patients with leukemia. These two patients were 6 and 15 years old, one female and the other male, from two oncology centers in Iran. The isolates were resistant to carbapenems (imipenem, meropenem), and two isolates were positive for carbapenemase production by modified Hodge test.

Conclusions
The emergence of New Delhi metallo-beta-lactamase-1-producing Escherichia coli is a threat for leukemia patients in oncology and hematology departments. We conclude that the incidence of multidrug resistant pathogens has increased among patients with leukemia and is life threatening.
Comparison of test performance on paper-based testing (PBT) and computer-based testing (CBT) by English-majored undergraduate students in China
Authors: Yu Wenjing , Iwashita Noriko 
Published: November 2021

AbstractComputer-based testing (CBT), which refers to delivering assessments with computers, has been widely used in large English proficiency tests worldwide. Despite an increasing CBT in China, limited research is available concerning whether CBT can be used for the Test for English Majors-Band 4 (TEM 4). The current study investigated whether testing mode impacted TEM 4 score and factors (i.e., computer familiarity level and attitude towards CBT) that might correlate with performance on CBT of TEM 4. Overall 92 Chinese undergraduate students were randomly assigned to one of the groups, i.e., CBT or paper-based testing (PBT), and took the test. A mixed method was employed, including (1) quantitative and qualitative analysis of test performance in two modes, as well as CBT group participants’ computer familiarity and attitudes towards the mode; and (2) thematic analysis of semi-structured interviews. The results revealed that (1) test scores in CBT and PBT were comparable; (2) two items in the computer familiarity questionnaire, i.e., comfort level of reading articles on the computer and forgetting time when using computers, positively correlated with CBT scores; and (3) participants’ attitude towards CBT did not impact test performance.
The effect of biodynamic preparations on growth and fruit quality of giant pumpkin (Cucurbita maxima D.)
Authors: Juknevičienė Edita , Danilčenko Honorata , Jarienė Elvyra , Živatkauskienė Vilma , Zeise Johanna , Fritz Jürgen 
Published: November 2021

Abstract
Background
Food quality of agricultural crops depends on environmental conditions, production system and cultivation method. A plant-based nutrition with food rich in vitamins, minerals and secondary plant compounds with antioxidative properties promotes human health. This investigation was inspired by an increasing global issue on how to improve product quality while using alternative preparations. The main aim of a 3-year study was to investigate the influence of fermented manure and silica products on yield and nutritive components in peel, fruit and seeds of three pumpkin cultivars. In four replicates as block design, the effects of individually as well as combined application of biodynamic horn manure and horn silica preparation were compared to a control variant.

Results
Horn manure application significantly increased total and marketable yield. Marketable yield, contents of macroelements, total carotenoids, single carotenoids (lutein + zeaxanthin, lycopene, ß-carotene) and antioxidants (catechins, total phenols, leuco-anthocyanins) were significantly increased by horn silica use. The combination of both biodynamic preparations had a significantly increasing effect on total and marketable yield, net photosynthetic productivity, dry matter content and total and single carotenoid contents (lutein + zeaxanthin, lycopene, ß-carotene).

Conclusions
The pumpkin trial results indicated a general growth-promoting effect by horn manure, a quality-enhancing effect by horn silica and a compensatory effect through both preparations on a high qualitative level. In accordance with other investigations, these effects did not occur in the same way in all plant species. Therefore, the effects of the biodynamic preparations should be tested in further trials on a plant species-specific basis.

Graphic abstract
Patient advocacy group involvement in health technology assessments: an observational study
Authors: Single Ann , Cabrera Ariana , Fifer Simon , Tsai Jane , Paik Jin-Young , Hope Philip 
Published: November 2021

Abstract
Background
In some jurisdictions, patients and patient groups may be invited to provide input when Health Technology Assessment (HTA) is used to inform decisions about which medicines should be subsidised or funded. This input can help frame the evidence from a patient perspective, address uncertainties in the evidence and interpret it for the local setting. However, there is currently no evidence linking patient involvement with positive reimbursement decisions.

Aim
We aimed to understand the expectations of patient involvement in the reimbursement process, especially among cancer patient advocacy groups (PAGs) in New Zealand (Aotearoa), South Korea and Taiwan.

Methods
We developed an online survey to help understand the role that cancer PAGs play in reimbursement processes and identify knowledge gaps about the processes that might impact the efforts of PAGs. The survey elicited the views of staff and patients affiliated with PAGs (n = 43) on current practices and how the assessment and reimbursement of new cancer drugs might be improved.

Results
There was variability in knowledge of the HTA assessment processes and in experience of being involved in them. Those with HTA experience were more likely to have confidence in the process. Those who had not been involved tended to have little awareness of, or frustration with, decision-making processes. Most identified cost, finances and economic assessments as key considerations in current processes. Some respondents had clear ideas about how their knowledge and involvement could improve processes to determine the value of new medicines. However, for many, a lack of information about the basis for decision making and opportunities to be involved was a barrier to identifying process improvement.

Conclusions
HTA is implemented primarily in countries seeking to have fair and equitable processes for funding medicines. PAGs often recognise the financial challenges of funding new medicines and share the desire for procedural fairness. The connection PAGs make between patient involvement and improved access to new medicines may be based on the belief they can add information to the evidence base, help solve problems, ensure fairness through transparency and/or influence the culture towards increased access to medicines they value.
Systematic review of clinical evidence on postoperative delirium: literature search of original studies based on validated diagnostic scales
Authors: Bilotta F. , Russo G. , Verrengia M. , Sportelli A. , Foti L. , Villa G. , Romagnoli S. 
Published: November 2021

Abstract
Background
Postoperative delirium is a serious complication that can occur within the 5th postoperative day. In 2017, the European Society of Anesthesiologists delivered dedicated guidelines that reported the need for routine monitoring using validated scales.

Objective
Aim of this systematic review is to identify clinical studies related to postoperative delirium that included postoperative monitoring with validated scales.

Design
Systematic review

Methods
Searched keywords included the following terms: postoperative, postsurgical, post anesthesia, anesthesia recovery, delirium, and confusion. Two researchers independently screened retrieved studies using a data extraction form.

Results
Literature search led to retrieve 6475 hits; of these, 260 studies (5.6% of the retrieved), published between 1987 and 2021, included in their methods a diagnostic workup with the use of a postoperative delirium validated scale and monitored patients for more than 24 h, therefore are qualified to be included in the present systematic review.

Conclusion
In conclusion, available clinical literature on postoperative delirium relies on a limited number of studies, that included a validated diagnostic workup based on validated scales, extracted from a large series of studies that used inconsistent diagnostic criteria. In order to extract indications based on reliable evidence-based criteria, these are the studies that should be selectively considered. The analysis of these studies can also serve to design future projects and to test clinical hypothesis with a more standardized methodological approach.