bluuebunny/crossref_metadata_2025_split huggingface dataset:
Economic evaluation of supplementing the diet with Souvenaid in patients with prodromal Alzheimer’s disease
Authors: Mar Javier , Gorostiza Ania , Ibarrondo Oliver , Larrañaga Igor , Arrospide Arantzazu , Martinez-Lage Pablo , Soto-Gordoa Myriam 
Published: December 2020

Abstract
Background
The LipiDiDiet trial showed that Souvenaid, a medical food, might delay progression to dementia in prodromal Alzheimer’s disease (AD). The objective of this study was to assess the cost-utility of Souvenaid compared to placebo in patients with prodromal AD under the conditions applied in that trial.

Methods
A discrete event simulation model was developed based on the LipiDiDiet trial and a literature review to assess the cost-utility of Souvenaid from a societal perspective considering direct and indirect costs. For both intervention and control groups, patient trajectories in terms of functional decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale in LipiDiDiet were reproduced statistically with mixed models by assigning time until events to simulated patients. From the societal perspective, four scenarios were analysed by combining different options for treatment duration and diagnostic test cost. Univariate sensitivity analysis assessed parameter uncertainties.

Results
Validation results at year 2 of disease progression fit with CDR-SB progression in LipiDiDiet. The incremental cost-utility ratio (ICUR) in the baseline case was €22,743/quality-adjusted life year (QALY). All scenarios rendered an ICUR lower than €25,000/QALY (the societal threshold). Moreover, the treatment option was cost-saving and increased health benefits when diagnostic costs were not considered and treatment was only administered during the prodromal stage.

Conclusions
Treating prodromal AD with Souvenaid is a cost-effective intervention in all scenarios analysed. The LipiDiDiet trial showed a modest improvement in disease course but as the social costs of AD are very high, the intervention was efficient. Assessing small benefits at specific stages of AD is relevant because it is reasonable to expect that no effective, safe and affordable disease-modifying therapies will become available in the short to medium term.
Hypoxia-preconditioned adipose-derived stem cells combined with scaffold promote urethral reconstruction by upregulation of angiogenesis and glycolysis
Authors: Wan Xiang , Xie Min-kai , Xu Huan , Wei Zi-wei , Yao Hai-jun , Wang Zhong , Zheng Da-chao 
Published: December 2020

Abstract
Rationale
Tissue engineering is a promising alternative for urethral reconstruction, and adipose-derived stem cells (ADSCs) are widely used as seeding cells. Hypoxia preconditioning can significantly enhance the therapeutic effects of ADSCs. The low oxygen tension of postoperative wound healing is inevitable and may facilitate the nutritional function of ADSCs. This study aimed to investigate if hypoxia-preconditioned ADSCs, compared to normoxia-preconditioned ADSCs, combined with scaffold could better promote urethral reconstruction and exploring the underlying mechanism.

Methods
In vitro, paracrine cytokines and secretomes that were secreted by hypoxia- or normoxia-preconditioned ADSCs were added to cultures of human umbilical vein endothelial cells (HUVECs) to measure their functions. In vivo, hypoxia- or normoxia-preconditioned ADSCs were seeded on a porous nanofibrous scaffold for urethral repair on a defect model in rabbits.

Results
The in vitro results showed that hypoxia could enhance the secretion of VEGFA by ADSCs, and hypoxia-preconditioned ADSCs could enhance the viability, proliferation, migration, angiogenesis, and glycolysis of HUVECs (p < 0.05). After silencing VEGFA, angiogenesis and glycolysis were significantly inhibited (p < 0.05). The in vivo results showed that compared to normoxia-preconditioned ADSCs, hypoxia-preconditioned ADSCs combined with scaffolds led to a larger urethral lumen diameter, preserved urethral morphology, and enhanced angiogenesis (p < 0.05).

Conclusions
Hypoxia preconditioning of ADSCs combined with scaffold could better promote urethral reconstruction by upregulating angiogenesis and glycolysis. Hypoxia-preconditioned ADSCs combined with novel scaffold may provide a promising alternative treatment for urethral reconstruction.
RETRACTED ARTICLE: The majority of conversion
total hip arthroplasties can be considered a primary replacement: a matched cohort
study
Authors: Aharram Soufiane , Yahyaoui Mounir , Amghar Jawad , Daoudi Abdelkarim , Agoumi Omar 
Published: December 2020

Abstract
Background and study aims
The success of conversion total hip arthroplasty (THA) among primary THA
and revision THA remains unclear. We hypothesized that most conversion THA’s can be
performed using primary implants and will have an uncomplicated post-operative
course.

Materials and methods
Thirty-six patients (23 females, mean age 68,0y) who underwent
conversion THA for failed interventions for proximal femur fractures in the period
2008–2018 were matched sequentially against patients of the same sex and age who
underwent primary THA or revision THA. Data were collected on implants used, major
complications, and mortality. PROMs used included the Western Ontario and McMaster
Osteoarthritis Index, Harris Hip Score, Visual Analogue Scale and the EQ-5D Health
Questionnaire.

Results
Seventy-two percent of patients who underwent conversion THA were
treated with primary implants and never suffered from a major complication. PROMs
were excellent for this group of patients. The distinction
primary/conversion/revision THA could not explain differences in outcomes; however,
the necessity of using revision implants and the development of major complications
could.

Conclusions
The majority of conversion total hip arthroplasties can be considered a
primary replacement. Predicting outcomes for THA should focus on patient frailty and
technical difficulties dealing with infection, stability and loss of bone stock and
should discard the conversion versus revision terminology.
LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method
Authors: Pokar Dhruvisha , Sahu Amit Kumar , Sengupta Pinaki 
Published: December 2020

AbstractVenetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies. Postmarketing surveillance of any drug depends on its acceptability based on risk to benefit ratio. When risk outweighs the benefits, withdrawal of an already marketed drug is warranted. Presence of impurity is the primary cause of increased risk in a drug substance or drug product. With the discovery of newer molecules, it is of great importance to establish advanced analytical techniques for quantification of the drugs as well as their related impurities to address the prospective regulatory queries even if it is already in the market. In this study, a quantitative analytical assay method has been developed and validated for quantification of venetoclax in presence of its degradation impurities. A stress study was performed to examine the stability of the drug in hydrolytic, oxidative, thermolytic and photolytic environments. Venetoclax was found to be prone to degradation in acidic hydrolytic and oxidative stress conditions. Three new degradation impurities have been identified and characterized with the help of LC-Q-TOF-MS with accurate mass measurement and their putative structures have been proposed. Furthermore, for the first time, a possible degradation pathway has been established with mechanistic explanation. Moreover, the analytical method developed in this study will be of immense help for routine analysis of quality control and stability study samples of venetoclax in industry and research laboratories.
Gravimetric geoid modeling from the combination of satellite gravity model, terrestrial and airborne gravity data: a case study in the mountainous area, Colorado
Authors: Jiang Tao , Dang Yamin , Zhang Chuanyin 
Published: December 2020

AbstractConstructing a high-precision and high-resolution gravimetric geoid model in the mountainous area is a quite challenging task because of the lack of terrestrial gravity observations, rough topography and the geological complexity. One way out is to use high-quality and well-distributed satellite and airborne gravity data to fill the gravity data gaps; thus, the proper combination of heterogeneous gravity datasets is critical. In a rough topographic area in Colorado, we computed a set of gravimetric geoid models based on different combination modes of satellite gravity models, terrestrial and airborne gravity data using the spectral combination method. The gravimetric geoid model obtained from the combination of satellite gravity model GOCO06S and terrestrial gravity data agrees with the GPS leveling measured geoid heights at 194 benchmarks in 5.8 cm in terms of the standard deviation of discrepancies, and the standard deviation reduces to 5.3 cm after including the GRAV-D airborne gravity data collected at ~ 6.2 km altitude into the data combination. The contributions of airborne gravity data to the signal and accuracy improvements of the geoid models were quantified for different spatial distribution and density of terrestrial gravity data. The results demonstrate that, although the airborne gravity survey was flown at a high altitude, the additions of airborne gravity data improved the accuracies of geoid models by 13.4%–19.8% in the mountainous area (elevations > 2000 m) and 12.7%–21% (elevations < 2000 m) in the moderate area in the cases of terrestrial gravity data spacings are larger than 15 km.
Development and validation of a CT-texture analysis nomogram for preoperatively differentiating thymic epithelial tumor histologic subtypes
Authors: Ren Caiyue , Li Mingli , Zhang Yunyan , Zhang Shengjian 
Published: December 2020

AbstractBackgroundThymic epithelial tumors (TETs) are the most common primary tumors in the anterior mediastinum, which have considerable histologic heterogeneity. This study aimed to develop and validate a nomogram based on computed tomography (CT) and texture analysis (TA) for preoperatively predicting the pathological classifications for TET patients.MethodsTotally TET 172 patients confirmed by postoperative pathology between January 2011 to April 2019 were retrospectively analyzed and randomly divided into training (n = 120) and validation (n = 52) cohorts. Preoperative clinical factors, CT signs and texture features of each patient were analyzed, and prediction models were developed using the least absolute shrinkage and selection operator (LASSO) regression. The performance of the models was evaluated and compared by the area under receiver-operator characteristic (ROC) curve (AUC) and the DeLong test. The clinical application value of the models was determined via the decision curve analysis (DCA). Then, a nomogram was developed based on the model with the best predictive efficiency and clinical utility and validated using the calibration plots.ResultsTotally 87 patients with low-risk TET (LTET) (types A, AB, B1) and 85 patients with high-risk TET (HTET) (types B2, B3, C) were enrolled in this study. We separately constructed 4 prediction models for differentiating LTET from HTET using clinical, CT, texture features, and their combination. These 4 prediction models achieved AUCs of 0.66, 0.79, 0.82, 0.88 in the training cohort and 0.64, 0.82, 0.86, 0.94 in the validation cohort, respectively. The DeLong test and DCA showed that the Combined model, consisting of 2 CT signs and 2 texture parameters, held the highest predictive efficiency and clinical utility (p < 0.05). A prediction nomogram was subsequently developed using the 4 independently risk factors from the Combined model. The calibration curves indicated a good consistency between the actual observations and nomogram predictions for differentiating TET classifications.ConclusionA prediction nomogram incorporating both the CT and texture parameters was constructed and validated in our study, which can be conveniently used for the preoperative individualized prediction of the simplified histologic subtypes in TET patients.
Agitation, confusion, and aggression in critically ill traumatic brain injury-a pilot cohort study (ACACIA-PILOT)
Authors:   for the Canadian Critical Care Trials Group, Williamson David R. , Cherifa Sofia Ihsenne , Frenette Anne Julie , Saavedra Mitjans Mar , Charbonney Emmanuel , Cataford Gabrielle , Williams Virginie , Lainer Palacios Julia , Burry Lisa , Mehta Sangeeta , Arbour Caroline , Bernard Francis 
Published: December 2020

Abstract
Background
Agitated behaviors are problematic in intensive care unit (ICU) patients recovering from traumatic brain injury (TBI) as they create substantial risks and challenges for healthcare providers. To date, there have been no studies evaluating their epidemiology and impact in the ICU. Prior to planning a multicenter study, assessment of recruitment, feasibility, and pilot study procedures is needed. In this pilot study, we aimed to evaluate the feasibility of conducting a large multicenter prospective cohort study.

Methods
This feasibility study recruited adult patients admitted to the ICU with TBI and an abnormal cerebral CT scan. In all patients, we documented Richmond Agitation Sedation Score (RASS) and agitated behaviors every 8-h nursing shift using a dedicated tool documenting 14 behaviors. Our feasibility objectives were to obtain consent from at least 2 patients per month; completion of screening logs for agitated behaviors by bedside nurses for more than 90% of 8-h shifts; completion of data collection in an average of 6 h or less; and obtain 6-month follow-up for surviving patients. The main clinical outcome was the incidence of agitation and individual agitated behaviors.

Results
In total, 47 eligible patients were approached for inclusion and 30 (64% consent rate) were recruited over a 10-month period (3 patients/month). In total, 794 out of 827 (96%) possible 8-h periods of agitated behavior logs were completed by bedside nurses, with a median of 24 observations (IQR 28.0) per patient. During the ICU stay, 17 of 30 patients developed agitation (56.7%; 95% CI 0.37–0.75) defined as RASS ≥ 2 during at least one observation period and for a median of 4 days (IQR 5.5). At 6 months post-TBI, among the 24 available patients, an unfavorable score (GOS-E < 5 including death) was reported in 12 patients (50%). In the 14 patients who were alive and available at 6 months, the median QOLIBRI score was 74.5 (IQR 18.5).

Conclusions
This study demonstrates the feasibility of conducting a larger cohort study to evaluate the epidemiology and impact of agitated behaviors in critically ill TBI patients. This study also shows that agitated behaviors are frequent and are associated with adverse events.
The child refugee in Calais: from invisibility to the ‘suspect figure’
Authors: Ibrahim Yasmin 
Published: December 2020

AbstractThis paper examines child refugees in the context of Calais in France, contextualizing them against the politics of the ‘Jungle’ (a makeshift camp) in policy and media discourses in the UK by delineating three distinct phases in the discursive production of these sites in the enactment of this ambiguous entity. These three phases trace the spatio-temporal emergence of the child refugee in the camps to their arrival in the UK. These camps, as transient and symbolic formations inhabited by the ‘dispossessed’ of forced global migration, provide a context in which the figure of the child is enacted from its incidental appearance to its visible manifestation to its final configuration as the ‘suspect figure’ in the UK. Through Derridean ‘hauntology’ of absent presence, the child refugee captures the conflicted morality of the West. As a disenfranchised entity, the child, forged through the turbulence of the Jungle, can be collapsed through the primal and deprived of his or her status as a child (and, in tandem, protection from harm) in public discourses. The child positioned as a ‘suspect figure’ becomes a spectral reflection of the beleaguered West, wrestling with the ideational image of the child and its recurrence as a threat to its moral reserve.
Survey study of research integrity officers’ perceptions of research practices associated with instances of research misconduct
Authors: Kalichman Michael 
Published: December 2020

Abstract
Background
Research on research integrity has tended to focus on frequency of research misconduct and factors that might induce someone to commit research misconduct. A definitive answer to the first question has been elusive, but it remains clear that any research misconduct is too much. Answers to the second question are so diverse, it might be productive to ask a different question: What about how research is done allows research misconduct to occur?

Methods
With that question in mind, research integrity officers (RIOs) of the 62 members of the American Association of Universities were invited to complete a brief survey about their most recent instance of a finding of research misconduct. Respondents were asked whether one or more good practices of research (e.g., openness and transparency, keeping good research records) were present in their case of research misconduct.

Results
Twenty-four (24) of the respondents (39% response rate) indicated they had dealt with at least one finding of research misconduct and answered the survey questions. Over half of these RIOs reported that their case of research misconduct had occurred in an environment in which at least nine of the ten listed good practices of research were deficient.

Conclusions
These results are not evidence for a causal effect of poor practices, but it is arguable that committing research misconduct would be more difficult if not impossible in research environments adhering to good practices of research.
Adsorbed leucaena protein on citrate modified Fe3O4 nanoparticles: synthesis, characterization, and its application as magnetic coagulant
Authors: Kristianto Hans , Reynaldi Edwin , Prasetyo Susiana , Sugih Asaf K. 
Published: December 2020

AbstractNatural coagulants from plants resources have gained a lot of attention as it is renewable, biodegradable, non-hazardous, lower cost, and less sludge generated compared to chemical coagulants. However there are still some drawbacks, namely long settling time and possible increase of dissolved organic carbon in the treated water. In this paper we tried to address these drawbacks by utilizing citrate modified Fe3O4 to adsorb protein from Leucaena leucocephala as the active coagulating agent. The effect of trisodium citrate concentration and protein adsorption pH to the adsorbed protein was investigated. It was found that the trisodium citrate concentration of 0.5 M and pH 4.0 gave the highest protein adsorption. The obtained magnetic coagulant was furthermore characterized using Scanning Electron Microscopy, X-ray Diffraction, Fourier Transform Infrared Spectroscopy, and Transmission Electron Microscopy to observe the characteristics before and after protein adsorption. Furthermore, the effect of pH (2 to 10) and coagulant dosage (60 to 600 mg L− 1) to the removal of synthetic Congo red wastewater and sludge volume formation was investigated. It was found that pH 3 was the best pH for coagulation due to charge neutralization mechanism of leucaena protein. Furthermore the highest removal was obtained at dosage 420 mg L− 1 with 80% removal. This result was comparable with crude extract of leucaena with half settling time (20 min) and lower increase of permanganate value, indicating lower increase of dissolved organics in the treated water.
Imaging of endometrial osseous metaplasia—an uncommon but treatable cause of infertility
Authors: Wani Abdul Haseeb , Parry Arshed Hussain , Feroz Imza , Jehangir Majid , Rashid Masarat 
Published: December 2020

Abstract
Background
Endometrial osseous metaplasia (EOM) is an uncommon condition characterised by metaplastic transformation of endometrial tissue into osteoblasts (mature or immature bone in the endometrium). Etiopathogenesis of EOM is explained by multiple putative mechanisms like dystrophic calcification, metaplastic ossification, retained foetal bones after abortions and genito-urinary tuberculosis. EOM has varied clinical presentation ranging from patient being asymptomatic to secondary infertility. Although hysteroscopy is the gold standard for its diagnosis and treatment, non-invasive imaging comprising chiefly of ultrasonography (USG) is increasingly becoming the mainstay of diagnosis. We aim to present the imaging findings in EOM to acquaint radiologists and gynaecologists with this condition to avert misdiagnosis of this uncommon yet treatable cause of infertility.

Results
Mean age of patients was 31.4 ± 5.4 (S.D) years. USG revealed linear or tubular densely echogenic endometrium with posterior acoustic shadowing in all the 14 patients. MRI in 3 patients revealed diffuse or patchy areas of T1W and T2W hypointense signal intensity with unilateral (n = 2) and bilateral (n = 1) ovarian cysts. One patient who underwent CT scan revealed dense endometrial calcification. Histopathologic examination (HPE) revealed lamellar (n = 6) or trabecular (n = 4) bone within endometrium (EOM) and inflammatory cells with calcification in four patients (calcific endometritis). Twelve patients conceived after dilatation and curettage within 15 months.

Conclusion
Familiarity with the imaging appearances of EOM is indispensable to clinch this diagnosis and avert misdiagnosis of this rare but potentially treatable cause of infertility. USG is usually sufficient for diagnosis. MRI and CT are only supplementary tools in difficult clinical scenarios.
A novel stability-indicating method for determination of a new antidepressant effect of vortioxetine in a pharmaceutical formulation by using RP-HPLC
Authors: Tiris Gizem , Alver Cansu , Erk Nevin 
Published: December 2020

Abstract
Background
A novel rapid, accurate, and stability-indicating reversed-phase high performance liquid chromatographic (RP-HPLC) and first derivative spectrophotometric determination were explained for the assay of vortioxetine (VRT) in bulk and pharmaceutical formulations. For RP-HPLC method, optimal separation and determination of VRT were achieved with a Waters Symmetry C18, (100 × 4.6 mm, 3.5 μm) analytical column using a mobile phase consisting of methanol:0.05 M potassium dihydrogen phosphate (pH:3.0 ± 0.05) (30:70, v/v) in isocratic mode with flow rate of 1.3 mL min−1. Injection volume was 20 μL. The maximum absorption wavelength of VRT is 225.0 nm; hence, 225.0 nm was studied as the detection wavelength and column at 50 °C temperature. The caffeine was used as the internal standard (IS). On the other hand, the first derivative spectrophotometric method for the analysis of vortioxetine was performed by measuring the amplitude at 251.7 and 272.6 nm.

Result
The HPLC method was found to be linear in the concentration ranges of 10.0-70.0 μg mL−1 with the coefficient value R2 of 0.9998, and the mean recovery value was 100.7%. Further stability studies were done through exposure of the analyte solutions to various stress conditions: acid, alkali hydrolysis, chemical oxidation, and exposure to UV radiation. For the first derivative spectrophotometric method, linearity was observed in the concentration range 6.0-30.0 μg mL−1 (for 237.7 nm R2 = 0.9999 and for 257.2 nm R2 = 0.9997).

Conclusion
The methods were validated in accordance with ICH guidelines with respect to linearity, accuracy, specificity, limit of detection, precision, and limit of quantification.