bluuebunny/crossref_metadata_2025 huggingface dataset:
Physicochemical Properties of Chromosomes in Live Cells Characterized by Label-Free Imaging and Fluorescence Correlation Spectroscopy
Authors: Kim Tae-Keun , Lee Byong-Wook , Fujii Fumihiko , Lee Kee-Hang , Park YongKeun , Kim Jun Ki , Pack Chan-Gi
Published: January 2019

The cell nucleus is a three-dimensional, dynamic organelle that is organized into many subnuclear bodies, such as chromatin and nucleoli. The structure and function of these bodies is maintained by diffusion and interactions between related factors as well as dynamic and structural changes. Recent studies using fluorescent microscopic techniques suggest that protein factors can access and are freely mobile in mitotic chromosomes, despite their densely packed structure. However, the physicochemical properties of the chromosome itself during cell division are not yet fully understood. Physical parameters, such as the refractive index (RI), volume of the mitotic chromosome, and diffusion coefficients of fluorescent probes inside the chromosome were quantified using an approach combining label-free optical diffraction tomography with complementary confocal laser scanning microscopy and fluorescence correlation spectroscopy. Variance in these parameters correlated among various osmotic conditions, suggesting that changes in RI are consistent with those in the diffusion coefficient for mitotic chromosomes and cytosol. Serial RI tomography images of chromosomes in live cells during mitosis were compared with three-dimensional confocal micrographs to demonstrate that compaction and decompaction of chromosomes induced by osmotic change were characterized by linked changes in chromosome RI, volume, and the mobility of fluorescent proteins.
Effectiveness of a mobile antiretroviral pharmacy and HIV care intervention on the continuum of HIV care in rural Uganda
Authors: Bajunirwe Francis , Ayebazibwe Nicholas , Mulogo Edgar , Eng Maria , McGrath Janet , Kaawa-Mafigiri David , Mugyenyi Peter , Sethi Ajay K.
Published: January 2019

Introduction

Adherence to antiretroviral therapy (ART) is critical in order to achieve viral suppression, one of three UNAIDS targets set for achievement before 2020. One of the main barriers to adherence is the long distance between patient residences and healthcare facilities. We designed an intervention, Mobile Antiretroviral Therapy and HIV care (MAP-HC) in rural southwestern Uganda aimed to reduce travel distance and hypothesized that MAP-HC would improve ART adherence and rates of viral load suppression.

Methods

The study was conducted at two sites, Kitagata and Itojo Hospitals, and these are public health facilities located in rural southwestern Uganda. Patients who lived >5km from the hospital were provided the option to participate. For each hospital, we identified 4 health centres in the catchment area to serve as site for the mobile pharmacy. Each site was visited once a month to provide ART refills, adherence counseling and treatment of other illnesses. We measured patient waiting time, adherence and viral load suppression before and after the intervention.

Results

We conducted baseline assessment among 292 patients at the two hospitals. The mean waiting time at Kitagata Hospital changed from 4.48 hours before the intervention but increased to 4.76 hours after the intervention (p=0.13). The proportion of patients who missed an ART dose in the last 30 days dropped from 20% at baseline to 8.5% at 12 months after the intervention (p=0.009). The proportion of patients with detectable viral load from 19.9% to 7.4% after the intervention (p=0.001).

Conclusions

Our study has showed that a mobile pharmacy intervention in rural Uganda is feasible and resulted in improvement in adherence and viral load suppression. Although it did not reduce patient waiting time at the clinic, we recommend a scale-up of this intervention in rural areas where patients face challenges of transportation to the clinic.
Characteristics of Beta Waveform Shape in Parkinson’s Disease Detected with Scalp Electroencephalography
Authors: Jackson Nicko , Cole Scott R. , Voytek Bradley , Swann Nicole C.
Published: January 2019

Neural activity in the beta frequency range (13-30 Hz) is excessively synchronized in Parkinson’s Disease (PD). Previous work using invasive intracranial recordings and non-invasive scalp electroencephalography (EEG) has shown that correlations between beta phase and broadband gamma amplitude (i.e., phase-amplitude coupling) are elevated in PD, perhaps a reflection of this synchrony. Recently, it has also been shown, in invasive human recordings, that nonsinusoidal features of beta oscillation shape also characterize PD. Here we show that these features of beta waveform shape also distinguish PD patients on and off medication using non-invasive recordings in a dataset of 15 PD patients with resting scalp EEG. Specifically, beta oscillations over sensorimotor electrodes in PD patients off medication had greater sharpness asymmetry and steepness asymmetry than on medication (sign rank, p=0.006, p=0.003 respectively). We also showed that beta oscillations over sensorimotor cortex most often had a canonical shape and that using this prototypical shape as an inclusion criterion increased the effect size of our findings. Together our findings suggest that novel ways of measuring beta synchrony that incorporate waveform shape could improve detection of PD pathophysiology in non-invasive recordings.
Leveraging chromatin accessibility for transcriptional regulatory network inference in T Helper 17 Cells
Authors: Miraldi Emily R. , Pokrovskii Maria , Watters Aaron , Castro Dayanne M. , De Veaux Nicholas , Hall Jason A. , Lee June-Yong , Ciofani Maria , Madar Aviv , Carriero Nick , Littman Dan R. , Bonneau Richard
Published: January 2019

Transcriptional regulatory networks (TRNs) provide insight into cellular behavior by describing interactions between transcription factors (TFs) and their gene targets. The assay for transposase-accessible chromatin (ATAC)–seq, coupled with TF motif analysis, provides indirect evidence of chromatin binding for hundreds of TFs genome-wide. Here, we propose methods for TRN inference in a mammalian setting, using ATAC-seq data to improve gene expression modeling. We test our methods in the context of T Helper Cell Type 17 (Th17) differentiation, generating new ATAC-seq data to complement existing Th17 genomic resources. In this resource-rich mammalian setting, our extensive benchmarking provides quantitative, genome-scale evaluation of TRN inference, combining ATAC-seq and RNA-seq data. We refine and extend our previous Th17 TRN, using our new TRN inference methods to integrate all Th17 data (gene expression, ATAC-seq, TF knockouts, and ChIP-seq). We highlight newly discovered roles for individual TFs and groups of TFs (“TF–TF modules”) in Th17 gene regulation. Given the popularity of ATAC-seq, which provides high-resolution with low sample input requirements, we anticipate that our methods will improve TRN inference in new mammalian systems, especially in vivo, for cells directly from humans and animal models.
Crystal structure of (2-acetylferrocen-1-yl)boronic acid
Authors: Preuss Andrea , Korb Marcus , Lang Heinrich
Published: January 2019

(2-Acetylferrocen-1-yl)boronic acid, [Fe(C5H5)(C7H8BO3)] or 2-C(O)CH3-1-B(OH)2–Fc [Fc = Fe(η5-C5H3)(η5-C5H5)], crystallizes in the centrosymmetric space group P21/n. The boronic acid functionality interacts via intramolecular hydrogen bonds with the acetyl group and with the –B(OH)2 functionality of an adjacent molecule. The resulting centrosymmetric dimer exhibits an anti-positioning of the ferrocenyl moieties towards the central B2O4 plane. Consequently, an (Rp
,Sp
)-, i.e. a meso configuration is present for this dimer. In the crystal, weak C—H...O hydrogen bonds consolidate the molecular packing.
Crystal structure of a host–guest complex between mephedrone hydrochloride and a tetraphosphonate cavitand
Authors: Biavardi Elisa , Massera Chiara
Published: January 2019

A new supramolecular complex (I) between the tetraphosphonate cavitand Tiiii[C3H7,CH3,C6H5] [systematic name: 2,8,14,20-tetrapropyl-5,11,17,23-tetramethyl-6,10:12,16:18,22:24,4-tetrakis(phenylphosphonato-O,O′)resorcin[4]arene] and mephedrone hydrochoride {C11H16NO+·Cl−; systematic name: methyl[1-(4-methylphenyl)-1-oxopropan-2-yl]azanium chloride} has been obtained and characterized both in solution and in the solid state. The complex of general formula (C11H16NO)@Tiiii[C3H7,CH3,C6H5]Cl·CH3OH or C11H16NO+·Cl−·C68H68O12P4·CH3OH, crystallizes in the monoclinic space group P21/c with one lattice methanol molecule per cavitand, disordered over two positions with occupancy factors of 0.665 (6) and 0.335 (6). The mephedrone guest interacts with the P=O groups at the upper rim of the cavitand through two charge-assisted N—H...O hydrogen bonds, while the methyl group directly bound to the amino moiety is stabilized inside the π basic cavity via cation...π interactions. The chloride counter-anion is located between the alkyl legs of the cavitand, forming C—H...Cl interactions with the aromatic and methylenic H atoms of the lower rim. The chloride anion is also responsible for the formation of a supramolecular chain along the b-axis direction through C—H...Cl interactions involving the phenyl substituent of one phosphonate group. C—H...O and C—H...π interactions between the guest and adjacent cavitands contribute to the formation of the crystal structure.
Redetermination of poly[di-μ3-iodido-[μ-1,2-trans-(pyridin-4-yl)ethene-κ2
N:N′]dicopper(I)]
Authors: Neal Henry C. , Tamtam Harsha , Smucker Bradley W. , Nesterov Volodymyr V.
Published: January 2019

The re-investigated structure of the title compound, [Cu2I2(C12H10N2)]
n
, a two-dimensional coordination polymer crystallizing with monoclinic (P21/n) symmetry, is based on data collected at 100 K, while the previously reported structure was obtained with data collected at 203 K [Blake et al. (1999). Cryst. Eng.
2, 181–195]. The refinement of the crystal structure is greatly improved; for example, the wR
2 residual converges to 0.047 for 1532 independent data, versus wR
2 = 0.179 for 992 independent data in the 1999 study.
Use of e-learning at higher educational institutions in Bangladesh
Authors: Sarker Md Fouad Hossain , Mahmud Rafi Al , Islam M. Saiful , Islam Md Kabirul
Published: January 2019

Purpose

Although e-learning has already been accepted globally as an effective medium of delivery of quality education and ensure optimum student participation, Bangladeshi higher educational institutions are still at a very early stage of adopting such technologies. Therefore, the purpose of this paper is to critically examine the suitability of implementing effective e-learning through learning management system (LMS) at the tertiary educational institutions in Bangladesh, and how both students and teachers experience and respond to this new learning platform. Following mixed-methods techniques, data for this study were collected from students and respective course teachers of a private university in Bangladesh by administering questionnaires and in-depth interviews. The findings of this paper reveal that e-learning has been well accepted by most of the students as they are found routinely spending time on the LMS on a regular basis for watching lecture videos, viewing course information, reading postings of the fellow students in the forum. However, there are constraints as well, since the learning materials are poorly designed that do not allow much interaction between students and lecturers. There are also some technical problems such as poor internet connection which restrict access to e-learning platforms. To harness the optimum benefit of e-learning, this paper recommends a concerted effort by all stakeholders, such as students, lecturers, administrators and policy makers so that each of their priorities and expectations are reflected in the designing and implementing e-learning platforms.

Design/methodology/approach

This paper is based on the qualitative evaluation of Education 3.0 platform. Primary data were collected from the students using a well-structured survey questionnaire, and the findings of the survey have subsequently been cross-referred and supplemented by non-participatory observations with semi-structured interviews which allowed a better in-depth understanding of the issue at hand.

Findings

The findings of the study suggest that a majority of the students are found to be highly enthusiastic about the online courses. They are eager to participate and interact in the online platforms, which are somehow limited in the traditional classroom settings. However, there are several institutional, administrative and technical limitations of implementing e-learning in Bangladesh. It is recommended that better orientation of the users, quality content distribution though user-friendly systems and enhanced asynchronous interaction between the lecturers and students are the key pre-requisites to harness the optimum benefit from e-learning technologies in Bangladesh.

Originality/value

The data have been analyzed and discussed using qualitative framework which allows an in-depth understanding of the opportunities and challenges of the use of e-learning technologies at the higher educational institutions in Bangladesh.
Feasibility and initial efficacy of project‐based treatment for people with ABI
Authors: Behn Nicholas , Marshall Jane , Togher Leanne , Cruice Madeline
Published: January 2019

Background

Communication impairments are common and pervasive for people a long time following acquired brain injury (ABI). These impairments have a significant impact on a person's quality of life (QOL) post‐injury. Project‐based treatment is a treatment approach that could have an impact on communication skills and QOL for people with ABI a long‐term post‐injury. This treatment is embedded in a context of meaningful activities chosen by people with ABI, whereby, as a group, they work collaboratively to achieve a tangible end product.

Aims

To evaluate the feasibility and initial efficacy of project‐based treatment on improving the communication skills and QOL for people with ABI.

Methods & Procedures

An exploratory controlled trial with alternate allocation of groups, and follow‐up at 6–8 weeks, was completed. Twenty‐one people with chronic ABI were recruited in groups of two to three from community settings, allocated to either a TREATMENT (n = 11) or WAITLIST group (n = 10). Participants attended a 20‐h group‐based treatment over 6 weeks where they worked towards achieving a project that helped others. To determine feasibility, four criteria were used: demand, implementation, practicality and acceptability. A range of communication and QOL outcomes was used to determine a fifth feasibility criterion, initial efficacy. Some of these criteria were additionally used to evaluate the feasibility of the outcomes.

Outcomes & Results

All participants received the treatment as allocated with high attendance and no dropouts. The treatment was feasible to deliver as intended and was highly acceptable to participants. Medium and large effect sizes were found from pre‐ to post‐treatment, and from pre‐treatment to follow‐up for measures of conversation, perceived communicative ability and QOL.

Conclusions & Implications

Project‐based treatment is feasible with indications of initial efficacy for both communication skills and QOL. The treatment provides a promising new approach for improving communication skills and QOL in people with chronic acquired brain injuries in the community setting.
Rule of Law and Rules‐Lawyering: Legal Corruption and ‘Reprivatization Business’ in Warsaw
Authors: Kusiak Joanna
Published: January 2019

Delving into the nexus between the state and informality, this paper discusses the informality of the legal and judicial systems. Produced by structurally powerful actors, this kind of informality is not so much legitimized by the law, but concealed within the very process of legitimization. To capture how legal engineering welds formalized laws with informal translations, I look at judicial outcomes that, while formally legal, are socially delegitimized and perceived as legal corruption. After analysing the contested judicial outcomes of Warsaw's ‘reprivatization’ process (property restitution), I define the mechanism of legal corruption as rules‐lawyering, by which I mean an attempt to gain legal advantage by obsessively sticking to the written laws, while deliberately desecrating its spirit. I describe three of its mechanisms: appropriation, redefinition and fraud laundering. Finally, in my preliminary vivisection of the recent and ongoing process of delegalizing the legal corruption that has been part of the reprivatization process, all the allied concepts of this forum come together to demonstrate the essential inseparability of informality and state.
Interlocking Lives: Employment Mobility and Family Fixity in Three Gentrifying Neighbourhoods of Montreal
Authors: High Steven , Goulet Lysiane Gervais , Duchesneau Michelle , Guay‐Bélanger Dany
Published: January 2019

This article explores the relationship between employment mobility, family fixity, and gentrification in the lives of 36 residents in and extended commuters to Montreal's southwest borough. Once described as the birthplace of industry in Canada, the neighbourhoods of Saint‐Henri, Little Burgundy and Point Saint‐Charles have undergone sweeping changes in recent decades. Inner‐city areas are not necessarily where one expects to find mobile workers, but this is changing due to shifting gender roles, the rise of dual‐income households and gentrification. Michael Savage's concept of ‘elective belonging’ proved particularly useful in understanding this connection. With its proximity to childcare, schools, stores and workplaces, the central city permits a more equitable division of labour within the household. Our place‐based approach to mobile work enables us to capture a wide spectrum of experience, ranging from people with extended daily commutes to those whose work takes them away from home for days, weeks or months at a time. Our interviews reveal a connection between employment mobility and family gentrification, as upwardly mobile families find ways to localize other aspects of their lives. The simultaneity of mobility and immobility are often essential, especially in dual‐income households. One parent's mobility often leads to the relative immobility of other family members.
Personal genomic testing for nutrition and wellness in Australia: A content analysis of online information
Authors: Tutty Erin , Hickerton Chriselle , Adamski Melissa M. , Metcalfe Sylvia A.
Published: January 2019

Aim

Personal genomic testing for nutrition and wellness (PGT‐NG) offers a new service delivery model to nutritionists and dietitians. However, research indicates that this type of testing currently lacks sufficient clinical validity and utility to be commercially available. Despite Australian guidelines to the contrary, healthcare professionals are currently offering testing to clients, and promoting these services online. Thus, it is important to understand how PGT‐NG is currently framed online to the public.

Methods

A mixed methods content analysis was conducted to assess the content, quality and marketing approaches of websites offering PGT‐NG to Australians. Websites were identified using popular search engines to mimic the behaviour of a consumer. A novel framework was developed for the purposes of the analysis.

Results

Thirty‐nine websites were analysed, comprising four nutritional genomic testing company websites and 35 healthcare provider websites. Healthcare providers relied on information from the testing companies. The content was emotive, and little attention was given to the scientific and ethical aspects of personal genomic testing. Websites appealed to consumer empowerment and framed testing as an essential and superior tool for optimising health.

Conclusions

Websites lacked the transparency necessary for informed consent. A basic checklist of key information was developed to aid healthcare providers when informing potential clients of PGT‐NG online.
Brettanomyces Spoilage in Albanian Wines Assessed by Culture‐Dependent and Culture‐Independent Methods
Authors: Lloha Ilir , Peçuli Anisa , Basha Elton , Zejnelhoxha Sanije , Mamoci Erjon , Milanović Vesna , Sabbatini Riccardo , Osimani Andrea , Garofalo Cristiana , Clementi Francesca , Agarbati Alice , Ciani Maurizio , Aquilanti Lucia
Published: January 2019

In the Albanian winemaking industry, there is little awareness of the potential detrimental effect of Brettanomyces in wines. The aim of this study was to detect and quantify Brettanomyces cells in 22 Albanian bottled wines, representing all the viticultural areas of Albania. A combined approach, including culture‐dependent (viable plate counting) and culture‐independent (qPCR) methods, was applied. Spoilage indicators (ethylphenols and total and volatile acidity), as well as the primary factors known to influence the growth of Brettanomyces in wine (pH, SO2, and ethanol concentration), were also investigated. Brettanomyces was detected in only five (one Merlot, four Sheshi i Zi) out of 22 samples analyzed using viable counting, with loads ranging from 1.30 ± 0.03 log CFU/mL to 3.99 ± 0.00 log CFU/mL, whereas it was never detected in the Kallmet samples. When qPCR was applied, Brettanomyces cells were detected and quantified in all of the samples with a generally low load ranging from 0.47 ± 0.13 to 3.99 ± 0.01 log cells/mL. As a general trend, the loads of spoilage by this yeast were low (≤1.92 log cells/mL), with the exception of five samples that were also positive by plate counting. A positive correlation between the growth of this spoilage yeast on Dekkera/Brettanomyces differential media and its detection at high levels by qPCR was observed. A significant positive correlation between Brettanomyces and the concentration of ethylphenols and volatile acidity was also found. In summary, the results of this study demonstrated the low incidence of Brettanomyces spoilage yeasts in Albanian red wines.

Practical Application

The awareness of Brettanomyces spoilage in the Albanian winemaking industry is very low. This study represents the first contribution to understand the extent of this spoilage yeast in Albanian autochthonous cultivars, which tend to have high economic value, to ensure product quality and safety. qPCR is confirmed to be a very sensitive method to rapidly detect Brettanomyces spoilage in wine samples.
Predictive performance of a new pharmacokinetic model for propofol in underweight patients during target‐controlled infusion
Authors: Yi Jung‐Min , Doh Il , Lee Seok‐Hwan , Kim Soo‐Young , Lee Yong‐Hun , Lee Eun‐Kyung , Lee Soo‐Han , Choi Byung‐Moon , Noh Gyu‐Jeong
Published: January 2019

Background

In a previous study, the modified Marsh and Schnider models respectively showed negatively‐ and positively‐biased predictions in underweight patients. To overcome this drawback, we developed a new pharmacokinetic propofol model‐the Choi model‐for use in underweight patients. In the present study, we evaluated the predictive performance of the Choi model.

Methods

Twenty underweight patients undergoing elective surgery received propofol via TCI using the Choi model. The target effect‐site concentrations (Ces) of propofol were 2.5, 3, 3.5, 4, 4.5, and 2 μg/mL. Arterial blood samples were obtained at least 10 minutes after achieving pseudo‐steady‐state. Predicted propofol concentrations with the modified Marsh, Schnider, and Eleveld pharmacokinetic models were obtained by simulation (Asan pump, version 2.1.3; Bionet Co. Ltd., Seoul, Korea). The predictive performance of each model was assessed by calculation of four parameters: inaccuracy, divergence, bias, and wobble.

Results

A total of 119 plasma samples were used to determine the predictive performance of the Choi model. Our evaluation showed that the pooled median (95% CI) bias and inaccuracy were 4.0 (−4.2 to 12.2) and 23.9 (17.6‐30.3), respectively. The pooled biases and inaccuracies of the modified Marsh, Schnider, and Eleveld models were clinically acceptable. However, the modified Marsh and Eleveld models consistently produced negatively biased predictions in underweight patients. In particular, the Schnider model showed greater inaccuracy at a target Ce ≥ 3 µg/mL.

Conclusion

The new propofol pharmacokinetic model (the Choi model) developed for underweight patient showed adequate performance for clinical use.
Outcome of chemotherapy with or without targeted agents in metastatic colorectal cancer patients with deficient DNA mismatch repair: A single center, cohort study
Authors: Yu Yue , Ying Jianming , Zhang Wen , Li Weihua , Sun Yongkun , Yang Lin , Cui Chengxu , Zeng Yixin , Zhou Aiping
Published: January 2019

Aims

Metastatic colorectal cancer (mCRC) with deficient DNA mismatch repair (dMMR) is a rare disease accounting only for 4–5% of the whole mCRC and its optimal treatment still remains unclear. We conducted a retrospective study to evaluate the outcome of chemotherapy with or without bevacizumab or cetuximab in this setting.

Methods

A total of 729 colorectal cancer patients with dMMR status were screened for eligibility. The Kaplan–Meier method, the log‐rank test and Cox analysis were utilized for survival analyses.

Results

A total of 43 patients met the inclusion criteria and enrolled in the study. The median overall survival (OS) of entire cohort was 21.7 months. Chemotherapy plus bevacizumab group exhibited a tendency of substantially higher overall response rate (ORR) than chemotherapy alone group (63.6% vs. 23.8%, P = 0.053), whereas the ORR between chemotherapy plus cetuximab group and chemotherapy alone group were similar (28.6% vs. 23.8%, P = 1.000). Compared with chemotherapy alone group, bevacizumab combined group achieved a significantly longer progression‐free survival (10.0 months vs. 4.8 months, P = 0.028), whereas cetuximab combined group was not (6.8 months vs. 4.8 months, P = 0.158). Although the median OS seemed to favor bevacizumab combined group, no significant differences were detected between the three arms (33.7, 21.7 and 15.3 months, respectively; P = 0.345). Prognostic analysis showed that primary tumor resection was the positive prognostic factor of OS (hazards ratio: 0.438; P = 0.041).

Conclusion

dMMR mCRC seems resistant to chemotherapy and cetuximab. Bevacizumab combined therapy shows a sign of potentially favorable outcome in this subtype.
Predictors of survival outcome following radical gastrectomy for gastric cancer
Authors: Lui Su‐Ann , Tan Wee Boon , Tai Bee Choo , Yong Wei Peng , Mu Yar Soe , Ti Thiow Kong , Shabbir Asim , So Jimmy
Published: January 2019

Background

Radical surgery with adjuvant therapy is now the standard treatment for locally advanced gastric cancer. However, the best regimen for adjuvant therapy remains controversial. We aim to determine the predictors of survival outcome of gastric cancer patients who underwent curative surgery with or without adjuvant therapy in our institution.

Methods

All patients who received surgery for gastric cancer from years 2000 to 2015 were studied using a prospective gastric cancer database at the National University Hospital, Singapore.

Results

A total of 405 patients underwent radical gastrectomy with curative intent. Seventy‐eight percent received extended lymphadenectomy (≥D1). R0 resection was achieved in 377 patients (93%) with 30‐day mortality rate of 1.7%. There was no significant difference in the complication rate between D1 and extended lymphadenectomy group. One hundred and forty‐five patients (36%) received adjuvant therapy. With a median follow‐up of 5.9 years, the 5‐year disease‐free survival for stage I to IV patients were 78%, 58%, 27% and 9%, respectively. Among the 141 patients with known recurrences, the first site of recurrence was 38% distant, 24% locoregional, 20% peritoneal and the rest were multiple sites. Stage of disease, adjuvant therapy, extent of lymphadenectomy, post‐operative complication and approach of surgery were independent risk factors for long‐term survival.

Conclusions

Stage of disease, adjuvant therapy, extent of lymphadenectomy, post‐operative complication and approach of surgery are significant predictors for long‐term survival. Adequate and safe surgery to allow adjuvant therapy should be the goal of all surgeons for our gastric cancer patients.
Myopic shift and lens turbidity following hyperbaric oxygen therapy – a prospective, longitudinal, observational cohort study
Authors: Riedl Philip , Škiljić Dragana , Arnell Per , Wannholt Roger , Zetterberg Madeleine , Andersson Grönlund Marita
Published: January 2019

Purpose

To examine visual acuity, refraction and ocular status before, during and after hyperbaric oxygen therapy (HBOT).

Methods

Twenty‐nine patients underwent 40 standard protocol HBOT treatments. In all subjects, refraction and best corrected visual acuity were measured at baseline and after ten, 20, 30 and 40 treatments, and at a 12‐week follow‐up. A subgroup (n = 19) were given additional examinations at baseline, after 40 treatments and at follow‐up including measuring central corneal thickness (CCT), corneal curvature, anterior chamber depth, lens thickness, axial length, fundus morphology, blood pressure and intraocular pressure (IOP). Lens colour and opalescence were graded using the Lens Opacities Classification System III (LOCS III).

Results

Myopic shifts [≥0.5 dioptre (D) spherical equivalent (SE)] occurred in 45 (77.6%) eyes. Median refractive changes of −0.75 D SE (right eye; p < 0.001) and −0.66 D SE (left eye; p < 0.001) were observed between pretreatment and treatment end (Wilcoxon signed rank test). Refraction returned to baseline at follow‐up, except for a small persisting change towards myopia, median –0.25 D SE (left eye; p = 0.01). Using the LOCS III, median increases in lens nuclear colour, of 0.6 (right eye; p < 0.001) and 0.7 (left eye; p < 0.001), and opalescence of 0.7 (both eyes; p = 0.01) were found at the last examination. Small reductions were noted in CCT of −6.00 μm (right eye; p = 0.03) and −4.00 μm (left eye; p = 0.03), and IOP of −1.50 mmHg (left eye; p = 0.01).

Conclusions

The transient myopic shift may have been due to lenticular refractive index changes. Reduced lens transparency is a potential consequence of HBOT.
Association of chronic hepatitis B virus infection with age‐related macular degeneration
Authors: Wu Chia‐Min , Su Fu‐Hsiung , Wang Wen‐Chang , Lin Chang‐Ping , Kamiza Abram Bunya , Chang Shih‐Ni , Yeh Chih‐Ching
Published: January 2019

Purpose

To study the association between chronic hepatitis B virus (HBV) and age‐related macular degeneration (AMD).

Methods

Data used in this retrospective, frequency‐matched cohort study were acquired from the Longitudinal Health Insurance Database 2000, which includes medical claims and registration files for 1 000 000 enrolees in the Taiwan National Health Insurance programme. The HBV cohort contained 17 796 patients who received a diagnosis of chronic HBV infection between January 1, 2000 and December 31, 2012. The non‐HBV cohort contained 71 184 participants who were frequency‐matched by age, sex and year of index date for comparison. Participants were followed until the end of 2013, and those who developed AMD during the study period were identified. A Cox proportional hazards regression model was used to compare the risk of AMD between cohorts.

Results

The incidence of any type of AMD in all participants was 3.88 per 1000 person‐years (PY; 2.27 per 1000 PY in the HBV cohort; 1.61 per 1000 PY in the non‐HBV cohort). Compared with the non‐HBV cohort, the adjusted hazard ratio (HR) for any type of AMD in the HBV cohort was 1.41 [95% confidence interval (CI) 1.23–1.63; p < 0.001]. This significant positive association was stronger among patients who exhibited disease progression from nonexudative to exudative AMD (adjusted HR = 1.74, 95% CI: 1.01–2.99).

Conclusion

Our results suggest that patients with chronic HBV infection in Taiwan have a significantly elevated risk of developing any type of AMD and that HBV infection may accelerate the progression of AMD.
A Cluster-Adjusted Rank-Based Test for a Clinical Trial Concerning Multiple Endpoints With Application to Dietary Intervention Assessment
Authors: Zhang Wei , Liu Aiyi , Tang Larry L. , Li Qizhai
Published: January 2019

Multiple endpoints are often naturally clustered based on their scientific interpretations. Tests that compare these clustered outcomes between independent groups may lose efficiency if the cluster structures are not properly accounted for. For the two-sample generalized Behrens-Fisher hypothesis concerning multiple endpoints we propose a cluster-adjusted multivariate test procedure for the comparison and demonstrate its gain in efficiency over test procedures that ignore the clusters. Data from a dietary intervention trial are used to illustrate the methods.
Efficient Methods for Signal Detection From Correlated Adverse Events in Clinical Trials
Authors: Diao Guoqing , Liu Guanghan F. , Zeng Donglin , Wang William , Tan Xianming , Heyse Joseph F. , Ibrahim Joseph G.
Published: January 2019

It is an important and yet challenging task to identify true signals from many adverse events that may be reported during the course of a clinical trial. One unique feature of drug safety data from clinical trials, unlike data from post-marketing spontaneous reporting, is that many types of adverse events are reported by only very few patients leading to rare events. Due to the limited study size, the p-values of testing whether the rate is higher in the treatment group across all types of adverse events are in general not uniformly distributed under the null hypothesis that there is no difference between the treatment group and the placebo group. A consequence is that typically fewer than percent of the hypotheses are rejected under the null at the nominal significance level of . The other challenge is multiplicity control. Adverse events from the same body system may be correlated. There may also be correlations between adverse events from different body systems. To tackle these challenging issues, we develop Monte-Carlo-based methods for the signal identification from patient-reported adverse events in clinical trials. The proposed methodologies account for the rare events and arbitrary correlation structures among adverse events within and/or between body systems. Extensive simulation studies demonstrate that the proposed method can accurately control the family-wise error rate and is more powerful than existing methods under many practical situations. Application to two real examples is provided.
Analysing multisource feedback with multilevel structural equation models: Pitfalls and recommendations from a simulation study
Authors: Mahlke Jana , Schultze Martin , Eid Michael
Published: January 2019

When multisource feedback instruments, for example, 360‐degree feedback tools, are validated, multilevel structural equation models are the method of choice to quantify the amount of reliability as well as convergent and discriminant validity. A non‐standard multilevel structural equation model that incorporates self‐ratings (level‐2 variables) and others’ ratings from different additional perspectives (level‐1 variables), for example, peers and subordinates, has recently been presented. In a Monte Carlo simulation study, we determine the minimal required sample sizes for this model. Model parameters are accurately estimated even with the smallest simulated sample size of 100 self‐ratings and two ratings of peers and of subordinates. The precise estimation of standard errors necessitates sample sizes of 400 self‐ratings or at least four ratings of peers and subordinates. However, if sample sizes are smaller, mainly standard errors concerning common method factors are biased. Interestingly, there are trade‐off effects between the sample sizes of self‐ratings and others’ ratings in their effect on estimation bias. The degree of convergent and discriminant validity has no effect on the accuracy of model estimates. The χ2 test statistic does not follow the expected distribution. Therefore, we suggest using a corrected level‐specific standardized root mean square residual to analyse model fit and conclude with further recommendations for applied organizational research.
Evaluation of L‐PRF combined with deproteinized bovine bone mineral for early implant placement after maxillary sinus augmentation: A randomized clinical trial
Authors: Pichotano Elton Carlos , de Molon Rafael Scaf , de Souza Ricardo Violante , Austin Rupert S. , Marcantonio Elcio , Zandim‐Barcelos Daniela Leal
Published: January 2019

Purpose

To investigate the effectiveness of adding leukocyte and platelet‐rich fibrin (L‐PRF) to deproteinized bovine bone mineral (DBBM) for early implant placement after maxillary sinus augmentation.

Materials and Methods

Twelve patients requiring two‐stage bilateral maxillary sinus augmentation were enrolled to the study. The elevated sinus cavities were randomly grafted with DBBM + L‐PRF (test) or DBBM alone (control) in a split‐mouth design. Implants were placed in the augmented sites after 4 months in the test group and 8 months in the control group. Bone biopsies were collected during implant placement for histomorphometric evaluation. Resonance frequency analysis was performed immediately after implant placement and at implant loading in both groups. Cone‐beam computed tomography was obtained preoperatively and postoperatively for evaluation of graft volume changes.

Results

Both procedures were effective for maxillary sinus augmentation. Cone‐beam computed tomography analysis did not reveal differences in graft volume between test and control group at any of the evaluated time points (P > .05). Histological evaluation demonstrated increased percentage of newly formed bone for the test group (44.58% ± 13.9%) compared to the control group (30.02% ± 8.42%; P = .0087). The amount of residual graft in the control group was significantly higher (13.75% ± 9.99%) than in the test group (3.59 ± 4.22; P = .0111). Implant stability quotient (ISQ) immediately after implant placement was significantly higher in the control group (75.13 ± 5.69) compared to the test group (60.9 ± 9.35; P = .0003). The ISQ values at loading did not differ between the groups (P = .8587). Implant survival rate was 100% for both groups.

Conclusion

The addition of L‐PRF to the DBBM into the maxillary sinus allowed early implant placement (4 months) with increased new bone formation than DBBM alone after 8 months of healing.
Implant vs abutment level connection in implant supported screw‐retained fixed partial dentures with cobalt‐chrome framework: 1‐year interim results of a randomized clinical study
Authors: Toia Marco , Stocchero Michele , Becktor Jonas P. , Chrcanovic Bruno , Wennerberg Ann
Published: January 2019

Background

Screw‐retained fixed partial dentures (FPD) have shown a lower incidence of biologic complications and an easier retrievability compared with cemented FPD.

Purpose

To compare the marginal bone loss at conical connection implant restored with a screw retained cobalt‐chrome FPD in an implant‐level (IL) or an abutment‐level (AL) setup.

Materials and Methods

Patients with at least two adjacent missing teeth were randomly allocated to be restored with IL or AL FPD. Periapical radiographs and clinical examination were taken at implant placement, prosthetic connection, 6 and 12 months to evaluate marginal bone loss (MBL), and soft tissue conditions. Complications were used to calculate prognostic indexes.

Results

Fifty patients were treated with 50 FPD supported by 119 implants. The difference of MBL between the IL and AL groups was statistically significant (P = 0.003). At 1 year, MBL was 0.086 ± 0.313 mm and 0.005 ± 0.222 mm in the IL and AL groups, respectively. The presence of BoP increased with time in IL, whereas it decreased in AL group (P < 0.001). A minor complication was encounted in one FPD.

Conclusions

A low grade of MBL was present after 1 year. IL showed greater amount of MBL and soft tissue inflammation indexes than AL. In FPD, AL may be a safer procedure than IL setup in order to preserve a healthy periimplant tissue.
Perceived challenges in the informed consent process: Mismatches between enrollers and researchers at a South African clinical research site
Authors: Scott Megan , Watermeyer Jennifer , Nolle Samantha , Penn Claire
Published: January 2019

Enrollers play a critical yet often overlooked role in clinical research, particularly in informed consent processes. Study retention may depend in part on how complex information is conveyed to potential participants. This qualitative study aimed to assess communicative barriers during consent and enrolment in two South African TB/HIV clinical studies. In particular, we compared our own perceptions of potential challenges to consent with that of thirteen enrollers, gained via reflective journaling and focus group discussions. Some overlap of identified challenges was evident, including terminology, jargon and consent document format. However there were mismatches to identified challenges. Enrollers provided further insights into potential challenges to consent, in particular, blood withdrawal, discussion of sexual issues and misunderstanding of study participation. Enrollers also reported feeling ill‐equipped to provide counselling when participants became distressed. We offer several recommendations for strengthening the inclusion of enrollers in the development of clinical research protocols and consent documents.
FDA guidance on antihyperglyacemic therapies for type 2 diabetes: One decade later
Authors: McGuire Darren K. , Marx Nikolaus , Johansen Odd Erik , Inzucchi Silvio E. , Rosenstock Julio , George Jyothis T.
Published: January 2019

In 2008, the US Food and Drug Administration (FDA) issued a guidance to industry statement concerning evaluation of the cardiovascular (CV) safety of new antihyperglycaemic therapies for type 2 diabetes. Fifteen CV outcome trials assessing three novel classes of antihyperglycaemic therapies, DPP‐4 inhibitors, GLP‐1 receptor agonists and SGLT‐2 inhibitors, were completed by the end of 2018 and several others are ongoing. In addition, one comparative insulin trial also has been completed. None of these trials reported an increase in risk for major adverse CV events (MACE), and six agents have demonstrated CV benefits. This experience has led to the first FDA‐approved indications for antihyperglycaemic medications to reduce the risk of CV death (empagliflozin) and to reduce the risk of MACE (liraglutide, canagliflozin), both indications specific to patients with established atherosclerotic cardiovascular disease (ASCVD). Because of the aggregate results from dedicated CV outcomes trials conducted in response to the FDA guidance statement, the contemporary paradigm for treatment of patients with type 2 diabetes has evolved substantially. However, the guidance has substantially increased the cost of developing new medications to address this important disease that afflicts hundreds of millions of adults worldwide, with reduction in quality of life as well as in life expectancy. The cost burden of drug development of medications proven effective that may directly impact cost to patients and to their insurers might be alleviated by modifications to the present guidance statement. These include areas of trial design, aspects of trial operation, expansion of composite outcomes to include broader component CV outcomes and continued evolution of analytic methodology. The guidance statement will benefit from consideration of a number of modifications to support continued innovation and, of course, the safety of marketed medications for type 2 diabetes. However, the requirement to assess each new antihyperglycaemic medication in at least one large‐scale standard randomized clinical outcomes trial should remain, so that clinicians can be reassured about the favourable efficacy/safety profiles of the medications they prescribe.
Anemia and iron deficiency in heart failure: a review of echocardiographic features
Authors: Sutil‐Vega Mario , Rizzo Marcelo , Martínez‐Rubio Antoni
Published: January 2019

Anemia and iron deficiency are often associated with heart failure, influencing the symptoms and prognosis. Correction of anemia and iron deficiency improves functional capacity and decreases hospitalizations. Many studies have analyzed echocardiographic parameters in iron deficiency and anemia and their evolution after iron treatment; however, the heterogeneity of the results makes it difficult to draw conclusions. The aim of this paper is to review the echocardiographic parameters during anemia and iron deficiency, and their evolution after treatment. Available data suggest that they lead to ventricular and atrial remodeling, a decrease in ventricular contractility, and an alteration of ventricular relaxation, although in heart failure with preserved ejection fraction these changes are not significant. Anemia and iron deficiency also increase systolic pulmonary artery pressure. There is consistent evidence that correction of these comorbidities leads to a reduction in preload and left ventricular cavity dimensions, an improvement in diastolic and load‐independent ventricular systolic function parameters, and a decrease in systolic pulmonary artery pressure. However, the evidence is less consistent about the changes produced in ventricular hypertrophy, load‐dependent systolic function parameters, and E‐wave. Generally, anemia and iron deficiency affect the echocardiographic findings, and correcting these conditions often results in improvement in the affected echocardiographic parameters.
CONSPICUOUS SPENDING AND THE INCOME DISTRIBUTION OF SOCIAL GROUPS
Authors: Chai Andreas , Kaus Wolfhard , Kiedaisch Christian
Published: January 2019

Using South African household expenditure data, we analyze how the spending of a household on visible goods, such as jewelry and clothes, depends on the distribution of income within its social group. We find that this spending is positively correlated with the share of peers who possess a similar income level to the household, what we dub the “local income share.” Moreover, we find that the spending of a household on visible goods is positively correlated with the average income of peers that are poorer than this household. We interpret this as evidence for cascade effects through which income changes among the poorest in the social group can trigger adjustments in the visible spending patterns of the wealthy. In line with previous research (Charles et al. 2009), we also find that visible spending of a household is negatively correlated with the average income of its social group. We present a simple model of status competition based on Hopkins and Kornienko (2004) that synthesizes these effects and can account for our results. (JEL D12, D31, O12)
The neoliberal turn in Higher Education
Authors: Tight Malcolm
Published: January 2019

Recent writing on Higher Education has seen much policy and practice attributed to the advent or impact of neoliberalism. This paper examines the origins and meaning of the term, its application to Higher Education and Higher Education research, and the issues and critique that have been raised in this context. It is argued that neoliberalism is just one more in a whole series of ‘fright terms’ used in an attempt to galvanise opposition and resistance to the current directions of Higher Education policy and practice.