bluuebunny/crossref_metadata_2025 huggingface dataset:
Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial
Authors: Lu Taoying , Zhang Huiyan , Yin Lingjia , Cai Jianxiong , Li Meiling , Dai Lin , Zhu Conghao , Zhang Yongping , Xiang Feng , Wang Li , Li Lu , Wang Lixin , Wu Darong
Published: December 2019

Background

Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0–6 years with acute diarrhea.

Methods/design

This study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15–25 min of Chinese pediatric Tuina, while the control group will receive 15–25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit.

Discussion

This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea.

Trial registration

ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.
Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial
Authors: Guo Jing , Yu Siyi , Liu Chunhong , Wang Guiling , Li Bin
Published: December 2019

Background

Insomnia is among the most prevalent of the sleep-related disorders. Insomnia disorder is associated with a brain hyperarousal state manifested by abnormal regional brain activity and resting state functional connectivity. Acupuncture improves sleep quality and modulates the hyperarousal state; however, the underlying neurobiological basis for improved sleep quality is poorly understood. The purpose of this clinical trial is to study the efficacy of acupuncture in the treatment of insomnia disorder. In addition, the neural mechanism by which acupuncture affects insomnia disorder will be explored using resting-state functional magnetic resonance imaging (rs-fMRI) and neuropsychological parameters.

Methods and design

A randomized, patient- and assessor-blinded trial will be conducted. We will randomize (in a 1:1 ratio) 60 eligible patients with insomnia disorder into a real acupuncture group or a sham acupuncture group. Interventions will be administered three times per week over a 4-week period, with an 8-week follow-up period. The healthy control group will consist of 30 age- and sex-matched healthy individuals who sleep well without any treatment intervention.

All participants will undergo neuropsychological and rs-fMRI evaluations. The change in Pittsburgh Sleep Quality Index (PSQI) scores is the primary outcome parameter. The secondary outcome parameters include the Hyperarousal scale (HAS), rs-fMRI measurements, the Fatigue scale-14 (FS-14), the Hamilton depression scale (HAMD), the Hamilton anxiety scale (HAMA), a sleep diary, and an actigraph.

Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up. Analyses will be implemented based on intention-to-treat.

Discussion

The study results will be used to clarify the effectiveness and elucidate the mechanism by which acupuncture improves sleep quality in patients with insomnia disorder.

Trial registration

Chinese Clinical Trials Register, ChiCTR1800015282. Registered on 20 March 2018.
ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction
Authors:   for the ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC), Chen Yen-I , Callichurn Kashi , Chatterjee Avijit , Desilets Etienne , Fergal Donnellan , Forbes Nauzer , Gan Ian , Kenshil Sana , Khashab Mouen A. , Kunda Rastislav , Lam Eric , May Gary , Mohamed Rachid , Mosko Jeff , Paquin Sarto C. , Sahai Anand , Sandha Gurpal , Teshima Christopher , Barkun Alan , Barkun Jeffrey , Bessissow Ali , Candido Kristina , Martel Myriam , Miller Corey , Waschke Kevin , Zogopoulos George , Wong Clarence
Published: December 2019

Background & aims

Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction.

Methods

The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events.

Discussion

The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design.

Trial registration

Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
Correction to: Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial
Authors: Brody Carinne , Tuot Sovannary , Chhoun Pheak , Swendeman Dallas , Kaplan Kathryn C. , Yi Siyan
Published: December 2019

After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. We would like to formally apologize and give credit to the authors of that article [2]: Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy and Caroline Free.
The effects of two weeks high-intensity interval training on fasting glucose, glucose tolerance and insulin resistance in adolescent boys: a pilot study
Authors: Cockcroft Emma J. , Bond Bert , Williams Craig A. , Harris Sam , Jackman Sarah R. , Armstrong Neil , Barker Alan R.
Published: December 2019

Background

Current evidence of metabolic health benefits of high-intensity interval training (HIIT) are limited to longer training periods or conducted in overweight youth. This study assessed 1) fasting and postprandial insulin and glucose before and after 2 weeks of HIIT in healthy adolescent boys, and 2) the relationship between pre intervention health outcomes and the effects of the HIIT intervention.

Methods

Seven healthy boys (age:14.3 ± 0.3 y, BMI: 21.6 ± 2.6, 3 participants classified as overweight) completed 6 sessions of HIIT over 2 weeks. Insulin resistance (IR) and blood glucose and insulin responses to a Mixed Meal Tolerance Test (MMTT) were assessed before (PRE), 20 h and 70 h after (POST) the final HIIT session.

Results

Two weeks of HIIT had no effect on fasting plasma glucose, insulin or IR at 20 h and 70 h POST HIIT, nor insulin and glucose response to MMTT (all P > 0.05). There was a strong negative correlation between PRE training IR and change in IR after HIIT (r = − 0.96, P < 0.05).

Conclusion

Two weeks of HIIT did not elicit improvements to fasting or postprandial glucose or insulin health outcomes in a group of adolescent boys. However the negative correlation between PRE IR and improvements after HIIT suggest that interventions of this type may be effective in adolescents with raised baseline IR.
Autism and family involvement in the right to education in the EU: policy mapping in the Netherlands, Belgium and Germany
Authors: van Kessel Robin , Roman-Urrestarazu Andres , Ruigrok Amber , Holt Rosemary , Commers Matt , Hoekstra Rosa A. , Czabanowska Katarzyna , Brayne Carol , Baron-Cohen Simon
Published: December 2019

Introduction

In recent years, the universal right to education has been emphasised by the Universal Declaration on Human Rights and the Convention on the Rights of Persons with Disabilities. In this paper, we mapped policies relevant to special education needs and parental involvement of children with autism at an international level and in the Netherlands, Germany and Belgium.

Methods

A policy path analysis was performed using a scoping review as an underlying methodological framework. This allowed for a rapid gathering of available data from which a timeline of adopted policies was derived.

Results and discussion

Internationally, the universal right to education has been reinforced repeatedly and the values of the Universal Declaration of Human Rights have been reiterated with every reinforcement. Also, the additional support that a child with special education needs requires is acknowledged and measures are taken to facilitate access to any education for all children. There are slight cross-country differences between the countries under study, attributable to differences in national regulation of education. However, all countries have progressed to a state where the right to education for all children is integrated on a policy level and measures are taken to enable children with special needs to participate in education. Recently, an attempt to implement a form of inclusive education was made as a form of special needs provision. Nevertheless, nowhere has this been implemented successfully yet.

Conclusion

The Universal Declaration of Human Rights was a critical juncture in international policy and created an environment where the universal right to education has been implemented for all children in the countries under study.
Using submerged fermentation to fast increase N6-(2-hydroxyethyl)-adenosine, adenosine and polysaccharide productions of Cordyceps cicadae NTTU 868
Authors: Ke Bo-Jun , Lee Chun-Lin
Published: December 2019

Cordyceps cicadae is a well-known traditional Chinese medicine for treating palpitations and eye diseases. It contains several bioactive compounds such as adenosine, N6-(2-hydroxyethyl)-adenosine (HEA), and polysaccharide. Those bioactive compounds have been reported to perform anti-oxidation and anti-inflammatory properties and provide renal protection. In this study, we researched different fermentation conditions in order to enhance the biomass, adenosine, HEA, and polysaccharide productions of C. cicadae NTTU 868. Solid fermentation was carried out with different grain substrates (barley, oat, rice and wheat). Various submerged fermentation scales were used to produce the C. cicadae NTTU 868 mycelium. The results of solid fermentation revealed that C. cicadae NTTU 868 produced higher adenosine and HEA concentrations in oat rather than in other substrates. C. cicadae NTTU 868 mycelium had obtained the highest concentrations of adenosine and HEA on Day 2 as using the small-scale submerged fermentation. Furthermore, potato dextrose broth with extra 0.2% of yeast extract was able to result in higher HEA concentration. In conclusion, using submerged fermentation to culture C. cicadae NTTU 868 resulted in more efficient adenosine, HEA, and polysaccharide productions than using solid-fermentation, especially when 0.2% of yeast extract was used in the PDB. Importantly, this can be easily scaled-up in the fermentation industry.
TGF-β in fibrosis by acting as a conductor for contractile properties of myofibroblasts
Authors: Vallée Alexandre , Lecarpentier Yves
Published: December 2019

Myofibroblasts are non-muscle contractile cells that play a key physiologically role in organs such as the stem villi of the human placenta during physiological pregnancy. They are able to contract and relax in response to changes in the volume of the intervillous chamber. Myofibroblasts have also been observed in several diseases and are involved in wound healing and the fibrotic processes affecting several organs, such as the liver, lungs, kidneys and heart. During the fibrotic process, tissue retraction rather than contraction is correlated with collagen synthesis in the extracellular matrix, leading to irreversible fibrosis and, finally, apoptosis of myofibroblasts. The molecular motor of myofibroblasts is the non-muscle type IIA and B myosin (NMMIIA and NMMIIB). Fibroblast differentiation into myofibroblasts is largely governed by the transforming growth factor-β1 (TGF-β1). This system controls the canonical WNT/β-catenin pathway in a positive manner, and PPARγ in a negative manner. The WNT/β-catenin pathway promotes fibrosis, while PPARγ prevents it. This review focuses on the contractile properties of myofibroblasts and the conductor, TGF-β1, which together control the opposing interplay between PPARγ and the canonical WNT/β-catenin pathway.
Nurses’ perspectives on human rights when coercion is used in psychiatry: a systematic review protocol of qualitative evidence
Authors: Pariseau-Legault Pierre , Vallée-Ouimet Sandrine , Goulet Marie-Hélène , Jacob Jean-Daniel
Published: December 2019

Background

The World Health Organization describes the perpetuation of human rights violations against people with mental health problems as a global emergency. Despite this observation, recent studies suggest that coercive measures, such as seclusion, restraints, involuntary hospitalization, or involuntary treatment, are steadily or increasingly being used without proof of their effectiveness. In nursing, several literature reviews have focused on understanding nurses’ perspectives on the use of seclusion and restraints. Although many studies describe the ethical dilemmas faced by nurses in this context, to this date, their perspectives on patient’s rights when a broad variety of coercive measures are used are not well understood. The aim of this review is to produce a qualitative synthesis of how human rights are actually integrated into psychiatric and mental health nursing practice in the context of coercive work.

Methods

Noblit and Hare’s meta-ethnographic approach will be used to conduct this systematic review. The search will be conducted in CINAHL, Medline, PsycINFO, ERIC, and Scopus databases, using the PICo model (Population, phenomenon of Interest, Context) and a combination of keywords and descriptors. It will be complemented by a manual search of non-indexed articles, gray literature, and other applicable data sources, such as human rights related documents. Qualitative and mixed-method study designs will be included in this review. Empirical and peer-reviewed articles published between 2008 and 2019 will be selected. Articles will be evaluated independently by two reviewers to determine their inclusion against eligibility criteria. The quality of the selected papers will then be independently evaluated by two reviewers, using the Joanna Briggs Institute’s Checklist for Qualitative Research. Data extraction and content analysis will focus on first- and second-order constructs, that is, the extraction of research participants’ narratives and their interpretation.

Discussion

This review will provide a synthesis of how psychiatric and mental health nurses integrate human rights principles into their practice, as well as it will identify research gaps in this area. The results of this review will then provide qualitative evidence to better understand how nurses can contribute to the recognition, protection, and advocate for human rights in a psychiatric context.

Systematic review registration

PROSPERO,
CRD42019116862
Singular traveling wave solutions for Boussinesq equation with power law nonlinearity and dual dispersion
Authors: Zheng Shan , Ouyang Zhengyong , Wu Kuilin
Published: December 2019

In this paper we study the Boussinesq equation with power law nonlinearity and dual dispersion which arises in fluid dynamics. A particular kind of product of distributions is introduced and applied to solve non-smooth solutions of this equation. It is proved that, under certain conditions, a distribution solution as a singular Dirac delta function exists for this model. For the first time, this kind of product of distributions is used to deal with a fourth order nonlinear partial differential equation.
Spatially explicit statistical modeling of random and systematic land cover transitions in the main grassland plain of Nech Sar National Park, Ethiopia
Authors: Deribew Kiros Tsegay
Published: December 2019

The main grassland plain of Nech Sar National Park (NSNP) is a federally managed protected area in Ethiopia designated to protect endemic and endangered species. However, like other national parks in Ethiopia, the park has experienced significant land cover change over the past few decades. Indeed, the livelihoods of local populations in such developing countries are entirely dependent upon natural resources and, as a result, both direct and indirect anthropogenic pressures have been placed on natural parks. While previous research has looked at land cover change in the region, these studies have not been spatially explicit and, as a result, knowledge gaps in identifying systematic transitions continue to exist. This study seeks to quantify the spatial extent and land cover change trends in NSNP, identify the strong signal transitions, and identify and quantify the location of determinants of change. To this end, the author classifies panchromatic aerial photographs in 1986, multispectral SPOT imagery in 2005, and Sentinel imagery in 2019. The spatial extent and trends of land cover change analysis between these time periods were conducted. The strong signal transitions were systematically identified and quantified. Then, the basic driving forces of the change were identified. The locations of these transitions were also identified and quantified using the spatially explicit statistical model. The analysis revealed that over the past three decades (1986–2019), nearly 52% of the study area experienced clear landscape change, out of which the net change and swap change attributed to 39% and 13%, respectively. The conversion of woody vegetation to grassland (~ 5%), subsequently grassland-to-open-overgrazed land (28.26%), and restoration of woody vegetation (0.76%) and grassland (0.72%) from riverine forest and open-overgrazed land, respectively, were found to be the fully systematic transitions whereas the rest transitions were recorded either partly systematic or random transitions. The location of these most systematic land cover transitions identified through the spatially explicit statistical modeling showed drivers due to biophysical conditions, accessibility, and urban/market expansions, coupled with successive government policies for biodiversity management, geo-politics, demographic, and socioeconomic factors. These findings provide important insights into biodiversity loss, land degradation, and ecosystem disruption. Therefore, the model for predicted probability generally suggests a 0.75 km and 0.72 km buffers which are likely to protect forest and grassland from conversion to grassland and open-overgrazed land, respectively.
Immune landscapes associated with different glioblastoma molecular subtypes
Authors: Martinez-Lage Maria , Lynch Timothy M. , Bi Yingtao , Cocito Carolina , Way Gregory P. , Pal Sharmistha , Haller Josephine , Yan Rachel E. , Ziober Amy , Nguyen Aivi , Kandpal Manoj , O’Rourke Donald M. , Greenfield Jeffrey P. , Greene Casey S. , Davuluri Ramana V. , Dahmane Nadia
Published: December 2019

Recent work has highlighted the tumor microenvironment as a central player in cancer. In particular, interactions between tumor and immune cells may help drive the development of brain tumors such as glioblastoma multiforme (GBM). Despite significant research into the molecular classification of glioblastoma, few studies have characterized in a comprehensive manner the immune infiltrate in situ and within different GBM subtypes.

In this study, we use an unbiased, automated immunohistochemistry-based approach to determine the immune phenotype of the four GBM subtypes (classical, mesenchymal, neural and proneural) in a cohort of 98 patients. Tissue Micro Arrays (TMA) were stained for CD20 (B lymphocytes), CD5, CD3, CD4, CD8 (T lymphocytes), CD68 (microglia), and CD163 (bone marrow derived macrophages) antibodies. Using automated image analysis, the percentage of each immune population was calculated with respect to the total tumor cells. Mesenchymal GBMs displayed the highest percentage of microglia, macrophage, and lymphocyte infiltration. CD68+ and CD163+ cells were the most abundant cell populations in all four GBM subtypes, and a higher percentage of CD163+ cells was associated with a worse prognosis. We also compared our results to the relative composition of immune cell type infiltration (using RNA-seq data) across TCGA GBM tumors and validated our results obtained with immunohistochemistry with an external cohort and a different method. The results of this study offer a comprehensive analysis of the distribution and the infiltration of the immune components across the four commonly described GBM subgroups, setting the basis for a more detailed patient classification and new insights that may be used to better apply or design immunotherapies for GBM.
Magnetic resonance imaging brain atrophy assessment in primary age-related tauopathy (PART)
Authors: Quintas-Neves Miguel , Teylan Merilee A. , Besser Lilah , Soares-Fernandes João , Mock Charles N. , Kukull Walter A. , Crary John F. , Oliveira Tiago Gil
Published: December 2019

Alzheimer disease (AD) is a neurodegenerative disorder characterized pathologically by the accumulation of amyloid-beta (Aβ) plaques and tau neurofibrillary tangles (NFTs). Recently, primary age-related tauopathy (PART) has been described as a new anatomopathological disorder where NFTs are the main feature in the absence of neuritic plaques. However, since PART has mainly been studied in post-mortem patient brains, not much is known about the clinical or neuroimaging characteristics of PART. Here, we studied the clinical brain imaging characteristics of PART focusing on neuroanatomical vulnerability by applying a previously validated multiregion visual atrophy scale. We analysed 26 cases with confirmed PART with paired clinical magnetic resonance imaging (MRI) acquisitions. In this selected cohort we found that upon correcting for the effect of age, there is increased atrophy in the medial temporal region with increasing Braak staging (r = 0.3937, p = 0.0466). Upon controlling for Braak staging effect, predominantly two regions, anterior temporal (r = 0.3638, p = 0.0677) and medial temporal (r = 0.3836, p = 0.053), show a trend for increased atrophy with increasing age. Moreover, anterior temporal lobe atrophy was associated with decreased semantic memory/language (r = − 0.5823, p = 0.0056; and r = − 0.6371, p = 0.0019, respectively), as was medial temporal lobe atrophy (r = − 0.4445, p = 0.0435). Overall, these findings support that PART is associated with medial temporal lobe atrophy and predominantly affects semantic memory/language. These findings highlight that other factors associated with aging and beyond NFTs could be involved in PART pathophysiology.
Internet of Things is a revolutionary approach for future technology enhancement: a review
Authors: Kumar Sachin , Tiwari Prayag , Zymbler Mikhail
Published: December 2019

Internet of Things (IoT) is a new paradigm that has changed the traditional way of living into a high tech life style. Smart city, smart homes, pollution control, energy saving, smart transportation, smart industries are such transformations due to IoT. A lot of crucial research studies and investigations have been done in order to enhance the technology through IoT. However, there are still a lot of challenges and issues that need to be addressed to achieve the full potential of IoT. These challenges and issues must be considered from various aspects of IoT such as applications, challenges, enabling technologies, social and environmental impacts etc. The main goal of this review article is to provide a detailed discussion from both technological and social perspective. The article discusses different challenges and key issues of IoT, architecture and important application domains. Also, the article bring into light the existing literature and illustrated their contribution in different aspects of IoT. Moreover, the importance of big data and its analysis with respect to IoT has been discussed. This article would help the readers and researcher to understand the IoT and its applicability to the real world.
Childhood adversities and prior involvement with child protective services
Authors: Suglia Shakira F. , Kulick Erin R. , Brown Jocelyn
Published: December 2019

Objectives

We aimed to determine the relation between childhood adversities and prior involvement with Child Protective Services (CPS) history among children presenting for evaluation at a Child Advocacy Center.

Study design

The study evaluated children presenting to a Child Advocacy Center (CAC) from 2009 to 2014. A five-item child adversity measure, based on mother’s report, was characterized into a scale of none, one, or two or more adversities. Caseworkers at the CAC assessed whether families had a prior history of involvement with CPS.

Results

Among the 727 children included in the analyses, 43% had a prior history of involvement with CPS. Twenty-six percent of the children experienced one childhood adversity while 29% experienced two or more. In regression analyses adjusting for socio-demographics, experiencing one (Prevalence Ratio (PR) 1.25 95%CI 1.0–1.5) or two or more adversities (PR1.67 95%CI 1.4, 2.0) was associated with higher prevalence of CPS history compared to those who reported none.

Conclusions

Childhood adversities are associated with prior contact with CPS, suggesting there are missed opportunities to provide services to high-risk families. CACs may be in a unique position to advocate for families and prevent further victimization of children.
Statistical analysis of low-latitude spread F observed over Puer, China, during 2015–2016
Authors: Lan Ting , Jiang Chunhua , Yang Guobin , Zhang Yuannong , Liu Jing , Zhao Zhengyu
Published: December 2019

Statistical analysis of spread F (SF), recorded at Puer (PUR, 22.7° N, 101.05° E, Dip Latitude 12.9° N) during 2015–2016, was carried out to reveal its characteristics at the northern equatorial ionization anomaly. In our study, SF was categorized into four types, frequency spread F (FSF), range spread F (RSF), mix spread F (MSF) and strong range spread F (SSF). The statistical results presented that FSF and MSF were dominant over Puer. Most types of SF appeared mostly in summer months, except the maximum occurrence of SSF in equinox months. Moreover, observations of SF events also showed that the solar activity and magnetic activity dependence of SF varied with seasons. Compared with observations at other region, the present results suggest that medium-scale traveling ionospheric disturbances (MSTIDs) may play a key role in generation of SF in low-latitude region.
RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study
Authors: Lucidarme Olivier , Wagner Mathilde , Gillard Paul , Kim Stefano , Bachet Jean-Baptiste , Rousseau Benoit , Mazard Thibault , Louvet Christophe , Chibaudel Benoist , Cohen Romain , Garcia-Larnicol Marie-Line , Gobert Aurelien , Henriques Julie , André Thierry
Published: December 2019

Background

To evaluate the objective response rate (ORR) at 2 months of treatment with regorafenib according to RECIST 1.1, Choi, and modified Choi (mChoi) criteria in patients with metastatic colorectal cancer (mCRC).

Methods

Baseline and 2-month contrast-enhanced computed-tomography (CECT) scans of 55 patients with mCRC, prospectively enrolled in phase II TEXCAN trial, were centrally assessed. The primary endpoint was 2-month ORR by RECIST 1.1, Choi, and mChoi criteria. Final outcome was overall survival (OS).

Results

Of 55 patients included in this study (Intention-to-treat [ITT1] population), 35 had CECT at 2 months (ITT2 population). According to RECIST 1.1 criteria, 20 (57%) patients were SD and 15 were PD (43%) in the ITT2 population. According to Choi criteria, 18 (51%) patients were responders and 17 (48%) were non-responders. Median OS was 5.3 months (95% CI 3.7–8.6) in the ITT1 population and 8.9 months (95% CI 5.1–12.6) in the ITT2 population. In the ITT2 population, median OS was 16 months (95% CI 6.6–17.5) in SD patients (n = 20) and 4.6 months (95% CI 3.3–5.8) in PD patients (n = 15), according to RECIST 1.1 criteria (HR = 6.48). Median OS was 7.9 months (95% CI 4.2–17.5) in responders (n = 18) and 9.9 months (95% CI 3.7-NA) in non-responders (n = 17) according to Choi criteria (HR = 1.06). All patients except one were classified as non-responders with mChoi criteria.

Conclusion

At 2 months, unlike RECIST 1.1, Choi and mChoi criteria could not identify mCRC patients with regorafenib survival benefit.

Trial registration

ClinicalTrials.gov Identifier: NCT02699073.Registered March 4, 2016, Retrospectively registered.
Systematic overview of Freedom of Information Act requests to the Department of Health and Human Services from 2008 to 2017
Authors: Egilman Alexander C. , Wallach Joshua D. , Morten Christopher J. , Lurie Peter , Ross Joseph S.
Published: December 2019

Background

The Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.

Methods

Using HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in three time increments, < 1–20, 21–60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated.

Results

Between 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs).

Conclusions

FOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies’ FOIA programs might be made more efficient through greater proactive record disclosure.
Can propofol procedural sedation implementation increase the acceptance of spinal anesthesia during cesarean section?
Authors: Mazy Alaa , Madkour Nadia , Shaalan Hesham
Published: December 2019

Background

Parturients are highly anxious preoperatively. The worries of spinal anesthesia may preclude its acceptance despite being recommended. Procedural sedation is not a routine during regional blocks, but it is sensible that anesthesiologists should provide their blocks comfortably. The proposal is that implementing the propofol procedural sedation (PPS) may increase the acceptance rate of spinal anesthesia for cesarean section.

Methods

In this prospective observational study, the patients who refused spinal anesthesia primarily were interrogated to implement PPS for painless comfortable spinal anesthesia. Their acceptance rate was the primary outcome. In the sitting position, propofol 0.7 mg/kg and 20 mg increments were used as required. Patients were well supported and monitored. Data were compared by Mann-Whitney, chi-square, Fisher’s exact, and Friedman’s ANOVA tests as appropriate.

Results

The acceptance rate of spinal anesthesia increased from 17 to 93%. During PPS, the mean values of minimal mean blood pressure were not significantly decreased, while the mean values of the heart rate slightly increased. The minimal values of oxygen saturation showed no significant reduction compared to the basal values. Patients expressed a marked relief of anxiety and high satisfaction.

Conclusion

The use of propofol procedural sedation was effective in increasing the acceptance rate of spinal anesthesia during CS with safety and high patient’s satisfaction.
Economic analysis and marketing margin of pistachios in Turkey
Authors: AŞKAN Emine
Published: December 2019

Background

In this study, producer and consumer prices and the marketing structure of pistachios in Turkey were examined. Between 2003 and 2017, production, consumption, foreign trade, price fluctuations, and marketing were emphasized. It was determined that the number of fruit trees in pistachios increased. According to current and real prices, pistachio marketing margins are calculated, and producer and consumer chain indexes are calculated according to current prices and compared with annual inflation rates. Supply and demand models related to pistachio were estimated and interpreted statistically.

Results

As a result, the real price of walnut and periodicity on the amount of pistachio production, on the consumption of Pistachio, the costumer real price of pistachio, population, and periodicity were determined to be effective.

Conclusion

Demand elasticity in pistachio (1.055) was found to be greater than supply elasticity (0.306), and consumers’ sensitivity to price changes was much higher than that of producers.
Effects of columbite/tantalite (COLTAN) mining activities on water quality in Edege-Mbeki mining district of Nasarawa state, North Central Nigeria
Authors: Isah Mohammed Engha , Abdulmumin Nuhu Abdulkadir , Elaoyi Paul D. , Audu Ephraim
Published: December 2019

Background

The release of environmental pollutants such as heavy metals due to mining activities has received worldwide condemnation. Therefore, understanding the contamination of both surface and groundwater in Edege-Mbeki mining district is very important for the health and wellbeing of its people. Hence, the purpose of this study was to determine the physicochemical parameters of water samples and the level of heavy metals in Edege-Mbeki Columbite/Tantalite (COLTAN) mining site, North Central Nigeria.

Results

A total of 15 water samples were collected and analyzed in triplicate. The concentrations of five heavy metals (Ni, Mn, Pb, Cd, and Fe) in surface and groundwater samples were measured using atomic absorption spectrophotometer (AA-6800 Shimadzu). The physicochemical properties of the water samples were also examined. The results of the water quality assessments show that the water samples were contaminated with alarming levels of Pb, Cd and Ni. Mean concentrations were Ni (0.008 mg/L), Mn (0.087 mg/L), Pb (0.324 mg/L), Cd (0.029 mg/L), and Fe (0.839 mg/L) in Edege-Mbeki groundwater, while the surface water (mining ponds) had Ni (0.102 mg/L), Mn (0.099 mg/L), Pb (0.358 mg/L), Cd (0.025 mg/L), and Fe (6.99 mg/L). The groundwater samples in Mararaban-Edege which served as the control site had mean concentration levels of Ni (0.032 mg/L), Mn (0.096 mg/L), Pb (0.122 mg/L), Cd (0.039 mg/L), and Fe (0.608 mg/L). The range of pH was found to be from 5.6 ± 0.02 to 6.5 ± 0.12, turbidity was between 39.27 ± 0.29 and 2271 ± 0.00 NTU, and conductivity ranged from 39.27 ± 0.29 to 757.33 ± 5.69 μS/cm, TDS from 25.0 ± 2.3 to 450.67 ± 6.03 mg/L while dissolved oxygen (DO) values from 3.1 ± 0.3 to 3.5 ± 0.3 mg/L.

Conclusion

This study confirmed that surface and ground water samples in Edege-Mbeki and Mararaban-Edege are not fit for human consumption and other domestic use. Hence, government and community leaders must provide alternative means of water for the people of these communities.
Fuel dynamics and reburn severity following high-severity fire in a Sierra Nevada, USA, mixed-conifer forest
Authors: Lydersen Jamie M. , Collins Brandon M. , Coppoletta Michelle , Jaffe Melissa R. , Northrop Hudson , Stephens Scott L.
Published: December 2019

Background

High-severity fire in forested landscapes often produces a post-fire condition of high shrub cover and large loads of dead wood. Given the increasing patch size of high-severity fire and the tendency for these areas to reburn at high severity in subsequent wildfires, post-fire management often targets restoration of these areas. However, these areas are challenging to manage, in part due to limited knowledge of post-fire fuel dynamics over space and time and uncertainties in how specific fuel components such as snags and logs influence future fire severity. In this study, we used high-resolution aerial imagery collected nine years after a wildfire to measure snags, logs, and shrub cover within high-severity patches, and to assess how fuel development influenced reburn severity in a subsequent wildfire.

Results

The abundance of snags, logs, and shrubs following high-severity fire varied with elevation and slope steepness; however, generalized additive models explained only 6 to 21% of their variation over the post-fire landscape. High densities of both snags and logs were associated with high reburn severity in a subsequent fire, while shrub cover had a marginally insignificant (P = 0.0515) effect on subsequent fire severity.

Conclusions

Our results demonstrate that high levels of large dead wood, which is often not considered in fire behavior modeling, corresponded with repeated high-severity fire effects. Future research should leverage the increasing availability of high-resolution imagery to improve our understanding of fuel load patterns in space and time and how they may impact landscape resilience to facilitate management planning for post-fire forest landscapes.
Exploring physiological signals on people with Duchenne muscular dystrophy for an active trunk support: a case study
Authors: Verros Stergios , Peeters Laura , Bergsma Arjen , Hekman Edsko E. G. , Verkerke Gijsbertus J. , Koopman Bart F. J. M.
Published: December 2019

Background

Arm support devices are available to support people with Duchenne muscular dystrophy (DMD), but active trunk support devices are lacking. An active trunk support device can potentially extend the reach of the arm and stabilize the unstable trunk of people with DMD. In a previous study, we showed that healthy people were able to control an active trunk support using four different control interfaces (based on joystick, force on feet, force on sternum and surface electromyography). All four control interfaces had different advantages and disadvantages. The aim of this study was to explore which of the four inputs is detectably used by people with DMD to control an active trunk support.

Results

The results were subject-dependent in both experiments. In the active experiment, the joystick was the most promising control interface. Regarding the static experiment, surface electromyography and force on feet worked for two out of the three subjects.

Conclusions

To our knowledge, this is the first time that people with DMD have engaged in a control task using signals other than those related to their arm muscles. According to our findings, the control interfaces have to be customised to every DMD subject.
Analytic time-of-flight positron emission tomography reconstruction: two-dimensional case
Authors: Zeng Gengsheng L. , Li Ya , Huang Qiu
Published: December 2019

In a positron emission tomography (PET) scanner, the time-of-flight (TOF) information gives us rough event position along the line-of-response (LOR). Using the TOF information for PET image reconstruction is able to reduce image noise. The state-of-the-art TOF PET image reconstruction uses iterative algorithms. Analytical image reconstruction algorithm exits for TOF PET which emulates the iterative Landweber algorithm. This paper introduces such an algorithm, focusing on two-dimensional (2D) reconstruction. The proposed algorithm is in the form of backprojection filtering, in which the backprojection is performed first, and then a 2D filter is applied to the backprojected image. For the list-mode data, the backprojection is carried out in the event-by-event fashion, and a profile function may be used along the projection LOR. The 2D filter depends on the TOF timing resolution as well as the backprojection profile function. In order to emulate the iterative algorithm effects, a Fourier-domain window function is suggested. This window function has a parameter, k, which corresponds to the iteration number in an iterative algorithm.
Silica applied as mixed matrix membrane inorganic filler for gas separation: a review
Authors: Setiawan Wahyu Kamal , Chiang Kung-Yuh
Published: December 2019

The trade-off relationship between gas permeability and selectivity is well-known as the primary barrier to developing polymeric membranes for the gas separation process. Mixed matrix membranes (MMMs) can be promoted as a solution to produce the desired membrane for gas separation processes. The general idea for synthesizing MMMs is to induce the thermal, electrical, mechanical, and molecular sieve properties of these nano materials into the base membrane. The incorporation of silica particles with molecular sieving properties in the polymer matrix is expected to lead to higher permeability and/or higher selectivity, compared to polymeric membranes. This paper reviews various types of silica incorporated into a polymer matrix and their gas transport mechanisms, MMM preparation methods and effect of silica on MMM characteristics and gas separation performance. MMM gas transport models after silica incorporation are also reviewed. In addition, the challenges and future works in developing MMMs with silica particles as inorganic filler are discussed.
Stable Immune Response Induced by Intradermal DNA Vaccination by a Novel Needleless Pyro-Drive Jet Injector
Authors: Chang Chinyang , Sun Jiao , Hayashi Hiroki , Suzuki Ayano , Sakaguchi Yuko , Miyazaki Hiroshi , Nishikawa Tomoyuki , Nakagami Hironori , Yamashita Kunihiko , Kaneda Yasufumi
Published: December 2019

DNA vaccination can be applied to the treatment of various infectious diseases and cancers; however, technical difficulties have hindered the development of an effective delivery method. The efficacy of a DNA vaccine depends on optimal antigen expression by the injected plasmid DNA. The pyro-drive jet injector (PJI) is a novel system that allows for adjustment of injection depth and may, thus, provide a targeted delivery approach for various therapeutic or preventative compounds. Herein, we investigated its potential for use in delivering DNA vaccines. This study evaluated the optimal ignition powder dosage, as well as its delivery effectiveness in both rat and mouse models, while comparing the results of the PJI with that of a needle syringe delivery system. We found that the PJI effectively delivered plasmid DNA to intradermal regions in both rats and mice. Further, it efficiently transfected plasmid DNA directly into the nuclei, resulting in higher protein expression than that achieved via needle syringe injection. Moreover, results from animal ovalbumin (OVA) antigen induction models revealed that animals receiving OVA expression plasmids (pOVA) via PJI exhibited dose-dependent (10 μg, 60 μg, and 120 μg) production of anti-OVA antibodies; while only low titers (< 1/100) of OVA antibodies were detected when 120 μg of pOVA was injected via needle syringe. Thus, PJI is an effective, novel method for delivery of plasmid DNA into epidermal and dermal cells suggesting its promise as a tool for DNA vaccination.
ПРОБЛЕМЫ ПРИМЕНЕНИЯ СИСТЕМ ДИСТАНЦИОННОГО ОБУЧЕНИЯ
Authors: Preobrazhenskiy Andrey Petrovich , Choporov Oleg Nikolaevich
Published: December 2019

В статье рассматриваются характеристики применения технологий, базирующихся на дистанционном обучении. Показано, как осуществляется взаимодействие между образовательными центрами. Дано описание ключевых составляющих образовательных платформ.
Researches of Radon Field Formation Indoors (through the Example of Far Eastern State Transport University)
Authors: Andreev A. , Atanova E. , Teslenko I. , Cycareva M.
Published: December 2019

Full-scale investigations have demonstrated that radon contained in soil air provides dominant influence on the university’s radon field formation. The change of radon volume activity in the university’s civil defense hideout and premises have strongly pronounced seasonal pattern with maximum values of radon concentration in July and August, and minimum values in March, April and November. Radon escaping from the soil surface in the summertime does not affect the radon field change in the university’s premises. The most precise estimation of radon annual average volume activity can be obtained when performing observations during a year. The substitution of this approach by the method of measurements with various duration leads to errors in the estimation of the normative parameter because of difficulties in registration of radon variations in various conditions.