bluuebunny/crossref_metadata_2025 huggingface dataset:
Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: An observational time and motion analysis
Authors: Ryan P , McBride A , Ray D , Pulgar S , Ramirez RA , Elquza E , Favaro JP , Dranitsaris G
Published: March 2019

Background

Lanreotide and octreotide acetate suspension for injectable (LAR) are both recommended for clinical use in patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. However, each agent possesses unique attributes in terms of their drug-delivery characteristics. The study objective was to compare overall drug-delivery efficiency between lanreotide and octreotide LAR in gastroenteropancreatic neuroendocrine tumor patients.

Methods

This study employed an observational time and motion design among patients treated with lanreotide or octreotide LAR across five US cancer centers. Baseline patient data collection included age, disease grade and duration, prior therapies and performance status. Drug-delivery time (drug preparation and administration), total patient time and resource use data were collected for gastroenteropancreatic neuroendocrine tumors receiving lanreotide (n = 22) or octreotide LAR (n = 22). Following each administration, qualitative data on the drug-delivery experience was collected from patients and nurses.

Results

Lanreotide was associated with a significant reduction in mean delivery time (2.5 min; 95% CI:2.0 to 3.1) compared to octreotide LAR (6.2 min; 95%CI: 4.4 to 7.9; p = 0.004). The mean total patient time for lanreotide and octreotide LAR was comparable between groups (32.1 vs. 36.6 minutes; p = 0.97). Nurses reported increased concerns with octreotide LAR related to needle clogging ( p = 0.034) and device failures ( p = 0.057). Overall, lanreotide had a median satisfaction score of 5.0 compared to a score of 4.0 with octreotide LAR ( p = 0.03).

Conclusions

Lanreotide was associated with significant reductions in drug-delivery time compared to octreotide LAR, which contributed to an improvement in overall healthcare efficiency.

Trial registration

clinicaltrials.gov Identifier: NCT03017690.
Shear-based vibration control of annular sandwich plates using different piezoelectric fiber composites: A comparative study
Authors: Dubey Manish Kumar , Panda Satyajit
Published: March 2019

This work presents the shear-based attenuation of vibration of an annular sandwich plate using two different shear mode piezoelectric fiber composite (PFC) actuators namely Shear Actuated Fiber Composite (SAFC) and Balanced Laminate of PFC (BL-PFC). A conventional shear mode monolithic piezoelectric (PZT5H) actuator is also used, and a comparative study on the shear actuation capabilities of all three shear actuators is performed to address the best one for shear-based control of the annular sandwich plate. Every actuator is used in the form of an actuator laminate that is inserted at the core of the sandwich plate in the form of the patches, where a fruitful arrangement of the patches and a shear-based control strategy are presented for effective attenuation of vibration of the sandwich plate according to the velocity feedback control law. First, the effective properties of the actuator laminate are determined using the Uniform Field Method. Next, a closed-loop finite element model of the sandwich plate is developed based on the layer-wise shear deformation theory. Subsequently, the suitability of the present arrangement of shear actuator patches and the shear-based control strategy are substantiated. This arrangement of the actuator patches is further optimized for every shear actuator, and the corresponding shear actuated resonant displacement-amplitudes of the sandwich plate are evaluated. These results reveal lesser actuation capability of the SAFC than that of the PZT5H while the BL-PFC is the best one for shear-based attenuation of vibration of the annular sandwich plate.
Visco-piezoelasticity-zigzag theories for blast response of porous beams covered by graphene platelet-reinforced piezoelectric layers
Authors: Hajmohammad Mohammad Hadi , Zarei Mohammd Sharif , Kolahchi Reza , Karami Hamed
Published: March 2019

Blast response of the embedded porous beams covered by nanocomposite piezoelectric layers is presented in this article. The facesheets are reinforced by non-uniform graphene platelet where the effective material properties are determined using modified Halpin–Tsai micromechanics model. The piezoelectric layers play the role of sensor and actuator of the core, however, a proportional–differential controller is used for controlling the dynamic deflection of the structure. The sandwich structure is rested on Kerr viscoelastic foundation with two springs, two damper, and one shear elements. Considering structural damping using Kelvin–Voigt model, using piezoelasticity theory, and applying zigzag shear deformation beam theory, the motion equations are derived. Differential quadrature method along with Newmark method is used for calculating the dynamic displacement of the sandwich structure. The effects of different parameters such as graphene platelets volume percentage and distribution type, porosity of the core, geometrical parameters of structure, applied voltage, structural damping, and boundary conditions are shown on the dynamic response of the sandwich structure. The results indicated that reinforcing the facesheets by graphene platelets reduces the dynamic deflection up to 59%.
Nutrition and Environmental Pollution Extension Curriculum Improved Diet-Related Behaviors and Environmental Health Literacy
Authors: Brewer Dawn , Bellamy Hannah , Hoover Anna , Koempel Annie , Gaetke Lisa
Published: March 2019

Kentucky experiences some of the nation’s worst health outcomes related to obesity, diabetes, high blood pressure, and other age-related chronic diseases linked with oxidative stress and inflammation, which in turn are associated with poor diet, lack of physical activity, and exposure to certain environmental pollutants. In the Commonwealth, deteriorating infrastructure, inappropriate waste disposal, and potential occupational injury related to mining, agriculture, and other regionally important industries exacerbate the need for residents to have basic knowledge of potential environmental health threats. Unfortunately, community-level understanding of the complex connections between environmental exposures and health is limited, with many Kentuckians unaware that the Commonwealth is home to 13 hazardous waste sites included in the United States Environmental Protection Agency Superfund National Priorities List (NPL). The NPL highlights priority sites for long-term remedial action to reduce environmental contaminants. To enhance the understanding of environmental health and protective actions, the University of Kentucky Superfund Research Center Community Engagement Core developed a 9-lesson extension curriculum “Body Balance: Protect Your Body from Pollution with a Healthy Lifestyle” (Body Balance) and partnered with Kentucky’s Family and Consumer Sciences (FCS) Cooperative Extension Service to pilot the curriculum in Kentucky communities. FCS agents in 4 Kentucky counties delivered the Body Balance pilot study (18-31 participants per lesson). Pre- and post-lesson questionnaires revealed increased knowledge and awareness of the effects of environmental pollution on health and the protective role of dietary strategies. Focus group participants (n = 18) self-reported positive behavior changes because of increases in knowledge and leadership from their FCS agent. The Body Balance curriculum appeared to be a promising mechanism for raising environmental health and diet knowledge, as well as for promoting positive behavior changes among white, middle/older-aged women in rural Kentucky communities.
Optimum design of the roller profile based on the elastohydrodynamic lubrication model
Authors: Wang Zhijian , Chen Xiaoyang , Shen Xuejin , Zhou Liye
Published: March 2019

Roller profile modification is often used to unify the pressure distribution and to prolong the life of the roller. In this paper, the formula of the optimum modification coefficient for the logarithmically profiled roller is derived to design the roller profile based on the elastohydrodynamic lubrication model of finite-length line contact. In order to demonstrate the feasibility of this formula, a set of fatigue life tests was conducted. The results show that the optimum roller profile predicted by the presented formula can provide the longest fatigue life. Thus, this method can be directly applied.
The integrity of the 2016 US Presidential Election: Exploring the possible impact of ideology on experts’ judgments
Authors: Curini Luigi
Published: March 2019

Using new comparative expert data about the 2016 US Presidential Election, this article explores the effects of experts’ ideological preferences on their evaluations of electoral integrity. Without contesting the claim that the 2016 election faced challenges of integrity, our analyses reveal a substantial association between negative evaluation of election integrity and experts’ ideological orientation. Our results also suggest that this ideological effect is stronger in States that ‘swung’ from Democratic to Republican in the 2016 election.
Issue ownership and the priorities of party elites in the United States, 2004–2016
Authors: Fagan EJ
Published: March 2019

Parties in government prioritize issues that voters trust them to handle more than other parties. However, scholars disagree about whether this relationship exists because parties strategically prioritize issues that voters trust them to handle or whether voters first observe core party priorities while in government and then trust them to handle those issues. This article disentangles these two explanations, arguing that issue ownership is caused by the core priorities of elites. I evaluate this argument by leveraging the privately financed structure of US party-aligned think tanks, which provide important policy information to US political parties. I introduce new data on the policy content of 15,897 white papers published by the leading party-aligned think tanks in the United States. I find that think tanks aligned with both parties tend to distribute more policy attention to their owned issues, although the process works differently for Republicans and Democrats, and that these patterns are durable. I conclude that these results are strong evidence to support elite prioritization explanations for issue ownership, although they do not rule out other explanations.
Larrikins? Wowsers? Hipsters? Snags? What does it mean to be a ‘real man’ in modern-day Australia?
Authors: Adegbosin Adeyinka Emmanuel , Plummer David , Yau Matthew , Franklin Richard , Cordier Reinie , Sun Jing
Published: March 2019

Gender is constructed from social and cultural meanings that dynamically shift and vary. Previous work has assumed that the constructions of masculinity in Australia are like those in other Western societies, and typically focus on qualities such as physical strength, courage and sometimes military engagement. This study explores whether these assumptions hold, by conducting telephone interviews among 617 Queensland men, aged 18 years and above, across all geographical parts of Queensland. This survey was administered in 2013, as part of the Queensland Social Survey series. The study explores the diverse meanings associated with being a ‘real man’ given by the survey participants. Three main dimensions emerged from the thematic analysis: physicality; personality and character; social roles and relationships. The study confirmed that masculinities are dynamic and complex. Responses revealed a surprising emphasis on character and morality 44.5% (n = 684) as defining manhood, as against physical qualities 13.7% (n = 153).
Application of deep artificial neural networks to multi-dimensional flamelet libraries and spray flames
Authors: Owoyele Opeoluwa , Kundu Prithwish , Ameen Muhsin M , Echekki Tarek , Som Sibendu
Published: March 2019

The “curse of dimensionality” has limited the applicability and expansion of tabulated combustion models. While the tabulated flamelet model and other multi-dimensional manifold approaches have shown predictive capability, the associated tabulation involves the storage of large lookup tables, requiring large memory as well as multi-dimensional interpolation subroutines, all implemented during runtime. This work investigates the use of deep artificial neural networks to replace lookup tables in order to reduce the memory footprint and increase the computational speed of tabulated flamelets and related approaches. Specifically, different strategic approaches to training the artificial neural network models are explored and a grouped multi-target artificial neural network is introduced, which takes advantage of the ability of artificial neural networks to map an input space to multiple targets by classifying the species based on their correlation to one another. The grouped multi-target artificial neural network approach is validated by applying it to an n-dodecane spray flame using conditions of the Spray A flame from the Engine Combustion Network and comparing global flame characteristics for different ambient conditions using a well-established large-eddy simulation framework. The same framework is then extended to the simulations of methyl decanoate combustion in a compression ignition engine. The validation studies show that the grouped multi-target artificial neural networks are able to accurately capture flame liftoff, autoignition, two-stage heat release and other quantitative trends over a range of conditions. The use of neural networks in conjunction with the grouping mechanism as performed in the grouped multi-target artificial neural network produces a significant reduction in the memory footprint and computational costs for the code and, thus, widens the operating envelope for higher fidelity engine simulations with detailed mechanisms.
In praise of lameness: A response to William Deresiewicz’s Excellent Sheep
Authors: Hayes David
Published: March 2019

In Excellent Sheep, William Deresiewicz describes ‘elite’ higher education as one in which students perform excellently, but only in a spirit of compliance with assigned tasks. The depth of this problem – which has a long pedigree in philosophy – is such that an advantage might be found in non-‘elite’ and even manifestly lame education. This advantage is illustrated through the story of a low point in my teaching career, in which affects of anger, shame and disappointment erupted into the classroom. Because these negative feelings can make it possible for us to discover that we actually do care, such experiences – precluded by excellent compliance – may be important ones in the course of a meaningful education.
Comprehending Science Writing: The Promise of Dialogic Reading for Supporting Upper Elementary Deaf Students
Authors: Scott Jessica A. , Hansen Sarah Grace
Published: March 2019

Dialogic reading is an instructional strategy that has shown promise for supporting the reading development of children both with and without disabilities. Specifically, there may be positive effects of vocabulary knowledge, morphological knowledge, participation during reading, and emergent literacy skills. However, the knowledge base on the efficacy of dialogic reading with informational text is extremely limited. In addition, there are much available data on the use of dialogic reading with deaf students. The current study describes a multiple baseline single-case design study of a dialogic reading approach used with a deaf student enrolled in upper elementary school. Findings show promise for the dialogic reading approach for use with this genre and this population, though further research is necessary.
Short- and Long-Term Effects of a Tobacco-Free Executive Order on Employee Tobacco Use
Authors: Hahn Ellen J. , Ickes Melinda J. , Wiggins Amanda , Kay Rayens Mary , Polivka Bradley J. , Whelan Parento Emily
Published: March 2019

Smoke-free workplace policies encourage cessation, reduce tobacco consumption, and shift the pro-tobacco norm. However, no research exists evaluating the impact of mandated tobacco-free policies on government property. The purpose of our study was to examine short- and long-term effects of a tobacco-free policy (executive order 2014-747) implemented in November 2014, prohibiting tobacco use on state executive property. Cross-sectional online surveys were administered at two time points to a total of 27,000 employees of the executive branch of the Commonwealth of Kentucky. The short-term evaluation (March 2015) comprised 4,170 employees and the long term (August 2015) included 3,070. Tobacco use, plans to quit using tobacco, personal characteristics, whether the county of their workplace was covered by a smoke-free policy, and social norms for tobacco use were assessed 4- and 9-month post-policy implementation. Current tobacco use and plans to quit were compared between short- and long-term evaluations using multiple logistic regression with relevant covariates included. Controlling for demographics and employment location, employees reported lower rates of tobacco use and higher rates of planning to quit in the long term than in the short term. Tobacco-free policies reduce tobacco use prevalence and promote plans to quit, particularly over time. We found differences in tobacco use prevalence and plans to quit using tobacco products from 4 to 9 months after the policy took effect, as reported by employees following implementation of the tobacco-free policy. These findings support the potential for avoiding long-term health care costs as a result of reduced tobacco use from these policies. Nurses can play an important advocacy and policy evaluation role to promote and assess the impact of tobacco-free policies.
Assessment of Gestational Diabetes Mellitus Outcomes for Hispanic Women Living in the Rio Grande Valley
Authors: Somohano-Mendiola Norma , Champion Jane Dimmitt , Vatcheva Kristina
Published: March 2019

Introduction:

Gestational diabetes mellitus (GDM) among women living along the U.S.–Mexico border are approximately twice that of the general population of pregnant U.S. women. This study compared outcomes for Hispanic pregnant women diagnosed and treated for GDM (i.e., two abnormal 3-hour oral glucose tolerance tests [OGTT]) with those who were screened but had only one abnormal 3-hour OGTT and therefore received no treatment.

Methods:

Retrospective chart review of pregnant Hispanic women of Mexican origin ( N = 95), with GDM ( N = 41) or one abnormal 3-hour OGTT value ( N = 54) who delivered between January 1, 2015, and December 31, 2017.

Results:

No significant differences were found between the two groups with regard to sociodemographic variables, hyperbilirubinemia, or other adverse neonatal outcomes. Comparisons identified differences between women with and without adverse neonatal outcomes concerned type of delivery; there were more C-sections among women with GDM.

Conclusion:

Pregnant women with one abnormal 3-hour OGTT value are at risk of giving birth to neonates with biomarkers similar to those diagnosed and treated for GDM. The treatment of hyperglycemia in Hispanic women of Mexican origin with one abnormal 3-hour OGTT value may improve the health outcomes and quality of life of the mother and the neonate. More research is warranted to clarify the risk of adverse outcomes of diverse pregnant women who do not meet guidelines for diagnosis of GDM.
Delay-constrained flooding in extremely low-duty-cycle sensor networks
Authors: Fan Zuzhi
Published: March 2019

Flooding is a fundamental function for the network-wide dissemination of command, query, and code update in wireless sensor networks. However, it is challenging to enable fast and energy-efficient flooding in sensor networks with low-duty cycles because it is rare that multiple neighboring nodes wake up at the same time, making broadcast instinct of wireless radio unavailable. The unreliability of wireless links deteriorates the situation. In this work, we study the delay-constrained flooding problem in order to disseminate data packets to all nodes within given expected delivery delay. In particular, a transmission power control–based flooding algorithm is proposed to reduce the flooding delay in such low-duty-cycle sensor networks. According to the soft delay bound, each node can locally adjust its transmission power level. To alleviate transmission conflicts, the backoff method with transmission power adaptive mechanism has been proposed. Based on the large-scale simulations, we validate that our design can reduce flooding delay with small extra energy expenditure compared with conventional flooding schemes.
From Law to Policy and Practice: Lessons Learned From a Policy Discriminating Against English Learners
Authors: Everson Emma G. , Hedges Samantha
Published: March 2019

This case illustrates the importance for school leaders and teachers to be knowledgeable about current legal precedent when creating district and school policies. We describe a legal battle that occurred in Lancaster, Pennsylvania, in which a school district instituted a policy affecting English learners that was in violation of two federal laws. Then, we analyze the case to explain the barriers school leaders encounter that prevent them from operationalizing federal laws and policies. We conclude by arguing the need for the legal literacy of school leaders to create district and school policies and train the teachers working under their direction.
The 70° Supinated Oblique View: A Cadaveric Analysis to Determine Ideal Radial Styloid Screw Position in Locked Volar Plating of Distal Radius Fractures
Authors: Sumner Kirsten , Grandizio Louis C. , Schultz Samantha , Klena Joel C.
Published: March 2019

Background: Defining an intraoperative radiographic view to best determine the radial styloid screw position in locked volar plating of distal radius fractures may improve fixation and aid in decreasing cortical penetration and implant complication. We used a cadaveric model to demonstrate a reproducible, oblique radiographic view to identify the radial styloid screw position. Methods: Nine fresh-frozen elbow-to-fingertip cadavers were used for this study. A 2.4-mm variable angle volar distal radius locking plate was applied to the distal radius. A Kirschner wire (K-wire) was inserted into the radial styloid through the plate. Placement of the K-wire through the tip of the styloid at the cortical edge was confirmed through a separate radial incision. A second K-wire was placed through the radius shaft into the ulna to aid in angular measurements. Live fluoroscopic imaging was used as the forearm was brought from full 90° of supination toward neutral. Once the K-wire was abutting the cortical edge, rotation ceased, and a goniometer was used to measure the angle of forearm rotation. This was repeated for a total of 3 repetitions on each specimen. Results: The average angle of supination best depicting the position of the radial styloid screw was 68.5° (range = 64.3°-70.5°). Conclusions: Radial styloid screw fixation in locked volar plating of distal radius fractures increases the ultimate strength to failure, but screw penetration and tendon irritation can occur. The 70° supinated oblique intraoperative view provides the most accurate evaluation of the position of the radial styloid screw.
Metameric spinal AVM: Long-term symptomatic relief achieved by embolization of the extradural component
Authors: Drake B , Patro S , Quateen A , Cora EA , Finitsis S , Sinclair J , Lesiuk H , Iancu D
Published: March 2019

Background

Metameric spinal cord arteriovenous malformations (AVMs) are rare lesions characterized by an intradural and extradural component. They are difficult to treat surgically by the endovascular route. We report a case in which symptomatic relief was achieved by embolization of the extradural component only.

Case presentation

A 35-year-old woman presented with acute worsening of back pain, weakness in the left leg and urinary retention. Spinal angiography showed a metameric spinal cord AVM with partial common venous drainage of the extradural and intradural components.

Conclusions

Targeted embolization of the extradural component led to dramatic improvement of the patient’s symptoms, probably by achieving venous decongestion. She remains neurologically stable at two years’ follow-up.
Balloon-assisted coiling of cerebral aneurysms with the dual-lumen Scepter XC balloon catheter: Experience at two high-volume centers
Authors: Wallace Adam N , Samaniego Edgar , Kayan Yasha , Derdeyn Colin P , Delgado Almandoz Josser E , Dandapat Sudeepta , Fease Jennifer L , Thomas Mary , Milner Anna M , Scholz Jill M , Ortega-Gutiérrez Santiago
Published: March 2019

Background

The Scepter XC is a dual-lumen balloon catheter that accommodates a 0.014-inch microwire and can be used for balloon-assisted coiling of cerebral aneurysms. We describe our experience with the use of this device.

Methods

Two high-volume institution neurointerventional databases were retrospectively reviewed for cerebral aneurysms treated with balloon-assisted coiling using the Scepter XC balloon catheter. Patient demographics, aneurysm characteristics, and procedural details were recorded. Major procedure-related neurologic complications were defined as events that caused an increase in modified Rankin Scale that persisted for more than 1 week after the procedure. Follow-up aneurysm occlusion was assessed using the Raymond-Roy classification.

Results

During the study period, 231 aneurysms were treated in 219 patients (152 women, 67 men) with a mean age of 58.4 ± 12.2 years. Mean aneurysm size was 6.1 ± 3.1 mm, with a mean neck diameter of 3.1 ± 1.3 mm. In total, 77.5% of aneurysms were wide necked, and 39.8% were treated in the setting of subarachnoid hemorrhage. The major complication rate was 0.9% (2/231) per treated aneurysm, including one stroke and one death related to intraoperative aneurysm rupture. Excluding patients who died, angiographic follow up was available for 85.3% (191/224) of aneurysms. During a mean follow up of 17.4 ± 13.0 months (range, 1.7–66.5 months), Raymond-Roy 1 and 2 occlusion rates were 56.5% (108/191) and 35.6% (68/191), respectively. The retreatment rate was 12.6% (24/191).

Conclusion

Our experience using the coaxial dual-lumen Scepter XC for balloon-assisted coiling demonstrates acceptable aneurysm occlusion and complication rates.
Experimental investigation of pressure pulsation induced by the floor-attached vortex in an axial flow pump
Authors: Song Xijie , Liu Chao
Published: March 2019

The pressure pulsation test in an axial flow pump with and without the floor-attached vortex was performed. Pressure sensors were mounted on the impeller inlet section and impeller outlet section and guide vane section outlet of the axial flow pump. The investigations showed that the pressure pulsation in the axial flow pump was mainly affected by the impeller rotation. The time-domain characteristic curves of the pressure pulsation at the impeller inlet and outlet changed the most at different periods when the floor-attached vortex appeared in the pump sump. There was no significant difference between the time-domain characteristic curves of the pressure pulsation with and without the floor-attached vortex at the guide vane outlet. The pressure pulsation induced by the floor-attached vortex was a low-frequency pulsation of 2.12 Hz, which fluctuates periodically with time in the form of a trigonometric function. The pressure pulsation amplitudes with the floor-attached vortex were larger than those without the floor-attached vortex. The floor-attached vortex mainly affected the pressure pulsation in the impeller and had less influence on the pressure pulsation at the guide vane outlet due to the rectifying effect of the guide vane.
Globalization of clinical trials: Variation in estimated regional costs of pivotal trials, 2015–2016
Authors: Qiao Yao , Alexander G Caleb , Moore Thomas J
Published: March 2019

Background/Aims

Despite the increasing globalization of clinical trials, little is known regarding how the trial site costs vary around the world. We quantified the geographical distribution and regional cost differences for the clinical trials that established the benefits for new therapeutic drugs approved by the US Food and Drug Administration in 2015 and 2016.

Methods

We included all pivotal clinical trials for 59 new molecular entities approved by the US Food and Drug Administration in 2015 and 2016 that included at least one site in North America. We derived cost estimates from IQVIA’s CostPro, a global clinical trial cost-estimating tool used by pharmaceutical sponsors. We assessed the patient and site allocation of these trials across eight geographic regions. To quantify the region-specific cost differences, we conducted a within-trial comparison by expressing the estimated regional costs associated with the sites in each global region as a percent of the same costs in North America. We also estimated the percentage breakdown of regional cost components (pass-through, site management, regulatory, and study conduct costs) for each trial and for all endpoints reported the median and interquartile range.

Results

Overall, 127 pivotal clinical trials enrolled 91,415 patients from 13,264 sites. Most patients (60.3%) and sites (57.3%) were outside North America. A median of 66% of the total estimated trial costs (interquartile range: 60%–72%) were spent on regional tasks, with the largest share (53.3%) going directly to trial sites and the remainder going to other regional trial management tasks. Differences were greatest in four lower cost regions: Africa, with an estimated regional cost per site of 49% of North America (interquartile range: 44%–56%), Central Europe 50% (interquartile range: 41%–63%), Middle East 53% (interquartile range: 42%–64%) and Latin America 59% (interquartile range: 50%–70%). Overall, 90 (71%) of the 127 pivotal trials had a total of 3160 sites in these lower cost regions. In contrast, savings were more limited in Western Europe, Oceania, and Asia, where estimated regional costs were 78% of North America (interquartile range: 67%–89%). One-quarter of the trials with sites in Asia and Oceana did not achieve cost savings in those regions relative to North America.

Conclusion

Among this sample of pivotal trials for recently approved US Food and Drug Administration products, most patients and sites enrolled were outside of North America, with selection of regional sites having a significant impact on total trial costs.
Instructional leadership and teachers' intent to leave: The mediating role of collective teacher efficacy and shared vision
Authors: Qadach Mowafaq , Schechter Chen , Da’as Rima’a
Published: March 2019

Keeping experienced and competent teachers in schools is becoming an important challenge for school leadership. Hence, this research tested an innovative model which explored the direct and indirect relationship between principals’ instructional leadership, collective teacher efficacy, a shared vision, and a teacher’s intent to leave their profession. Data were collected from a survey of 1700 teachers from 130 Jewish and Arab elementary schools randomly selected from the database of the Israeli education system. To test the proposed multilevel model, we conducted multilevel structural equation modeling. The analysis confirmed that collective teacher efficacy and shared vision emerge as prominent mediators between principals’ instructional leadership and a teacher’s intent to leave. Regarding the differences between the two sectors (Arab and Jewish) that exist in the Israeli education system, collective teacher efficacy, as well as shared vision, played a mediating role between instructional leadership and a teacher’s intent to leave in the Jewish elementary schools, while in the Arab elementary schools, only collective teacher efficacy played a mediating role between instructional leadership and a teacher’s intent to leave. This study adds to the body of research directed at identifying administrative support and work-related factors that may decrease a teacher’s intent to leave and are amenable to leadership intervention.
The randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion (SKIP study)
Authors: Suzuki Kentaro , Kimura Kazumi , Takeuchi Masataka , Morimoto Masafumi , Kanazawa Ryuzaburo , Kamiya Yuki , Shigeta Keigo , Ishii Norihiro , Takayama Yohei , Koguchi Yorio , Takigawa Tomoji , Hayakawa Mikito , Ota Takahiro , Okubo Seiji , Naito Hiromichi , Akaji Kazunori , Kato Noriyuki , Inoue Masato , Hirano Teruyuki , Miki Kazunori , Ueda Toshihiro , Iguchi Yasuyuki , Fujimoto Shigeru , Otsuka Toshiaki , Matsumaru Yuji
Published: March 2019

Rationale

Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear.

Aim

This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy.

Methods and design

This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy.

Study outcome

The primary efficacy endpoint is a modified Rankin Scale score of 0–2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h.

Discussion

This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities.

Trial registration

UMIN000021488.
The potential risk of tumor progression after use of dehydrated human amnion/chorion membrane allograft in a positive margin resection model
Authors: Alvim Ricardo G. , Hughes Christopher , Somma Alexander , Nagar Karan K. , Wong Nathan C. , La Rosa Stephen , Monette Sebastien , Kim Kwanghee , Coleman Jonathan A.
Published: March 2019

Objective:

The objective of this study was to examine the impact of dehydrated human amnion/chorion membrane (dHACM) allografts on prostate and bladder cancer growth in the setting of residual disease and positive surgical margins.

Materials and methods:

A commercially available version of dHACM was used. Cytokines were identified and quantified, followed by comparative analysis of cell growth in two different human cell lines: prostate cancer (LNCaP) and bladder cancer (UM-UC-3), in vitro and in vivo. Tumor growth between the two groups, membrane versus no membrane implant, was compared and immunohistochemistry studies were conducted to quantify CD-31, Ki-67, and vimentin. A Student’s unpaired t-test was used to determine statistical significance.

Results:

The UM-UC-3 and LNCaP cells grew quicker in medium plus 10% serum and dHACM extract than in the other media ( p = 0.03). A total of 28 distinct cytokines were found in the extract, 11 of which had relatively high concentrations and are associated with prostate and bladder cancer tumor progression. In vivo LNCaP model, after 10 weeks, the median tumor volume in the membrane group was almost threefold larger than the partial resection alone ( p = 0.01). Two weeks after resection, in the UM-UC-3 model, the membrane group reached fourfold larger than the partial resection without membrane group ( p < 0.01). In both groups, the expression of CD-31 and Ki-67 markers were similar and showed no statistical significance ( p > 0.05). It was only in the LNCaP tumors that vimentin expression was significantly higher in the group without membrane compared with the membrane group ( p = 0.008).

Conclusion:

The use of dHACM after partial tumor resection is related to faster tumor relapse and growth in prostate and urothelial cancer in vivo models, showing a potential risk of rapid local recurrence in patients at high risk of positive margins.
The use of penile traction therapy in the management of Peyronie's disease: current evidence and future prospects
Authors: Valenzuela Robert , Ziegelmann Matthew , Tokar Sam , Hillelsohn Joel
Published: March 2019

Peyronie’s disease is a disorder of abnormal and dysregulated wound healing leading to scar formation in the tunica albuginea of the penis. Penile traction therapy has emerged as an attractive therapeutic option for men with Peyronie’s disease in both the acute and chronic phases. Currently, clinical studies are limited by lack of randomization, small cohorts, and lack of patient compliance with therapy. Despite these shortcomings, studies have shown a potential benefit with minimal morbidity. Specifically, penile traction may help to preserve or increase penile length and reduce penile curvature when used as monotherapy or as adjuvant therapy for surgical and intralesional treatments. Further study is necessary to define patient characteristics that are predictive of improved outcomes, determine the duration of treatment needed for clinical effect, and improve patient compliance.
Clinical importance of the posterior meningeal artery: a review of the literature
Authors: Wang Guangming , Yu Jing , Hou Kun , Guo Yunbao , Yu Jinlu
Published: March 2019

The posterior meningeal artery, which arises from the vertebral artery, is a critical artery in neurological lesions. However, a comprehensive review of the importance of the posterior meningeal artery is currently lacking. In this study, we used the PubMed database to perform a review of the literature on the posterior meningeal artery to increase our understanding of its role in vascular lesions. The posterior meningeal artery provides the main blood supply to the paramedial and medial portions of the dura covering the cerebellar convexity. The posterior meningeal artery is often involved in dural arteriovenous fistulas occurring near the posterior fossa, and the posterior meningeal artery can be the path for transarterial embolisation or a path through which to monitor the degree of dural arteriovenous fistula embolisation. In posterior circulation ischaemia and moyamoya disease, the posterior meningeal artery can form transdural anastomoses with pial arteries at the surface of the brain, and these can help prevent ischemia. The posterior meningeal artery can also develop aneurysms, most of which are traumatic pseudoaneurysms; patients should therefore be treated in a timely manner or followed up carefully in cases of rebleeding. In addition, during a craniotomy, the posterior meningeal artery should be protected intraoperatively to avoid damaging any transdural anastomosis that may be present. In addition, when the posterior meningeal artery is the main feeding artery of an intracranial tumour, that artery is a satisfactory path for preoperative embolisation. Briefly, the posterior meningeal artery is a very important artery in neurosurgery.
Restarting antidepressant and antipsychotic medication after intentional overdoses: need for evidence-based guidance
Authors: Tay Emma , Sotiriou Andreas , Graham Garry G. , Wilhelm Kay , Snowden Leone , Day Richard O.
Published: March 2019

Intentional drug overdoses with antidepressant and antipsychotic medications are an increasingly common problem. Currently, there is little guidance with regard to reintroduction of these medications after intentional overdoses. We have used published toxicological and pharmacokinetic data to obtain factors which control the recovery from overdoses. From such data, we have proposed guidance regarding their reintroduction, provided there are no adverse effects or contraindications. Tentatively, we suggest that when adverse effects from the overdose are lost, treatment could recommence after a further mean half-life of elimination. Most antidepressant and antipsychotic drugs are metabolized by cytochrome P450 enzymes and, where cytochrome P450 inhibitors are co-ingested, serial plasma concentrations should optimally be obtained in order to assess a suitable time for reintroduction of the psychoactive drugs. We hope the proposals presented will stimulate research and discussion that lead to better guidance for clinicians concerning reintroduction of psychoactive medication after intentional overdose.
The treatment of achalasia patients with esophageal varices: an international study
Authors: Pesce M , Magee C , Holloway RH , Gyawali CP , Roman S , Pioche M , Savarino E , Quader F , Sarnelli G , Sanagapalli S , Bredenoord AJ , Sweis R
Published: March 2019

Background

Treatment options for achalasia include endoscopic and surgical techniques that carry the risk of esophageal bleeding and perforation. The rare coexistence of esophageal varices has only been anecdotally described and treatment is presumed to carry additional risk.

Methods

Experience from physicians/surgeons treating this rare combination of disorders was sought through the International Manometry Working Group.

Results

Fourteen patients with achalasia and varices from seven international centers were collected (mean age 61 ± 9 years). Five patients were treated with botulinum toxin injections (BTI), four had dilation, three received peroral endoscopic myotomy (POEM), one had POEM then dilation, and one patient underwent BTI followed by Heller's myotomy. Variceal eradication preceded achalasia treatment in three patients. All patients experienced a significant symptomatic improvement (median Eckardt score 7 vs 1; p < 0.0001) at 6 months follow‐up, with treatment outcomes resembling those of 20 non‐cirrhotic achalasia patients who underwent similar therapy. No patients had recorded complications of bleeding or perforation.

Conclusion

This study shows an excellent short‐term symptomatic response in patients with esophageal achalasia and varices and demonstrates that the therapeutic outcomes and complications, other than transient encephalopathy in both patients who had a portosystemic shunt, did not differ to disease‐matched patients without varices.
Recurrence rate of hepatocellular carcinoma in patients with treated hepatocellular carcinoma and hepatitis C virus‐associated cirrhosis after ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin therapy
Authors: Preda Carmen M , Baicus Cristian , Sandra Irina , Oproiu Alexandru , Manuc Teodora , Constantinescu Ileana , Gavrila Daniel , Diculescu Mircea , Dumitru Radu , Vasilescu Catalin , Tieranu Cristian , Istratescu Doina , Voiosu Theodor , Manuc Mircea
Published: March 2019

Introduction

Recent studies have suggested a higher recurrence rate of hepatocellular carcinoma (HCC) in patients with a history of HCC and hepatitis C virus (HCV)‐associated cirrhosis treated with direct‐acting antiviral (DAA) agents.

Material and methods

We conducted a prospective analysis of 24 patients with HCV‐associated cirrhosis and treated HCC who received ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for 12 weeks. Prior therapies for HCC included resection (9/24 patients), radiofrequency ablation (RFA) (7/24) and trans‐arterial chemoembolization (TACE) (8/24). All patients were eligible for treatment if they had no HCC recurrence 6 months after their last procedure. A control group was defined. All patients were followed every 6 months, with dynamic computed tomography and/or magnetic resonance imaging.

Results

The sustained virological response rate per protocol was 21/24 (87.5%). The study group included 14 (59%) males, median age 64 years (51–77), 50% with associated non‐alcoholic steatohepatitis and 24% with Child–Pugh A6 points. HCC recurrence rate/100 patient‐years was lower in the DAA‐HCC group versus control: 5.5 versus 24.6% patient‐years for the resection+RFA group (p = 0.044), respectively, and 18.6 versus 72.7% patient‐years for TACE group (p = 0.002). Survival without recurrence was higher in the resection+RFA group (45 compared to 18 months (p < 0.001)) and also in the TACE group (44 compared to 11.5 months (p = 0.002)).

Conclusions

DAA therapy significantly reduced the recurrence rate of HCC and improved survival without recurrence in patients with treated HCV‐associated HCC.
Free Speech and Safe Spaces: How Moderation Policies Shape Online Discussion Spaces
Authors: Gibson Anna
Published: March 2019

How do moderation policies affect online discussion? This article analyzes nearly a quarter of a million anonymous comments over a 14-month period from two online Reddit forums matched in topic and size, but with differing moderation policies of “safe space” and “free speech.” I found that in the safe space, moderators removed significantly more comments, and authors deleted their own comments significantly more often as well, suggesting higher rates of self-censorship. Looking only at relatively low frequency posters, I found that language in the safe space is more positive and discussions are more about leisure activities, whereas language in the free speech space is relatively negative and angry, and material personal concerns of work, money, and death are more frequently discussed. Importantly, I found that many of these linguistic differences persisted even in comments by users who were concurrently posting in both subreddits. Altogether, these results suggest that differences in moderation policies may affect self-censorship and language use in online space, implicating moderation policies as key sites of inquiry for scholars of democratic discussion.
The Relationship Between Social Media Data and Crime Rates in the United States
Authors: Wang Yan , Yu Wenchao , Liu Sam , Young Sean D.
Published: March 2019

Crime monitoring tools are needed for public health and law enforcement officials to deploy appropriate resources and develop targeted interventions. Social media, such as Twitter, has been shown to be a feasible tool for monitoring and predicting public health events such as disease outbreaks. Social media might also serve as a feasible tool for crime surveillance. In this study, we collected Twitter data between May and December 2012 and crime data for the years 2012 and 2013 in the United States. We examined the association between crime data and drug-related tweets. We found that tweets from 2012 were strongly associated with county-level crime data in both 2012 and 2013. This study presents preliminary evidence that social media data can be used to help predict future crimes. We discuss how future research can build upon this initial study to further examine the feasibility and effectiveness of this approach.