bluuebunny/crossref_metadata_2025_split huggingface dataset:
Advances in extracorporeal membrane oxygenator design for artificial placenta technology
Authors: Blauvelt David G. , Abada Emily N. , Oishi Peter , Roy Shuvo 
Published: September 2020

AbstractExtreme prematurity, defined as a gestational age of fewer than 28 weeks, is a significant health problem worldwide. It carries a high burden of mortality and morbidity, in large part due to the immaturity of the lungs at this stage of development. The standard of care for these patients includes support with mechanical ventilation, which exacerbates lung pathology. Extracorporeal life support (ECLS), also called artificial placenta technology when applied to extremely preterm (EPT) infants, offers an intriguing solution. ECLS involves providing gas exchange via an extracorporeal device, thereby doing the work of the lungs and allowing them to develop without being subjected to injurious mechanical ventilation. While ECLS has been successfully used in respiratory failure in full‐term neonates, children, and adults, it has not been applied effectively to the EPT patient population. In this review, we discuss the unique aspects of EPT infants and the challenges of applying ECLS to these patients. In addition, we review recent progress in artificial placenta technology development. We then offer analysis on design considerations for successful engineering of a membrane oxygenator for an artificial placenta circuit. Finally, we examine next‐generation oxygenators that might advance the development of artificial placenta devices.
The expression and prognostic relevance of programmed cell death protein 1 in tongue squamous cell carcinoma
Authors: Tervo Sanni , Seppälä Miia , Rautiainen Markus , Huhtala Heini , Salo Tuula , Al‐Samadi Ahmed , Kuopio Teijo , Ahtiainen Maarit , Tommola Satu , Paavonen Timo , Toppila‐Salmi Sanna 
Published: September 2020

Programmed cell death protein 1 (PD‐1) is an immune checkpoint receptor which plays an important role in a patient's immune responses to microbial and cancer antigens. It is expressed in tumor‐infiltrating lymphocytes (TILs) with many different malignancies. The aim of the study was to evaluate PD‐1 expression and its prognostic value in tongue cancer. The data of tongue squamous cell carcinoma (TSCC) patients (N = 81) treated in Tampere University Hospital between 1999 and 2013 were used. Control data consisted of patients with non‐malignant tongue mucous membrane lesions (N = 48). The formalin‐fixed paraffin‐embedded samples were stained immunohistochemically and scanned via digital microscope. The staining of PD‐1 was examined semi‐quantitatively. The density and intensity of PD‐1 + cells were significantly higher in TSCC than in control samples. The expression of PD‐1 correlated with better survival. The expression of PD‐1 could be a potential prognostic marker in TSCC. Further research using larger sample size is needed.
The Selective Shield of Due Process: Analysis of the U.S. Department of Education's 2020 Title IX Regulations on Live Cross‐Examination
Authors: Holland Kathryn J. , Bedera Nicole , Webermann Aliya R. 
Published: September 2020

AbstractThe U.S. Department of Education (DoE) released new Title IX regulations in May 2020, including the requirement that postsecondary institutions conduct live hearings with direct cross‐examination for sexual misconduct reports. The 2,033‐page document included a summary of public comments and the DoE's discussion of those comments. We analyzed this publicly available document to answer two questions. (1) What are the primary concerns of the cross‐examination requirement for victims within the Department's summary of public comments? (2) How did the Department respond to these victim concerns? We conducted a content analysis, with a specific focus on the DoE's summary of survivor‐focused comments regarding cross‐examination and the DoE's discussion of and changes made in response to those comments. We identified four overarching survivor‐focused concerns and four categories of DoE responses. Our findings suggest that the DoE did not meaningfully address survivor‐focused concerns, but instead, selectively wielded “due process” as a shield to deflect critiques and legitimize the myth that sexual misconduct allegations inherently lack “credibility.” The lack of protections for victims is a significant departure from legal norms in other settings. Our findings identify the importance of legislators working with survivor‐activists, practitioners, and researchers to ensure complainants receive adequate procedural protections.
The cooccurrence of heightened media attention and adverse drug reaction reports for hormonal contraception in the United Kingdom between 2014 and 2017
Authors: Postma Lobke Geesje Maria , Donyai Parastou 
Published: September 2020

AimThe aim of this study was to examine the cooccurrence of heightened media attention after the publication of a paper by Skovlund et al in September 2016 on the link between hormonal contraception and depression or mood on adverse drug reaction (ADR) reports in the UK.MethodsA quantitative analysis of relevant newspaper articles published between January 2014 and December 2017 was performed, as well as a content analysis. ADR reports were collected from the Medicines and Healthcare Products Regulatory Agency website and via a Freedom of Information request. A quantitative analysis was performed on ADR reports of hormonal contraceptives for all ADRs and for depressed mood disorders and disturbances.ResultsThe publication of the Skovlund et al paper did not lead to a peak in relevant newspaper articles, but there was a change in the content of the newspaper articles, which focussed more on the link between hormonal contraceptives and depression or mood. There was an overall increase in ADR reports by women relating to hormonal contraceptives between 2016 and 2017, and for combined contraceptives this was due to an increase in ADR reports of depressed mood disorders and disturbances.ConclusionsThe content of media attention appears to affect ADR reporting by women for combined contraceptives. In general, patients report the majority of depressed mood disorders and disturbances ADRs as opposed to health professionals, who report other ADRs. Care providers can anticipate the effect of heightened media attention and help patients when they experience these ADRs.
Risky research and bystander consent
Authors: Hanser Matthew 
Published: September 2020

AbstractThere is no quick and easy answer to the question whether research activities that endanger bystanders without their consent ever thereby violate those bystanders’ rights. We cannot dismiss the idea that bystanders possess strong rights against researchers simply on the grounds that they are, after all, merely bystanders. Indeed, it is easy to imagine scenarios in which researchers would be morally required to gain the informed consent of bystanders whom they risk harming. Whether bystander consent is required in any particular real‐world case will depend, in part, upon exactly how the research activity endangers them.
Improving precision and power in randomized trials for COVID‐19 treatments using covariate adjustment, for binary, ordinal, and time‐to‐event outcomes
Authors: Benkeser David , Díaz Iván , Luedtke Alex , Segal Jodi , Scharfstein Daniel , Rosenblum Michael 
Published: September 2020

AbstractTime is of the essence in evaluating potential drugs and biologics for the treatment and prevention of COVID‐19. There are currently 876 randomized clinical trials (phase 2 and 3) of treatments for COVID‐19 registered on clinicaltrials.gov. Covariate adjustment is a statistical analysis method with potential to improve precision and reduce the required sample size for a substantial number of these trials. Though covariate adjustment is recommended by the U.S. Food and Drug Administration and the European Medicines Agency, it is underutilized, especially for the types of outcomes (binary, ordinal, and time‐to‐event) that are common in COVID‐19 trials. To demonstrate the potential value added by covariate adjustment in this context, we simulated two‐arm, randomized trials comparing a hypothetical COVID‐19 treatment versus standard of care, where the primary outcome is binary, ordinal, or time‐to‐event. Our simulated distributions are derived from two sources: longitudinal data on over 500 patients hospitalized at Weill Cornell Medicine New York Presbyterian Hospital and a Centers for Disease Control and Prevention preliminary description of 2449 cases. In simulated trials with sample sizes ranging from 100 to 1000 participants, we found substantial precision gains from using covariate adjustment–equivalent to 4–18% reductions in the required sample size to achieve a desired power. This was the case for a variety of estimands (targets of inference). From these simulations, we conclude that covariate adjustment is a low‐risk, high‐reward approach to streamlining COVID‐19 treatment trials. We provide an R package and practical recommendations for implementation.
Collective cancer cell invasion in contact with fibroblasts through integrin‐α5β1/fibronectin interaction in collagen matrix
Authors: Miyazaki Kaoru , Togo Shinsaku , Okamoto Reiko , Idiris Alimjan , Kumagai Hiromichi , Miyagi Yohei 
Published: September 2020

AbstractInteraction of cancer cells with cancer‐associated fibroblasts (CAFs) plays critical roles in tumor progression. Recently we proposed a new tumor invasion mechanism in which invasive cancer cells individually migrate on elongate protrusions of CAFs (CAF fibers) in 3‐D collagen matrix. In this mechanism, cancer cells interact with fibronectin fibrils assembled on CAFs mainly through integrin‐α5β1. Here we tested whether this mechanism is applicable to the collective invasion of cancer cells, using two E‐cadherin‐expressing adenocarcinoma cell lines, DLD‐1 (colon) and MCF‐7 (breast). When hybrid spheroids of DLD‐1 cells with CAFs were embedded into collagen gel, DLD‐1 cells collectively but very slowly migrated through the collagen matrix in contact with CAFs. Epidermal growth factor and tumor necrosis factor‐α promoted the collective invasion, possibly by reducing the E‐cadherin junction, as did the transforming growth factor‐β inhibitor SB431542 by stimulating the outgrowth of CAFs. Transforming growth factor‐β itself inhibited the cancer cell invasion. Efficient collective invasion of DLD‐1 cells required large CAF fibers or their assembly as stable adhesion substrates. Experiments with function‐blocking Abs and siRNAs confirmed that DLD‐1 cells adhered to fibronectin fibrils on CAFs mainly through integrin‐α5β1. Anti‐E‐cadherin Ab promoted the single cell invasion of DLD‐1 cells by dissociating the E‐cadherin junction. Although the binding affinity of MCF‐7 cells to CAFs was lower than DLD‐1, they also collectively invaded the collagen matrix in a similar fashion to DLD‐1 cells. Our results suggest that the direct interaction with CAFs, as well as environmental cytokines, contributes to the collective invasion of cancers.
The fence technique: Autogenous bone graft versus 50% deproteinized bovine bone matrix / 50% autogenous bone graft—A clinical double‐blind randomized controlled trial
Authors: Merli Mauro , Nieri Michele , Mariotti Giorgia , Merli Marco , Franchi Lorenzo , Quiroga Souki Bernardo 
Published: September 2020

AbstractObjectivesThe aim of this short‐term double‐blind, parallel, randomized clinical trial was to compare bone augmentation grafting with 100% autogenous bone (AB) or 50% deproteinized bovine bone matrix (DBBM)/ 50% autogenous bone (BOAB) using a guided bone regeneration procedure, the fence technique, in a two‐stage implant placement.Material and methodsPartially edentulous patients with extensive three‐dimensional osseous defects were included in this study. The main outcome measure was the differences in bone volume from pre‐surgery (T1) to 6 months post‐surgery (T2). Bone height, chair‐time, pain, functional limitation, and complications were also assessed.ResultsFifteen patients were allocated to the AB group and 15 patients to the BOAB group. The difference in bone volume from T1 to T2 was 648 mm3 for the AB group and 869mm3 for the BOAB group (difference between groups 221 mm3, 95% CI from −363 to 804, p = .442). The surgery pain VAS was 1.6 for the AB group and 2.3 for the BOAB group (difference between groups 0.8, 95% CI from 0.0 to 1.5, p = .045 favoring the AB group). The height difference in bone from T1 to T2 was 2.2 mm for the AB group and 3.7 mm for the BOAB group (difference between groups 1.5mm, 95% CI from 0.1 to 2.9, p = .038 favoring the BOAB group). For complications, chair‐time, post‐surgery pain, and functional limitation, there were no differences between AB and BOAB.ConclusionsNo significant differences, except for surgery pain VAS and difference in bone height, were observed in this trial comparing grafting with AB or BOAB.
Approaches to interdisciplinary mixed methods research in land‐change science and environmental management
Authors: Kinnebrew Eva , Shoffner Elizabeth , Farah‐Pérez Aldo , Mills‐Novoa Megan , Siegel Katherine 
Published: September 2020

AbstractCombining qualitative and quantitative methods and data is crucial to understanding the complex dynamics and often interdisciplinary nature of conservation. Many conservation scientists use mixed methods, but there are a variety of mixed methods approaches, a lack of shared vocabulary, and few methodological frameworks. We reviewed articles from 2 conservation‐related fields that often incorporate qualitative and quantitative methods: land‐change science (n = 16) and environmental management (n = 16). We examined how authors of these studies approached mixed methods research by coding key methodological characteristics, including relationships between method objectives, extent of integration, iterative interactions between methods, and justification for use of mixed methods. Using these characteristics, we created a typology with the goal of improving understanding of how researchers studying land‐change science and environmental management approach interdisciplinary mixed methods research. We identified 5 types of mixed methods approaches, which we termed simple nested, informed nested, simple parallel, unidirectional synthesis, and bidirectional synthesis. Methods and data sources were often used to address different research questions within a project, and only around half of the reviewed papers methodologically integrated different forms of data. Most authors used one method to inform the other, rather than both informing one another. Very few articles used methodological iteration. Each methodological type has certain epistemological implications, such as the disciplinary reach of the research and the capacity for knowledge creation through the exchange of information between distinct methodologies. To exemplify a research design that can lead to multidimensional knowledge production, we provide a methodological framework that bidirectionally integrates and iterates qualitative and quantitative methods.
Epidemiology of haemorrhoids and publicly funded excisional haemorrhoidectomies in New Zealand (2007–2016): a population‐based cross‐sectional study
Authors: Xia Weisi , Barazanchi Ahmed W. H. , Coomarasamy Christin , Jin James , Maccormick Andrew D. , Sammour Tarik , Hill Andrew G. 
Published: September 2020

AbstractAimHaemorrhoids are frequently encountered by the general or colorectal surgeon. Although a benign disease, those with symptomatic, advanced grades frequently require excisional haemorrhoidectomy for definitive management. Despite their widespread nature, the epidemiological burden of haemorrhoids and haemorrhoidectomies on populations is not well described. This study seeks to establish the incidence of both haemorrhoids diagnosed and haemorrhoidectomies performed in New Zealand.MethodThis is a population‐based cross‐sectional study examining the incidence of all patients who were newly diagnosed with haemorrhoids in New Zealand public hospital outpatient clinics and those who received excisional haemorrhoidectomy in New Zealand public hospitals from 2007 to 2016. Data were extracted and linked using the New Zealand National Minimum Dataset and the National Non‐Admitted Patient Collection. Variables collected included age group, sex, ethnicity and geographical location.ResultsA total of 46 095 recorded diagnoses of haemorrhoids were made, with a total of 18 739 haemorrhoidectomies in the 10‐year period recorded. The incidence rate of diagnosis increased from 84.6 to 120.5 per 100 000 and the incidence rate of haemorrhoidectomies performed from 30.4 to 51.1 per 100 000, a significantly increased annual incidence. There was a unimodal peak prevalence in the fifth decade of life with women more affected. Europeans formed the largest group affected, with Asians showing the highest rate of increased incidence.ConclusionThere is an increasing incidence of patients with symptomatic haemorrhoids presenting to the New Zealand public healthcare system, with a preponderance in working age adults, especially women.
Pelvic exenteration combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for advanced primary or recurrent colorectal cancer with peritoneal metastases
Authors: Brown Kilian G. M. , Ansari Nabila , Solomon Michael J. , Austin Kirk K. S. , Hamilton Auerilius E. R. , Young Christopher J. 
Published: September 2020

AbstractAimThe aim was to report early outcomes of six patients who underwent combined pelvic exenteration (PE), cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for advanced or recurrent colorectal cancer with colorectal peritoneal metastases at a single centre. The literature contains limited data on the safety and oncological outcomes of patients who undergo this combined procedure.MethodsSix patients who underwent combined PE, CRS and HIPEC at Royal Prince Alfred Hospital, Sydney, between January 2017 and February 2020 were identified and included. Data were extracted from prospectively maintained databases.ResultsThree patients underwent surgery for advanced primary rectal cancer, while two patients had recurrent sigmoid cancer and one had recurrent rectal cancer. All patients had synchronous peritoneal metastases. Two patients required total PE and two patients had a central (bladder‐sparing) PE. The median peritoneal carcinomatosis index was 6 (range 3–12) and all patients underwent a complete cytoreduction. The median operating time was 702 min (range 485–900) and the median blood loss was 1650 ml (range 700–12,000). The median length of intensive care unit and hospital stay was 4.5 and 25 days, respectively. There was no inpatient, 30‐day or 90‐day mortality. Three patients (50%) experienced a major (Clavien–Dindo III/IV) complication. At a median follow‐up of 11.5 months (range 2–18 months), two patients died with recurrent disease, one patient was alive with recurrence, while three patients remain alive and disease‐free. Of the three patients who developed recurrent disease, one had isolated pelvic recurrence, one had pelvic and peritoneal recurrences and one had bone metastases.ConclusionEarly results from this initial experience with simultaneous PE, CRS and HIPEC suggest that this combined procedure is safe and feasible; however, the long‐term oncological and quality of life outcomes require further investigation.
Intra‐operative assessment of left‐sided colorectal anastomotic integrity: a systematic review of available techniques
Authors: Clifford Rachael E. , Fowler Hayley , Manu Nicola , Sutton Paul , Vimalachandran Dale 
Published: September 2020

AbstractAimAnastomotic leak (AL) after colorectal resection is associated with increased rates of morbidity and mortality: potential permanent stoma formation, increased local recurrence, reduced cancer‐related survival, poor functional outcomes and associated quality of life. Techniques to reduce leak rates are therefore highly sought.MethodA literature search was performed for published full text articles using PubMed, Cochrane and Scopus databases with a focus on colorectal surgery 1990–2020. Additional papers were detected by scanning references of relevant papers.ResultsA total of 53 papers were included after a thorough literature search. Techniques assessed included leak tests, endoscopy, perfusion assessment and fluorescence studies. Air‐leak testing remains the most commonly used method across Europe, due to ease of reproducibility and low cost. There is no evidence that this reduces the leak rate; however, identification of a leak intra‐operatively provides the opportunity for either suture reinforcement or formal takedown with or without re‐do of the anastomosis and consideration of diversion. Suture repair alone of a positive air‐leak test is associated with an increased AL rate. The use of fluorescence studies to guide the site of anastomosis has demonstrated reduced leak rates in distal anastomoses, is safe, feasible and has a promising future.ConclusionAlthough over reliance on any assessment tool should be avoided, intra‐operative techniques with the aim of reducing AL rates are increasingly being employed. Standardization of these methods is imperative for routine use. However, in the interim it is recommended that all anastomoses should be assessed intra‐operatively for mechanical failure, particularly distal anastomoses.
The palliative care needs of lung transplant candidates
Authors: Pawlow Patricia C. , Blumenthal Nancy P. , Christie Jason D. , Matura Lea Ann , Courtright Katherine R. , Aryal Subhash , Ersek Mary 
Published: September 2020

AbstractBackgroundLittle is known about the palliative care needs of patients awaiting lung transplantation. The aim of this study was to describe these needs in patients undergoing evaluation for or awaiting lung transplantation.MethodsCross‐sectional survey using an adapted version of the Needs at the End‐of‐life Screening Tool (NEST‐13) at a US‐based transplant program.ResultsAmong the 111 participants, 83.5% were White, 60.0% were female, and almost three‐quarters had either restrictive or obstructive lung disease. The greatest palliative care needs included difficulty being physically active (mean: 7.9/10; SD: 2.6; median: 9.0), physical symptoms (mean: 7.4/10; SD: 2.6; median: 8.0), missing work due to illness (mean: 6.2/10; SD: 4.0; median: 8.0), and concerns that life might end (mean: 5.1/10; SD: 3.6; median: 5.0). Participants reported that religious/spiritual beliefs contribute to their sense of purpose (mean: 4.1/10; SD: 3.9) but had few unmet needs in this area (mean: 0.9/10; median: 0.0). Only 6.4% reported seeing a palliative care specialist, and 48.2% were unsure what a palliative care specialist is.ConclusionThere are substantial palliative care needs among lung transplant candidates, particularly physical symptoms and end‐of‐life concerns. These findings support integrating palliative care and end‐of‐life discussions in the management of lung transplant candidates.