bluuebunny/crossref_metadata_2025 huggingface dataset:
Rights Protection Against Registration and Use of Domain Names within a New gTLD
Authors: Bettinger Torsten , Waddell Allegra , Xue Hong
Published: March 2021

Pursuant to the Rights Protection Mechanisms (RPMs) implemented in the course of the New gTLD Program, registry operators of the new gTLDs are required to provide certain services designed to avoid the registration of domain names by potential trademark infringers. These RPMs include a Sunrise Registration Service, which affords trademark owners the ability to pre-emptively register domain names before registration becomes generally available. Furthermore, the Trademark Claims Service requires registry operators to notify registrants and trademark owners if the registrant applies for registration of a domain name which is identical to another’s trademark.
Other ICANN Consensus Policies
Authors: Bettinger Torsten
Published: March 2021

In addition to the Uniform Domain Name Dispute Resolution Policy (UDRP), ICANN has established eight other consensus policies which apply to the gTLD spaces under its purview. Consensus policies are the product of policy development processes at the Generic Names Supporting Organization (GNSO) in its function to develop and recommend to the ICANN Board substantive policies relating to generic top-level domains. They are intended to produce a consensus of Internet stakeholders and relate to issues including interoperability, security and stability of the Internet or the registry database for a TLD, the provision of registry services or operations, or the resolution of domain name disputes. Only policies which are developed through the Policy Development Process and receive appropriate approval by the GNSO Council and ICANN board may be considered consensus policies. Consensus policies are incorporated into registry contracts and in the Registrar Accreditation Agreement, ensuring that GNSO recommendations are implemented. These policies apply to different groups of individuals and/or entities and are suited to different purposes, which will be briefly outlined in the sections below.
Alternative Dispute Resolution Procedures for ccTLDs
Authors: Bettinger Torsten
Published: March 2021

As described in Part I, the ultimate public policy authority for the operation of ccTLDs rests with the relevant government or public authority, and how this authority is exercised is determined by applicable law. While ICANN retains the role of coordinating and ensuring the stability and security of the domain name system with regard to the gTLDs, with respect to the ccTLDs, the registries and the relevant governmental authorities retain important administration and self-determination rights. This includes the ability to determine the types of dispute resolution procedures that apply under a particular ccTLD.
Egypt (‘.eg’)
Authors: Bettinger Torsten , Waddell Allegra
Published: March 2021

The information in this section was helpfully supplied and researched by Dr. Mohamed-Hossam Loutfi, Professor of Civil Law at Bani-Suef University.
Practice and Procedure: Creditor Schemes
Authors: O’Dea Geoff , Long Julian , Smyth Alexandra
Published: March 2021

Set out below is an indicative timetable and documents list for a bank debt scheme of a type commonly used in practice.
National Report for the People’s Republic of China
Authors: Weiguo Wang
Published: March 2021

The 2006 Enterprise Bankruptcy Law (hereafter referred to as ‘EBL’) establishes some rules dealing with executory contracts. This is a new achievement which fills a vacancy in the EBL’s predecessor, the 1986 bankruptcy legislation.
National Report for Israel
Authors: Hahn David
Published: March 2021

Israel’s insolvency law is trifurcated and is comprised of the Bankruptcy Ordinance, the Companies Ordinance, and the Companies Act. The first of these regulates insolvency proceedings pertaining to individuals, and the other two regulate proceedings pertaining to corporations. The Companies Ordinance deals with corporate liquidation and receivership, and the Companies Act handles corporate reorganization. While certain provisions appear in all three Acts, other provisions appear only in one or two of them. The subject of executory contracts is one of the main matters with respect to which the three Acts differ. The Bankruptcy Ordinance (Pkudat Pshitat Ha-Regel) and the Companies Ordinance (Pkudat Ha-Havarot) address the issue of executory contracts within the context of onerous property. As a result, this legislation covers only the ability of the trustee to release the estate from burdensome, unprofitable contracts.
Composite Marks
Authors: Fhima Ilanah , Gangjee Dev S.
Published: March 2021

The logical starting point for any discussion of composite marks should be to define what composite marks are. Unfortunately, there is no clear agreement on their meaning in the jurisprudence or scholarship. The archetypical example of a composite mark is sometimes thought to include a word element and a figurative element, and indeed such marks can pose particular problems because, if one element points towards similarity while the other points away from it, it is particularly difficult to analyse how these quite different phenomena will interact. However, the meaning of composite marks seems to be considerably wider than this example, and certainly includes marks which consist of just words. Prominent examples include THOMSON LIFE and BIMBO DOUGHNUTS. These examples include a company name and a subsidiary mark or type of product, but in other cases the elements of the mark are less discrete. For example, the name BARBARA BECKER was treated as a composite mark, and outside the context of confusion, HAVE A BREAK, HAVE A KIT KAT was also labelled as a composite mark.
Collective Marks and Certification Marks
Authors: Annette Kur , Senftleben Martin
Published: March 2021

It is a defining feature of ‘ordinary’, individual trade marks that they indicate a single commercial source. Collective marks and certification marks, by contrast, are meant to signify membership in an association, or a particular quality, or compliance with other, specific conditions. Furthermore, while an individual mark’s quality function, that is, consumer expectations with regard to the quality level and the consistency of product characteristics, is in most cases only indirectly protected, meaning that competitors or members of the public cannot request sanctions under trade mark law in case that quality changes occur (see Chapter 7, sections 7.2.3 and 7.6.4.4.2), collective marks and certification marks risk losing their validity when the standards they are meant to indicate are neglected.
Administrative Measures
Authors: Annette Kur , Senftleben Martin
Published: March 2021

In the field of administrative measures, proceedings before the registration authorities, such as registration, opposition, and cancellation proceedings, including the possibility of appeal, are of particular importance. These administrative procedures have already been discussed in detail in Part III. Apart from these office procedures, Regulation No. 608/2013 concerning customs enforcement of intellectual property rights (hereinafter: ‘Customs Regulation’ or ‘CR’) occupies centre stage when administrative enforcement measures are sought.
Harmonization of Patent Law
Authors: Grubb Philip W , Thomsen Peter R , Hoxie Tom , Wright Gordon
Published: March 2021

This chapter details developments in the harmonization of patent laws. The Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement has made significant strides in harmonizing levels of patent protection. TRIPs requires practically all countries of the world to have patent systems in which compounds, including pharmaceuticals, can be patented per se for a term of at least twenty years, with no local working requirements and no routine granting of compulsory licences; with importation of a product and sale of the product or a process being clearly defined as infringement; and with clear standards for the enforcement of patent rights. Other harmonization initiatives include the Patent Law Treaty, the Substantive Patent Law Treaty, the Trilateral Cooperation, the Convention on Biological Diversity, and the Nagoya Protocol.
Chemical Inventions
Authors: Grubb Philip W , Thomsen Peter R , Hoxie Tom , Wright Gordon
Published: March 2021

This chapter considers the law governing the patentability of chemical inventions, including novel compounds, polymeric compounds, new salt forms, new physical forms, new synthetic processes, analogy processes, new compositions and mixtures, and new uses and new application processes. A novel compound, for instance, cannot be patented unless it is industrially applicable. Despite being new and useful, a compound may not be patentable if it is so close to the prior art that there is no inventive step involved in making it. For polymers, it is still possible to obtain new and patentable polymers using various kinds of modification, provided that these give useful and non-obvious results. If a group of compounds is new and inventive, then not only are claims to the compounds per se patentable, but also claims to the process for the preparation of the compounds, even if it is known as a method for making similar compounds.
Drafting the Patent Specification
Authors: Grubb Philip W , Thomsen Peter R , Hoxie Tom , Wright Gordon
Published: March 2021

This chapter explains the procedure for drafting a patent specification. When an invention of any kind has been made, the first step towards drafting a patent specification is defining the scope of the invention, or forming a mental picture of what is to be claimed. The second step is putting that mental picture into words. Once the patent attorney gains a clear picture of the correct scope of the invention, he or she can begin the task of drafting the specification and claims of the application. The remainder of the chapter discusses the structure of the patent specification; priority and foreign filing texts; sufficient requirements in the US, UK, and other countries; and special requirements for biotech inventions.
Prosecution of the Patent Application to Grant
Authors: Grubb Philip W , Thomsen Peter R , Hoxie Tom , Wright Gordon
Published: March 2021

This chapter considers some problems that may arise when objections of lack of unity, lack of novelty, or lack of inventive step are raised against a patent application. Objections of lack of unity are more of a nuisance than a real threat. One can avoid the problem by filing one or more divisional applications on time. Apart from questions of whether or not a citation really is prior art and whether or not it has been interpreted correctly, objections of lack of novelty are a relatively straightforward matter: either the claim is anticipated or it is not, and if it is, it must be limited accordingly. Obviousness or lack of inventive step, however, is a subjective matter and for this reason by far the greatest part of the work involved in patent prosecution is in arguing that the invention is not obvious over the citations that have been made.
Context and Background
Authors: Wolanski Adam , Shore Victoria
Published: March 2021

The law of privacy has come a long way since the Human Rights Act 1998 (HRA) came into force in October 2000. Before then, the prevailing view was that there was no right to privacy at common law and that it had ‘so long been disregarded here that it can be recognised only by the legislature’. Instead, indirect, piecemeal protection of privacy was afforded through existing causes of action where the facts of individual cases permitted it. Despite judicial dicta leaving the question open, this appears to have remained the position at least until the HRA came into force.
Privacy in European, Civil, and Common Law
Authors: Moreham N A , Aplin Tanya
Published: March 2021

The purpose of this chapter is to examine some of the external sources that influence the shape and scope of the protection of privacy in English law. Those influences are diverse. They include the jurisprudence of the European Court of Human Rights (ECtHR) and other institutions of the Council of Europe, European Union instruments, international human rights obligations, foreign common law jurisdictions, and European civil law. All of these sources form part of the multifaceted context in which English privacy protections are developing.
Harassment by Publication
Authors: Moreham N A
Published: March 2021

The Protection from Harassment Act 1997 (PHA) is becoming an increasingly important tool for those seeking to protect their privacy against intrusion by the media and private individuals. The Act was introduced to combat stalking, racial harassment, and disruption from neighbours but ‘harassment’ is not defined in the Act and its reach is therefore in fact much wider. As will be discussed in Chapter 10, the PHA has the potential to catch a range of media news-gathering activities including persistent photography, trailing, and door-stepping.
Remedies and Sanctions
Authors: QC Matthew Nicklin , Strong Chloe
Published: March 2021

This chapter considers the legal remedies that may be available to those who complain that an invasion of their privacy has occurred or is threatened by the actions of the media, as well as touching briefly on the criminal sanctions that may be applicable. Regulatory remedies under the Data Protection Act are considered in Chapter 7 and the remedies available from the media regulators in Chapter 14. Whether a remedy is sought before or after publication, and whether the complaint relates to the content of an actual or proposed publication or the method by which personal information has been obtained, it is likely that any relief granted will affect the exercise of the right to freedom of expression enshrined in Article 10 of the European Convention on Human Rights (ECHR). In such circumstances s 12 of the Human Rights Act 1998 (HRA) applies. The interpretation given to this important statutory provision by the courts is considered in Section C, but this chapter begins by looking at Parliament’s intention in enacting s 12. This is not necessarily to suggest that courts should have regard to such material as an aid to construction under the rule in Pepper v Hart but rather to explain the legislative background to this highly relevant provision.
The Problem of Public Authority Negligence Liability
Authors: Fairgrieve Duncan , Squires QC Dan
Published: March 2021

For a number of reasons the courts have exhibited some wariness about imposing liability on public authorities. They are concerned that the threat of negligence liability might hamper the authority in its attempt to discharge its public duties, or that the limited resources of a public authority should not be spent compensating those whom the authority failed to protect from harm. There is also a concern that decisions about the allocation of public resources should be made not by the courts at all but by the authorities themselves, which are generally answerable to political processes. It is apparent that such consideration does not arise in relation to negligence claims brought against private parties, and this book attempts to examine the principles the courts have formulated to determine how defendants’ liabilities are affected by the fact that they were discharging public obligations at the time of their alleged negligence.
Human Rights Act 1998
Authors: Fairgrieve Duncan , Squires QC Dan
Published: March 2021

The following chapter examines claims that can be brought under the Human Rights Act 1998 (HRA). The HRA makes it unlawful for a ‘public authority’ to breach the European Convention on Human Rights (‘the Convention’). The HRA accords to the victims of a breach of the Convention the right to pursue a claim against the offending public authority in the UK courts, when previously they were required to apply to the European Court of Human Rights in Strasbourg to vindicate their Convention rights.
A Meta-Analytical Assessment of the Aggregation Parameter of the Binary Power Law for Characterizing Spatial Heterogeneity of Plant Disease Incidence
Authors: Madden Laurence V. , Moraes Wanderson Bucker , Hughes Gareth , Xu Xiangming
Published: March 2021

The binary power law (BPL) is often used to characterize spatial heterogeneity of disease incidence. A hierarchical mixed model, coupled with multiple imputation to randomly generate any missing standard errors, was used to conduct a meta-analysis of >200 published values of the estimated aggregation (b) parameter of the BPL. Approximately 50% of estimated b values ranged from 1.1 to 1.3. Moderator variable analysis showed that the number of individuals per sampling unit (n) had a strong positive effect on b, with a linear relation between estimated b and ln(n). Estimated expected value of b for the population of published regressions at a reference n of 15 was 1.22. The increase in the variance due to the imputations was only 0.03, and the efficiency exceeded 0.98. Results were confirmed with an alternative mixed model that considered a range of possible within-trial correlations of the estimated b values and with a random-coefficient mixed model fitted to the subset of the data. Cropping system, dispersal mode, and pathogen type all had significant effects on b, with annuals having larger expected value than woody perennials, soilborne and rain-splashed dispersed pathogens having the largest expected values for dispersal mode, and bacteria and oomycetes having the largest expected values for pathogen type. However, there was considerable variation within each of the levels of the moderators, and the differences of expected values from smallest to largest were small, ≤0.16. Results are discussed in relation to previously published findings from stochastic simulations.
Communication as a High-Stakes Clinical Skill: “Just-in-Time” Simulation and Vicarious Observational Learning to Promote Patient- and Family-Centered Care and to Improve Trainee Skill
Authors: Rock Laura K.
Published: March 2021

Patient–provider communication is a hallmark of high-quality care and patient safety; however, the pace and increasingly complex challenges that face overextended teams strain even the most dedicated clinicians. The COVID-19 pandemic has further disrupted communication between clinicians and their patients and families. The dependence on phone communication and the physical barriers of protective gear limit nonverbal communication and diminish clinicians’ ability to recognize and respond to emotion. Developing new approaches to teach communication skills to trainees who are often responsible for communicating with patients and their families is challenging, especially during a pandemic or other crisis. “Just-in-time” simulation—simulation-based training immediately before an intervention—provides the scaffolding and support trainees need for conducting difficult conversations, and it enhances patients’ and families’ experiences. Using a realistic scenario, the author illustrates key steps for effectively using just-in-time simulation-based communication training: assessing the learner’s understanding of the situation; determining what aspects of the encounter may prove most challenging; providing a script as a cognitive aid; refreshing or teaching a specific skill; preparing learners emotionally through reflection and mental rehearsal; coaching on the approach, pace, and tone for a delivery that conveys empathy and meaning; and providing specific, honest, and curious feedback to close a performance gap. Additionally, the author acknowledges that clinical conditions sometimes require learning by observing rather than doing and has thus provided guidance for making the most of vicarious observational learning: identify potential challenges in the encounter and explicitly connect them to trainee learning goals, explain why a more advanced member of the team is conducting the conversation, ask the trainee to observe and prepare feedback, choose the location carefully, identify everyone’s role at the beginning of the conversation, debrief, share reactions, and thank the trainee for their feedback and observations.
The Relationship Between Children's Problematic Internet-related Behaviors and Psychological Distress During the Onset of the COVID-19 Pandemic: A Longitudinal Study
Authors: Chen Chao-Ying , Chen I-Hua , Hou Wen-Li , Potenza Marc N. , O’Brien Kerry S. , Lin Chung-Ying , Latner Janet D.
Published: March 2021

Background:

The outbreak of the coronavirus disease 2019 (COVID-19) pandemic has generated negative effects on psychological well-being worldwide, including in schoolchildren. Government requirements to stay at home and avoid social and school settings may impact psychological well-being by modifying various behaviors such as problematic phone and Internet use, yet there is a paucity of research on this issue. This study examined whether the COVID-19 outbreak may have impacted problematic smartphone use (PSU), problematic gaming (PG), and psychological distress, specifically the pattern of relationships between PSU, PG, and psychological distress in schoolchildren.

Methods:

Longitudinal data on psychological distress, PSU, and PG were collected from 575 children in primary schools in 3 waves: Waves 1 and 2 were conducted before the COVID-19 outbreak and Wave 3 during the outbreak. Cross-lagged panel models were used to examine relationships between factors across the 3 waves.

Results:

Cross-lagged models found that higher levels of PSU were not significantly related prospectively to greater psychological distress before the COVID-19 outbreak, but this prospective relationship became significant during the COVID-19 outbreak. Whereas PG was associated prospectively with psychological distress before the COVID-19 outbreak (ie, between Waves 1 and 2), this association became nonsignificant during the COVID-19 lockdown (ie, between Waves 2 and 3).

Conclusions:

The COVID-19 outbreak has seemed to change prospective relationships between PSU and psychological distress and PG and psychological distress in schoolchildren. Future research should examine whether restrictions on or information provided to schoolchildren may exacerbate PSUs effects on psychological distress.
How to provide fertility treatment during COVID-19 pandemic
Authors: Cruz M. , Requena Antonio
Published: March 2021

Purpose of review

The emergence of the novel coronavirus infection that arose in Wuhan, China in December 2019 has resulted in an epidemic that has quickly expanded to become one of the most significant public health threats in recent times. The objective of this review is to summarize how this pandemic has affected the activity of a Reproductive Medicine Center, which established a series of measures in parallel with governments decisions and scientific societies.

Recent findings

The control measures adopted for restarting the healthcare activity should be equitable and inclusive. Moreover, this pandemic has implied changes in treatments and strategies to be alert regarding the daily changing information. Finally, for ensuring a safe practice both for patients and staff, it is important to detect asymptomatic patients, so Reproductive Medicine centers must take special care with screening and testing procedures.

The pandemic has pushed up toward a new reality in terms of Assisted Reproductive treatments, where social distance and responsibility are protagonists. We face a new challenge of balancing between responding to the committed efforts of infertile couples to achieve pregnancy and safeguarding the health of the future parents and their children during this time of pandemic.
Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients
Authors: Maxwell Daniel , Estes Megan M. , Walcott Jennifer McMillen , Canady John W. , Hunter Tina D. , Gache Larry , Wang-Ashraf Bernadette , Alexander Diane
Published: March 2021

Background:

In the United States, 2-stage expander-to-implant–based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders.

Methods:

This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant–based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes.

Results:

A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%).

Conclusion:

Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.
Muscle Cuff in Distal Pedicled Adipofascial Sural Artery Flaps: A Retrospective Case Control Study
Authors: Schmidt Karsten , Jakubietz Michael Georg , Gilbert Fabian , Fenwick Annabel , Meffert Reiner Heribert , Jakubietz Rafael Gregor
Published: March 2021

Background:

Amputation after open tibial fracture occurs in 3% of cases. The rate increases when flap reconstruction is required. The standard care involves microsurgical tissue transfer although the pedicled reverse sural artery adipofascial flap (PRSAF) is a local alternative in patients endangered by a prolonged operative time. Incorporation of a gastrocnemius muscle cuff in this flap can be used to fill dead space and increase healing potential. Literature shows superior survival rates for both PRSAF and inclusion of a muscle cuff in comparison with the cutaneous version. The aim of the study was to compare the outcome of the PRSAF and the musculoadipofascial version (PRSMAF). We hypothesize that the PRSMAF provides similar lap viability and flap-related complication rates as does the adipofascial version. The muscle component may reduce the long-term osteomyelitis rate.

Methods:

Patients were evaluated retrospectively after reconstruction with either PRSAF or PRSMAF. Preoperative osteomyelitis, flap survival, complications and osteomyelitis clearance were analyzed.

Results:

The study shows preliminary results supporting the potential use of the PRSMAF. We compare either 23 PRSMAF or 20 PRSAF flaps. We found no statistically significant differences in flap survival or in complication rate.

Conclusions:

Although the anatomical situation may sometimes dictate the use of a free flap, a technically less-complicated option may in some cases offer a viable alternative. This study shows that the PRSMAF can serve as an alternative for complex bone defects in the limb, though it does not provide statistical improvement to the PRSAF.
Aortic regurgitation in Marfan syndrome patients who underwent prophylactic surgery: A single-center experience
Authors: Fan Wen-Po , Li Hsing-Yuan , Tseng Szu-Yin , Juan Chien-Chang , Hwang Betau , Niu Dau-Ming , Lee Pi-Chang
Published: March 2021

Background:

Marfan syndrome is an inherited connective tissue disease that causes aortic root dilatation and dissection and requires surgical intervention. Apart from emergent surgery for aortic dissection or aortic aneurysmal rupture, prophylactic surgical intervention can also be administered, depending on the severity of aortic root dilatation. The direct relationship between surgical intervention and aortic regurgitation was seldom mentioned in previous studies.

Methods:

A retrospective cohort study was designed to determine the clinical presentations of prophylactic surgery in patients with Marfan syndrome. Between January 2009 and May 2019, 112 patients, adolescents and young adults, treated in the Department of Pediatric Cardiology of Taipei Veterans General Hospital, were enrolled. All patients’ sex, body measurements, echocardiography reports, and surgical notes were collected for statistical analysis.

Results:

Among the participants, nine patients (8%) underwent the Bentall procedure, and the other 103 did not receive surgical intervention. The operation group had a larger aortic root size (4.89 vs 2.86 cm, p < 0.001), more dilated left ventricle (4.81 vs 4.1 cm, p = 0.002), and higher prevalence of moderate and severe aortic regurgitation (66% vs 1%, p < 0.001) than the nonoperation group.

Conclusion:

Among adolescents and young adults with Marfan syndrome, echocardiographic presentation of aortic root dilatation, left ventricular dilatation, and significant aortic regurgitation was significantly associated with prophylactic surgical intervention. According to the study, significant aortic regurgitation should also be considered as an important indication for prophylactic surgery.
Effect of Glucocorticoids on Athletic Performance: A Systematic Review and Meta-Analysis
Authors: Trinh Kien V. , Chen Kevin Jia Qi , Diep Dion
Published: March 2021

Objective:

To determine the effects of glucocorticoids in enhancing athletic performance.

Design:

At least 2 independent reviewers conducted study selection and extracted demographic and outcome data. Relevant outcomes were stratified by administration time frame and the specific type of drug used. Study quality was assessed using the Cochrane Risk-of-Bias tool and the Cochrane Grading of Recommendations Assessment Development and Education scale. Where appropriate, meta-analyses were performed. Data sources: Embase, MEDLINE, and SPORTDiscus were searched from their beginning to April 2020.

Participants:

Participants of any sex and training status aged 18 to 65 years were included.

Interventions and Main Outcome Measures:

Any type of published randomized controlled trial (RCT) that examined any enhancement in sport as well as aerobic, anaerobic, or body compositional parameters for glucocorticoids compared with placebo.

Results:

There is low-to-moderate evidence suggesting that the administration of glucocorticoids may be more beneficial than placebo in enhancing athletic performance. short-term administration of glucocorticoids significantly improved time to exhaustion, maximal force, and total distance travelled. By contrast, acute administration of glucocorticoids predominantly yielded no changes to athletic performance, except for reductions in total work and maximal power output.

Conclusions:

Although there is evidence suggesting glucocorticoids have ergogenic effects, these improvements may differ depending on the specific type of drug, dose, and the administration time frame and are also limited by small sample sizes. Therefore, there is a need for large, high-quality RCTs as this may influence future doping policy and athlete care.
Implementation of office-based buprenorphine treatment for opioid use disorder
Authors: Carroll Emily
Published: March 2021

Background:

Buprenorphine-based medication-assisted treatment (B-MAT) is a powerful, concrete intervention that can be provided by nurse practitioners (NPs) to reduce opioid-related overdoses in patients with opioid use disorder (OUD). However, multiple barriers exist to provide and access this therapy.

Local problem:

A rural Midwestern county struggled with increasing OUD and scant access to B-MAT. A nurse-led, community clinic had the potential to expand access to treatment but no support structure to provide it.

Methods:

In this quality improvement project, a one-group posttest-only design was used to assess treatment access, care quality, and patient characteristics.

Interventions:

An evidence-based, nurse led weekly B-MAT clinic using a low-threshold, chronic-care model for treatment of OUD.

Results:

The B-MAT clinic expanded county-wide access by 34% over seven months. A total of 23 patients were seen with 21 eligible for treatment with B-MAT. All nine patients with at least 90-day continuous treatment were retained in the program. Three quarters of patients had at least 30 days of active buprenorphine-naloxone coverage and 17% of all patients were lost to follow up. There were no induction-related adverse events, no fatalities, and one nonfatal overdose. In a chart review, 85% of patients met at least six of eight quality criteria.

Conclusions:

This low-barrier approach to OUD expanded access to treatment and demonstrated a model stable enough to continue delivering care throughout the first 5 months of the novel coronavirus (COVID-19) pandemic. NPs in primary care settings can effectively provide B-MAT in a low-threshold, office-based setting.
Acute blood loss anemia after COVID-19 nasopharyngeal sampling
Authors: Watkins April Kathleen , Heinzman Kristopher M. , Kurian Thomas K. , Hong Mauricio , Clark Angela P. , Champion Jane Dimmitt
Published: March 2021

Long-term care residents with novel coronavirus disease 2019 (COVID-19) experience high mortality rates and require frequent screening. Most resident testing occurs via nasopharyngeal swab that potentially causes epistaxis with rates of 5% to 8% in healthy populations. It is estimated that 48% of long-term care residents receive oral anticoagulation that increases risk of bleeding. A long-term care resident receiving oral anticoagulation experienced an episode of acute blood loss anemia after nasopharyngeal sampling. Current medications were not reviewed before testing, and oral anticoagulation was not held resulting in acute blood loss anemia. A medication review is indicated for skilled nursing and assisted living residents to identify oral anticoagulation before nasopharyngeal testing. Less invasive testing may be recommended or should bleeding occur, discontinuation of oral anticoagulation for a short term may be appropriate.
Favorable Hemocompatibility in HeartMate 3 May Prevent Thrombosis After Prolonged Pump Cessation
Authors: Rohm Charlene , Howard Brian , Lakhani Baqir , Luu Theresa , Snipelisky David
Published: March 2021

The HeartMate 3 Left Ventricular Assist System has demonstrated a reduction in risk of pump thrombosis. The improved hemocompatibility of this device is largely attributed to the pump mechanics including a large-diameter outflow graft, increased retrograde flow through the pump during pump cessation, and the textured blood-contacting surfaces of the pump. We present a 55-year-old man with a HeartMate 3 device who presented with heart failure symptoms, prolonged pump cessation for 7 days, and subtherapeutic anticoagulation therapy. Despite prolonged pump cessation and interrupted anticoagulation therapy, there was no evidence of pump thrombosis as determined by both laboratory and imaging studies. This case suggests favorable hemocompatibility of the HeartMate 3 device, which clinicians may consider in the management of patients needing advanced therapies.
Novel splicing (c.6529-1G>T) and missense (c.1667G>A) mutations causing factor V deficiency
Authors: Maharaj Satish , Saenz Ayala Sofia , Hu Xiaolin , Chang Simone , Sharma Vivek , Majerus Julie , Pruthi Rajiv
Published: March 2021

Congenital factor V deficiency (FVD) is a rare bleeding disorder. In this study, we investigated the genetic basis in an African American patient with factor V activity 3%. Custom sequence capture and targeted next-generation (NGS) sequencing of the F5 gene were undertaken followed by PCR and Sanger sequencing. Two novel variants were identified. In silico analyses correlated clinically with the patient's factor V activity and hemorrhagic tendency. A review of the literature regarding these genomic alterations is presented. We described two novel mutations causing moderate FVD. The first, Chr1:g.169483698C>A with cDNA change (F5):c.6529-1G>T, occurred in a conserved nucleotide at the canonical acceptor splice site of intron 24. The second, Chr1:g.169515775C>T with cDNA change (F5):c.1667G>A, was a missense variant of exon 11, affecting a highly conserved amino acid in the A2 domain. Further research into the mechanisms of F5 mutations leading to FVD and residual factor V expression are needed.
Transportation during and after cardiac arrest: who, when, how and where?
Authors: Ho Andrew Fu Wah , Ong Marcus Eng Hock
Published: March 2021

Purpose of review

Out-of-hospital cardiac arrest (OHCA) is the most devastating and time-critical medical emergency. Survival after OHCA requires an integrated system of care, of which transport by emergency medical services is an integral component. The transport system serves to commence and ensure uninterrupted high-quality resuscitation in suitable patients who would benefit, terminate resuscitation in those that do not, provide critical interventions, as well as convey patients to the next appropriate venue of care. We review recent evidence surrounding contemporary issues in the transport of OHCA, relating to who, where, when and how to transport these patients.

Recent findings

We examine the clinical and systems-related evidence behind issues including: contemporary approaches to field termination of resuscitation in patients in whom continued resuscitation and transport to hospital would be medically futile, OHCA patients and organ donation, on-scene versus intra-transport resuscitation, significance of response time, intra-transport interventions (mechanical chest compression, targeted temperature management, ECMO-facilitated cardiopulmonary resuscitation), OHCA in high-rise locations and cardiac arrest centers. We highlight gaps in current knowledge and areas of active research.

There remains limited evidence to guide some decisions in transporting the OHCA patient. Evidence is urgently needed to elucidate the roles of cardiac arrest centers and ECPR in OHCA.
Sodium/glucose cotransporter 2 inhibitors in chronic kidney disease and heart failure: ready for prime time in patients without diabetes
Authors: Vlasschaert Caitlyn , Sidhu Bikrampal , Silver Samuel A.
Published: March 2021

Purpose of review

The benefits of sodium/glucose cotransporter 2 (SGLT2) inhibitors seem to extend beyond glycemic control. We review recent randomized trial evidence evaluating SGLT2 inhibition in nondiabetic settings, including in patients with chronic kidney disease (CKD) and heart failure (HF).

Recent findings

DAPA-CKD, DAPA-HF and EMPEROR-Reduced compared SGLT2 inhibitors to placebo, enrolling 5868 patients without diabetes. In DAPA-CKD, patients with an estimated glomerular filtration rate (eGFR) of 25–75 ml/min/1.73 m2 and macroalbuminuria irrespective of kidney disease aetiology had improved cardiovascular and kidney outcomes if randomized to receive SGLT2 inhibitors (primary composite endpoint: hazard ratio [HR] 0.61, 95% CI 0.51–0.72; absolute risk reduction [ARR] 5.3%). In DAPA-HF and EMPEROR-Reduced, participants with reduced ejection fraction (HFrEF) had improved cardiovascular outcomes when an SGLT2 inhibitor was added to guideline-directed medical therapy, mainly through a reduction in HF hospitalizations (HR 0.70, 95% CI 0.59–0.83; ARR 3.7% and HR 0.69, 95% CI 0.59–0.81; ARR 5.1% with dapagliflozin and empagliflozin, respectively). In all 3 trials, the benefits were not modified by diabetes, baseline eGFR or proteinuria.

SGLT2 inhibitors improve kidney and HF outcomes in patients with high-risk CKD and HFrEF, irrespective of diabetes. Clinicians should become more comfortable prescribing these medications as we await studies that may further broaden their indications.
Complement and kidney disease, new insights
Authors: Medjeral-Thomas Nicholas R. , Pickering Matthew C. , Cook H. Terence
Published: March 2021

Purpose of review

In this review, we discuss recent studies showing the importance of the complement pathway in kidney disease.

Recent findings

Recent findings in C3 glomerulopathy (C3G) include: acute postinfectious glomerulonephritis is characterised by the presence of antifactor B antibodies; human leukocyte antigen type, but not rare complement gene variation, is associated with primary immunoglobulin-associated membranoproliferative GN and C3G. Immunohistochemistry in C3G shows that factor H related protein 5 (FHR5) is the most prevalent complement protein and correlates with kidney function. A multicentre study supported the use of mycophenolate mofetil (MMF) in C3G even after a propensity matching analysis. In immunoglobulin A nephropathy (IgAN) several studies have emphasised the importance of complement. Imbalances of circulating FH and FHR1 and FHR5, which interfere with the regulatory functions of FH, associate with IgAN. Immunohistochemistry has shown associations between glomerular FHR5 deposition and C3 activation; glomerular FHR5 associated with clinical markers of IgAN severity. Data also suggest the lectin complement pathway contributes to IgAN severity. We also discuss complement activation in thrombotic microangiopathy and other kidney diseases.

Complement activity can be detected in a wide range of kidney diseases and this provides pathogenic insight and potential for therapy with the ongoing development of several drugs directed at complement activation.
DNA J homolog subfamily B member 9 and other advances in fibrillary glomerulonephritis
Authors: Andeen Nicole K. , Avasare Rupali S.
Published: March 2021

Purpose of review

Fibrillary glomerulonephritis (FGN) involves ∼1% of native kidney biopsies and is characterized by glomerular deposition of fibrils larger than amyloid (12–24 nm diameter) composed of polyclonal immunoglobulin G (IgG). The recent discovery of DNA J homolog subfamily B member 9 (DNAJB9) in FGN glomerular deposits has contributed a specific and sensitive biomarker, informing morphologic classification and pathogenesis. This review will consider contemporary FGN incidence and genetics, pathogenesis, (lack of) paraprotein association, variants, treatment, and transplantation.

Recent findings

DNAJB9 tissue assays have enabled the identification of morphologic variants and improved classification of fibrillary-like glomerular diseases. Together with paraffin immunofluorescence and IgG subclass studies, these have established that FGN is only rarely monoclonal and these patients usually do not have an monoclonal gammopathy. The discovery of DNAJB9 opens new avenues of investigation into FGN pathogenesis, especially those of the unfolded protein response. Treatment for FGN remains empiric, with some encouraging data on rituximab-based therapy. Transplantation is a good option for patients progressing to end-stage kidney disease.

Advances building on the discovery of DNAJB9 in FGN should lead to long-term evolution in targeted treatment and outcome of this glomerular disease.
Pathogenesis of coronavirus disease 2019-associated kidney injury
Authors: Smith Kelly D. , Akilesh Shreeram
Published: March 2021

Purpose of review

The current review summarizes the pathologic findings in kidneys from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected patients who have had autopsies or undergone biopsy, and the pathogenic mechanisms implicated in coronavirus disease 2019 (COVID-19)-associated kidney diseases.

Recent findings

Direct infection of the kidney by SARS-CoV-2 is not common, and convincing morphologic evidence of substantive kidney infection by SARS-CoV-2 is lacking. Severe COVID-19-associated acute kidney injury is likely multifactorial and results from the physiologic disturbances and therapies used to treat this illness. COVID-19-associated collapsing glomerulopathy (COVAN) is seen almost exclusively in patients with apolipoprotein L1 high-risk genotypes with no evidence of direct infection of the kidney by SARS-CoV-2.

The prevailing evidence does not support substantive or persistent infection of kidneys in COVID-19 and indirect means of tissue injury are favored, although a ‘hit and run’ model cannot be excluded. COVAN frequently occurs in patients with mild respiratory systems, suggesting that innate and adaptive immune responses to SARS-CoV-2 infection may provide the second hit needed for the development of collapsing glomerulopathy in susceptible individuals.
Approach to stable angina in patients with advanced chronic kidney disease
Authors: Arif Hasan , Yadav Anju
Published: March 2021

Purpose of review

Chronic kidney disease is one of the major risk factors for coronary artery disease. Both end-stage renal disease (ESRD) and advanced chronic kidney disease patients have atypical presentations of coronary artery disease (CAD) due to modifications in cardinal symptoms and clinical presentation. Data on evaluation and management of coronary artery or stable angina is limited in advanced chronic kidney disease (CKD) patients due to a limited number of trials. There are sparse data supporting either percutaneous coronary intervention (PCI) or coronary artery bypass graft in advanced CKD patients.

Recent findings

The ISCHEMIA-CKD trial to date is the most extensive prospective randomized study looking at advanced CKD patients study looking at advanced CKD stage 4/5 patients randomized to medical treatment alone vs. invasive strategy for moderate to severe myocardial ischemia. There was no evidence found that an initial invasive strategy compared with conservative strategy with maximal medical management resulted in reduced risk of death or nonfatal myocardial infarction in patients with advanced CKD and coronary artery disease with stable angina.

In this review, we will discuss the existing data on assessment and management of stable coronary artery disease/stable angina. And how this extrapolates to the application in advanced CKD patients awaiting kidney transplant.
Vulvar Basal Cell Carcinoma: Clinical and Histopathologic Features
Authors: Flipo Rémi , Bani Mohamed A. , Rejaibi Salsabil , Talhi Naima , Sastre-Garau Xavier
Published: March 2021

Basal cell carcinoma (BCC) is the most frequent skin cancer but <1% of the cases develop in the vulva. Histoprognostic features of vulvar BCCs are not recognized and, consequently, the treatment of the disease is not well codified. To overcome this lack of knowledge, we have performed a retrospective analysis of vulvar BBCs to assess the value of various histological features regarding the disease outcome. In all, 19 patients surgically treated for a vulvar BCC in the Centre Hospitalier Intercommunal de Créteil from March 1, 2000 to September 26, 2019 were retrieved. Clinical and histologic features were reviewed in all cases and analyzed in comparison with disease recurrence and patient’s survival. The median age of the patients was 74 (range 54–99) yr. Tumor location on the labium majus was the most frequent (68%). None presented with a medical condition related to BCC. All the patients were treated by surgery alone, except one who benefited from additional radiotherapy. We found a significant association between tumor size and recurrences (P=0.031). Other features associated with disease outcome were tumor thickness, treatment type, and surgical margins. Recurrence was observed for tumors larger than 20 mm with a surgical margin of less than 3 mm. A combination of tumor size, thickness, and surgical margin are histoprognostic factors more significant than tumor subtype.