Secrecy for the Sake of It: The Defend Trade Secrets Act

With foreign economic espionage and national security concerns thrust to the forefront of the discussion, Congress nearly unanimously passed the Defend Trade Secrets Act after a concerted effort by the executive branch, federal law enforcement, and intellectual property scholars. While this landmark legislation provides the long sought-after grounds of original federal jurisdiction for trade secret misappropriation claims, the statute also offers litigants a powerful remedy—the ex parte seizure provision. This unprecedented provision in trade secrets law allows a plaintiff, with no notice to the defendant, to file an application with the court requesting that U.S. Marshals seize and hold the defendant’s property containing the allegedly wrongfully acquired or disclosed trade secrets until a hearing is set on the matter. Although subject to numerous procedural safeguards and with an order in favor of ex parte seizure only to be granted in “extraordinary circumstances,” this potent provision all but assures that litigants with deep pockets (and in businesses wholly unrelated to national security) will be able to silence a less financially robust competitor—more often than not, a former employee—who may be especially vulnerable to unexpected seizures at precarious moments for a newly launched start-up such as on the eve of an initial public offering or product release. Trade secrets should be considered as a viable property interest, yet are materially distinct from established forms of federally registerable intellectual property (e.g., copyrights, trademarks, patents) and as a result, the vast majority of ex parte proceedings in the trade secrets context will needlessly violate the defendant’s due process rights. This note proposes that the “extraordinary circumstances” language of the ex parte seizure provision should be narrowed to comport with basic constitutional tenets, and further suggests that as a matter of policy, employers should be fostering launchpad and knowledge-sharing environments, rather than punishing top talent and restricting innovation

Clinical population pharmacokinetics and toxicodynamics of linezolid

Thrombocytopenia is a common side effect of linezolid, an oxazolidinone antibiotic often used to treat multidrug-resistant Gram-positive bacterial infections. Various risk factors have been suggested, including linezolid dose and duration of therapy, baseline platelet counts, and renal dysfunction; still, the mechanisms behind this potentially treatment-limiting toxicity are largely unknown. A clinical study was conducted to investigate the relationship between linezolid pharmacokinetics and toxico-dynamics and inform strategies to prevent and manage linezolid-associated toxicity. Forty-one patients received 42 separate treatment courses of linezolid (600 mg every 12 h). A new mechanism-based, population pharmacokinetic/toxicodynamic model was developed to describe the time course of plasma linezolid concentrations and platelets. A linezolid concentration of 8.06 mg/ liter (101% between-patient variability) inhibited the synthesis of platelet precursor cells by 50%. Simulations predicted treatment durations of 5 and 7 days to carry a substantially lower risk than 10- to 28-day therapy for platelet nadirs o

Epidemiologia kliniczna depresji w opiece paliatywnej i wartość predykcyjna objawów somatycznych — przekrojowe badanie ankietowe z 4-tygodniowym okresem obserwacji

Celem przedstawionego w niniejszej pracy przekrojowego badania ankietowego było określenie rozpowszechnienia i remisji depresji u pacjentów objętych opieką paliatywną oraz oszacowanie wartości predykcyjnej objawów somatycznych w ustalaniu rozpoznania wspomnianego schorzenia. Z 300 kolejnymi pacjentami przeprowadzono wywiady w ciągu tygodnia od pierwszej oceny diagnostycznej przez pielęgniarkę specjalistyczną z placówki zajmującej się stacjonarną i domową opieką paliatywną w południowym Londynie (Wielka Brytania). Oceny pod kątem występowania depresji dokonywano, korzystając z kwestionariusza PRIME-MD PHQ-9. Obecność objawów somatycznych ustalono na podstawie kwestionariusza oceny jakości życia EORTC-QLQ-C30. Kryteria rozpoznawcze dużego zaburzenia depresyjnego zostały spełnione w przypadku 58 pacjentów [19,3% (15,3&#8211;23,3%)], a kryteria dowolnego zespołu depresyjnego &#8212; w przypadku 109 pacjentów [36,3% (32,3&#8211;40,3%)]. Wśród chorych z dużym zaburzeniem depresyjnym więcej było osób płci męskiej, częściej notowano brak nowotworu złośliwego, dolegliwości bólowe, zły stan ogólny i pragnienie szybkiej śmierci. Spośród chorych z dużym zaburzeniem depresyjnym stwierdzonym na początku badania u 69% (27/39) pacjentów odnotowano remisję depresji 4 tygodnie później. Wśród chorych bez depresji na początku badania u 11% (19/174) osób stwierdzono spełnienie kryteriów tego schorzenia podczas wizyty kontrolnej. Wartości predykcyjne dodatnie zaburzeń snu, obniżonego łaknienia i zmęczenia były niskie (< 24%), natomiast wartości predykcyjne ujemne tych objawów &#8212; wysokie (> 89%). Duże rozpowszechnienie depresji wśród pacjentów objętych opieką paliatywną świadczy o konieczności dokonywania oceny psychologicznej tych osób i udzielania im wsparcia psychologicznego. Przebieg depresji u pacjentów objętych opieką paliatywną charakteryzuje się małą stabilnością, w związku z czym jej objawy powinno się uważnie monitorować

Expert opinion on detecting and treating depression in palliative care: A Delphi study

<p>Abstract</p> <p>Background</p> <p>There is a dearth of data regarding the optimal method of detecting and treating depression in palliative care. This study applied the Delphi method to evaluate expert opinion on choice of screening tool, choice of antidepressant and choice of psychological therapy. The aim was to inform the development of best practice recommendations for the European Palliative Care Research Collaborative clinical practice guideline on managing depression in palliative care.</p> <p>Methods</p> <p>18 members of an international, multi-professional expert group completed a structured questionnaire in two rounds, rating their agreement with proposed items on a scale from 0-10 and annotating with additional comments. The median and range were calculated to give a statistical average of the experts' ratings.</p> <p>Results</p> <p>There was contention regarding the benefits of screening, with 'routine informal asking' (median 8.5 (0-10)) rated more highly than formal screening tools such as the Hospital Anxiety and Depression Scale (median 7.0 (1-10). Mirtazapine (median 9 (7-10) and citalopram (median 9 (5-10) were the considered the best choice of antidepressant and cognitive behavioural therapy (median 9.0 (3-10) the best choice of psychological therapy.</p> <p>Conclusions</p> <p>The range of expert ratings was broad, indicating discordance in the views of experts. Direct comparative data from randomised controlled trials are needed to strengthen the evidence-base and achieve clarity on how best to detect and treat depression in this setting.</p

Risk factors for mental illness in adults with atopic eczema or psoriasis: protocol for a systematic review.

INTRODUCTION: Evidence indicates that people with the common inflammatory skin diseases atopic eczema or psoriasis are at increased risk of mental illness. However, the reasons for the relationship between skin disease and common mental disorders (ie, depression and anxiety) or severe mental illnesses (ie, schizophrenia, bipolar disorder and other psychoses) are unclear. Therefore, we aim to synthesise the available evidence regarding the risk factors for mental illness in adults with atopic eczema or psoriasis. METHODS AND ANALYSIS: We will conduct a systematic review of randomised controlled trials, cohort, case-control and cross-sectional studies. We will search the following databases from inception to March 2020: Medline, Embase, Global Health, Scopus, the Cochrane Library, Web of Science, Base, PsycInfo, the Global Resource of Eczema Trials, and the grey literature databases Open Grey, PsycExtra and the New York Academy of Medicine Grey Literature Report. We will also search the bibliographies of eligible studies and relevant systematic reviews to identify additional relevant studies. Citation searching of large summary papers will be used to further identify relevant publications. Two reviewers will initially review study titles and abstracts for eligibility, followed by full text screening. We will extract data using a standardised data extraction form. We will assess the risk of bias of included studies using the Quality in Prognosis Studies tool. We will synthesise data narratively, and if studies are sufficiently homogenous, we will consider a meta-analysis. We will assess the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation framework. ETHICS AND DISSEMINATION: Ethical approval is not required for a systematic review. Results of the review will be published in a peer-reviewed journal and disseminated through conferences. PROSPERO REGISTRATION NUMBER: CRD42020163941

Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines

The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77–94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines

Systematic, continental scale temporal monitoring of marine pelagic microbiota by the Australian Marine Microbial Biodiversity Initiative

Sustained observations of microbial dynamics are rare, especially in southern hemisphere waters. The Australian Marine Microbial Biodiversity Initiative (AMMBI) provides methodologically standardized, continental scale, temporal phylogenetic amplicon sequencing data describing Bacteria, Archaea and microbial Eukarya assemblages. Sequence data is linked to extensive physical, biological and chemical oceanographic contextual information. Samples are collected monthly to seasonally from multiple depths at seven sites: Darwin Harbour (Northern Territory), Yongala (Queensland), North Stradbroke Island (Queensland), Port Hacking (New South Wales), Maria Island (Tasmania), Kangaroo Island (South Australia), Rottnest Island (Western Australia). These sites span ~30° of latitude and ~38° longitude, range from tropical to cold temperate zones, and are influenced by both local and globally significant oceanographic and climatic features. All sequence datasets are provided in both raw and processed fashion. Currently 952 samples are publically available for bacteria and archaea which include 88,951,761 bacterial (72,435 unique) and 70,463,079 archaeal (24,205 unique) 16 S rRNA v1-3 gene sequences, and 388 samples are available for eukaryotes which include 39,801,050 (78,463 unique) 18 S rRNA v4 gene sequences.Additional Authors: Bronwyn Holmes, Guy C.J. Abell, Pascal Craw, Tim Kahlke, Swan Li San Sow, Kirsty McAllister, Jonathan Windsor, Michele Skuza, Ryan Crossing, Nicole Patten, Paul Malthouse, Paul D. van Ruth, Ian Paulsen, Jed A. Fuhrman, Anthony Richardson, Jason Koval, Andrew Bissett, Anna Fitzgerald, Tim Moltmann & Levente Bodross

Multi-ancestry genome-wide study in &gt;2.5 million individuals reveals heterogeneity in mechanistic pathways of type 2 diabetes and complications

Type 2 diabetes (T2D) is a heterogeneous disease that develops through diverse pathophysiological processes. To characterise the genetic contribution to these processes across ancestry groups, we aggregate genome-wide association study (GWAS) data from 2,535,601 individuals (39.7% non-European ancestry), including 428,452 T2D cases. We identify 1,289 independent association signals at genome-wide significance (P&lt;5×10 - 8 ) that map to 611 loci, of which 145 loci are previously unreported. We define eight non-overlapping clusters of T2D signals characterised by distinct profiles of cardiometabolic trait associations. These clusters are differentially enriched for cell-type specific regions of open chromatin, including pancreatic islets, adipocytes, endothelial, and enteroendocrine cells. We build cluster-specific partitioned genetic risk scores (GRS) in an additional 137,559 individuals of diverse ancestry, including 10,159 T2D cases, and test their association with T2D-related vascular outcomes. Cluster-specific partitioned GRS are more strongly associated with coronary artery disease and end-stage diabetic nephropathy than an overall T2D GRS across ancestry groups, highlighting the importance of obesity-related processes in the development of vascular outcomes. Our findings demonstrate the value of integrating multi-ancestry GWAS with single-cell epigenomics to disentangle the aetiological heterogeneity driving the development and progression of T2D, which may offer a route to optimise global access to genetically-informed diabetes care. </p

Genetic drivers of heterogeneity in type 2 diabetes pathophysiology

Type 2 diabetes (T2D) is a heterogeneous disease that develops through diverse pathophysiological processes1,2 and molecular mechanisms that are often specific to cell type3,4. Here, to characterize the genetic contribution to these processes across ancestry groups, we aggregate genome-wide association study data from 2,535,601 individuals (39.7% not of European ancestry), including 428,452 cases of T2D. We identify 1,289 independent association signals at genome-wide significance (P &lt; 5 × 10-8) that map to 611 loci, of which 145 loci are, to our knowledge, previously unreported. We define eight non-overlapping clusters of T2D signals that are characterized by distinct profiles of cardiometabolic trait associations. These clusters are differentially enriched for cell-type-specific regions of open chromatin, including pancreatic islets, adipocytes, endothelial cells and enteroendocrine cells. We build cluster-specific partitioned polygenic scores5 in a further 279,552 individuals of diverse ancestry, including 30,288 cases of T2D, and test their association with T2D-related vascular outcomes. Cluster-specific partitioned polygenic scores are associated with coronary artery disease, peripheral artery disease and end-stage diabetic nephropathy across ancestry groups, highlighting the importance of obesity-related processes in the development of vascular outcomes. Our findings show the value of integrating multi-ancestry genome-wide association study data with single-cell epigenomics to disentangle the aetiological heterogeneity that drives the development and progression of T2D. This might offer a route to optimize global access to genetically informed diabetes care.</p