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Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.
We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.
Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.
Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
To describe the infection control preparedness measures undertaken for coronavirus disease (COVID-19) due to SARS-CoV-2 (previously known as 2019 novel coronavirus) in the first 42 days after announcement of a cluster of pneumonia in China, on December 31, 2019 (day 1) in Hong Kong.
A bundled approach of active and enhanced laboratory surveillance, early airborne infection isolation, rapid molecular diagnostic testing, and contact tracing for healthcare workers (HCWs) with unprotected exposure in the hospitals was implemented. Epidemiological characteristics of confirmed cases, environmental samples, and air samples were collected and analyzed.
From day 1 to day 42, 42 of 1,275 patients (3.3%) fulfilling active (n = 29) and enhanced laboratory surveillance (n = 13) were confirmed to have the SARS-CoV-2 infection. The number of locally acquired case significantly increased from 1 of 13 confirmed cases (7.7%, day 22 to day 32) to 27 of 29 confirmed cases (93.1%, day 33 to day 42; P < .001). Among them, 28 patients (66.6%) came from 8 family clusters. Of 413 HCWs caring for these confirmed cases, 11 (2.7%) had unprotected exposure requiring quarantine for 14 days. None of these was infected, and nosocomial transmission of SARS-CoV-2 was not observed. Environmental surveillance was performed in the room of a patient with viral load of 3.3 × 106 copies/mL (pooled nasopharyngeal and throat swabs) and 5.9 × 106 copies/mL (saliva), respectively. SARS-CoV-2 was identified in 1 of 13 environmental samples (7.7%) but not in 8 air samples collected at a distance of 10 cm from the patient’s chin with or without wearing a surgical mask.
Appropriate hospital infection control measures was able to prevent nosocomial transmission of SARS-CoV-2.
Osteoporosis is a skeletal disease characterized by bone loss and bone microarchitectural deterioration. The combination of smart materials and stem cells represents a new therapeutic approach. In the present study, highly porous scaffolds are prepared by combining the conducting polymer PEDOT:PSS with collagen type I, the most abundant protein in bone. The inclusion of collagen proves to be an effective way to modulate their mechanical properties and it induces an increase in scaffolds’ electrochemical impedance. The biomimetic scaffolds support neural crest-derived stem cell osteogenic differentiation, with no need for scaffold pre-conditioning contrarily to other reports.
Copy number variants (CNVs) play a significant role in disease pathogenesis in a small subset of individuals with schizophrenia (~2.5%). Chromosomal microarray testing is a first-tier genetic test for many neurodevelopmental disorders. Similar testing could be useful in schizophrenia.
To determine whether clinically identifiable phenotypic features could be used to successfully model schizophrenia-associated (SCZ-associated) CNV carrier status in a large schizophrenia cohort.
Logistic regression and receiver operating characteristic (ROC) curves tested the accuracy of readily identifiable phenotypic features in modelling SCZ-associated CNV status in a discovery data-set of 1215 individuals with psychosis. A replication analysis was undertaken in a second psychosis data-set (n = 479).
In the discovery cohort, specific learning disorder (OR = 8.12; 95% CI 1.16–34.88, P = 0.012), developmental delay (OR = 5.19; 95% CI 1.58–14.76, P = 0.003) and comorbid neurodevelopmental disorder (OR = 5.87; 95% CI 1.28–19.69, P = 0.009) were significant independent variables in modelling positive carrier status for a SCZ-associated CNV, with an area under the ROC (AUROC) of 74.2% (95% CI 61.9–86.4%). A model constructed from the discovery cohort including developmental delay and comorbid neurodevelopmental disorder variables resulted in an AUROC of 83% (95% CI 52.0–100.0%) for the replication cohort.
These findings suggest that careful clinical history taking to document specific neurodevelopmental features may be informative in screening for individuals with schizophrenia who are at higher risk of carrying known SCZ-associated CNVs. Identification of genomic disorders in these individuals is likely to have clinical benefits similar to those demonstrated for other neurodevelopmental disorders.
To report an outbreak of measles with epidemiological link between Hong Kong International Airport (HKIA) and a hospital.
Epidemiological investigations, patients’ measles serology, and phylogenetic analysis of the hemagglutinin (H) and nucleoprotein (N) genes of measles virus isolates were conducted.
In total, 29 HKIA staff of diverse ranks and working locations were infected with measles within 1 month. Significantly fewer affected staff had history of travel than non–HKIA-related measles patients [10 of 29 (34.5%) vs 28 of 35 (80%); P < .01]. Of 9 airport staff who could recall detailed exposure history, 6 (66.7%) had visited self-service food premises at HKIA during the incubation period, where food trays, as observed during the epidemiological field investigation, were not washed after use. Furthermore, 1 airport baggage handler who was admitted to hospital A before rash onset infected 2 healthcare workers (HCWs) known to have 2 doses of MMR vaccination with positive measles IgG and lower viral loads in respiratory specimens. Infections in these 2 HCWs warranted contact tracing of another 168 persons (97 patients and 71 HCWs). Phylogenetic comparison of H and N gene sequences confirmed the clonality of outbreak strains.
Despite good herd immunity with overall seroprevalence of >95% against measles, major outbreaks of measles occurred among HKIA staff having daily contact with many international pssengers. Lessons from severe acute respiratory syndrome (SARS) and measles outbreaks suggested that an airport can be a strategic epidemic center. Pre-exanthem transmission of measles from airport staff to HCWs with secondary vaccine failure poses a grave challenge to hospital infection control.
Interfacing organic electrochemical transistors (OECTs) with biological systems holds considerable promise for building-sensitive biosensors and diagnostic tools. We present a simple model that describes the performance of biosensors in which an OECT is integrated with a biological barrier layer. Using experimentally derived parameters we explore the limits of sensitivity and find that it is dependent on the resistance of the barrier layer. This work provides guidelines on how to optimize biosensors in which OECTs transduce changes in the impedance of biological layers, including lipid bilayer membranes and confluent cell layers.
In 1959 the notoriously elusive yet evidently fraternal Chris Marker lent both his name and his pet owl Anabase to Walerian Borowczyk's short animation The Astronauts (Les Astronautes), the Polish director's first film after his emigration to France. According to Catherine Lupton, Marker cosigned the film as a “favor” to Borowczyk, who then lacked a permit to work in his adopted country. Just as Marker provided The Astronauts with one of the creatures particularly privileged in his own cinema, so, a few years later, did Borowczyk's wife and favored female star Ligia Branice appear briefly in Marker's celebrated “stills movie” The Pier (La jetée, 1962). These wisps of collaboration point to the underexplored connection between Borowczyk and the “Left Bank Group,” a band of (mostly) French filmmakers, including Marker, who are alternately considered a “subset” of the Nouvelle Vague and its more literary and politically engaged counterpart. These gestures not only suggest a shared milieu and real-life sympathies, but also foreground tactics and tropes common to both the Parisian “movement” and the fiercely independent Polish émigré.
The contribution of cherished mainstays from one's domestic life, whether a pet owl or a spouse, points to the modest, artisanal, and “home-made” qualities of Borowczyk's or Marker's cinema: to that extent The Astronauts itself, a vignette concerning an eccentric inventor and his little home-made spaceship, is a portrait of the artists involved and the inscription of its own production methods.
The opening up of Poland economically and politically to global influences after the fall of the Berlin Wall in 1989, coupled with the rise of transnational approaches to the study of film, present ideal conditions for an examination of Polish cinema from a transnational vantage point. Yet not only have studies of Polish cinema remained largely within a national framework but Polish, and many other Eastern European cinemas, have also been virtually excluded from accounts of transnational cinema. 'Polish Cinema in a Transnational Context' addresses this lacuna in film studies by examining the international reception of Polish films in Europe and North America, Polish international coproductions and the presence of Polish performers in foreign films, and the works of subversive émigré auteurs like Andrzej Zulawski and Walerian Borowczyk. Authors in this collection present familiar films and filmmakers in a new and revealing light, while also shifting the focus to lesser known filmmakers and aspects of Polish cinema. The resulting volume moves discussion beyond the border of Polish national belonging. Contributors: Peter Hames, Darragh O'Donoghue, Helena Goscilo, Dorota Ostrowska, Charlotte Govaert, Eva Näripea, Izabela Kalinowska-Blackwood, Ewa Mazierska, Alison Smith, Lars Kristensen, Jonathan Owen, Michael Goddard, Robert Murphy, Kamila Kuc, Elzbieta Ostrowska. Ewa Mazierska is professor of film studies at the University of Central Lancashire. Michael Goddard is senior lecturer at the University of Salford.
Since Prince (1981) and Givón (1983), studies on discourse reference have explained the grammatical realization of referents in terms of general concepts such as “assumed familiarity” or “discourse coherence.” In this paper, we develop a complementary approach based on a detailed statistical tracking of subjects in Emirati Arabic, from which two major categories of subject expression emerge. On the one hand, null subjects are opposed to overt ones; on the other, subject-verb (SV) is opposed to verb-subject (VS). Although null subjects strongly correlate with coreferentiality with the subject of the previous clause, they can also index more distant referents within a single episode. With respect to SV vs. VS, morpholexical classes are found to be biased toward one or the other: nouns are typically VS, pronouns SV. We conclude that the null subject variant is the norm in Emirati Arabic, and when an overt subject is appropriate, lexical identity biases the subject into SV or VS order, generating word order as a discourse-relevant parameter. Overall, our approach attempts to understand Arabic discourse from a microlevel perspective.
Observing galaxies in the radio and submillimeter continuum has the advantage of being unaffected by dust extinction, which is a major drawback of studying galaxy evolution using optical data. Submillimeter single-dish surveys have made tremendous progress in understanding the high-redshift dusty population, but the low angular resolution of single-dish telescopes has also hampered these studies. Our recent JCMT and SMA imaging of high-redshift submillimeter sources revealed z > 4 objects that are radio and optically faint. Such objects cannot be easily identified with the combination of submillimeter single-dish and radio imaging. We also found a large fraction of multiple objects that are blended in single-dish images. Such objects may be early-stage mergers, or dusty starbursts in group environments. Since our work, larger surveys with PdBI and ALMA have been carried out to further address these issues. Additional to submillimeter imaging, future ultradeep EVLA imaging at 20 cm can also detect large samples of ultraluminous star forming galaxies at z ≳ 2. Sensitivities in radio and submillimeter observations have different redshift and dust temperature dependencies. Radio observations are also less affected by confusion. It will be necessary to combine deep surveys in both wavebands in order to achieve a more complete picture of the evolution of high-redshift star forming galaxies.