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Clinical trials often struggle to recruit enough participants, with only 10% of eligible patients enrolling. This is concerning for conditions like stroke, where timely decision-making is crucial. Frontline clinicians typically screen patients manually, but this approach can be overwhelming and lead to many eligible patients being overlooked.
Methods:
To address the problem of efficient and inclusive screening for trials, we developed a matching algorithm using imaging and clinical variables gathered as part of the AcT trial (NCT03889249) to automatically screen patients by matching these variables with the trials’ inclusion and exclusion criteria using rule-based logic. We then used the algorithm to identify patients who could have been enrolled in six trials: EASI-TOC (NCT04261478), CATIS-ICAD (NCT04142125), CONVINCE (NCT02898610), TEMPO-2 (NCT02398656), ESCAPE-MEVO (NCT05151172), and ENDOLOW (NCT04167527). To evaluate our algorithm, we compared our findings to the number of enrollments achieved without using a matching algorithm. The algorithm’s performance was validated by comparing results with ground truth from a manual review of two clinicians. The algorithm’s ability to reduce screening time was assessed by comparing it with the average time used by study clinicians.
Results:
The algorithm identified more potentially eligible study candidates than the number of participants enrolled. It also showed over 90% sensitivity and specificity for all trials, and reducing screening time by over 100-fold.
Conclusions:
Automated matching algorithms can help clinicians quickly identify eligible patients and reduce resources needed for enrolment. Additionally, the algorithm can be modified for use in other trials and diseases.
This chapter considers the place of epic, above all Homer, in three overlapping areas of ancient Greek and Roman culture – education at all levels, elite literary culture, and the more specialised interpretations of scholars and philosophers. Homer was central to Greek education and Hunter considers the various types of evidence for this centrality – anecdotes, literary descriptions, papyri – and the reasons for the greater attention given to the Iliad over the Odyssey. He then illustrates the place of epic in the creative poetry and prose of the Hellenistic and imperial periods and finally samples the scholarly and philosophical approaches taken to Homer from Ptolemaic Alexandria to late antiquity. The chapter brings together a range of authors and thinkers, from Quintilian to Horace, Dio Chrysostom to Eustathius, and Porphyry’s remarkable allegorical treatment of Homer.
This chapter considers some aspects of the intertextual and intervisual dynamics of Euripides’ Cyclops with particular reference to the cave represented by the skēnē. The particular links of the Cyclops to Sophocles’ Philoctetes are used to explore a network of allusive possibilities in both plays going back to Homer’s ‘Cave of the Nymphs’ in Odyssey 13 and embracing the lost Philoctetes plays of Aeschylus and Euripides. The powerful mediating role of Homer’s cave is seen to be transferred to the caves of drama as the boundary between the seen and the unseen, between the past, present, and future, and as a strongly suggestive marker of the difference between epic narrative and dramatic representation. As the Homeric cave had separate entrances for mortals and gods, so did the Athenian stage. In exploring some of the richness of ‘intertextual allusion’ in fifth-century drama, the chapter also contributes to the appreciation of the differences in allusive practice between tragedy, comedy, and satyr play and of how poets acknowledged and exploited those differences.
This chapter concerns Lucian’s presentation of the contemporary display of literate knowledge and the practice of criticism and scholarship. That presentation is often obviously satirical, but Lucian’s tone and purpose also often remain elusive; Lucian’s voice is never easy to capture. Examples include Lucian’s account of the art of reading in On the Ignorant Book-Collector, and the posturing philosophers and ignorant grammarians of the Symposium; this latter case illustrates how Lucian’s concern with ‘the culture of criticism’ is always part of the ever-present negotiation with classical models which is a hallmark of his work, as of any major figure of the Second Sophistic. The same is true of the satire on Atticism in Lexiphanes. The final part of the chapter considers Lucian’s presentation of artistic technai, whether that be that art of writing history or the treatise on pantomime, On the Dance.
This chapter discusses Plutarch’s On the Oracles at Delphi, and in particular the account of the grammarian Theon as to how prose came to replace verse, not just in the delivery of the Delphic oracle, but in literary discourse as a whole. Theon’s account of the history of Greek literate culture is an important document of how learned Greeks in the Roman empire imagined how their world had changed, along with the literature in which it was represented. The first part of the chapter considers another Plutarchan account of cultural and intellectual change, namely the opening of On the Obsolescence of Oracles, which tells the foundation story of Delphi. Both texts lay weight upon the fact of change itself, rather than on any detailed plotting of that change, let alone a chronology for it; so too, both illustrate a tendency to see recurrent patterns of change, by which the outlines of Greek literary history are found already adumbrated in classical literature itself. Among the classical texts which are central to this appropriation of past models are the programmatic chapters of Thucydides and Aristotle’s account of the development of poetic language.
Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device.
Methods:
This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial. We identified key factors contributing to delays in clinical trial execution and potential best practices to expedite the process while maintaining safety, ethics, and efficacy.
Results:
The total time from site contact to first patient enrollment averaged 14 months. CTA and budget negotiations were the most time-consuming processes, averaging nearly 10 and 9 months, respectively. Reliance and local IRB processing also contributed significantly to the timeline, overall adding an average of 6.5 months across institutions. Nearly half of all costs were devoted to regulatory oversight. The COVID-19 pandemic caused significant slowdowns and delays at multiple institutions during study enrollment. Despite these pandemic-induced delays, it is important to note that the issues and themes highlighted remain relevant and have post-pandemic applicability.
Conclusions:
Our case study results underscore the importance of establishing efficient and standardized processing of CTAs, budget negotiations, and use of reliance IRBs to expedite clinical trial execution for pediatric devices. The findings also highlight the need for a national clinical trials network to streamline the clinical trial process.
Among nursing home outbreaks of coronavirus disease 2019 (COVID-19) with ≥3 breakthrough infections when the predominant severe acute respiratory coronavirus virus 2 (SARS-CoV-2) variant circulating was the SARS-CoV-2 δ (delta) variant, fully vaccinated residents were 28% less likely to be infected than were unvaccinated residents. Once infected, they had approximately half the risk for all-cause hospitalization and all-cause death compared with unvaccinated infected residents.
Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse.
Aims
This study aims to evaluate whether the Engager intervention improves mental health outcomes following release.
Method
The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3–5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT).
Results
In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI –1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact.
Conclusions
Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.
Glass bangles are found in southern England and Wales from the mid-first century ad and become common in the north of England and southern Scotland in the late first century, before their numbers decline a century later. British bangles develop at a time of change, as Roman glassmaking practices were introduced across large areas of Britain, and as blown, transparent, colourless and naturally-coloured glassware became increasingly popular. In many communities, however, there was still a demand for strongly coloured opaque glass, including for bangles, and glassworkers devised ways of extending their supplies of opaque coloured glass. This study is based on over one hundred and fifty analyses of bangle fragments from sites in Wales, northern England and southern Scotland, spanning this transitional period. The bangle makers recycled coloured glass from imported vessels, and probably beads and bangle-making waste, to supplement supplies of fresh coloured glass. The novel methods used to modify and extend the coloured glass may derive from pre-Roman bead-making industries, and made use of widely available materials, including smithing hammerscale and possibly plant ashes. The results show the shifting balance of indigenous and Roman influences on different bangle types, depending on when and where they were made, and by whom.
Sexual orientation is considered from Savin-Williams’ continuum perspective, and gender and sexual orientation are both conceptualized from a fluid, rather than a categorical viewpoint. A Minority Stress Model is applied to the experience of LGBTQ+ communities, whereby stress reactions relate to concerns about one’s safety, discrimination, oppression, and internalized oppression, among many other negative mental and physical health outcomes. Proximal and distal stressors are presented in conjunction with the Minority Stress Model and applied to several domains illustrating community gaps and interventions in academic, legislative, religious, economic, medical, social, and social-environmental realms. Key policies are presented supporting greater rights for LGBTQ+ communities. Despite these advances, significant gaps remain with regard to responsiveness to the needs of LGBTQ+ communities. A case study highlights adverse effects and policy regarding conversion therapy.
This paper considers the use which both Celsus and Origen made of the Homeric poems and of the prior tradition of interpretative and grammatical exegesis of those poems. The paper sets the exploitation of Homer by Celsus and Origen against the background of the leading role which Homer played in the culture of the so-called Second Sophistic.
The purpose of this study was to determine if the mixed evidence of almond consumption on HbA1c stems from testing people with different body fat distributions (BFD) associated with different risks of glucose intolerance. A 6-month randomised controlled trial in 134 adults was conducted. Participants were randomly assigned to the almond (A) or control (C) group based on their BFD. Those in the almond group consumed 1·5 oz of almonds with their breakfast and as their afternoon snack daily. Those in the control group continued their habitual breakfast and afternoon snack routines. Body weight and composition were measured and blood samples were collected for determination of HbA1c, glycaemia and lipaemia at 0 and 6 months. Appetite ratings, energy intake and diet quality were collected at 0, 2, 4 and 6 months. Participants consuming almonds ingested 816 (sem 364) kJ/d more than participants in the control group (P = 0·03), but this did not result in any differences in body weight (A: –0·3 (sem 0·4), C: –0·4 (sem 0·4); P > 0·3). Participants in the almond, high android subcutaneous adipose tissue (SAT) group had a greater reduction in android fat mass percentage (A: –1·0 (sem 0·6), C: 1·1 (sem 0·6); P = 0·04), preserved android lean mass percentage (A: 0·9 (sem 0·6), C: –1 (sem 0·6); P = 0·04) and tended to decrease android visceral adipose tissue mass (A: –13 (sem 53) g, C: 127 (sem 53) g; P = 0·08) compared with those in the control, high SAT group. There were no differences in HbA1c between groups (A: 5·4 (sem 0·04), C: 5·5 (sem 0·04); P > 0·05). Thus, BFD may not explain the mixed evidence on almond consumption and HbA1c. Long-term almond consumption has limited ability to improve cardiometabolic health in those who are overweight and obese but otherwise healthy.
Chapter 20 of The Cambridge Companion to Sappho looks at Sappho’s significance for the rich poetic culture of the Hellenistic world, including Apollonius, Theocritus, and Posidippus, as a parallel development to the scholarly discourse surrounding the editing of her work during this period.
Dionysius of Halicarnassus was a rhetorician, critic and historiographer in Augustan Rome. This volume seeks to understand Dionysius as a writer positioned between Greece and Rome and between rhetoric and historiography. The introduction discusses the complex relationship between Dionysius’ history of early Rome and his rhetorical and critical works, and it presents Dionysius as both thoroughly Greek and very Roman. Dionysius’ works are interpreted as part of the Greek literature of the Augustan Age and as responding to the political, cultural and intellectual climate of Rome under Augustus. The following chapters are presented in three parts: (1) Dionysius and Augustan Rhetoric and Literary Criticism, (2) Dionysius and Augustan Historiography, and (3) Dionysius and Augustan Rome. The introduction concludes with a consideration of Dionysius’ intended audience.