bluuebunny/crossref_metadata_2025_split huggingface dataset:
Predictors of premature termination of cardiac surgery trials: insights from the Clinicaltrial.gov database
Authors: Cancelli Gianmarco , Rossi Camilla S , Dell'Aquila Michele , Mantaj Polina , Hirofuji Aina , Soletti Giovanni , Harik Lamia , Cangut Busra , Al Zaghari Talal , Leith Jordan , Falco Giorgia , Ibrahim Mudathir , Dimagli Arnaldo , Rahouma Mohamed , Gaudino Mario F L 
Published: August 2024

Abstract

OBJECTIVES
Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it.

METHODS
We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis.

RESULTS
A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America [294 (39.4%)], Europe [264 (35.4%)] or Asia [141 (18.9%)]. Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3 and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (CI) (1.65–8.00) P = 0.001], valve surgery trials [OR 4.30, 95% CI (2.33–8.00) P &lt; 0.001], aortic surgery trials [OR 2.86 95% CI (1.22–6.43) P = 0.012], phase 2 [OR 3.02, 95% CI (1.31–7.93) P = 0.015] and phase 4 trials [OR 3.62, 95% CI (1.43–10.23) P = 0.010] were at higher risk of premature termination while trials performed in Asia [OR 0.18, 95% CI (0.07–0.39) P ≤ 0.001] and Europe [OR 0.49, 95% CI (0.30–0.80) P = 0.004] were less likely to be terminated prematurely.

CONCLUSIONS
Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on left ventricular assist device, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.
Extraction of lumenless pacing leads from the His bundle and left bundle branch area: outcomes of the high-volume centre
Authors: Gardas Rafal , Loboda Danuta , Biernat Jolanta , Soral Tomasz , Kulesza Piotr , Gladysz-Wanha Sylwia , Joniec Michal , Sajdok Mateusz , Zub Kamil , Golba Krzysztof S 
Published: August 2024

Abstract

Aims
The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal.

Methods and results
Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads.

Conclusion
The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.
Entrepreneurial Frame Alignment: Framing Foreign Policy Change under a Veil of Continuity
Authors: Wikman Lars 
Published: August 2024

Abstract
How can entrepreneurs frame foreign policy change so it forces political opposition into acquiescence? In this article, I show how foreign policy entrepreneurs use six frame alignment strategies to situate policy within the confines of the dominating discourse in ways that generate political support, exploit windows of opportunity, and manage coalitions. This contributes to our knowledge of the available framing tools for entrepreneurs and advances our understanding of the relationship between change and continuity in foreign policy. In the empirical analysis, based predominantly on twenty-three in-depth interviews, I show how a new venture of Swedish foreign policy, the deployment of Special Forces to Afghanistan, was successfully framed firmly within the confines of the foreign policy orientation and in line with previous policies. The analysis demonstrates how potential opposition was forestalled through the use of alignment strategies as sensitive and controversial aspects were masked as foreign policy continuity.
Genomic prediction of the performance of tropical doubled haploid maize lines under artificial Striga hermonthica (Del.) Benth. infestation
Authors: Kimutai Joan J C , Makumbi Dan , Burgueño Juan , Pérez-Rodríguez Paulino , Crossa Jose , Gowda Manje , Menkir Abebe , Pacheco Angela , Ifie Beatrice E , Tongoona Pangirayi , Danquah Eric Y , Prasanna Boddupalli M 
Published: August 2024

Abstract
Striga hermonthica (Del.) Benth., a parasitic weed, causes substantial yield losses in maize production in sub-Saharan Africa. Breeding for Striga resistance in maize is constrained by limited genetic diversity for Striga resistance within the elite germplasm and phenotyping capacity under artificial Striga infestation. Genomics-enabled approaches have the potential to accelerate identification of Striga resistant lines for hybrid development. The objectives of this study were to evaluate the accuracy of genomic selection for traits associated with Striga resistance and grain yield (GY) and to predict genetic values of tested and untested doubled haploid maize lines. We genotyped 606 doubled haploid lines with 8,439 rAmpSeq markers. A training set of 116 doubled haploid lines crossed to 2 testers was phenotyped under artificial Striga infestation at 3 locations in Kenya. Heritability for Striga resistance parameters ranged from 0.38–0.65 while that for GY was 0.54. The prediction accuracies for Striga resistance-associated traits across locations, as determined by cross-validation (CV) were 0.24–0.53 for CV0 and from 0.20 to 0.37 for CV2. For GY, the prediction accuracies were 0.59 and 0.56 for CV0 and CV2, respectively. The results revealed 300 doubled haploid lines with desirable genomic estimated breeding values for reduced number of emerged Striga plants (STR) at 8, 10, and 12 weeks after planting. The genomic estimated breeding values of doubled haploid lines for Striga resistance-associated traits in the training and testing sets were similar in magnitude. These results highlight the potential application of genomic selection in breeding for Striga resistance in maize. The integration of genomic-assisted strategies and doubled haploid technology for line development coupled with forward breeding for major adaptive traits will enhance genetic gains in breeding for Striga resistance in maize.
Replicability, adaptability and long-term impact of the ‘Healthy Youngsters, Healthy Dads’ program in Newcastle, Australia
Authors: Ashton Lee M , Grounds Jacqueline A , Barnes Alyce T , Pollock Emma R , Young Myles D , Kennedy Stevie-Lee , Rayward Anna T , Lee Daniel R , Morgan Philip J 
Published: August 2024

Abstract
‘Healthy Youngsters, Healthy Dads’ (HYHD) targets fathers to improve the health of their preschool-aged children. In a previous randomized trial, fathers and children experienced meaningful improvements in physical activity and eating behaviours. The next phase is to test the replicability and adaptability of HYHD when delivered in the community by trained facilitators. Fathers/father-figures and children aged 3–5 years were recruited from Newcastle, Australia into a 9-week, non-randomized trial with assessments at baseline, 10 weeks, and 12 months. The primary outcome was achievement of pre-registered targets for recruitment (≥ 96 dyads), attendance (≥ 70%), compliance (completing ≥ 70% of home-based tasks), fidelity (≥ 80% of content delivered as intended) and program satisfaction (≥ 4/5). Secondary outcomes included physical activity, nutrition, screen time and parenting measures. Process targets were surpassed for recruitment (140 fathers, 141 children), attendance (79% for fathers-only workshops, 81% for father–child sessions), compliance (80% of home-tasks completed), fidelity (99% for education, ≥ 97% for practical) and program satisfaction (4.8/5). Mixed effects regression models revealed significant effects in fathers for moderate-to-vigorous physical activity, co-physical activity, dietary intake and parenting practises, which were maintained at 12 months. Significant effects were also established for screen time at 10 weeks only. For children, significant effects were observed for screen time and dietary intake at 10 weeks, while effects on energy-dense, nutrient-poor foods and healthy, nutrient-dense core food intake were maintained at 12 months. Findings demonstrate the replicability and adaptability of HYHD when delivered in the community by local trained facilitators. Further investigation into how to optimally scale-up HYHD is warranted.
Climate damage from fishing the mesopelagic zone exceeds its economic benefits
Authors: Groeneveld Rolf A , Richter Andries , Sen Suphi 
Published: August 2024

Abstract
Mesopelagic fish represent an opportunity for fishing companies and food production, but their exploitation carries substantial environmental risks related to these populations’ role in the oceanic carbon pump. We assess the economic viability of mesopelagic fishing from a private economic perspective, focusing on costs and revenues accruing to the fishing industry, and a public economic perspective, considering impacts on society at large, notably climate change. We develop a stylized model, which we apply to four pelagic trawling fleets in the European Union. We find that a mesopelagic fishery operated with current excess capacity in the four fleets considered is profitable from a private perspective, but the climate impacts potentially outweigh the private economic benefits. This implies that strict governance arrangements are needed to safeguard the sustainability of the mesopelagic zone. Considering long-term dynamics, we explore potential natural limits to an expanding mesopelagic fishery. First, a growing fishery will reduce biomass level, affecting profitability. Second, an increase in mesopelagic production may lower the price, also limiting potential for expansion. For the time being, however, it is unlikely that the fishery will reach a scale level where such feedbacks can be expected, making effective governance arrangements even more crucial.
Graft Take Outcomes of Burn Patients Transplanted With CEA Derived From a Modified Composite Culture Technique: A Case Series
Authors: Kleintjes Wayne George , Prinsloo Tarryn Kay 
Published: August 2024

AbstractLow-cost and efficient culture environments comparable to standard techniques would undoubtedly improve burn outcomes in underresourced settings. The aim of this case series was to report on the cultured epithelial autografting (CEA) graft-take using a modified composite culture technique. Cultured epithelial autografting transplants, following emergency ethical approval, occurred for patients with burns (n = 25) with low survival prognosis and/or exhausted donor sites. Keratinocytes were retrieved from skin biopsies, seeded centrally on routinely used dressing gauze, and incubated at 37 °C in pediatric incubators. Fresh autogenous plasma was applied daily and hydrogel every third or fourth day. After confluence, the CEA was transplanted onto debrided wound beds. Xenografts were used for temporary cover during the culture period. Final graft take assessment (21 days) was assessed and calculated as a graft take percentage for total CEA area transplanted. Central indices were described as mean (95% confidence interval [CI]) and frequency (%) for age, total body surface area, abbreviated burn severity index scores, survival prognosis, and graft take. Eleven patients survived with a mean age of 36.1 years (95% CI: 25.8-46.4), 45.0% total body surface area burns (95% CI: 35.1-54.9), 9.7 abbreviated burn severity index scores (95% CI: 8.6-10.8), and 79.5% graft take (95% CI: 62.9-96.0). Reduced graft take (61.2%) was observed in patients with perineum burns and increased graft take (97%) in uncomplicated burns. The average CEA graft take was 79.5% using a low-cost culture technique and was comparable to the largest case series in the literature. The survival of the major burn cases was highly favorable considering injury severity, expected outcomes without CEA and the observed challenges.
Radical Thought and Political Practice: Officeholding and Accountability in Seventeenth-Century Britain
Authors: Peacey Jason 
Published: August 2024

Abstract
This article connects changes in administrative and bureaucratic processes that historians associate with state formation in early modern Britain with overlooked developments in thinking about political accountability. It blends the social history of state administration with intellectual history, and involves synoptic analysis as well as striking case studies. It argues that innovative political thinking emerged from new forms of political practice, and from the experiences of humble officials in the localities. Such individuals were increasingly professionalized and specialized, and their work was increasingly described using the language of trust, public interest, and state’s service. The mid-seventeenth century accentuated the process by which they came to be accountable to a centralized state, not least through the routinization and intensification of quotidian practices associated with enhanced communication between center and locality. Ultimately, the article argues that such processes, as well as more regular and direct interactions between political elites and humble officials, encouraged new kinds of political thinking. These were not quite unintended, but they may not have been fully anticipated either, and they involved innovative attempts to subject higher officials to oversight from “below,” and to legitimize their accountability to an adjudicating public, in ways that may even have had a lasting effect on English political culture.
Vigilance, Popular Control and Neighborhood Surveillance in Besieged Paris (1589–1591)
Authors: Roussel Diane 
Published: August 2024

Abstract
Surveillance studies often recall that Michel Foucault had identified the health crises of the plagues of the Ancien Régime as precursory moments in the establishment of modern surveillance. Episodes of civil wars are certainly another example. This study takes for object the capital of the kingdom of France at the siege of Paris, in 1589–1591, when Henry III and then Henri IV tried to reduce to their authority in the rebellious city, head of the Ultra-Catholic Ligue. This unprecedented experience of fear and generalized suspicion allows us to study how the usual mechanisms of social control are used for political ends, but also how new surveillance procedures emerge, based on the written word and a desire for rationalization. This article uses a wide range of sources, from municipal decisions to the reports of chroniclers, but relies mainly on the judicial archives of the Parlement and the Hôtel de Ville to draw up a social history as close as possible to ordinary Parisians. Taking a ground-level approach, the study is particularly interested in ordinary agents of urban control and forms of day-to-day and face-to-face surveillance. In this exceptional climate, the routine work of watching others in the neighborhood turned to political surveillance. The key actors were the Militia, whose action relied on the Parisians themselves, considered as “the eyes and ears” of the League authorities to know who the enemies were and to testify of the loyalty of the inhabitants.
Popular Control through Public Accountability in Iberia (Thirteenth to Sixteenth Centuries)
Authors: Martín Romera María Ángeles 
Published: August 2024

Abstract
This article analyzes the participation of the people in the Castilian procedure of accountability called juicio de residencia (comparable to the Italian sindacato) as a fertile ground for the development of popular control in urban settings. It adopts a longue-durée approach considering its transformations from its origins in the thirteenth century to the sixteenth century and from Castile to the Spanish Monarchy. In addition, it draws on a bottom-up approach and makes a case for qualitative instead of quantitative research, taking into account the massive but heterogeneous archival material related to residencias from the fifteenth century to the sixteenth century in the Hispanic Monarchy. In order to prove the main hypothesis, after presenting the limits and virtues of the Hispanic sources, I focus on two aspects. The first part presents evidence of people of all sorts consistently participating in the juicios de residencias that held officials accountable, as well as the development of a modality of collective action that was propitious for popular control: the presentaciones de capítulos. The second part shifts from the actors to the effects of that participation, testing different indicators of the potential of residencias for popular control. Ultimately, this article argues that officers’ accountability under the form of residencias was a consistent instrument for Castilian people to exert pressure on authorities and a habitual resource for popular actions.
The Boundaries of Popular Control in Late Medieval English Towns
Authors: Hartrich Eliza 
Published: August 2024

Abstract
Scholarship on pre-modern popular politics often focuses on speech, identifying the ways in which people outside the elite could have a “voice” in government. Using examples from late medieval English towns, this article argues for the existence of a particular kind of popular politics that centered on seeing and hearing rather than speaking. This type of politics—labeled “popular control”—concerned the right of the urban political community at large to observe rituals of governance and to audit financial accounts. Through these acts of collective witnessing, lesser citizens and non-citizens exerted an indirect political power to restrict leaders’ freedom of action and to ensure that their performance of office abided by set rules. The unusually detailed Hall Rolls and Hall Books produced by the civic government of Lynn in 1412–13 and 1418–25 illustrate that “popular control,” far from being a vehicle for increasing the urban commons’ “voice” in municipal decision-making, often stood in opposition to principles of elected representation. After 1418, more people were being admitted to the inner sanctum of virtuous individuals deemed capable of offering rational counsel to mayors and jurats, but there were fewer opportunities for the wider public to witness performances of governance by this expanded group of decision-makers. The crux of debate in fifteenth-century English towns—and, perhaps, in the tumultuous world of late medieval Europe more generally—was often less about who should exercise political influence and more about how popular political power could be exercised most appropriately and effectively.
Improved diagnostic accuracy for leptomeningeal dissemination in pediatric brain tumors using contrast-enhanced FLAIR imaging
Authors: Aygun Berna , Biswas Asthik , Blaaza Mohammed , Cooper Jessica , Gaur Pritika , Avsenik Jernej , Rao Harini R , Stegeman James , Löbel Ulrike , Szychot Elwira , D’Arco Felice , Sudhakar Sniya , Mankad Kshitij 
Published: August 2024

Abstract

Background
Central nervous system cancers are a leading cause of childhood cancer-related mortality. Accurate staging and assessment of leptomeningeal spread, particularly in aggressive neoplasms such as embryonal tumors, is crucial for treatment planning and prognosis. Conventional diagnostic methods, relying on magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) cytology, have limitations, including high false-negative rates and sensitivity issues. In this retrospective study, we aim to compare the diagnostic sensitivity of contrast-enhanced T2-weighted fluid-attenuated inversion recovery (CE-T2W-FLAIR) and 2D and 3D contrast-enhanced T1-weighted imaging (CE-T1WI) for detecting leptomeningeal disease.

Methods
We retrospectively reviewed 1372 MRI brain studies of 297 patients aged 1–19 years. We included only those MRI examinations adhering to our neuro-oncology protocol while excluding incomplete or suboptimal studies. A control group without leptomeningeal disease was matched for disease and age. Three groups of 2 neuroradiologists each, blinded to case status, reviewed the images using various sequences. The results were compared using the McNemar test and chi-squared test for P-values.

Results
The sensitivity of CE-T2W-FLAIR sequence was significantly higher compared with that of CE-T1WI (P = .025). There was no statistically significant difference between the sensitivity of 2D CE-T1WI and 3D CE-T1WI (P = .3173). The specificity of the 3D CE-T1WI was significantly lower compared with those of CE-T2W-FLAIR and 2D CE-T1WI (P = .014). The positive predictive values for CE-T2W-FLAIR, 2D CE-T1WI, and 3D CE-T1WI were 100%, 100%, and 68.4%, respectively, whereas the negative predictive values were 100%, 85.7%, and 85.71%, respectively.

Conclusions
The inclusion of CE-T2W-FLAIR in the MRI protocol improves sensitivity and specificity in diagnosing leptomeningeal spread in pediatric brain tumors.
Association of rare and common genetic variants in MOCOS with inadequate response to allopurinol
Authors: Fanning Niamh C , Cadzow Murray , Topless Ruth K , Frampton Chris , Dalbeth Nicola , Merriman Tony R , Stamp Lisa K 
Published: August 2024

Abstract

Objectives
The minor allele of the common rs2231142 ABCG2 variant predicts inadequate response to allopurinol urate lowering therapy. We hypothesize that additional variants in genes encoding urate transporters and allopurinol-to-oxypurinol metabolic enzymes also predict allopurinol response.

Methods
This study included a subset of participants with gout from the Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO), whose whole genome was sequenced (n = 563). Good responders had a 4:1 or 5:1 ratio of good [serum urate (SU) &lt;0.36 mmol/l on allopurinol ≤300 mg/day] to poor (SU ≥0.36 mmol/l despite allopurinol &gt;300 mg/day) responses over five to six time points, while inadequate responders had a 1:4 or 1:5 ratio of good to poor responses. Adherence to allopurinol was determined by pill counts, and for a subgroup (n = 303), by plasma oxypurinol &gt;20μmol/l. Using the sequence kernel association test (SKAT), we estimated the combined effect of rare and common variants in urate secretory (ABCC4, ABCC5, ABCG2, SLC17A1, SLC17A3, SLC22A6, SLC22A8) and reuptake genes (SLC2A9, SLC22A11) and in allopurinol-to-oxypurinol metabolic genes (AOX1, MOCOS, XDH) on allopurinol response.

Results
There was an association of rare and common variants in the allopurinol-to-oxypurinol gene group (PSKAT-C = 0.019), and in MOCOS, encoding molybdenum cofactor sulfurase, with allopurinol response (PSKAT-C = 0.011). Evidence for genetic association with allopurinol response in the allopurinol-to-oxypurinol gene group (PSKAT-C = 0.002) and MOCOS (PSKAT-C &lt; 0.001) was stronger when adherence to allopurinol therapy was confirmed by plasma oxypurinol.

Conclusion
We provide evidence for common and rare genetic variation in MOCOS associating with allopurinol response.