bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rapid reviews methods series: assessing the appropriateness of conducting a rapid review
Authors: Garritty Chantelle , Nussbaumer-Streit Barbara , Hamel Candyce , Devane Declan 
Published: March 2024

This paper, part of the Cochrane Rapid Review Methods Group series, offers guidance on determining when to conduct a rapid review (RR) instead of a full systematic review (SR). While both review types aim to comprehensively synthesise evidence, RRs, conducted within a shorter time frame of typically 6 months or less, involve streamlined methods to expedite the process. The decision to opt for an RR depends on the urgency of the research question, resource availability and the impact on decision outcomes. The paper categorises scenarios where RRs are appropriate, including urgent decision-making, informing guidelines, assessing new technologies and identifying evidence gaps. It also outlines instances when RRs may be inappropriate, cautioning against conducting them solely for ease, quick publication or only cost-saving motives.When deciding on an RR, it is crucial to consider both conceptual and practical factors. These factors encompass the urgency of needing timely evidence, the consequences of waiting for a full SR, the potential risks associated with incomplete evidence, and the risk of not using synthesised evidence in decision-making, among other considerations. Key factors to weigh also include having a clearly defined need, a manageable scope and access to the necessary expertise. Overall, this paper aims to guide informed judgements about whether to choose an RR over an SR based on the specific research question and context. Researchers and decision-makers are encouraged to carefully weigh potential trade-offs when opting for RRs.
Guillain-Barré syndrome and checkpoint inhibitor therapy: insights from pharmacovigilance data
Authors: Abrahao Andre , Tenório Pedro Henrique de Magalhães , Rodrigues Mariana , Mello Monica , Nascimento Osvaldo José Moreira 
Published: March 2024

BackgroundThere are increasing reports of cases of Guillain-Barré syndrome (GBS), as an adverse event of an immune checkpoint inhibitor (ICI) but postmarket data on the incidence of this remains scarce. This study sought to conduct a comprehensive review of GBS events arising as a secondary outcome of ICI treatments in real-world patients, using the Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsData covering the period from the third quarter of 2003 to the second quarter of 2023 were extracted from the FAERS database. GBS cases (associated with the usage of avelumab, atezolizumab, ipilimumab, nivolumab and pembrolizumab) were subjected to disproportionality analysis to detect potential signals.ResultsA total of 2208 reports of GBS were identified within the FAERS database, with 242 of these cases (10.9%) being associated with ICIs. All five drugs exhibited a disproportionality in the reporting of adverse events, with the highest observed for avelumab (reporting OR, ROR: 29.8), followed by atezolizumab (ROR: 17.0), ipilimumab (ROR: 16.0), pembrolizumab (ROR: 11.9) and nivolumab (ROR: 8.2).ConclusionThese checkpoint inhibitors are associated with a statistically significant disproportionate number of reports of GBS as an adverse event, with avelumab being the ICI with the highest association. The present pharmacovigilance study serves as a valuable tool, offering a more comprehensive and nuanced perspective on GBS associated with ICIs. This study contributes to a deeper comprehension of this rare adverse drug effect.
Innovation in sport medicine and science: a global social network analysis of stakeholder collaboration in rugby union
Authors: Erskine Natalie R , Hendricks Sharief , Jones Ben , Salie Faatiema 
Published: March 2024

ObjectivesTo investigate the network of stakeholders involved in rugby union research across the globe.MethodsUsing author affiliations listed on scientific publications, we identified the organisations that contributed to rugby union research from 1977 to 2022 and examine collaboration through coauthorship indicators. We determined the locations and sectors of identified organisations and constructed a collaboration network. Network metrics, including degree centrality and betweenness centrality, are computed to identify influential organisations and measure intersector collaboration.ResultsThere is an increase in scientific knowledge creation and collaboration between organisations for rugby union research over time. Among the sectors, the university, professional sports team and sports governing body sectors exhibit the highest intersectoral and intrasectoral density. Predominantly, influential actors are located in England, Australia, France, New Zealand, Ireland and South Africa. Australian Catholic University, Leeds Beckett University, Stellenbosch University, Swansea University, University College London and the University of Cape Town emerge as influential actors between 2016 and 2022.ConclusionsOur study underscores the ongoing growth of scientific knowledge generation in rugby union, primarily led by organisations in tier 1 rugby-playing nations within the university sector. Intersectoral collaboration with sports governing bodies plays a crucial role, acting as a broker between sectors. However, the overall collaboration landscape between and within sectors is low. These results highlight an opportunity for improved collaboration opportunities, as the organisations driving knowledge creation have been identified.
Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars)
Authors: Malekzadeh Fatemeh , Gandomkar Abdullah , Poustchi Hossein , Etemadi Arash , Roshandel Gholamreza , Attar Armin , Abtahi Firoozeh , Sadeghi Boogar Shahrokh , Mohammadkarimi Vahid , Fattahi Mohammad Reza , Mohagheghi Abbas , Malekzadeh Reza , Sepanlou Sadaf G 
Published: March 2024

BackgroundWe aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting.MethodsThe PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect.ResultsDuring December 2015–December 2016, a total of 4415 participants aged 50–75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4–4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups.ConclusionsThe fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level.Trial registration numberNCT03459560.
Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial
Authors: Lenz Heinz-Josef , Parikh Aparna , Spigel David R , Cohn Allen L , Yoshino Takayuki , Kochenderfer Mark , Elez Elena , Shao Spencer H , Deming Dustin , Holdridge Regan , Larson Timothy , Chen Eric , Mahipal Amit , Ucar Antonio , Cullen Dana , Baskin-Bey Edwina , Kang Tong , Hammell Amy B , Yao Jin , Tabernero Josep 
Published: March 2024

BackgroundStandard first-line therapies for metastatic colorectal cancer (mCRC) include fluoropyrimidine-containing regimens with oxaliplatin and/or irinotecan and a biologic agent. Immunotherapy may enhance antitumor activity in combination with standard therapies in patients with mCRC. Here, we present phase 2 results of nivolumab plus standard-of-care therapy (SOC; 5-fluorouracil/leucovorin/oxaliplatin/bevacizumab) versus SOC in the first-line treatment of patients with mCRC (CheckMate 9X8).MethodsCheckMate 9X8 was a multicenter, open-label, randomized, phase 2/3 trial. Eligible patients were at least 18 years of age with unresectable mCRC and no prior chemotherapy for metastatic disease. Patients were randomized 2:1 to receive nivolumab 240 mg plus SOC or SOC alone every 2 weeks. The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included PFS by investigator assessment; objective response rate (ORR), disease control rate, duration of response, and time to response, all by BICR and investigator assessments; overall survival; and safety. Preplanned exploratory biomarker analyses were also performed.ResultsFrom February 2018 through April 2019, 310 patients were enrolled, of which 195 patients were randomized to nivolumab plus SOC (n=127) or SOC (n=68). At 21.5-month minimum follow-up, PFS with nivolumab plus SOC versus SOC did not meet the prespecified threshold for statistical significance; median PFS by BICR was 11.9 months in both arms (HR, 0.81 (95% CI, 0.53 to 1.23); p=0.30). Higher PFS rates after 12 months (18 months: 28% vs 9%), higher ORR (60% vs 46%), and durable responses (median 12.9 vs 9.3 months) were observed with nivolumab plus SOC versus SOC. Grade 3–4 treatment-related adverse events were reported in 75% versus 48% of patients; no new safety signals were identified.ConclusionsThe CheckMate 9X8 trial investigating first-line nivolumab plus SOC versus SOC in patients with mCRC did not meet its primary endpoint of PFS by BICR. Nivolumab plus SOC showed numerically higher PFS rates after 12 months, a higher response rate, and more durable responses compared with SOC alone, with acceptable safety. Further investigation to identify subgroups of patients with mCRC that may benefit from nivolumab plus SOC versus SOC in the first-line setting is warranted.Trial registration numberNCT03414983.
Phase II study of nivolumab in patients with genetic alterations in DNA damage repair and response who progressed after standard treatment for metastatic solid cancers (KM-06)
Authors: Kim Ju Won , Lee Hyo Jin , Lee Ji Yoon , Park Sook Ryun , Kim Yu Jung , Hwang In Gyu , Kyun Bae Woo , Byun Jae Ho , Kim Jung Sun , Kang Eun Joo , Lee Jeeyun , Shin Sang Joon , Chang Won Jin , Kim Eun-Ok , Sa Jason K , Park Kyong Hwa 
Published: March 2024

BackgroundImmune-modulating antibodies targeting programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) have demonstrated promising antitumor efficacy in various types of cancers, especially highly mutated ones. Genetic alterations in DNA damage response and repair (DDR) genes can lead to genetic instability, often accompanied by a high tumor mutation burden (TMB). However, few studies have validated the aberration of DDR genes as a predictive biomarker for response to immune-modulating antibodies.MethodsThe KM-06 open-label, multicenter, single-arm, phase II trial evaluated the safety and efficacy of nivolumab in refractory solid cancers with DDR gene mutations assessed by clinically targeted sequencing. Nivolumab (3 mg/kg) was administered every 2 weeks until disease progression, unacceptable toxicity, or for 24 months. The primary endpoint was the objective response rate (ORR) as per RECIST V.1.1 criteria.ResultsA total of 48 patients were enrolled in the study (median age 61, 58.3% male). The most common cancer type was colorectal cancer (41.7%), followed by prostate and biliary tract cancer (8.3% each). Eight patients achieved a partial response as their best overall response, resulting in an ORR of 17.8%. The disease control rate was 60.0%. The median progression-free survival was 2.9 months. Treatment-related adverse events of any grade and grade ≥3 occurred in 44 (91.7%) and 4 (8.3%) patients, respectively. Clinically targeted sequencing data inferred both TMB and microsatellite instability (MSI). Using a TMB cut-off of 12 mut/Mb, there were significant differences in overall survival (p=0.00035), progression-free survival (p=0.0061), and the best overall response (p=0.05). In the RNA sequencing analysis, nivolumab responders showed activation of the interleukin signaling pathway. Patients who experienced early progression presented high epithelial-mesenchymal transition signaling pathway activation. The responders exhibited a marked increase in PD-1−/Ki67+CD8 T cells at the early stage of treatment (C3D1) compared with non-responders (p=0.03).ConclusionsIn this phase II trial, nivolumab demonstrated moderate efficacy and manageable toxicity in patients with solid cancer harboring DDR gene mutations. A high TMB (>12 mut/Mb) and MSI score (>2.5) determined through clinically target sequencing presented significant discriminatory power for the nivolumab response.Trial registration numberNCT04761744.
Time to childbirth and assisted reproductive treatment in women with congenital heart disease
Authors: Jonsson Sara , Sundström-Poromaa Inger , Johansson Bengt , Alenius Dahlqvist Jenny , Christersson Christina , Dellborg Mikael , Trzebiatowska-Krzynska Alexandra , Sörensson Peder , Thilén Ulf , Wikström Anna-Karin , Bay Annika 
Published: March 2024

ObjectiveTo investigate the time to first childbirth and to compare the prevalence of assisted reproductive treatment (ART) in women with congenital heart disease (CHD) compared with women without CHD.MethodsAll women in the national register for CHD who had a registered first childbirth in the Swedish Pregnancy Register between 2014 and 2019 were identified. These individuals (cases) were matched by birth year and municipality to women without CHD (controls) in a 1:5 ratio. The time from the 18th birthday to the first childbirth and the prevalence of ART was compared between cases and controls.Results830 first childbirths in cases were identified and compared with 4137 controls. Cases were slightly older at the time for first childbirth (28.9 vs 28.5 years, p=0.04) and ART was more common (6.1% vs 4.0%, p<0.01) compared with controls. There were no differences in ART when stratifying for the complexity of CHD. For all women, higher age was associated with ART treatment (OR 1.24, 95% CI 1.20 to 1.28).ConclusionsWomen with and without CHD who gave birth to a first child did so at similar ages. ART was more common in women with CHD, but disease severity did not influence the need for ART. Age was an important risk factor for ART also in women with CHD and should be considered in consultations with these patients.
Searching for supermassive charged gravitinos in underground experiments
Authors: Meissner Krzysztof A. , Nicolai Hermann 
Published: March 2024

AbstractWe examine possible experimental signatures that may be exploited to search for stable supermassive particles with electric charges of $${{\mathcal {O}}}(1)$$

O
(
1
)

in future underground experiments, and the upcoming JUNO experiment in particular. The telltale signal providing a unique signature of such particles, would be a correlated sequence of three or more nuclear recoils along a straight line, corresponding to the motion of a non-relativistic ($$\beta \lesssim 10^{-2}$$

β
≲

10

-
2

) particle that could enter the detector from any direction. We provide some preliminary estimates for the expected event rates.
Observations of orbiting hot spots around scalarized Reissner–Nordström black holes
Authors: Chen Yiqian , Wang Peng , Yang Haitang 
Published: March 2024

AbstractThis paper investigates the observational signatures of hot spots orbiting scalarized Reissner–Nordström black holes, which have been reported to possess multiple photon spheres. In contrast to the single-photon sphere case, hot spots orbiting black holes with two photon spheres produce additional image tracks in time integrated images capturing a complete orbit of hot spots. Notably, these newly observed patterns manifest as a distinct second-highest peak in temporal magnitudes when observed at low inclination angles. These findings offer promising observational probes for distinguishing black holes with multiple photon spheres from their single-photon sphere counterparts.
EMBRACE (Empowering Medical students’ skills in BReaking bAd news with Compassion and Empathy) module improves the skills of undergraduate medical students in effectively breaking the bad news: a case-control study
Authors: Arumugam Kaviya , Nandagopal Harshavardhini , Joseph Joseline , Balaji Jyotsna Needamangalam , Surapaneni Krishna Mohan 
Published: March 2024

The Empowering Medical students’ skills in BReaking bAd news with Compassion and Empathy (EMBRACE) module is noteworthy for its holistic approach to training medical students in the delicate art of delivering distressing news to patients. It not only incorporates the evidence-based setting, perception, invitation, knowledge, emotions, and strategy (SPIKES) method but also distinguishes itself by providing real-life conversation examples and self-assessment cases, which make the training highly relatable and practical for students to actively engage in their learning and personal development.
Association of Posttraumatic Stress Disorder and Race on Readmissions After Stroke
Authors: Lin Chen , King Peter H. , Richman Joshua S. , Davis Lori L. 
Published: March 2024

BACKGROUND:
There is limited research on outcomes of patients with posttraumatic stress disorder (PTSD) who also develop stroke, particularly regarding racial disparities. Our goal was to determine whether PTSD is associated with the risk of hospital readmission after stroke and whether racial disparities existed.

METHODS:

The analytical sample consisted of all veterans receiving care in the Veterans Health Administration who were identified as having a new stroke requiring inpatient admission based on the
International Classification of Diseases
codes. PTSD and comorbidities were identified using the
International Classification of Diseases
codes and given the date of first occurrence. The retrospective cohort data were obtained from the Veterans Affairs Corporate Data Warehouse. The main outcome was any readmission to Veterans Health Administration with a stroke diagnosis. The hypothesis that PTSD is associated with readmission after stroke was tested using Cox regression adjusted for patient characteristics including age, sex, race, PTSD, smoking status, alcohol use, and comorbidities treated as time-varying covariates.

RESULTS:

Our final cohort consisted of 93 651 patients with inpatient stroke diagnosis and no prior Veterans Health Administration codes for stroke starting from 1999 with follow-up through August 6, 2022. Of these patients, 12 916 (13.8%) had comorbid PTSD. Of the final cohort, 16 896 patients (18.0%) with stroke were readmitted. Our fully adjusted model for readmission found an interaction between African American veterans and PTSD with a hazard ratio of 1.09 ([95% CI, 1.00–1.20]
P
=0.047). In stratified models, PTSD has a significant hazard ratio of 1.10 ([95% CI, 1.02–1.18]
P
=0.01) for African American but not White veterans (1.05 [95% CI, 0.99–1.11];
P
=0.10).

CONCLUSIONS:
Among African American veterans who experienced stroke, preexisting PTSD was associated with increased risk of readmission, which was not significant among White veterans. This study highlights the need to focus on high-risk groups to reduce readmissions after stroke.
Damascius and the Ineffable Thread of Reality
Authors: Vlad Marilena 
Published: March 2024

Abstract
This article discusses the problem of the ineffable in Damascius’ treatises De principiis and In Parmenidem. I argue that the ineffable—which is the ultimate principle proposed by Damascius—is also the theme that underlies the whole frame of the reality, in his perspective. Each level of reality that he discusses comes into play on the background of the original attempt to suggest the ineffable principle. Each of them—One, unified, soul, material forms, matter and sensible realm—tries to approximate and suggest the previous level and thus, eventually, the ineffable itself. Consequently, each level of reality develops its own degree of ineffability, and therefore presents itself to our mind in an aporetical manner. It is impossible for our mind to reveal in an exhaustive and noncontradictory fashion even the levels closest to us. The aporiai that are specific for every part of reality are eventually consequences of the original aporia of an absolute and unique principle that governs everything.
The Allegorical Readings of the Shāh-nāma in Comparison with the Allegoreses of Homer’s Epics
Authors: Nematollahi Narges 
Published: March 2024

Abstract
There is a consensus that the Greek epic does not present itself as “veiled expressions (ainos),” but in the Greek literary tradition, several episodes of Homer’s works have received allegorical readings by literary critics and philosophers. These readings are categorized according to the motivations of their authors into two groups: defensive or apologetic and appropriative or exegetical. Against this background, this paper examines the Shāh-nāma and its broader literary tradition, arguing that, first, the Shāh-nāma, too, does not present itself as a multi-layered text in need of interpretation. Second, we can identify the same two categories within the admittedly fewer allegorical readings offered for the Shāh-nāma; Ferdowsi’s prologues to some tragic stories of the Shāh-nāma resemble Homeric defensive allegoreses, whereas the allegorical readings by some Sufi poets and thinkers represent the appropriative group. Similarities and differences between the Greek and the Iranian traditions in each group will be also discussed.
Ugly Yet Popular: the Remarkably Long Life of the Safavid Coins of Hoveyza
Authors: Akopyan Alexander V. 
Published: March 2024

Abstract
The aim of the work is to identify explanations for the lengthy circulation of Safavid coins bearing the central inscription, “ʿAli is the friend of God (ʿAli vali Allāh),” from the seventeenth to nineteenth centuries. Studying the coins from the period and the hoards in which they were found, alongside historical narratives, ethnographic information, and religious texts, sheds light on their meaning and reception in their Shiʿi environment. The special attitude towards these coins accounts for the widespread imitation of these coins, which came to dominate Iranian markets during this period, as predicted by Gresham’s law of “bad money.”