bluuebunny/crossref_metadata_2025_split huggingface dataset:
A systematic literature review on direct and indirect costs of triple-negative breast cancer
Authors: Rezaei Sadeq , Babaei Majid 
Published: November 2023

Abstract
Background
Triple-negative breast cancer (TNBC) is an aggressive and therapy-resistant form of breast cancer with a significant economic burden on patients and healthcare systems. Therefore, we completed a systematic review to classify and synthesize the literature on the direct and indirect costs of TNBC.

Methods
Databases including ISI Web of Science, Scopus, PubMed, and Google Scholar were searched for all related articles assessing the economic burden of TNBC from 2010 until December 2022. The quality and eligibility assessments were done accordingly. We adjusted all costs to January 2023 $US.

Results
From 881 records, 15 studies were eligible. We found that studies are widely disparate in the timetable, study design, patient populations, and cost components assessed. The annual per-patient direct costs of metastatic TNBC (mTNBC) were about $24,288 to $316,800. For early TNCB patients (eTNBC) this was about $21,120 to $105,600. Cancer management anticancer therapy costs account for the majority of direct costs. Along with an increase in cancer stage and line of therapy, healthcare costs were increased. Moreover, the indirect costs of patients with mTNBC and eTNBC were about $1060.875 and about $186,535 for each patient respectively.

Conclusion
The results showed that the direct and indirect costs of TNBC, mainly those of mTNBC, were substantial, suggesting attention to medical progress in cancer prognosis and therapy approaches.
Distal aortic biomechanics after transcatheter versus surgical aortic valve replacement: a hypothesis generating study
Authors: Rong Lisa Q. , Zheng William , Martinez Andrew , Rahouma Mohammed , Devereux Richard B. , Kim Jiwon , Osman Bassam , Palumbo Maria C. , Redfors Björn , Girardi Leonard N. , Weinsaft Jonathan W. , Gaudino Mario 
Published: November 2023

Abstract
Background
Biomechanical effects of transcatheter (TAVR) versus surgical (SAVR) aortic valve interventions on the distal aorta have not been studied. This study utilized global circumferential strain (GCS) to assess post-procedural biomechanics changes in the descending aorta after TAVR versus SAVR.

Methods
Patients undergoing TAVR or SAVR for aortic stenosis were included. Transesophageal (TEE) and transthoracic (TTE) echocardiography short-axis images of the aorta were used to image the descending aorta immediately before and after interventions. Image analysis was performed with two-dimensional speckle tracking echocardiography and dedicated software. Delta GCS was calculated as: post-procedural GCS—pre-procedural GCS. Percentage delta GCS was calculated as: (delta GCS/pre-procedural GCS) × 100.

Results
Eighty patients, 40 TAVR (median age 81 y/o, 40% female) and 40 SAVR (median 72 y/o, 30% female) were included. The post-procedure GCS was significantly higher than the pre-procedural GCS in the TAVR (median 10.7 [interquartile range IQR 4.5, 14.6] vs. 17.0 [IQR 6.1, 20.9], p = 0.009) but not in the SAVR group (4.4 [IQR 3.3, 5.3] vs. 4.7 [IQR 3.9, 5.6], p = 0.3). The delta GCS and the percentage delta GCS were both significantly higher in the TAVR versus SAVR group (2.8% [IQR 1.4, 6] vs. 0.15% [IQR − 0.6, 1.5], p < 0.001; and 28.8% [IQR 14.6%, 64.6%] vs. 4.4% [IQR − 10.6%, 5.6%], p = 0.006). Results were consistent after multivariable adjustment for key clinical and hemodynamic characteristics.

Conclusions
After TAVR, there was a significantly larger increase in GCS in the distal aorta compared to SAVR. This may impact descending aortic remodeling and long-term risk of aortic events.
The use of checklists in the intensive care unit: a scoping review
Authors: Erikson Ethan J. , Edelman Daniel A. , Brewster Fiona M. , Marshall Stuart D. , Turner Maryann C. , Sarode Vineet V. , Brewster David J. 
Published: November 2023

Abstract
Background
Despite the extensive volume of research published on checklists in the intensive care unit (ICU), no review has been published on the broader role of checklists within the intensive care unit, their implementation and validation, and the recommended clinical context for their use. Accordingly, a scoping review was necessary to map the current literature and to guide future research on intensive care checklists. This review focuses on what checklists are currently used, how they are used, process of checklist development and implementation, and outcomes associated with checklist use.

Methods
A systematic search of MEDLINE (Ovid), Embase, Scopus, and Google Scholar databases was conducted, followed by a grey literature search. The abstracts of the identified studies were screened. Full texts of relevant articles were reviewed, and the references of included studies were subsequently screened for additional relevant articles. Details of the study characteristics, study design, checklist intervention, and outcomes were extracted.

Results
Our search yielded 2046 studies, of which 167 were selected for further analysis. Checklists identified in these studies were categorised into the following types: rounding checklists; delirium screening checklists; transfer and handover checklists; central line-associated bloodstream infection (CLABSI) prevention checklists; airway management checklists; and other. Of 72 significant clinical outcomes reported, 65 were positive, five were negative, and two were mixed. Of 122 significant process of care outcomes reported, 114 were positive and eight were negative.

Conclusions
Checklists are commonly used in the intensive care unit and appear in many clinical guidelines. Delirium screening checklists and rounding checklists are well implemented and validated in the literature. Clinical and process of care outcomes associated with checklist use are predominantly positive. Future research on checklists in the intensive care unit should focus on establishing clinical guidelines for checklist types and processes for ongoing modification and improvements using post-intervention data.
High lithium concentration at delivery is a potential risk factor for adverse outcomes in breastfed infants: a retrospective cohort study
Authors: Whaites Heinonen Essi , Tötterman Katarina , Bäck Karin , Sarman Ihsan , Forsberg Lisa , Svedenkrans Jenny 
Published: November 2023

Abstract
Background
Neonatal effects of late intrauterine and early postpartum exposure to lithium through mother’s own milk are scarcely studied. It is unclear whether described symptoms in breastfed neonates are caused by placental lithium transfer or postnatal exposure to lithium through breastfeeding. We aimed to investigate lithium clearance and neonatal morbidity in breastfed infants with high versus low serum lithium concentrations at birth.

Methods
This retrospective study focused on breastfed infants to women treated with lithium during and after pregnancy, born between 2006 and 2021 in Stockholm, Sweden. Information on serum lithium concentrations and adverse neonatal outcomes was obtained from medical records. Neonatal symptoms and lithium clearance were compared between a high exposure group (HEG, lithium concentrations ≥ 0.6 meq/l) and a low exposure group (LEG, < 0.6 meq/l).

Results
A total of 25 infant-mother dyads were included. Median lithium serum concentration at birth was 0.90 meq/l in the HEG as compared with 0.40 meq/l in the LEG (p < 0.05). The difference was still significant at follow-up (0.20 meq/l vs 0.06 meq/l, p < 0.05), despite reduction in maternal dose. The rate of neonatal symptoms was 85.7% in HEG and 41.2% in LEG (p = 0.08) at birth and 28.6% vs 11.8% at follow-up (p = 0.55). Furthermore, 28.6% of infants in HEG were admitted to neonatal care, vs 5.9% in LEG (p = 0.19). Two infants in the HEG had therapeutic lithium levels at follow-up. All infants with symptoms at follow-up were either in the HEG or exposed to﻿ additional psychotropic medication.

Conclusions
Neonatal symptoms are common after late intrauterine lithium exposure, however transient, treatable and mostly mild. In this study, a high lithium concentration at birth was a risk factor for an increased lithium level at follow-up. Polypharmacy may constitute an additional risk factor. This study suggests that the late intrauterine exposure to lithium might add to the adverse effects in lithium-exposed, breastfed infants. Consequently we recommend breastfed infants with therapeutic lithium concentrations at birth to be followed up promptly to avoid lithium toxicity.
Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis
Authors: Chen Congqin , Zhou Rijing , Fu Fang , Xiao Jie 
Published: November 2023

Abstract

Background
Recent reports of individuals experiencing suicidal and/or self-injurious behaviors while using liraglutide and semaglutide have heightened the concerns regarding neuropsychiatric safety of Glucagon-like peptide-1 agonists (GLP-1RAs). As real-world evidence is very limited, we explored the association between GLP-1RA and suicide/self-injury by mining the FDA Adverse Event Reporting System (FAERS) database.

Methods
The FAERS database was queried from 2005 Q2 to 2023 Q2. The Reporting Odds Ratio (ROR) and Empirical Bayes Geometric Mean (EBGM) were used to conduct the disproportionality analysis.

Results
A total of 534 GLP-1RA-associated suicide/self-injury cases were reported in the FAERS during the study period. GLP-1RA did not cause a disproportionate increase in overall suicidal and self-injurious cases (ROR: 0.16, 95%CI 0.15-0.18, P < 0.001; EBGM05: 0.15). Stratified analyses found no safety signal of suicide/injury for GLP-1RA in both females and males. The ROR for suicide/self-injury with GLP-1RA was slightly elevated (ROR: 2.50, 95%CI 1.02-6.13, P = 0.05) in children, while the EBGM05 was < 2 in this population. No significant signal value was observed in other age groups. No over-reporting of suicide/self-injury was identified for GLP-1RA before or after the COVID-19 pandemic outbreak.

Conclusions
The cases of suicide or self-injury reported to FAERS do not indicate any overall safety signal attributable to GLP-1RA at this time. Subgroup analysis revealed a marginal elevation of ROR for suicide and self-injury with GLP-1RA in children, but no safety signal was detected by EBGM05 in this population. Further large-scale prospective investigations are still warranted to further confirm this finding.
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921
Authors: Brivio Erica , Pennesi Edoardo , Willemse Marieke E. , Huitema Alwin D.R. , Jiang Yilin , van Tinteren Harm D.R. , van der Velden Vincent H.J. , Beverloo Berna H. , den Boer Monique L. , Rammeloo Lukas A.J. , Hudson Chad , Heerema Nyla , Kowalski Karey , Zhao Huadong , Kuttschreuter Luke , Bautista Sirvent Francisco J. , Bukowinski Andrew , Rizzari Carmelo , Pollard Jessica , Murillo-Sanjuán Laura , Kutny Matthew , Zarnegar-Lumley Sara , Redell Michele , Cooper Stacy , Bertrand Yves , Petit Arnaud , Krystal Julie , Metzler Markus , Lancaster Donna , Bourquin Jean-Pierre , Motwani Jayashree , van der Sluis Inge M. , Locatelli Franco , Roth Michael E. , Hijiya Nobuko , Zwaan Christian M. 
Published: November 2023

PURPOSE Bosutinib is approved for adults with chronic myeloid leukemia (CML): 400 mg once daily in newly diagnosed (ND); 500 mg once daily in resistant/intolerant (R/I) patients. Bosutinib has a different tolerability profile than other tyrosine kinase inhibitors (TKIs) and potentially less impact on growth (preclinical data). The primary objective of this first-in-child trial was to determine the recommended phase II dose (RP2D) for pediatric R/I and ND patients. PATIENTS AND METHODS In the phase I part of this international, open-label trial (ClinicalTrials.gov identifier: NCT04258943 ), children age 1-18 years with R/I (per European LeukemiaNet 2013) Ph+ CML were enrolled using a 6 + 4 design, testing 300, 350, and 400 mg/m2 once daily with food. The RP2D was the dose resulting in 0/6 or 1/10 dose-limiting toxicities (DLTs) during the first cycle and achieving adult target AUC levels for the respective indication. As ND participants were only enrolled in phase II, the ND RP2D was selected based on data from R/I patients. RESULTS Thirty patients were enrolled; 27 were evaluable for DLT: six at 300 mg/m2, 11 at 350 mg/m2 (one DLT), and 10 at 400 mg/m2 (one DLT). The mean AUCs at 300 mg/m2, 350 mg/m2, and 400 mg/m2 were 2.20 μg h/mL, 2.52 μg h/mL, and 2.66 μg h/mL, respectively. The most common adverse event was diarrhea (93%; ≥grade 3: 11%). Seven patients stopped because of intolerance and eight because of insufficient response. Complete cytogenetic and major molecular response to bosutinib appeared comparable with other published phase I/II trials with second-generation TKIs in children. CONCLUSION Bosutinib was safe and effective. The pediatric RP2D was 400 mg/m2 once daily (max 600 mg/d) with food in R/I patients and 300 mg/m2 once daily (max 500 mg/d) with food in ND patients, which achieved targeted exposures as per adult experience.
Characteristics and Risk of Diabetes in People With Rare Glucose Response Curve During an Oral Glucose Tolerance Test
Authors: Tatsumi Yukako , Miyamoto Yoshihiro , Asayama Kei , Satoh Michihiro , Miyamatsu Naomi , Ohno Yuko , Ikei Hajime , Ohkubo Takayoshi 
Published: November 2023

Abstract

Context
Existing differences in persons with lower 30- or 60-minute plasma glucose (PG) levels during 75-g oral glucose tolerance test (OGTT) than fasting PG remain unclear.

Objective
To clarify the characteristics of persons whose PG levels decrease after glucose administration during OGTT and their risk of incidence of diabetes in a Japanese general population.

Methods
In this cohort study, a total of 3995 men and 3500 women (mean age 56.7 years) without diabetes were classified into 3 groups: (1) PG at both 30 and 60 minutes ≥ fasting PG; (2) PG at 30 minutes ≥ fasting PG and PG at 60 minutes &lt; fasting PG; (3) PG at 30 minutes &lt; fasting PG. The characteristics and the risk of diabetes onset were analyzed using ordered logistic regression and Cox proportional hazard regression, respectively.

Results
Among 7495 participants, the numbers of individuals in the group 1, 2, and 3 were 6552, 769, and 174, respectively. The glucose response curve of the group 3 was boat shaped. Group 3 had the youngest age, lowest percentage of men, and best health condition, followed by groups 2 and 1. Among 3897 participants analyzed prospectively, 434 developed diabetes during the mean follow-up period of 5.8 years. The hazard ratio for diabetes onset in the group 2 was 0.30 with reference to the group 1. No-one in group 3 developed diabetes.

Conclusion
People with lower 30-minute PG than fasting PG tended to be women, young, healthy, and at low risk of diabetes onset.
Placement of a Kickstand Rod in Adult Spinal Deformity Surgery: A Simple 8-Step Process With Intraoperative Images and Video
Authors: Younus Iyan , Chanbour Hani , Ali Mir Amaan , Zuckerman Scott L. 
Published: November 2023

BACKGROUND AND OBJECTIVES:
In adult spinal deformity (ASD) surgery, operative correction of coronal malalignment remains a challenging surgical task. Given the proven effectiveness and longevity of the kickstand rod (KSR) technique and its powerful ability to correct coronal malalignment, this technique is an important tool to have available. Therefore, we sought to provide a simple 8-step description of the KSR technique using intraoperative images and video in a patient undergoing combined sagittal and coronal malalignment correction.

METHODS:
A 68-year-old female with a previous history of T11-S1 posterior spinal fusion presented with mid thoracic back pain, leg paresthesias, and a right-leaning posture. The patient underwent a T4-pelvis extension of fusion, T8-11 posterior column osteotomies, and placement of a right-sided KSR to address her coronal malalignment.

RESULTS:
The KSR technique is summarized in the following steps: (1) place kickstand screw, (2) place contralateral main rod and tighten all set plugs, (3) place ipsilateral main rod and keep rod long distally, (4) place a domino in the lower/mid thoracic area, (5) place the KSR and leave the rod long proximally, (6) tighten the ipsilateral main rod above the domino, (7) loosen the ipsilateral main rod below the domino, and (8) place a rod gripper below the domino and distract. Postoperatively, the coronal vertical axis improved from 4.8 to 0.6 cm, and the sagittal vertical axis improved from 9.5 to 3.9 cm.

CONCLUSION:
The current case report provides a simple 8-step description of the KSR technique to improve coronal malalignment accompanied by intraoperative images and video.
Translational control of furina by an RNA regulon is important for left-right patterning, heart morphogenesis and cardiac valve function
Authors: Nagorska Agnieszka , Zaucker Andreas , Lambert Finnlay , Inman Angus , Toral-Perez Sara , Gorodkin Jan , Wan Yue , Smutny Michael , Sampath Karuna 
Published: November 2023

ABSTRACT
Heart development is a complex process that requires asymmetric positioning of the heart, cardiac growth and valve morphogenesis. The mechanisms controlling heart morphogenesis and valve formation are not fully understood. The pro-convertase FurinA functions in heart development across vertebrates. How FurinA activity is regulated during heart development is unknown. Through computational analysis of the zebrafish transcriptome, we identified an RNA motif in a variant FurinA transcript harbouring a long 3′ untranslated region (3′UTR). The alternative 3′UTR furina isoform is expressed prior to organ positioning. Somatic deletions in the furina 3′UTR lead to embryonic left-right patterning defects. Reporter localisation and RNA-binding assays show that the furina 3′UTR forms complexes with the conserved RNA-binding translational repressor, Ybx1. Conditional ybx1 mutant embryos show premature and increased Furin reporter expression, abnormal cardiac morphogenesis and looping defects. Mutant ybx1 hearts have an expanded atrioventricular canal, abnormal sino-atrial valves and retrograde blood flow from the ventricle to the atrium. This is similar to observations in humans with heart valve regurgitation. Thus, the furina 3′UTR element/Ybx1 regulon is important for translational repression of FurinA and regulation of heart development.
On the origins of developmental robustness: modeling buffering mechanisms against cell-level noise
Authors: Cano-Fernández Hugo , Tissot Tazzio , Brun-Usan Miguel , Salazar-Ciudad Isaac 
Published: November 2023

ABSTRACT
During development, cells are subject to stochastic fluctuations in their positions (i.e. cell-level noise) that can potentially lead to morphological noise (i.e. stochastic differences between morphologies that are expected to be equal, e.g. the right and left sides of bilateral organisms). In this study, we explore new and existing hypotheses on buffering mechanisms against cell-level noise. Many of these hypotheses focus on how the boundaries between territories of gene expression remain regular and well defined, despite cell-level noise and division. We study these hypotheses and how irregular territory boundaries lead to morphological noise. To determine the consistency of the different hypotheses, we use a general computational model of development: EmbryoMaker. EmbryoMaker can implement arbitrary gene networks regulating basic cell behaviors (contraction, adhesion, etc.), signaling and tissue biomechanics. We found that buffering mechanisms based on the orientation of cell divisions cannot lead to regular boundaries but that other buffering mechanisms can (homotypic adhesion, planar contraction, non-dividing boundaries, constant signaling and majority rule hypotheses). We also explore the effects of the shape and size of the territories on morphological noise.
Biological timekeeping in polar environments: lessons from terrestrial vertebrates
Authors: Hazlerigg David G. , Appenroth Daniel , Tomotani Barbara M. , West Alexander C. , Wood Shona H. 
Published: November 2023

ABSTRACT
The polar regions receive less solar energy than anywhere else on Earth, with the greatest year-round variation in daily light exposure; this produces highly seasonal environments, with short summers and long, cold winters. Polar environments are also characterised by a reduced daily amplitude of solar illumination. This is obvious around the solstices, when the Sun remains continuously above (polar ‘day’) or below (polar ‘night’) the horizon. Even at the solstices, however, light levels and spectral composition vary on a diel basis. These features raise interesting questions about polar biological timekeeping from the perspectives of function and causal mechanism. Functionally, to what extent are evolutionary drivers for circadian timekeeping maintained in polar environments, and how does this depend on physiology and life history? Mechanistically, how does polar solar illumination affect core daily or seasonal timekeeping and light entrainment? In birds and mammals, answers to these questions diverge widely between species, depending on physiology and bioenergetic constraints. In the high Arctic, photic cues can maintain circadian synchrony in some species, even in the polar summer. Under these conditions, timer systems may be refined to exploit polar cues. In other instances, temporal organisation may cease to be dominated by the circadian clock. Although the drive for seasonal synchronisation is strong in polar species, reliance on innate long-term (circannual) timer mechanisms varies. This variation reflects differing year-round access to photic cues. Polar chronobiology is a productive area for exploring the adaptive evolution of daily and seasonal timekeeping, with many outstanding areas for further investigation.