bluuebunny/crossref_metadata_2025 huggingface dataset:
First-in-human study of SBRT and adenosine pathway blockade to potentiate the benefit of immunochemotherapy in early-stage luminal B breast cancer: results of the safety run-in phase of the Neo-CheckRay trial
Authors: De Caluwe Alex , Romano Emanuela , Poortmans Philip , Gombos Andrea , Agostinetto Elisa , Marta Guilherme Nader , Denis Zoe , Drisis Stylianos , Vandekerkhove Christophe , Desmet Antoine , Philippson Catherine , Craciun Ligia , Veys Isabelle , Larsimont Denis , Paesmans Marianne , Van Gestel Dirk , Salgado Roberto , Sotiriou Christos , Piccart-Gebhart Martine , Ignatiadis Michail , Buisseret Laurence
Published: December 2023

Background

Luminal B breast cancer (BC) presents a worse prognosis when compared with luminal A BC and exhibits a lower sensitivity to chemotherapy and a lower immunogenicity in contrast to non-luminal BC subtypes. The Neo-CheckRay clinical trial investigates the use of stereotactic body radiation therapy (SBRT) directed to the primary tumor in combination with the adenosine pathway inhibitor oleclumab to improve the response to neo-adjuvant immuno-chemotherapy in luminal B BC. The trial consists of a safety run-in followed by a randomized phase II trial. Here, we present the results of the first-in-human safety run-in.

Methods

The safety run-in was an open-label, single-arm trial in which six patients with early-stage luminal B BC received the following neo-adjuvant regimen: paclitaxel q1w×12 → doxorubicin/cyclophosphamide q2w×4; durvalumab (anti-programmed cell death receptor ligand 1 (PD-L1)) q4w×5; oleclumab (anti-CD73) q2w×4 → q4w×3 and 3×8 Gy SBRT to the primary tumor at week 5. Surgery must be performed 2–6 weeks after primary systemic treatment and adjuvant therapy was given per local guidelines, RT boost to the tumor bed was not allowed. Key inclusion criteria were: luminal BC, Ki67≥15% or histological grade 3, MammaPrint high risk, tumor size≥1.5 cm. Primary tumor tissue samples were collected at three timepoints: baseline, 1 week after SBRT and at surgery. Tumor-infiltrating lymphocytes, PD-L1 and CD73 were evaluated at each timepoint, and residual cancer burden (RCB) was calculated at surgery.

Results

Six patients were included between November 2019 and March 2020. Median age was 53 years, range 37–69. All patients received SBRT and underwent surgery 2–4 weeks after the last treatment. After a median follow-up time of 2 years after surgery, one grade 3 adverse event (AE) was reported: pericarditis with rapid resolution under corticosteroids. No grade 4–5 AE were documented. Overall cosmetical breast evaluation after surgery was ‘excellent’ in four patients and ‘good’ in two patients. RCB results were 2/6 RCB 0; 2/6 RCB 1; 1/6 RCB 2 and 1/6 RCB 3.

Conclusions

This novel treatment combination was considered safe and is worth further investigation in a randomized phase II trial.

Trial registration number

NCT03875573.
Resolving Charging Station Placement Issues for Electric Vehicles: Hybrid Optimization-Assisted Multi-Objective Framework
Authors: Raval Sanket , Patel Nilesh , Natarajan Thangadurai , Deb Sanchari
Published: December 2023

As new energy technology has advanced to a respectable level, Electric Vehicles (EV) have gained recognition from people all over the world and have become increasingly popular in a number of nations. Effective charging station placement is critical for the rapid growth of electric vehicles, as it is vital to provide convenience for electric vehicles while also ensuring the effectiveness of traffic networks. The location of an EV charging station is simply an application situation for the facility location problem. Traditional works often pay attention to the mileage concerns of electric vehicle customers while ignoring their competitive and strategic charging tactics. This research aims to frame the allocation of charging stations issue as a multi-faceted venture by assessing the aspects economically along with the characteristics of the power grid like “cost, Voltage stability, Reliability, and Power loss (VRP) index, waiting time, and accessibility index”. Further, we proposed a hybrid artificial intelligence to resolve the allocation issue. The proposed new Artificial Intelligence (AI) based algorithm is termed as Hybridized Salp and Harris Algorithm (HS-HA). The effectiveness and scalability of the presented algorithm for the charging station placement issue are also assessed through different plans in the IEEE 33-bus distribution systems. Finally, the efficiency of the presented approach is proved over the existing approaches with respect to various measures.
Preventing Violence against Healthcare Workers in Hospital Settings: A Systematic Review of Nonpharmacological Interventions
Authors: Mundey Natasha , Terry Victoria , Gow Jeff , Duff Jed , Ralph Nicholas
Published: December 2023

Aims and Objectives. To evaluate nonpharmacological interventions for preventing patient and visitor-perpetrated violence against healthcare workers within hospital settings. Background. Up to 92% of health workers experience some form of patient-perpetrated violence. The highest risk environments include emergency departments, acute care settings, and mental health units. Given such elevated rates of violence, current interventions have questionable efficacy or implementation challenges. Design. We conducted a systematic review conforming to PRISMA reporting requirements. We searched PubMed, CINAHL, PsycINFO, Scopus, and the Cochrane Library. Studies reporting interventions to prevent patient-initiated violence against healthcare workers in hospitals were included, and findings were synthesised. Results. Based on meeting eligibility criteria, twelve studies were included in the review. Most interventions reported an effect with eleven of the twelve studies describing changes in the incidence of violence postintervention. Most studies were evaluations of education and training programs (n = 7), followed by action plans (n = 2), and a reporting instrument, risk assessment tool, and legislation (n = 1). Conclusions. Insights into effective strategies to prevent hospital patient and visitor-initiated violence are necessary to develop guidelines for better aggression/violence deterrence. Violence prevention requires strong, evidence-based, and clinically applicable interventions that promote the safety and satisfaction of all healthcare workers. Relevance to Clinical Practice. Formulating effective and appropriate strategies that aid in early recognition, prevention, and management of aggression/violence will benefit all health workers. Patient and staff satisfaction will rise; healthcare workers will regain a sense of preparedness, and higher levels of safety will be achieved. Without these effective interventions being established, the magnitude of adverse outcomes from patient-perpetrated violence will continue in healthcare.
Dietary Cholesterol Requirements of Large Red Swamp Crayfish (Procambarus clarkii)
Authors: Tian Juan , Xiao Wenfu , Gao Weihua , Zhang Jianmin , Xu Liangzi , Li Mingzhu , Liang Hongwei , Xie Ningning , Dong Lixue , Li Jie
Published: December 2023

To investigate the dietary cholesterol requirements of large red swamp crayfish (Procambarus clarkii), crayfish (initial body weight: 13.49 ± 0.22 g) were hand-fed six diets containing 2.47 (C0), 4.27 (C1), 6.80 (C2), 8.77 (C3), 11.74 (C4), and 14.24 (C5) g/kg cholesterol. After 8 weeks of feeding, the maximum weight gain rate and specific growth rate occurred in group C4. The lowest feed conversion ratio was observed in group C3. Total flesh percentage increased significantly by 15.33% in group C2 compared to group C0. The increase in dietary cholesterol resulted in significant quadratic trends in concentrations of crude protein and lipid in muscle and whole body; cholesterol and free fatty acid in hemolymph, hepatopancreas, and muscle; activities of lipase and amylase in hepatopancreas and intestine; and total antioxidant capacity and catalase activity in hepatopancreas. Group C3 experienced a noteworthy increase in hemolymph glucose and total protein content compared to group C0. Additionally, malondialdehyde content and superoxide dismutase activity in hepatopancreas displayed significant linear and quadratic trends. The optimal dietary cholesterol level for large P. clarkii is between 7.42 and 10.93 g/kg, as revealed by the quadratic regression analysis.
Front & Back Matter
Authors: Dai Weiwei , Yang Jiajia , Chen Ting , Yang Zhuo
Published: December 2023

Background: Bexarotene, a retinoid X receptor agonist, has been shown to reverse neurodegeneration in mouse models of Alzheimer's disease (AD), accompanied by a decreased level of amyloid-β (Aβ), which is a hallmark of AD. However, the mechanism underlying this therapeutic effect may involve enhancing the sensitivity to insulin. Objective: This study was to test the hypothesis that bexarotene would protect against Aβ25-35-induced dysfunction through the insulin signaling pathway. Methods: Using a whole-cell patch clamp technique, the excitability and voltage-gated potassium currents of hippocampal neurons were examined in four groups of cells (control, Aβ, Aβ + bexarotene and bexarotene). Results: It was found that insulin increased the excitability of neurons. Bexarotene could enhance this effect and reverse the Aβ25-35-induced decrease in the firing rate of the action potential (AP). In addition, the properties of the single AP (sAP) and voltage-gated outward K+ currents were recorded, which finally showed similar changes to those in the firing frequency. Conclusion: The effects of bexarotene on Aβ-impaired excitability and sAP duration were mainly associated with K+ channels through insulin signaling pathway, which may be an additional mechanism underlying the protective effect of bexarotene on AD.
Sequence Variants in the WNT10B Underlying Non-Syndromic Split-Hand/Foot Malformation
Authors: Bilal Muhammad , Haack Tobias B. , Buchert Rebecca , Peralta Susana , Ahmad Imtiaz , Faisal  , Abbasi Sanaullah , Ahmad Wasim
Published: December 2023

Introduction: Split hand and foot malformation (SHFM) or ectrodactyly is a rare limb deformity characterized by median cleft of the hand and foot with impaired or missing central rays. It can occur as an isolated anomaly or in association with abnormalities of other body parts. Methods: After delineating the clinical features of two families (A–B), with non-syndromic SHFM, exome and Sanger sequencing were employed to search for the disease-causing variants. Results: Analysis of exome and Sanger sequencing data revealed two causative variants in the WNT10B gene in affected members of the two families. This included a novel missense change [c.338G>C; p.(Gly113Ala)] in family A and a previously reported frameshift variant [c.884-896delTCCAGCCCCGTCT; p.(Phe295Cysfs*87)] in family B. Conclusion: Our findings add a novel variant in WNT10B gene as the underlying cause of SHFM. The finding adds to the growing body of knowledge about the genetic basis of developmental disorders and provides valuable insights into the molecular mechanisms that regulate limb development.
Female Hyperplastic PSA-Positive Prostate Tissue in the Bladder Neck
Authors: Garaz Radion , Stenzl Arnulf , Singer Stephan , Mattern Sven , Bedke Jens , Amend Bastian
Published: December 2023

Introduction: We report a rare case of Skene’s gland hyperplasia where the serum prostate-specific antigen (PSA) level was measurable. Case Presentation: The patient was a 91-year-old woman with a suspected bladder mass at the bladder trigone. Cystoscopy revealed a suspected lesion and an obstructed anterior bladder neck with a large mass located from a “7 o’clock” to “11 o’clock” area. The photodynamic diagnosis was negative. Transurethral subtotal resection of the mass was performed. The serum PSA level at the third postoperative day was 0.08 ng/mL. Postoperative cystography showed no contrast media extravasation. Thus, histopathology revealed massive adenomyomatous hyperplasia of the Skene’s gland, as well as nondysplastic urothelium and glandular and squamous epithelium. Immunohistochemistry showed strong PSA and NKX3.1 positivity, confirming the diagnosis of “female prostate.” FISH analysis showed only green signals that confirm an XX karyotype. In follow-up to 17 months, there was no disease recurrence or need for a urinary catheter. Conclusion: Effective therapeutic strategies for these lesions are unknown due to the absence of reported cases. Given the patient’s age, we assumed that bladder neck resection by transurethral resection with a controlled level of serum PSA would be a suitable therapeutic approach.
Knowledge of Day and Time Contact Preferences Assists in Successful Telephone Follow-Up
Authors: Brancatisano Olivia , Reyneke Megan , Cameron Jan , Kilkenny Monique F. , Harris Dawn , Lannin Natasha A. , Cadilhac Dominique A.
Published: December 2023

Objectives: There is limited evidence as to whether knowing a participant’s contact preferences improves completion of telephone assessments in clinical trials. We examined (i) participants’ preferences for telephone contact and these preferences related to day and time of actual contact; (ii) the number of contact attempts to successfully complete telephone assessments; (iii) the association between participant characteristics and successful telephone contacts. Materials and Methods: A prospective observational study nested within the Recovery-focused Community support to Avoid readmissions and improve participant after Stroke (ReCAPS) trial was undertaken. Information was collected on preferences (set days of the week, any weekday, morning, afternoon, evening, anytime) for assessment calls at 3 months post-randomization. Descriptive statistics and logistic regression were used. Results: Of the 232 participants (average age 66 years, 69% male), 59% preferred calls on any weekday. Wednesday (26%) and Monday (21%) and mornings (49%) were preferred. Approximately 70% of telephone calls were completed within three contact attempts. Approximately 60% of all calls were completed on participants’ preferred day and time. There was no association between participant characteristics (sex, age, employment status, and living alone) and the number of contact attempts made for the telephone call assessment. There were no participant characteristics associated with the successful completion of assessments on participants’ preferred time/day. Conclusions: We provide new evidence, based on a case study in stroke, highlighting the importance of knowing a participant’s preferred contact day and time for the timely completion of assessments via telephone call.
Genotypic markers associated with cold storage survival of the entomopathogenic nematode Heterorhabditis bacteriophora
Authors: Ogaya Christopher , Moges Yohannes , Dörfler Verena , Barg Mike , Ehlers Ralf-Udo , Molina Carlos
Published: December 2023

Limited shelf life is a major constraint to successful commercialisation of entomopathogenic nematodes (EPN), and to extend shelf life, dauer juveniles (DJ) are formulated and stored at low temperatures (4-8°C). We evaluated the cold storage potential of strains of Heterorhabditis bacteriophora formulated in diatomaceous earth at storage temperatures between 5 and 9°C. When assessing DJ decline to reach 75% survival (MT75) in the formulation for the respective temperatures, H. bacteriophora strain HB4 had the highest survival of 25 days at 9°C, while strain D2D6 survived longest at 8°C for 28 days. A set of 22 H. bacteriophora wild type inbred lines was then phenotyped for cold tolerance in water under oxidative stress in 70 mM H2O2 at 2°C. The MT50 (time to 50% survival) ranged from 11 to 23 days. The phenotypic data were correlated with the respective genotypic data, identifying four single nucleotide polymorphic (SNP) markers associated with cold tolerance. The survival of two lines (PT11 and IR11) with opposite extreme cold tolerance pheno- and genotypes was evaluated in diatomaceous earth formulation at 2°C with the cold tolerant IR11 surviving 3 days longer than PT11. Our study yields a set of valuable SNP markers employable in rapid genotyping of cold tolerance and tracking this trait during the breeding process.
Dramatic Dissent in Wole Soyinka’s Metaphysical Play Death and the King’s Horseman (1975) and Biyi Bandele’s Netflix Adaptation Elesin Oba: The King’s Horseman (2022)
Authors: Pardey Hannah
Published: December 2023

Approaching the theme of this special issue as a dramatic structure, the contribution investigates the representation of dissenting practices in Wole Soyinka’s Death and the King’s Horseman and Biyi Bandele’s Elesin Oba: The King’s Horseman. First published in 1975, Soyinka’s metaphysical play dramatises the events surrounding the eponymous protagonist Elesin Oba who, according to Yoruba cosmology, must follow the king in death to ensure harmony between this world and the next. Questioning both metaphysical and Marxist readings of the play, I argue that its employment of ritual as a dramaturgical device functions to explore the intricate reasons for failed leadership in post-independence Nigeria. This re-reading of Soyinka’s classic is informed by its recent screen adaptation, Elesin Oba: The King’s Horseman, which was co-produced by Ebonylife Films and Netflix and directed by the late Nigerian playwright and filmmaker Biyi Bandele. Reinforcing new Nollywood’s budding relationship with Netflix and its accompanying globalisation, Bandele’s movie appropriates the play’s dramatic structure of dissent on the levels of cinematography and editing, mise-en-scène and sound, inviting its transnational viewers to consider past and present manifestations of dissent as a means of managing and envisioning possible solutions to contemporary conflicts. The conclusion stresses that the ritual form presents a flexible device to interrogate historically specific power relations and encourage distinct generations of audiences to imagine their forms, causes, and alternatives; whereas Soyinka’s play suggests that these alternatives rest on the capabilities of the educated middle classes, Bandele’s movie constructs more diversified audiences which may settle for its consoling or dissenting aesthetics, respectively.
Literature as Worldly Action
Authors: Di Pietro Alessandra
Published: December 2023

This paper aims to demonstrate how the various declinations of public and private dissent represented in a contemporary work of African literature, The Death of Vivek Oji (2020) by Akwaeke Emezi, can be read as an instance of literature’s world-making capacity. As the novel’s title anticipates, The Death of Vivek Oji reconstructs the life of its eponymous protagonist and the events that led to their death (Vivek is a non-binary, transgender person and both male and female pronouns are used to refer to them). Emezi’s novel is set in Nigeria during the late 1990s and the narrative actively engages in a representation of the socio-political situation of the country back then, covering the impact that the sudden death of the head of state, Sani Abacha, had on the population. Throughout the novel, dissent is depicted on two levels: on the one hand, it appears as an expression of democratic desire through the public protests against the country’s politics, as well as acts of violence against and among ethno-religious groups; on the other hand, there is also a parallel representation of private dissent in terms of the affirmation of one’s own identity. Vivek’s decision to not cut their long hair becomes, therefore, a form of personal opposition against society’s pre-imposed gendered constructs. In this sense, if the social stigma attached to members of the LGBT community is personified by the incapacity of Vivek’s parents to accept and understand their non-binary child, Vivek’s friends represent a communal act of resistance against such an oppressive social system. Ultimately, the opposition between public and private dissent finds its climax in Vivek’s death, in its causes and consequences. Building the critical analysis of the novel upon recent conceptualisations of literature as an active force that provokes dissent (Cheah 2016, Burns 2019), this paper demonstrates how Emezi’s narrative uses representations of public and private dissent to contest the current world in order to engage in the construction of a more equal one.
Violence-as-Norm in the Postcolony
Authors: Orhero Mathias Iroro , Nwoke Chikezirim
Published: December 2023

In this paper, we explore forms of statist violence in both colonial and postcolonial contexts to underscore it as a constant in a postcolonial location like Nigeria. In addition to exploring how statist violence works, we also position civic dissent as a strategy employed in the colony and postcolony to confront statist violence. Our theorization of “violence-as-norm” is motivated by earlier ideas like the works of the South Asian Subaltern Studies Collective, Tejumola Olaniyan’s “postcolonial incredible,” Toyin Falola’s views on violence within Nigerian history, and Achille Mbembe’s notions of banality and vulgarity in the postcolony. Our paper engages with Peter Omoko’s Majestic Revolt to demonstrate how “violence-as-norm” mediates colonial violence and civic dissent. Furthermore, by close-reading Chiedozie Omeje’s “When Cowards Win,” we explore postcolonial forms of violence through the EndSARS movement against police brutality in Nigeria to demonstrate how civic dissent is performed and ruptured in the contemporary moment. Ultimately, our research positions the Fanonist category of violence as a way to imagine the inherent coloniality of postcolonial nation-states, thereby extending the critique of the nation-form in postcolonial studies.
First record of the plant bug genus Punctifulvius Schmitz from the Oriental Region, with descriptions of three new species (Hemiptera, Heteroptera, Miridae, Cylapinae)
Authors: YASUNAGA TOMOHIDE , WOLSKI ANDRZEJ , TASZAKOWSKI ARTUR
Published: December 2023

Three new species of the fungal-inhabiting plant bug genus Punctifulvius Schmitz, 1978 (Cylapinae: Fulviini) are described, namely P. aleksanderi n. sp. from Selangor, Malaysia, P. parvus n. sp. from East Kalimantan, Indonesia, and P. sakaerat n. sp. from Nakhon Ratchasima, Thailand. The present discovery represents the first record of the genus from the Oriental Region. Punctifulvius members are now confirmed to be widespread from the cold temperate climatic zones in the eastern Palearctic regions, across the tropics of the Oriental Region, to the temperate rainforest of Australia. Punctifulvius kerzhneri Schmitz, 1978 is recorded from Taiwan for the first time. The systematic position of Teratofulvioides Carvalho & Lorenzato, 1978 is discussed, and its single species Teratofulvioides punctatus Carvalho & Lorenzato, 1978 is redescribed. Color adult habitus images of Punctifulvius aleksanderi, P. kerzhneri, P. parvus, P. sakaerat, and Teratofulvius punctatus, images of male (P. parvus and P. sakaerat) and female (P. aleksanderi) genitalic structures, as well as scanning electron micrographs of selected structures of P. aleksanderi, P. kerzhneri, P. parvus, P. sakaerat, and T. punctatus are provided. Key to the species of Punctifulvius is given.
Coronary balloon-assisted navigation of aspiration catheter for stroke thrombectomy
Authors: Chulsky Semyon , Zur Gil , Doron Omer , Sacagiu Tzvika , Abergel Eitan
Published: December 2023

In recent years, A Direct Aspiration First Pass Technique (ADAPT) has emerged as an effective and safe method of thrombectomy. Large trials have shown noninferiority of ADAPT compared to primary stent retriever approach, while new studies emphasize on its shorter procedural time with potentially fewer complications and costs.1,2. Failure of the A Direct Aspiration First Pass Technique (ADAPT) is often due to the inability to successfully navigate the aspiration catheter to the thrombus site. As a solution, several techniques have been considered such as the use of stiffer microcatheters or a wedge device. 3 In Video 1 , we present our technique of navigating aspiration catheters with the assistance of coronary balloons. This technique has been very successful in our experience of about 30 cases in the past 6 months. Thanks to its safety and efficacy, this technique has dramatically changed our technical management of acute ischemic stroke. It can increase the ADAPT success rate while potentially reducing procedural costs.
Association of systemic immune inflammatory index with all-cause and cause-specific mortality among individuals with type 2 diabetes
Authors: Chen Chaoyang , Chen Yuwen , Gao Qiyue , Wei Qucheng
Published: December 2023

Background

The evidence regarding the association between the systemic immune inflammatory index (SII) and mortality among individuals with diabetes is limited. This study aims to evaluate the associations between SII and all-cause and cause-specific mortality among individuals with diabetes.

Methods

The study included 8,668 participants with diabetes from the National Health and Nutrition Examination Survey (NHANES) 1999–2018 with follow-up until 31 December 2019. The calculation of SII in this study was performed using the following formula: the neutrophil-to-lymphocyte ratio multiplied by the platelet count (10^9 cells/µL).

Results

The study documented 2,463 deaths over 68,542 person-years, including 853 deaths from CVD and 424 from cancer. An increase in SII was significantly associated with higher all-cause and CVD mortality risk after multivariate adjustment. For each standard deviation increment in natural log transformed SII (lnSII), all-cause mortality increased by 17%, and CVD mortality increased by 34% (both P < 0.001). Additionally, the association between SII and all-cause mortality was U-shaped, with the inflection point at 6.02. The association between SII and CVD mortality was non-linear and J-shaped, where the risk increased significantly when lnSII exceeded 6.22. Furthermore, the association between SII and CVD mortality was attenuated in female and hyperlipidemia patients.

Conclusion

In this study, we observed a significant positive association between the SII and both all-cause and CVD mortality in patients with diabetes. Additionally, it was discovered that this association exhibited a non-linear pattern. These findings suggest that maintaining SII within an optimal range may play a critical role in mitigating the risk of mortality.
Time and change: a typology for presenting research findings in qualitative longitudinal research
Authors: Audulv Åsa , Westergren Thomas , Ludvigsen Mette Spliid , Pedersen Mona Kyndi , Fegran Liv , Hall Elisabeth O. C. , Aagaard Hanne , Robstad Nastasja , Kneck Åsa
Published: December 2023

Background

Qualitative longitudinal research (QLR) is an emerging methodology used in health research. The method literature states that the change in a phenomenon through time should be the focus of any QLR study, but in empirical studies, the analysis of changes through time is often poorly described, and the emphasis on time/change in the findings varies greatly. This inconsistency might depend on limitations in the existing method literature in terms of describing how QLR studies can present findings. The aim of this study was to develop and describe a typology of alternative approaches for integrating time and/or change in QLR findings.

Methods

In this method study, we used an adapted scoping review design. Articles were identified using EBSCOhost. In total, methods and results sections from 299 QLR articles in the field of health research were analyzed with inspiration from content analysis.

Results

We constructed a typology of three types and seven subtypes. The types were based on the underlying structural principles of how time/change was presented: Type A) Findings have a low utilization of longitudinal data, Type B) Findings are structured according to chronological time, and Type C) Findings focus on changes through time. These types differed in 1) the way the main focus was on time, change or neither; 2) the level of interpretation in the findings; and 3) how theoretical understandings of time/change were articulated in the articles. Each type encompassed two or three subtypes that represented distinct approaches to the aim and results presentation of QLR findings.

Conclusions

This method study is the first to describe a coherent and comprehensive typology of alternative approaches for integrating time/change into QLR findings in health research. By providing examples of various subtypes that can be used for results presentations, it can help researchers make informed decisions suitable to their research intent.
Biomechanical characteristics of a novel interspinous distraction fusion device in the treatment of lumbar degenerative diseases: a finite element analysis
Authors: Chen Mengmeng , Deng Jiechao , Bao Li , Jia Pu , Feng Fei , Shi Guan , Tang Hai , Chen Hao
Published: December 2023

Background

A novel interspinous distraction fusion (ISDF) device has been used to treat lumbar degenerative diseases. As a minimally invasive technique, ISDF differs from the traditional interspinous process distraction devices. Currently, biomechanical studies on ISDF are rare.

Objective

To investigate the biomechanical properties of the ISDF device (BacFuse) which is used to treat lumbar degenerative diseases.

Methods

Three-dimensional L3-L5 models were created. The models were divided into four groups: intact (M1), local decompression alone (M2), internal fixation alone (M3) and local decompression combined with internal fixation (M4), based on different surgical procedures. Local laminectomy was performed to resect the lower part of the L4 lamina and the upper part of the L5 lamina at the right lamina of L4/5 in the M2 and M4 groups. After meshing the models elements, Abaqus were used to perform the finite element (FE) analysis. The intervertebral range of motion (ROM) was measured during flexion, extension, left lateral bending, right lateral bending, left rotation and right rotation under a follower load of 400 N with a 7.5Nm moment. The distributions of disc and facet joint stresses were observed and recorded. Spinal vertebral stress was compared, and internal fixation device stress was observed.

Results

The ROM of L4/5 in M2 increased in flexion, extension, left lateral bending, right lateral bending, left rotation and right rotation compared with that in M1. In all motion directions, the ROM at L4/5 decreased, and the ROM at L3/4 increased after implantation of the ISDF device in M3 and M4 groups. The disc stress and facet joint stresses in the instrumented segment decreased after implantation of the ISDF device. The spinous process loaded a certain amount of stress in M3 and M4 groups. The spikes of the internal fixation device were loaded with the maximum stress.

Conclusion

BacFuse exhibited a reduction in intervertebral ROM, as well as decreased stress on the intervertebral disc and facet joint, while also demonstrating a discernible impact on the upper adjacent segment.
Association between serum osteocalcin and atherosclerosis in Type-2 diabetes mellitus: a cross-sectional study
Authors: Sharma Vishal Chandra , Vidyasagar Sudha , Sukumar Cynthia Amrutha , Krishna B Nanda , Shree Sharanya
Published: December 2023

Background

The past few decades have seen a marked increase in the macrovascular complications of Type-2 diabetes mellitus (T2DM) such as coronary heart disease, peripheral arterial disease, and cerebrovascular disease. This has been predominantly attributed to the increased atherosclerosis in these patients. Atherosclerosis usually remains an asymptomatic condition and this poses a significant challenge in its early diagnosis and timely intervention. Hence, there is an immediate need for exploring novel tools to aid in the early detection of atherosclerosis, especially in T2DM patients. Osteocalcin (OC), synthesized by osteoblasts, is a protein hormone found in the skeletal system. This protein is considered as a marker for bone density and in recent times has been gaining interest due to its protective role in cerebrovascular diseases(CVD).

Methods

We conducted a cross-sectional study and evaluated the association between serum OC levels and atherosclerosis in 113 T2DM patients. Carotid intima-media thickness (CC-IMT) was used as an estimate of atherosclerosis and patients were divided into two groups (CC-IMT < 0.9 and ≥ 0.9). Correlation of serum OC levels and glycemic parameters and lipid profiles were studied and compared between both groups.

Results

There is a significant negative correlation between the CC-IMT estimates and serum OC levels. CC-IMT also has a significant association with other biochemical parameters such as fasting blood sugar, glycated hemoglobin and high-density lipoprotein.

Conclusion

Although the independent association of serum OC could not be established in the T2DM patient population, overall, the results favor low serum OC as a prognostic marker for atherosclerosis.
An in vitro study measuring marginal gaps of inlay restorations fabricated from different CAD-CAM materials after thermocycling
Authors: Taha Ahmed Ismail , Hafez Mona Elshirbini
Published: December 2023

Background

Many monolithic machined materials have been introduced and provided a suitable mechanical and physical properties for inlay restorations. However, there is shortage in the studies evaluating the marginal adaptation using these materials.

Purpose

This study aimed to compare the effect of fabricating inlay restorations from 3 different CAD-CAM materials on marginal gaps before and after thermocycling.

Materials and methods

Sixty human premolars were randomly divided into 3 groups (n = 20) according to the material used: (e.max CAD, Ivoclar AG, Schaan, Liechtenstein), (HC, Shofu, Koyoto, Japan) and (Brilliant Crios, Coltene, Altstätten, Switzerland) (n = 20). A scanning electron microscope (SEM) (JSM- 6510 lv, JEOL, Tokyo, JAPAN) was used to for measuring the marginal gaps after cementation of inlay restorations. The magnification was adapted to 250x. Marginal gaps were revaluated with SEM after thermocycling. The temperatures of baths were 5 and 55 °C was applied for a total of 5000 cycles. All data were statistically analyzed by using ANCOVA to demonstrate if there were any statistically significant differences between the gap measures after thermocycling of the three independent (unrelated) groups. A Bonferroni adjustmen was used to perform post hoc analysis (α = 0.05).

Results

Post-intervention marginal gap was statistically significantly lower in group EX (110.8 μm) which was statistically significant compared with group SF (112.5 μm) (mean difference=-1.768,P = .007) and group BR (113 μm) (mean difference=-2.272,P = .001), however, in. comparing SF and BR groups, there was no significant difference (mean difference=-0.5,P = .770).

Conclusions

Thermocycling affected the marginal gaps of composite based restoration and resin-modified ceramics widely. However, it had a very small effect on glass ceramics marginal adaptation.

Clinical implications

The marginal gaps of CAD-CAM inlays varied according to material used (ceramic based, combination, or resin based). Thermocycling has a minor effect on the marginal adaptation of lithium disilicate glass-ceramic inlays, where it affected the margin of resin-modified ceramic and composite based inlays greatly. Using lithium disilicate glass-ceramic might improve the clinical longevity of inlay restored teeth.
The design and psychometric evaluation of a COVID-19 social stigma questionnaire in nurses
Authors: Rahmani Narges , Roshan FatemehSadat SeyedNematollah , Nabavian Majedeh , Alipour Hossein
Published: December 2023

Background

The patient’s fear of social reactions, the disease stigma, and being a transmission agent is a psychological and social consequence of contracting some diseases, especially infectious ones, in any society. The present study aimed to design and psychometrically evaluate a COVID-19 social stigma questionnaire in nurses.

Methods

This mixed-method study was conducted using a sequential exploratory approach according to the Creswell method in Mazandaran Province (Iran) during 2021-22. The study was performed in three phases: (1) a qualitative phase to explain the key concept, (2) designing the scale items, and (3) an experimental phase with the scale psychometric evaluation. In the first phase, nurses’ experiences regarding the concept of COVID-19 social stigma were evaluated using a qualitative method with an inductive qualitative content analysis approach. In this phase, the lived experiences of 12 nurses working at hospitals of Babol University of Medical Sciences were extracted through in-depth interviews with semi-structured questions and analyzed by conventional content analysis. The main classes are contradictory feelings, rejection, and adaptation strategies. In the second phase, the designed items were validated by determining face validity, content validity, and construct validity using exploratory factor analysis (EFA). In addition, the scale’s reliability was determined through internal consistency and stability.

Results

Following the study’s first phase, a pool of questions with 64 initial items was formed. After evaluating face and content validity, the number of items was reduced to 24 cases. An excellent total content validity (S-CVI/Ave) of 0.93 was calculated for the scale. According to EFA outputs, three factors accounted for the most variance (52.82%), and four items were excluded in this phase. The Kaiser-Meyer-Olkin (KMO) statistic and Bartlett’s test of sphericity were calculated at 0.776 and P < 0.001, respectively. The results of Cronbach’s alpha (0.796) and intraclass correlation (0.793) indicated the correlation and internal consistency of the scale.

Conclusion

This scale can help healthcare managers and policymakers apply necessary protective measures by evaluating the social stigma of COVID-19 in nurses and emerging infectious diseases that may occur in the future.
Validation of the Chinese version of academic goals orientation questionnaire in nursing student: a study based on SEM and IRT multidimensional models
Authors: Li Yuqing , Guo Lei-lei , Gui Jiaofeng , Zhang Xiaoyun , Wang Ying , Liu Haiyang , Li Jinlong , Lei Yunxiao , Li Xiaoping , Sun Lu , Yang Liu , Yuan Ting , Wang Congzhi , Zhang Dongmei , Wei Huanhuan , Li Jing , Liu Mingming , Hua Ying , Zhang Lin
Published: December 2023

Objective

To translate the Academic Goals Orientation Questionnaire (AGOQ) into Chinese and to determine the validity and reliability of the (AGOQ) in Chinese nursing students based on SEM and IRT multidimensional models.

Methods

The participants were 654 nursing students with an age range of 17–26 years (mean age 21.61 ± 1.73 years). The psychometric properties of AGOQ were investigated based on a dual analytical perspective of structural equation modeling (SEM) and item response theory (IRT).

Results

The Cronbach’s α value of the questionnaire is 0.895. A four-factor model was obtained by exploratory factor analysis, which explained the variance of 71.892%. With confirmatory factor analysis, a new four-factors model was built and showed an acceptable goodness-of-fit, chi-square/degree of freedom (CMIN/DF) = 4.008, goodness of fit index (GFI) = 0.932, adjusted goodness of fit index (AGFI) = 0.905, comparative fit index (CFI) = 0.952, incremental fit index (IFI) = 0.952, Tucker Lewis index (TLI) = 0.941. In the analysis part of IRT, according to the comparison between Akek’s information criterion (AIC) and Bayesian information criterion (BIC), we choose the Graded Response Model (GRM) for analysis. The results show that the difficulty value is monotonically increasing, and the discrimination of all items is greater than 0.19, which shows that 16 items can be retained.

Conclusions

This study tested the psychometric characteristics of AGOQ of nursing students in China. The results confirmed that the Chinese version of AGOQ has good psychometric characteristics and can be used to measure the academic goal orientation of nursing students in China.
PTK2-associated gene signature could predict the prognosis of IPF
Authors: Feng Anlin , Caro Yesenia Moreno , Gardner Colin , Grischo Garrett , Liang Ying , Wickremasinghe Praveen D. , Polmann Michaela , Kala Mrinalini , Marlowe Timothy , Black Stephen M. , Knox Kenneth S. , Wang Ting
Published: December 2023

Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal lung disease with a poor prognosis. Current/available clinical prediction tools have limited sensitivity and accuracy when evaluating clinical outcomes of IPF. Research has shown that focal adhesion kinase (FAK), produced by the protein tyrosine kinase 2 (PTK2) gene, is crucial in IPF development. FAK activation is a characteristic of lesional fibroblasts; Thus, FAK may be a valuable therapeutic target or prognostic biomarker for IPF. This study aimed to create a gene signature based on PTK2-associated genes and microarray data from blood cells to predict disease prognosis in patients with IPF. PTK2 levels were found to be higher in lung tissues of IPF patients compared to healthy controls, and PTK2 inhibitor Defactinib was found to reduce TGFβ-induced FAK activation and increase α-smooth muscle actin. Although the blood PTK2 levels were higher in IPF patients, blood PTK level alone could not predict IPF prognosis. From 196 PTK2-associated genes, 11 genes were prioritized to create a gene signature (PTK2 molecular signature) and a risk score system using univariate and multivariate Cox regression analysis. Patients were divided into high-risk and low-risk groups using PTK2 molecular signature. Patients in the high-risk group experienced decreased survival rates compared to patients in the low-risk group across all discovery and validation cohorts. Further functional enrichment and immune cell proportion analyses revealed that the PTK2 molecular signature strongly reflected the activation levels of immune pathways and immune cells. These findings suggested that PTK2 is a molecular target of IPF and the PTK2 molecular signature is an effective IPF prognostic biomarker.
Lower myostatin and higher MUC1 levels are associated with better response to mepolizumab and omalizumab in asthma: a protein–protein interaction analyses
Authors: Akenroye Ayobami , Nopsopon Tanawin , Cho Laura , Moll Matthew , Weiss Scott T.
Published: December 2023

Introduction

Biomarkers are needed to inform the choice of biologic therapy in patients with asthma given the increasing number of biologics. We aimed to identify proteins associated with response to omalizumab and mepolizumab.

Methods

Aptamer-based proteomic profiling (SomaScan) was used to assess 1437 proteins from 51 patients with moderate to severe asthma who received omalizumab (n = 29) or mepolizumab (n = 22). Response was defined as the change in asthma-related exacerbations in the 12 months following therapy initiation. All models were adjusted for age, sex, and pre-treatment exacerbation rate. Additionally, body mass index was included in the omalizumab model and eosinophil count in the mepolizumab model. We evaluated the association between molecular signatures and response using negative binomial regression correcting for the false discovery rate (FDR) and gene set enrichment analyses (GSEA) to identify associated pathways.

Results

Over two-thirds of patients were female. The average age for omalizumab patients was 42 years and 57 years for mepolizumab. At baseline, the average exacerbation rate was 1.5/year for omalizumab and 2.4/year for mepolizumab. Lower levels of LOXL2 (unadjusted p: 1.93 × 10E−05, FDR-corrected: 0.028) and myostatin (unadjusted: 3.87 × 10E−05, FDR-corrected: 0.028) were associated with better response to mepolizumab. Higher levels of CD9 antigen (unadjusted: 5.30 × 10E−07, FDR-corrected: 0.0006) and MUC1 (unadjusted: 1.15 × 10E−06, FDR-corrected: 0.0006) were associated with better response to omalizumab, and LTB4R (unadjusted: 1.12 × 10E−06, FDR-corrected: 0.0006) with worse response. Protein–protein interaction network modeling showed an enrichment of the TNF- and NF-kB signaling pathways for patients treated with mepolizumab and multiple pathways involving MAPK, including the FcER1 pathway, for patients treated with omalizumab.

Conclusions

This study provides novel fundamental data on proteins associated with response to mepolizumab or omalizumab in severe asthma and warrants further validation as potential biomarkers for therapy selection.
Preventive effect of intermittent cerebrospinal fluid drainage for secondary chronic hydrocephalus after aneurysmal subarachnoid hemorrhage
Authors: Yamanaka Tomoyasu , Nishikawa Yusuke , Iwata Takashi , Shibata Teishiki , Uchida Mitsuru , Hayashi Yuki , Katano Hiroyuki , Tanikawa Motoki , Yamada Shigeki , Mase Mitsuhito
Published: December 2023

Background

The efficacy of intermittent cerebrospinal fluid (CSF) drainage compared with that of continuous CSF drainage in patients with subarachnoid hemorrhage (SAH) remains undetermined to date. Therefore, we investigated whether intermittent CSF drainage is effective in reducing secondary chronic hydrocephalus (sCH) after aneurysmal SAH.

Methods

Overall, 204 patients (69 men and 135 women) treated for aneurysmal SAH between 2007 and 2022 were included in this study. Following SAH onset, 136 patients were managed with continuous CSF drainage, whereas 68 were managed with intermittent CSF drainage. Logistic regression analyses were used to calculate the age-adjusted and multivariate odds ratios for the development of sCH. The Cox proportional hazards regression model were used to compare the effects of intermittent and continuous CSF drainage on sCH development.

Results

Overall, 96 patients developed sCH among the 204 patients with SAH. In total, 74 (54.4%) of the 136 patients managed with continuous CSF drainage developed sCH, whereas 22 (32.4%) of the 68 patients managed with intermittent CSF drainage developed sCH. This demonstrated that the rate of sCH development was significantly lower among patients managed with intermittent CSF drainage. Compared with continuous CSF drainage, intermittent CSF drainage exhibited a multivariate odds ratio (95% confidential interval) of 0.25 (0.11–0.57) for sCH development. Intermittent CSF drainage was more effective (0.20, 0.04–0.95) in patients with severe-grade SAH than in those with mild-grade SAH (0.33, 0.12–0.95). Intermittent CSF drainage was ineffective in patients with acute hydrocephalus (8.37, 0.56–125.2), but it was effective in patients without acute hydrocephalus (0.11, 0.04–0.31).

Conclusions

Compared with continuous CSF drainage, intermittent drainage is more effective in reducing sCH after aneurysmal SAH. Although intermittent drainage was ineffective in cases of co-occurrence of acute hydrocephalus, it was effective in reducing sCH development regardless of the severity of initial symptoms at SAH onset.
Clinical characteristics of suicidal behavior in first hospitalization and drug-naïve patients with major depressive disorder
Authors: Sun Xianzhi , Yin Lili , Zhang Yingying , Liu Xuebing , Ma Jun
Published: December 2023

Background

Major depressive disorder (MDD) is a major and common cause of suicide. The purpose of this article is to report the clinical characteristics and patterns of co-morbid suicidal behavior (SB) in first hospitalized and drug-naïve MDD patients.

Methods

A total of 345 patients with first hospitalization and drug-naïve MDD with SB were included in this study, while 183 patients without SB were included as a control group. We collected socio-demographic, general clinical data and common biochemical indicators of all participants and assessed their clinical symptoms.

Results

Compared to patients without SB, MDD with SB had more severe clinical symptoms and worse metabolic indicators. Duration of disease, depressive symptom scores, and thyroid stimulating hormone (TSH) levels was risk factors for SB and its number.

Conclusions

MDD patients with SB suffered more severe clinical symptoms and worse metabolic indicators, and risk factors for SB in this population were identified, which may provide beneficial insight and reference for clinical prevention and intervention of SB in MDD patients.