bluuebunny/crossref_metadata_2025_split huggingface dataset:
Neoadjuvant adebrelimab plus dalpiciclib in HPV-negative locally advanced head and neck squamous cell carcinoma: A phase II clinical trial.
Authors: Liu Lei , Li Yi , Chen Fei , Li Chunjie , Xie Huixu , Zhang Zhuoyuan , Xz Xiang , Zeng Yuanyuan , Wang Jun , Zhang Bowen , Tan Chenfeng , Dai Zelei 
Published: July 2024

TPS6129 Background: The efficacy and safety of neoadjuvant immunotherapy (NAI) for treating resectable locally advanced head and neck squamous cell carcinoma (LAHNSCC) remain uncertain, and the comprehensive protocol of NAI needs further explored. The tumor suppressor gene CDKN2A plays a pivotal role in cell cycle regulation by modulating cyclin-dependent kinase (CDK) activity. Mutations in CDKN2A lead to continuous activation of CDK4/6, resulting in uncontrolled cell proliferation and tumor growth. Approximately 35.7% of HNSCC patients exhibit CDKN2A mutations, with the incidence rising to 58% among HPV-negative LAHNSCC patients. Studies have shown that combining immunotherapy with a CDK4/6 inhibitor produces a synergistic anti-tumor effect. This study aims to assess the efficacy and safety of combining anti-PD-L1 (adebrelimab) with a CDK4/6 inhibitor (dalpiciclib) as NAI in resectable LAHNSCC patients. Methods: This open-label, single-arm, prospective phase II trial will enroll LAHNSCC patients eligible for surgery. Inclusion criteria include: being 18 to 75 years old at study entry; pathologically confirmed HPV-negative HNSCC (oral, laryngeal, hypopharyngeal, and HPV-negative oropharyngeal carcinoma), determined via p16 immunohistochemistry or HPV DNA tests; with CDKN2A mutation; resectable LAHNSCC, staged III-IVB according to the UICC/AJCC 8th edition TNM system; an ECOG Performance Status score of 0 or 1; no prior relevant anti-tumor treatments; intent for curative treatment; and adequate organ function. Key exclusion criteria are active autoimmune diseases, use of immunosuppressive drugs, or systemic corticosteroids. Eligible patients receive 3 cycles of adebrelimab (1200 mg intravenously every 3 weeks, Day 1, 22 and 43) and 2 cycles of dalpiciclib (150 mg, po, every 4 weeks, day 1-21 and 29-49) before surgery. Dose adjustments are allowed based on toxicity. Surgery will follow 2-4 weeks post-NAI, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. The primary endpoints are 1-year disease-free survival (defined as the time from surgical resection to local recurrence) and major pathological response (MPR, defined as ≤10% residual viable tumor cells), with secondary endpoints focusing on safety and predictive biomarkers. Clinical trial information: NCT06199271 .
Preparation and Evaluation of Berberine-Excipient Complexes in Enhancing the Dissolution Rate of Berberine Incorporated into Pellet Formulations
Authors: Abbaspour Mohammadreza , Faeznia Faezeh , Zanjanian Parisa , Ruzbehi Milad , Shourgashti Kamran , Ziaee Amirhosseinn , Sardou Hossein Shahdadi , Nokhodchi Ali 
Published: July 2024

AbstractBerberine is used in the treatment of metabolic syndrome and its low solubility and very poor oral bioavailability of berberine was one of the primary hurdles for its market approval. This study aimed to improve the solubility and bioavailability of berberine by preparing pellet formulations containing drug-excipient complex (obtained by solid dispersion). Berberine-excipient solid dispersion complexes were obtained with different ratios by the solvent evaporation method. The maximum saturation solubility test was performed as a key factor for choosing the optimal complex for the drug-excipient. The properties of these complexes were investigated by FTIR, DSC, XRD and dissolution tests. The obtained pellets were evaluated and compared in terms of pelletization efficiency, particle size, mechanical strength, sphericity and drug release profile in simulated media of gastric and intestine. Solid-state analysis showed complex formation between the drug and excipients used in solid dispersion. The optimal berberine-phospholipid complex showed a 2-fold increase and the optimal berberine-gelucire and berberine-citric acid complexes showed more than a 3-fold increase in the solubility of berberine compared to pure berberine powder. The evaluation of pellets from each of the optimal complexes showed that the rate and amount of drug released from all pellet formulations in the simulated gastric medium were significantly lower than in the intestine medium. The results of this study showed that the use of berberine-citric acid or berberine-gelucire complex could be considered a promising technique to increase the saturation solubility and improve the release characteristics of berberine from the pellet formulation.
Graphical Abstract
The stationary Klein-Gordon equation with a delta-like source: A generalized function approach
Authors: Ferreira J. P. , Barone F. E. , Barone F. A. 
Published: July 2024

Abstract
This work aims to initiate a discussion on finding solutions to non-homogeneous differential equations in terms of generalized functions. For simplicity, we conduct the analysis within the specific context of the stationary Klein-Gordon equation with a point-like source, identifying a generalized function that solves such an equation and aligns with the solution obtained through the Fourier approach with dimensional regularization. In addition to being regular at the source singularity, a notable advantage of our solution is its presentation as a single expression, eliminating the need for piecewise definitions. The arguments presented here are applicable to a broader range of situations, offering a novel approach to addressing divergences in field theories using generalized functions. Moreover, we anticipate that the approach introduced in this work could provide a new method for handling Green functions regularized at coincident points, thereby simplifying the renormalization process in a wide range of theories.
Exploring the reciprocity between pioneer factors and development
Authors: Freund Meghan M. , Harrison Melissa M. , Torres-Zelada Eliana F. 
Published: July 2024

ABSTRACT
Development is regulated by coordinated changes in gene expression. Control of these changes in expression is largely governed by the binding of transcription factors to specific regulatory elements. However, the packaging of DNA into chromatin prevents the binding of many transcription factors. Pioneer factors overcome this barrier owing to unique properties that enable them to bind closed chromatin, promote accessibility and, in so doing, mediate binding of additional factors that activate gene expression. Because of these properties, pioneer factors act at the top of gene-regulatory networks and drive developmental transitions. Despite the ability to bind target motifs in closed chromatin, pioneer factors have cell type-specific chromatin occupancy and activity. Thus, developmental context clearly shapes pioneer-factor function. Here, we discuss this reciprocal interplay between pioneer factors and development: how pioneer factors control changes in cell fate and how cellular environment influences pioneer-factor binding and activity.
Factors influencing patient decision-making to undergo shoulder arthroplasty
Authors: Davies Andrew R. , Sabharwal Sanjeeve , Reilly Peter , Sankey R. A. , Griffiths Dylan , Archer Stephanie 
Published: July 2024

AimsShoulder arthroplasty is effective in the management of end-stage glenohumeral joint arthritis. However, it is major surgery and patients must balance multiple factors when considering the procedure. An understanding of patients’ decision-making processes may facilitate greater support of those considering shoulder arthroplasty and inform the outcomes of future research.MethodsParticipants were recruited from waiting lists of three consultant upper limb surgeons across two NHS hospitals. Semi-structured interviews were conducted with 12 participants who were awaiting elective shoulder arthroplasty. Transcribed interviews were analyzed using a grounded theory approach. Systematic coding was performed; initial codes were categorized and further developed into summary narratives through a process of discussion and refinement. Data collection and analyses continued until thematic saturation was reached.ResultsTwo overall categories emerged: the motivations to consider surgery, and the information participants used to inform their decision-making. Motivations were, broadly, the relief of pain and the opportunity to get on with life and regain independence. When participants’ symptoms and restrictions prevented them enjoying life to a sufficient extent, this provided the motivation to proceed with surgery. Younger participants tended to focus on maintaining employment and recreational activities, and older patients were eager to make the most of their remaining lifetime. Participants gathered information from a range of sources and were keen to optimize their recovery where possible. An important factor for participants was whether they trusted their surgeon and were prepared to delegate responsibility for elements of their care.ConclusionRelief of pain and the opportunity to get on with life were the primary reasons to undergo shoulder arthroplasty. Participants highlighted the importance of the patient-surgeon relationship and the need for accurate information in an accessible format which is relevant to people of different ages and functional demands.Cite this article: Bone Jt Open 2024;5(7):543–549.
Influence of Laminate Twist and Clamping Pressure on Bonding Performance of Low-Grade Lumber in Cross-Laminated Timber
Authors: Adeniran Abiola Teslim , Englund Karl , Li Hui , Silva do Carmo Dalisson Peterson 
Published: July 2024

Abstract
The geometric variations of low-grade lumber raise concerns about bond strength of cross-laminated timber (CLT) produced from such lumber. This study seeks to investigate the effect of low clamping pressure and geometric variations of laminates on the bond strength of CLT. CLT panels were manufactured from low-grade grand fir (Abies grandis). Block shear tests and cyclic delamination tests were conducted on specimens randomly taken at specific points that correspond to a wide range of twist magnitude. Twist distribution in the lumber used as laminates in the CLT ranges from 0 to 160 mm. Results showed that twist magnitude and clamping pressure have significant effect on bond performance, with twist magnitude having an overriding effect on pressure.
Healthcare experiences of pregnant and postnatal women and healthcare professionals when facing child protection in the perinatal period: A systematic review and Critical Interpretative Synthesis
Authors: Backer Kaat De , Rayment-Jones Hannah , Lever Taylor Billie , Bicknell-Morel Tamsin , Montgomery Elsa , Sandall Jane , Easter Abigail 
Published: July 2024

Background
The perinatal period is known as time of transition and anticipation. For women with social risk factors, child protection services may become involved during the perinatal period and this might complicate their interactions with healthcare providers.

Aim
To systematically review and synthesise the existing qualitative evidence of healthcare experiences of women and healthcare professionals during the perinatal period while facing child protection involvement.

Methods
A systematic search of databases (Web of Science, MEDLINE, EMBASE, PsychINFO, CINAHL, ASSIA, MIDIRS, Social Policy and Practice and Global Health) was carried out in January 2023, and updated in February 2024. Quality of studies was assessed using the Critical Appraisal Skills Programme. A Critical Interpretative Synthesis was used alongside the PRISMA reporting guideline.

Results
A total of 41 studies were included in this qualitative evidence synthesis. We identified three types of healthcare interactions: Relational care, Surveillance and Avoidance. Healthcare interactions can fluctuate between these types, and elements of different types can coexist simultaneously, indicating the complexity and reciprocal nature of healthcare interactions during the perinatal period when child protection processes are at play.

Conclusions
Our findings provide a novel interpretation of the reciprocal interactions in healthcare encounters when child protection agencies are involved. Trust and transparency are key to facilitate relational care. Secure and appropriate information-sharing between agencies and professionals is required to strengthen healthcare systems. Healthcare professionals should have access to relevant training and supervision in order to confidently yet sensitively safeguard women and babies, while upholding principles of trauma-informed care. In addition, systemic racism in child protection processes exacerbate healthcare inequalities and has to be urgently addressed. Providing a clear framework of mutual expectations between families and healthcare professionals can increase engagement, trust and accountability and advance equity.
Maternal excessive weight gain as a potential risk factor for prolonged labor in Japanese pregnant women: The Japan Environment and Children’s Study
Authors: Shinohara Satoshi , Horiuchi Sayaka , Kojima Reiji , Shinohara Ryoji , Otawa Sanae , Kushima Megumi , Miyake Kunio , Yui Hideki , Ooka Tadao , Akiyama Yuka , Yokomichi Hiroshi , Yamagata Zentaro ,   the Japan Environment and Children’s Study Group
Published: July 2024

Aim
This study aimed to determine whether excessive maternal weight gain during pregnancy was associated with a higher risk of prolonged labor.

Methods
We analyzed the data regarding maternal weight gain during pregnancy for the participants of Japan Environment and Children’s Study (JECS), which is an ongoing nationwide prospective birth cohort study in Japan. After excluding participants with multiple pregnancies, with deliveries before 37 or beyond 42 weeks of gestation, or who had undergone cesarean section, 71,154 (nulliparous, n = 28,442) Japanese women were included. Prolonged labor was defined by a cutoff ranking at the 95th percentile and consequently defined as labor duration exceeding 12.7 h in multiparous women and exceeding 23.2 h in nulliparous women. These classifications were made according to labor curves established by the Japanese Society of Obstetrics and Gynecology Perinatal Committee developed in June 2021. Considering that no studies have conducted an investigation based on this new guideline, we analyzed the association between excessive maternal weight gain during pregnancy and prolonged labor by parity.

Results
The overall incidence of prolonged labor was 10.2% (2,907/28,442) in nulliparous women and 6.1% (2,597/42,712) in multiparous women. Multivariable analysis indicated that excessive maternal weight gain was significantly associated with prolonged labor in nulliparous (adjusted odds ratio, 1.21; 95% confidence interval, 1.10–1.32) and multiparous women (adjusted odds ratio, 1.15; 95% confidence interval, 1.05–1.27). Kaplan–Meier survival analysis showed that as labor progressed, the percentage of women who had not yet delivered was higher among those with excessive maternal weight gain than among those with normal maternal weight gain in both the nulliparous (median labor duration 12.9 h vs 12.2 h, p<0.001) and multiparous (median labor duration 6.2 h vs 5.8 h, p<0.001) groups.

Conclusion
Excessive maternal weight gain was significantly associated with prolonged labor in Japanese women.
Targeted psychological and psychosocial interventions for auditory hallucinations in persons with psychotic disorders: Protocol for a systematic review and meta-analysis
Authors: Fässler Laura , Bighelli Irene , Leucht Stefan , Sabé Michel , Bajbouj Malek , Knaevelsrud Christine , Böge Kerem 
Published: July 2024

Background
In recent years, a growing body of evidence has demonstrated the efficacy of non-pharmacological interventions for schizophrenia spectrum disorders (SSD) including positive symptoms such as auditory hallucinations (AH). However, clinical trials predominantly examine general treatment effects for positive symptoms. Therefore, previous research is lacking in comprehensive and clear evidence about psychological and psychosocial approaches that are primarily tailored to treat AH. To overcome this knowledge gap in the current literature, we will conduct a systematic review and meta-analysis to assess the efficacy of clearly targeted psychological and psychosocial interventions for AH in persons with SSD.

Methods and analysis
This study protocol has been developed according to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. We will include all randomized controlled trials analyzing the efficacy of targeted psychological and psychosocial interventions especially aimed at treating AH in SSD. We will include studies on adult patients with SSD experiencing AH. The primary outcome will be the change on a published rating scale measuring AH. Secondary outcomes will be delusions, overall symptoms, negative symptoms, depression, social functioning, quality of life, and acceptability (drop-out). We will search relevant databases and the reference lists of included literature. The study selection process will be conducted by two independent reviewers. We will conduct a random-effect meta-analysis to consider heterogeneity across studies. Analyses will be carried out by software packages in R. The risk of bias in each study will be evaluated using the Cochrane Risk of Bias tool. Assessment of heterogeneity and sensitivity analysis will be conducted.

Discussion
The proposed study will augment the existing evidence by providing an overview of effective treatment approaches and their overall efficacy at treating AH in SSD. These findings will complement existing evidence that may impact future treatment implementations in clinical practice by addressing effective strategies to treat AH and therefore improve outcomes for the addressed population.

Ethics and dissemination
No ethical issues are foreseen. We will publish the results from this study in peer-reviewed journals and at relevant scientific conferences.

Trial registration
PROSPERO registration number: CRD42023475704.
Is yearly interferon gamma release assay latent tuberculosis infection screening warranted among patients with rheumatological diseases on disease-modifying drugs in non-endemic settings?
Authors: Palacios Carlo Foppiano , Chowdhary Vaidehi , Hao Ritche , Danve Abhijeet , Malinis Maricar 
Published: July 2024

Objective
Patients living with rheumatologic diseases on disease-modifying antirheumatic drugs (DMARD) are at an increased risk of developing tuberculosis (TB). Current guidelines recommend screening for latent tuberculosis infection (LTBI) before initiating DMARD. However, data is lacking on the value of yearly screening for LTBI.

Methods
A retrospective chart review was conducted on adult patients (≥ 18 years) with rheumatologic disease on DMARD followed longitudinally in the outpatient rheumatology clinics between 2017–2021. Collected data included patient demographics, rheumatologic diagnosis, medications, TB-related risk factors, interferon gamma release assay (IGRA) results, LTBI diagnosis and treatment. Descriptive statistics were performed.

Results
Among 339 patients, 81 (23.9%) were male, 259 (76.4%) were white, and 93 (27.5%) were Latinx. Inflammatory arthritis (84.1%) was the most common rheumatic diagnosis. Common DMARD were JAK inhibitors (19.2%), TNF-alpha inhibitors (18.9%), and IL-17 A inhibitors (18.0%). Only 2 patients at baseline had positive IGRA, and both had a history of treated LTBI. Positive IGRA tests were recorded in 1 (0.7%), 3 (1.8%), 3 (1.3%), and 3 (1.1%) in the years 2018, 2019, 2020, and 2021, respectively. Four patients converted from negative to positive during serial yearly IGRA testing. After reviewing the IGRA test and TB risk factors, only one patient was considered newly diagnosed with LTBI, requiring 4 months of rifampin.

Conclusion
In a non-endemic area, serial IGRA testing of low-risk patients on DMARD yielded very low rate of newly diagnosed LTBI. A targeted LTBI screening based on TB-related risk factors should be performed prior to IGRA testing rather than universal yearly screening in a non-endemic setting.
Sprawozdanie z Międzynarodowej konferencji naukowej „«Niemand darf in Sklaverei oder Leibeigenschaft gehalten werden». Freiheit und Unfreiheit in Mitteleuropa (vom Frühmittelalter bis 1989)” Würzburg, 28–29 września 2023 r.
Authors: Baranowska Marta , Fiktus Paweł 
Published: July 2024

Sprawozdanie z Międzynarodowej konferencji naukowej „«Niemand darf in Sklaverei oder Leibeigenschaft gehalten werden». Freiheit und Unfreiheit in Mitteleuropa (vom Frühmittelalter bis 1989)” [„«Nikt nie może być trzymany w niewoli lub poddaństwie». Wolność i niewola w Europie Środkowej (od wczesnego średniowiecza do 1989 roku)”], Würzburg, 28–29 września 2023 r.
Amylase and lipase levels in the metabolic syndrome and type 2 diabetes: A longitudinal study in rhesus monkeys
Authors: Chaudhari Uddhav K. , Hansen Barbara C. 
Published: July 2024

AbstractLatent associations between low serum amylase and reduced plasma insulin levels and increased adiposity have been described previously in a small study of asymptomatic middle‐aged humans. In the present study, we sought to determine the nature of such changes during the longitudinal progression from metabolically normal to overt type 2 diabetes mellitus (T2DM) in nonhuman primates (NHPs), a disease that appears to be the same in both pathophysiology and underlying mechanisms as that which most commonly develops in middle‐aged adult humans. Amylase and lipase levels were characterized in 157 unrelated adult rhesus monkeys (Macaca mulatta); 38% developed T2DM while under study. In all monkeys, multivariable linear regression analysis revealed that amylase could be negatively predicted by % body fat (β −0.29; p = 0.002), age (β −0.27; p = 0.005), and HbA1c (β −0.18; p = 0.037). Amylase levels were positively predicted by lipase levels (β = 0.19; p = −0.024) in all NHPs included in the study. Amylase was significantly lower in NHPs with metabolic syndrome (p < 0.001), prediabetes (PreDM) (p < 0.001), and T2DM (p < 0.001) compared to metabolically normal adult NHPs. Lipase increased in NHPs with PreDM (p = 0.005) and T2DM (p = 0.04) compared to normal NHPs. This is the first longitudinal study of any species, including humans, to show the dynamics of amylase and lipase during the metabolic progression from normal to metabolic syndrome, to PreDM and then to overt T2DM. The extraordinary similarity between humans and monkeys in T2DM, in pancreatic pathophysiology and in metabolic functions give these findings high translational value.