bluuebunny/crossref_metadata_2025_split huggingface dataset:
A PHASE II OPEN LABEL STUDY OF NEIHULIZUMAB, AN ANTI-CD162 (PSGL-1) ANTIBODY, IN PATIENTS WITH MODERATE TO SEVERE ACTIVE, ANTI-TNFα AND/OR ANTI-INTEGRIN REFRACTORY ULCERATIVE COLITIS
Authors: Rubin David , Lee Scott D , Flores Lucky , Albizu-Angulo Gustavo , Scherl Ellen , Saini Surinder , Cho Iming , Lin Shih-Yao , Reed Simona , Hall Jesse 
Published: January 2023

Abstract

BACKGROUND
Neihulizumab (ALTB-168) is a novel immune checkpoint agonistic antibody that binds to human CD162 (PSGL-1), and leads to downregulation of activated T-cells. Early-phase trials of neihulizumab have suggested a benefit in patients with immune conditions, including psoriasis, psoriatic arthritis and steroid-refractory acute graft-versus-host disease. Here, we report the results of a Phase II study investigating the use of neihulizumab for ulcerative colitis (UC) (ClinicalTrials.gov Identifier: NCT03298022).

AIMS
The aims of this study were to evaluate efficacy, safety, tolerability and immunogenicity of neihulizumab in patients with moderate to severe active UC who are refractory or intolerant to anti-TNFα and/or anti-integrin therapy.

METHODS
Two regimens were tested: 5 weekly IV doses plus 3 bi-weekly IV doses of 9 mg/kg neihulizumab (5 + 3 regimen), and 8 weekly IV doses plus 2 bi-weekly IV doses of 9 mg/kg neihulizumab (8 + 2 regimen). The primary efficacy outcome is the proportion of patients with clinical response at Week 12. The key secondary efficacy outcomes are the proportion of patients with clinical remission, mucosa healing, histological healing and the change in Inflammatory Bowel Disease Questionnaire (IBDQ).

RESULTS
24 subjects enrolled in this study; study demographics and baseline disease characteristics are shown in Table 1.

In the 5 + 3 regimen, 10 subjects were enrolled into this study and 2 (20%) subjects completed the study. The mean duration of study treatment exposure was 59.5 days. Among 10 enrolled subjects, 9 subjects were included in the efficacy analysis: 2 (22%) subjects achieved clinical response at Week 12 and 1 (11%) subject achieved clinical response at Week 2. The overall efficacy is summarized in Table 2. In this regimen, 9/10 (90%) subjects reported an AE: 7 (70%) subjects with AEs related to study treatment, 9 (90%) subjects with AEs that were not related to study treatment, 1 (10%) subject with an SAE not related to study treatment, and no deaths were reported in this regimen.

In the 8 + 2 regimen, 14 subjects were enrolled into this study and 9 (64%) subjects completed the study. The mean duration of study treatment exposure was 78.1 days. Among 14 enrolled subjects, 7 (50%) subjects achieved clinical response at Week 12 and 5 (36%) subjects achieved clinical response at Week 26 (Table 2). In this regimen, 13/14 (93%) of subjects reported an AE: 2 (14%) subjects with AEs related to study treatment and 12 (86%) subjects with AEs that were not related to study treatment; there was no SAE reported and no deaths.

CONCLUSIONS
This phase 2 study of neihulizumab suggest efficacy and safety signals in treatment-refractory UC that warrant further investigation.
Justifying the Protection of Legitimate Expectations in International Investment Law: Legal Certainty and Arbitrary Conduct
Authors: Henckels Caroline 
Published: January 2023

Abstract
This article argues that legal certainty provides the most compelling justification for recognizing legitimate expectations in international investment law, and that the prohibition on arbitrary conduct provides the most persuasive reason for their protection. After considering other rationales for recognizing legitimate expectations, the article analyses the types of government action typically arising in investment cases through the lens of legal certainty, arguing that the strength of the claim for recognizing legitimate expectations depends on the government conduct at issue, with interference with legal rights or formal decisions generating the strongest claim for recognition, and changes to laws generating the weakest claim. The article discusses the prohibition on arbitrary conduct as the relevant touchstone for protecting legitimate expectations, demonstrates that this interpretation accords with recent treaty innovations, and explains how the expected degree of legal certainty correlates with the risk of arbitrariness in relation to different types of government conduct.
Does thoracoscopic basal pyramid segmentectomy really offer functional advantages in comparison with thoracoscopic lower lobectomy?
Authors: Bongiolatti Stefano , Salvicchi Alberto , Mugnaini Giovanni , Vokrri Eduart , Viggiano Domenico , Gonfiotti Alessandro , Lavorini Federico , Voltolini Luca 
Published: January 2023

AbstractOBJECTIVESThe functional impact of thoracoscopic basal segmentectomy in comparison with lower lobectomy has not been investigated in-depth and the aim of this study was to clarify this topic.METHODSWe retrospectively analysed a cohort of patients who underwent surgery between 2015 and 2019 for non-small-cell lung cancer, peripherally located lung nodules, far enough from both the apical segment and the lobar hilum to allow an oncologically safe thoracoscopic lower lobectomy or basal segmentectomy. Pulmonary function tests (PFTs) including spirometry and plethysmography were performed 1 month after surgery and forced expiratory volume in 1 s, forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO) were collected; the difference, the loss and the recovery rate of pulmonary function were calculated and compared with the Wilcoxon–Mann–Whitney test.RESULTSDuring the study period, n = 45 and n = 16 patients for video-assisted thoracoscopic surgery (VATS) lower lobectomy and for VATS basal segmentectomy, respectively, completed the study protocol: the 2 groups were homogeneous as to preoperative variables and PFT values. Postoperative outcomes were similar and PFTs revealed significant differences between postoperative forced expiratory volume in 1 s %, FVC%, ΔFVC and ΔFVC%. The loss percentage of FVC%, DLCO% and the recovery rate was better for FVC and DLCO in the VATS basal segmentectomy group.CONCLUSIONSThoracoscopic basal segmentectomy seems to be associated with a more preserved lung function, maintaining more FVC and DLCO levels than lower lobectomy, and could be performed in selected cases ensuring also adequate oncological margins.
Characterization and analysis of fish waste as feedstock for biogas production
Authors: Ingabire Hortence , Ntambara Boniface , Mazimpaka Ezgad 
Published: January 2023

Abstract
Fish waste (FW) is biodegradable waste that remains underutilized and causes a problem to the environment since the existing disposal techniques result in health risks and environmental pollution. FW has significant potential for producing biogas that decreases the reliance on fossil fuels because it contains easily biodegradable organic matter. The physicochemical analysis of the FW such as moisture content of 61.78%, volatile solids (VS) of 93.94%, total solids of 38.21%, ash content (AC) of 0.52%, total organic carbon of 54.2%, total Kjeldahl nitrogen of 9.2% and carbon to nitrogen (C/N) ratio of 5.89% were considered and analyzed in this research. In addition, the methane potential was determined and obtained using gas detector. The results shown that the methane (CH4) content in FW was 50.12%, which was the potential feedstock of FW for biogas production. Nevertheless, the VS of FW was high, which was good for this feedstock to be easily digested as the sign of producing biogas and demonstrates 99.9985% of performance rate. Finally, the FW had a lower C/N ratio compared with other biogas production waste. Future work needs to consider co-digestion with higher C/N ratio feedstocks.
Teaching cultural competence to undergraduate pharmacy students using vignettes (case scenarios) as an innovative teaching intervention
Authors: Nkhoma Gloria , Lim Chiao Xin , Kennedy Gerard A , Stupans Ieva 
Published: January 2023

AbstractObjectiveCultural competence is instrumental in reducing health equities. Addressing cultural competence at higher education level in healthcare students lays a solid cultural competence foundation for professional practice. The use of vignettes as a teaching intervention was effective because it allowed the use of role-modelling in real-life situations.The study aimed to enhance cultural competence in undergraduate pharmacy students using a self-directed online interactive cultural competence module embedded with three vignettes (case scenarios).MethodThis study was an exploratory longitudinal mixed method (survey and written feedback) study and used a convenience sample of 90 pharmacy students at an Australian University. Students’ self-perceived transcultural self-efficacy was evaluated pre- and post-intervention using Jeffreys’ Transcultural Self-Efficacy Tool (TSET) which is a validated outcome measure.Key findingsVignettes were effective in teaching cultural competence as shown by significant (P &lt; 0.0005) changes pre- to post-intervention in cognitive, practical and affective domains scores using TSET. The affective domain had the least positive mean score change. There was no significant association between any of the demographic factors such as age, gender or birthplace/parents’ birthplace and changes in any of the three domains. Cronbach’s alpha of &gt;0.90 in all domains confirmed the test’s internal consistency and reliability.ConclusionsThe findings were indicative of the students’ positive receptivity to learning cultural competence and that they had a well-developed understanding of cultural competence. Further research is needed to determine why most cultural competence teaching methods produce little or no meaningful change in enhancing the affective domain.
Tautological classes on low-degree Hurwitz spaces
Authors: Canning Samir , Larson Hannah 
Published: January 2023

Abstract
Let ${\mathcal {H}}_{k,g}$ be the Hurwitz stack parametrizing degree $k$, genus $g$ covers of ${\mathbb {P}}^{1}$. We define the tautological ring of ${\mathcal {H}}_{k,g}$ and we show that all Chow classes, except possibly those supported on the locus of “factoring covers,” are tautological up to codimension roughly $g/k$ when $k \leq 5$. The set-up developed here is also used in our subsequent work [6], wherein we prove new results about the structure of the Chow ring for $k \leq 5$.
In vitroactivity of isavuconazole against clinically relevantTrichosporonspecies: a comparative evaluation of EUCAST broth microdilution and MIC Test Strip methods
Authors: Francisco Elaine Cristina , Dieleman Chendo , Hagen Ferry , Colombo Arnaldo Lopes ,   Trichosporon Brazilian Network, Chaves Guilherme M , Mendes Ana Verena A , de Oliveira Silva Marcio , de Andrade Barberino Maria Goreth , Neves Rejane Pereira , Botura Monica Borges , Hahn Rosane C , de Almeida Junior João Nóbrega , Ponzio Vinicius , de Tarso O e Castro Paulo , Guimarães Thais , Santos Daniel Wagner , de Miranda Bianca Grassi , Silva Ivan Leonardo A França E , Carlesse Fabianne , Ramos Jéssica Fernandes , Queiroz-Telles Flávio , Aquino Valério Rodrigues , Motta Fabio Araújo , Schwarzbold Alexandre Vargas , Perozin Jamile Sardi 
Published: January 2023

AbstractObjectivesTo evaluate the in vitro activity of isavuconazole on 154 clinical and reference strains of Trichosporon asahii, Trichosporon asteroides, Trichosporon coremiiforme, Trichosporon faecale and Trichosporon inkin by using the EUCAST broth microdilution method (BMD) and Liofilchem MIC Test Strips (MTS).MethodsAntifungal susceptibility testing for isavuconazole, fluconazole, voriconazole and posaconazole was assessed by EUCAST E.DEF 7.3.2. MIC values of isavuconazole obtained by BMD after 48 h of incubation were compared with MTS MICs after 24 and 48 h of incubation.ResultsT. asahii and T. asteroides showed the highest isavuconazole MIC90 values (0.5 mg/L). In clinical isolates, T. asahii exhibited the highest MIC90 values (0.5 mg/L) compared with non-T. asahii (0.06–0.25 mg/L). The five non-WT T. asahii isolates for fluconazole, voriconazole and posaconazole also exhibited high MICs of isavuconazole (≥0.5 mg/L). A better correlation between MTS and BMD MICs was observed after 24 h incubation for all species tested. MTS measurements performed at 48 h increased by at least 122% the number of isolates with &gt;2 dilutions compared with the standard method.ConclusionsIsavuconazole exhibited variable in vitro activity among the Trichosporon species tested, showing higher or equal MICs than the other azoles. The five non-WT T. asahii clinical isolates tested also exhibited high isavuconazole MICs, suggesting the occurrence of triazole cross-resistance. Our MTS data indicate that there is no advantage in extended reading time for MTS from 24 to 48 h for Trichosporon yeasts.
Exploration of plasma metabolite levels in healthy nursery pigs in response to environmental enrichment and disease resilience
Authors: Dervishi Elda , Bai Xuechun , Cheng Jian , Fortin Frederic , Dyck Mike K , Harding John C S , Seddon Yolande M , Dekkers Jack C M , Canada PigGen , Plastow Graham 
Published: January 2023

AbstractThe purpose of this study was to explore plasma metabolite levels in young healthy pigs and their potential association with disease resilience and estimate genetic and phenotypic correlation with the change in lymphocyte concentration following disease challenge. Plasma samples were collected from 968 healthy nursery pigs over 15 batches at an average of 28 ± 3.23 d of age. Forty-four metabolites were identified and quantified by nuclear magnetic resonance. Pigs were then introduced into a natural disease challenge barn, and were classified into four groups based on the growth rate of each animal in the grow-to-finish phase (GFGR) and treatment rate (TR): resilient (RES), average (MID), susceptible (SUS), and dead (pigs that died before harvest). Blood samples were collected from all pigs before and 2 wk after disease challenge and complete blood count was determined. Environmental enrichment (inedible point source objects) was provided for half of the pigs in seven batches (N = 205) to evaluate its impact on resilience and metabolite concentrations. Concentration of all metabolites was affected by batch, while entry age affected the concentration of 16 metabolites. The concentration of creatinine was significantly lower for pigs classified as “dead” and “susceptible” when compared to “average” (P &lt; 0.05). Pigs that received enrichment had significantly lower concentrations of six metabolites compared with pigs that did not receive enrichment (P ≤ 0.05). Both, group classification and enrichment affected metabolites that are involved in the same pathways of valine, leucine, and isoleucine biosynthesis and degradation. Resilient pigs had higher increase in lymphocyte concentration after disease challenge. The concentration of plasma l-α-aminobutyric acid was significantly negatively genetically correlated with the change in lymphocyte concentration following challenge. In conclusion, creatinine concentration in healthy nursery pigs was lower in pigs classified as susceptible or dead after disease challenge, whilst l-α-aminobutyric may be a genetic biomarker of lymphocyte response after pathogen exposure, and both deserve further investigation. Batch, entry age, and environmental enrichment were important factors affecting the concentration of metabolites and should be taken into consideration in future studies.
Post-operative progress of arm abduction function and rate of lymph node metastasis around the region of the accessory nerve: a multicentre prospective observational study
Authors: Tomioka Toshifumi , Beppu Takeshi , Onitsuka Tetsuro , Fujimoto Yasushi , Kawabata Kazuyoshi , Matsuura Kazuto , Fujii Takashi , Hayashi Ryuichi , Asakage Takahiro 
Published: January 2023

AbstractObjectiveAlthough neck dissection is an essential technique in the surgical treatment of head and neck carcinoma, arm abduction disorders occurring after neck dissection reduce the patient’s quality of life.MethodsWe prospectively evaluated the rate of lymph node metastasis in Levels IIB and V in head and neck cancer patients who underwent neck dissection at eight centres in Japan. In addition, post-operative arm abduction disability was classified according to functional assessment values at 1 month post-operatively, and the rate of maintained function at 6 and 12 months was evaluated.ResultsLymph node metastasis occurred in Level IIB in 12 of 242 cases (4.9%) and in Level V in 5 cases (2.1%) during the 12-month post-operative course. In patients with preservation of the ipsilateral accessory nerve, arm abduction function was maintained in 142 of 209 patients (67.9%) at 12 months after surgery. Post-operative radiotherapy and Level V dissection had no statistically significant effect on the recovery of arm abduction function. Level V dissection caused a temporary loss of abduction function post-operatively. A higher arm abduction test score at 1 month post-operatively was associated with a higher rate of subsequent ability to maintain arm abduction function.ConclusionsIn patients classified as cN0, metastatic rate at Levels IIB and V was low. In this cohort, omitting Level V dissection may be an option in strategies aimed at maintaining arm abduction function.
Patient-reported outcome and quality of life research policy: Japan Clinical Oncology Group (JCOG) policy
Authors: Ishiki Hiroto , Kikawa Yuichiro , Terada Mitsumi , Mizusawa Junki , Honda Michitaka , Iwatani Tsuguo , Mizutani Tomonori , Mori Keita , Nakamura Naoki , Miyaji Tempei , Yamaguchi Takuhiro , Ando Masahiko , Nakamura Kenichi , Fukuda Haruhiko , Kiyota Naomi ,   PRO/QOL research Committee of Japan Clinical Oncology Group
Published: January 2023

AbstractAssessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials.The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials.The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.
The aid of microsurgical instruments in nasolabial cyst enucleation. A report of two cases with critical review of the therapeutic approach
Authors: Tilaveridis Ioannis , Venetis Gregory , Tatsis Dimitris , Kalaitsidou Ioanna , Zouloumis Lambros 
Published: January 2023

Abstract
Nasolabial cysts are rare non-odontogenic cysts related to epithelial remnants of the nasolacrimal duct, slowly enlarging and provoking extraoral swelling in the nasolabial fold with obstruction of the naris. Two patients of large unilateral nasolabial cysts are reported, appearing as cosmetically unappealing distention of the nasolabial fold. Diagnosis is based on clinical characteristics. Computed tomography imaging reveals the dimensions of the cyst, the correlation to the nasal cavity and might depict a depression on the labial surface of the maxilla. Intraoral surgical enucleation of the cystic wall or nasal marsupialization is the main treatment modalities. However, both procedures are related to a small percentage of recurrence. Microsurgical instruments were used to dissect the cystic wall from the nasal mucosa. The aim of this paper is to stress the implementation of microsurgical instruments to separate the cystic wall of the nasolabial cyst from the thin and friable nasal mucosa to avoid recurrence.
Duplicated inferior vena cava-trifurcated portal vein: a rare anatomical variation encountered during Whipple procedure
Authors: Chrysikos Dimosthenis , Delis Spiros , Smerdi Dimitra , Charitaki Eugenia , Solia Eirini , Troupis Theodore 
Published: January 2023

Abstract
The inferior vena cava (IVC) is the largest single vein in humans. However, during embryogenesis, abnormalities can occur resulting in a duplicated IVC. The portal vein (PV) offers the main blood flood to the liver, forming by the left and right PV. A number of anatomical variations are noticed, underlying the great importance of the pre-operative imaging workup. This case report presents a duplicated IVC and a trifucated PV that were incidentally found in an 82 year-old Caucasian male with pancreatic ductal adenocarcinoma who underwent pancreatoduodenectomy (Whipple procedure). Although some anatomical variations, including the duplication of the IVC and the trifurcation of PV, may be rare to the general population, the suspicion of their existence should always be taken under consideration from surgeons during hepatobiliary or retroperitoneal operations.
Culturally Responsive School-Based Practices
Authors: Goforth Anisa N. , Pham Andy V. 
Published: January 2023

Abstract
As the trends continue in our country’s schools toward a more racially, ethnically, and linguistically diverse K–12 student population, school-based professionals have an important role in supporting students’ mental health and learning. Practitioners, including school psychologists, school counselors, and social workers, are expected to have the knowledge, skills, and dispositions to provide culturally responsive services to promote safe, supportive, and inclusive schools. Using a framework that integrates cultural humility and social justice, this book provides practical strategies for implementing culturally responsive practices in assessment and interventions that recognize assets of culturally and linguistically diverse populations, including refugee, immigrant, racial, and ethnic-minoritized students and English-language learners. The book emphasizes positive psychology and collaborative approaches that minimize the use of deficit thinking, which historically has contributed to systemic inequities, oppression, and disproportionalities of student outcomes in schools. For the emerging and experienced professional, this book is organized into three parts: (1) the foundations of culturally responsive practice, (2) culturally responsive assessment, and (3) culturally responsive interventions to support resilience and well-being. It provides foundational knowledge and practical strategies for educators, trainers, and practitioners who deliver educational and mental health supports in schools, including culturally responsive assessment, evidence-based interventions, counseling, or multi-tiered systems of support. Given the increasing diversity of students and families, the book highlights the intersectionality and heterogeneity within these groups. With case examples, practical resources, opportunities for self-reflection or critical reflexivity, and discussion questions, readers can develop and demonstrate cultural humility, cultural responsiveness, and advocacy within educational settings.