bluuebunny/crossref_metadata_2025_split huggingface dataset:
Near Infrared Spectroscopy: Cerebral and Splanchnic Regional Saturation in Healthy Indian Neonates During the First Hour of Life
Authors: Palanisamy Ashwin Sangamesh , Venkatachalam Suresh Dhanam , Soundararajan Deepika , Viswanathan Suresh , Ramakrishnan Santhanakrishnan 
Published: October 2024

Background Near infrared spectroscopy (NIRS) measures regional tissue oxygen saturation (rSO2) and is used in Western neonatal intensive care units (ICUs) to monitor early organ dysfunction, but its effectiveness on Indian neonates is not well documented. Objectives We evaluated cerebral, splanchnic regional oxygen saturation (CrSO2 and SrSO2) and fractional tissue oxygen extraction (FTOE) in healthy Indian neonates using an U.S. Food and Drug Administration (FDA)-approved NIRS device. Study Design A prospective observational study. Participants Healthy neonates above 34 weeks gestation born at private tertiary hospital were studied. The study excluded babies with congenital anomalies, low APGAR scores, and babies requiring respiratory support. Intervention An INVOSTM 5100 C Regional Oximeter with two sensors were attached to the baby’s forehead and infraumbilical area for an hour following the initial transition period of the first ten minutes of life. Results Mean CrSO2 was significantly higher than SrSO2 by 10.87, p < 0.0001. Late preterm and low birth weight babies had higher CrSO2, while late preterm infants had lower SrSO2 than term infants. There was no significant SrSO2 difference based on weight. Regional saturations and calculated FTOE’s at 15, 30, 45, and 60 minutes were reported. Outcomes Findings indicate similar rSO2 and FTOE ranges as described in literature. Conclusion CrSO2 was higher than SrSO2, with notable differences among late preterm and lower-weight infants compared to term infants. Larger studies involving Indian neonates are warranted.
A Comparative Effectiveness Study of Speech and Surgical Outcomes: Study Overview
Authors: Chapman Kathy L. , Sitzman Thomas , Baylis Adriane , Hardin-Jones Mary , Kirschner Richard , Temkit M'hamed (Hamy) ,   on behalf of the Cleft Outcomes Research NETwork (CORNET) Consortium
Published: October 2024

Aims To provide an overview of the Cleft Outcomes Research NETwork (CORNET) and the CORNET Speech and Surgery study. The study is (1) comparing speech outcomes and fistula rate between two common palate repair techniques, straight-line closure with intra-velar veloplasty (IVVP) and Furlow Double-Opposing Z-palatoplasty (Furlow Z-plasty); (2) summarizing practice variation in the utilization of early intervention speech-language (EI-SL) services; and (3) exploring the association between EI-SL services and speech outcomes. Design Prospective, longitudinal, observational, comparative effectiveness, multi-center. Sites Twenty sites across the United States. Participants One thousand two hundred forty-seven children with cleft palate with or without cleft lip (CP ± L). Children with submucous cleft palate or bilateral sensorineural severe to profound hearing loss were excluded from participation. Interventions Straight-line closure with IVVP or Furlow Z-plasty based on each surgeon's standard clinical protocol. Main Outcome Measure(s) The primary study outcome is perceptual ratings of hypernasality judged from speech samples collected at 3 years of age. Secondary outcomes are fistula rate, measures of speech production, and quality of life. The statistical analyses will include generalized estimating equations with propensity score weighting to address potential confounders. Current Progress Recruitment was completed in February 2023; 80% of children have been retained to date. Five hundred sixty two children have completed their final 3-year speech assessment. Final study activities will end in early 2025. Conclusions This study addresses long-standing questions related to the effectiveness of the two most common palatoplasty approaches and describes CORNET which provides an infrastructure that will streamline future studies in all areas of cleft care.
Recurrent, multisystem angioedema induced by 5-azacitidine
Authors: Alchaikh Hassan Ruba , Salmasi Shiva , Ghafarzadeh Zahra , Dasanu Constantin A. 
Published: October 2024

Introduction 5-azacitidine is a hypomethylating agent (HMA) used for treating myelodysplastic syndrome (MDS) and certain myeloproliferative neoplasms (MPNs). Common side effects include myelosuppression, nausea and injection site reactions. Serious allergic reactions are rare with this class of agents. Case Report We describe a 71-year-old man with MDS/MPN who developed repeated episodes of angioedema after starting treatment with subcutaneous 5-azacitidine. Angioedema involved multiple body areas including the neck, genitalia, lower back and gastrointestinal system. Causality assessment linked this entity to 5-azacitidine via the Naranjo nomogram questionnaire, by scoring 9. Management and Outcome 5-azacitidine was discontinued due to recurrent episodes of angioedema that occurred even after dose reduction. Steroids were helpful in terms of reversing this reaction. Afterwards, no further episodes of angioedema have been documented. The patient's thrombocytosis is currently well-controlled with low dose hydroxyurea. Discussion/Conclusion We report herein a unique case of recurrent, multisystem angioedema likely related to 5-azacitidine. The exact mechanism of azacitidine-induced angioedema is not currently known. Symptoms, clinical findings and timing of presentation are not always clear-cut, and it may take more than one cycle of 5-azacitidine before the diagnosis is made. Supportive and symptomatic treatment will be provided based on the severity of the reaction. Future studies may offer more insights into the mechanism underlying this rare and serious, yet intriguing side effect.
Biomarkers From Discovery to Clinical Application: In Silico Pre-Clinical Validation Approach in the Face of Lung Cancer
Authors: Kori Medi , Gov Esra , Arga Kazim Yalcin , Sinha Raghu 
Published: October 2024

Background: Clinical biomarkers, allow better classification of patients according to their disease risk, prognosis, and/or response to treatment. Although affordable omics-based approaches have paved the way for quicker identification of putative biomarkers, validation of biomarkers is necessary for translation of discoveries into clinical application. Objective: Accordingly, in this study, we emphasize the potential of in silico approaches and have proposed and applied 3 novel sequential in silico pre-clinical validation steps to better identify the biomarkers that are truly desirable for clinical investment. Design: As protein biomarkers are becoming increasingly important in the clinic alongside other molecular biomarkers and lung cancer is the most common cause of cancer-related deaths, we used protein biomarkers for lung cancer as an illustrative example to apply our in silico pre-clinical validation approach. Methods: We collected the reported protein biomarkers for 3 cases (lung adenocarcinoma-LUAD, squamous cell carcinoma-LUSC, and unspecified lung cancer) and evaluated whether the protein biomarkers have cancer altering properties (i.e., act as tumor suppressors or oncoproteins and represent cancer hallmarks), are expressed in body fluids, and can be targeted by FDA-approved drugs. Results: We collected 3008 protein biomarkers for lung cancer, 1189 for LUAD, and 182 for LUSC. Of these protein biomarkers for lung cancer, LUAD, and LUSC, only 28, 25, and 6 protein biomarkers passed the 3 in silico pre-clinical validation steps examined, and of these, only 5 and 2 biomarkers were specific for lung cancer and LUAD, respectively. Conclusion: In this study, we applied our in silico pre-clinical validation approach the protein biomarkers for lung cancer cases. However, this approach can be applied and adapted to all cancer biomarkers. We believe that this approach will greatly facilitate the transition of cancer biomarkers into the clinical phase and offers great potential for future biomarker research.
Development and Validation of an Automatic Computerized Neurocognitive Battery in Chinese
Authors: Zhang Ji , Hong Ze-yu , Yang Liu , Li Xiao-Jia , Ye Fang 
Published: October 2024

Objectives Neuropsychological test batteries, which accurately and comprehensively assess cognitive functions, are a crucial approach in the early detection of and interventions for cognitive impairments. However, these tests have yet to gain wide clinical application in China owing to their complexity and time-consuming nature. This study aimed to develop the Computerized Neurocognitive Battery for Chinese-Speaking participants (CNBC), an autorun and autoscoring cognitive assessment tool to provide efficient and accurate cognitive evaluations for Chinese-Speaking individuals. Methods The CNBC was developed through collaboration between clinical neurologists and software engineers. Qualified volunteers were recruited to complete CNBC and traditional neurocognitive batteries. The reliability and validity of the CNBC were evaluated by analyzing the correlations between the measurements obtained from the computerized and the paper-based assessment and those between software-based scoring and manual scoring. Results The CNBC included 4 subtests and an autorun version. Eighty-six volunteers aged 51-82 years with 7-22 years of education were included. Significant correlations (0.256-0.666) were observed between paired measures associated with attention, executive function, and episodic memory from the CNBC and the traditional paper-based neurocognitive batteries. This suggests a strong construct validity of the CNBC in assessing these cognitive domains. Furthermore, the correlation coefficients between manual scoring and system scoring ranged from 0.904-1.0, indicating excellent inter-rater reliability for the CNBC. Interpretation A novel CNBC equipped with automated testing and scoring features was developed in this study. The preliminary results confirm its strong reliability and validity, indicating its promising potential for clinical utilization.
Clinical Outcomes After Distal Bypass in Patients With Chronic Limb-Threatening Ischemia due to Connective Tissue Disease
Authors: Kobayashi Taira , Hamamoto Masaki , Okazaki Takanobu , Okusako Ryo , Shimoda Hironori , Hasegawa Misa , Takahashi Shinya 
Published: October 2024

Objectives Chronic limb-threatening ischemia (CLTI) is mostly caused by arteriosclerosis, but is sometimes due to connective tissue disease. However, there is a limited knowledge of clinical outcomes of patients with CLTI with connective tissue disease. The objective of the study was to assess outcomes after distal bypass in these patients using global vascular guidelines. Material and Methods Data from distal bypasses performed for CLTI at a single center from 2014 to 2023 were evaluated retrospectively. Clinical outcomes after distal bypass were compared for patients with CLTI with arteriosclerosis (AS group) and those with connective tissue disease (CD group). The primary endpoints were limb salvage and wound healing. Results Of the 282 distal bypasses performed for 222 patients with CLTI, 22 were conducted for 21 patients with connective tissue disease (CD group). The connective tissue disease was progressive systemic scleroderma (n = 11 patients), pemphigoid diseases (n = 2), polyarteritis nodosa (n = 2), rheumatoid arthritis (n = 2), and others (n = 4). Compared with the AS group, the CD group included more females ( P = .007) and had greater oral steroid use ( P < .001) and a higher Global Limb Anatomical Staging System (GLASS) inframalleolar (IM) modifier P2 ( P < .001). The mean follow-up period of the whole cohort was 27 ± 22 months with no significant difference between the groups ( P = .25), and 22 limbs required major amputation during this period. The 2-year limb salvage rate was significantly lower in the CD group compared to the AS group (75% vs 94%, P = .020). Wound healing was achieved in 220 (78%) limbs, and the 12-month wound healing rate was significantly lower in the CD group (52% vs 86%, P = .006). Conclusion The low 2-year limb salvage and 12-month wound healing rates in patients with CLTI with connective tissue disease indicate that distal bypass may be challenging in these patients.
Jugular venous narrowing and spontaneous spinal cerebrospinal fluid leaks: A case–control study exploring association and proposed mechanism
Authors: Manupipatpong Sasicha , Primiani Christopher T , Fargen Kyle M , Amans Matthew R , Leithe Linda , Schievink Wouter I , Luciano Mark G , Hui Ferdinand K 
Published: October 2024

Background Spontaneous skull base cerebrospinal fluid leaks (CSFLs) are associated with increased intracranial pressure in idiopathic intracranial hypertension (IIH) and hypothesized to relate to skull base erosions due to increased CSF pressure. Given the increasing recognition of internal jugular venous stenosis (IJVS) as a cause of intracranial hypertension (IH), we evaluated the relationship between spinal CSFL and venous causes of IH. Methods The spinal CSFL database at a single institution was assessed to identify 12 consecutive spontaneous, non-traumatic spinal CSFL patients with CTV data. Exclusion criteria included documented IIH and iatrogenic CSFL. Demographics, clinical parameters, imaging characteristics, and IJV manometry results were recorded. Internal jugular venous stenosis was graded as: none (0–10%), mild (10–50%), moderate (50–80%), severe (>80–99%), and occluded (100%). Twelve consecutive patients who presented with cerebrovascular accidents without CSFL, matched by age and sex, were similarly analyzed as a control group. STROBE guidelines were used in reporting results. Results All CSFL patients had IJVS (83.3% bilateral, 33.3% severe) compared to 41.7% of the control group (33.3% bilateral, 16.7% severe-occluded); p = 0.04. All CSFL patients with available venogram manometry data had at least unilateral IJV gradients. Most patients presented with modified Rankin score (mRS) of 1 (66.7%), but in those with higher mRS, medical and/or surgical interventions were associated with decreased morbidity. Conclusion Spontaneous spinal CSFL was associated with IJVS in patients not meeting IIH criteria. Persistently high CSF pressure resulting in CSFL may cause opening pressure to be falsely normal or low. Internal jugular venous stenosis may be a viable target in recurrent CSFL management and improve morbidity.
Differential diagnosis between low-risk and high-risk thymoma: Comparison of diagnostic performance of radiologists with and without deep learning model
Authors: Yoshida Yuriko , Yanagawa Masahiro , Sato Yukihisa , Miyata Tomo , Kawata Atsushi , Hata Akinori , Tomiyama Noriyuki 
Published: October 2024

Background There are few CT-based deep learning (DL) studies on thymoma according to the World Health Organization classification. Purpose To develop a CT-based DL model to distinguish between low-risk and high-risk thymoma and to compare the diagnostic performance of radiologists with and without the DL model. Material and Methods 159 patients with 160 thymomas were included. A fine-tuning VGG16 network model with Adam optimizer was used, followed by k-fold cross validation. The dataset consisted of three axial slices, including the maximum tumor size from the CT volume data. The data were augmented 50 times by rotation, zoom, shear, and horizontal/vertical flip. Three independent networks for the CT dataset were considered, and the result was determined by voting. Three radiologists independently diagnosed thymomas with and without the model. The area under the curve (AUC) of the diagnostic performance was compared using receiver operating characteristic analysis. Results Accuracy of the DL model was 71.3%. Diagnostic performance of the radiologists was as follows: AUC and accuracy without the DL model, 0.61–0.68 and 61.9%–69.3%; and with the DL model, 0.66–0.69 and 68.1%–70.0%, respectively. AUC of the diagnostic performance showed no significant differences between radiologists with and without the DL model. The DL model tended to increase the diagnostic accuracy, but AUC was not significantly improved. Conclusion Diagnostic performance of the DL was comparable to that of radiologists. The DL model assistance tended to increase diagnostic accuracy.
Practice Patterns and Return-to-Sports Timing of National Football League Head Team Physicians for ACL Reconstruction
Authors: Arner Justin W. , Bradley James P. 
Published: October 2024

Background: Previous surveys of the practice patterns for anterior cruciate ligament (ACL) reconstruction in collegiate and professional team physicians have shown bone–patellar tendon–bone (BPTB) autograft being the most common graft, with variable return-to-sports timing. Purpose: To evaluate the current practice patterns and return-to-sports timing of National Football League (NFL) head team physicians for ACL reconstruction. Study Design: Cross-sectional study. Method: All 32 NFL head team orthopaedic surgeons were surveyed and asked their primary ACL graft preference, revision ACL graft preference, use of lateral extra-articular tenodesis (LET) or anterolateral ligament reconstruction (ALL), use of suture brace augmentation, return-to-sport timing, and whether functional testing was utilized in determining readiness of return to play. The years of experience of the physician were also evaluated. Results: All 32 head team physicians responded, with 31 (97%) using ipsilateral BPTB autograft in the primary setting and 1 using ipsilateral quadriceps autograft. In the revision setting, 24 (75%) physicians preferred a contralateral BPTB autograft, while 5 (16%) used an ipsilateral quadriceps autograft, 1 (3%) used a contralateral quadriceps autograft, and 2 (6%) used a BPTB allograft. One respondent (3%) used suture brace augmentation “most of the time” in the primary setting and always in the revision setting. No respondents utilized an ALL or LET in the primary setting and 2 (6%) respondents always performed an LET in revisions. Five others (16%) have performed at least 1 ALL or LET in an NFL athlete. Mean return to sports was at 9 months postoperatively, with no physicians allowing players to return before 7 months. All but 1 respondent used functional testing in return-to-sports decision-making. Conclusion: All but 1 of the 32 NFL head team physicians used BPTB autograft in primary ACL reconstruction. The majority preferred contralateral BPTB autograft in revisions, with a few considering extra-articular procedures or suture bracing in addition. On average, head team physicians allowed players to return at 9 months postoperatively, with none allowing return before 7 months. Nearly all utilized functional testing to aid in return-to-play decision-making. These homogenous findings in this high-risk and public athletic cohort aid in patient education and clinical decision-making for best treatment of ACL injuries, particularly in contact athletes.
Selective Migration Policies With Chinese Characteristics
Authors: Koslowski Rey , Ding Sheng 
Published: October 2024

Executive Summary This article examines China’s recruitment of high-skilled migrants within a broader comparative analysis of selective migration strategies and adds the neglected Chinese case to the comparative immigration policy literature. China adopted certain selective migration polices from other countries, such as Canada and the United States, but its selective migration strategy does not fit established categories. Beginning in 2013, the Chinese communist government enacted new laws and issued new regulations to attract foreign talent and better regulate the entry, residence and employment of foreigners. The contours of China’s distinctive selective migration policy became more defined as Beijing established a point system combined with a job offer requirement; reformed the Z visa, which is issued to those with a college degree who intend to work in China; established the R visa for exceptionally high-skilled migrants; and adopted more liberal policies on permanent residency for the highly skilled. These policies, combined with the opportunities presented by China’s rapidly growing economy, attracted growing numbers of university graduates and propelled China, to become, for a brief period before the COVID-19 pandemic, a major destination for high-skilled migrants.
Interventions to improve clinical trial recruitment with a focus on clinical staff from the recruiting site: a systematic review
Authors: Hermann Laura , Arundel Catherine , Thomas Abin , Twiddy Maureen , Clark Laura 
Published: October 2024

Background Difficulties recruiting to clinical trials are well-documented. Strategies to engage staff from the clinical site where recruitment takes place may be helpful in increasing recruitment rates. Aim To systematically review the literature to evaluate the effectiveness of interventions that aim to increase recruitment to clinical trials, focused on clinical site staff who support recruitment. Methods A systematic search for randomised studies within a trial (SWATs) that aimed to improve recruitment to a randomised host trial in the field of health or social care aimed at clinical site staff was conducted. Studies were excluded if they aimed to increase retention, were targeted at participants, or the SWAT or host trial were non-randomised. Database and hand searches were conducted up to 25th July 2024. The primary outcome was the rate of recruitment. The Cochrane RoB2 tool was used to assess the risk of bias of included studies. Results A total of seven studies were retrieved; all had a high risk or some concerns of bias. Studies evaluated heterogenous interventions and were synthesised narratively. A digital training package for trainee principal investigators was the only intervention to demonstrate a statistically significant effect. Conclusion Due to the small number of studies retrieved and the heterogeneity between them, it was not possible to make any conclusions of effectiveness of any strategy at helping clinical site staff to recruit optimally. To prevent research waste, future SWATs need to focus on replications of recruitment interventions in populations and settings of need, rather than further single-study replications. Registration PROSPERO CRD42022346585.