bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prediction of survival after eribulin chemotherapy for breast cancer by absolute lymphocyte counts and progression types
Authors: Morisaki Tamami , Kashiwagi Shinichiro , Asano Yuka , Goto Wataru , Takada Koji , Ishihara Sae , Shibutani Masatsune , Tanaka Hiroaki , Hirakawa Kosei , Ohira Masaichi 
Published: November 2021

Abstract
Background
In the Response Evaluation Criteria for Solid Tumors (RECIST) diagnostic criteria, the concepts of progression by preexisting disease (PPL) and progression by new metastases (PNM) have been proposed to distinguish between the progression types of cancer refractory to treatment. According to the tumor biology of cancer progression forms, the “PPL” form indicates invasion, and the “PNM” form indicates metastasis. On the other hand, recent studies have focused on the clinical importance of inflammatory markers as indicators of the systemic tumor immune response. In particular, absolute lymphocyte count (ALC) is an indicator of the host’s immune response. Thus, we developed a new measure that combined progression form with ALC. In this study, we clinically validated the combined assessment of progression form and ALC in eribulin chemotherapy.

Methods
From August 2011 to April 2019, a total of 486 patients with locally advanced or metastatic breast cancer (MBC) underwent treatment. In this study, only 88 patients who underwent chemotherapy using eribulin were included. The antitumor effect was evaluated based on the RECIST criteria, version 1.1. To measure ALC, peripheral blood samples collected before eribulin treatment were used. The cut-off value for ALC in this study was 1500/μl, based on previous studies.

Results
The PPL group (71 patients, 80.7%) had significantly longer progression-free survival (PFS) (p = 0.022, log-rank) and overall survival (OS) (p < 0.001, log-rank) than the PNM group (17 patients, 19.3%). In the 51 patients with ALC < 1500/μl, the PPL group had a significantly better prognosis than the PNM group (PFS: p = 0.035, OS: p < 0.001, log-rank, respectively). On the other hand, in the 37 patients with ALC ≥ 1500/μl, the PPL group had a better OS compared with the PNM group (p = 0.055, log-rank), but there was no significant difference in PFS between the two groups (p = 0.541, log-rank). Furthermore, multivariate analysis that validated the effect of OS showed that high ORR and “high-ALC and PPL” were factors for a good prognosis (p < 0.001, HR = 0.321; p = 0.036, HR = 0.290).

Conclusions
The progression form of PNM had a worse prognosis than PPL in patients treated with eribulin. In breast cancer patients with eribulin chemotherapy, good systemic immune status, such as ALC ≥ 1500/μl, was associated with less progression, particularly metastasis, and better prognosis. Furthermore, the biomarker “high-ALC (ALC ≥ 1500/μl) and PPL” was particularly useful as a prognostic marker following eribulin chemotherapy.
Standard- versus intermediate-dose enoxaparin for anti-factor Xa guided thromboprophylaxis in critically ill patients with COVID-19
Authors: Hamilton David Oliver , Main-Ian Alexander , Tebbutt Jessie , Thrasher Maya , Waite Alicia , Welters Ingeborg 
Published: November 2021

AbstractThe prevalence of venous thromboembolism (VTE) is high in critically ill patients with COVID-19. Dosing of Low Molecular Weight Heparin (LMWH) for thromboprophylaxis in patients with severe COVID-19 is subject to ongoing debate.In this brief report, we describe our study where we retrospectively examined the efficacy of standard- versus intermediate-dosing of enoxaparin in attaining and maintaining accepted prophylactic levels of anti-Factor Xa (anti-FXa) in critically ill patients with COVID-19.We collected data for all patients with confirmed COVID-19 who were treated with enoxaparin for thromboprophylaxis in a single Intensive Care Unit (ICU) in the United Kingdom between 31st March and 16th November 2020. Standard-dose of enoxaparin was 40 mg subcutaneously once daily for patients with normal renal function and body weight between 50 and 100 kg; the intermediate-dose was 40 mg subcutaneously twice daily. Anti-FXa peak concentrations between 0.2-0.4 IU/ml were considered appropriate for thromboprophylaxis.Age, sex, weight, Body Mass Index, APACHE II score, ICU length of stay, initial P/F ratio and creatinine were not statistically significantly different between standard- and intermediate-dose thromboprophylaxis cohorts. In the standard-dose group, the median initial anti-FXa level was 0.13 (interquartile range 0.06-0.18) compared to 0.26 (0.21-0.33) in the intermediate-dose cohort (p < 0.001). On repeated measurement, in the standard dose cohort, 44 of 95 (46%) anti-FXa levels were < 0.2 IU/ml compared with 24 of 132 (18%) levels in the intermediate-dose cohort even after dose-adjustment. There was one radiologically confirmed pulmonary embolism (PE) on computed tomography pulmonary angiogram during hospital admission in each cohort.Our study supports starting intermediate-dose thromboprophylaxis for critically ill patients with COVID-19 to achieve anti-FXa levels in the accepted thromboprophylactic range although further study is required to investigate whether anti-FXa guided thromboprophylaxis is safe and effective in reducing the incidence of VTEs in critically ill patients with COVID-19.
Tofacitinib effectiveness in Blau syndrome: a case series of Chinese paediatric patients
Authors: Zhang Song , Cai Zhe , Mo Xiaolan , Zeng Huasong 
Published: November 2021

Abstract
Objective
Blau syndrome (BS), a rare, autosomal-dominant autoinflammatory syndrome, is characterized by a clinical triad of granulomatous recurrent uveitis, dermatitis, and symmetric arthritis and associated with mutations of the nucleotide-binding oligomerization domain containing 2 (NOD2) gene. Aim of this study was to assess the efficacy of tofacitinib in Chinese paediatric patients with BS.

Methods
Tofacitinib was regularly administered to three BS patients (Patient 1, Patient 2, and Patient 3) at different dosages: 1.7 mg/day (0.11 mg/kg), 2.5 mg/day (0.12 mg/kg), and 2.5 mg/day (0.33 mg/kg). The clinical manifestations of the patients, magnetic resonance imaging results, serological diagnoses, therapeutic measures and outcomes of treatments are described in this report.

Results
The clinical characteristics and serological diagnoses of all BS patients were greatly improved after the administration of tofacitinib treatment. All patients reached clinical remission of polyarthritis and improvements in the erythrocyte sedimentation rate (ESR) and levels of C-reactive protein (CRP) and inflammatory cytokines.

Conclusion
Tofacitinib, a Janus kinase (JAK) inhibitor, is a promising agent for BS patients who have unsatisfactory responses to corticosteroids, traditional disease-modifying antirheumatic drugs, and biological agents.
Robotic arm-assisted total knee arthroplasty improves preoperative planning and intraoperative decision-making
Authors: Wan Xufeng , Su Qiang , Wang Duan , Yuan Mingcheng , Lai Yahao , Xu Hong , Zhou Zongke 
Published: November 2021

Abstract
Background
The reliability of robotic arm-assisted total knee arthroplasty (RA-TKA) has been previously reported. In this study, we evaluated the predictive accuracy of the RA-TKA system in determining the required bone resection and implant size preoperatively and its effect on intraoperative decision-making.

Methods
Data on the outcomes of RA-TKA procedures performed in our department were prospectively collected. A three-dimensional model of the femur, tibia, and fibula was reconstructed using standard computed tomography (CT) images. The model was used preoperatively to predict bone required resection for the femur and tibia and implant size. Intraoperatively, the images were registered to the local anatomy to create a patient-specific model for decision-making, including real-time measurement of the medial-to-lateral difference in the extension/flexion gap and TKA component alignment. Differences between predicted and real bone resections and implant size were evaluated, and the post-TKA mechanical axis of the lower limb and difference in medial-to-lateral flexion/extension gap were measured.

Results
The analysis was based on the data of 28 patients who underwent TKA to treat severe osteoarthritis. The RA-TKA system successfully predicted the femoral and tibial component within one implant size in 28/28 cases (100%). For the 168 bone resections performed, including both femoral and tibial cuts, the resection was within 1 mm of the predicted value in 120/168 (71%) of the cuts. The actual versus predicted bone resection was statistically different only for the lateral tibial plateau (p = 0.018). The medial-to-lateral gap difference was between − 1 and 1 mm, except in one case. The achieved lower limb alignment was accurate overall, with the alignment being within < 1.0° of the neutral mechanical axis in 13/28 cases (46%) and within < 3.0° in 28/28 cases (100%).

Conclusions
The RA-TKA system provided considerable pre- and intraoperative surgical assistance to achieve accurate bone resection, appropriate component sizing, and postoperative alignment after RA-TKA.
Effect of acupuncture at Zusanli (ST36) point on antral contraction function under ultrasound guidance: study protocol of a randomized controlled trial
Authors: Chen Yingqi , Bian Yu , Li Shanshan , Zhao Yuanyuan , Li Jiaying , Zheng Yuanyi , Chen Jie , Xu Shifen , Mi Yiqun 
Published: November 2021

AbstractBackgroundAlthough the relationship betweendeqisensations and curative effect has always been controversial,deqisensations has been regarded as the key indicator of clinical efficacy of acupuncture therapy. There is little evidence for standardization or visualization of the mechanism of acupuncture’s therapeutic effect. This trial aims to evaluate the effect of needling at Zusanli (ST36) on antral contraction function as visualized by ultrasound.MethodsThis is a two-arm, single-blind, randomized, controlled trial. A total of 116 acupuncture-naïve healthy subjects will be randomly allocated to the acupuncture group or sham acupuncture group in a 1:1 ratio. Participants in the acupuncture group will receive manual acupuncture at Zusanli (ST36) with the needling depth at crural interosseous membrane. Those in the sham acupuncture group will be given penetrating needling depth at the superficial fascia layer. The primary outcome will be the changes in antral contraction frequency (ACF) before and after acupuncture. The secondary outcomes will be the changes in the thermal infrared spectrum of gastric area skin, the antral contraction amplitude (ACA), the antral movement index (AMI), and the scores on the Chinese version of Massachusetts General Hospital Acupuncture Sensation Scale (C-MASS). The adverse events will be evaluated and recorded in detail.DiscussionThis study may provide visual and objective evidence regarding the safety and efficacy of manual acupuncture at Zusanli (ST36). In addition, the results of this study will help to identify the role of Zusanli (ST36)in the inducingdeqi.Trial registrationChinese Clinical Trial RegistryChiCTR2000040686. Registered on 8 December 2020
Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial
Authors: Gaillard Martin , Lainas Panagiotis , Agostini Hélène , Dagher Ibrahim , Tranchart Hadrien 
Published: November 2021

Abstract
Background
Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The basic principle is to create a narrow stomach along the lesser curvature, using a calibration bougie as a template to perform a vertical partial gastrectomy, resecting the greater curvature and fundus of the stomach. The most common postoperative complication is gastric leak from the staple line, observed in approximately 3% of cases, which can result in long and incapacitating treatment. The diametre of the bougie used to calibrate the remnant stomach could impact the rate of postoperative gastric leak, a higher diametre being correlated with a lower risk of leak, without lowering long-term weight loss. This is the first randomized trial to compare the outcomes of LSG regarding the use of two different bougie diametres on postoperative gastric leak and mid-term weight loss.

Methods
Bougie Sleeve Trial (BOUST) is a superiority single-blinded randomized national trial, involving 17 centres. Participants will be randomized into two groups. LSG will be performed using a 48-Fr diametre calibration bougie in the experimental group and a standard care (34 to 38-Fr diametre) calibration bougie in the control group. Both groups will take part in a 2-year postoperative follow-up to assess postoperative gastric leak rate and weight loss and quality of life evolution.

Discussion
This study protocol will allow the investigators to determine if the use of a larger calibration bougie during LSG is associated with lower postoperative gastric leak occurrence without impairing mid-term weight loss and quality of life. The results of this trial will provide important data on patient safety and promote best practice for LSG procedures.

Trial registration
ClinicalTrials.govNCT02937649. Registered on 18 October 2016
A cluster analysis of patients with axial spondyloarthritis using tumour necrosis factor alpha inhibitors based on clinical characteristics
Authors: Lee Seulkee , Kang Seonyoung , Eun Yeonghee , Won Hong-Hee , Kim Hyungjin , Cha Hoon-Suk , Koh Eun-Mi , Lee Jaejoon 
Published: November 2021

AbstractBackgroundThis study aimed to classify the distinct group of patients with axial spondyloarthritis (SpA) on tumour necrosis factor alpha inhibitors (TNFi) according to the baseline characteristics using a clustering algorithm.MethodsThe clinical characteristics and demographic data of patients with axial SpA included in the Korean College of Rheumatology Biologics and Targeted Therapy registry were investigated. The patterns of disease manifestations were examined using divisive hierarchical cluster analysis. After clustering, we compared the clinical characteristics of patients and the drug survival of TNFi between the classified groups.ResultsA total of 1042 patients were analysed. The cluster analysis classified patients into two groups: axial group predominantly showing isolated axial manifestations (n= 828) and extra-axial group more frequently showing extra-axial symptoms (n= 214). Almost all extra-axial symptoms (peripheral arthritis, enthesitis, uveitis, and psoriasis) were more frequently observed in the extra-axial group than in the axial group. Moreover, patients in the extra-axial group had shorter disease duration, later disease onset, and higher disease activity than those in the axial group. The disease activity was comparable between the two groups after 1 year of treatment with TNFi. Interestingly, the extra-axial group had a lower drug survival with TNFi than the axial group (p= 0.001).ConclusionsCluster analysis of patients with axial SpA using TNFi classified two distinct clinical phenotypes. These clusters had different TNFi drug survival, clinical characteristics, and disease activity.
Effectiveness of interventions for prevention of common infections in people who use opioids: a protocol for a systematic review of systematic reviews
Authors: Kudrina Irina , Puzhko Svetlana , Filion Kristian B. , Gore Genevieve , Paraskevopoulos Elena , Windle Sarah , Martel Marc O. , Eisenberg Mark J. 
Published: November 2021

Abstract
Background
The North American opioid crisis is driven by opioid-related mortality and morbidity, including opioid use-associated infections (OUAIs), resulting in a substantial burden for society. Users of legal and illegal opioids are at an increased risk of OUAIs compared to individuals not using opioids. As reported for hepatitis C virus (HCV), human immunodeficiency virus (HIV), bacterial, fungal, and other infections, OUAIs transmission and acquisition risks may be modifiable. Several systematic reviews (SRs) synthetized data regarding interventions to prevent infections in persons using drugs (e.g., opioid substitution therapy, needle and syringes exchange programs, psycho-social interventions); however, their conclusions varied. Therefore, SR of published SRs is needed to synthesize the highest level of evidence on the scope and effectiveness of interventions to prevent OUAIs in people using opioids legally or illegally.

Methods
We will comprehensively search for SRs in the PubMed, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Epistemonikos, and Google Scholar databases from inception to November 2020. Data selection and extraction for each SR will be performed independently by two researchers, with disagreements resolved by consensus. All SRs regarding interventions with evaluated effectiveness to prevent OUAI in legal and/or illegal opioid users will be eligible. Risk of bias assessment will be performed using the AMSTAR2 tool. The results will be qualitatively synthesized, and a typology of interventions’ effectiveness with a statement on the strength of evidence for each category will be created.

Discussion
Our pilot search of PubMed resulted in 379 SRs analyzing the effectiveness of interventions to prevent HCV and HIV in persons who inject different types of drugs, including opioids. Of these 379 SRs, 8 evaluated primary studies where participants used opioids and would therefore be eligible for inclusion. The search results thus justify the application of SR of SRs approach. Comprehensive data on the scope and effectiveness of existing interventions to prevent OUAIs will help policy-makers to plan and implement preventive interventions and will assist clinicians in the guidance for their patients using opioids.

Systematic review registration
Registered in PROSPERO on 30 July 2020 (#195929).
Morphological characterization of Arab and Oromo goats in northwestern Ethiopia
Authors: Sheriff Oumer , Alemayehu Kefyalew , Haile Aynalem 
Published: November 2021

Abstract
Background
An exploratory field research was conducted in northwestern Ethiopia, to characterize the morphological features of Arab and Oromo goat populations as an input to design community-based breeding programs. Ten qualitative and nine quantitative traits were considered from 747 randomly selected goats. All data collected during the study period were analyzed using R statistical software.

Results
Plain white coat color was predominantly observed in Arab goats (33.72%) while plain brown (deep and light) coat color was the most frequent in Oromo goats (27.81%). The morphometric measurements indicated that Oromo goats have significantly higher body weight and linear body measurements than Arab goats. Positive, strong and highly significant correlations were obtained between body weight and most of the body measurements in both goat populations. The highest correlation coefficients of chest girth with body weight for Arab (r  =  0.95) and Oromo (r  =  0.92) goat populations demonstrated a strong association between these variables. Live body weight could be predicted with regression equations of y  =  − 33.65  +  0.89  ×  for Arab goats (R2  =  90) and y  =  − 37.55  +  0.94  ×  for Oromo goats (R2  =  85), where y and x are body weight and chest girth, respectively, in these goat types.

Conclusions
The morphological variations obtained in this study could be complemented by performance data and molecular characterization using DNA markers to guide the overall goat conservation and formulation of appropriate breeding and selection strategies.
Stereoscopic facial imaging for pain assessment using rotational offset microlens arrays based structured illumination
Authors: Kwon Jae-Myeong , Yang Sung-Pyo , Jeong Ki-Hun 
Published: November 2021

AbstractConventional pain assessment methods such as patients’ self-reporting restrict the possibility of easy pain monitoring while pain serves as an important role in clinical practice. Here we report a pain assessment method via 3D face reading camera assisted by dot pattern illumination. The face reading camera module (FRCM) consists of a stereo camera and a dot projector, which allow the quantitative measurement of facial expression changes without human subjective judgement. The rotational offset microlens arrays (roMLAs) in the dot projector form a uniform dense dot pattern on a human face. The dot projection facilitates evaluating three-dimensional change of facial expression by improving 3D reconstruction results of non-textured facial surfaces. In addition, the FRCM provides consistent pain rating from 3D data, regardless of head movement. This pain assessment method can provide a new guideline for precise, real-time, and continuous pain monitoring.
Type 2 diabetes reversal with digital twin technology-enabled precision nutrition and staging of reversal: a retrospective cohort study
Authors: Shamanna Paramesh , Joshi Shashank , Shah Lisa , Dharmalingam Mala , Saboo Banshi , Mohammed Jahangir , Mohamed Maluk , Poon Terrence , Kleinman Nathan , Thajudeen Mohamed , Keshavamurthy Ashok 
Published: November 2021

Abstract
Background
Type 2 diabetes reversal has been viewed in the literature primarily as a dichotomous event (reversed or not reversed), even though this viewpoint may not be optimal for clinicians or patients. This cohort study’s objectives were to define stages of type 2 diabetes reversal and measure changes in reversal stages before and after 90 days of digital twin-enabled precision nutrition therapy.

Methods
This study defines seven stages of diabetes reversal. The study is a retrospective pre/post comparison of changes in reversal stage, hemoglobin A1c (HbA1c), weight, body mass index (BMI), and other metrics measured before and after precision nutrition therapy. Reversal stages were defined as Stage 0: HbA1c < 5.7% without medication for > 1 year, Stage 1: HbA1c < 5.7% without medication for < 1 year, Stage 2: HbA1c < 6.5% without medication, Stage 3: estimated HbA1c (eA1c) between 5.7 and 6.4% without medication, Stage 4: estimated HbA1c (eA1c) between 5.7 and 6.4% with metformin monotherapy, Stage 5: dual oral therapy, Stage 6: > = 3 medications.

Results
Reversal stage information was available for 463 patients at baseline and 90 days. At baseline, the proportions of patients in each reversal stage were Stages 1 and 2: 0%, Stage 3: 1%, Stage 4: 8%, Stage 5: 6%, and Stage 6: 85%. After 90 days, the proportions in each reversal stage were Stage 1: 2%, Stage 2: 9%, Stage 3: 32%, Stage 4: 39%, Stage 5: 7%, and Stage 6: 11%, indicating significant progress. Reversal stage progression rates varied by patient subgroup.

Conclusions
Type 2 diabetes patients reached differing reversal stages during 90 days of precision nutrition therapy. Use of reversal stages may benefit patients during therapy.

Trial registration
This was a retrospective study that was approved by the Medisys Clinisearch Ethical Review Board (without registration number) in 2019.