bluuebunny/crossref_metadata_2025_split huggingface dataset:
Increased dose primary thromboprophylaxis in ambulatory patients with advanced pancreatic ductal adenocarcinoma, a single centre cohort study.
Authors: Maraveyas Anthony , Haque Farzana , Muazzam Iqtedar Ahmed , Ilyas Waqas , Bozas George 
Published: May 2020

Abstract
Background: Advanced pancreatic ductal adenocarcinoma (aPDAC) patients have a lifetime all type thromboembolic event (ATTE) rate of 25- 35%. Efficacy and safety of increased dose primary thromboprophylaxis (IDPTP) with low molecular heparin (LMWH) given for 3 months has been shown in two prospective randomized trials. Objectives: To report on efficacy -reduction of all type thromboembolic events (ATTE)-, safety -incidence of Major Bleeding (MB)- and compliance in a single-centre cohort of receiving first line chemotherapy and LMWH-IDPTP. Methods: From May 2009 to October 2016, eighty two patients received IDPTP –LMWH with dalteparin. Schedule: 55kg and below: 7500 IU, between 55 and 80kg: 10,000 IU, above 80kg: 12,500 IU. MB is reported using the International Society of Thrombosis and Haemostasis (ISTH) criteria. ATTE was defined as any arterial or venous event, incidental or clinically symptomatic, including visceral VTE. Results: Mean and median time on dalteparin was 10.2 (95%CI 8.1, 12.4) and 8.0 (95%CI 6.2, 9.7) months respectively. ATTE was observed in 7 (8.5%) of patients, with a median time on IDPTP of 6.2 months (95% CI 10.0, 13.2). MB was seen in 10 (12.2%) patients with a median time on IDPTP of 4.5 months (95% CI 1.6--7.4). Six major bleeds (60%) were the direct or indirect result of aPDAC. Eighty-one patients had died at the time of data collection with a median overall survival time of 8.7 months (95%CI 6.4, 11.0). Thromboembolism and bleeding were late events. No impact of thromboembolism or bleeding on overall survival was observed. Conclusions: IDPTP-dalteparin was associated with lower ATTE occurrence rates than expected and comparable major bleeding rates. ATTE and MB were late events; the majority of MB was from direct or indirect result of locally progressing aPDAC. Since these conditions can frequently arise in aPDAC, IDPTP should be regularly reviewed beyond 3 months.
Human epididymis protein 4 is a new biomarker to predict the prognosis of progressive fibrosing interstitial lung disease
Authors: Nishiyama Naoki , Masuo Masahiro , Nukui Yoshihisa , Tateishi Tomoya , Kishino Mitsuhiro , Tateishi Ukihide , Morota Kaori , Ohbo Kazuyuki , Miyazaki Yasunari 
Published: May 2020

Abstract
BACKGROUND The clinical course and prognosis of progressive fibrosing interstitial lung diseases ( PF-ILDs) vary from individual to individual. Predictive serum biomarkers for the management of the disease are needed. Serum human epididymis protein 4 (HE4) has been reported to be elevated in patients with IPF, yet its clinical utility has not been elucidated. We evaluated whether serum HE4 could be a biomarker for patients with PF-ILD. METHODS Serum HE4 was measured in a retrospective study that consisted of 34 patients with PF-ILD and 40 healthy volunteers. The relationship between serum HE4 levels and clinical parameters or prognosis was investigated. To validate the significance of the results, a prospective observational study that consisted of 37 patients with PF-ILD and 40 control patients without PF-ILD was performed.RESULTS Serum HE4 was higher in patients with PF-ILD than in health volunteers ( P < 0.01). A correlation of the serum HE4 levels with the extent of honeycombing on chest high-resolution computed tomography was identified (r = 0.41, P = 0.015). In multivariate analysis by the Cox proportional hazard model, higher HE4 levels (> 238 pmol/l) were associated with elevated mortality risk (HR 7.27, 95% CI 1.56-34.0, P = 0.01 in the derivation cohort; HR 44.3, 95% CI 4.19-468, P < 0.01 in validation cohort). CONCLUSIONS Serum HE4 levels may serve as a new diagnostic and prognostic biomarker for patients with PF-ILD.
Methodological framework for radiomics applications in Hodgkin Lymphoma
Authors: Sollini Martina , Kirienko Margarita , Cavinato Lara , Ricci Francesca , Biroli Matteo , Ieva Francesca , Calderoni Letizia , Tabacchi Elena , Nanni Cristina , Zinzani Pier Luigi , Fanti Stefano , Guidetti Anna , Alessi Alessandra , Corradini Paolo , Seregni Ettore , Stella Carmelo Carlo , Chiti Arturo 
Published: May 2020

Abstract
Background According to published data radiomics features differ between lesions of refractory/relapsing HL patients from those of long-term responders. However, several methodological aspects have not been elucidated yet.Purpose The study aimed at setting up a methodological framework in radiomics applications in Hodgkin Lymphoma (HL), especially at: a) developing a novel feature selection approach; b) evaluating radiomic intra-patient lesions’ similarity; c) classifying relapsing refractory (R/R) vs non-(R/R) patients.Methods We retrospectively included 85 patients (male:female=52:33; median age 35 years, range 19-74). LIFEx (www.lifexsoft.org) was used for [18F]FDG-PET/CT segmentation and feature extraction. Features were a-priori selected if they were highly correlated or uncorrelated to the volume. Principal component analysis-transformed features were used to build the fingerprints, that were tested to assess lesions’ similarity, using the silhouette. For intra-patient similarity analysis, we used patients having multiple lesions only. To classify patients as non-R/R and R/R, the fingerprint considering one single lesion (fingerprint_One) and all lesions (fingerprint_All) was tested using Random Undersamplig Boosting of Tree Ensemble (RUBTE). Results HL fingerprints included up to 15 features. Intra-patient lesion similarity analysis resulted in mean/median silhouette values below 0.5 (low similarity especially in the non-R/R group). In the test set, the fingerprint_One classification accuracy was 62% (78% sensitivity and 53% specificity); the classification by RUBTE using fingerprint_All resulted in 82% accuracy (70% sensitivity and 88% specificity). Conclusions Lesion similarity analysis was developed, and it allowed to demonstrate that HL lesions were not homogeneous within patients in terms of radiomics signature. Therefore, a random target lesion selection should not be adopted for radiomics applications. Moreover, the classifier to predict R/R vs non-R/R, performed the best when all the lesions were used.
Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.
Authors: Klaver Kete , Duijts Saskia , Geusgens Chantal , Aarts Maureen , Ponds Rudolf , Beek Allard van der , Schagen Sanne 
Published: May 2020

Abstract
Background Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems. Methods/ Design A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18 – 65 years) who have returned to work, and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment, will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0), and at 12 weeks (T1) and 26 weeks (T2) post-randomization. Discussion About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors’ employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.Trial registration The trial is registered at ClinicalTrials.gov (NCT03900806) at 03 April 2019 (current status: ongoing),https://clinicaltrials.gov/ct2/show/NCT03900806?term=NCT03900806&draw=2&rank=1.
The Effects of Immediate Programmed Cryotherapy and Continuous Passive Motion in Patients after Computer-Assisted Total Knee Arthroplasty: A prospective, randomized controlled trial
Authors: Chen Mei-Chu , Lin Chiu-Chu , Ko Jih-Yang , Kuo Feng-Chih 
Published: May 2020

Abstract
Background: The postoperative nursing intervention with immediate cryotherapy and continuous passive motion (CPM) remains elusive regarding the postoperative pain and range of motion (ROM) for patients undergoing computer-assisted total knee arthroplasty (CAS-TKA).Methods: A prospective, randomized controlled trial with a purposive sampling method was utilized. Sixty patients scheduled for a unilateral CAS-TKA at a medical center were randomly assigned to the intervention group (n=30) and control group (n=30). The intervention group applied programed cryotherapy and CPM within one hour while returning to the ward on the day of surgery, while the control group did not. Data were analyzed using mixed models to compare the numeric rating scale (NRS) for pain, ROM, and swelling at postoperative day (POD) 4.Results: There was no significant difference in the NRS score between the groups (p = 0.168). The intervention group had significantly higher ROM than the control group (98 degrees vs. 91 degrees, p = 0.004) at POD 4. Although no significant difference in joint swelling was found between groups (p = 0.157), the intervention group had lower mean joint swelling (32.2 cm) than the control group (33.9 cm).Conclusions: Immediate programmed cryotherapy and continuous passive motion could help to improve ROM quickly after CAS-TKA. It should be incorporated into the daily nursing plan for patients undergoing CAS-TKA.Keywords: Postoperative nursing intervention, total knee arthroplasty, continuous passive motion, cryotherapy, computer-assistedTrial registration: ClinicalTrials.gov: NCT04136431. Registered 23 October 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04136431
Identification and validation of quantitative trait loci for ascites syndrome in broiler chickens using whole genome resequencing.
Authors: Parveen Alia , Jackson Christa D. , Dey Shatovisha , Tarrant Katy , Anthony Nicholas B , Rhoads Douglas D. 
Published: May 2020

Abstract
Background Ascites syndrome is a hypertensive, multifactorial, multigene trait affecting meat-type chickens imposing significant economic losses on the broiler industry. A region containing the CPQ gene has been previously identified as significantly affecting ascites phenotype. The region was discovered through whole genome resequencing focused on chicken chromosome 2. The association was confirmed through further genotyping in multiple broiler populations. Results The whole genome resequencing analyses have now been extended to the current chicken genome assembly. DNA samples were pooled according to gender and phenotype and the pools subjected to next generation sequencing. Loci were identified as clusters of single nucleotide polymorphisms where frequencies of the polymorphisms differed between resistant and susceptible chickens. The chickens are an unselected line descended from a commercial elite broiler line. Regions identified were specific to one or both genders. The data identify a total of 28 regions as potential quantitative trait loci for ascites. The genes from these regions have been associated with hypertensive-related traits in human association studies. One region on chicken chromosome 28 contains the LRRTM4 gene. Additional genotyping for the LRRTM4 region demonstrates an epistatic interaction with the CPQ region for ascites phenotype. Conclusions The 28 regions identified were not previously identified in a multi-generational genome wide association study using 60k Single Nucleotide Polymorphism panels. This work demonstrates the utility of whole genome resequencing as a cost effective, direct, and efficient method for identifying specific gene regions affecting complex traits. The approach is applicable to any organism with a genome assembly and requires no a priori assumptions.
Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial : An application to the "Stratall ANRS 12110 / ESTHER" trial
Authors: Sandie Arsene , Molinari Nicholas , Wanjoya Anthony , Kouanfack Charles , Laurent Christian , Tchatchueng-Mbougua Jules Brice 
Published: May 2020

Abstract
Background: The non-inferiority trials are becoming increasingly popular in public health and clinical research. The choice of the non-inferiority margin is the cornerstone of the non-inferiority trial. When the effect of active control intervention is unknown, it can be interesting to choose the non-inferiority margin as a function of the active control intervention effect. In this case, the uncertainty surrounding non-inferiority margin should be taken into account in statistical tests.Methods: It was proposed in this study two procedures for the non-inferiority test with a flexible margin for the continuous endpoint. The proposed test procedures are based on the asymptotic test and confidence interval approach. Simulations have been used to assess the performances and properties of the proposed test procedures. An application was done on clinical real data. The purpose of this study was to assess the effectiveness and safety of clinical monitoring alone versus laboratory and clinical monitoring in HIV infected adults patients.Results: The two proposed test procedures have good properties for large sample sizes. It has been found that the confidence interval level determines approximately the level of significance. The The 80%, 90% and 95% two-sided confidence interval levels led approximately to a type I error of 5%, 2:5% and 1%respectively. For small sample sizes, the test with 80% confidence interval level was the most powerful.Conclusions: This study highlights the choice of non-inferiority margin as flexible and depending on the reference treatment in an active trial of non-inferiority. The results of the study show that the proposed methods are applicable in the practice.Trial registration : The trial data used in this study was from the "Stratall ANRS 12110 / ESTHER", registered with ClinicalTrials.gov, number NCT00301561. Date : March 13, 2006, url : https://clinicaltrials.gov/ct2/show/NCT00301561.
Clinical and economic outcomes of hospital pharmaceutical care: A systematic review and meta-analysis
Authors: Lin Guohua , Huang Rong , Zhang Jing , Li Gaojie , Chen Lei , Xi Xiaoyu 
Published: May 2020

Abstract
Background: Hospital clinical pharmacists have been working in many countries for many years and clinical pharmaceutical care have a positive effect on the recovery of patients. In order to evaluate the clinical effectiveness and economic outcomes of clinical pharmaceutical care, relevant clinical trial studies were reviewed and analysed. Methods: Two researchers searched literatures published from January 1992 to October 2019, and screened them by keywords like pharmaceutical care, pharmaceutical services, pharmacist interventions, outcomes, effects, impact, etc. Then, duplicate literatures were removed and the titles, abstracts and texts were read to screen literatures according to inclusion and exclusion criteria. Key data in the literature were extracted, and Meta-analysis was conducted using the literature with common outcome indicators. Results: A total of 3299 articles were retrieved, and 42 studies were finally included. Twelve of them were used for meta-analysis. Among the 42 studies included, the main results of pharmaceutical care showed positive effects, 36 experimental groups were significantly better than the control group, and the remaining 6 studies showed mixed or no effects. Meta-analysis showed that clinical pharmacists had significant effects on reducing systolic blood pressure and diastolic blood pressure and shortening hospitalization days (P<0.05), but no statistical significance in reducing medical costs (P>0.05). Conclusion: clinical pharmacists' pharmaceutical care has a significant positive effect on patients' clinical effects, but has no significant economic effect.
LINC02418 promotes colon cancer progression by suppressing apoptosis via interaction with miR-34b-5p/BCL2 axis
Authors: Tian Jun , Cui Peng , Li Yifei , Yao Xuequan , Wu Xiaoyu , Wang Zhirong , Li Chunsheng 
Published: May 2020

Abstract
Background
LncRNAs have been demonstrated to be functional regulators in tumor progression through interaction with various signaling pathways in multiple cancer types. However, the effect of LINC02418 on CRC progression still remains unclear.
Methods
LncRNA expression profile in CRC tissues was explored by using the TCGA database. The expressional level of LINC02418 in CRC patients was confirmed by qRT-PCR. Kaplan-Meier analyses was used to investigate the correlations between LINC02418 and OS of patients with CRC. After stably transducing sh-LINC02418 and sh-NC into HCT116 and LoVo cells, cell proliferative, migratory and invasive abilities were detected by CCK-8 assay, colony formation assay and trans-well assay, respectively. The binding between LINC02418 and miR-34b-5p, and the interaction between miR-34b-5p and BCL2 were determined by dual-luciferase assay. Western blot experiments were conducted to further explore the effect of miR-34b-5p on BCL2 signaling pathway. Rescue experiments were performed to uncover the role of LINC02418 /miR-34b-5p/ BCL2 axis in CRC progression.
Results
LINC02418 was upregulated in human colon cancer samples and its high expression correlated with poor prognosis. LINC02418 promoted cancer progression by enhancing tumor growth, cell mobility and invasiveness of colon cancer cells. Additionally, LINC02418 could physically bind to miR-34b-5p and subsequently interact with BCL2 signaling pathway. Down-regulation of LINC02418 reduced cell proliferation, but transfection of miR-34b-5p inhibitor or BCL2 in LINC02418-silenced colon cancer cells significantly promoted cell growth.
Conclusions
LINC02418 was upregulated in human colon cancer samples and could be used as indicator for prediction of prognosis. LINC02418 acted as a tumor driver by negatively regulating cell apoptosis through LINC02418 /miR-34b-5p/ BCL2 axis and in colorectal cancer.
How to Restore Rotation Center in Total Hip Arthroplasty for Developmental Dysplasia of the Hip with the Assistance of Three Dimensional Printing Technology? A Pilot Study
Authors: Zhang Heng , Liu Yang , Li Kuanxin , Zhang Zheng , Guan Jianzhong , Dong Qirong , Zhou Jiansheng 
Published: May 2020

Abstract
Background: It is technically challenging to restore hip rotation center exactly in total hip arthroplasty (THA) for patients with end-stage osteoarthritis secondary to developmental dysplasia of the hip (DDH) due to the complicated acetabular morphology changes.In this study, we developed a new method to restore hip rotation center exactly and rapidly in THA with the assistance of three dimensional (3-D) printing technology.Methods: Seventeen patients (21 hips) with end-stage osteoarthritis secondary to DDH who underwent THA were included in this study. Simulated operations were performed on 3-D printed hip models for preoperative planning. The Harris fossa and acetabular notches were recognized and restored to locate acetabular center. The agreement in the size of acetabular cup and bone defect between simulated operations and actual operations were analyzed.Clinical and radiographic outcomes were recorded and evaluated.Results: The sizes of the acetabular cup of simulated operations on 3-D printing models showed a high rate of coincidence with the actual sizes in the operations(ICC value=0.930) There was no significant difference statistically between the sizes of bone defect in simulated operations and the actual sizes of bone defect in THA( t value=0.03，P value=0.97). The average Harris score of the patients was improved from (38.33±6.07) preoperatively to the last follow-up (88.61±3.44) postoperatively.The mean vertical and horizontal distances of hip rotation center on the pelvic radiographs were restored to (15.12 ± 1.25）mm and ( 32.49±2.83) mm respectively. No case presented dislocation or radiological signs of loosening until last follow-up.Conclusions: The application of 3-D printing technology faciliate orthopedists to recognize the morphology of Harris fossa and acetabular notches , locate the acetabular center and restore the hip rotation center rapidly and acurately.
Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-Label Study
Authors: Uemura Hiroji , Koroki Yosuke , Iwaki Yuki , Imanaka Keiichiro , Kambara Takeshi , Lopez-Gitlitz Angela , Smith Andressa , Uemura Hirotsugu 
Published: May 2020

Abstract
Background A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC).Methods This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT01946204; patients with nonmetastatic castration-resistant PC [nmCRPC]) and TITAN (NCT02489318; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 (NCT02162836; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio.Results Data from 68 patients (SPARTAN: n = 34, TITAN: n = 28, 56021927PCR1008: n = 6) receiving apalutamide 240 mg orally once-daily were analysed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0–24 hours) (AUC0 − 24ss) at steadystate of plasma apalutamide concentration were numerically slightly higher in patients with skin rash than those without.Conclusions No clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamiderelated skin rash is easily managed, with appropriate treatment with or without dose adjustment.