bluuebunny/crossref_metadata_2025_split huggingface dataset:
Landscape of Cardiovascular Device Registries in the United States
Authors: Rajan Prashant V. , Holtzman Jessica N. , Kesselheim Aaron S. , Yeh Robert W. , Kramer Daniel B. 
Published: June 2019

Background

Regulators increasingly rely on registries for decision making related to high‐risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of
US
cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access.

Methods and Results

A systematic review using Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) guidelines identified studies (1995–2017) referencing cardiovascular device registries with a
US
‐based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry‐funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications.

Conclusions
The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.
Differential modulatory effects of Propofol and Sevoflurane anesthesia on blood monocyte HLA-DR and CD163 expression during and after cardiac surgery with cardiopulmonary bypass: a preliminary randomized flow cytometry study
Authors: Sbrana Silverio , Nunziata Anna , Storti Simona , Haxhiademi Dorela , Mazzone Annamaria , Leone Maria , Solinas Marco , Del Sarto Paolo 
Published: June 2019

Introduction: The increase of the anti-inflammatory CD163highHLA-DRlow blood monocyte subset is one of the mechanisms dampening inflammation during cardiac surgery with cardiopulmonary bypass. We evaluated the effect of two different anesthetic protocols, intravenous Propofol infusion or Sevoflurane-gas administration, on the perioperative frequency of this subset. Methods: Blood from patients (Propofol = 11, Sevoflurane = 13) undergoing minimally invasive mitral valve surgery was drawn preoperatively (T1), before declamping (T2), at 6 (T3), 24 (T4), 48 (T5), and 72 hours (T6) after declamping. C-reactive protein, haptoglobin, and lactate dehydrogenase were measured. A hemolytic index, as C-reactive protein/haptoglobin ratio, was introduced. Monocyte expression of HLA-DR, CD163, and the CD163highHLA-DRlow subset fraction was quantified by flow cytometry. Baseline-referred variations of plasmatic and cellular data at T2 were normalized for clamping times. Subsequent time-point variations were normalized for the final cardiopulmonary bypass times. Results: Variations of hemolytic index and lactate dehydrogenase were higher with Propofol at T3 (p = 0.004 and p = 0.02, respectively) when compared with Sevoflurane. At T2, the down-modulation of CD163 was higher with Propofol (p = 0.005). Starting from T3, the up-regulatory trend of CD163 was basically higher with Propofol, although not significantly. Propofol induced higher increments of HLA-DR low fractions, at T2 (p = 0.04) and, to a lesser extent, at T4 (p = 0.06). Starting from T3, the CD163highHLA-DRlow subset variations were higher with Propofol, especially at T4 and T6. Conclusion: Propofol seems to induce a higher postoperative fraction of the CD163highHLA-DRlow monocyte subset. This could represent either a compensatory mechanism dampening the higher inflammatory condition observed with Propofol at T2 or a consequence of a higher postoperative Propofol-induced hemolysis.
Reduced field-of-view diffusion-weighted MR imaging for assessing the local extent of uterine cervical cancer
Authors: Takeuchi Mayumi , Matsuzaki Kenji , Bando Yoshimi , Harada Masafumi 
Published: June 2019

Background Recently, the evaluation of the tumor size and local extension of early-stage uterine cervical cancer on magnetic resonance imaging is important for the accurate clinical staging and to determine the indication of less extensive surgery such as fertility sparing radical trachelectomy. Purpose To compare the diagnostic ability of reduced field-of-view diffusion-weighted imaging with those of three-dimensional (3D) contrast-enhanced T1-weighted imaging and T2-weighted imaging for assessing the tumor margin delineation and local extent of uterine cervical cancer. Material and Methods 3T magnetic resonance images, including T2-weighted imaging, reduced field-of-view diffusion-weighted imaging, and 3D contrast-enhanced T1-weighted imaging, in 27 women with surgically proven cervical cancer (19 FIGO stage IB1, 3 IB2, and 5 IIA1) were retrospectively evaluated. Tumor margins and local tumor extent, including the presence of invasion to parametrium and vagina were evaluated on both sagittal and oblique axial (short axis) images; the results were compared with histologically confirmed tumor extension. Results Reduced field-of-view diffusion-weighted imaging diagnosed the tumor margins, which was more accurate than T2-weighted imaging ( P<0.001) and slightly better than 3D contrast-enhanced T1-weighted imaging. Reduced field-of-view diffusion-weighted imaging could define the tumor margins well even in small lesions (≤ 20 mm). Histological examination revealed parametrial invasion in two cases (clinically under-staged) and vaginal invasion in four cases. Reduced field-of-view diffusion-weighted imaging could demonstrate local extension of all lesions, which was more accurate than clinical examination and T2-weighted imaging. Conclusion Addition of reduced field-of-view diffusion-weighted imaging may improve the staging accuracy of magnetic resonance imaging for cervical cancer in assessing the local tumor extent.
Radiation exposure of radiologists during different types of CT-guided interventions: an evaluation using dosimeters placed above and under lead protection
Authors: Elsholtz Fabian Henry Jürgen , Vahldiek Janis Lucas , Wyschkon Sebastian , Bucourt Maximilian De , Koletzko Gerd , Hamm Bernd , Niehues Stefan Markus 
Published: June 2019

Background Computed tomography (CT) is widely used not only for diagnostic purposes but also for image guidance during different types of interventions. Therefore, radiation exposure of both patients and interventional radiologists remains a much-discussed topic. Purpose To quantify radiation exposure of interventional radiologists during multiple CT-guided interventions using dosimeters placed under and outside standard protective lead clothing. Material and Methods A total of 113 consecutive interventions covering three different types of procedures (grouped as periradicular infiltration therapy, biopsies, and drain placement) and performed using routine clinical protocols were prospectively analyzed. The interventions were performed by two radiologists of different experience levels with identically placed dosimeters outside and underneath their protective clothing. Personal doses (right hand, eye lens, thyroid gland, thorax, gonads) were cumulatively measured for each type of intervention and separately for the two radiologists. Results Personal dose was below the detection limit of the dosimeters during periradicular infiltration therapy. In the biopsy and drain placement groups, the highest dose was found for the right hand (maximum cumulative dose = 1.84 ± 1.30 mSv in 19 consecutive drain placements). Under the protective gear, exposure was only observed for drain placements performed by the less experienced radiologist (maximum = 0.05 ± 0.04 mSv for the eye lens). Conclusion Personal doses measured here were far below annual thresholds published by the International Commission on Radiological Protection. Therefore, performing multiple CT-guided interventions appears to be safe for interventional radiologists in terms of radiation exposure.
Treatment patterns and characteristics of patients with migraine in Japan: A retrospective analysis of health insurance claims data
Authors: Meyers Juliana L , Davis Keith L , Lenz Robert A , Sakai Fumihiko , Xue Fei 
Published: June 2019

Objective To describe treatment patterns of migraine patients in the Japan Medical Data Center (JMDC) database. Methods Patients aged ≥18 years with ≥1 inpatient or ≥2 outpatient migraine diagnoses, ≥1 outpatient diagnosis and ≥1 migraine-specific acute treatment (triptan or ergotamine), or ≥2 migraine-specific acute treatments from 1 May 2011 to 30 April 2014 were identified. Patients were required to be enrolled in a health plan for ≥1 year before and after the index date. The first migraine diagnosis or acute treatment defined the index date. Patients were stratified by the migraine treatments observed after the index date (i.e. migraine-specific acute treatment only [AT], prophylactic with or without migraine-specific acute treatment [PT], or no treatment [NT]) and described regarding the first migraine treatment regimen and subsequent treatment patterns during up to 1 year of follow-up. Results A total of 16,443 patients met the eligibility criteria (9873 AT, 3022 PT, and 3548 NT). AT patients had mean (SD) 10.3 (20.5) acute treatment days during 1-year follow-up, and 81.9% received triptans. When assessing the first migraine treatment regimen during follow-up in PT patients, 29.2% received prophylactic treatment only and 51.7% received both acute and prophylactic treatment. Calcium-channel blockers with or without concomitant triptans (34.4%) were the most common first regimen. Approximately 62.2% discontinued initial prophylactic treatment after an average of 61.2 days (SD = 65.3) of persistent treatment. Among discontinuers, 15.2% reinitiated original treatment and 7.0% switched treatment post-discontinuation within a year, while the remaining patients did not receive prophylactic therapy following discontinuation. Conclusions Among Japanese migraine patients, prophylactic use was low and associated with a high rate of discontinuation following a brief treatment period. Many patients reinitiated or switched treatment following discontinuation, while a significant proportion of patients remained discontinued from prophylactic therapy, suggesting a high unmet need.
Online patient feedback: a cross-sectional survey of the attitudes and experiences of United Kingdom health care professionals
Authors: Atherton Helen , Fleming Joanna , Williams Veronika , Powell John 
Published: June 2019

Objectives Online patient feedback is a growing phenomenon but little is known about health professional attitudes and behaviours in relation to it. We aimed to identify the characteristics, attitudes and self-reported behaviours and experiences of doctors and nurses towards online feedback from their patients or their carers. Methods We conducted a cross-sectional self-completed online questionnaire of 1001 registered doctors and 749 nurses and midwives involved in direct patient care in the United Kingdom. Results Just over a quarter (27.7% or 277/1001) of doctors and 21% (157/749) of nurses were aware that patients/carers had provided online feedback about an episode of care in which they were involved, and 20.5% (205/1001) of doctors and 11.1% (83/749) of nurses had experienced online feedback about them as an individual practitioner. Feedback on reviews/ratings sites was seen as more useful than social media feedback to help improve services. Both types of feedback were more likely to be seen as useful by nurses compared with doctors and by hospital-based professionals compared with those based in community settings. Doctors were more likely than nurses to believe that online feedback is unrepresentative and generally negative in tone. The majority of respondents had never encouraged patients/carers to leave online feedback. Conclusions Despite enthusiasm from health policymakers, many health care professionals have little direct experience of online feedback, and rarely encourage it, as they view it as unrepresentative and with limited value for improving the quality of health services. The difference in opinion between doctors and nurses has the potential to disrupt any use of online patient feedback. The findings have implications for policy and practice in how online patient feedback is solicited and acted upon.
Upper limb vascular mapping with Doppler ultrasound: Technique precision evaluated in healthy volunteers
Authors: Germano Ana S , Gomes António P , Martins Rita , Sousa Marta , Nunes Vitor 
Published: June 2019

Introduction Doppler ultrasound is recommended by international societies for preoperative vascular mapping in vascular access surgery. Literature is scarce regarding data on Doppler ultrasound-associated errors. Objectives Our aim was to evaluate Doppler ultrasound precision for upper limb vascular mapping. Methods Fifty-two adult healthy volunteers were evaluated for superficial vein diameter, brachial artery flow and diameter in the lower third of non-dominant arm by a dedicated vascular access radiologist blinded for the identification of the participants. Each participant was scheduled for three evaluations one week apart. Friedman test and multivariate analysis of variance for repeated measures were used. Results There were no statistical differences within subjects across the three weeks except for brachial artery flow in participants who had basilic vein as the dominant vein. Discussion Repeated anatomical and haemodynamic parameters measured by Doppler ultrasound performed by an experienced medical sonographer, according to our protocol, did not show statistical differences within subjects, independently of age, gender and body mass index.
The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with type 2 diabetes mellitus at 12-month follow-up: a cluster randomized controlled trial
Authors: Chew Boon-How , Vos Rimke C. , Fernandez Aaron , Shariff Ghazali Sazlina , Shamsuddin Nurainul Hana , Ismail Mastura , Rutten Guy E.H.M. 
Published: June 2019

Background: Diabetes distress (DD) is an increasingly important part of clinical medicine, diabetes self-management and research topic in people with diabetes mellitus. The present study evaluated the effectiveness of a value-based emotion-focused educational program in Malay adults with type 2 diabetes (VEMOFIT) at 12-month follow-up compared with a program with systematic attention to participants’ emotions (attention-control). Methods: VEMOFIT consisted of four biweekly group sessions and a booster session after 3 months; the attention-control program consisted of three sessions over the same period. Intention-to-treat analysis with multilevel mixed modelling was done to estimate the intervention effect. Results: Participants ( n = 124) randomized to VEMOFIT ( n = 53) or attention-control ( n = 71). Mean (SD) age 55.7 (9.7) years, median diabetes duration 7.0 (8.0) years and mean HbA1c level 9.7% (82 mmol/mol). The mean DD (DDS-17 scale) level decreased in both groups (from 3.4 to 3.3 versus 3.1–2.5, respectively), significantly more in the attention-control group [adjusted difference −0.6, 95% confidence interval (CI) −1.1, −0.2]. The VEMOFIT group had a significant improvement in self-efficacy (DMSES, range 0–200; adjusted difference 16.4, 99.4% CI 1.9, 30.9). Other outcomes did not differ. Conclusions: Because the attention-control program resulted in a decreased DD 1 year later, its implementation on a larger scale seems justified. Trial registration: NCT02730078; NMRR-15-1144-24803
ROR1-targeted delivery of miR-29b induces cell cycle arrest and therapeutic benefit in vivo in a CLL mouse model
Authors: Chiang Chi-Ling , Goswami Swagata , Frissora Frank W. , Xie Zhiliang , Yan Pearlly S. , Bundschuh Ralf , Walker Logan A. , Huang Xiaomeng , Mani Rajeswaran , Mo Xiaokui M. , Baskar Sivasubramanian , Rader Christoph , Phelps Mitch A. , Marcucci Guido , Byrd John C. , Lee L. James , Muthusamy Natarajan 
Published: June 2019

AbstractChronic lymphocytic leukemia (CLL) occurs in 2 major forms: aggressive and indolent. Low miR-29b expression in aggressive CLL is associated with poor prognosis. Indiscriminate miR-29b overexpression in the B-lineage of mice causes aberrance, thus warranting the need for selective introduction of miR-29b into B-CLL cells for therapeutic benefit. The oncofetal antigen receptor tyrosine kinase orphan receptor 1 (ROR1) is expressed on malignant B-CLL cells, but not normal B cells, encouraging us with ROR1-targeted delivery for therapeutic miRs. Here, we describe targeted delivery of miR-29b to ROR1+ CLL cells leading to downregulation of DNMT1 and DNMT3A, modulation of global DNA methylation, decreased SP1, and increased p21 expression in cell lines and primary CLL cells in vitro. Furthermore, using an Eμ-TCL1 mouse model expressing human ROR1, we report the therapeutic benefit of enhanced survival via cellular reprograming by downregulation of DNMT1 and DNMT3A in vivo. Gene expression profiling of engrafted murine leukemia identified reprogramming of cell cycle regulators with decreased SP1 and increased p21 expression after targeted miR-29b treatment. This finding was confirmed by protein modulation, leading to cell cycle arrest and survival benefit in vivo. Importantly, SP1 knockdown results in p21-dependent compensation of the miR-29b effect on cell cycle arrest. These studies form a basis for leukemic cell–targeted delivery of miR-29b as a promising therapeutic approach for CLL and other ROR1+ B-cell malignancies.
Dynamic dual threshold cooperative spectrum sensing for cognitive radio under noise power uncertainty
Authors: Wan Runze , Ding Lixin , Xiong Naixue , Shu Wanneng , Yang Li 
Published: June 2019

Abstract
The spectrum sensing performance depends on the accuracy of the detection about whether primary users are busy or idle. Previous studies on cognitive radio spectrum sensing have shown that the cooperation between secondary users can improve their spectrum detection performance in real cognitive networks. Aiming at the problem of threshold mismatch of energy detectors under noise power uncertainty, a cooperative spectrum sensing method with dynamic dual threshold is proposed. Firstly, the utility function is defined with the objective of minimizing the error probability of spectrum sensing, and the optimum threshold of energy detector is derived. Secondly, in order to mitigate the influence derived from noise uncertainty, an effective dynamic dual threshold adjustment mechanism is presented, and the optimizing combinative fusion rule is discussed with the prerequisite of the minimum global error probability. In addition, in view of insufficient number of cognitive users whose sensing results lie in decision zones, the parameter of credibility is defined to choose the secondary users with reliable local detection for final fusion. Simulation results show that our proposed method can mitigate the influence of noise uncertainty and increase the spectrum sensing accuracy compared with other existing methods.
Trust-based recommendation systems in Internet of Things: a systematic literature review
Authors: Mohammadi Venus , Rahmani Amir Masoud , Darwesh Aso Mohammed , Sahafi Amir 
Published: June 2019

Abstract
Internet of Things (IoT) creates a world where smart objects and services interacting autonomously. Taking into account the dynamic-heterogeneous characteristic of interconnected devices in IoT, demand for a trust model to guarantee security, authentication, authorization, and confidentiality of connected things, regardless of their functionality, is imperative. However, as far as we know, against the centrality of trust-based recommendation mechanisms in the IoT environment, there is no ambient study for investigating its techniques. In this paper, we present a systematic literature review (SLR) of trust based IoT recommendation techniques so far. Detailed classifications based on extracted parameters as well as investigation existing techniques in three different IoT layers put forth. Moreover, the advantages, disadvantages and open issues of each approach are introduced that can expand more frontier in obtaining accurate IoT recommendation in the future.
Prognostic values and clinical implications of programmed cell death-ligand 1 (PD-L1), fork head transcription factor P-1 (FOXP-1) and signal transducer and activator of transcription-3 (STAT-3) expression in diffuse large B-cell lymphoma (DLBCL); an immunohistochemical study
Authors: Harb Ola A. , Kaf Randa Mohamed , Taha Heba F. , Ahmed Rham Z. , Mandour Doaa , Al Attar Ahmed Z. , Fathy Ayman , Almoregy Abdelwahab S. , Osman Gamal , Gertallah Loay M. 
Published: June 2019

AbstractContextPD-L1 is an inhibitory ligand that functions as an essential immune checkpoint.FOXP-1is a member of the FOXP family.STAT-3plays a critical role in regulation of cell proliferation and survival. The detailed expression of the three markers together in DLBCL tissues and their prognostic value in patients with DLBCL were not fully investigated.Aim was to assess the expression of PD-L1,FOXP-1andSTAT-3in diffuse large B-cell lymphoma (DLBCL) and to correlate their expression with the pathological findings, prognostic parameters and clinical implications of patients.MethodsPD-L1,FOXP-1andSTAT-3were assessed in DLBCL tissues derived from 50 patients using immunohistochemistry. Patients were followed up for 3 years for response to therapy progression, recurrence and survival.ResultsHigh PD-L1 expression was associated with bone marrow involvement (p = 0.004), extra-nodal involvement (p = 0.006) and advanced stage (p = 0.003). High FOXP-1 expression was associated with presence of bone marrow involvement and high risk group (p < 0.001). HighSTAT-3expression was associated with older age of the patient (p < 0.001), presence of bone marrow involvement (p = 0.002), extra-nodal involvement (p = 0.009), and high risk group (p = 0.005). High expression of PD-L1, FOXP-1 and STAT-3 was related to poor response to therapy, poor OS rate and RFS rates (p < 0.001).ConclusionHigh expression of PD-L1,FOXP-1andSTAT-3was related poor prognosis in DLBCL patients.