bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)
Authors: Kleinecke Caroline , Yu Jiangtao , Neef Philip , Buffle Eric , de Marchi Stefano , Fuerholz Monika , Nietlispach Fabian , Valgimigli Marco , Streit Samuel R , Fankhauser Mate , Duenninger Erich , Windecker Stephan , Meier Bernhard , Gloekler Steffen 
Published: January 2020

Abstract

Aims
This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC).

Methods and results
Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66–1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29–1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55–1.12; P = 0.26) were similar for both groups.

Conclusion
This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.
Premature ventricular contractions cause a position shift in 3D mapping systems: analysis, quantification, and correction by hybrid activation mapping
Authors: De Potter Tom , Iliodromitis Konstantinos , Bar-On Tal , Silva Garcia Etel , Ector Joris 
Published: January 2020

Abstract

Aims
Using a modified CARTO 3D mapping system, we studied if premature ventricular contractions (PVCs) cause position shifts within the 3D co-ordinate system. We quantified magnitude of the phenomenon and corrected for it, by creating both an activation map that represents the conventional local activation time (LAT) and one corrected for this position shift (hybrid LAT map).

Methods and results
We prospectively enrolled patients planned for PVC ablation. Distances between the earliest LAT, the earliest hybrid-LAT, and the best pacemap positions were calculated in a 3D model. Ablation was performed at the best hybrid-LAT location. Efficacy was evaluated by acute response to ablation as well as clinical outcome on 24-h Holter at 1 year. One hundred and twenty-seven LAT-hybrid pairs were studied in 18 patients (age 48.3 ± 18.0 years, 12 female). Baseline PVC burden was 16 ± 12%. The mean position shift between LAT-hybrid and its associated LAT position was 8.9 ± 5.5 mm. The mean position shift between best LAT-hybrid and best pacemap was 6.2 ± 5.0 mm and the mean shift between best conventional LAT and best pacemap was 13.5 ± 7.0 mm (P &lt; 0.0001 for all pairwise comparisons). Exclusive targeting of best LAT-hybrid position resulted in acute abolition of PVC activity in all patients. After 1-year follow-up, mean PVC burden reduction was 16% (baseline) to &lt;1%.

Conclusion
Premature ventricular contractions cause a position shift in 3D mapping systems compared with the same endocardial position in sinus rhythm. An approach to account for this phenomenon, correct it and target exclusively the adjusted 3D position is feasible and highly efficient in terms of acute and 1-year clinical outcome after radiofrequency ablation.
A Biomarker for Concussion: The Good, the Bad, and the Unknown
Authors: Reece Jenna T , Milone Michael , Wang Ping , Herman Daniel , Petrov Dmitriy , Shaw Leslie M 
Published: January 2020

Abstract

Background
Traumatic brain injury (TBI) is a significant cause of morbidity, mortality, and disability in the US, with &gt;2.8 million patients presenting to the emergency department (ED) annually. However, the diagnosis of TBI is challenging and presents a number of difficulties, particularly at the mildest end of the spectrum: concussion. A number of groups have researched biomarkers to aid in the evaluation of TBI, and most recently in 2018 the Food and Drug Administration approved a new blood-based immunoassay biomarker using ubiquitin carboxyl hydrolase L1 and glial fibrillary acidic protein to aid in head computed tomography (CT) triage.

Content
This review clarifies the practical challenges in assessing and implementing a new blood biomarker. It then examines the clinical context and need, as well as the evidence used to validate this new immunoassay.

Summary
Concussion is a multifaceted diagnosis with a need for biomarkers to assist in diagnostic and prognostic assessment. Recent articles in the lay press have revealed misunderstanding about the function of this new test, expressing hopes that this biomarker serves patients at the mildest end of the spectrum and is useful for athletes and children. None of these assumptions are correct, as this biomarker has been evaluated in patients only at the moderate end of the spectrum and has been validated only in adults presenting to the ED who have already been triaged to receive head CT, not in athletes or children. The next steps for this assay should consider clinical work flow and clarifying its intended use, including integration with existing triage methods, and validating the assay for a broader population.
Innovative Burn Treatment Using Tilapia Skin as a Xenograft: A Phase II Randomized Controlled Trial
Authors: Lima Júnior Edmar Maciel , De Moraes Filho Manoel Odorico , Costa Bruno Almeida , Rohleder Andréa Vieira Pontes , Sales Rocha Marina Becker , Fechine Francisco Vagnaldo , Forte Antonio Jorge , Alves Ana Paula Negreiros Nunes , Silva Júnior Francisco Raimundo , Martins Camila Barroso , Mathor Mônica Beatriz , de Moraes Maria Elisabete Amaral 
Published: January 2020

Abstract
Skin substitutes are considered a useful alternative for occlusive dressings in the treatment of superficial burns as they reduce the frequency of dressing replacement. This phase II randomized controlled trial aimed to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive xenograft dressing for the treatment of burn wounds in humans. In order to assess the use of tilapia skin, the following variables were evaluated: number of days for wound healing, the number of times the occlusive dressing was changed, use of anesthetics or analgesics, pain assessment using the Visual Analogue Scale, and evaluation of burn improvement on the day of dressing removal. In total, 62 participants completed the study. It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine. In our study, the tilapia skin xenograft showed good efficacy as an occlusive biological dressing for burn wound treatment in humans.
Evaluation of anticoagulants and hemocyte-maintaining solutions for the study of hemolymph components in the spiny lobster Panulirus argus (Latreille, 1804) (Decapoda: Achelata: Palinuridae)
Authors: Perdomo-Morales Rolando , Montero-Alejo Vivian , Rodríguez-Viera Leandro , Perera Erick 
Published: January 2020

AbstractFunctional studies on humoral or cellular responses in the hemolymph of crustaceans require the selection of suitable anticoagulant- and hemocyte-maintaining solutions. We studied the suitability of several anticoagulant- and hemocyte-maintaining solutions in the spiny lobster Panulirus argus (Latreille, 1804), with emphasis in the preservation of hemocyte number and viability. It was found that the modified Alsever solution was the ideal anticoagulant, while modified L-15 medium and Panulirus argus saline (PAS) were the best hemocyte-maintaining solutions. It is striking that whereas avoiding plasma clotting is relatively simple to achieve, avoiding lysis and aggregation of hemocytes could be challenging and variable among closely related crustaceans. The reasons are hardly known and might indicate different composition or sensitivity of both membrane-bound and soluble mediators in any of the three types of hemocytes identified among decapod crustaceans. Hemolymph volume average in P. argus was 10.5% of fresh body weight (more than 50 ml per adult individual), which makes this species an attractive model for functional studies of hemolymph components in crustaceans.
JPOS/JASCC clinical guidelines for delirium in adult cancer patients: a summary of recommendation statements
Authors: Matsuda Yoshinobu , Tanimukai Hitoshi , Inoue Shinichiro , Inada Shuji , Sugano Koji , Hasuo Hideaki , Yoshimura Masafumi , Wada Saho , Dotani Chikako , Adachi Hiroyoshi , Okamoto Yoshiaki , Takeuchi Mari , Fujisawa Daisuke , Kako Jun , Sasaki Chiyuki , Kishi Yasuhiro , Akizuki Nobuya , Inagaki Masatoshi , Uchitomi Yosuke , Matsushima Eisuke , Okuyama Toru 
Published: January 2020

Abstract

Background
The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline and summarizes the recommendations made.

Methods
The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development and Evaluation system. The modified Delphi method was used to validate the recommendation statements.

Results
This article provides a summary of the recommendations with rationales for each, as well as a short summary.

Conclusions
These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium.
Retrospective DVH analysis of point A based intracavitary brachytherapy for uterine cervical cancer
Authors: Someya Masanori , Hasegawa Tomokazu , Tsuchiya Takaaki , Kitagawa Mio , Gocho Toshio , Fukushima Yuuki , Hori Masakazu , Miura Katsutoshi , Takada Yu , Nakata Kensei , Sakata Koh-ichi 
Published: January 2020

ABSTRACT
Combining external beam radiotherapy (EBRT) with intracavitary brachytherapy (ICBT) is important for definitive treatment of cervical cancer. In cervical cancer patients receiving radiotherapy, we evaluated treatment outcomes in relation to dose–volume histogram parameters, including the computed tomography (CT)-based high-risk clinical target volume (HR-CTV) for ICBT. Between 2010 and 2015, 89 consecutive cervical cancer patients were mostly treated with 40 Gy of EBRT in 20 fractions and 18 Gy of ICBT prescribed to point A in 3 fractions. CT scans were obtained during ICBT. The HR-CTV D90 was calculated and the total doses of ICBT and EBRT were converted to the equivalent dose in 2 Gy fractions (EQD2). When the patients were divided into four groups according to EQD2 of the HR-CTV D90, the 3-year local recurrence-free survival rates were 95.2, 78.4, 52.7 and 42.9% for patients receiving &gt;80 , 70–80 , 60–70 and &lt;60 Gy, respectively. There was a significant negative correlation between EQD2 of the HR-CTV D90 and the HR-CTV volume at first ICBT (r = −0.713). Local recurrence was more frequent when the HR-CTV volume was ≥22 cc and EQD2 of the HR-CTV D90 was &lt;70 Gy. Multivariate analysis showed that EQD2 of the HR-CTV D90 and concurrent chemotherapy (≥4 cycles) were significant determinants of overall survival. HR-CTV D90 was an important prognostic indicator for local recurrence. HR-CTV D90 &gt;70 Gy is required for the better local control, especially in patients with a larger HR-CTV (≥22 cc at initial ICBT).
A rare case of acquired benign tracheoesophageal fistula
Authors: Bouayyad Sarah , Beena Meera , Nigam Ajay 
Published: January 2020

Abstract
Acquired benign tracheoesophageal fistula (TOF) is a rare medical condition that usually results from trauma, foreign bodies or granulomatous infections. This is an unusual presentation of a male patient with a history of laryngectomy who has had over a period of several years inappropriately and vigorously used valve cleaning brushes to clean tracheal secretions, which has led to the formation of a TOF. Due to the patient’s obsessive habit, we could not manage him using conventional surgical methods. Instead, we opted for the placement of a salivary bypass tube, which yielded good results and recovery. To the best of our knowledge, no other case of similar aetiology has been published. We would like to highlight the importance of appropriate patient selection and education prior to performing a tracheoesophageal puncture to avoid developing life-threatening complications as demonstrated in our case report.
DNA methylation is involved in the regulation of pepper fruit ripening and interacts with phytohormones
Authors: Xiao Kai , Chen Jie , He Qixiumei , Wang Yixin , Shen Huolin , Sun Liang 
Published: January 2020

AbstractThere is growing evidence to suggest that epigenetic tags, especially DNA methylation, are critical regulators of fruit ripening. To examine whether this is the case in sweet pepper (Capsicum annuum) we conducted experiments at the transcriptional, epigenetic, and physiological levels. McrBC PCR, bisulfite sequencing, and real-time PCR demonstrated that DNA hypomethylation occurred in the upstream region of the transcription start site of some genes related to pepper ripening at the turning stage, which may be attributed to up-regulation of CaDML2-like and down-regulation of CaMET1-like1, CaMET1-like2, CaCMT2-like, and CaCMT4-like. Silencing of CaMET1-like1 by virus-induced gene silencing led to DNA hypomethylation, increased content of soluble solids, and accumulation of carotenoids in the fruit, which was accompanied by changes in expression of genes involved in capsanthin/capsorubin biosynthesis, cell wall degradation, and phytohormone metabolism and signaling. Endogenous ABA increased during fruit ripening, whereas endogenous IAA showed an opposite trend. No ethylene signal was detected during ripening. DNA hypomethylation repressed the expression of auxin and gibberellin biosynthesis genes as well as cytokinin degradation genes, but induced the expression of ABA biosynthesis genes. In mature-green pericarp, exogenous ABA induced expression of CaDML2-like but repressed that of CaCMT4-like. IAA treatment promoted the transcription of CaMET1-like1 and CaCMT3-like. Ethephon significantly up-regulated the expression of CaDML2-like. Treatment with GA3 and 6-BA showed indistinct effects on DNA methylation at the transcriptional level. On the basis of the results, a model is proposed that suggests a high likelihood of a role for DNA methylation in the regulation of ripening in the non-climacteric pepper fruit.
Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study
Authors: Russo Marc , Brooker Charles , Cousins Michael J , Taylor Nathan , Boesel Tillman , Sullivan Richard , Holford Lewis , Hanson Erin , Gmel Gerrit Eduard , Shariati Nastaran Hesam , Poree Lawrence , Parker John 
Published: January 2020

Abstract

BACKGROUND
Spinal cord stimulation (SCS) activates the dorsal column fibers using electrical stimuli. Current SCS systems function in fixed-output mode, delivering the same stimulus regardless of spinal cord (SC) activation.

OBJECTIVE
To present long-term outcomes of a novel closed-loop SCS system that aims to maintain the SC activation near a set target level and within a therapeutic window for each patient. SC activation is measured through the evoked compound action potential (ECAP) generated by each stimulus pulse.

METHODS
Fifty patients with lower back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (visual analog scale), quality of life, function, sleep, and medication use were collected at baseline and at each visit. SC activation levels were reported in summary statistics. The therapeutic window for each individual patient was defined as the range of ECAP amplitudes between sensation threshold and uncomfortably strong stimulation.

RESULTS
At 12 mo, the proportion of patients with ≥50% relief was 76.9% (back), 79.3% (leg), and 81.4% (overall), and the proportion with ≥80% pain relief was 56.4% (back), 58.6% (leg), and 53.5% (overall). Patients spent a median of 84.9% of their time with stimulation in their therapeutic window, and 68.8% (22/32) eliminated or reduced their opioid intake. Statistically significant improvements in secondary outcomes were observed.

CONCLUSION
The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo, providing evidence for the long-term effectiveness of the Evoke closed-loop SCS system.
Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis
Authors: Fongen Camilla , Dagfinrud Hanne , Bilberg Annelie , Pedersen Elisabeth , Johansen Melissa Woll , van Weely Salima , Hagen Kåre Birger , Sveaas Silje Halvorsen 
Published: January 2020

Abstract

Background
Maintenance or improvement of physical function is an important treatment target in the management of patients with axial spondyloarthritis (axSpA); measurement tools that can detect changes in physical function are therefore important.

Objectives
The objective of this study was to compare responsiveness and interpretability of the patient-reported Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Performed-Based Improvement (ASPI) in measuring change in physical function after exercise in patients with axSpA.

Design
This was a sub-study of 58 patients nested within a randomized controlled trial comparing the effect of 12 weeks of exercise with usual care.

Methods
Responsiveness and interpretability were assessed according to the Consensus-based Standards for the selection of health status Measurement Instrument. Responsiveness was assessed by testing 8 predefined hypotheses for ASPI and BASFI. Interpretability was assessed by: (1) using patients’ reported change as an anchor (“a little better” = minimal important change) and (2) by categorizing patients with a 20% improvement as responders.

Results
For ASPI and BASFI, 5 of 8 (63%) versus 2 of 8 (25%) of the predefined hypotheses for responsiveness were confirmed. The minimal important change values for improvement in physical function were 3.7 seconds in ASPI and 0.8 points (on a scale from 0 to 10) for BASFI. In the intervention group, 21 of 30 (70%) and 13 of 30 (43%) of the patients were categorized as responders measured with ASPI and BASFI, respectively. There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline.

Limitations
This study was limited by its moderate sample size.

Conclusions
Our findings suggest that ASPI is preferable over BASFI when evaluating physical function after exercise interventions in patients with axSpA.
Doctor and healthcare workers strike: are they ethical or morally justifiable: another view
Authors: Chima Sylvester C. 
Published: January 2020

Purpose of review
This review analyzed legal and ethical issues surrounding recent doctor and healthcare worker (HCW) strikes and considered whether HCW strikes are legally and morally justifiable, underlying causes, and impact of such strikes on healthcare service delivery.

Recent findings
Recent reports show that doctor and HCW strikes are an ongoing phenomenon globally, occurring in both developed and developing countries. The main reasons for HCW strikes are failed employer–employee negotiations regarding fair wages and working conditions, policy issues, infrastructural deficiencies in poorer countries, and concerns by HCWs regarding personal security in the workplace. The main impact of HCW strikes is disruption of healthcare service delivery, such as canceled outpatients’ appointments, hospital admissions, and elective surgeries. There was no clear evidence of increased patients’ mortality during strikes, except in isolated cases, where emergency services were also withdrawn during strikes.

Summary
Doctors and HCWs strikes are lawful deadlock-breaking mechanisms when collective bargaining negotiations have reached an impasse. Doctors’ strikes appear to create an ethical conflict with the Hippocratic tradition and obligation to place patients’ best interests as the primary moral consideration in medical practice. However, the rise of consumerism in healthcare, and loss of power by doctors, many of whom now work as employees, subject to regulations imposed by different stakeholders, including governments, health-maintenance organizations, and healthcare insurers, has impacted on modern medical practice. Therefore, doctors, like other employees may occasionally resort to strikes to extract concessions from employers. Mortality is rarely increased during HCW strikes, especially where emergency healthcare services are provided.