bluuebunny/crossref_metadata_2025_split huggingface dataset:
Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke
Authors: Shkirkova Kristina , Schuberg Samuel , Balouzian Emma , Starkman Sidney , Eckstein Marc , Stratton Samuel , Pratt Franklin D. , Hamilton Scott , Sharma Latisha , Liebeskind David S. , Conwit Robin , Saver Jeffrey L. , Sanossian Nerses ,   for the FAST-MAG Investigators and Coordinators
Published: January 2020

Background and Purpose—
The prehospital setting is a promising site for therapeutic intervention in stroke, but current stroke screening tools do not account for the evolution of neurological symptoms in this early period. We developed and validated the Paramedic Global Impression of Change (PGIC) Scale in a large, prospective, randomized trial.

Methods—
In the prehospital FAST-MAG (Field Administration of Stroke Therapy-Magnesium) randomized trial conducted from 2005 to 2013, EMS providers were asked to complete the PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change during transport for consecutive patients transported by ambulance within 2 hours of onset. We analyzed PGIC concurrent validity (compared with change in Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity (compared with National Institutes of Health Stroke Scale severity measure performed in the emergency department), and predictive validity (of neurological deterioration after hospital arrival and of final 90-day functional outcome). We used PGIC to characterize differential prehospital course among stroke subtypes.

Results—
Paramedics completed the PGIC in 1691 of 1700 subjects (99.5%), among whom 635 (37.5%) had neurological deficit evolution (32% improvement, 5.5% worsening) during a median prehospital care period of 33 (IQR, 27–39) minutes. Improvement was associated with diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits on emergency department arrival, and more frequent nondisabled and independent 3-month outcomes. Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.

Conclusions—
The PGIC scale is a simple, validated measure of prehospital patient course that has the potential to provide information useful to emergency department decision-making.

Registration—

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT00059332.
Predicted and Projected Water Resources Changes in the Chari Catchment, the Lake Chad Basin, Africa
Authors: Mahmood Rashid , Jia Shaofeng , Mahmood Tariq , Mehmood Asif 
Published: January 2020

AbstractThe water resources of the Chari River basin, contributing more than 90% of the water to one of the largest lakes in Africa, known as Lake Chad, are highly vulnerable to natural and anthropogenic changes. Therefore, the changes in water resources were predicted for the next 20 years (i.e., 2016–35) by using the harmonic regression model (HRM), one of the most sophisticated time series methods, and also projected under representative concentration pathways (RCPs) by using the multimodel approach for the periods 2021–50, 2051–80, and 2081–2100, with respect to the baseline period (1971–2001). The Tropical Rainfall Measuring Mission (TRMM), Climatic Research Unit (CRU), and dynamically downscaled climatic data were used in the analysis of the present study. The results showed that under MME-RCP2.6 (multimodel ensemble of RCMs), low flow (average of low-flow months, December–July), high flow (August–November), and annual flow were projected to decrease in the future. In contrast, under MME-RCP4.5 and MME-RCP8.5, high and annual flows were projected to increase in all three time horizons, while low flow will decrease except in 2021–50 under MME-RCP8.5. In the next two decades, the HRM showed decrease in all type of flows (low, high, and annual), very similar to the results under MME-RCP2.6 for the same period. In contrast, almost all flows are expected to increase under MME-RCP4.5 and MME-RCP8.5 in the next two decades. On the whole, the flows are expected to decrease under the HRM and RCP2.6 but to increase under RCP4.5 and RCP8.5.
Numerical Study of the 6 May 2012 Tsukuba Supercell Tornado: Vorticity Sources Responsible for Tornadogenesis
Authors: Tao Tao , Tamura Tetsuro 
Published: January 2020

AbstractRemarkable progress has been achieved in understanding the vorticity source responsible for tornadogenesis. Nevertheless, the answer to this question remains elusive, particularly after introducing surface friction in realistic tornado simulations. In this study, a simulation using the Weather Research and Forecasting (WRF) Model is conducted based on the F3 supercell tornado that hit Tsukuba City, Japan, on 6 May 2012. The simulation uses triply nested domains, and the tornado is successfully reproduced in the innermost domain with 50-m horizontal grid spacing. The circulation analyses reveal that the frictional term is the dominant vorticity source responsible for the vortices at both the pretornadic and tornadogenesis times. The detailed vorticity source analyses of the air parcels show that the vorticity of the tornado at the genesis time mainly originates from the frictionally generated crosswise vorticity near the ground. The crosswise vorticity is directly tilted (or first exchanged into streamwise vorticity and then tilted) into vertical vorticity when the air parcels enter the tornado. A rear-flank downdraft (RFD) surge from the south and west sides of a primary low-level mesocyclone (LMC) may trigger tornadogenesis by increasing the convergence near the ground. The RFD surge is not necessarily associated with the baroclinically generated vorticity. In this study, the baroclinity is weak across the hook echo, which may cause a lack of baroclinically generated vorticity in the RFD surge.
The Framework for Assimilating All-Sky GPM Microwave Imager Brightness Temperature Data in the NASA GEOS Data Assimilation System
Authors: Kim Min-Jeong , Jin Jianjun , El Akkraoui Amal , McCarty Will , Todling Ricardo , Gu Wei , Gelaro Ronald 
Published: January 2020

Abstract
Satellite radiance observations combine global coverage with high temporal and spatial resolution, and bring vital information to NWP analyses especially in areas where conventional data are sparse. However, most satellite observations that are actively assimilated have been limited to clear-sky conditions due to difficulties associated with accounting for non-Gaussian error characteristics, nonlinearity, and the development of appropriate observation operators for cloud- and precipitation-affected satellite radiance data. This article provides an overview of the development of the Gridpoint Statistical Interpolation (GSI) configurations to assimilate all-sky data from microwave imagers such as the GPM Microwave Imager (GMI) in the NASA Goddard Earth Observing System (GEOS). Electromagnetic characteristics associated with their wavelengths allow microwave imager data to be highly sensitive to precipitation. Therefore, all-sky data assimilation efforts described in this study are primarily focused on utilizing these data in precipitating regions. To utilize data in cloudy and precipitating regions, state and analysis variables have been added for ice cloud, liquid cloud, rain, and snow. This required enhancing the observation operator to simulate radiances in heavy precipitation, including frozen precipitation. Background error covariances in both the central analysis and EnKF analysis in the GEOS hybrid 4D-EnVar system have been expanded to include hydrometeors. In addition, the bias correction scheme was enhanced to reduce biases associated with thick clouds and precipitation. The results from single observation experiments demonstrate the capability of assimilating all-sky microwave brightness temperature data in GEOS both when the model forecast produces excessive precipitation and too little precipitation. Additional experiments show that hydrometeors and dynamic variables such as winds and pressure are adjusted in physically consistent ways in response to the assimilation.
Systematic review and meta-analysis of rates of clozapine-associated myocarditis and cardiomyopathy
Authors: Siskind Dan , Sidhu Ashneet , Cross John , Chua Yee-Tat , Myles Nicholas , Cohen Dan , Kisely Steve 
Published: January 2020

Background: Clozapine is the most effective medication for treatment refractory schizophrenia, but is associated with cardiac adverse drug reactions. Myocarditis and cardiomyopathy are the most serious cardiac adverse drug reactions although reported rates of these conditions vary in the literature. We systematically reviewed and meta-analysed the event rates, the absolute death rates and case fatality rates of myocarditis and cardiomyopathy associated with clozapine. Methods: PubMed, EMBASE and PsycINFO were searched for studies that reported on the incidence of cardiomyopathy or myocarditis in people exposed to clozapine. Data were meta-analysed using a random effects model, with subgroup analysis on study size, time frame, region, quality, retrospective vs prospective, and diagnostic criteria of myocarditis or cardiomyopathy. Results: 28 studies of 258,961 people exposed to clozapine were included. The event rate of myocarditis was 0.007 (95% confidence interval [CI] = [0.003, 0.016]), absolute death rate was 0.0004 (95% CI = [0.0002, 0.0009]) and case fatality rate was 0.127 (95% CI = [0.034, 0.377]). The cardiomyopathy event rate was 0.006 (95% CI = [0.002, 0.023]), absolute death rate was 0.0003 (95% CI = [0.0001, 0.0012]) and case fatality rate was 0.078 (95% CI = [0.018, 0.285]). Few included studies provided information on criteria for diagnosis of myocarditis and cardiomyopathy. Event rates of cardiomyopathy and myocarditis were higher in Australia. Conclusion: Clarity of diagnostic criteria for myocarditis remains a challenge. Observation bias may, in part, influence higher reported rates in Australia. Monitoring for myocarditis is warranted in the first 4 weeks, and treatment of comorbid metabolic syndrome and diabetes may reduce the risk of cardiomyopathy. The risks of myocarditis and cardiomyopathy are low and should not present a barrier to people with treatment refractory schizophrenia being offered a monitored trial of clozapine.
T-shaped linear-stapled cervical esophagogastric anastomosis for minimally invasive esophagectomy: a pilot study
Authors: Li Xinju , Wang Zhe , Zhang Guangjian , Fu Junke , Wu Qifei 
Published: January 2020

Background: Minimally invasive esophagectomy (MIE) has become a good option in the surgical treatment of esophageal cancer. Cervical esophagogastric anastomoses (CEGA) are widely used during esophagectomy. However, CEGA are related with a higher incidence of anastomotic complications. In the present study, a new procedure of T-shaped linear-stapled cervical esophagogastric anastomosis was used during MIE and the short-term outcomes are presented. Methods: From May 2014 to December 2018, 32 consecutive patients with esophageal cancer who underwent total MIE followed by T-shaped linear-stapled cervical esophagogastric anastomosis were included. Postoperative outcomes were analyzed. Results: Fifteen men and 17 women were included this pilot study. The histology of all cases was squamous cell carcinoma. Mean operation time of T-shaped linear-stapled cervical esophagogastric anastomosis was 17.6 minutes. There were no early or late mortalities. A minor cervical anastomotic leakage occurred in 1 patient. No complications of anastomotic stenosis occurred in this study. Conclusion: The T-shaped linear-stapled cervical esophagogastric anastomosis is efficient, reliable, easy to perform, and associated with lower postoperative complication rate.
The Case for Disclosure of Biologics Manufacturing Information
Authors: Heled Yaniv 
Published: January 2020

Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
Parecoxib as an adjunct therapy for the treatment of refractory non-surgical cancer pain
Authors: Thakerar Arti , Dines-Muntaner Seamus , Trifunovich Tijana , Alexander Marliese , Fullerton Sonia 
Published: January 2020

Background Evidence for the use of short-term daily parenteral parecoxib for refractory or uncontrolled non-surgical cancer pain is limited. This study aimed to characterise the real-world off-label use and report on clinical experiences in an Australian cancer cohort. Methods Eligible patients received at least one dose of parecoxib of an intended three-day course between October 2015 and December 2018. Data were collected to characterise the parecoxib treatment cohort (cancer diagnosis, metastases, sites and types of pain and prior analgesia). Parecoxib-related adverse events, pain scores (worst and median), and concurrent opioid use were assessed at 24 h pre (T0) and 24 (T1), 48 (T2), 72 (T3) and 96 h (T4) post first parecoxib dose. Results Sixty-five patients (39 males and 26 females) and 68 courses of parecoxib (three patients treated twice) were included in analyses: metastatic disease (86%), bone pain (54%) and taking ≥3 classes of analgesic medications (69%). Pain types varied (46% non-specific, 22% neuropathic and 32% other). Most (94%) received parecoxib by subcutaneous administration. Following parecoxib, median 24-h pain scores and worst pain scores improved for 59% (40/68) and 50% (34/68) of patients, respectively. In the first 24 h (T0 to T1), median (4 vs. 2, p < 0.01) and worst (6 vs. 5, p < 0.01) pain scores were reduced and sustained to T4 (4 vs. 2.5, p = 0.01). Breakthrough analgesia requirements reduced for 63% (43/68) of patients, while total concurrent opioid use remained constant. Mean/median oral morphine equivalence for T0 vs. T1 was 111 mg/75 mg vs. 162 mg/90 mg, (p > 0.8). Two patients ceased parecoxib due to renal/liver function abnormalities and two experienced mild injection-site reactions. Conclusions In this real-world study, parecoxib was utilised as adjunctive therapy in a select patient cohort to contribute to reduced pain scores with no new safety signals. Prospective randomised studies in larger cohorts would improve understanding of the effects of parecoxib.
Serological, molecular and clinicopathological findings associated with Leishmania infantum infection in cats in Northern Italy
Authors: Urbani Lorenza , Tirolo Alessandro , Salvatore Daniela , Tumbarello Michele , Segatore Sofia , Battilani Mara , Balboni Andrea , Dondi Francesco 
Published: January 2020

Objectives The aims of this study were to investigate the prevalence of Leishmania species infection in cats in Northern Italy and to evaluate the associations between infection and signalment and clinicopathological data. Methods The study was carried out in a veterinary university hospital from June to November 2017. Blood, urine, conjunctival swabs and hair were collected from all randomly selected cats. Leishmania species infection was evaluated using the indirect fluorescent antibody test (IFAT), setting a cut-off value of 1:80, and using real-time PCR on blood, conjunctival and hair samples. A complete blood count, serum chemistry profile, serum electrophoresis and urinalysis were also carried out. The cats were grouped on the basis of the results of the diagnostic criteria adopted in positive, negative and unconfirmed Leishmania cases. Non-parametric variables and continuous data were compared among the study groups using the χ2 test and the Mann–Whitney U-test, respectively. Results One hundred and fifty-two cats were included. Nineteen of the 152 (12.5%) cats were positive (18/152 [11.8%] showed an IFAT titre of ⩾1:80 and 1/152 [0.7%] was real-time PCR-positive from a hair sample); 106/152 (69.7%) cats were negative; and 27/152 (17.8%) cats were unconfirmed for Leishmania species. Total proteins, beta2-globulin and gamma-globulin were significantly increased in the positive Leishmania group compared with the negative group. Conclusions and relevance The results of the present study demonstrated the spread of Leishmania infantum infection in cats in Northern Italy. Hyperproteinaemia and hypergammaglobulinaemia appeared to be significant clinicopathological abnormalities in this population of cats with L infantum infection.
Short segment myelitis as the initial and only manifestation of aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorders
Authors: Fang* Wei , Zheng* Yang , Yang Fan , Cai Meng-Ting , Shen Chun-Hong , Liu Zhi-Rong , Zhang Yin-Xi , Ding Mei-Ping 
Published: January 2020

Background: Short segment myelitis (SSM, < 3 vertebral segments) is an under-recognized initial manifestation of neuromyelitis optica spectrum disorders (NMOSD). Though infrequent, failure to recognize SSM in patients with NMOSD would lead to incorrect diagnosis and treatment. Therefore, delineation of features of NMOSD-associated SSM is of paramount importance. Objective: Our study aimed to determine the demographic, clinical and radiological features of NMOSD-associated SSM, and compare those with NMOSD-associated longitudinally extensive transverse myelitis (LETM) and multiple sclerosis (MS)-associated SSM, respectively. Methods: Chinese patients presenting initially only with acute myelitis and diagnosed with NMOSD ( n = 46) and MS ( n = 11) were included. Clinical, serological, imaging and disability data were collected. Mann–Whitney U test or two-tailed Fisher’s exact tests were used to analyse the data. Results: Of the 46 enrolled NMOSD patients, 34 (74%) collectively had 38 LETM lesions, while 12 (26%) had 14 SSM lesions. When compared with LETM, NMOSD presenting with SSM were more likely to have a delayed diagnosis and a lower level of disability at nadir during the first attack. T1-weighted imaging hypointensity was more prominent in NMOSD-associated LETM lesions than NMOSD-associated SSM lesions. When compared with MS-associated SSM, NMOSD-associated SSM lesions were more likely to be centrally located, grey matter involving and transversally extensive on axial imaging and spanned no less than 2 vertebral segments on sagittal imaging. Conclusion: These findings suggest that SSM does not preclude the possibility of a NMOSD diagnosis. Testing for serum aquaporin-4 immunoglobulin G (AQP4-IgG) and careful study of lesions on spinal cord magnetic resonance imaging could aid in an earlier and correct diagnosis.
Multivariable non-invasive association of isocitrate dehydrogenase mutational status in World Health Organization grade II and III gliomas with advanced magnetic resonance imaging T2 mapping techniques
Authors: Kern Maike , Auer Timo A , Fehrenbach Uli , Tanyildizi Yasemin , Picht Thomas , Misch Martin , Wiener Edzard 
Published: January 2020

Aim To investigate multivariable analyses for noninvasive association of the isocitrate dehydrogenase (IDH) mutational status in grade II and III gliomas including evaluation of T2 mapping-sequences. Methods Magnetic resonance imaging (MRI) examinations with histopathologically proven World Health Organization grade II and III gliomas were retrospectively enrolled. Multivariate receiver operating characteristics (ROC) analyses to associate IDH mutational status were performed containing quantitative T2 mapping analyses and qualitative characteristics (sex, age, localization, heterogeneity, oedema, necrosis and diameter). Relaxation times were calculated pixelwise by means of standardized ROI analyses. Interobserver variability also was tested. Results Out of 32 patients (mean age: 50.7 years; range: 32–83), nine had grade II gliomas and 24 grade III, while 59.5% showed a positive IDH mutated state (IDHm) and 40.5% were wildtype (IDHw). Multivariable ROC analyses were calculated for relaxation time and range, localization and age with a cumulative 0.955 area under the curve (AUC) ( p < 0.001), while central T2-relaxation time had by far the highest single variable sensitivity (AUC: 0.873; range: 0.762; age: 0.809; localization: 0.713). Age (cut off: 49 years; p = 0.031) and localization ( p = 0.014) were the only qualitative parameters found to be significant as IDHw gliomas were older and IDHm gliomas were preferentially located fronto-temporal. Conclusions This is the first study evaluating quantitative T2 mapping sequences for association of the IDH mutational status in grade II and III gliomas demonstrating an association between relaxation time and mutational status. Analyses of T2 mapping relaxation times may even be suitable for predicting the correct IDH mutational state. Prognostic accuracy increases significantly in predicting the correct mutational state when combing T2 relaxation time characteristics and the qualitative MRI features age and localization.