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To identify the characteristic diagnostic features of hepatocellular carcinoma (HCC) and focal nodular hyperplasia (FNH) in Fontan-associated liver disease (FALD) patients using dynamic gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI).Thirty-one FALD patients (mean age, 28.3 ± 7.2 years) with liver nodules who underwent dynamic Gd-EOB-DTPA-enhanced MRI were enrolled prospectively. Twenty-five patients (mean age, 72.8 ± 11.4 years) with hepatitis C virus (HCV)-related HCC constituted the control group. The tumour-to-liver signal intensity (SI) ratio was measured at 30, 60, 100, 180 seconds and 15 minutes, and the SI ratio was compared among FALD-HCC, FALD-FNH, and HCV-HCC.FALD-HCC exhibited weak early enhancement with mild washout in late phases. FALD-FNH exhibited marked early enhancement that continued until the late phases. The SI ratio was significantly lower for FALD-HCC than for FALD-FNH in all phases. The SI ratio was significantly lower for FALD-HCC than for HCV-HCC only at 30 seconds (p0.05), whereas poorer washout was seen in FALD-HCC than HCV-HCC in other phases. In 15 minutes, FALD-HCC had a significantly lower SI ratio compared to FALD-FNH (p0.001).The time course of Gd-EOB-DTPA-enhanced MRI signal intensity in FALD-HCC was different from that in FALD-FNH or HCV-HCC. This imaging finding may be useful adjunctive information to distinguish FALD-HCC from FALD-FNH.

Surgical antimicrobial prophylaxis (SAP) is one of the major purposes of antimicrobial use.To determine the adherence to the Japanese SAP guidelines in Japanese university hospitals.This was a retrospective cohort study including 15 general hospitals and one dental university hospital. Up to three cases of 18 designated surgeries were evaluated regarding adherence to Japanese SAP guidelines: selection of antibiotics, timing of administration, re-dosing intervals, and duration of SAP. When all items were appropriate, surgery was defined as 'appropriate'.In total, 688 cases (22-45 cases per surgery) were included. The overall appropriateness was 46.8% (322/688), and the appropriateness of each surgery ranged from 8.0% (2/25, cardiac implantable electronic device implantation) to 92.1% (35/38, distal gastrectomy). The appropriateness of each item was as follows: pre/intraoperative selections, 78.5% (540/688); timing of administrations, 96.0% (630/656); re-dosing intervals, 91.6% (601/656); postoperative selection, 78.9% (543/688); and duration of SAP, 61.4% (423/688). The overall appropriateness of hospitals ranged from 17.6% (9/51) to 73.3% (33/45). The common reasons for inappropriateness were the longer duration (38.5%, 265/688) and choice of antibiotics with a non-optimal antimicrobial spectrum before/during, and after surgery (19.0%, 131/688 and 16.9%, 116/688, respectively), compared to the guideline.Adherence to the guidelines differed greatly between the surgeries and hospitals. Large-scale multi-centre surveillance of SAP in Japanese hospitals is necessary to identify inappropriate surgeries, factors related to the appropriateness, and incidences of surgical site infections.

The *Kāśyapaparivarta, an early Mahāyāna sūtra, has a complex history. Sanskrit and Tibetan versions, and some of its Chinese translations, have been available to scholars for almost a century, thanks to Staël-Holstein’s 1926 editio princeps. Yet no comprehensive survey of available sources, or critical appraisal of their antecedants, has been published, and most importantly, essential Chinese materi- als have long been overlooked. The present contribution focuses most centrally on the Chinese translations of the scripture. In addition, the relation of the sūtra to the Mahāratnakūṭa collection of forty-nine texts and the possible Indic origins of the latter are explored.

We have investigated the local structure of BiS2-based layered materials by Bi L3-edge extended X-ray absorption fine structure (EXAFS) measurements performed on single crystal samples with polarization of the X-ray beam parallel to the BiS2 plane. The results confirm highly instable nature of BiS2 layer, characterized by ferroelectric like distortions. The distortion amplitude, determined by the separation between the two in-plane (Bi-S1) bonds, is found to be highest in LaO0.77F0.23BiS2 with ΔR∼0.26 Å and lowest in NdO0.71F0.29BiS2 with ΔR∼0.13 Å. Among the systems with intrinsic doping, CeOBiS2 shows smaller distortion (ΔR∼0.15 Å) than PrOBiS2 (ΔR∼0.18 Å) while the highest distortion appears for EuFBiS2 revealing ΔR∼0.22 Å. It appears that the distortion amplitude is controlled by the nature of the RE(O,F) spacer layer in the RE(O,F)BiS2 structure. The X-ray absorption near edge structure (XANES) spectra, probing the local geometry, shows a spectral weight transfer that evolves systematically with the distortion amplitude in the BiS2-layer. The results provide a quantitative measurements of the local distortions in the instable BiS2-layer with direct implication on the physical properties of these materials.

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Clinical Pharmacology Leadership Group (CPLG) held its first meeting of Japan‐based representatives at Astellas Pharma headquarters in Tokyo on October 1, 2019. The meeting was also attended by Japan Pharmaceutical Manufactures Association (JPMA) Clinical Pharmacology Task Force (CPTF) members. Overall, nearly 30 clinical pharmacologists representing 14 companies attended the event. The meeting met its goal of enhancing mutual understanding of each organization’s activities. In a number of break‐out sessions, participants identified scientific topics for potential future collaboration between JPMA CPTF and IQ CPLG.

High-performance computing resources allow us to conduct numerical simulations with a horizontal grid spacing that is sufficiently high to resolve cloud systems on a global scale, and high-resolution models (HRMs) generally provide better simulation performance than low-resolution models (LRMs). In this study, we execute a next-generation model that is capable of simulating global aerosols using version 16 of the Nonhydrostatic Icosahedral Atmospheric Model (NICAM.16). The simulated aerosol distributions are obtained for 3 years with an HRM using a global 14 km grid spacing, an unprecedentedly high horizontal resolution and long integration period. For comparison, a NICAM with a 56 km grid spacing is also run as an LRM, although this horizontal resolution is still high among current global aerosol climate models. The comparison elucidated that the differences in the various variables of meteorological fields, including the wind speed, precipitation, clouds, radiation fluxes and total aerosols, are generally within 10 % of their annual averages, but most of the variables related to aerosols simulated by the HRM are slightly closer to the observations than are those simulated by the LRM. Upon investigating the aerosol components, the differences in the water-insoluble black carbon and sulfate concentrations between the HRM and LRM are large (up to 32 %), even in the annual averages. This finding is attributed to the differences in the aerosol wet deposition flux, which is determined by the conversion rate of cloud to precipitation, and the difference between the HRM and LRM is approximately 20 %. Additionally, the differences in the simulated aerosol concentrations at polluted sites during polluted months between the HRM and LRM are estimated with normalized mean biases of −19 % for black carbon (BC), −5 % for sulfate and −3 % for the aerosol optical thickness (AOT). These findings indicate that the impacts of higher horizontal grid spacings on model performance for secondary products such as sulfate, and complex products such as the AOT, are weaker than those for primary products, such as BC. On a global scale, the subgrid variabilities in the simulated AOT and cloud optical thickness (COT) in the 1∘×1∘ domain using 6-hourly data are estimated to be 28.5 % and 80.0 %, respectively, in the HRM, whereas the corresponding differences are 16.6 % and 22.9 % in the LRM. Over the Arctic, both the HRM and the LRM generally reproduce the observed aerosols, but the largest difference in the surface BC mass concentrations between the HRM and LRM reaches 30 % in spring (the HRM-simulated results are closer to the observations). The vertical distributions of the HRM- and LRM-simulated aerosols are generally close to the measurements, but the differences between the HRM and LRM results are large above a height of approximately 3 km, mainly due to differences in the wet deposition of aerosols. The global annual averages of the effective radiative forcings due to aerosol–radiation and aerosol–cloud interactions (ERFari and ERFaci) attributed to anthropogenic aerosols in the HRM are estimated to be -0.293±0.001 and -0.919±0.004 W m−2, respectively, whereas those in the LRM are -0.239±0.002 and -1.101±0.013 W m−2. The differences in the ERFari between the HRM and LRM are primarily caused by those in the aerosol burden, whereas the differences in the ERFaci are primarily caused by those in the cloud expression and performance, which are attributed to the grid spacing. The analysis of interannual variability revealed that the difference in reproducibility of both sulfate and carbonaceous aerosols at different horizontal resolution is greater than their interannual variability over 3 years, but those of dust and sea salt AOT and possibly clouds were the opposite. Because at least 10 times the computer resources are required for the HRM (14 km grid) compared to the LRM (56 km grid), these findings in this study help modelers decide whether the objectives can be achieved using such higher resolution or not under the limitation of available computational resources.

This paper discusses the cloud/clear discrimination algorithm (CLAUDIA) and the cloud microphysical properties algorithm (CAPCOM), which are used by the Second-generation GLobal Imager (SGLI) aboard the GCOM-C satellite, launched in December 2017. Also described are the preliminary results of cloud products’ validation. CLAUDIA was validated by comparing cloud fractions derived from satellite data against data from whole-sky images captured by ground-based fisheye cameras. User’s accuracy and producer’s accuracy were mostly high at around 90%, and the resulting overall accuracy was also high, ranging from 83 to 100% (average of all sites was 90.5%). CLAUDIA has proven to be sufficiently accurate to apply a cloud mask to measurements and meets the requirements for releasing data for SGLI cloud flag products (the minimum for a successful GCOM-C mission). CAPCOM was evaluated by comparing cloud properties obtained by SGLI products against data from MODIS collection 6 products (MOD06). This was done for both ocean and land in the low to middle latitudes (60° N–60° S) from August 22, 2018 to September 14, 2018. The comparison showed good correlation coefficients for cloud optical thickness, effective particle radius, and cloud-top temperature for water clouds: 0.88 (0.83), 0.92 (0.88), and 0.94 (0.92) for ocean (land), respectively. CAPCOM data for ice cloud optical thickness correlated well with data from MODIS products: 0.86 (ocean) and 0.82 (land).

The Japan Meteorological Agency (JMA) successfully launched the Himawari-8 (H-8) new-generation geostationary meteorological satellite with the Advanced Himawari Imager (AHI) sensor on October 7, 2014. The H-8/AHI level-2 (L2) operational cloud property products were released by the Japan Aerospace Exploration Agency during September 2016. The Voronoi light scattering model, which is a fractal ice particle habit, was utilized to develop the retrieval algorithm called “Comprehensive Analysis Program for Cloud Optical Measurement” (CAPCOM-INV)-ice for the AHI ice cloud product. In this paper, we describe the CAPCOM-INV-ice algorithm for ice cloud products from AHI data. To investigate its retrieval performance, retrieval results were compared with 2000 samples of the ice cloud optical thickness and effective particle radius values. Furthermore, AHI ice cloud products are evaluated by comparing them with the MODIS collection-6 (C6) products. As an experiment, cloud property retrievals from AHI measurements, with an observation interval time of 2.5 min and ground-based rainfall observation radar data (the latter of which is supplied by the JMA, with a 1-km grid mesh), are used to investigate the generation processes of deep convective (DC) cloud in the vicinity of the Kyushu island, Japan. It revealed that AHI measurements have the capability of monitoring the growth processes, including variation of the cloud properties and the precipitation in the DC cloud.

This study newly applies measurements from two geostationary satellites, the Advanced Himawari Imager (AHI) onboard the geostationary satellite Himawari-8 and the Geostationary Ocean Color imager (GOCI) onboard the geostationary satellite COMS, to evaluate a unique regional aerosol-transport model coupled to a non-hydrostatic icosahedral atmospheric model (NICAM) at a high resolution without any nesting technique and boundary conditions of the aerosols. Taking advantage of the unique capability of these geostationary satellites to measure aerosols with unprecedentedly high temporal resolution, we focus on a target area (115°E-155°E, 20°N-50°N) in East Asia in May 2016, which featured the periodic transport of industrial aerosols and a very heavy aerosol plume from Siberian wildfires. The aerosol optical thickness (AOT) fields are compared among the AHI, GOCI, MODIS, AERONET and NICAM data. The results show that both AHI- and GOCI-retrieved AOTs were generally comparable to the AERONET-retrieved ones, with high correlation coefficients of approximately 0.7 in May 2016. They also show that NICAM successfully captured the detailed horizontal distribution of AOT transported from Siberia to Japan on the most polluted day (18 May 2016). The monthly statistical metrics, including correlation between the model and either AHI or GOCI, are estimated to be >0.4 in 42–49% of the target area. With the aid of sensitivity model experiments with and without Siberian wildfires, it was found that a long-range transport of aerosols from Siberian wildfires (from as far as 3000 km) to Japan influenced the monthly mean aerosol levels, accounting for 7–35% of the AOT, 26–49% of the surface PM2.5 concentrations, and 25–66% of the aerosol extinction above 3 km in height over Japan. Therefore, the air pollutants from Siberian wildfire cannot be ignored for the spring over Japan.

The development of more sustainable societies has become an urgent goal worldwide. Electrical batteries are currently seen as one of the most important energy storage technologies for the development of decarbonized societies. However, many lithium-ion battery manufacturers currently utilize cobalt, a toxic and hazardous mineral, in their batteries. Lithium-deficient manganese nickel oxide spinels are considered promising candidates owing to their high potential and environmental friendliness. Their electrochemical performance highly depends on their average and local structures, such as phase purities, lattice parameters, and cation sites. Thus, a synthesis protocol should be designed to control these structural parameters to improve their electrochemical performance. In this study, we controlled the average and local structures of Li

This TB focuses on the electrical insulation systems at cryogenic temperatures as one of the common and critical issues for the efficient, reliable and practical development of superconducting power apparatus, fusion reactors, accelerators and industry applications. The dielectric and thermomechanical properties with physical mechanisms of insulation materials at cryogenic temperatures, and the state-of-the-art R&D projects on superconducting power apparatus with their design, test and failure experiences are summarized.

Background 13N-ammonia PET (NH3-PET) can detect myocardial perfusion abnormalities in patients with coronary artery disease (CAD) and also obtain diagnostic quantitative values of absolute myocardial blood flow and myocardial flow reserve (MFR). Low MFR (MFR Purpose We aimed to investigate the affect of LAP to MFR in intermediate CAD. Methods One hundred five patients (age 67±9 years, 65% male) with CAD underwent NH3-PET and CCTA within 6 months between April 2015 and March 2019 were enrolled. Based on the results of CCTA, mild and moderate stenosis were defined as 1% to 49% and 50% to 69% stenosis. Ischemic territories for major three vessels were identified by stress/rest NH3-PET images. Finally, 194 coronary arteries with mild to moderate stenosis corresponding to non-ischemic territory were analyzed in this study. LAP was defined as plaques containing CT value less than 90HU. Partially calcified plaques were included in LAP. Entirely calcification plaque without LAP was defined as calcified plaque. MFR for major three vessels were calculated from dynamic scan at stress/rest NH3-PET. Results CCTA showed 80 coronary arteries with LAP (41%), 104 coronary arteries with calcified plaque (54%), 102 vessels with mild stenosis (53%), and 92 vessels with moderate stenosis (47%). MFRs for coronary arteries with LAP were significantly lower than those without LAP (2.1±0.6 vs 2.5±0.6, p In 58 coronary arteries with MFR Conclusion The presence of LAP burdens MFR in mild to moderate CAD. On the other hand, calcified plaque alone had no adverse effect on MFR. LAP is an important sign in CAD risk assessment even without significant coronary stenosis. MFR and stress MPI Funding Acknowledgement Type of funding source: None

We developed a new aerosol retrieval algorithm combining a numerical aerosol forecast. In the retrieval algorithm, the short-term forecast from an aerosol data assimilation system was used for a priori estimate instead of spatially and temporally constant values. This method was demonstrated using the Advanced Himawari Imager onboard the Japan Meteorological Agency’s geostationary satellite Himawari-8, and the results showed spatially finer distributions than the model forecast and less noisy distributions than the original algorithm. We validated the new algorithm using ground observation data and found that the aerosol parameters detectable by satellite sensors were retrieved more accurately than a priori model forecast by adding satellite information. Moreover, the retrieval accuracy was improved by using the model forecast as compared with using constant a priori estimates. By using the assimilated forecast for a priori estimate, information from previous observations can be propagated to future retrievals, thereby leading to better retrieval accuracy. Observational information from the satellite and aerosol transport by the model is incorporated cyclically to effectively estimate the optimum field of aerosol.

Leachables from pharmaceutical container closure systems are a subset of impurities that present in drug products and may pose a risk to patients or compromise product quality. Extractable studies can identify potential leachables, and extractables and leachables (ELs) should be evaluated during development of the impurity control strategy. Currently, there is a lack of specific regulatory guidance on how to risk assess ELs; this may lead to inconsistency across the industry. This manuscript is a cross-industry Extractables and Leachables Safety Information Exchange (ELSIE) consortium collaboration and follow-up to Broschard et al. (2016), which aims to provide further clarity and detail on the conduct of EL risk assessments. Where sufficient data are available, a health-based exposure limit termed Permitted Daily Exposure (PDE) may be calculated and to exemplify this, case studies of four common ELs are described herein, namely bisphenol-A, butylated hydroxytoluene, Irgafos® 168, and Irganox® 1010. Relevant discussion points are further explored, including the value of extractable data, how to perform route-to-route extrapolations and considerations around degradation products. By presenting PDEs for common EL substances, the aim is to encourage consistency and harmony in approaches for deriving compound-specific limits.

形態: カラー図版あり, Physical characteristics: Original contains color illustrations, Accepted: 2017-12-22, 資料番号: PA1810010000

形態: カラー図版あり, Physical characteristics: Original contains color illustrations, 資料番号: PA1910017000

形態: カラー図版あり, Physical characteristics: Original contains color illustrations, 資料番号: PA1810011000

形態: カラー図版あり, Physical characteristics: Original contains color illustrations, 資料番号: PA1810046000

Purpose Papillary muscle ischemia (PMI) is caused by micro-vessels' occlusion in the broad endocardium because papillary muscle perfusion is supply from micro-vessels of peripheral coronary arteries and is easy to fail by the increase in peripheral vascular resistance. However, the clinical significant is not understood because PMI could not be detected by existing perfusion imaging such as SPECT and MRI. We propose the detection method of PMI using 13N-ammonia PET (NH3-PET), and investigate the association with the global myocardial flow reserve (Global-MFR) reflecting coronary microvascular dysfunction. Methods Data of adenosine-stress NH3-PET for consecutive 260 patients with coronary artery disease (CAD) or suspected CAD was retrospectively analyzed. Using high-resolution cine imaging derived from NH3-PET, PMI was defined as the absence of the PM accumulation at stress conditions. Myocardial flow was generated from the time activity curve of left ventricle input and myocardial uptake using 3-compartment model and the first 2 minutes' dataset of list mode images. Global-MFR was calculated by stress to rest flow ratio. Summed stress score (SSS) was used as an estimate of the extent of myocardial ischemia. 150 out of 260 patients (58%) with SSS ≥4 or with the past history of coronary artery diseases were classified as ischemic group, and 110 patients (42%) with SSS Results PMI was seen in 68 of 260 patients (26.6%). The frequency of PMI was higher in the ischemic group than the non-ischemic group (37.8% vs. 10.1%, p Typical case of PMI Conclusion High-resolution cine imaging derived from NH3-PET makes it possible to detect PMI in about a quarter of patients with CAD or suspected CAD. PMI associates with reduced Global-MFR regardless of the presence of myocardial ischemia, suggesting that PMI is an important sign of early ischemia confined to the papillary muscle or the broad microvascular injury.

Purpose Risk stratification and early detection of cardiac allograft vasculopathy (CAV) are essential in heart transplantation patients. CAV is associated with poor outcome in the chronic phase after heart transplantation. CAV presents a diffuse vascular involvement and has been difficult to noninvasively diagnose by the lack of a sensitive method to detect developing vascular pathology in the allograft. The present study investigates the ability of 13N-ammonia PET for detection of CAV in heart transplant patients. Methods Data of adenosine-stress 13N-ammonia PET imaging for thirty-one patients (mean age, 39 years-old) after 11 + 7 years from transplant was analyzed. Five patients had undergone percutaneous coronary intervention (PCI), and the remaining 26 patients had no history of definite myocardial ischemia. Myocardial flow was generated from the time activity curve of left ventricle input and myocardial uptake using 3-compartment model and the first 2 minutes' dataset of list-mode acquisition. Global - myocardial flow reserve (MFR) was calculated by stress to rest flow ratio. Patient with global-MFR 2 was identified as those having significant ischemia. Results The mean Global-MFR of our subjects were 2.3 (1.2 to 3.9). MFR using 13N-ammonia PET significantly decreases in one third of heart transplant patients in chronic stage. Eleven patients with Global-MFR 2 (26%) including three patients having a history of PCI. The proportion of patients with a history of PCI tends to be high with SDS >2 (38% vs 9%, p=0.056). Conclusion This modality using 13N ammonia PET is useful for easily detection of CAV before manifestation of symptomatic myocardial ischemia in heart transplant patients.

Japanese geostationary meteorological satellite "Himawari-8" was launched in October 2014. Japan Meteorology Agency (JMA) started its official operation of Himawari-8 satellite in July 2015. Japan Aerospace Exploration Agency (JAXA) has been developing the geophysical retrieval algorithms from Himawari observation data and has been generating the products since August 2015 in an attempt to seek synergies between Himawari and JAXA’s Earth observation satellites, especially with the Global Change Observation Mission – Climate (GCOM-C), which was launched in December 2017. Several algorithms developed for GCOM-C was applied to Himawari data to produce consistent dataset, taking the opportunity of both satellites loading a multispectral imaging sensor. Application of Himawari products in numerical models and synergies with GCOM – Water (GCOM-W) are also shown.

Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace. This includes the development of guidelines or "resolutions" and normative instructions describing the Brazilian medicines agency's (Anvisa) expectations for demonstrating OINDP therapeutic equivalence. The Anvisa regulatory framework for OINDP therapeutic equivalence, challenges, and comparisons with the US Food and Drug Administration and European Medicines Agency approaches are assessed and discussed.