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SUMMARY In this paper, we propose a parallel processing method of map simplification using spatial database that supports data management, spatial operations, and spatial queries. This method simplifies geometry figures in parallel without splitting original figures on boundaries of meshes that are conventionally used as rectangular data management units. The simplified result of our method has fewer vertices than a conventional method, since unnecessary vertices are not added in the simplification process. In order to evaluate the effectiveness of our method, its processing time and simplified results for actual map data are compared with those of the conventional method. [ABSTRACT FROM AUTHOR]

Crown heights of seawalls should be designed to suppress overtopping discharge to a permissible level. The permissible level is determined from viewpoints of the structure types of coastal seawalls and hinterland use. It is usually difficult to design the crown heights of seawalls, especially in the present time where climate change due to global warming is expected. This study analyzes climate change effects such as sea level rise (SLR) and increase of waves and surges on the failure probability of seawalls under various conditions of crown height, toe depth and slope by using a Level III reliability analysis. It was found that the difference of SLR trends (fast, medium or low) has less impact on overtopping rates than the differences in wave height change for a seawall at a target location. [ABSTRACT FROM AUTHOR]

The current study proposes prediction formulas both for random wave runup and mean overtopping discharge at seawalls constructed on land or in very shallow water. Although several existing formulas for runup and overtopping use the incident wave characteristics at the toes of seawalls, this study adopts the equivalent deepwater wave characteristics and an imaginary seawall slope for easy application of the formulas, especially in relation to seawalls constructed on land. The prediction formulas for overtopping use the predicted runup values. For the wave runup prediction formulas two sets of experimental data are used; i.e., a new set of data and the data obtained in a previous study. For the wave overtopping prediction formulas, the experimental data measured in a previous study are used. Comparisons with measurements show good performances of both new prediction methods. [ABSTRACT FROM AUTHOR]

Simple Summary: Ramucirumab has been shown to be effective as a second-line agent after sorafenib in hepatocellular carcinoma (HCC) patients whose α-fetoprotein was ≥400 ng/mL. We performed a retrospective cohort study to investigate ramucirumab efficacy in a real-world setting. Progression-free survival (PFS) was consistent through treatment lines, modified albumin–bilirubin (mALBI) grade, Barcelona Clinic for Liver Cancer (BCLC) stage, and α-fetoprotein (AFP) level. By contrast, ascites was more frequently seen in mALBI 2b/3 patients and, therefore, should be carefully monitored. Background: The present study aimed to clarify the efficacy and safety of ramucirumab in a real-world setting, including patients who experienced two or more systemic treatments or whose hepatic reserve was deteriorated. Methods: In total, 79 patients with hepatocellular carcinoma (HCC) from 14 institutes throughout Japan were retrospectively analyzed. The response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and AEs were recorded according to the Common Terminology Criteria for AEs (CTCAE) version 5.0. Results: Median overall survival (OS) in the total cohort was 7.5 months (m). Median OS was 8.8 m in patients who were administered ramucirumab as a second-line treatment, while it was 7.3 m in third- or later-line treatment. Progression-free survival rates in the second- and third- or later-line therapies were 3.2 m and 3.2 m, respectively. The disease control rate (DCR) in the study was 43%. There were no statistically significant differences in DCR between the treatment courses. Regarding adverse events (AEs), the development of ascites was observed significantly more frequently in modified albumin–bilirubin (mALBI) 2b/3 patients than in mALBI 1/2a patients (54.5% vs. 25.0%, p = 0.03). Conclusions: Ramucirumab is useful as a second-line therapy and feasible as a third- or later-line treatment for HCC. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to describe the real‐world efficacy and safety of sofosbuvir (SOF) + ribavirin (RBV) for chronic hepatitis C, genotype 2. Methods: This was a retrospective analysis of a nationwide, multicenter registry including 914 hepatitis C genotype 2 Japanese patients treated with SOF + RBV for 12 weeks. The rate of sustained virologic response at 12 weeks after treatment (SVR12), incidence of adverse events, and changes in serological parameters were analyzed. Results: Treatment was completed in 98.9% of patients. Ribavirin dose reduction was required in 29.7% of patients. The SVR12 rate was 96.8% in the intention‐to‐treat population and 97.6% in the per‐protocol population. Factors associated with SVR12 were absence of advanced fibrosis (odds ratio, 5.76, P = 0.003) and interferon‐treatment‐naïve status (odds ratio, 4.79, P = 0.017). Dose reduction or total adherence of RBV was not associated with SVR. The resistance‐associated substitution S282 T in NS5B was not detected in any patient at virologic failure. Serum albumin levels significantly increased, and the degree of increase was greater in patients with advanced fibrosis than in those without (0.21 ± 0.32 vs. 0.05 ± 0.29, P < 0.0001). Alpha‐fetoprotein decreased significantly at end of treatment (P < 0.0001), and the degree of decrease was greater in patients with advanced fibrosis than in those without (21.7 ± 60.8 vs. 2.5 ± 15.5, P < 0.001). The most commonly reported adverse event was anemia (13.7%). Conclusions: Treatment with SOF + RBV was highly effective and safe in Japanese patients with HCV genotype 2 infection. [ABSTRACT FROM AUTHOR]

Background: We aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection.Methods: This retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC).Results: Among the 1461 patients included (mean age, 69 years; 29.5% aged > 75 years; cirrhosis, 23.8%; history of treatment for HCC, 10.9%), the overall SVR12 rate was 98.4% (1438/1461). Factors associated with treatment failure were cirrhosis (odds ratio, 4.19; p = 0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p = 0.0004). The SVR12 rate in patients with cirrhosis and NS5A RASs was 93.0% compared to 100% in patients without cirrhosis or NS5A RASs. In patients with SVR, the levels of alpha-fetoprotein (AFP), AFP-L3, and Mac-2 binding protein glycosylation isomer (M2BPGi) decreased from baseline to end of treatment (from 13.4 ± 37.6 to 6.0 ± 10.6 ng/mL, p < 0.0001; from 2.2 ± 4.9 to 1.5 ± 6.3%, p < 0.005; and from 3.6 ± 3.7 to 2.0 ± 3.5 cut-off index, p < 0.0001; respectively). Adverse events were rare and not associated with age. No decrease in estimated glomerular filtration rate was observed in patients with baseline chronic kidney disease stage 3.Conclusions: LDV/SOF therapy is highly effective and safe in elderly Japanese patients with HCV GT1, even in the presence of cirrhosis or NS5A RASs. Patients with SVR may have a lower risk of HCC. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the virologic responses and clinical course of daclatasvir plus asunaprevir treatment in non‐hemodialysis (non‐HD) and hemodialysis (HD) patients infected with genotype 1 hepatitis C virus (HCV). Methods: A total of 1113 non‐HD patients and 67 HD patients were assessed. To evaluate pretreatment factors contributing to sustained virological response at 12 weeks (SVR12), univariate and multivariate analyses were carried out. To adjust for differences in patient background, propensity score matching was undertaken. Results: The overall SVR12 rates were 91.6% in non‐HD patients and 95.5% in HD patients. Compared with non‐HD patients, HD patients were younger, were more likely to be male, were less likely to have received interferon‐based pretreatment, had a lower viral load, and had lower levels of alanine transaminase, hemoglobin, and α‐fetoprotein. Multivariate analysis revealed that viral load, α‐fetoprotein, L31 substitution negative, and Y93 substitution negative were independent predictive factors for SVR12 in non‐HD patients. The proportion of patients with undetectable HCV‐RNA during the initial 4 weeks was significantly higher in HD patients than in non‐HD patients. The SVR12 rate was clearly higher in HD patients than in non‐HD patients, although the difference was not statistically significant. After propensity score matching to adjust for viral load, α‐fetoprotein, L31 substitution, and Y93 substitution, these trends disappeared. Conclusions: For treatment of HCV genotype 1 infection, daclatasvir plus asunaprevir is useful not only in non‐HD patients but also in HD patients. Viral load, α‐fetoprotein levels, L31 substitution, and Y93 substitution influence treatment course and outcome. [ABSTRACT FROM AUTHOR]

Backgrounds & Aims: We aimed to clarify the characteristics of resistance-associated substitutions (RASs) after treatment failure with NS5A inhibitor, daclatasvir (DCV) in combination with NS3/4A inhibitor, asunaprevir (ASV), in patients with chronic hepatitis C virus genotype 1b infection. Methods: This is a nationwide multicenter study conducted by the Japanese Red Cross Liver Study Group. The sera were obtained from 68 patients with virological failure after 24 weeks of DCV/ASV treatment. RASs in NS5A and NS3 were determined by population sequencing. Results: The frequency of signature RASs at position D168 of NS3 was 68%, and at positions L31 and Y93 of NS5A was 79 and 76%, respectively. The frequency of dual signature RASs in NS5A (L31-RAS and Y93-RAS) was 63%. RASs at L28, R30, P32, Q54, P58, and A92 in addition to dual signature RAS were detected in 5, 5, 1, 22, 2, and 0 patients, respectively. In total, triple, quadruple, and quintuple RASs in combination with dual signature RAS were detected in 35, 10, and 1.5% patients, respectively. These RASs were detected in patients without baseline RASs or who prematurely discontinued therapy. Co-existence of D168 RAS in NS3 and L31 and/or Y93 RAS in NS5A was observed in 62% of patients. Conclusion: Treatment-emergent RASs after failure with DCV/ASV combination therapy are highly complex in more than 50% of the patients. The identification of complex RAS patterns, which may indicate high levels of resistance to NS5A inhibitors, highlights the need for RAS sequencing when considering re-treatment with regimens including NS5A inhibitors. [ABSTRACT FROM AUTHOR]

Background: Endoscopic submucosal dissection (ESD) has been developed for early gastric cancer (EGC). Helicobacter pylori eradication therapy has been reported to have a preventive effect against metachronous recurrence of EGC after ESD. However, the efficacy and safety of eradication therapy on ESD-induced ulcer healing are not clear. In a randomized control study, we compared the standard therapy (8-week proton pump inhibitor) and eradication therapy combined with subsequent treatment with 7-week rebamipide for healing ESD-induced ulcers. Methods: A multicenter, randomized, open-label study was conducted. In group A, patients received 20 mg of omeprazole for 56 days. In group B, patients received 40 mg of omeprazole, 1,500 mg of amoxicillin, and 800 mg of clarithromycin for 7 days, and then 300 mg of rebamipide for 49 days. The primary end point was to evaluate the scarring ratio. Results: The scarring rate in group A was significantly higher than that in group B [85.0 % (34/40) vs. 56.8 % (21/37), P = 0.011]. The scarring rate of ulcers with an area ≥565.5 mm in group A was significantly higher than that in group B [78.9 % (15/19) vs. 37.5 % (6/16), P = 0.018]. There was no significant difference between the groups in the scarring rate of smaller ulcers. No serious adverse events were observed in any of the patients in either group. Conclusion: H. pylori eradication therapy and 7-week rebamipide monotherapy were not superior to PPI monotherapy, but this combination therapy for smaller sized ulcers was an optimal therapeutic option for healing. Serious adverse events were not observed in either group. [ABSTRACT FROM AUTHOR]

The field survey results obtained by the team of authors in the north of Miyagi Prefecture between April 1 and 6, 2011 are summarized referring to a part of the survey results by other teams of the 2011 Tohoku Earthquake Tsunami Joint Survey Group. The inundation height above sea level was measured using a laser range finder with a reflection prism. The inundation height was generally larger at bay heads, as well as promontory tips, except several points, which were sheltered by a peninsula or had a tapering area. The tsunamis reached inland far away from the sea along valleys and rivers. Not only steel frame buildings but also many reinforced concrete buildings were collapsed in Onagawa Town. According to the numerical results, the first of tsunamis from the west coast and the second of tsunamis from the east coast should come together in Utatsusaki Peninsula, which is consistent with the interviews to survivors. [ABSTRACT FROM AUTHOR]

Background and Aims: The hepatitis C virus (HCV) invariably shows wide heterogeneity in infected patients, referred to as a quasispecies population. Massive amounts of genetic information due to the abundance of HCV variants could be an obstacle to evaluate the viral genetic heterogeneity in detail. Methods: Using a newly developed massive-parallel ultra-deep sequencing technique, we investigated the viral genetic heterogeneity in 27 chronic hepatitis C patients receiving peg-interferon (IFN) &agr;2b plus ribavirin therapy. Results: Ultra-deep sequencing determined a total of more than 10 million nucleotides of the HCV genome, corresponding to a mean of more than 1000 clones in each specimen, and unveiled extremely high genetic heterogeneity in the genotype 1b HCV population. There was no significant difference in the level of viral complexity between immediate virologic responders and non-responders at baseline (p = 0.39). Immediate virologic responders (n = 8) showed a significant reduction in the genetic complexity spanning all the viral genetic regions at the early phase of IFN administration (p = 0.037). In contrast, non-virologic responders (n = 8) showed no significant changes in the level of viral quasispecies (p = 0.12), indicating that very few viral clones are sensitive to IFN treatment. We also demonstrated that clones resistant to directacting antivirals for HCV, such as viral protease and polymerase inhibitors, preexist with various abundances in all 27 treatment-nai&vuml;e patients, suggesting the risk of the development of drug resistance against these agents. Conclusion: Use of the ultra-deep sequencing technology revealed massive genetic heterogeneity of HCV, which has important implications regarding the treatment response and outcome of antiviral therapy. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial (RCT) is to investigate whether Spiral-thread sutures are superior to conventional sutures (0-Vicryl) for preventing uterine scar thinning following elective cesarean section. This multicenter, parallel-group RCT will be conducted in four hospitals across three medical regions in Japan to assess 200 women (≥20 years old) with singleton pregnancies who are scheduled to undergo cesarean sections. Eligible women will be randomly assigned (1:1 ratio) to receive either the conventional uterine suture continuous absorption thread, which is most commonly used in Japan, or the Spiral thread. The primary endpoint is the degree of scar thinning, measured by transvaginal ultrasonography 6–7 months postoperatively, to evaluate the position of the uterus (anterior or posterior tilt) and myometrial wound thickness. The degree of thinning will be compared between the groups, and four measurements (mm) of the thinning area, including caudal distance, depth of the depression, remaining thickness of the myometrium on the serous side of the most depressed area, and width of the depression, will be recorded in the sagittal view on transvaginal ultrasound. Secondary endpoints will include total operative time, suture application time (from birth to the end of uterine suturing), operative blood loss, number of additional Z -sutures or continuous sutures required to stop bleeding, maternal abnormality frequency (surgical complications and postoperative infections), surgeon's years of experience, and clinical interpretation of individual subscale scores. This study shall provide important evidence on the optimal suture for preventing hysterotomy wound thinning after the first cesarean section. National Institute of Public Health, Japan: jRCT1062200001 (May 7, 2020; https://rctportal.niph.go.jp/en/detail?trial%5fid=jRCT1062200001) and Okayama University Certified Review Board: CRB6180001 (April 9, 2020, version 3.0). [ABSTRACT FROM AUTHOR]

: ObjectivesDevelopment of oropharyngeal candidiasis is a frequently reported adverse effect of inhaled corticosteroid use, but the prevalence of esophageal candidiasis is unknown. The aim of this study was to estimate the prevalence of esophageal candidiasis among patients treated with an inhaled corticosteroid, fluticasone propionate.: MethodsUpper GI endoscopy was performed on 49 patients treated with inhaled fluticasone propionate to examine the prevalence of esophageal candidiasis. Of the patients, 36 had bronchial asthma and 13 had chronic obstructive pulmonary disease. To compare the prevalence with control patients, upper GI endoscopy was performed on 700 consecutive patients without malignancy or immunosuppression.: ResultsThe prevalence of esophageal candidiasis was 37% among patients treated with inhaled fluticasone propionate, whereas only 0.3% of the control patients had the infection. The prevalence was especially high among patients with diabetes mellitus or those who were treated with a high dose of inhaled fluticasone propionate. Moreover, a reduction in the daily dose of inhaled fluticasone propionate eliminated the infection in four of five patients.: ConclusionsEsophageal candidiasis is a common complication of inhaled corticosteroid use. [Copyright &y& Elsevier]