12 research outputs found

    Back Reaction of 4D Conformal Fields on Static Geometry

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    Static, spherically symmetric solutions to the semi-classical Einstein equation are studied, including the effect of the quantum energy-momentum tensor for conformal matters with 4D Weyl anomaly. Through both perturbative and non-perturbative methods, we show that the quantum effect can play a crucial role in shaping the near-horizon geometry, and that the existence of the horizon requires fine-tuning.Comment: 35 pages, minor modificatio

    Early-stage antibody kinetics after the third dose of BNT162b2 mRNA COVID-19 vaccination measured by a point-of-care fingertip whole blood testing

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    Amid the Coronavirus Disease 2019 pandemic, we aimed to demonstrate the accuracy of the fingertip whole blood sampling test (FWT) in measuring the antibody titer and uncovering its dynamics shortly after booster vaccination. Mokobio SARS-CoV-2 IgM & IgG Quantum Dot immunoassay (Mokobio Biotechnology R&D Center Inc., MD, USA) was used as a point-of-care FWT in 226 health care workers (HCWs) who had received two doses of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) at least 8 months prior. Each participant tested their antibody titers before and after the third-dose booster up to 14-days. The effect of the booster was observed as early as the fourth day after vaccination, which exceeded the detection limit (>30,000 U/mL) by 2.3% on the fifth day, 12.2% on the sixth day, and 22.5% after the seventh day. Significant positive correlations were observed between the pre- and post-vaccination (the seventh and eighth days) antibody titers (correlation coefficient, 0.405; p<0.001). FWT is useful for examining antibody titers as a point-of-care test. Rapid response of antibody titer started as early as the fourth day post-vaccination, while the presence of weak responders to BNT162b2 vaccine was indicated

    Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency

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    Objective or Purpose To confirm the efficacy and safety of Good Manufacturing Practice (GMP)-compliant autologous cultivated limbal epithelial cell sheets in government-controlled clinical trials that adhered to Good Clinical Practice stipulations for patients with unilateral limbal stem cell deficiency (LSCD). Design A prospective, multi-center, open-label, uncontrolled, single-arm clinical trial. Subjects, Participants or Controls Ten consecutive eyes of 10 patients with unilateral LSCD were followed for two years after surgery. Preoperative LSCD stage was IIB in four eyes and III in six eyes. Methods A limbal tissue biopsy was obtained from the healthy eye, after which limbal stem cells were dissociated and cultivated on temperature-responsive culture surfaces. All cell sheets were fabricated in a GMP-grade facility under established standard operating procedures. Cell sheets were evaluated using defined shipment criteria before transplantation, and only those that met the criteria were used. The cell sheet was transplanted onto each of the patients' diseased eye after removing the conjunctival scar tissue that covered the corneal surface. The severity of LSCD was determined according to a staging method agreed upon by global consensus, with eyes evaluated as being in stages IA–C representing successful corneal epithelial reconstruction. LSCD diagnosis and staging were determined by the trial's Eligibility Judgment Committee and Effect Assessment Committee using slit-lamp photographs including fluorescein staining. Both committees comprised two or three third-party cornea specialists, who were provided with information anonymously and randomly. Main Outcome Measure Corneal epithelial reconstruction rate was the primary endpoint. Results Corneal epithelial reconstruction was successful in six of 10 eyes (60%) one year postoperatively and was significantly higher than the 15% clinically significant efficacy rate achieved by allogeneic limbal transplantation. The reconstruction rate was 70% of eyes two years postoperatively. Additionally, improvements in visual acuity were noted in 50% and 60% of eyes at one and two years, respectively. No clinically significant transplantation-related adverse events were observed. Conclusion The efficacy and safety of cultivated limbal epithelial cell sheet transplantation were thus confirmed, and the cell sheet, named Nepic, is now approved as a Cellular and Tissue-Based Product in Japan

    Controlling Nutritional Status (CONUT) Score is Associated with Overall Survival in Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Cohort Study

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    We aimed to investigate the impact of the controlling nutritional status (CONUT) score, an immuno-nutritional biomarker, on the prognosis of patients with hepatocellular carcinoma (HCC) treated with lenvatinib (LEN). This retrospective study enrolled 164 patients with HCC and treated with LEN (median age 73 years, Barcelona Clinic Liver Cancer (BCLC) stage B/C 93/71). Factors associated with overall survival (OS) were evaluated using multivariate and decision tree analyses. OS was calculated using the Kaplan&ndash;Meier method and analyzed using the log&ndash;rank test. Independent factors for OS were albumin&ndash;bilirubin grade 1, BCLC stage B, and CONUT score &lt;5 (hazard ratio (HR) 2.9, 95% confidence interval (CI) 1.58&ndash;5.31, p &lt; 0.001). The CONUT score was the most important variable for OS, with OS rates of 70.0% and 29.0% in the low and high CONUT groups, respectively. Additionally, the median survival time was longer in the low CONUT group than in the high CONUT group (median survival time not reached vs. 11.3 months, p &lt; 0.001). The CONUT score was the most important prognostic variable, rather than albumin&ndash;bilirubin grade and BCLC stage, in patients with HCC treated with LEN. Accordingly, immuno-nutritional status may be an important factor in the management of patients with HCC treated with LEN
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