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  • 1
    Online Resource
    Online Resource
    Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
    BMJ ; 2018
    In:  BMJ Open Vol. 8, No. 5 ( 2018-05), p. e019083-
    Details
    In: BMJ Open, BMJ, Vol. 8, No. 5 ( 2018-05), p. e019083-
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2017-019083
    DOI: 10.1136/bmjopen-2017-019083.supp1
    DOI: 10.1136/bmjopen-2017-019083.supp2
    DOI: 10.1136/bmjopen-2017-019083.supp3
    DOI: 10.1136/bmjopen-2017-019083.supp4
    DOI: 10.1136/bmjopen-2017-019083.supp5
    DOI: 10.1136/bmjopen-2017-019083.supp6
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2599832-8
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  • 2
    Online Resource
    Online Resource
    Randomized trial of granulocyte colony-stimulating factor for spinal cord injury
    Oxford University Press (OUP) ; 2021
    In:  Brain Vol. 144, No. 3 ( 2021-04-12), p. 789-799
    Details
    In: Brain, Oxford University Press (OUP), Vol. 144, No. 3 ( 2021-04-12), p. 789-799
    Abstract: Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 μg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. The present trial failed to show a significant effect of G-CSF in primary end point.
    Type of Medium: Online Resource
    ISSN: 0006-8950 , 1460-2156
    URL: Article
    DOI: 10.1093/brain/awaa466
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 1474117-9
    SSG: 12
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  • 3
    Online Resource
    Online Resource
    Peritoneal Dialysis Guidelines 2019 Part 2: Main Text (Position paper of the Japanese Society for Dialysis Therapy)
    Springer Science and Business Media LLC ; 2021
    In:  Renal Replacement Therapy Vol. 7, No. 1 ( 2021-12)
    Details
    In: Renal Replacement Therapy, Springer Science and Business Media LLC, Vol. 7, No. 1 ( 2021-12)
    Abstract: This article is a duplicated publication from the Japanese version of “2019 JSDT Guidelines for Peritoneal Dialysis” with permission from the Japanese Society for Dialysis Therapy (JSDT). This clinical practice guideline (CPG) was developed primarily by the Working Group on Revision of Peritoneal Dialysis (PD) Guidelines of the Japanese Society for Dialysis Therapy. Recently, the definition and creation process for CPGs have become far more rigorous; traditional methods and formats no longer adhere to current standards. To improve the reliability of international transmission of our findings, CPGs are created in compliance with the methodologies developed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group. Part 2 of this PD guideline is the first CPG developed by our society that conforms to the GRADE approach. Methods Detailed processes were created in accordance with the Cochrane handbook and the GRADE approach developed by the GRADE working group. Results Clinical question (CQ)1: Is the use of renin-angiotensin system inhibitors (RAS inhibitors), such as angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB ) , effective in PD patients? Recommendation: We suggest the usage of RAS inhibitors (ACEI and ARB) in PD patients (GRADE 2C). CQ2: Icodextrin or glucose solution: which is more useful as a dialysate among patients with PD? Recommendation: We suggest using icodextrin when managing body fluids in PD patients (GRADE 2C). CQ3: Is it better to apply or not apply mupirocin/gentamicin ointment to the exit site? Recommendation: We suggest not applying mupirocin/gentamicin ointment to the exit sites of PD patients (GRADE 2C). CQ4: Which surgical approach is more desirable when a PD catheter is placed, open surgery or laparoscopic surgery? No recommendation. CQ5: Which administration route of antibiotics is better in PD patients with peritonitis, intravenous or intraperitoneal? Recommendation: We suggest intraperitoneal administration of antibiotics in PD patients with peritonitis (GRADE 2C). Note: The National Insurance does not currently cover intraperitoneal administration. CQ6: Is peritoneal dialysis or hemodialysis better as the first renal replacement therapy in diabetic patients? No recommendation. Conclusions In the future, we suggest that society members construct their own evidence to answer CQs not brought up in this guideline, and thereby show the achievements of Japan worldwide.
    Type of Medium: Online Resource
    ISSN: 2059-1381
    URL: Article
    DOI: 10.1186/s41100-021-00361-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2866852-2
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  • 4
    Online Resource
    Online Resource
    A 4D-Var inversion system based on the icosahedral grid model (NICAM-TM 4D-Var v1.0) – Part 2: Optimization scheme and identical twin experiment of atmospheric CO〈sub〉2〈/sub〉 inversion
    Copernicus GmbH ; 2017
    In:  Geoscientific Model Development Vol. 10, No. 6 ( 2017-06-15), p. 2201-2219
    Details
    In: Geoscientific Model Development, Copernicus GmbH, Vol. 10, No. 6 ( 2017-06-15), p. 2201-2219
    Abstract: Abstract. A four-dimensional variational method (4D-Var) is a popular technique for source/sink inversions of atmospheric constituents, but it is not without problems. Using an icosahedral grid transport model and the 4D-Var method, a new atmospheric greenhouse gas (GHG) inversion system has been developed. The system combines offline forward and adjoint models with a quasi-Newton optimization scheme. The new approach is then used to conduct identical twin experiments to investigate optimal system settings for an atmospheric CO2 inversion problem, and to demonstrate the validity of the new inversion system. In this paper, the inversion problem is simplified by assuming the prior flux errors to be reasonably well known and by designing the prior error correlations with a simple function as a first step. It is found that a system of forward and adjoint models with smaller model errors but with nonlinearity has comparable optimization performance to that of another system that conserves linearity with an exact adjoint relationship. Furthermore, the effectiveness of the prior error correlations is demonstrated, as the global error is reduced by about 15 % by adding prior error correlations that are simply designed when 65 weekly flask sampling observations at ground-based stations are used. With the optimal setting, the new inversion system successfully reproduces the spatiotemporal variations of the surface fluxes, from regional (such as biomass burning) to global scales. The optimization algorithm introduced in the new system does not require decomposition of a matrix that establishes the correlation among the prior flux errors. This enables us to design the prior error covariance matrix more freely.
    Type of Medium: Online Resource
    ISSN: 1991-9603
    URL: Article
    DOI: 10.5194/gmd-10-2201-2017
    Language: English
    Publisher: Copernicus GmbH
    Publication Date: 2017
    detail.hit.zdb_id: 2456725-5
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  • 5
    Online Resource
    Online Resource
    Effect of febuxostat on left ventricular diastolic function in patients with asymptomatic hyperuricemia: a sub analysis of the PRIZE Study
    Springer Science and Business Media LLC ; 2022
    In:  Hypertension Research Vol. 45, No. 1 ( 2022-01), p. 106-115
    Details
    In: Hypertension Research, Springer Science and Business Media LLC, Vol. 45, No. 1 ( 2022-01), p. 106-115
    Abstract: Hyperuricemia is related to an increased risk of cardiovascular events from a meta-analysis and antihyperuricemia agents may influence to cardiac function. We evaluated the effect of febuxostat on echocardiographic parameters of diastolic function in patients with asymptomatic hyperuricemia as a prespecified endpoint in the subanalysis of the PRIZE study. Patients in the PRIZE study were assigned randomly to either add-on febuxostat treatment group or control group with only appropriate lifestyle modification. Of the 514 patients in the overall study, 65 patients (31 in the febuxostat group and 34 in the control group) who had complete follow-up echocardiographic data of the ratio of peak early diastolic transmitral flow velocity (E) to peak early diastolic mitral annular velocity (e′) at baseline and after 12 and 24 months were included. The primary endpoint was a comparison of the changes in the E/e′ between the two groups from baseline to 24 months. Interestingly, e′ was slightly decreased in the control group compared with in the febuxostat group (treatment p  = 0.068, time, p  = 0.337, treatment × Time, p  = 0.217). As a result, there were significant increases in E/e′ (treatment p  = 0.045, time, p  = 0.177, treatment × time, p  = 0.137) after 24 months in the control group compared with the febuxostat group. There was no significant difference in the serum levels of N-terminal-pro brain natriuretic peptide and high-sensitive troponin I between the two groups during the study period. In conclusions, additional febuxostat treatment in patients with asymptomatic hyperuricemia for 24 months might have a potential of preventable effects on the impaired diastolic dysfunction.
    Type of Medium: Online Resource
    ISSN: 0916-9636 , 1348-4214
    URL: Article
    DOI: 10.1038/s41440-021-00752-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2110941-2
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  • 6
    Online Resource
    Online Resource
    A conjugate BFGS method for accurate estimation of a posterior error covariance matrix in a linear inverse problem
    Wiley ; 2020
    In:  Quarterly Journal of the Royal Meteorological Society Vol. 146, No. 732 ( 2020-10), p. 3118-3143
    Details
    In: Quarterly Journal of the Royal Meteorological Society, Wiley, Vol. 146, No. 732 ( 2020-10), p. 3118-3143
    Abstract: One effective data assimilation/inversion method is the four‐dimensional variational method (4D‐Var). However, it is a non‐trivial task for a conventional 4D‐Var to estimate a posterior error covariance matrix. This study proposes a method to estimate a posterior error covariance matrix applied to the linear inverse problem of an atmospheric constituent. The method was constructed within a 4D‐Var framework using a quasi‐Newton method with the Broyden–Fletcher–Goldfarb–Shanno (BFGS) algorithm. The proposed method was constructed such that conjugacy among the set of increment vector pairs was ensured. It is theoretically demonstrated that, when this conjugate property is coupled with preconditioning, an analytical solution of a posterior error covariance matrix could be obtained from the same number of vector pairs as observations. Furthermore, to accelerate the speed of convergence, the method can be coupled with an ensemble approach. By performing a simple advection test, it was confirmed that the proposed method could obtain an analytical matrix of the posterior error covariance within the same number of iterations as the observations. Furthermore, the method was also evaluated using an atmospheric CO 2 inverse problem, which demonstrated its practical utility. The evaluation revealed that the proposed method could provide accurate estimates not only of the diagonal but also of the off‐diagonal elements of the posterior error covariance matrix. Although far more expensive than optimal state estimation, the computational efficiency was found to be reasonable for practical use, especially in conjunction with an ensemble approach. The accurate estimation of a posterior error covariance matrix resulting from the proposed method could provide valuable quantitative information regarding the uncertainties of estimated variables as well as the observational impacts, which would be beneficial for designing observation networks. Furthermore, error correlations derived from the estimated off‐diagonal elements could benefit the interpretation of optimised parameter variations.
    Type of Medium: Online Resource
    ISSN: 0035-9009 , 1477-870X
    URL: Issue
    URL: Article
    DOI: 10.1002/qj.v146.732
    DOI: 10.1002/qj.3838
    RVK:
    UA 1000
    RVK:
    UA 7650
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 3142-2
    detail.hit.zdb_id: 2089168-4
    SSG: 14
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  • 7
    Online Resource
    Online Resource
    Phase I study of glasdegib ( PF ‐04449913), an oral smoothened inhibitor, in Japanese patients with select hematologic malignancies
    Wiley ; 2017
    In:  Cancer Science Vol. 108, No. 8 ( 2017-08), p. 1628-1633
    Details
    In: Cancer Science, Wiley, Vol. 108, No. 8 ( 2017-08), p. 1628-1633
    Abstract: The hedgehog signaling pathway regulates multiple morphogenetic processes during embryogenesis. Aberrant activation of the hedgehog pathway signal transduction in adult tissues is associated with the pathogenesis of hematologic malignancies and solid tumors. We report findings from an open‐label, multicenter phase I trial of the selective, small‐molecule hedgehog signaling inhibitor glasdegib ( PF ‐04449913) in Japanese patients with select advanced hematologic malignancies. Glasdegib was administered as once‐daily oral doses (25, 50 and 100 mg) in 28‐day cycles after a lead‐in dose on Day −5. The primary objectives were to determine first‐cycle dose‐limiting toxicities, safety, vital signs and laboratory test abnormalities. Secondary objectives included evaluation of pharmacokinetics, pharmacodynamics and preliminary evidence of clinical activity of glasdegib. No dose‐limiting toxicities were noted in the 13 patients in the present study. All patients experienced at least one treatment‐emergent, all‐causality adverse event. The most frequent treatment‐related adverse events (observed in ≥3 patients) were dysgeusia ( n  = 9), muscle spasms ( n  = 5), alopecia, decreased appetite ( n  = 4 each), and increased blood creatinine phosphokinase, constipation and diarrhea ( n  = 3 each). Two deaths occurred during the study and were deemed not to be treatment‐related due to disease progression. Glasdegib demonstrated dose‐proportional pharmacokinetics, marked downregulation of the glioma‐associated transcriptional regulator GLI 1 expression in normal skin, and evidence of preliminary clinical activity, although data are limited. Glasdegib was safe and well tolerated across the dose levels tested. It is confirmed that the 100‐mg dose is safe and tolerable in Japanese patients, and this dose level will be examined in the future clinical trial.
    Type of Medium: Online Resource
    ISSN: 1347-9032 , 1349-7006
    URL: Issue
    URL: Article
    DOI: 10.1111/cas.2017.108.issue-8
    DOI: 10.1111/cas.13285
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2115647-5
    detail.hit.zdb_id: 2111204-6
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  • 8
    Online Resource
    Online Resource
    Three-dimensional transesophageal echocardiographic morphological evaluation of the tricuspid valve
    Oxford University Press (OUP) ; 2022
    In:  Interactive CardioVascular and Thoracic Surgery Vol. 35, No. 2 ( 2022-07-09)
    Details
    In: Interactive CardioVascular and Thoracic Surgery, Oxford University Press (OUP), Vol. 35, No. 2 ( 2022-07-09)
    Abstract: OBJECTIVES The morphology of the tricuspid valve (TV), particularly valves with two posterior leaflets, is attracting attention. The present study was performed to investigate the usefulness of three-dimensional transoesophageal echocardiographic data for morphological evaluation of the TV . METHODS Sixty patients underwent morphological evaluation of the TV by preoperative transoesophageal echocardiography followed by TV repair with median sternotomy, and each leaflet was measured intraoperatively. We analysed the TV morphology in 51 patients whose preoperative echocardiographic findings were consistent with intraoperative findings. RESULTS The mid-systolic echo data, which included the annulus diameter of each leaflet, were correlated with the intraoperative evaluation findings compared with those in the mid-diastole. The annulus and area of the posterior leaflet were larger in patients with two than one posterior leaflet valve (42.4 ± 13.5 vs 30.7 ± 9.1 mm, P  & lt; 0.001 and 327 ± 185 vs 208 ± 77 mm2, P = 0.006, respectively). In the severe tricuspid regurgitation patients, the annulus of the posterior leaflet was larger and the annulus of the anterior leaflet was smaller in patients with two than one posterior leaflet valve [posterior: 48 mm [95% confidence interval (CI), 41–54 mm] vs 36 mm (95% CI, 27–45 mm), respectively; P = 0.043 and anterior: 38 mm (95% CI, 33–42 mm) vs 46 mm (95% CI, 40–52 mm), respectively; P = 0.025] . CONCLUSIONS Patients who had a TV with two posterior leaflets had a larger annulus and area of the posterior leaflets. Preoperative three-dimensional transoesophageal echocardiography is useful for the morphological evaluation of the TV.
    Type of Medium: Online Resource
    ISSN: 1569-9293 , 1569-9285
    URL: Article
    DOI: 10.1093/icvts/ivac145
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2096257-5
    detail.hit.zdb_id: 3167862-2
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  • 9
    Online Resource
    Online Resource
    Vagal response in cryoballoon ablation of atrial fibrillation and autonomic nervous system: Utility of epicardial adipose tissue location
    Wiley ; 2017
    In:  Journal of Arrhythmia Vol. 33, No. 4 ( 2017-08), p. 275-282
    Details
    In: Journal of Arrhythmia, Wiley, Vol. 33, No. 4 ( 2017-08), p. 275-282
    Abstract: Mechanism and effects of vagal response (VR) during cryoballoon ablation procedure on the cardiac autonomic nervous system (ANS) are unclear. The present study aimed to evaluate the relationship between VR during cryoballoon catheter ablation for atrial fibrillation and ANS modulation by evaluating epicardial adipose tissue (EAT) locations and heart rate variability (HRV) analysis. Methods Forty‐one patients with paroxysmal atrial fibrillation (11 with VR during the procedure and 30 without VR) who underwent second‐generation cryoballoon ablation were included. EAT locations and changes in HRV parameters were compared between the VR and non‐VR groups, using Holter monitoring before ablation, immediately after ablation and one month after ablation. Results The total EAT volume surrounding the left atrium (LA) in the VR and non‐VR groups was 29.0±18.4 cm 3 vs 27.7±19.7 cm 3 , respectively ( p =0.847). The VR group exhibited greater EAT volume overlaying the LA‐left superior pulmonary vein (PV) junction (6.1±3.6 cm 3 vs 3.6±3.3 cm 3 , p =0.039) than the non‐VR group. HRV parameters similarly changed following ablation in both the groups. EAT volume overlaying LA‐right superior PV junction was significantly correlated with the relative changes in root‐mean‐square successive differences ( r =−0.317, p =0.043) and high frequency ( r =−0.331, p =0.034), immediately after the ablation. Conclusions Changes in HRV parameters following ablation were similarly observed in both the groups. EAT volume on the LA‐PV junction is helpful for interpretation of VR occurrence and ANS modulation.
    Type of Medium: Online Resource
    ISSN: 1880-4276 , 1883-2148
    URL: Article
    DOI: 10.1016/j.joa.2017.03.001
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2696593-8
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  • 10
    Online Resource
    Online Resource
    Factors associated with carotid intima-media thickness progression in patients with asymptomatic hyperuricemia: insights from the PRIZE study
    Springer Science and Business Media LLC ; 2023
    In:  Scientific Reports Vol. 13, No. 1 ( 2023-07-05)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2023-07-05)
    Abstract: Hyperuricemia is reportedly associated with the progression of carotid intima-media thickness (IMT), a surrogate of cardiovascular risks and events. However, factors associated with carotid IMT progression in patients with asymptomatic hyperuricemia are largely unknown. In this post-hoc analysis of the multicenter, randomized PRIZE study, we analyzed data from a total of 326 patients who underwent carotid ultrasonography in a blind manner at baseline and 24 months to evaluate carotid IMT. Mean and maximum IMT at the common carotid artery (CCA) were measured at a central core laboratory. Factors related to the absolute change in mean and maximum IMT from baseline to 24 months were explored. Overall, the adjusted mean [0.0032 (− 0.0214 to 0.0278) mm] and maximum [0.0011 (− 0.0327 to 0.0351) mm] CCA-IMT increased numerically from baseline to 24 months. Multivariable analysis identified higher body mass index, history of atherosclerotic cardiovascular disease (ASCVD), and lower mean CCA-IMT at baseline as significant factors associated with the increase in mean CCA-IMT. In addition, older age and lower mean CCA-IMT at baseline were significant factors for an increased absolute change in the maximum CCA-IMT at 24 months. The present sub-analysis of the PRIZE study showed higher body mass index, history of ASCVD, and older age as significant factors associated with CCA-IMT progression in patients with asymptomatic hyperuricemia. These factors may be considered when identifying the possible risk of atherosclerotic progression in this specific patient population of hyperuricemia. Trial registration: UMIN000012911 and UMIN000041322.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-023-37183-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2615211-3
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