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Open AccessModels to predict the surgical outcome of mini-ECIRS (endoscopic combined intrarenal surgery) for renal and/or ureteral stones
To establish a safer and more efficient treatment strategy with mini-endoscopic combined intrarenal surgery (ECIRS), the present study aimed to develop models to predict the outcomes of mini-ECIRS in patients ...
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Open AccessExperience of distance education for project-based learning in data science
Data science plays an important role in many fields. Project-based learning is an effective teaching approach because students can learn data science practices based on real-world problems and real-world data....
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Open AccessStatistical methods and graphical displays of quality of life with survival outcomes in oncology clinical trials for supporting the estimand framework
Although there are discussions regarding standards of the analysis of patient-reported outcomes and quality of life (QOL) in oncology clinical trials, that of QOL with death events is not within their scope. F...
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Survival analysis of a prospective multicenter observational study on surgical palliation among patients with malignant bowel obstruction caused by peritoneal dissemination of gastric cancer
Our previous report showed that surgical palliation maintained quality of life (QOL), improved solid food intake, and had an acceptable surgical safety among patients with malignant bowel obstruction (MBO) cau...
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Open AccessDefinitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and c...
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QOL assessment after palliative surgery for malignant bowel obstruction caused by peritoneal dissemination of gastric cancer: a prospective multicenter observational study
Patients with peritoneal dissemination of gastric cancer have poor oral intake caused by malignant bowel obstruction (MBO). Palliative surgery has often been undertaken to improve quality of life (QOL), but fe...
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Article
Open AccessValidation of tissue factor pathway inhibitor 2 as a specific biomarker for preoperative prediction of clear cell carcinoma of the ovary
Tissue factor pathway inhibitor 2 (TFPI2) is a novel serum biomarker that discriminates ovarian clear cell carcinoma (CCC) from borderline ovarian tumors (BOTs) and non-clear cell epithelial ovarian cancers (E...
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Survival analysis of a prospective multicenter observational study on surgical palliation among patients receiving treatment for malignant gastric outlet obstruction caused by incurable advanced gastric cancer
We had previously reported that surgical palliation could maintain quality of life (QOL) while improving solid food intake among patients with malignant gastric outlet obstruction (GOO) caused by advanced gast...
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Article
The efficacy of sequential second-line endocrine therapies (ETs) in postmenopausal estrogen receptor-positive and HER2-negative metastatic breast cancer patients with lower sensitivity to initial ETs
Second-line endocrine therapy (ET) for estrogen receptor (ER)-positive and human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (MBC) is offered based on the response to first-line ET. Howe...
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Article
Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan
Two issues in clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, the relationship between rare events and endpoints, and the differences in multiplicity adjustmen...
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Open AccessHigh gamma-glutamyl hydrolase and low folylpolyglutamate synthetase expression as prognostic biomarkers in patients with locally advanced gastric cancer who were administrated postoperative adjuvant chemotherapy with S-1
The enzymes gamma-glutamyl hydrolase (GGH) and folylpolyglutamate synthetase (FPGS) regulate intracellular folate concentrations needed for cell proliferation, DNA synthesis, and repair. High GGH expression af...
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Open AccessJapanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer
The number of deaths from colorectal cancer in Japan continues to increase. Colorectal cancer deaths exceeded 50,000 in 2016. In the 2019 edition, revision of all aspects of treatments was performed, with corr...
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Open AccessAtypical femoral fracture in patients with bone metastasis receiving denosumab therapy: a retrospective study and systematic review
While denosumab has been shown to prevent skeletal-related events in patients with bone metastasis, there is a concern that it may cause atypical femoral fracture (AFF). While AFF has been reported in patients...
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Article
Comparison between instantaneous wave-free ratio versus morphometric assessments by intracoronary imaging
Anatomical measurements obtained by intracoronary imaging devices are reported to correlate significantly with fractional flow reserve (FFR). Instantaneous wave-free ratio (iFR) is a nonhyperemic index of sten...
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Comparison of anti-inflammatory effects of rivaroxaban vs. dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study): multicenter randomized study
Some experimental studies have shown that direct oral anticoagulants (DOACs) have anti-inflammatory effects. However, the interval changes in inflammatory markers in patients with non-valvular atrial fibrillat...
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Article
Open AccessGood arm identification via bandit feedback
We consider a novel stochastic multi-armed bandit problem called good arm identification (GAI), where a good arm is defined as an arm with expected reward greater than or equal to a given threshold. GAI is a pure...
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Open AccessClinical prediction models for progression of chronic kidney disease to end-stage kidney failure under pre-dialysis nephrology care: results from the Chronic Kidney Disease Japan Cohort Study
Reliable prediction tools are needed to identify patients with chronic kidney disease (CKD) at greater risk of develo** end-stage kidney failure (ESKF). We developed and validated clinical prediction models ...
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Open AccessValidation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study
The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Scor...
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Survival impact of post-progression chemotherapy in advanced gastric cancer: systematic review and meta-analysis
We conducted a systematic review and meta-analysis on survival impact of post-progression chemotherapy (post-Cx) after first-line chemotherapy (1st-Cx) and after second-line chemotherapy (2nd-Cx), and survival...
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Liver fibrosis: noninvasive assessment using supersonic shear imaging and FIB4 index in patients with non-alcoholic fatty liver disease
Shear wave elastography (SWE) has been validated in chronic hepatitis C and B; however, limited data are available in non-alcoholic fatty liver disease (NAFLD). This study aimed to evaluate the accuracy of SWE...