Effects of D-Allulose with Sucrose Beverage on Glucose Tolerance and Insulin Levels among Thai Healthy Volunteers.

D-Allulose has blood glucose suppression effects in both animal and clinical studies. The mechanism mediating glucose suppression in animals is controlled by several actions including the inhibition of sucrase. To investigate the dose-response effects of D-allulose with a sucrose beverage on glucose tolerance and insulin levels using Thai volunteers.

Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET) in Japan.

Background: The Medical Information Database Network (MID-NET) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-established GIP identification algorithm exists in MID-NET.

Methods: This study evaluated 12 identification algorithms by combining ICD-10 codes with GIP therapeutic procedures.

Information heterogeneity between progress notes by physicians and nurses for inpatients with digestive system diseases.

This study focused on the heterogeneity in progress notes written by physicians or nurses. A total of 806 days of progress notes written by physicians or nurses from 83 randomly selected patients hospitalized in the Gastroenterology Department at Kagawa University Hospital from January to December 2021 were analyzed. We extracted symptoms as the International Classification of Diseases (ICD) Chapter 18 (R00-R99, hereinafter R codes) from each progress note using MedNER-J natural language processing software and counted the days one or more symptoms were extracted to calculate the extraction rate.

Evaluation of Machine Translation Accuracy Focused on the Adverse Event Terminology for Medical Devices.

The purpose of this study was to evaluate the accuracy of deep neural machine translation focused on medical device adverse event terminology. 10 models were obtained, and their English-to-Japanese translation accuracy was evaluated using quantitative and qualitative measures. No significant difference was found in the quantitative index except for a few pairs.

Japanese Regulatory Considerations for Interoperability of Medical Devices.

With the rapid technological innovations of the Internet of Things (IoT), the situation surrounding medical devices and medical systems has been changing. Interoperable medical devices-medical devices capable of interoperating in a clinically significant way with other medical devices-have been developed, and interoperable medical systems consisting of two or more interconnected interoperable medical devices are being used in clinical settings. However, general points that need to be considered to ensure safe and effective interoperability have yet to be fully established in Japan.

COVID-19 outbreak trends in South Africa: A comparison of Omicron (B.1.1.529), Delta (B.1.617.2), and Beta (B.1.351) variants outbreak periods.

Objectives: We provided COVID-19 outbreak trends in South Africa during the Omicron (B.1.1.

t-SNE Visualization of Vector Pairs of Similar and Dissimilar Definition Sentences Created by Word2vec and Doc2vec in Japanese Medical Device Adverse Event Terminology.

The purpose of our study is to identify the patterns of vectors in similar/dissimilar pairs of definition sentence created by Word2vec and doec2vec for elaboration of the terminology for Japanese Medical Device Adverse Events. 2-dimension vector space created by t-SNE showed that the pair with true positive located closer in a vector space, especially Doc2vec had a strong tendency. Comparing with Word2vec, Similar vectors in Doc2vec were close and tended to form clusters.

Using Natural Language Processing Techniques to Detect Adverse Events From Progress Notes Due to Chemotherapy.

Objective: In recent years, natural language processing (NLP) techniques have progressed, and their application in the medical field has been tested. However, the use of NLP to detect symptoms from medical progress notes written in Japanese, remains limited. We aimed to detect 2 gastrointestinal symptoms that interfere with the continuation of chemotherapy-nausea/vomiting and diarrhea-from progress notes using NLP, and then to analyze factors affecting NLP.

Trends in per Capita Food and Protein Availability at the National Level of the Southeast Asian Countries: An Analysis of the FAO's Food Balance Sheet Data from 1961 to 2018.

We aimed to analyze the temporal trends in the per capita food (kcal/day/person) and protein (g/day/person) availability at the national level in the Southeast Asian (SEA) countries from 1961 to 2018. To avoid intercountry variations and errors, we used a dataset derived from the FAO's old and new food balance sheets. We used the joinpoint model and the jump model to analyze the temporal trends.

Validity of identification algorithms combining diagnostic codes with other measures for acute ischemic stroke in MID-NET®.

Purpose: We aimed to develop a reliable identification algorithm combining diagnostic codes with several treatment factors for inpatients with acute ischemic stroke (AIS) to conduct pharmacoepidemiological studies using the administrative database MID-NET® in Japan.

Methods: We validated 11 identification algorithms based on 56 different diagnostic codes (International Classification of Diseases, Tenth Revision; ICD-10) using Diagnosis Procedure Combination (DPC) data combined with information on AIS therapeutic procedures added as "AND" condition or "OR" condition. The target population for this study was 366 randomly selected hospitalized patients with possible cases of AIS, defined as relevant ICD-10 codes and diagnostic imaging and prescription or surgical procedure, in three institutions between April 1, 2015 and March 31, 2017.

Terminology integration and inconsistency identification of adverse event terminology for Japanese medical devices using SPARQL.

Background: For standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015. The 89 terminologies were developed independently by 13 industry associations, suggesting that there may be inconsistencies among the terms proposed. The purpose of this study was to integrate the 89 sets of terminologies and evaluate inconsistencies among them using SPARQL.

Evaluation of a Treatment Algorithm for Tsushima Mamushi (Gloydius tsushimaensis) Snakebites, after Its Introduction to Tsushima Island, Nagasaki, Japan.

Objective Tsushima mamushi (Gloydius tsushimaensis) is an endemic species of snake inhabiting only Tsushima Island, a remote Japanese island. We conducted a multicenter, retrospective study of G. tsushimaensis bites for the first time and developed a treatment algorithm that unified treatment on the island and is still in use today.

Establishment of the MID-NET medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Purpose: To establish a new medical information database network (designated MID-NET ) to provide real-world data for drug safety assessments in Japan.

Methods: This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET is a distributed and closed network system that connects all collaborative organizations through a central data center.

Evaluation of Similar Term Definitions in Medical Device Adverse Event Terminology.

The purpose of this study is to extract similar term definitions used in the terminology of Japanese medical device adverse events. We employed Levenshtein and Jaro-Winkler distances as edit distances and Skip-gram, continuous-bag of words, and fast text to produce distributed representations in Word2Vec. A comparison of the accuracies of the models showed that Levenshtein distance had higher specificity whereas Skip-gram had higher sensitivity as compared to the other models.

Evaluating the impact of regulatory action on denosumab-induced hypocalcaemia in Japan.

What Is Known And Objective: Since its introduction in April 2012, denosumab has been administered to approximately 7,300 patients as of August 2012, and 32 cases of serious hypocalcaemia after denosumab administration, including two deaths, have been reported in Japan. A Dear Healthcare Professional Letter of Rapid Safety Communication ('Blue letter') was released to warn about the risks of hypocalcaemia associated with denosumab. The goal of this study therefore was to measure the impact of regulatory action on denosumab-induced hypocalcaemia in Japan by using an electronic medical information database (MID).

Identification of gastrointestinal perforation based on ICD-10 code in a Japanese administrative medical information database and associated drug exposure risk factors.

Purpose: The purpose of this study is to evaluate the accuracy of gastrointestinal (GI) perforation ICD-10 coding in the Diagnosis Procedure Combination (DPC) database and to examine drug exposure risk factors for GI perforation.

Methods: A total of 100 patients with GI perforation ICD-10 codes were selected randomly from Kagawa University Hospital's DPC database between April 2011 and December 2016. Two experienced specialist physicians independently reviewed the medical records and classified cases as "definite A," "definite B," "probable," or "no GI perforation.

The utilization and challenges of Japan's MID-NET medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies.

Purpose: To examine the potential role of Medical Information Database Network (MID-NET ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies.

Methods: The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions.

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators.

Background: The new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions.

[Gallbladder Malignant Lymphoma Diagnosed after Surgery for Acute Cholecystitis - A Case Report].

An 84-year-old man visited our hospital with epigastralgia.Levels of hepatic and biliary enzymes and CRP were elevated, as detected by a blood test.On a CT scan, a swollen gallbladder with stones was detected.

Integration of Japanese Medical Device Adverse Event Terminologies.

The purpose of this study is to integrate Japanese medical device adverse event terminologies for evaluating terminological consistency. We represented hierarchy and relations among terms using Resource Description Framework (RDF). There were 3521 classes and 14650 properties.

Estimating Sample Size for a Feasibility Study of Computer-Assisted Input Support to EDC.

The aim of this study was to to estimate the sample size for the assumed feasibility study of the computer-assisted input support on a clinica trial. More than 1,500 observations were required for the feasibility study with assumed settings. Further study was required for more efficient research design.

[A Case of Stage IV Gastric Cancer Successfully Treated Using Salvage Surgery after S-1/CDDP Therapy].

A 75-year-old man admitted for left lateral abdominal pain was found to have advanced poorly differentiated gastric adenocarcinoma with abdominal para-aortic and Virchow's lymph node metastases, which was diagnosed to be clinical Stage IV (T3N3H0M1[LYM]). As curative surgery was not deemed possible, we started chemotherapy administration using S-1 (120mg/day)administered orally for 3 weeks and cisplatin(CDDP 100mg/body)administered intravenously on day 8. After 6 courses of chemotherapy, a CT scan showed that all lymph nodes metastases had disappeared, resulting in downstaging to clinical Stage II (T3[SE]N0H0P0M0).