Background Factors Contributing to Safety Warning Discordance in the Initial Labeling of New Drugs in Japan, the United States, and the European Union.

Drug labels summarize essential safety information for healthcare professionals and patients. However, studies have reported a discordance of safety information in drug labeling among countries/regions. We aimed to identify the characteristics of adverse events associated with discordant safety warnings during the initial labeling of new drugs approved at approximately the same time in Japan, the United States, and the European Union.

Nobiletin-rich kososan, a Kampo formula, prevents the onset of apathy-like behavior and neuroinflammation in sickness behavior mouse model induced by increasing doses of lipopolysaccharide.

Infectious diseases are often concomitant with symptoms of lassitude and emotional disturbances, including depression, the so-called sickness behavior. Kososan, a Kampo (traditional Japanese herbal) formula, has been clinically used for depressive mood, with demonstrated efficacy in stress-induced depressive-like behavior mouse models. Additionally, our previous study has shown that nobiletin-rich kososan (NKS) prevents aging-related depressive-like behaviors and neuroinflammation in mice.

Leucine-Rich Alpha-2 Glycoprotein Is Associated With Transmural Inflammation Assessed by Intestinal Ultrasound in Patients With Crohn's Disease.

Background: Intestinal ultrasound (IUS) is a non-invasive tool for evaluating transmural inflammation in Crohn's disease (CD). However, its utility is constrained by operator dependency and limited accessibility.

Aims: To explore the feasibility of serum biomarkers-specifically leucine-rich alpha-2 glycoprotein (LRG)-as an alternative to IUS for assessing transmural inflammation.

Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial.

Background: There is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.

Methods: This phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries.

Assessment of mumps virus-specific antibodies: Comparison of three different enzyme immunoassays and neutralization test.

Introduction: We evaluated the application of a newly improved enzyme immunoassay (EIA) kit, Mumps IgG Seiken®, by comparing antibody responses to different EIA kits, and neutralization tests (NTs), using clinical samples.

Methods: Serum samples were collected before and 4-6 weeks after vaccination from 128 children who had no history of mumps or mumps vaccination. Using three different EIA kits, Mumps IgG Seiken®, a commercial kit from Enzygnost®, and an in-house kit, mumps-specific IgG antibodies were measured.

Status of perioperative venous thromboembolism (VTE) prophylaxis in gastrointestinal surgery based on national clinical database (NCD) data in Japan.

Purpose: To investigate the current status of perioperative venous thromboembolism (VTE) prophylaxis in gastrointestinal surgery in Japan.

Methods: We reviewed data on eight gastroenterological procedures from the Japanese National Clinical Database (NCD), accrued between 2018 and 2020. Patient characteristics, prophylactic methods, postoperative bleeding, cardiac arrest, and postoperative mortality rate within 30 days were retrieved.

Comparison of outcomes between surgery and chemoradiotherapy after endoscopic resection for pT1a-MM with lymphovascular invasion or pT1b esophageal squamous cell carcinoma: Japanese multicenter propensity score-matched study.

Background: Lymphovascular invasion (LVI) or pT1b is noncurative after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC), and therefore surgery or chemoradiotherapy (CRT) is recommended. However, there has been debate regarding which treatment has better outcomes and whether individual risks should be considered.

Methods: This was a multicenter, retrospective study conducted at 65 hospitals in Japan.

Development of a novel gut microphysiological system that facilitates assessment of drug absorption kinetics in gut.

There is an urgent need for novel methods that can accurately predict intestinal absorption of orally administered drugs in humans. This study aimed to evaluate the potential of a novel gut microphysiological system (MPS), gut MPS/Fluid3D-X, to assess the intestinal absorption of drugs in humans. The gut MPS/Fluid3D-X model was constructed using a newly developed flow-controllable and dimethylpolysiloxane-free MPS device (Fluid3D-X).

Long-Term Trajectories of Cognitive Disability Among Older Adults Following a Major Disaster.

Importance: Older adults are at high risk for cognitive impairments following natural disasters, but the persistence of such effects is not well understood.

Objective: To track older adults' postdisaster cognitive disability trajectories over a decade and examine associations of cognitive disability with disaster damage exposure.

Design, Setting, And Participants: This prospective cohort study used predisaster baseline surveys conducted in August 2010 and 4 follow-ups approximately every 3 years until November 10, 2022.

Nanaomycin K Inhibited Cell Proliferation and Epithelial-Mesenchymal Transition in Renal Cell Carcinoma.

Nanaomycin K is a natural compound found in the culture broth of "Streptomyces rosa subsp. notoensis" OS-3966. Studies have shown that it inhibits epithelial-mesenchymal transition (EMT), a recognized mechanism of cancer cell migration.

[Cannulation Techniques for Cardiopulmonary Bypass During Cardiac Surgery].

Cannulation for cardiopulmonary bypass is a fundamental procedure in cardiac surgery. Different surgeons perform it in a different way without any scientific reason, and therefore, it is extremely important that the whole surgical team remember and follow the routine of each attending surgeon to avoid confusion or needlestick accidents. In this section, the author's routine cannulation technique is described.

Oxidative stress on the male reproductive organs of wild mice collected from an area contaminated by radioactive materials in Fukushima.

The Fukushima Daiichi Nuclear Power Plant accident caused the release of large amounts of radioactive material into the environment. Radiation from radionuclides cause DNA lesions, mainly via oxidation, which adversely affect wild organisms by damaging their germ cells. Here, we investigated the effects of radiation on the reproductive organs of Japanese field mice (Apodemus speciosus) by estimating the dose rate of radiation exposure, the accumulation of DNA lesions, and the expression of DNA repair enzymes.

Esophago-jejunal anastomosis with open approach using the parachute technique to prioritize safety after resection of esophagogastric junction cancer.

Background: The appropriate extent of resection for esophagogastric junction cancer and the method of surgical approach remain controversial. This study aimed to assess the safety and outcomes of the parachute technique, which is an open transhiatal reconstruction method that facilitates stable reconstruction.

Materials And Methods: The surgical outcomes of 20 consecutive patients who underwent open lower- esophagogastrectomy for EGJ cancer at Kitasato University Hospital from June 2019 to July 2023 were retrospectively reviewed.

Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study.

Background: A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.

Significance of REV7 Expression in p16-Negative Oropharyngeal Squamous Cell Carcinoma.

Background: REV7 is a multifunctional protein involved in various biological processes, including DNA damage response. REV7 expression in human cancer cells influences sensitivity to DNA-damaging agents, and its high expression level is reportedly associated with a poor prognosis in many carcinomas. However, the significance of REV7 expression in human papillomavirus 16-negative oropharyngeal squamous cell carcinoma (OPSCC) remains unclear.

Development of the Followership Evaluation Instrument for Nurses: A Prospective Longitudinal Survey.

Maintaining a healthy work environment in nursing practice depends not only on the leader's skill but also on the nursing staff's followership. The study purpose is to develop a followership instrument for nurses. We developed a followership evaluation instrument using data from two surveys conducted in 2013 and 2014 and assessed its validity using a questionnaire with nurses in Japan.

Thyrotropin-Releasing Hormone Analog Taltirelin Inhibits Acute and Chronic Itch in Mice.

Itch is an unpleasant sensation that induces a desire to scratch. Chronic itch is accompanied by inflammatory skin diseases and causes repetitive scratching leading to tissue damage. The thyrotropin-releasing hormone analog taltirelin exerts analgesic effects on acute and chronic pain by activating the descending inhibitory systems.

The role of osteocrin in memory formation during early learning, as revealed by visual imprinting in chicks.

Osteocrin (OSTN) is structurally associated with natriuretic peptides. Its expression in the brain, which has only been recognized in anthropoid primates, is induced by sensory stimuli and regulates the activity-dependent dendritic growth of neurons. However, details on the signaling mechanisms of OSTN and its function in plastic changes during learning and memory have yet to be elucidated.

Microsomal Prostaglandin E Synthase-1 Controls Colonic Prostaglandin E Production and Exerts a Protective Effect on Colitis Induced by Trinitrobenzene Sulfonic Acid in Mice.

Microsomal prostaglandin E synthase-1 (mPGES-1) is an isozyme of the prostaglandin (PG) E synthase that acts downstream of cyclooxygenase and catalyzes the conversion of PGH to PGE. The impact of genetic deletion of mPGES-1 on the development of 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis, a well-established model of inflammatory bowel disease (IBD), was investigated in this study. After administration of TNBS, mice deficient in mPGES-1 (mPGES-1 mice) showed more severe colitis than did wild-type (WT) mice.

Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy.

Background: Biweekly irinotecan plus cisplatin combination therapy (BIRIP) and irinotecan monotherapy (IRI) are both expectable second-line chemotherapy (SLC) options for treating advanced gastric cancer (AGC). Although many patients receiving SLC have undergone gastrectomy, the impact of gastrectomy on SLC remains unclear, and the impact of gastrectomy may vary from regimen to regimen.

Patients And Methods: A total of 290 eligible patients registered in two randomized phase III trials evaluating BIRIP (IRI, 60 mg/m; CDDP, 30 mg/m, q2w) or IRI (150 mg/m, q2w) for patients with AGC was classified into the prior gastrectomy subgroup (PGG) or the no gastrectomy subgroup (NGG).

Reliability and Validity of Measuring the Strength of the Chin-Tuck Maneuver in Community-Dwelling Older Adults as a Means of Evaluating Swallowing-Related Muscle Strength.

: The chin-tuck maneuver has been suggested to increase suprahyoid muscle activation, but a method to measure the strength of the chin-tuck maneuver has not been established. We developed a method to measure the strength of the chin-tuck maneuver (chin-tuck strength) and examined the reliability and validity of chin-tuck-strength measurement in community-dwelling older adults. : The participants were 233 older adults aged ≥65 years without dysphagia or physical disability.