With the rapid increase in the ageing population, the use of procedural sedation and analgesia (PSA) for diagnostic procedures such as prostate biopsy in older adults is increasing. However, elderly patients are particularly susceptible to respiratory depression during PSA testing and have a significantly higher risk of hypoxaemia during procedures requiring deep sedation. Although propofol combined with fentanyl is commonly used, it frequently causes hypoxaemia and apnoea. Remimazolam, a novel ultrashort-acting benzodiazepine, may be a safer alternative with less respiratory compromise; however, the supporting evidence remains limited. This study aims to assess whether remimazolam combined with fentanyl reduces the incidence of respiratory depression compared with propofol combined with fentanyl in elderly patients undergoing prostate biopsy under deep sedation requiring immobility.

This is a single-centre, participant and assessor-blinded (with pragmatic blinding of participants), parallel-group, superiority randomised controlled trial conducted at the Jichi Medical University Saitama Medical Centre, Japan. Eligible participants are men aged ≥70 years who are scheduled to undergo prostate biopsy under intravenous sedation. Participants will be randomised in a 1:1 ratio to receive either remimazolam or propofol, each administered in combination with fentanyl at a fixed effect-site concentration. The primary outcome is the incidence of severe apnoea (≥1 min). The primary analysis will follow the intention-to-treat principle, implemented practically as a full analysis set analysed using a complete case approach. Sensitivity analyses will include a per-protocol analysis and multiple imputations of missing data. A subgroup analysis of patients aged ≥75 years was performed.

This study was approved by the Jichi Medical University Central Clinical Research Ethics Committee (approval number: 24JMU001S-2) and was registered with the Japan Registry of Clinical Trials on 11 November 2024. Written informed consent was obtained from all participants before enrolment. These findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

jRCTs031240478.

To evaluate the risk of invasive pneumococcal disease (IPD) and non-bacteraemic pneumonia (NBP)/acute otitis media (AOM)/sinusitis in Japanese individuals under 19 years of age with chronic medical conditions (CMCs) compared with those without.

An observational, retrospective, cohort study.

A large, longitudinal health insurance claims database in Japan (JMDC database).

A total of 12.3 million individuals aged

Adjusted incidence rate ratios (IRRs) for IPD and NBP/AOM/sinusitis for individuals with CMCs versus those without CMCs were calculated using multivariate Poisson regression models with age and sex as covariates.

The incidence rate of IPD was higher in individuals with a CMC (0.9 (95% CI: 0.8 to 0.9)) than in those without (0.1 (95% CI: 0.1 to 0.1)). A similar trend was observed for the incidence rate of NBP/AOM/sinusitis, with rates of 928.7 (95% CI: 927.4 to 929.9) in individuals with a CMC compared with 433.2 (95% CI: 432.8 to 433.7) in those without. The risk of IPD increases with the number of CMCs. The IRRs for IPD for those with one CMC and with two or more CMCs were 7.2 (95% CI: 6.4 to 8.1) and 128.1 (95% CI: 114.8 to 143.0), respectively, compared with individuals without a CMC. The IRRs for IPD in the immunocompromised and immunocompetent groups were 156.1 (95% CI: 133.4 to 182.7) and 16.3 (95% CI: 14.6 to 18.1), respectively. The IRRs for NBP/AOM/sinusitis were 1.9 (95% CI: 1.9 to 1.9) and 2.1 (95% CI: 2.1 to 2.2) for individuals with one CMC and with two or more CMCs, respectively.

Individuals aged

To investigate the relationship between a quality of life (QOL) score and clinical parameters in patients with hypertrophic cardiomyopathy (HCM).

A multicentre cross-sectional study.

We analysed data from the Searching for Atrial Fibrillation and Early Recruitment of Heart Failure in HCM registry, collected between 2018 and 2023.

Patients with HCM (n=499) aged ≥18 years from 12 institutions (Shizuoka Prefecture, Japan) were consecutively enrolled.

Clinical parameters, along with data from a short form of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), were collected. The association between each clinical parameter and the KCCQ-12 score was analysed. Clinical parameters with a significant univariable association (p

In the univariable analysis, KCCQ-12 scores exhibited significant associations with 21 clinical parameters, including sex, left ventricular morphology and the Pittsburgh Sleep Quality Index (PSQI). The multiple regression model with 12 parameters that had a significant univariable association exhibited an adjusted R² of 0.48. In this model, the PSQI (standardised coefficient –0.39; p

In patients with HCM, we investigated the association between the KCCQ-12 score and various clinical parameters. PSQI, as well as known heart failure-related clinical parameters, was significantly associated with the KCCQ-12 score. Visualising the associations of various clinical parameters with the KCCQ-12 score will help physicians to consider factors linked to the decline in QOL in patients with HCM.

In preparation for becoming a super-aged society with high mortality, Japan is strengthening its comprehensive community care systems and promoting end-of-life care at home. Many nurses realise that providing grief care to families experiencing loss and bereavement is important, but several studies have identified a lack of competence when specialised care is provided to families in need. The aim of this study is to systematically review research on grief care to target families utilising home nursing services in Japan and to identify methods of care that have been published and research that has been reported in the Japanese literature.

This scoping review will follow the Arksey and O’Malley methodology framework. An exploratory review of the literature on grief care in home healthcare will help to clarify the research question (step 1). A broad range of electronic databases (ICHUSHI-Web, PubMed/MEDLINE, CINAHL/EBSCO and SCOPUS) and search terms will be used to retrieve relevant articles published between 1983 and 2024 (step 2). Studies are systematically selected by two independent reviewers based on eligibility criteria (step 3). The title and abstract are scrutinised to determine if the article meets the eligibility criteria. Full-text screening is then conducted to retrieve only relevant publications. Data are then extracted, collated and charted (step 4), and a summary of the aggregate results is presented (step 5).

This scoping review will collect data from publicly available sources and will not require ethics review. Once data collection and summarisation are complete, the results will be disseminated through peer-reviewed publications, and the key findings of the review will be presented at relevant conferences.

Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.

This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.

This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.

UMIN ID: 000055173.

Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Atopic dermatitis (AD) is a chronic inflammatory skin condition that impairs the quality of life of affected paediatric patients and their families. Dupilumab, an antagonist of the shared alpha chain subunit of the cytokines interleukin-4 and interleukin-13, has revolutionised the management of moderate-to-severe AD by effectively targeting type 2 inflammation. However, live attenuated vaccines, including live attenuated influenza vaccines (LAIVs), are contraindicated during dupilumab therapy owing to limited safety data. This restriction poses challenges to immunisation strategies, particularly in paediatric populations. This study aims to evaluate the safety and efficacy of LAIV in paediatric patients with AD undergoing dupilumab therapy.

This multicentre, prospective, single-arm, open-label trial will enrol 50 paediatric patients aged 2–18 years with AD undergoing dupilumab treatment. The participants will receive intranasal LAIV, followed by a 25-week observation period after vaccination. The primary outcome is the proportion of participants with a four-fold or greater increase in haemagglutination inhibition titres against influenza strains A(H1N1), A(H3N2) and B at 4 weeks post vaccination. The secondary outcomes include the incidence of influenza and systemic or local adverse events, such as injection site reactions, fever and other influenza-like symptoms observed within 4 weeks of vaccination. Exploratory endpoints include the evaluation of immunosuppressive markers such as neutrophil counts, lymphocyte subsets and serum immunoglobulin G levels. Safety analyses will assess the frequency of each adverse event, whereas efficacy analyses will focus on immunogenicity and influenza incidence during the 25-week follow-up period. This study aims to provide critical safety and immunogenicity data to guide immunisation strategies in biologically treated paediatric patients with AD.

This study complies with the principles of the Declaration of Helsinki and received ethics approval from the Institutional Review Board of Chiba University Hospital as a specified clinical trial. Informed consent and assent will be obtained as appropriate based on the participants’ ages. These findings will be disseminated through peer-reviewed journals and scientific conferences to inform clinical vaccination strategies for biologically treated populations.

jRCTs031240442.