To develop a simple screening scale to predict depression after discharge in patients with acute coronary syndrome after percutaneous coronary intervention (ACS-PCI) and to verify its reliability, validity and cutoff value.

Prospective longitudinal study was conducted 1 week and 3 months after discharge.

Two hospitals where PCI is performed in Japan.

A total of 183 patients were potential candidates for the survey, of whom 42 provided valid responses (response rate: 23.0%).

The number of items was reduced from 14 to 12 with item-total correlations and principal component analysis. Cronbach’s alpha coefficient was 0.832 and the intraclass correlation coefficient (1, 2) was 0.811 (95% CI 0.650 to 0.898). Significant correlations were observed for concurrent validity (r=0.699, p

This study developed a simple screening scale for predicting postdischarge depression in patients with ACS-PCI (SDACS-12) and demonstrated its reliability, validity and predictive ability with 12 items. Nevertheless, its results should be interpreted cautiously given the moderate variance explained by PCA and the low specificity and PPV.

Obsessive-compulsive disorder (OCD) is characterised by obsessive thoughts and compulsive actions. These obsessive-compulsive symptoms (OCS) are subclinical manifestations that do not meet the full diagnostic criteria for OCD and are associated with anxiety, depression and lower quality of life (QoL). Medical students are vulnerable to developing OCS due to stress in medical school. This study assessed OCS prevalence and its association with the mental well-being and QoL of medical students in Egypt.

A nationwide cross-sectional study was conducted across 15 Egyptian medical schools. Using convenience sampling, 1850 students participated by completing a self-administered questionnaire that used validated scales. We assessed OCS with the Obsessive-Compulsive Inventory-Revised (OCI-R) using a screening cut-off of ≥21, QoL with the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-QSF), and anxiety and depression with the 4-item Patient Health Questionnaire (PHQ-4). Descriptive statistics and logistic regression were employed.

Clinically significant OCS prevalence among medical students was 51.1%. Significant predictors for OCS included being female (adjusted OR (AOR)=1.25), attending a private university (AOR=1.64), and having personal (AOR=2.05) or combined personal and family history of mental illness (AOR=2.69). OCS presence was associated with a lower QoL score (Q-LES-QSF: 41.00 vs 43.97) and higher psychological distress score (PHQ-4: 5.93 vs 3.57) compared with students without OCS (p

OCS are prevalent among Egyptian medical students, especially females, private university attendees and those with a personal or family history of mental illness. These symptoms are associated with higher psychological distress and a lower QoL. As OCS were identified using a screening cut-off, and given the cross-sectional design, findings should be interpreted cautiously, warranting further longitudinal investigation. Universities should consider implementing mental health support, screening and awareness programmes to address these issues.

As of 2024, paid paternity leave was available in 102 countries worldwide. However, the accessibility and methods of taking paternity leave are influenced by cultural background and individual values, leading to variations in uptake rate. Both positive and negative effects of paternity leave have been reported on the health of fathers, partners and children. A comprehensive understanding of this topic is essential for medical professionals supporting fathers undertaking childcare. The aim of this review is to identify and provide an overview of research related to the impact of paternity leave on the health of fathers, their partners and their children.

PubMed, CINAHL, Web of Science and Ichushi-Web (Japan’s medical literature database) will be searched for published studies, and Google Scholar, ProQuest and CiNii Research (a database used to search for academic information in Japan) will be searched for grey literature. Screening will be performed by two independent reviewers. In this scoping review, we will include studies that focus on fathers taking paternity leave, their partners and their children, regardless of ethnicity or geographic location. This review will focus only on studies related to effects within 3 years after childbirth. We will not restrict study inclusion by whether paternity leave is paid or unpaid, the length of the leave or whether it was taken solely by the father. Furthermore, we will include both English and Japanese literature. The findings of this scoping review will be presented in tabular form and summarised in a way that aligns with the review questions.

This paper does not involve human participants, so approval by an ethics committee is not required. The results of this scoping review will be presented in academic conferences and disseminated in peer-reviewed journals.

https://osf.io/jsc89.

Addition of bevacizumab and paclitaxel as induction therapy prior to standard atezolizumab and nab-paclitaxel in patients with programmed death-ligand 1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) may help to overcome vascular endothelial growth factor-associated resistance mechanisms that limit the immune-mediated antitumour efficacy of atezolizumab and nab-paclitaxel.

The Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+TNBC (INDUCE) study is a multicentre, randomised, open-label, phase II trial designed to evaluate the efficacy and safety of two cycles of induction therapy with bevacizumab and paclitaxel followed by atezolizumab and nab-paclitaxel compared with standard atezolizumab and nab-paclitaxel in patients with PD-L1-positive mTNBC. The primary outcome of the study is progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumours, V.1.1. We have estimated that 89 PFS events are needed to allow a power of 80% to detect a difference between treatment groups at a one-sided significance level of 10% in this study. The target sample size is set to 106 patients to account for dropouts.

The study protocol and informed consent form have been approved by the Certified Research Review Board at the Nagoya University Graduate School of Medicine, Nagoya, Japan. Study results will be presented at international conferences and published in a peer-reviewed journal.

jRCTs041240039 NCT06793553.

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

jRCTs062240066

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

jRCTs031240007.

To characterise patient and medication-related patterns observed in drug-related pressure ulcers (DRPUs) and provide descriptive findings that may support future consensus-building.

Multicentre retrospective observational study.

20 hospitals across Japan participated in the study with hospital pharmacists specialised in PU care.

A total of 1113 hospitalised patients with existing PUs were included and classified into three groups (definite, probable and no-possibility of DRPUs) based on predefined criteria.

The primary outcome was the description of medication-related characteristics observed in each DRPU classification group, including polypharmacy, initiation of new medications and dose adjustments. Secondary outcomes included differences in ulcer characteristics and functional status across DRPU categories.

The definite group (n=128, 11.5%) showed a significantly higher prevalence of polypharmacy (83.6% vs 71.1% in the no-possibility group, p

Medication-related characteristics such as polypharmacy, initiation of new medications, dose modifications and use of antipsychotics were more frequently observed in the definite DRPU group. These descriptive findings may help characterise the clinical patterns of DRPUs and may inform future hypothesis generation.

The standard treatment for unresectable head and neck cancer typically involves radiotherapy (RT) alone or chemoradiotherapy (chemo-RT). Non-squamous cell carcinomas exhibit relatively low radiosensitivity, limiting the efficacy of conventional photon RT. Carbon-ion (C-ion) RT, characterised by high linear energy transfer (LET) and high relative biological effectiveness (RBE), has shown promising outcomes in treating radioresistant head and neck cancers. However, local recurrences still occur, and further improvements in treatment outcomes are needed. To enhance the local control rate, an increase in dose-averaged LET (LETd) to the tumour was considered.

Following a simulation study, a clinical trial was conducted to optimise LETd using only C-ion therapy, and its safety was confirmed. However, in this clinical trial, LETd could only be increased to approximately 70 keV/μm. To further escalate LETd, multi-ion therapy using ions heavier than carbon was developed. Simulation studies demonstrated that multi-ion therapy incorporating carbon, oxygen and neon ions could increase LETd up to 90 keV/μm, regardless of tumour size, while maintaining high-dose uniformity within the tumour. Based on these results, a clinical study was planned to evaluate the safety of escalating LETd from 70 keV/μm to 90 keV/μm using multi-ion therapy. The primary objective of this study is to evaluate the safety of escalating LETd to the tumour using multi-ion therapy for head and neck cancer, with the secondary goal of identifying the maximum tolerated LETd.

This is a non-randomised, open-label, phase 1 study focused on LETd escalation. A maximum of 18 patients with histologically confirmed inoperable head and neck malignancies will be enrolled. All patients will receive multi-ion therapy using helium, carbon, oxygen or neon ions, either alone or in combination, at an RBE-weighted dose ranging from 57.6 to 70.4 Gy, delivered in 16 fractions (4 fractions per week) over 4 weeks. The specific dose will be determined according to histology. LETd escalation will begin at 70 keV/μm and will increase by 10 keV/μm increments, reaching a maximum of 90 keV/μm. The safety of multi-ion therapy will be assessed based on the frequency and severity of dose-limiting toxicities, monitored up to 90 days after the initial irradiation. Patients will be followed up according to the protocol for 180 days after the initial multi-ion therapy irradiation.

The study protocol has been approved by the National Institutes for Quantum Science and Technology Certified Review Board (#L24-002). The results will be published in a peer-reviewed journal and presented at a scientific conference.

jRCTs032240451.

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

Adherence to treatment strategies is essential for preventing future complications during diabetes management. This study evaluated the association between dropout history, glycated haemoglobin (HbA1c) levels and subsequent risks of dropout (missed appointment)in patients with type 2 diabetes.

This was a secondary analysis of a cluster-randomised trial (the Japan Diabetes Outcome Intervention Trial 2 Large-Scale Trial), focusing on the non-intervention group over the study period.

Data were obtained from a multisite trial conducted in Japan, encompassing patients with type 2 diabetes who received routine clinical care at participating clinics.

A total of 996 patients with type 2 diabetes from the non-intervention group were included in the analysis. Baseline characteristics (eg, age, sex, smoking status, occupational status and diabetes medication use) were recorded at study entry.

The primary outcome measure was subsequent treatment dropout. The Cox proportional hazards model with the Huber/White method was used to estimate HRs and 95% CIs, with adjustment for age, sex, smoking status, occupational status and diabetes medication use at baseline.

Participants with treatment dropout history had a higher dropout rate than those without dropout history (multivariable-adjusted HR=3.59; 95% CI=2.25 to 5.71). Overall, HbA1c levels were not significantly associated with dropout risk. However, among the 855 participants without dropout history, the dropout risk was higher in the group with HbA1c level ≥10.0% (HR=3.76; CI=1.29 to 10.9) than in the group with HbA1c level of 6.0–6.9%.

This prospective cohort study of Japanese patients with type 2 diabetes suggests that dropout history is strongly associated with a higher subsequent dropout risk. High HbA1c levels (≥10%) may be related to a higher dropout risk in patients without a dropout history. These findings may provide actionable indicators for tailored interventions, enhancing targeted healthcare strategies and improving continuity of care.

UMIN000002186.