Haemoglobin vesicles (HbVs) (product name, NMU-HbVs [Nara Medical University-Haemoglobin Vesicles]), which contain purified human haemoglobin encapsulated within liposomes, have been developed as a potential alternative to blood transfusions in emergency situations. A previous phase I study examined doses up to 100 mL in 11 healthy volunteers. Here, we describe the protocol for a phase Ib study, wherein we will evaluate the safety and pharmacokinetics of NMU-HbV in healthy Japanese adults.

This single-centre, open-label, dose-escalation study will enrol 16 healthy volunteers divided into four cohorts. Planned doses are 100 mL for cohorts 1 and 2, 200 mL for cohort 3 and 400 mL for cohort 4, with infusion rates gradually increasing to a maximum of 5.0 mL/min. The primary endpoint will be safety, which will be assessed as the incidence of adverse events within 14 days and significant clinical changes within 72 hours after administration. Safety evaluations will include subjective symptoms, vital signs, electrocardiograms and laboratory test results compared with the baseline. The secondary endpoint will be pharmacokinetics, which will be assessed as changes in NMU-HbV concentration immediately after infusion until day 4 to determine the maximum blood concentration, time to reach the maximum blood concentration, area under the blood concentration-time curve and elimination half-life. This study will provide data on the safety and pharmacokinetic profiles of NMU-HbV at doses up to 400 mL. The findings are expected to support the further development of NMU-HbV as a viable alternative to emergency transfusions.

The study protocol was approved by the Institutional Review Board of Nara Medical University on 10 December 2024. Dissemination plans include publishing in peer-reviewed scientific journals and presentation at international conferences.

Japan Registry of Clinical Trials (jRCT2051240249). Registered on 27 January 2025 (https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051240249).

To investigate the association between occupation and Parkinson’s disease (PD) risk and whether patients with PD change occupation after onset.

A matched case–control study using secondary analysis of the Inpatient Clinico-Occupational Survey of the Rosai Hospital Group in Japan.

A nationwide multicentre inpatient dataset in Japan from 2005 to 2021.

The PD group comprised 2205 inpatients diagnosed with PD (International Statistical Classification of Diseases and Related Health Problems, 10th Revision code G20) and 10 436 matched controls without PD, matched for age, sex, year of admission and hospital.

Associations between the longest-held occupation—classified by industry (blue-collar, service, white-collar) and occupational class (blue-collar workers, service workers, professionals, managers)—and PD risk.

Occupations and industries with increased PD risk; occupational changes before and after diagnosis among participants aged

After adjustment for smoking and alcohol, professionals in the service (OR=2.01, 95% CI 1.24 to 3.25) and white-collar (OR=1.33, 95% CI 1.10 to 1.61) industries had higher PD risk than service workers. Doctors, dentists, veterinarians and pharmacists showed elevated risk. Among 160 PD patients, 47% were unemployed, 20% left voluntarily and 30% continued working after diagnosis. Chemical handling was not associated with PD risk after adjustment of multiple comparisons. Former or current smokers among blue-collar and service workers in blue-collar industry had a decreased risk of PD.

Professionals in the service and white-collar industries, particularly those in healthcare occupations, had a higher risk of PD. Approximately 20% became unemployed after diagnosis.

Burnout and reduced well-being are highly prevalent among Japanese medical students during clinical training. Scalable, evidence-based interventions are urgently needed. This protocol outlines a nationwide randomised controlled trial (RCT) to evaluate a self-guided, on-demand Acceptance and Commitment Training (ACT) programme for reducing burnout and improving well-being during clinical clerkships.

This two-arm, open-label, parallel-group RCT will recruit 128 Japanese medical students in clinical clerkships, randomised to on-demand ACT or no-intervention control. The ACT intervention comprises three self-guided online modules at weeks 0, 2 and 4, plus a 30 min online booster (weeks 8–10). Self-reported outcomes are measured at baseline, mid-intervention, postintervention and at 14-week primary endpoint (week 14). The primary outcome is medical student burnout (Oldenburg Burnout Inventory for Medical Students). Secondary outcomes include well-being (Mental Health Continuum-Short Form), professional burnout (Maslach Burnout Inventory–Human Service Survey), psychological flexibility (Work-related Acceptance and Action Questionnaire, Valuing Questionnaire), depressive symptoms (Patient Health Questionnaire-9), mental illness stigma (Mental Illness: Clinicians’ Attitudes Scale version 4), ACT process knowledge (ACT Check, applied section); adverse events and serious adverse events and adherence (platform completion and engagement metrics), all assessed at prespecified time points. Data will be analysed using mixed-effects models for repeated measures on an intention-to-treat basis.

This protocol was approved by the Nagoya City University Clinical Research Review Board (No. 70-22-0022) and registered with the Japan Registry of Clinical Trials (jRCT1042250024). Results will be disseminated via publications and conference presentations.

jRCT1042250024.