Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in cancer, and it is one of the distressing symptoms in patients with cancer receiving chemotherapy. Information about side effects may exacerbate CINV due to the nocebo effect. This study aims to examine the efficacy of pharmacist-led enhanced support for coping with side effects during medication counselling, which includes providing information about side effects, with the goal of mitigating the nocebo effect and reducing CINV.

This multicentre exploratory open-label randomised controlled trial will examine the efficacy of pharmacist-led enhanced support for coping with the side effects of treatments during medication counselling in patients with advanced lung cancer. The control group will receive medication counselling as usual. The study population will consist of patients with advanced lung cancer who have not received chemotherapy and are receiving highly emetogenic chemotherapy or equivalent chemotherapy. The primary endpoint is the prevention of nausea, and the secondary endpoints include complete response (no vomiting event and no rescue medication), stress (objectively assessed using the salivary cortisol and immunoglobulin A), coping strategies and quality of life.

This study received approval from the medical ethics committee of Kansai Medical University. The results will be submitted for publication in an international peer-reviewed journal, and the findings will be presented at international scientific conferences.

1.0, 18 Mar 2025

Registration number: UMIN000056068.

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

Prophylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.

40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.

Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.

ChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.

The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.

This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.

This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.

NCT06357806.