Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.

This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.

Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).

Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.

www.clinicaltrials.gov (NCT06262620).

Surgery represents the cornerstone for the treatment of several benign and malignant oesophageal disorders. Yet synthesising the growing body of evidence from clinical research is becoming increasingly challenging. Evidence mapping with living systematic reviews (SRs) and living meta-analyses offers a structured, continuously updated approach to navigating emerging data. This study aims to provide a real-time, interactive resource to support evidence-based decision-making for oesophageal surgery.

This study follows PRISMA guidelines and uses the EVIglance Studio web application to develop a living evidence map in oesophageal surgery. A systematic literature search will be conducted across the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and MEDLINE (PubMed) to identify randomised controlled trials (RCTs) and SRs related to oesophageal surgery, without any date or language restrictions. Study selection and data extraction will be performed independently by two reviewers. Key clinical and surgical outcomes, including morbidity, mortality, quality of life and oncological endpoints, will be extracted. Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system will be applied to evaluate the certainty of evidence. If at least three randomised trials address the same research question, a living meta-analysis will be conducted using random-effects models. The evidence map will be updated at least every 6 months.

This study does not involve individual patient data or any private information. Therefore, ethical approval is not required. As it uses only publicly available data, this study design qualifies as exempt from institutional review. The resulting evidence map is designed to support fast and structured access to high-quality surgical data - an approach not yet available in oesophageal surgery. The tool is expected to aid patients, clinicians and researchers alike by improving access to reliable information, supporting clinical decision-making and highlighting gaps in current evidence. On completion, results will be published in an open-access format and made permanently accessible via www.evidencemap.surgery, with continuous updates.

CRD420251022736 (https://www.crd.york.ac.uk/prospero/)

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

NCT02727296.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.

Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.

This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary^+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.

This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.

NCT06815380 (Pre-results).

Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.

This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).

The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

This study aimed to explore the barriers to the implementation of the improved Community Health Fund (iCHF) electronic-claim (e-claim) process in primary healthcare services in Tanzania.

A phenomenological study design using a qualitative approach.

In-depth interviews were conducted to collect data from 19 participants from Mkalama and Iramba districts.

The data were collected from the regional health managers, district health managers, information technology officers, facility in-charges and iCHF focal persons from dispensaries, health centres and hospitals. Thematic analysis was employed to analyse the data in this study.

This study identified several key barriers to the implementation of the iCHF e-claim process. The barriers include financial governance and oversight, institutional capacity for the iCHF e-claim process, staff negligence in complying with iCHF guidelines, resource availability, and logistical shortcomings for handling iCHF e-claim processes.

The iCHF e-claim process is inadequately implemented and does not attract healthcare workers due to the observed challenges. There is a need for joint efforts to improve the implementation of the iCHF e-claim process involving stakeholders at all levels.

Post-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.

186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.

This study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.

This protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).