To systematically review the evidence on the association between non-standard working time arrangements (such as night work or shift work) and the occurrence of safety incidents.

Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and using a structured narrative approach and the Synthesis Without Meta-analysis framework to evaluate and summarise findings.

MEDLINE, Embase, PsycINFO, Web of Science and ProQuest Health and Safety Science Abstracts were searched through February 2024.

We included peer-reviewed English-language studies of paid workers (18–70 years) that examined the association between non-standard working time arrangements and safety incidents (accidents, near-accidents, safety incidents or injuries), excluding cross-sectional designs and studies on unpaid workers, athletes or military personnel.

Two reviewers independently extracted data and assessed risk of bias using standardised forms, extracting study characteristics (author, year, country, sector and population), working time arrangements and exposure assessment, outcomes and their assessment, and reported risk estimates. We conducted a narrative synthesis, classifying studies into three exposure contrasts (shift worker versus non-shift worker, time-of-day and shift intensity), and summarised risk estimates using forest plots without calculating pooled effects.

A total of 13 569 records were screened, and 24 studies met the inclusion criteria. The results indicated that shift workers generally had an elevated safety incident risk compared with non-shift workers (risk estimates ranged from 1.11 to 5.33). Most of the included studies found an increased risk of safety incidents during or after night shifts. Accumulated exposure to evening or night shifts increased the risk of safety incidents during the following 7 days. However, bias and heterogeneity across studies in design, populations and outcome measures resulted in an overall low to very low certainty of the evidence.

Non-standard working time arrangements, including night and evening shifts, appear to increase the risk of occupational safety incidents. Despite the low certainty of evidence, the findings highlight a potential area for preventive measures in work scheduling. Future longitudinal studies using individual data on daily working hours are needed.

Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.

The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.

This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.

NCT05915663.

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.

Care pathways (CPs) are widely used to standardise and improve healthcare delivery. However, CP development is often shaped by value (or normative) complexity. This study empirically explores how value complexity unfolds in a CP development programme.

A qualitative single-case study was conducted as part of a 2-year action research programme. The study followed a ‘research-follow-action’ strategy, in which action and learning occurred during the programme phase, followed by retrospective analysis using Greenhalgh et al’s ‘rules of thumb’ as a reflective lens.

A Dutch specialised rehabilitation hospital (13 sites, 800 employees approximately, ~16 000 patients annually). In three CP development cycles, 11 multidisciplinary teams were guided in CP development in a quality collaborative approach.

26 respondents participated in 44 reflective conversations; 19 respondents completed reflective questionnaires and 169 participatory observation reports were included. Participants were purposively sampled and included representatives from the leadership triad (rehabilitation physicians, managers and healthcare professionals) and members of senior management involved in CP development.

Two overarching themes were identified: goal (mis)alignment and prolonged decision-making processes negatively impacted motivation and impeded CP development. Goal alignment between stakeholders was hindered by shifting organisational priorities, creating tensions between improving care quality and ensuring financial viability. Decision-making was challenged by role uncertainty and the complexities of multidisciplinary collaboration in CP development teams. Reflective dialogues, small-scale experimentation and financial modelling supported teams in navigating these tensions to varying degrees.

This study illustrates how value complexity unfolds in CP development and underscores the importance of ongoing stakeholder management, reflectivity, formative evaluation and dialogue. Greenhalgh et al’s rules of thumb provided interpretive value in exploring these complexities but require a solid theoretical understanding and an awareness of the rules’ interrelationships. A complexity-informed approach integrating ongoing reflection and adaptability can enrich CP development methodologies, enabling healthcare professionals and action researchers to engage constructively with value complexity in complex change processes. Further research is needed to develop and implement practical strategies for enhancing stakeholder engagement and decision-making in diverse healthcare settings.

Recent studies have demonstrated a beneficial role of steroids in severe community-acquired pneumonia, severe COVID-19 infection and acute respiratory distress syndrome (ARDS) of diverse aetiology. This multicentre randomised controlled trial in severe scrub typhus pneumonitis and ARDS will compare the effects of 6 mg of dexamethasone once per day with placebo, in addition to standard treatment, on ventilator-free days (VFD), mortality and ventilatory requirement.

The study, involving six sites, will recruit 440 patients with severe scrub typhus pneumonitis or ARDS to concealed, block-randomised, site-specific assignment of dexamethasone or placebo for 4–7 days. The primary outcome will be VFD, defined as days alive and free of ventilation at 28 days. Secondary outcomes will include 28-day mortality, need and duration of ventilation, and treatment failure, defined as death, or escalation of respiratory support from simple devices (nasal cannula, mask) to non-invasive or invasive ventilation, or the use of open-labelled steroids for worsening shock. The study will also ascertain if antinuclear antibody (ANA) expression during the acute phase of illness will predict steroid responsiveness. Subgroup analyses will be conducted a priori on ANA expression and the need for ventilation. All analyses will be conducted on an intention-to-treat basis. The trial, which commenced in April 2025, would clarify the role of corticosteroids in scrub typhus pneumonitis.

The Institutional Review Board and Ethics Committee of the lead site, Christian Medical College, Vellore, India, has approved the study (IRB Min No 15920 (INTERVE) dated 22 November 2023). The remaining five sites have obtained approval from their respective ethics committees. Study results will be published in an international peer-reviewed journal.

CTRI/2024/12/077709. Registered 5 December 2024.

Dyspnoea frequently leads to admissions in the Emergency Department (ED). Rapid and accurate diagnosis, specifically to distinguish acute heart failure from pneumonia and exacerbations of chronic obstructive pulmonary disease (COPD), is imperative to initiate appropriate therapy. This study aims to evaluate the feasibility and performance of the EMERgency ALgorithm efficiency for Dyspneic patient-UltraSound (EMERALD-US) algorithm using ultrasound (US) to diagnose the etiology of dyspnea in the ED-admitted patients.

225 patients of 50 years and above, presenting with acute non-traumatic dyspnoea, across six participating EDs will be enrolled. Patients will undergo a lung, a simplified four-chamber cardiac and a venous US. A physician, blinded to any clinical data or previous results, will execute the algorithm. The algorithm’s performance will be assessed using a receiver operating characteristic (ROC) curve. Secondary objectives include an evaluation of the protocol’s feasibility in the ED, an assessment of the concordance between the EMERALD-US algorithm diagnoses and results from other diagnostic tests (including laboratory work and imaging), as well as an evaluation of the algorithm’s performance in diagnosing other causes of dyspnoea, such as pulmonary embolism or pleural effusion, and the 30-day mortality rate.

The study protocol was approved by the French Committee for the Protection of Persons (CPP) (RCB n°2018-A02136-49). Misdiagnosis of dyspneic patients on ED admission has been associated with inappropriate treatment, prolonged hospital stays and increased mortality, particularly among elderly patients. The implementation of protocols like the EMERALD-US algorithm can help physicians in expedited decision-making and diagnosis without increasing ED visit durations.

NCT03691857.

Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.

The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t₀), the first, third and sixth treatment sessions (t₁, t₃, t₆) and at 3 months follow-up (t₇). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.

The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.

DRKS00031694.

Cortical spreading depolarisation (SD) is a pathological wave of depolarisation in the cortex. SDs occur frequently after severe acute brain injury, and SDs in clusters can contribute to secondary brain damage in patients with severe acute brain injury through hypoperfusion and upregulation of cerebral metabolism in vulnerable brain tissue. Ketamine appears to inhibit SDs both in vitro and in patient series of severe acute brain injury. The KETA-BID trial aims to examine the efficacy and safety of S-ketamine for SDs in severe acute brain injury, as well as the feasibility of the trial design.

This randomised, blinded feasibility and pilot trial includes adults (≥ 18 years) undergoing a supratentorial craniotomy or craniectomy for severe acute brain injury (ie, traumatic brain injury, aneurysmal subarachnoid haemorrhage or spontaneous intracerebral haemorrhage). During surgery, an electrocorticography (ECoG) strip is placed adjacent to injured brain tissue. Patients are continuously monitored throughout their stay at the neurointensive care unit and the neurosurgical step-down unit. In the case of an SD, physiological optimisation of intracranial pressure, brain tissue oxygen tension (PbtO₂), core temperature and blood glucose is initiated. Participants developing SD clusters are randomised for continuous infusion with S-ketamine or matching placebo in a 1:1 allocation with full blinding of the treatment allocation. Infusion rates (ie, dose) and duration of trial medication are adjusted following a dosing algorithm according to SD occurrence. Surviving participants are followed until 6 months after the injury with recording of functional outcome. The primary outcome is occurrence of SDs per hour of monitoring after randomisation.

The Scientific Ethics Committee of the Capital Region of Denmark (H-21056972), the Danish Medicines Agency (EudraCT 2021-003716-12), as well as the Clinical Trials Information System (CTIS 2024-515315-22-00) approved this trial. This trial will provide insight into both SD and the clinical effects of ketamine following severe acute brain injury, presenting a potential new treatment for these patients. The findings will be submitted for publication in peer-reviewed publications.

NCT05095857.

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.

Maintaining a healthy workforce is crucial for safe, high-quality care. To enhance well-being and engagement in Dutch university medical centres (UMCs), an overview of staff well-being and job perceptions is needed first. Surveys are widely used to improve working conditions, but varying questionnaires hinder a comprehensive view. This study aimed to evaluate the content of employee surveys currently used in UMCs in the Netherlands from a well-being perspective and to analyse the survey results at a national level.

All seven UMCs were approached to participate in the study and share employee survey data. The primary outcome of interest is work experience; a secondary analysis was conducted. Items were categorised following the Job Demands-Resources model. Descriptive statistics were presented as percentages, means and medians with IQRs.

Two UMCs participated and 31 862 completed surveys were included. Variation in survey items (eg, 15–18 subcategories, 21–33 question items), response options (eg, 1–5, 1–10), frequency (1–3 times per year) and timing were found. Scores on the following outcomes are presented: work overload, coworker support, job control, organisational justice, participation in decision-making, performance feedback, possibilities for learning and development, recognition, task variety, team atmosphere, team effectiveness, trust in leadership, other job resources, connecting/inspiring leadership, self-efficacy, goal-directiveness, boredom, burnout, job satisfaction, work engagement, other employee well-being, commitment organisation/team and work ability. Results should be interpreted with caution, and solely found for hospital A, for certain job control items, median scores of 2 or 3 were observed, whereas the majority of other question items revealed a median score of 4.

There is a significant lack of cohesion across employee surveys. As it stands, employee surveys in Dutch UMCs are not effective tools for monitoring the work experience or well-being of the healthcare workforce. While these surveys may support management decisions, this support is not reflected in interventions related to work and the work environment.

There is evidence for significant inequalities in morbidity and mortality due to cancer and other major non-communicable diseases (NCDs) both within and between European countries. Up-to-date evidence highlighting best practices for future policies is needed to reduce these inequalities.

The objective is to map and summarise published evidence on the impact of national and/or supranational policies on social inequalities in cancer and other NCDs, and their risk factors in Europe, and explore the nature and characteristics of these policies. The criteria for studies to be included are Population: any population group(s), whole population(s) or supranational population in Europe. Concept: any national or supranational policy directly targeting social inequalities in NCDs and/or their risk factors, or NCDs or their risk factors in general, while reporting effects on inequalities or targeting root causes of social inequality. Context: policies implemented by one or more governments or authorities in the WHO European region, in one or more sectors, and applied in a primordial, primary, secondary or tertiary prevention context. The policies may be universal, targeted or proportionate universal. The review will follow the Johanna Briggs Institute guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews. We will search 13 databases from 2008 up to present for eligible experimental or quasi-experimental studies in any language, and reference lists of relevant reviews and included studies. The databases for the main search will include MEDLINE, Embase, Cochrane CENTRAL, Global Health, American Psychological Association (APA) PsycInfo, Cumulated Index in Nursing and Allied Health Literature (CINAHL), Education Resources Information Center (ERIC), Web of Science Core Collection, Sociological Abstracts, Scopus, EconLit, The Social Interventions Research and Evaluation Network and FRANCIS. Study quality will be assessed using the Effective Practice and Organisation of Care (EPOC) risk of bias tool or the Risk of Bias in Non-Randomised studies of Interventions (ROBINS-I) tool depending on study design. Results will be synthesised narratively using descriptive statistics and visuals.

Ethical approval will not be sought as scoping reviews do not involve primary data collection or direct interaction with human participants. The results of this review, which is part of the JA-PreventNCD project, funded by the European Commission, and involving 25 European countries, will feed into one of the project’s deliverables, which comprises recommendations for policymakers based on the best available knowledge. We will also aim to present the results of the review at international conferences and publish the full review in an international peer-reviewed journal.

This protocol is registered on Open Science Framework (https://doi.org/10.17605/OSF.IO/H7MUW).

Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

Patient-centred care (PCC) is one of the six key attributes of healthcare quality. However, despite its significant contribution to improving healthcare quality, PCC is often poorly implemented. This study aimed to explore the determinants of effective PCC implementation among healthcare providers at Kahama Municipal Hospital in Tanzania.

To explore the determinants influencing the effective implementation of PCC among healthcare providers at Kahama Municipal Hospital in Tanzania.

A qualitative approach was used, with 21 healthcare providers recruited through purposive and convenience sampling methods. Data were collected through focus group discussions and key informant interviews, and content analysis was employed to analyse the data.

The study was conducted at Kahama Municipal Hospital, in the Kahama Municipal Council of the Shinyanga region, Tanzania, from February to June 2019. As a referral hospital, Kahama Municipal Hospital serves a vast catchment area, including rural and semiurban communities across more than eight regions in Tanzania’s Lake and Western zones.

The study identified several factors related to healthcare professionals, including awareness of PCC, staff motivation, heavy workload, professional competencies and effective communication. Organisational-related determinants, such as the absence of ethical guidelines, a lack of a clear organisational culture and the absence of specific policies and guidelines on PCC, were also found to affect its effective implementation.

PCC is recognised at Kahama Municipal Hospital, but key barriers hinder its implementation, including unclear policies, lack of a PCC-focused vision, staff shortages, excessive workloads, low motivation, limited practical exposure and communication issues. To improve PCC implementation, healthcare policymakers and hospital administrators should: (1) establish clear PCC policies, (2) integrate a patient-centred vision into leadership, (3) address workforce shortages, (4) provide targeted training on PCC and (5) boost staff motivation through recognition and career development. Implementing these measures will improve care quality and health outcomes. Further large-scale research is needed to assess PCC implementation across Tanzania and guide national policy.

Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.

The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.

The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.

ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.