This study examined social determinants and structural barriers to lung cancer outcomes in Kern and Fresno counties, California, and co-developed a multilevel intervention strategy informed by community perspectives.

Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.

We identified and trained four community members from two community-based organisations in Central Valley, California, to help recruit GMB participants. 14 community members representing patient advocacy organisations, cancer survivors, clinicians, caregivers, public health professionals, medical interpreters, housing, agriculture, sanitation, healthcare payer organisations and local policymaking sectors were recruited.

The GMB protocol consisted of two in-person and four virtual workshops from 22 August to 11 November 2024. The SD simulation model was built with iSee System’s Stella Architect SD modelling software (V.4.0).

The 181 variables suggested by the GMB workshop participants were categorised into 3 themes and 13 subthemes, which shaped the system boundary and model structure. 7 of the 16 intervention scenarios tested showed a cumulative reduction in the at-risk population and increases in screening, diagnoses, treatment and cancer-free survival. Participants selected a multilevel strategy focused on expanding public health and insurance education and advocating for air pollution-related screening within existing protocols.

Community engagement is essential for understanding lung cancer disparities and designing practical multilevel interventions. Scenario testing enables informed planning to improve long-term population health outcomes.

Despite advances in diabetes care, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in type 2 diabetes mellitus (T2DM), with significant residual risk despite optimal glycaemic control. Targeting upstream vascular mechanisms beyond metabolic endpoints is therefore essential through more holistic and integrative approaches to effectively prevent cardiovascular complications in T2DM. Endothelial dysfunction plays a central role in accelerating atherosclerosis and premature vascular ageing in T2DM, thereby increasing the cardiovascular risk, making it a key therapeutic target. This study aims to rigorously evaluate the effect of a structured yoga-based lifestyle programme on endothelial function, markers of vascular ageing and quality of life in individuals with T2DM and to elucidate potential mechanisms of action through assessment of autonomic, inflammatory, oxidative and metabolic pathways.

A prospective, four-arm, parallel-group, randomised, open-label, blinded end-point study will be conducted at a tertiary care hospital on a total of 248 (62 per arm) adults aged between 30 and 70 years and have a confirmed diagnosis of T2DM for at least 1 year. Three yoga-based intervention groups will receive different components of yoga-based lifestyle intervention in addition to standard medical care, and the control group will receive standard medical care alone. The yoga intervention will be delivered over 12 weeks, comprising supervised sessions twice weekly, supplemented by guided home practice. The primary outcome is the change in endothelial function assessed by flow-mediated dilatation. Secondary outcomes include arterial stiffness, vascular ageing markers, glycaemic and lipid profiles, autonomic function, oxidative stress, quality of life and cost of care. Outcome assessments will be performed at baseline, 3, 6 and 12 months, with outcome assessors blinded to group allocation. Data will be analysed according to the intention-to-treat principle. Analysis of covariance and mixed-effects models will assess intervention effects, with sensitivity analyses. Effect estimates and their 95% CIs will be reported.

The study has received approval from the Institutional Ethics Committee of SDM College of Medical Sciences and Hospital, India (approval no. SDMIEC/2025/1075). The study findings will be disseminated through peer-reviewed scientific publications, presentations at national and international conferences and stakeholder meetings, with the aim of informing integrative strategies for effectively preventing cardiovascular complications in T2DM.

CTRI/2024/10/075712.

Internationally, medical schools increasingly use standardised selection assessments to select applicants. The University Clinical Aptitude Test (UCAT) is the most popular standardised medical selection assessment across Europe and Australasia. The UCAT consists of cognitive assessments and a situational judgement test. The UCAT scores have been shown to offer incremental predictive validity for medical school academic attainment: they add predictive value beyond that already provided by prior educational attainment such as secondary school grades. However, the use of standardised medical selection assessments imposes burdens on applicants and institutions. Therefore, to justify their widespread adoption, scores from these assessments should predict doctors’ future clinical competency. This can be evaluated by their performance in post-qualification practical clinical examinations. Hence, this study aims to evaluate whether UCAT scores offer incremental predictive validity for doctors’ performance in UK post-qualification practical clinical examinations.

This observational retrospective national cohort study will use data from the United Kingdom Medical Education Database (UKMED). The UKMED is a national database containing pseudo-anonymised routine data on UK doctors. The population included will be those who attempted the UCAT as part of their medical school application and subsequently attempted UK post-qualification practical clinical examinations. The predictors are the UCAT total and subtest scores. The primary outcomes are performance in the UK post-qualification practical clinical examinations, such as the Membership of the Royal College of Physicians Practical Assessment of Clinical Examination Skills (MRCP PACES). The sample size estimate is >270.

Descriptive statistics will summarise the study data. Univariable logistic regression will estimate the probability of passing post-qualification practical clinical examinations as a binary categorical outcome variable (pass vs fail), based on UCAT scores. Multivariable logistic regression will estimate whether UCAT scores offer incremental predictive validity for passing post-qualification practical clinical examinations by adjusting for the predictive validity offered by prior educational attainment. Similarly, univariable and multivariable linear regression will estimate the predictive validity of UCAT scores for performance in post-qualification practical clinical examination scores as a continuous interval variable. Path analyses will be developed and tested to explore how the educational predictors relate to each other and the outcomes of interest. Missing data will be addressed using multiple imputation by chained equations.

As this is a secondary analysis of pseudo-anonymised data, the Chair of Hull York Medical School Ethics Committee confirmed in writing that ethical approval will not be required. Results will be published in a peer-reviewed journal, presented at academic conferences, and shared with relevant policy bodies.

The protocol was registered prospectively on the Open Science Framework (10.17605/OSF.IO/VZ2QC).

To characterise demographics, comorbidities, co-medications and healthcare resource utilisation (HCRU) in patients newly diagnosed with Alzheimer’s disease (AD) in England using published and validated AD algorithms.

Observational cohort study.

Real-world data in England from the Clinical Practice Research Datalink Aurum primary care database linked to the Hospital Episode Statistics secondary care database.

Two disease-based algorithms (Imfeld et al and Douros et al) and one medication-based algorithm (Schroeder et al) were selected from the literature to identify patients with AD. The index period for patient selection was from 1 January to 31 December 2019. Patients were grouped into three non-mutually exclusive cohorts reflecting these algorithms (cohorts A–C), then patients aged ≥60 years were further grouped into three subcohorts (subcohorts 1–3). Subcohort 1 included 9826 patients, subcohort 2 included 10 265 patients and subcohort 3 included 7355 patients.

Demographics, comorbidities, co-medications and HCRU present up to and including the date of cohort qualification were described.

Across subcohorts 1–3, mean age at index ranged from 81 to 83 years, and most patients were female (59%–63%) and White (93%). Common comorbidities were hypertension (67%–71%), asthma and chronic obstructive pulmonary disease (60%–63%) and arthritis and osteoarthritis (51%–53%). Common co-medications were analgesics (87%–89%), systemic corticosteroids (83%–84%) and anti-inflammatory and anti-rheumatic agents (81%–82%). Up to 34% of patients had a specialist referral or visit, with up to 18% involving a neurologist. In the 12 months prior to and including the index date, up to 46% of patients had an emergency department visit or inpatient visit for any cause.

In England, most newly diagnosed patients with AD were White females in their early 80s with common comorbidities including hypertension, asthma, chronic obstructive pulmonary disease, arthritis and osteoarthritis. This study addresses a critical evidence gap by quantifying the England-specific burden of comorbidity, polypharmacy, and HCRU among patients with AD using multiple validated and published AD algorithms. Findings were broadly consistent across the three subcohorts identified using disease-based and medication-based algorithms, strengthening internal validity of the study and demonstrating that the findings are robust to the method of AD case definition. This study provides a novel insight into the real-world AD population in England, and findings may help healthcare professionals to identify patients living with AD, understand patients’ needs and tailor treatment strategies.

Sinonasal carcinomas are rare malignancies with an overall poor prognosis. These tumours arise in close proximity to vital structures, critical organs and cranial nerves involved in essential sensory and endocrine functions. Although multimodal treatment strategies combining surgery and radiotherapy (RT) are required to maximise the chances of cure while sparing surrounding tissues and reducing the risk of recurrence, they are associated with substantial cumulative morbidity. Building on high conformality and steep gradients of modern dose-painting RT, multidisciplinarity can be exploited on technical inter-disciplinary aspects. In particular, minimally morbid endoscopic endonasal multi-block surgery (EES), together with accurate histosurgical mapping, can be leveraged to individualise target tumour subvolumes delineation by risk level to avoid unnecessarily large irradiation and reduce the morbidity of RT while maintaining or improving local tumour control.

We designed a randomised multicentre phase II study to assess whether EES-based histosurgical mapping delineation and optimisation using a dose-painting approach can reduce treatment-related toxicity compared with standard intensity-modulated RT using conventional delineation in sinonasal carcinomas. The primary endpoint is the proportion of patients free from severe clinically significant radiation-induced toxicity involving the nasal mucosa, eyes, auditory system, endocrine system and/or brain within 3 months following RT completion. Secondary objectives include assessing the proportion of patients free from severe toxicities at 12 months, tumour control, quality of life, tolerance profile, RT plan quality and the association of histoclinical characteristics and radiomic features with toxicities. To ensure tumour control and avoid quality biases on toxicity outcomes, multidisciplinary volume delineation with the surgeon, as well as prospective individual case review (ICR) of the first 2 cases for each centre and both technique arms, and retrospective ICR for all cases, will be conducted.

Eligible patients will be 1:1 randomised between dose-painting based on histosurgical mapping (experimental arm) or standard delineation/optimisation (control arm), with stratification according to RT modality (photons or protons). We plan to enrol 52 patients. RT will start no earlier than 4 weeks and no later than 8 weeks after surgery, and will be delivered over a 7-week period. Patients will be followed-up for 18 months after completion of RT. We hypothesise that dose-painting RT, which relies on extensive interdisciplinary optimisation, will enable a selective de-escalation of irradiated volumes, which should translate into lower treatment-related toxicities.

Ethical approval was obtained from the Comité de Protection des Personnes Nord-Ouest IV (N°ID-RCB: 2022-A02011-42; cppnordouestiv@univ-lille.fr) on 12 April 2023, and authorisation from the National Agency for Medical and Health Products Safety on 15 May 2023. The most recent amendment (V2) was approved on 25 January 2024. Written informed consent will be obtained from all participants. Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.

NCT05943119.

To conduct a Delphi study to develop a consensus-based definition of complex case management within the UK context.

This study was conducted with members of the British Association of Brain Injury and Complex Case Management (BABICM).

A methodological approach informed by a modified Delphi design was employed, incorporating expert focus groups and two rounds of questionnaires distributed to members of the BABICM.

Initial focus groups (n=2) with eight expert case managers generated themes which were used to create a draft definition. Five definitions—four existing and one newly developed definition—were reviewed and refined through two rounds of online questionnaires. The top two definitions in round 1 were retained for round 2 (with no refinement required based on qualitative responses). The final definition was agreed-on when consensus was reached ≥80% agreement.

In round 1, 130 (10.8% of the 1200-member population) BABICM members ranked five definitions and provided qualitative feedback. Based on round 1 rankings, two definitions were retained for round 2. Definition 4, developed through expert focus groups, was ranked as the most preferred in round 1 (60%) and round 2 (85%), thus meeting the consensus threshold. The final definition emphasised collaborative, tailored support across systems, advocacy and person-centred care for clients and their families.

This study provides a consensus-based definition of complex case management in the UK, reflecting the complexity and interdisciplinary nature of the role. The definition offers a foundation for standardising practice, informing training and guiding future research and policy development.

Despite numerous studies on surgical outcomes in Crohn’s disease (CD), global evidence remains fragmented, with limited synthesis of data on international surgical trends, regional variations and comparative outcomes. This systematic review aims to evaluate the rates of CD-related surgeries in the biologic era and to identify evidence gaps to inform future surgical strategies.

A comprehensive search will be conducted in MEDLINE, Embase, and CINAHL from 9 February 2015 to 10 February 2025. A combination of controlled vocabulary and free-text terms related to surgical interventions and CD will be used to identify relevant literature. Studies eligible for inclusion include observational studies and randomised controlled trials (RCTs). The primary outcome is overall surgical rates in CD. Secondary outcomes include emergency versus elective surgery, minimally invasive vs conventional approaches, disease duration prior to surgery, permanent stoma formation rates, reconstruction approach and postoperative complications. Both adult and paediatric populations are considered. The risk of bias will be assessed independently by reviewers using appropriate tools. Meta-analyses or narrative synthesis will be conducted based on study heterogeneity, with subgroup and sensitivity analyses to explore regional, temporal and methodological variability.

This protocol does not require ethical approval, as it involves secondary data analysis. Findings will be disseminated via peer-reviewed journal publications and relevant conferences.

CRD420251006137

Parenting interventions have shown promise in improving mental well-being for parents and children and strengthening family relationships. Parenting for lifelong health (PLH) is an open-access, evidence-informed programme that aims to improve positive parenting practices, reduce family violence and promote mental health, particularly in low-resource settings. This study will evaluate the implementation and (cost-)effectiveness of an adapted version of the PLH for Parents and Teens programme. It will focus on supporting positive parenting, communication, mental health and well-being of adolescents and their caregivers in North Macedonia and Moldova.

This multicountry hybrid type 1 effectiveness-implementation randomised waitlist-controlled trial will recruit 660 adolescents aged 10–14 years and their caregivers through schools, Youth Clinics and community partner organisations, including vulnerable and linguistically diverse families. The intervention group will receive the adapted PLH programme with assessments conducted postintervention and at 6-month follow-up. The waitlist control group will receive the adapted PLH programme after completion of the intervention group’s 6-month post-baseline assessment. Primary outcomes include adolescent emotional problems, family functioning, parenting practices, adolescent and caregiver quality of life. Secondary outcomes assess a range of mental well-being, family and other psychosocial outcomes. Other prespecified outcomes include implementation and cost outcomes. Primary analyses will compare intervention and waitlist control groups at postintervention and 6-month follow-up using intention-to-treat, baseline-adjusted linear mixed models. A within-trial economic evaluation will include cost–utility analysis and cost-effectiveness analysis. A macroeconomic analysis will assess broader economic impacts using public financing and budget impact analysis. The study uses a mixed-methods process evaluation, and integrates qualitative data, budget impact analysis and simulation modelling to inform scale-up considerations.

The study has received ethical approval from all relevant sites. Results will be disseminated through peer-reviewed publications, scientific conferences and webinars, newsletters, social media and open-access platforms, alongside engagement with researchers, clinicians, policymakers and the public. The Family-Focused Adolescent & Lifelong Health Promotion project uses a targeted communication and dissemination strategy for families, implementers and policy stakeholders to promote the adoption and scale-up of evidence-informed, open-access parenting interventions for adolescents and caregivers in low-resource settings. Dissemination focuses primarily on North Macedonia and Moldova while also engaging actors across the wider Eastern European region.

NCT07240571.

Cardiovascular disease remains a leading cause of preventable mortality in Aotearoa New Zealand (NZ), with Māori continuing to experience earlier onset, higher hospitalisation rates and greater mortality than non-Māori. Despite this inequity, community-based data describing cardiac structure, function and circulating cardiovascular biomarkers in older Māori are very limited, particularly for those over 65 years. The Hauora Manawa mō ngā Kaumātua me ngā Whānau (Heart Health of Older Māori and Families; Kaumātua Manawa) study aims to examine associations between ethnicity and age on cardiac structure, function and plasma cardiovascular biomarkers in Māori and to evaluate the suitability of current clinical reference standards.

Kaumātua Manawa is a community-based, co-designed study comprising a baseline assessment of cardiac structure, function and biomarkers, combined with prospective ascertainment of hospitalisation, all-cause mortality, pharmaceutical dispensing and clinical laboratory outcomes via ongoing linkage to national administrative health data held by the Ministry of Health and Te Whatu Ora | Health NZ. The study is conducted in partnership with Māori communities in Canterbury, NZ, with study clinics conducted at marae to ensure cultural safety for participants. Adults aged ≥18 years are recruited using convenience sampling, with a primary focus on Māori aged ≥65 years. Participants undergo nurse assessment (demographics, medical history, cardiovascular risk factors), 12-lead ECG, comprehensive transthoracic echocardiography following American Society of Echocardiography guidelines and non-fasting blood sampling. Biomarkers include N-terminal pro-B-type natriuretic peptide, high-sensitivity troponin T, growth differentiation factor-15 and lipoprotein(a). Descriptive statistics will summarise cardiac measures overall and by marae. Associations between biomarkers and demographic and clinical variables will be examined using regression modelling. Echocardiographic parameters indexed according to international and NZ-specific recommendations will be compared with existing NZ European cohorts. This methodology paper uses the principles of the CONSolIDated CritERia for Strengthening the Reporting of Health Research Involving Indigenous Peoples statement (CONSIDER).

Ethics approval has been obtained from the NZ Health and Disability Ethics Southern Committee (2022 EXP 11434), and the protocol is registered at the Australian NZ Clinical Trials Registry. The study is governed by a dedicated Māori Governance Rōpū (Group) to ensure alignment with tikanga Māori (Māori protocols) and community priorities. Meetings will be conducted with participating marae and communities to discuss findings prior to publication. Results will be disseminated through open-access peer-reviewed publications and via presentations.

ACTRN12626000348358.

Liver transplantation remains the only curative option for end-stage liver disease, yet high waitlist mortality and organ scarcity continue to challenge the field. The randomised multicentre ExTra trial aims to decrease time-to-transplant by safely improving access to transplantation through viability assessment of otherwise discarded grafts with normothermic machine perfusion (NMP).

The ExTra trial is a prospective, randomised, multicentre study conducted across German transplant centres. Participants listed for liver transplantation with a reMELD-Na-Score ≤21 (refitted MELD-Natrium Score) who are not eligible for Standard or Non-Standard Exceptions will be randomised for a 1-year intervention period into two groups: the experimental arm, in which they have—in addition to regular organ allocation—the extra option to receive a graft that was initially deemed non-transplantable based on clinical criteria, but meets specified quality criteria after at least 4 hours of NMP, and the control arm, which consists of conventional allocation procedures alone. The primary endpoint is time-to-transplant, defined as the period between randomisation and transplantation. Secondary outcomes include competing events (death, disease progression or recovery without transplantation), graft and patient survival, quality of life and cost-effectiveness. Additional analyses will assess early graft function, length of hospital stay, biliary complications and 1-year post-transplant outcomes. A centralised biobank will collect perfusate, tissue and blood samples for biomarker research. Safety will be monitored through quarterly reviews by a Data Safety Monitoring Board.

The study protocol received approval from the Institutional Review Board of the Charité – Universitätsmedizin Berlin on 2 April 2025 (EA1/04/25). Participating study centres will need local Institutional Review Board approval prior to initiation. This study complies with Good Clinical Practice guidelines and all applicable national and local regulations. Results will be disseminated during international and national conference meetings and through publication in a peer-reviewed journal with open access.

NCT06874296.

Language and communication difficulties are common across a range of dementias including primary progressive aphasia (PPA). Better Conversations with PPA (BCPPA) is a co-designed communication partner training intervention that aims to improve the experience of conversations for a person with communication difficulties. An NHS-based pilot study of face-to-face BCPPA demonstrated positive outcomes but also raised questions about when and where this intervention should be delivered (at diagnosis or later; face to face and/or remotely), how to best measure the effectiveness of the intervention in line with participant’s priorities and whether BCPPA might be acceptable and useful to people with a range of dementia types. We also had questions about the possible economic implications of BCPPA. In preparation for a future full effectiveness study, the present study will address the following questions:

What is the optimal schedule and dosage of BCPPA versus treatment as usual?

What are the eligibility criteria for the BCPPA intervention? Is remote delivery of BCPPA acceptable to people with PPA and other dementias? Can the BCPPA be delivered remotely as intended? Do planned outcome measures show sensitivity to change pre-/post-/3 months post BCPPA? What are the barriers and facilitators to implementation of BCPPA in an NHS setting? What is the most appropriate perspective of analysis and way of measuring costs and outcomes in a future cost-effectiveness analysis of BCPPA versus usual care?

In line with Medical Research Council guidance on development and management of complex interventions, Skivington et al, 2021 this protocol paper describes a phase II mixed-methods process evaluation and health economic study. This protocol for a randomised controlled pilot feasibility study compares the BCPPA communication partner training intervention with a deferred entry group for people with PPA and other rare dementias and their communication partners. Participants will be recruited at diagnosis and review appointments from two NHS trusts. Participants who have completed a repeated baseline measure will be randomised to either the BCPPA intervention or a deferred entry group. The intervention will be delivered remotely, via teletherapy, over 4–6 weeks depending on goal achievement. The deferred entry group will receive the intervention after a 6-week waiting period, and all participants will be assessed immediately post intervention and again at 3 months post intervention. Outcome measures have been selected in line with the current recommendations for a core outcome set for PPA and to address questions of implementation and health economic evaluation. Qualitative and quantitative analysis methods will be used to explore the data.

Ethical approval for this study was granted by the Health Research Authority for England and Wales IRAS (Project ID: 341322 REC REF 24-NI-0123). Results from this study will be published in peer-reviewed journal articles and shared with participants and patient and public involvement advisors in accessible formats.

ISRCTN16268666.

This study estimates the cost of managing infertility, including intrauterine insemination (IUI) from health system perspective in India.

This was a retrospective cross-sectional microcosting study using mixed approach. Unit costs were estimated at the cost-centre level based on average resource utilisation and aggregated by facility type and cause of infertility. The cost data was collected for the year 2022–2023 and adjusted for inflation in 2025.

The study was conducted at five healthcare facilities providing infertility services, of which three were public and two were private hospitals situated in different parts of country.

The cost data was collected from different departments of hospitals. To determine the service utilisation, 100 infertility patients were enrolled at each hospital. Patients undergoing infertility treatment (including IUI) for five selected causes of infertility and willing to participate in the study were included.

The cost of providing infertility treatment for 1 year was the primary outcome measure. The share of different cost-components in the total cost was the secondary outcome measure.

The one-year health system cost of infertility management ranged from INR 5515 (USD 63) to INR 15 139 (USD 173). Median costs were generally higher in public hospitals compared to private hospitals. Outpatient consultations contributed about two-thirds of total costs. The mean cost of one IUI cycle ranged from INR 8272 (USD 94) to INR 8887 (USD 101).

This first-of-its-kind study provides robust evidence on the health system cost of infertility management in India. The findings highlight significant cost variations by infertility cause and facility type, underscoring the need for inclusion of infertility services, particularly IUI, within public health financing packages. These results offer a foundation for future cost-effectiveness analyses and policy decisions related to infertility treatment in India.

Leptospirosis is a zoonotic infection caused by the bacterium Leptospira, which typically enters humans through contact with water or soil contaminated with infected urine. One of the most important causes of death due to leptospirosis is leptospirosis pulmonary haemorrhage syndrome (LPHS). LPHS occurs due to an inappropriate immune response, resulting in excessive release of cytokines/chemokines or direct damage to alveoli by bacteria. Mortality remains high in LPHS, and management strategies of this deadly complication are under-investigated. Survivors have minimal residual lung injury, necessitating evidence-based treatment to improve mortality in LPHS. Steroids and plasmapheresis have been tried in many case series but lack robust evidence. Plasmapheresis has become a standard practice in Sri Lanka for managing LPHS, guided by expert opinion. This study will try to determine the effect of moderate-dose or high-dose steroid combination with plasmapheresis compared with plasmapheresis alone as a treatment for LPHS.

This open-label, randomised controlled trial will enrol LPHS patients from four selected tertiary care hospitals in Sri Lanka. Participants will be randomly assigned to three groups in a 1:1:1 ratio to receive plasmapheresis alone, plasmapheresis with 150 mg/day methylprednisolone for 3 days or plasmapheresis with 1000 mg/day methylprednisolone for 3 days. Recruitment will consist of 28 participants to each arm of the trial. Diagnosis will be confirmed by Leptospira-specific PCR and microscopic agglutination test. Analysis will follow intention-to-treat principles with adjustment for multiple comparisons. Primary outcome is all-cause mortality at 28 days. Secondary outcomes include hospital-acquired infections, duration of respiratory support, duration of intensive care unit stay, duration of hospital stay and side effects of steroid therapy.

The ethical approval was obtained from the Research Ethics Committee of the University of Sri Jayewardenepura (ERC 20/24) and the trial has been registered in the Sri Lanka Clinical Trials Registry (SLCTR/2024/037). Trial is approved by the National Medicines Regulatory Authority in Sri Lanka (NMRA/CTRD/PA4/54). Study findings will be disseminated through peer-reviewed publications and conference presentations.

Sri Lanka Clinical Trials Registry, Number SLCTR/2024/037.