Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Retinal neurodegeneration has recently been shown to occur in tandem with neurodegenerative disease. In the expectation that disease-modifying treatments for Alzheimer’s disease (AD) and Parkinson’s disease (PD) will soon become available, it will be important to have clinically useful biomarkers for neurodegenerative disease subtyping to guide early diagnosis, inform on prognosis and stratify subgroups for treatment. Understanding differences in detectable retina changes in individuals with different neurodegenerative disease subtypes is therefore fundamental. The emerging field of oculomics posits that systemic and neurodegenerative disease can be characterised using detectable ocular biomarkers within retinal diagnostics. The aim of this review is to compare the performance of common retinal imaging modalities in neurodegenerative disease detection and subtyping.

This protocol has been reported in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. A comprehensive literature search will be conducted in PubMed, Web of Science and Scopus. Eligible studies will have reported using retinal diagnostic tools defined as optical coherence tomography (OCT), OCT angiography (OCTA), colour fundus photography (CFP) and electroretinography (ERG) in individuals with neurodegenerative diseases, including AD, PD, dementia with Lewy bodies, frontotemporal dementia, vascular dementia and mild cognitive impairment. There will be no time restrictions placed in these searches. Studies not written in English, not peer-reviewed and grey literature will be excluded. Screening for eligible studies and data extraction will be conducted by two independent reviewers, using predefined inclusion criteria. Any disagreements between the reviewers will be settled by discussion, and if required, third senior reviewer arbitration. The systematic review primary outcome is the performance of retinal diagnostics, namely OCT, OCTA, CFP and ERG in the detection and subtyping of aforementioned neurodegenerative diseases. The secondary outcome is to evaluate the association between changes in retinal diagnostic features (eg, retinal layer thicknesses) and neurodegenerative disease subtypes. The quality of the included studies will be assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluations) tool. A narrative synthesis approach will be used to analyse the results, with meta-analysis performed if there is sufficient data.

Ethical approval for this manuscript is not required, as this is a protocol for a systematic review and therefore no data are to be collected. Findings for this systematic review will be disseminated as a peer-reviewed publication and presentations at national and international symposiums including International Lewy Body Dementia Conference, International Congress of Parkinson’s Disease and Movement Disorders, The Association for Research in Vision and Ophthalmology.

CRD42023434024.

Depression and depressive symptoms are common in the elderly population and contribute to a lower quality of life. One change that is common in depression is the disruption of circadian cycles, which are regulated by melatonin and other neurotransmitters. Oral melatonin and melatonin agonists are well tolerated, being the main clinical indication of insomnia. A melatonin agonist is approved as an antidepressant. Thus, the objective of the systematic review will be to provide an up-to-date synthesis of the findings of randomised controlled trials that used melatonin or melatonin agonists as a therapeutic intervention in elderly people with depression.

This systematic review protocol was registered with PROSPERO under the number CRD42023391092. We will conduct a systematic review and possible meta-analysis of the efficacy of melatonin and melatonin agonists in the treatment of depression. Comparators will include placebo and active treatments (eg, antidepressants). We will search international electronic databases, including the Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials), EMBASE, PUBMED/MEDLINE and SciELO for published randomised control trial studies, and ongoing work and trials in progress by searching key internet-based relevant databases from inception to April 2025. There will be no restrictions on the language or geography of publication. The Cochrane’s risk of bias tool for randomised trials (RoB2) will be used to appraise the risk of bias, and GRADE tools will be used to evaluate the overall quality of the included studies. A descriptive summary with data tables will be constructed, and if adequate, we will perform a meta-analysis. A random-effects model will be used when substantial heterogeneity is present, otherwise, a fixed-effects model will be considered (I²). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist will be followed for reporting.

Since this systematic review will be based only on published and retrievable literature, no ethics approval will be required. A multidisciplinary team has been assembled for this systematic review and will participate in relevant dissemination activities, namely reports, publications and presentations.

CRD42023391092.

The rise of electronic nicotine delivery systems (ENDS) has introduced new challenges to tobacco control and regulation, particularly among young adults, raising questions about their safety. This umbrella review aimed to synthesise existing systematic reviews with or without meta-analyses to evaluate the health impacts of ENDS.

We conducted a systematic literature search via the PICO strategy across multiple databases, focusing on e-cigarettes, ENDS and e-liquids, while excluding non-nicotine e-cigarette and nicotine replacement therapies (NRTs). Health outcomes include a range of clinical diseases and physiological changes. Quality assessment was performed via assessing the methodoligcal quality of systematic reviews 2 (AMSTAR-2), and the findings were synthesised narratively and in tables, prioritising the highest-rated reviews. The meta-analyses used R software (V.4.3) random effects models, and evidence quality was assessed via the Grading of Recommendations, Assessment, Development and Evaluation criteria.

Of the 5055 records, 69 systematic reviews were included. Systematic reviews have indicated increased risks of cardiovascular and respiratory diseases, mental health issues and substance abuse with ENDS use, especially among adolescents. Cardiovascular risk factors included increased heart rate (mean difference (MD) 1.41, 95% CI 0.81 to 2.01, I²=91%) from 25 studies; increased blood pressure (MD for systolic blood pressure=0.51 mm Hg, 95% CI 0.26 to 0.75, I²=89%; MD for diastolic blood pressure=0.59 mm Hg, 95% CI 0.35 to 0.83, I²=82%) from 23 studies; endothelial dysfunction and increased platelet activity. Respiratory risk factors included reduced lung function and a higher incidence of asthma in nine studies (OR 1.30, 95% CI 1.1 to 1.55; I²=43%) and chronic obstructive pulmonary disease. Mental health concerns, such as depression and suicidality, were also prevalent among adolescent ENDS users. Nine studies reported a negative effect of ENDS on periodontal health. Evidence of carcinogens has been found in the urinary examinations of ENDS users in some studies. The adverse events reported in seven randomised controlled trials with 2611 participants were similar between ENDS and NRT (RR 1.13, 95% CI 0.83 to 1.54, I²=12%).

Exposure to ENDS is harmful to various organ systems, especially cardiovascular and respiratory systems. Comprehensive regulatory measures and public health strategies are necessary to curb the use of ENDS, particularly among young people.

This study aimed to assess the prevalence and determinants of vaccine hesitancy among pregnant women in South-West Nigeria.

An explanatory sequential mixed-methods study was conducted between January and March 2023. Participants for the quantitative phase were selected using a systematic sampling technique, while those for the qualitative phase were purposively selected. A modified parent attitude about childhood vaccines questionnaire was used for data collection and analysed using IBM SPSS V.25.0. Qualitative data were collected through focus group discussions and analysed using NVivo V.14. Univariable, bivariable and multivariable logistic regression analysis was done. A p

A tertiary health facility in South-West Nigeria.

Three hundred and forty-five pregnant women participated in the quantitative phase, while 24 pregnant women were involved in the qualitative phase.

The overall prevalence of vaccine hesitancy was 32%. Based on the domains, only 15.4% of the respondents were hesitant due to vaccination behaviour, 38.6% for safety and efficacy, and 49.6% were hesitant due to general attitude and trust for healthcare providers. Maternal age, number of children, religion and occupation showed significant association with vaccine hesitancy. Regarding the predictors of vaccine hesitancy, employed pregnant women (adjusted OR (aOR), 4.33; 95% CI: 1.60 to 9.70) and younger pregnant women (aOR, 2.53; 95% CI: 1.04 to 7.70) had a significantly higher odds of being vaccine-hesitant. The qualitative analyses revealed several major themes that contributed to vaccine hesitancy, including concerns about vaccine safety and efficacy, distrust of healthcare providers and the government, and the spread of misinformation through social networks and peers.

A significant proportion of pregnant women in this study were vaccine-hesitant. The major reasons for vaccine hesitancy are concerns about the safety of vaccines and lack of trust for healthcare providers. Policies and programmes should be aimed at improving vaccination behaviour, addressing safety concerns and building trust in vaccination systems.

Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.

Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.

A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.

The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.

These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

CRD42023452537.

Post-COVID-19 conditions (PCC) may include pulmonary sequelae, fatigue and other symptoms, but its mechanisms are not fully elucidated.

This study investigated the correlation between fatigue and the presence of pulmonary abnormalities in PCC patients with respiratory involvement 6–12 months after hospitalisation.

Cross-sectional study.

A tertiary hospital in Brazil.

315 patients, aged ≥18 years, were considered eligible based on SARS-CoV-2 infection confirmed by reverse transcription-PCR.

Pulmonary function tests (PFT), cardiopulmonary exercise tests (CPET), chest CT and hand grip were performed. The following scales were applied: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Euroqol 5 Dimensions quality of life (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Participants were divided between the fatigue group (FACIT-F≤30) and the non-fatigue group (FACIT-F>30). For the statistical analysis, the primary outcome was the difference in the diffusing capacity of the lungs for carbon monoxide (DLCO) between groups. Considered secondary outcomes were differences in PFT, CPET, chest CT, hand grip, EQ-5D and HADS.

The fatigue group had 81 patients (25.7%) against 234 (74.3%). PFT and CPET showed no significant difference in DLCO and oxygen consumption peak values between groups. The fatigue group had a lower workload (mean 55.3±21.3 watts vs 66.5±23.2 watts, p=0.003), higher breathing reserve (median 41.9% (33.8–52.5) vs 37.7% (28.9–47.1), p=0.028) and lower prevalence of ground glass opacity (60.8% vs 77.7%, p=0.003) and reticulation (36.7% vs 54.9%, p=0.005) in chest CT. The fatigue group had higher anxiety (57% vs 24%, p

Fatigue in patients with PCC 6–12 months after hospitalisation is relatively common and had weak correlation with pulmonary disorders. Our results suggested fatigue could be strongly related with peripheral disorders such as reduced musculoskeletal strength or psychosocial limitations.

It is unclear how mis- and disinformation regarding healthcare policy changes propagate throughout Latino communities via social media. This may lead to chilling effects that dissuade eligible individuals from enrolling in critical safety net programmes such as Medicaid. This study will examine pathways and mechanisms by which sentiment in response to mis- and disinformation regarding healthcare policies on social media differentially impact health disparity populations, thus supporting the design of tailored social media interventions to mitigate this.

We will search social media from X/Twitter, Facebook/Instagram and Reddit for keywords relating to health benefit programmes. Demographic, geographical location and other characteristics of users will be used to stratify social media data. Posts will be classified as fake-news-related or fact-related based on curated lists of fake-news-related websites. The number, temporal dissemination and positive or negative sentiment in reacting to posts and threads will be examined using the Python-based Valence Aware Dictionary and sEntiment Reasoner (VADER). Using a crowd-sourcing methodology, a novel Spanish-language VADER (S-VADER) will be created to rate sentiment to social media among Spanish-speaking Latinos. With the proposed approach, we will explore reactions to the dissemination of fake-news- or fact-related social media tweets and posts and their sources. Analyses of social media posts in response to healthcare-related policies will provide insights into fears faced by Latinos and Spanish speakers, as well as positive or negative perceptions relating to the policy over time among social media users.

Our study protocol was approved by the University of California, Los Angeles IRB (IRB#23–0 01 123). Results from this study will be disseminated in peer-reviewed journals and conference presentations, and S-VADER will be disseminated to public repositories such as GitHub.