Growing evidence exists about the pivotal role of immune mechanisms in the physiopathology of atrial fibrillation (AF). Drugs that modulate the immune system (immunomodulators) may contribute to the development of AF. We aimed to identify immunomodulators that are associated with AF to better define their safety profile, and elucidating their mechanisms of action could yield novel insights into AF’s immune physiopathology.

A descriptive and disproportionality analysis of claims data.

World pharmacovigilance database VigiBase until 1 March 2025.

First, we ascertained the association of immunomodulators with AF over-reporting with a disproportionality analysis evaluating the multivariable-adjusted reporting odds ratio (aROR) for AF reporting performed for 141 immunomodulators in VigiBase. Then, a literature review was done to explore the underlying mechanisms of AF through immunomodulator mechanisms.

A total of 6 148 556 reports encompassing at least one of the 141 immunomodulators were identified in Vigibase. Our primary analysis revealed 20 immunomodulators associated with AF over-reporting. The three immunomodulators with the greatest signal were: recombinant interleukin-11 with an aROR=20.91 (99.96% CI 12.08 to 36.17), efgartigimod alfa with an aROR=6.75 (99.96% CI 3.96 to 11.52) and recombinant interleukin-2 with an aROR=6.15 (99.96% CI 3.62 to 10.45). A derivative literature review posited a hypothetical immune ‘vicious circle’ promoting AF, involving T helper cells, macrophages and natural killer cells which could lead to electrophysiologic and histologic atrial remodelling.

Twenty Food and Drug Administration (FDA)-labelled immunomodulators are associated with AF overreporting in Vigibase with a substantial signal on recombinant IL-11. These data contribute substantively to the prevailing understanding of the safety profile of these immunomodulators. Moreover, these findings support a multidirectional interaction between the immune system and AF development and might lead to considering future therapeutic targets.

NCT06095791.

Vital signs such as heart rate (HR) and respiratory rate (RR), crucial for clinical assessment, are often challenging to measure in paediatric populations. Remote photoplethysmography (rPPG), a video-based measurement tool, has demonstrated accuracy in adults. The objective of this study is to compare HR and RR measurements obtained using rPPG with those from standard clinical monitoring in a paediatric population.

This is a monocentric, prospective study enrolling 600 paediatric participants. Each participant will have standard monitoring electrodes (ECG/impedance) placed on the chest while seated facing a camera for rPPG recording. Simultaneous HR and RR measurements will be recorded over periods of 30 and 60 s using both the standard monitor and the rPPG device. The intraclass correlation coefficient will be calculated to assess agreement between the rPPG and standard monitor measurements.

The study protocol has been approved by the French Agency for the Safety of Health Products (ANSM (Agence nationale de sécurité du médicament) registration no. IDRCB 2023-A02524-41) and by a French ethics committee (CPP Sud Méditerranée III at 29 August 2024, n°2024-A01324-43). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through press releases.

Clinical Trials Registry (NCT06231654).

Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF’s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.

An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2–5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.

This study’s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.

NCT06786975.

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

NCT05953155.

Epidermolysis bullosa (EB) is a group of rare genetic skin disorders characterised by skin and mucosal fragility, leading to painful blisters and erosions. Among its subtypes, the severe form of EB simplex (EBS-sev, OMIM 131760) is associated with widespread blistering from birth, mucosal involvement and increased neonatal mortality due to infections. EBS is primarily caused by dominant mutations in the KRT5 or KRT14 genes.

There is currently no curative treatment for EBS; management is symptomatic and multidisciplinary. Our recent data indicate that EBS-sev is associated with an inflammatory profile involving elevated levels of Th17-polarising cytokines (TGF-β, IL-6, IL-21), suggesting a role for the Th17 immune response in disease pathogenesis.

EBULO is an open-label, multicentre phase 2 study, over a 20-week period, to evaluate the oral daily intake of apremilast (dosage depending on the age and the weight of patients) based on a challenge/dechallenge/rechallenge design. Patients are evaluated during five on-site visits, and apremilast is administered for 16 weeks during two treatment periods, with a 4-week treatment interruption in between. The primary outcome will be to assess the efficacy of apremilast in the treatment of patients with EBS-sev evaluated by counting the number of new blisters, a method specifically developed for this protocol to overcome the lack of reliable assessment tools in EBS-sev. The secondary outcome will include assessing the safety and tolerability of apremilast treatment through the description of the specific events occurring during the treatment periods of the study.

The French Ethical Review Authority has approved the EBULO trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.

NCT06509984.

Despite having more medical and social vulnerabilities than men with substance use disorder (SUD), women with SUD are underrepresented in addiction healthcare structures. This is because they experience double stigma—from society (including the medical community) and from themselves—which hinders them from accessing healthcare.

Using a mixed-methods approach, the main objective of the Calliope study is to explore and compare healthcare satisfaction among women with SUD according to the category of healthcare structure they attend: specialised addiction centres versus primary care centres called ‘microstructures’. A total of 240 women receiving care for SUD will be included in the study, with equal representation from specialised addiction centres and ‘microstructures’. All participants will complete a standardised questionnaire to collect quantitative data. Additionally, a subsample of 40 women will be selected to participate in in-depth, semistructured interviews to gather qualitative data. Additionally, focus groups will be conducted with healthcare professionals to explore their perspectives and practices.

Calliope was reviewed and approved by the institutional ethics committee of Paris Cité University (IRB: 00012024–02). The study’s findings will provide a greater understanding of the characteristics, needs and satisfaction with healthcare of women with SUD living in France. Moreover, they will help guide the development of tailored therapeutic interventions for this population.