SEARCH · PubMed Health

Search PubMed Health

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 577 records · Page 32Linked to original sources

PubMed2026

Immune Checkpoint Inhibitor-related Adverse Events in Publicly Accessible United States Malpractice Records: A Systematic Legal Database Review, 2015 to 2026.

OBJECTIVES: By 2023, an estimated 56.7% of US patients with advanced or metastatic cancer were eligible for immune checkpoint inhibitor (ICI) therapy. Grade 3 to 4 immune-related adverse events (irAEs) occur in ∼14% to 21% of patients depending on regimen, yet publicly accessible malpractice records involving ICI administration or irAE management have not been systematically described. METHODS: We searched Lexis+ and Westlaw Advantage for publicly accessible US malpractice records filed from January 1, 2015, through March 31, 2026. Sources included jury verdicts and settlement databases, federal and state dockets, and briefs, pleadings, and motions databases. Cases were included only when ICI administration, indication selection, toxicity counseling, toxicity recognition, toxicity monitoring, or irAE management was causally central to the alleged negligence. RESULTS: Among 38 legal matters identified after cross-platform deduplication, 4 met eligibility criteria. These matters reflected 4 pleaded negligence theories: inappropriate ICI indication, toxicity counseling and informed-consent failure, irAE mismanagement, and treatment-related multiorgan toxicity. Publicly visible irAE-centered malpractice records were rare relative to the clinical burden, but the data do not support a national litigation incidence estimate. CONCLUSIONS: Publicly accessible irAE-centered malpractice records appear rare. As ICI use expands, litigation risk may increasingly focus on indication documentation, individualized toxicity counseling, and structured monitoring.

immune checkpoint inhibitors↗

PubMed2026

Disruption of GAD1 protein architecture by a novel missense variant in a consanguineous family with autosomal recessive intellectual disability.

BACKGROUND: Intellectual disability represents a heterogeneous group of neurodevelopmental disorders marked by significant impairments in intellectual functioning and adaptive behavior. Among the various causes, genetic factors play a major role, with autosomal recessive intellectual disability (ARID) constituting a genetically diverse subgroup. ARID is prevalent in consanguineous families and arises from homozygous mutations that disrupt critical genes involved in brain development and function. OBJECTIVE: This study aimed to identify disease-causing genetic variants responsible for ARID in a consanguineous Pakistani family and to evaluate the structural and functional impact of a novel variant identified in GAD1 through protein modeling. METHODS: A consanguineous family affected with intellectual disability was enrolled. Whole-exome sequencing was performed on an affected individual, followed by bioinformatics analysis including alignment to the GRCh38 reference genome, variant calling, and annotation. Variants were filtered based on rarity, predicted functional impact, and autosomal recessive inheritance pattern. Candidate variants were validated and assessed by Sanger sequencing and segregation analysis. Protein modeling was performed to evaluate the structural impact of the identified variant. RESULTS: A novel homozygous missense variant NM_000817:c.1700G>A;p.Arg567Gln in GAD1 was identified. Segregation analysis confirmed co-segregation of the variant with the affected phenotype. Protein modeling suggested that the variant may disrupt GAD1 enzymatic function involved in gamma-aminobutyric acid synthesis. CONCLUSION: This study emphasizes the significance of genetic investigation in familial cases and the crucial role that GAD1 mutations play in neurodevelopmental disorders with intellectual disability. The results advance the knowledge of molecular causes of ARID and broaden the mutational range.

Pakistani↗

PubMed2026

Genomic characterization and phylogenetic placement of Matryoshka RNA virus 1 associated with Plasmodium vivax malaria in Africa.

Plasmodium vivax is a major cause of human malaria. It harbours Matryoshka RNA virus 1 (MaRNAV-1), a bi-segmented positive-sense RNA virus. MaRNAV-1 was first described in P. vivax and is now recognized as part of a wider group of Matryoshka viruses. These viruses also infect other haemosporidian parasites such as Leucocytozoon and Haemoproteus. The presence of MaRNAV-1 in African-origin human P. vivax, however, has not been clearly established. This study investigated whether MaRNAV-1 is present in public African-origin P. vivax transcriptomic datasets. Any viral sequences recovered were characterized using comparative genomic and phylogenetic analyses. A secondary in silico analysis targeted African-origin P. vivax RNA-seq runs from public repositories. Although the search covered Africa, only Ethiopian datasets could be confidently identified, retrieved and compiled at the time. After quality control and screening for MaRNAV-1 RNA-dependent RNA polymerase (RdRp) signals, three high-confidence runs were selected for further analysis. Reference-guided reconstruction, ORF prediction, blast-based validation and RdRp phylogenetic analysis were performed. MaRNAV-1 was identified in three Ethiopian P. vivax malaria transcriptomes. This was supported by strong segment-level mapping, near-complete coverage, high mean depth and minimal low-depth masking. The recovered genomes showed the expected bisegmented organization of MaRNAV-1. Segment I was highly conserved and encoded the canonical RdRp in all three consensus sequences. Segment II showed the conserved organization of two overlapping hypothetical ORFs in all three consensus sequences. Blast analyses confirmed close similarity to MaRNAV-1 reference sequences. Phylogenetic inference grouped the Ethiopian sequences within the broader P. vivax-associated MaRNAV-1 lineage, alongside other recognized MaRNAV lineages distinct from more divergent narna-like viruses. These findings provide genomic evidence for MaRNAV-1 in publicly available African-origin P. vivax transcriptomic datasets and add to the emerging evidence for the virus in the African malaria context.

MaRNAV↗

PubMed2026

Analysis of the genome of a Pseudomonas monsensis isolate that produces the antifungal dipeptide maculosin.

Candida species have been attributed to causing ~647,000 deaths annually. Candida albicans has been identified by the WHO as a priority pathogen for targeted antifungal drug development. To this end, we have screened microbial strains from the public outreach project Swab and Send for anti-Candida activity. This process identified Pseudomonas sp. SS1954.14, which displayed potent activity against C. albicans, both on agar and in a cell-free supernatant assay. Whole-genome sequence analysis identified this strain as Pseudomonas monsensis. It contains several biosynthetic gene clusters, suggesting that it can produce hydrogen cyanide, lokisin, pyoverdine and colicin/carocin, which may contribute to the observed antifungal activity. However, an active compound was separated by preparative high-performance liquid chromatography and identified through high-resolution mass spectrometry as maculosin [cyclo(Pro-Tyr)]. This cyclic dipeptide has previously been found to possess antifungal activity, but the exact biosynthetic mechanism remains undetermined. Reporting this genome alongside the associated evidence of maculosin production represents a valuable resource for biosynthetic investigations.

Candida albicans↗

PubMed2026

Phosphorylation of BigH1 regulates its expression pattern and promotes embryonic development.

Metazoan genomes typically encode several linker histone variants, often expressed in a tissue- or developmental stage-specific manner. The Drosophila melanogaster genome contains only two linker histone variants: H1 is present in somatic cells, while BigH1 substitutes H1 in the germline and early embryos. In the early stages of embryogenesis, BigH1 is replaced by H1 in the chromatin of somatic cells, contributing to the initiation and maintenance of the zygotic gene expression program. Nevertheless, the molecular mechanism of this exchange and the possible functions of post-translational modifications of BigH1 in this process remain elusive. Here, we identify phosphorylation as a key post-translational regulator of BigH1 dynamics. Using proteomics and targeted mutagenesis of the endogenous BigH1 locus, we show that the loss of N-terminal phosphorylation results in persistent retention of BigH1 in somatic nuclei throughout embryogenesis, indicating a failure in BigH1 turnover. In contrast, disruption of C-terminal phosphorylation does not markedly affect BigH1 clearance but increases defects during early nuclear divisions and compromises embryonic development, particularly under suboptimal conditions. Together, these findings demonstrate that domain-specific phosphorylation differentially regulates BigH1 function, coordinating its early embryonic role with its subsequent removal from the chromatin.

BigH1↗

PubMed2026

Donor Microbiota Features Associated With Liver Transplant Recipient Infectious Complications: A Pilot Study Using Deep Intestinal Sampling During Liver Procurement.

BACKGROUND: The gut microbiota of living organ donors has been linked to transplant outcomes. However, little is known about the characteristics of the deceased donor gut microbiota or its potential impact on recipient outcomes. METHODS: We analyzed the deep intestinal microbiota from 24 deceased donors. Samples included luminal stool from the right and left colon as well as bile. Microbial composition was characterized using 16S V4 rRNA sequencing. α- and β-diversity analyses were performed to compare microbial communities between donor enteric sites and against stool samples from 28 healthy community controls, 14 critically ill intensive care comparators, and 12 matched liver transplant recipients. Machine learning models and logistic regression analysis were applied to explore whether features of the donor microbiota could predict recipient post-transplant complications. FINDINGS: The deceased donor microbiota showed an absence of the expected compositional variability between sampling sites, with no significant differences in either α- or β-diversity observed between bile, right and left colonic samples (all p > 0.05). Donor samples exhibited distinct microbial profiles compared with stool from both healthy and ICU comparators, including increased abundance of potential pathogens within the Enterobacteriaceae family (all p < 0.001). Features of the donor microbiota, particularly enrichment of Enterobacteriaceae, were associated with an increased risk of early post-transplant infection in recipients (≤ 30 days; p = 0.011). INTERPRETATION: The deceased donor gut microbiota may represent a distinct microbial community with potential clinical relevance. Microbial profiling of donor enteric microbiota may help identify recipients at heightened risk of early post-transplant infectious complications.

Enterobacteriaceae↗

PubMed2026

First Report of Enterocytozoon bieneusi, Encephalitozoon spp. and Blastocystis spp. in Hair Goats in Türkiye.

INTRODUCTION: Blastocystis spp., Enterocytozoon bieneusi and Encephalitozoon spp. are prevalent zoonotic gastrointestinal parasites that cause severe diarrhoea and enteric diseases in humans and animals worldwide. This study investigated the molecular occurrence, genetic diversity and zoonotic potential of E. bieneusi, Blastocystis spp. and Encephalitozoon spp. in domestic hair goats in Central Anatolia. METHODS: A total of 300 faecal samples were collected from hair goats in Kayseri, Aksaray and Sivas Provinces and genomic DNA was extracted from these samples. The presence of the three pathogens was detected using PCR and nested PCR targeting the SSU rRNA for Blastocystis spp., the internal transcribed spacer (ITS) for E. bieneusi and Encephalitozoon spp., respectively. Positive PCR products were sequenced to determine the species, subtypes and genotypes of the pathogens. RESULTS: The overall prevalence rates of E. bieneusi and Blastocystis spp. were 5.3% (16/300) and 6.7% (20/300), respectively. None of the faecal samples tested was positive for Encephalitozoon spp. and no co-infections among these three pathogens were detected. The SSU rRNA sequence analysis revealed Blastocystis spp. ST10, a subtype predominantly associated with animals. Additionally, one known E. bieneusi genotype (BEB6) was identified. The BEB6 genotype falls into zoonotic Group 2 of E. bieneusi in the phylogenetic tree. CONCLUSION: Our study is the first report of Blastocystis spp. and E. bieneusi infection in hair goats in Türkiye, highlighting their potential role in zoonotic transmission within a One Health framework. Our results provide scientific data for the prevention and control of these two intestinal pathogens. Further investigations are necessary to better understand their genetic characteristics and zoonotic potential in Türkiye.

Enterocytozoon bieneusi↗

PubMed2026

Isolation of rhizobia from Ontario soils that are effective at fixing nitrogen with common bean (Phaseolus vulgaris).

UNLABELLED: Common bean (Phaseolus vulgaris) is an important crop in Canada and globally. Like other legumes, common bean establishes symbiotic interactions with nitrogen-fixing bacteria called rhizobia. However, nitrogen fixation by rhizobia in association with common bean is often suboptimal, constraining its productivity and necessitating the application of nitrogen fertilizer. To support the development of high-performing, locally adapted rhizobial inoculants for Ontario common bean growers, we isolated 216 common bean-nodulating rhizobia from southern Ontario soils using a nodule trapping approach with four common bean cultivars. Whole genome sequencing followed by phylogenomic analyses of all rhizobial isolates revealed substantial diversity, assigning them to 11 Rhizobium species, including two novel species. Nearly all isolates belong to the symbiovar phaseoli, spanning the nodC γ-a, γ-b, and α alleles, with four isolates belonging to the symbiovar gallica. Soil origin had a significant impact on the species-level community composition recovered during the nodule trapping experiments. In contrast, host trapping cultivar had only a minor influence on the recovered Rhizobium population. Greenhouse assays demonstrated that one of the novel Rhizobium species exhibited the highest average symbiotic effectiveness, although high-quality isolates were found across multiple species. Together, these results revealed a diverse and genomically variable Rhizobium community capable of forming effective symbioses with common bean in southern Ontario soils. Importantly, our genome-sequenced Rhizobium collection will serve as a valuable resource for identifying competitive and high-quality strains for the development of inoculants tailored to Ontario common bean production. IMPORTANCE: Common bean is a globally important food crop, yet its productivity is often limited by suboptimal nitrogen fixation, forcing growers to rely on synthetic fertilizers. Consequently, identifying high‑performing, locally adapted inoculant strains is essential for reducing dependence on synthetic nitrogen fertilizers and improving the sustainability of temperate agroecosystems. Our study provides a genome‑sequenced collection of common bean-nodulating Rhizobium from southern Ontario, revealing substantial species and genomic diversity across sampling locations. Greenhouse studies allowed us to identify multiple isolates that consistently fix nitrogen with, and enhance the growth of, common bean plants. Our findings highlight strong biogeographical structuring of the effective and competitive subpopulations of rhizobial communities and demonstrate that Ontario soils already harbor strains with high symbiotic potential. In addition, our Rhizobium collection represents a foundational resource to support future inoculant development and enables future work on the ecology, evolution, and applied optimization of legume-rhizobium symbioses.

Nanopore↗

PubMed2026

Whole-genome surveillance supports hazard profiling of Escherichia coli lineages in recycled water treatment systems.

UNLABELLED: The use of treated wastewater is increasingly important for sustainable water management under a changing climate, yet conventional monitoring based on Escherichia coli enumeration provides limited insight into strain diversity and associated public health hazards. Here, we applied longitudinal whole-genome sequencing (WGS) to 180 E. coli isolates collected across the treatment continuum of a recycled water facility, from influent to final effluent. Genomic analysis revealed extensive strain-level heterogeneity, comprising 88 sequence types across eight phylogroups, with greater diversity in influent than in treated effluent. Phylogenetic comparisons with contextual Australian genomes indicated clustering with strains associated with companion animals, wild birds, humans, and livestock, suggesting multiple potential source reservoirs rather than a single dominant origin, although source contributions were not definitive. Despite a >90% reduction in total E. coli loads, isolates recovered from upstream and downstream stages exhibited broadly comparable virulence factor and antimicrobial resistance gene (ARG) profiles, suggesting that, within the cultured isolate collection, reductions in abundance exceeded shifts in genomic composition. To assess operational relevance, we prototyped a genomics-informed hazard framework integrating virulence determinants, ARGs, plasmid-associated mobility, and reuse-specific exposure context. Using this framework, 92.8% of isolates were classified as low hazard, and 7.2% as moderate hazard, with no isolates meeting criteria for high or critical hazard classifications. These findings demonstrate that genomic profiling of indicator organisms can reveal population structure and hazard heterogeneity not captured by conventional enumeration alone, and can provide a practical basis for incorporating genomic information into hazard-informed monitoring of recycled water systems. IMPORTANCE: Routine recycled water monitoring relies largely on culture-based E. coli counts, which indicate regulatory compliance but provide limited insight into strain diversity, persistence, and genomic characteristics relevant to public health. Using longitudinal whole-genome sequencing, we show that genetically distinct E. coli lineages, including isolates carrying combinations of virulence and antimicrobial resistance determinants, can persist through advanced treatment despite substantial reductions in overall E. coli loads. While most isolates were classified as low genomic hazard and no high- or critical-hazard isolates were detected, these findings demonstrate that conventional enumeration alone cannot distinguish between genetically diverse lineages with differing hazard potential in highly treated systems. By integrating genomic data into a hazard classification framework, this study demonstrates an applied approach to contextualize E. coli detections and distinguish low-risk background populations from isolates with elevated genomic hazard profiles. This work supports the use of genomic profiling of indicator organisms to improve surveillance, inform treatment performance assessment, and enable more risk-based management of recycled water systems.

Escherichia coli↗

PubMed2026

Chemo-selective proteomics in microbial systems.

SUMMARYOver the past two decades, the field of bioorthogonal chemistry has transitioned from emerging to an established cornerstone of scientific inquiry. In parallel, advances in microbial and host-microbe research have highlighted the need for functional approaches that extend beyond genomic and transcriptomic analyses to directly interrogate protein-level activity. Despite this need, proteomic strategies capable of resolving dynamic, heterogeneous, and low-abundance protein populations remain underdeveloped in microbial systems. This review highlights the convergence of chemo-selective proteomic technologies with microbial biology, focusing on bioorthogonal non-canonical amino acid tagging (BONCAT), activity- or affinity-based protein profiling, and bioorthogonal post-translational modifications, and comments on possibilities for novel applications for the use of click chemistry-based tools in the functional interrogation of microbial systems. Together, these strategies enable spatiotemporal resolution of protein synthesis, selective profiling of microbial subpopulations, and direct characterization of protein activity and regulation in complex biological contexts, including single-species cultures, host-associated environments, and polymicrobial communities. Continued development and utilization of these technologies will enable deeper mechanistic insight into how microbial systems function and respond to environmental and host-derived cues.

bioorthogonal chemistry↗

PubMed2026

Men's experiences of multiple long-term conditions and/or disability in the UK Game of Stones weight management trial: a mixed-methods evaluation.

OBJECTIVES: To explore experiences, health outcomes and retention of men with multiple long-term conditions (MLTCs) and/or disability within the Game of Stones weight management randomised controlled trial (RCT). DESIGN: Mixed-methods process evaluation within an RCT where secondary outcomes included the Weight Self-Stigma Questionnaire, EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ-5D-5L anxiety and depression subscale, Patient Health Questionnaire-4 and retention. Semistructured interviews were conducted at 12 months and analysed using the framework method. SETTING: Conducted across three UK trial centres: Belfast, Bristol and Glasgow. PARTICIPANTS: 585 men with obesity (mean (SD) age, 50.7 (13.3) years) were randomised to one of three groups: behavioural text messages with financial incentives, texts alone or waiting-list control. Interviews were conducted with 54 participants from the two intervention groups. RESULTS: 235 (40%) participants lived with MLTCs, 181 (31%) had a single condition, 167 (29%) had no conditions and 165 (29%) had a disability. Of those with MLTCs, 99 were disabled and 93 were living in deprived areas. Participants with MLTCs and/or disability were older, fewer had a degree-level qualification and fewer were in full-time work. Retention at 12 months was higher for men with disability (76%) or no long-term conditions (75%) and lower for men with diabetes (65%). Self-reported weight stigma, well-being and quality-of-life scores improved or stayed the same for men living with MLTCs in the intervention groups; however, results for anxiety and depression screening scores were inconsistent. Participant experiences indicated complex dynamic health, social and life situations which could provide motivation to lose weight for some but not others. Hospitalisation and poor mobility, with inability to exercise, were demotivating for making changes to reach weight loss targets. CONCLUSIONS: Men living with MLTCs and/or disability varied from very successful weight loss and improved health to not prioritising or feeling helped by the programme or disengagement due to immobility or diabetes. TRIAL REGISTRATION NUMBER: isrctn.org Identifier: ISRCTN91974895.

Humans↗

PubMed2026

CanDo (Canadian Donor Milk) randomised controlled trial: pasteurised human donor milk supplementation in the well-baby unit - protocol.

INTRODUCTION: Mother's milk is the gold standard for feeding newborns. Despite lactation support while in hospital, supplementation rates remain high in Canadian well-baby units at 35-50%. When supplementation is needed, the choice between formula milk and pasteurised human donor milk (donor milk) remains uncertain with a lack of clinical trials to inform this practice. This study aims to compare the effect of supplementing mother's milk with donor milk versus formula in infants at higher risk for supplementation (infants of diabetic mothers, infants born small for gestational age or with a birth weight less than 2.5 kg and late preterm infants born between 350/7 and 366/7 weeks gestation). METHODS AND ANALYSIS: This is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital, Toronto, Canada. A total of 112 infants (56 per group) will be randomised to receive donor milk or infant formula as a supplement to mother's milk during their initial hospital stay, when supplementation is deemed necessary by the family and/or healthcare team. The primary outcome is exclusive human milk feeding at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months; infant growth and health indicators and breastfeeding self-efficacy. Exploratory outcomes encompass infant temperament; parental mental health (assessed using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale); milk cortisol concentrations; and informal milk sharing comparing donor milk and formula supplementation. Follow-up includes monthly telephone assessments and a virtual or in-person visit at 4 months post partum. Data will be analysed using intention-to-treat principles. ETHICS AND DISSEMINATION: The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. Results will be disseminated through peer-reviewed journals, conference presentations and stakeholder engagement with hospital and public health decision-makers. Findings will address a critical evidence gap regarding the use of donor milk supplementation in well-baby units and may inform future clinical practice and policy in newborn feeding. TRIAL REGISTRATION NUMBER: NCT06315127.

Humans↗

PubMed2026

Acceptability of capillary point-of-care testing: a systematic review.

OBJECTIVE: To identify and synthesise evidence on the acceptability and perceived experience of finger-prick point-of-care testing (POCT) among patients and clinicians across healthcare settings. DESIGN: Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines. DATA SOURCES: Medline, Embase, PsycInfo, CINAHL, Cochrane and Web of Science were searched from inception to January 2024 and re-run in July 2025, supplemented by citation tracking of relevant studies. ELIGIBILITY CRITERIA: Studies reporting patient and clinicians' experiences, perceptions, satisfaction or acceptability relating to finger-prick POCT for any health condition or blood parameter were eligible. Quantitative, qualitative and mixed-methods designs were included. DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by two reviewers and synthesised using thematic analysis and narrative synthesis. Methodological quality was appraised using the Mixed-Methods Appraisal Tool. RESULTS: 21 studies met the inclusion criteria, encompassing 9128 participants (17 quantitative, 3 qualitative, 1 mixed methods). Across diverse clinical contexts, finger-prick POCT was reported as generally acceptable, less distressing and perceived as a convenient alternative to venous sampling in comparative studies. Thematic synthesis identified two major themes: (1) enhancing the patient-clinician relationship through improved engagement, communication and understanding of care and (2) clinical implications of finger-prick POCT on clinicians' workflow, confidence and skill acquisition. Finger-prick POCT was perceived to promote personalised consultations, enable immediate discussion of results and streamline decision-making. Clinicians highlighted its potential to expand task sharing, improve efficiency and strengthen continuity of care, although concerns regarding training, reliability and quality assurance were identified. CONCLUSIONS: Finger-prick POCT is generally acceptable to patients and clinicians, improving comfort, convenience, engagement and perceived efficiency. Implementation should prioritise training, infrastructure and quality assurance frameworks to maximise clinical and experiential benefits. PROSPERO REGISTRATION NUMBER: CRD42024512130.

Humans↗

PubMed2026

BLIS study: a feasibility randomised controlled trial assessing compliance, acceptability and colonisation with different dosing regimens of the probiotic supplement Streptococcus salivarius K12 (Bactoblis) in adults in England.

OBJECTIVES: Streptococcus salivarius K12 (SsK12) is a bacterium used as a probiotic with some evidence for preventing acute sore throat/tonsillitis, but the optimal dosing strategy is unclear. This study aimed to evaluate two dosing regimens of SsK12 to establish (a) the prevalence and duration of colonisation with SsK12 and (b) the acceptability and feasibility of these regimens. DESIGN: A randomised, non-blinded feasibility trial. SETTING: Primary care in the south of England. PARTICIPANTS: Adults with ≥2 episodes of sore throat within the 3 years before recruitment. INTERVENTIONS: Participants were randomised to take SsK12 lozenges once weekly or daily over 14 days. MAIN OUTCOME MEASURES: The primary outcome was the prevalence and duration of colonisation with SsK12. This was determined by real-time PCR conducted on self-taken whole-mouth swabs provided by participants at baseline and on days 2, 7, 14, 21 and 35. Secondary outcomes were the compliance and acceptability of the two SsK12 dosing regimens, based on questionnaire data. RESULTS: 53 participants were recruited (26 randomised to weekly and 27 to daily dosing) between 26 April and 5 December 2023. All swabs were returned by 65.4% (17/26) and 70.4% (19/27) of the weekly and daily groups respectively. Swabs at all timepoints from participants with PCR positives observed at baseline (two and four from the weekly and daily group, respectively) were excluded. Therefore, swabs from 23 participants in the weekly and 22 in the daily group did not have evidence of baseline colonisation and were included in the microbiology analysis. SsK12 colonisation was found in 59.1% (13/22, 95% CI 38.6% to 79.6%) of samples in both groups on day 2; in 13.6% (3/22, 95% CI 0.0% to 28.0%) and 85.7% (18/21, 95% CI 70.8% to 100.0%) of the weekly and daily groups, respectively, on day 7; in 19.1% (4/21, 95% CI 2.3% to 35.8%) and 59.1% (13/22, 95% CI 38.6% to 79.6%), respectively, on day 14; and in only one participant (weekly group) on days 21 and 35. The dosing regimen was reported as easy to follow by 85.0% (17/20, 95% CI 69.4% to 100.0%) of the weekly and 96.2% (25/26, 95% CI 88.8% to 100.0%) of the daily dosing groups. CONCLUSIONS: SsK12 colonisation was more prevalent with daily dosing; however, colonisation was not maintained when dosing stopped. Both dosing regimens were acceptable to participants. These findings support the use of daily dosing in a future trial to evaluate the efficacy of SsK12 in preventing recurrence of sore throat/tonsillitis. TRIAL REGISTRATION NUMBER: NCT04297878.

Humans↗

PubMed2026

Patient expectations assessed before randomisation and after the first treatment session, and their associations with pain outcome at 3 months in patients with tennis elbow: a secondary analysis of a randomised controlled feasibility trial in Norwegian secondary care.

OBJECTIVE: To evaluate patients' expectations of pain improvement before randomisation (T1) and after the first treatment (T2), and to examine how expectations at these two time points were associated with pain outcome measured at 3 months (T3). DESIGN: Exploratory secondary analyses of a three-arm, randomised controlled feasibility trial in patients with tennis elbow comparing heavy slow resistance training, shock wave therapy and advice (1:1:1). SETTING: Outpatient clinic at Oslo University Hospital. PARTICIPANTS: Adults with lateral epicondylalgia, commonly known as tennis elbow. MAIN OUTCOME MEASURES: Expected pain was rated on a Numeric Rating Scale (NRS, 0-10) at T1 and T2. Present pain (NRS, 0-10) was reported at 3 months (T3). Changes in expectations from T1 to T2 were summarised descriptively. Univariable linear regressions assessed associations between T3 pain and expectations at T1 and T2, treatment group and baseline factors. Explained variance was quantified by R2. Multivariable models including demographics and baseline pain were evaluated via adjusted R2. RESULTS: Fifty-four participants were included. In the shock wave group, nine (47%) came to expect greater improvement from T1 to T2; by contrast, in the advice group, seven (41%) expected less improvement. Expectations at T1 were not associated with T3 pain, whereas expectations at T2 were positively associated with T3 pain (b=0.61, 95% CI 0.33 to 0.89, p<0.01, R2=0.27), suggesting that higher expected pain at T2 was associated with higher reported pain at T3. Adding education and baseline pain increased explained variance modestly (R2 from 0.27 to 0.32). CONCLUSION: In this study, expectations measured after randomisation and one treatment session were associated with pain at 3 months for patients with tennis elbow. Larger, prospectively designed studies should investigate how postrandomisation expectations relate to clinical outcomes in non-blinded musculoskeletal trials. TRIAL REGISTRATION NUMBER: NCT04803825.

Humans↗

PubMed2026

Comparison between the thoracoabdominal rebalancing (TAR) method and the slow expiratory flow acceleration (SEFA) technique in preterm newborns: protocol for a randomised controlled clinical trial.

INTRODUCTION: Preterm newborns (PTNB) present respiratory immaturity and increased susceptibility to muscle fatigue. The thoracoabdominal rebalancing (TAR) method is a physiotherapeutic intervention developed in Brazil that aims to reorganise the synergy of the thoracoabdominal muscles and reduce the effort of the respiratory muscles, a benefit that is particularly important for PTNB; however, the evidence regarding its effectiveness in this population remains inconclusive. Therefore, this study aims to compare the short-term effects of the TAR method and the slow expiratory flow acceleration (SEFA) technique in improving respiratory distress and peripheral oxygen saturation (SpO2) in PTNB admitted to neonatal intensive care unit (NICU). METHODS AND ANALYSIS: The study will be a randomised, controlled, two-arm, parallel-group, single-blind clinical trial. 68 participants will be randomly assigned to one of the two treatment groups. Group 1 will receive four handling techniques of the TAR method for 10 min, followed by the rhinopharyngeal retrograde clearance with saline instillation (RRC+I) technique. Group 2 will receive the SEFA technique for 10 min, also followed by RRC+I. Primary outcomes are respiratory distress and SpO2. Secondary outcomes are respiratory rate (RR), heart rate (HR), pain, behaviour and diaphragmatic excursion. Assessments will be conducted by a blinded researcher at baseline (T0), immediately after the intervention (T1) and at the 30-minute follow-up (T2). Data will be described using measures of central tendency and dispersion and absolute and relative frequencies. An intention-to-treat analysis will be performed, and intragroup and intergroup comparisons will be assessed using generalised estimating equations (GEE). ETHICS AND DISSEMINATION: The Research Ethics Committee of the Faculty of Health Sciences of Trairi of the Federal University of Rio Grande do Norte approved this study (number 8,055,786). The results will be disseminated through peer-reviewed journal publications, scientific conferences presentations and knowledge translation to the public. TRIAL REGISTRATION NUMBER: This study was registered on Brazilian Registry of Clinical Trials (ReBEC) on 9 January 2026 (RBR-3gbsyc2).

Humans↗

PubMed2026

Impact of real-time respiratory function monitoring on neonatal mask ventilation training: a multicentre simulation-based crossover study.

OBJECTIVE: To evaluate whether visibility of respiratory function monitor (RFM) feedback improves mask ventilation performance and influences subsequent ventilation performance during neonatal resuscitation training. DESIGN: multicentre randomised crossover simulation study. PARTICIPANTS: Healthcare professionals involved in neonatal resuscitation training across participating centres. INTERVENTION: Participants performed positive pressure ventilation (PPV) on both term and premature manikins under two conditions: with visible RFM feedback and with the display masked. The order of feedback visibility was randomised. Each participant completed ventilation assessments in both conditions. MAIN OUTCOME MEASURES: Primary outcomes were expired tidal volume (Vte) and mask leak (%). The proportion of breaths within the target Vte range (4-8 mL/kg) was calculated as a performance indicator. Secondary outcomes included variability in Vte and mask leak to assess ventilation stability between conditions. RESULTS: Visible RFM feedback was associated with lower mask leak and improved ventilation stability in the preterm manikin and with tidal volumes entering the target range in the term manikin. Participants initially ventilated with visible feedback maintained performance after feedback removal, suggesting a carry-over learning effect. CONCLUSION: In this multicentre crossover simulation study, visible RFM feedback was associated with changes in mask ventilation performance and evidence of a carry-over learning effect following feedback removal. Real-time visibility of respiratory parameters may strengthen neonatal resuscitation training.

Humans↗

PubMed2026

Risk of stroke in SLE: a systematic review and meta-analysis.

UNLABELLED: The association between SLE and composite stroke, ischaemic stroke and haemorrhagic stroke remains incompletely understood. This meta-analysis aims to assess the risk of stroke in patients with SLE. METHODS: Data sources included PubMed, Embase, the Cochrane Library and reference lists of included studies. This meta-analysis included cohort studies evaluating whether stroke risk is associated with SLE. The risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale (NOS). Risk ratios (RRs) with 95% CIs were pooled using a random-effects model, and publication bias was assessed with funnel plots and Egger's test. RESULTS: A total of 25 cohort studies involving 5 220 837 individuals were included in this meta-analysis, which were published between 2001 and 2026. The pooled analysis demonstrated a significantly increased risk of stroke in patients with SLE (RR of 2.60, 95% CI 2.21 to 3.05, I²=97.9%, p<0.001). The risk of composite stroke (RR of 2.83, 95% CI 2.25 to 3.57, I²=98.0%, p<0.001), ischaemic stroke (RR of 2.34, 95% CI 1.75 to 3.12, I²=97.6%, p<0.001) and haemorrhagic stroke (RR of 2.66, 95% CI 1.57 to 4.49, I²=96.2%, p<0.001) was also increased in SLE. Despite the large heterogeneity, the sensitivity analysis indicated that the results were robust, and there was little evidence of publication bias. CONCLUSION: The risk of composite stroke, ischaemic stroke and haemorrhagic stroke is increased in SLE. PROSPERO REGISTRATION NUMBER: CRD420261294082.

Humans↗