Tag: pubmed

JAMA Netw Open. 2026 May 1;9(5):e2613904. doi: 10.1001/jamanetworkopen.2026.13904.

ABSTRACT

IMPORTANCE: Mental health services fail to provide culturally safe care for Aboriginal peoples, contributing to persistent health disparities. Understanding how psychiatric care is organized, alongside lived experiences of care, may identify leverage points for service redesign.

OBJECTIVE: To examine Aboriginal mental health care pathways using integrated qualitative and quantitative analysis.

DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods study was conducted from June 2022 to December 2023 at the Great Southern Mental Health Service in Western Australia. Twenty Aboriginal adults were recruited; the quantitative component included 19 patients with 1108 documented clinical interactions, and 7 participated in in-depth yarning interviews. Novel analytical methods included a community-preserving surrogate network algorithm and transition-matrix trajectory clustering.

MAIN OUTCOMES AND MEASURES: Centrality metrics identifying key agents in the clinical interaction network; patient trajectory clustering based on clinical action sequences; qualitative themes from yarning interviews using reflexive thematic analysis.

RESULTS: A total of 20 Aboriginal adults were recruited; the quantitative analysis included 19 patients (mean [SD] age, 38.4 [15.9] years; 10 women and 9 men) with 1108 documented interactions, with 7 patients (mean [SD] age, 44.0 [17.8] years; 4 women and 3 men) participating in qualitative yarning interviews. The clinical interaction network had a core-periphery structure in which patients often served as the main link between external agents and hospital staff. Aboriginal mental health workers had closeness centrality above the 99th percentile in surrogate networks, indicating a structurally distinctive central position within the network. Trajectory analysis identified 3 care pathways: predominantly internal care, prolonged internal engagement, and complex external referral with repeated readmissions. Qualitative themes emphasized cultural safety, kinship, and ongoing trauma and showed inconsistent Aboriginal mental health worker presence during crises, while integrated analyses highlighted their pivotal yet vulnerable role within fragmented care pathways, underscoring the need for trauma-informed, culturally safe redesign.

CONCLUSIONS AND RELEVANCE: In this mixed-methods study, Aboriginal mental health workers occupied central bridging positions, and patients were intermediaries between disconnected parts of the system. Strengthening culturally grounded roles and redesigning care pathways based on operational information flow may improve care coordination and cultural safety in multisetting mental health systems.

PMID:42160050 | DOI:10.1001/jamanetworkopen.2026.13904

J Biopharm Stat. 2026 May 20:1-15. doi: 10.1080/10543406.2026.2670521. Online ahead of print.

ABSTRACT

The hERG safety assay is crucial for assessing the risk of delayed repolarization and QT interval prolongation in investigational drugs, yet a lack of consensus exists on classifying drugs into appropriate risk categories based on assay results. We propose a two-stage statistical framework for quantitative assessment of hERG safety assay classification for investigational products adhering to ICH E14 S7b Q&A Best Practice protocols. Our framework employs a fixed margin equivalence testing approach to evaluate concurrent positive controls against the positive control reference in Stage 1, followed by a logistic regression model based on a T-score to classify the investigational product into two risk categories (QT effect ≥ 10 msec or < 10 msec) in Stage 2. Applied to real-world data, our method demonstrates the ability to classify investigational products with an AUROC of at least 0.9, using a pre-specified probability margin. Additionally, our approach addresses lab-to-lab variability in hERG safety assay assessment, providing a standardized, quantitative method for evaluating hERG assay results that could improve consistency in drug risk assessment across the pharmaceutical industry.

PMID:42160048 | DOI:10.1080/10543406.2026.2670521

J Craniofac Surg. 2026 May 20. doi: 10.1097/SCS.0000000000012931. Online ahead of print.

ABSTRACT

OBJECTIVES: Previous studies are insufficient concerning the impact of fasting on nasal functions. This study aimed to investigate the effects of Ramadan fasting (RF) on nasal respiratory function (NRF) utilizing objective assessments, based on the hypothesis that RF leads to functional improvement in healthy subjects.

METHODS: Forty-one male and 21 female subjects were included in this prospective study. The nasal volume, minimal cross-sectional area (MCA)s, total airflow (TF), total resistance (TR) values, and breathing comfort were determined by acoustic rhinometry, rhinomanometry, and visual analog scale (VAS) initially (baseline) and on the first and last day (30th) of RF. The outcomes were analyzed statistically.

RESULTS: Significant differences were found in the analysis of nasal MCAs (P=0.001), volumes (P=0.001), TF (P=0.001), and TR (P=0.008), and VAS values (P=0.0001) at different times. The TF (P=0.003), TR (P=0.019), right (P=0.001) and left (P=0.001) MCAs, right (P=0.002) and left (P=0.001) volumes, and VAS (P=0.001) values detected on 30th day were significantly higher than baseline. Furthermore, the TF (P=0.003), and TR (P=0.02), right (P=0.001) and left (P=0.0001) MCAs, right (P=0.002) and left (P=0.001) volumes, and VAS (P=0.001) values measured on 30th day were significantly higher than first day (P<.05).

CONCLUSIONS: The present findings suggest that RF may have a positive effect on NRF.

PMID:42160037 | DOI:10.1097/SCS.0000000000012931

Small. 2026 May 20:e09831. doi: 10.1002/smll.202509831. Online ahead of print.

ABSTRACT

Colorectal cancer (CRC) is frequently diagnosed at advanced stages due to the asymptomatic nature of early disease and the semi-invasive nature of colonoscopy. Developing effective noninvasive methods for CRC-related biomarker detection is crucial for reducing CRC mortality. Notably, miR-451 has been reported as a CRC-related biomarker candidate. We present an in situ single-particle spectroscopic assay for amplification-free quantitative detection of miR-451 using gold nanoparticles (AuNPs). Functionalized substrates with immobilized AuNPs enable real-time monitoring of localized surface plasmon resonance (LSPR) peak shifts at the single-particle level. By statistically analyzing the proportion of AuNPs exhibiting LSPR shifts, we achieved quantitative detection of miR-451. This in situ microfluidic configuration allows spectral analysis of the same nanoparticles before and after detection, eliminating spatial sampling errors. Specificity is conferred by a stem-loop DNA probe on the AuNP surface via strand displacement. The main advance lies in in situ tracking of the same immobilized nanoparticles with statistical single-particle readout. This strategy demonstrates a detection limit of 58 fm and excellent specificity against other miRNAs, with proof-of-concept feasibility in spiked FBS samples.

PMID:42160030 | DOI:10.1002/smll.202509831

Minerva Urol Nephrol. 2026 May 20. doi: 10.23736/S2724-6051.26.06822-9. Online ahead of print.

ABSTRACT

BACKGROUND: Intradetrusor botulinum neurotoxin type A (BoNT/A) with onabotulinumtoxinA (onabotA), is an established treatment for overactive bladder (OAB). This study aims to evaluate the safety, usability, and initial efficacy of ViXe – a combination of incobotulinumtoxinA with the needle-free, ultrasound-assisted intravesical Vibe delivery system – in women with OAB.

METHODS: Parallel, exploratory, multicenter, randomized, double-masked, placebo- and sham-controlled. Women (18-80 years) with idiopathic OAB were randomized 1:1 to ViXe or placebo.

PRIMARY ENDPOINTS: 12-week safety and patient satisfaction. Secondary endpoints: initial efficacy measured by bladder diaries and validated questionnaires.

RESULTS: Eighty-two screened, 48 were randomized (ViXe 25; placebo 23); 47 completed.

SAFETY: Treatment-emergent adverse events occurred in 44.0% ViXe vs. 39.1% placebo patients; fewer events were reported in the ViXe group (13 vs. 17); all mild-moderate; no serious events. Treatment-related adverse events were fewer with ViXe (8.0%) than with placebo (21.7%). Patient experience favored ViXe on several comfort domains; willingness to continue was higher (73.7% vs. 28.6%). Urinary incontinence decreased by 58% compared to 35% at week 6 and 59% compared to 45% at week 12 (ViXe vs. placebo); Overactive bladder questionnaires showed improvement in both groups, but it was not statistically significant. Satisfaction favored ViXe, with 63.16% patients satisfied, versus 57.14% dissatisfied in the placebo group.

CONCLUSIONS: ViXe is safe and well-tolerated, with only mild to moderate AEs. The needle-free, office-amenable workflow and handling advantages of incobotulinumtoxinA support feasibility and patient acceptability. These data collectively justify a larger, adequately powered Phase 2b/3 trial to determine clinical efficacy and assess durability.

PMID:42160008 | DOI:10.23736/S2724-6051.26.06822-9

Pediatr Allergy Immunol. 2026 May;37(5):e70350. doi: 10.1111/pai.70350.

ABSTRACT

BACKGROUND: Access to patient-centered medical homes (PCMH)-defined as having a primary care provider who provides comprehensive, family-centered care-is critical for children with asthma, which affects nearly 5 million children in the US. Management can be complex, and uncontrolled disease increases morbidity among children. Therefore, we examined rates and associations of PCMH status, asthma severity, and sociodemographic factors.

METHODS: This cross-sectional study used the 2022 National Survey of Children’s Health, a nationally representative dataset, to assess PCMH status among children with asthma and conducted design-based X² tests to measure differences between groups based on asthma severity, parental factors, and other social determinants of health.

RESULTS: Among a sample of 3636 children with asthma, 41.5% met criteria for a PCMH. Significant associations were observed between PCMH access, asthma severity, and several sociodemographic variables (p < .001), except the child’s age. Only 19.0% of children with severe asthma ratings met PCMH criteria. In contrast, 45.1% of children with mild asthma met PCMH criteria. Parental education and PCMH access were positively correlated, and the highest rates of PCMH access were among children with two biological parents.

CONCLUSION: Our results showed that having access to a PCMH was associated with a decreased likelihood of severe asthma symptoms. Additionally, there are sociodemographic factors that significantly impact the likelihood of children with asthma meeting criteria for a PCMH. Given the scale of children with asthma not having comprehensive medical care, national and state policies are needed to enhance access to services.

PMID:42159992 | DOI:10.1111/pai.70350

Insights Imaging. 2026 May 20;17(1):135. doi: 10.1186/s13244-026-02309-1.

ABSTRACT

OBJECTIVES: To investigate the role of super-resolution contrast-enhanced ultrasound (SR-CEUS) in evaluating inflammatory activity in Crohn’s disease (CD).

MATERIALS AND METHODS: In this prospective study, we consecutively enrolled CD patients confirmed by clinical and ileocolonoscopic findings. All patients underwent B-mode ultrasound (BMUS), color Doppler flow imaging (CDFI), CEUS, and SR-CEUS within 1 week of ileocolonoscopy. SR-CEUS quantitative parameters were recorded, with simple endoscopic score for Crohn’s disease (SES-CD) as the reference standard. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis.

RESULTS: 52 consecutive CD patients were categorized into active (SES-CD ≥ 3, n = 30) and inactive (SES-CD < 3, n = 22) groups. SR-CEUS clearly visualized the intramural microvascular architecture of the bowel wall. SR-CEUS yielded an AUC of 0.903 with 86.4% sensitivity (95% CI: 66.7-95.3%), and 86.7% specificity (95% CI: 70.3-94.5%) for assessing inflammatory activity, significantly outperforming both CDFI (p = 0.014) and CEUS (p = 0.045), while showing no statistically significant difference in comparison with BMUS (p = 0.988). Furthermore, the combination of BMUS and SR-CEUS achieved an AUC of 0.967 for diagnosing active CD, with 100% sensitivity (95% CI: 85.1-100%) and 86.7% specificity (95% CI: 70.3-94.7%), which was significantly superior to BMUS alone (p = 0.038).

CONCLUSIONS: SR-CEUS provides quantitative microvascular perfusion maps that display vascular density, flow velocity, and direction, offering a non-invasive tool for evaluating inflammatory activity in CD.

CRITICAL RELEVANCE STATEMENT: This study demonstrates that super-resolution contrast-enhanced ultrasound (SR-CEUS) provides a novel, non-invasive approach for quantitative evaluation of inflammatory activity in Crohn’s disease (CD), which serves as a valuable supplement or alternative to endoscopy in routine monitoring.

KEY POINTS: An unmet need remains for accurate, non-invasive tools to assess CD activity. SR-CEUS outperforms conventional CDFI and CEUS in distinguishing active from inactive CD. Combining SR-CEUS with standard BMUS yields excellent diagnostic accuracy, establishing this combined approach as a promising non-invasive alternative for monitoring inflammatory activity in CD patients.

PMID:42159961 | DOI:10.1186/s13244-026-02309-1

Pediatr Allergy Immunol. 2026 May;37(5):e70371. doi: 10.1111/pai.70371.

ABSTRACT

BACKGROUND: Respiratory tract infections (RTIs) are a leading cause of morbidity in preschool children, particularly in those with recurrent wheezing. Natural compounds such as resveratrol and carboxymethyl-β-glucan have shown immunomodulatory, antiviral, and anti-inflammatory activity, supporting their potential role in preventing pediatric airway infections.

OBJECTIVE: To evaluate the efficacy, safety, and tolerability of Linfovir®, a nasal spray containing resveratrol and carboxymethyl-β-glucan, in reducing respiratory infectious symptoms in preschool children with recurrent respiratory infections and wheezing.

METHODS: This multicenter, randomized, double-blind, placebo-controlled trial enrolled children aged 2-6 years with a history of recurrent respiratory infections. Participants were randomized 1:1 to receive Linfovir® or placebo once daily for 12 weeks, with follow-up at 16 weeks. Primary and secondary outcomes including days with respiratory symptoms, number of infections, antibiotic courses, and medical visits were recorded via the VIRAPP® electronic diary.

RESULTS: Eighty-two children were included in the Full Analysis Set. The primary endpoint was not statistically significant. However, a numerical reduction in days with respiratory symptoms was observed in the resveratrol/β-glucan nasal spray group compared with placebo (15.0 vs. 20.4 days in the FAS population), corresponding to an approximate 26% relative difference. Similar non-significant patterns favoring the intervention were observed for infectious episodes, antibiotic courses, and medical visits. Treatment adherence was high in both groups, and no serious adverse events occurred.

CONCLUSIONS: In this pilot randomized controlled trial, the resveratrol/β-glucan nasal spray was safe and well tolerated. Although the study did not show a statistically significant effect on the primary endpoint, the observed numerical differences consistently favored the intervention. These findings should be interpreted as exploratory and hypothesis-generating and require confirmation in larger adequately powered studies.

PMID:42159960 | DOI:10.1111/pai.70371

Adv Ther. 2026 May 20. doi: 10.1007/s12325-026-03635-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Lack of head-to-head comparative safety and efficacy data for abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) represented an important gap for informed spasticity management. This study compared the safety and efficacy of aboBoNT-A and onaBoNT-A for upper limb spasticity (ULS).

METHODS: DIRECTION (NCT04936542), a phase IV, randomized, double-blind, crossover study, involved 72 sites. Patients stratified by botulinum toxin A status (naïve/non-naïve) were randomized (1:1) to aboBoNT-A 900U followed by onaBoNT-A 360U (one cycle each), or vice versa. Muscles (wrist/finger flexors, biceps brachii) were injected with a fixed volume, using instrument-guided injection techniques. Participants fulfilling retreatment criteria received a second cycle at Week 12; otherwise, they were reassessed every 4 weeks (to Week 24) until requiring retreatment. Primary analyses tested non-inferiority based on treatment-emergent adverse events (TEAEs) from injection to Week 12 using a 5% non-inferiority margin [non-inferiority demonstrated if upper bound of the 80% confidence interval (CI) of the adjusted difference in TEAE rates was < 5%]. Secondary analyses compared duration of response based on time to symptom re-emergence.

RESULTS: Overall, 464 patients [mean (standard deviation) age 56.8 (13.1) years, 34.1% female] were randomized (aboBoNT-A → onaBoNT-A [n = 231]; onaBoNT-A → aboBoNT-A [n = 233)]. Baseline characteristics were similar in both sequence arms. Adjusted rate of TEAEs for aboBoNT-A (20.3%) was non-inferior to onaBoNT-A (23.0%); adjusted difference (aboBoNT-A – onaBoNT-A) was – 2.7% (80%CI – 6.2%, 0.9%). Adjusted mean duration of response was 99.3 days for aboBoNT-A and 96.3 days for onaBoNT-A; adjusted difference of 3.0 (80%CI 0.2, 5.9) days favoring aboBoNT-A (p = 0.17; statistically significant under the pre-specified α = 0.20 framework). Longer duration of response with aboBoNT-A versus onaBoNT-A was seen across most subgroups over a fixed-interval follow-up.

CONCLUSION: In this first head-to-head study of aboBoNT-A and onaBoNT-A in ULS, the aboBoNT-A TEAE rate was non-inferior to onaBoNT-A. At 90% of the maximum unit dose for adult ULS in the approved label for each formulation, duration of response was 3 days longer with aboBoNT-A than onaBoNT-A. These findings may support informed therapeutic decision-making.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT04936542; EudraCT: 2023-509196-16-00.

PMID:42159955 | DOI:10.1007/s12325-026-03635-y

Trop Anim Health Prod. 2026 May 20;58(5):273. doi: 10.1007/s11250-026-05033-6.

ABSTRACT

This study investigates the prevalence and determinants of repeat breeding and infertility among small dairy farms in a district with intensive crossbred and traditional dairy farming systems in India. Data were collected from 2,254 animals and 579 farmers representing diverse herd compositions and management systems. Results revealed that repeat breeding affected 20.4% of animals, while infertility was observed in 44.7%, exceeding national averages. Species, breed type, age, milk yield, and farmer type were significant factors influencing reproductive outcomes. Crossbred cows (based on Holstein-Friesian, Jersey, and indigenous breeds) exhibited higher reproductive disorders than indigenous cattle breeds, while buffaloes recorded the highest infertility rates (62.5%). The consequences of reproductive inefficiencies include involuntary extended calving intervals, reduced lifetime milk yield, and hence an increased carbon footprint through increased methane emission intensity. Poor reproductive efficiency therefore impacts both farm profitability and environmental sustainability. The study emphasizes evidence-based reproductive management, digital herd monitoring, and farmer training as essential strategies for improving fertility and advancing climate-smart dairy practices in Tamil Nadu.

PMID:42159948 | DOI:10.1007/s11250-026-05033-6