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PubMed2026

Diagnostic utility of high-risk HPV polymerase chain reaction-based testing in head and neck FNA specimens with indeterminate cytomorphology.

BACKGROUND: Fine-needle aspiration (FNA) is critical in the initial diagnosis of many high-risk human papillomavirus (HR-HPV)-associated, metastatic oropharyngeal squamous cell carcinomas. Updated guidelines recommend HR-HPV-specific polymerase chain reaction (PCR) analysis over p16 immunohistochemistry on FNA specimens because p16 performs poorly on cytology material. PCR-based assays on liquid cytology material have demonstrated excellent analytic performance; however, the diagnostic utility of a positive HR-HPV PCR result in specimens with indeterminate cytomorphology remains uncharacterized. METHODS: The authors retrospectively identified 279 head and neck FNA specimens that had paired HR-HPV PCR testing on residual liquid cytology material over a 5-year period. The positive predictive value for histopathologically confirmed squamous cell carcinoma on surgical follow-up was calculated within each cytologic interpretive category. RESULTS: The HR-HPV PCR results were positive in 50.2% of specimens, negative in 40.9%, and indeterminate in 9.0%. The HR-HPV positivity rate ranged from 0% in specimens categorized as negative for malignancy to 57.3% in cytologically positive specimens, with 19.0%, 41.2%, and 50.0% positivity in the atypical, suspicious, and nondiagnostic categories, respectively. Among cytologically indeterminate specimens with positive HR-HPV PCR results (n = 14), the positive predictive value was 100% (95% confidence interval, 78.5%-100.0%). Blinded slide review additionally identified 15 cytologically positive specimens in which the definitive malignant interpretation depended substantially on HR-HPV positivity; all 15 were confirmed as squamous cell carcinoma. CONCLUSIONS: A positive HR-HPV PCR result on liquid cytology material carries a positive predictive value of 100% for malignancy in cytologically indeterminate head and neck FNA specimens. These findings support integrating HR-HPV PCR analysis into routine cytologic interpretation with the potential to upgrade some indeterminate specimens to malignant when HR-HPV is detected, expediting definitive treatment and sparing patients additional, invasive sampling.

Humans↗
PubMed2026

Primary pulmonary salivary gland-type tumors in cytopathology practice: A systematic review and meta-analysis.

BACKGROUND: Primary pulmonary salivary gland-type tumors (PSGTs) are rare but clinically significant tumors that originate from the submucosal glands of the tracheobronchial tree. Cytologic samples taken during bronchoscopy are a key component of preoperative evaluation. However, cytologic diagnosis remains challenging because of the submucosal growth and morphologic overlap of PSGTs. In addition, current knowledge of the cytohistologic correlation of PSGTs is fragmented. The objective of this study was to assess the effectiveness of cytologic diagnoses of PSGTs. METHODS: A comprehensive, systematic literature search of the PubMed database was conducted to identify studies with cytologic and histologic diagnoses of PSGTs. Comprehensive data on diagnostic and clinical factors, when available, were collected for all individual patients. The data were tabulated in Microsoft Excel and analyzed using OpenMeta (Analyst) software. RESULTS: In total, 49 studies comprising 106 patients were identified. Final cytohistologic concordance was demonstrated in 48.1% of cases. Fine-needle aspiration showed the highest sensitivity (75.0%), followed by bronchial/tracheal washing (38.1%), and bronchial brushing (34.2%). Adenoid cystic carcinoma was the most common histologic subtype, accounting for 67 cases, followed by mucoepidermoid carcinoma, which accounted for 27 cases. CONCLUSIONS: The cytologic diagnosis of rare PSGTs remains challenging. Overall, cytohistologic concordance was 48.1%. However, fine-needle aspiration demonstrated greater diagnostic accuracy than exfoliative cytology and may facilitate a more accurate preoperative assessment.

Humans↗
PubMed2026

Endoscopic Ultrasound-Guided Franseen Fine-Needle Biopsy for Solid Pancreatic Lesions: A Systematic Review and Meta-Analysis.

INTRODUCTION: Accurate tissue acquisition (TA) of solid pancreatic lesions is essential for guiding treatment with endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) being the preferred method. Among FNB designs, the three-pronged Franseen-tip needle demonstrates strong diagnostic performance, though direct head-to-head comparisons with other FNB designs remain limited. METHODOLOGY: This meta-analysis was conducted in accordance with PRISMA guidelines (PROSPERO: CRD420251123856). Eligible studies enrolled patients with solid pancreatic lesions who underwent EUS-guided FNB, directly compared the Franseen-tip with other FNB needles. Six databases were systematically searched through July 2025, and study selection, data extraction, and risk of bias assessment (QUADAS-2 tool) were performed independently by two reviewers. Pooled estimates were generated using random-effects and bivariate hierarchical models. RESULTS: Sixteen studies (2,010 Franseen vs. 2,811 comparator) were included. Bivariate analysis showed that sensitivity and specificity of the Franseen needle were comparable to newer-generation comparator needles (sensitivity 91.3% vs. 94.0%; specificity 99.99% vs. 99.15%), whereas older-generation needles demonstrated lower sensitivity (80.8%) and inferior discriminatory performance (Negative Likelihood Ratio [LR⁻] 0.19 vs. 0.09). Diagnostic accuracy was higher with the Franseen needle (RR 1.07, 95% CI 1.01-1.14; I2 = 69%). Sample adequacy was similar overall (RR 1.04, 95% CI 0.95-1.14) but superior to older-generation needles (RR 1.19, 95% CI 1.02-1.41) and in lesions > 30 mm (RR 1.14, 95% CI 1.02-1.28, I2 = 81.2%). The Franseen needle achieved nominally strong diagnostic performance (DOR 116.6), although small-study effects were observed. Primary procedural outcomes were comparable between Franseen and comparator needles, including technical success (RR 1.00, 95% CI 0.98-1.02) and histological core procurement (RR 1.04, 95% CI 0.92-1.17). The Franseen needle had fewer low-cellularity samples (RR 0.56, 95% CI 0.45-0.69) and lower specimen bloodiness (RR 0.48, 95% CI 0.25-0.90) but a slightly higher overall adverse event rate (RR 1.29, 95% CI 1.06-1.57). CONCLUSION: The Franseen needle provides superior diagnostic accuracy and sample adequacy compared to older-generation FNB needles with comparable performance to newer-generation designs. It reduces low-cellularity samples and specimen bloodiness, although adverse events are slightly increased, with other primary procedural outcomes remaining comparable. TRIAL REGISTRATION: PROSPERO (Registration No. CRD420251123856).

Humans↗
PubMed2026

Robotic Needle Insertion for CT-guided Percutaneous Biopsy of Thoracoabdominal Lesions: A Prospective Multicenter Randomized Trial.

Purpose To compare safety and feasibility between a novel CT-guided robotic system and the conventional freehand technique for puncture biopsy of thoracoabdominal lesions. Materials and Methods In this prospective multicenter randomized trial, individuals with suspected lesions were enrolled between July 2023 and April 2024 across three university teaching hospitals and randomized to the robot-assisted group (n = 82) or the freehand group (n = 83). Procedure outcomes included the technical success rate, targeting error, number of CT scans and needle adjustments, puncture time, and complications. Descriptive and inferential statistics were calculated. Results A total of 165 participants (mean age, 60 years &#xb1; 10 [SD]; 83 male) were included. Compared with the freehand group, the robot-assisted group demonstrated a higher technical success rate (97.56% [80 of 82] vs 62.65% [52 of 83], P < .001), lower targeting error (mean Euclidean deviation: 1.7 mm &#xb1; 1.1 vs 4.5 mm &#xb1; 3.9, P < .001), and fewer CT scans (mean, 4.3 &#xb1; 1.9 vs 5.2 &#xb1; 2.3; P = .002) and needle adjustments (mean, 0.7 &#xb1; 0.7 vs 1.6 &#xb1; 1.6; P = .003). Despite differences in geometric precision, both groups achieved 100% (82 of 82 and 83 of 83) diagnostic yield. The median puncture time was comparable between groups (5.5 minutes &#xb1; 4.3 vs 4.8 minutes &#xb1; 7.0, P = .50). During lung biopsies, the robot-assisted approach yielded fewer complications compared with the freehand approach (4.88% [four of 82] vs 16.87% [14 of 83], P = .014). Conclusion Compared with the freehand approach, robot-assisted biopsy yielded greater precision and reduced adjustments and complications while demonstrating noninferior diagnostic efficacy and comparable duration. Keywords: Robotic Needle Insertion, Biopsy, Thoracoabdominal Lesions, Robot-assisted Biopsy, CT-guided Intervention, Percutaneous Needle Biopsy, Randomized Controlled Trial, Algorithm Development, CT, Clinical Testing, Interventional-Body, Biopsy/Needle Aspiration, Percutaneous, Thorax, Abdomen/GI, Liver, Lung, Kidney &#xa9;RSNA, 2026.

Humans↗
PubMed2026

"Everybody thinks that it won't happen to them": A mixed-methods study of HIV prevention strategies among people experiencing homelessness who use drugs.

BACKGROUND: HIV disproportionately affects people experiencing homelessness, particularly those who use drugs. Although effective prevention strategies exist, uptake remains suboptimal in high-risk populations. Limited research has examined how this population engages with HIV prevention strategies and the contextual factors shaping behaviors. METHODS: We conducted a mixed-methods study of adults (&#x2265;18 years) experiencing homelessness with recent drug use, recruited from three Boston sites (Feb 2024-Jan 2025). Participants completed a survey assessing HIV prevention strategy uptake. A subsample completed in-depth interviews on factors influencing behavior. Guided by the Theoretical Domains Framework, we coded qualitative data and identified themes to help contextualize uptake. RESULTS: Among 196 participants, mean age was 48; 61% identified as male and 44% as non-Hispanic White. Forty-two percent reported condomless sex, and among those who had ever injected drugs (n = 123), 24% reported syringe sharing in the prior three months. Only 9% reported current PrEP use, and 12% had ever used HIV self-tests. Qualitative findings highlighted perceived control as a key facilitator, while low perceived HIV risk hindered uptake across strategies. Additional barriers varied by strategy and included partner dynamics and substance use affecting condom use, structural constraints affecting syringe use, and knowledge, stigma, and cost concerns affecting PrEP and self-testing. CONCLUSION: In this cohort of people experiencing homelessness who use drugs, HIV prevention strategy uptake was suboptimal, with particularly low PrEP and HIV self-testing use. Qualitative findings suggest that interventions to promote HIV prevention strategy uptake in this population should leverage perceived control, address perceived risk, and target strategy-specific interpersonal and structural barriers.

Humans↗
PubMed2026

A cooperative regulatory module between TAGL2 and JMJC1 activates specific defense genes against root-knot nematodes in tomato.

Plant-parasitic nematodes (PPNs) threaten global food security. Although epigenetic modifications are crucial for plant immunity, how histone modifiers contribute to root-knot nematodes (RKNs, Meloidogyne incognita) resistance remains unclear. Here, using genetic, molecular and biochemical approaches, we investigated the epigenetic and transcriptional mechanisms underlying RKN resistance mediated by the histone demethylase (HDM) JMJC1 and the MADS-box transcription factor TAGL2 in tomato (Solanum lycopersicum). We identified JMJC1 as an RKN-induced positive defense regulator targeting H3K9me3 and H3K27me3 histone marks. JMJC1 physically interacts with TAGL2, which also positively regulates RKN resistance. Transcriptomic analysis indicated that TAGL2 regulates multiple layers of the plant defense network, transcriptionally activating representative genes from distinct pathways (including PUB10, bHLH98, CCaMK, and SAUR3), which we validated as positive regulators of RKN resistance via virus-induced gene silencing (VIGS). At the chromatin level, TAGL2 and JMJC1 co-regulate these loci, associating with localized H3K9me3 and H3K27me3 reduction. Furthermore, TAGL2 directly activates JMJC1 transcription, establishing a positive feedback loop that amplifies immune signaling. Our findings reveal a cooperative model wherein a HDM and a transcription factor coordinate at specific loci to fine-tune multiple defense layers at both epigenetic and transcriptional levels, providing insights for breeding durable nematode-resistant plants.

Solanum lycopersicum↗
PubMed2026

Hysteroscopic platelet-rich plasma and medically assisted reproduction outcomes: a systematic review and SWOT analysis.

BACKGROUND: Platelet-rich plasma (PRP) has been proposed as an adjuvant treatment in reproductive medicine. While most evidence refers to blind intrauterine instillation, subendometrial administration under hysteroscopic guidance allows targeted delivery under direct visualisation. This systematic review aimed to synthesise the available evidence on hysteroscopic PRP administration and its impact on clinical medically assisted reproduction (MAR) outcomes. METHODS: A systematic search was conducted from inception to December 2025 across major databases. Studies were included if they evaluated hysteroscopic PRP administration in women undergoing MAR, comparing reproductive outcomes between treated and control groups. RESULTS: Out of 142 records, 3 studies met the inclusion criteria. Study populations were heterogeneous and included women with refractory thin endometrium and/or a history of implantation failure. Hysteroscopic PRP administration protocols varied in timing, technique, and dosage. In a prospective case-control study, hysteroscopic intraendometrial PRP injection at a depth of 2-3&#x2009;mm in the four uterine walls, using an ovum aspiration needle, on days 11-13 of the cycle prior to euploid frozen embryo transfer (ET), was associated with higher implantation (IR), clinical pregnancy (CPR), and live birth rates (LBR) compared with standard therapy. Conversely, no significant differences in CPR, miscarriage rate, or LBR were observed in an observational study evaluating a single intraendometrial PRP injection (35-40&#x2009;mL, 2-3&#x2009;mm depth), administered via endoscopic needle on days 6-8 of the menstrual cycle preceding frozen ET, alone or after electrical impulse therapy. A randomised controlled trial in women undergoing intrauterine insemination reported a significant improvement in CPR following hysteroscopic subendometrial PRP instillation in the four uterine walls (1.0&#x2009;mL each). CONCLUSIONS: Current literature on hysteroscopic PRP administration in reproductive medicine is limited, and robust conclusions cannot yet be drawn. Well-designed randomised controlled trials with standardised protocols are needed to clarify its clinical role.

Humans↗
PubMed2026

Plant cis-regulatory grammar: Decoding the multidimensional code of transcriptional regulation for programmable crop engineering.

Cis-regulatory elements (CREs) orchestrate the spatiotemporal precision of gene expression that underlies plant development, adaptation, and domestication. Decoding the cis-regulatory grammar of plant genomes remains a central challenge in modern biology, with profound implications for programmable crop engineering. Here, recent conceptual and technological advances are synthesized to reshape our understanding of plant CREs. This review first argues that CRE function is not only an intrinsic property of DNA sequence alone but also emerges from a multidimensional context, including chromatin accessibility, histone modifications, three-dimensional genome topology, and cell type-specific regulatory landscapes. Furthermore, the convergence of single-cell epigenomics, high-throughput functional assays, and CRISPR-based dissection has begun to unravel this contextual grammar, revealing the computational principles governing transcriptional regulation. Critically, we propose that artificial intelligence (AI) platforms are catalyzing an ongoing transition from descriptive discovery to predictive engineering, wherein these platforms outperform natural evolution in designing synthetic CREs. Finally, a roadmap is outlined toward a plant regulatory grammar foundation model, which will enable truly predictive engineering of gene expression when fine-tuned for specific tasks. Collectively, the integration of single-cell resolution maps, precise genome editing, AI-driven design, and regulatory-compliant delivery systems promises to transform our ability to reprogram plant gene regulation for next-generation agriculture, bridging the gap between foundational regulatory biology and tangible crop improvement.

artificial intelligence↗
PubMed2026

Analyzing the impact of subcutaneous injection needle, device, and administration characteristics on patient pain, anxiety, and safety: a systematic literature review.

The subcutaneous (SC) injection route is a commonly used and important method for therapeutic delivery of a wide range of compounds, and needle characteristics have a significant influence on patient pain, anxiety, safety, and other outcomes. This systematic review evaluates the evidence on how needle-specific characteristics (e.g. gauge, length, tip design, wall thickness, concealment) and administration- or device-related factors can affect patient-reported outcomes and clinical safety indicators during and following SC injections. A comprehensive search was conducted in MEDLINE, PubMed, Embase, and ClinicalTrials.gov in June 2024. Studies were included if they assessed the relationship between needle characteristics and pain, anxiety, safety, or related outcomes in individuals receiving SC injections. A dual-reviewer process was used for study selection, data extraction, and quality assessment. Sixty-two studies met inclusion criteria. Evidence consistently indicated that thinner and shorter needles reduced patient-reported pain and adverse events such as bruising and bleeding. Tapered and lubricated needles, hidden or retractable needle designs, and use of autoinjectors or prefilled syringes also contributed to reduced anxiety and improved user satisfaction. However, results were heterogeneous, and many studies lacked sufficient power or single-variable evaluation of individual needle parameters, limiting definitive conclusions. Needle characteristics significantly influence patient experience and safety with SC delivery. While both clinical evidence and practical experience clearly favor thinner, shorter, and concealed needles, further standardized, high-quality research is needed to isolate and quantify the specific contributions of individual needle characteristics to optimize injection practices and support patient-centered device design.

Humans↗
PubMed2026

Risk factors and management strategies for needle disengagement from the visual field in pediatric robot-assisted laparoscopic pyeloplasty.

OBJECTIVE: This study aimed to identify risk factors for suture needle disengagement from the visual field during pediatric robot-assisted laparoscopic pyeloplasty (RALP) and propose effective strategies for prevention and management. METHODS: A retrospective cohort study analyzed clinical data from 339 pediatric patients who underwent RALP for ureteropelvic junction obstruction (UPJO) at a single institution between August 2017 and December 2020. Patients were categorized based on the occurrence of needle disengagement from the visual field. Various patient demographics and surgical procedural factors were evaluated. Univariate and multivariate logistic regression, along with LASSO regression, identified independent risk and protective factors. RESULTS: Needle disengagement occurred in 38 (11.21%) of 339 cases. Multivariate logistic regression identified five independent risk factors for needle disengagement: use of a 3-mm auxiliary trocar (OR = 4.69, 95% CI: 1.98-12.53, P < 0.001), non-standard needle holder use (OR = 2.32, 95% CI: 1.04-5.18, P = 0.038), unshaped suture needles (OR = 3.16, 95% CI: 1.44-7.19, P = 0.005), simultaneous use of &#x2265;2 intra-abdominal sutures (OR = 2.46, 95% CI: 1.15-5.48, P = 0.023), and clamping the needle shank during withdrawal (OR = 3.42, 95% CI: 1.40-8.21, P = 0.006). Conversely, sufficient assistant experience (>10 cases) was identified as a protective factor (OR = 0.39, 95% CI: 0.18-0.88, P = 0.021). CONCLUSION: Suture needle disengagement from the visual field during pediatric RALP is associated with specific technical and instrumental factors. Implementing targeted strategies-such as mandating specialized needle holders, preoperative needle shaping, a single-needle workflow, prioritizing clamping the suture thread over the needle shank during withdrawal, and ensuring adequate assistant training-has the potential to significantly reduce significantly mitigate the risk of needle loss and enhance overall surgical safety in pediatric RALP.

Humans↗
PubMed2026

Complication rates of 16- and 18-gauge needles for native kidney biopsies: a systematic review and proportional meta-analysis.

This systematic review and meta-analysis evaluated complication rates and diagnostic yield reported in studies of adult native kidney biopsy using 16-gauge (16&#x2009;G) or 18-gauge (18&#x2009;G) needles. We included randomized trials and cohort studies of real-time ultrasound-guided biopsies, including case series. MEDLINE, Embase, and CENTRAL were searched through October 2024. Two reviewers independently performed study selection, data extraction, and risk of bias assessment using Joanna Briggs Institute tools. Random-effects meta-analyses estimated pooled proportions with 95% confidence intervals (CI), and univariable random-effects meta-regression explored study-level associations with major complications, transfusion, or gross hematuria. We screened 4,499 titles and abstracts and reviewed 319 full-text articles; 62 studies comprising 68 biopsy series were included. The pooled major complication rate in studies using 16&#x2009;G needles was 1.83% (95% CI: 1.20-2.79) and 1.29% (95% CI: 0.78-2.13) in studies using 18&#x2009;G needles, with no statistically significant difference. Mean glomerular yield was 18.8 with 16&#x2009;G and 17.5 with 18&#x2009;G needles. In study-level meta-regression, studies with higher prevalence of acute kidney injury, lower mean estimated glomerular filtration rate, or lower mean hemoglobin reported higher pooled complication rates. Most studies were single-arm cohorts; between-needle differences therefore reflect indirect study-level contrasts. Interpretation is limited by retrospective design and heterogeneity across studies. Overall, studies using both needle sizes reported low complication rates and similar diagnostic yield, although definitions and reporting varied. Direct comparative studies are needed to determine whether meaningful differences exist.

Humans↗
PubMed2026

[Effect of oblique needling after equal division and positioning of anatomic points on acute sacroiliac joint injury assessed with infrared thermography].

OBJECTIVE: To evaluate the clinical therapeutic effect of oblique needling after equal division and positioning of anatomic points on acute sacroiliac joint injury assessed with infrared thermography. METHODS: A total of 150 patients with acute sacroiliac joint injury were randomly divided into an oblique needling group, a perpendicular needling group, and an acupressure+tuina group, with 50 cases in each group. After equal division and positioning of anatomic points at sacroiliac joints, the oblique needling, perpendicular needling and acupressure+tuina techniques of acupuncture were operated in three groups, respectively. The treatment was administered once daily, 5 sessions per week; 10 sessions constituted one treatment course, with a total of one course required in the trial. Before and after treatment, the scores of Japanese Orthopaedic Association (JOA), visual analogue scale (VAS) of pain, and World Health Organization quality of life-BREF (WHO QOL-BREF), as well as the average temperature of the lumbosacral region were observed in each group. Additionally, the correlation between the average lumbosacral temperature and efficacy indicators was explored. RESULTS: After treatment, the scores of JOA, WHO QOL-BREF in the oblique needling group were higher (P<0.01, P<0.001), and the VAS score was lower (P<0.01, P<0.001) than those in the perpendicular needling group and the acupressure+tuina group; and the average temperature of the affected lumbosacral region in the oblique needling group was lower compared with that in the other two groups (P<0.001). After treatment, the average lumbosacral temperature of the affected side showed a negative correlation with the JOA score in each group (r=-0.645, -0.482, -0.809, P<0.001). CONCLUSION: Following equal division and positioning of anatomic points, the therapeutic effect of acupuncture with oblique needling is superior to the perpendicular needling and acupressure+tuina on acute sacroiliac joint injury. The average temperature of the affected lumbosacral region is correlated with the severity of lumbosacral dysfunction after treatment.

Humans↗
PubMed2026

Excimer laser angioplasty for acute coronary occlusion: a stratified meta-analysis of efficacy against aspiration thrombectomy and conventional PCI.

Primary percutaneous coronary intervention (PCI) achieves epicardial reperfusion in most STEMI patients, yet microvascular obstruction persists in up to 60% of patients. Excimer laser coronary angioplasty (ELCA) vaporizes thrombus in situ and may reduce distal embolization, but the evidence base has not been systematically synthesized. This systematic review and meta-analysis (PROSPERO CRD420261422463) included comparative studies of adjunctive ELCA versus aspiration thrombectomy (Stratum A) or PCI alone (Stratum B) in acute coronary occlusion. Primary outcomes were final TIMI-3 flow and myocardial blush grade (MBG) 3; secondary outcomes were short-term mortality, MACCE, and slow-flow/no-reflow. A random-effects model with Hartung-Knapp-Sidik-Jonkman confidence intervals was applied to all outcomes. Certainty was assessed with GRADE. Ten studies (1 RCT, 9 observational) were included, from a total enrolled population exceeding 3,500. In Stratum A, no outcome reached significance: MBG-3 (OR 3.57, 95% CI 0.07-185.10), mortality (OR 0.31, 0.02-4.04), MACCE (OR 0.22, 0.04-1.26), TIMI-3 flow (OR 1.58, 0.67-3.75) and slow-flow/no-reflow (OR 0.78, 0.22-2.78). In Stratum B, using each study's propensity-matched data, no outcome differed significantly (TIMI-3 OR 0.88, 0.38-2.03; MBG-3 OR 1.06, 0.13-8.43; slow-flow/no-reflow OR 0.93, 0.29-3.02; mortality OR 0.44, 0.05-3.80). Composite endpoints were not pooled across incompatible follow-up horizons, and all outcomes were of very low certainty. Adjunctive ELCA-containing strategies during primary PCI were not associated with improved angiographic or short-term clinical outcomes against either comparator. Multicenter randomized trials are required before recommending clinical adoption.

Humans↗
PubMed2026

Phase 1 Study Evaluating Gefurulimab Pharmacokinetics and Safety Following Delivery Via Autoinjector or Prefilled Syringe With Needle Safety Device in Healthy Adults.

PURPOSE: Gefurulimab, a novel dual-binding nanobody targeting complement component 5 (C5), is in clinical development for anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. Gefurulimab has a low molecular weight, enabling subcutaneous (SC) self-administration by autoinjector (AI) or prefilled syringe with needle safety device (PFS-SD). We compared gefurulimab pharmacokinetic (PK) exposure and safety in healthy adults following a single SC dose administered by AI versus PFS-SD. METHODS: In this phase 1, open-label, randomized, parallel-group study (NCT06208488), healthy participants aged 18 to 65 years were stratified by weight and randomized equally to 1 of 6 combination groups of device and injection site (abdomen/thigh/upper arm). Participants received a single SC dose of gefurulimab on day 1 and were assessed throughout the 92-day evaluation period. Primary endpoints were PK parameters for each device: maximum observed concentration (Cmax) and area under the serum concentration-time curve (AUCinf, AUClast). PK across injection sites, pharmacodynamics, safety, immunogenicity, and device performance were also assessed. FINDINGS: Overall, 175 participants were randomized: AI (n = 87), PFS-SD (n = 88). Geometric least squares mean ratios (90% CI) comparing AI/PFS-SD for Cmax, AUCinf, and AUClast were 97.6% (94.5-100.8), 99.6% (96.1-103.3), and 98.8% (95.2&#x2012;102.6), respectively. Secondary analyses found no meaningful differences in PK parameters across injection sites. Serum-free C5 concentrations over time, treatment-emergent adverse event (TEAE) profiles, and antidrug antibody responses were similar between cohorts. Most TEAEs were mild; none led to study discontinuation. IMPLICATIONS: SC administration of gefurulimab by AI and PFS-SD was well tolerated with comparable exposure, meeting bioequivalence criteria.

Humans↗
PubMed2026

Hydrodissection-assisted laparoscopic orchiopexy utilizing needle grasper for palpable undescended testes: Clinical efficacy analysis.

OBJECTIVE: Laparoscopic orchiopexy has emerged as a viable alternative for the treatment of palpable undescended testis (UDT). This study aims to evaluate the feasibility and efficacy of needle-grasper hydrodissection-assisted laparoscopic orchiopexy (NHLO) in comparison to conventional laparoscopic orchiopexy (CLO) for palpable UDT. METHODS: A cohort of 96 patients diagnosed with palpable UDT, admitted between January 2020 and April 2024, was included in this study. Among these, 54 patients underwent NHLO, while 42 patients were treated with CLO. In the NHLO procedure, normal saline was injected into the retroperitoneal space to create a hydrodissection barrier, facilitating the separation and protection of the vas deferens and spermatic cord. The vas deferens and spermatic cord were meticulously dissected following the principles of integrity and minimal tissue trauma. Outcome measures included final testicular position, testicular volume growth, testicular atrophy, success rate, and postoperative complications. RESULTS: No significant differences were observed between the NHLO and CLO groups in terms of age, laterality, operative time (NHLO: 38-46 min; CLO: 39-48 min), or complication rates (NHLO: 1.9 %; CLO: 0.0 %). At follow-up, all patients in both groups exhibited palpable testes in satisfactory scrotal positions. Notably, no visible abdominal scarring was observed in the NHLO group, whereas there were two noticeable scars on the abdomen in CLO. CONCLUSION: Needle-grasper hydrodissection-assisted laparoscopic orchiopexy is a safe, effective, and minimally invasive technique that provides optimal protection of the vas deferens and spermatic cord while achieving excellent cosmetic outcomes.

Humans↗
PubMed2026

Congenital Laryngomalacia: Pathophysiology, Clinical Spectrum, and Holistic Management.

Congenital laryngomalacia is the most common cause of infant stridor and arises from interacting structural, neuromuscular, and inflammatory mechanisms that produce dynamic supraglottic collapse. Disease severity spans mild stridor to significant obstruction, aspiration, and failure to thrive, often influenced by comorbid medical conditions. Diagnosis relies on flexible laryngoscopy supported by instrumental swallowing studies and microdirect laryngoscopy and bronchoscopy when indicated. Most infants respond to conservative management, particularly targeted feeding modifications, while acid suppression offers benefit in selective cases. Supraglottoplasty provides effective, durable improvement for severe disease and significantly enhances infant outcomes and family quality of life.

Humans↗
PubMed2026

Robotic-assisted transbronchial biopsy versus computed tomography-guided transthoracic needle biopsy for peripheral pulmonary lesions: a systematic review and meta-analysis of direct comparative studies.

Robotic-assisted bronchoscopy (RAB) and computed tomography-guided transthoracic biopsy (CTTB) are competing strategies for sampling peripheral pulmonary lesions (PPLs). Whether they differ in yield or safety is uncertain. To our knowledge, this is the first systematic review restricted to direct comparisons. We searched MEDLINE, Europe PMC, Scopus, Web of Science and ClinicalTrials.gov from inception to 7 July 2026 for studies directly comparing RAB with CTTB in adults with PPLs. The primary outcome was strict 2024 American Thoracic Society/American College of Chest Physicians diagnostic yield. Risk of bias was assessed with ROBINS-I and certainty with GRADE. A cohort-genealogy step identified, per outcome, the largest set of cohorts sharing no patients; only that set was pooled, with Hartung-Knapp and Mantel-Haenszel sensitivity analyses. Five retrospective studies from one US health system were eligible. Four share patients; at most three cohorts are mutually independent. Across those three, diagnostic yield was comparable (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.93-1.06; I&#xb2;=24%; Hartung-Knapp 0.87-1.13), with an identical relative effect under strict and intermediate definitions although absolute yields fell from 88% to 74-84% under strict criteria. Pneumothorax requiring a chest tube and/or admission was about three-quarters less frequent with RAB across all three cohorts (RR 0.25, 95% CI 0.14-0.46; I&#xb2;=0%; Hartung-Knapp 0.07-0.96). Strict yield (RR 0.99) and any pneumothorax (RR 0.06) were reported by two cohorts each and neither survives the few-studies correction. RAB took about 50&#xa0;min longer than CTTB where same-session staging endobronchial ultrasound was counted in the robotic time, but only about 8&#xa0;min longer than CTTB where it was not. Only one cohort reported yield by lesion size category and none reported yield by bronchus sign or lung zone, so lesion-level subgroups could not be pooled. Certainty was low for pleural complications and very low elsewhere. Low-certainty evidence indicates that RAB is associated with fewer pleural complications, with no statistically detectable difference in diagnostic yield; equivalence was not formally established. Because all evidence is retrospective, confined to one health system, and almost never stratified by lesion size or accessibility, these findings are hypothesis-generating and require a multicenter randomized trial.

Humans↗
PubMed2026

Oro-esophageal feeding for tracheostomized patients with severe traumatic brain injury: a randomized controlled trial.

BACKGROUND: This study reports the clinical effects of intermittent oro-esophageal tube feeding (IOE) versus nasogastric tube feeding (NGT) on nutritional status, aspiration pneumonia, decannulation, and level of consciousness in tracheostomized patients with severe traumatic brain injury (sTBI). METHODS: A randomized controlled trial was conducted between March 2024 and October 2025 in China and included tracheostomized patients with sTBI. Participants were randomized 1:1 to the intervention and control groups for 28-day interventions. IOE or NGT was used for nutritional supports, respectively. The primary outcome was nutritional status, including hemoglobin, albumin, prealbumin and body mass index. The secondary outcomes included aspiration pneumonia, decannulation, and level of consciousness assessed using the Glasgow Coma Scale (GCS). Generalized linear mixed-effects models, generalized estimating equations, and Cox regression were used for data analyze. RESULTS: A total of 104 participants were included in the analysis. After intervention, significant interaction effects were observed in hemoglobin (&#x3b2;&#x2009;=&#x2009;5.272, 95% CI: 2.707, 7.837), albumin (&#x3b2;&#x2009;=&#x2009;3.675, 95% CI: 1.854, 5.496), prealbumin (&#x3b2;&#x2009;=&#x2009;11.835, 95% CI: 6.623, 17.047), body mass index (&#x3b2;&#x2009;=&#x2009;1.719, 95% CI: 0.868, 2.569), the GCS (&#x3b2;&#x2009;=&#x2009;0.981, 95% CI: 0.572, 1.390), and aspiration pneumonia (OR= 0.304, 95% CI: 0.133, 0.693). The Cox model revealed that group significantly influenced the decannulation outcomes [HR (95% CI) =5.556 (3.197, 9.657), p&#x2009;<&#x2009;0.001]. CONCLUSIONS: In tracheostomized patients with sTBI who received routine treatment, IOE is more conducive to decannulation and the improvement in nutritional status, aspiration pneumonia, and level of consciousness than NGT. CLINICAL TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.gov (NCT06328985, 03/18/2024, clinicaltrials.gov/study/NCT06328985).

Humans↗