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Immune checkpoint inhibitors such as anti-PD-1 and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies have transformed cancer therapy, but their clinical use is often limited by severe systemic toxicities, particularly with anti-CTLA-4. To address this, we developed Myo-P3, a retrievable hollow-fiber encapsulated cell therapy device containing genetically engineered human myoblasts that secrete low doses of anti-CTLA-4 directly into the tumor microenvironment. In a murine colorectal cancer model, peritumoral implantation of Myo-P3 significantly delayed tumor progression and improved survival versus untreated controls. Treatment induced local immune modulation, with early reductions in intratumoral FoxP3+ regulatory T cells and hCTLA-4+ CD4+ T cells, consistent with CTLA-4 blockade, while maintaining substantially lower systemic antibody levels than systemic ipilimumab. Although this model does not permit comprehensive assessment of long-term secretion or toxicity, these data support the feasibility and biological activity of localized anti-CTLA-4 delivery and highlight a controllable, retrievable platform to reduce systemic exposure.

Clinical symptoms do not necessarily align with disease activity in ulcerative colitis (UC). It remains unclear whether patient-reported outcomes (PROs), particularly quality of life (QOL) measures, can help characterize clinically meaningful subphenotypes among Japanese patients with UC in remission. This study aimed to identify and characterize UC subphenotypes using clustering analysis. We used data from a multicenter, prospective UC patient registry in Japan, called "YOu and Ulcerative colitis: Registry and Social network (YOURS)" (December 2018-June 2022). We assessed laboratory values and PRO data, including clinical symptoms and QOL data (e.g., fatigue, anxiety, disease-specific QOL), of patients with UC in remission. Discovery (N = 365) and replication (N = 982) datasets were independently created and subjected to clustering analysis. Data were standardized for sex (a potential confounder for various measures). PRO data correlated poorly with traditional clinical laboratory parameters. Three reproducible clusters were detected in both datasets: one cluster was characterized by lower QOL and average laboratory profiles, while the other two clusters showed preserved QOL scores either with or without distinct laboratory profiles. The cluster with lower QOL and average laboratory profiles demonstrated increased relapse rates during a 3-year follow-up in each dataset compared with the respective other two clusters. PRO assessments offer unique, clinically relevant data, distinct from routine biomarkers and clinical scores. Stratifying patients with UC using combined QOL and clinical laboratory parameters may help identify patients at higher risk of relapse and warrants further evaluation for its potential role in clinical decision-making. This study was funded by Takeda Pharmaceutical Company Limited.

The expansion of invasive European wild boar (Sus scrofa scrofa) populations in Brazil and the increasing commercialization of this species raise concerns about their role as reservoirs of zoonotic and antimicrobial-resistant bacteria. This study aimed to determine the prevalence, antimicrobial resistance profiles, and detection of virulence and resistance genes in Escherichia coli and Salmonella spp. isolated from captive wild boars. A total of 100 rectal swab samples were collected from animals raised on commercial farms in Goiás State, Brazil. One Salmonella isolate (1%) was detected and identified as serotype O:6,8, showing phenotypic resistance to ampicillin, amoxicillin, and sulfonamides, but no virulence or resistance genes were detected. E. coli was isolated from 56% of samples, with 98.2% of isolates classified as multidrug-resistant and all presenting antimicrobial resistance index values above 0.2. High resistance rates were observed for sulfonamides (96.8%), tetracycline (92.1%), amoxicillin (87.3%), ampicillin (85.7%), doxycycline (81.0%), whereas most isolates remained susceptible to ceftriaxone. Virulence genes were detected in a subset of isolates, including tsh (29.8%), papC (12.3%), and iss (7.0%), with some isolates presenting gene combinations associated with increased pathogenic potential. The eae gene was not detected, and no β-hemolytic activity was observed. These findings indicate a low occurrence of Salmonella but a high prevalence of multidrug-resistant and potentially pathogenic E. coli in captive wild boars, highlighting their potential role as reservoirs of antimicrobial resistance within a One Health context.

Fall dormancy (FD) and forage yield (FY) are two key traits in alfalfa (Medicago sativa L.) breeding programs. However, genetic progress has remained limited over the past decades, largely due to the complexity of alfalfa breeding and the reliance on labor-intensive phenotyping methods. High-throughput phenotyping (HTP) using unmanned aerial vehicles (UAVs) represents a promising alternative for rapid and non-destructive crop evaluation. The objectives of this study were to i) estimate FD using UAV-derived canopy height and RGB vegetation indices and ii) evaluate the predictive performance of machine learning (ML) models for FY estimation. A total of 210 alfalfa populations with diverse genetic backgrounds were evaluated over two growing seasons (2023 to 2025) across seven harvests under Mediterranean conditions in central Chile. FY was measured manually, while FD was estimated using both manual and UAV-based approaches. A total of 19 RGB-derived indices (VIs) including plant height (PH) were extracted and used as predictor variables. Five complex predictive ML models were evaluated: PLS, PCR, SVM, ANN, and MLR. The results showed that UAV-derived FD was significantly correlated with FD obtained through conventional methods (R 2 = 0.88). The automated UAV-based FD phenotyping framework demonstrated slightly higher precision (R 2 = 0.92) and broad-sense heritability (H 2 = 0.69) compared to manual measurements (R 2 = 0.87-0.89; H 2 = 0.64), providing a more reliable selection tool for breeders. Among the tested ML models, SVM and ANN achieved the highest accuracy (R 2 ≈ 0.73) for FY prediction. These findings demonstrate that integrating low-cost RGB imagery with complex modeling offers a promising avenue that could assist in refining future selection strategies for this genetically complex species.

This study aimed to examine the changes in orthorexia nervosa (ON) tendencies among dancers at different levels before and during the COVID-19 pandemic. This retrospective repeated-measures observational study included 128 professional, semi-professional, and amateur dancers (86 females, 42 males; 19-40 years) from various dance styles. Orthorexia nervosa tendencies before and during COVID-19 were assessed using ORTO-11 and ORTO-15. Physical activity and anthropometric data were collected for both recalled pre-pandemic and pandemic periods, while energy and macronutrient intakes were assessed using a retrospective 24-h dietary recall. Data were analyzed using paired tests, effect sizes (ES), and multivariate linear regression. During the pandemic, dancers reported approximately 50% lower weekly dance frequency and daily dance duration than recalled pre-pandemic values, with large and significant effect sizes. Significant decreases were observed in ORTO-11 and ORTO-15 scores, indicating an increase in orthorexic tendencies. Pandemic-period self-reported body weight was higher than pre-pandemic body weight, whereas BMI did not differ significantly between the recalled pre-pandemic and pandemic-period assessments. In multivariate analyses, female sex remained an independent predictor for both ORTO-11 and ORTO-15 scores. Compared with recalled pre-pandemic scores, pandemic-period ORTO-11 and ORTO-15 scores were lower, suggesting higher ORTO-measured health-oriented eating tendencies among dancers. Given the retrospective self-report design and the methodological limitations of ORTO-based instruments, these findings should not be interpreted as evidence of clinical ON prevalence or precise longitudinal change. Nevertheless, these ORTO-measured tendencies appeared to differ not only behaviorally but also in relation to nutrient intake patterns. Female sex was associated with pandemic-period ORTO scores, but this finding should be interpreted cautiously because psychological, sociocultural, and clinical variables were not assessed.

This study aimed to explore the impact of introducing robotic technologies on employees' mental and physical health across three Czech and one Slovak manufacturing company. It sought to understand employees' subjective experiences and perceptions of organizational support during the robotization process. A qualitative study was conducted between 2023 and 2025 in four companies. 27 semi-structured interviews with employees (15 women, 12 men) and 19 unstructured interviews with managers (3 women, 16 men) were conducted on-site during working hours. Data were analyzed using thematic analysis with open and axial coding. Nine thematic areas were identified: general perceptions, change, fear, problems, support, social relations and communication, employee characteristics, physical health, and mental health. Employees generally perceived robotization positively, noting reduced physical workload and less monotonous or hazardous work. Initial adaptation was challenging, especially due to technical demands and workflow changes. Technical staff experienced higher stress than operators, related to responsibility, troubleshooting, and learning new skills. Technical malfunctions, elevated noise and vibration, and cognitive demands were reported as stressors. Personifying robots and informal knowledge sharing facilitated adaptation. No significant sleep disturbances or substance use linked to robotization were reported. Managers faced a high mental workload due to coordination and supervision responsibilities. When the implementation process is well designed, robotization does not necessarily negatively affect employees' mental health. The findings highlight the importance of actively addressing organizational and human factors that influence the success of technological change in the workplace. Attention should focus on monitoring cognitive and psychological demands, particularly for technical and managerial staff.

With limited evidence-based options, treatment of depressive episodes in bipolar disorder (BD-DE) remains challenging. This study examines the trajectories of psychotropic drug use and polypsychopharmacy in psychiatric inpatients with acute BD-DE. Using data from the German pharmacovigilance program "Arzneimittelsicherheit in der Psychiatrie" (AMSP), the pharmacological treatment of 1,902 psychiatric inpatients with BD-DE between 2007-2024 was analyzed. Temporal changes in drug use between early (T1: 2007-2010) and late (T2: 2021-2024) periods were calculated using prevalence ratios (PR) with 95% confidence intervals (CI) and Welch's t-test. Overall, 98.5% of inpatients with acute BD-DE were treated with psychotropic drugs. Antipsychotic drugs (APD) were the most used psychotropic drug group (76.2%), followed by antidepressant (ADD; 70.3%) and antiepileptic drugs (AED; 44.3%) during the entire study period. Over time, APD use increased from 70.1% in T1 to 80.7% in T2 (PR 1.15, CI 1.06-1.25), attributable to the increased use of second-generation APD (PR 1.19, CI 1.07-1.32), especially quetiapine and aripiprazole. ADD (T1: 78.1% vs T2: 67.6%; PR 0.87, CI 0.79-0.95) and AED (T1: 56.7% vs T2: 34.6%; PR 0.61, CI 0.51-0.73) use significantly declined, while lithium use remained stable (31.7% from 2007-2024). Although the mean number of psychotropic drugs per patient decreased (T1: 3.85 vs T2: 3.34, p&#x2009;<&#x2009;0.001, d=-0.30), complex polypsychopharmacy consisting of &#x2265;3 psychotropic drugs remained prevalent (66.1% of patients during the entire study period). Combination strategies involving APD, especially use of two APD, significantly increased (T1: 15.6% vs T2: 31.5%; PR 2.01, CI 1.51-2.69). Pharmacological treatment of BD-DE has shifted towards an increased use of second-generation APD while AED are less utilized. ADD use and complex polypsychopharmacy continue to be prevalent, indicating a persistent gap between guideline recommendations and real-world practice.

Functional foods enriched with probiotics and bioactive compounds are promising for health promotion and chronic disease prevention. This study developed a functional yogurt containing Lactococcus lactis subsp. lactis R7 and red cattley guava (Psidium cattleianum) extract, recognised for probiotic and antioxidant properties. The product was evaluated for physicochemical composition, bioactive profile, probiotic viability during storage and simulated gastrointestinal conditions, sensory acceptance, and microbiological quality. Guava extract improved the nutritional profile by increasing protein and carbohydrate contents and reducing fat, while significantly enhancing phenolic compounds, anthocyanins, and antioxidant activity. L. lactis R7 remained viable above 6 log CFU g-1 for 14&#x2009;days and tolerated gastrointestinal simulation. Sensory acceptance was high, supporting the yogurt's potential as a functional food vehicle for probiotics and bioactive compounds.

How can leaders guide diverse organizations to work together on society's biggest challenges when power is unevenly distributed? Cross-sector partnerships (CSPs) bring together companies, governments, and nongovernmental organizations (NGOs) to address complex problems, yet their success hinges on how leaders navigate competing interests and shifting power dynamics. This study examines a high-profile CSP involving a Fortune 500 company, two international development organizations, and an NGO. Drawing on Mary Parker Follett's ideas about "power-with" and "power-over," I show how NGO leaders combined collaborative and more coercive tactics to move the partnership forward. My analysis reveals that responsible leadership (RL) in CSPs is not a static trait or style but evolves through a dynamic choreography of power as challenges and priorities change. The findings offer practical lessons for leaders seeking to balance ethics, inclusion, and influence in multi-stakeholder collaborations, and they extend theory by reframing RL as a shifting, context-sensitive process rather than a fixed style.

This study evaluated the in vitro antiviral-associated effects of prebiotics, probiotic-derived preparations, and synbiotic formulations against Herpes simplex virus type 1 (HSV-1) and vesicular stomatitis virus (VSV) in Vero cells. Lactobacillus acidophilus, L. rhamnosus, and L. plantarum preparations were tested as cell-free supernatants, cell sonicates, and combinations with plant-derived prebiotic extracts. Cytotoxicity was assessed using the MTT assay to determine non-cytotoxic concentrations, while antiviral activity was evaluated by cytopathic effect (CPE)-based TCID50 endpoint titration. Several preparations produced statistically significant reductions in viral infectivity compared with untreated controls (p&#x2009;<&#x2009;0.05). Among the tested preparations, L. plantarum and L. acidophilus showed the greatest reductions in infectivity, with reductions reaching approximately 41.66% for HSV-1 and 38.88% for VSV under the tested experimental conditions. Selected synbiotic formulations also demonstrated measurable reductions in infectivity. These findings suggest that probiotic-derived preparations and synbiotic formulations may reduce infectivity of both DNA and RNA viral models in vitro and warrant further investigation as adjunct antiviral strategies.

This study aimed to evaluate the non-inferiority of acetaminophen compared with non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of chronic osteoarthritis-related pain in older adults. This multicenter, randomized, double-blind, parallel-group study enrolled patients aged 65 years or older with osteoarthritis-related pain. Participants were randomly assigned to receive acetaminophen (1800 mg/day) or NSAIDs (loxoprofen 180 mg/day or celecoxib 200 mg/day). The primary endpoint was the change in Brief Pain Inventory (BPI) item 3 (worst pain) score from baseline to week 8. The secondary endpoints included the change in BPI item 3 score from baseline to week 4, quality of life, gastrointestinal disorders, and renal and liver function parameters. Of the 400 patients enrolled, 191 and 197 were in the acetaminophen (mean age 73.6 years; 83.2% female) and NSAID groups (mean age 73.3 years; 74.6% female), respectively. The least-squares mean change in BPI item 3 scores at 8 weeks was -1.79 in the acetaminophen group and -1.94 in the NSAIDs group. The between-group difference in BPI item 3 scores change was 0.14 (95% CI, -0.33 to 0.61). No major safety concerns were identified; however, gastrointestinal disorders occurred more frequently with NSAIDs and were the most common cause of treatment discontinuation. In this RETHINK study, acetaminophen achieved a similar reduction in osteoarthritis-related pain to NSAIDs in older adults after eight weeks; however, non-inferiority was not demonstrated. In terms of adverse events, acetaminophen was associated with fewer gastrointestinal disorders. These findings suggest that treatment choice may depend on the balance between analgesic efficacy and safety considerations. The study is registered in the Japan Registry of Clinical Trials (jRCTs071200112).

Graphene is increasingly produced and utilized in industrial applications, raising concerns regarding occupational exposure and associated health risks. While numerous toxicological studies have investigated the hazard potential of laboratory-produced graphene, relatively little is known about exposure to airborne graphene particles in actual workplace environments or the toxicity of samples collected in the workplace. In the present study, we combined occupational exposure assessment in a graphene production facility with in vitro toxicological evaluation of graphene samples produced by liquid-phase exfoliation of graphite versus particulate matter collected in the same production facility. Workplace air sampling was performed using stationary and personal samplers and particulate matter was collected for elemental carbon (EC) analysis, Raman microscopy-spectroscopy, and toxicological testing using human lung cell lines (A549 and BEAS-2B). Personal EC concentrations ranged from 3 to 484&#x202f;&#x3bc;g/m3, with the highest exposure levels observed during graphite powder handling. Raman analysis confirmed the presence of graphene in the collected samples. Toxicological assessments showed that samples collected in the workplace did not elicit cytotoxic effects at the tested concentrations while dispersions of as-produced graphene evoked a dose-dependent loss of cell viability. Overall, this pilot study demonstrates the feasibility of combining occupational exposure measurements with toxicological testing of real-world samples and suggests that airborne materials collected during graphene production exhibit low hazard potential in human lung cells.

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The objectives of this study were to: 1) assess the effects of acetylsalicylic acid (ASA) administration 14 days before the expected calving date to Holstein dairy cows on the type 1/ type 2 immunity in the neonatal period of their Holstein dairy calves, and 2) investigate correlations between type1 /type2 immunity with serum total protein (TP) and immunoglobulin G (IgG) concentration in dairy calves during the neonatal period. Prepartum cows (n=205) from a commercial dairy farm located in central Pennsylvania were enrolled in the study. At 14&#xb1;3 d before calving, cows were blocked by parity (Nulliparous [NULL], n=58; parous [PAR], n=147) and randomly allocated into one of two treatment groups: 1) ASA (n=102): Cows received one oral administration with 4 boluses of acetylsalicylic acid (480 grain/bolus; equivalent to 125 grams/cow); or 2) PLC (n=103): Cows received one oral administration with 4 gelatine boluses filled with water. Only live singleton heifer calves were enrolled in the study (ASA-CLF, n= 47 and PLC-CLF, n=46). Blood samples were collected within 3 days after birth and then weekly until week 4. The data were analyzed using UNIVARIATE and MIXED procedures of SAS as a randomized complete block design, and pearson correlation coefficients were computed using the PROC CORR procedure. Within three days after birth, calves born to ASA-treated cows had higher type 1/ type 2 immunity values compared with calves from placebo-treated cows (ASA-CLF: 0.079 &#xb1; 0.003; PLC-CLF: 0.059 &#xb1; 0.003; p=0.0003). Regardless of treatment, the type 1/ type 2 immunity values on study calves significantly declined over time, peaking at 24-72h of life and reaching its lowest value at 21-23 days of life (24-72h= 0.06 &#xb1;0.002; 7-9 d= 0.04 &#xb1;0.002, 14-16 d= 0.02 &#xb1;0.002, 21-23 d= 0.01 &#xb1;0.002, p <.0001). The type 1/ type 2 immunity ratios were correlated to both TP and IgG serum concentrations. These findings suggest that ASA treatment might alter neonatal calf immunity, as evidenced by a higher type 1/ type 2 immunity values and that a type-1 biased immunity may be associated with a better passive immune transfer as shown by the correlation between type 1/type 2 immunity values with TP and IgG. Further research is needed to understand the possible mechanisms involved with the type-1 biased immunity observed in study calves and its associations with prepartum dam's ASA treatment.

We evaluat the efficacy and safety of adeno-associated virus-mediated gene therapy for CNGA3- and CNGB3-associated achromatopsia. Human studies were systematically searched from database inception to March, 2026, and 9 studies were included. Pooled analysis showed modest, but statistically significant, improvement in best-corrected visual acuity, with a mean difference of 2.65 ETDRS letters, and significant improvement in contrast sensitivity. Retinal sensitivity did not improve significantly, whereas color discrimination showed small but significant improvement. Dose-stratified findings suggested a non-linear response, with greater benefit at lower to intermediate doses than at the highest dose. Safety analysis indicated an approximate adverse-event probability of 29%, with events generally mild, transient, and manageable. Current evidence suggests favorable short- to mid-term safety and modest functional benefit, mainly in CNGA3-associated achromatopsia, while efficacy in CNGB3-associated disease remains uncertain.

The AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) received its first marketing authorization in May 2023 for the prevention of respiratory syncytial virus lower respiratory tract disease in individuals aged &#x2265; 60 years. We conducted a review of post-marketing safety surveillance data following adjuvanted RSVPreF3 administration. Spontaneous adverse events (AEs) that were reported worldwide since the first approval (3 May, 2023) to 2 May, 2025 in the GSK global safety database were analyzed. Up to 2 May, 2025, 13.4 million doses of adjuvanted RSVPreF3 were distributed globally. A total of 2861 spontaneous reports, including 7012 AEs (serious: 11.0%), were received. The most frequent AEs consisted mainly of non-serious reactogenic events. Of all reports, 1164 described vaccination errors, with most frequent errors consisting of either wrong product administration (N = 243) or administration to patients of an inappropriate age (N = 204). The majority (90.3%) of vaccination error reports were not associated with any other AEs. Adjuvanted RSVPreF3 was erroneously administered to pregnant individuals in 415 cases; most reports (95.2%) occurred without associated AEs. Observed-to-expected analysis of reports of Guillain-Barr&#xe9; syndrome (N = 37) did not suggest an increased risk compared to background incidence of this event and the reports of atrial fibrillation (N = 29) did not indicate an excess risk. Review of the post-marketing surveillance data from 2 years of exposure to adjuvanted RSVPreF3 showed that the safety profile of the vaccine is consistent with that observed in clinical trials supporting an unchanged and favorable benefit-risk profile for the vaccine. Additional post-marketing surveillance is ongoing to further evaluate a potential risk of rare AEs, such as Guillain-Barr&#xe9; syndrome, following adjuvanted RSVPreF3 vaccination. Respiratory syncytial virus is an important cause of severe lung infections in older adults. Adjuvanted RSVPreF3 vaccine was first approved in 2023 to prevent respiratory syncytial virus disease in adults aged 60 years and older. Regularly analyzing safety information from ongoing studies and real-world data (from routine healthcare practice) is essential to identify any potential new risks linked to adjuvanted RSVPreF3. Using the manufacturer&#x2019;s (GSK) safety database, we analyzed the real-world safety data from individuals who experienced adverse events after vaccination with adjuvanted RSVPreF3. These data were collected during the first 2 years since the vaccine&#x2019;s initial approval. The majority of adverse events reported to the manufacturer were mild and consistent with those reported in clinical trials. Most individuals who received the vaccine by mistake did not experience adverse events. The proportion of individuals who experienced Guillain&#x2013;Barr&#xe9; syndrome after vaccination was within the range of background incidence rates of this disease in older adults. The reports of atrial fibrillation reflected the natural history of the disease for the older population. The safety data, collected over 2 years of substantial exposure to adjuvanted RSVPreF3, show that the safety profile of this vaccine is similar to that seen in clinical trials. Together with pre-licensure data demonstrating the vaccine&#x2019;s ability to protect and help the immune system against respiratory syncytial virus disease, and real-world data demonstrating that adjuvanted RSVPreF3 protects against respiratory syncytial virus-associated hospitalization, the safety information collected so far supports the vaccine&#x2019;s use for the people for whom it is authorized.

Although automated external defibrillators (AEDs) improve outcomes in shockable rhythms, their use introduces interruptions in chest compressions. In single-rescuer scenarios, AED retrieval and application may further increase no-flow time. The effect of dispatcher instruction strategy on these interruptions remains unclear. This study aims to evaluate whether AED-optimized dispatcher-assisted CPR (DACPR) instructions reduce no-flow time compared with standard instructions in a simulated single-rescuer OHCA setting. This prospective, randomized, controlled, parallel-group simulation trial will include adult laypersons and healthcare professionals. Participants will be allocated in a 1:1 ratio to either standard or AED-optimized DACPR instruction groups. All scenarios will be conducted in a controlled simulation environment with standardized AED accessibility (&#x2264;1&#xa0;min retrieval distance) to isolate the effect of dispatcher communication on CPR performance. The primary outcome will be total no-flow time. Secondary outcomes include chest compression fraction, time to first compression, time to first shock, peri-shock pauses, and CPR quality metrics. This study investigates dispatcher instruction as a modifiable determinant of CPR interruption during AED use in single-rescuer scenarios. Findings will provide mechanistic insight into how communication strategies influence CPR quality under controlled conditions and may inform refinement of DACPR protocols. The study protocol was approved by the Institutional Ethics Committee of the University of P&#xe9;cs (PTE/87175-1/2025). Written informed consent will be obtained. Results will be disseminated via peer-reviewed publication and scientific conferences. ClinicalTrials.gov: NCT07520877, prospectively registered on 8 April 2026.

Background Document control is a core requirement of laboratory quality management and accreditation, including under the College of American Pathologists (CAP), International Organization for Standardization (ISO) 17025, ISO 15189, the Association for the Advancement of Blood & Biotherapies (AABB), and the Central Board for Accreditation of Healthcare Institutions (CBAHI). Before 2024, many Saudi laboratories relied on paper-based systems or imported platforms that lacked Arabic-language functionality, local hosting, and explicit alignment with Saudi regulatory and governance requirements. Objective To describe the development, standards-based internal validation, and early multisite implementation of the Makeen Document Control System (Makeen DCS), a Saudi-built laboratory document control platform designed for accreditation-oriented use in Saudi Arabia, and to assess early feasibility and user-perceived acceptability rather than comparative effectiveness. Methods This descriptive implementation and feasibility study was conducted from October 2024 to January 2026. System requirements were derived from CAP, ISO 17025, ISO 15189:2022, AABB, CBAHI, FDA 21 CFR Part 11, and Saudi Personal Data Protection Law (PDPL) requirements and translated into software specifications. Development followed staged requirements definition, prototyping, workflow refinement, internal validation, and pilot deployment. Internal validation used 126 structured test cases across user access, document creation and upload, approval workflow, version control, retrieval, audit trail behavior, and administrative functions. Early implementation was undertaken in seven purposively selected pioneer laboratory sites. User feedback was collected through an internally developed implementation survey completed by eight participants from pilot sites. Results The Makeen DCS provided end-to-end document lifecycle management, role-based access control, bilingual Arabic-English interfaces, dynamic master document lists, searchable retrieval, audit-oriented reporting, and a personnel-documentation module. The system supported both Saudi-hosted cloud deployment and on-premises implementation. Functional alignment was mapped against selected CAP, ISO 17025, ISO 15189:2022, CBAHI, AABB, FDA Part 11, and PDPL requirements.&#xa0;Among 126 validation test cases, 109/126 (86.5%) passed on first execution, and 17/126 (13.5%) failed initially; all failed items were corrected and retested, resulting in a final pass rate of 100% (126/126). Early deployment was achieved across seven diverse sites, of which six were fully active, and one remained partially implemented by study cut-off. Median active users across sites were 80 (range: 30-200), median configured departments were 10 (range: 5-15), and median migrated or newly created controlled documents were 76 (range: 10-274) across six sites with available data. User feedback was favorable, with a mean satisfaction score of 9/10, 7/8 (87.5%) respondents willing to recommend the platform, and 8/8 (100.0%) perceiving improved inspection readiness and reduced manual or paper-based workload. Conclusions Makeen DCS was feasible as a Saudi-built/bilingual/locally hosted lab platform for accreditation workflows. Internal validation, pilot use, and small-sample feedback show readiness/acceptability, not operational effectiveness; independent longitudinal evaluation is needed.

This study aimed to assess the effect of Cinnamomum tamala leaf-extract (CTE) on the growth, immune response, antioxidant status, gene expression, and disease resistance of Cyprinus carpio. Over a 70-day period, fish (8.82&#x2009;&#xb1;&#x2009;0.04&#xa0;g) were fed diets supplemented with graded levels of CTE (mg/kg): 0 (Control), 200 (CTE2), 300 (CTE3), 400 (CTE4), 500 (CTE5), and 600 (CTE6). Cytokine gene expression was studied 3&#xa0;days post-challenge with A. hydrophila. CTE at 400-600&#xa0;mg/kg maximized the growth performance. Key immune parameters, such as total protein, lysozyme, ACH50, alkaline phosphatase, skin mucosal protease activity, serum phagocytosis, and peroxidase levels were enhanced (P&#x2009;<&#x2009;0.05) in CTE4 and/or CTE5 than in the control. Dietary CTE did not influence serum glucose, cortisol, creatinine, urea, total immunoglobulin, or liver metabolic enzyme levels. Intestinal amylase activity, and serum antioxidant levels were higher in CTE4-CTE6; whereas, serum MDA level was decreased in CTE5 (P&#x2009;<&#x2009;0.05). The 15-day relative post-challenge survival was highest in CTE5 (54.76%). The transcript levels of sod, cat, and nrf2 were strongly upregulated in the liver tissues of CTE4 and CTE5; whereas keap1 transcription was downregulated in CTE5. The expression of tnf-&#x3b1;, il-1&#x3b2;, and hsp70 was down-regulated in CTE4 and CTE5. Conversely, il-10 expression was significantly upregulated in liver tissues of CTE4. The expression of occludin, occludin 7, and zo-1 were significantly upregulated in the intestinal tissues of CTE4 and CTE5. Overall, dietary CTE at appropriate level can enhance growth performance, immunity, and disease resistance in C. carpio. HIGHLIGHTS: C. tamala leaf extract (CTE) at 400-500&#xa0;mg/kg improved growth performance of Cyprinus carpio. Dietary CTE at 400-500&#xa0;mg/kg modulated the skin mucosal immunity of fish. CTE enhanced the resistance against Aeromonas hydrophila challenge. CTE at 400-500 mg/kg enhanced serum antioxidant enzymes.