Resultados de investigación

Cribratge pediatric; Test de visió; Agudesa visual, Cribado pediátrico; Test de visión; Agudeza visual, Pediatric screening; Vision test; Visual acuity, Objectiu: Fer cribratge d’agudesa visual a població pediàtrica d’una comarca amb una nova App de suport (eVISIO®). Determinar la prevalença d’alteració visual en nens de 6-7 anys escolaritzats. Millorar cobertura de cribratge d’alteració visual d’acord amb protocol d’activitats preventives en pediatria, considerant les dificultats de col·laboració en alguns casos. Metodologia: Revisió de visió en nens escolaritzats de primer de primaria (6-7 anys), previa acceptació de les direccións de 9 escoles d’una Àrea Bàsica de Salut, i previ Consentiment Informat dels pares. Revisió a l’escola per infermeria pediàtrica. Aplicació de test de visió mitjançant App de suport de propia creació (eVISIO®) validat en adults i nens en àmbit sanitari. Segona revisió en centre sanitari en cas de primera prova anormal per acurar el diagnòstic. Anàlisi de frquencies i de concordança de resultats. Resultats: De 161 convidats están presents i s’aplica test eVirio® en àmbit escolar a 151 infants. Valoració correcte 135 casos (89,4%), incorrecte 16 casos (10,6%). Reavaluacio amb retest 139 correctes (92%) i 12 incorrectes (8%). Falsos positius 4/151 (2,65%). Molt bona colaboració majoritària per part dels alumnes. Conclusions: La prevalença d’alteracions de visió en ppoblació escolaritzada de 6-7 anys és de 8%. Falsos positius de 2,65% en aquest entorn d’aplicació. Bona concordança en resultats entre atenció primaria i especialitzada. La pràctica de test de visió en població escolaritzada permet incrementar el cribratge poblacional. L’App eVISIO® ha demostrat facilitat d’aplicació en l’àmbit d’atenció primaria i en l’àmbit escolar. Bona satisfacció per part dels professionals i alumnes

Se presentan imágenes y animaciones de un dado identificado en la necrópolis del Largo do Terreiro da Feira (Mértola), fechado en el siglo V a.C., Modelo fotogramétrico (formato fbx); animaciones derivadas del modelo tridimensional (formatos mp4 y gif); renders obtenidos del modelo (mostrando todas las caras).

Se estudia la segmentación y reconocimiento de imágenes con SAM (la IA de Meta) para la identificación de posición y tamaño de aceitunas en canjilones de las máquinas deshuesadoras, en comparación con la detección con visión artificial estándar., 1 carpeta: images 1 carpeta: result-files

This Phase 1b/2 study assessed the efficacy in terms of objective response rate (ORR) of the FGFR1/2/3 kinase inhibitor derazantinib as monotherapy or in combination with atezolizumab in patients with metastatic urothelial cancer (mUC) and FGFR1-3 genetic aberrations (FGFR1-3GA). This multicenter, open-label study comprised 5 substudies. In Substudies 1 and 5, patients with mUC with FGFR1-3GA received derazantinib monotherapy (300 mg QD in Substudy 1, 200 mg BID in Substudy 5). In Substudy 2, patients with any solid tumor received atezolizumab 1200 mg every 3 weeks plus derazantinib 200 or 300 mg QD. In Substudy 3, patients with mUC harboring FGFR1-3GA received derazantinib 200 mg BID plus atezolizumab 1200 mg every 3 weeks. In Substudy 4, patients with FGFR inhibitor-resistant mUC harboring FGFR1-3GA received derazantinib 300 mg QD monotherapy or derazantinib 300 mg QD plus atezolizumab 1200 mg every 3 weeks. The ORR for Substudies 1 and 5 combined was 4/49 (8.2%, 95% confidence interval = 2.3% to 19.6%), which was based on 4 partial responses. The ORR in Substudy 4 was 1/7 (14.3%, 95% confidence interval = 0.4% to 57.9%; 1 partial response for derazantinib 300 mg monotherapy, zero for derazantinib 300 mg plus atezolizumab 1200 mg). In Substudy 2, derazantinib 300 mg plus atezolizumab 1200 mg was identified as a recommended dose for Phase 2. Only 2 patients entered Substudy 3. Derazantinib as monotherapy or in combination with atezolizumab was well-tolerated but did not show sufficient efficacy to warrant further development in mUC. Clinicaltrials.gov NCT04045613, EudraCT 2019-000359-15.

Response determinants to immunotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC) remain unclear, limiting treatment advancements. We report a single-arm phase 1b/2 study (OPTIMIZE-1) evaluating the safety and efficacy of the cluster of differentiation 40 (CD40) agonist mitazalimab combined with modified FOLFIRINOX (mFOLFIRINOX), in chemotherapy-naive patients with mPDAC. Patients receive an initial dose of mitazalimab one week before starting biweekly cycles of mFOLFIRINOX plus mitazalimab. The study meets its pre-specified primary endpoint, achieving a confirmed objective response rate (ORR) of 42.1%. Median duration of response, progression-free survival, and overall survival was 12.6 months, 7.7 months, and 14.9 months, respectively. Multi-omic analyses of tumor and blood specimens identify a baseline tumor-intrinsic gene signature related to fibrosis associated with improved survival. Additionally, mitazalimab-induced increases in activated circulating myeloid, B cell, and T cell frequencies correlate with better outcomes. These results may inform future patient stratification strategies supporting a planned randomized confirmatory trial of mitazalimab with mFOLFIRINOX in mPDAC. This study was registered at ClinicalTrials.gov (NCT04888312)., Si

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin lymphoma worldwide. DLBCL is an aggressive disease that can be cured with upfront standard chemoimmunotherapy schedules. However, in approximately 35-40% of the patients DLBCL relapses, and therefore, especially in this setting, the search for new prognostic and predictive biomarkers is an urgent need. Natural killer (NK) are effector cells characterized by playing an important role in antitumor immunity due to their cytotoxic capacity and a subset of circulating NK that express CD8 have a higher cytotoxic function. In this substudy of the R2-GDP-GOTEL trial, we have evaluated blood CD8+ NK cells as a predictor of treatment response and survival in relapsed/refractory (R/R) DLBCL patients. 78 patients received the R2-GDP schedule in the phase II trial. Blood samples were analyzed by flow cytometry. Statistical analyses were carried out in order to identify the prognostic potential of CD8+ NKs at baseline in R/R DLBCL patients. Our results showed that the number of circulating CD8+ NKs in R/R DLBCL patients were lower than in healthy donors, and it did not change during and after treatment. Nevertheless, the level of blood CD8+ NKs at baseline was associated with complete responses in patients with R/R DLBCL. In addition, we also demonstrated that CD8+ NKs levels have potential prognostic value in terms of overall survival in R/R DLBCL patients. CD8+ NKs represent a new biomarker with prediction and prognosis potential to be considered in the clinical management of patients with R/R DLBCL. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-001620-29 EudraCT, ID:2014-001620-29., Si

Retrospective analysis of a prospective study. The study aimed to evaluate and compare the clinical results of three surgical techniques for the resection of the hypertrophic ligamentum flavum in patients with lumbar stenosis. Lumbar spinal stenosis is a common degenerative condition. Biportal endoscopic surgery is a modern technique that has gained popularity in recent years. Although various techniques have been proposed for resecting the ligament, no studies have identified the most superior method. This retrospective study enrolled patients with severe lumbar canal stenosis who underwent biportal endoscopic "Z" technique decompression between 2021 and 2023. Patients with any clinical or radiological signs of spondylolisthesis were excluded. The resection of the ligamentum flavum was classified into piecemeal resection, one-piece "butterfly" resection, and the novel variant "two-wings" or two-piece resection. Several demographic and clinical statistical variables were collected, with a specific focus on surgical time, postoperative complications, and clinical outcomes. Ninety lumbar decompression surgeries were performed on 70 patients. The patients were divided into the butterfly group (en bloc) with 27 levels, "two-wings" group with 35 levels, and "piecemeal" group with 28 levels. No significant differences in demographics or clinical variables were found among the three groups. However, piecemeal resection was associated with a higher incidence of dural tears and a longer surgical time (p The results revealed that removing the ligamentum flavum en bloc (either in two pieces or one) may reduce the surgical time and incidence of dural tears. Randomized and prospective studies are warranted to establish definitive conclusions., Si

Background and aims Gut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, focusing on growth, gastrointestinal (GI) tolerance, and gut health biomarkers from birth to 15 months. Materials and methods Healthy infants aged ≤14 days were randomized to receive either the experimental formula (SYN; control formula supplemented with six HMOs and two probiotics [B. infantis, B. lactis]) or the control formula (CTRL; partially hydrolyzed 100% whey-based formula). A non-randomized breastfed (BF) group served as a reference. The primary endpoint was weight gain velocity in SYN vs. CTRL through 4 months of age. Secondary endpoints included fecal outcomes (abundance of bifidobacteria, immune and gut health markers), GI tolerance, and adverse events (AEs). Results: The full analysis set (FAS) included 313 infants (118 in SYN, 114 in CTRL, and 81 BF), while the per-protocol population (PP) included 227 infants (84 in SYN, 84 in CTRL, and 59 BF). Weight gain velocity through 4 months in the SYN group was non-inferior to that in the CTRL group in both FAS and PP analyses (both p < 0.0001). Parent-reported GI tolerance and stool patterns were similar between SYN and CTRL groups through 4 months. At 3 months, Bifidobacteria abundance was significantly higher in the SYN group compared to the CTRL group (p = 0.004). Fecal pH was lower in the SYN group than in the CTRL group (p = 0.018) and more closely resembled that of the BF group. Immune and gut health markers were similar between the SYN and BF groups. No significant differences in AEs were observed across groups. Conclusion: The synbiotic-supplemented infant formula supported healthy, age-appropriate growth, good GI tolerance, and increased the abundance of beneficial bifidobacteria through 4 months of age., Si

Everolimus is the only approved therapy for patients with advanced neuroendocrine tumors (NET) of lung and thymus and new treatment options are urgently needed. Expression of somatostatin receptor 2 (SSTR2) is frequently seen in functional imaging in lung-NETs opening the opportunity to treat SSTR2 positive patients with radioligand therapies (RLT). Retrospective data suggest a potential meaningful benefit of RLT directed to SSTR2 in lung-NET patients. The LEVEL trial is a randomized, open-label, phase III international trial of 177Lu-edotreotide versus everolimus in patients with progressive, locally advanced or metastatic, and well/moderately differentiated NETs of lung (typical/atypical) or thymic origin. Patients could be treatment-naïve or have progressed (PD) on somatostatin analogues or ≤ 2 additional systemic treatments. Prior RLT or mTOR inhibitors are not permitted. Eligible patients are randomly assigned 3:2 to 6 cycles of 177Lu-edotreotide (total administered activity 7.5 ± 0.7 GBq / cycle) or to oral everolimus 10 mg once daily until PD or unacceptable toxicity. Only patients with positivity in somatostatin receptor imaging will be included. CT or MRI scans are performed every 12 weeks until PD. Blood samples are analyzed at baseline, at 1st tumor assessment, and at PD for pharmacodynamic endpoints. Archival tumor tissue samples will be analyzed for ancillary studies. The primary endpoint is progression-free survival (PFS) according to RECIST v1.1 based on local investigator assessment. Secondary endpoints include overall survival, overall response rate, safety, and quality of life (EORTC QLQ-C30). The expected sample size is 120 patients to demonstrate statistical significant risk reduction of 46.4% (HR = 0.536) in PFS with the experimental treatment using an overall 5% two-sided alpha error with 80% power. An interim PFS analysis was included using the Lan-DeMets with O'Brian-Fleming-like boundaries. The LEVEL trial will investigate if 177Lu-edotreotide has the potential to be incorporated as a standard treatment option for patients with NETs from the lung and Thymus. EU CT: 2022-502154-13-00 / www. gov : NCT05918302 (June 23rd, 2023)., Si