Deception and Fraud in the Justification of "Pediatric Drug Development": A Challenge at the Interface of Medicine and Law.

United States and European Union laws demand separate clinical studies in children as a condition for drugs' marketing approval. Justified by carefully framed pseudo-scientific wordings, more so the European Medicines Agency than the United States Food and Drug Administration, "Pediatric Drug Development" is probably the largest abuse in medical research in history. Preterm newborns are immature and vulnerable, but they grow.

Human migrations, anthropogenic changes, and insect-borne diseases in Latin America.

Rapid urbanization and migration in Latin America have intensified exposure to insect-borne diseases. Malaria, Chagas disease, yellow fever, and leishmaniasis have historically afflicted the region, while dengue, chikungunya, and Zika have been described and expanded more recently. The increased presence of synanthropic vector species and spread into previously unaffected areas due to urbanization and climate warming have intensified pathogen transmission risks.

Faricimab efficacy in type 1 macular neovascularization: AI-assisted quantification of pigment epithelium detachment (PED) volume reduction over 12 months in Naïve and switch eyes.

Background: This study evaluates the efficacy of intravitreal Faricimab in reducing pigment epithelium detachment (PED) and fluid volumes in both treatment-naïve eyes and eyes unresponsive to anti-VEGF mono-therapies, all diagnosed with type 1 macular neovascularization (T1 MNV) over a period of 12-month.

Methods: A retrospective, single-center cohort study was conducted at the Jules Gonin Eye Hospital, Lausanne, Switzerland. Clinical records of treatment-naïve and non-responder switch patients presenting T1 MNV secondary to neovascular age-related macular degeneration (nAMD) from September 2022 to March 2023 were reviewed.

Unraveling the genetic architecture of blueberry fruit quality traits: major loci control organic acid content while more complex genetic mechanisms control texture and sugar content.

Background: Fruit quality traits, including taste, flavor, texture, and shelf-life, have emerged as important breeding priorities in blueberry (Vaccinium corymbosum). Organic acids and sugars play crucial roles in the perception of blueberry taste/flavor, where low and high consumer liking are correlated with high organic acids and high sugars, respectively. Blueberry texture and appearance are also critical for shelf-life quality and consumers' willingness-to-pay.

Sublethal and lethal toxicity assessment of lanthanum and gadolinium to Daphnia magna in a 7-day test method.

The use of rare earth elements has increased in recent years, leading to a rise in environmental concentrations. Despite the growth in number of studies regarding toxicity, knowledge gaps remain. For Daphnia magna, standardized test methods involve exposure periods of either 48 h or 21 days to assess toxicological effects.

The role of a "volume sparing" strategy in kidney replacement therapy of AKI: a retrospective single-center study.

Background: The KDIGO recommendation in acute kidney injury (AKI) patients requiring kidney replacement therapy is to deliver a Urea Kt/V of 1.3 for intermittent thrice weekly hemodialysis, and an effluent volume of 20-25 ml/kg/hour when using continuous renal replacement therapy (CRRT). Considering that prior studies have suggested equivalent outcomes when using CRRT-prolonged intermittent renal replacement therapy (PIRRT) effluent doses below 20 mL/kg/h, our group investigated the possible benefits of low effluent volume CRRT-PIRRT (12.

Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON.

Purpose: In the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.

Circumferential nerve wrapping with muscle autograft: a modified strategy of microvascular decompression for trigeminal neuralgia.

Microvascular decompression is considered a first-line treatment in classical trigeminal neuralgia. Teflon is the material commonly used. The use of autologous muscle has been occasionally reported.

Long-term monitoring of total suspended matter concentration in fishponds in the Guangdong-Hong Kong-Macao Greater Bay Area.

Excessive total suspended matter (TSM) concentrations can exert a considerable impact on the growth of aquatic organisms in fishponds, representing a significant risk to aquaculture health. This study revised existing unified models using empirical data to develop an optimized TSM retrieval model tailored for the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) (R = 0.69, RMSE = 7.

Non-Caucasian Race/Ethnicity Predisposes to Unfavorable Stage and Grade at Upper Tract Urothelial Carcinoma Diagnosis.

Objective: To test whether race/ethnicity affects stage or grade distribution at upper tract urothelial carcinoma (UTUC) diagnosis.

Methods: Within the Surveillance, Epidemiology, and End Results (SEER) database 2004-2020, UTUC patients were identified. Multivariable logistic regression models tested for the association between race/ethnicity and stage as well as grade at diagnosis according to renal pelvis vs.

Age Matters: Early-Onset Rectal Cancer Exhibits Higher Rates of Pathological Complete Response: A Retrospective Analysis of the Influence of Young Age on Treatment Success in Stage II-III Rectal Cancer.

Background: The incidence of rectal cancer has decreased overall, but the incidence of early-onset rectal cancer (eoRC) has increased. Early-onset rectal cancer and late-onset rectal cancer (loRC) differ due to phenotypical, genetic characteristics, and higher stage presentations in eoRC. Thus, eoRC patients undergo more aggressive neoadjuvant treatments.

Endoscopic sleeve gastroplasty versus lifestyle modifications for class II obesity patients: a French cost-effectiveness analysis.

Introduction: Obesity is a worldwide epidemic, with up to 17% of French population affected. European guidelines recommend surgical management at specific weight and comorbidity level; however, less than 2% of eligible patients undergo surgical bariatric interventions. To extend the benefits of bariatric interventions to the untreated population with obesity, endoscopic techniques such as endoscopic sleeve gastroplasty (ESG) have been developed.

Deep learning model for automatic detection of different types of microaneurysms in diabetic retinopathy.

Purpose: This study aims to develop a deep-learning-based software capable of detecting and differentiating microaneurysms (MAs) as hyporeflective or hyperreflective on structural optical coherence tomography (OCT) images in patients with non-proliferative diabetic retinopathy (NPDR).

Methods: A retrospective cohort of 249 patients (498 eyes) diagnosed with NPDR was analysed. Structural OCT scans were obtained using the Heidelberg Spectralis HRA + OCT device.

Alkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study.

Background: Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (Ra) treatment, but their association with treatment outcomes is unclear.

Methods: For patients with metastatic castration-resistant prostate cancer treated with Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).

Uncovering the Fungal Community Composition of Alive and Dead Posidonia oceanica Matte.

Posidonia oceanica retains a large amount of carbon within its belowground recalcitrant structure, the 'matte,' which is characterized by low oxygen availability and biodegradation. Fungi may play a pivotal role in carbon sequestration within the matte, even if little/no information is available. To fill this gap, we profiled fungal communities from the upper and lower layers of alive and dead matte, by using an ITS2-5.

Deep learning-integrated MRI brain tumor analysis: feature extraction, segmentation, and Survival Prediction using Replicator and volumetric networks.

The most prevalent form of malignant tumors that originate in the brain are known as gliomas. In order to diagnose, treat, and identify risk factors, it is crucial to have precise and resilient segmentation of the tumors, along with an estimation of the patients' overall survival rate. Therefore, we have introduced a deep learning approach that employs a combination of MRI scans to accurately segment brain tumors and predict survival in patients with gliomas.

Hereditary haemorrhagic telangiectasia.

Hereditary haemorrhagic telangiectasia (HHT) is a vascular dysplasia inherited as an autosomal dominant trait and caused by loss-of-function pathogenic variants in genes encoding proteins of the BMP signalling pathway. Up to 90% of disease-causal variants are observed in ENG and ACVRL1, with SMAD4 and GDF2 less frequently responsible for HHT. In adults, the most frequent HHT manifestations relate to iron deficiency and anaemia owing to recurrent epistaxis (nosebleeds) or bleeding from gastrointestinal telangiectases.

Digital microfluidic platform for dried blood spot newborn screening of lysosomal storage diseases in Campania region (Italy): Findings from the first year pilot project.

Background: Newborn screening (NBS) is a simple, non-invasive test that allows for the early identification of genetic diseases within the first days of a newborn's life. The aim of NBS is to detect potentially fatal or disabling conditions in newborns as early as possible, before the onset of disease symptoms. Early diagnosis enables timely treatments and improves the quality of life for affected patients.

Concomitant antihistamine administration is associated with improved survival outcomes in patients with locally advanced or metastatic urothelial carcinoma treated with atezolizumab. Analysis of individual participant data from IMvigor210 and IMvigor211.

Objectives: Survival outcomes of patients with metastatic urothelial carcinoma (mUC) are still suboptimal and strategies to enhance response to immune-oncology (IO) compounds are under scrutiny. In preclinical studies, it has been demonstrated that antihistamines may reverse macrophage immunosuppression, reactivate T cell cytotoxicity, and enhance the immunotherapy response. We aimed to evaluate the role of concomitant antihistamines administration on oncological outcomes among patients with mUC.

Computational pathology applied to clinical colorectal cancer cohorts identifies immune and endothelial cell spatial patterns predictive of outcome.

Colorectal cancer (CRC) is a histologically heterogeneous disease with variable clinical outcome. The role the tumour microenvironment (TME) plays in determining tumour progression is complex and not fully understood. To improve our understanding, it is critical that the TME is studied systematically within clinically annotated patient cohorts with long-term follow-up.

Drivers of extended spectrum β-lactamase (ESBL)-producing Enterobacterales colonization among residents of long-term health care facilities: a European multicentric prospective cohort study.

Background: ESBL-producing Enterobacterales (ESBL-PE) are highly prevalent in long-term healthcare (LTCF) settings. In order to estimate the acquisition rate of ESBL-producing Escherichia coli and Klebsiella pneumoniae in LTCF settings and identify clinical and environmental risk factors, a multicentric, prospective cohort study was conducted in six LTCFs in Germany, France, Spain and the Netherlands.

Methods: Longitudinal screening of residents was performed over 32 weeks, collecting epidemiological and clinical data and environmental samples.

Serological evidence of Crimean-Congo haemorrhagic fever in domestic animals from eight regions of Namibia.

Crimean-Congo haemorrhagic fever (CCHF) is a viral zoonotic disease endemic to regions of Africa, the Balkans, the Middle East, and Asia, with increasing reports of cases in southern Europe. Human transmission occurs primarily through the bite of infected ticks and by body fluids from infected human. Crimean-Congo haemorrhagic fever virus (CCHFV) affects a broad host range, including both domestic and wild vertebrates.

High- versus Low-dose Oxytocin Regimens for Labor Augmentation: A Systematic Review and Meta-analysis.

Objective: To assess whether high- versus low-dose oxytocin regimens for labor augmentation are associated with differential risk for low Apgar score, neonatal acidosis, and other adverse labor outcomes.

Data Sources: We searched electronic databases (MEDLINE, EMBASE, the Cochrane Library, CINAHL, Scopus, ClinicalTrials.gov) from inception up to March 2024 using combinations of the following keywords: "oxytocin," "oxytocin regimen," "oxytocin protocol," "oxytocin dosage," "active management," "high dose protocol," "low dose protocol," "augmentation of labor.

Comparison of two aspirin doses for the prophylaxis of pre-eclampsia in twin pregnancy: a multicentre retrospective study with propensity score matching.

Background: Aspirin has proved its efficacy in reducing the rate of preeclampsia in singleton pregnancy, however, there is discrepancy about the efficient dosage that should be used. While some societies recommend daily 75-81mg, others recommend higher dosage (160mg). This discrepancy is due to the lack of randomized controlled studies that compare these two dosages.