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.

Nitrogen Assimilation Plays a Role in Balancing the Chloroplastic Glutathione Redox Potential Under High Light Conditions.

Nitrate reduction requires reducing equivalents produced by the photosynthetic electron transport chain. Therefore, it has been suggested that nitrate assimilation provides a sink for electrons under high light conditions. We tested this hypothesis by monitoring photosynthetic efficiency and the chloroplastic glutathione redox potential (chl-E) of plant lines with mutated glutamine synthetase 2 (GS2) and ferredoxin-dependent glutamate synthase 1 (GOGAT1).

Elevated risk of possible sarcopenia and weak muscle strength with higher dietary inflammatory index in Iranian breast cancer survivors: a cross-sectional study.

Background: Increased levels of inflammation in cancer patients and survivors can make them more prone to muscle wasting and sarcopenia. Diet can be an appropriate treatment for alleviating patient complications. Therefore, this study was performed to determine the association between sarcopenia and its components with the dietary inflammatory index (DII) among breast cancer survivors.

Molecular characterization of swine acute diarrhea syndrome coronavirus detected in Vietnamese pigs.

Swine acute diarrhea syndrome coronavirus (SADS-CoV) is a novel porcine coronavirus that was recently identified in southern China in 2017. At present, there is a lack of nationwide epidemiological investigations of the newly emerged SADS-CoV. Because Vietnam is geographically adjacent to southern China, many diseases have spread from China to Vietnam.

Histamine N-methyltransferase (HNMT) as a potential auxiliary biomarker for predicting adaptability to anti-HER2 drug treatment in breast cancer patients.

Background: Up to 23% of breast cancer patients recurred within a decade after trastuzumab treatment. Conversely, one trial found that patients with low HER2 expression and metastatic breast cancer had a positive response to trastuzumab-deruxtecan (T-Dxd). This indicates that relying solely on HER2 as a single diagnostic marker to predict the efficacy of anti-HER2 drugs is insufficient.

The Healthy Supermarket Coach: effects of a nutrition peer-education intervention in Dutch supermarkets on adolescents' food purchases.

Background: Dutch adolescents predominantly purchase unhealthy snacks in supermarkets, which negatively influence their health. The aim of this study was to investigate the short- and longer-term effects of a nutrition peer-education intervention in supermarkets on food purchases and determinants of food purchase behaviour among adolescents of different education levels.

Methods: We performed a quasi-experimental study in three supermarkets (two intervention and one comparison school) in Amsterdam, the Netherlands.

Late-life physical activity, midlife-to-late-life activity patterns, APOE ε4 genotype, and cognitive impairment among Chinese older adults: a population-based observational study.

Background: Although physical activity (PA) has been linked to cognitive health, the nuanced relationships between different dimensions of PA and cognitive impairment remain inconclusive. This study investigated associations between late-life PA levels, midlife-to-late-life activity patterns, and cognitive impairment in Chinese older adults, considering potential moderation by apolipoprotein E (APOE) ε4 genotype.

Methods: We analyzed baseline data from 6,899 participants (median age 68 years, 55.

Simulated retail food environments: A literature review of systems science approaches to advance equity in access to healthy diets.

As researchers increasingly utilize systems science simulation modeling (SSSM), little is known about how and by whom SSSMs are being leveraged to address inequities in access to healthy diets. We evaluated the extent to which studies (n = 66) employing SSSM to examine retail food environments (RFEs): included three pillars of equity (social position, human capital, socioeconomic and political context) that shape RFEs and access to healthy diets; grounded model design and development in theory; engaged with diverse stakeholders and lived experiences related to RFEs; and translated model findings towards addressing inequities in RFEs. Most studies (n = 58) included some model characteristics related to social position (e.

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.

Active biomonitoring of stream ecosystems: untargeted metabolomic and proteomic responses and free radical scavenging activities in mussels.

Many contaminants from scattered sources constantly endanger streams that flow through heavily inhabited areas, commercial districts, and industrial hubs. The responses of transplanted mussels in streams in active biomonitoring programs will reflect the dynamics of environmental stream conditions. This study evaluated the untargeted metabolomic and proteomic responses and free radical scavenging activities of transplanted mussels Sinanodonta woodiana in the Winongo Stream at three stations (S1, S2, S3) representing different pollution levels: low (S1), high (S2), and moderate (S3).

Alterations in the uterine echotexture, hemodynamics, and histological findings in relation to metabolomic profiles in goats with different ovarian activities (active versus inactive ovaries).

This study investigated, for the first time, the alterations in the uterine echotexture and blood flow in cyclic and acyclic (inactive ovary) goats using ultrasonography. The study aimed also to evaluate the metabolomic changes in the plasma of cyclic and acyclic goats. Furthermore, the histopathological approach was applied to the specimens of the uterus to validate the findings of this study.

Accumulation of chlorinated paraffins in adipocytes is determined by cellular lipid content and chlorination level.

Chlorinated paraffins (CPs) are environmental pollutants extensively used in industries. While the use of short-chain chlorinated paraffins (SCCPs) has been restricted since 2017, the use of medium-chain chlorinated paraffins (MCCPs) has risen as their replacement. Due to lipophilic character, it can be expected that CPs enter the cells; however, the in vitro accumulation potential of CPs remains poorly understood.

Virus Association with Bacteria and Bacterial Cell Components Enhance Virus Infectivity.

The transmission and infection of enteric viruses can be influenced by co-existing bacteria within the environment and host. However, the viral binding ligands on bacteria and the underlying interaction mechanisms remain unclear. This study characterized the association of norovirus surrogate Tulane virus (TuV) and murine norovirus (MNV) as well as the human enteric virus Aichi virus (AiV) with six bacteria strains (Pantoea agglomerans, Pantoea ananatis, Bacillus cereus, Enterobacter cloacae, Exiguobacterium sibiricum, Pseudomonas spp.

Targeted Assay Engineering Enhances Bile Salt Hydrolase Activity in Heyndrickxia coagulans ATCC 7050 and Lactiplantibacillus plantarum ATCC 10012.

The recent emergence of bile salt hydrolase (BSH) enzyme as a therapeutic target reflects its unbound potential in mitigating hypercholesterolemia, obesity, and gastrointestinal issues. However, to bolster its industrial application, optimization of BSH assay lays the cornerstone for enhancing sensitivity, specificity, and reproducibility. The current study delved into optimizing the BSH assay parameters utilizing response surface methodology (RSM) and one-factor-at-a-time (OFAT) method for two novel, natural BSH producers, Heyndrickxia coagulans ATCC 7050 and Lactiplantibacillus plantarum ATCC 10012.

Standardized patient profile review using large language models for case adjudication in observational research.

Using administrative claims and electronic health records for observational studies is common but challenging due to data limitations. Researchers rely on phenotype algorithms, requiring labor-intensive chart reviews for validation. This study investigates whether case adjudication using the previously introduced Knowledge-Enhanced Electronic Profile Review (KEEPER) system with large language models (LLMs) is feasible and could serve as a viable alternative to manual chart review.

The trophic distribution of biomass in ecosystems with co-occurring wildlife and livestock.

Trophic interactions regulate populations, but anthropogenic processes influence primary productivity and consumption by both herbivore and carnivore species. Trophic ecology studies often focus on natural systems such as protected areas, even though livestock globally comprise the majority of terrestrial vertebrate biomass. Here we explore spatial and temporal patterns in the distribution of biomass between plants, and large herbivores and carnivores (> 10 kg) in Norwegian rangelands, including both wildlife and livestock.

Isolation of New Strains of Lactic Acid Bacteria from the Vaginal Microbiome of Postmenopausal Women and their Probiotic Characteristics.

Lactic acid bacteria (LAB), traditionally consumed as fermented foods, are now being applied to the medical field beyond health-functional food as probiotics. Therefore, it is necessary to continuously discover and evaluate new strains with suitable probiotic characteristics, mainly focusing on safety. In this study, we isolated eight new strains from postmenopausal vaginal fluid using culturomics approaches, an emerging area of interest.

State-level policies alone are insufficient to meet the federal food waste reduction goal in the United States.

The United States Food Loss and Waste Reduction Goal seeks to reduce national food waste by 50%, down to 74 kg per capita, by 2030. Here we investigate state policies' alignment with the federal goal across four policy categories. We develop a policy scoring matrix and apply it to wasted food solutions listed in the non-profit ReFED's database to derive ranges of food waste diversion potential and projected generation across states.

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).

Driving force analysis and multi-scenario simulation of landscape ecological risk in the Jianghan Plain, China.

As a key food production base, land use changes in the Jianghan Plain (JHP) significantly affect the surface landscape structure and ecological risks, posing challenges to food security. Assessing the ecological risk of the JHP, identifying its drivers, and predicting the risk trends under different scenarios can provide strategic support for ecological risk management and safeguarding food security in the JHP. In this study, the landscape ecological risk (LER) index was constructed by integrating landscape indices from 2000 to 2020, firstly analyzing its spatiotemporal characteristics, subsequently identifying the key influencing factors by using the GeoDetector model, and finally, simulating the risk changes under the four scenarios by using the Markov-PLUS model.

Modelling mixed crop-livestock systems and climate impact assessment in sub-Saharan Africa.

Climate change significantly challenges smallholder mixed crop-livestock (MCL) systems in sub-Saharan Africa (SSA), affecting food and feed production. This study enhances the SIMPLACE modeling framework by incorporating crop-vegetation-livestock models, which contribute to the development of sustainable agricultural practices in response to climate change. Applying such a framework in a domain in West Africa (786,500 km) allowed us to estimate the changes in crop (Maize, Millet, and Sorghum) yield, grass biomass, livestock numbers, and greenhouse gas emission in response to future climate scenarios.

Exploring the antioxidant and antimicrobial properties of five indigenous Kenyan plants used in traditional medicine.

Defined by the World Health Organization (WHO) as indigenous knowledge and practices used for maintaining health and treating illnesses, traditional medicine (TM) represents a rich reservoir of ancient healing practices rooted in cultural traditions and accumulated wisdom over centuries. Five indigenous Kenyan plant species traditionally used in African TM, named Afzelia quanzensis, Azadirachta indica, Gigasiphon macrosiphon, Grewia bicolor, and Lannea schweinfurthii, represent a valuable resource in healing practices, yet their chemical composition and bioactivity remain understudied. To depict a primary bio-chemical characterization of these plants, their antioxidant and antimicrobial features have been evaluated by the use of methods validated in this context.

Global Crop-Specific Fertilization Dataset from 1961-2019.

As global fertilizer application rates increase, high-quality datasets are paramount for comprehensive analyses to support informed decision-making and policy formulation in crucial areas such as food security or climate change. This study aims to fill existing data gaps by employing two machine learning models, eXtreme Gradient Boosting and HistGradientBoosting algorithms to produce precise country-level predictions of nitrogen (N), phosphorus pentoxide (PO), and potassium oxide (KO) application rates. Subsequently, we created a comprehensive dataset of 5-arcmin resolution maps depicting the application rates of each fertilizer for 13 major crop groups from 1961 to 2019.

The anti-melanoma roles and mechanisms of tricholoma isoflavone derivative CA028.

As a form of skin cancer, melanoma's incidence rate is continuing to rise globally. Therefore, there is an urgent need to find new agents to improve survival in melanoma patients. Isoflavones, a class of phytoestrogens, are primarily found in soy and other legumes.

Deep sequencing-derived Metagenome Assembled Genomes from the gut microbiome of liver transplant patients.

Recurrence of metabolic dysfunction-associated steatotic liver disease (MASLD) after liver transplantation (LT) is a continuing concern. The role of gut microbiome dysbiosis in MASLD initiation and progression has been well established. However, there is a lack of comprehensive gut microbiome shotgun sequence data for patients experiencing MASLD recurrence after LT.