Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.

Objective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes.

Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies.

From Extractables to Exposure Data: Sensitivity Analysis of Extrapolation Algorithms with Focus on USP 〈665〉.

We evaluated algorithms designed to extrapolate extractables data for predicting process equipment-related leachables (PERLs) and assessing PERL exposure in single-use systems (SUSs) and their assemblies. The robustness and sensitivity of these algorithms were tested against variations in input data, including extrapolation algorithms for both short and long contact time extractables data obtained from the standardized extractables protocol provided in USP 〈665〉. Our findings demonstrate that extrapolated data for SUS and assemblies are suitable for safety assessments.

Lung cancer screening program quality indicators - review & recommendations - An International Association for the Study of Lung Cancer Delphi process study.

Introduction: Lung cancer screening (LCS) using low-dose-computed tomography reduces lung cancer mortality in high-risk individuals. Evaluating and monitoring LCS programs are important to ensure and improve quality, efficiency and participant outcomes. There is no agreement on LCS quality indicators (QIs).

The International Association for the Study of Lung Cancer Staging Project: The Database and Proposal for the Revision of the Staging of Pulmonary Neuroendocrine Carcinoma in the Forthcoming Ninth Edition of the TNM Classification for Lung Cancer.

Introduction: Pulmonary high-grade neuroendocrine carcinoma (NEC) includes small cell lung carcinoma (SCLC) and large cell neuroendocrine carcinoma (LCNEC). The seventh and eighth editions of the TNM classification for lung cancer confirmed the applicability of this staging system for SCLC. With the proposal of N2 and M1c subcategories for the ninth edition classification, we assessed the applicability to NECs.

Global impact of 10- and 13-valent pneumococcal conjugate vaccines on pneumococcal meningitis in all ages: the PSERENADE project.

Background: Pneumococcal conjugate vaccines (PCVs) introduced in childhood national immunization programs lowered vaccine-type invasive pneumococcal disease (IPD), but replacement with non-vaccine-types persisted throughout the PCV10/13 follow-up period. We assessed PCV10/13 impact on pneumococcal meningitis incidence globally.

Methods: The number of cases with serotyped pneumococci detected in cerebrospinal fluid and population denominators were obtained from surveillance sites globally.

Neurodevelopmental Follow-Up in Children with Intrauterine and Perinatal Exposure to Chikungunya Virus.

Objective: To investigate the effects of intrauterine and perinatal exposure to chikungunya virus (CHIKV) on neurodevelopment in infants and toddlers.

Study Design: We conducted a cohort study comparing children with intrauterine or perinatal exposure to maternal CHIKV infection with unexposed controls in Rio de Janeiro, Brazil. Neurodevelopment was assessed with General Movement Assessments (GMA) in the first six months of life, and the Bayley-III Scales of Infant and Toddler Development and Modified Checklist for Autism in Toddlers (M-CHAT) for older children.

Update in Clinical Science: Autoimmune Hepatitis.

Autoimmune hepatitis (AIH) is an enigmatic, relatively rare disease with a variable spectrum of presentation whose pathogenesis, diagnosis and management remain a major challenge. Methods. We have performed a review incorporating recent developments in basic science, epidemiology, clinical science, therapeutics, regulatory science and evaluated the challenges associated with the application of translational research and clinical trial design to a condition that is a chameleon in nature, where outcomes range from relatively benign disease through cirrhosis and acute liver failure.

High-performance thin-layer chromatography-umu combined with nontarget analysis-a sensitive genotoxicity screening tool applicable for potable water analysis.

Monitoring of genotoxic chemicals released into the water cycle or formed through transformation processes is critical to prevent harm to human health. The development of the high-performance thin-layer chromatography (HPTLC)-umu bioassay combines sample separation and detection of genotoxic substances in the low ng/L concentration range. In this study, raw, process, and drinking water samples from 11 different waterworks in Germany were analyzed using the HPTLC-umu.

Clinical Outcomes of the PAUL® Glaucoma Implant for secondary glaucoma after vitreoretinal surgery.

Background: To report clinical outcomes from a single-center cohort undergoing PAUL® Glaucoma Implant (PGI) surgery for secondary glaucoma after vitreoretinal surgery (VR).

Methods: Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from 04/2021 to 05/2023.

Results: 33 eyes of 33 patients were included.

Development of a versatile system for evaluating the target protein degradation activity of novel ubiquitin ligases utilizing existing PROTACs.

Proteolysis-Targeting Chimeras (PROTAC) are a bifunctional molecule that binds to a protein of interest (POI) and a ubiquitin ligase, thereby inducing the ubiquitination and degradation of POI. Many PROTACs currently utilize a limited number of ubiquitin ligases, such as von Hippel-Lindau (VHL) and Cereblon. Because these ubiquitin ligases are widely expressed in normal tissues, unexpected side effects can occur.

Providing care to cancer patients parenting minor children: A qualitative study on healthcare professionals' communication practice.

Aim: To explore healthcare professionals' (HCPs) experiences when communicating about child- and family-related aspects in cancer care and their attitudes about the importance of including these aspects in cancer care.

Methods: We conduced semi-structured interviews with HCPs working in oncology. Interviews were audio-recorded, transcribed verbatim and analyzed using Kuckartz's method for qualitative content analysis.

Infants' saccadic behavior during 2-dimensional displays of a bounce.

The study examined the saccadic behavior of 4- to 10-month-old infants when tracking a two-dimensional linear motion of a circle that occasionally bounced off a barrier constituted by the screen edges. It was investigated whether infants could anticipate the angle of the circle's direction after the bounce and the circle's displacement from the location of bounce. Seven bounce types were presented which differed in the angle of incidence.

Acquired vulnerability against EGF receptor inhibition in gastric cancer promoted by class I histone deacetylase inhibitor entinostat.

Introduction: Histone deacetylase inhibitors (HDACi) have shown promising preclinical activity in gastric cancer cells; unfortunately, however, these could not be confirmed in clinical trials. This highlights the need for the identification of underlying reasons, which may also provide the basis for possible combination therapies. Here, we delineated the effects of HDACi on components of EGFR signalling in gastric cancer cells.

Soft tissue-like coupling materials for in vitro acoustic emission studies in total hip arthroplasty.

In hip arthroplasty, relative movements between the femoral stem and bone can lead to implant loosening, resulting in extensive bone loss. Acoustic emission (AE) analysis is a promising technique for a nondestructive and noninvasive detection of these relative movements. To develop such a detection method, in vitro investigations using piezoelectric AE sensors on implant stems in artificial or human femora are required to characterize the AE signals induced by loosening.

Selective activity of Tabebuia avellanedae against Giardia duodenalis infecting organoid-derived human gastrointestinal epithelia.

Giardia duodenalis is a widespread intestinal protozoan that affects mammals, including humans. Symptoms can range from being subclinical to causing severe abdominal pain and diarrhoea. Giardiasis often requires repeated treatment with synthetic drugs like metronidazole.

Risk stratification for violent behavior in critically ill patients: Current assessment tools.

Background: Workplace violence (WPV) presents challenges in intensive care units (ICUs) calling for reliable prediction of violence. This narrative review aimed to identify and evaluate risk assessment tools from acute care settings which are or might be used to predict violent behavior in adult ICU patients focusing on their performance and clinical utility.

Methods: A screening of PubMed, Scopus and Google Scholar was conducted to identify risk scores used in the acute care setting such as emergency departments, hospitals and ICUs.

Hydrocarbon biodegradation processes at a historic oil production site - A signature metabolite study.

Decades of research demonstrated that microbes can remediate petroleum-contaminated environments through biodegradation of hydrocarbons. Recent studies have applied signature metabolite analysis to investigate hydrocarbon-contaminated sites, focusing primarily on aquifer systems and metabolites of relatively water-soluble monoaromatic hydrocarbons. However, the number of studies involving non-targeted analysis and identification of individual metabolites in environmental samples is limited.

Immobilization of per- and polyfluorinated alkyl substances (PFAS) from field contaminated groundwater by a novel organo-clay vs. colloidal activated carbon under flow conditions.

Two novel and unique adsorptive materials, one (Fluorolock®) from clay mineral sepiolite coated with the cationic polymer polydiallyldimethylammionium chloride (pDADMAC) and the other (Intraplex®) from colloidal activated carbon were specially developed for the in situ remediation of per- and polyfluoroalkyl substances (PFAS) in the saturated zone. We evaluated the potential of both materials to immobilize PFAS in soils under flow conditions via soil column experiments using groundwater, which was contaminated with PFAS in the field. Furthermore, the potential ecotoxicological effects of both materials on aquatic organisms were assessed by exposing the soil column effluent to Daphnia magna.

Cognitive behavioral therapy for insomnia across the spectrum of alcohol use disorder: A systematic review and meta-analysis.

Insomnia is prevalent among patients with alcohol use disorder (AUD), potentially undermining treatment and increasing the risk of relapse. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia, but its efficacy is not well-characterized in patients across the spectrum of AUD. The aim of this meta-analysis was to quantify the effectiveness of CBT-I in improving insomnia severity and alcohol-related outcomes in adults with heavy alcohol use and/or varying levels of AUD severity and comorbid insomnia.

Dancing Molecules: Group A bZIPs and PEBPs at the Heart of Plant Development and Stress Responses.

Group A basic leucine zipper (bZIP) transcription factors play critical roles in abscisic acid (ABA) signaling and plant development. In Arabidopsis thaliana, these factors are defined by a highly conserved core bZIP domain, and four conserved domains throughout their length: three at the N-terminus (C1 to C3) and a phosphorylatable C-terminal SAP motif located at the C4 domain. Initially, members such as ABI5 and ABFs were studied for their roles in ABA signaling during seed germination or stress responses.

Potential roles of mitochondrial carrier proteins in plant responses to abiotic stress.

The transport of metabolites across the inner mitochondrial membrane (IMM) is crucial for maintaining energy balance and efficient distribution of metabolic intermediates between cellular compartments. Under abiotic stress, mitochondrial function becomes particularly critical, activating complex signaling pathways essential for plant stress responses. These pathways modulate stress-responsive gene expression, influencing key physiological processes such as cell respiration and senescence, helping plants adapt to stress.

Automated spinopelvic measurements on radiographs with artificial intelligence: a multi-reader study.

Purpose: To develop an artificial intelligence (AI) algorithm for automated measurements of spinopelvic parameters on lateral radiographs and compare its performance to multiple experienced radiologists and surgeons.

Methods: On lateral full-spine radiographs of 295 consecutive patients, a two-staged region-based convolutional neural network (R-CNN) was trained to detect anatomical landmarks and calculate thoracic kyphosis (TK), lumbar lordosis (LL), sacral slope (SS), and sagittal vertical axis (SVA). Performance was evaluated on 65 radiographs not used for training, which were measured independently by 6 readers (3 radiologists, 3 surgeons), and the median per measurement was set as the reference standard.