Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials.

While patient-reported outcome measures are regularly incorporated into phase 3 clinical trials, they have been infrequently used in early phase trials. However, the patient's perspective is vital to fully understanding dose toxicity and selecting an optimal dose. This viewpoint paper reviews the rationale for and practical approach to collecting patient-reported outcome data in early phase oncology drug development and the rationale for electronic collection.

The 2024 ILTS-ILCA consensus recommendations for liver transplantation for hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

Background: Liver transplantation (LT) provides the best long-term survival outcomes for patients with liver cancer. As a result, the field of transplant oncology has grown greatly over the past few decades, and many centers have expanded their criteria to allow increased access to LT for liver malignancies. Center-level guidelines and practices in transplant oncology significantly vary across the world, leading to debate regarding the best course of treatment for this patient population.

Efficacy of the FIFA cooling break heat policy during an intermittent treadmill football simulation in hot conditions in trained females.

Objectives: To investigate the efficacy of the current FIFA cooling break heat policy against alternative cooling configurations in attenuating physiological strain during a football simulation in the heat.

Design: Five randomised counterbalanced experimental trials in 40 °C and 41 % relative humidity (32 °C wet-bulb globe temperature).

Methods: Twelve females (age 25 ± 5 y, V̇O 51 ± 5 mL·kg·min) completed five 90-min football simulations with different cooling configurations: regular match without cooling breaks (REG), 3-min breaks without cooling (BRK), 3-min breaks with cooling (BRK: current FIFA policy; chilled fluid and ice towel across neck/shoulders), 5-min extended half-time without cooling breaks (ExtHT), and 5-min extended half-time with 3-min cooling breaks (ExtHT).

Associations Between Match-Play Characteristics and Environmental Temperatures in 4 Professional Football Leagues.

This study investigated the association between environmental temperature and match-play characteristics (shooting, passing, dribbling and defending) in four professional football leagues. Twenty-seven performance indicators (PI's) were collated from 1585 matches from the German Bundesliga 1 and 2, Spanish La Liga and Australian A-League. Environmental data were obtained for dry-bulb temperature (T) and wet-bulb globe temperature (WBGT) retrospectively from public sources.

Emergency response planning for sudden cardiac arrest in amateur football clubs in Germany (federal state Saarland).

Objective: While emergency care for sudden cardiac arrest (SCA) is strictly regulated in professional football, the situation in amateur football is unclear. This study investigated the emergency readiness for SCA in German amateur football clubs.

Methods: A cross-sectional survey of 253 German amateur football clubs (fifth division and lower) was conducted between January and August 2023.

Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study.

Purpose: Approximately 50% of patients with advanced Merkel cell carcinoma (MCC) have primary or acquired resistance to PD-(L)1 blockade, which may be overcome using combination immune checkpoint inhibition (ICI) with anti-cytotoxic T lymphocyte antigen-4 antibody. We present results from the recurrent/metastatic MCC cohort in CheckMate 358, a nonrandomized, multicohort, phase I/II study of nivolumab (NIVO) with or without ipilimumab (IPI) in virus-associated cancers (ClinicalTrials.gov identifier: NCT02488759).

Engineered heart muscle allografts for heart repair in primates and humans.

Cardiomyocytes can be implanted to remuscularize the failing heart. Challenges include sufficient cardiomyocyte retention for a sustainable therapeutic impact without intolerable side effects, such as arrhythmia and tumour growth. We investigated the hypothesis that epicardial engineered heart muscle (EHM) allografts from induced pluripotent stem cell-derived cardiomyocytes and stromal cells structurally and functionally remuscularize the chronically failing heart without limiting side effects in rhesus macaques.

Associations between injury occurrence and environmental temperatures in the Australian and German professional football leagues.

A cross-sectional analysis was performed to investigate associations between environmental temperatures and injury occurrence in two professional male football (soccer) leagues. Data from seven seasons of the German Bundesliga (2142 matches) and four seasons of the Australian A-League (470 matches) were included. Injuries were collated via media reports for the Bundesliga and via team staff reports in the A-League and comprised injury incidence, mechanisms (contact, noncontact), locations (e.

Characterization of Loss-of-Imprinting in Breast Cancer at the Cellular Level by Integrating Single-Cell Full-Length Transcriptome with Bulk RNA-Seq Data.

Genomic imprinting, the parent-of-origin-specific gene expression, plays a pivotal role in growth regulation and is often dysregulated in cancer. However, screening for imprinting is complicated by its cell-type specificity, which bulk RNA-seq cannot capture. On the other hand, large-scale single-cell RNA-seq (scRNA-seq) often lacks transcript-level detail and is cost-prohibitive.

Injury prevention in youth football (soccer): a comprehensive description of the development process of the 'FUNBALL' programme.

Many football injury prevention programmes (IPPs) have been developed to target various injuries and populations. There was no specific IPP for youth players in place before. However, several existing IPPs designed for adults were also assessed in the youth population.

Single-cell RNA sequencing-derived signatures define response patterns to atezolizumab + bevacizumab in advanced hepatocellular carcinoma.

Background & Aims: The combination of atezolizumab and bevacizumab (atezo+bev) is the current standard of care for advanced hepatocellular carcinoma (HCC), providing a median overall survival (OS) of 19.2 months. Here, we aim to uncover the underlying cellular processes driving clinical benefit vs.

Independent Genetic Mapping Experiments Identify Diverse Molecular Determinants of Host Adaptation in a Generalist Herbivore.

Interactions between plants and herbivores promote evolutionary change. Studying the evolution of herbivore mechanisms aimed to cope with different host plant species is a critical intersection between evolutionary biology and sustainable pest management. Generalist herbivores are of particular interest, as hybridization between genetically distinct populations can increase the standing genetic variation and therefore the adaptive potential of the species.

Pancreatic Adenocarcinoma: Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 Phase III Trial.

Purpose: The ESPAC4 trial showed that adjuvant chemotherapy with gemcitabine plus capecitabine (GemCap) produced longer overall survival (OS) than gemcitabine monotherapy. Subsequently, the PRODIGE24-CCTG PA.6 trial showed even longer survival for modified fluorouracil, folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) than gemcitabine but had more restrictive eligibility criteria.

Has COVID-19 led to more sudden cardiac deaths in football?

Introduction: It is unclear whether the number of sudden cardiac death (SCD) and survived sudden cardiac arrest (SCA) has increased among football players during the COVID-19 pandemic. This study aims to compare the SCD/SCA burden between the pre-pandemic period and COVID-19 pandemic in football players worldwide.

Methods: The COVID-19 pandemic and an equivalent pre-pandemic period (each lasting 1151 days) were analyzed for SCD/SCA by extracting data from the prospective FIFA (Fédération Internationale de Football Association) Sudden Death Registry.

Proteome-Wide Genetic Investigation of Large Artery Stiffness.

The molecular mechanisms contributing to large artery stiffness (LAS) are not fully understood. The aim of this study was to investigate the association between circulating plasma proteins and LAS using complementary proteomic and genomic analyses. A total of 106 proteins associated with carotid-femoral pulse-wave velocity, a noninvasive measure of LAS, were identified in 1,178 individuals from the Asklepios study cohort.

Decoding the diagnostic and therapeutic potential of microbiota using pan-body pan-disease microbiomics.

The human microbiome emerges as a promising reservoir for diagnostic markers and therapeutics. Since host-associated microbiomes at various body sites differ and diseases do not occur in isolation, a comprehensive analysis strategy highlighting the full potential of microbiomes should include diverse specimen types and various diseases. To ensure robust data quality and comparability across specimen types and diseases, we employ standardized protocols to generate sequencing data from 1931 prospectively collected specimens, including from saliva, plaque, skin, throat, eye, and stool, with an average sequencing depth of 5.