Cangrelor versus crushed ticagrelor in patients with acute myocardial infarction and cardiogenic shock: rationale and design of the randomised, double-blind DAPT-SHOCK-AMI trial.

Cardiogenic shock (CS) is a devastating and fatal complication of acute myocardial infarction (AMI). CS can affect the pharmacokinetics and pharmacodynamics of medications. The unique properties of cangrelor make it the optimal P2Y12 inhibitor for CS-AMI, in terms of both efficacy and safety.

Subpleural pulmonary nodule marking with patent blue V dye prior to surgical resection.

Background And Objective: Subpleural located pulmonary nodules are perioperatively invisible to the surgeon. Their precise identification is conventionally possible by palpation, but often at the cost of performing a thoracotomy. The aim of the study was to evaluate the success rate and feasibility of the pre-operative CT-guided marking subpleural localized nodule using a mixture of Patent Blue V and an iodine contrast agent prior to the extra-anatomical video-assisted thoracoscopic surgery (VATS) resection in patients for whom the primary anatomical resection in terms of segmentectomy or lobectomy was not indicated.

Effectiveness of the adapted bivalent mRNA COVID-19 vaccines against hospitalisation in individuals aged ≥ 60 years during the Omicron XBB lineage-predominant period: VEBIS SARI VE network, Europe, February to August, 2023.

We conducted a multicentre hospital-based test-negative case-control study to measure the effectiveness of adapted bivalent COVID-19 mRNA vaccines against PCR-confirmed SARS-CoV-2 infection during the Omicron XBB lineage-predominant period in patients aged ≥ 60 years with severe acute respiratory infection from five countries in Europe. Bivalent vaccines provided short-term additional protection compared with those vaccinated > 6 months before the campaign: from 80% (95% CI: 50 to 94) for 14-89 days post-vaccination, 15% (95% CI: -12 to 35) at 90-179 days, and lower to no effect thereafter.

The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium.

Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey.

Vaccine effectiveness against COVID-19 hospitalisation in adults (≥ 20 years) during Alpha- and Delta-dominant circulation: I-MOVE-COVID-19 and VEBIS SARI VE networks, Europe, 2021.

IntroductionTwo large multicentre European hospital networks have estimated vaccine effectiveness (VE) against COVID-19 since 2021.AimWe aimed to measure VE against PCR-confirmed SARS-CoV-2 in hospitalised severe acute respiratory illness (SARI) patients ≥ 20 years, combining data from these networks during Alpha (March-June)- and Delta (June-December)-dominant periods, 2021.MethodsForty-six participating hospitals across 14 countries follow a similar generic protocol using the test-negative case-control design.

Vaccine effectiveness against COVID-19 hospitalisation in adults (≥ 20 years) during Omicron-dominant circulation: I-MOVE-COVID-19 and VEBIS SARI VE networks, Europe, 2021 to 2022.

IntroductionThe I-MOVE-COVID-19 and VEBIS hospital networks have been measuring COVID-19 vaccine effectiveness (VE) in participating European countries since early 2021.AimWe aimed to measure VE against PCR-confirmed SARS-CoV-2 in patients ≥ 20 years hospitalised with severe acute respiratory infection (SARI) from December 2021 to July 2022 (Omicron-dominant period).MethodsIn both networks, 46 hospitals (13 countries) follow a similar test-negative case-control protocol.

Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial.

Introduction: Colistin is a lipopeptide antibiotic administered as an inactive prodrug-colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, dependent on plasma concentrations. The number of patients with infections caused by multidrug-resistant Gram-negative bacteria sensitive only to colistin and the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure increased significantly in association with COVID-19-induced infections.

VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe.

Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines.

Enhancing Public Health Communication Regarding Vaccine Trials: Design and Development of the Pan-European VACCELERATE Toolkit.

Background: The pan-European VACCELERATE network aims to implement the first transnational harmonized and sustainable vaccine trial Volunteer Registry, being a single entry point for potential volunteers of large-scale vaccine trials across Europe. This work exhibits a set of harmonized vaccine trial-related educational and promotional tools for the general public, designed and disseminated by the pan-European VACCELERATE network.

Objective: This study primarily aimed to design and develop a standard toolkit to increase positive attitudes and access to trustworthy information for better access and increased recruitment to vaccine trials for the public.

The Effect of Glass Fiber Storage Time on the Mechanical Response of Polymer Composite.

The growing demand for polymer composites and their widespread use is inevitably accompanied by the need to know their degradation behavior over a sufficiently long period of time. This study focuses on commercial glass fiber rovings, which were stored in the indoor environment for up to 11 years. Fibers with different storage times, from fresh up to the oldest, were used to produce unidirectional fiber-reinforced polyester composites that were characterized to determine their shear and flexural properties dependent on fiber storage time.

Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases.

Background: Academic-sponsored trials for rare diseases face many challenges; the present paper identifies hurdles in the set-up of six multinational clinical trials for drug repurposing, as use cases.

Methods: Six academic-sponsored multinational trials aiming to generate knowledge on rare diseases drug repurposing were used as examples to identify problems in their set-up. Coordinating investigators leading these trials provided feedback on hurdles linked to study, country, and site set up, on the basis of pre-identified categories established through the analysis of previous peer-reviewed publications.

VACCELERATE Volunteer Registry: A European study participant database to facilitate clinical trial enrolment.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has evidenced the key role of vaccine design, obtention, production and administration to successfully fight against infectious diseases and to provide efficient remedies for the citizens. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry.

Prediction of Vagal Nerve Stimulation Efficacy in Drug-Resistant Epilepsy (PRECISE): Prospective Study for Pre-implantation Prediction/Study Design.

Background: Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy, who are not eligible for resective epilepsy surgery. In VNS therapy, the responder rate (i.e.

Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes.

Objectives: Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes.

Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial.

Background: Enteral nutrition is part of the treatment of critically ill patients. Administration of enteral nutrition may be associated with signs of intolerance, such as high gastric residual volumes, diarrhea, and vomiting. Clinical trials regarding the effects of the mode of administration of enteral nutrition on the occurrence of these complications have yielded conflicting results.

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.

Introduction: Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work.

Dendritic Cell-Based Immunotherapy in Advanced Sarcoma and Neuroblastoma Pediatric Patients: Anti-cancer Treatment Preceding Monocyte Harvest Impairs the Immunostimulatory and Antigen-Presenting Behavior of DCs and Manufacturing Process Outcome.

Despite efforts to develop novel treatment strategies, refractory and relapsing sarcoma, and high-risk neuroblastoma continue to have poor prognoses and limited overall survival. Monocyte-derived dendritic cell (DC)-based anti-cancer immunotherapy represents a promising treatment modality in these neoplasias. A DC-based anti-cancer vaccine was evaluated for safety in an academic phase-I/II clinical trial for children, adolescents, and young adults with progressive, recurrent, or primarily metastatic high-risk tumors, mainly sarcomas and neuroblastomas.

Evaluation of the potential for caesium transfer from contaminated soil to the food chain as a consequence of uptake by edible vegetables.

This paper analyzes the effect of caesium (Cs) concentration on seed germination, seedling growth, root uptake, and leaf uptake of Lactuca sativa to understand the potential transfer of the metal from contaminated soil to humans through the food chain. The results of germination experiments show that seed germination and seedling growth strongly depend on increasing Cs concentration, with a decrease in the number of germinated seeds compared to the control up to 13.6% and a reduction in seedling growth up to 10.

Influence of potassium concentration gradient on stable caesium uptake by Calla palustris.

The effect of potassium (K) concentration gradient on stable caesium (Cs) uptake by Calla palustris was studied under hydroponic conditions after eight-day exposure in a greenhouse experiment. The plants were exposed to two different concentrations of Cs (provided as 0.5 and 1 mM CsCl) and five different concentrations of K (provided as KSO in 0.

Quantitative analysis of drug losses administered via nasogastric tube--In vitro study.

Purpose: Drug administration through nasogastric tube (NGT) is a standard practice but the real amount of the delivered drug is unknown. Therefore, we designed a study to determine the losses of various dosage forms administered by different methods through NGT.

Methods: In vitro model was used.

Slow pathway ablation for typical atrioventricular nodal re-entrant tachycardia significantly alters the autonomic modulation of atrioventricular conduction.

Purpose: Atrioventricular (AV) conduction turbulence, biphasic dromotropic response of AV node to single ventricular premature contraction (VPC), consists of early shortening and later prolongation of AV conduction intervals due to the direct electrophysiological mechanisms and perturbation in autonomic modulation. We investigated the acute effect of radiofrequency catheter ablation of slow pathway on AV turbulence.

Methods: The electrophysiological study was performed in 18 patients (7 men, mean age 49 ± 15 years) undergoing catheter ablation for AV nodal reentrant tachycardia.