Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials.

Purpose: Over the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner.

[Delayed appendectomy in the pediatric patient. How safe is it?].

Unlabelled: Delayed appendectomy is an option in centers where there is no pediatric surgeon on call.

Objective: to analyze the results of delayed versus immediate surgery in non-complicated appendicitis in pediatric patients.

Patients And Method: Analytical quasi-experimental study including appendectomies performed for uncomplicated appendicitis in children aged between 6 and 14 years.

Ovarian Carcinomas: Clinicopathologic and Molecular Features With Comments on 2014 FIGO Staging.

According to histopathology and molecular genetics, there are 5 major subtypes of ovarian carcinomas: high-grade serous (70%), endometrioid (10%), clear cell (10%), mucinous (3% to 4%), and low-grade serous (<5%) carcinomas. These tumors, which constitute over 95% of cases, represent distinct diseases with different prognoses and therapy. This review outlines contemporary advances in molecular pathology, which have expanded our knowledge of the biology of epithelial ovarian cancer and are also important to patient management.

Exploring the Relationship Between Humoral and Cellular T Cell Responses Against SARS-CoV-2 in Exposed Individuals From Emilia Romagna Region and COVID-19 Severity.

COVID-19 remains a significant global health problem with uncertain long-term consequences for convalescents. We investigated the relationships between anti-N protein antibody levels, severe acute respiratory syndrome (SARS)-CoV-2-associated TCR repertoire parameters, HLA type and epidemiological information from three cohorts of 524 SARS-CoV-2-infected subjects subgrouped in acute phase, seronegative and seropositive convalescents from the Emilia Romagna region. Epidemiological information and anti-N antibody index were associated with TCR repertoire data.

SAHD-10: Development and initial validation of a short version of the Schedule of Attitudes Toward Hastened Death based on a large multinational sample.

Objectives: Wishes to hasten death (WTHDs) are common in patients with serious illness. The Schedule of Attitudes Toward Hastened Death (SAHD) is a validated 20-item instrument for measuring WTHD. Two short versions have also been developed based on statistical item selection.

New recommendations of Spanish Society of Emergency Medicine (SEMES) for emergency department diagnosis of HIV infection based on results from Spain's "Leave Your Mark" program.

Hidden infections and late diagnoses are currently the main challenges of the HIV pandemic. Emergency departments (EDs) are one of the health care system's key resources addressing these challenges. In 2020, the Spanish Society of Emergency Medicine (SEMES) published recommendations for ordering HIV serology testing for patients with certain health conditions, and in 2021 SEMES launched the "Leave Your Mark" (Deja tu Huella - DTH) program to facilitate implementing the recommendations during emergency care.

Epidemiologic and clinical characteristics and course of acute heart failure and cardiogenic shock diagnosed in emergency departments.

Objective: To describe the characteristics of patients diagnosed with acute heart failure (AHF) in emergency departments (EDs) who develop cardiogenic shock (CS) not associated with ST-segment elevation acute coronary syndrome (STACS).

Methods: Information for patients diagnosed with AHF in 23 Spanish EDs and registered between 2009 and 2019 were included for analysis if the patients developed symptoms consistent with CS. We described baseline clinical characteristics related to cardiac decompensation and CS, as well as 30-day mortality.

Do national cancer control plans address care and research for children, adolescents, and young adults? A review of status, priorities, and recommendations across 41 European countries.

Paediatric cancers, although rare, are the leading cause of disease-related mortality in European children above one year. A key pillar of the European Health Union, Europe's Beating Cancer Plan (EBCP) puts a spotlight on childhood cancer. National Cancer Control Plans (NCCPs) have a key role but did not address childhood cancers sufficiently previously.

Intraoperative liquid biopsy as a tool for detecting R1 resection during pancreatoduodenectomy in patients with pancreatic carcinoma: the CETUPANC trial (part II).

Introduction: A positive surgical margin (R1 resection) is a relevant risk factor for local recurrence in patients with pancreatic ductal adenocarcinoma of the pancreas (PDAC). An intraoperative liquid biopsy (ILB) based on tumor cell mobilization could help to detect R1 resection intraoperatively.

Objective: To evaluate the potential role of the intraoperative circulating tumor cells (CTCs) and cluster mobilization on the R0/R1 detection.

Transapical beating heart septal myectomy learning curve and training of future surgeons: an observational study.

Background: Description of the learning curve for transapical beating heart septal myectomy (TA-BSM) helps to understand the potential for wider adaptability. The authors elaborate and examine a competency-based training assessment for TA-BSM that could serve to disseminate septal myectomy expertise.

Materials And Methods: Data on 177 consecutive patients who underwent the TA-BSM for hypertrophic obstructive cardiomyopathy (HOCM) between April 2022 and June 2023 was collected prospectively, which was registered on ClinicalTrials.

Hypomethylating agents for patients with VEXAS without myelodysplastic syndrome: Clinical outcome and longitudinal follow-up of vacuolization and UBA1 clonal dynamics.

VEXAS syndrome is a haemato-inflammatory disease caused by somatic UBA1 mutations and characterized by cytoplasmic vacuoles in myeloid and erythroid precursor cells. Although there is currently no standard treatment algorithm for VEXAS, patients are generally treated with anti-inflammatory therapies focused on symptom management, with only partial effectiveness. Hypomethylating agents (HMA) have shown promise in VEXAS patients with concomitant myelodysplastic syndrome (MDS), while the efficacy of HMA in VEXAS patients without MDS is largely unknown.

Impact of hyper- and hypothermia on cellular and whole-body physiology.

The incidence of heat-related illnesses and heatstroke continues to rise amidst global warming. Hyperthermia triggers inflammation, coagulation, and progressive multiorgan dysfunction, and, at levels above 40 °C, can even lead to cell death. Blood cells, particularly granulocytes and platelets, are highly sensitive to heat, which promotes proinflammatory and procoagulant changes.

Assessment of a novel unidirectional mid-term absorbable barbed suture versus a competitor barbed suture for vaginal cuff closure after gynaecology surgery, study protocol of a randomized controlled trial - BARHYSTER.

Background: Total laparoscopic hysterectomy (TLH) is nowadays the standard to treat benign and malignant disease occurring in the uterus, but the number of robotic-assisted surgeries is increasing worldwide. To facilitate the handling of sutures in a bi- and tri-dimensional plane, a new type of suture material has been developed, named barbed sutures, which are in use in different indications. In comparison to conventional suture materials, the barbs anchor the suture in the tissue, provide tissue approximation and prevent slippage without the need for knot tying.

Finding the right dose: a scoping review examining facilitation as an implementation strategy for evidence-based stroke care.

Background: Despite evidence supporting interventions that improve outcomes for patients with stroke, their implementation remains suboptimal. Facilitation can support implementation of research into clinical practice by helping people develop the strategies to implement change. However, variability in the amount (dose) and type of facilitation activities/facilitator roles that make up the facilitation strategies (content), may affect the effectiveness of facilitation.

Mitochondrial dysfunction is a major cause of thromboinflammation and inflammatory cell death in critical illnesses.

Background: Mitochondria generate the adenosine triphosphate (ATP) necessary for eukaryotic cells, serving as their primary energy suppliers, and contribute to host defense by producing reactive oxygen species. In many critical illnesses, including sepsis, major trauma, and heatstroke, the vicious cycle between activated coagulation and inflammation results in tissue hypoxia-induced mitochondrial dysfunction, and impaired mitochondrial function contributes to thromboinflammation and cell death.

Methods: A computer-based online search was performed using the PubMed and Web of Science databases for published articles concerning sepsis, trauma, critical illnesses, cell death, mitochondria, inflammation, coagulopathy, and organ dysfunction.

Searching for the minimum required dose of daratumumab to induce effective plasma cell depletion in antibody-mediated rejection of the kidney graft: a case report.

There is no established treatment for late or chronic antibody-mediated rejection of a kidney graft. Rituximab-based treatment is not effective, since long-lived high-affinity plasma cells do not express CD20 and do not depend on previous maturation steps to generate donor-specific antibodies. Conversely, daratumumab, an anti-CD38 monoclonal antibody, directly targets plasma cells, with proven efficacy in multiple myeloma.

Second-Line Treatment Options for Patients with Metastatic Triple-Negative Breast Cancer: A Review of the Clinical Evidence.

Metastatic triple-negative breast cancer has a poor prognosis and poses significant therapeutic challenges. Until recently, limited therapeutic options have been available for patients with advanced disease after failure of first-line chemotherapy. The aim of this review is to assess the current evidence supporting second-line treatment options in patients with metastatic triple-negative breast cancer.

INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety.

Purpose: To describe the development of INSIGHT, a real-world data quality tool to assess completeness, consistency, and fitness-for-purpose of observational health data sources.

Methods: We designed a three-level pipeline with data quality assessments (DQAs) to be performed in ConcePTION Common Data Model (CDM) instances. The pipeline has been coded using R.

Albendazole-ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial.

Background: Treatments for soil-transmitted helminthiases face challenges, especially in addressing Trichuris trichiura. Combination regimens, particularly of ivermectin and albendazole, are promising. We aimed to assess the safety, efficacy, and palatability of a combination tablet for the treatment of T trichiura, hookworm, and Strongyloides stercoralis infections among school-aged children in Ethiopia, Kenya, and Mozambique.