SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.

Unlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.

CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.

Unlabelled: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete.

Upregulation of interferon-γ response genes in monocytes and T cells identified by single-cell transcriptomics in patients with anti-citrullinated peptide antibody-positive early rheumatoid arthritis.

Introduction: Our aim was to investigate the insufficiently understood differences in the immune system between anti-citrullinated peptide antibody (ACPA)-positive (ACPA) and ACPA-negative (ACPA) early rheumatoid arthritis (eRA) patients.

Methods: We performed multiple cytokine assays using sera from drug-naïve ACPA and ACPA eRA patients. Additionally, we conducted single-cell RNA sequencing of CD45 cells from peripheral blood samples to analyze and compare the distribution and functional characteristics of the cell subsets based on the ACPA status.

A preliminary study of linear accelerator-based spatially fractionated radiotherapy.

Purpose: This study aimed to provide quantitative information for implementing Lattice radiotherapy (LRT) using a medical linear accelerator equipped with the Millennium 120 multi-leaf collimator (MLC). The research systematically evaluated the impact of varying vertex diameters and separations on dose distribution, peak-to-valley dose ratio (PVDR), and normal tissue dose.

Methods: A cylindrical Virtual Water™ phantom was used to create LRT treatments using the Eclipse version 16.

Effect of early administration of fibrinogen replacement therapy in traumatic haemorrhage: a systematic review and meta-analysis of randomised controlled trials with narrative synthesis of observational studies.

Background: In severely injured trauma patients, hypofibrinoginaemia is associated with increased mortality. There is no evidence-based consensus for what constitutes optimal fibrinogen therapy, treatment dose or timing of administration. The aim of this systematic review was to evaluate the effects of early fibrinogen replacement, either cryoprecipitate or fibrinogen concentrate (FgC) on mortality, transfusion requirements and deep venous thrombosis (DVT).

A pediatric emergency prediction model using natural language process in the pediatric emergency department.

This study developed a predictive model using deep learning (DL) and natural language processing (NLP) to identify emergency cases in pediatric emergency departments. It analyzed 87,759 pediatric cases from a South Korean tertiary hospital (2012-2021) using electronic medical records. Various NLP models, including four machine learning (ML) models with Term Frequency-Inverse Document Frequency (TF-IDF) and two DL models based on the KM-BERT framework, were trained to differentiate emergency cases using clinician transcripts.

The Global Prevalence of Reported Penicillin Allergy: A Systematic Review and Meta-Analysis.

Objectives: Patients labelled with penicillin allergy (PenA) often receive broader spectrum antibiotics, associated with antimicrobial resistance and poorer outcomes. However, ~95% of patients are likely mis-labelled. Whilst de-labelling programmes are gaining momentum, they have been restricted to a few countries.

Drilling and Groove-cutting Technique for Safe and Complete Removal of Forehead Osteomas on the Anterior Table of the Frontal Sinus.

Forehead osteomas are benign tumors commonly excised for cosmetic and functional reasons. However, removing osteomas from the anterior table of the frontal sinus presents specific challenges, particularly in determining the appropriate removal thickness. Inaccurate resection depth may result in fracture or perforation of the anterior table of the frontal sinus, or incomplete resection.

Intra-Articular Injection of Human Bone Marrow-Derived Mesenchymal Stem Cells in Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Trial.

To assess the impact of a single intra-articular (IA) injection of bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with knee osteoarthritis (OA), a randomized, double-blind, placebo-controlled study was conducted. The study included 24 patients with knee OA who were randomly assigned to receive either a single IA injection of BM-MSCs or normal saline. Changes in the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Injury and Osteoarthritis Outcome Score (KOOS) after IA injection were assessed at 3, 6, 9, and 12 months.

Exploring the efficacy of fluorouracil and platinum based chemotherapy in advanced hepatocellular carcinoma to bridge the treatment gap in resource limited settings.

Advanced hepatocellular carcinoma (HCC) poses treatment challenges, especially where access to multi-kinase inhibitors and ICIs is limited by high costs and lack of insurance. This study evaluates the effectiveness of 5-fluorouracil (5-FU) plus platinum-based chemotherapy as an alternative systemic treatment for advanced HCC. A retrospective analysis of advanced HCC patients treated with 5-FU plus platinum-based chemotherapy was conducted.

Multicenter validation of secondary hemophagocytic lymphohistiocytosis diagnostic criteria.

Background: Five fulfilled hemophagocytic lymphohistiocytosis (HLH)-2004 criteria, and the HScore are widely used and recommended by international expert consensus to diagnose secondary HLH. Both diagnostic scores have never been validated in heterogeneous patient cohorts of secondary HLH patients. We aimed to systematically optimize and validate diagnostic criteria of secondary HLH using a multicenter approach.

Moderate PM exposure increases prostate cancer: a longitudinal nationwide cohort study (2010-2020).

Introduction: Fine dust exposure has been reported to affect patients with prostate cancer, making it crucial to understand how environmental pollutants impact health. This study aimed to determine the risk of prostate cancer in South Korea associated with moderate levels of fine dust (PM) exposure.

Methods: We analyzed data from 20,430 individuals in the National Health Insurance Sharing Service database from 2010 to 2020, comparing a new prostate cancer group ( = 4,071, 19.

Enhanced membrane protein production in HEK293T cells via gene knockout: A CRISPR-Cas9 mediated approach.

HEK293T cells are extensively utilized for therapeutic protein production due to their human origin, which enables accurate post-translational modifications. This study aimed to enhance membrane protein production in HEK293T cells by knocking out the ATF4 gene using CRISPR-Cas9 technology. The ATF4 gene was edited by infecting HEK293T cells with a lentivirus carrying optimized single-guide RNA (ATF4-KO-3) and Cas9 genes.

Alloanti-Hy in antenatal patients: A multi-case review.

Introduction: Introduction The Hy antigen is one of ten red cell antigens belonging to the Dombrock blood group system, with an antigen frequency of almost 100% in the majority of populations. Alloantibodies to high prevalence antigens cause difficulties with antibody identification and exclusion in serological investigations.

Case Presentation: This review describes the management of four antenatal cases where the presence of alloanti-Hy had been identified.

Characteristics of transition to turbulence in a healthy thoracic aorta using large eddy simulation.

This study employed large eddy simulation (LES) with the wall-adapting local eddy-viscosity (WALE) model to investigate transitional flow characteristics in an idealized model of a healthy thoracic aorta. The OpenFOAM solver pimpleFoam was used to simulate blood flow as an incompressible Newtonian fluid, with the aortic walls treated as rigid boundaries. Simulations were conducted for 30 cardiac cycles and ensemble averaging was employed to ensure statistically reliable results.

The incidence of Popeye Deformity after Soft Tissue Biceps Tenodesis is Comparable to Biceps Anchor Tenodesis and Lower than Biceps Tenotomy During Arthroscopic Rotator Cuff Repair.

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Impact of Uterine Leiomyomas on Cardiovascular Disease Risk in Young Reproductive-Aged Women: A Nationwide Population-Based Cohort Study.

Uterine leiomyomas are the most common benign gynecological tumors in women of reproductive age and are often associated with localized symptoms. However, emerging evidence suggests a link between uterine leiomyomas and systemic conditions such as cardiovascular disease (CVD), particularly myocardial infarction (MI) and ischemic stroke (IS). This study aimed to investigate the relationship between uterine leiomyomas and the risk of CVD events in young women aged 20-39 years using a large, nationwide, population-based cohort.

A Multi-Center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of an Olmesartan/Amlodipine Plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia.

This study assessed the therapeutic effectiveness of a single-pill combination (SPC) of olmesartan/amlodipine plus rosuvastatin for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in patients with hypertension and dyslipidemia. Adult patients with hypertension and dyslipidemia who were decided to be treated with the study drug were eligible. The primary endpoint was the proportion of patients who achieved BP, LDL-C and both BP and LDL-C treatment goals at weeks 24-48.

Analysis of Clinically Symptomatic Patients to Differentiate Inflammatory Breast Cancer from Mastitis in Asian Women.

Purpose: To differentiate inflammatory breast cancer (IBC) from mastitis in Asian women presenting with symptoms of inflammation.

Methods: Between January 2012 and June 2024, 101 Asian women with symptoms of inflammation underwent breast ultrasound (US). Clinical and demographic data were extracted from patients' medical records.

Establishment of iPSC-Derived MSCs Expressing hsa-miR-4662a-5p for Enhanced Immune Modulation in Graft-Versus-Host Disease (GVHD).

The immune-modulatory effects of mesenchymal stromal cells (MSCs) are widely used to treat inflammatory disorders, with indoleamine 2,4-dioxygenase-1 (IDO-1) playing a pivotal role in suppressing stimulated T-cell proliferation. Taking that three-dimensional (3D) cultures enhance MSCs' anti-inflammatory properties compared with two-dimensional (2D) cultures, the differentially expressed miRNAs were examined. Thus, we identified hsa-miR-4662a-5p (miR-4662a) as a key inducer of IDO-1 via its suppression of bridging integrator-1 (BIN-1), a negative regulator of the IDO-1 gene.

Assessing the Efficacy of Mitochondria-Accumulating Self-Assembly Peptides in Pancreatic Cancer: An Animal Study.

Although pancreatic cancer presents with one of the most unfavorable prognoses, its treatment options are very limited. Mitochondria-targeting moieties, considered a new and prominent treatment modality, are expected to demonstrate synergistic anticancer effects due to their distinct mechanism compared to conventional chemotherapeutic approaches. This study evaluated the therapeutic potential of mitochondria-accumulating self-assembly peptides, referred to as Mito-FFs, utilizing both in vitro and in vivo pancreatic cancer models.

Comparison of Proximal Tibiofibular Joint Detachment with Tibial-Sided Osteotomy for Fibular Untethering in Lateral Closing-Wedge High Tibial Osteotomy: A Cadaveric Study.

Proximal tibiofibular joint detachment (PTFJD) is a fibular untethering procedure during lateral closing-wedge high tibial osteotomy (LCWHTO) for varus knee osteoarthritis. However, the PTFJD procedure is technically demanding, and confirmation of clear joint separation is not straightforward. The aim of this study was to compare the degree of completion and safety of PTFJD versus tibial-sided osteotomy (TSO); this latter procedure is our novel technique for fibular untethering during LCWHTO.

The Effectiveness and Safety of Tibial-Sided Osteotomy for Fibula Untethering in Lateral Close-Wedge High Tibial Osteotomy: A Novel Technique with Video Illustration.

: Despite its advantages, lateral close-wedge high tibial osteotomy (LCWHTO) requires proximal tibiofibular joint detachment (PTFJD) or fibular shaft osteotomy for gap closing. These fibula untethering procedures are technically demanding and not free from the risk of neurovascular injuries. Our novel fibula untethering technique, tibial-sided osteotomy (TSO) near the proximal tibiofibular joint (PTFJ), aims to reduce technical demands and the risk of injury to the peroneal nerve and popliteal neurovascular structures.

Efficacy of Intraoperative Paracetamol and Nefopam Infusions in Addition to Transversus Abdominis Plane Block in Kidney Transplant Recipients.

: Kidney transplantation (KT) is an important treatment modality for renal failure. However, moderate-to-severe pain often occurs in KT recipients. Multimodal analgesia using combined analgesic measures has been recommended to enhance postoperative recovery.