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Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.

BACKGROUND: There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL. OBJECTIVES: The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims data

Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer's Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data.

BACKGROUND: Amyloid beta (Aβ) oligomers play a critical role in the pathogenesis of Alzheimer's disease (AD) and represent a promising target for drug development. Tramiprosate is a small-molecule Aβ anti-aggregation agent that was evaluated in phase III clinical trials for AD but did not meet the primary efficacy endpoints; however, a pre-specified subgroup analysis revealed robust, sustained, and clinically meaningful cognitive and functional effects in patients with AD homozygous for the ε4 allele of apolipoprotein E4 (APOE4/4 homozygotes), who carry an increased risk for the disease. There

Psychosocial impact of acne among medical, Speech and Hearing Sciences, and Occupational Therapy undergraduates at a Sri Lankan University.

BACKGROUND: Acne vulgaris is associated with substantial psychosocial effects, including impaired socioemotional well-being among young adults. This study aimed to determine the prevalence of acne and to examine the relationships and predictive effects of acne-related quality of life on psychological distress and self-esteem, in addition to exploring gender differences among medical and allied health undergraduates. METHODS: A descriptive cross-sectional study was conducted from April to June 2025 among undergraduates aged 18–28 years from three degree programmes: Medicine (MBBS), Speech and H

[Determination of polychlorinated naphthalenes in soil using accelerated solvent extraction-molecular sieves solid-phase extraction coupled with gas chromatography-tandem mass spectrometry].

Emerging pollutants (EPs) are chemical substances that are commonly not regulated and can be detected at low or very low concentrations. However, EPs have triggered special concern because their long-term adverse effects on the environment and human health remain unknown. Most EPs show biological toxicity, environmental persistence, and bioaccumulation. Even at low concentrations in the environment, EPs may pose significant environmental and health risks. Therefore, their treatment has been explicitly included in the 14th Five Year Plan for National Economic and Social Development of the Peopl

[Establishment and international comparison of reference methods for glycated hemoglobin].

To promote the standardization and harmonization of glycated hemoglobin A1c （HbA1c） testing results in medical laboratories across Beijing， we established a reference method for HbA1c. This method participated in the International Comparison Program for HbA1c Reference Laboratories organized by the European Reference Laboratory Network for HbA1c to validate its accuracy. The experimental samples consisted of HbA1c network reference laboratory proficiency testing samples imported annually from the Netherlands， including six calibrators （A-F）， ten intercomparison samples， several quality control

Future perspectives in melanoma research : Meeting report from the "Melanoma Bridge". Napoli, December 1st-4th 2015.

The sixth "Melanoma Bridge Meeting" took place in Naples, Italy, December 1st-4th, 2015. The four sessions at this meeting were focused on: (1) molecular and immune advances; (2) combination therapies; (3) news in immunotherapy; and 4) tumor microenvironment and biomarkers. Recent advances in tumor biology and immunology has led to the development of new targeted and immunotherapeutic agents that prolong progression-free survival (PFS) and overall survival (OS) of cancer patients. Immunotherapies in particular have emerged as highly successful approaches to treat patients with cancer including

Conditioned Media-Derived Tumor Extracellular Vesicles: Bridging Molecular Insights and Therapeutic Applications in Oncology.

Tumor-derived extracellular vesicles (EVs) are major mediators of oncogenic intercellular communication. However, many studies using conditioned media (CM) recover operationally defined EV- or small EV-enriched fractions rather than biogenesis-proven exosomes. This review synthesizes evidence from CM-derived tumor EV studies and aligns their biological interpretation with current EV nomenclature, characterization, and reporting principles. We first discuss exosome biogenesis as a defined endosomal pathway and then examine how CM collection, serum handling, culture format, oxygen tension, condi

Dynamic multimodal survival prediction in multiple myeloma integrating gene expression, longitudinal laboratory measurements, and treatment history.

Prognostic stratification in multiple myeloma (MM) relies on staging systems fixed at diagnosis, discarding temporal information accumulated during treatment. We developed a dynamic multimodal framework that predicts residual overall survival from observation windows of 1-18 months post-diagnosis. The model integrates DeepInsight-transformed gene expression, longitudinal trajectories of 10 laboratory analytes, and treatment history through missingness-aware gated fusion. On the Multiple Myeloma Research Foundation (MMRF) cohort from the Relating Clinical Outcomes in Multiple Myeloma to Persona

Биомаркеры крови отражают патологию мозга - от общих земель до редких границ.

Понимание патологических изменений в мозге имеет важное значение для принятия решений о лечении травм мозга и заболеваний. Несмотря на значительные достижения в методах сканирования мозга, клиническая практика по-прежнему сталкивается с проблемами из-за зависимости от инфраструктуры и высоких потребностей в ресурсах. В ходе этого обзора изучаются нынешние знания о биомаркерах на основе крови, которые указывают на патологию мозга, которая может помочь в идентификации пациентов, подверженных риску, диагностике пациентов, прогнозировании прогрессии заболеваний и лечении. Мы сосредоточимся на унас

Аналитическая проверка множественного пептида для многоантигенного серологического профилирования вируса Эпштейн-Барр по различным клиническим образцам.

Вирус Эпштейн-Барр (ЭБВ) заражает более 95% взрослых и связан с различными результатами: от асимптомной запоздалости до инфекционного мононуклеоза (IM), малигнации и множественного склероза (MS). Обычная серология, основанная на ЭЛИСА, часто ограничивается небольшим количеством растворимых, цельнопротеиновых антигенов и не сохраняет информацию о конкретных линейных районах обнаружения антигенов, которые способствуют общей реакции антител. Множественные пептидные микроархивы устраняют это ограничение, однако их использование в клинической практике требует характеристики их аналитических характе

Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: data from the Connect® MM Registry.

Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) question

A Systematic Review of Machine Learning Techniques in Hematopoietic Stem Cell Transplantation (HSCT).

Machine learning techniques are widely used nowadays in the healthcare domain for the diagnosis, prognosis, and treatment of diseases. These techniques have applications in the field of hematopoietic cell transplantation (HCT), which is a potentially curative therapy for hematological malignancies. Herein, a systematic review of the application of machine learning (ML) techniques in the HCT setting was conducted. We examined the type of data streams included, specific ML techniques used, and type of clinical outcomes measured. A systematic review of English articles using PubMed, Scopus, Web o

Update on the role of bone turnover markers in the diagnosis and management of osteoporosis: a consensus paper from The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), International Osteoporosis Foundation (IOF), and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

PurposeThe International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have proposed procollagen type I N propeptide (PINP) and β isomerized C-terminal telopeptide of type I collagen (β-CTX-I) as reference bone turnover markers (BTMs) for osteoporosis. This report examines the published literature since the 2011 IOF-IFCC position paper in order to determine the clinical potential of the reference BTMs and newer markers for the prediction of fracture risk and monitoring the treatment of osteoporosis.MethodsEvidence for the re

Совпадение в полном тексте источника
… As outlined by the CLSI, technical issues pertaining to the pre-analytical phase are paramount mainly during urinary sample collection [ 45 ]. …

Network approach in liquidomics landscape.

Tissue-based biopsy is the present main tool to explore the molecular landscape of cancer, but it also has many limits to be frequently executed, being too invasive with the risk of side effects. These limits and the ability of cancer to constantly evolve its genomic profile, have recently led to the need of a less invasive and more accurate alternative, such as liquid biopsy. By searching Circulating Tumor Cells and residues of their nucleic acids or other tumor products in body fluids, especially in blood, but also in urine, stools and saliva, liquid biopsy is becoming the future of clinical

Совпадение в полном тексте источника
… The pre-analytical phase of liquid biopsy (Table 1 ) includes all the steps prior to analysis such as specimen collection, stabilization, transport, enrichment, processing, and isolation and quality assessment of the analyte. … The pre-analytical phase is arguably the most important part of liquid biopsy workflows as 46% to 68% of errors occur during this phase [ 29 ]. These errors can adversely affect data quality in the following phases and can result in incorrect treatment decisions [ 29 ]. …

Application of High Throughput Technologies in the Development of Acute Myeloid Leukemia Therapy: Challenges and Progress.

Acute myeloid leukemia (AML) is a complex hematological malignancy characterized by extensive heterogeneity in genetics, response to therapy and long-term outcomes, making it a prototype example of development for personalized medicine. Given the accessibility to hematologic malignancy patient samples and recent advances in high-throughput technologies, large amounts of biological data that are clinically relevant for diagnosis, risk stratification and targeted drug development have been generated. Recent studies highlight the potential of implementing genomic-based and phenotypic-based screen

Предлагаемый протокол наблюдений для ранней дифференциации синдрома высвобождения цитокина и сепсиса в реципиентах CAR-T с гематологическими аномалиями с использованием IL-6Соотношение ПХТ: исследование ДРАКАРИС.

Терапия антигенного рецептора T-клеток (CAR-T) произвела революцию в лечении гематологических магнатов, продемонстрировав замечательную эффективность в лейкемиях B-клеток, лимфомах и множестве миелом. Однако синдром сильного токсина, особенно синдрома цитокина (CRS) и сепсиса, сопряженный с серьезными клиническими проблемами. Оба эти условия имеют совпадающие черты, включая лихорадку, гипотенцию и многоорганическую дисфункцию, что делает важную роль своевременной и точной дифференциации. В основе ДУС лежит чрезмерное высвобождение цитокина, главным образом IL-6, и лечится IL-6 Блокада рецептор

Расовые и этнические различия в использовании психотерапии для борьбы с заболеваниями среди взрослых с множественным склерозом: анализ реального мира в рамках программы исследований " Все мы " .

ВВЕДЕНИЕ: Расовые и этнические различия в использовании множественных методов лечения склероза (МС) с модифицирующими заболеваниями (ДМТ) задокументированы, но не до конца описаны на всех этапах лечения. МЕТОДЫ: Мы провели ретроспективное когортное исследование с использованием программы исследований " Все мы " ( " Все мы " ).2024 (выпуск данных) среди взрослых ≥18 годы с подтвержденным MS (N = 3,508). Итогом этого были инициирование DMT, время до первого DMT, отбор наркоклассов, замена, эскалация и прекращение. Высокоэффективные ДМТ были определены как агенты, ≥50% - относ

Saliva как матрица для терапевтического мониторинга наркотиков и биомаркеров заболеваний у детей и подростков.

Saliva — более доступная, менее напряженная и менее дорогостоящая биологическая матрица, чем кровь, и она может применяться в терапевтическом мониторинге лекарственных средств (ПТМ). Концентрации слюны отражают фармацевтический активный ненавязанный препарат. В этом обзоре содержится последняя информация о слюне в качестве матрицы для лечебного контроля за наркотиками и определения биомаркеров у младенцев, детей и подростков. К октябрю 2024 года по базе данных PubMed были проведены обыски литературы, 64 исследования были включены в TDM, стероиды, добавки, биомаркеры заболеваний, стоматология,

Воздействие внутритехекулярной инъекции мезенхимальных стволовых клеток-недуральных прогенераторов на биомаркеры цереброспинной жидкости в прогрессивном множественном склерозе.

Misenchymal стволовые клетки (MSC-NP) — мезенхимальная популяция клеток с трофическими и иммунодулятивными свойствами, имеющих терапевтический потенциал при множественном склерозе (MS). В ходе клинических испытаний на раннем этапе изучался вопрос о безопасности и эффективности внутритехнологического управления автологическими МСЦ-НП у людей с прогрессивными НР. Чтобы лучше понять биологическую реакцию на лечение MSC-NP, мы проанализировали биомаркеры цереброспиновой жидкости (CSF) в 2 отдельные группы пробных субъектов со вторичными прогрессивными или первичными прогрессивными НР от обеих фазы

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.

Cell and gene therapies (CGTs) have progressed from proof of concept to an established commercial pipeline, yet global translation remains constrained by fragmented regulatory frameworks; heterogeneous Chemistry, Manufacturing, and Controls (CMC) requirements; and divergent approval pathways. This narrative review compares CGT quality, CMC, and approval-pathway regulation across the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), together with five emerging-market agencies: Brazil, Russia, India, China, and