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| http://dx.doi.org/10.1016/j.lanepe.2024.101175 | DOI Listing |
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Executive Summary: Clinical Practice Guidelines on the Management of Resistant Tuberculosis of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).
Arch Bronconeumol
December 2024
Pulmonology Service, Cruces University Hospital (OSI EEC), Barakaldo, Spain; BioBizkaia Health Research Institute, Spain.
The Spanish Society of Pneumology and Thoracic Surgery (SEPAR) and the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) have developed together Clinical Practice Guidelines (GPC) on the management of people affected by tuberculosis (TB) resistant to drugs with activity against Mycobacterium tuberculosis. These clinical practice guidelines include the latest updates of the SEPAR regulations for the diagnosis and treatment of drug-resistant TB from 2017 and 2020 as the starting point. The methodology included asking relevant clinical questions based on PICO methodology, a literature search focusing on each question, and a systematic and comprehensive evaluation of the evidence, with a summary of this evidence for each question.
View Article and Find Full Text PDFDemonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology.
Clin Pharmacol Ther
January 2025
European Medicines Agency, Amsterdam, The Netherlands.
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment. If such satisfactory methods exist, the new medicinal product must hold a major therapeutic advantage for those affected, meaning that it must demonstrate an improvement in efficacy or safety over existing methods or, in exceptional cases, a major improvement in patient care.
View Article and Find Full Text PDFL-arginine in patients with spinocerebellar ataxia type 6: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
EClinicalMedicine
December 2024
Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.
Background: Therapeutic advancements for the polyglutamine diseases, particularly spinocerebellar degeneration, are eagerly awaited. We evaluated the safety, tolerability, and therapeutic effects of L-arginine, which inhibits the conformational change and aggregation of polyglutamine proteins, in patients with spinocerebellar ataxia type 6 (SCA6).
Methods: A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (clinical trial ID: AJA030-002, registration number: jRCT2031200135) was performed on 40 genetically confirmed SCA6 patients enrolled between September 1, 2020, and September 30, 2021.
A noninvasive urinary microRNA-based assay for the detection of pancreatic cancer from early to late stages: a case control study.
EClinicalMedicine
December 2024
Department of Pathology and Genetics, Laboratory of Cancer Medical Science, Hokuto Hospital, Obihiro, Hokkaido, Japan.
Background: Pancreatic cancer is highly aggressive and has a low survival rate primarily due to late-stage diagnosis and the lack of effective early detection methods. We introduce here a novel, noninvasive urinary extracellular vesicle miRNA-based assay for the detection of pancreatic cancer from early to late stages.
Methods: From September 2019 to July 2023, Urine samples were collected from patients with pancreatic cancer (n = 153) from five distinct sites (Hokuto Hospital, Kawasaki Medical School Hospital, National Cancer Center Hospital, Kagoshima University Hospital, and Kumagaya General Hospital) and non-cancer participants (n = 309) from two separate sites (Hokuto Hospital and Omiya City Clinic).
Can gut microbiota explain acute diverticulitis occurrence in patients with symptomatic uncomplicated diverticular disease?
Biosci Microbiota Food Health
September 2024
Unit of Microbiome Science and Biotechnology, Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.
Why patients with symptomatic uncomplicated diverticular disease (SUDD) may develop acute diverticulitis (AD) is still unknown. We analyzed the gut microbiota (GM) in two SUDD patients, one who did experience SUDD recurrence but not AD occurrence (case 1) and one who did experience AD occurrence during follow-up (case 2). The GM of these patients showed differences in terms of phyla (Firmicutes and Bacteroidota in case 1; Actinobacteriota and Proteobacteria in case 2) and subgenera ( and in case 1 and , , , , group, and in case 2).
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