Articles: human.
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The lancet oncology · Feb 2025
Multicenter StudyClaudin 18.2-targeting antibody-drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial.
CMG901 is a novel first-in-class antibody-drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours. ⋯ KYM Biosciences.
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Randomized Controlled Trial Multicenter Study
Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies.
Interleukin-23 inhibition is effective in treating ulcerative colitis. Guselkumab is a dual-acting, human IgG1, interleukin-23p19 subunit inhibitor that potently neutralises interleukin-23 and can bind to CD64. We aimed to evaluate the efficacy and safety of guselkumab as induction and maintenance therapy in patients with ulcerative colitis. ⋯ Janssen Research and Development.
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Multicenter Study
What are the challenges to quality in modern, hybrid general practice? A multi-site longitudinal study.
Since 2022, general practice has shifted from responding to the acute challenges of COVID-19 to restoring full services using a hybrid of remote, digital, and in-person care. ⋯ Contemporary hybrid general practice features changes (digitalisation, physical distancing, extension of roles, and protocolisation) that have had the unintended effect of dehumanising, compromising, and fragmenting care. Policymakers and practices should urgently address the risks to patients and the traditional core values of general practice should be urgently addressed.
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of intravenous recombinant human prourokinase for acute ischaemic stroke within 4·5 h after stroke onset (PROST-2): a phase 3, open-label, non-inferiority, randomised controlled trial.
Intra-arterial prourokinase has been shown to be a promising thrombolytic agent in patients with acute ischaemic stroke. Given the global shortage of thrombolytics, we aimed to assess the non-inferiority of intravenous recombinant human prourokinase compared with alteplase in patients with acute ischaemic stroke who were ineligible for or who refused endovascular thrombectomy. ⋯ For the Chinese translation of the abstract see Supplementary Materials section.
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Randomized Controlled Trial Multicenter Study
Ponsegromab for the Treatment of Cancer Cachexia.
Cachexia is a common complication of cancer and is associated with an increased risk of death. The level of growth differentiation factor 15 (GDF-15), a circulating cytokine, is elevated in cancer cachexia. In a small, open-label, phase 1b study involving patients with cancer cachexia, ponsegromab, a humanized monoclonal antibody inhibiting GDF-15, was associated with improved weight, appetite, and physical activity, along with suppressed serum GDF-15 levels. ⋯ Among patients with cancer cachexia and elevated GDF-15 levels, the inhibition of GDF-15 with ponsegromab resulted in increased weight gain and overall activity level and reduced cachexia symptoms, findings that confirmed the role of GDF-15 as a driver of cachexia. (Funded by Pfizer; ClinicalTrials.gov number, NCT05546476.).