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Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 µg and Selective Laser Trabeculoplasty.
Am J Ophthalmol
January 2025
Piedmont Eye Center, Lynchburg, Virginia.
Purpose: To evaluate the intraocular pressure (IOP)-lowering effect and safety of up to two bimatoprost implant administrations versus selective laser trabeculoplasty (SLT).
Design: Phase 3 (Stage 2), randomized, 24-month, multicenter, patient- and efficacy evaluator-masked, paired-eye clinical trial (NCT02507687).
Participants: Patients (n=183) with open-angle glaucoma or ocular hypertension inadequately managed with topical IOP-lowering medication for reasons other than efficacy.
Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study.
Lancet
January 2025
Department of Diagnostic and Interventional Radiology, University of Pisa School of Medicine, Pisa, Italy.
Background: Transarterial chemoembolisation (TACE) is standard of care for patients with unresectable hepatocellular carcinoma that is amenable to embolisation; however, median progression-free survival is still approximately 7 months. We aimed to assess whether adding durvalumab, with or without bevacizumab, might improve progression-free survival.
Methods: In this multiregional, randomised, double-blind, placebo-controlled, phase 3 study (EMERALD-1), adults aged 18 years or older with unresectable hepatocellular carcinoma amenable to embolisation, an Eastern Cooperative Oncology Group performance status of 0 or 1 at enrolment, and at least one measurable intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours (RECIST) were enrolled at 157 medical sites including research centres and general and specialist hospitals in 18 countries.
Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial.
Lancet Microbe
December 2024
Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Germany; German Center for Infection Research, Munich Partner Site, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection, and Pandemic Research, Munich, Germany; Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany. Electronic address:
Background: The broad use of bedaquiline and pretomanid as the mainstay of new regimens to combat tuberculosis is a risk due to increasing bedaquiline resistance. We aimed to assess the safety, bactericidal activity, and pharmacokinetics of BTZ-043, a first-in-class DprE1 inhibitor with strong bactericidal activity in murine models.
Methods: This open-label, dose-expansion, randomised, controlled, phase 1b/2a trial was conducted in two specialised tuberculosis sites in Cape Town, South Africa.
Objective: We aimed to evaluate the risks of death and cardiovascular death of different subtypes of masked hypertension, defined by either isolated daytime or nighttime blood pressure (BP) elevation, or both, compared with patients with normal both office and 24-h BP.
Methods: We selected 4999 patients with masked hypertension (normal office BP and elevated 24-h BP). They were divided in three different categories: isolated daytime masked hypertension (elevated daytime BP and normal nighttime BP, 800 patients), isolated nighttime masked hypertension (elevated nighttime BP and normal daytime BP, 1069 patients) and daytime and nighttime masked hypertension (elevation of both daytime and nighttime BP, 2989).
Ambulatory blood pressure profiles of children with asthma compared to healthy controls.
Pediatr Nephrol
January 2025
Pediatric Nephrology, Faculty of Medicine, Ankara City Hospital, Ankara Yıldırım Beyazıt University Ankara, Bilkent, Turkey.
Background: Studies suggest that asthma and hypertension may be comorbid conditions. Most of these studies are epidemiological research. However, data on the relationship between asthma and hypertension in childhood are limited.
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