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| http://dx.doi.org/10.1038/s41392-020-00266-9 | DOI Listing |
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Safety, tolerability, pharmacokinetics, and antimalarial activity of MMV533: a phase 1a first-in-human, randomised, ascending dose and food effect study, and a phase 1b Plasmodium falciparum volunteer infection study.
Lancet Infect Dis
December 2024
MMV Medicines for Malaria Venture, Geneva, Switzerland.
Background: Novel antimalarials are needed to address emerging resistance to artemisinin and partner drugs. We did two trials to evaluate safety, tolerability, pharmacokinetics, and activity against blood stage Plasmodium falciparum for the drug candidate MMV533.
Methods: A phase 1a first-in-human (FIH) trial was conducted at Nucleus Network (Melbourne, VIC, Australia).
Evaluation of the safety, biodistribution, dosimetry of [F]AlF-NYM005 and initial experience in clear cell renal cell carcinoma: an interim analysis of a prospective trial.
Eur J Nucl Med Mol Imaging
December 2024
Department of PET-CT, Harbin Medical University Cancer Hospital, Harbin, 150001, China.
Purpose: This first-in-human study aimed to evaluate the radiation dosimetry and whole-body biodistribution of [F]AlF-NYM005, a novel small-molecule carbonic anhydrase IX (CAIX) targeting agent, and to investigate its ability to detect CAIX-positive tumors using PET scans in a cohort of clear cell renal cell carcinoma (ccRCC) patients.
Methods: [F]AlF-NYM005 was synthesized using a fully automatic cassette module Mortenon M1 (Nuoyu, China). Thirty-five patients with a suspicious lesion considered primary renal malignancy or a history of ccRCC were prospectively recruited and studied.
First in Human Evaluation of a Novel Thin Convex Probe Endobronchial Ultrasound System.
Respiration
December 2024
Department of Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Columbus, Ohio, USA.
Introduction: The incidence of pulmonary imaging abnormalities continues to increase. While standard convex probe endobronchial ultrasound bronchoscope (CP-EBUS) is safe and accurate, it has limited reach through smaller bronchi. Olympus BF-Y0069 thin convex probe EBUS (TCP-EBUS) has a smaller diameter and improved angulation.
View Article and Find Full Text PDFDigital nerve reconstruction with a new composite silk fibroin nerve conduit.
J Peripher Nerv Syst
March 2025
Department of Plastic Surgery and Hand Surgery, University Hospital Zurich, Zurich, Switzerland.
Background And Aims: Peripheral nerve injuries often require bridging when direct repair is not feasible. Nerve autografts are the gold standard, but they can lead to donor site morbidity. Silk fibroin-based nerve conduits, like the novel SILKBridge, offer a promising alternative.
View Article and Find Full Text PDFA pilot study of novel ultrahigh-frequency dorsal root ganglia stimulation for chronic lower limb pain: Focusing on safety and feasibility.
Pain Pract
January 2025
School of Medicine, China Medical University, Taichung, Taiwan.
Objectives: This single-arm, open-label, single-center observational pilot study assessed the safety and efficacy of ultrahigh-frequency dorsal root ganglia (UHF-DRG) stimulation in patients with chronic leg pain with or without low back pain. Such high-frequency electrostimulation had not been conducted in the human central nervous system previously.
Materials And Methods: The primary objective was to evaluate the safety of UHF-DRG stimulation (2 Hz pulses with 50 msec pulse-width and 500 kHz intrapulse sine waves, 5-min duration per stimulation) by identifying incident adverse events (AE) and severe adverse events (SAE) during the trial.
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