Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea

Introduction Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of coronavirus disease 2019 (COVID-19) in South Korea in 2021. The Ministry of Food and Drug Safety in South Korea mandate that new medications be re-examined for safety and effectiveness post-approval in at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate the safety and effectiveness of regdanvimab in real-world clinical care. Methods This prospective, multicentre, phase 4 PMS study was conducted between February 2021 and March 2022 in South Korea. Eligible patients were aged ≥ 18 years with confirmed mild COVID-19 at high risk of disease progression or moderate COVID-19. Patients were hospitalised and treated with regdanvimab (40 mg/kg, day 1) and then monitored until discharge, with a follow-up call on day 28. Adverse events (AEs) were documented, and the COVID-19 disease progression rate was used to measure effectiveness. Results Of the 3123 patients with COVID-19 infection identified, 3036 were eligible for inclusion. Approximately 80% and 5% of the eligible patients were diagnosed with COVID-19 during the delta- and omicron-dominant periods, respectively. Median (range) age was 57 (18–95) years, and 50.6% of patients were male. COVID-19 severity was assessed before treatment, and high-risk mild and moderate COVID-19 was diagnosed in 1030 (33.9%) and 2006 (66.1%) patients, respectively. AEs and adverse drug reactions (ADRs) were experienced by 684 (22.5%) and 363 (12.0%) patients, respectively. The most common ADR was increased liver function test (n = 62, 2.0%). Nine (0.3%) patients discontinued regdanvimab due to ADRs. Overall, 378 (12.5%) patients experienced disease progression after regdanvimab infusion, with extended hospitalisation/re-admission (n = 300, 9.9%) as the most common reason. Supplemental oxygen was required by 282 (9.3%) patients. Ten (0.3%) patients required intensive care monitoring and 3 (0.1%) died due to COVID-19. Conclusion This large-scale PMS study demonstrated that regdanvimab was effective against COVID-19 progression and had an acceptable safety profile when used in real-world clinical practice.This study and the journals Rapid Service fee was funded by Celltrion Inc. (Incheon, Republic of Korea)

Ischemic and Bleeding Events Associated with Thrombocytopenia and Thrombocytosis after Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction

The early and late ischemic and bleeding clinical outcomes according to baseline platelet count after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) remain unclear. Overall, 10,667 patients from the Cardiovascular Risk and identification of potential high-risk population in AMI (COREA-AMI) I and II registries were classified according to the following universal criteria on baseline platelet counts: (1) moderate to severe thrombocytopenia (platelet \u3c 100 K/µL, n = 101), (2) mild thrombocytopenia (platelet = 100~149 K/µL, n = 631), (3) normal reference (platelet = 150~450 K/µL, n = 9832), and (4) thrombocytosis (platelet \u3e 450 K/µL, n = 103). The primary endpoint was the occurrence of major adverse cardiovascular events (MACE). The secondary outcome was Bleeding Academic Research Consortium (BARC) 2, 3, and 5 bleeding. After adjusting for confounders, the moderate to severe thrombocytopenia (HR, 2.03; 95% CI, 1.49–2.78); p \u3c 0.001), mild thrombocytopenia (HR, 1.15; 95% CI, 1.01–1.34; p = 0.045), and thrombocytosis groups (HR, 1.47; 95% CI, 1.07–2.03; p = 0.019) showed higher 5-year MACE rates than the normal reference. In BARC 2, 3, and 5 bleeding outcomes, the bleedings rates were higher than the normal range in the moderate to severe thrombocytopenia (HR, 2.18; 95% CI, 1.36–3.49; p = 0.001) and mild thrombocytopenia (HR, 1.41; 95% CI, 1.12–1.78; p = 0.004) groups. Patients with AMI had higher 5-year MACE rates after PCI if they had lower- or higher-than-normal platelet counts. Thrombocytopenia revealed higher early and late bleeding rates whereas thrombocytosis showed long-term bleeding trends, although these trends were not statistically significant

Automated Textile Circuit Generation using Machine Vision and Embroidery Technique

© The Author(s) 2022.An automated textile circuit generation method was developed using machine vision and embroidery technique. For this, an image acquisition device was designed to capture the physical layout image of electronic devices on the fabric. A series of image analysis algorithms were developed to calibrate the image and recognize the type, location, and orientation of each device from the image. Dedicated computer-aided design software was developed that can design a circuit and modify it according to the actual device layout on the fabric. It can also convert the circuit elements such as conductive path and insulation layer into data for a computerized embroidery machine. An example circuit consisting of seven electronic devices was designed and repeatedly produced to verify the developed method. The method has shown promising results.N

Systematic investigation of wear-induced cold welding in ultrahigh vacuum piezoelectric motors with non-metallic coatings

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Novel Use of a Fibular Strut Allograft with Fibular Head in an Elderly Patient with Proximal Humeral Fracture and Severe Metaphyseal Comminution: An Alternative to Shoulder Arthroplasty

Treatment of a comminuted proximal humerus fracture (PHF) in elderly patients with severe osteoporosis is challenging, often leading to arthroplasty (such as hemiarthroplasty or reverse shoulder arthroplasty) as the treatment of choice. However, arthroplasty does not always guarantee favorable outcomes. In contrast, the use of intramedullary fibular strut allografts provides additional reduction stability during locking plate fixation; however, to our knowledge, there is limited literature on the use of fibular strut allografts, including the fibular head. Here we aim to report the advantages of using a fibular strut containing the fibular head in severe osteoporotic PHFs. We present the case of an 88-year-old female patient with severe osteoporosis diagnosed with a left PHF accompanied by severe metaphyseal comminution following a fall from a chair. Rather than shoulder arthroplasty, we performed osteosynthesis using a fibular strut allograft containing the fibular head. At the one-year follow-up after surgery, we observed excellent bony union and a favorable functional outcome without major complications, such as reduction loss. The novel use of a fibular strut allograft containing the fibular head could be promising for PHFs with severe metaphyseal comminution, potentially avoiding the need for arthroplasty

Post-glaciation depositional changes in Wijdefjorden, northern Svalbard, using grain-size end-member modelling

Grain-size end-member (EM) modelling is a robust statistical approach for identifying and quantifying dominant grain-size distributions. This approach provides a novel perspective for understanding the impact of interactions between depositional processes in complex sedimentary environments. This study examines grain-size distributions of six glacimarine sediment cores collected along an Nsingle bondS transect from the continental shelf to the Wijdefjorden system in northern Svalbard. In addition, we integrate grain-size EMs with lithologic and acoustic facies, allowing us to identify three distinct groups of EMs (EM1–3), each closely associated with specific depositional processes: turbid meltwater discharge (EM1), sediment winnowing by bottom currents (EM2), and the deposition of ice-rafted debris in glacimarine conditions and subglacial till (EM3). An analysis of the three EM groups reveals that the glacial retreat during the last deglaciation and the Atlantic Water inflow significantly impacted depositional changes within the Wijdefjorden system. In contrast, a decrease in the Atlantic Water inflow during the late Holocene corresponds to glacial re-advance, resulting in shifts in the depositional environment. This study demonstrates the utility of EM modelling in deciphering complex grain-size distributions and reconstructing different climate-driven depositional processes in glacimarine sediments in Svalbard fjords. This integrated approach enhances our understanding of the intricate interplay among climate change, glacier dynamics, and oceanic forcing in polar fjord environment

Effect of Neuromuscular Blockade on Intraoperative Respiratory Mechanics and Surgical Space Conditions during Robot-Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial

The aim of this study was to investigate whether deep neuromuscular blockade (NMB) may affect intraoperative respiratory mechanics, surgical condition, and recovery profiles in patients undergoing robot-assisted radical prostatectomy (RARP). Patients were randomly assigned to the moderate or deep NMB groups. Pneumoperitoneum was maintained with carbon dioxide (CO2) insufflation at 15 mmHg during surgery. The primary outcome was peak inspiratory pressure (PIP) after CO2 insufflation. Mean airway pressure (Pmean) and dynamic lung compliance (Cdyn) were also recorded. The surgeon rated the surgical condition and surgical difficulty on a five-point scale (1 = extremely poor; 2 = poor; 3 = acceptable; 4 = good; 5 = optimal). Recovery profiles, such as pulmonary complications, pain scores, and recovery time, were recorded. We included 58 patients in this study. No significant differences were observed regarding intraoperative respiratory mechanics including PIP, Pmean and Cdyn, between the two groups. The number of patients with optimal surgical conditions was significantly higher in the deep than in the moderate NMB group (29 vs. 20, p = 0.014). We found no differences in recovery profiles. In conclusion, deep NMB had no significant effect on the intraoperative respiratory mechanics but resulted in optimal endoscopic surgical conditions during RARP compared with moderate NMB

Non-Destructive Monitoring of Crop Fresh Weight and Leaf Area with a Simple Formula and a Convolutional Neural Network

Crop fresh weight and leaf area are considered non-destructive growth factors due to their direct relation to vegetative growth and carbon assimilation. Several methods to measure these parameters have been introduced; however, measuring these parameters using the existing methods can be difficult. Therefore, a non-destructive measurement method with high versatility is essential. The objective of this study was to establish a non-destructive monitoring system for estimating the fresh weight and leaf area of trellised crops. The data were collected from a greenhouse with sweet peppers (Capsicum annuum var. annuum); the target growth factors were the crop fresh weight and leaf area. The crop fresh weight was estimated based on the total system weight and volumetric water content using a simple formula. The leaf area was estimated using top-view images of the crops and a convolutional neural network (ConvNet). The estimated crop fresh weight and leaf area exhibited average R2 values of 0.70 and 0.95, respectively. The simple calculation was able to avoid overfitting with fewer limitations compared with the previous study. ConvNet was able to analyze raw images and evaluate the leaf area without additional sensors and features. As the simple calculation and ConvNet could adequately estimate the target growth factors, the monitoring system can be used for data collection in practice owing to its versatility. Therefore, the proposed monitoring system can be widely applied for diverse data analyses