Safety Monitoring Research Articles

Ensuring safety and monitoring adverse events in clinical trials: Challenges and innovations

Safety and adverse events (AEs) monitoring in clinical trials are critical to ensuring participant safety and the successful development of new therapies. Effective monitoring not only protects patients but also helps identify any risks associated with the investigational product. This paper elaborates on the methodologies used to detect, categorize, and report adverse events during clinical trials, and how these processes are governed by stringent regulatory frameworks. Additionally, the discussion highlights the role of pharmacovigilance systems, the ethical obligations researchers face in AE reporting, and the technological innovations that are transforming safety monitoring. Challenges, including under-reporting, data variability, and interpretation difficulties, are examined in depth. Ultimately, advancements in real-time data collection, adaptive trial designs, and artificial intelligence (AI) are promising to improve the accuracy and timeliness of adverse event monitoring, shaping the future of clinical research and patient safety.

Designing real-time safety monitoring dashboards for industrial operations: A data-driven approach

Designing real-time safety monitoring dashboards for industrial operations: A data-driven approach

Feasibiliy, safety and patient perceptions of an exercise-based cardiac telerehabilitation programme

Abstract Background Despite proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction (MI) complete these programs and there is a need to develop more flexible and evidence-based options. Purpose The aim of this study was to evaluate feasibility, safety, and patient perceptions of remotely delivered EBCR. Methods This study was conducted at 23 cardiac rehabilitation centres during the Covid-19 pandemic (March 2020-September 2022), when access to centre-based EBCR was restricted. A total of 231 patients with MI <80 years were included 2-4 weeks after discharge to participate in a remote EBCR programme 2 times/week for 3-4 months. Exercise was delivered through a real-time group-based video meeting, connecting the physiotherapist to patients exercising at home. Safety monitoring in terms of adverse events (AE) and serious adverse events (SAE) were recorded. Outcomes were assessed before and after remote EBCR completion and comprised tests of physical fitness and questionnaires: self-reported physical activity and exercise (Haskell questionnaire), physical capacity (VAS), kinesiophobia (TSK-Heart), health-related quality of life (EQ5D-VAS), self-efficacy for exercise, and patient acceptance of the program. Results Patients performed in median 19 (Q1 9 - Q3 23) remote EBCR sessions. A total of 16 AEs were registered during exercise (e.g chest pain, syncope, dizziness, musculoskeletal symptoms) which were all resolved. Two SAEs that required hospitalization were reported (chest pain, in-stent restenosis), both unrelated to exercise. At end of remote EBCR, significant improvements in physical fitness, self-reported exercise and physical capacity, kinesiophobia, and health-related quality of life were observed (Table 1). Delta values were similar to previous centre-based EBCR studies. Patients agreed that remote EBCR improved health care access (83%), was easy to use (94%), and 95% found exercise performance and interaction acceptable. Conclusions This study supports that remote EBCR is feasible and safe with a high patient acceptance post-MI. The clinical effectiveness needs to be confirmed in a randomized controlled design.

Antiplatelet Agents in Endovascular Neurointerventional Procedures

Minimally invasive, image-guided endovascular procedures are becoming increasingly prevalent as techniques and technologies have advanced, particularly within the realm of neurovascular interventions. Endovascular approaches ubiquitously result in endothelial injury with subsequent risk of thromboembolic complications. Periprocedural antiplatelet agent use is an integral component of the management of patients undergoing endovascular neurointerventional procedures. This patient population has a unique risk profile encompassing thromboembolic and hemorrhagic complications simultaneously, and the precise balance of these risks impacts patient outcomes almost as much as the interventional procedure itself. Clinical experience and study consensus demonstrate overall improved outcomes with the use of periprocedural antiplatelet agents, though current practices remain highly institution and practitioner-dependent. This focused review will discuss the major mechanisms of action of antiplatelet agents, and their clinical indications and management in the periprocedural neurointerventional setting. Despite the importance of antiplatelet agents in the management of neurointerventional patients, many questions remain. Further research and clinical expertise are needed to establish standardized, procedure-specific, antiplatelet regimens as well as standardized monitoring of antiplatelet agent regimen efficacy and safety.

Evaluating off-target drug effects seen in RCTs using proteomics and mendelian randomisation

Abstract Introduction Serious adverse drug effects are often not detected until late in drug development after thousands of patients have been exposed to an investigational drug in long and costly clinical trials. More efficient approaches are desirable. Proteomics-informed Mendelian randomisation (MR) can identify potential molecular mechanisms underlying off-target effects of pharmaceuticals and drug repurposing opportunities. Purpose As a demonstration of this approach, we used findings from a previous plasma proteomics study nested within a clinical trial of torcetrapib, which was terminated early because of an increased risk of cardiac events and mortality, in which 200 plasma proteins significantly increased (n=68) or decreased (n=132) after three months of torcetrapib use. We surveyed potential plasma protein-mediated causal effecs of torcetrapib on a wide array of relevant phenotypes in three broad domains: cardiovascular(n=10), immunological(n=9) and cancer(n=4), representing major categories of adverse outcomes that were more common in the treatment arm. Methods We performed three-sample MR on torcetrapib-associated proteins. First, we identified independent cis-pQTL instruments for these proteins in the Atherosclerosis Risk in Communities (ARIC) Study. Then, we used pQTL effect estimates from the deCODE study, to reduce the potential for bias due to winner’s curse and to increase precision. Lastly, we conducted MR analyses on disease-relevant phenotypes using a debiased-IVW estimator and summary results from the largest available GWAS on these phenotypes: coronary artery disease, ischaemic stroke, blood pressure, lipids, heart rate, QT interval, eGFR, serious infections, blood cell counts, immune cell fractions, and several cancers. The significance level for causal protein-phenotype associations was p=1.85E-5 (0.05/(104*26)), correcting for the 104 proteins with valid instruments and the 26 tested outcomes. Results Thirty-three proteins had evidence of a causal association with at least one phenotype. Seventeen proteins were associated with cardiovascular outcomes, including 8 for blood pressure and 9 for lipid levels. We identified more proteins, 25, associated with immune-related phenotypes. One protein was associated with cancer. Of note, 9 proteins had pleiotropic effects across several domains. Conclusions Our approach of using Mendelian randomisation to investigate the causal effects of plasma proteins impacted by medication with known off-target adverse effects revealed several novel causal relationships, highlighting the role of immune function in the development of cardiovascular disease. These results support the use of intermediate omics evaluation to identify potential biomarkers for safety monitoring for drug development and reveal avenues of investigation for drug repurposing.

GenePHIT phase 2 study design: a double blind, placebo-controlled trial to assess efficacy, safety, and tolerability of AB-1002 gene therapy in adults with heart failure

Abstract Introduction Heart failure (HF) is associated with substantial morbidity and mortality, highlighting a critical need for novel therapies. AB-1002, an engineered adeno-associated virus (AAV) vector gene therapy candidate, delivers a constitutively active form of protein phosphatase inhibitor (I-1c) to restore cardiomyocyte intracellular calcium homeostasis. Preliminary results from an ongoing Phase (Ph) 1 trial (NCT04179643) of AB-1002 showed favourable safety and tolerability. Here we describe the design of AB-1002 Ph 2 trial (GenePHIT; NCT05598333) to evaluate efficacy, safety, and tolerability. Methods This phase 2 adaptive, double-blind, placebo-controlled, randomised, multi-centre trial (currently United States; European sites planned) includes a 52-week observation and 4-year follow-up period. Eligible patients are ≥18 years of age with non-ischaemic cardiomyopathy and New York Health Association (NYHA) Class III heart failure symptoms (Figure). Patients will be randomised 1:1:1 (n=30–50/treatment arm), including a single dose of AB-1002 administered via antegrade intracoronary infusion at 1 of 2 different doses, or placebo, all in addition to standard of care. The primary endpoint will evaluate efficacy at 52 weeks based on the composite endpoint by modified win ratio, which includes cardiovascular-related death, change in NYHA classification, and for the responders, improvements in left ventricular ejection fraction (LVEF) (≥5%), peak oxygen uptake (pVO2) ≥1.5 mL/kg/min, and 6-min walk test (6MWT) >30 metres. Key secondary efficacy endpoints include functional status and hospitalisations at 24 and 52 weeks, by assessing changes over time in NYHA classification, LVEF, pVO2, 6MWT, biomarkers (N-terminal pro-hormone b-type natriuretic peptide and troponin), quality of life questionnaires (Minnesota Living with Heart Failure, Kansas City Cardiomyopathy), and physiological assessments. Key safety endpoints will be assessed through 52 weeks and include treatment-emergent adverse events (AEs) and serious AEs (SAEs). Exploratory endpoints will evaluate AAV2i8 antibody titres, T-cell response to AAV2i8 capsid and I-1c, and optional right ventricular biopsy testing. Long-term follow-up will assess treatment-emergent AEs and SAEs, and number of HF hospitalisations. Data safety monitoring board assessment will occur every 3 months. Primary efficacy endpoint will compare both active dose groups combined versus placebo using the joint rank test (1). Key secondary endpoints will be analysed using Analysis of Covariance with baseline as a continuous covariate. Multiple imputations will be used to address missing data. Interim efficacy analysis will be performed using a Bayesian adaptive sample size algorithm. Conclusions GenePHIT is currently recruiting and will evaluate the efficacy, safety, and tolerability of intracoronary infusion of AB-1002, an innovative gene therapy targeting ventricular dysfunction in HF.

Thirty days clinical outcomes following stent implantation with aspirin-free prasugrel monotherapy in non-ST segment elevation myocardial infarction. Interim report from ASET-Japan pilot study

Abstract Background Dual antiplatelet therapy with a P2Y12 inhibitor, in addition to aspirin, is the standard therapy after percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) to prevent ischemic cardiovascular events. The Acetyl-Salicylic Elimination Trial (ASET) pilot studies conducted in Japan in patients with NSTE-ACS investigated the safety and feasibility of a low-dose prasugrel monotherapy after PCI. Purpose To ensure the safety of the patients, enrolment in the study was implemented only after confirmation of a successful procedure. The abstract reports our interim analysis, aimed at evaluating preliminary safety and feasibility. Methods The ASET-Japan pilot study was designed to explore the feasibility and safety of a low dose of prasugrel monotherapy (3.75mg/day), without adjunctive aspirin, after optimal PCI using Everolimus eluting stent (EES) in Japanese patients with non-ST-segment elevation acute coronary syndromes. The primary endpoint in the ASET-Japan NSTE-ACS (Phase 2) is a 12-month clinical outcome. The study is currently in the follow-up phase. All the target lesions were treated with a platinum-chromium everolimus-eluting stent. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 12-month. If more than 3 events occurred, trial enrollment would have to be terminated by the data and safety monitoring board. Results One hundred one patients were enrolled after successful index PCI and completed a 30 days follow-up. The mean age was 69.1±12.3 years and 75.2% was male. The mean anatomical SYNTAX score was 7.9±4.7. Unstable angina (UAP) and NSTEMI were seen in 24.8% (25/101) and 75.2% (75/101) patients, respectively. According to the Braunwald classification, 8 percent of the patients were categorised as Class IA UAP, 48% as Class IB, 20% as Class IIB, 4% as Class IIIA and 20% as Class IIIB. In NSTEMI patients, the median (IQR) pre-procedural troponin value (cardiac Troponin T or I) was 2.79 (1.12 – 22.27) times the Upper Limit of Normal. According to the PRECISE DAPT score, 36.6% of patients were categorised as High Bleeding Risk (HBR) with scores above 25. At one month, the primary ischemic endpoints of cardiac death, target-vessel spontaneous MI or definite Stent thrombosis did not occur. Two patients (2.0%) had BARC type 3a bleeding. Conclusion Prasugrel monotherapy in the first 30 days following platinum-chromium everolimus-eluting stent deployment is a feasible and safe strategy in NSTE-ACS patients with simple anatomy and successful PCI.

Long-term safety of mepolizumab for up to ∼10 years in patients with severe asthma: open-label extension study

Objectives Long-term safety monitoring of mepolizumab is necessary to support real-world use for the treatment of severe asthma. This Long-Term Access Program assessed the safety and benefit:risk of mepolizumab in pediatric, adolescent, and adult patients with severe asthma. Materials and methods This was a multicenter, Phase IIIb safety, open-label extension study of multiple prior studies assessing mepolizumab in addition to standard of care (Aug 2015 − Aug 2022). Adults/adolescents (≥12 years of age) received mepolizumab 100 mg subcutaneously (SC) every 4 weeks until mepolizumab was commercialized. Pediatric patients (6–11 years of age) received mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) every 4 weeks. Safety was assessed every 4 weeks and benefit:risk every 12 weeks. Results Of the 514 patients enrolled, 57% were female and the mean age was 51.1 (standard deviation: 14.9) years; 24 (5%) patients were 6–17 years of age. Total cumulative mepolizumab exposure across all mepolizumab studies included in this analysis was 1500.59 patient-years; median exposure was 2.03 (range, 0.08 to 9.97) years. Overall, 37 (7%) patients experienced on-treatment serious adverse events (SAEs): 34/502 (7%) in the 100 mg SC group and 3/7 (43%) in the 40 mg SC pediatric group. Two patients experienced SAEs considered to be treatment-related by the investigator. Infections were the most common SAEs of special interest (9 [2%] patients). Physician-assessed benefit:risk of mepolizumab supported continued treatment over the study period. Conclusions This long-term safety analysis of mepolizumab was consistent with previous reports, with no emerging safety concerns; most patients had a favorable benefit:risk up to ∼10 years. Clinical trial identifier NCT00244686 (GSK ID 201956)

Distal versus conventional transradial access for coronary angiography: a pooled analysis from the randomized RAPID trial

Abstract Background Transradial access (TRA) is the recommended approach for coronary procedures considering safety benefits over femoral access with radial artery occlusion (RAO) being the most frequent complication. Although usually not clinically significant, the presence of RAO affects potential future procedures and medical treatments. Distal TRA (dTRA) has been suggested to reduce the risk of postprocedural RAO compared to conventional TRA (cTRA) with, however, inconsistent results in clinical trials. Purpose This study aimed to compare the efficacy and safety of dTRA versus cTRA in patients undergoing diagnostic coronary angiography. Methods The RAPID trial is a single-center, open-label, 2x2 factorial, randomized study of patients undergoing coronary angiography through a 6-F radial access. The trial was stopped early by the data and safety monitoring board after the second pre-planned interim analysis and inclusion of 600 participants. Patients were randomized to dTRA or cTRA with further stratification according to periprocedural heparin use and preexisting oral anticoagulation. The primary endpoints were the incidence of RAO assessed by vascular ultrasound and puncture-site related bleedings. Results The final study population consisted of 298 patients randomized to dTRA and 302 patients to cTRA. Periprocedural heparin was administered in 382 patients (63.7%) and percutaneous coronary intervention was performed in 161 cases (26.8%) without differences between the study groups (p=0.700 and p=0.465; respectively). Distal TRA was associated with a significantly increased number of puncture attempts (2.4 ± 2.0 versus 1.5 ± 1.2; p&amp;lt;0.001) and failed punctures leading to access site crossover (11.7% versus 5.0%; p=0.003). Consequently, the total procedure time was longer in the dTRA group (30 min versus 25 min; p=0.004) without increasing fluoroscopy time (p=0.320), dose area product (p=0.245), or contrast volume (p=0.884). Patent hemostasis was achieved in 91.7% of patients with cTRA. The rates of RAO (16.1% versus 15.6%, p=0.855) and puncture-site related bleedings (6.7% versus 8.3%; p=0.466) were similar in both groups. Conclusions According to this study, dTRA does not reduce the risk of RAO or bleeding events compared to cTRA.

Hyperspectral Imaging Aiding Artificial Intelligence: A Reliable Approach for Food Qualification and Safety

Hyperspectral imaging (HSI) is one of the non-destructive quality assessment methods providing both spatial and spectral information. HSI in food quality and safety can detect the presence of contaminants, adulterants, and quality attributes, such as moisture, ripeness, and microbial spoilage, in a non-destructive manner by analyzing spectral signatures of food components in a wide range of wavelengths with speed and accuracy. However, analyzing HSI data can be quite complicated and time consuming, in addition to needing some special expertise. Artificial intelligence (AI) has shown immense promise in HSI for the assessment of food quality because it is so powerful at coping with irrelevant information, extracting key features, and building calibration models. This review has shown various machine learning (ML) approaches applied to HSI for quality and safety control of foods. It covers the basic concepts of HSI, advanced preprocessing methods, and strategies for wavelength selection and machine learning methods. The application of HSI to AI increases the speed with which food safety and quality can be inspected. This happens through automation in contaminant detection, classification, and prediction of food quality attributes. So, it can enable decisions in real-time by reducing human error at food inspection. This paper outlines their benefits, challenges, and potential improvements while again assessing the validity and practical usability of HSI technologies in developing reliable calibration models for food quality and safety monitoring. The review concludes that HSI integrated with state-of-the-art AI techniques has good potential to significantly improve the assessment of food quality and safety, and that various ML algorithms have their strengths, and contexts in which they are best applied.

Simple strategy for dual-responsive ratio electrochemical-colorimetric detection of nitrite in food and environment.

A dual-responsive ratio electrochemical-colorimetric method for nitrite (NO2-) is established based on the combination of nanoenzyme (Mn3O4) catalysis with diazotization reactions. The Mn3O4 can oxidize colorless 3,3',5,5'-tetramethylbenzidine (TMB) into blue TMBox. The NO2- induces the diazotization reaction of TMBox, leading to a decrease of the signal at 652nm and the generation of a new signal from diazotized TMBox at 445nm. Furthermore, the presence of NO2- reduces the electrochemical oxidation signal of TMB and simultaneously provides its electrochemical signal. Compared withtraditional single-mode detection, dual-mode detection offers higher sensitivity, lower detection limits, and better interference resistance. The inherent advantages of this method make it feasible to detect NO2- in real samples, offering broad prospects for applications in food safety and environmental monitoring.

Enhancement of Operational Safety in Marine Cargo Cranes on a Container Ship Through the Application of Authenticated Wi-Fi Based Wireless Data Transmission from Multiple Sensors

The use of wireless technology in common marine engineering applications as a medium for data transaction in measurement and control systems, is not as popular as it should be. This article aims to demonstrate the advantages of using wireless technology in maritime engineering applications through a proposed Wi-Fi based wireless system dedicated to performance and safety monitoring in marine cargo cranes. The system is based on some concepts that were suggested in the earlier literature to perform authenticated data transmission from multiple sensors through using both the ESP-NOW protocol and the WebSerial remote serial monitor. The introduced system will be integrated with an already installed system in order to render the means for implementing effective principles in automation and control engineering, such as functional safety and predictive maintenance. Additionally, this article will highlight the economic efficiency of adopting wireless technology instead of cabling as a medium for data transaction in measurement and control systems in marine engineering applications such as cargo cranes.

Massive Point Cloud Processing for Efficient Construction Quality Inspection and Control

The construction of large-scale civil infrastructures requires massive spatiotemporal data to support the management and control of scheduling, quality control, and safety monitoring. Existing artificial-intelligence-based data processing algorithms rely heavily on experienced engineers to adjust the parameters of data processing, which is inefficient and time-consuming when dealing with huge datasets. Limited studies have compared the performance of different algorithms on a unified dataset. This study proposes a framework and evaluation system for comparing different data processing policies for processing huge spatiotemporal data in construction quality control. The proposed method compares the combination of multiple types of algorithms involved in the processing of massive point cloud data. The performance of data processing strategies is evaluated through this framework, and the optimal point cloud processing strategies are explored based on registration accuracy and data fidelity. Results show that a reasonable choice of combinations of point cloud sampling, filtering, and registration algorithms can significantly improve the efficiency of point cloud data processing and satisfy engineering demands for data accuracy and completeness. The proposed method can be applied to the civil engineering problem of processing a large amount of point cloud data and selecting the optimal processing method.

Advancement of Finite Element Method Solver Used in Dam Safety Monitoring System by Interpolation of Pore Pressure and Temperature Values

In this paper, we focused on the advancement of Dam Monitoring Software that incorporates the Finite Element Method (FEM), as these large infrastructure constructions are crucial for ensuring a dependable water supply, irrigation, flood control, renewable electric energy generation, and safe operation, which is of utmost importance to any country. However, the material properties and geotechnical environments of dams can change (deteriorate) over time, while the standards and legal norms that govern them become more and more rigorous, so in order to accurately assess the state of a dam and detect any concerning behavior, the software must be updated as well. The custom-developed FEM solver, unlike many commercial alternatives, is adaptable and can be reconfigured to function within a Dam Monitoring System. In this paper, we present the procedure for interpolating numerical values at measurement points, when the position of the measurement point does not align with the node of the element, allowing for additional instrument locations to be added to the monitored system without the need for remeshing the numerical model. This procedure is used to compare the actual pore pressures and temperature values of the concrete dam structure with the prediction of the numerical model, and the agreement is much greater with the new interpolation algorithm in comparison to the nearest nodal values, with the average relative difference for pore pressure reduced from 8.89% to 8.10%, justifying this implementation.

RE-Trace : Re-identification of Modified GPS Trajectories

GPS trajectories are a critical asset for building spatio-temporal predictive models in urban regions in the context of road safety monitoring, traffic management, and mobility services. Currently, reliable and efficient data misuse detection methods for such personal, spatio-temporal data, particularly in data breach cases, are missing. This article addresses an essential aspect of data misuse detection, namely, the re-identification of leaked and potentially modified GPS trajectories. We present RE-Trace —a contrastive learning-based model that facilitates reliable and efficient re-identification of GPS trajectories and resists specific trajectory transformation attacks aimed to obscure a trajectory’s origin. RE-Trace utilizes contrastive learning with a transformer-based trajectory encoder to create trajectory representations, robust to various trajectory modifications. We present a comprehensive threat model for GPS trajectory modifications and demonstrate the effectiveness and efficiency of the RE-Trace re-identification approach on three real-world datasets. Our evaluation results demonstrate that RE-Trace significantly outperforms state-of-the-art baselines on all datasets and identifies modified GPS trajectories effectively and efficiently.

Coadministration of Cariprazine with a Moderate CYP3A4 Inhibitor in Patients with Schizophrenia: Implications for Dose Adjustment and Safety Monitoring.

Cariprazine is metabolised mainly by CYP3A4 and to a lesser extent by CYP2D6. This study aimed to evaluate the effects of erythromycin, a moderate cytochrome P450 (CYP)3A4 inhibitor, on the pharmacokinetics of cariprazine in male patients with schizophrenia, and to assess the influence of CYP2D6 phenotypes on cariprazine metabolism. Forty-two patients received oral doses of 1.5 mg cariprazine alone for 28 days (to reach steady state), followed by a co-administration of cariprazine 1.5 mg daily with erythromycin 500 mg twice daily (BID) and Enterol 250 mg BID for 21 days, followed by a 14-day post-treatment period. Blood samples were collected at predefined time points and analysed for cariprazine, its two active metabolites: desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), and erythromycin using validated high performance liquid chromatography-tandem mass spectrometry methods. CYP2D6 phenotypes were determined by genotyping. The pharmacokinetic parameters were calculated using non-compartmental analysis. Erythromycin increased the area under the curve (AUCτ) and peak concentration (Cmax) of Total cariprazine (cariprazine + DCAR + DDCAR) by about 40-50% but did not affect the time to peak concentration (Tmax). The CYP2D6 phenotypes had no substantial effect on the pharmacokinetics of cariprazine and its metabolites, either alone or in combination with erythromycin. Cariprazine was well tolerated and safe. The findings suggest that co-administration of cariprazine with moderate CYP3A4 inhibitors may require dose adjustment or monitoring; however, pharmacogenetic testing for CYP2D6 is not necessary for optimising cariprazine therapy. Trial registration number (EudraCT Number): 2018-003721-28. Date of registration: 21-SEP-2018.

Investigation of Unsafe Construction Site Conditions Using Deep Learning Algorithms Using Unmanned Aerial Vehicles.

The rapid adoption of Unmanned Aerial Vehicles (UAVs) in the construction industry has revolutionized safety, surveying, quality monitoring, and maintenance assessment. UAVs are increasingly used to prevent accidents caused by falls from heights or being struck by falling objects by ensuring workers comply with safety protocols. This study focuses on leveraging UAV technology to enhance labor safety by monitoring the use of personal protective equipment, particularly helmets, among construction workers. The developed UAV system utilizes the tensorflow technique and an alert system to detect and identify workers not wearing helmets. Employing the high-precision, high-speed, and widely applicable Faster R-CNN method, the UAV can accurately detect construction workers with and without helmets in real-time across various site conditions. This proactive approach ensures immediate feedback and intervention, significantly reducing the risk of injuries and fatalities. Additionally, the implementation of UAVs minimizes the workload of site supervisors by automating safety inspections and monitoring, allowing for more efficient and continuous oversight. The experimental results indicate that the UAV system's high precision, recall, and processing capabilities make it a reliable and cost-effective solution for improving construction site safety. The precision, mAP, and FPS of the developed system with the R-CNN are 93.1%, 58.45%, and 27 FPS. This study demonstrates the potential of UAV technology to enhance safety compliance, protect workers, and improve the overall quality of safety management in the construction industry.

Automated Video Analytics for Workplace Safety Monitoring

This paper presents an automated human detection system using the YOLOv5 deep learning model, which triggers an alarm when a person enters a predefined area within the frame. The solution is designed to enhance security systems by providing real-time detection. We describe the development, implementation, and evaluation of this system, highlighting its efficiency in detecting people and responding to security breaches in safety zones

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

Background Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ‘Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial’, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James’s Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019

Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review.

The beneficial effects of polyethylene glycol (PEG)-conjugated therapeutics, such as increased half-life, solubility, stability, and decreased immunogenicity, have been well described. There have been concerns, however, about adverse outcomes with their use, but understanding of those adverse outcomes is still relatively limited. The present study aimed to characterize adverse outcomes associated with PEGylation of protein-based therapeutics on immunogenicity, pharmacologic properties, and safety. A targeted review of English language articles published from 1990 to September 29, 2023, was conducted. Of the 29 studies included in this review, 18 reported adverse safety outcomes such as hematologic complications, hepatic toxicity, injection site reactions, arthralgia, nausea, infections, grade 3 or 4 adverse events (AEs), and AE-related discontinuations and dose modifications. Fifteen studies reported immunogenicity-related outcomes, such as the prevalence of pre-existing antibodies to PEG, treatment-emergent antibody response, and hypersensitivity reactions to PEGylated drugs. Seven studies reported pharmacological outcomes such as increased clearance and reduced activity in response to PEGylated drugs. This review aims to contribute to a balanced view of PEGylated therapies by summarizing the adverse outcomes or lack of benefit associated with PEGylated therapeutics reported in the literature. We identified several studies characterizing adverse outcomes, pharmacological effects, and immunogenicity associated with the use of PEGylated therapeutics. Our findings suggest that using PEGylated therapeutics may require careful monitoring for adverse safety outcomes, including screening and monitoring for pre-existing antibodies and those induced in response to PEGylated therapy, as well as monitoring and adjusting the dosing of PEGylated therapeutics.