Evaluation Protocol Research Articles

A simple and efficient method for betalain quantification in RUBY-expressing plant samples.

The RUBY reporter system has demonstrated great potential as a visible marker to monitor gene expression in both transiently and stably transformed plant tissues. Ectopic expression of the RUBY reporter leads to bright red pigmentation in plant tissues that do not naturally accumulate betalain. Unlike traditional visual markers such as β-glucuronidase (GUS), luciferase (LUC), and various fluorescent proteins, the RUBY reporter system does not require sample sacrifice or special equipment for visualizing the gene expression. However, a robust quantitative analysis method for betalain content has been lacking, limiting accurate comparative analyses. In this work, we present a simple and rapid protocol for quantitative evaluation of RUBY expression in transgenic plant tissues. Using this method, we demonstrate that differential RUBY expression can be quantified in transiently transformed leaf tissues, such as agroinfiltrated Nicotiana benthamiana leaves, and in stable transgenic maize tissues, including seeds, leaves, and roots. We found that grinding fresh tissues with a hand grinder and plastic pestle, without the use of liquid nitrogen, is an effective method for rapid betalain extraction. Betalain contents estimated by spectrophotometric and High-Performance Liquid Chromatography (HPLC) analyses were highly consistent, validating that our rapid betalain extraction and quantification method is suitable for comparative analysis. In addition, betalain content was strongly correlated with RUBY expression level in agroinfiltrated N. benthamiana leaves, suggesting that our method can be useful for monitoring transient transformation efficiency in plants. Using our rapid protocol, we quantified varying levels of betalain pigment in N. benthamiana leaves, ranging from 110 to 1066 mg/kg of tissue, and in maize samples, ranging from 15.3 to 1028.7 mg/kg of tissue. This method is expected to streamline comparative studies in plants, providing valuable insights into the effectiveness of various promoters, enhancers, or other regulatory elements used in transgenic constructs.

Recall and Appraisal of the Risks, Benefits, and Objectives of Interrupting HIV Treatment in an HIV Cure-Related Study.

The goal of HIV cure research is to either eliminate HIV from the body or durably suppress it in the absence of antiretroviral therapy (ART). This research often requires participants to interrupt ART. However, there are numerous risks associated with ART interruptions and therefore it is critical to understand how people with HIV (PWH) who participate recall the elements of consent, to safeguard their rights and welfare. Participants were recruited from the SCOPE Analytic Treatment Interruption (SCOPE-ATI: NCT04359186) study at the University of California San Francisco. We interviewed 12 SCOPE-ATI participants to assess their recall of informed consent elements and therapeutic misconception, using the Brief Informed Consent Evaluation Protocol (BICEP). Interviewees were primarily older adults, male, White, and non-Hispanic/Latinx. Their responses indicated that they understood the primary purpose of the SCOPE-ATI study to be scientific research. Nearly all participants demonstrated high recall of key elements of consent and no therapeutic misconception. We also found that the role of study staff was a major factor in participants' appraisal of risks and that associated psychosocial risks of pausing ART were of minimal concern (e.g., anxiety off ART, possible forward HIV transmission to sex partners). As HIV cure research expands, it is important to reiterate the duty of the investigative team to clearly communicate with participants about the associated risks and to assess their understanding throughout these studies.

Comparative Effectiveness of Teledermatology Versus In-person Consultations: A Systematic Review of Diagnostic Information Elements

Context: Teledermatology is delivered through two primary methods: Live video conferencing, which enables real-time interaction between patients and doctors, and the store-and-forward technique, where images of skin lesions are sent over the internet for later examination. Objectives: This systematic review evaluates the concordance between in-person and telemedicine follow-up methods in dermatology. Methods: In February 2024, a comprehensive literature search was conducted across PubMed, Medline, ISI Web of Science, and the ACM Digital Library. Keywords such as "teledermatology," "telemedicine," and "mobile health" were used, following the PICOS criteria. Results: Initially, 716 articles were identified from the databases, along with four studies from the gray literature search. After removing duplicates, screening studies, and applying the inclusion and exclusion criteria, 21 studies were selected for the final review. These studies detailed follow-up procedures and assessed both direct and indirect costs and effectiveness. The consensus indicates that teledermatology reduces costs and satisfies both patients and healthcare professionals. Conclusions: Teledermatology has been shown to potentially increase the efficiency of follow-up care compared to traditional methods. However, further research is needed to develop standardized evaluation protocols and to more accurately measure and validate key variables. Publications suggest that teledermatology is cost-effective, reduces patient wait times, extends access to dermatological care in remote areas, and enhances satisfaction among patients, doctors, and nurses.

Sampling of N-methyl-N-nitrosourea-induced Rat's Retina Damage and Multi-index Evaluation of Pathological Changes.

Retinopathy can be observed in most ocular diseases and the late complications of diabetes mellitus. The specific pigment epithelial cells and optic cells' damage and degeneration are the main features of retinopathy. Manytraditional medicines have shown substantial clinical efficacy in treating retinopathy. How to obtain a retina quickly and completely is a key step in traditional medicine research for the treatment of retinopathy. In this study, we aim to provide a standardized and exercisable procedure for sampling of N-methyl-N-nitrosourea (MNU)-induced rat's retina damage and multi-index evaluation of pathological changes. Rats were injected intraperitoneally with 60 mg/kg MNU once to induce retina damage, and retina samples were obtained after 7 days. Additionally, we performed hematoxylin-eosin staining to assess retinal pathologicalchanges.Determination of the apoptosis rate and apoptosis protein by TUNEL and Western blot. These standardized protocols for retinal sampling and evaluation of pathological changes are helpful in promoting the exploration of the mechanism of retinopathy and the discovery of novel and effective traditional herbs.

Pathophysiology and clinical implications of coronary artery calcifications.

To provide a summary of current understanding of coronary artery calcifications (CACs), outlining the role of calcium in atherosclerosis to comprehend the clinical implications of CAC. CAC serves as a reliable indicator of coronary artery disease (CAD) and it is associated with cardiovascular events. In recognition of its significance, recent global guidelines have integrated CAC assessment into risk evaluation protocols, highlighting its role as a noninvasive tool for evaluating and stratifying patients' risk for cardiovascular events. Beyond the amount of CAC values, also, calcium morphology had been linked to cardiovascular events.By leveraging CAC assessment, healthcare providers can effectively up or down reclassify patients' risk and tailor preventive strategies accordingly. This comprehensive approach may involve lifestyle modifications, meticulous management of risk factors, and judicious use of preventive medications to mitigate the likelihood of future cardiovascular events, or withhold treatments in those without signs of CAC, to optimize resource use. The identification of CAC burden and morphology through noninvasive imaging modalities can reclassify the prediction of future cardiovascular risk and serve as a risk modifier for atherosclerosis. These data underscore the utility of selectively using CAC assessment in both primary and secondary prevention strategies for atherosclerotic cardiovascular disease.

Artificial-Intelligence Cloud-Based Platform to Support Shared Decision-Making in the Locoregional Treatment of Breast Cancer: Protocol for a Multidimensional Evaluation Embedded in the CINDERELLA Clinical Trial.

Shared decision-making (SDM) plays a crucial role in breast cancer care by empowering patients and reducing decision regret. Patient decision aids (PtDAs) are valuable tools for facilitating SDM, now available in digital and artificial intelligence (AI)-powered formats to offer increasingly personalized contents. The ongoing CINDERELLA clinical trial (ClinicalTrials.gov: NCT05196269) evaluates an innovative AI cloud-based approach using a web platform and a mobile application (CINDERELLA APProach) versus the conventional approach to support SDM in breast cancer patients undergoing locoregional treatment. This protocol outlines a trial-based multidimensional evaluation, encompassing economic, financial, implementability, and environmental considerations associated with the CINDERELLA APProach. A within-trial cost-consequence and cost-utility analysis from a societal perspective will be performed using patient-level data on outcomes and resource use. The latter will be valued in monetary terms using country-specific unit costs or patient valuations. A budget impact analysis will be performed over 1 and 5 years from the budget holder perspectives. The CINDERELLA APProach implementability will be assessed through an evaluation of its usability, acceptability, organizational impact, and overall feasibility. The environmental impact will be quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data for the evaluation will be gathered from patient questionnaires, interviews with patients and managers, focus groups with healthcare professionals, and app electronic data. A thorough understanding of the broad consequences of the CINDERELLA APProach may foster its successful translation into real-world settings, hopefully benefiting breast cancer patients and clinical practice.

A Comprehensive Review on Studying and Developing Guidelines to Standardize the Inspection of Properties and Production Methods for Mycelium-Bound Composites in Bio-Based Building Material Applications.

Mycelium-bound composites (MBCs) represent a promising advancement in bio-based building materials, offering sustainable alternatives for engineering and construction applications. This review provides a comprehensive overview of the current research landscape, production methodologies, and standardization ideas related to MBCs. A basic search on Scopus revealed over 250 publications on MBCs between 2020 and 2024, with more than 30% focusing on engineering and materials science. Key studies have investigated the physical and mechanical properties of MBCs, optimizing parameters such as substrate type, fungal species, incubation time, and post-processing to enhance material performance. Standardizing the inspection of MBC properties is crucial for ensuring quality and reliability. Various testing standards, including those from the American Society for Testing and Materials (ASTM), the International Organization for Standardization (ISO), the Japanese Industrial Standard (JIS), European Standards (EN), Deutsches Institut für Normung (DIN), and the Thai Industrial Standards Institute (TIS), are utilized to evaluate density, water absorption, compression strength, tensile strength, insulation, and other critical properties. This review highlights the distinction between lab-scale and apply-scale testing methodologies, emphasizing the need for comprehensive evaluation protocols. Additionally, the production process of MBCs involves critical steps like substrate preparation, fungal species selection, and mycelium growth, necessitating the implementation of good manufacturing practices (GMPs) to ensure consistency and quality. The internal and external structures of MBCs significantly influence their performance, necessitating standardized inspection methods using advanced techniques such as scanning electron microscopy (SEM), X-ray computed tomography (CT) scanning, and surface profilometry. By establishing robust inspection protocols and production standards, the industry can enhance the reliability and adoption of MBCs, contributing to innovations in materials science and promoting environmental sustainability. This review underscores the importance of interdisciplinary collaboration, advanced characterization tools, and regulatory frameworks to address challenges and advance the field of MBCs.

Sim-to-real transfer of adaptive control parameters for AUV stabilisation under current disturbance

Learning-based adaptive control methods hold the potential to empower autonomous agents in mitigating the impact of process variations with minimal human intervention. However, their application to autonomous underwater vehicles (AUVs) has been constrained by two main challenges: (1) the presence of unknown dynamics in the form of sea current disturbances, which cannot be modelled or measured due to limited sensor capability, particularly on smaller low-cost AUVs, and (2) the nonlinearity of AUV tasks, where the controller response at certain operating points must be excessively conservative to meet specifications at other points. Deep Reinforcement Learning (DRL) offers a solution to these challenges by training versatile neural network policies. Nevertheless, the application of DRL algorithms to AUVs has been predominantly limited to simulated environments due to their inherent high sample complexity and the distribution shift problem. This paper introduces a novel approach by combining the Maximum Entropy Deep Reinforcement Learning framework with a classic model-based control architecture to formulate an adaptive controller. In this framework, we propose a Sim-to-Real transfer strategy, incorporating a bio-inspired experience replay mechanism, an enhanced domain randomisation technique, and an evaluation protocol executed on a physical platform. Our experimental assessments demonstrate the effectiveness of this method in learning proficient policies from suboptimal simulated models of the AUV. When transferred to a real-world vehicle, the approach exhibits a control performance three times higher compared to its model-based nonadaptive but optimal counterpart.

Extending speech emotion recognition systems to non-prototypical emotions using mixed-emotion model

In the conventional approach to speech emotion recognition (SER), the classifier is usually trained on acted emotional speech data to predict individual basic emotions. In this work, we extend the SER systems with the realistic assumption of the coexistence of multiple basic emotions in an utterance. We utilize the MSP-Podcast database for developing the SER system, which contains spontaneous speech utterances. From the primary and secondary emotion annotations of this database, we organize six prototypical and seven non-prototypical emotions. We then propose the mixed-emotion model and express the non-prototypical emotions as a linear combination of prototypical emotions. The combination weights of the mixed-emotion model are computed using a normalized dominance scale based algorithm inspired by the integration of basic emotion theory and dimensional emotion theory in human psychology. We first train a prototypical SER model using the ECAPA-TDNN architecture. The softmax predictions from this model serve as emotion profile inputs to the mixed-emotion model, which then predicts the non-prototypical emotions. Assuming the coexistence of multiple emotions, we only apply the utterances with uniform emotion profiles to the mixed-emotion model. The developed system continues with the conventional SER model if the emotion profile tends to delta function owing to the probable occurrence of a single prototypical emotion. We develop the proposed mixed-emotion model based SER framework using MFCC and wav2vec 2.0 extracted features. Further, we show that due to human perception variations, there exist prominent annotation variations in the non-prototypical emotion ground truths. To address that, we extend the supervised evaluation protocols in four different formulations that capture the subjective variability at different levels. The proposed system shows a best-case performance improvement of 7.10% and 8.39% over the conventional prototypical SER model for the MFCC and wav2vec 2.0 features, respectively.

Enhancing Facial Expression Recognition through Light Field Cameras.

In this paper, we study facial expression recognition (FER) using three modalities obtained from a light field camera: sub-aperture (SA), depth map, and all-in-focus (AiF) images. Our objective is to construct a more comprehensive and effective FER system by investigating multimodal fusion strategies. For this purpose, we employ EfficientNetV2-S, pre-trained on AffectNet, as our primary convolutional neural network. This model, combined with a BiGRU, is used to process SA images. We evaluate various fusion techniques at both decision and feature levels to assess their effectiveness in enhancing FER accuracy. Our findings show that the model using SA images surpasses state-of-the-art performance, achieving 88.13% ± 7.42% accuracy under the subject-specific evaluation protocol and 91.88% ± 3.25% under the subject-independent evaluation protocol. These results highlight our model's potential in enhancing FER accuracy and robustness, outperforming existing methods. Furthermore, our multimodal fusion approach, integrating SA, AiF, and depth images, demonstrates substantial improvements over unimodal models. The decision-level fusion strategy, particularly using average weights, proved most effective, achieving 90.13% ± 4.95% accuracy under the subject-specific evaluation protocol and 93.33% ± 4.92% under the subject-independent evaluation protocol. This approach leverages the complementary strengths of each modality, resulting in a more comprehensive and accurate FER system.

Static Factors in Sitting Comfort: Seat Foam Properties, Temperature, and Contact Pressure

The seat characteristics have high relevance in overall comfort on any transportation means. In particular, the foam’s mechanical properties, interface pressure, and contact temperature play an important role in low- or no-vibration situations regarding static comfort. The present work presents the complete protocol for a static evaluation of different foams and seat covers to assess railway seats. Based on the evaluation of the foam’s mechanical properties and interface pressure profiles, it was concluded that higher-density foam (80 kg/m3) is the most favorable. Regarding the foam cover, a thermographic assessment demonstrated that the fabric cover that induces lower temperatures at passenger interface contact promotes higher comfort levels. It should be highlighted that experiments were conducted on real train seat cushions and environments using a thermographic camera and pressure map sensor.

Few-Shot Object Detection: A Comprehensive Survey.

Humans are able to learn to recognize new objects even from a few examples. In contrast, training deep-learning-based object detectors requires huge amounts of annotated data. To avoid the need to acquire and annotate these huge amounts of data, few-shot object detection (FSOD) aims to learn from few object instances of new categories in the target domain. In this survey, we provide an overview of the state of the art in FSOD. We categorize approaches according to their training scheme and architectural layout. For each type of approach, we describe the general realization as well as concepts to improve the performance on novel categories. Whenever appropriate, we give short takeaways regarding these concepts in order to highlight the best ideas. Eventually, we introduce commonly used datasets and their evaluation protocols and analyze the reported benchmark results. As a result, we emphasize common challenges in evaluation and identify the most promising current trends in this emerging field of FSOD.

Importance of H-FABP in Early Diagnosis of Acute Myocardial Infarction.

Over the years, troponins have aced the para-clinical tests for confirming the diagnosis of acute myocardial infarction. However, the rise in their levels is entirely time-dependent, which can cause a delay in the initiation of treatment protocols. Heart fatty acid binding protein (H-FABP) can serve comparatively as a better biological marker for overcoming this flaw of troponins, as it is quickly released into the bloodstream once the myocardial injury occurs due to decreased blood supply. This study aimed to evaluate the usefulness of this marker as well as establish the specificity and sensitivity of testing the H-FABP, if it adds to early diagnosis and can be relied upon in the future. We evaluated 83 patients and their H-FABP levels, along with the standard cardiac markers like hsTni and CK-MB, in patients presenting with symptoms indicating an ongoing coronary event, who had presented to our hospital between August 2020 and June 2021. The patients were divided into two groups: group 1 comprised patients who had first medical contact within 4 hours of the onset of chest pain, and group 2 patients who had first medical contact after 4 hours of the appearance of symptoms. Statistical analysis was performed using MedCalc v20.023, considering statistical significance values of p <0.05. Results for targeted variables are presented using descriptive statistics (mean, standard deviation, range, median, and associated interquartile range) for continuous data, and counts with associated percentages for categorical data. H-FABP was found to have better sensitivity and specificity of 89.67 and 95.65 in group 1 patients and 86.73 and 49.84, respectively, in group 2 patients. The other two cardiac biomarkers evaluated had lower values in response to H-FABP in the first 4 hours of presentation. Results for group 2 showed that specificitivity for hsTni is higher than that of H-FABP, that is, 69.98. Heart fatty acid binding protein (H-FABP) should be included in the protocol for biochemical evaluation of all patients presenting to the emergency services with a suspicion of possible myocardial infarction. Early detection of this protein can help in effective and timely management of myocardial infarction, thus further decreasing mortality rates and the financial burden on healthcare systems worldwide.

Repeatability of the Calibration Protocol for Emg Evaluation of the Occlusion With the Teethan Device

Abstract Objective The aim of the study was to investigate the repeatability of the calibration protocol performed by the Teethan® device (Teethan S.p.A. Italy) for surface electromyography (sEMG) when biting on cotton rolls to eliminate the effect of occlusal contacts. Materials and methods Thirty-three fully dentate subjects aged 13-43 years (mean 21.33 years) of which 15 men and 18 women were enrolled in the study All subjects had a good state of dental and periodontal health without temporomandibular disorders (TMDs). Each examined participant performed two distinct maximal voluntary clenches on cotton rolls: the first one for calibration of the device and the second one for recording of the signals. The results were presented as the indices: Percentage overlapping coefficient (POC), Barycenter (BAR), Torsion (TORS), Impact (IMPACT), Global index and Asymmetry (ASIM). Results All the examined indices showed good repeatability during the test, compared with the normal values, determined by the manufacturer of the device. Some of the recorded indices were insignificantly lower than the norm (POC TA, POC MM, BAR and TORS). Global index and IMPACT were within the reference values and showed highest repeatability in this study. Conclusion Instrument calibration is an important prerequisite for exact testing. The indices, recorded by this device are rather repeatable, with Global index and Impact found to be the most repeatable ones. The values of the measured indices show that the process of calibration is highly reliable.

P02-40 Novel in vitro protocol for evaluation of safety of intraoral medical devices

P02-40 Novel in vitro protocol for evaluation of safety of intraoral medical devices

PreVenTB trial: protocol for evaluation of efficacy and safety of two vaccines VPM1002 and Immuvac (Mw) in preventing tuberculosis (TB) in healthy household contacts of newly diagnosed sputum smear-positive pulmonary TB patients: phase III, randomised, double-blind, three-arm placebo-controlled trial

IntroductionTuberculosis (TB) continues to be one of the deadliest infectious diseases over the centuries, killing more people worldwide than any other single infectious disease. There is an urgent need for...

Scaling Up Stability: Navigating from Lab Insights to Robust Oxygen Evolution Electrocatalysts for Industrial Water Electrolysis

AbstractIn the pursuit of sustainable hydrogen production via water electrolysis, paramount importance of electrocatalyst stability emerges as a defining factor for long‐term industrial viability. A thorough understanding and enhancement of stability not only ensure extended catalyst lifetimes but also pave the way for consistent and efficient hydrogen generation. This review focuses on the pivotal role of stability in determining the practical viability of oxygen evolution electrocatalysts (OECs) for large‐scale applications in water electrolysis for hydrogen production. The paper explores the pivotal role of stability over initial activity, citing examples and hypothetical scenarios. First, figures of merits for stability evaluation of the electrocatalyst are explained along with the available benchmarking protocols for stability evaluation. Further, the text delves into various strategies that can enhance the stability of the electrocatalyst which include self‐healing/regeneration pathway, oxygen evolution reaction (OER) mechanism optimization to achieve highly stable OER and stabilization of active metals atoms within the electrocatalyst to inhibit dissolution as a way forward for industrial application. The interplay of stability, activity, and cost is also explained to suit the industrial application of the electrocatalyst. Lastly, it outlines challenges, prospects, and future directions, presenting a guide for advancing OECs in the hydrogen generation landscape.

An Audit of Outcomes in Cosmetic Rhinoplasty with the Mandatory Psychiatric Evaluation Protocol.

With the high demand of rhinoplasty surgery, careful selection and management of aspirants, as well as proper assessment of outcomes after surgery, are imperative for achieving successful outcomes and learning from it. The aim of this study was to answer two important questions: (1) What is the success rate in cosmetic rhinoplasty? (2) How can we best identify candidates who would achieve good outcomes in cosmetic rhinoplasty? In this study cohort, we excluded patients with any functional concerns and confounding factors that could in any way influence patient satisfaction with a cosmetic surgery. This study is a part of the trilogy of articles on "psychology of rhinoplasty" submitted to this volume of Facial Plastic Surgery, using mandatory psychiatric evaluation (MPE) to optimize candidacy. In total, 184 patients (144 females and 40 males) aged 16 to 63 years (M = 31.09) met the inclusion criteria and were included in this study (follow-up: 3-122 months; M = 70.18 months), and outcome satisfaction was assessed using the visual analog scale (VAS) score and a 5-point Likert scale. The mean improvement between preoperative (M = 4.26) and postoperative VAS scores (M = 8.47) was 4.23. Most patients were happy or very happy (95.1%) about the surgical outcome. Patients who were very happy generally scored between 8 and 10 on the VAS (77.2%) and those who were happy generally scored between 6 and 7.9 (21.2%). Some patients, however, were neutral (3.3%) or unhappy (1.6%) about their surgical outcome, and generally scored around ≤7 on the VAS. Although the successful outcome in 95.1% patients reflects a carefully designed protocol for rhinoplasty candidacy, 4.9% patients reported poor satisfaction despite these efforts. An ever-present proportion of unhappy outcomes is a reality of this popular surgery.

Cochlear implants for hereditary ATTR amyloidosis: a case report of two cases.

To analyze the clinical presentation, management, and outcome of two sisters affected by hereditary transthyretin related amyloidosis (ATTRv) and bilateral severe-to-profound hearing loss treated with cochlear implant. A description of two patients underwent three cochlear implant (CI) surgery was performed. Age at time of implantation ranged from 48 to 53years. Both patients were initially equipped with a bilateral hearing aid and subsequently underwent cochlear implant. A bimodal stimulation was maintained thereafter. One case underwent bilateral surgery. Hearing outcomes were assessed by comparing pre- and post-operatively tonal and vocal hearing thresholds and speech perception tests (Common Evaluation Protocol Results in Rehabilitation Audiology). In both patients, a significant and stable improvement of hearing threshold and speech perception was observed up to the last follow-up. No post-operative complication were observed during the follow-up. ATTRv amyloidosis may be the cause of cochlear function impairment. Restoring the hearing in these group of patients is of paramount importance since the vision is often compromised too. Cochlear implant could be a viable strategy of rehabilitation for selected patients affected by severe-to-profound sensorineural hearing loss caused by ATTRv amyloidosis.

Addressing mental illness stigma in German higher education: study protocol for a mixed-methods evaluation of a psychosocial setting-based intervention

IntroductionMental illness stigma is associated with a range of negative consequences, such as reduced help-seeking for mental health problems. Since stigma affects individual, social, and structural aspects, multilevel interventions such...