A Freehand 3D Ultrasound Carotid Scanning System for Point-of-Care Ultrasonography

Stroke is a leading cause of morbidity and mortality throughout the world. Three-dimensional ultrasound (3DUS) imaging was shown to be more sensitive to treatment effect and more accurate in stratifying stroke risk than two-dimensional ultrasound (2DUS) imaging. Point-of-care ultrasound screening (POCUS) is important for patients with limited mobility and at times when the patients have limited access to the ultrasound scanning room, such as in the COVID-19 era. We used an optical tracking system to track the 3D position and orientation of the 2DUS frames acquired by a commercial wireless ultrasound system and subsequently reconstructed a 3DUS image from these frames. The tracking requires spatial and temporal calibrations. Spatial calibration is required to determine the spatial relationship between the 2DUS machine and the tracking system. Spatial calibration was achieved by localizing the landmarks with known coordinates in a custom-designed Z-fiducial phantom in an 2DUS image. Temporal calibration is needed to synchronize the clock of the wireless ultrasound system and the optical tracking system so that position and orientation detected by the optical tracking system can be registered to the corresponding 2DUS frame. Temporal calibration was achieved by initiating the scanning by an abrupt motion that can be readily detected in both systems. This abrupt motion establishes a common reference time point, thereby synchronizing the clock in both systems. We demonstrated that the system can be used to visualize the three-dimensional structure of a carotid phantom. The error rate of the measurements is 2.3%. Upon in-vivo validation, this system will allow POCUS carotid scanning in clinical research and practices. © 2023 SPIE.

A Qualitative Investigation of the Impact of the Sars-Cov-2 Pandemic on Goal Attainment Scaling in a Clinical Research Setting

Objectives: Goal Attainment Scaling (GAS) quantifies the effect of interventions on individuals' personal goals. Goals that are meaningful to individual patients are set by GAS interviewers (physicians/academics, experienced in clinical research/trials) in collaboration with patients and/or their caregivers. The SARS-CoV-2 pandemic presented a major challenge to health care worldwide. We investigated how the SARS-CoV-2 pandemic affected the use and implementation of GAS in clinical/research settings. Method(s): Eleven GAS interviewers in Canada, the US, UK and Australia with current/past experience working with patient-caregivers to identify goals and build scales to measure goal attainment as an outcome were interviewed using a semi-structured approach. They described how the pandemic affected GAS use in clinical/research settings. Interviews were recorded and transcribed, then themes were identified and coded in Nvivo 12. Result(s): Most GAS interviews were moved to the virtual environment during the pandemic (9/11). GAS interviewers identified few negative impacts. Some goals required modification (e.g. going to the gym or shops). Pandemic stress impacted both interviewers and interviewees. Even so, most GAS interviewers (8/11) emphasized positive impacts of the pandemic. These were: 1) the virtual environment meant patients were more readily available as they did not need to travel;2) because interviewers did not have to travel, patient recruitment could be expanded into more remote geographical areas;3) researchers could recruit and retain more participants and collect data more quickly;and 4) interviewers commented they became more open to technology because of the pandemic (9/11). Conclusion(s): Despite the challenges of the SARS-CoV-2 pandemic for health care, most GAS interviewers found that the impacts were largely positive for using GAS in clinical/research settings. The ability to deploy GAS through a virtual platform could facilitate the uptake of GAS as a patient-centric outcome measure.Copyright © 2023

Classic Augmentation based Classifier Generative Adversarial Network (CACGAN) for COVID-19 Diagnosis

Computer-aided diagnosis of COVID-19 from lung medical images has received increasing attention in previous clinical practice and research. However, developing such automatic model is usually challenging due to the requirement of a large amount of data and sufficient computer power. With only 317 training images, this paper presents a Classic Augmentation based Classifier Generative Adversarial Network (CACGAN) for data synthetising. In order to take into account, the feature extraction ability and lightness of the model for lung CT images, the CACGAN network is mainly constructed by convolution blocks. During the training process, each iteration will update the discriminator's network parameters twice and the generator's network parameters once. For the evaluation of CACGAN. This paper organized multiple comparison between each pair from CACGAN synthetic data, classic augmented data, and original data. In this paper, 7 classifiers are built, ranging from simple to complex, and are trained for the three sets of data respectively. To control the variable, the three sets of data use the exact same classifier structure and the exact same validation dataset. The result shows the CACGAN successfully learned how to synthesize new lung CT images with specific labels. © 2023 SPIE.

A Hybrid Model of Deep Learning Features and Clinical Features for Severe Cases Predication of COVID-19

COVID-19 has spread around the world since 2019. Approximately 6.5% of COVID-19 a risk of developing severe disease with high mortality rate. To reduce the mortality rate and provide appropriate treatment, this research established an integrated models with to predict the clinical outcome of COVID-19 patients with clinical, deep learning and radiomics features. To obtain the optimal feature combination for prediction, 9 clinical features combination was selected from all available clinical factors after using LASSO, 18 deep learning features from U-Net architecture, and 9 radiomics features from segmentation result. A total of 213 COVID-19 patients and 335 non-COVID-19 patients from 5 hospitals were enrolled and used as training and test sample in this research. The proposed model obtained an accuracy, precision, recall, specificity, F1-score and ROC curve of 0.971, 0.943, 0.937, 0.974, 0.941 and 0.979, respectively, which exceeds the related work using only clinical, deep learning or radiomics factors. © 2023 SPIE.

Active rehabilitation of coronary artery disease: today and tomorrow.

In 2020, the European Association of Preventive Cardiology proposed the important role of exercise-based cardiac rehabilitation (CR) in the management of cardiovascular and metabolic diseases, and called on everyone to take action. This paper discusses the current status and future perspective of individualized active exercise-based CR for coronary artery disease (CAD) from 4 dimensions, including the basic and clinical research progress of exercise-based CR for CAD, evidence on the benefits of exercise-based CR on ameliorating CAD complications, the exercise-based CR guidelines in different countries, and the implementation of exercise-based CR under coronavirus disease 2019 pandemic, so as to provide reference for research and clinical work.Copyright © 2022, Second Military Medical University Press. All rights reserved.

Application of MSCs therapy in COVID-19

The year 2019 ended with the official report of an unknown pneumonia outbreak in Wuhan, Hubei Province, China. Subsequently, this novel pneumonia was named COVID-19, which mainly attacks the respiratory system, causing severe damage. Although vaccination has relieved the stress of combating pandemics around the world after one year, there are still unknowns and challenges that come with hope. In this regard, stem cell therapy has been proposed as an effective approach to treating COVID-19. Mesenchymal stem cells (MSCs) can potentially be used as a hopeful tool in the cell-based therapy due to their ability to regenerate and regulate immune response. Although research and clinical results have shown encouraging achievement in patients who were treated with MSCs, drawbacks and challenges still exist in the face of new opportunities. This review aims to introduce the challenges of the COVID-19 vaccine and the possible clinical use of MSC-based therapy. Through analysis of COVID-19 and MSC-based therapy, the author aims to find the possibilities and feasibility of using MSCs to treat acute respiratory diseases, such as COVID. As a result, the author finds that MSC treatment is very practical, and it shows significant potential to treat COVID-19. © 2023 SPIE.

Longitudinal robustness of a thoracic radiographic AI model for COVID-19 severity prediction

The 'ging' of artificial intelligence/machine learning (AI/ML) models after initial development and evaluation is known to frequently occur and can pose substantial problems. When there are changes in population, disease characteristics, imaging equipment, or protocols, model performance may start to deteriorate, and the performance predicted in a research setting may no longer hold after deployment (either in a clinical setting or in further research). This data shift phenomenon is a common problem in AI/ML. We trained and evaluated a previously in-house developed AI/ML model for COVID severity prediction using two COVID-19-positive consecutive adult patient cohorts from a single institution. The first cohort was from the time that the Delta strain was dominant accounting for <95% of cases (June 24-December 11, 2021, 820 patients, 1331 chest radiographs (CXRs)) and the second cohort was from the time that the Omicron variant was dominant (Jan 1-21, 2022, 656 patients, 970 CXRs). Inclusion criteria were COVID-positivity and the availability of CXR imaging exams, in general for patients not admitted to ICU and prior to ICU admission for those patients admitted to ICU as part of their treatment. Exclusion criteria were image acquisition in ICU or the presence of mechanical ventilation. Our image-based AI/ML model was trained to predict, based on each frontal CXR from a COVID-positive patient, whether this patient would be admitted to ICU within a 24, 48, 72, or 96-hour window. The model was evaluated 1) in a cross-sectional test when trained on a subset/tested on an independent subset of the Delta cohort, 2) similarly for the Omicron cohort, and 3) in a longitudinal test when trained on the Delta cohort/tested on the Omicron cohort. Cohorts were similar in ICU admission rate and fraction of portable CXRs, while immunization rate was higher for the Omicron cohort. The model did not demonstrate signs of aging with performances in the longitudinal test being very similar to those within the Delta cohort, e.g., an area under the ROC curve in the task of predicting ICU admission within 24 hours of 0.76 [0.68;0.84] when trained/tested within the Delta cohort and 0.77 [0.73;0.80] for the longitudinal test (p>0.05). The performance within the Omicron cohort was similar as well, at 0.76 [0.66;0.84]. Our AI/ML model for COVID-severity prediction did not demonstrate signs of aging in a longitudinal test when trained on the Delta cohort and applied as-is to the Omicron cohort. © COPYRIGHT SPIE. Downloading of the is permitted for personal use only.

The Importance of Clinical Research Organizations (CRO) in Clinical Research and Impact of COVID-19 Pandemic

Background: CROs play a major role in ensuring clinical trials (CTs) are executed in line with ethical and regulatory requirements, ultimately to support the development of new drugs that benefit patients worldwide. To meet the evolving needs of pharmaceutical and biotech companies, CROs have expanded their services they provide. Innovations in the areas of decentralized trials, artificial intelligence and patient recruitment strategies, among others, enhance efficiency and help bring new life-saving drugs, therapies and medical devices to the market faster. As a result of how they adapted during the pandemic, the value CROs deliver has increased significantly, thereby strengthening the role they play in the industry overall. Objective(s): To investigate how the COVID-19 pandemic has impacted CRO activities and the implementation and conduct of CTs. Method(s): An online survey of 52 EUCROF members was conducted between July and September 2022. Topics covered included the impact of COVID-19 on CTs and on in-field activities, and how CROs have come to terms with this reality. Result(s): The results evidenced that COVID-19 had significant impacts on CR activities. Key findings included: 77% of respondents adapted their internal organization, adopting home-based work, the most frequently reported negative outcomes were a slowdown in recruitment in CTs and the postponement of on-site monitoring visits. Approximately 61% set up remote visits and extended trial duration. 65% have been involved in COVID-19 CTs with, on average, at least two CTs fully dedicated to COVID-19. However, COVID-19 CTs represent less than 10% of respondents' activities. 69% implemented new digital tools and 77% implemented the "Guidelines on the Management of Trials during the Pandemic" released by the EMA. Conclusion(s): Investments in new technologies and processes have allowed CROs to adapt positively and quickly. This will enable them to deliver greater value to sponsors in a post-pandemic environment.Copyright © 2023

Profile of clinical trial protocols for Covid-19 with the participation of Fiocruz / Perfil dos protocolos de ensaios clínicos sobre Covid-19 com participação da Fiocruz

Resumo Objetivo Identificar a atuação da Fiocruz em estudos clínicos relacionados à Covid-19. Analisar as diferentes terminologias utilizadas para se referir à participação da Fiocruz. Mapear a região desses estudos. Mensurar a quantidade dos estudos aprovados nas plataformas de registro de estudos clínicos e bases ético-regulatórias. Dentre estes, analisar as características metodológicas e de boas práticas dos protocolos dos estudos intervencionais. Métodos Foram revisadas as bases de dados da Agência Nacional de Vigilância Sanitária (ANVISA), Comissão Nacional de Ética em Pesquisa (Conep), Registro Brasileiro de Ensaios Clínicos (ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) e Instituto Nacional de Propriedade Industrial (INPI). Resultados Foram encontrados 53 estudos clínicos sobre Covid-19 com a participação da Fiocruz em 39 destes como instituição proponente. Dentre os 53 estudos, 19 estão em plataformas de registro. Sobre os estudos intervencionais registrados, cinco são de prevenção e nove de tratamento. A intervenção mais analisada nestes estudos foi cloroquina/hidroxicloroquina. Observou-se ainda maior concentração dos estudos clínicos na Região Sudeste, com o total de 37. Conclusão Foram analisadas algumas limitações no delineamento metodológico que podem afetar o alcance dos estudos. Espera-se que os dados obtidos sejam utilizados para orientação futura de estudos clínicos sobre Covid-19 com participação da Fiocruz.

Abstract Objective To identify Fiocruz's performance in clinical studies related to Covid-19. Analyze the different terminologies used to refer to Fiocruz participation. Map the region of these studies. Measure the number of studies approved on clinical study registration platforms and regulatory ethical bases. Analyze the methodological characteristics and good practices of the interventional study protocols. Methods We reviewed databases of Brazilian National Research Ethics Committee, databases of Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) and Brazilian National Institute of Industrial Property (Instituto Nacional de Propriedade Industrial-INPI). Results 53 clinical studies on Covid-19 were found with the participation of Fiocruz in 39 of them as a proponent institution. Among the 53 studies, 19 are on registration platforms. Of the registered interventional studies, 5 are for prevention and 9 for treatment. The intervention most frequently evaluated in these studies was chloroquine / hydroxychloroquine. There was also a greater concentration of clinical studies in the southeastern region, with a total of 37 studies. Conclusion Some limitations in the methodological design were analyzed, which may affect the scope of the studies. It is expected that the data obtained will be used to guide future clinical studies on Covid-19 with Fiocruz participation.

Examining the factor structure of the DSM-5 Level 1 cross-cutting symptom measure.

OBJECTIVES: The DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM-XC) was developed by the American Psychiatric Association as a transdiagnostic mental health symptom survey. Despite its promise as a screening tool, few studies have assessed its latent dimensionality or provided guidance on interpreting responses. We examined the factor structure of the DSM-XC in a convenience sample of participants with varying degrees of psychopathology. METHODS: Participants (n = 3533) were enrolled in an online study on the mental health impact of COVID-19 (NCT04339790). We used a factor analytic framework with exploratory and confirmatory analyses to evaluate candidate factor solutions. Convergent validity analysis with concurrent study measures was also performed. RESULTS: Six-factor and bifactor candidate solutions both had good fit and full measurement invariance across age, sex, and enrollment date. The six-factor solution resulted in constructs labeled as: mood, worry, activation, somatic, thought, and substance use. A general psychopathology factor and two residual factors (mood and anxiety constructs) explained the variance of the bifactor solution. CONCLUSIONS: Our analysis supports that the DSM-XC is a multidimensional instrument spanning many mental health symptoms. We provide scoring solutions for two factor structures that capture broader constructs of psychopathology. Use of a convenience sample may limit generalizability of findings.

Erratum: Conducting clinical research in the era of the COVID-19 pandemic: Challenges and lessons for Speech-Language Pathology and Audiology research.

No abstract available.

Impact of the COVID-19 pandemic on CTSA Clinical Research Centers over 2 years.

Introduction: The COVID-19 pandemic had an abrupt impact on patient-oriented research early in the pandemic. CTSA Clinical Research Centers (CRCs) rapidly adapted to this challenge, but the continued impact of later phases of the pandemic on CRC operations is not clear. Methods: An online REDCap survey of CTSA CRCs was developed that covered the first 2 years of the pandemic. The survey focused on impact on CRC functions, mitigation strategies, recovery of CRC activities, CRC contributions to COVID-related research, and potential lessons for future public health emergencies. The survey was sent to CRC directors at 61 CTSA Hubs in May 2022. Results: Twenty-seven Hubs (44%) responded to the survey. Most CRCs reported greater than 50% declines in inpatient census in the first year of the pandemic, with less severe impacts on outpatient census. CRCs pivoted to support COVID-related research and adopted innovative technology-driven approaches to support clinical research. Census improved in the second year of the pandemic in most CRCs but often remained below pre-pandemic levels, and greater than half of CRCs reported decreased revenue. Conclusions: CTSA-supported CRCs faced unprecedented challenges at the onset of the COVID-19 pandemic and responded rapidly to support COVID-related research and implement innovative approaches that allowed patient-oriented research activities to resume. However, many CRCs continued to report decreased research activities in the second year of the pandemic, and the long-term effects on CRC operations on finances are not clear. CRCs will likely need to evolve to provide support in nontraditional ways.

Development and prospect of clinical research on lung transplantation in post-COVID-19 era

Lung transplantation has been advanced for nearly half a century around the globe, and it has been developed rapidly for over 20 years in China. The field of lung transplantation in China has been gradually integrated into the international community. The outbreak of novel coronavirus pneumonia (COVID-19) in 2020 brought big challenges, as well as diverted the worldwide attention to the development of lung transplantation in China, accelerating international communication and cooperation. With the steadily deepening of clinical and basic research on lung transplantation for severe cases of COVID-19, organ transplant physicians have deepened the understanding and thinking of the maintenance of donors, selection of elderly and pediatric candidates, and perioperative management of recipients, as the future perspective of lung transplantation in China. For interdisciplinary research related to lung transplantation, it is necessary to carry out multi-center clinical trials with qualified study design and constantly promote the theoretic and practical innovation.Copyright © 2021 The authors.

Active rehabilitation of coronary artery disease: today and tomorrow

In 2020, the European Association of Preventive Cardiology proposed the important role of exercise-based cardiac rehabilitation (CR) in the management of cardiovascular and metabolic diseases, and called on everyone to take action. This paper discusses the current status and future perspective of individualized active exercise-based CR for coronary artery disease (CAD) from 4 dimensions, including the basic and clinical research progress of exercise-based CR for CAD, evidence on the benefits of exercise-based CR on ameliorating CAD complications, the exercise-based CR guidelines in different countries, and the implementation of exercise-based CR under coronavirus disease 2019 pandemic, so as to provide reference for research and clinical work.Copyright © 2022, Second Military Medical University Press. All rights reserved.

Visual Analysis of Clinical Studies of Xuebijing Injection Based on Bibliometrics*

OBJECTIVE To analyze the current situation and development trend of Xuebijing injection research based on relevant literature of clinical research on Xuebijing injection, and to provide a reference for subsequent studies. METHODS The literature related to the clinical study of Xuebijing injection was searched from CNKI, Wanfang V2.0, VIP Chinese Journal Service platform, and SinoMed (China Biomedical Literature Service System) for the period from the establishment of the database to March 2022. CiteSpace 5.8.R3 was used to analyze the research hotspots, perform cluster analysis, build knowledge graphs, organize the statistical and visual analysis of the diseases, syndrome types, and drug combinations involved in the literature, and explore the cross-sectional association among the studies by using bibliometric methods. RESULTS The final included literature was 2253 articles. In recent years, the amount of literature published in this field tends to be stable, and a relatively stable core team has been formed, but there is less cooperation among research teams, sepsis and pneumonia are the current research hotspots. The main clinical diseases treated by Xuebijing injection involve 19 categories, with a wide therapeutic scope, and the main syndrome type of treatment syndrome is blood stasis syndrome, which is mostly combined with related drugs and therapies in disease treatment. The efficacy is significantly improved after intervention for severe COVID-19, but the quality of relevant literature is generally low. CONCLUSION Xuebijing injection has high research interest, diversified and detailed research direction, and has extensive clinical application. It has an outstanding therapeutic effect in the treatment of critical illness type of disease, and the combination with related drugs and therapies is universal in the treatment of the disease. It has a significant curative effect in the treatment of severe COVID-19, and has a promising clinical application. © 2022 IEEE.

Clinical manifestations and emotional disorders in patients with new coronavirus infection (COVID-19)

The Novel Coronavirus Disease (COVID-19) is characterized by a variety of clinical manifestations, including a predominant lesion of the respiratory system with the possible development of distress syndrome, the development of multiple organ failure. COVID-19 can cause depression, anxiety, and other emotional disorders, which may interfere with subsequent physical recovery. The aim - clinical analysis of emotional disorders in patients with the Novel Coronavirus Infection (COVID-19). Material and methods. A retrospective analysis of electronic medical records of 124 patients admitted to the infectious diseases department of Chelyabinsk City Clinical Hospital No. 8 in 2020-2021 was carried out. The methods of clinical and psychological research (including clinical conversation, observation and testing using the "Hospital Scale of Anxiety and Depression" HADS and the "Symptom Check List" SCL-90-R) were used to identify the features of the emotional states of patients with COVID-19. Statistical analysis was performed using the statistical package <<Statistica 6.0>>. The Spearman rank correlation coefficient was used. Results. Typical complaints upon admission to the hospital are fever, cough, general weakness, loss of smell and taste, runny nose. The majority of patients showed elevated levels of C-reactive protein and protein of the acute phase of inflammation - ferritin, an increase in the D-dimer by more than 2.5 times compared with the average standard values, a decrease in the value of the prothrombin index (mean value 88.7+/-6.4%) indicate coagulopathy as a manifestation of hyperinflammation that develops in COVID-19. More than half of patients (52.08+/-9.42%) experienced psychological distress of moderate and high severity: an increased level of distress was recorded in 42.78+/-9.33% of the examined patients, a high level of distress was found in 9.30+/-5.48% of patients. Direct correlations of varying degrees of strength between general somatic distress and indicators of anxiety, depression, psychopathological manifestations (obsessive-compulsiveness and interpersonal sensitivity) and mental distress were identified. Revealed negative emotional experiences in patients with COVID-19 can cause adverse effects on the course and prognosis of the disease, reduce adherence to treatment, negatively affect the social functioning and quality of life of patients.Copyright © Infectious Diseases: News, Opinions, Training 2022.

The evolution of the COVID-19 pandemic in paediatric patients with sickle cell disease: From Alpha to Omicron.

We compare the impact of SARS-CoV-2 variants on healthcare utilization and clinical presentation in paediatric patients with sickle cell disease (SCD). One hundred and ninety-one unique patients with SCD and positive SARS-CoV-2 polymerase chain reactions were identified between March 2020 and January 2022. Hospitalizations, which accounted for 42% (N = 81) of cases, were highest during the Delta dominant era (48%) and lowest during Omicron (36%) (p = 0.285). The most common SCD-related complication was vaso-occlusive pain (37%, N = 71), which accounted for 51% of all hospital admissions (N = 41), and acute chest was highest in the Alpha variant era (N = 15). Overall, COVID-19 remained mild in clinical severity within most paediatric SCD patients.