Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces

Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.

Enhancing competency of clinical research nurses:A comprehensive training and evaluation framework

The Sun et al's training program for clinical research nurses(CRNs)in the World Journal of Clinical Cases is a comprehensive and scientific approach.It includes structured frameworks for CRN training,aiming to improve CRN competency.This program emphasizes practical abilities,updates training content,and improves evaluation methods.The cultivation of CRN talents focuses on enhancing the training system,establishing a multifaceted evaluation framework,and continuously refining the training programs.Regular feedback and evalua-tion are essential to improve CRNs'competency in practical settings.

Machine learning applications in healthcare clinical practice and research

Machine learning(ML)is a type of artificial intelligence that assists computers in the acquisition of knowledge through data analysis,thus creating machines that can complete tasks otherwise requiring human intelligence.Among its various applications,it has proven groundbreaking in healthcare as well,both in clinical practice and research.In this editorial,we succinctly introduce ML applications and present a study,featured in the latest issue of the World Journal of Clinical Cases.The authors of this study conducted an analysis using both multiple linear regression(MLR)and ML methods to investigate the significant factors that may impact the estimated glomerular filtration rate in healthy women with and without non-alcoholic fatty liver disease(NAFLD).Their results implicated age as the most important determining factor in both groups,followed by lactic dehydrogenase,uric acid,forced expiratory volume in one second,and albumin.In addition,for the NAFLD-group,the 5th and 6th most important impact factors were thyroid-stimulating hormone and systolic blood pressure,as compared to plasma calcium and body fat for the NAFLD+group.However,the study's distinctive contribution lies in its adoption of ML methodologies,showcasing their superiority over traditional statistical approaches(herein MLR),thereby highlighting the potential of ML to represent an invaluable advanced adjunct tool in clinical practice and research.

Near-Infrared Fluorescence Imaging Contrast Agents for Clinical Research: Limitations and Alternatives

Introduction: Near-infrared fluorescence imaging is a technique that will establish itself in the short term at the international level because it is recognized for its potential to improve the performance of surgical interventions, its moderate investment and operating costs and its portability. Although the technology is now mature, there is currently the problem of the availability of contrast agents to be injected IV. The aim of this methodology article is to propose an alternative solution to the need for contrast agents for clinical research, particularly in oncology. Methodology: They consist of coupling a fluorescent marker in the form of an NHS derivative, such as IR DYE manufactured in compliance with GMP, with therapeutic monoclonal antibodies having marketing authorization for molecular imaging. For a given antibody, the marking procedure must be the subject of a validation file on the final preparation filtered on a sterilizing membrane at 0.22 μm. Once the procedure has been validated, it would be unnecessary to repeat the tests before each clinical research examination. A check of the marking by thin-layer chromatography (TLC) and place it in a sample bank at +4˚C for 1 month of each injected formulation would be sufficient for additional tests if necessary. Conclusion: Molecular near-infrared fluorescence imaging is experiencing development, the process of which could be accelerated by greater availability of clinical contrast agents. Alternative solutions are therefore necessary to promote clinical research in this area. These methods must be shared to make it easier for researchers.

Current Status of Clinical Application and Basic Research on Draba nemerosa Hebecarpa Jujube Lung-Diarrhoea Soup

The clinical application and basic research of Draba nemerosa Hebecarpa jujube diarrhoea lung soup focus on respiratory diseases and circulatory diseases, and its clinical application is more compared with the basic research, and Draba nemerosa Hebecarpa jujube diarrhoea lung soup is mostly used in the form of “Draba nemerosa Hebecarpa Hebecarpa jujube diarrhoea lung soup with additional subtractions or other formulas combining Draba nemerosa Hebecarpa Hebecarpa Hebecarpa jujube diarrhoea lung soup” in the clinical application. This article will focus on the main mechanisms of Draba nemerosa Hebecarpa jujube diarrhoea lung soup and its main components in the treatment of respiratory and circulatory diseases, and will give a review of the basic research on Draba nemerosa Hebecarpa Hebecarpa jujube diarrhoea lung soup as follows.

Demand and Analysis of Clinical Research Curriculum in Medical Universities

Objective:To investigate the needs of medical students regarding clinical research curricula to provide scientifically sound offerings and cultivate their clinical research thinking.Methods:From June to October 2022,medical students at medical universities in Shaanxi Province were surveyed using online questionnaires.The survey covered their demographic information,awareness of their major,understanding of clinical research,and preferences for curriculum content.Results:A total of 341 valid questionnaires were analyzed.Medical students demonstrated a strong awareness of their majors but a relatively low awareness of clinical research.There was significant demand for clinical research courses,with preferences for professionally oriented(81.8%),market-oriented(100%),theoretically and practically integrated teaching(78.6%),and application-focused(73.0%)courses.Conclusion:Medical colleges and universities should align clinical research curricula with the actual needs of medical students and clinical practice.Reforms in curriculum design and teaching methods are essential to better prepare students for careers in public health.

CLINICAL REPORT ON MULTI-CENTER RANDOMIZED CONTROLLED TRIAL OF TREATMENT OF MIGRAINE BY ELECTRO-ACUPUNCTURE AT QI■X■(丘墟GB40)

Objective To observe the therapeutic effect of electro acupuncture at QIǖXǖ（丘墟GB40） for treating migraine and provide clinical study for Acupoints Dictionary of People＇s Republic of China. Methods Multi-center （3 First-Class hospitals） study was adopted, and the involved 3 hospitals did clinical observation according to the requirements of the project. The methods are as follows. All cases were randomized into treatment group and control group according to their sequence. QIǖXǖ（丘墟GB40） was selected in treatment group, while Tiānshū （天枢 ST25） was selected in control group. Both groups were performed electro acupuncture, and syndromes indexes of migraine and 5-HT were observed before and after treatment. All data were analyzed by statistic software SPSS11.5. Results There was significant difference of VAS margin between two groups in each center and the combined center （u= -3. 362, P=0. 001 ）. There was significant difference of therapeutic effect of 4-week treatment between two groups in each clinical center and the combined center. The therapeutic effect of 3-month treatment between two groups in No. 1 and No. 3 hospitals, showed significant difference, the treatment group was better; while that of No. 2 hospital had no obvious difference. The therapeutic effect of 6-month treatment between two groups in each center and the combined center had significant difference, the treatment group was better. Conclusion The therapy of electro acupuncture at QIǖXǖ（丘墟GB40） is effective for migraine.

Guidelines on clinical research evaluation of artificial intelligence in ophthalmology(2023)

With the upsurge of artificial intelligence(AI)technology in the medical field,its application in ophthalmology has become a cutting-edge research field.Notably,machine learning techniques have shown remarkable achievements in diagnosing,intervening,and predicting ophthalmic diseases.To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI,the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification.The main content includes the background and method of developing this guideline,an introduction to international guidelines on the clinical research evaluation of AI,and the evaluation methods of clinical ophthalmic AI models.This guideline introduces general evaluation methods of clinical ophthalmic AI research,evaluation methods of clinical ophthalmic AI models,and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail,and amply elaborates the evaluation methods of clinical ophthalmic AI trials.This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI,promote the development of regularization and standardization,and further improve the overall level of clinical ophthalmic AI research evaluations.

Study on The Current Status and Progress of Clinical Application of Ciprofol

Ciprofol,as a new type of short-acting intravenous anesthetic drug,belongs to the category of gamma-aminobutyric acid(GABA)receptor agonists.Its unique chemical structure,through the introduction of the cyclopropyl group in the isopropyl side chain of propofol,constructs a new type of chiral molecule,which significantly enhances the spatial effect,and improves the affinity for GABA receptors.Its pharmacological properties are characterized by high potency,rapid onset of action,rapid recovery,low accumulation,and minimal adverse reactions.Therefore,it has a wide range of applications in various endoscopic diagnostic and therapeutic operations,ICU sedation,and general anesthesia.In this paper,the related knowledge of ciprofol and the development of clinical application research are comprehensively sorted out and synthesized,to provide a solid theoretical basis for the rational application of ciprofol in clinical practice.At the same time,the future research direction of ciprofol will also be prospected to provide valuable references for research in related fields.

基于ClinicalTrials.gov和ChiCTR数据库对牙体牙髓病的临床试验注册特点分析

目的汇总注册于美国ClinicalTrials.gov和中国临床研究注册中心(Chinese Clinical Trial Registry,ChiCTR)的牙体牙髓病临床注册资料,分析牙体牙髓病临床试验的注册特征。方法通过检索2000年1月1日至2023年8月20日期间在两个数据库中注册的牙体牙髓病临床研究,提取并分析牙体牙髓病相关临床研究的信息,提取的内容包括注册地区、注册年度、试验题目、研究方向、样本量、试验进展、研究类型、试验设计、盲法、临床试验分期和参与机构名称等信息。结果两个数据库中临床研究的总注册数为536191项,其中牙体牙髓病的临床研究共634项;涉及到43个国家,排名前三的分别是埃及(188项)、中国(130项)和美国(46项);2015年开始牙体牙髓病临床研究注册数量显著增加;研究方向以牙髓病(434项)、龋病(106项),根尖周病(77项)为主,内容主要涉及到病因学、药物干预、外科干预、新技术、新材料等方面;临床试验样本量<100例的临床研究有430项(67.82%),样本量为100~999例的有185项(29.18%);注册时的研究进展状态为已完成试验的项目数最多,有286项(45.11%),其次是未知项(125项)、招募中(110项)、尚未招募(81项);研究类型主要是干预性研究546项,占86.12%,以随机平行对照设计方式为主要设计模式(473项,74.61%);研究设计类型中使用盲法的有423项(66.72%),其中以双盲为主(195项),其次是其他/未注明情况(123项,19.40%),开放性研究(88项,13.88%);临床分期中标记为其他/未标记的项目数量最多(388项),其次是Ⅱ期研究(69项)和初步研究(62项)。临床研究参与机构数量<3的有611项(96.37%),参与机构数量≥3的有23项(3.63%)。结论牙体牙髓病的临床试验注册数量总体呈上升趋势,但仍旧偏少,研究设计的质量有待加强,临床分期的注册信息的完整性有待提高,且多中心临床研究数量较少。今后应充分开展高质量、多中心的临床研究,实现成果的转化。

Clinical research progress of traumatic brain injury related markers

Traumatic brain injury is a brain injury caused by biomechanics effects on brain tissue,In addition to primary brain injury,secondary brain injury caused by local brain injury,edema and high intracranial pressure on surrounding brain tissue further aggravates the disease.The improvement of modern medical equipment and medical technology can provide early intervention treatment for patients.However,due to the particularity of the disease and the complexity of pathological and physiological reactions,irreversible damage often occurs in the central nervous system,with high disability rate and mortality.In recent years,it has been found that the related biological markers in the process of TBI are related to brain tissue injury and neurological function,and have important clinical application value in judging the severity of brain injury and prognosis evaluation,which has been widely studied.This paper intends to summarize the clinical research progress of TBI-related prognostic markers.

Study on good clinical practices among researchers in a tertiary healthcare institute in India

BACKGROUND Good clinical practice(GCP)is put in place to protect human participants in clinical trials as well as to ensure the quality of research.Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community.Therefore,it must be ensured that researchers are wellversed in the GCP.But not much is known about the knowledge and practices of the GCP in the medical colleges of North India.AIM To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants.METHODS This is a cross-sectional study.A self-structured questionnaire about GCP,after expert validations,was circulated among researchers,at a tertiary healthcare institute,All India Institute of Medical Sciences(AIIMS),Rishikesh.A total of 59 individuals,who were selected by universal sampling,participated in the study.All healthcare workers who have been investigators of Institutional Ethics Committee-approved research projects,except residents and faculty,and are still a part of the institute have been included in the study.The study was approved by the Institutional Ethics Committee of AIIMS,Rishikesh.We used descriptive analysis and the Chi-squared test to analyze data.P value<0.05 was considered significant.RESULTS Out of 59 participants,only 11(18.6%)were certified for GCP.Most of the participants(64.4%)had“Average”knowledge,33.9%had“Good”knowledge and 1.7%had“Poor”knowledge.Only 49%of participants had satisfactory practices related to GCP.There was a significant difference in the knowledge based on the current academic position for the items assessing knowledge of institutional review board(P=0.010),confidentiality&privacy(P=0.011),and participant safety&adverse events(P<0.001).There was also a significant difference in knowledge of research misconduct(P=0.024)and participant safety&adverse events(P=0.011)based on certification of GCP.There was a notable difference in the practices related to recruitment&retention on the basis of current academic position(P<0.001)and certification of GCP(P=0.023).We also observed a considerable difference between the knowledge and practices of GCP among the participants(P=0.013).CONCLUSION Participants have basic knowledge of GCP but show a lack thereof in certain domains of GCP.This can be addressed by holding training sessions focusing on these particular domains.

Xi-Feng-Hua-Shi granules for diarrhea-predominant irritable bowel syndrome:protocol for a randomized,double-blind,placebo-controlled multi-center clinical trial

Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.

CLINICAL RESEARCH OF IMPACTS ON PLASMA ENDOTHELIN AND INTELLIGENCE IN MULTI-INFARCT DEMATIA TREATED WITH CLUSTER PRICKING ON HEAD POINTS

Objective To probe into the impacts on the therapeutic effects and endothelin （ET） in multi-infarct dementia （MID） treated with cluster pricking on head points.Methods 60 cases of MID were randomized into acupuncture group and western medicine group,treated with cluster pricking on head points and huperzien A tablet respectively.Plasma ET lever,HDS,ADL and CNFDS （clinical neurological functional defect scoring） were determined before treatment,and the statistical analysis showed that there were no significant difference （P〉0.05）.Results In 8-week treatment,ET level in both groups were decreased,but it was decreased much more obviously in acupuncture group,indicating significant difference in the statistical comparison （P〈0.05）.The scores of HDS and ADL were all up in acupuncture and western medicine groups,but the significant statistical difference was obtained in the comparison between acupuncture group and western medicine group （P〈0.05）.In acupuncture group,the result of CNFDS was much down comparing with that before the treatment,indicating significant difference （P〈0.05）;but in western medicine group,there was no significant difference in CNFDS before and after treatment （P〉0.05）,suggesting that acupuncture reduces CNFDS of MID patient,neither for western medicine.Conclusion Cluster pricking on head points improves the intelligence of MID patient,reduces ET level and grades up HDS and ADL,moreover,it reduces CNFDS of MID patients and releases the symptoms.

Risk factors, preventive interventions, overlapping symptoms, and clinical measures of delirium in elderly patients

Delirium is an acute reversible neuropsychiatric syndrome caused by multiple factors.It is associated with many adverse clinical outcomes including cognitive impairment,functional decline,prolonged hospitalization,and increased nursing service.The prevalence of delirium was high in department of cardiology,geriatric,and intensive care unit of hospital.With the increase in the aged population,further increases in delirium seem likely.However,it remains poorly recognized in the clinical practice.This article comprehensively discusses the latest research perspectives on the epidemiological data,risk factors,preventive interventions,overlapping symptoms,and clinical measures of delirium,including specific measures to manage delirium in clinical real-world situations.This article helps readers improve their knowledge and understanding of delirium and helps clinicians quickly identify and implement timely therapeutic measures to address various delirium subtypes that occur in the clinical settings to ensure patients are treated as aggressively as possible.

Quality Control and Nonclinical Research on CAR-T Cell Products: General Principles and Key Issues

Adoptive cell therapy using chimeric antigen receptor T (CAR-T) cells, which is a promising cancer immunotherapy strategy, has been developing very rapidly in recent years. CAR-T cells are genetically modified T cells that can specifically recognize tumor specific antigens on the surface of tumor cells, and then effectively kill tumor cells. At present, exciting results are being achieved in clinical applications of CAR-T cells for patients with hematological malignancies. The research and development of CAR-T cells for various targets and for the treatment of solid tumors have become a hot topic worldwide, so an increasing number of investigational new drug applications (INDAs) and new drug applications (NDAs) of CAR-T cell products are expected to be submitted in future. The quality control and nonclinical research of these products are of great significance in ensuring the safety and effectiveness of these products;however, they also present great challenges and difficulties. This article discusses the general principles of and key issues regarding the quality control and nonclinical research of CAR-T cell products based on their product characteristics and on relevant guidelines for gene and cell therapy products.

Liver alveolar echinococcosis in China: Clinical aspect with relative basic research

This paper deals with all aspects of liver alveolar echinococcosis (AE) including epidemiology, pathology, clinical manifestations, imaging examinations, diagnosis and differential diagnosis, surgical treatment and chemotherapy.The review is not only based on personal clinical experiences but also in combination with relative basic research such as proliferation and growth of alveococcus, preclinical studies of a novel compound extracted from TCM for treatment of liver AE, and molecular immunology used for specific AE diagnosis, etc.

Advances in clinical research of hepatocellular carcinoma in China

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A study of clinical psychological nursing research hotspots in China and variation trends based on word frequency analysis and visualization analysis

Objective: To analyze clinical psychological nursing research hotspots in China and variation trends in order to provide reference points on the current state of development of clinical psychological nursing and future research hotspots.Method: Clinical psychological nursing research literature sourced from Wanfang Data for the three periods of 2007-2009, 2010-2012, and 2013-2015 were selected as the research sample. A bibliographic co-occurrence analysis system(BICOMB software) was used to perform keyword word frequency analysis and generate a keyword co-occurrence matrix. In addition, Ucinet software's Netdraw tool was used to create visualized network diagrams.Results: A total of 27890 articles were retrieved, and word frequency analysis revealed that the highestfrequency keywords consisted of anxiety, depression, the elderly, expectant women, coronary heart disease, diabetes, breast cancer, perioperative period, quality of life, and psychological intervention.Research hotspot analysis revealed that consistent hotspots comprised anxiety, depression, health education, and perioperative period; expectant women became a hotspot during 2010-2012, and quality of life and efficacy became hotspots during 2013-2015.Conclusions: In addition to the care process, clinical psychological nursing research hotspots in China have increasingly included the effectiveness of psychological nursing and impact on patient quality of life. In addition, research hotspots have been influenced by the incidence of illnesses and people's health consciousness.

Summary and clinical application of Zhuang medicine medicated thread moxibustion

Zhuang medicine medicated thread moxibustion is a kind of external therapy with ethnic medicine characteristics that spreads in Guangxi Zhuang region.It has a wide range of clinical application and significant curative effect,and can be used to treat diseases such as internal medicine,surgery,dermatology,gynecology,pediatrics,and five sense organs.Through reviewing and combing the literature on the Zhuang medicine medicated thread moxibustion in recent years,this paper summarizes and prospects its clinical application,with a view to further explaining the basic principles and application rules of Zhuang medicine medicated thread moxibustion and digging its clinical value.