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.

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.

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.

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.

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.

Data analysis guidelines for single‑cell RNA‑seq in biomedical studies and clinical applications

The application of single-cell RNA sequencing(scRNA-seq)in biomedical research has advanced our understanding of the pathogenesis of disease and provided valuable insights into new diagnostic and therapeutic strategies.With the expansion of capacity for high-throughput scRNA-seq,including clinical samples,the analysis of these huge volumes of data has become a daunting prospect for researchers entering this field.Here,we review the workflow for typical scRNA-seq data analysis,covering raw data processing and quality control,basic data analysis applicable for almost all scRNA-seq data sets,and advanced data analysis that should be tailored to specific scientific questions.While summarizing the current methods for each analysis step,we also provide an online repository of software and wrapped-up scripts to support the implementation.Recommendations and caveats are pointed out for some specific analysis tasks and approaches.We hope this resource will be helpful to researchers engaging with scRNA-seq,in particular for emerging clinical applications.

The most important questions in cancer research and clinical oncology Question 2-5.Obesity-related cancers:more questions than answers

Obesity is recognized as the second highest risk factor for cancer. The pathogenic mechanisms underlying tobaccorelated cancers are well characterized and efective programs have led to a decline in smoking and related cancers, but there is a global epidemic of obesity without a clear understanding of how obesity causes cancer. Obesity is heterogeneous, and approximately 25% of obese individuals remain healthy(metabolically healthy obese, MHO), so which fat deposition(subcutaneous versus visceral, adipose versus ectopic) is "malignant"? What is the mechanism of carcinogenesis? Is it by metabolic dysregulation or chronic inflammation? Through which chemokines/genes/signaling pathways does adipose tissue influence carcinogenesis? Can selective inhibition of these pathways uncouple obesity from cancers? Do all obesity related cancers(ORCs) share a molecular signature? Are there common(overlapping) genetic loci that make individuals susceptible to obesity, metabolic syndrome, and cancers? Can we identify precursor lesions of ORCs and will early intervention of high risk individuals alter the natural history? It appears unlikely that the obesity epidemic will be controlled anytime soon; answers to these questions will help to reduce the adverse efect of obesity on human condition.

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.

A study on clinical nursing research trends and hotspots based on bibliometric analysis

Objective: This study was conducted to understand the trends and research hotspots of clinical nursing in China and abroad, thereby to provide guidance for nursing practice and studies.Methods: We retrieved clinical nursing literature(excluding literature related to psychological nursing and traditional Chinese medicine nursing) cited in Wanfang Data(www.wanfangdata.com.cn) and PubMed between 2007 and 2015 and subsequently performed bibliometric analyses on article volume,journal, clustering of high-frequency keywords, and co-occurrence of keywords.Results: A total of 10374 publications, excluding those related to psychological nursing, were retrieved via a PubMed search. The literature displayed a rising trend in terms of annual publication volume. The journal distribution of clinical nursing publications overall was consistent with Bradford's Law. The main contents of clinical nursing literature between 2007 and 2009 included:(1) studies on effects of the midwife and midwifery methods for natural childbirth;(2) studies on emergency nursing care;(3)studies on dementia care;(4) studies on bandage dressing in trauma nursing; and(5) studies on quality of life in cancer patients nursing. The main contents of clinical nursing literature between 2010 and 2012 included:(1) studies on obstetric nurse-patient relationships;(2) studies on patients' medical team in stroke nursing;(3) studies on cancer nursing methods;(4) studies on nursing patients with trauma related to urinary incontinence; and(5) studies on the quality of life of caregivers of dementia patients.The main contents of clinical nursing literature between 2013 and 2015 included(1) studies on skin care and bandaging in trauma nursing;(2) studies on evidence-based nursing in AIDS care;(3) studies on nurses' role in obstetric nurse-patient relationships; studies on cancer nursing methods;(4) studies on nursing for Alzheimer's disease and dementia; and(5) studies on caregivers and nursing of stroke patients. A Wanfang Data search retrieved a total of 85570 publications, whose volume also exhibited an annual rising trend, in particular with regard to those in core journals. However, percentage of total publication volume, mean cited frequency per article, and total ranking of clinical nursing publications overall displayed a decreasing trend. The main contents of clinical nursing literature between 2007 and 2009 included:(1) diabetes nursing;(2) nursing for cancer;(3) nursing for senility-related diseases;(4)nursing in the event of complications;(5) nursing for hypertension;(6) studies on quality of life after nursing interventions;(7) chemotherapy nursing;(8) studies on compliance after nursing interventions;(9) constipation nursing; and(10) nursing for stroke patients. The main contents of clinical nursing literature between 2010 and 2012 included:(1) diabetes nursing;(2) nursing for cancer;(3) nursing for senility-related diseases;(4) studies on quality of life after nursing interventions;(5) nursing in the event of complications;(6) nursing for hypertension;(7) prevention nursing;(8) perioperative nursing;(9)pain nursing; and(10) studies on compliance after nursing interventions. The main contents of clinical nursing literature between 2013 and 2015 included:(1) diabetes nursing;(2) nursing in the event of complications;(3) cancer nursing;(4) studies on quality of life after nursing interventions;(5) nursing for stroke patients;(6) nursing for the elderly;(7) studies on compliance after nursing interventions;(8)nursing for hypertension;(9) constipation nursing; and(10) prevention nursing.Conclusions: Clinical nursing research in China is in a rapid development stage as defined by Price's law whereby there is a rapid growth in publication volume. By comparison, clinical nursing research in developed countries is in the stable development stage or maturation phase, which is characterized by a flat curve of publication volume and stable development rate. There is a gap of 25-30 years between China and these countries in terms of the growth phases of clinical nursing literature.

Clinical Application and Research Progress of Accelerated Rehabilitation Surgery in Perioperative Period of Advanced Gastric Cancer in the Elderly

Enhanced recovery after surgery (ERAS) has been used in various surgical professions in recent years and is widely accepted by doctors. This concept not only helps patients speed up postoperative recovery, reduce the incidence of related complications and shorten hospital stays, but also has been proved to be effective and safe in the perioperative application of gastric cancer. This article reviews the clinical application and research progress of enhanced recovery after surgery in the perioperative period of advanced gastric cancer in the elderly.

Progress in clinical research on the integration of Chinese and Western medicines for treating primary liver cancer

Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.