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.

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.

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.

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.

Status and Analysis of 832 Investigator-Initiated Coronavirus-Related Clinical Studies

Objective:To contribute to the development of clinical research on novel coronavirus by analyzing the clinical research data of COVID-19.Methods:Searches were performed on the database of“National Health Insurance Information Platform Medical Research Registration Information System”using the keywords“COVID-19”and“Novel coronavirus.”The search was performed till 31 December 2022.This paper presents a statistical analysis of the status quo of the registered projects in terms of the number of registered projects,the types of projects,the levels of the institutions,the types of research,the intervention measures,the research design,the main objectives of the research,and so on.Results:A total of 823 investigator-initiated clinical studies of COVID-19 were documented,and the number of studies registered peaked on December 31,2020,and December 31,2022.Among them,there were 819 items from general medical research(99.5%),812 items from medical institutions(98.7%),and 713 items from Medical Grade III,and Class A hospitals(86.6%).Among these items,534(64.9%)were observational studies.The most common intervention method used was administering existing drugs,with 140 studies utilizing them.This data analysis also included 128 case-control studies and 247 treatment-oriented studies.Conclusion:Researchers in local medical institutions have been actively carrying out clinical research related to COVID-19.However,they should refer to registered research to avoid duplicate research.

Patient-centric periodontal research:A pioneering application of patient-reported outcome measures

Conventional dentistry or periodontal research often ignores the human component in favor of clinical outcomes and biological causes.Clinical research is driven by the statistical significance of outcome parameters rather than the satisfaction level of the patient.In this context,patient-centric periodontal research(PCPR)is an approach that considers the patient´s feedback concerning their functional status,experience,clinical outcomes,and accessibility to their treatments.It is argued that data self-reported by the patient might have low reliability owing to the confounding effect of their personal belief,cultural background,and social and economic factors.However,literature has shown that the incorporation of“patient-centric outcome”components considerably enhances the validity and applicability of research findings.Variations in the results of different studies might be due to the use of different and non-standardized assessment tools.To overcome this problem,this editorial enlists various reliable tools available in the literature.In conclusion,we advocate that the focus of researchers should shift from mere periodontal research to PCPR so that the results can be effectively applied in clinical settings and the therapeutic strategy can also change from mere periodontal therapy to patient-centric periodontal therapy.

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.

Clinical Effect of Zishenwan on Elderly Patients with Prediabetes Based on the Method of Sweet-Bitter Therapeutic

[Objectives]To study the clinical effect of Zishenwan on elderly patients with prediabetes based on the method of Sweet-Bitter Therapeutic.[Methods]Total 64 elderly patients with prediabetes in Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine from April,2020 to July,2021 were randomly divided into control group(32 cases)and Zishenwan group(32 cases).The control group received basic treatment(diet control and regular luck exercise),while the Zishenwan group was treated with Zishenwan on the basic treatment.[Results]The results of intragroup comparisons after treatment show that both of the groups improved plasma glucose,insulin,plasma lipid metabolism and other related indexes.The results of inter-group comparisons were as follows.(i)The FPG and 2hPG of the Zishenwan group were significantly lower than the control group(P<0.05).(ii)The FINS and HOMA-IR of the Zishenwan group were significantly lower than the control group(P<0.05).(iii)The LDL-C of the Zishenwan group were significantly lower than the control group(P<0.05).(iv)The ADP,hs-CRP,and GLP-1 of the Zishenwan group were significantly improved compared to those of the control group(P<0.05).Although there was no significant difference in other indicators,the improvement trend is better than that of the control group.[Conclusions]Zishenwan can further improve plasma glucose level of the elderly patients with prediabetes on the basis of basic treatment,and to a certain extent,reduce the plasma glucose to normal,which is beneficial to the benign outcome of the elderly patients with prediabetes.In addition,it can improve insulin secretion and reduce insulin resistance,which provides a basis for the disease control of elderly patients with prediabetes.It can also improve the lipid metabolism of elderly patients with prediabetes,and the effect on LDL-C is significant.It is speculated that its mechanism may be closely related to the changes of ADP,hs-CRP and GLP-1 in the body of elderly patients with prediabetes.

Advances in clinical studies of cardiopulmonary resuscitation

BACKGROUND: The survival rate of patients after cardiac arrest(CA) remains lower since 2010 International Consensus on Cardiopulmonary Resuscitation(CPR) and Emergency Cardiovascular Care(ECC) was published. In clinical trials, the methods and techniques for CPR have been overly described. This article gives an overview of the progress in methods and techniques for CPR in the past years.DATA SOURCES: Original articles about cardiac arrest and CPR from MEDLINE(PubM ed) and relevant journals were searched, and most of them were clinical randomized controlled trials(RCTs).RESULTS: Forty-two articles on methods and techniques of CPR were reviewed, including chest compression and conventional CPR, chest compression depth and speed, defibrillation strategies and priority, mechanical and manual chest compression, advanced airway management, impedance threshold device(ITD) and active compression-decompression(ACD) CPR, epinephrine use, and therapeutic hypothermia. The results of studies and related issues described in the international guidelines had been testifi ed.CONCLUSIONS: Although large multicenter studies on CPR are still difficult to carry out, progress has been made in the past 4 years in the methods and techniques of CPR. The results of this review provide evidences for updating the 2015 international guidelines.

Clinical study on tri-tongue acupuncture combined with lowfrequency electrical stimulation for treating post-stroke dysarthria

BACKGROUND Few studies have investigated low-frequency electrical stimulation combined with tri-tongue acupuncture for the treatment of post-stroke dysarthria.This randomized clinical study assessed the correlation between the clinical efficacy of low-frequency electrical stimulation combined with tri-tongue acupuncture in patients with post-stroke dysarthria.AIM To investigate the clinical effects of tri-tongue acupuncture combined with lowfrequency electrical stimulation for treating post-stroke dysarthria.METHODS Ninety patients with post-stroke dysarthria,who were admitted to our hospital from December 2019 to June 2021,were selected and equally divided into two groups(n=45/group)according to the random number table method.Tri-tongue acupuncture was administered in the control group.The treatment group received both tri-tongue acupuncture and low-frequency electrical stimulation.The clinical efficacy,Western Aphasia Battery(WAB)score,general quality of life inventory(GQOLI-74)score,Frenchay Dysarthria Assessment score,and speech function grades were compared and analyzed between both groups.RESULTS The overall efficacy in the treatment group was better than that in the control group(P<0.05).Before treatment,the WAB,Frenchay Dysarthria Assessment,or GQOLI-74 scores(P>0.05)did not differ between the groups.After therapy,the WAB,Frenchay Dysarthria Assessment,and GQOLI-74 scores in both groups increased significantly(P<0.05),and the treatment group exhibited a significantly greater increase than that of the controls(P<0.05).Moreover,the classification of speech function did not differ between the two groups before treatment(P>0.05),whereas significant improvements were observed in both groups after treatment(P<0.05).The degree of improvement in the treatment group was greater than that in the control group(P<0.05).CONCLUSION Low-frequency electrical stimulation,in conjunction with tri-tongue acupuncture,exhibits a good clinical effect on post-stroke dysarthria.

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.

The ethics of exercise in eating disorders:Can an ethical principles approach guide the next generation of research and clinical practice?

1.Introduction Eating disorders(ED)are the most common psychiatric disorders afflicting young women^1 and contribute to great detriments in psychological,social,and physical health.^(2,3)Unfortunately,ED treatments tend to be long lasting,intensive,and expensive.~4Additionally,individuals with ED seeking treatment use healthcare services more frequently than non-ED individu-

Clinical Research progress of traditional Chinese medicine in treating esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.

Clinical research progress of oral administration of traditional Chinese medicine in the treatment of dry eyes

Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.

Anti-tumor Effects of Aspirin: Progress in Clinical and Basic Studies

Beyond the antipyretic analgesic and anti-inflammatory effects for which aspirin has historically been used,studies have shown that aspirin also plays an important role in the prevention or treatment a variety of diseases.The anti-tumor effects of aspirin have received increasing attention during the past decade.Many studies have explored the molecular mechanisms underlying these anti-tumor effects in vitro and in vivo,and abundant discoveries have been made through observational or interventional clinical studies.In terms of its molecular function,aspirin has been shown to prevent tumor cell growth through inhibiting the signal transduction of the COX,tumor necrosis factor-related apoptosis-inducing ligand(TRAIL),NFκB/IκB,and Bcl-2/Bax pathways.Under certain conditions,aspirin can also induce autophagy,which is an inhibitory mechanism for some tumors.This article provides a comprehensive overview of the anti-tumor effects of aspirin and discusses the concrete mechanisms underlying aspirin’s anti-tumor effects that have been discovered in the past 30 years.

Clinical Study of Acupoint Application of Jiezi Fangxiao Ointment Combined with Pingchuan Prescription in the Treatment of Pediatric Asthma

[Objectives]To study the clinical effect of Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription in the treatment of pediatric asthma.[Methods]A total of 40 children with asthma admitted to the First Affiliated Hospital of Heilongjiang University of Chinese Medicine from July 2017 to September 2018 were selected as the research subjects,and divided into control group and observation group according to random classification method,with 20 cases in each group.Among which the control group was given routine symptomatic treatment,the observation group was treated with Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription on the basis of the control group.After 4 weeks of continuous treatment,the clinical efficacy was observed and the changes of traditional Chinese medicine symptom scores,forced expiratory volume in the first second(FEV1),maximum expiratory flow(PEF),forced vital capacity(FVC),peripheral blood eosinophils(EOS)and interleukin-17(IL-17)were compared between the two groups before and after treatment.[Results]After treatment,the traditional Chinese medicine(TCM)scores such as asthma,cough,expectoration,chest tightness,dyspnea and wheezing sound of lungs in the two groups were significantly improved,and the improvement in the observation group was superior to that in the control group.The difference was statistically significant(P<0.05).FEV1,PEF and FVC in the two groups were significantly improved after treatment,and the improvement in the observation group was superior to that in the control group.The difference was statistically significant(P<0.05);after treatment,the levels of EOS and IL-17 decreased in both groups,and the improvement in the observation group was superior to that in the control group,the difference was statistically significant(P<0.05).[Conclusions]The clinical effects of Acupoint Application of Jiezi Fangxiao Ointment combined with Pingchuan Prescription in the treatment of infantile asthma were obvious,which can significantly improve the TCM symptoms scores,pulmonary function and immune function of patients.

Russian clinical research policy does not guarantee results availability

AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS: We analyzed Russian legislation and ethical regulations about drug and devices approval,clinical research registration and the results availability.In August 2012,we searched International Clinical Trials Registry Platform and clinicaltrials.gov to find all registered studies that had an investigational site in the territory of the Russian Federation.To find publication status,we searched the Pub Med and Scirus bibliographical databases with trial registration number to find journal publications of the registered studies.RESULTS: We identified 2062 registered research protocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies.The number of the studies enrolling Russian subjects increased dramatically from three studies in 2002 to 252 studies in 2012.Most studies(92%) were funded exclusively by industry,were interventions(94.6%),examined drugs(87%) and enrolled exclusively adults(86%) of both genders(89%).Only 383(19%) of multinational studies and two(4.4%) of exclusively Russian studies werepublished.Posting of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study funded exclusively by Russian sponsors.Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts.Federal laws require clinical study registration and conflict of interest disclosure.However,routine monitoring of compliance to clinical research policy is not available.CONCLUSION: Russian legislation does not guarantee the availability of clinical research results.Russian legislation should mandate transparent evidence- based market approval of the drugs and devices.