Clinical trial registration， as a cornerstone for transparency in medical scientific research， aims to systematically and comprehensively disclose key information such as trial design and implementation protocols before trial initiation. This reduces selective reporting and outcome bias， avoids unnecessary duplicate research， thereby protects research participants’ legitimate rights and interests and ethical compliance， and ultimately upholds research integrity and public trust. However， despite the widespread international recognition of its importance and necessity， registration practices worldwide still exhibit significant disparities. From an ethical perspective， this paper deeply analyzed the current status of clinical trial registration and the challenges it confronted， including issues such as insufficient awareness of prospective registration， inconsistent registration standards， persistent difficulties in data openness， sharing， and result disclosure， as well as imbalanced global governance of registration. It further explored multi-dimensional paths involving institutional coordination， technological empowerment， global collaboration， and ethical guidance， to promote clinical trial registration to realize full-cycle closed-loop management from registration and implementation to result reporting. These will provide solid theoretical support and practical references for establishing a more ethically resilient， highly transparent， and sustainably operational clinical trial registration system.

OBJECTIVE To explore the effect of tracking methodology on investigation of contamination incidents of bronchoalveolar lavage fluid(BALF)specimens from the children.METHODS The onsite tracking was carried out for the contamination incidents of BALF specimens of the children through the tracking methodology,the quality control processes of cleaning and disinfection of bronchofiberscopes and the tracking routes were determined.The quality control process of cleaning and disinfection of bronchofiberscopes were evaluated,the existing risks were found out,and the specific improvement measures were formulated.RESULTS The onsite tracking was carried out for the incident of carbapenem-resistant Klebsiella pneumoniae(CRKP)that was caused by the contamination of 12 BALF specimens from pediatrics department wards before and after Nov.1,2021.No.2180014C bronchofiber-scope without biological surveillance was determined as the high-risk point of contamination of BALF specimens,the monitoring procedure of cleaning and disinfection of the bronchofiberscopes was revised.The BALF specimens that were submitted from Dec.1,2021 to Dec.31,2021 were tracked,and no CRKP was detected among the 23 submitted specimens.Totally 12 bronchofiberscope specimens were collected for biological surveillance,and the qualified rate was 100.00％.The treatment rooms of pediatrics department,hand disinfection effect of health care workers of cleaning and disinfection rooms and disinfection effect of object surfaces were monitored,and the quali-fied rate was increased from 98.39％to 100.00％.CONCLUSIONS The tracking methodology is an effective tool for quality management and can be used for evaluation of quality process of cleaning and disinfection of bronchofi-berscopes,which may find out the causes for adverse events in a timely manner and raise the medical safety.

OBJECTIVE To explore the effect of tracking methodology on investigation of contamination incidents of bronchoalveolar lavage fluid(BALF)specimens from the children.METHODS The onsite tracking was carried out for the contamination incidents of BALF specimens of the children through the tracking methodology,the quality control processes of cleaning and disinfection of bronchofiberscopes and the tracking routes were determined.The quality control process of cleaning and disinfection of bronchofiberscopes were evaluated,the existing risks were found out,and the specific improvement measures were formulated.RESULTS The onsite tracking was carried out for the incident of carbapenem-resistant Klebsiella pneumoniae(CRKP)that was caused by the contamination of 12 BALF specimens from pediatrics department wards before and after Nov.1,2021.No.2180014C bronchofiber-scope without biological surveillance was determined as the high-risk point of contamination of BALF specimens,the monitoring procedure of cleaning and disinfection of the bronchofiberscopes was revised.The BALF specimens that were submitted from Dec.1,2021 to Dec.31,2021 were tracked,and no CRKP was detected among the 23 submitted specimens.Totally 12 bronchofiberscope specimens were collected for biological surveillance,and the qualified rate was 100.00％.The treatment rooms of pediatrics department,hand disinfection effect of health care workers of cleaning and disinfection rooms and disinfection effect of object surfaces were monitored,and the quali-fied rate was increased from 98.39％to 100.00％.CONCLUSIONS The tracking methodology is an effective tool for quality management and can be used for evaluation of quality process of cleaning and disinfection of bronchofi-berscopes,which may find out the causes for adverse events in a timely manner and raise the medical safety.

OBJECTIVE: To evaluate the risks and benefits of different resuscitation fluids in patients with early sepsis and septic shock by observing and comparing clinical indicators, clinical outcomes, and the concentration changes of glycocalyx biomarkers, and to determine how to appropriately select suitable resuscitation fluids for sepsis patients to aid fluid therapy. METHODS: A single center, prospective, randomized controlled trial was conducted. Patients with early sepsis and septic shock who have required fluid resuscitation after capacity status assessment admitted to the department of critical care medicine of Fourth Hospital of Hebei Medical University from April to October 2023 were enrolled. Patients were randomly assigned to either the experimental group (balanced crystalloid solution+albumin) or the control group (balanced crystalloid solution) by a random number table method. Clinical data of both groups of patients before and after resuscitation at 3, 8, and 24 hours were monitored, and blood samples were collected, enzyme-linked immunosorbent assay (ELISA) was used to measure the concentration of plasma glycocalyx biomarker syndecan-1. The 28-day and 90-day survival rates and complications were also assessed. RESULTS: A total of 66 patients were enrolled, including 44 in the experimental group and 22 in the control group. The baseline data of two groups were balanced and comparable. There was no statistically significant difference in the plasma concentration of syndecan-1 between the experimental group and the control group before and after resuscitation, and both showed a trend of first increasing and then decreasing. However, the plasma syndecan-1 level in the control group at 8 hours and 24 hours after resuscitation were significantly higher than the baseline level before resuscitation [ng/L: 19.02 (14.41, 27.80), 18.95 (12.40, 22.50) vs. 14.67 (11.57, 21.14), both P < 0.05], while there was no statistically significant difference at any time point within the experimental group. The correlation analysis between plasma syndecan-1 level and lactic acid, albumin, and sequential organ failure assessment (SOFA) in all patients showed that a positive correlation between syndecan-1 level and SOFA score before resuscitation (r = 0.247, P = 0.046), and a negative correlation between syndecan-1 level and albumin level at 24 hours after resuscitation (r = -0.308, P = 0.012). There were no statistically significant differences in 28-day and 90-day mortality, length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation, blood purification time, number of organ injuries, and complications between the two groups. However, the baseline albumin level in the experimental group was significantly lower than that in the control group (g/L: 28.7±4.5 vs. 31.6±4.2, P < 0.05). Analysis of clinical treatment data showed that compared with the control group, the experimental group had lower absolute lactate level at 8 hours and 24 hours after resuscitation [mmol/L: 8 hours was 1.30 (1.00, 1.88) vs. 1.60 (1.30, 3.05), 24 hours was 1.15 (0.80, 1.78) vs. 1.55 (1.08, 2.05), both P < 0.05], and higher lactate clearance rate [8 hours was 45% (27%, 56%) vs. 20% (-4%, 46%), 24 hours was 55% (34%, 70%) vs. 34% (-14%, 59%), both P < 0.05]. However, there were no statistically significant differences in the amount of fluid resuscitation, use of vasoactive drugs, and oxygenation index between the two groups during the resuscitation process. Multivariate Logistic regression analysis showed that body mass index (BMI) was independently correlated with 90-day mortality [odds ratio (OR) = 1.991, 95% confidence interval (95%CI) was 1.023-3.387, P = 0.043]. CONCLUSIONS There are no significant difference in plasma syndecan-1 level during fluid resuscitation of early sepsis and septic shock patients using balanced crystalloid fluid and balanced crystalloid fluid combined with albumin resuscitation, and there are no statistically significant differences in the impact on 28-day and 90-day prognosis, length of hospital stay, complications, and other aspects of the patients. However, compared to balanced crystalloid fluid, the combination of balanced crystalloid fluid and albumin for fluid resuscitation in sepsis patients has lower lactate level and better lactate clearance effect, but further validation is still needed through large-scale randomized controlled trials.
Humans ; Clinical Relevance ; Crystalloid Solutions/administration & dosage* ; Fluid Therapy/methods* ; Glycocalyx/metabolism* ; Isotonic Solutions/administration & dosage* ; Prospective Studies ; Resuscitation/methods* ; Sepsis/therapy* ; Shock, Septic/therapy* ; Syndecan-1/blood*

In medical scientific research, the contradiction between the adequacy of professional talents and the lack of interdisciplinary talents has gradually become a bottleneck for the high-quality development of medical scientific research. In order to effectively promote interdisciplinarity and high-quality cultivation of interdisciplinary talents, the West China Hospital of Sichuan University takes the lead in incorporating medical scientific research knowledge into general education for lower-grade undergraduate students. The general education system of medical scientific research spreads professional medical scientific research knowledge that is "highly concentrated and purified", and "simple" but not "shallow" to lower-grade undergraduate students while cultivating students' interdisciplinary awareness and ability of condensing scientific research problems. The system, based on curriculum design, refers to a series of teaching activities, such as professional teaching material compilation, teaching project research, course video recording, scientific research platform support, medical scientific research practice guarantee, and interdisciplinary evaluation. By adhering to the teaching concept of precise interdisciplinary education oriented by medical research, a paradigm for the reform of medical education and the training mode of interdisciplinary talents has been explored through the advancement of medical knowledge and the breakthrough of disciplinary boundaries.

By searching the papers about medical ethics education in Chinese database CNKI and foreign database Web of Science Core Collection, and using the bibliometrics software CiteSpace to draw the knowledge map of medical ethics education at home and abroad, this paper conducted a quantitative and qualitative analysis of the evolution of hot spots and the development trend of medical ethics education research, and found that the development level of medical ethics education in the world varies greatly. China has experienced the development and evolution from medical ethics education to medical humanities, and its research hotspots mainly focus on the topics of "medical ethics" "medical education" "practice teaching" "medical humanities" "teaching reform" and so on. While foreign countries focus on "medical education" "clinical ethics" "hospice care" "health care" "global public health" "science and technology ethics" "organ transplantation" "curriculum construction" "health policy" and other topics. Through the comparative analysis of the development trend and the evolution of hot spots of education, this paper put forward theoretical reference direction for improving the medical ethics education system in China and further perfecting the discipline construction of medical ethics in China.

Due to the physiological peculiarities of pregnant women, general clinical studies exclude pregnant women. Therefore, there is a lack of evidence of precise medication for pregnant women with diseases worldwide, which poses a significant risk for them to use medication during pregnancy. Whether to include pregnant women as subjects in clinical research has always been a focus of ethical discussion. By providing a broad overview of pregnant women’s participation in clinical research from an ethical perspective, this paper explored the risks and challenges faced by pregnant women’s participation in clinical research, and provided theoretical basis and thinking paths for how to fairly and effectively include pregnant women as subjects and promoting clinical research on pregnant women.

Objective:To investigate the longitudinal trajectory and influencing factors of cancer-related fatigue (CRF) in breast cancer patients during chemotherapy.Methods:From March 2019 to January 2020, breast cancer patients in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine and Peking Union Medical College Hospital were selected as the research objects to conduct follow-up investigation. The survey tools included general information questionnaire, Cancer-related Fatigue Assessment Scale, International Physical Activity Questionnaire, and the Pittsburgh Sleep Quality Index Scale.Results:A total of 91 patients were included in the study. The incidence of severe CRF at each time point before chemotherapy, 3 weeks after chemotherapy and 6 weeks after chemotherapy were 1.1% (1/91), 8.8% (5/57) and 2.1% (1/48), respectively. The results of the generalized estimation equation showed that the trajectory of the total score CRF firstly increased and then decreased, reaching a peak at 3 weeks after chemotherapy (35.45±13.07), and mild CRF change showed statistical difference ( P<0.05). In addition, BMI and sleep and daytime dysfunction were the influencing factors of the total score of CRF. Disease stage, sleep disturbance and daytime dysfunction were the influencing factors of CRF with different severity. Conclusions:CRF is a prominent problem in breast cancer patients during chemotherapy. Attention should be paid to high-risk individuals with abnormal BMI and daytime function by medical staff.

Objective: To analyze the comparability of different detection systems and methods for tumor markers (TM) by reviewing the results of TM external quality assessment (EQA) in Shandong province during 2015 and 2017. Methods: The results of TM EQA from the Shandong Provincial Clinical Laboratory Center during 2015 and 2017 were collected, and grouped by the detection system or method. After outliers were removed by the CLInet EQA software, the mean and coefficient of variation (CV) in each group were calculated with median as the target value. The difference of TM results in different detection systems were compared by the Kruskal-Wallis H test. Results: Taking alpha-fetoprotein (AFP) as an example, the average CV of different detection methods of TM EQA during 2015 and 2017 ranged from small to large in order of microparticle enzyme immunoassay, electrochemiluminescence, acridine ester chemiluminescence and chemiluminescence. The trends of CV of the other tumor markers were similar to AFP. The average CV of individual marker in electrochemiluminescence group was lower than that in microparticle enzyme immunoassay group. The intra-group CVs of imported detection systems such as Roche, Beckman etc. were relatively ideal, and the average CVs of most tumor markers were less than 10%. However, the intra-group CVs of domestic detection systems such as Shenzhen Snibe, Zhengzhou Autobio etc. were not ideal, and the average CVs of most tumor markers were more than 10%. The target values of different detection systems varied with different items and batches, and there were great variation in carbohydrate antigen (CA) series. Conclusion The results of TM detected by the same automatic detection system are comparable. However, the results of TM detected by most different detection systems and methods are not comparable.

Objective To analyze the radiographic characteristics of right hand X-ray film of adult patients with Kaschin-Beck disease (KBD) in Qinghai Province, to understand the most affected locations in adult KBD. Methods According to the criteria of KBD diagnose (WS/T 207-2010), 111 cases of patients were taken X-ray films of right hands. Joint space narrow, joint deformity, subchondral sclerosis, osteophyte, coarse and irregularity of joint, marginal retraction sign and capsule changes were chosen as the descriptive indexes, and these indexes were analyzed with SPSS 17.0. Results A total of 111 cases adult patients with KBD were examined right hand by X-ray, abnormality on X-ray film were 103 cases, the abnormal rate was 92.79%. The most affected fingers were Ⅱ- Ⅳphalanx bones, Ⅱphalanx bones accounted for about 92.23% (95/103), Ⅲ phalanx bones accounted for about 99.03% (102/103), and Ⅳ phalanx bones accounted for about 99.03% (102/103). There was significant difference of the abnormality between th e proximal phalanx and the middle phalanx among the Ⅱ - Ⅳ phalanx bones(χ2=79.33, P<0.05). Abnormal numbers of joint deformity, marginal retraction sign, coarse and irregularity of joint, osteophyte, capsule changes and joint space narrow in the proximal phalanx were 212, 7, 134, 47, 15 and 115 in Ⅱ - Ⅳ proximal phalanx, respectively; while the abnormal numbers of joint deformity, marginal retraction sign, coarse and irregularity of joint, osteophyte, capsule changes and joint space narrow in the middle phalanx were 77, 37, 137, 26, 19 and 126 in Ⅱ - Ⅳmiddle phalanx, respectively. Conclusion The Ⅱ - Ⅳ phalanx bones of right hand are the most affected locations in adult KBD.