Objective To provide references for the registration and implementation of related clinical trials by analyzing the current status of clinical trial registration of TCM for the treatment of cervical spondylosis.Methods Relevant clinical trials of TCM for the treatment of cervical spondylosis were retrieved from China Clinical Trial Registry,International Clinical Trial Registry Platform and US Clinical Trials Registry database from the establishment to 1 July 2024.The relevant data were extracted and entered into Excel 2019,and GraphPad Prism 9.0 was used to statistically analyse the registration characteristics of clinical trials of TCM for the treatment of cervical spondylosis.Results A total of 126 clinical trials of TCM for the treatment of cervical spondylosis were included in this study,of which 112 were interventional studies.Domestic registrations covered a total of 19 provincial administrative regions,with the top two being Shanghai and Guangdong Province.The research on disease types included all subtypes of cervical spondylosis,with the largest number of registered items(37 items,29.37%)related to cervical spondylostic radiculopathy,followed by projects with unspecified cervical spondylosis subtypes(44 projects,34.92%).Research projects from universities and affiliated hospitals accounted for 89.7%(113 projects),with Guangdong Provincial Hospital of Traditional Chinese Medicine(12 projects)registering the most projects.Totally 110 research projects were funded,with local financial support accounting for 39.09%(43 projects)and national financial support accounting for 16.36%(18 projects).The study designs were mainly randomized parallel controlled studies(112 projects,88.9%),mostly single-centre research projects(92 projects,73.0%),with sample sizes concentrated between 50-200(86 projects,68.3%).The interventions were mostly external TCM treatments,such as acupuncture(41 items,32.5%)and tuina(23 items,18.3%).Conclusion The number of registered clinical trials of TCM for the treatment of cervical spondylosis has shown a fluctuating upward trend,but there are problems such as a small number,uneven geographical development,low methodological quality,mostly single-centre trials,and a lack of projects with Chinese materia medica intervention projects.

Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4％)were phase Ⅰ clinical trials,17(17.9％)were phase Ⅱ clinical trials,19(20.0％)were phase Ⅲ clinical trials,and 13(13.7％)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.

Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4％)were phase Ⅰ clinical trials,17(17.9％)were phase Ⅱ clinical trials,19(20.0％)were phase Ⅲ clinical trials,and 13(13.7％)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.

Objective To provide references for the registration and implementation of related clinical trials by analyzing the current status of clinical trial registration of TCM for the treatment of cervical spondylosis.Methods Relevant clinical trials of TCM for the treatment of cervical spondylosis were retrieved from China Clinical Trial Registry,International Clinical Trial Registry Platform and US Clinical Trials Registry database from the establishment to 1 July 2024.The relevant data were extracted and entered into Excel 2019,and GraphPad Prism 9.0 was used to statistically analyse the registration characteristics of clinical trials of TCM for the treatment of cervical spondylosis.Results A total of 126 clinical trials of TCM for the treatment of cervical spondylosis were included in this study,of which 112 were interventional studies.Domestic registrations covered a total of 19 provincial administrative regions,with the top two being Shanghai and Guangdong Province.The research on disease types included all subtypes of cervical spondylosis,with the largest number of registered items(37 items,29.37%)related to cervical spondylostic radiculopathy,followed by projects with unspecified cervical spondylosis subtypes(44 projects,34.92%).Research projects from universities and affiliated hospitals accounted for 89.7%(113 projects),with Guangdong Provincial Hospital of Traditional Chinese Medicine(12 projects)registering the most projects.Totally 110 research projects were funded,with local financial support accounting for 39.09%(43 projects)and national financial support accounting for 16.36%(18 projects).The study designs were mainly randomized parallel controlled studies(112 projects,88.9%),mostly single-centre research projects(92 projects,73.0%),with sample sizes concentrated between 50-200(86 projects,68.3%).The interventions were mostly external TCM treatments,such as acupuncture(41 items,32.5%)and tuina(23 items,18.3%).Conclusion The number of registered clinical trials of TCM for the treatment of cervical spondylosis has shown a fluctuating upward trend,but there are problems such as a small number,uneven geographical development,low methodological quality,mostly single-centre trials,and a lack of projects with Chinese materia medica intervention projects.

Objective To standardize the management of clinical trials in our hospital,reduce the incidence of protocol deviations,and provide a reference for improving the quality of clinical trials.Methods The healthcare failure mode and effect analysis(HFMEA)method was used to determine the potential failure modes of the current protocol deviation.The frequency,severity and detectability of failure modes were quantified and evaluated.The risk priority number(RPN)was calculated and the corresponding improvement measures were proposed.The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect.Results After the implementation of HFMEA activities,the RPN values of 14 potential failure modes decreased significantly(P<0.05);The risk level of 12 potential failure modes decreased.The HFMEA team members'ability in finding and solving problems,communication and cooperation were significantly improved.Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials,can effectively reduce the occurrence of protocol deviation,and provides experience for improving the quality of drug clinical trials.

Objective To investigate the change rule of T1ρ value in the process of lumbar intervertebral disc degeneration(IVDD)based on Pfirrmann grading by Meta-analysis.Methods PubMed,EMBASE,Cochrane Library,CNKI,Wanfang Data,VIP and Sinomed were searched to collect studies on quantitative assessment of IVDD using T1ρ imaging technology.The retrieval time limit was from the establishment of the database to December 20,2022.Meta-analysis was performed using RevMan 5.4 and Stata 14.0 software.Results A total of 12 articles were included,and the numbers of Pfirrmann grade Ⅰ-Ⅴ lumbar discs were 316,1 460,769,430 and 98,respectively.T1ρ relaxation time decreased gradually with the increase of the grade of degeneration.The T1ρ values of grade Ⅰlumbar discs were significantly higher than those of grade Ⅱ lumbar discs[weighted mean difference(WMD)=14.55,95%confidence interval(CI)6.35-22.75,P<0.01],and the T1ρ values of grade Ⅱ lumbar discs were significantly higher than those of grade Ⅲlumbar discs(WMD=34.20,95%CI 27.05-41.34,P<0.01).The T1ρ values of grade Ⅲ lumbar discs were significantly higher than that of grade Ⅳ lumbar discs(WMD=22.94,95%CI 17.08-28.80,P<0.01).The T1ρ values of grade Ⅳ lumbar discs were significantly higher than that of grade Ⅴ lumbar discs(WMD=9.35,95%CI 6.81-11.89,P<0.01).Conclusion T1ρ imaging technology can objectively and quantitatively evaluate degeneration at different stages,especially sensitive to IVDD in the early and middle stages,which can provide imaging evidence for clinical diagnosis of early IVDD.

Methods: This retrospective study analyzed patients who underwent chest CT and DXA at our hospital between August 2021 and August 2022. Thoracic thoracolumbar segment HU values, lumbar T-scores, and hip T-scores were computed for comparison, and thoracic thoracolumbar segment HU thresholds suggestive of potential bone density abnormalities were established using receiver operating characteristic curves. Results: In total, 470 patients (72.4% women; mean age, 65.5±12.3 years) were included in this study. DXA revealed that of the 470 patients, 90 (19%) had osteoporosis, 180 (38%) had reduced osteopenia, and 200 (43%) had normal bone mineral density (BMD). To differentiate osteoporosis from osteopenia, the HU threshold was established as 105.1 (sensitivity, 54.4%; specificity, 72.2%) for T11 and 85.7 (sensitivity, 69.4%; specificity, 61.1%) for T12. To differentiate between osteopenia and normal BMD, the HU threshold was 146.7 for T11 (sensitivity, 57.5%; specificity, 84.4%) and 135.7 for T12 (sensitivity, 59.5%; specificity, 80%). Conclusions This study supports the significance of HU values from chest CT for BMD assessment. Chest CT provides a new method for clinical opportunistic screening of osteoporosis. When the T11 HU is >146.7 or the T12 HU is >135.7, additional osteoporosis testing is not needed unless a vertebral fracture is detected. If the T11 HU is <105.1 or the T12 HU is <85.7, further DXA testing is strongly advised. In addition, vertebral HU values that fall faster than those of the T11 and L1 vertebrae may explain the high incidence of T12 vertebral fractures.