Objective To analyze the specific reasons for the suspension and termination of domestic medical device clinical trial projects.Based on the analysis results,provide reference suggestions and improvement measures for all parties in-volved in the trials.Methods Data collection method was used to collect samples of domestic medical device clinical trials,and visits were made to multiple medical institutions.For projects that were suspended or terminated,specific reasons were obtained through on-site interviews with research teams and clinical trial institution staff,reviewing"Project Suspension/Termination Let-ters"stored in the investigator's folder,and telephone consultations with clinical research associates(CRAs)of the projects.A contract research organization(CRO)commercial company was also visited,and specific reasons for project suspension or termi-nation were obtained through on-site interviews or telephone consultations with project managers,CRA-related personnel,etc.Descriptive analysis was used to summarize the reasons for suspension and termination and their rates.Results Statistical analy-sis showed that the suspension and termination rate of medical device clinical trials in China was 17.30％,with a rate of 16.04％in samples collected from medical institutions and 21.30％in samples collected from CRO companies.The reasons leading to the overall suspension and termination of domestic medical device clinical trials included sponsor strategy adjustments,medical insti-tution or research team issues,product or design defects,switching to registration using data from similar products,trial result-re-lated factors,third-party service provider issues,other reasons,safety-related factors,pandemic reasons,regulatory updates,and difficulties in obtaining informed consent.Conclusion The reasons for the suspension and termination of domestic medical de-vice clinical trial projects are complex and diverse,with a statistical analysis showing a rate of 17.30％in China.

Purpose To explore the clinical and pathological characteristics of gastric amphicrine carcinoma(AC).Methods Clinical data of 12 patients with gastric AC were collected,and their clinical pathological character-istics and histological morphology were observed.Immunohistochemical staining,special staining,and electron micros-copy techniques were used to analyze their immune phenotype and ultrastructure.Molecular pathology was used to de-tect microsatellite status.Relevant literature was reviewed.Results Ten cases of gastric AC were located at the junc-tion of the esophagus and stomach/cardia,1 case at the gastric angle,and 1 case in the gastric antrum.The average maximum diameter of tumors was 4.25 cm.There were different proportions of tumor cells with signet-ring like charac-teristics in all cases.Four cases had neuroendocrine carcinoma components,and another 4 had adenocarcinoma.Elev-en cases had nerve invasion and vascular cancer thrombus.Eleven cases invaded the serosal layer/submucosal layer,and 1 case invaded the submucosal layer.Ten cases had lymph node metastasis.All 12 cases showed diffuse expression of CKpan and Syn,with 3 cases showed diffuse expression of CgA and 7 cases showed diffuse expression of CD56.The average proliferation index of Ki67 was 78.9％.Special staining showed clear intracellular mucus.Electron microscopy examination revealed electron dense particles and mucus particles within the tumor cells.A total of 10 patients were fol-lowed up,of which 7 survived,and 3 patients died from multiple systemic metastases at 0,24,and 30 months postop-eratively.Conclusion Gastric AC was more common in the junction of the esophagus and stomach/cardia,and histol-ogy shows a higher invasiveness.Their clear diagnosis depends on histological morphology,immunohistochemistry,and special staining.

Objective To analyze the specific reasons for the suspension and termination of domestic medical device clinical trial projects.Based on the analysis results,provide reference suggestions and improvement measures for all parties in-volved in the trials.Methods Data collection method was used to collect samples of domestic medical device clinical trials,and visits were made to multiple medical institutions.For projects that were suspended or terminated,specific reasons were obtained through on-site interviews with research teams and clinical trial institution staff,reviewing"Project Suspension/Termination Let-ters"stored in the investigator's folder,and telephone consultations with clinical research associates(CRAs)of the projects.A contract research organization(CRO)commercial company was also visited,and specific reasons for project suspension or termi-nation were obtained through on-site interviews or telephone consultations with project managers,CRA-related personnel,etc.Descriptive analysis was used to summarize the reasons for suspension and termination and their rates.Results Statistical analy-sis showed that the suspension and termination rate of medical device clinical trials in China was 17.30％,with a rate of 16.04％in samples collected from medical institutions and 21.30％in samples collected from CRO companies.The reasons leading to the overall suspension and termination of domestic medical device clinical trials included sponsor strategy adjustments,medical insti-tution or research team issues,product or design defects,switching to registration using data from similar products,trial result-re-lated factors,third-party service provider issues,other reasons,safety-related factors,pandemic reasons,regulatory updates,and difficulties in obtaining informed consent.Conclusion The reasons for the suspension and termination of domestic medical de-vice clinical trial projects are complex and diverse,with a statistical analysis showing a rate of 17.30％in China.

Purpose To explore the clinical and pathological characteristics of gastric amphicrine carcinoma(AC).Methods Clinical data of 12 patients with gastric AC were collected,and their clinical pathological character-istics and histological morphology were observed.Immunohistochemical staining,special staining,and electron micros-copy techniques were used to analyze their immune phenotype and ultrastructure.Molecular pathology was used to de-tect microsatellite status.Relevant literature was reviewed.Results Ten cases of gastric AC were located at the junc-tion of the esophagus and stomach/cardia,1 case at the gastric angle,and 1 case in the gastric antrum.The average maximum diameter of tumors was 4.25 cm.There were different proportions of tumor cells with signet-ring like charac-teristics in all cases.Four cases had neuroendocrine carcinoma components,and another 4 had adenocarcinoma.Elev-en cases had nerve invasion and vascular cancer thrombus.Eleven cases invaded the serosal layer/submucosal layer,and 1 case invaded the submucosal layer.Ten cases had lymph node metastasis.All 12 cases showed diffuse expression of CKpan and Syn,with 3 cases showed diffuse expression of CgA and 7 cases showed diffuse expression of CD56.The average proliferation index of Ki67 was 78.9％.Special staining showed clear intracellular mucus.Electron microscopy examination revealed electron dense particles and mucus particles within the tumor cells.A total of 10 patients were fol-lowed up,of which 7 survived,and 3 patients died from multiple systemic metastases at 0,24,and 30 months postop-eratively.Conclusion Gastric AC was more common in the junction of the esophagus and stomach/cardia,and histol-ogy shows a higher invasiveness.Their clear diagnosis depends on histological morphology,immunohistochemistry,and special staining.

Objective:To compare the pregnancy and perinatal outcomes following cleavage-stage embryo transfer and blastocyst-stage embryo transfer, and to explore the best strategy of embryo transfer for infertile patients.Methods:In this retrospective cohort study, data of patients who underwent in vitro fertilization/intracytoplasmic sperm injection from January 2021 to December 2022 in Reproductive Medicine Department of the Fifth Hospital and the First Hospital of Shanxi Medical University and Jinzhong Yingtai Women's and Children's Hospital were collected. Patients were divided into cleavage-stage embryo transfer group (named D3 group, n=2 827) and blastocyst-stage embryo transfer group (named D5 group, n=1 253). The main observation indicators were large for gestational age (LGA) and preterm birth (PTB). The secondary observation indicators were multiple pregnancy, gestational age, birth weight and newborn gender. Univariate and multivariate logistic regression were applied to analyze the correlation between embryo transfer type and adverse outcomes. Results:Clinical pregnancy rate [64.5% (808/1 253)], live birth rate [55.5% (696/1 253)], implantation rate [46.0% (1 026/2 230)], multiple pregnancy rate [22.6% (183/808)], male newborn rate [58.6% (515/879)], single LGA rate [19.8% (103/520)] and single PTB rate [21.7% (113/520)] in D5 group were significantly higher than those in D3 group [54.3% (1 535/2 827), P<0.001; 48.2% (1 362/2 827), P<0.001; 36.7% (1 962/5 346), P<0.001; 19.0% (291/1 535), P=0.026; 49.7% (822/1 653), P=0.001; 7.5% (80/1 071), P<0.001; 17.2% (184/1 071), P=0.029]. LGA rate [24.8% (72/290)] in the single frozen-embryo transfer and LGA rate [13.5% (31/230)] in the single fresh-embryo transfer of D5 group were significantly higher than those of D3 group [8.8% (36/409), P<0.001; 6.6% (44/662), P=0.002]. LGA in male newborns [24.8% (82/330)] and female newborns [11.1% (21/190)] of D5 group were significantly higher than those of D3 group [9.1% (54/592), a OR=2.95, 95% CI: 2.01-4.33, P<0.001; 5.4% (26/479), a OR=2.04, 95% CI: 1.10-3.77, P=0.024]. Conclusion:The risk of LGA and premature birth in blastocyst-stage embryo transfer is higher than that in cleavage-stage embryo transfer. In clinical practice, embryo transfer methods should be selected based on the condition of patient and embryo.

Objective:To compare the pregnancy and perinatal outcomes following cleavage-stage embryo transfer and blastocyst-stage embryo transfer, and to explore the best strategy of embryo transfer for infertile patients.Methods:In this retrospective cohort study, data of patients who underwent in vitro fertilization/intracytoplasmic sperm injection from January 2021 to December 2022 in Reproductive Medicine Department of the Fifth Hospital and the First Hospital of Shanxi Medical University and Jinzhong Yingtai Women's and Children's Hospital were collected. Patients were divided into cleavage-stage embryo transfer group (named D3 group, n=2 827) and blastocyst-stage embryo transfer group (named D5 group, n=1 253). The main observation indicators were large for gestational age (LGA) and preterm birth (PTB). The secondary observation indicators were multiple pregnancy, gestational age, birth weight and newborn gender. Univariate and multivariate logistic regression were applied to analyze the correlation between embryo transfer type and adverse outcomes. Results:Clinical pregnancy rate [64.5% (808/1 253)], live birth rate [55.5% (696/1 253)], implantation rate [46.0% (1 026/2 230)], multiple pregnancy rate [22.6% (183/808)], male newborn rate [58.6% (515/879)], single LGA rate [19.8% (103/520)] and single PTB rate [21.7% (113/520)] in D5 group were significantly higher than those in D3 group [54.3% (1 535/2 827), P<0.001; 48.2% (1 362/2 827), P<0.001; 36.7% (1 962/5 346), P<0.001; 19.0% (291/1 535), P=0.026; 49.7% (822/1 653), P=0.001; 7.5% (80/1 071), P<0.001; 17.2% (184/1 071), P=0.029]. LGA rate [24.8% (72/290)] in the single frozen-embryo transfer and LGA rate [13.5% (31/230)] in the single fresh-embryo transfer of D5 group were significantly higher than those of D3 group [8.8% (36/409), P<0.001; 6.6% (44/662), P=0.002]. LGA in male newborns [24.8% (82/330)] and female newborns [11.1% (21/190)] of D5 group were significantly higher than those of D3 group [9.1% (54/592), a OR=2.95, 95% CI: 2.01-4.33, P<0.001; 5.4% (26/479), a OR=2.04, 95% CI: 1.10-3.77, P=0.024]. Conclusion:The risk of LGA and premature birth in blastocyst-stage embryo transfer is higher than that in cleavage-stage embryo transfer. In clinical practice, embryo transfer methods should be selected based on the condition of patient and embryo.

Department of Orthopedics, Yang Pu Hospital Affiliated to Tongji University,

Objective ① To investigate the level of the vitamin D endocrine system in peripheral relationships with bone mineral density (BMD) and the disease activity respectively. Methods The level of the 25-hydroxylate vitamin D3 (25OHD3) and 1,25-dihydroxyvitamin D3 [1,25(OH)D3] in plasma from 43 SLE patients and 44 normal controls were detected by enzyme linked immunosorbent assay. Vitamin D receptor (VDR) gene expression was determinied by real-time PCR in peripheral blood. BMD measurements in the lumbar spine (L1-4) and left proximal femur (femoral neck) were performed using dual X-ray absorptiometry before treatment. The relationship between the vitamin D endocrine system and the bone mass were studied. We also discussed the relationship between the vitamin D endocrine system and the disease activity. Results The levels of 25OHD3 and 1,25 (OH)2D3 were lower in the initial SLE patients than normal controls (P<0.01, P<0.01). The expressions of VDR gene were significantly increased in initial SLE compared with normal controls (P<0.01). The initial SLE patients had significantly lower BMD values, and higher frequency of osteopenia (35%) at both sites of measurement compared with matched healthy controls (P<0.01). The initial SLE patients were divided into two groups by BMD, abnormal group and normal group. There were no differences in 25OHD3, 1,25 (OH)D3 and VDR gene expression (P0.05). There was no correlation between the vitamin D endocrine system and BMD in initial SLE patients. There was no correlation between the vitamin D endocrine system and the disease activity either. Conclusion Vitamin D endocrine system may play an important role in SLE, but the level of VDR gene is not correlated with BMD and disease activity.