Objective To explore change and significance of serum and urinary transforming growth factor-? 1(TGF-? 1)in the patients with primary chronic glomerulonephropathy (PCG). Methods 65 patients with PCG were divided into four groups according to the degree of renal function damage: normal renal function,renal compensatory,renal decompensatory and renal function failure groups. Levels of serum and urinary TGF-? 1 were determined with ELISA, and the levels of urinary protein and renal function were examined as well. Results Levels of serum and urinary TGF-? 1 in patients with PCG were singificantly higher than those in control, and the levels of serum and urinary TGF-? 1 among four groups were significantly different. The TGF-? 1 level of urinary was associated with the degree of renal function damage(r=0 28,P

Background: Tibiotalocalcaneal arthrodesis is an established surgical procedure for treating patients with end-stage ankle joint arthritis and subtalar joint arthritis. Although it greatly relives pain, a major drawback is loss of range of motion. Although it is known to restrict an additional subtalar joint compared to tibiotalar arthrodesis, there is a lack of gait analysis studies comparing the two methods. This study aimed to evaluate the differences in kinematics of the foot and ankle joints between tibiotalar and tibiotalocalcaneal arthrodesis. We also compared preoperative and postoperative statuses for each surgical method. Methods: The study included 12 and 9 patients who underwent tibiotalar and tibiotalocalcaneal arthrodesis, respectively, and 40 healthy participants were included in the control group. The DuPont foot model was used to analyze intersegmental foot and ankle kinematics during gait. Results: Compared to controls, both tibiotalar and tibiotalocalcaneal arthrodesis resulted in slow gait speed with reduced stride length, increased step width, and decreased range of sagittal plane motion. Both fusion methods showed similar range of motion in all segments and planes following surgery. Coronal positions showed more supination of the forefoot and pronation of the hindfoot segment after each operation, particularly tibiotalocalcaneal arthrodesis. Gait after tibiotalocalcaneal arthrodesis did not significantly differ from that after tibiotalar arthrodesis, but there was a tendency of more pronation in the hindfoot segment. Conclusions Both fusion methods limited foot and ankle motion in similar ways. Comparing tibiotalar and tibiotalocalcaneal arthrodesis suggests that additionally fusing the subtalar joint does not cause greater movement restriction in patients. Objectively comparing tibiotalar and tibiotalocalcaneal arthrodesis will facilitate further understanding of the effect of tibiotalocalcaneal arthrodesis on movement and the value of subtalar joint motion for improved preoperative counselling.

Objective:In order to put forward relevant measures and suggestions to improve the quality of the Investigator-Initiated Trials of oncology in medical institutions.Methods:Through literature research, comparative study, combined with the implementation and management of investigator initiated trials, the current status and challenges of the administration of these trials were analyzed.Results:Investigator-Initiated Trials of oncology become increasingly important. However, its quality is poor compared with Industry-Sponsored Trials due to insufficient funds and lack of effective supervision. Besides, four main challenges as follows were identified: lack of clinical research professionals, the quality concerns of ethical review in some institutions, insufficient funding for clinical research, and imperfect quality management system.Conclusions:Based on the actual needs of IITs of oncology, medical institutions should strengthen the talent cultivation, establish electronic information management platform, increase project support, strengthen scientific research supervision and deepen the awareness of risk prevention to improve the quality of investigator initiated trials.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective:To analyze the current situation of Investigator-Initiated Trials in medical and health institutions in Shandong Province, the problems in the process of conducting clinical research, and put forward proposals for the establishment of a clinical research management system with effective supervision, sound systems and supporting services, taking into account the progress of the projects since the pilot work was carried out.Methods:A questionnaire was created, an online survey was conducted, a database was set up, a status analysis was conducted and a post-launch analysis of the progress of the pilot was carried out using the National Medical Research Registry Information System, culminating in recommendations using the literature summary method and empirical analysis.Results:Statistical analysis of the questionnaire found that 29.39% of the institutions have a dedicated clinical research management department, and 75.97% of the institutions have a management approach. 25.52%, 40.30%, and 43.07% of institutions established biobanks, clinical research centers, and follow-up centers. There was a statistically significant difference in the establishment of clinical research centers, biobanks, and follow-up centers in secondary and tertiary medical institutions ( P<0.05). The number of general clinical research projects filed, the number of submissions and the number of ethics committees filed in the filing system have all increased significantly after the pilot work, with growth percentages of 126%, 141% and 62% respectively. Conclusions:Shandong Province clinical research pilot work has begun to bear fruit, the current clinical research project still exists in the lack of special funding support, perfect service platform and system support and training system to be improved and other issues.