Clinical trial, an important research method, plays a crucial role in the development of medicine. It provides important decision support for medical workers. Medical research proposal should be posted at clinical trial registries. Researchers should update original data and research results, which contributes to data sharing. Clinical trial registration can avoid repetitive research and make clinical trials more transparent and standardized. This paper briefly introduces the clinical trial registration, including the definition, the significance, the history, the scope of registration, the organization of registration, and some common problems in the process of registration. Taking the application of clinical trial registration in the field of neurological research as an example, the article describes the current application status of clinical trial registration and explores it’s value and deficiency in specific clinical research, to provoke the awareness on trial registration, which can help to improve the quality of clinical trials.
ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Objective To investigate the correlation of intracranial arachnoid cyst (IAC) with epilepsy and the possible mechanism of seizure induced by IAC. Methods Patients with IAC, who were treated in West China Hospital of Sichuan University between January 2009 and January 2019, were included and divided into IAC with epilepsy group and IAC without epilepsy group according to whether they were diagnosed with epilepsy. We collected the IAC location information of all subjects after the establishment of a three-dimensional spatial coordinate system of MRI images. Computational fluid dynamics technology was used to establish a blood vessel model in cyst area and perform hemodynamic analysis basing on contrast-enhanced CT images. Results A total of 72 patients were enrolled, including 24 in the IAC with epilepsy group and 48 in the IAC without epilepsy group. There was no significant difference between the two groups in terms of sex, age, IAC location, the volumes or the maximum diameters of IAC (P>0.05). Consecutive areas formed by the seven high-risk areas found in the IAC with epilepsy group were located in the temporal area. The seven high-risk areas were simultaneous IAC location in 5 patients in the IAC with epilepsy group and in 1 patient in the IAC without epilepsy group, and the difference was statistically significant (χ2=5.114, P=0.024). Comparison of the hemodynamic parameters between the two types of vascular models revealed similar pressure changes and blood pressure parameters, with lower blood flow and higher mean vascular wall shear stress in the IAC with epilepsy group. Conclusions IAC may cause epilepsy by increasing adjacent blood vessel stenosis and blood vessel wall shear stress through cyst space-occupying effect. The most common location of IAC with epilepsy is the temporal area. The occupying effect of IAC should be considered in the location of epileptogenic foci before surgery for IAC patients with epilepsy.