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.
This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.
Objective To explore and solve the key technologies of the three dimensional (3D) visual ization reconstruction of functional fascicular groups inside long segmented peri pheral nerve. Methods A 20 cm ulnar nerve from upper arm of fresh adult dead body was embedded by OCT with four pieces of woman’s hair which was used as locating material, then the samples were serially horizontally sl iced into 400 sl ices with 15 μm thickness and 0.5 mm interval. All sl iceswere stained with acetylcholinesterase (AchE) histochemical staining. After that, the 2D panorama images of the same sl ice were obtained with Olympus stereomicroscope and MSHOT MD90 micro figure image device before and after AchE staining. Using the layer processing technique of Photoshop image processing software, the recomposition images including complete 4 location pots were obtained, based on which the algorithm of optimized least square support vector machine (Optimized LS-SVM) and space transformation method was used to fulfill automatic registration. Finally, with artificial assistant outline obtaining, the 3D visual ization reconstruction model of functional fascicular groups of 20 cm ulnar nerve was made using Amira 4.1, and the effects of reverse reduction and the suitabil ity of 3D reconstruction software were evaluated. Results The two-time imaging technique based on the layer process of Photoshop image processing software had the advantages: the image outline had high goodness of fit; the locating pots of merging image was accurate; and the whole procedure was simple and fast. The algorithm of Optimized LS-SVM had high degree of accuracy, and the error rate was only 8.250%. The 3D reconstruction could display the changes of the chiastopic fusion of different nerve functional fascicular groups directly. It could extract alone, merge and combine arbitrarily, and revolve at any angles. Furthermore, the reverse reduction on arbitrarily level dissection of the 3D model was very accurately. Conclusion Based on the two-time imaging technique and computer image layer processing technology, the compute algorithm of auto-registration can be developed and appl ied to 3D visual ization reconstruction of long segmented peripheral nerve. The technological processes is fast, and the reconstruction effect is good.
The registration of preoperative magnetic resonance (MR) images and intraoperative ultrasound (US) images is very important in the planning of brain tumor surgery and during surgery. Considering that the two-modality images have different intensity range and resolution, and the US images are degraded by lots of speckle noises, a self-similarity context (SSC) descriptor based on local neighborhood information was adopted to define the similarity measure. The ultrasound images were considered as the reference, the corners were extracted as the key points using three-dimensional differential operators, and the dense displacement sampling discrete optimization algorithm was adopted for registration. The whole registration process was divided into two stages including the affine registration and the elastic registration. In the affine registration stage, the image was decomposed using multi-resolution scheme, and in the elastic registration stage, the displacement vectors of key points were regularized using the minimum convolution and mean field reasoning strategies. The registration experiment was performed on the preoperative MR images and intraoperative US images of 22 patients. The overall error after affine registration was (1.57 ± 0.30) mm, and the average computation time of each pair of images was only 1.36 s; while the overall error after elastic registration was further reduced to (1.40 ± 0.28) mm, and the average registration time was 1.53 s. The experimental results show that the proposed method has prominent registration accuracy and high computational efficiency.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
Objective To establishadatabase to fully investigate current situation of antiepileptic drugs among pregnant women with epilepsy in West China. Analyzing the epidemiological characteristics and correlated influence factors of anti-epileptic drugs use among women with epilepsy in this area to promote management quality for women with epilepsy. Methods Adigital registration system was established with JAVA andastandard registration procedure was formulated. Standard registration was implemented in different levels of hospital of West China with regular follow-up. Results Registration system about antiepileptic drugs among pregnant women with epilepsy in West China was successfully established, which wasadigital registration within local area network. Information about registration centre and pregnant women with epilepsy was collected in the West China registration network. And elementary database was successfully established. Conclusion This is the first extensive and standard pregnancy register of antiepileptic drugs in China which meet the need of not only patient information management but also the development of academic subject.
Coronary angiography (CAG) as a typical imaging modality for the diagnosis of coronary diseases hasbeen widely employed in clinical practices. For CAG-based computer-aided diagnosis systems, accurate vessel segmentation plays a fundamental role. However, patients with bradycardia usually have a pacemaker which frequently interferes the vessel segmentation. In this case, the segmentation of vessels will be hard. To mitigate interferences of pacemakers and then extract main vessels more effectively in CAG images, we propose an approach. At first, a pseudo CAG (pCAG) image is generated through a part of a CAG sequence, in which the pacemaker exists. Then, a local feature descriptor is employed to register the relative location of pacemaker between the pCAG image and the target CAG image. Finally, combining the registration result and segmentation results of main vessels and pacemaker, interferences of pacemaker are removed and the segmentation of main vessels is improved. The proposed method is evaluated based on 11 CAG images with pacemakers acquired in clinical practices. An optimization ratio of the Dice coefficient is 12.04%, which demonstrates that our method can remove overlapping pacemakers and achieve the improvement of main vessel segmentation in CAG images.Our method can further become a helpful component in a CAG-based computer-aided diagnosis system, improving its diagnosis accuracy and efficiency.
Objective To explore the certification management of specialty nurses in China based on the existent problems to provide evidence for practice and decision making for management of the specialty nurses. Methods The modified Delphi technique was applied in this study from July to December 2017. A structured consultation questionnaire based on expert interview and literature review was designed, and modified after preliminary experiment. Then the questionnaires were delivered to 32 nurse experts to complete 3 rounds of Delphi process, which reached consensus gradually. Results The response rates of three round consultations were 96.9% (31/32), 100.0% (31/31), and 96.8% (30/31), respectively. The suggestion rates were 25.8% (8/31), 16.1% (5/31), 0% (0/31), respectively. The familiar coefficient, adjustment coefficient and authority coefficient was 0.82, 0.87 and 0.85, respectively. The experts had the agreement finally for all of the 16 items in the consultation questionnaire, and they formed an expert opinion draft on specialty nurse certification and registration. Conclusion It’s crucial and essential to establish a certification and registration system in China and renew the credentials regularly to promote the management and construction of specialty nurse team.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
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.