Objective To systematically evaluate the efficacy and safety of iris-registration in wavefront-guided LASIK (IR+WG LASIK) versus conventional LASIK for correction of myopia accompanied with astigmatism. Methods Such databases as PubMed, EMbase, The Cochrane library (Issue 2, 2012), CBM, CNKI, VIP, and WangFang Data were searched to collect the randomized controlled trials (RCTs) and quasi-RCTs about IR+WG LASIK versus conventional LASIK for correction of myopia accompanied with astigmatism. The retrieval time was from inception to February 2012, and the language was in both Chinese and English. Two reviewers independently screened the literature, extracted the data and assessed the quality of the included studies. Then the meta-analysis was performed by using RevMan 5.1 software. Results A total of 9 studies involving 3 903 eyes were included. The results of meta-analysis showed that, compared with the conventional LASIK group, the IR+WG LASIK group had a higher ratio in patients with postoperative uncorrected visual acuity no less than 1.0 (RR=1.03, 95%CI 1.01 to 1.05, P=0.002), as well as in patients with best-corrected visual acuity gained over 1 line (RR=1.75, 95%CI 1.49 to 2.16, Plt;0.000 01); it was smaller in the postoperative high order aberration RMS (WMD=?0.16, 95%CI ?0.21 to ?0.11, Plt;0.000 01), coma-like RMS (WMD=?0.05, 95%CI ?0.11 to 0.00, P=0.07), spherical-like RMS (WMD=?0.15, 95%CI ?0.23 to ?0.07, P=0.000 2), and residual astigmatism (WMD=0.14, 95%CI 0.10 to 0.18, Plt;0.000 01); moreover, it was lower in the incidence of postoperative glare (RR=0.27, 95%CI 0.15 to 0.50, Plt;0.000 1), and it was higher in the subjective satisfaction of patients (RR=1.08, 95%CI 1.04 to 1.13, P=0.000 3). Conclusion Compared with conventional LASIK, IR+WG LASIK can more effectively reduce astigmatism, postoperative high order aberration RMS and spherical-like RMS. It can also get visual function including uncorrected visual acuity and best-corrected visual acuity, consequently increase patient’s satisfaction. But further studies are still required for its long-term effect.
Objective To investigate the number of Chinese clinical trials and the completeness of registered information on the source of their funding. Methods We searched the five primary registers in the World Health Organization’s International Clinical Trial Registration Platform to identify Chinese clinical trials, calculated the number Chinese clinical trials with specific funding and evaluated the completeness of the information on the source of this funding. Results We identified 383 registered Chinese clinical trials, of which 219 (27 trials per year on average) were registered in clinicaltrials.gov, 94 in the Chinese Clinical Trial Register Center (113 per year on average), 62 in controlled-trials.com (12.4 per year on average) and 8 (1.6 per year on average) in the Australian and New Zealand Clinical Trials Registry. 360 trials had some information on their source of funding: 230 from the mainland of China (62 funded by colleges/universities, 47 by national/local organizations, 47 by the Ministry of Science and Technology, 34 by hospitals, 28 by commercial organizations, 9 by international foundations, and 3 by the Ministry of Health), 117 from Hongkong and 13 from Taiwan. The information in the registers on the source of funding was incomplete. Conclusion The number of funded Chinese clinical trials in these registers is too small. The registrations should be improved to improve the completeness of information on the source of funding. It is important to disseminate the importance of registering clinical trials and doing so in a local register to promote the transparency and accessibility of trial registration.
By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
Objective To analyze the current research status, characteristics and development trends of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyze the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The trial sponsors of the study covered 9 countries and a total of 34 provinces/autonomous regions/municipalities in China, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. A total of 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and 213 large-sample studies with a sample size of more than 1 000 cases were included. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral prescription of herbal medicine interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule intervention studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.
Non-rigid medical image registration is a popular subject in the research areas of the medical image and has an important clinical value. In this paper we put forward an improved algorithm of Demons, together with the conservation of gray model and local structure tensor conservation model, to construct a new energy function processing multi-modal registration problem. We then applied the L-BFGS algorithm to optimize the energy function and solve complex three-dimensional data optimization problem. And finally we used the multi-scale hierarchical refinement ideas to solve large deformation registration. The experimental results showed that the proposed algorithm for large deformation and multi-modal three-dimensional medical image registration had good effects.
Objective To evaluate the quality of the registration information for trials sponsored by China registered in the WHO International Clinical Trial Registration Platform (ICTRP) primary registries or other registries that meet the requirements of the International Committee Medical Journal Editor (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry – India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scoreda median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.
ObjectivesTo analyze the development of acupuncture registered trials based on WHO international clinical trial registration platform (ICTRP) in the past 5 years.MethodsWHO ICTRP database was electronically searched to collect acupuncture-related clinical trials registered from January 1st, 2014 to December 31st, 2018. Two reviewers independently screened items, extracted data, and descriptive analysis was performed for the included trials.ResultsThe results showed that there were 1 556 registered clinical trials on acupuncture, and the most registered year was 2017. China was in the main country in applying for acupuncture-related clinical trials, however, the most registered unit was Kyung Hee University in Korea. The trials were mainly interventional research, mostly used randomized, blinded methods, and design modes were mainly based on parallel trials. In clinical trial phase, the majority were in the clinical trial period of treatment of new technologies. The field of clinical research was expected to be on pain in the future.ConclusionsAlthough acupuncture research is currently in a good stage of development, it should still value on the quality and innovative training of relevant trials, strengthen Chinese ties with other countries, focus on regional, domestic and international cooperation, expand research types, and enhance acupuncture applicability.
Craniofacial malformation caused by premature fusion of cranial suture of infants has a serious impact on their growth. The purpose of skull remodeling surgery for infants with craniosynostosis is to expand the skull and allow the brain to grow properly. There are no standardized treatments for skull remodeling surgery at the present, and the postoperative effect can be hardly assessed reasonably. Children with sagittal craniosynostosis were selected as the research objects. By analyzing the morphological characteristics of the patients, the point cloud registration of the skull distortion region with the ideal skull model was performed, and a plan of skull cutting and remodeling surgery was generated. A finite element model of the infant skull was used to predict the growth trend after remodeling surgery. Finally, an experimental study of surgery simulation was carried out with a child with a typical sagittal craniosynostosis. The evaluation results showed that the repositioning and stitching of bone plates effectively improved the morphology of the abnormal parts of the skull and had a normal growth trend. The child’s preoperative cephalic index was 65.31%, and became 71.50% after 9 months’ growth simulation. The simulation of the skull remodeling provides a reference for surgical plan design. The skull remodeling approach significantly improves postoperative effect, and it could be extended to the generation of cutting and remodeling plans and postoperative evaluations for treatment on other types of craniosynostosis.
We applied Demons and accelerated Demons elastic registration algorithm in radiotherapy cone beam CT (CBCT) images, We provided software support for real-time understanding of organ changes during radiotherapy. We wrote a 3D CBCT image elastic registration program using Matlab software, and we tested and verified the images of two patients with cervical cancer 3D CBCT images for elastic registration, based on the classic Demons algorithm, minimum mean square error (MSE) decreased 59.7%, correlation coefficient (CC) increased 11.0%. While for the accelerated demons algorithm, MSE decreased 40.1%, CC increased 7.2%. The experimental verification with two methods of demons algorithm obtained the desired results, but the small difference appeared to be lack of precision, and the total registration time was a little long. All these problems need to be further improved for accuracy and reducing of time.
