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find Keyword "Clinical trial" 98 results
  • The Application of Central Randomization System in Clinical Trials

    Objective To introduce the use of Central Randomization System in clinical trials. Methods We discussed the application of Central Randomization System in clinical trials from object management, drug management and user management, and made a brief description of minimization method. Results Central Randomization Systems can guarantee the nnplementation of the scheme of randomization, and can be used in clinical trials with minimization. Conclusion Central Randomization Systems are feasible in clinical trials especially in traditional Chinese medicine and open clinical trials.

    Release date:2016-09-07 02:26 Export PDF Favorites Scan
  • The efficacy of absorbable barbed suture versus traditional absorbable suture in total knee arthroplasty: a meta-analysis

    ObjectivesTo systematically review the efficacy of absorbable barbed suture versus traditional absorbable suture in total knee arthroplasty (TKA).MethodsPubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect clinical trials of absorbable barbed suture versus traditional absorbable suture in TKA from inception to November, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 randomized controlled trials (RCTs) and 5 cohort studies were included, involving 2 008 patients. Meta-analysis showed that the joint capsule suture time of the absorbable barbed suture group [MD=–4.31, 95% CI (–4.72, –3.90), P<0.000 01], the incidence of acupuncture injury during suture [OR=0.14, 95% CI (0.03, 0.61),P=0.009], and incision complication rate [OR=0.56, 95% CI (0.36, 0.88), P=0.01] were significantly lower than the traditional absorbable suture group, but the incidence of suture fracture [OR=23.03, 95% CI (3.08, 172.09),P=0.002] was higher, yet the difference was statistically significant. There were no significant differences in the incidence of superficial infection, deep infection, aseptic redness, incision dehiscence and KSS score at 3 months after operation (P>0.05).ConclusionsAvailable evidence suggests that the use of absorbable barbed sutures to close the TKA surgical incision shortens the time to suture the joint capsule, reduces the incidence of acupuncture injury as well as the overall incidence of incision complications without increasing superficial infection, deep infection, and sterility. The incidence of redness and incision splitting has no significant effects on joint function at 3 months after surgery, however the incidence of suture fracture is higher. Due to limited quality and quantity of the included studies, the above conclusions are required to be verified by more high-quality studies.

    Release date:2018-10-19 01:55 Export PDF Favorites Scan
  • Commentary on the Chinese Translation of the CONSORT Extension for Harms

    Release date:2016-09-07 02:25 Export PDF Favorites Scan
  • Updates of European clinical trials in hyperthermic intraperitoneal chemotherapy for gastric and colorectal cancers

    Hyperthermic intraperitoneal chemotherapy (HIPEC) has been used in clinical setting, and is one of the optional treatment for peritoneal surface tumors. It can be used as adjuvant therapy to prevent peritoneal recurrence after gastric or colorectal cancer resection, or to treat those diseases with peritoneal metastasis alone through cytoreductive surgery +HIPEC or HIPEC alone, based on a multidisciplinary model. The updates of European HIPEC-related clinical trials, GASTRIPEC, GASTRICHIP, PRODIGE 7, PROPHYLOCHIP, COLOPEC, COMBATAC, were reported at the 11th International Workshop on Peritoneal Surface Malignancy. In those trials, there was no definitive result surporting that HIPEC treatment might bring survival benefits to patients with gastric or colorectal cancer. However, long-term follow-up results remain to be seen, and some studies are still recruiting. Although several studies were designed as phase Ⅲ trials, the overall sample size was small-scaled. In addition, in the trials, diagnostic laparoscopy were widely used in gastric or colorectal cancer patients, which was helpful to improve staging accuracy and optimizing treatment strategies. The indications for HIPEC therapy (peritoneal cancer index) and technical issues (duration, temperature, approach, and agents) need further investigate.

    Release date:2018-12-24 02:03 Export PDF Favorites Scan
  • Promoting standardization of clinical trial data management in China

    Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.

    Release date:2018-06-20 02:05 Export PDF Favorites Scan
  • Development and changes of quality control of clinical trials in China

    The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the development direction of quality control in clinical trials in China is explored in order to improve the overall level of clinical trials in China.

    Release date:2018-08-14 02:01 Export PDF Favorites Scan
  • Exploration and establishment of individual applicability evaluation method on traditional Chinese medicine clinical trials

    In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.

    Release date:2021-08-19 03:41 Export PDF Favorites Scan
  • Development and changes of CRO of clinical trials in China

    In recent years, CRO has developed rapidly in China, and has played an important role in improving the level of Chinese clinical trials and drug development. However, the development of CRO industry also has problems. This paper discusses the beneficial factors of the main problems and the future direction of CRO, in attempt to attract the attention of government supervision and management departments and CRO industries.

    Release date:2018-08-14 02:01 Export PDF Favorites Scan
  • A review of the ethical issues related to the use of placebo controls in conducting clinical trials

    Controversy exists regarding the ethics of using placebo control groups in clinical trials when effective treatments exist. The debate was fueled by the announcement of the 5th revision of the Declaration of Helsinki (2000). This study reviews the history and scientific background surrounding the controversy and investigates the prevailing attitudes of Hong Kong researchers regarding this issue. The controversy has centered on a few issues. The first involves the methodological superiority of placebo-controlled trials in discerning treatment effects. Secondly, it is unclear if the treatment effects encompass absolute treatment effects (including placebo effects) or are confined to treatment-specific effects (excluding placebo effects). Thirdly, there are worries that subjects in the placebo group could be exposed to higher risk for developing serious adverse events. Fourthly, it is debated whether the standard of best available treatment should be a local one, or an international one. Preliminary research findings suggest that the opinions of the Hong Kong researchers seemed to be divided on the use of placebo control groups in clinical trials when effective treatment exists. Further researcher on the topic is therefore warranted, training and consensus meeting may be necessary to minimize the confusion related to this issue.

    Release date:2016-09-07 02:29 Export PDF Favorites Scan
  • Consolidated Standards for Reporting Trials of Traditional Chinese Medicine (CONSORT for TCM) (For Solicitation of Comments)

    Release date:2016-09-07 02:16 Export PDF Favorites Scan
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