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Zhongguo Zhong Yao Za Zhi · Apr 2021
[Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0)].
At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). ⋯ The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
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Review Meta Analysis
Incidence of Subsidence of 7 intervertebral Devices in Anterior Cervical Discectomy and Fusion: A Network Meta-analysis.
Subsidence is an incapacitating complication in anterior cervical discectomy and fusion (ACDF). However, the debate over which of the intervertebral devices is associated with lower incidence of subsidence remains to be settled. ⋯ CP and IP resulted in a lower rate of subsidence than cage alone or ICAG. Zero-P and ROI-C cages led to similar subsidence rates with plate. All types of intervertebral device can be applied to both single-level and multilevel ACDF with comparable subsidence rate.
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Am. J. Clin. Oncol. · Jun 2007
Radiotherapy and concomitant intraarterial cisplatin (RADPLAT) for advanced squamous cell carcinomas of the head and neck.
Review of the University of Florida experience in treating advanced squamous cell carcinomas of the head and neck with concurrent intraarterial cisplatin and radiotherapy (RADPLAT). ⋯ RADPLAT results in excellent local-regional control and survival in patients with advanced squamous cell carcinomas of the head and neck. Outcomes from the University of Florida are comparable to those reported by other institutions. However, in our limited experience, the likelihood of osteoradionecrosis and permanent gastrostomy may be higher than what might be anticipated after RT alone or combined with intravenous chemotherapy.
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The fluid challenge is used in the fluid management of many sick patients. The principle behind the fluid challenge technique is that by giving a small amount of fluid in a short period of time, the clinician can assess whether the patient has a preload reserve that can be used to increase the stroke volume with further fluids. The key components of a fluid challenge are described. ⋯ A fluid challenge identifies and simultaneously treats volume depletion, whilst avoiding deleterious consequences of fluid overload through its small volume and targeted administration.
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Pleural transudates are most commonly due to heart failure (HF) or hepatic hydrothorax (HH), but a number of these effusions are misclassified as exudates by standard (Light's) criteria. The aim of this study was to determine the prevalence of mislabelled transudates and to establish simple alternative parameters to correctly identify them. ⋯ If the clinical picture is consistent with HF but the pleural fluid meets Light's exudative criteria, the measurement of the albumin rather than the protein gradient is recommended. In the context of cirrhosis, a potentially 'false' exudate is identified better by the pleural fluid-to-serum albumin ratio.