Bariatric surgeries have been demonstrated to be safe and effective treatment options for morbid obesity patients, but operative risks and high health care costs limit their clinical application. Endoscopic bariatric ...Bariatric surgeries have been demonstrated to be safe and effective treatment options for morbid obesity patients, but operative risks and high health care costs limit their clinical application. Endoscopic bariatric therapies are emerging as valuable alternatives for patients with doubts about bariatric surgery or ineligible for it. Endoscopic sleeve gastroplasty(ESG), a relatively novel technique of endoscopic bariatric therapies, has gained standing in the past few years. The safety, feasibility, repeatability, and potential for reversibility of ESG have been proven by multicenter studies. Compared to other weight loss strategies, current evidence demonstrates that ESG offers satisfactory efficacy in weight loss. Even though it is inferior to laparoscopic sleeve gastrectomy, it has lower risks of adverse events than surgical interventions and intragastric balloon within oneyear follow-up. Furthermore, ESG may be the ideal weight control strategy for patients who have poor adherence to behavioral interventions. Even so, trends in decreased weight loss effect over time, post-procedure weight regain, postprocedure gut hormone alteration, and possible effects of race and ethnicity on ESG still remain undetermined due to very limited reports and very short followups. Further clinical trials are required to validate and answer these questions.展开更多
A 16-year-old man had aswelling over the anterior aspect of the proximal third of the tibia for 1 year, which was peanut size initially and progressively increased to its present size of 10 cm × 8 cm. He underwen...A 16-year-old man had aswelling over the anterior aspect of the proximal third of the tibia for 1 year, which was peanut size initially and progressively increased to its present size of 10 cm × 8 cm. He underwent fine needle aspiration cytology(FNAC) twice during this period and reported aspindle cell sarcoma. Malignant peripheral nerve sheath tumor(MPNST) is a malignancy of the connective tissue surrounding the nerves. Previously, MPNST was also known as neurofibrosarcoma, malignant schwannoma, andneurogenic sarcoma. We are reporting this case for its rarity and peculiar mode of presentation. FNAC/core biopsy can be used as an effective tool to achievethe correct pathological diagnosis.展开更多
Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants...Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants,this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs.Methods This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were sub-mitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023.Based on Chinese and inter-national research regulations and guidelines,these documents,as well as initial and follow-up review resolutions,have been classified and analyzed.Results Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vul-nerability of participants enrolled with advanced cancer status,it is important to review investigator qualifica-tions,preliminary findings,research methods,inclusion and exclusion criteria in the protocol,as well as the validity and readability of informed consent.Additionally,attention should be given to follow-up reviews,particularly regard-ing safety reports and protocol deviations.Conclusion To effectively protect the rights,interests and safety of research participants.Relevant stakeholders,including sponsors,researchers,and regulatory bodies,should diligently evaluate potential risks and provision contin-gency plan to minimize the latent risk.展开更多
文摘Bariatric surgeries have been demonstrated to be safe and effective treatment options for morbid obesity patients, but operative risks and high health care costs limit their clinical application. Endoscopic bariatric therapies are emerging as valuable alternatives for patients with doubts about bariatric surgery or ineligible for it. Endoscopic sleeve gastroplasty(ESG), a relatively novel technique of endoscopic bariatric therapies, has gained standing in the past few years. The safety, feasibility, repeatability, and potential for reversibility of ESG have been proven by multicenter studies. Compared to other weight loss strategies, current evidence demonstrates that ESG offers satisfactory efficacy in weight loss. Even though it is inferior to laparoscopic sleeve gastrectomy, it has lower risks of adverse events than surgical interventions and intragastric balloon within oneyear follow-up. Furthermore, ESG may be the ideal weight control strategy for patients who have poor adherence to behavioral interventions. Even so, trends in decreased weight loss effect over time, post-procedure weight regain, postprocedure gut hormone alteration, and possible effects of race and ethnicity on ESG still remain undetermined due to very limited reports and very short followups. Further clinical trials are required to validate and answer these questions.
文摘A 16-year-old man had aswelling over the anterior aspect of the proximal third of the tibia for 1 year, which was peanut size initially and progressively increased to its present size of 10 cm × 8 cm. He underwent fine needle aspiration cytology(FNAC) twice during this period and reported aspindle cell sarcoma. Malignant peripheral nerve sheath tumor(MPNST) is a malignancy of the connective tissue surrounding the nerves. Previously, MPNST was also known as neurofibrosarcoma, malignant schwannoma, andneurogenic sarcoma. We are reporting this case for its rarity and peculiar mode of presentation. FNAC/core biopsy can be used as an effective tool to achievethe correct pathological diagnosis.
基金The research belongs to the project“influencing factors and countermeasures of clinical research ethical cognition implementation of medical researchers in the context of scientific research innovation”,financed by Zhejiang Provincial Medical Health Science and Technology Project 2022,No.2022KY643.
文摘Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants,this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs.Methods This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were sub-mitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023.Based on Chinese and inter-national research regulations and guidelines,these documents,as well as initial and follow-up review resolutions,have been classified and analyzed.Results Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vul-nerability of participants enrolled with advanced cancer status,it is important to review investigator qualifica-tions,preliminary findings,research methods,inclusion and exclusion criteria in the protocol,as well as the validity and readability of informed consent.Additionally,attention should be given to follow-up reviews,particularly regard-ing safety reports and protocol deviations.Conclusion To effectively protect the rights,interests and safety of research participants.Relevant stakeholders,including sponsors,researchers,and regulatory bodies,should diligently evaluate potential risks and provision contin-gency plan to minimize the latent risk.
