The bioavailability, metabolism and microbial modulation of curcumin-loaded nanodelivery systems.

Curcumin (Cur), the major bioactive component of turmeric (Curcuma longa) possesses many health benefits. However, low solubility, stability and bioavailability restricts its applications in food. Recently, nanocarriers such as complex coacervates, nanocapsules, liposomes, nanoparticles, nanomicelles, have been used as novel strategies to solve these problems. In this review, we have focused on the delivery systems responsive to the environmental stimuli such as pH-responsive, enzyme-responsive, targeted-to-specific cells or tissues, mucus-penetrating and mucoadhesive carriers. Besides, the metabolites and their biodistribution of Cur and Cur delivery systems are discussed. Most importantly, the interaction between Cur and their carriers with gut microbiota and their effects of modulating the gut health synergistically were discussed comprehensively. In the end, the biocompatibility of Cur delivery systems and the feasibility of their application in food industry is discussed. This review provided a comprehensive review of Cur nanodelivery systems, the health impacts of Cur nanocarriers and an insight into the application of Cur nanocarriers in food industry.

A Multicenter, Randomized, Controlled Study of the Breast Biopsy and Circumferential Excision System for Breast Lesions.

BACKGROUND: This study aimed to verify the effectiveness, safety, and reliability of the breast biopsy and circumferential excision system. METHODS: It was designed as a multicenter, randomized, open-label, positive control, noninferiority trial. A total of 168 subjects who met the breast lesion screening requirements of the clinical trial protocol were randomly divided into a breast biopsy and circumferential excision dual cutting system test group or Mammotome control group. The main outcome was the successful removal rate of suspected lumps during surgery. Secondary outcomes included the operative times for individual lumps, weight of removed cord tissue, and several indicators of device performance. Safety indicators, including routine blood, blood biochemical and electrocardiogram examinations, were measured at baseline and 24 hours and 48 hours after the operation. Postoperative complications and combined medication use were observed and recorded until 7 days after the operation. RESULTS: The results showed no significant differences in efficacy and safety between the 2 groups (main efficacy, P = .7463; all secondary efficacy indicators, P > .05, except weight of removed cord tissue [P = .0070] and touch sensitivity of the device interface [P = .0275]; all safety indicators, P > .05). The results suggested that the test device is effective and is acceptable safe for use in breast lesion biopsy. CONCLUSION: For patients with a high incidence of breast lesions, the results of this study provide a safe, effective, sensitive and accessible option for the removal of breast mass biopsies at a price much lower than that of imported devices.

The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality.

OBJECTIVE: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed. METHODS: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc. RESULT: The most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%. DISCUSSION: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator. CONCLUSION: The clinical research coordinators' access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.

The impact of COVID-19 on the clinical trial.

The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.