This paper aims to analysis of the general problem in the registration dossier and make recommendations on in vitro diagnostic device of tumor markers. On the basis of introducing declarations of the reagents, analysis registration dossier common problems occurs in the products intend to detect novel tumor markers and the combined detection product for multiple tumor markers, and analysis the special requirements for such products.
Biomarkers, Tumor ; analysis ; Humans ; Neoplasms ; diagnosis ; Reagent Kits, Diagnostic ; standards

To review the registration and technical data for prenatal diagnosis of chromosome aneuploidy by next generation sequencing technology. On the basis of introducing declarations of the reagents, analysis registration dossier common problems. And analysis the requirement of performance evaluation, reference intervals and clinical evaluation study.
Aneuploidy ; Female ; High-Throughput Nucleotide Sequencing ; Humans ; Pregnancy ; Prenatal Diagnosis ; standards

Objective To investigate Aβ42 and P-tau levels in cerebrospinal fluid (CSF) of patients with mild cognitive impairment (MCI). Methods CSF of 25 cases of MCI and 14 cases of cognitively normal (CN) were investigated. The CSF levels of Aβ42 and P-tau were detected by ELISA method. Correlation analysis was used to analyze the correlation between P-tau level and MMSE score in MCI. Results The CSF level of Aβ 42 was higher and P-tau was lower in MCI than CN group(P<0.05). P-tau level in MCI was also negatively correlated with MMSE score (P<0.05). Conclusion Aβ42 and P-tau levels in CSF may be valuable biological markers in the diagnosis of MCI. P-tau level in CSF of MCI may be related to the severity of cognitive impairment.

Dynamic culture conditions serve as a critical factor in constructing physiologically functional blood vessel substitutes. With the development of tissue engineering, many experiments have verified the hypothesis that proper dynamic conditions are important for cells' behaving ways such as attachment, proliferation, differentiation and the remodeling of the extracellular matrix. By means of simulating the physiological dynamic conditions, one can enhance cell growth and extracellular matrix remodeling, and further improve the function of engineered vessel. In this paper is reviewed the current state of dynamic culture conditions provided for tissue engineering vessel graft, including the effects of different dynamic culture conditions on the proliferation of vascular cells and the remodeling of extracellular matrix. The use of bioreactor in constructing tissue engineering blood vessels and the effects of dynamic culture environments are also discussed with respect to the biological properties of vascular grafts.
Animals ; Biomechanical Phenomena ; Bioreactors ; Blood Vessel Prosthesis ; Cell Adhesion ; Cell Culture Techniques ; methods ; Cell Differentiation ; Cells, Cultured ; Pulmonary Artery ; cytology ; Rabbits ; Tissue Engineering ; methods

As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

Objective: To explore the feasibility of applying Omaha system theory to patients with coronary heart disease (CHD) through comparative analysis of nursing description. Methods: Using content extraction analysis method, the nursing records, nursing plans and nursing measures of discharged patients with CHD were retrieved from the medical records, and then the conceptual consistency of the extracted records and the problem classification system and intervention measures in the Omaha system were evaluated by cross mapping method. Results: A total of 2 609 nursing problems and intervention measures were extracted from the medical records of 68 patients with CHD. Among them, 1 844 (70.68%) records were labeled as "perfect fit", 608 records (23.30%) as "partial fit", and 157 (6.02%) recordsas "not fit at all". The total fit rate was 93.98% (perfect fit and partial fit). The most frequently reported problems were in physiological domain, followed by health-related behaviors domain, psychosocial domain and environmental domain. The nursing interventions extracted accounted for 26.67% (1 968 sentences) of directions and l00.00% (4 kinds) of categories in the intervention scheme of Omaha system. Conclusions The conceptual congruence between the medical records of patients with CHD and the Omaha System is quite high. It can help to improve nursing problems of patients of CHD in health-related behavioral domain, psychosocial domain and environmental domain, and can be applied to such patients after appropriate adjustment, so as to help clinical nursing staff to provide specialized and all-round guidance for patients with CHD.

Humans ; Computed Tomography Angiography ; Deep Learning ; Coronary Angiography ; Coronary Artery Disease ; Tomography, X-Ray Computed ; Coronary Stenosis/diagnosis* ; Retrospective Studies ; Fractional Flow Reserve, Myocardial ; Predictive Value of Tests

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone