Journal of clinical trials最新文献

{"title":"Therapeutic Targets and Mechanism of Banxia Xiexin Decoction on Precancerous Lesions of Gastric Cancer: Network pharmacology","authors":"Guoxiu Zu, Ke-yi Sun, Ling Li, Xiu-song Zu, T. Han, Hai-liang Huang","doi":"10.21203/rs.3.rs-764301/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-764301/v1","url":null,"abstract":"\u0000 BackgroundPrecancerous Lesions of Gastric Cancer (PLGC) is a common gastrointestinal tract and digestive systemdisease that lacks effective therapeutic drugs with good curative effects and few adverse reactions. Traditional Chinese medicine (TCM) has the advantages of multiple components, multiple channels, and fewer adverse reactions in the treatment of PLGC. Although Banxia xiexin Decoction (BXD) demonstrates a good therapeutic effect on PLGC, the pharmacological mechanism underlying its anticancer effect is still unclear. MethodsWe used a network pharmacology strategy, including the construction and analysis of a complex drug-disease network, to explore the complex mechanism of BXD treatment of PLGC. In addition, molecular docking technology was used to preliminarily study the binding ability of the potential active components and core therapeutic targets of BXD. ResultsThe networkpharmacology results showed 80 targets of BXD that are involved in PLGC. PPI network analysis demonstrated that the top10 core targets were JUN, TP53, MAPK3, MAPK1, TNF, VEGFA, MAPK14, ESR1, NR3C1, and MAPK8. The GO enrichment analysis results showed that the BXD anti-cancer and anti-inflammatory mechanism mainly involves cellular response to organic cyclic compound, response to toxic substance, response to oxidative stress, cellular response to nitrogen compound, response to inorganic substance, and others. The KEGG analysis results indicated that BXD may regulate 167 pathways such as MAPK signaling pathway and pathway in cancer in the treatment of PLGC. The molecular docking resultsshowed that the binding energies of beta sitosterol withMAPK1, MAPK3, MAPK14, JUN, and VEGFA were less than−7.0 kcal·mol−1, indicating a good docking effect. ConclusionsThis study reflects the characteristics of the mechanism of action by which BXD treats PLGC, which includes multiple components, multiple targets, and multiple pathways, and provides a biological basis for further verification and a novel perspective for drug discoveryin PLGC.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"74 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2021-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87150550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Swedish healthcare for women subjected to Female Genital Mutilation/Cutting (FGM/C)","authors":"Sharareh Akhavan","doi":"10.21203/rs.3.rs-775861/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-775861/v1","url":null,"abstract":"\u0000 Background: FGM/C can lead to a number of health complications, such as pain during intercourse or childbirth, psychological problems, and postpartum complications. This study seeks to describe and assess Swedish healthcare for women subjected to FGM/C.Methods: This aim encompasses three research foci: (1) to inventory Swedish regional healthcare guidelines and policies for care for women who have undergone FGM/C, (2) to map healthcare consumption among women who have undergone FGM/C, and (3) to map the type of care measures and treatment they have been offered in the Swedish healthcare system. A questionnaire was sent to healthcare regional managers and a database study was conducted.Results: The inventory of the healthcare regions' guidelines shows that five of 21 had no guidelines. The number of women who have been subjected to FGM/C and sought care has increased steadily between 2012 and 2018. Women who have been subjected to FGM/C seek care mostly in connection with pregnancy and childbirth.Conclusions: The type of care that should be offered to women who have been subjected to FGM/C vary depending on individual needs. Care may include surgical procedures in the form of defibulation, clitoral reconstruction, or removal of cysts, as well as psychosexual care. Existing treatment options in surgical care, together with psychosexual treatment, are the care measures that seem to be helpful for some women who have undergone FGM/C, but not for all. Communication and treatment are of great importance in order to be able to offer care to women who have undergone FGM/C.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"91 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2021-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85763804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Malnutrition in Emergency Laparotomy Patients. A QIP Highlights Simple Measures To Improve Early Recognition and Optimisation of High-Risk Patients.","authors":"C. Raslan, F. Tomalieh, O. Lasheen, K. Siddique","doi":"10.21203/rs.3.rs-706520/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-706520/v1","url":null,"abstract":"\u0000 Aim Early recognition of high-risk malnourished patients is important for optimisation of nutritional status leading to better outcomes. The accurate recording of malnutrition universal screening tool (MUST) results is vital in this regard. This quality improvement project (QIP) aimed to review the quality of nutritional assessment of emergency laparotomy patients against the National Institute for Health and Care Excellence (NICE) guidelines and outline area of improvement.Method The QIP was conducted at Royal Oldham Hospital in 2019-2020 over a seven-month period. Fifty random patients were included in the first audit cycle over a 4-month period, followed by implementation of recommended changes and a re-audit of 30 patients over a 2-month period. The initial MUST scores which were calculated and documented by nursing staff were identified as the nursing staff MUST score (NSMS). To assess the accuracy of NSMS, we developed a MUST rescoring method which was performed by a senior member of the medical team and was identified as the medical team MUST rescore (MTMR). Results The initial audit showed a significant difference between NSMS and MTMR scores. According to MTMR, 23 patients (46%) had an inaccurate MUST score assessment by the nursing staff. A multidisciplinary approach using a standard online calculator were recommended. The second phase of the QIP showed an obvious improvement in the accuracy of MUST assessment. Our interventions improved the accuracy rate of MUST scores significantly (27, 54% vs 29, 96.6%, P = 0.00005).Conclusion A multidisciplinary team approach and online calculator are useful in improving the accuracy of MUST assessment in emergency laparotomy patients. This helped early involvement of the dietitian leading to improvement in morbidity and mortality.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"6 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2021-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84736877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact Factor of Colon Polyp","authors":"Zheng Zhou, Guangming Wang","doi":"10.21203/rs.3.rs-659158/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-659158/v1","url":null,"abstract":"\u0000 Objective: To evaluate the relationship between Helicobacter pylori and colonic polyp.Methods: The clinical data of 850 patients who underwent both colonoscopy and Helicobacter pylori check were collected in our hospital from January 2018 year to January 2019 year. Patients were divided into polyp group and control group. To analyze the helicobacter pylori infection of two groups, and the relationship among helicobacter pylori infection, eradication treatment and recurrence of colonic polyp. Further to analyze the impact factor of the recurrence of colonic polyp.Results: There were no significant difference in sex and age aspects of two groups. Through SPSS software analysis, the infection rate of helicobater pylori was higher in polyp group than in control group. The recurrence rate of helicobacter pylori positive patients were more higher than helicobacter pylori negative patients. The recurrence rate of helicobacter pylori eradication group was lower than helicobacter pylori no eradication group. the impact factor of the recurrence of colonic polyp include helicobacter pylori infection, pathological type of polyp and the number of polyps.Conclusion: The helicobacter pylori infection rate of colonic polyp group were more higher. The impact factor of colonic polyp recurrence include helicobacter pylori infection, pathological types of polyp and polyp number.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"546 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2021-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75859877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges during COVID-19","authors":"Abigail Mk","doi":"10.35248/2167-0870.21.11.E458","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.E458","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"4 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77284575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pre-Pandemic State of Public Health","authors":"Jeanne Kurien","doi":"10.35248/2167-0870.21.S11.E002","DOIUrl":"https://doi.org/10.35248/2167-0870.21.S11.E002","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"31 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84990925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perspectives on Central Statistical Monitoring in Risk Based Approach of Clinical Trials","authors":"Tomoyoshi Hatayama, Seiichi Yasui","doi":"10.35248/2167-0870.21.11.450","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.450","url":null,"abstract":"In recent years, Risk-Based Monitoring (RBM) approach has been receiving increased attention as the efficient method to ensure data quality in clinical trials. In RBM, Central Statistical Monitoring (CSM) has an important role to monitor the status of operational process in clinical trials and detect its abnormalities. Many of statistical methods for CSM are proposed so far, but most of those studies are proposed based on somewhat strong assumptions, in addition, its performance evaluations are not practical in real setting of clinical trials. Authors think that it is still imperfect to fit them to practical clinical trials. In this article, we focus to clearly articulating the current problems on CSM and the matters to consider for further consecutive study activities of CSM.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"6 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80240738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Probiotics on Gut Microbiome Bifidobacterium Relative Abundance: First Do No Harm","authors":"Daniels Jordan, Papoutsis Andreas, Barrows Brad, Hänniger Sabine","doi":"10.35248/2167-0870.21.11.473","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.473","url":null,"abstract":"Background: Several reports have raised safety concerns regarding the use of probiotics. To address these concerns, this study examined the relative abundance (proportion of the microbiome made up of a particular taxa) and normalized read counts (number of times a particular microbe was identified) of Bifidobacteria in the gut microbiome of healthy subjects participating in an ongoing study on the microbiome. Bifidobacteria is a critically important constituent of the human microbiome and plays roles in digestion, gut immunity, and cancer prevention. Methods: Fecal samples were analyzed using next-generation sequencing to evaluate composition and relative abundance of bacterial phyla through species level in each subject`s microbiome. The primary outcomes of this subgroup analysis were relative abundance and normalized read count of genus Bifidobacteria in subjects who took unregulated probiotics, regulated probiotics, or no probiotics. Results: The relative abundance and normalized read count of Bifidobacteria were significantly lower in the microbiome of subjects who took unregulated probiotics (n=15) than in the microbiomes of both those who took regulated probiotics (n=12, P=0.0002) and no probiotics (n=13, P=0.0483) (0.18 vs. 9.59 vs. 5.66 relative abundance). Discussion: Subjects taking unregulated probiotics had a significantly lower relative abundance of Bifidobacteria, which could potentially have a detrimental impact on health. Next-generation sequencing could be a useful tool to guide decisions on the appropriate use of probiotics based on dysbiosis.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"23 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81372174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Factors and a Prognostic Scoring System for Severe Disease in Patients with COVID-19: A Retrospective Cohort Study","authors":"Sen Yang, Le Ma, Yu-Lan Wang, Q. Tong, De-Hua Yu, S. Dai, R. Cui","doi":"10.35248/2167-0870.21.11.470","DOIUrl":"https://doi.org/10.35248/2167-0870.21.11.470","url":null,"abstract":"Background: The corona virus disease 2019 (COVID-19) has made a big threat on the global public health. The aim of the study is to comprehensively explore the risk factor for severe disease events (intensive care, invasive ventilation, or death) in patients with COVID-19, and to establish a prognostic scoring system. Methods: Patients with laboratory-confirmed COVID-19 admitted to the Wuhan Leishenshan Hospital from February 13 to March 14, 2020, was retrospectively analyzed. Demographic data, symptoms, laboratory values at baseline, comorbidities, treatments and clinical outcomes were extracted. The LASSO and multivariate logistic regression models were developed to explore the risk factors for critical-ill events. A risk model was established via nomogram. Results: 463 COVID-19 patients were included, of whom 397 were non-critically ill and 66 were critically ill. The LASSO identified four risk factors (hypersensitive cardiac troponin I [cTnI], Blood Urea Nitrogen [BUN], haemoglobin, and Interleukin-6 [IL-6]) contributing to the critical-ill events. Multivariable regression showed increasing odds of in-hospital critical-ill events associated with hypersensitive cTnI greater than 0.04 ng/mL (OR, 95% CI: 20.98, 3.51-125.31), BUN greater than 7.6 mmol/L (OR, 95% CI: 5.22, 1.52-17.81), decreased haemoglobin (OR, 95% CI: 1.06, 1.04-1.10), and higher IL-6 (OR, 95% CI: 1.05, 1.02-1.08) on admission. The risk model constructed by the selected four risk factors showed high calibration (Hosmer-Lemeshow, p=1.00). Conclusion: Elevated hypersensitive cTnI, BUN, IL-6, and decreased hemoglobin were risk factors of critical-ill events. The risk model could help clinicians with early identification of patients with COVID-19 who will progress to severe disease.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"23 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78820309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Type 2 Diabetes in Youth","authors":"Marge Kars","doi":"10.35248/2167-0870.21.S10.E001","DOIUrl":"https://doi.org/10.35248/2167-0870.21.S10.E001","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90931387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}