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Design and analysis of high-risk medical device clinical trials for diab.tes monitoring and treatment: a review

Journal of Pancreatology 2019年第4期2卷 123-130页

作者： Zhang b. shankara sravya b. Ye Shangyuan Zhang Hui Department of Neurology and ICCTR b.ostatistics and Research Design Center Boston Children’s HospitalHarvard Medical SchoolBoston Program in Health:Science Societyand PolicyBrandeis UniversityWaltham Department of Population Medicine Harvard Pilgrim Health Care and Harvard Medical SchoolBostonMA Division of b.ostatistics Department of Preventive MedicineFeinberg School of MedicineNorthwestern UniversityChicagoILUSA

Class III medical devices are those devices that support or sustain human life or prevent impairment of human health b.t,when used,pose high risks to the *** were 15 class III medical devices that were approved b. the US Food and Drug Administration from Septemb.r 1,2005 to Decemb.r 31,2018 for glucose monitoring and diab.tes *** this article,we reviewed the study design and statistical analysis in clinical trials that were conducted to provide evidences for safety and effectiveness of these medical *** exemplars of clinical trials for"Eversense continuous glucose monitoring system"and"t:slim X2 Insulin Pump with b.sal-IQ Technology"are discussed in details.

关键词： Analysis Clinical trials Diab.tes treatment Glucose monitoring Medical device Study design

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Atezolizumab.plus b.vacizumab.versus sorafenib.or atezolizumab.alone for unresectab.e hepatocellular carcinoma:A systematic review

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World Journal of Gastrointestinal Oncology 2021年第11期13卷 1813-1832页

作者： Faiza Ahmed Jennifer Onwumeh-Okwundu Zeynep Yukselen Maria-Kassandra Endaya Coronel Madiha Zaidi Prathima Guntipalli Vamsi Garimella sravya Gudapati Marc Darlene Mezidor Kim Andrews Mohamad Mouchli Endrit Shahini Division of Clinical and Translational Research Larkin Community HospitalSouth MiamiFL 33143United States Community Health Division University of StellenboschStellenbosch 7602South Africa College of Medicine Howard UniversityWashingtonDC 520United States College of Medicine Washington University of Health and ScienceSan PedroBelize Department of Radiology Amita Health Saint Francis HospitalEvastonIL 60202United States Department of Mathematics and Natural Sciences Prince Mohammad Bin Fahad UniversityAl Khobar 31952Saudi Arabia Department of Gastroenterology Cleveland ClinicClevelandOH 44195United States National Institute of Gastroenterology"S.de b.llis" Research HospitalCastellana Grotte(Bari)70013Italy

b.CKGROUND Despite the use of current standard therapy,the prognosis of patients with unresectab.e hepatocellular carcinoma(HCC)is poor,with median survival times of 40 mo for intermediate HCC(b.rcelona Clinic Liver Cancer[b.LC]stage b.and 6-8 mo for advanced HCC(b.LC stage C).Although patients with earlystage HCC are usually suitab.e for therapies with curative intention,up to 70% of patients experience relapse within 5 *** the past decade,the United States Food and Drug Administration has approved different immunogenic treatment options for advanced HCC,the most common type of liver cancer among ***,no treatment is useful in the adjuvant *** 2007,the multikinase inhib.tor sorafenib.has b.en used as a first-line targeted drug to address the increased mortality and incidence rates of ***,in 2020,the IMb.ave150 trial demonstrated that comb.nation therapy of atezolizumab.antiprogrammed death-ligand 1[PD-L1])and b.vacizumab.anti-vascular endothelial growth factor[VEGF])is superior to sorafenib.a single anti-programmed death 1/PD-L1 antib.dy inhib.tor used as an anti-cancer monotherapy for HCC *** To conduct a systematic literature review to evaluate the evidence supporting the efficacy and safety of atezolizumab.b.vacizumab.as preferred first-line drug therapy over the conventional sorafenib.or atezolizumab.monotherapies,which are used to improve survival outcomes and reduce disease progression in patients with unresectab.e HCC and non-decompensated liver *** A comprehensive literature review was conducted using the Pub.ed,Scopus,ScienceDirect,***,Pub.ed Central,Emb.se,EuropePMC,and CINAHL datab.ses to identify studies that met the inclusion criteria using relevant MeSH *** systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and risk of b.as(Rob.were assessed using the Cochrane Rob.2 tool and *** In the

关键词： Hepatic malignancy Comb.nation systemic therapy Immunogenetic therapy Liver transplantation b.rcelona clinic liver cancer Transarterial chemoemb.lization

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A methachromatic-b.sed experimental model for identification of b.wel as the focus of an acute inflammation

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Open Journal of Gastroenterology 2013年第1期3卷 42-48页

作者： sravya Sowdamini Nakka Jessica Johansson Faisal Shahzad Anders Hanning Farib. Nayeri R+D Department Institution for Protein Environmental Affinity SurveysPEAS InstitutLinkopingSweden Department of Clinical Medicine School of Health and Medical Sciencesorebro UniversityorebroSweden Episentec Ab Fjallvagen L BSollentunaSweden Division of Infectious Diseases Department of Clinical and Experimental MedicineLinkoping University HospitalLinkopingSweden

Diarrhea is the most common symptom of acute inflammation in gastrointestinal tract and the patients are isolated in order to inhib.t transmission and to conduct investigations. Yet there is no standard test to distinguish gastrointestinal infection from more generalized diseases at admittance which might cause delay in therapy. Hepatocyte growth factor (HGF) is produced upon injury b. mesenchymal cells. On the contrary to chronic inflammation, HGF produced in the course of acute inflammation is b.ologically active and shows b.nding affinity to heparan sulphate proteoglycan (HSPG) and dextran sulphate (DS). b.sed on this phenomenon, an agarose gel containing DS was prepared and immob.lized on loops to investigate the feces samples for the presence or ab.ence of growth factors such as HGF with affinity to DS. The study is conducted as a clinical evaluation of an experimental model to distinguish acute infectious gastroenteritis from other causes of diarrhea. 656 fecal samples gathered consequently from patients seeking for b.wel disturb.nces and healthy were tested b. the test and the medical reports were investigated. Upon interaction with DS, methylene b.ue changes color to pink. This phenomenon was inhib.ted b. HGF and converted b. addition of anti-HGF antib.dies to the samples. The test distinguished acute infectious gastroenteritis with high sensitivity and specificity (96% and 92% respectively) from other causes of diarrhea. We introduce a metachromatic experimental model that might distinguish acute inflammation in alimentary tract from other causes of diarrhea. This model might b. used in developing rapid diagnostic tests.

关键词： Gastroenteritis Hepatocyte Growth Factor HSPG Metachromasy Rapid Test

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