学科分类
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5 个结果
  • 简介:Objective:Toevaluatetheefficacyandfeasibilityofscreeningprocedureforuppergastrointestinalcancerinbothhigh-riskandnon-high-riskareasinChina.Setting:Sevencities/counties,representingthreeeconomical-geographicalregions(Eastern,CentralandWestern)inChina,wereselectedasscreeningcenters:threeinhigh-riskareasandfourinnon-high-riskareas.Participants:Villages/communitiesinthesesevencentersregardedasclusterswererandomlyassignedtoeitherinterventiongroup(screeningbyendoscopicexamination)orcontrolgroup(withnormalcommunitycare)ina1:1ratiostratifiedbyeachcenter.Eligibleparticipantsarelocalresidentsaged40–69yearsintheselectedvillages/communitieswithnohistoryofcancerorendoscopicexaminationinthelatest3yearswhoarementallyandphysicallycompetent.Thosewhoarenotwillingtotakeendoscopicexaminationorareunwillingtosigntheconsentformareexcludedfromthestudy.Totally140,000participantswillbeenrolled.Interventions:Inhigh-riskareasofuppergastrointestinalcancer,allsubjectsinscreeninggroupwillbescreenedbyendoscopy.Innon-high-riskareas,30%ofthesubjectsinscreeninggroup,identifiedthroughasurvey,willbescreenedbyendoscopy.Primaryandsecondaryoutcomemeasures:Theprimaryoutcomeisthemortalitycausedbyuppergastrointestinalcancer.Thesecondaryoutcomesincludedetectionrate,incidencerate,survivalrate,andclinicalstagedistribution.Additionaldataonqualityoflifeandcost-effectivenesswillalsobecollectedtoanswerimportantquestionsregardingscreeningeffects.Conclusions:ScreeningstrategyevaluatedinthoseareaswithpositivefindingsmaybepromotednationallyandappliedtothemajorityofChinesepeople.Ontheotherhand,negativefindingswillprovidescientificevidenceforabandoningatestandshiftingresourceselsewhere.Trialregistration:ThestudyhasbeenregisteredwiththeProtocolRegistrationSysteminChineseClinicalTrialRegistry.

  • 标签: 随机对照试验 注册协议 中国人 消化道 筛查 癌症
  • 简介:Acupunctureiswidelyusedtotreatfunctionaldyspepsiawithsatisfactoryoutcomes.CombinationoftheHeandMuacupointsiscommonlyusedandhasasynergisticeffectonfunctionaldyspepsia;however,itsunderlyingmechanismsremainunclear.Therefore,arandomizedcontrolledparallelclinicaltrialiscurrentlyunderwayatChengduUniversityofTraditionalChineseMedicine,China.ThistrialisdesignedtoexploretheefficacyofandcentralresponsestotheHe-Mupointcombinationinpatientswithfunctionaldyspepsiausingfunctionalmagneticresonanceimaging.Atotalof105patientswithfunctionaldyspepsiawillbeallocatedinto3groups:thelow-Hepointgroup(puncturingatZusanli(ST36)),Mupointgroup(puncturingatZhongwan(CV12)),andHe-Mupointcombinationgroup(puncturingatST36andCV12).Everyparticipantwillreceive20sessionsofmanualacupuncturefor4weeks.Theneedleswillbeinsertedperpendicularlytoadepthof1to2cun.Theangleofrotationandtwistingwillrangefrom90to180degrees,whileliftingandthrustingwillrangefrom0.3to0.5cm.Thevariousmanipulationswillbeperformed60to90timesperminute.Theneedleswillremaininplacefor30minutes,duringwhichmanipulationwillbeappliedevery10minutes.Magneticresonanceimagingwillbeperformedbeforeandafter20sessionsofacupuncture.TheprimaryoutcomeissymptomimprovementaccordingtotheChineseversionoftheNepeanDyspepsiaIndex.SecondaryoutcomesincludetheLeedsdyspepsiaquestionnaire,Self-RatingAnxietyScale,Self-RatingDepressionScale,BeckAnxietyInventory,BeckDepressionInventory,andvisualanaloguescalescoresbeforeandafter10and20sessionsofacupuncture.Needlesensationandadverseeventswillbeusedtoassessthetherapeuticeffects.ThisstudywillpromotemorewidespreadawarenessofthebenefitsofacupointcombinationintheclinicalsettingandprovideafurtherexplanationoftheneuromechanismbywhichacupunctureattheHe-Mupointcombinationforfunctio

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  • 简介:Abducensnervepalsy(ANP)iscommonlyseeninpatientswithdiabetesmellitus.ThevalidityofacupunctureasatraditionalChinesemedicinemethodinperipheralnerverepairiswellestablished.However,itsefficacyinrandomizedcontrolledtrialsremainsunclear.Herein,wedesignedaprotocolforaprospective,single-center,randomizedcontrolledtrialtoinvestigatetheeffectofintraorbitalelectroacupunctureondiabeticANP.Weplantorecruit60patientswithdiabeticANP,andrandomlydividethemintotreatmentandcontrolgroups.Patientsinbothgroupswillcontinuetheirglucose-loweringtherapy.Aneuralnutritiondrugwillbegiventobothgroupsforsixweeks.Thetreatmentgroupwillalsoreceiveintraorbitalelectroacupuncturetherapy.Wewillassessefficacyoftreatment,eyeballmovement,diplopiadeviationandthelevelsoffastingblood-glucoseandglycosylatedhemoglobinbeforetreatmentat2,4,and6weeksaftertreatment.Theefficacyandrecurrencewillbeinvestigatedduringfollow-up(1monthafterintervention).ThisprotocolwasregisteredatChineseClinicalTrialRegistryon16January2015(ChiCTR-IPR-15005836).ThisstudywasapprovedbytheEthicsCommitteeofFirstAffiliatedHospitalofHarbinMedicalUniversityofChina(approvalnumber:201452).AllprotocolswillbeinaccordancewithDeclarationofHelsinki,formulatedbytheWorldMedicalAssociation.Writteninformedconsentwillbeprovidedbyparticipants.WeenvisagethattheresultsofthisclinicaltrialwillprovideevidenceforpromotingclinicaluseofthisnewtherapyformanagementofANP.

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  • 简介:Objective:Therandomizedcontrolledtrial(ClinicalTrials.govidentifierNCT02990741)willinvestigatewhethermorefrequentelectrocardiographic(ECG)recordingsandanalyseswithanautomatedECGsystemwouldimprovedetectionofatrialfibrillationcomparedwithasingleannualECGscreeninelderlyChineseincommunityhealthcenters.Design:Menandwomen(≥65years)willberandomizedintointensive(n=3500)andusual(n=3500)screeninggroups,andwithintheintensivescreeninggroupintointensivescreening(n=2625)andmoreintensivescreening(n=875)subgroups.ECGrecordingswillbeperformedwithanautomatedECGanalysissystem(AliveCorheartmonitor)at1yearintheusualscreeninggroup,at3,6,9,and12monthsintheintensivescreeningsubgroup,andat1,2,3,and4weeksand3,6,9,and12monthsinthemoreintensivescreeningsubgroup.Theprimaryoutcomeisthedetectionrateofatrialfibrillationbetweentheusualscreeninggroupandtheintensivescreeninggroup.Samplesizeestimationwasbasedonaprojecteddetectionrateofatrialfibrillationof2.0%byasingleECGrecordingat12months,animprovementof50%withmorefrequentECGrecordings,α=0.05,powerof80%,andaone-sidedtest.Conclusions:ThetrialwillprovideevidenceontheclinicaleffectivenessofmorefrequentECGrecordingsbyahandheldautomatedanalysissysteminthedetectionofatrialfibrillation.

  • 标签: randomized controlled trial atrial fibrillation SCREENING