2024
Editor's Choice – Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: 24 Month Outcomes of the Randomised TRANSCEND Study
Brodmann M, Gray W, Schneider P, Kurzmann-Guetl K, Schweiger L, Zeller T, Thieme M, Kilaru S, Bachinsky W, Feldman R, Holden A, Varcoe R, Lansky A, Rosenfield K, Investigators T. Editor's Choice – Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: 24 Month Outcomes of the Randomised TRANSCEND Study. European Journal Of Vascular And Endovascular Surgery 2024, 69: 452-462. PMID: 39615582, DOI: 10.1016/j.ejvs.2024.11.351.Peer-Reviewed Original ResearchFemoropopliteal artery diseasePrimary safetyPrimary patencyTRANSCEND studiesNon-inferiorityArtery diseaseRutherford stage 2Procedure related deathNon-inferiority clinical studyTarget lesion revascularisationTarget vessel revascularisationPaclitaxel coated balloonTarget limb amputationPrimary efficacyEfficacy endpointBinary restenosisClinical studiesFemoropopliteal arteriesSecondary outcomesRelated deathsCoated balloonsPatientsMonthsEfficacyPatencyA Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF)
Kobayashi T, Secemsky E, Klein A, Faintuch S, Bulman J, Weinstein J, Bitton-Faiwiszewski Y, Bisharat M, Metzger D, Rosenberg R, Weinberg I, Vadlamudi V, Matthai W, Saleh A, Cristea E, Lansky A, Giri J. A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF). Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102049. PMID: 39132596, PMCID: PMC11307881, DOI: 10.1016/j.jscai.2024.102049.Peer-Reviewed Original ResearchIntermediate-risk PELife-threatening bleedingPulmonary embolismRV/LV ratioAcute PEAdverse eventsThrombectomy catheterPostprocedure computed tomography angiographyTreatment of acute PEDevice-related serious adverse eventsTreatment of pulmonary embolismFirst-in-human studyPreprocedural computed tomography angiographyCatheter-directed embolectomyRight ventricle/left ventricleSecondary safety outcomesVARC-2 criteriaSerious adverse eventsDays post-procedureSingle-arm studyRisk of mortalityPrimary efficacyVARC-2Embolectomy devicesHours postprocedure
2023
A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial
Kanagaratnam P, Francis D, Chamie D, Coyle C, Marynina A, Katritsis G, Paiva P, Szigeti M, Cole G, de Andrade Nunes D, Howard J, Esper R, Khan M, More R, Barreto G, Meneguz-Moreno R, Arnold A, Nowbar A, Kaura A, Mariveles M, March K, Shah J, Nijjer S, Lip G, Mills N, Camm A, Cooke G, Corbett S, Llewelyn M, Ghanima W, Toshner M, Peters N, Petraco R, Al-Lamee R, Boshoff A, Durkina M, Malik I, Ruparelia N, Cornelius V, Shun-Shin M. A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial. Journal Of Thrombosis And Haemostasis 2023, 21: 2213-2222. PMID: 37230416, PMCID: PMC10204350, DOI: 10.1016/j.jtha.2023.04.045.Peer-Reviewed Original ResearchConceptsCoronary disease risk factorsIntervention arm participantsAcute coronary syndrome trialsRisk factorsDisease risk factorsLength of hospital stayLow-dose rivaroxabanAcute coronary syndrome therapyOpen-label trialCoronary artery diseaseRandomized Controlled TrialsAcute hospitalsArm participantsPrimary efficacyStandard careNo significant differenceMedian timeThrombotic complicationsTreatment regimenHospital staySyndrome therapyPoor outcomeClinical statusSecondary outcomesArtery disease
2021
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors
Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors. JAMA Network Open 2021, 4: e215731. PMID: 33956134, PMCID: PMC8103227, DOI: 10.1001/jamanetworkopen.2021.5731.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsSafety end pointEnd pointClinical trialsDrug pairsPrimary end point resultsEnd point resultsImproved efficacyEfficacy end pointCochrane Central RegistrySeparate end pointsSingle-enantiomer drugsSingle enantiomer formulationPrimary efficacySecondary efficacyControlled TrialsOvid EmbaseOvid MEDLINESuperior efficacyDrug AdministrationCentral RegistrySystematic reviewMore efficacyTrialsRacemic drugs
2018
Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC).
Quick A, Zvinovski F, Hudson C, Hundley A, Evans C, Suresh A, Stephens J, Carpenter K, Ramaswamy B, Reinbolt R, Noonan A, VanDeusen J, Wesolowski R, Stover D, Williams N, Sardesai S, Smith K, Faubion S, Loprinzi C, Lustberg M. Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC). Journal Of Clinical Oncology 2018, 36: 202-202. DOI: 10.1200/jco.2018.36.34_suppl.202.Peer-Reviewed Original ResearchVaginal Assessment ScaleSerious adverse eventsFractional CO2 laser therapyCO2 laser therapyFemale Sexual Function IndexUrogenital Distress InventoryVaginal drynessBC survivorsBreast cancerLaser therapyStudy treatmentSingle-arm feasibility studySecondary efficacy endpointsFinal efficacy analysisSexual Function IndexER/PRFractional CO2 laser treatmentFractional CO2 laserEndocrine therapySham laserEfficacy endpointFSFI scoreAdverse eventsGenitourinary syndromePrimary efficacy
2017
O-GYN-MD-126 Primary Efficacy and Safety Results from Two Double-Blind, Randomized, Placebo-Controlled Studies Of Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist, in Women With Endometriosis-Associated Pain
Singh S, Taylor H, Giudice L, Lessey B, Abrao M, Kotarski J, Duan W, Schwefel B, Thomas J, Chwalisz K. O-GYN-MD-126 Primary Efficacy and Safety Results from Two Double-Blind, Randomized, Placebo-Controlled Studies Of Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist, in Women With Endometriosis-Associated Pain. Journal Of Obstetrics And Gynaecology Canada 2017, 39: 401. DOI: 10.1016/j.jogc.2017.03.067.Peer-Reviewed Original Research
2015
Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids‐DOTT trial): pilot/feasibility phase findings
Goldenberg N, Abshire T, Blatchford P, Fenton L, Halperin J, Hiatt W, Kessler C, Kittelson J, Manco‐Johnson M, Spyropoulos A, Steg P, Stence N, Turpie A, Schulman S, Punzalan R, Wang M, Jaffray J, Young G, Rajpurkar M, Carpenter S, Diab Y, Verdun N, Tarango C, Acharya S, Torres M, Kucine N, Mitchell B, Shah N, Thornburg C, Takemoto C, Kulkarni R, O'Brien S, Haley K, Recht M, Knoll C, Thornburg C, Geddis A, Ahuja S, Simpson M, Srivaths L, Journeycake J, Zia A. Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids‐DOTT trial): pilot/feasibility phase findings. Journal Of Thrombosis And Haemostasis 2015, 13: 1597-1605. PMID: 26118944, PMCID: PMC4561031, DOI: 10.1111/jth.13038.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAnticoagulantsChildChild, PreschoolColoradoDiagnostic ImagingEndpoint DeterminationFeasibility StudiesFemaleFloridaHemorrhageHumansInfantMaleObserver VariationPilot ProjectsQuality Assurance, Health CareRecurrenceReproducibility of ResultsResearch DesignSingle-Blind MethodTime FactorsVenous ThrombosisYoung AdultConceptsRandomized Controlled TrialsVenous thromboembolismSymptomatic recurrent venous thromboembolismControlled TrialsKids-DOTTDuration of anticoagulationClinically Relevant BleedingRecurrent venous thromboembolismPersistent antiphospholipid antibodiesDuration of therapyPatients aged <Pediatric venous thromboembolismMulticenter randomized controlled trialSafety event ratesAnticoagulant-relatedRelevant bleedingAntiphospholipid antibodiesPrimary efficacyPoor accrualSafety endpointsVenous thrombosisVenous occlusionInterobserver agreementRCT designObservational cohort
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