2025
CAPTAIN RANDOMIZED CONTROLLED TRIAL OF TULSA AGAINST RADICAL PROSTATECTOMY FOR INTERMEDIATE-RISK PROSTATE CANCER: DESIGN AND RECRUITMENT UPDATE
Meng X, Lotan Y, Kella N, Koch M, Pavlovich C, George A, Michel K, Sprenkle P, Sonn G, Mynderse L, Anttinen M, Chin J, Inman B, Mehan R, Banapour P, Sharif-Afshar A, Woodrum D, Ghanouni P, Arora S, Macura K, Princenthal R, Cohen M, Staruch R, Clarke G, Costa D, Klotz L. CAPTAIN RANDOMIZED CONTROLLED TRIAL OF TULSA AGAINST RADICAL PROSTATECTOMY FOR INTERMEDIATE-RISK PROSTATE CANCER: DESIGN AND RECRUITMENT UPDATE. Urologic Oncology Seminars And Original Investigations 2025, 43: 79. DOI: 10.1016/j.urolonc.2024.12.200.Peer-Reviewed Original ResearchRadical prostatectomyRandomized Controlled TrialsProstate cancerAblation therapyAlternative to radiation therapyLocalized prostate cancerPCa-specific deathPad-free continencePrimary safety endpointPoor patient acceptanceStandard of careOrgan-confinedProstatectomy groupSignificant functional impairmentMetastatic diseaseRadiation therapyOpen-labelEfficacy endpointSecondary endpointsSafety endpointsSurgical approachPivotal studiesEfficacy dataNon-inferioritySub-sitesImmunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil
Puga M, de Oliveira R, da Silva P, Charu V, Hedlin H, Lu D, Zhang A, Shaw B, Rosser J, Seidman J, Carter A, Qamar F, Luby S, Garrett D, Croda J. Immunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil. The Lancet Regional Health - Americas 2025, 44: 101031. PMID: 40083966, PMCID: PMC11904515, DOI: 10.1016/j.lana.2025.101031.Peer-Reviewed Original ResearchDose of BNT162b2Fractionated dosesNon-inferiorityNon-inferiority thresholdSeroresponse ratesDouble-blindBooster vaccinationAdverse eventsSystemic adverse eventsPhase IV clinical trialBaseline antibody levelsIV clinical trialDose of COVID-19 vaccineDose of vaccineNon-inferiority studyReduced side effectsAdministering booster vaccinationResource-limited settingsBinding IgG antibodiesImmunocompetent adultsStudy vaccineDose boosterTreatment armsParallel-groupBooster doseStandard to Handheld: A New Wave in Thoracic Ultrasound and Patient Care—A Direct Comparison of Portable Handheld Against Standard in Thoracic Ultrasound
Halim D, Kelly A, Hayes J, Bennett K, Tzouvelekis A, Ampazis D, Sampsonas F. Standard to Handheld: A New Wave in Thoracic Ultrasound and Patient Care—A Direct Comparison of Portable Handheld Against Standard in Thoracic Ultrasound. Medicina 2025, 61: 313. PMID: 40005430, PMCID: PMC11857366, DOI: 10.3390/medicina61020313.Peer-Reviewed Original ResearchConceptsLevels of experienceNon-inferiorityPortable ultrasound deviceOverall image qualityLung pathologyUltrasound deviceInterquartile rangeRespiratory departmentThoracic ultrasoundAnatomical visualizationHandheld ultrasound devicePatient careImprove healthcareOperator's level of experienceNo significant differenceLikert scaleTrainee levelStatistically significant variablesDiagnostic accuracyClinical decisionsOverall perceptionOnline questionnaireClinical utilityMedian rateClinical setting
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 balloonsPatientsMonthsEfficacyPatencyEffectiveness of primary repair for low anorectal malformations in Uganda
Oyania F, Ullrich S, Hellmann Z, Stephens C, Kotagal M, Commander S, Shui A, Situma M, Odongo C, Kituuka O, Bajunirwe F, Ozgediz D, Poenaru D. Effectiveness of primary repair for low anorectal malformations in Uganda. Pediatric Surgery International 2024, 40: 315. PMID: 39560775, PMCID: PMC12032398, DOI: 10.1007/s00383-024-05905-8.Peer-Reviewed Original ResearchConceptsThree-stage repairTwo-stage repairPrimary repairLength of hospital stayLow anorectal malformationPost-operative complicationsLonger treatment durationLength of treatmentNon-inferiority analysisResource-limited settingsBackgroundAnorectal malformationsNeonatal surgeryProspective armRetrospective armAnorectal malformationsPostoperative complicationsSurgeon experienceColostomy closureHospital stayLive birthsSurgical accessColostomy formationUgandan childrenNon-inferiorityClinical trialsComparing the brief Holistic Health for HIV (3H+) to the Holistic Health Recovery Program (HHRP+) among people with HIV and opioid use disorder: Results from a randomized, controlled non-inferiority trial
Zelenev A, Huedo-Medina T, Shrestha R, Mistler C, Altice F, Sibilio B, Copenhaver M. Comparing the brief Holistic Health for HIV (3H+) to the Holistic Health Recovery Program (HHRP+) among people with HIV and opioid use disorder: Results from a randomized, controlled non-inferiority trial. PLOS ONE 2024, 19: e0312165. PMID: 39509356, PMCID: PMC11542883, DOI: 10.1371/journal.pone.0312165.Peer-Reviewed Original ResearchConceptsHolistic Health Recovery ProgramEvidence-based interventionsHolistic healthHIV treatmentRisk behaviorsReduce HIV risk behaviorsDifference-in-differencesEnd-of-interventionControlled non-inferiority trialHIV Epidemic goalsDrug treatment settingsAttainment of viral suppressionNon-inferiority trialRecovery programViral suppressionHigh ART adherenceHIV risk behaviorsNon-inferiorityHHRP+ART adherenceBehavioral interventionsReal-world settingsNon-parametric bootstrappingCondom useOpioid-dependent peopleMeta-analysis: The utility of the anterior quadratus lumborum block in abdominal surgery
Evans B, Ihnat J, Zhao K, Kim L, Pierson D, Yu C, Lin H, Li J, Golshan M, Ayyala H. Meta-analysis: The utility of the anterior quadratus lumborum block in abdominal surgery. The American Journal Of Surgery 2024, 239: 116014. PMID: 39454308, DOI: 10.1016/j.amjsurg.2024.116014.Peer-Reviewed Original ResearchAnterior quadratus lumborum blockTransversus abdominis planeTransversus abdominis plane blockQuadratus lumborum blockAbdominal surgeryRandomized Controlled TrialsMorphine equivalentsPost-operativelyMeta-analysisTotal oral morphine equivalentsPost-operative opioid consumptionPost-operative pain scoresOral morphine equivalentsPost-operative recovery timeRandom-effects meta-analysisOpioid consumptionPain scoresOpioid useSurgery typeNon-inferioritySurgeryPresence of confounding variablesRegional anesthesiaQuadratus lumborumSurgery pathwayA Randomized Trial of Hypofractionated Post-Mastectomy Radiation Therapy (PMRT) in Women with Breast Reconstruction (RT CHARM, Alliance A221505)
Poppe M, Le-Rademacher J, Haffty B, Hansen E, Agarwal J, Wagner J, Kong I, Armer J, Arthur D, Whelan T, Lee M, Kour O, Lustberg M, Partridge A, Carey L, Ruddy K, Gaffney D, Stecklein S, Bernstein M, Khan A. A Randomized Trial of Hypofractionated Post-Mastectomy Radiation Therapy (PMRT) in Women with Breast Reconstruction (RT CHARM, Alliance A221505). International Journal Of Radiation Oncology • Biology • Physics 2024, 120: s11. DOI: 10.1016/j.ijrobp.2024.07.002.Peer-Reviewed Original ResearchPost-mastectomy radiation therapyNeoadjuvant chemotherapyBreast reconstructionComplication rateReconstruction complicationsBreast cancerNon-inferiorityHigh-risk breast cancerBody mass index >Conventionally fractionated radiationGenetic predisposition genesImplant-only reconstructionsMedian Follow-UpImmediate breast reconstructionOne-sided type I errorNon-inferiority marginStandard of careHypofractionated radiationRegional recurrenceRadiation therapyTumor characteristicsInvasive BCAdjuvant chemotherapyPredisposition genesMedian ageEffect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial
Ma X, Wang J, Shi Y, Tan J, Guan Y, Sun Y, Zhang B, Zhao J, Liu J, Cao Y, Li H, Zhang C, Chen F, Yi H, Wang Z, Xin X, Kong P, Lu Y, Huang L, Yuan Y, Liu H, Li C, Mol B, Hu Z, Zhang H, Chen Z, Liu J. Effect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial. Nature Communications 2024, 15: 7747. PMID: 39237545, PMCID: PMC11377718, DOI: 10.1038/s41467-024-52008-y.Peer-Reviewed Original ResearchConceptsLive birth rateIn vitro fertilizationCumulative live birth rateCumulative live birthBlastocyst transferBlastocyst-stageCleavage-stageEmbryo transferLive birthsHigher preterm birth rateBlastocyst-stage groupBlastocyst-stage transferCleavage-stage groupCleavage-stage transferPreterm birth rateYear of randomizationMulticenter randomized controlled trialPrognosis womenRandomized Controlled TrialsPregnancy outcomesCounseling patientsRandomized trialsNon-inferiorityPrimary outcomeSecondary outcomesFour-factor prothrombin complex concentrate is not inferior to andexanet alfa for the reversal or oral factor Xa inhibitors: An Eastern Association for the Surgery of Trauma multicenter study
Estroff J, Devlin J, Hoteit L, Hassoune A, Neal M, Brown J, Lu L, Kotch S, Hazelton J, Christian A, Yeates E, Nahmias J, Jacobson L, Williams J, Schuster K, O'Connor R, Semon G, Straughn A, Cullinane D, Egodage T, Kincaid M, Rollins A, Amdur R, Sarani B. Four-factor prothrombin complex concentrate is not inferior to andexanet alfa for the reversal or oral factor Xa inhibitors: An Eastern Association for the Surgery of Trauma multicenter study. Journal Of Trauma And Acute Care Surgery 2024, 97: 541-545. PMID: 38685190, DOI: 10.1097/ta.0000000000004345.Peer-Reviewed Original ResearchProthrombin complex concentrateAmount of RBC transfusionRed blood cell transfusionAndexanet alfaRed blood cellsRBC transfusionMulticenter study of adult patientsNon-inferiorityComparing prothrombin complex concentrateOral factor Xa inhibitorsStudy of adult patientsTransfused red blood cellsIncreased RBC transfusionsReversal of DOACsComplex concentrateFactor Xa inhibitorsTreatment of hemorrhageTraumatically injured patientsDOAC reversalMedian transfusionTransfusion rateUnit transfusionsMulticenter studyAdult patientsXa inhibitors
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