2025
First-line immunotherapy with or without chemotherapy versus BRAF plus MEK inhibitors for patients with BRAF V600E -mutated metastatic non-small cell lung cancer: The FRONT-BRAF study.
Di Federico A, Wang K, Chen M, Barsouk A, Pagliaro A, Chen L, Ogliari F, Stockhammer P, Thawani R, Raslan S, Gariazzo E, Fusco F, Hambelton G, Citarella F, Meyer D, Corassa M, Langer C, Offin M, Negrao M, Ricciuti B. First-line immunotherapy with or without chemotherapy versus BRAF plus MEK inhibitors for patients with BRAF V600E -mutated metastatic non-small cell lung cancer: The FRONT-BRAF study. Journal Of Clinical Oncology 2025, 43: 8574-8574. DOI: 10.1200/jco.2025.43.16_suppl.8574.Peer-Reviewed Original ResearchTP53 co-mutationsTumor proportion scoreShorter mPFSCo-mutationsBRAF V600EMEK inhibitorsPD-L1 tumor proportion scoreMetastatic non-small cell lung cancerNon-small cell lung cancerHistory of tobacco smokingFirst-line immunotherapyMedian overall survivalSubgroups of ptsTreated with BRAFProgression-free survivalRate of adverse eventsWild-type TP53Cell lung cancerHistory of smokingTobacco smoking historyScore-matched cohortWild-type IDH1PD-L1Brain metastasesLine therapyPatient preference effects in a randomized comparative effectiveness study of electroconvulsive therapy and ketamine for treatment resistant depression: An ELEKT-D trial secondary analysis
Sanacora G, Barnett B, Hu B, Goes F, Mathew S, Murrough J, Reti I, Wilkinson S, Anand A. Patient preference effects in a randomized comparative effectiveness study of electroconvulsive therapy and ketamine for treatment resistant depression: An ELEKT-D trial secondary analysis. Psychiatry Research 2025, 347: 116411. PMID: 40049091, DOI: 10.1016/j.psychres.2025.116411.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionElectroconvulsive therapyResistant depressionTreatment adherenceResponse to ketamineECT-treated patientsTreatment outcome measuresInfluence treatment adherencePatient-Centered Outcomes Research InstituteAssociated with greater likelihoodKetamine treatmentIV ketamineAdverse eventsEffect of patients' preferencesPreference effectsPatient preferencesRandomized patients to treatmentKetamineRate of adverse eventsTreatment responseGreater likelihoodPatients to treatmentPhase completionTreatment preferencesDepression
2024
Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial
Ranade M, Foster M, Brady P, Sokol S, Butty S, Klein A, Maholic R, Safar A, Patel T, Zlotnick D, Gans D, Pollak J, Ferrera D, Stegman B, Basra S, Moriarty J, Keeling B, Investigators A. Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 4: 102463. PMID: 40061412, PMCID: PMC11887559, DOI: 10.1016/j.jscai.2024.102463.Peer-Reviewed Original ResearchAcute intermediate-risk PEMechanical aspiration thrombectomyIntermediate-risk PEPulmonary embolismAspiration thrombectomyRV/LV ratioClot burdenAdverse eventsMm HgLow rate of adverse eventsMean pulmonary artery pressureEnd pointsRate of adverse eventsAcute pulmonary embolismPulmonary artery pressureSafety end pointDevice-related deathsTreat pulmonary embolismSingle-arm studyEffectiveness end pointAccess site bleedingStatistically significant reductionCardiac injuryClinical deteriorationArterial pressureAnticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion
Reinhardt S, Gibson D, Hsu J, Kapadia S, Yeh R, Price M, Piccini J, Nair D, Christen T, Allocco D, Freeman J. Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion. Journal Of The American College Of Cardiology 2024, 84: 889-900. PMID: 39197978, DOI: 10.1016/j.jacc.2024.05.067.Peer-Reviewed Original ResearchConceptsLeft atrial appendage occlusionRate of adverse eventsAdverse eventsLAA closure deviceAppendage occlusionAntithrombotic strategiesP2Y<sub>12</sub> inhibitorsDays of follow-upMultivariable Cox proportional hazards regressionClosure deviceRisk of adverse eventsCox proportional hazards regressionWatchman FLX deviceDual antiplatelet therapyDevice-related thrombusProportional hazards regressionStroke/transient ischemic attackAntithrombotic regimensFLX deviceAntiplatelet therapyDOACsGroup patientsFollow-upMultivariate analysisHazards regression640 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. 640 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. British Journal Of Dermatology 2024, 191: ljae266.021. DOI: 10.1093/bjd/ljae266.021.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1Water-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisDermatitisPrescription productsTrialsFascial Plane Blocks With Glucocorticoids or Liposomal Bupivacaine Versus Local Infiltration for Laparoscopic Non-donor Nephrectomy: A Propensity Score-Weighted Study
Sobhani K, Hocevar M, Hanchuk S, Press B, He Z, Lin H, Li J. Fascial Plane Blocks With Glucocorticoids or Liposomal Bupivacaine Versus Local Infiltration for Laparoscopic Non-donor Nephrectomy: A Propensity Score-Weighted Study. Cureus 2024, 16: e66005. PMID: 39221354, PMCID: PMC11366221, DOI: 10.7759/cureus.66005.Peer-Reviewed Original ResearchFascial plane blocksLocal anesthetic infiltrationLength of hospital stayPostoperative opioid useLiposomal bupivacaineMilligram morphine equivalentsAnesthetic infiltrationDexamethasone sodium phosphatePain scoresOpioid useLocal infiltrationMethylprednisolone acetateLaparoscopic nephrectomyPlane blockHospital stayAdverse eventsUltrasound-guided fascial plane blocksDecrease postoperative opioid useLong-acting local anestheticRate of adverse eventsLower pain scoresPostoperative pain scoresReduced pain scoresSignificant adverse eventsRetrospective cohort studyAdjuvant Everolimus in Non–Clear Cell Renal Cell Carcinoma
Gulati S, Tangen C, Ryan C, Vaishampayan U, Shuch B, Barata P, Pruthi D, Bergerot C, Tripathi A, Lerner S, Thompson I, Lara P, Pal S. Adjuvant Everolimus in Non–Clear Cell Renal Cell Carcinoma. JAMA Network Open 2024, 7: e2425288. PMID: 39106067, PMCID: PMC11304111, DOI: 10.1001/jamanetworkopen.2024.25288.Peer-Reviewed Original ResearchConceptsChromophobe renal cell carcinomaRecurrence-free survivalPapillary renal cell carcinomaRenal cell carcinomaNon-clear cell renal cell carcinomaResected renal cell carcinomaCell renal cell carcinomaOverall survivalWeeks of treatmentCell carcinomaAdverse eventsClinical trialsHazard ratioPhase 3 randomized clinical trialWeeks of everolimusHigher adverse eventsRate of adverse eventsIntermediate-high riskIntervention groupVery-high-riskCox regression modelsPotential treatment benefitsClinical trial dataTreatment-naivePartial nephrectomyPrediction models for risk assessment of surgical site infection after spinal surgery: A systematic review
Lauinger A, Blake S, Fullenkamp A, Polites G, Grauer J, Arnold P. Prediction models for risk assessment of surgical site infection after spinal surgery: A systematic review. North American Spine Society Journal (NASSJ) 2024, 19: 100518. PMID: 39253699, PMCID: PMC11382011, DOI: 10.1016/j.xnsj.2024.100518.Peer-Reviewed Original ResearchSurgical site infectionPreoperative risk modelSpinal surgerySite infectionAdverse eventsAssessment of surgical site infectionACS NSQIP surgical risk calculatorPostoperative surgical site infectionNSQIP surgical risk calculatorRate of adverse eventsSpine surgery patientsRisk of adverse eventsStratify patient riskSurgical risk calculatorField of spine surgeryClinical prediction toolSpine surgeryRisk modelSurgery patientsSurgeryAddressing factorsPatient riskClinical utilitySystematic reviewUnique susceptibilityPreliminary safety and efficacy of oral azacitidine (Oral-AZA) in patients (pts) with low-/Intermediate (Int)-risk myelodysplastic syndromes (MDS): Phase 2 results from the ASTREON trial.
Garcia-Manero G, Yee K, Hernandez F, Della Porta M, Paolini S, Ahn S, Santini V, Fenaux P, Suzuki T, Sekeres M, He J, Li J, Barkalifa R, Vigil C, Prebet T, Lopes de Menezes D, Burnett J, Komrokji R, Giagounidis A. Preliminary safety and efficacy of oral azacitidine (Oral-AZA) in patients (pts) with low-/Intermediate (Int)-risk myelodysplastic syndromes (MDS): Phase 2 results from the ASTREON trial. Journal Of Clinical Oncology 2024, 42: 6509-6509. DOI: 10.1200/jco.2024.42.16_suppl.6509.Peer-Reviewed Original ResearchLower-risk MDSOral-AZAMyelodysplastic syndromeAdverse eventsPreliminary efficacy dataComplete remissionEfficacy dataOverall responseLower-risk myelodysplastic syndromesHigher-risk myelodysplastic syndromesIPSS-R scoreRBC transfusion burdenRate of adverse eventsDose-optimization studyErythropoiesis-stimulating agentsSerious adverse eventsAcute myeloid leukemiaMITT populationOral azacitidineTransfusion burdenIPSS-ROpen-labelEligible ptsPhase 2/3Primary endpointFeasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study
Makkar A, Alkhouli M, Ellis C, Shah A, Coylewright M, Freeman J, Anderson J, Gage R, Lakkireddy D. Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study. Heart Rhythm 2024, 21: 2126-2135. PMID: 38768843, DOI: 10.1016/j.hrthm.2024.05.004.Peer-Reviewed Original ResearchLeft atrial appendage occlusionAmulet occluderPost-approval studiesAdverse eventsImplant successOccluder implantationLow rate of adverse eventsRate of adverse eventsOutcomes of patientsSafety composite endpointImplantation attemptLAAO proceduresAppendage occlusionSafety endpointsPatient cohortComposite endpointFDA approvalPatientsHospital dischargeIntricate anatomyAnatomical scenariosOccluderImplantationEndpointLow rateSafety and prescribing recommendations for verapamil in newly diagnosed pediatric type 1 diabetes (T1D): The CLVer experience
Ekhlaspour L, Buckingham B, Bauza C, Clements M, Forlenza G, Neyman A, Norlander L, Schamberger M, Sherr J, Bailey R, Beck R, Kollman C, Beasley S, Cobry E, DiMeglio L, Paprocki E, Van Name M, Moran A, Group F. Safety and prescribing recommendations for verapamil in newly diagnosed pediatric type 1 diabetes (T1D): The CLVer experience. Journal Of Clinical & Translational Endocrinology 2024, 36: 100352. PMID: 38860154, PMCID: PMC11163172, DOI: 10.1016/j.jcte.2024.100352.Peer-Reviewed Original ResearchSide effectsDiabetes care teamRate of adverse eventsTreated with placeboLiver function abnormalitiesBeta-cell preservationPediatric type 1 diabetesComplete AV blockObservational extension studyAsymptomatic ECG changesPotential side effectsSide effect monitoringCare teamType 1 diabetesPlacebo groupStudy drugVerapamil doseFull dosageNewly-diagnosedAdverse eventsAV blockDrug doseECG changesStudy endFunctional abnormalitiesEfficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation
Piccini J, Ahlsson A, Dorian P, Gillinov A, Kowey P, Mack M, Milano C, Noiseux N, Perrault L, Ryan W, Steinberg J, Voisine P, Waldron N, Gleason K, Titanji W, Leaback R, O’Sullivan A, Ferguson W, Benussi S, Investigators N, Akhter S, Andreas M, Benussi S, Castella M, Dalrymple-Hay M, El-Eshmawi A, Groh M, Hanke T, Jeanmart H, Katz M, McCullough J, Melby S, Miller J, Noiseux N, Romano M, Perrault L, Piccini J, Podgoreanu M, Ryan W, Sharma V, Shults C, Teman N, Voisine P, Whitson B, Wickbom A, Vallabhajosyula P, Yau T. Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clinical Electrophysiology 2024, 10: 930-940. PMID: 38661602, DOI: 10.1016/j.jacep.2024.01.020.Peer-Reviewed Original ResearchPrevention of postoperative atrial fibrillationPostoperative atrial fibrillationCoronary artery bypass graftingRate of postoperative atrial fibrillationSafety of botulinum toxin type ACardiac surgeryPrimary endpointBotulinum toxin type AToxin type AAtrial fibrillationAssociated with increased morbidityRate of adverse eventsDose-ranging studyPlacebo-controlled trialOpen-chest cardiac surgeryType of surgeryEpicardial fat padsInjection of botulinum toxinArtery bypass graftingRandomized clinical trialsPlacebo-ControlledValve surgeryDouble-blindPlacebo groupContinuous AFReduced racial disparities among newborns with intraventricular hemorrhage
Sayeed S, Reeves B, Theriault B, Hengartner A, Ahsan N, Sadeghzadeh S, Elsamadicy E, DiLuna M, Elsamadicy A. Reduced racial disparities among newborns with intraventricular hemorrhage. Child's Nervous System 2024, 40: 2051-2059. PMID: 38526575, DOI: 10.1007/s00381-024-06369-w.Peer-Reviewed Original ResearchLength of stayIntroductionIntraventricular hemorrhageAdverse eventsMultivariate logistic regression analysisRate of adverse eventsPermanent neurological dysfunctionProlonged length of stayNational Inpatient Sample databaseRates of NECInpatient Sample databaseLogistic regression analysisIntraventricular hemorrhageAA patientsImpact of raceCost of admissionIndependent predictorsRate of mortalityPatient characteristicsMultivariate analysisPercentage of AAWhite patientsNeurological dysfunctionNewbornsPatient genderPatientsDeucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2)
Strober B, Blauvelt A, Warren R, Papp K, Armstrong A, Gordon K, Morita A, Alexis A, Lebwohl M, Foley P, Kisa R, Colston E, Wang T, Banerjee S, Thaçi D. Deucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 1543-1554. PMID: 38451052, DOI: 10.1111/jdv.19925.Peer-Reviewed Original ResearchPhase 3 trialPlaque psoriasisAdverse eventsTyrosine kinase 2Exposure-adjusted incidence ratesPooled safety dataRate of adverse eventsIncidence rate of adverse eventsVenous thromboembolic eventsExposure-adjusted incidence rates of adverse eventsAdverse cardiovascular eventsOral placeboDiscontinuation ratesLaboratory parametersThromboembolic eventsHerpes zosterDeucravacitinibCardiovascular eventsPooled analysisSafety signalsSafety dataPooled safetyPlaceboApremilastPsoriasis533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure
Bunick C, Chovatiya R, Guttman E, Shahriari M, Boguniewicz M, Gao X, Greiwe J, Blauvelt A, Schuttelaar M, Irvine A, Levy G, Platt A, Dilley D, Teixeira H, Altman K, Grada A, Silverberg J. 533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure. British Journal Of Dermatology 2024, 190: ii35-ii36. DOI: 10.1093/bjd/ljad498.037.Peer-Reviewed Original ResearchNon-melanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsAtopic dermatitisAdverse eventsAdjudicated major adverse cardiovascular eventsOral Janus kinase 1Rate of serious infectionTreatment-emergent adverse eventsLong-term safety dataDuration of follow-upConcomitant topical corticosteroidsEfficacy of upadacitinibDouble-blind periodRate of adverse eventsPhase 3 studyDoses of upadacitinibEczematous skin lesionsExposure-adjusted ratesMATERIALS & METHODSYear of treatmentAdverse cardiovascular eventsBenefit-risk profileInflammatory skin diseaseLong-term safety504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. 504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. British Journal Of Dermatology 2024, 190: ii9-ii10. DOI: 10.1093/bjd/ljad498.012.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasAtopic dermatitisRoflumilast creamDay 1Seborrheic dermatitisWater-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisPrescription productsTrialsClinicAdverse Events After Isolated Posterior Cruciate Ligament Reconstruction: A National Database Study
Kammien A, Price R, McLaughlin W, Park N, Richter D, Schenck R, Grauer J, Medvecky M. Adverse Events After Isolated Posterior Cruciate Ligament Reconstruction: A National Database Study. Orthopaedic Journal Of Sports Medicine 2024, 12: 23259671231222123. PMID: 38249782, PMCID: PMC10798085, DOI: 10.1177/23259671231222123.Peer-Reviewed Original ResearchRate of adverse eventsSurgical site infectionIsolated PCL reconstructionAdverse eventsPCL reconstructionPulmonary embolismSite infectionCompartment syndromePosterior cruciate ligamentVariable rates of complicationsOdds ratioVascular eventsOptimal managementIsolated posterior cruciate ligament reconstructionConcomitant ligament surgeryEmergency departmentNational cohortDeep vein thrombosesRate of complicationsElixhauser Comorbidity Index scoreDay of surgeryDeep vein thrombosisCalculate odds ratiosPosterior cruciate ligament reconstructionComorbidity Index scoreInvestigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Stein Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s309. DOI: 10.25251/skin.8.supp.309.Peer-Reviewed Original ResearchPhase 3 trialLocal toleranceAdverse eventsPatient treatment adherencePatients discontinued due to adverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1RoflumilastWater-based creamInvestigator-Investigational productPatientsPsoriasisDermatitisPrescription productsReal‐world analysis of adverse event rates after initiation of ibrutinib among Medicare beneficiaries with chronic lymphocytic leukemia
Huntington S, de Nigris E, Puckett J, Kamal‐Bahl S, Farooqui M, Ryland K, Sarpong E, Leng S, Yang X, Doshi J. Real‐world analysis of adverse event rates after initiation of ibrutinib among Medicare beneficiaries with chronic lymphocytic leukemia. Cancer Medicine 2024, 13: e6953. PMID: 38348963, PMCID: PMC10832339, DOI: 10.1002/cam4.6953.Peer-Reviewed Original ResearchConceptsChronic lymphocytic leukemiaRate of adverse eventsIncidence rate of adverse eventsAdverse eventsPatient-monthsLymphocytic leukemiaIncidence ratePatients treated with ibrutinibTreatment of chronic lymphocytic leukemiaStandard-of-care therapyNon-discontinuationInitiation of ibrutinibBTK inhibitor ibrutinibAdverse event ratesPotential side effectsInhibitor ibrutinibMedicare beneficiariesReal-world analysisAtrial fibrillationFollow-upIbrutinibSide effectsReal-world outcomesEvent ratesLeukemia
2023
Six-Year Follow-up of People Who Use Methamphetamine in Iran: A Case Series Study
Mohammad Aghaei A, Gholami J, Amin-Esmaeili M, Baheshmat S, Rostam-Abadi Y, Rahimi-Movaghar A. Six-Year Follow-up of People Who Use Methamphetamine in Iran: A Case Series Study. International Journal Of High Risk Behaviors And Addiction 2023, 12 DOI: 10.5812/ijhrba-131659.Peer-Reviewed Original ResearchMethamphetamine useIranian Mental Health SurveyFollow-up of peopleSubstance use treatment servicesMental Health SurveyCase series studyFrequency of methamphetamine useHealth care treatmentSix-year follow-upUse disorderSeries studyMethamphetamine use disorderHealth SurveyCompleted interviewsAdverse eventsStudy participantsTreatment servicesEligible casesRate of adverse eventsCare treatmentParticipantsProspective studyTwo-thirdsIncidence of adverse eventsInterviews
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