2025
Quality of Care and Opportunities for Improvement in Prehospital Care of Critically Ill Pediatric Patients: An Observational, Simulation-Based Study
Cicero M, Schissler K, Baird J, Brown L, Auerbach M, Irgens-Moller N, Pavlinetz N, Adelgais K. Quality of Care and Opportunities for Improvement in Prehospital Care of Critically Ill Pediatric Patients: An Observational, Simulation-Based Study. Prehospital Emergency Care 2025, ahead-of-print: 1-10. PMID: 40353808, DOI: 10.1080/10903127.2025.2500715.Peer-Reviewed Original ResearchEmergency medical servicesPediatric emergency care coordinatorCare of critically ill pediatric patientsQuality of careProspective cohort studyCare coordinationPrehospital carePediatric simulationClinical skillsPrehospital scenariosEvaluate performance differencesMedical servicesSkills checklistTeam performanceCritically ill pediatric patientsPediatric emergenciesSkill performanceIll pediatric patientsClinicians informationSecondary objectivesStandard toolPediatric patientsAgency levelTeamSkillsMAT2A inhibitor AG-270/S095033 in patients with advanced malignancies: a phase I trial
Gounder M, Johnson M, Heist R, Shapiro G, Postel-Vinay S, Wilson F, Garralda E, Wulf G, Almon C, Nabhan S, Aguado-Fraile E, He P, Romagnoli M, Hossain M, Narayanaswamy R, Sadou-Dubourgnoux A, Cooper M, Askoxylakis V, Burris H, Tabernero J. MAT2A inhibitor AG-270/S095033 in patients with advanced malignancies: a phase I trial. Nature Communications 2025, 16: 423. PMID: 39762248, PMCID: PMC11704051, DOI: 10.1038/s41467-024-55316-5.Peer-Reviewed Original ResearchConceptsAdvanced malignanciesEvidence of clinical activityPaired tumor biopsiesTreatment-related toxicityPhase I trialPhase 1 trialFirst-in-humanLiver function testsProof-of-mechanismHomozygous MTAP deletionPlasma SAM concentrationsPartial responseConcentrations of S-adenosylmethionineTumor biopsiesI trialSafety profileMTAP deletionHomozygous deletionMAT2A inhibitionClinical activityPlasma concentrationsFunction testsPatientsSecondary objectivesMaximal reduction
2024
Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT)
Bertolaccini L, Ciani O, Lucchi M, Zaraca F, Bertani A, Crisci R, Spaggiari L, Group L. Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT). JMIR Research Protocols 2024, 13: e57183. PMID: 39378423, PMCID: PMC11496920, DOI: 10.2196/57183.Peer-Reviewed Original ResearchConceptsLocally advanced lung cancerNon-small cell lung cancerOutcomes of patientsAdvanced lung cancerLung cancerWeb-based registryINTERNATIONAL REGISTERED REPORT IDENTIFIERObservational studySecondary objectivesSuboptimal response ratesEvolving treatment paradigmCell lung cancerLung cancer managementTraditional open surgeryInfluence treatment strategiesStudy's secondary objectivePatient-reported outcomesNational benchmarksOpen surgeryProcess of care indicatorsRisk-adjusted outcomesTreatment paradigmNSCLC treatmentCancer managementFollow-upA phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer
Planchard D, Wolf J, Solomon B, Sebastian M, Wermke M, Heist R, Sun J, Min Kim T, Reguart N, Sanmamed M, Felip E, Garrido P, Santoro A, Bootle D, Couillebault X, Gaur A, Mueller C, Poggio T, Yang J, Moschetta M, Dooms C. A phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer. Lung Cancer 2024, 197: 107964. PMID: 39383771, DOI: 10.1016/j.lungcan.2024.107964.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerBRAF-mutated non-small cell lung cancerLung cancerDose-escalation/dose-expansion studyTreatment-related adverse eventsAntitumor activityDose-limiting toxicityNRAS-mutant melanomaMEK1/2 inhibitor trametinibPartial responseInhibitor trametinibFrequent gradeSafety profileAdverse eventsPharmacodynamic effectsTrametinibGenetic alterationsMedian reductionPan-RAFIncreased lipasePatientsSecondary objectivesMRNA levelsEvaluate toleranceNeoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study
Dent R, Cortés J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Haiderali A, Jia L, Nguyen A, Pan W, O'Shaughnessy J, Schmid P. Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study. Journal Of The National Cancer Institute 2024, 116: 1654-1663. PMID: 38913881, PMCID: PMC11461162, DOI: 10.1093/jnci/djae129.Peer-Reviewed Original ResearchEarly-stage triple-negative breast cancerTriple-negative breast cancerLS mean changeBaseline to weekPatient-reported outcomesAdjuvant pembrolizumabBetween-group differencesKEYNOTE-522Neoadjuvant phaseAdjuvant phaseBreast cancerMean changePathological complete responseEvent-free survivalQuality-of-life resultsNeoadjuvant pembrolizumabPatient-reported outcome assessmentsComplete responseNeoadjuvant chemotherapyEORTC QLQ-30PembrolizumabQuality-of-lifeSecondary objectivesQLQ-30PlaceboA phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation.
Heumann T, Stockton S, Cecchini M, Aljumaily R, Shyr C, Whisenant J, Starr J, Dayyani F, Baranda J, Trikalinos N, Ivy S, LoRusso P, Das S, Gore S, Beumer J, Berlin J. A phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation. Journal Of Clinical Oncology 2024, 42: 3077-3077. DOI: 10.1200/jco.2024.42.16_suppl.3077.Peer-Reviewed Original ResearchAdvanced solid tumorsMaximum tolerated doseDose escalationSolid tumorsPhase I study of irinotecanRecommended phase 2 doseRefractory advanced solid tumorsPhase 2 dosePhase I studyAnti-tumor activityBiweekly irinotecanInhibitor irinotecanIrinotecan exposureWeekly irinotecanTolerated doseDosing scheduleCancer xenograftsAdult patientsIrinotecanAssess safetyATR inhibitorsElimusertibSecondary objectivesDoseStandard care
2023
Prehospital Management of Pediatric Behavioral Health Emergencies: A Scoping Review
Zorovich E, Kothari K, Adelgais K, Alter R, Mojica L, Salinas A, Auerbach M, Adams C, Fishe J. Prehospital Management of Pediatric Behavioral Health Emergencies: A Scoping Review. Cureus 2023, 15: e38840. PMID: 37303422, PMCID: PMC10254945, DOI: 10.7759/cureus.38840.Peer-Reviewed Original ResearchEmergency medical services protocolsEmergency medical servicesBehavioral health emergenciesPrehospital managementEvidence-based guidelinesPediatric agitationScoping ReviewEMS protocolsMedical servicesPrehospitalPharmacological restraintAdult populationPediatrics recommendationsLiterature searchInternet searchHealth emergencySecondary objectivesResearch studiesUnited StatesNonpharmaceutical interventionsNeurodevelopmental conditionsPracticePublicationsInterventionEmergencyDesign and rationale of FINE-REAL: A prospective study of finerenone in clinical practice
Desai N, Navaneethan S, Nicholas S, Pantalone K, Wanner C, Hamacher S, Gay A, Wheeler D. Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. Journal Of Diabetes And Its Complications 2023, 37: 108411. PMID: 36857997, DOI: 10.1016/j.jdiacomp.2023.108411.Peer-Reviewed Original ResearchConceptsMineralocorticoid receptor antagonistsChronic kidney diseaseNonsteroidal mineralocorticoid receptor antagonistClinical practicePatterns of care of patientsAssociated with type 2 diabetesCare of patientsHealthcare resource utilizationInclusion of participantsType 2 diabetesReceptor antagonistDiabetic retinopathyTreatment patternsProspective studyKidney diseaseFinerenoneAssessment of safetyPatientsSecondary objectivesT2DPrimary objectiveDiseaseUnited StatesTreatmentDecision-making
2019
Using pharmacokinetics for tailoring prophylaxis in people with hemophilia switching between clotting factor products: A scoping review
Yu J, Iorio A, Edginton A, co‐investigators O, Ahuja S, Román M, Arrieta M, Arola M, Barillari G, Balasa V, Belletrutti M, Moreno R, Beurrier P, Bidlingmaier C, Blanchette V, Blatny J, Bonanad S, Brose K, Brown D, Byant P, Canaro M, Carvalho M, Catarino C, Chitlur M, Cockrell E, Chowdary P, Cnossen M, Collins P, Coppens M, Croteau S, Cultrera D, de Cristofaro R, de Raucourt E, Desprez D, Dunn A, El‐Ekiabi M, Kotnik B, Fischer K, Frotscher B, Garbiero S, Ruiz R, Gill J, del Castillo C, Gottstein S, Lassandro G, Giordano P, Hart D, Hegemann I, Hermans C, Hua B, Hwang N, Jackson S, James P, Katsarou O, Kavakli K, Kempton C, Kentouche K, Khan O, Kobelt R, Kruse‐Jarres R, Laane E, Larson E, Lassila R, Lee A, Poon M, Lissick J, Langstrom S, Mahlangu J, Makris M, Marchesini E, Mateo J, Vera P, Martorell M, Matsushita T, McCrae S, Mignot‐Castellano E, Montcrieff C, Maes P, Mondelars V, Bekart M, Mora E, Morales J, Mourey G, Bertrand M, Napolitano M, Siragusa S, Negrier C, Neme D, Niinimaki R, Oldenburg J, Albert T, Ornstein D, Ozelo M, Panetta J, Neufeld E, P'Ng S, Peerlinck K, Pollio B, Pouplard C, Gruel Y, Prezotti A, Price V, Primacakti F, Puyade M, Radossi P, Raffini L, Ragni M, Rangarajan S, Reding M, Reid R, Restrepo J, Ramirez J, Recht M, Lopez M, Ruiz‐Sàez A, Saleh M, Shapiro A, Sharathkumar A, Selmeczi A, Simpson M, Singleton T, Cruz M, Soto V, Steele M, Streif W, Sun H, Ritchie B, Sun J, Feng X, Suzuki T, Nagao A, Takemoto C, Tapp H, Teitel J, Tinmouth A, Thornburg C, Tosseto A, Turnstall O, Vezina C, Warren B, Wheeler A, Gutierrez J, Wu J, Wynn T, Yang R, Young G, Zanon E, Zupan I. Using pharmacokinetics for tailoring prophylaxis in people with hemophilia switching between clotting factor products: A scoping review. Research And Practice In Thrombosis And Haemostasis 2019, 3: e12204. PMID: 31294337, PMCID: PMC6611373, DOI: 10.1002/rth2.12204.Peer-Reviewed Original ResearchClotting factor productsFactor concentrationsClotting factorsPrediction of pharmacokineticsDosing regimenClinical benefitHemophilia patientsInadequate dosingTitrated treatmentComparative pharmacokinetic studyPharmacokinetic studiesSecondary objectivesRisks associated with switchingDevelopment studiesHemophiliaPharmacokineticsPatientsFactor productivityInhibitor developmentProphylaxisClotPK knowledgeDoseInhibitorsRegimenComparison of the Standardized Video Interview and Interview Assessments of Professionalism and Interpersonal Communication Skills in Emergency Medicine
Hopson L, Dorfsman M, Branzetti J, Gisondi M, Hart D, Jordan J, Cranford J, Williams S, Regan L. Comparison of the Standardized Video Interview and Interview Assessments of Professionalism and Interpersonal Communication Skills in Emergency Medicine. AEM Education And Training 2019, 3: 259-268. PMID: 31360819, PMCID: PMC6637001, DOI: 10.1002/aet2.10346.Peer-Reviewed Original ResearchInterpersonal communication skillsEmergency medicineInterview assessmentAssessment of professionalismRank order list positionSVI scoresRank order listsEM residency programsIndependent-groups t-testKnowledge of professionalsOne-way analysis of variancePotential influence of genderGender differencesStandardized Video InterviewOne-way analysisResidency programsProfessionalsNo group differencesObservational studyStandardized instrumentsPositive correlationCommunication skillsSecondary objectivesIndependent-groupsAnalysis of variance
2018
Creation, Implementation, and Assessment of a General Thoracic Surgery Simulation Course in Rwanda
Ramirez A, Nuradin N, Byiringiro F, Ssebuufu R, Stukenborg G, Ntakiyiruta G, Daniel T. Creation, Implementation, and Assessment of a General Thoracic Surgery Simulation Course in Rwanda. The Annals Of Thoracic Surgery 2018, 105: 1842-1849. PMID: 29476717, PMCID: PMC5964001, DOI: 10.1016/j.athoracsur.2018.01.043.Peer-Reviewed Original ResearchConceptsGeneral surgery residentsThoracic proceduresSurgery residentsLow-middle income country settingFellowship training opportunitiesSimulation courseDiaphragm repairLow-middle income countriesIncome country settingsStatistically significant improvementUnivariate analysisResident knowledge baseSecondary objectivesSimulated surgeryLocal facultyIncome countriesCountry settingsKnowledge assessmentTraining levelTraining opportunitiesResident feedbackParticipants' responsesLikert scaleEnhance confidenceSignificant improvement
2017
Telemedicine-Enabled Clinical Trial of Metformin in Patients With Prostate Cancer
Galsky M, Shahin M, Jia R, Shaffer D, Gimpel-Tetra K, Tsao C, Baker C, Leiter A, Holland J, Sablinski T, Mehrazin R, Sfakianos J, Acon P, Oh W. Telemedicine-Enabled Clinical Trial of Metformin in Patients With Prostate Cancer. JCO Clinical Cancer Informatics 2017, 1: 1-10. PMID: 30657386, DOI: 10.1200/cci.17.00044.Peer-Reviewed Original ResearchConceptsClinical trialsProstate cancerAdverse eventsSerum prostate-specific antigenStudy visitsClinical trials of metforminProstate-specific antigenTrial of metforminProspective clinical trialLocal therapySlow accrualOncology clinical trialsOral metforminStudy treatmentAnticancer activityTelehealth video visitsPatientsQuality of lifeSecondary objectivesPatient satisfactionCancerMetforminProstateTrial participantsTrialsTelemedicine-enabled clinical trial of metformin in patients (pts) with biochemically-recurrent prostate cancer (PCa).
Galsky M, Shahin M, Olson A, Shaffer D, Gimpel-Tetra K, Tsao C, Baker C, Leiter A, Holland J, Sablinski T, Mehrazin R, Sfakianos J, Acon P, Oh W. Telemedicine-enabled clinical trial of metformin in patients (pts) with biochemically-recurrent prostate cancer (PCa). Journal Of Clinical Oncology 2017, 35: 243-243. DOI: 10.1200/jco.2017.35.6_suppl.243.Peer-Reviewed Original ResearchProstate cancerAdverse eventsClinical trialsClinical trials of metforminTelemedicine visitsQuality of lifeGleason score 7Trial of metforminProspective clinical trialAnti-PCa activityCourse of metforminPSA riseRising PSAPSA changesLocal therapySlow accrualClinical trial sitesMedian ageOncology clinical trialsMonth courseScore 7Disease progressionPSASecondary objectivesMetformin
2010
Rotating Resident Didactics in the Emergency Department: A Cross‐sectional Survey on Current Curricular Practices
Branzetti J, Aldeen A, Courtney D. Rotating Resident Didactics in the Emergency Department: A Cross‐sectional Survey on Current Curricular Practices. Academic Emergency Medicine 2010, 17: s49-s53. PMID: 21199084, DOI: 10.1111/j.1553-2712.2010.00852.x.Peer-Reviewed Original ResearchConceptsAcademic emergency departmentEmergency departmentRotating residentsDidactic curriculumAllopathic EM residency programsConfidence intervalsCross-sectional surveyEM residency programsInterquartile rangeWeb-based surveyCurricular contentEM rotationClinical rotationsDidactic educationResidency programsResident didacticsResidency directorsInstitutional review boardSecondary objectivesEducational formatResidentsLearning needsResponse rateIdeal curriculumE-mail
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