2022
Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2020
Effect of adding azithromycin to the antimalarials used for seasonal malaria chemoprevention on the nutritional status of African children
Gore‐Langton G, Cairns M, Compaoré Y, Sagara I, Kuepfer I, Zongo I, de Wit M, Barry A, Diarra M, Tapily A, Coumare S, Thera I, Nikiema F, Yerbanga R, Guissou R, Tinto H, Dicko A, Chandramohan D, Greenwood B, Ouedraogo J. Effect of adding azithromycin to the antimalarials used for seasonal malaria chemoprevention on the nutritional status of African children. Tropical Medicine And International Health 2020, 25: 740-750. PMID: 32166877, DOI: 10.1111/tmi.13390.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionMalaria transmission seasonMalaria chemopreventionNutritional statusTransmission seasonTreatment armsAddition of azithromycinEffect of azithromycinNutritional status indicatorsCross-sectional surveyHospital admissionRecent trialsMass administrationAnthropometric measurementsChronic malnutritionAzithromycinAfrican childrenChemopreventionNutritional outcomesBurkina FasoContinuous outcomesStudy periodMode of actionProtocol analysisYoung children
2019
Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactors
2018
Generalizing the per-protocol treatment effect: The case of ACTG A5095
Lu H, Cole S, Hall H, Schisterman E, Breger T, Edwards J, Westreich D. Generalizing the per-protocol treatment effect: The case of ACTG A5095. Clinical Trials 2018, 16: 52-62. PMID: 30326736, PMCID: PMC6693502, DOI: 10.1177/1740774518806311.Peer-Reviewed Original ResearchConceptsFour-drug antiretroviral regimenThree-drug regimenConventional intentionAntiretroviral regimenVirologic failureTreat comparisonProtocol deviationsRisk differenceTarget populationTreatment assignmentThree-drug armInverse probability weightsACTG A5095Protocol effectUS HIVHazard ratioRandomized trialsInverse oddsTreatment protocolRegimenUS individualsHIVProtocol estimatesTrialsProtocol analysis
2014
Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
Vilas-Boas A, Fontoura M, Xavier-Souza G, Araújo-Neto C, Andrade S, Brim R, Noblat L, Barral A, Cardoso M, Nascimento-Carvalho C, Matutino A, Barreto B, Silva C, Braga D, Oliveira F, Nogueira G, Oliveira Í, Lorgetto I, Costa I, Araripe J, Vieira J, Neiva L, Santana M, Nobre-Bastos M, Santos P, Câmara S, Carneiro S, Sirmos U, Araújo V, Silva C, Vilas-Boas C, Gantois D, Azevedo F, Maia J, Pirajá L, Jesus P, Fonseca T, Vilar T. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. Journal Of Antimicrobial Chemotherapy 2014, 69: 1954-1959. PMID: 24648506, DOI: 10.1093/jac/dku070.Peer-Reviewed Original ResearchConceptsNon-severe pneumoniaTreatment failureOral amoxicillinFirst-line therapyChildhood pneumoniaPrimary outcomeTreat analysisRespiratory complaintsBlinded investigationDaily dosesChest radiographsPatient allocationPneumoniaPatientsIndependent radiologistsAmoxicillinProtocol analysisThriceMonthsChildrenParticipantsFailureConcordant readingsPlaceboTherapy
2013
Fostering informed decisions: A randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer
Williams RM, Davis KM, Luta G, Edmond SN, Dorfman CS, Schwartz MD, Lynch J, Ahaghotu C, Taylor KL. Fostering informed decisions: A randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer. Patient Education And Counseling 2013, 91: 329-336. PMID: 23357414, PMCID: PMC3727283, DOI: 10.1016/j.pec.2012.12.013.Peer-Reviewed Original ResearchConceptsDecisional conflictDA participantsProstate cancerProstate cancer screening programsCancer screening programsDecision aidPrint-based decision aidUC participantsAsymptomatic menScreening programLinear regression analysisMass screeningImproved knowledgeTime interactionInformed decision makingTrialsProtocol analysisMenRegression analysisCancerOutcomesParticipantsInformed decisionsSettingDecisions of men
1998
US double‐blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori
Laine, Johnson, Suchower, Ronca, Hwang, Neil. US double‐blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori. Alimentary Pharmacology & Therapeutics 1998, 12: 377-382. PMID: 9690729, DOI: 10.1046/j.1365-2036.1998.00303.x.Peer-Reviewed Original ResearchConceptsH. pylori eradicationDual therapyEradication ratePylori eradicationDuodenal ulcerControlled TrialsHelicobacter pylori eradication ratesOmeprazole/amoxycillinPylori eradication ratesCompletion of therapyActive duodenal ulcerH. pylori diagnosisEndoscopic biopsy testsAmoxycillin resistanceAmoxycillin therapyAdverse eventsAmoxycillinTherapyHelicobacter pyloriOmeprazolePatientsBiopsy testsProtocol analysisUlcersTrials
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