2023
0841 Feasibility of Actigraphy during a Daytime Bright Pilot Study in the Medical ICU
Lukas M, Doyle M, Intihar T, Wright K, Redeker N, Pisani M, Yaggi H, Knauert M. 0841 Feasibility of Actigraphy during a Daytime Bright Pilot Study in the Medical ICU. Sleep 2023, 46: a370-a371. DOI: 10.1093/sleep/zsad077.0841.Peer-Reviewed Original ResearchRest-activity patternsCircadian quotientMICU patientsPilot studyCosinor analysisStudy days 1Illness severity scoresCritical illnessMedical ICUMethods PatientsOngoing RCTsMean ageSeverity scorePatient outcomesActigraphy recordingsPatientsDay 1Patient careCircadian disruptionResults ThirteenActigraphyTotal recordingCircadian alignmentCircadian misalignmentMesor0842 Feasibility of daytime bright light exposure and urinary 6-sulfatoxymelatonin profiling in the medical ICU: A pilot study
Intihar T, Doyle M, Lukas M, Wright K, Redeker N, Pisani M, Yaggi H, Knauert M. 0842 Feasibility of daytime bright light exposure and urinary 6-sulfatoxymelatonin profiling in the medical ICU: A pilot study. Sleep 2023, 46: a371-a371. DOI: 10.1093/sleep/zsad077.0842.Peer-Reviewed Original ResearchMedical intensive care unitMICU patientsDaytime bright light exposureStudy days 1Intensive care unitIllness severity scoresBright light exposureWarrants further investigationCircadian outcomesMedical ICUCritical illnessIll patientsOngoing RCTsCare unitCircadian timingMean ageMelatonin useCircadian phaseSeverity scorePilot trialSufficient urinePatientsStudy daysBright lightDay 1
2022
Gastrointestinal Microbiome Disruption and Antibiotic-Associated Diarrhea in Children Receiving Antibiotic Therapy for Community-Acquired Pneumonia
Kwon J, Kong Y, Wade M, Williams DJ, Creech CB, Evans S, Walter EB, Martin JM, Gerber JS, Newland JG, Hofto ME, Staat MA, Chambers HF, Fowler VG, Huskins WC, Pettigrew M. Gastrointestinal Microbiome Disruption and Antibiotic-Associated Diarrhea in Children Receiving Antibiotic Therapy for Community-Acquired Pneumonia. The Journal Of Infectious Diseases 2022, 226: 1109-1119. PMID: 35249113, PMCID: PMC9492313, DOI: 10.1093/infdis/jiac082.Peer-Reviewed Original ResearchConceptsAAD groupAntibiotic-associated diarrheaCommunity-acquired pneumoniaCommon side effectsStudy days 1Days of diarrheaPatient characteristicsAntibiotic therapyNineteen childrenStool samplesSide effectsDay 1Microbiome disruptionMicrobiota profilesGastrointestinal microbiotaMicrobiota characteristicsDiarrheaBacteroides speciesPneumoniaChildrenAntibioticsΒ-lactamsAADBaseline abundanceDysbiosis
2021
Phase 3 VERONA study of venetoclax with azacitidine to assess change in complete remission and overall survival in treatment-naïve higher-risk myelodysplastic syndromes.
Zeidan A, Garcia J, Fenaux P, Platzbecker U, Miyazaki Y, Xiao Z, Zhou Y, Naqvi K, Kye S, Garcia-Manero G. Phase 3 VERONA study of venetoclax with azacitidine to assess change in complete remission and overall survival in treatment-naïve higher-risk myelodysplastic syndromes. Journal Of Clinical Oncology 2021, 39: tps7054-tps7054. DOI: 10.1200/jco.2021.39.15_suppl.tps7054.Peer-Reviewed Original ResearchHematopoietic stem cell transplantOverall survivalAcute myeloid leukemiaCR rateComplete remissionTransfusion independenceCell transplantationDisease progressionMyeloid leukemiaDay 1B-cell lymphoma-2 inhibitorRed blood cell transfusion independenceHigh-risk myelodysplastic syndromeAllogenic stem cell transplantationCo-morbid patientsIWG 2006 criteriaPhase 1b studyPlatelet transfusion independenceMedian overall survivalFirst-line treatmentPhase 3 studyBone marrow blastsDe novo patientsHematopoietic cell transplantationStudy days 1
2017
Phase II randomised discontinuation trial of the MET/VEGF receptor inhibitor cabozantinib in metastatic melanoma
Daud A, Kluger HM, Kurzrock R, Schimmoller F, Weitzman AL, Samuel TA, Moussa AH, Gordon MS, Shapiro GI. Phase II randomised discontinuation trial of the MET/VEGF receptor inhibitor cabozantinib in metastatic melanoma. British Journal Of Cancer 2017, 116: 432-440. PMID: 28103611, PMCID: PMC5318966, DOI: 10.1038/bjc.2016.419.Peer-Reviewed Original ResearchConceptsObjective response rateStable diseaseWeek 12Metastatic melanomaEvaluable patientsDiscontinuation trialUveal melanomaCommon grade 3/4 adverse eventsGrade 3/4 adverse eventsTreatment-related deathsMedian overall survivalProgression-free survivalResponse Evaluation CriteriaCohort of patientsStudy days 1Further clinical investigationPhase IIAbdominal painDiverticular perforationPrimary endpointAdverse eventsOverall survivalTarget lesionsClinical activityClinical investigation
2013
Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT).
Daud A, Kluger H, Edelman G, Gordon M, Schimmoller F, Weitzman A, Samuel T, Moussa A, Flaherty K, Shapiro G. Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2013, 31: 9094-9094. DOI: 10.1200/jco.2013.31.15_suppl.9094.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalMetastatic uveal melanomaUveal melanomaMelanoma cohortRandomized phase 2 studyGNA11 mutationsActivity of cabozantinibGrade 3/4 AEsSafety of cabozantinibSubstantial tumor burdenObjective tumor regressionPhase 2 studyStudy days 1Long-term followupTumor mutation statusGNAQ/GNA11 mutationsUpregulation of METEligible ptsAbdominal painMeasurable diseaseMedian PFSPrior regimensTerm FollowupMedian age
2012
Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT).
Hellerstedt B, Edelman G, Vogelzang N, Kluger H, Yasenchak C, Shen X, Ramies D, Gordon M, Lara P. Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 7514-7514. DOI: 10.1200/jco.2012.30.15_suppl.7514.Peer-Reviewed Original ResearchObjective tumor regressionMedian PFSTumor regressionWk 12Median age 67 yearsOverall disease control ratePost-baseline tumour assessmentPrior exposureActivity of cabozantinibDisease control rateGrade 3/4 AEsGrade 5 AEsMedian prior linesAge 67 yearsStudy days 1Dysregulation of METMET upregulationNSCLC ptsPrior EGFRPrior erlotinibRECIST responseTherapy 50Eligible patientsMeasurable diseaseMetastatic NSCLCActivity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT).
Gordon M, Kluger H, Shapiro G, Kurzrock R, Edelman G, Samuel T, Moussa A, Ramies D, Laird A, Schimmoller F, Shen X, Daud A. Activity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 8531-8531. DOI: 10.1200/jco.2012.30.15_suppl.8531.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalObjective tumor regressionTumor regressionPost-baseline tumour assessmentMedian age 66 yearsActivity of cabozantinibGrade 3/4 AEsGrade 5 AEsMedian prior linesOpen-label leadAge 66 yearsStudy days 1BRAF mutation statusMeasurable diseaseDiverticular perforationEligible patientsPrimary endpointFree survivalPain reliefPrior linesMonth 6VEGFR-TKIDiscontinuation trialSafety profileActivity of cabozantinib (XL184) in metastatic breast cancer (MBC): Results from a phase II randomized discontinuation trial (RDT).
Winer E, Tolaney S, Nechushtan H, Berger R, Kurzrock R, Ron I, Schoffski P, Awada A, Yasenchak C, Burris H, Ramies D, Rafferty T, Shen X. Activity of cabozantinib (XL184) in metastatic breast cancer (MBC): Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 535-535. DOI: 10.1200/jco.2012.30.15_suppl.535.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBone scanTumor regressionWk 12Common grade 3/4 AEsMedian progression-free survivalPost-baseline tumour assessmentActivity of cabozantinibGrade 5 AEsMedian age 56Median prior linesObjective response rateObjective tumor regressionStudy days 1Breast cancer developmentDysregulation of METBone painEligible patientsEvaluable ptsMeasurable diseasePrior anthracyclineSerum NTxImproved painPrimary endpoint
2011
Denosumab for Treatment of Hypercalcemia of Malignancy in Patients with Solid Tumors or Hematological Malignancies Refractory to IV Bisphosphonates: A Single-Arm Multicenter Study
Hu M, Gucalp R, Insogna K, Glezerman I, Leboulleux S, Misiorowski W, Yu B, Ying W, Yeh H. Denosumab for Treatment of Hypercalcemia of Malignancy in Patients with Solid Tumors or Hematological Malignancies Refractory to IV Bisphosphonates: A Single-Arm Multicenter Study. Blood 2011, 118: 2483. DOI: 10.1182/blood.v118.21.2483.2483.Peer-Reviewed Original ResearchHypercalcemia of malignancyDose of denosumabTreatment of hypercalcemiaAdverse eventsBP treatmentInterim analysisDay 10RANK ligandComplete responseAdvanced cancerCSC levelsBone resorptionHematological malignanciesTreatment of HCMSolid tumorsSingle-arm multicenter studyAmgen Inc.Denosumab-treated patientsDoses of denosumabStudy day 10Serious adverse eventsSerum calcium levelsSingle-arm studyStudy days 1Population of patients
2007
Efficacy and Safety of Oral Aripiprazole Compared with Haloperidol in Patients Transitioning from Acute Treatment with Intramuscular Formulations
DANIEL D, CURRIER G, ZIMBROFF D, ALLEN M, OREN D, MANOS G, MCQUADE R, PIKALOV A, CRANDALL D. Efficacy and Safety of Oral Aripiprazole Compared with Haloperidol in Patients Transitioning from Acute Treatment with Intramuscular Formulations. Journal Of Psychiatric Practice 2007, 13: 170-177. PMID: 17522560, DOI: 10.1097/01.pra.0000271658.86845.81.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdministration, OralAdolescentAdultAgedAntipsychotic AgentsAripiprazoleDouble-Blind MethodDyskinesia, Drug-InducedFemaleHaloperidolHumansInjections, IntramuscularMaleMiddle AgedPiperazinesPsychiatric Status Rating ScalesPsychomotor AgitationPsychotic DisordersQuinolonesSchizophreniaConceptsOral aripiprazoleOral formulationHaloperidol IMOral phaseIntramuscular formulationEfficacy measuresSchizoaffective disorderExtrapyramidal symptom-related adverse eventsPrimary efficacy measureStudy days 1Negative Syndrome ScalePlacebo IMAcute treatmentAdverse eventsGood tolerabilityClinical statusMean changePEC scoresPatientsDay 1HaloperidolAripiprazoleSyndrome ScaleInitial benefitComponent scores
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