2023
Initial interactions with the FDA on developing a validation dataset as a medical device development tool
Hart S, Garcia V, Dudgeon S, Hanna M, Li X, Blenman K, Elfer K, Ly A, Salgado R, Saltz J, Gupta R, Hytopoulos E, Larsimont D, Lennerz J, Gallas B. Initial interactions with the FDA on developing a validation dataset as a medical device development tool. The Journal Of Pathology 2023, 261: 378-384. PMID: 37794720, PMCID: PMC10841854, DOI: 10.1002/path.6208.Peer-Reviewed Original ResearchLongitudinal head-to-head comparison of 11C-PiB and 18F-florbetapir PET in a Phase 2/3 clinical trial of anti-amyloid-β monoclonal antibodies in dominantly inherited Alzheimer’s disease
Chen C, McCullough A, Gordon B, Joseph-Mathurin N, Flores S, McKay N, Hobbs D, Hornbeck R, Fagan A, Cruchaga C, Goate A, Perrin R, Wang G, Li Y, Shi X, Xiong C, Pontecorvo M, Klein G, Su Y, Klunk W, Jack C, Koeppe R, Snider B, Berman S, Roberson E, Brosch J, Surti G, Jiménez-Velázquez I, Galasko D, Honig L, Brooks W, Clarnette R, Wallon D, Dubois B, Pariente J, Pasquier F, Sanchez-Valle R, Shcherbinin S, Higgins I, Tunali I, Masters C, van Dyck C, Masellis M, Hsiung R, Gauthier S, Salloway S, Clifford D, Mills S, Supnet-Bell C, McDade E, Bateman R, Benzinger T. Longitudinal head-to-head comparison of 11C-PiB and 18F-florbetapir PET in a Phase 2/3 clinical trial of anti-amyloid-β monoclonal antibodies in dominantly inherited Alzheimer’s disease. European Journal Of Nuclear Medicine And Molecular Imaging 2023, 50: 2669-2682. PMID: 37017737, PMCID: PMC10330155, DOI: 10.1007/s00259-023-06209-0.Peer-Reviewed Original ResearchConceptsStandardized uptake value ratioPhase 2/3 clinical trialsPositron emission tomographyAnti-Aβ monoclonal antibodyClinical trialsPlacebo armDrug effectsLongitudinal changesMonoclonal antibodiesGlobal cortical standardized uptake value ratioHead comparisonCortical standardized uptake value ratioRegional standardized uptake value ratiosAβ positron emission tomographyAmyloid-β positron emission tomographyAlzheimer's disease clinical trialsPET imagingUptake value ratioAβ PET imagingSimulated clinical trialTwo-sample t-testDrug armPittsburgh CompoundPET scansWelch two sample t-test
2022
In Vivo Head‐To‐Head Comparison of [18F]GTP1 and [18F]PI2620 in Alzheimer’s Disease
Bohorquez S, Constantinescu C, Manser P, Gunn R, Russell D, Tonietto M, Bullich S, Stephens A, Mueller A, Klein G, Teng E, Pickthorn K. In Vivo Head‐To‐Head Comparison of [18F]GTP1 and [18F]PI2620 in Alzheimer’s Disease. Alzheimer's & Dementia 2022, 18 DOI: 10.1002/alz.063517.Peer-Reviewed Original ResearchChoroid plexusAlzheimer's diseaseTau pathology distributionModerate AD subjectsTarget cortical regionsTherapeutic trialsTau pathologyHead studiesPathology distributionCentrum semiovaleCortical greyBraak regionsAD subjectsHuman studiesInferior cerebellumSubcortical regionsHead comparisonQuantification scaleCortical regionsSubcortical structuresMinute imagesCSF spaceDiseaseUnimpaired subjectsSUVRIn Vivo Head‐To‐Head Comparison of [18F]GTP1 and [18F]PI2620 in Alzheimer’s Disease
Bohorquez S, Constantinescu C, Manser P, Gunn R, Russell D, Tonietto M, Bullich S, Stephens A, Mueller A, Klein G, Teng E, Pickthorn K. In Vivo Head‐To‐Head Comparison of [18F]GTP1 and [18F]PI2620 in Alzheimer’s Disease. Alzheimer's & Dementia 2022, 18 DOI: 10.1002/alz.063513.Peer-Reviewed Original ResearchChoroid plexusAlzheimer's diseaseTau pathology distributionModerate AD subjectsTarget cortical regionsTherapeutic trialsTau pathologyHead studiesPathology distributionCentrum semiovaleCortical greyBraak regionsAD subjectsHuman studiesInferior cerebellumSubcortical regionsHead comparisonQuantification scaleCortical regionsSubcortical structuresMinute imagesCSF spaceDiseaseUnimpaired subjectsSUVRPerformance of current risk stratification models for predicting mortality in patients with heart failure: a systematic review and meta-analysis
Siddiqi TJ, Ahmed A, Greene SJ, Shahid I, Usman MS, Oshunbade A, Alkhouli M, Hall ME, Murad MH, Khera R, Jain V, Van Spall HGC, Khan MS. Performance of current risk stratification models for predicting mortality in patients with heart failure: a systematic review and meta-analysis. European Journal Of Preventive Cardiology 2022, 29: 2027-2048. PMID: 35919956, DOI: 10.1093/eurjpc/zwac148.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsChronic heart failureLong-term mortalityMid-term mortalityAcute HFHeart failureRisk scoreGeneric inverse variance random effects modelInverse variance random-effects modelCurrent risk stratification modelsExcellent discriminationAcute heart failureRisk stratification modelShort-term mortalityLack of headRandom-effects modelGood discriminationAHF mortalityCause mortalityC-statisticNineteen studiesPatientsMortality predictionSystematic reviewHead comparisonMortalitySlip versus Slop: A Head-to-Head Comparison of UV-Protective Clothing to Sunscreen
Berry EG, Bezecny J, Acton M, Sulmonetti TP, Anderson DM, Beckham HW, Durr RA, Chiba T, Beem J, Brash DE, Kulkarni R, Cassidy PB, Leachman SA. Slip versus Slop: A Head-to-Head Comparison of UV-Protective Clothing to Sunscreen. Cancers 2022, 14: 542. PMID: 35158810, PMCID: PMC8833350, DOI: 10.3390/cancers14030542.Peer-Reviewed Original ResearchImportant modifiable risk factorModifiable risk factorsSun-protective clothingSkin cancer developmentUltraviolet radiation exposureRisk factorsSun protection factorProtection factorUV-protective clothingBroad-spectrum protectionHead comparisonCancer developmentUV-protective capacityRadiation exposureUVR exposureUVR protectionSunscreensOrganic sunscreensExposureUVRHeadFactors
2021
Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis
Johnston K, Popoff E, Deighton A, Dabirvaziri P, Harris L, Thiry A, Croop R, Coric V, L’Italien G, Moren J. Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis. Expert Review Of Pharmacoeconomics & Outcomes Research 2021, 22: 155-166. PMID: 34148501, DOI: 10.1080/14737167.2021.1945444.Peer-Reviewed Original ResearchConceptsPain freedomAcute treatmentAdverse eventsLow dosesSustained pain freedomAbsence of headFixed-effect Bayesian NMAHigh rateStudy 303Acute migraineEfficacy outcomesPain reliefBayesian NMAEfficacy resultsLasmiditanACHIEVE IComparative efficacyHigh dosesHead comparisonRCTsMigraineDosesRelative efficacySomnolenceOutcomesWheat oral immunotherapy
Leeds S, Liu EG, Nowak-Wegrzyn A. Wheat oral immunotherapy. Current Opinion In Allergy And Clinical Immunology 2021, 21: 269-277. PMID: 33840798, DOI: 10.1097/aci.0000000000000743.Peer-Reviewed Original ResearchConceptsWheat oral immunotherapyOral immunotherapyMaintenance dosesSevere reactionsFood allergy epidemiologyLow maintenance dosesNonrandomized clinical trialRisk of reactionSustained unresponsivenessSuccessful desensitizationAdjunct therapeuticsFood allergyTrial protocolClinical trialsAllergic reactionsAllergy epidemiologyHuman trialsSafety outcomesHead comparisonAugmenting factorSmall sample sizeTrialsFood modificationImmunotherapyDosesReducing Underdiagnosis of Hirschsprung-Associated Enterocolitis: A Novel Scoring System
Lewit RA, Veras LV, Cowles RA, Fowler K, King S, Lapidus-Krol E, Langer JC, Park CJ, Youssef F, Vavilov S, Gosain A. Reducing Underdiagnosis of Hirschsprung-Associated Enterocolitis: A Novel Scoring System. Journal Of Surgical Research 2021, 261: 253-260. PMID: 33460971, PMCID: PMC8166452, DOI: 10.1016/j.jss.2020.12.030.Peer-Reviewed Original ResearchConceptsHirschsprung-associated enterocolitisNew scoring systemSensitivity/specificityScoring systemHirschsprung's diseaseMultivariate analysisPercent of patientsReceipt of treatmentStepwise multivariate analysisProspective data collectionNovel scoring systemHAEC episodesRectal irrigationBowel restSignificant underdiagnosisRadiographic findingsPatient cohortColonic diseaseMore episodesUnivariate analysisHigh riskDiagnostic cutoffHead comparisonClinical settingLogistic regression
2019
Are all stem cells equal? Systematic review, evidence map, and meta-analyses of preclinical stem cell-based therapies for bronchopulmonary dysplasia
Augustine S, Cheng W, Avey MT, Chan ML, Lingappa SMC, Hutton B, Thébaud B. Are all stem cells equal? Systematic review, evidence map, and meta-analyses of preclinical stem cell-based therapies for bronchopulmonary dysplasia. Stem Cells Translational Medicine 2019, 9: 158-168. PMID: 31746123, PMCID: PMC6988768, DOI: 10.1002/sctm.19-0193.Peer-Reviewed Original ResearchConceptsMesenchymal stromal cellsCell-based therapiesBronchopulmonary dysplasiaStem cell-based therapiesSystematic reviewDifferent cell-based therapiesExperimental neonatal lung injuryAvailable preclinical dataNeonatal lung injuryPreterm birth complicationsClinical translationPreclinical experimental designLung injuryUnclear riskBirth complicationsPreclinical dataEffective therapyPreclinical studiesRodent modelsSuccessful clinical translationHead comparisonTherapyStromal cellsSelect outcomesCell productsAdrenal vein sampling with and without cosyntropin stimulation for detection of surgically remediable aldosteronism
Violari EG, Arici M, Singh CK, Caetano CM, Georgiades CS, Grady J, Tendler BR, Shichman SJ, Malchoff CD. Adrenal vein sampling with and without cosyntropin stimulation for detection of surgically remediable aldosteronism. Endocrinology Diabetes & Metabolism 2019, 2: e00066. PMID: 31008369, PMCID: PMC6458460, DOI: 10.1002/edm2.66.Peer-Reviewed Original ResearchBilateral adrenal vein samplingAdrenal vein samplingCosyntropin stimulationBiochemical cureSelectivity indexRemediable aldosteronismLateralization indexPlasma renin activitySerum aldosterone concentrationSerum cortisol concentrationsAcceptable selectivity indicesAVS protocolsAdrenal veinAntihypertensive medicationsRenin activityAldosterone concentrationReferral centerPeripheral veinVenous concentrationsRetrospective headCortisol concentrationsHead comparisonDiagnostic standardEnd pointPatients
2018
Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies
Pennells L, Kaptoge S, Wood A, Sweeting M, Zhao X, White I, Burgess S, Willeit P, Bolton T, Moons KGM, van der Schouw YT, Selmer R, Khaw KT, Gudnason V, Assmann G, Amouyel P, Salomaa V, Kivimaki M, Nordestgaard BG, Blaha MJ, Kuller LH, Brenner H, Gillum RF, Meisinger C, Ford I, Knuiman MW, Rosengren A, Lawlor DA, Völzke H, Cooper C, Ibañez A, Casiglia E, Kauhanen J, Cooper JA, Rodriguez B, Sundström J, Barrett-Connor E, Dankner R, Nietert PJ, Davidson KW, Wallace RB, Blazer DG, Björkelund C, Donfrancesco C, Krumholz HM, Nissinen A, Davis BR, Coady S, Whincup PH, Jørgensen T, Ducimetiere P, Trevisan M, Engström G, Crespo CJ, Meade TW, Visser M, Kromhout D, Kiechl S, Daimon M, Price JF, de la Cámara A, Jukema J, Lamarche B, Onat A, Simons LA, Kavousi M, Ben-Shlomo Y, Gallacher J, Dekker JM, Arima H, Shara N, Tipping RW, Roussel R, Brunner EJ, Koenig W, Sakurai M, Pavlovic J, Gansevoort RT, Nagel D, Goldbourt U, Barr ELM, Palmieri L, Njølstad I, Sato S, Verschuren W, Varghese CV, Graham I, Onuma O, Greenland P, Woodward M, Ezzati M, Psaty BM, Sattar N, Jackson R, Ridker PM, Cook NR, D'Agostino RB, Thompson SG, Danesh J, Di Angelantonio E, Tipping R, Simpson L, Pressel S, Couper D, Nambi V, Matsushita K, Folsom A, Shaw J, Magliano D, Zimmet P, Knuiman M, Whincup P, Wannamethee S, Willeit J, Santer P, Egger G, Casas J, Amuzu A, Ben-Shlomo Y, Gallacher J, Tikhonoff V, Casiglia E, Sutherland S, Nietert P, Cushman M, Psaty B, Søgaard A, Håheim L, Ariansen I, Tybjærg-Hansen A, Jensen G, Schnohr P, Giampaoli S, Vanuzzo D, Panico S, Palmieri L, Balkau B, Bonnet F, Marre M, de la Cámara A, Herrera M, Friedlander Y, McCallum J, McLachlan S, Guralnik J, Phillips C, Guralnik J, Guralnik J, Guralnik J, Khaw K, Wareham N, Schöttker B, Saum K, Holleczek B, Nissinen A, Tolonen H, Giampaoli S, Donfrancesco C, Vartiainen E, Jousilahti P, Harald K, D’Agostino R, Massaro J, Pencina M, Vasan R, D’Agostino R, Massaro J, Pencina M, Vasan R, Kayama T, Kato T, Oizumi T, Jespersen J, Møller L, Bladbjerg E, Chetrit A, Rosengren A, Wilhelmsen L, Björkelund C, Lissner L, Nagel D, Dennison E, Kiyohara Y, Ninomiya T, Doi Y, Rodriguez B, Nijpels G, Stehouwer C, Sato S, Kazumasa Y, Iso H, Goldbourt U, Salomaa V, Vartiainen E, Kurl S, Tuomainen T, Salonen J, Visser M, Deeg D, Meade T, Nilsson P, Hedblad B, Melander O, De Boer I, DeFilippis A, Verschuren W, Sattar N, Watt G, Meisinger C, Koenig W, Koenig W, Meisinger C, Verschuren W, Rosengren A, Kuller L, Tverdal A, Gillum R, Cooper J, Kirkland S, Shimbo D, Shaffer J, Sato S, Kazumasa Y, Iso H, Ducimetiere P, Bakker S, van der Harst P, Hillege H, Crespo C, Amouyel P, Dallongeville J, Assmann G, Schulte H, Trompet S, Smit R, Stott D, van der Schouw Y, Després J, Cantin B, Dagenais G, Laughlin G, Wingard D, Khaw K, Trevisan M, Aspelund T, Eiriksdottir G, Gudmundsson E, Ikram A, van Rooij F, Franco O, Rueda-Ochoa O, Muka T, Glisic M, Tunstall-Pedoe H, Völzke H, Howard B, Zhang Y, Jolly S, Gallacher J, Davey-Smith G, Can G, Yüksel H, Nakagawa H, Morikawa Y, Miura K, Njølstad I, Ingelsson M, Giedraitis V, Ridker P, Gaziano J, Kivimaki M, Shipley M, Brunner E, Shipley M, Arndt V, Brenner H, Cook N, Ridker P, Ford I, Sattar N, Ibañez A, Geleijnse J. Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies. European Heart Journal 2018, 40: 621-631. PMID: 30476079, PMCID: PMC6374687, DOI: 10.1093/eurheartj/ehy653.Peer-Reviewed Original ResearchConceptsSystematic Coronary Risk EvaluationReynolds Risk ScoreFramingham risk scoreRisk algorithmStatin therapyCVD riskProspective studyRisk discriminationRisk scoreCardiovascular disease risk estimationPrimary prevention guidelinesCoronary Risk EvaluationRisk factor profileYear CVD riskCardiovascular risk algorithmsCVD risk algorithmsIndividual participant dataDisease risk estimationCohort EquationsCVD eventsCVD incidencePrevention guidelinesHigh riskFactor profileHead comparisonClustering of Directions Improves Goodness of Fit in Kinematic Data Collected in the Transverse Plane During Robot-Assisted Rehabilitation of Stroke Patients
Li L, Hartigan J, Peduzzi P, Guarino P, Beed AT, Wu X, Wininger M. Clustering of Directions Improves Goodness of Fit in Kinematic Data Collected in the Transverse Plane During Robot-Assisted Rehabilitation of Stroke Patients. Frontiers In Robotics And AI 2018, 5: 57. PMID: 33500939, PMCID: PMC7805826, DOI: 10.3389/frobt.2018.00057.Peer-Reviewed Original Research
2016
Whole genome sequencing of Plasmodium falciparum from dried blood spots using selective whole genome amplification
Oyola S, Ariani C, Hamilton W, Kekre M, Amenga-Etego L, Ghansah A, Rutledge G, Redmond S, Manske M, Jyothi D, Jacob C, Otto T, Rockett K, Newbold C, Berriman M, Kwiatkowski D. Whole genome sequencing of Plasmodium falciparum from dried blood spots using selective whole genome amplification. Malaria Journal 2016, 15: 597. PMID: 27998271, PMCID: PMC5175302, DOI: 10.1186/s12936-016-1641-7.Peer-Reviewed Original ResearchConceptsVenous bloodSelective whole genome amplificationMalaria patientsDBS samplesBlood spotsPlasmodium falciparumClinical samplesSymptomatic malaria patientsHigh quality clinical samplesDried Blood SpotsP. falciparum DNAMalaria parasite Plasmodium falciparumHead comparisonParasite Plasmodium falciparumDrug resistance lociHealthcare applicationsPatientsWhole-genome sequencingGenome amplificationDBS extractsSNP concordanceWhole genome amplificationFalciparumCurrent dataScalable wayDiagnosis of sessile serrated adenomas/polyps with image-enhanced endoscopy: a systematic review and meta-analysis
Parikh ND, Chaptini L, Njei B, Laine L. Diagnosis of sessile serrated adenomas/polyps with image-enhanced endoscopy: a systematic review and meta-analysis. Endoscopy 2016, 48: 731-739. PMID: 27223636, DOI: 10.1055/s-0042-107592.Peer-Reviewed Original ResearchConceptsImage-enhanced endoscopyWhite light endoscopyNarrow-band imagingNon-neoplastic lesionsSSA/PsAdenomas/polypsFlexible spectral imaging color enhancementSystematic reviewCorresponding histologic diagnosesSSA/P detection rateSessile serrated adenomas/polypsSerrated adenomas/polypsNon-neoplastic tissuesAppearance of polypsSSA/PNBI studiesPrimary outcomeHistologic diagnosisInclusion criteriaEndoscopic diagnosisHyperplastic polypsSSA/P.Autofluorescence imagingHead comparisonBand imaging
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