2024
The NAVigate-HPV Registry: A comprehensive biomarker evidence base for HPV-driven cancers.
Roof S, Hanna G, Rettig E, Routman D, Holsinger F, Kalman N, Bhatia A, Patel M, Jabalee J, Yom S, Baliga S, Raben A, Sims J, Kaczmar J, Bhayani M, Berger B, Del Vecchio Fitz C. The NAVigate-HPV Registry: A comprehensive biomarker evidence base for HPV-driven cancers. Journal Of Clinical Oncology 2024, 42: e15045-e15045. DOI: 10.1200/jco.2024.42.16_suppl.e15045.Peer-Reviewed Original ResearchHPV-driven cancersHPV-related cancersHuman papillomavirusClinical dataHead and neckClinical outcome dataBlood-based assayPrecision cancer medicineClinical careRoutine clinical careDNA scoreUterine cervixAcademic medical facilityImprove patient outcomesAnal canalClinicopathological featuresEligible subjectsU.S. cancer centersBlood testsOncogenic driversCancer CenterTherapeutic approachesTumor biomarkersPatientsCancer medicine
2022
Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol
Maciel CB, Teixeira FJP, Dickinson KJ, Spana JC, Merck LH, Rabinstein AA, Sergott R, Shan G, Miao G, Peloquin CA, Busl KM, Hirsch LJ. Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol. Neurological Research And Practice 2022, 4: 4. PMID: 35067230, PMCID: PMC8785535, DOI: 10.1186/s42466-022-00168-x.Peer-Reviewed Original ResearchStatus epilepticusClinical trialsVigabatrin levelsClinical trial study protocolPost-cardiac arrest periodRefractory focal-onset seizuresDose-linear pharmacokineticsPrimary feasibility endpointBlinded outcome assessmentEffective adjunctive treatmentSingle loading doseTrial study protocolBrain GABA levelsCardiac arrest survivorsPilot clinical trialLast quantifiable concentrationFocal onset seizuresGABA-ergic pathwaysReports of survivorsConcentration-time curvePrimary pharmacokinetic endpointsFeasibility endpointsAggressive treatmentEligible subjectsNeuronal injuryThe Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients
Trant A, Chagpar A, Wei W, Neumeister V, Rimm D, Stavris K, Lurie B, Frederick C, Andrejeva L, Raghu M, Killelea B, Horowitz N, Lannin D, Knill-Selby E, Sturrock T, Hofstatter E. The Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients. Integrative Cancer Therapies 2022, 21: 15347354221137290. PMID: 36444764, PMCID: PMC9716631, DOI: 10.1177/15347354221137290.Peer-Reviewed Original ResearchConceptsTumor volumeBlack cohoshSitu patientsDuctal carcinomaAnti-inflammatory effectsTumor cellular proliferationBreast cancer treatmentCellular proliferationWilcoxon signed-rank testDCIS patientsAdverse eventsEligible subjectsWindow trialsCore biopsyInvasive diseaseKi67 expressionSigned-rank testBreast cancerGrade 3Hormone changesPatientsQuantitative immunofluorescenceBC extractSignificant toxicityCancer treatment
2021
24. An analysis of the National Institutes of Health All of Us Research Database: Sociodemographic Disparities Among Patients Who Received Vaccinations
Ng D, Jia S, Cadiz C, Wisseh C, Nguyen M, Lee J, McBane S, Nguyen L, Chan A, Hurley-Kim K. 24. An analysis of the National Institutes of Health All of Us Research Database: Sociodemographic Disparities Among Patients Who Received Vaccinations. Open Forum Infectious Diseases 2021, 8: 135-136. PMCID: PMC8643889, DOI: 10.1093/ofid/ofab466.226.Peer-Reviewed Original ResearchAnnual household incomeProportion of subjectsVaccinated cohortPneumococcal vaccineElectronic health recordsNational Institutes of HealthInstitutes of HealthDocumenting influenza vaccinationSociodemographic characteristicsSociodemographic characteristics of subjectsConfidence intervalsUs Research ProgramInfluenza vaccineThe National Institutes of HealthInfluenza cohortEligible subjectsDocumented vaccinationCharacteristics of subjectsAdult subjectsProportion of whitesCohortVaccination historyHealth recordsSociodemographic disparitiesEthnic disparitiesPost-acute sequelae of SARS-CoV-2 infection (PASC): a protocol for a multidisciplinary prospective observational evaluation of a cohort of patients surviving hospitalisation in Sao Paulo, Brazil
Busatto G, de Araújo A, da Silva Duarte A, Levin A, Guedes B, Kallas E, Pinna F, de Souza H, da Silva K, Sawamura M, Seelaender M, Imamura M, Garcia M, Forlenza O, Nitrini R, Damiano R, Rocha V, Batisttella L, de Carvalho C, Initiative O, da Costa Leite C, Gomes C, Burdmann E, Miguel E, Cerri G, Fonseca G, Hallak J, Krieger J, Yu L, Castro L, Corrêa M, Mancini M, Rossi M, Gouveia N, Lotufo P, Bento R, Chammas R, Francisco R, Mauad T, Avelino-Silva T, Filho W, Group H, Bonfá E, Utiyama E, Segurado A, Perondi B, Miethke-Morais A, Montal A, Harima L, Fusco S, Silva M, Rocha M, Marcilio I, Rios I, Kawano F, de Jesus M, Carmo C, Tanaka C, Marchini J, Ferreira J, Oliveira M, Guimarães T, dos Santos Lázari C, Sabino E, MC Magri M, Barros-Filho T, Francisco M. Post-acute sequelae of SARS-CoV-2 infection (PASC): a protocol for a multidisciplinary prospective observational evaluation of a cohort of patients surviving hospitalisation in Sao Paulo, Brazil. BMJ Open 2021, 11: e051706. PMID: 34193506, PMCID: PMC8249176, DOI: 10.1136/bmjopen-2021-051706.Peer-Reviewed Original ResearchConceptsMultidisciplinary assessmentLaboratory-confirmed COVID-19SARS-CoV-2 infectionProspective observational evaluationCohort of patientsCOVID-19 inpatientsPost-acute sequelaeProspective observational studyLarge academic health centerGreater disease severityCOVID-19Cardiopulmonary functioningMultiorgan symptomsEligible subjectsInflammatory markersPeer-reviewed journalsResearch Ethics CommitteeBlood testsClinical manifestationsMuscle ultrasoundOlfactory statusHealth centersObservational studyDisease featuresPathophysiological investigations
2020
Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer.
Powderly J, Chmielowski B, Brahmer J, Piha-Paul S, Bowyer S, LoRusso P, Catenacci D, Wu C, Barve M, Chisamore M, Nasrah N, Johnson D, Ho W. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. Journal Of Clinical Oncology 2020, 38: tps3163-tps3163. DOI: 10.1200/jco.2020.38.15_suppl.tps3163.Peer-Reviewed Original ResearchCheckpoint inhibitorsExpansion cohortT cellsPhase 1 dose escalationAnti-tumor immune responseTumor microenvironmentPhase I/IIPreliminary anti-tumor activityCohort expansion phaseCohort expansion studyPhase 2 dosePredominant chemokine receptorPhase 1/2 studyDose-escalation phaseEffector T cellsRegulatory T cellsAnti-tumor responseTumor-associated macrophagesAnti-tumor efficacyAnti-tumor activityEligible subjectsDendritic cellsDose escalationPhase 1/2Advanced cancerLong-term efficacy and safety of subcutaneous C1-inhibitor in women with hereditary angioedema: subgroup analysis from an open-label extension of a phase 3 trial
Levy DS, Farkas H, Riedl MA, Hsu FI, Brooks JP, Cicardi M, Feuersenger H, Pragst I, Reshef A. Long-term efficacy and safety of subcutaneous C1-inhibitor in women with hereditary angioedema: subgroup analysis from an open-label extension of a phase 3 trial. Allergy, Asthma & Clinical Immunology 2020, 16: 8. PMID: 32042283, PMCID: PMC7001333, DOI: 10.1186/s13223-020-0409-3.Peer-Reviewed Original ResearchOpen-label extensionC1-INHHealthy babyFemale subjectsFirst trimesterSubgroup analysisHereditary angioedemaHAE-C1INHIU/Severe angioedema attacksSubcutaneous C1-INHPhase 3 trialParallel-arm trialAttacks/monthLong-term efficacyFemale sex hormonesPre-study periodSubgroup of subjectsHAE attacksRoutine prophylaxisEfficacy endpointEligible subjectsUneventful pregnancyAngioedema attacksSex hormones
2019
Fructose Consumption Contributes to Hyperinsulinemia in Adolescents With Obesity Through a GLP-1–Mediated Mechanism
Galderisi A, Giannini C, Van Name M, Caprio S. Fructose Consumption Contributes to Hyperinsulinemia in Adolescents With Obesity Through a GLP-1–Mediated Mechanism. The Journal Of Clinical Endocrinology & Metabolism 2019, 104: 3481-3490. PMID: 30938760, PMCID: PMC6599430, DOI: 10.1210/jc.2019-00161.Peer-Reviewed Original ResearchConceptsLean adolescentsGLP-1Insulin responseFructose consumptionBaseline oral glucose tolerance testGlucagon-like peptide-1 secretionOral glucose tolerance testGlucose-dependent insulinotropic polypeptideHigher GLP-1Plasma glucose excursionsGLP-1 responsePeptide-1 secretionGlucose tolerance testIngestion of glucoseΒ-cell functionMeasures of glucoseEligible subjectsGlucose ingestionGlucose toleranceLean adultsAnorexic effectFructose challengeGreater insulinInsulinotropic polypeptideLean groupFactors Associated with Utilization of 17-Hydroxyprogesterone Caproate for the Prevention of Recurrent Preterm Birth
DeNoble AE, Wynn CE, Weaver KE, Wheeler SM, Swamy GK. Factors Associated with Utilization of 17-Hydroxyprogesterone Caproate for the Prevention of Recurrent Preterm Birth. American Journal Of Perinatology 2019, 37: 264-270. PMID: 30708392, DOI: 10.1055/s-0039-1678532.Peer-Reviewed Original ResearchConceptsSpontaneous preterm birthPrior term birthPrenatal care initiationEligible womenPreterm birthPrimary outcomeTerm birthsWeeks' gestationCare initiationHispanic ethnicityRecurrent spontaneous preterm birthSingleton spontaneous preterm birthPrior spontaneous preterm birthRecurrent preterm birthRetrospective cohort studyAcademic health systemStepwise logistic regressionSPTB rateCohort studyEligible subjectsSingleton pregnanciesClinical predictorsPoor adherenceMaternal ageCare barriers
2018
Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD)
Fava M, Freeman MP, Flynn M, Judge H, Hoeppner BB, Cusin C, Ionescu DF, Mathew SJ, Chang LC, Iosifescu DV, Murrough J, Debattista C, Schatzberg AF, Trivedi MH, Jha MK, Sanacora G, Wilkinson ST, Papakostas GI. Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD). Molecular Psychiatry 2018, 25: 1592-1603. PMID: 30283029, PMCID: PMC6447473, DOI: 10.1038/s41380-018-0256-5.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionSingle doseActive placeboSubanesthetic dosesIntravenous ketamineAdult treatment-resistant depressionTransient blood pressure elevationTransient antidepressant effectsBlood pressure elevationPlacebo-controlled studyDose-ranging trialInfusion of ketaminePrimary outcome measureAbility of ketamineCurrent depressive episodeSingle intravenous doseNMDA receptor antagonistTime interaction effectsMeaningful efficacyAntidepressant doseGreater dissociative symptomsAdjunctive therapyAntidepressant effectsEligible subjectsSecondary outcomes
2017
Discontinuing a non-steroidal anti-inflammatory drug (NSAID) in patients with knee osteoarthritis: Design and protocol of a placebo-controlled, noninferiority, randomized withdrawal trial
Goulet JL, Buta E, Brennan M, Heapy A, Fraenkel L. Discontinuing a non-steroidal anti-inflammatory drug (NSAID) in patients with knee osteoarthritis: Design and protocol of a placebo-controlled, noninferiority, randomized withdrawal trial. Contemporary Clinical Trials 2017, 65: 1-7. PMID: 29198731, DOI: 10.1016/j.cct.2017.11.020.Peer-Reviewed Original ResearchMeSH KeywordsAcetaminophenAdultAge FactorsAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalDisability EvaluationDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleMeloxicamMiddle AgedOsteoarthritis, KneePain MeasurementPatient Education as TopicResearch DesignSeverity of Illness IndexSex FactorsSocial SupportYoung AdultConceptsNon-steroidal anti-inflammatory drugsUse of NSAIDsOA knee painKnee painKnee osteoarthritisAnti-inflammatory drugsWithdrawal trialCurrent non-steroidal anti-inflammatory drugsKnee OA painPainful knee osteoarthritisClasses of medicationsLower extremity disabilityTwo-week runFirst clinical trialVA healthcare systemOA painEligible subjectsSecondary outcomesPrimary outcomeGlobal ImpressionNSAID toxicityNoninferiority marginClinical trialsExtremity disabilityCommon cause
2016
A Genetic Test Predicts Providence Brace Success for Adolescent Idiopathic Scoliosis When Failure Is Defined as Progression to >45 Degrees
Bohl DD, Telles CJ, Ruiz FK, Badrinath R, DeLuca PA, Grauer JN. A Genetic Test Predicts Providence Brace Success for Adolescent Idiopathic Scoliosis When Failure Is Defined as Progression to >45 Degrees. Clinical Spine Surgery A Spine Publication 2016, 29: e146-e150. PMID: 27007790, DOI: 10.1097/bsd.0b013e3182aa4ce1.Peer-Reviewed Original ResearchConceptsAdolescent idiopathic scoliosisPotential confoundingIdiopathic scoliosisGenetic testsRetrospective cohort studyMainstay of treatmentRisk of progressionCohort studyEligible subjectsRetrospective cohortAIS patientsPotential confoundersClinical managementAvailable genetic testsBACKGROUND DATAGenetic predispositionPatientsClinical practiceSaliva samplesScoliScoreProvidence braceGenetic factorsPolygenic fashionScoliosisProgression
2015
Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial
Bernstein SL, D’Onofrio G, Rosner J, O’Malley S, Makuch R, Busch S, Pantalon MV, Toll B. Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial. Annals Of Emergency Medicine 2015, 66: 140-147. PMID: 25920384, PMCID: PMC4819432, DOI: 10.1016/j.annemergmed.2015.03.030.Peer-Reviewed Original ResearchConceptsEmergency department patientsDepartment patientsUS EDsTobacco abstinence ratesGroup of smokersTobacco dependence treatmentMultivariable logistic modelingState Smokers' QuitlineLow incomeED smokersFaxed referralsQuitline referralQuitline useSecondary endpointsEligible subjectsPrimary outcomeIntervention armMedicaid insuranceNicotine patchNicotine replacementAbstinence ratesBooster callsIntervention subjectsControl armControl subjects
2013
A pilot chemoprevention study of isopropanolic black cohosh extract in women with ductal carcinoma in situ.
Hofstatter E, Stavris K, Horowitz N, Killelea B, Tsangaris T, Lannin D, Andrejeva L, Cong X, Yao X, Rimm D, Chagpar A. A pilot chemoprevention study of isopropanolic black cohosh extract in women with ductal carcinoma in situ. Journal Of Clinical Oncology 2013, 31: tps1609-tps1609. DOI: 10.1200/jco.2013.31.15_suppl.tps1609.Peer-Reviewed Original ResearchIsopropanolic black cohosh extractBlack cohosh extractBlack cohoshDuctal carcinomaBreast cancerBreast epithelial cell proliferationPre-operative courseTwo-sided significance levelDisease-free survivalLiver function testsBreast cancer preventionSerum hormone levelsAnti-inflammatory effectsBreast cancer patientsPost-menopausal womenCohort of womenRecent preclinical dataSignificant protective effectKi-67 stainingBreast core biopsyLevels of Ki67Years of ageEpithelial cell proliferationWilcoxon signed-rank testEligible subjectsLONG‐TERM OUTCOME IN ADULTS WITH OBSESSIVE‐COMPULSIVE DISORDER
Bloch MH, Green C, Kichuk SA, Dombrowski PA, Wasylink S, Billingslea E, Landeros‐Weisenberger A, Kelmendi B, Goodman WK, Leckman JF, Coric V, Pittenger C. LONG‐TERM OUTCOME IN ADULTS WITH OBSESSIVE‐COMPULSIVE DISORDER. Depression And Anxiety 2013, 30: 716-722. PMID: 23532944, PMCID: PMC3932438, DOI: 10.1002/da.22103.Peer-Reviewed Original ResearchConceptsLong-term outcomesObsessive-compulsive disorderEvidence-based treatmentsAdult OCD patientsLong-term clinical outcomesSymptom severitySerotonin reuptake inhibitor medicationsOCD patientsPlacebo-controlled trialSerotonin reuptake inhibitorsReuptake inhibitor medicationsPercent of subjectsInitial responseSymptom dimensionsLater symptom severityOCD symptomsSignificant OCD symptomsOCD symptom dimensionsAdult patientsClinical characteristicsClinical improvementEligible subjectsPartial respondersInhibitor medicationReuptake inhibitors
2012
Diabetic Ketoacidosis at Diabetes Onset: Still an All Too Common Threat in Youth
Klingensmith GJ, Tamborlane WV, Wood J, Haller MJ, Silverstein J, Cengiz E, Shanmugham S, Kollman C, Wong-Jacobson S, Beck RW, Consortium P. Diabetic Ketoacidosis at Diabetes Onset: Still an All Too Common Threat in Youth. The Journal Of Pediatrics 2012, 162: 330-334.e1. PMID: 22901739, DOI: 10.1016/j.jpeds.2012.06.058.Peer-Reviewed Original ResearchConceptsSevere diabetic ketoacidosisDiabetic ketoacidosisHemoglobin A1cIncidence of DKAInitial hemoglobin A1cNew-onset T1DPediatric Diabetes ConsortiumDiabetes-associated autoantibodiesLife-threatening complicationsOnset of T1DAfrican American raceType 1 diabetesNon-Hispanic CaucasiansClinical characteristicsEligible subjectsDiabetes onsetMean ageFamily historyPrivate health insuranceInclusion criteriaT1DMultivariate analysisYounger ageDemographic informationHealth insurance
2011
Are Quality Improvements in the Get With The Guidelines-Stroke Program Related to Better Care or Better Data Documentation?
Reeves M, Grau-Sepulveda M, Fonarow G, Olson D, Smith E, Schwamm L. Are Quality Improvements in the Get With The Guidelines-Stroke Program Related to Better Care or Better Data Documentation? Circulation Cardiovascular Quality And Outcomes 2011, 4: 503-511. PMID: 21828344, DOI: 10.1161/circoutcomes.111.961755.Peer-Reviewed Original ResearchConceptsGuidelines-Stroke programAtrial fibrillation/flutterIntravenous recombinant tissue plasminogen activator (rt-PA) therapyRecombinant tissue plasminogen activator therapyDeep vein thrombosis prophylaxisTissue plasminogen activator therapyBetter careTarget populationGWTG-Stroke hospitalsIschemic stroke admissionsPlasminogen activator therapyNumber of patientsProportion of subjectsData collection formDischarge antithromboticsEarly antithromboticsThrombosis prophylaxisTreatment contraindicationsEligible subjectsStroke admissionsActivator therapySmoking cessationLipid therapyMeasure complianceContraindications
2008
The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants
Payne K, J. J, Daley W, Khan Z, Ishak K, Stark K, Purkayastha D, Flack J, Velázquez E, Nesbitt S, Morisky D, Califf R, Committee F. The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants. International Journal Of Clinical Practice 2008, 62: 1313-1321. PMID: 18647193, PMCID: PMC2658016, DOI: 10.1111/j.1742-1241.2008.01840.x.Peer-Reviewed Original ResearchConceptsAntihypertensive medicationsObservational studyInteractive voice response systemPressure controlUsual care visitsBlood pressure controlLongitudinal observational studyHealth education programsUsual careCare visitsEligible subjectsTreatment satisfactionHypertension managementPatient satisfactionStudy completionHealthcare databasesVoice response systemProgram participantsMedicationsStudy designPhysiciansAdherenceProgram enrollmentEnrollmentNationwide initiative
2007
A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303)
Lu C, Lee J, Komaki R, Herbst R, Evans W, Choy H, Desjardins P, Esparaz B, Truong M, Fisch M. A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303). Journal Of Clinical Oncology 2007, 25: 7527-7527. DOI: 10.1200/jco.2007.25.18_suppl.7527.Peer-Reviewed Original ResearchNon-small cell lung cancerStage III non-small cell lung cancerUnresectable stage III non-small cell lung cancerMedian survival timeConcomitant chemoradiotherapyInduction chemotherapyOverall survivalPerformance statusMedian age 63 yearsExperienced grade 3Site of enrollmentHigher adverse eventsPlacebo-controlled trialPhase III studyType of chemotherapyAge 63 yearsCell lung cancerShark cartilage extractMaintenance therapyMedian followPrimary endpointStage IIIBStudy drugAdverse eventsEligible subjectsDesigns of RADIANCE 1 and 2:carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis*
Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML. Designs of RADIANCE 1 and 2:carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis*. Current Medical Research And Opinion 2007, 23: 885-894. PMID: 17407645, DOI: 10.1185/030079907x182121.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlgorithmsAnticholesteremic AgentsAtherosclerosisAtorvastatinCarotid ArteriesClinical Trials as TopicDouble-Blind MethodDrug Therapy, CombinationFemaleHeptanoic AcidsHumansHyperlipidemia, Familial CombinedHyperlipoproteinemia Type IIMaleMiddle AgedModels, BiologicalPyrrolesQuinolinesResearch DesignTunica IntimaUltrasonographyConceptsCarotid intima-media thicknessMaximum carotid intima-media thicknessNCEP ATP III guidelinesATP III guidelinesCarotid ultrasound studiesDose of atorvastatinPrimary efficacy measureLDL-C levelsIntima-media thicknessHeterozygous familial hypercholesterolemiaEnd of studyB-mode ultrasonographyFurther outcome measuresRADIANCE studyEligible subjectsControlled TrialsAtherosclerotic progressionEfficacy measuresMixed hyperlipidemiaTreatment periodOutcome measuresUltrasound studyNumber of subjectsFamilial hypercholesterolemiaCarotid segments
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