2023
Adding Inflammatory Markers and Refining National Institute on Alcohol Abuse and Alcoholism Criteria Improve Diagnostic Accuracy for Alcohol-associated Hepatitis
Avitabile E, Díaz A, Montironi C, Pérez-Guasch M, Gratacós-Ginès J, Hernández-Évole H, Moreira R, Sehrawat T, Malhi H, Olivas P, Hernández-Gea V, Bataller R, Shah V, Kamath P, Ginès P, Pose E. Adding Inflammatory Markers and Refining National Institute on Alcohol Abuse and Alcoholism Criteria Improve Diagnostic Accuracy for Alcohol-associated Hepatitis. Clinical Gastroenterology And Hepatology 2023, 21: 3080-3088.e9. PMID: 37004974, DOI: 10.1016/j.cgh.2023.03.023.Peer-Reviewed Original ResearchConceptsAlcohol-associated hepatitisAlcohol-related liver diseaseAlcoholic steatohepatitisLiver biopsyDiagnostic accuracyLiver diseaseValidation cohortNIAAA criteriaAlcohol abuseSevere alcohol-associated hepatitisC-reactive proteinGold standardNational InstituteInflammatory markersConsecutive patientsDerivation cohortHistological diagnosisMayo ClinicHospital ClínicTherapeutic studiesAlcoholism criteriaClinical investigatorsConsensus criteriaAbstractTextNoninvasive diagnosis
2017
Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report
Newman JH, Rich S, Abman SH, Alexander JH, Barnard J, Beck GJ, Benza RL, Bull TM, Chan SY, Chun HJ, Doogan D, Dupuis J, Erzurum SC, Frantz RP, Geraci M, Gillies H, Gladwin M, Gray MP, Hemnes AR, Herbst RS, Hernandez AF, Hill NS, Horn EM, Hunter K, Jing ZC, Johns R, Kaul S, Kawut SM, Lahm T, Leopold JA, Lewis GD, Mathai SC, McLaughlin VV, Michelakis ED, Nathan SD, Nichols W, Page G, Rabinovitch M, Rich J, Rischard F, Rounds S, Shah SJ, Tapson VF, Lowy N, Stockbridge N, Weinmann G, Xiao L. Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report. American Journal Of Respiratory And Critical Care Medicine 2017, 195: 1661-1670. PMID: 28430547, PMCID: PMC5476915, DOI: 10.1164/rccm.201701-0150ws.Peer-Reviewed Original ResearchConceptsPulmonary vascular diseaseClinical trialsPulmonary hypertensionVascular diseaseNational Biological SamplePrecision medicine principlesVascular disease phenotypesNational Precision Medicine InitiativeSmall clinical trialsFuture clinical trialsPrecision medicine approachInnovative statistical designLung diseasePatient populationPatient advocacy organizationsPrecision Medicine InitiativeTherapeutic interventionsClinical investigatorsMedicine approachMedicine principlesMetabolic testsTrialsDiseaseBreakthrough InitiativePharmaceutical industry experts
2016
Moderate Alcohol Consumption and Chronic Disease: The Case for a Long‐Term Trial
Mukamal KJ, Clowry CM, Murray MM, Hendriks HF, Rimm EB, Sink KM, Adebamowo CA, Dragsted LO, Lapinski PS, Lazo M, Krystal JH. Moderate Alcohol Consumption and Chronic Disease: The Case for a Long‐Term Trial. Alcohol Clinical And Experimental Research 2016, 40: 2283-2291. PMID: 27688006, PMCID: PMC5073014, DOI: 10.1111/acer.13231.Peer-Reviewed Original ResearchConceptsModerate alcohol consumptionChronic diseasesAlcohol consumptionRandomized trialsLong-term clinical trialsCoronary heart diseaseMajor chronic diseasesStrong epidemiological associationLong-term trialsGold standard evidenceNutritional interventionHeart diseaseClinical trialsBreast cancerEpidemiological associationModerate drinkingYears durationClinical investigatorsBiological mediatorsAvailable evidenceDiseaseObserved associationsTrialsStandard evidenceVariety of settingsDevelopment of an evidence-based decision pathway for vestibular schwannoma treatment options
Linkov F, Valappil B, McAfee J, Goughnour SL, Hildrew DM, McCall AA, Linkov I, Hirsch B, Snyderman C. Development of an evidence-based decision pathway for vestibular schwannoma treatment options. American Journal Of Otolaryngology 2016, 38: 57-64. PMID: 27780583, DOI: 10.1016/j.amjoto.2016.09.019.Peer-Reviewed Original ResearchConceptsVestibular schwannomaGroup of patientsPost-operative symptomsEvidence-based dataPittsburgh Medical CenterEffectiveness of treatmentQuality of lifeComplex medical problemsHealth care systemTreatment Decision Support SystemVS patientsTreatment optionsTreatment pathwaysTreatment decisionsMedical CenterClinical informationTreatment selectionFocus groupsSide effectsPatient valuesPatientsPatient feedbackClinical investigatorsTreatment alternativesMedical problems
2015
Chapter 1 Introduction Research Misconduct in Biomedical Research Institutions
Snyder P, Mayes L, Smith W. Chapter 1 Introduction Research Misconduct in Biomedical Research Institutions. 2015, 1-12. DOI: 10.1016/b978-0-12-405198-0.00001-1.Peer-Reviewed Original ResearchCardiac healthModerate alcohol consumptionSimple lifestyle changesCertain health benefitsPositive health effectsAlcohol ingestionLifestyle changesAge-related memory declineAlcohol consumptionAlzheimer's diseaseClinical investigatorsProtective factorsHealth effectsHealth benefitsDiseaseMemory declineNumerous reportsAlcoholic beveragesHealthRiskCancerProgressionIngestion
2011
Nurturing the Global Workforce in Clinical Research: The National Institutes of Health Fogarty International Clinical Scholars and Fellows Program
Heimburger DC, Carothers CL, Gardner P, Primack A, Warner TL, Vermund SH. Nurturing the Global Workforce in Clinical Research: The National Institutes of Health Fogarty International Clinical Scholars and Fellows Program. American Journal Of Tropical Medicine And Hygiene 2011, 85: 971-978. PMID: 22144429, PMCID: PMC3225173, DOI: 10.4269/ajtmh.2011.11-0141.Peer-Reviewed Original ResearchConceptsHealth research partnershipsChronic disease researchClinical research settingClinical trialsObservational studyGlobal health expertsClinical investigatorsInfectious diseasesClinical researchTranslational researchHealth expertsInternational investigatorsNational InstituteFogarty International Clinical Research ScholarsHealth researchClinical scholarsDisease researchGlobal health researchResearch settingsHigh-impact journalsInvestigatorsTraining opportunitiesDiseaseTrialsIncreasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies
Schlaff WD, Zhang H, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Barnhart KT, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Santoro N, Eisenberg E, Huang H, Legro RS, Network R. Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertility And Sterility 2011, 96: 15-18. PMID: 21645894, PMCID: PMC3151556, DOI: 10.1016/j.fertnstert.2011.05.069.Peer-Reviewed Original ResearchConceptsPolycystic Ovary Syndrome IReproductive Medicine NetworkMulticenter clinical trialMulticenter trialClinical trialsSubstantial burdenInstitutional reviewClinical investigatorsMedicine NetworkSignificant increaseBurdenTrialsInstitutional review board requirementsObjective dataIRB submissionPregnancyInfertilityHuman research participantsYearsSignificant variability
2010
Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology
Peppercorn J, Shapira I, Collyar D, Deshields T, Lin N, Krop I, Grunwald H, Friedman P, Partridge AH, Schilsky RL, Bertagnolli MM. Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology. Journal Of Clinical Oncology 2010, 28: 2635-2640. PMID: 20406927, PMCID: PMC5596502, DOI: 10.1200/jco.2009.27.2443.Peer-Reviewed Original ResearchConceptsResearch biopsiesResearch participantsVoluntary informed consentCorrelative end pointsEthical concernsRisk of harmScientific questionsEthics CommitteeClinical trialsInformed consentInformed adultsScientific issuesEnd pointConsentClinical investigatorsCancer clinical trialsQuestionsEthicsPredictive biomarkersBiopsyIssuesCancer tissuesConductNovel interventionsBiologic basis
2008
Informed Consent for Research: Current Practices in Academic Emergency Medicine
Monico E, Larkin GL, Degutis L. Informed Consent for Research: Current Practices in Academic Emergency Medicine. Academic Emergency Medicine 2008, 15: 573-576. PMID: 18616447, DOI: 10.1111/j.1553-2712.2008.00098.x.Peer-Reviewed Original ResearchConceptsAcademic EDInformed consentHealth care personnelEmergency department environmentEmergency medicine residency training programsHalf of respondentsCare personnelClinical investigatorsSpecific research protocolsResidency training programsClinical EDsUnique barriersEmergency medicineAcademic Emergency MedicineInformed consent practicesConsent processResidents' knowledgeGraduate Medical EducationDepartment environmentFurther studiesEM residentsResearch protocolConsentPotential research subjectsAccreditation Council
2006
Study participants’ perceptions of the process and impact of receiving results of N9831
Partridge A, Wolff A, Marcom P, Kaufman P, Moore C, Lake D, Fleming G, Rugo H, Collyar D, Winer E. Study participants’ perceptions of the process and impact of receiving results of N9831. Journal Of Clinical Oncology 2006, 24: 518-518. DOI: 10.1200/jco.2006.24.18_suppl.518.Peer-Reviewed Original ResearchTrial participantsLarge cooperative group trialsPhase III trialsCooperative group trialsSubset of womenClinical trial participantsHealth care providersAdjuvant chemotherapyRecurrent diseaseIII trialsMultivariable analysisClinical trialsBreast cancerGroup trialsCare providersAverage ageFavorable responseClinical investigatorsPsychosocial supportPatientsWomenSubstantial proportionTrialsStudy resultsGreater satisfaction
1997
Loss, Loneliness, and the Desire for Love: Perspectives on the Social Lives of People with Schizophrenia
Davidson L, Stayner D. Loss, Loneliness, and the Desire for Love: Perspectives on the Social Lives of People with Schizophrenia. Psychiatric Rehabilitation Journal 1997, 20: 3-12. DOI: 10.1037/h0095369.Peer-Reviewed Original Research
1995
Clinical investigative perspective
Wackers F. Clinical investigative perspective. Journal Of Nuclear Cardiology 1995, 2: 75-77. PMID: 9420766, DOI: 10.1016/s1071-3581(05)80012-1.Peer-Reviewed Original ResearchConceptsClinical useExciting new agentPhase III studyNew imaging agentWidespread clinical useIII studyNew agentsClinical protocolsClinical investigatorsNew radiopharmaceuticalsExperienced investigatorsImaging agentCliniciansAcademic investigatorsInvestigatorsFinal approvalExciting new discoveriesScientific evaluationRadiopharmaceutical researchAgentsImaging methodology
1993
Factors affecting uniformity in interpretation of planar thallium-201 imaging in a Multicenter trial
Wackers F, Bodenheimer M, Fleiss J, Brown M, Investigators T. Factors affecting uniformity in interpretation of planar thallium-201 imaging in a Multicenter trial. Journal Of The American College Of Cardiology 1993, 21: 1064-1074. PMID: 8459059, DOI: 10.1016/0735-1097(93)90226-q.Peer-Reviewed Original ResearchConceptsClinical centersThallium-201 imagesCore laboratoryClinical investigatorsSilent myocardial ischemiaPlanar thallium-201 imagesThallium-201 imagingLack of standardizationCircumferential profile analysisPlanar thallium-201 imagingReproducibility of interpretationMulticenter trialMulticenter studyMyocardial ischemiaMyocardial perfusion imagesSuboptimal reproducibilityInterobserver agreementKappa statisticsPerfusion imagesPoor interlaboratory agreementComputer quantificationObjective criteriaInterlaboratory agreementPoor agreementEffects of standardization
1990
Neurotransmitter Assessment in Neuropsychiatric Disorders of Childhood
Rasmusson A, Riddle M, Leckman J, Anderson G, Cohen D. Neurotransmitter Assessment in Neuropsychiatric Disorders of Childhood. 1990, 33-59. DOI: 10.1007/978-1-4613-0525-5_3.Peer-Reviewed Original ResearchChild psychiatric disordersNeurotransmitter assessmentNeuropharmacologic agentsPsychiatric illnessNeurotransmitter systemsPsychiatric disordersNeurobiologic processesClinical investigatorsNeuropsychiatric disordersClinical researchFunctional neuroanatomyConstitutional factorsArea of childNeural substratesPotential roleAdolescent psychiatryPsychodynamic factorsDisordersPathophysiologyPowerful effectEtiologyIllness
1989
Molecular diagnosis of genital human papillomavirus infection: Comparison of two methods used to collect exfoliated cervical cells
Vermund S, Schiffman M, Goldberg G, Ritter D, Weltman A, Burk R. Molecular diagnosis of genital human papillomavirus infection: Comparison of two methods used to collect exfoliated cervical cells. American Journal Of Obstetrics And Gynecology 1989, 160: 304-308. PMID: 2537011, DOI: 10.1016/0002-9378(89)90430-4.Peer-Reviewed Original ResearchConceptsHuman papillomavirus infectionCervicovaginal lavagePapillomavirus infectionHuman papillomavirusLavage methodGenital human papillomavirus (HPV) infectionGenital tract infectionHuman papillomavirus detectionHuman papillomavirus typesDevelopment of neoplasiaCell collection methodsTract infectionsEndocervical swabsColposcopic examinationPapillomavirus detectionPapanicolaou testInvasive carcinomaPapillomavirus typesLavageEtiologic agentClinical investigatorsWomen resultsCell collectionVirus typeInfection
1978
The chemotherapy of Hodgkin's disease. Past experiences and future directions
Devita V, Lewis B, Rozencweig M, Muggia F. The chemotherapy of Hodgkin's disease. Past experiences and future directions. Cancer 1978, 42: 979-990. PMID: 356960, DOI: 10.1002/1097-0142(197808)42:2+<979::aid-cncr2820420721>3.0.co;2-s.Peer-Reviewed Original ResearchConceptsHodgkin's diseaseCombination chemotherapyAntitumor response rateAdvanced Hodgkin's diseaseComplete remissionDrug therapyDrug combinationsEffective treatmentTherapeutic experimentsAntitumor effectsResponse rateChemotherapyClinical investigatorsNatural historyEffective agentDiseasePatientsMarked increaseTreatmentNitrogen mustardRemissionTherapy
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