2024
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Yu Q, George S, Kyriakides T, Rhon D, Morasco B, Dziura J, Fritz J, Geda M, Peduzzi P, Long C. Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Medicine 2024, 25: s49-s53. PMID: 39514871, PMCID: PMC11548855, DOI: 10.1093/pm/pnae073.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryStatistical analysis planTrial protocolAnalysis planEvaluate nonpharmacological interventionsNonpharmacological interventionsTrial launchStudy designSecondary outcomesTrials RegistryPrimary outcomeStudy armsPrincipal investigatorInstitutional review boardClinical trialsTrial initiationCOVID-19-related issuesBest practicesPainSample sizeReview boardSafety monitoring boardOutcomesTrials
2023
A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial
Boomer T, Hoerner L, Fernandes C, Maslar A, Aiudi S, Kyriakides T, Fiellin L. A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial. PLOS ONE 2023, 18: e0291298. PMID: 37683047, PMCID: PMC10490848, DOI: 10.1371/journal.pone.0291298.Peer-Reviewed Original ResearchConceptsMental health outcomesOpioid misuseMental healthHealth gamesHealth outcomesMeasures of depressionMental health symptomsGreater riskHelp-seeking behaviorSecondary outcome measuresCritical developmental periodOpioid use disorderPerception of riskRisk of initiationHealth symptomsSchool gradesProfessional helpMisusing opioidsPrimary outcomeDevelopmental periodAdolescentsOutcome measuresSubstance misuseUse disordersHealth settings
2022
Extra-Virgin Olive Oil Enhances the Blood–Brain Barrier Function in Mild Cognitive Impairment: A Randomized Controlled Trial
Kaddoumi A, Denney T, Deshpande G, Robinson J, Beyers R, Redden D, Praticò D, Kyriakides T, Lu B, Kirby A, Beck D, Merner N. Extra-Virgin Olive Oil Enhances the Blood–Brain Barrier Function in Mild Cognitive Impairment: A Randomized Controlled Trial. Nutrients 2022, 14: 5102. PMID: 36501136, PMCID: PMC9736478, DOI: 10.3390/nu14235102.Peer-Reviewed Original ResearchConceptsClinical Dementia RatingMild cognitive impairmentBBB permeabilityAlzheimer's diseaseProtective effectP-tau/t-tau ratioCognitive impairmentBlood-brain barrier breakdownBlood-brain barrier functionBrain connectivityBehavioral scoresAbnormal BBB permeabilityAD mouse modelClearance of AβT-tau ratioEarly Alzheimer's diseaseFunctional brain activationSecondary outcomesBrain atrophyControlled TrialsPrimary outcomePreclinical findingsBrain amyloidBlood biomarkersBarrier breakdown
2018
Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial
Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS And Behavior 2018, 23: 211-221. PMID: 30073637, PMCID: PMC6476298, DOI: 10.1007/s10461-018-2241-z.Peer-Reviewed Original ResearchConceptsHIV-positive patientsHeavy drinking daysVACS Index scoreXR-NTXART adherenceDrinking daysIndex scoreUndetectable HIV viral loadCD4 cell countExtended-release naltrexoneDouble-blind placeboHIV viral loadRandomized-controlled trialDrinking outcomesHIV biomarkersSecondary outcomesHIV outcomesPrimary outcomeViral loadAntiretroviral adherenceClinical trialsCell countAlcohol treatmentHIVPatients
2017
Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial
Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. Journal Of Medical Internet Research 2017, 19: e314. PMID: 28923788, PMCID: PMC5625130, DOI: 10.2196/jmir.8148.Peer-Reviewed Original ResearchConceptsSexual health attitudesHuman immunodeficiency virusIntervention groupHealth attitudesInitiation of intercourseVideo game interventionControl groupHIV sexual riskSexual health outcomesSexual risk reductionDelay of initiationDigital health interventionsSecondary outcomesControlled TrialsGame interventionPrimary outcomeImmunodeficiency virusMean ageAnal intercourseHealth outcomesHealth interventionsSexual riskMonthsMinority adolescentsIntervention
2012
Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm
Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT, Kohler TR, Kougias P, Jean-Claude JM, Cikrit DF, Swanson KM. Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm. New England Journal Of Medicine 2012, 367: 1988-1997. PMID: 23171095, DOI: 10.1056/nejmoa1207481.Peer-Reviewed Original ResearchConceptsEndovascular repair groupOpen repair groupAbdominal aortic aneurysmYears of ageEndovascular repairOpen repairLong-term survivalAortic aneurysmSimilar long-term survivalAsymptomatic abdominal aortic aneurysmVeterans Affairs Medical CenterElective endovascular repairLong-term morbidityTraditional open repairType of treatmentCause mortalityPerioperative mortalityTime of registrationOlder patientsYounger patientsEndovascular approachPrimary outcomeAneurysm ruptureMedical CenterSurvival advantage
2011
Results of Antiretroviral Treatment Interruption and Intensification in Advanced Multi-Drug Resistant HIV Infection from the OPTIMA Trial
Holodniy M, Brown ST, Cameron DW, Kyriakides TC, Angus B, Babiker A, Singer J, Owens DK, Anis A, Goodall R, Hudson F, Piaseczny M, Russo J, Schechter M, Deyton L, Darbyshire J, . Results of Antiretroviral Treatment Interruption and Intensification in Advanced Multi-Drug Resistant HIV Infection from the OPTIMA Trial. PLOS ONE 2011, 6: e14764. PMID: 21483491, PMCID: PMC3069000, DOI: 10.1371/journal.pone.0014764.Peer-Reviewed Original ResearchConceptsRe-treatment optionsART interruptionHIV infectionPrimary outcomeRetreatment optionsMultidrug resistanceAdvanced HIV diseaseAntiretroviral treatment interruptionARV treatment failurePrior AIDS diagnosisResistant HIV InfectionMedian CD4 countPrimary composite outcomeSerious adverse eventsMean viral loadBest medical managementOPTIMA trialCD4 countOpen labelTreatment interruptionAdverse eventsComposite outcomeFirst AIDSHIV diseaseAntiretroviral treatment