2024
70-OR: PROTECT Per-Protocol Analysis—Preserving ß-Cell Function in Children and Adolescents with Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)
HEROLD K, DAYAN C, CHATENOUD L, GITELMAN S, SUMNIK Z, SIMMONS K, SZYPOWSKA A, KNECHT L, NIEMOELLER E, TIAN W, RAMOS E. 70-OR: PROTECT Per-Protocol Analysis—Preserving ß-Cell Function in Children and Adolescents with Newly Diagnosed Stage 3 Type 1 Diabetes (T1D). Diabetes 2024, 73 DOI: 10.2337/db24-70-or.Peer-Reviewed Original ResearchIntent-to-treatInsulin doseFunction preservationPer-protocolIntent-to-treat populationß-cell functionAnti-CD3 mAbReduced insulin doseLower insulin doseSustained glycemic controlPP populationTeplizumabMetabolic outcomesPBO groupHbA1c levelsPP analysisGlycemic controlTreatment complianceDoseDelayed onsetRandomized participantsIncorrect treatmentInsulinWeeksTreatmentVideo-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis
L’Italien G, Oikonomou E, Khera R, Potashman M, Beiner M, Maclaine G, Schmahmann J, Perlman S, Coric V. Video-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis. Neurology And Therapy 2024, 13: 1287-1301. PMID: 38814532, PMCID: PMC11263303, DOI: 10.1007/s40120-024-00625-6.Peer-Reviewed Original ResearchMovement qualityVideo-based kinematic analysisGait stability measuresTandem walking taskRating of AtaxiaGait qualityGait assessmentGait parametersTandem walkingWalking assessmentsWalking taskSpinocerebellar ataxiaVideo-based assessmentClinical expertiseNatural walkingRandomized participantsGaitHigh riskPost Hoc AnalysisStandardized scalesAdultsWalkingParticipantsHoc AnalysisPhase 3
2023
The ability of contemporary cardiologists to judge the ischemic impact of a coronary lesion visually
Foley M, Rajkumar C, Ahmed-Jushuf F, Nour D, Fung C, Seligman H, Pathimagaraj R, Petraco R, Sen S, Nijjer S, Howard J, Ahmad Y, Allahwala U, Bhindi R, Chamie D, Doi S, Kuwata S, Kaihara T, Koga M, Ishibashi Y, Higuma T, Tanabe Y, Nakayama M, Kawase Y, Watanabe A, Funayama N, Horinaka R, Hijikata N, Takahashi T, Matsuo H, Hansen P, Manica A, Weaver J, Alzuhairi K, Yong T, Warisawa T, Francis D, Shun-Shin M, Al-Lamee R. The ability of contemporary cardiologists to judge the ischemic impact of a coronary lesion visually. Cardiovascular Revascularization Medicine 2023, 59: 60-66. PMID: 37612169, DOI: 10.1016/j.carrev.2023.08.003.Peer-Reviewed Original ResearchConceptsInstantaneous wave-free ratioAmount of ischaemiaOptimal medical therapyVessel coronary artery diseaseSingle vessel coronary artery diseaseCoronary artery diseaseSingle vessel coronary diseaseVessel coronary diseaseInvasive pressure measurementsVisual assessmentLandmark trialsBlinded investigatorAngina trialArtery diseaseCoronary diseaseCoronary lesionsInvasive counterpartsInterventional cardiologistsVisual estimationCoronary stentingIschemic impactInvasive measurementsStentLesionsRandomized participants
2022
Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial
Pashchenko O, Bromberg D, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, de Leon S, Morozova O, Dvoriak S, Altice F. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Global Public Health 2022, 2: e0000344. PMID: 36962514, PMCID: PMC10021202, DOI: 10.1371/journal.pgph.0000344.Peer-Reviewed Original ResearchPrimary care clinicsOpioid use disorderOpioid agonist therapyPrimary careComplete self-reported dataPatient medical record dataMedical record dataComprehensive health outcomesAddiction treatment clinicsAdult PWIDAgonist therapySecondary outcomesParent trialPrimary outcomeRandomized participantsCare clinicsTreatment clinicsIntervention sitesUse disordersHealth outcomesAddiction treatmentRecord dataSelf-reported dataHealth indicatorsClinicA Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes
Reiss AL, Jo B, Arbelaez AM, Tsalikian E, Buckingham B, Weinzimer SA, Fox LA, Cato A, White NH, Tansey M, Aye T, Tamborlane W, Englert K, Lum J, Mazaika P, Foland-Ross L, Marzelli M, Mauras N. A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes. Nature Communications 2022, 13: 4940. PMID: 36042217, PMCID: PMC9427757, DOI: 10.1038/s41467-022-32289-x.Peer-Reviewed Original ResearchConceptsHybrid closed-loop insulin delivery systemStandard care groupType 1 diabetesClosed-loop insulin delivery systemWhite matter volumeCare groupPrimary outcomeInsulin delivery systemsMatter volumeFractional anisotropyCognitive AssessmentRigorous glucose controlDiagnosis of T1DClosed-loop groupBetter diabetes controlDiabetes care groupsConcept pilot studyYears of ageAcademic medical centerFunctional brain activityCortical surface areaMonths study durationRandomized participantsDiabetes controlGlucose control
2021
Recruitment of a multi‐site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial
Shadyab AH, LaCroix AZ, Feldman HH, van Dyck C, Okonkwo OC, Tam SP, Fairchild JK, Welsh‐Bohmer K, Matthews G, Bennett D, Shadyab AA, Schafer KA, Morrison RH, Kipperman SA, Mason J, Tan D, Thomas RG, Cotman CW, Baker LD, Group F. Recruitment of a multi‐site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial. Alzheimer's & Dementia 2021, 17: 1808-1817. PMID: 34297895, PMCID: PMC9292825, DOI: 10.1002/alz.12401.Peer-Reviewed Original ResearchConceptsMild cognitive impairmentAmnestic mild cognitive impairmentAerobic exerciseOlder adultsCognitive impairmentMass mailingElectronic health recordsClinic rostersRandomized participantsExercise trialsIntervention trialsPublic service announcementsLocal registryTrialsHealth recordsAdultsCognitive trajectoriesCommunity presentationsImpairmentMailingAgeExerciseRecruitment rates
2019
1141-P: Detailed Phenotype of Randomized Participants by Age in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
ARODA V, KRAUSE-STEINRAUF H, BUSE J, GULANSKI B, FLOREZ H, AHMANN A, LOVELAND A, KUHN A, LONIER J, MATHER K, WEXLER D. 1141-P: Detailed Phenotype of Randomized Participants by Age in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). Diabetes 2019, 68 DOI: 10.2337/db19-1141-p.Peer-Reviewed Original ResearchNovo Nordisk A/SMannKind CorporationBaseline characteristicsKidney diseaseSpouse/partnerInclusion criteriaClinical phenotypeAge groupsGlycemia Reduction ApproachesComparative effectiveness studiesDistinct clinical phenotypesNational InstituteEli LillyAdvisory PanelEisai Inc.More CVDProminent hyperglycemiaSecond medicationAdvancing Translational SciencesDiabetic dyslipidemiaMore medicationsPrevalent comorbiditiesRandomized participantsAge-related differencesRandomized treatment
2013
Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial.
White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. The Journal Of Clinical Psychiatry 2013, 74: 400-6. PMID: 23656848, PMCID: PMC4021866, DOI: 10.4088/jcp.12m08071.Peer-Reviewed Original ResearchConceptsBinge-eating disorderPlacebo-controlled trialObese womenOutcome measuresWeight lossDSM-IV-TR research criteriaTreatment of BEDInappropriate weight compensatory behaviorsRandomized placebo-controlled trialShort-term weight lossFood cravingsPercent BMI lossSecondary outcome measuresPrimary outcome measureShort-term efficacyTerm weight lossBinge-eating frequencySignificant time effectStand-alone treatmentLong-term trialsBMI lossPlacebo groupLifestyle interventionOverweight womenRandomized participants
2011
Treatment outcomes of a stage 1 cognitive–behavioral trial to reduce alcohol use among human immunodeficiency virus‐infected out‐patients in western Kenya
Papas RK, Sidle JE, Gakinya BN, Baliddawa JB, Martino S, Mwaniki MM, Songole R, Omolo OE, Kamanda AM, Ayuku DO, Ojwang C, Owino‐Ong'or W, Harrington M, Bryant KJ, Carroll KM, Justice AC, Hogan JW, Maisto SA. Treatment outcomes of a stage 1 cognitive–behavioral trial to reduce alcohol use among human immunodeficiency virus‐infected out‐patients in western Kenya. Addiction 2011, 106: 2156-2166. PMID: 21631622, PMCID: PMC3208780, DOI: 10.1111/j.1360-0443.2011.03518.x.Peer-Reviewed Original ResearchConceptsHuman immunodeficiency virusAlcohol useDrinking daysLarge human immunodeficiency virusCognitive behavioral therapy interventionAlcohol intervention studyAlcohol use disorderGroup Cognitive Behavioral Therapy InterventionEffect sizeTreatment effect sizeCognitive behavioral therapyDual epidemicsRandomized participantsPatient clinicImmunodeficiency virusPreliminary efficacyHuman immunodeficiencyClinical trialsTreatment outcomesAlcohol abstinenceAssessment-only controlBinge drinkingUse disordersTherapy interventionFeasible intervention
2001
Two Recruitment Strategies for a Clinical Trial of Physically Frail Community‐Living Older Persons
Gill T, McGloin J, Gahbauer E, Shepard D, Bianco L. Two Recruitment Strategies for a Clinical Trial of Physically Frail Community‐Living Older Persons. Journal Of The American Geriatrics Society 2001, 49: 1039-1045. PMID: 11555064, DOI: 10.1046/j.1532-5415.2001.49206.x.Peer-Reviewed Original ResearchConceptsOffice-based strategiesCommunity-living personsPrimary care physiciansPhysical frailtyNumber of personsCare physiciansClinical trialsAge 75Older personsRefusal rateRecruitment strategiesSlow gait speedLower extremity functionPotential participantsQuadriceps weaknessRandomized participantsOffice visitsGait speedMean ageFrail communityFrailtyPatient rosterGeneral communityPhysiciansTrials
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