2024
Adaptive multi-interventional trial platform to improve patient care for fibrotic interstitial lung diseases
Kawano-Dourado L, Kulkarni T, Ryerson C, Rivera-Ortega P, Baldi B, Chaudhuri N, Funke-Chambour M, Hoffmann-Vold A, Johannson K, Khor Y, Montesi S, Piccari L, Prosch H, Molina-Molina M, Torres J, Bauer-Ventura I, Rajan S, Jacob J, Richards D, Spencer L, Wendelberger B, Jensen T, Quintana M, Kreuter M, Gordon A, Martinez F, Kaminski N, Cornelius V, Lewis R, Adams W, Jenkins G, consortium R, Bravery A, Goodwin A, Etges A, Boshoff A, Günther A, Briggs A, Palmer A, Wilson A, Crawshaw A, Hoffmann-Vold A, Bergeron A, Holland A, Gordon A, Prasse A, Tzouvelekis A, Trachalaki A, Wells A, Nair A, Adegunsoye A, Wendelberger B, Hope-Gill B, Kaul B, Gooptu B, Baldi B, Crestani B, Polanczyk C, Vancheri C, Crobal C, Summers C, Grainge C, Ryerson C, von Garnier C, Huntley C, Ravaglia C, Valenzuela C, Hayton C, McCarthy C, Chambers D, Babalis D, Thicket D, Turner D, Talwar D, Anand D, Dhasmana D, Parek D, Griffiths D, Villegas D, Richards D, Santucci E, Bendstrup E, Balestro E, Tsitoura E, Falaschetti E, Gupta E, Farrand E, Khan F, Martinez F, Bonella F, Lombardi F, Hunninghake G, Saini G, Jenkins G, Gudmundsson G, Collard H, Parfrey H, Prosch H, Fainberg H, Adamali H, Stewart I, Forrest I, Glaspole I, Bauer-Ventura I, Noth I, Cox I, Strambu I, Sellares J, Eaden J, Johnston J, Swigris J, Blaikley J, Kim J, Chung J, Lasky J, Jacob J, Lee J, Behr J, Storrer K, Lewandowska K, Johnson K, Antoniou K, Hostettler K, Johannson K, Hurley K, Hett K, Schwarzkopf L, Fabbri L, Price L, Pearmain L, Kawano-Dourado L, Galvin L, Spencer L, Watson L, Crowley L, Richeldi L, Piccari L, Funke-Chambour M, Molina-Molina M, Jones M, Spears M, Toshner M, Wijsenbeek-Lourens M, Brutsche M, Vasakova M, Quintana M, Gibbons M, Henry M, Keane M, Kreuter M, Man M, Sadatsafavi M, Kaminski N, Chaudhuri N, Weatherley N, Hirani N, Mladinescu O, Spagnolo P, Beirne P, Bryce P, George P, Molyneaux P, Rivera-Ortega P, Crisan-Dabija R, Maida R, Borie R, Takei R, Lewis R, Rolo R, Guler S, Paganoni S, Singh S, Freitas S, Piciucchi S, Malik S, Barratt S, Hart S, Dal Corso S, Fletcher S, Stanel S, Bianchi S, Jones S, Nathan S, Rajan S, Birring S, Montesi S, Reoto T, Corte T, Zaman T, Kulkarni T, Gatheral T, Jensen T, McMillan T, Quinn V, Poletti V, Cornelius V, Cottin V, Adams W, Wuyts W, Kondoh Y, Miyazaki Y, Khor Y, Haider Y. Adaptive multi-interventional trial platform to improve patient care for fibrotic interstitial lung diseases. Thorax 2024, 79: 788-795. PMID: 38448221, PMCID: PMC11287572, DOI: 10.1136/thorax-2023-221148.Peer-Reviewed Original ResearchConceptsFibrotic interstitial lung diseaseInterstitial lung diseaseRandomised controlled trial approachTarget populationCare of peopleImprove patient careLung diseaseDisease associated with significant morbiditySafety of interventionsDissemination of resultsTrial deliveryImprove careProgression of fibrosisPatient careResponse adaptive randomisationPrimary outcomeCareSignificant morbidityAdult patientsApproaches to drug developmentClinical trialsDrug development pipelineTrial approachHeterogeneous groupPatients
2019
Recommendations for analytical antiretroviral treatment interruptions in HIV research trials—report of a consensus meeting
Julg B, Dee L, Ananworanich J, Barouch DH, Bar K, Caskey M, Colby DJ, Dawson L, Dong KL, Dubé K, Eron J, Frater J, Gandhi RT, Geleziunas R, Goulder P, Hanna GJ, Jefferys R, Johnston R, Kuritzkes D, Li JZ, Likhitwonnawut U, van Lunzen J, Martinez-Picado J, Miller V, Montaner LJ, Nixon DF, Palm D, Pantaleo G, Peay H, Persaud D, Salzwedel J, Salzwedel K, Schacker T, Sheikh V, Søgaard OS, Spudich S, Stephenson K, Sugarman J, Taylor J, Tebas P, Tiemessen CT, Tressler R, Weiss CD, Zheng L, Robb ML, Michael NL, Mellors JW, Deeks SG, Walker BD. Recommendations for analytical antiretroviral treatment interruptions in HIV research trials—report of a consensus meeting. The Lancet HIV 2019, 6: e259-e268. PMID: 30885693, PMCID: PMC6688772, DOI: 10.1016/s2352-3018(19)30052-9.Peer-Reviewed Original ResearchConceptsAnalytical antiretroviral treatment interruptionsAntiretroviral treatment interruptionAntiretroviral therapyHIV researchTreatment interruptionSustained viral controlSafety of interventionsNovel therapeutic interventionsViral setpointViral suppressionViral loadImmunological markersViral controlConsensus meetingTrial designConcept trialTherapeutic interventionsTrialsInterventionRiskATI studiesMeeting of stakeholdersAdvocacy groupsHIVGroup
2003
Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries
Stone GW, Cox DA, Babb J, Nukta D, Bilodeau L, Cannon L, Stuckey TD, Hermiller J, Cohen EA, Low R, Bailey SR, Lansky AJ, Kuntz RE, Investigators F. Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries. Journal Of The American College Of Cardiology 2003, 42: 2007-2013. PMID: 14662267, DOI: 10.1016/j.jacc.2003.10.001.Peer-Reviewed Original ResearchConceptsDiseased saphenous vein graftsSaphenous vein graftsNative coronary arteriesPeri-procedural myocardial infarctionEvent-free survivalCoronary arteryMyocardial infarctionControl patientsStent implantationRoutine thrombectomyVein graftsSize patientsLate event-free survivalMajor adverse cardiac eventsPeri-procedural myonecrosisAdverse cardiac eventsHigh-risk patientsPercutaneous coronary interventionLarge myocardial infarctionSafety of interventionsPrior thrombectomyCardiac eventsCoronary interventionPercutaneous interventionLate outcomes
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