2005
Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia
Woods SW, Gueorguieva RV, Baker CB, Makuch RW. Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. JAMA Psychiatry 2005, 62: 961-970. PMID: 16143728, DOI: 10.1001/archpsyc.62.9.961.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAntipsychotic AgentsBrief Psychiatric Rating ScaleDouble-Blind MethodDrug Administration ScheduleFemaleHumansMalePlacebosPsychotic DisordersRandomized Controlled Trials as TopicResearch DesignSchizophreniaSchizophrenic PsychologySelection BiasSeverity of Illness IndexSex FactorsTreatment OutcomeConceptsBrief Psychiatric Rating ScalePlacebo-controlled trialPsychiatric Rating ScalePlacebo-controlled studyAtypical antipsychotic medicationsDose-controlled studyMedication trialsAntipsychotic medicationRating ScaleDouble-blind clinical trialNew atypical antipsychotic medicationsDose-controlled trialsTreatment completion ratesPlacebo control groupEnd point changePercentage of menDrug Administration databaseRandom effects analysisIll adultsMedication armClinical trialsNew medicationsNovel medicationsSame drugAverage age
2003
103 Multicenter randomized placebo-controlled trial of non-selective beta-blockers in the prevention of the complications of portal hypertension: final results and identification of a predictive factor
Groszmann R, Garcia-Tsao G, Makuch R, Bosch J, Escorsel A, Garcia-Pagan J, Grace N, Matloff D, Burroughs A, Patch D. 103 Multicenter randomized placebo-controlled trial of non-selective beta-blockers in the prevention of the complications of portal hypertension: final results and identification of a predictive factor. Hepatology 2003, 38: 206. DOI: 10.1016/s0270-9139(03)80146-5.Peer-Reviewed Original ResearchPlacebo-controlled trialPortal hypertensionPredictive factorsMulticenterHypertensionComplicationsTrialsPrevention
1994
Low-dose indomethacin therapy and extension of intraventricular hemorrhage: A multicenter randomized trial
Ment L, Oh W, Ehrenkranz R, Phillip A, Vohr B, Allan W, Makuch R, Taylor K, Schneider K, Katz K, Scott D, Duncan C. Low-dose indomethacin therapy and extension of intraventricular hemorrhage: A multicenter randomized trial. The Journal Of Pediatrics 1994, 124: 951-955. PMID: 8201485, DOI: 10.1016/s0022-3476(05)83191-9.Peer-Reviewed Original ResearchConceptsLow-grade intraventricular hemorrhageIntraventricular hemorrhageAdverse eventsBirth weightLow birth weight infantsDistribution of hemorrhageGrade intraventricular hemorrhageBirth weight infantsPlacebo-controlled trialPercentage of infantsPatent ductus arteriosusGm birth weightHours of ageIndomethacin therapyWeight infantsApgar scoreParenchymal involvementSaline placeboDuctus arteriosusGestational ageIntracranial hemorrhagePostnatal hoursCascade of eventsPatent ductusCranial sonogramsLow-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial.
Ment L, Ehrenkranz R, Duncan C, Scott D, Taylor K, Katz K, Schneider K, Makuch R, Oh W, Vohr B, Philip A, Allan W. Low-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial. Pediatrics 1994, 93: 543-50. PMID: 8134206, DOI: 10.1542/peds.93.4.543.Peer-Reviewed Original ResearchConceptsLow birth weight neonatesSeverity of IVHBirth weight neonatesIntraventricular hemorrhageWeight neonatesDose indomethacinBirth weightGrade 4 intraventricular hemorrhageSerial cranial ultrasound examinationsSignificant adverse drug eventsPercent of neonatesPlacebo-controlled trialPatent ductus arteriosusCranial ultrasound examinationMajor risk factorAdverse drug eventsHours of ageFirst postnatal dayDuctal closureProphylactic indomethacinApgar scoreNeurodevelopmental handicapParenchymal involvementPlacebo groupAdverse events
1990
A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy
Roberts R, Hollinger F, Parks W, Rasheed S, Laurence J, Heseltine P, Makuch R, Lubina J, Johnson K, Group R. A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy. AIDS 1990, 4: 67-72. PMID: 1690551, DOI: 10.1097/00002030-199001000-00009.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAIDS-Related ComplexDouble-Blind MethodFemaleGene Products, gagHIVHIV AntigensHIV Core Protein p24HIV InfectionsHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesRNA-Directed DNA PolymeraseUnited StatesViral Core ProteinsConceptsOral ribavirinPeripheral blood mononuclear cellsPlacebo-controlled trialBlood mononuclear cellsMulticenter clinical trialHIV isolationP24 antigenemiaStudy drugMulticenter trialActive treatmentDaily dosesMononuclear cellsClinical trialsMedical CenterWeek 6HIV activityAdult menRibavirinTrialsLymphadenopathyHIVInterlaboratory variationCritical roleAntigenemiaPlaceboA multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.
Roberts R, Dickinson G, Heseltine P, Leedom J, Mansell P, Rodriguez S, Johnson K, Lubina J, Makuch R. A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group. JAIDS Journal Of Acquired Immune Deficiency Syndromes 1990, 3: 884-92. PMID: 1974628.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdministration, OralAdolescentAdultCD4 AntigensCD4-Positive T-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodEvaluation Studies as TopicHumansImmunoblastic LymphadenopathyLeukocyte CountMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesConceptsOral ribavirinActive treatmentBaseline CD4 cell countMajor protocol violationsCD4 cell countPlacebo-controlled trialMulticenter clinical trialSignificant differencesPlacebo patientsPlacebo groupPlacebo treatmentStudy entryTreat analysisWashout periodDaily dosesClinical trialsKaposi's sarcomaProtocol violationsMedical CenterTreatment superiorityTreatment groupsPlaceboRibavirinPatientsOverall significant difference