2010
Sample size for post‐marketing safety studies based on historical controls
Wu Y, Makuch RW. Sample size for post‐marketing safety studies based on historical controls. Pharmacoepidemiology And Drug Safety 2010, 19: 869-875. PMID: 20572025, DOI: 10.1002/pds.1990.Peer-Reviewed Original ResearchLow-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial
Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O’Malley S. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial. Drug And Alcohol Dependence 2010, 111: 200-206. PMID: 20542391, PMCID: PMC3771701, DOI: 10.1016/j.drugalcdep.2010.04.015.Peer-Reviewed Original ResearchConceptsWeight gainSmoking cessationPoint prevalence smoking abstinence ratePre-specified primary outcomesLow-dose naltrexoneOpen-label therapySmoking abstinence ratesPoint prevalence abstinenceReduced weight gainNaltrexone augmentationPlacebo groupNicotine replacementPrimary outcomeQuit dateAbstinence ratesLabel therapyNicotine patchBehavioral counselingNaltrexoneAbstinent participantsSmokersWeight concernsWeeksCessationLower rates
2000
Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial
Silverstein F, Faich G, Goldstein J, Simon L, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal N, Stenson W, Burr A, Zhao W, Kent J, Lefkowith J, Verburg K, Geis G. Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial. JAMA 2000, 284: 1247-1255. PMID: 10979111, DOI: 10.1001/jama.284.10.1247.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidAspirinCelecoxibCyclooxygenase 1Cyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDiclofenacDouble-Blind MethodFemaleGastrointestinal DiseasesHumansIbuprofenIsoenzymesMaleMembrane ProteinsMiddle AgedOsteoarthritisPeptic UlcerProportional Hazards ModelsProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesSulfonamidesConceptsNonsteroidal anti-inflammatory drugsConventional nonsteroidal anti-inflammatory drugsCelecoxib Long-term Arthritis Safety StudyCOX-2-specific inhibitorsUlcer complicationsSymptomatic ulcersAnti-inflammatory drugsRheumatoid arthritisIncidence rateAspirin useLower incidenceChronic GI blood lossToxic effectsAdverse effectsCelecoxib-treated patientsUpper GI toxicityUpper GI ulcersGI blood lossInhibition of cyclooxygenaseGI intoleranceCardiovascular eventsGastrointestinal toxicityGI toxicityImportant toxic effectsStudy drugUpper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Bensen W, Zhao S, Burke T, Zabinski R, Makuch R, Maurath C, Agrawal N, Geis G. Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo. The Journal Of Rheumatology 2000, 27: 1876-83. PMID: 10955327.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDigestive SystemDouble-Blind MethodDyspepsiaFemaleHumansIsoenzymesMaleMembrane ProteinsMiddle AgedNaproxenNauseaOsteoarthritisProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesRisk FactorsSulfonamidesTime FactorsTreatment OutcomeConceptsUpper gastrointestinal tolerabilityUpper GI symptomsSevere abdominal painComposite endpointAbdominal painGastrointestinal tolerabilityGI symptomsIndependent predictorsRheumatoid arthritisRelative riskCOX-2-specific inhibitorsUpper GI tolerabilityTreatment group patientsDose-response relationshipGI tolerabilityPlacebo patientsGroup patientsCumulative incidenceParallel groupClinical trialsPlaceboPatientsCelecoxibTolerabilityEndpoint
1999
Early-onset intraventricular hemorrhage in preterm neonates: Incidence of neurodevelopmental handicap
Vohr B, Allan W, Scott D, Katz K, Schneider K, Makuch R, Ment L. Early-onset intraventricular hemorrhage in preterm neonates: Incidence of neurodevelopmental handicap. Seminars In Perinatology 1999, 23: 212-217. PMID: 10405190, DOI: 10.1016/s0146-0005(99)80065-2.Peer-Reviewed Original ResearchConceptsIntraventricular hemorrhageEarly intraventricular hemorrhageLow birth weight infantsBirth weight infantsHours of lifeYears of agePostnatal indomethacinNeurodevelopmental handicapWeight infantsPreterm infantsPreterm neonatesNeurodevelopmental outcomesNeurological examinationCerebral palsyPostnatal hoursStudy infantsHigh riskMotor handicapIntelligence quotient scoresInfantsEarly onsetHemorrhageAgeQuotient scoresChildren
1995
Psychiatric status after human fetal mesencephalic tissue transplantation in Parkinson's disease
Price L, Spencer D, Marek K, Robbins R, Leranth C, Farhi A, Naftolin F, Roth R, Bunney B, Hoffer P, Makuch R, Redmond D. Psychiatric status after human fetal mesencephalic tissue transplantation in Parkinson's disease. Biological Psychiatry 1995, 38: 498-505. PMID: 8562661, DOI: 10.1016/0006-3223(95)00129-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBrain Tissue TransplantationCaudate NucleusDepressive DisorderDopamineFemaleFetal Tissue TransplantationFollow-Up StudiesHumansMaleMesencephalonMiddle AgedNeurocognitive DisordersNeuropsychological TestsPanic DisorderParkinson DiseasePostoperative ComplicationsProspective StudiesConceptsParkinson's diseasePsychiatric statusHuman fetal mesencephalic tissueAdrenal medullary graftsAdrenal medullary transplantationFetal mesencephalic tissueSystematic psychiatric assessmentPerioperative sequelaeMesencephalic tissuePsychiatric sequelaeCaudate nucleusPsychiatric assessmentNeurobiological effectsBehavioral symptomsTissue transplantationDiseasePatientsTransplantationSequelaeSuch episodesEpisodesGroup effectsStatusDeliriumDiscrete episodesAntenatal steroids, delivery mode, and intraventricular hemorrhage in preterm infants
Ment L, Oh W, Ehrenkranz R, Philip A, Duncan C, Makuch R. Antenatal steroids, delivery mode, and intraventricular hemorrhage in preterm infants. American Journal Of Obstetrics And Gynecology 1995, 172: 795-800. PMID: 7892866, DOI: 10.1016/0002-9378(95)90001-2.Peer-Reviewed Original ResearchConceptsEarly intraventricular hemorrhageAntenatal steroidsIntraventricular hemorrhageCesarean sectionPreterm infantsAntenatal steroid treatmentCesarean section deliveryHours of lifeMore vaginal deliveriesDelivery modePostnatal indomethacinSection deliveryWeight infantsSteroid treatmentVaginal deliveryHemorrhageInfantsSteroidsIndependent roleHoursDeliveryMulticenterIndomethacinTrialsEchoencephalography
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
1993
Risk period for intraventricular hemorrhage of the preterm neonate is independent of gestational age.
Ment L, Oh W, Ehrenkranz R, Philip A, Schneider K, Katz K, Taylor K, Duncan C, Makuch R. Risk period for intraventricular hemorrhage of the preterm neonate is independent of gestational age. Seminars In Perinatology 1993, 17: 338-41. PMID: 8290976.Peer-Reviewed Original Research
1992
A model-based prediction for transvaginal ultrasonographic identification of early intrauterine pregnancy
Shapiro B, Escobar M, Makuch R, Lavy G, DeCherney A. A model-based prediction for transvaginal ultrasonographic identification of early intrauterine pregnancy. American Journal Of Obstetrics And Gynecology 1992, 166: 1495-1500. PMID: 1595805, DOI: 10.1016/0002-9378(92)91625-k.Peer-Reviewed Original ResearchConceptsHuman chorionic gonadotropin titersEarly intrauterine pregnancyMHz vaginal transducerIntrauterine pregnancyGestational ageUltrasonographic identificationVaginal transducerNormal intrauterine pregnancyHuman chorionic gonadotropinLogistic regression analysisIntrauterine sacIntrauterine gestationEmbryo transfer programInfertility clinicMIU/Ultrasonographic detectionChorionic gonadotropinPregnancyTitersRegression analysisAgeUltrasonographic equipmentPatientsGestationGonadotropin
1988
A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients
Messerschmidt G, Makuch R, Appelbaum F, Ungerleider R, Abrams R, O'Donnell J, Holohan T, Fontana J, Wright D, Anagnou N, Shan T, Chesbro B, Deisseroth A. A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients. Cancer 1988, 62: 795-801. PMID: 3293762, DOI: 10.1002/1097-0142(19880815)62:4<795::aid-cncr2820620426>3.0.co;2-7.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAmbulatory CareAntibody FormationBlood DonorsBlood PlateletsBlood TransfusionChildChild, PreschoolClinical Trials as TopicFemaleHemorrhageHistocompatibility TestingHumansInfantMaleMiddle AgedNeoplasmsPlatelet TransfusionProspective StudiesRandom AllocationThrombocytopeniaTransfusion ReactionConceptsSingle-donor platelet transfusionsPlatelet transfusionsCancer patientsFebrile patientsPosttransfusion incrementsThrombocytopenic cancer patientsTransfusion of HLASevere bleeding episodesMulti-institution trialNonfebrile patientsIntensive chemotherapyBleeding episodesAntiplatelet antibodiesAntibody titersSignificant thrombocytopeniaHistocompatability antigensTransfusionPatientsMismatched groupHLAThrombocytopeniaPlateletsEpisodesSeparate episodesTrialsStatistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies
Makuch R, Parks W. Statistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies. AIDS Research And Human Retroviruses 1988, 4: 305-316. PMID: 3061416, DOI: 10.1089/aid.1988.4.305.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsInitiation of therapyPlacebo-controlled studyHIV-1 antigensDemonstrated clinical efficacyHIV-1 coreAntiretroviral effectClinical efficacyAIDS patientsAntiretroviral activityClinical studiesLymphocyte culturesVirus expressionSerum dataAntigen dataPatientsSurvival analysis methodsLaboratory dataAZTGroup differencesMost laboratory dataCulture dataStatistical methodsSignificant declineSerum
1986
Pulmonary toxicity with combined modality therapy for limited stage small-cell lung cancer.
Brooks B, Seifter E, Walsh T, Lichter A, Bunn P, Zabell A, Johnston-Early A, Edison M, Makuch R, Cohen M. Pulmonary toxicity with combined modality therapy for limited stage small-cell lung cancer. Journal Of Clinical Oncology 1986, 4: 200-9. PMID: 3003259, DOI: 10.1200/jco.1986.4.2.200.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Small CellCombined Modality TherapyCyclophosphamideDoxorubicinFemaleHumansLomustineLung NeoplasmsMaleMethotrexateMiddle AgedProcarbazinePrognosisProspective StudiesPulmonary FibrosisRadiographyRandom AllocationRespiratory Function TestsVincristineConceptsPulmonary function testsLimited stage small cell lung cancerStage small cell lung cancerSmall cell lung cancerModality therapyPulmonary toxicityPulmonary complicationsVital capacityLung cancerRadiation therapyLife-threatening pulmonary toxicityInitial pulmonary function testLower vital capacitySubsequent pulmonary complicationsBilateral pulmonary infiltratesDisease-free survivalModality armPulmonary infiltratesPulmonary morbidityExpiratory volumeOverall survivalPerformance statusProspective trialClinical courseHospital admission
1985
The role of radiation therapy in the treatment of small cell lung cancer
Lichter A, Bunn P, Ihde D, Cohen M, Makuch R, Carney D, Johnston‐Early A, Minna J, Glatstein E. The role of radiation therapy in the treatment of small cell lung cancer. Cancer 1985, 55: 2163-2175. PMID: 2983875, DOI: 10.1002/1097-0142(19850501)55:9+<2163::aid-cncr2820551420>3.0.co;2-y.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarcinoma, Small CellClinical Trials as TopicCombined Modality TherapyCyclophosphamideDoxorubicinFollow-Up StudiesHumansLomustineLung NeoplasmsMethotrexateProcarbazineProspective StudiesRadiotherapyRadiotherapy DosageRandom AllocationTime FactorsVincristineWhole-Body IrradiationConceptsSmall cell lung cancerLimited-stage small cell lung cancerProphylactic cranial irradiationCell lung cancerCranial irradiationThoracic irradiationLung cancerExtensive-stage small-cell lung cancerComplete response statusLimited-stage diseaseOptimal treatment approachCombination of chemotherapyMinimum of toxicityLong-term survivalSystemic irradiationSystemic chemotherapyAggressive therapyPartial responseCNS failureResponse statusTreatment protocolOngoing protocolRadiation therapyTreatment approachesPatients
1983
Delayed hypersensitivity skin testing as a prognostic indicator in patients with small cell lung cancer
Johnston‐Early A, Cohen M, Fossieck B, Harwood S, Ihde D, Bunn P, Matthews M, Minna J, Makuch R. Delayed hypersensitivity skin testing as a prognostic indicator in patients with small cell lung cancer. Cancer 1983, 52: 1395-1400. PMID: 6311393, DOI: 10.1002/1097-0142(19831015)52:8<1395::aid-cncr2820520810>3.0.co;2-t.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedCarcinoma, Small CellFemaleHumansHypersensitivity, DelayedLung NeoplasmsMaleMiddle AgedProbabilityPrognosisProspective StudiesSkin TestsConceptsSkin test reactivityGood performance statusLow tumor burdenTest reactivityAnergic patientsPerformance statusTumor burdenReactive patientsSmall cell lung cancer patientsHypersensitivity skin test reactivityCell lung cancer patientsSmall cell lung cancerGood prognosis patientsHypersensitivity skin testingCell lung cancerLung cancer patientsSkin test antigensPrognosis patientsSkin testingPoor prognosisPrognostic importancePrognostic utilityPrognostic indicatorCancer patientsLung cancer
1979
Abnormalities of Zinc and Copper During Total Parenteral Nutrition
LOWRY S, GOODGAME J, SMITH J, MAHER M, MAKUCH R, HENKIN R, BRENNAN M. Abnormalities of Zinc and Copper During Total Parenteral Nutrition. Annals Of Surgery 1979, 189: 120. PMID: 103506, PMCID: PMC1396940, DOI: 10.1097/00000658-197901000-00023.Peer-Reviewed Original ResearchConceptsParenteral nutritionSerum zincSerum levelsLimited oral intakeTotal parenteral nutritionMean serum zincNormal serum levelsSupplementation of zincCopper levelsPositive nitrogen retentionOral intakeUrinary outputBlood administrationUrinary nitrogen excretionHyperalimentation fluidsNormal limitsUrinary zincPatientsCopper excretionCopper intakeCopper supplementationExcretionNutritionIntakeSupplementation