2023
Homelessness and Treatment Outcomes Among Black Adults With Opioid Use Disorder: A Secondary Analysis of X:BOT
Justen M, Scodes J, Pavlicova M, Choo T, Gopaldas M, Haeny A, Opara O, Rhee T, Rotrosen J, Nunes E, Hawk K, Edelman E. Homelessness and Treatment Outcomes Among Black Adults With Opioid Use Disorder: A Secondary Analysis of X:BOT. Journal Of Addiction Medicine 2023, 17: 463-467. PMID: 37579110, PMCID: PMC10323031, DOI: 10.1097/adm.0000000000001125.Peer-Reviewed Original ResearchConceptsClinical trialsTreatment outcomesSecondary analysisOpioid use disorder treatmentBlack individualsExtended-release naltrexoneOpioid use disorderAdditional clinical supportBlack participantsUse disorder treatmentBuprenorphine-naloxoneStudy medicationWeeks postrandomizationMedication initiationClinical characteristicsOpioid useTrial entryUrine toxicologyBlack patientsSedative useExtramedical useUse disordersClinical supportDisorder treatmentBlack adults
2022
Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double‐blind, randomized, placebo‐controlled, dose‐ranging trial
Croop R, Madonia J, Stock D, Thiry A, Forshaw M, Murphy A, Coric V, Lipton R. Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double‐blind, randomized, placebo‐controlled, dose‐ranging trial. Headache The Journal Of Head And Face Pain 2022, 62: 1153-1163. PMID: 36239038, PMCID: PMC9827820, DOI: 10.1111/head.14389.Peer-Reviewed Original ResearchConceptsAcute treatmentNasal sprayH postdosePain freedomBothersome symptomsAdverse eventsCommon treatment-emergent adverse eventsCalcitonin gene-related peptide receptor antagonistInteractive web response systemTreatment-emergent adverse eventsCoprimary efficacy endpointsMost adverse eventsSevere pain intensityWeb response systemDose-ranging trialFavorable safety profilePeptide receptor antagonistPhase 2/3 trialUS study sitesStudy medicationNasal discomfortCoprimary endpointsEfficacy endpointPain intensityPhase 2/3Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial.
Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. The Journal Of Clinical Psychiatry 2022, 83 PMID: 36198061, DOI: 10.4088/jcp.22m14447.Peer-Reviewed Original ResearchConceptsAcute agitationHours postdoseSchizoaffective disorderTotal scorePrimary efficacy endpointPlacebo-controlled studyAdrenergic receptor agonistFifth Edition criteriaNegative Syndrome ScaleDexmedetomidine groupOral hypoesthesiaStudy medicationDry mouthEfficacy endpointOrthostatic hypotensionRandomized PlaceboAdverse eventsReceptor agonistEdition criteriaDexmedetomidineMean changePEC scoresPlaceboSyndrome ScaleUS sites
2021
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial
Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD, team D, Antinori A, Apea V, Asmuth D, Avery A, Benson P, Bergin C, Berhe M, Brar I, Brinson C, Brunetta J, Burack J, Campbell T, Cespedes M, Clarke A, Coleman M, Coll J, Casal M, Creticos C, Crofoot G, Cruickshank F, Cua E, Daar E, de Wet J, DeJesus E, Del Romero Guerrero J, Dinges W, Doblecki-Lewis S, Donovan T, Dosekun O, Flamm J, Gallant J, Gerstoft J, Gilson R, Gladstein J, Grant R, Grossberg R, Haas B, Halperin J, Hardy W, Hare C, Hassler S, Hengel R, Henry W, Hodge T, Hosek S, Hurt C, Iandiorio M, Jessen H, Kegg S, Knecht G, Kronborg G, Krznaric I, LaMarca A, Larsen C, Larsen O, Lazzarin A, Leen C, Lucasti C, Mallon P, Mannheimer S, Markowitz M, Martorell C, Mayer K, Mills A, Molina J, Morris S, Mounzer K, Nwokolo N, Ogbuagu O, Osiyemi O, Petroll A, Philibert P, Phoenix J, Pialoux G, Podzamczer D, Post F, Prins M, Ramgopal M, Rashbaum B, Reeves I, Richmond G, Rieger A, Ruane P, Salazar L, Scarsella A, Schembri G, Scott M, Shalit P, Sinclair G, Sobieszczyk M, Spinner C, Stephens J, Szabo J, Taylor S, Thompson M, Tremblay C, Trottier B, Voskuhl G, Wade B, Wohl D, Workowski K, Yawetz S, Young B. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet HIV 2021, 8: e397-e407. PMID: 34197772, DOI: 10.1016/s2352-3018(21)00071-0.Peer-Reviewed Original ResearchConceptsTenofovir disoproxil fumaratePre-exposure prophylaxisTenofovir alafenamideDisoproxil fumarateBone mineral densityHIV infectionPlacebo tabletsMineral densityHIV preventionHIV-1 pre-exposure prophylaxisTransgender womenAdult cisgender menNon-inferior efficacyWeek 96 resultsPrimary efficacy outcomeCisgender menPhase 3 trialIncident HIV infectionHIV-1 infectionNon-inferiority trialLong-term safetyMore weight gainRenal safety biomarkersSelf-reported sexual behaviorStudy medicationUpdated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB).
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Zhang C, Winer E. Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2021, 39: 1043-1043. DOI: 10.1200/jco.2021.39.15_suppl.1043.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesOverall survivalTyrosine kinase inhibitorsBreast cancerPlacebo armAnalysis of OSOral tyrosine kinase inhibitorECOG performance statusPlacebo-controlled trialTotal study populationKaplan-Meier timeHER2CLIMB trialMeaningful prolongationMetastatic HER2Study medicationTolerability assessmentsMetastatic settingAdverse eventsDose modificationHazard ratioLast patientPerformance statusDisease progressionStudy population
2020
Combination Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD (HIDE): A Randomized, Placebo-Controlled, Pilot Trial.
Charytan D, Hsu J, Mc Causland F, Waikar S, Ikizler T, Raj D, Landis J, Mehrotra R, Williams M, DiCarli M, Skali H, Kimmel P, Kliger A, Dember L, Himmelfarb J, Anderson A, Hung A, Sharma S, Weiner D. Combination Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD (HIDE): A Randomized, Placebo-Controlled, Pilot Trial. Kidney360 2020, 1: 1380-1389. PMID: 35372900, PMCID: PMC8815530, DOI: 10.34067/kid.0004342020.Peer-Reviewed Original ResearchConceptsIsosorbide dinitrateCoronary flow reserveAdverse eventsMaintenance HDMitral annular e' velocityDouble-blind pilot trialFlow reserveRecurrent intradialytic hypotensionRandomized to placeboMaximum tolerated doseTissue Doppler echocardiographyParticipants discontinued therapyGastrointestinal side effectsDetect between-group differencesPilot trialIntra-dialytic hypotensionPlacebo-ControlledPositron emission tomographyDose escalationHeart failure mortalityDose reductionStudy medicationTolerated dosePlacebo groupCombination therapyOral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial
Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. The Lancet 2020, 397: 51-60. PMID: 33338437, DOI: 10.1016/s0140-6736(20)32544-7.Peer-Reviewed Original ResearchConceptsDouble-blind treatment phasePlacebo-controlled trialStudy medicationMigraine daysPreventive treatmentAdverse eventsPhase 2/3Observation periodTreatment phaseWeek 9Calcitonin gene-related peptide receptor antagonistMean numberInteractive web response systemPrimary efficacy endpointWeb response systemPeptide receptor antagonistEfficacy endpointPrimary endpointAcute treatmentEligible participantsReceptor antagonistPlaceboMigraineMedicationsRimegepantAML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine
Wang E, Bell T, Zeidan A, Bhattcharyya H, Kudla A, Chan G, Sekeres M. AML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s191. DOI: 10.1016/s2152-2650(20)30732-1.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeAcute myeloid leukemiaChronic myelomonocytic leukemiaPatient Global ImpressionMyelodysplastic syndromeIntensive chemotherapyPatient's impressionGlobal ImpressionAML cohortMDS cohortMyeloid leukemiaAML/myelodysplastic syndromeMD Anderson Symptom InventoryFirst-line treatment optionLower symptom burdenHRQoL of patientsOpen-label studyHealth-related qualityPatient-reported outcomesEnd of treatmentMain outcome measuresTotal symptom severityQuality of lifeTrend of improvementStudy medicationHealth-related quality of life (HRQoL) in patients with untreated higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) receiving glasdegib + azacitidine (AZA).
Wang E, Bell T, Zeidan A, Bhattacharyya H, Kudla A, Chan G, Sekeres M. Health-related quality of life (HRQoL) in patients with untreated higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) receiving glasdegib + azacitidine (AZA). Journal Of Clinical Oncology 2020, 38: 7527-7527. DOI: 10.1200/jco.2020.38.15_suppl.7527.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaAcute myeloid leukemiaMyelodysplastic syndromeIntensive chemotherapyGlobal ImpressionAML cohortAML/myelodysplastic syndromeHigh-risk myelodysplastic syndromeMD Anderson Symptom InventoryFirst-line treatment optionLower symptom burdenPhase Ib studyEnd of treatmentQuality of lifeStudy medicationRemission rateOverall survivalSymptom burdenMDS cohortTreatment optionsMyeloid leukemiaMedian numberMyelomonocytic leukemiaGlasdegibAzacitidineSafety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy
Gonzales P, Grieco A, White E, Ding R, Ignacio RB, Pinto-Santini D, Lama JR, Altice FL, Duerr A. Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy. PLOS ONE 2020, 15: e0228433. PMID: 32134956, PMCID: PMC7058313, DOI: 10.1371/journal.pone.0228433.Peer-Reviewed Original ResearchConceptsAlcohol use disorderAntiretroviral therapyClinical adverse eventsAdverse eventsTransgender womenUse disordersDouble-blind randomized placebo-controlled trialMSM/transgender womenRandomized placebo-controlled trialART-naïve participantsPossibility of hepatotoxicityPlacebo-controlled trialSerious adverse eventsHIV-positive menMedication-Assisted TherapyProportion of subjectsAdverse event dataMultiple new medicationsOral naltrexoneStudy medicationTransaminase elevationPlacebo armNTX treatmentTreatment armsNew medications
2019
N-Acetylcysteine for Pediatric Obsessive-Compulsive Disorder: A Small Pilot Study
Li F, Welling MC, Johnson JA, Coughlin C, Mulqueen J, Jakubovski E, Coury S, Landeros-Weisenberger A, Bloch MH. N-Acetylcysteine for Pediatric Obsessive-Compulsive Disorder: A Small Pilot Study. Journal Of Child And Adolescent Psychopharmacology 2019, 30: 32-37. PMID: 31800306, PMCID: PMC7133418, DOI: 10.1089/cap.2019.0041.Peer-Reviewed Original ResearchConceptsCY-BOCS total scoreN-acetylcysteineYale-Brown ObsessiveTotal scorePlacebo groupNAC groupStudy populationBenefit of NACPlacebo-controlled clinical trialSymptom severityEffect of NACMild adverse eventsOCD symptom severityLarger study populationPediatric obsessive-compulsive disorderSmall pilot studyChildren's Yale-Brown ObsessiveStudy medicationAdverse eventsPrimary outcomeGlutamate dysfunctionObsessive-compulsive disorderWeek 12Future trialsNAC treatmentEfficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial
Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. The Lancet 2019, 394: 737-745. PMID: 31311674, DOI: 10.1016/s0140-6736(19)31606-x.Peer-Reviewed Original ResearchConceptsAcute treatmentAdverse eventsBothersome symptomsH postdoseMigraine attacksSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistInteractive web response systemMulticentre phase 3 trialSevere pain intensitySingle migraine attackCommon adverse eventsPlacebo-controlled trialSerious adverse eventsPhase 3 trialTreatment group assignmentWeb response systemUrinary tract infectionPeptide receptor antagonistHistory of migraineStandard tablet formulationModified intentionStudy medicationTreat populationCoprimary endpoints
2017
Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial
Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointestinal Endoscopy 2017, 87: 1297-1303. PMID: 28159539, PMCID: PMC5537051, DOI: 10.1016/j.gie.2017.01.028.Peer-Reviewed Original ResearchConceptsDouble-blind trialAdequate sedationStudy medicationModerate sedationAlertness/Sedation scoreAdequacy of sedationStudy medication dosePsychiatric medication useModified Observer's AssessmentMOAA/SAdditional medicationElective colonoscopyPrimary endpointOpioid combinationsOpioid useMedication useMore patientsSedation scoreSuch patientsMedication doseUsual dosesBenzodiazepine useCurrent guidelinesSedate patientsSedation
2016
Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials
DeWorsop D, Creatura G, Bluez G, Thurnauer H, Forselius-Bielen K, Ranganathan M, Deaso E, Bhat JA, D’Souza D. Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials. Drug And Alcohol Dependence 2016, 163: 24-30. PMID: 27068252, DOI: 10.1016/j.drugalcdep.2016.02.045.Peer-Reviewed Original ResearchConceptsMedication adherenceClinical trialsStudy medicationMedication nonadherenceDrug levelsActive study medicationWeekly study visitsPlacebo-controlled trialPlasma drug levelsSubstance abuse disordersPill countStudy visitStudy completionFace visitsClinical careAbuse disordersMedicationsCannabis dependencePilot studyTrialsAdherenceVisitsNonadherenceWeekly faceHigh rate
2014
Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community
Di Paola A, Lincoln T, Skiest DJ, Desabrais M, Altice FL, Springer SA. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community. Contemporary Clinical Trials 2014, 39: 256-268. PMID: 25240704, PMCID: PMC4283549, DOI: 10.1016/j.cct.2014.09.002.Peer-Reviewed Original ResearchConceptsOpioid agonist treatmentPlacebo-controlled trialXR-NTXAgonist treatmentOpioid dependenceTreatment outcomesPoor HIV treatment outcomesOpioid treatment outcomesOpioid-dependent prisonersExtended-release naltrexoneHIV treatment outcomesHIV transmission riskEvidence-based treatmentsCriminal justice settingsEarly acceptabilityStudy medicationFirst injectionStudy acceptabilityHIVTotal referralsJail detaineesCommunity settingsTransmission riskDrug relapseHigh internal validity
2013
Adherence reporting in randomized controlled trials
Zhang Z, Peluso MJ, Gross CP, Viscoli CM, Kernan WN. Adherence reporting in randomized controlled trials. Clinical Trials 2013, 11: 195-204. PMID: 24357665, DOI: 10.1177/1740774513512565.Peer-Reviewed Original ResearchConceptsAdherence monitoringGeneral medicineStudy drug adherenceReporting of adherenceImportance of adherenceReporting Trials (CONSORT) statementRank correlation coefficientStudy medicationOral pharmacotherapyStudy drugMedian adherencePharmacologic interventionsTreatment acceptanceTreatment adherenceTrials statementTrial characteristicsAdherence reportingLow adherenceStudy qualityTherapeutic effectChi-square analysisConsolidated StandardsRCT manuscriptsAdherence informationAdherence measurementBioidentical compounded hormones: A pharmacokinetic evaluation in a randomized clinical trial
Sood R, Warndahl RA, Schroeder DR, Singh RJ, Rhodes DJ, Wahner-Roedler D, Bahn RS, Shuster LT. Bioidentical compounded hormones: A pharmacokinetic evaluation in a randomized clinical trial. Maturitas 2013, 74: 375-382. PMID: 23384975, DOI: 10.1016/j.maturitas.2013.01.010.Peer-Reviewed Original ResearchConceptsClinical trialsEstradiol patchLarge clinical trialsRandomized clinical trialsSerum progesterone levelsStudy medicationOral progesteronePostmenopausal womenHormone therapyEstriol levelsSerum levelsStudy armsEstrogen creamPharmacokinetic trialProgesterone levelsComparable dosesHormonal preparationsPharmacokinetic evaluationPharmacokinetic informationDosesTrialsFurther studiesEstrogenProgesteroneBioidenticalTopical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides
Lessin S, Duvic M, Guitart J, Pandya A, Strober B, Olsen E, Hull C, Knobler E, Rook A, Kim E, Naylor M, Adelson D, Kimball A, Wood G, Sundram U, Wu H, Kim Y. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides. JAMA Dermatology 2013, 149: 25-32. PMID: 23069814, PMCID: PMC3662469, DOI: 10.1001/2013.jamadermatol.541.Peer-Reviewed Original ResearchConceptsIndex Lesion SeverityClinical end pointsMycosis fungoidesResponse rateMechlorethamine gelAdverse eventsMulticenter trialTreatment armsLesion severityDrug-related serious adverse eventsSeverity-weighted assessment toolPrimary clinical end pointCutaneous T-cell lymphomaEnd pointSecondary clinical end pointsIIA mycosis fungoidesSerious adverse eventsSubset of patientsTreatment of patientsSerum drug levelsT-cell lymphomaComposite assessmentCarmustine therapyStudy medicationTopical mechlorethamine
2012
Sudden unexpected death in epilepsy in lamotrigine randomized‐controlled trials
Tomson T, Hirsch LJ, Friedman D, Bester N, Hammer A, Irizarry M, Ishihara L, Krishen A, Spaulding T, Wamil A, Leadbetter R. Sudden unexpected death in epilepsy in lamotrigine randomized‐controlled trials. Epilepsia 2012, 54: 135-140. PMID: 23030403, DOI: 10.1111/j.1528-1167.2012.03689.x.Peer-Reviewed Original ResearchConceptsSudden unexpected deathProbable SUDEPTreatment armsAntiepileptic drugsClinical trialsOdds ratioUnexpected deathTonic-clonic seizure frequencyRate of SUDEPRisk of SUDEPRandomized clinical trialsRandomized-controlled trialPotential risk factorsCause deathPossible SUDEPStudy medicationPatient yearsSeizure frequencyTreatment deathsComparator armActive comparatorNonrandomized studyUnadjusted ratesComparator groupRisk factorsLUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Burtness B, Bourhis J, Vermorken J, Dai L, Lind C, Ehrnrooth E, Cohen E. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Journal Of Clinical Oncology 2012, 30: tps5599-tps5599. DOI: 10.1200/jco.2012.30.15_suppl.tps5599.Peer-Reviewed Original ResearchDisease-free survivalNeck dissectionPO QDAdvanced squamous cell cancerIrreversible ErbB family blockerAdequate bone marrowErbB family blockerStudy of afatinibSubsequent neck dissectionCompletion of chemoradiationEvidence of diseaseHigh-risk patientsSecond primary tumorsHealth-related qualityBase of tongueSquamous cell cancerRisk of recurrenceNeck cancer patientsPlatinum-based chemoradiationSalivary gland cancerConcurrent cisplatinCurative intentDefinitive chemoradiationPrior therapyStudy medication
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