2025
Prescribing methadone in prison predicts linkage to HIV care after release from prison: A randomized and patient preference trial
Mobley A, Wegman M, Bazazi A, Shenoi S, Bromberg D, Ahmad A, Kamarulzaman A, Altice F. Prescribing methadone in prison predicts linkage to HIV care after release from prison: A randomized and patient preference trial. International Journal Of Drug Policy 2025, 137: 104733. PMID: 39923270, PMCID: PMC11875876, DOI: 10.1016/j.drugpo.2025.104733.Peer-Reviewed Original ResearchConceptsLinkage to HIV careHIV careIncrease linkage to HIV careTreatment-as-prevention strategiesHIV treatment cascadeHIV treatment outcomesOpen-label trialCox proportional hazards modelsPatient preference trialOpioid use disorderMalaysia’s largest prison.Impact of methadoneProportional hazards modelTreatment cascadeInverse probability weighted Cox proportional hazards modelAnalytic sampleStudy participantsCareTreatment outcomesPrescribed methadoneOpioidConfounding variablesHIVUse disorderHazards modelPralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial
Iyer S, Dakhil S, Shinohara M, Zain J, Acosta M, Foss F. Pralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial. Blood Neoplasia 2025, 2: 100055. DOI: 10.1016/j.bneo.2024.100055.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaT-cell lymphomaOral mucositisTreatment of relapsed/refractory peripheral T-cell lymphomaRelapsed/refractory peripheral T-cell lymphomaGrade 2 oral mucositisMulticenter phase 2 trialIncidence of grade 2Cutaneous T-cell lymphomaHigh-dose methotrexate therapyCoadministration of leucovorinPhase 2 trialOpen-label trialEffect of leucovorinWeek of restAdministered 3 timesMucositis managementOral leucovorinPralatrexate dosesDose modificationMethotrexate therapyProphylactic therapyGastrointestinal mucositisSingle-armClinical benefitNeural network analysis as a novel skin outcome in a trial of belumosudil in patients with systemic sclerosis
Gunes I, Bernstein E, Cowper S, Panse G, Pradhan N, Camacho L, Page N, Bundschuh E, Williams A, Carns M, Aren K, Fantus S, Volkmann E, Bukiri H, Correia C, Kolachalama V, Wilson F, Mawe S, Mahoney J, Hinchcliff M. Neural network analysis as a novel skin outcome in a trial of belumosudil in patients with systemic sclerosis. Arthritis Research & Therapy 2025, 27: 85. PMID: 40217251, DOI: 10.1186/s13075-025-03508-9.Peer-Reviewed Original ResearchConceptsModified Rodnan skin scoreSystemic sclerosisFibrosis scoreHistological parametersDiffuse cutaneous systemic sclerosisInterquartile rangeSystemic sclerosis skin biopsiesRodnan skin scoreCutaneous systemic sclerosisOpen-label trialSkin scorePathological parametersSkin biopsiesBiopsySkin outcomesStudy terminationFibrosisHistological analysisBlinded dermatopathologistStained sectionsSpearman correlationBelumosudilPatientsSkin featuresScores
2024
Factors associated with non-publication of clinical trials in cardiovascular medicine: a cross-sectional analysis
Alawajneh M, Aljabai A, Theeb L, Badwan Z, Alnabi A, Theeb H, Altibi A. Factors associated with non-publication of clinical trials in cardiovascular medicine: a cross-sectional analysis. European Heart Journal 2024, 45: ehae666.3639. DOI: 10.1093/eurheartj/ehae666.3639.Peer-Reviewed Original ResearchCross-sectional analysisClinical trialsIntervention typeLogistic regressionCardiovascular medicineNon-randomised trialsOpen-label trialPublication statusMultivariate logistic regressionArea of clinical researchEnrollment sizeNon-publicationCardiovascular clinical trialsCardiovascular-relatedParticipant ageTriple-blindTrial completionDecreased likelihoodRandomised trialsTrial publicationsPredictor factorsFunding sourcesResearch fundingClinical researchEnrollmentRandomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Silverman M, Van Besien K, Schuster M, Law A, Larkin K, Pandit-Taskar N, Rowley S, Munshi P, Cook R, Levy M, Lazarus H, Sandmaier B, Pagel J, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. Journal Of Clinical Oncology 2024, 43: 201-213. PMID: 39298738, PMCID: PMC11709001, DOI: 10.1200/jco.23.02018.Peer-Reviewed Original ResearchEvent-free survivalIntention-to-treat populationIntention-to-treatHazard ratioRR-AMLOverall survivalOlder patientsPhase III open-label trialEvent-free survival HRTreatment-related adverse eventsAllogeneic hematopoietic cell transplantationConventional careIncomplete platelet recoveryOS hazard ratioSecondary end pointsHematopoietic cell transplantationOpen-label trialConventional care groupPretransplant regimenRefractory AMLRelapsed/refractory AMLChemotherapy initiationDismal prognosisPlatelet recoveryCell transplantationFinal Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma
Barata P, Tangen C, Plets M, Thompson I, Narayan V, George D, Heng D, Shuch B, Stein M, Gulati S, Tretiakova M, Tripathi A, Bjarnason G, Humphrey P, Adeniran A, Vaishampayan U, Alva A, Zhang T, Cole S, Lara P, Lerner S, Balzer-Haas N, Pal S. Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. Journal Of Clinical Oncology 2024, 42: 3911-3916. PMID: 39255440, PMCID: PMC11575905, DOI: 10.1200/jco.24.00767.Peer-Reviewed Original ResearchAdvanced papillary renal cell carcinomaPapillary renal cell carcinomaRenal cell carcinomaOverall survivalCell carcinomaProlonged progression-free survivalLack of survival benefitProgression-free survivalRandomized phase IIMedian follow-upPrimary end pointOpen-label trialOverall survival analysisCrizotinib armMedian OSSurvival benefitClinical trial updateNo significant differenceCabozantinibTreatment armsSunitinibFollow-upClinical trialsSavolitinibCrizotinib
2023
Trial in Progress: An Open-Label Expansion Trial Evaluating the Safety, PK/PD, and Clinical Activity of Emavusertib (CA-4948) + Ibrutinib in R/R Primary CNS Lymphoma
Grommes C, Nowakowski G, Rosenthal A, Lunning M, Ramchandren R, Regales L, Fowle M, Lane M, Wang C, Omuro A, Leslie L, Soussain C, Dabrowska-Iwanicka A, Ferreri A, Tun H. Trial in Progress: An Open-Label Expansion Trial Evaluating the Safety, PK/PD, and Clinical Activity of Emavusertib (CA-4948) + Ibrutinib in R/R Primary CNS Lymphoma. Blood 2023, 142: 3143. DOI: 10.1182/blood-2023-190391.Peer-Reviewed Original ResearchPrimary central nervous system lymphomaInterleukin-1 receptor-associated kinase 4FMS-like tyrosine kinase 3Toll-like receptorsExpansion cohortPCNSL patientsDisease progressionRefractory primary central nervous system lymphomaDiagnosis of PCNSLCentral nervous system lymphomaPathogenesis of PCNSLSafety/tolerabilityOpen-label trialBlood-brain barrier penetrationPrimary CNS lymphomaSufficient blood-brain barrier penetrationNervous system lymphomaInitial clinical dataKey inclusion criteriaPotent oral inhibitorCentral nervous systemBrain barrier penetrationPK/PDTyrosine kinase 3Further preclinical studiesTakeaim Lymphoma: An Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Combination with Ibrutinib in Patients with Relapsed or Refractory Hematologic Malignancies
Grommes C, Tun H, Rosenthal A, Lunning M, Ramchandren R, Regales L, Zhao W, Lane M, Wang C, von Roemeling R, Isufi I, Leslie L, Nowakowski G. Takeaim Lymphoma: An Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Combination with Ibrutinib in Patients with Relapsed or Refractory Hematologic Malignancies. Blood 2023, 142: 4497. DOI: 10.1182/blood-2023-189746.Peer-Reviewed Original ResearchInterleukin-1 receptor-associated kinase 4Non-Hodgkin lymphomaFMS-like tyrosine kinase 3Bid dose levelToll-like receptorsDose escalationBTK inhibitorsNHL patientsDose levelsAcceptable long-term safety profileRefractory non-Hodgkin lymphomaLong-term safety profileB-cell non-Hodgkin lymphomaBruton tyrosine kinase inhibitorsBTK inhibitor resistanceContinuous oral dosingMurine PDX modelPhase 2 doseRelapsed/Refractory Non-Hodgkin LymphomaMedian treatment durationOpen-label trialRefractory hematologic malignanciesBlood-brain barrierPreliminary efficacy dataNovel oral inhibitorOpen-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease
Siegel S, Griffith D, Philley J, Brown-Elliott B, Brunton A, Sullivan P, Fuss C, Strnad L, Wallace R, Winthrop K. Open-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease. CHEST Journal 2023, 164: 846-859. PMID: 37419144, PMCID: PMC10645596, DOI: 10.1016/j.chest.2023.05.036.Peer-Reviewed Original ResearchConceptsAmikacin liposome inhalation suspensionAmikacin resistanceCulture conversionInhalation suspensionMycobacterium abscessus lung diseasePresence of macrolide resistanceEnd pointsMicrobiological end pointsMonthly sputum culturesSputum culture conversionTreatment-refractory diseaseOpen-label protocolSecondary end pointsOpen-label trialCohort of patientsCavitary diseaseSputum culturePretreatment isolatesM abscessusOpen-labelOral antimicrobialsParenteral antibioticsCompanion therapyMacrolide resistanceMultidrug therapyA randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial
Kanagaratnam P, Francis D, Chamie D, Coyle C, Marynina A, Katritsis G, Paiva P, Szigeti M, Cole G, de Andrade Nunes D, Howard J, Esper R, Khan M, More R, Barreto G, Meneguz-Moreno R, Arnold A, Nowbar A, Kaura A, Mariveles M, March K, Shah J, Nijjer S, Lip G, Mills N, Camm A, Cooke G, Corbett S, Llewelyn M, Ghanima W, Toshner M, Peters N, Petraco R, Al-Lamee R, Boshoff A, Durkina M, Malik I, Ruparelia N, Cornelius V, Shun-Shin M. A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial. Journal Of Thrombosis And Haemostasis 2023, 21: 2213-2222. PMID: 37230416, PMCID: PMC10204350, DOI: 10.1016/j.jtha.2023.04.045.Peer-Reviewed Original ResearchConceptsCoronary disease risk factorsIntervention arm participantsAcute coronary syndrome trialsRisk factorsDisease risk factorsLength of hospital stayLow-dose rivaroxabanAcute coronary syndrome therapyOpen-label trialCoronary artery diseaseRandomized controlled trialsAcute hospitalsArm participantsPrimary efficacyStandard careNo significant differenceMedian timeThrombotic complicationsTreatment regimenHospital staySyndrome therapyPoor outcomeClinical statusSecondary outcomesArtery diseasePartial Meal Replacement for Weight Loss after Stroke: Results of a Pilot Clinical Trial
Dearborn Tomazos J, Viscoli C, Amin H, Lovelett L, Rivera J, Gull A, Kernan W. Partial Meal Replacement for Weight Loss after Stroke: Results of a Pilot Clinical Trial. Cerebrovascular Diseases 2023, 53: 54-61. PMID: 37231793, DOI: 10.1159/000530996.Peer-Reviewed Original ResearchRecent ischemic strokeBody mass indexIschemic strokeStandard carePMR groupWeight lossSC groupMeal replacementMean percent weight changePartial meal replacementOpen-label trialAcute ischemic strokeCo-primary outcomesHalf of patientsSuccessful weight lossPilot clinical trialPercent weight changeBMI 27Eligible patientsAdverse eventsObese patientsMass indexVascular inflammationLarge trialsFunctional outcomeP111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11)
Harbeck N, Boileau J, Modi S, Kelly C, Ohno S, Wu J, Konpa A, Herbolsheimer P, Safdar S, Zhang Y, Pusztai L. P111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11). The Breast 2023, 68: s57. DOI: 10.1016/s0960-9776(23)00228-x.Peer-Reviewed Original Research
2022
Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia
Bazazi A, Culbert G, Wegman M, Heimer R, Kamarulzaman A, Altice F. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infectious Diseases 2022, 22: 837. PMID: 36368939, PMCID: PMC9652918, DOI: 10.1186/s12879-022-07804-6.Peer-Reviewed Original ResearchConceptsOpioid use disorderOpioid agonist therapyInfectious etiologyMost deathsUse disordersSample of menPrison releaseOpen-label trialT-lymphocyte countsPredictors of mortalityNational death recordsCrude mortality rateProportional hazards modelCovariate-adjusted modelsLow CD4Methadone initiationModified intentionAgonist therapySurvival benefitTreat analysisMethodsThis studyHIVHazards modelMortality rateMethadoneKetamine use in pediatric depression: A systematic review
Meshkat S, Rosenblat J, Ho R, Rhee T, Cao B, Ceban F, Danayan K, Chisamore N, Vincenzo J, McIntyre R. Ketamine use in pediatric depression: A systematic review. Psychiatry Research 2022, 317: 114911. PMID: 37732856, DOI: 10.1016/j.psychres.2022.114911.Peer-Reviewed Original ResearchConceptsSafety of ketamineRandomized clinical trialsPediatric depressionIntravenous ketamineNon-competitive N-methyl-D-aspartate (NMDA) receptor antagonistN-methyl-D-aspartate receptor antagonistSystematic reviewOpen-label trialSevere adverse eventsCommon psychiatric disordersDifferent administration modalitiesAdverse eventsAntidepressant effectsSignificant morbidityMean ageCase reportReceptor antagonistClinical trialsAdministration modalitiesDepressive symptomsPsychiatric disordersKetamine useElectronic databasesLarger sample sizeKetamineFORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysisThe Potential of N-acetyl Cysteine in Behavioral Addictions and Related Compulsive and Impulsive Behaviors and Disorders: a Scoping Review
Greenberg N, Farhadi F, Kazer B, Potenza M, Angarita G. The Potential of N-acetyl Cysteine in Behavioral Addictions and Related Compulsive and Impulsive Behaviors and Disorders: a Scoping Review. Current Addiction Reports 2022, 9: 660-670. PMID: 38362235, PMCID: PMC10868722, DOI: 10.1007/s40429-022-00446-3.Peer-Reviewed Original ResearchN-acetylcysteineSelf-injurious behaviorEffectiveness of NACEfficacy of NACSmall open-label trialsUse of NACCompulsive sexual behaviorOpen-label trialRepetitive self-injurious behaviorSexual behaviorCompulsive behaviorsGambling disorderGlutamate dysregulationBehavioral addictionsCase reportClinical trialsPreclinical studiesGlutamate homeostasisAcetyl cysteineDisordersMore studiesScoping ReviewCompulsive featuresAddictionImpulsive behaviorIncobotulinimtoxinA (Xeomin) for the treatment of adductor laryngeal dystonia: A prospective, open-label clinical trial
Kohli N, Lerner M, Rashty J, Kirke D, Stewart T, Blitzer A. IncobotulinimtoxinA (Xeomin) for the treatment of adductor laryngeal dystonia: A prospective, open-label clinical trial. American Journal Of Otolaryngology 2022, 43: 103613. PMID: 36055061, DOI: 10.1016/j.amjoto.2022.103613.Peer-Reviewed Original ResearchConceptsAdductor spasmodic dysphoniaSpasmodic dysphoniaOpen-label clinical trialProspective open-label trialAdductor laryngeal dystoniaOpen-label trialFirst-line treatmentVoice Handicap Index-10Side effect profileTransient side effectsNormal functionVHI-10 scoresIncobotulinumtoxinA injectionsEffect profileLine treatmentSystemic diseaseTA muscleBotulinum toxinClinical trialsLaryngeal dystoniaNursing womenThyroarytenoid muscleInjection sessionsExclusion criteriaSide effectsIntravenous Infusion of Autoserum-Expanded Autologous Mesenchymal Stem Cells in Patients With Chronic Brain Injury: Protocol for a Phase 2 Trial
Oka S, Yamaki T, Sasaki M, Ukai R, Takemura M, Yokoyama T, Kataoka-Sasaki Y, Onodera R, Ito YM, Kobayashi S, Kocsis JD, Iwadate Y, Honmou O. Intravenous Infusion of Autoserum-Expanded Autologous Mesenchymal Stem Cells in Patients With Chronic Brain Injury: Protocol for a Phase 2 Trial. JMIR Research Protocols 2022, 11: e37898. PMID: 35793128, PMCID: PMC9301565, DOI: 10.2196/37898.Peer-Reviewed Original ResearchChronic brain injuryAutologous mesenchymal stem cellsSpinal cord injuryINTERNATIONAL REGISTERED REPORT IDENTIFIERBrain injuryIntravenous infusionRankin Scale gradesCord injuryMesenchymal stem cellsClinical trialsScale gradeTherapeutic efficacyJapan Medical Association CenterSapporo Medical University HospitalInvestigator-initiated clinical trialsModified Rankin Scale gradesOpen-label trialPhase 2 studyPhase 2 trialMedical University HospitalCause of disabilityMotor vehicle accidentsPotential therapeutic efficacyProportion of casesStem cellsInhibition of type 1 immunity with tofacitinib is associated with marked improvement in longstanding sarcoidosis
Damsky W, Wang A, Kim DJ, Young BD, Singh K, Murphy MJ, Daccache J, Clark A, Ayasun R, Ryu C, McGeary MK, Odell ID, Fazzone-Chettiar R, Pucar D, Homer R, Gulati M, Miller EJ, Bosenberg M, Flavell RA, King B. Inhibition of type 1 immunity with tofacitinib is associated with marked improvement in longstanding sarcoidosis. Nature Communications 2022, 13: 3140. PMID: 35668129, PMCID: PMC9170782, DOI: 10.1038/s41467-022-30615-x.Peer-Reviewed Original ResearchConceptsType 1 immunityInternal organ involvementOrgan involvementT cell-derived IFNIdiopathic inflammatory disorderOpen-label trialMonths of treatmentType 1 cytokinesJanus kinase inhibitorImmunologic changesLongstanding sarcoidosisSarcoidosis activitySarcoidosis symptomsClinical improvementCutaneous sarcoidosisSecondary outcomesComplete responsePrimary outcomeTofacitinib treatmentActivity scoreCytokine mediatorsIL-12IL-15IL-6Inflammatory disordersKetamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review
Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimarães D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harvard Review Of Psychiatry 2022, 30: 135-145. PMID: 35267254, DOI: 10.1097/hrp.0000000000000330.Peer-Reviewed Original ResearchConceptsObsessive-compulsive disorderSystematic reviewN-methyl-D-aspartate receptor antagonistAppropriate washout periodOpen-label trialPlacebo-controlled trialFirst-line treatmentRetrospective chart reviewUse of ketamineEffects of ketamineMeta-analysis protocolCombination of ketaminePubMed/MEDLINEPreferred Reporting ItemsMore effective treatmentsPotent N-methyl-d-aspartate receptor antagonistKetamine treatmentChart reviewGlutamate modulatorsGood tolerabilityReuptake inhibitorsWashout periodCase reportGlutamatergic neurotransmissionReceptor antagonist
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