2025
Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial
Khanna S, Yoho D, Van Handel D, Clark B, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. Therapeutic Advances In Gastroenterology 2025, 18: 17562848251339697. PMID: 40321366, PMCID: PMC12049624, DOI: 10.1177/17562848251339697.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase IIIb trialAntibiotic treatmentPrevention of recurrent CDINo treatment emergent adverse eventsTreatment successRecurrent Clostridioides difficile infectionClostridioides difficile</i> infectionIntensive care unit admissionParticipation benefitsPrevent CDI recurrenceClostridioides difficile infectionRoute of administrationPhysicians' perceptionsPreventing rCDICDI recurrenceTreatment failureEligible adultsSecondary endpointsFecal microbiotaEffects of fecal microbiotaUnit admissionDifficile infectionAdverse eventsPhysician experienceUnderstanding eyebrow and eyelash involvement in patients with alopecia areata and responsiveness to treatment with baricitinib
Mostaghimi A, Craiglow B, King B, Shapiro J, Ko J, Tosti A, Ohyama M, Brogan Y, Yu G, Sontag A, Somani N. Understanding eyebrow and eyelash involvement in patients with alopecia areata and responsiveness to treatment with baricitinib. British Journal Of Dermatology 2025, ljaf088. PMID: 40179237, DOI: 10.1093/bjd/ljaf088.Peer-Reviewed Original ResearchBaricitinib 4 mgBaricitinib 2 mgHair-bearing sitesAlopecia areataResponse rateBenefit of baricitinibTreated with baricitinibRandomised to placeboPlacebo-controlled trialResponse to treatmentScalp hair lossSALT scoreDouble-blindClinical presentationBaricitinib treatmentTreatment successHair regrowthBaricitinibBaseline severityPatientsClinician reportsHair lossPlaceboPooled dataScalpP-1503. Dual β-Lactam Approach for Treatment of Mycobacterium abscessus Infections in Adults – Results in 19 Patients
Kalyatanda G, Dousa K, Lyons H, Mardourian M, Rhodes J, Iakovidis A, El-Helou G, Wilson B, Daley C, Holland S, Kreiswirth B, Nguyen D, Shin E, Kurz S, Johnson J, Bonomo R. P-1503. Dual β-Lactam Approach for Treatment of Mycobacterium abscessus Infections in Adults – Results in 19 Patients. Open Forum Infectious Diseases 2025, 12: ofae631.1672. PMCID: PMC11778049, DOI: 10.1093/ofid/ofae631.1672.Peer-Reviewed Original ResearchSubspecies abscessusB-lactamAssociated with high cure ratesIn vitro susceptibility resultsMulti-drug regimensCurrent treatment regimensSolid organ transplantationHigh cure ratesTime to initiationOptimize treatment outcomesMab infectionSynergy testClinical cureImmunocompromised patientsPulmonary infectionDiscontinued treatmentTreatment regimensCase reportClinical outcomesCure rateImmunocompromised individualsAutoimmune diseasesTreatment successEarly treatmentCulture conversionSafety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS
Allegretti J, Feuerstadt P, Knapple W, Orenstein R, Pinton P, Sheh A, Khanna S. Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS. Inflammatory Bowel Diseases 2025, izae291. PMID: 39862395, DOI: 10.1093/ibd/izae291.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionInflammatory bowel diseaseClostridioides difficile infectionWeeks of administrationPrevention of recurrent CDISerious treatment-emergent adverse eventsSubgroup analysisSustained clinical response ratesBowel diseaseSustained clinical responseClinical response rateModerate gastrointestinal symptomsUS Food and Drug AdministrationTreatment success rateFood and Drug AdministrationClinical responseSingle-doseProspective trialsFecal microbiotaEfficacy outcomesDifficile infectionAdverse eventsGastrointestinal symptomsTreatment success
2024
Cost-effectiveness of a simplified acute malnutrition program: a secondary analysis of the OptiMA randomized clinical trial in the Democratic Republic of the Congo
Resch S, Sato R, Phelan K, Cazes C, Ombotimbe A, Hubert V, Boubacar H, Bozama L, Sakubu G, Tshiala B, Tusuku T, Alitanou R, Kouamé A, Yao C, Gabillard D, Kinda M, Becquet R, Shepherd S, Hecht R. Cost-effectiveness of a simplified acute malnutrition program: a secondary analysis of the OptiMA randomized clinical trial in the Democratic Republic of the Congo. Health Policy And Planning 2024, 40: 273-286. PMID: 39513752, PMCID: PMC11886841, DOI: 10.1093/heapol/czae106.Peer-Reviewed Original ResearchMid-upper arm circumferenceIncremental cost-effectiveness ratioAcute malnutritionTreatment successReady-to-use supplementary foodFixed dose regimenRandomized clinical trialsCost-effectiveness ratioSecondary analysisChildren Aged 6Tapering doseNo significant differenceArm circumferenceClinical trialsModerate casesMalnutrition programsCost-effectiveness analysisTherapeutic foodMean costStandard careAged 6Significant differenceStatistical differenceStandard groupRUTFClindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.
Lain E, Bhatia N, Kircik L, Gold L, Harper J, Bunick C, Guenin E, Baldwin H, Feldman S, Rosso J. Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis. Journal Of Drugs In Dermatology 2024, 23: 873-881. PMID: 39361705, DOI: 10.36849/jdd.2024.8484.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsModerate-to-severe acneWeeks of once-daily treatmentInflammatory/noninflammatory lesion countsMild to moderate severityTriple-combination treatmentOnce-daily treatmentBaseline to weekPhase 3 studyTreatment success rateQuality-of-life improvementAcne-specific quality of lifePost Hoc AnalysisCutaneous safety/tolerabilityFixed-doseVehicle gelDouble-blindNoninflammatory lesionsFemale acneNo significant differenceImpact of sexEfficacy measuresLesion countsAdverse eventsTreatment successCalcium channel blockers and beta blockers in pediatric supraventricular tachycardia
Sullivan J, Pompa A, Schieber J, Arora G, Dionne A, Beach C. Calcium channel blockers and beta blockers in pediatric supraventricular tachycardia. Journal Of Cardiovascular Electrophysiology 2024, 35: 2237-2241. PMID: 39313851, DOI: 10.1111/jce.16432.Peer-Reviewed Original ResearchCalcium channel blockersBeta blockersSupraventricular tachycardiaPediatric supraventricular tachycardiaChannel blockersAssociated with more side effectsCalcium-channel blockers patientsHemodynamically significant heart diseaseSide effectsMulticenter retrospective cohort studyEctopic atrial tachycardiaSignificant heart diseaseIntolerable side effectsRetrospective cohort studySuccess rateSupraventricular tachycardia diagnosisData abstraction toolAcademic children's hospitalIndividuals aged 1Pediatric arrhythmiasBB patientsDosage adjustmentAtrial tachycardiaTreatment successCohort studyPUNCH CD3-OLS: A Phase 3 Prospective Observational Cohort Study to Evaluate the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) in Adults With Recurrent Clostridioides difficile Infection
Feuerstadt P, Chopra T, Knapple W, Van Hise N, Dubberke E, Baggott B, Guthmueller B, Bancke L, Gamborg M, Steiner T, Van Handel D, Khanna S. PUNCH CD3-OLS: A Phase 3 Prospective Observational Cohort Study to Evaluate the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) in Adults With Recurrent Clostridioides difficile Infection. Clinical Infectious Diseases 2024, 80: 43-51. PMID: 39180326, PMCID: PMC11797394, DOI: 10.1093/cid/ciae437.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionPreventing recurrent Clostridioides difficile infectionStandard-of-careSerious treatment-emergent adverse eventsTreatment successSustained clinical response ratesStandard-of-care antibioticsSustained clinical responseClinical response rateOpen-label studyTreatment success rateClostridioides difficile infectionMicrobiota-basedBaseline characteristic subgroupsObservational cohort studyFood and Drug AdministrationInflammatory bowel diseaseAntibiotic completionClinical responseSingle-doseEfficacy ratePrimary endpointSecondary endpointsImmunocompromised conditionsTriple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis
Kircik L, Stein Gold L, Gold M, Weiss J, Harper J, Del Rosso J, Bunick C, Bhatia N, Tanghetti E, Eichenfield L, Baldwin H, Draelos Z, Callender V, Han G, Gooderham M, Sadick N, Lupo M, Lain E, Werschler W. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatology And Therapy 2024, 14: 1211-1227. PMID: 38724841, PMCID: PMC11116301, DOI: 10.1007/s13555-024-01155-7.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acneClear/almost clear skinTopical acne productsFixed-doseVehicle gelClear skinAcne productsLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreIdentical phase 3Acne lesion countsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesCutaneous safety/tolerabilityDouble-blindNoninflammatory lesionsResultsAt weekLesion countsAdverse eventsClinical studiesAcne treatment0568 Promoting Shared Decision Making with a Novel Self-Monitoring Program for Veterans with Obstructive Sleep Apnea
Mak S, Ghadimi S, Der-Mcleod E, Moore V, Naeem S, Chohan M, Zeidler M, Ash G, Fung C. 0568 Promoting Shared Decision Making with a Novel Self-Monitoring Program for Veterans with Obstructive Sleep Apnea. Sleep 2024, 47: a243-a243. DOI: 10.1093/sleep/zsae067.0568.Peer-Reviewed Original ResearchObstructive sleep apneaObstructive sleep apnea treatmentSleep apneaShared decision makingPAP therapyOSA treatmentAirway pressurePAP treatmentSleep centerTreatment optionsTreatment successDaytime sleepinessSleep cliniciansAlternative therapiesPatientsPulse oximetryTherapyTherapy effectsSpO2 dataApneaTreatmentQuality improvement projectPAPSpO2Patient preference elicitationTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s357. DOI: 10.25251/skin.8.supp.357.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost Hoc AnalysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety resultsEfficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection
Feuerstadt P, Allegretti J, Dubberke E, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Tillotson G, Bancke L, LaPlante K, Garey K, Khanna S. Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection. Infectious Diseases And Therapy 2024, 13: 221-236. PMID: 38236515, PMCID: PMC10828144, DOI: 10.1007/s40121-023-00907-w.Peer-Reviewed Original ResearchRecurrence of CDIHealth-related quality of lifeTreatment successPost Hoc AnalysisAntibiotic treatmentDouble-blind placebo-controlled clinical trialPlacebo-controlled clinical trialBlinded phaseHealth-related qualityProbability of treatment successBaseline to weekOdds of recurrenceBaseline patient characteristicsHealth-related quality of life impactCD3- patientsFecal microbiotaAnalyzed efficacyDifficile infectionEligible patientsPatient characteristicsClinical trialsPlaceboRecurrenceEffective treatmentPatientsTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s339. DOI: 10.25251/skin.8.supp.339.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost Hoc AnalysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety resultsRetrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection
Knapple W, Yoho D, Sheh A, Thul J, Feuerstadt P. Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection. Therapeutic Advances In Gastroenterology 2024, 17: 17562848241239547. PMID: 38529070, PMCID: PMC10962041, DOI: 10.1177/17562848241239547.Peer-Reviewed Original ResearchClostridioides difficile</i> infectionSustained clinical responseClinical responsePrevention of recurrent CDITreatment successRecurrent Clostridioides difficile infectionConsistent with clinical trialsAlternative routes of administrationRetrospective subgroup analysisClostridioides difficile infectionReal-world safetyRoute of administrationFood and Drug AdministrationAnalysis of fecal microbiotaCDI recurrenceSingle-doseFecal microbiotaDifficile infectionAdverse eventsRetrospective analysisLive biotherapeutic productsColonoscopyDrug AdministrationClinical interestTEAEs
2023
Amygdala downregulation training using fMRI neurofeedback in post-traumatic stress disorder: a randomized, double-blind trial
Zhao Z, Duek O, Seidemann R, Gordon C, Walsh C, Romaker E, Koller W, Horvath M, Awasthi J, Wang Y, O’Brien E, Fichtenholtz H, Hampson M, Harpaz-Rotem I. Amygdala downregulation training using fMRI neurofeedback in post-traumatic stress disorder: a randomized, double-blind trial. Translational Psychiatry 2023, 13: 177. PMID: 37230984, PMCID: PMC10209552, DOI: 10.1038/s41398-023-02467-6.Peer-Reviewed Original ResearchConceptsPost-traumatic stress disorderControl groupAmygdala activityPTSD treatmentDouble-blind clinical trialStress disorderDouble-blind trialSecondary outcome measurementsTrauma recallNeurofeedback trainingGreater improvementAmygdala controlsPotential clinical applicationsSymptom scoresActive groupClinical trialsTreatment successOutcome measurementsTrauma scriptsSymptom reductionNeurofeedback interventionPTSD symptomsFMRI neurofeedbackAmygdalaNeural markersCharacteristics and outcomes for participants with congenital ichthyosis who responded to treatment with the topical isotretinoin formulation TMB-001: results from the Phase IIb CONTROL study
Bunick C, Teng J, Guenthner S, Marathe K, Kempers S, Eads K, Castelo-Soccio L, Mendelsohn A, Raiz J, Murrell D. Characteristics and outcomes for participants with congenital ichthyosis who responded to treatment with the topical isotretinoin formulation TMB-001: results from the Phase IIb CONTROL study. Clinical And Experimental Dermatology 2023, 48: 765-769. PMID: 36928932, DOI: 10.1093/ced/llad105.Peer-Reviewed Original ResearchConceptsBSA involvementCongenital ichthyosisHigher DLQIIgA responsesTreatment successControl studyDermatology Life Quality Index scoresBody surface area involvementDose-limiting adverse effectGlobal assessmentLife Quality Index scoresInvestigator's Global AssessmentSurface area involvementProportion of participantsRating Scale scoresSystemic retinoid treatmentYears of ageQuality Index scoresCharacteristics of participantsIgA respondersBaseline demographicsEfficacy endpointMedian ageArea involvementScale score
2022
Maximizing treatment efficacy through patient stratification in neuropathic pain trials
Baron R, Dickenson A, Calvo M, Dib-Hajj S, Bennett D. Maximizing treatment efficacy through patient stratification in neuropathic pain trials. Nature Reviews Neurology 2022, 19: 53-64. PMID: 36400867, DOI: 10.1038/s41582-022-00741-7.Peer-Reviewed Original ResearchConceptsNeuropathic painPain medicineOutcome measuresClinical practiceNeuropathic pain etiologyNeuropathic pain trialsPatient stratification approachesMultiple pathophysiological mechanismsSubgrouping of patientsRoutine clinical practiceNovel outcome measuresPain etiologyBaseline characteristicsPain trialsPathophysiological mechanismsClinical trialsTreatment successTherapeutic approachesAnimal modelsPatient stratificationTreatment efficacyPainHuman painTherapeutic compoundsPatientsThe effect of incarceration on TB treatment outcomes
O Marr J, Gonçalves C, Arakaki-Sanchez D, Pelissari D, Costa F, Croda J, Walter K, Andrews J. The effect of incarceration on TB treatment outcomes. The International Journal Of Tuberculosis And Lung Disease 2022, 26: 252-258. PMID: 35197165, DOI: 10.5588/ijtld.21.0449.Peer-Reviewed Original ResearchConceptsNon-incarcerated individualsTreatment successTreatment outcomesDrug-susceptible TB casesImproved treatment successTB treatment outcomesTB treatment successClinical risk factorsIncarcerated individualsMultivariate logistic regressionGreater treatment successTB casesClinical factorsObserved therapyPoor outcomeTB notificationsRisk factorsElevated riskGreater efficacyLogistic regressionNotifiable diseaseOutcomesIncarcerated populationsVulnerable individualsUse of DOTSplenic Abscess in the New Millennium: A Descriptive, Retrospective Case Series
Radcliffe C, Tang Z, Gisriel SD, Grant M. Splenic Abscess in the New Millennium: A Descriptive, Retrospective Case Series. Open Forum Infectious Diseases 2022, 9: ofac085. PMID: 35299986, PMCID: PMC8923382, DOI: 10.1093/ofid/ofac085.Peer-Reviewed Original ResearchSplenic abscessHematogenous spreadAntimicrobial therapyLargest North American seriesHospital systemRetrospective case seriesNorth American seriesIndex hospitalizationImmunocompromised stateMedian durationClinical stabilityMedian agePercutaneous drainageCase seriesDiabetes mellitusProlonged hospitalizationRetrospective reviewMedian lengthRare infectionTreatment successHematological malignanciesPancreatic diseaseProbable casesInterventional radiologyAbscess
2021
Eptacog Beta Efficacy in Children and Adolescents with Hemophilia A or B and Inhibitors: Subset Analysis Suggests Improved Caregiver Capacity to Assess Bleeding Episode Resolution with Subject Age
Young G, Pipe S, Hermans C, Carcao M, Castaman G, Davis J, Ducore J, Dunn A, Escobar M, Journeycake J, Khan O, Mahlangu J, Meeks S, Mitha I, Négrier C, Nowak-Göttl U, Recht M, Chrisentery-Singleton T, Stasyshyn O, Vilchevska K, Martinez L, Wang M, Windyga J, Alexander W, Al-Sabbagh A, Bonzo D, Macie C, Mitchell I, Wilkinson T, Shapiro A. Eptacog Beta Efficacy in Children and Adolescents with Hemophilia A or B and Inhibitors: Subset Analysis Suggests Improved Caregiver Capacity to Assess Bleeding Episode Resolution with Subject Age. Blood 2021, 138: 3195. DOI: 10.1182/blood-2021-147434.Peer-Reviewed Original ResearchInitial dosing regimensEntity's Board of DirectorsEptacog betaBleeding episodesPhase 3 trialCSL BehringPediatric age subgroupsConfidence intervalsTreatment successHemophilia AYears subgroupIncreasing subject ageAge subgroupsSubject ageBeta infusionAdvisory CommitteeResearch fundingOregon Health & Science UniversitySuccess proportionTreatment of bleeding episodesControl of bleeding episodesModerate bleeding episodesTreat bleeding episodesNational Hemophilia FoundationOpen-label trial
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply