2025
Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial)
Klausen M, Kuzey T, Pedersen J, Justesen S, Rasmussen L, Knorr U, Mason G, Ekstrøm C, Holst J, Koob G, Benveniste H, Volkow N, Knudsen G, Vilsbøll T, Fink-Jensen A. Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial). BMJ Open 2025, 15: e086454. PMID: 39779270, PMCID: PMC11749217, DOI: 10.1136/bmjopen-2024-086454.Peer-Reviewed Original ResearchConceptsAlcohol use disorderUse disorderGamma-aminobutyric acidComorbid obesityAlcohol cue reactivityCognitive behavioral therapyHeavy drinking daysWhite matter tract integrityBrain gamma-aminobutyric acidGlucagon-like peptide-1Alcohol consumptionMental health disordersReduce alcohol consumptionClinical trialsCue reactivityPlacebo-controlled clinical trialBehavioral therapyDrinking daysFunctional connectivityGLP-1 receptor agonist semaglutideWeeks of treatmentDouble-blind clinical trialTract integrityEthics Committee of the Capital Region of DenmarkHealth disorders
2024
BCG-Induced DNA Methylation Changes Improve Coronavirus Disease 2019 Vaccine Immunity Without Decreasing the Risk for Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Longlax S, Koster K, Kamat A, Lozano M, Lerner S, Hannigan R, Nishiguchi T, Abhimanyu, Sheikh D, Ladki M, Portillo A, Koirala A, Patel T, Spieler Z, Benjamin A, Lebedev M, Ofili T, Hutchison R, Udeani G, Opperman L, Neal G, Mandalakas A, Netea M, Arditi M, Avalos P, Grimm S, Coarfa C, Cirillo J, DiNardo A. BCG-Induced DNA Methylation Changes Improve Coronavirus Disease 2019 Vaccine Immunity Without Decreasing the Risk for Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Open Forum Infectious Diseases 2024, 12: ofaf007. PMID: 39872813, PMCID: PMC11770274, DOI: 10.1093/ofid/ofaf007.Peer-Reviewed Original ResearchVaccine immunityDNA methylation changesBCG-induced trained immunityClinical trialsBCG vaccinationPlacebo-controlled clinical trialStudy enrollmentAcute respiratory syndrome coronavirus 2 infectionSevere acute respiratory syndrome coronavirus 2 infectionCovid-19 specific vaccineMethylation changesCoronavirus 2 infectionCOVID-19 vaccine immunitySymptomatic COVID-19Secondary analysisSARS-CoV-2 antigensInnate immune responseDouble-blindPlacebo armBCG TiceTrained immunitySevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Coronavirus immunityRespiratory syndrome coronavirus 2Study Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy
Heerspink H, Jardine M, Kohan D, Lafayette R, Levin A, Liew A, Zhang H, Noronha I, Trimarchi H, Hou F, Renfurm R, Gray T, Camargo M, Barratt J. Study Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy. Kidney International Reports 2024, 10: 217-226. PMID: 39810771, PMCID: PMC11725817, DOI: 10.1016/j.ekir.2024.10.004.Peer-Reviewed Original ResearchRenin-angiotensin system inhibitorsEndothelin-AStable doseIgA nephropathyEndothelin-A receptor antagonistSodium-glucose cotransporter-2 inhibitorsPlacebo-controlled clinical trialRenin-angiotensin system inhibitor therapyBiopsy-proven IgANBaseline to weekCotransporter-2 inhibitorsMethods Eligibility criteriaKidney function lossRandomized controlled studyDouble-blindReceptor antagonistReduce proteinuriaEGFR changeBaseline characteristicsSystem inhibitorsIgAN populationAtrasentanKidney functionKidney inflammationClinical trialsActivated sputum eosinophils associated with exacerbations in children on mepolizumab
Wilson G, Knight J, Liu Q, Shelar A, Stewart E, Wang X, Yan X, Sanders J, Visness C, Gill M, Gruchalla R, Liu A, Kattan M, Khurana Hershey G, Togias A, Becker P, Altman M, Busse W, Jackson D, Montgomery R, Chupp G. Activated sputum eosinophils associated with exacerbations in children on mepolizumab. Journal Of Allergy And Clinical Immunology 2024, 154: 297-307.e13. PMID: 38485057, PMCID: PMC11305967, DOI: 10.1016/j.jaci.2024.01.031.Peer-Reviewed Original ResearchAirway eosinophilsSputum eosinophilsPatients treated with mepolizumabPlacebo-controlled clinical trialAnti-IL-5 treatmentEffect of mepolizumabEosinophil subpopulationsSevere eosinophilic asthmaAnti-interleukin-5Expression of CD62LFrequency of exacerbationsEosinophilic asthmaActivation markersSputum samplesUnsupervised cluster analysisMepolizumabTreatment armsReduce exacerbationsCD62LClinical trialsExacerbationMass cytometryEosinophilsExacerbation riskIntracellular markersEfficacy 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 treatmentPatientsChikungunya Arthritis Treatment with Methotrexate and Dexamethasone: A Randomized, Double-blind, Placebo-controlled Trial
Amaral J, Lucena G, Schoen R. Chikungunya Arthritis Treatment with Methotrexate and Dexamethasone: A Randomized, Double-blind, Placebo-controlled Trial. Current Rheumatology Reviews 2024, 20: 337-346. PMID: 38173199, DOI: 10.2174/0115733971278715231208114037.Peer-Reviewed Original ResearchChronic chikungunya arthritisChikungunya arthritisDouble-blindJoint countPlacebo-controlled clinical trialPain visual analog scalePlacebo-controlled trialChikungunya feverPatient global assessmentVisual analog scaleAffected individualsSwollen joint countTender joint countChikungunya virus infectionDAS28-ESRDexamethasone groupSD ageAnalog scaleBiphasic diseaseTreatment responseClinical trialsAcute phaseDexamethasoneVirus infectionGlobal assessment
2023
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.Peer-Reviewed Original ResearchConceptsErbB2-positive metastatic breast cancerMetastatic breast cancerPlacebo-combination groupPositive metastatic breast cancerNew brain lesionsBrain metastasesOverall survivalSubgroup analysisBrain lesionsBreast cancerIntracranial progression-free survivalPlacebo-controlled clinical trialIntracranial objective response rateStable brain metastasesMedian overall survivalObjective response rateProgression-free survivalExploratory subgroup analysisGreater clinical benefitCNS-PFSHER2CLIMB trialIntracranial outcomesFirst progressionMedian ageClinical benefit
2022
Heterogeneity of response to methylphenidate in apathetic patients in the ADMET 2 Trial
Lanctôt K, Perin J, Vieira D, Rosenberg P, Herrmann N, Shade D, Lerner A, Padala P, Brawman‐Mintzer O, van Dyck C, Porsteinsson A, Craft S, Levey A, Mintzer J. Heterogeneity of response to methylphenidate in apathetic patients in the ADMET 2 Trial. Alzheimer's & Dementia 2022, 18 DOI: 10.1002/alz.066932.Peer-Reviewed Original ResearchHeterogeneity of responseAlzheimer's diseaseAD patientsBaseline anxietyPlacebo-controlled clinical trialApathetic AD patientsDaily Living ScaleCommon neuropsychiatric symptomsLow functional capacityLower functional capabilityNPI apathy scoreLower baseline anxietyAD medicationsDifference of changesNeuropsychiatric InventoryNeuropsychiatric symptomsApathetic patientsClinical trialsMonth visitTreatment outcomesEffect differencesSignificant apathyLiving ScaleApathy scoresFunctional capacityAlleviation of opioid withdrawal by cannabis and delta-9-tetrahydrocannabinol: A systematic review of observational and experimental human studies
De Aquino J, Bahji A, Gómez O, Sofuoglu M. Alleviation of opioid withdrawal by cannabis and delta-9-tetrahydrocannabinol: A systematic review of observational and experimental human studies. Drug And Alcohol Dependence 2022, 241: 109702. PMID: 36434879, PMCID: PMC9772106, DOI: 10.1016/j.drugalcdep.2022.109702.Peer-Reviewed Original ResearchConceptsOpioid withdrawalObservational studySystematic reviewDelta-9-tetrahydrocannabinol administrationPlacebo-controlled clinical trialCannabis useNon-opioid therapeuticsPotential of cannabinoidsDose of opioidsOpioid withdrawal symptomsOpioid use disorderNarrow therapeutic windowExperimental human studiesDose-dependent increaseMain psychoactive constituentPatient characteristicsWithdrawal symptomsClinical trialsPharmacological factorsStudy qualityTherapeutic windowTherapeutic benefitUse disordersHuman studiesAbuse liabilityEfficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial
Dwyer J, Landeros-Weisenberger A, Johnson J, Londono Tobon A, Flores J, Nasir M, Couloures K, Sanacora G, Bloch M. Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial. FOCUS The Journal Of Lifelong Learning In Psychiatry 2022, 20: 241-251. PMID: 37153136, PMCID: PMC10153503, DOI: 10.1176/appi.focus.22020004.Peer-Reviewed Original ResearchTreatment-resistant depressionDepression Rating ScaleIntravenous ketamineClinical trialsAdolescent treatment-resistant depressionAdult treatment-resistant depressionPlacebo-controlled clinical trialSignificant short-term efficacySerious adverse eventsPrimary outcome measureSingle intravenous infusionChildren's Depression Rating ScaleCrossover clinical trialShort-term efficacyMajor depressive disorderSingle ketamine infusionSymptoms 24 hoursLater time pointsKetamine’s safetyAdverse eventsAntidepressant medicationKetamine infusionPediatric populationSignificant morbidityIntravenous infusionShort- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia in Children
Williams DJ, Creech CB, Walter EB, Martin JM, Gerber JS, Newland JG, Howard L, Hofto ME, Staat MA, Oler RE, Tuyishimire B, Conrad TM, Lee MS, Ghazaryan V, Pettigrew MM, Fowler VG, Chambers HF, Zaoutis TE, Evans S, Huskins WC, Team A. Short- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia in Children. JAMA Pediatrics 2022, 176: 253-261. PMID: 35040920, PMCID: PMC8767493, DOI: 10.1001/jamapediatrics.2021.5547.Peer-Reviewed Original ResearchConceptsChildhood community-acquired pneumoniaAntibiotic-associated adverse effectsShort-course strategyClinical responseAdverse effectsDouble-blind placebo-controlled clinical trialPlacebo-controlled clinical trialEnd pointDays of antibioticsEarly clinical improvementInadequate clinical responseOutpatient antibiotic therapyShorter antibiotic durationsSimilar clinical responseCommunity-Acquired PneumoniaPrimary end pointComposite end pointResolution of symptomsAntibiotic treatment strategiesSubset of childrenAntibiotic daysAntibiotic durationClinical improvementAntibiotic therapyInitial treatment
2021
Change in impulsivity is prospectively associated with treatment outcomes for binge-eating disorder
Boswell RG, Gueorguieva R, Grilo CM. Change in impulsivity is prospectively associated with treatment outcomes for binge-eating disorder. Psychological Medicine 2021, 53: 2789-2797. PMID: 34812713, PMCID: PMC9124732, DOI: 10.1017/s003329172100475x.Peer-Reviewed Original ResearchConceptsEating-disorder psychopathologyCognitive behavioral therapyTreatment outcomesDepression scoresPharmacological treatmentRandomized placebo-controlled clinical trialPlacebo-controlled clinical trialEfficacy of CBTBinge-eating disorderBaseline impulsivityAssociation of rapidClinical trialsTreatment groupsOverall changeDisorder psychopathologyMixed effects modelsOutcomesTreatmentBMIPatientsMeasures of impulsivityScoresPsychopathologyGeneral outcomeImpulsivityLow-Dose Augmentation With Buprenorphine for Treatment-Resistant Depression: A Multisite Randomized Controlled Trial With Multimodal Assessment of Target Engagement
Lee H, Blumberger D, Lenze E, Anderson S, Barch D, Black K, Cristancho P, Daskalakis Z, Eisenstein S, Huang Y, Li S, Lissemore J, McConathy J, Mulsant B, Rajji T, Reynolds C, Su Y, Tu Z, Voineskos D, Karp J. Low-Dose Augmentation With Buprenorphine for Treatment-Resistant Depression: A Multisite Randomized Controlled Trial With Multimodal Assessment of Target Engagement. Biological Psychiatry Global Open Science 2021, 2: 127-135. PMID: 36325158, PMCID: PMC9616305, DOI: 10.1016/j.bpsgos.2021.09.003.Peer-Reviewed Original ResearchTranscranial magnetic stimulation measuresTreatment-resistant depressionPositron emission tomographyFunctional magnetic resonanceTarget engagementClinical trialsCortical transmissionMontgomery-Åsberg Depression Rating ScalePlacebo-controlled clinical trialEmission tomographyLow-dose augmentationVenlafaxine extended releasePrimary outcome measureBlood oxygen level-dependent (BOLD) responseMajor depressive episodeDepression Rating ScaleExperimental therapeutic approachesYears of ageMultimodal assessmentLevel-dependent responsesMonetary incentive delay taskBrain positron emission tomographyPlacebo groupIncentive delay taskClinical effectsDesign of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016
Krystal JH, Chow B, Vessicchio J, Henrie AM, Neylan TC, Krystal AD, Marx BP, Xu K, Jindal RD, Davis LL, Schnurr PP, Stein MB, Thase ME, Ventura B, Huang GD, Shih MC, Team T. Design of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016. Contemporary Clinical Trials 2021, 109: 106540. PMID: 34416369, DOI: 10.1016/j.cct.2021.106540.Peer-Reviewed Original ResearchConceptsCooperative Studies ProgramInsomnia medicationsMedical CenterRandomized placebo-controlled clinical trialPlacebo-controlled clinical trialVeterans Affairs Medical CenterVA Cooperative Studies ProgramPrimary outcome measureVA Medical CenterInsomnia Severity IndexAdaptive trialsPosttraumatic stress disorderFuture biomarker developmentStudy armsBiochemical predictorsEffective pharmacotherapyClinical trialsOutcome measuresTreatment responseInterim analysisRecruitment targetInsomniaPhone contactStress disorderBiomarker developmentThe Pharmacology of Buprenorphine Microinduction for Opioid Use Disorder
De Aquino JP, Parida S, Sofuoglu M. The Pharmacology of Buprenorphine Microinduction for Opioid Use Disorder. Clinical Drug Investigation 2021, 41: 425-436. PMID: 33818748, PMCID: PMC8020374, DOI: 10.1007/s40261-021-01032-7.Peer-Reviewed Original ResearchConceptsUnique pharmacological profileOpioid use disorderOpioid withdrawalPotential dose-dependent effectsPlacebo-controlled clinical trialLong-term treatment outcomesFull opioid agonistsStandard induction regimensOpen-label studyFirst-line pharmacotherapySchedule of administrationMu-opioid receptorsAvailability of buprenorphineDose-dependent effectFuture translational researchInduction regimensOpioid taperOpioid toneFirst doseClinical outcomesClinical evidenceOpioid agonistsBuprenorphine formulationsDaily dosesClinical trialsThe effect of berberine adjunctive treatment on glycolipid metabolism in patients with schizophrenia: A randomized, double-blind, placebo-controlled clinical trial
Li M, Liu Y, Qiu Y, Zhang J, Zhang Y, Zhao Y, Jia Q, Li J. The effect of berberine adjunctive treatment on glycolipid metabolism in patients with schizophrenia: A randomized, double-blind, placebo-controlled clinical trial. Psychiatry Research 2021, 300: 113899. PMID: 33812218, DOI: 10.1016/j.psychres.2021.113899.Peer-Reviewed Original ResearchConceptsAdjunctive treatmentNon-psychiatric patientsDouble-blindSerum prolactin concentrationsPlacebo-controlled clinical trialSchizophreniaMetabolic disturbancesGlycolipid metabolic parametersBaseline body mass indexImprove metabolic disturbancesLow-density lipoprotein cholesterolProlactin concentrationsSixty-five patientsFasting serum insulinWeek 8Body mass indexEffects of berberineLipoprotein cholesterolMass indexPlaceboWeek 4Previous studiesClinical trialsMetabolic parametersTotal cholesterolTandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias
Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Advances 2021, 5: 1535-1539. PMID: 33683337, PMCID: PMC7948269, DOI: 10.1182/bloodadvances.2020003880.Peer-Reviewed Original ResearchConceptsHigh-dose influenza vaccinationPlasma cell dyscrasiaInfluenza vaccinationProtective immunityCell dyscrasiaPCD patientsPlacebo-controlled clinical trialHigh-dose vaccinationHigh-dose vaccineInfluenza-specific immunityBurden of influenzaSaline placebo injectionsAge-based vaccinationHigher seroprotectionSerologic immunityPlacebo injectionsVaccine strategiesTiter responseClinical trialsFlu seasonPatientsVaccinationImmunityNovel coronavirusSeroprotectionEfficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial
Dwyer JB, Landeros-Weisenberger A, Johnson JA, Londono Tobon A, Flores JM, Nasir M, Couloures K, Sanacora G, Bloch MH. Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial. American Journal Of Psychiatry 2021, 178: 352-362. PMID: 33653121, DOI: 10.1176/appi.ajp.2020.20010018.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionDepression Rating ScaleIntravenous ketamineClinical trialsAdolescent treatment-resistant depressionAdult treatment-resistant depressionPlacebo-controlled clinical trialSignificant short-term efficacySerious adverse eventsPrimary outcome measureSingle intravenous infusionChildren's Depression Rating ScaleCrossover clinical trialShort-term efficacyMajor depressive disorderSingle ketamine infusionSymptoms 24 hoursLater time pointsKetamine’s safetyAdverse eventsAntidepressant medicationKetamine infusionPediatric populationSignificant morbidityIntravenous infusionAnti-seizure medications and efficacy against focal to bilateral tonic-clonic seizures: A systematic review with relevance for SUDEP prevention
Cutillo G, Tolba H, Hirsch LJ. Anti-seizure medications and efficacy against focal to bilateral tonic-clonic seizures: A systematic review with relevance for SUDEP prevention. Epilepsy & Behavior 2021, 117: 107815. PMID: 33640562, DOI: 10.1016/j.yebeh.2021.107815.Peer-Reviewed Original ResearchConceptsAnti-seizure medicationsBilateral tonic-clonic seizuresTonic-clonic seizuresSUDEP preventionSystematic reviewPlacebo-controlled clinical trialFocal impaired awareness seizuresRisk of SUDEPSudden unexpected deathMajor risk factorAwareness seizuresRisk factorsClinical trialsUnexpected deathFBTCSHigh dosesSeizuresStrong associationSUDEPPreventionMedicationsTiagabineEfficacyLamotrigineBrivaracetam
2020
Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
Paidas MJ, Tita ATN, Macones GA, Saade GA, Ehrenkranz RA, Triche EW, Streisand JB, Lam GK, Magann EF, Lewis DF, Dombrowski MP, Werner EF, Branch DW, Habli MA, Grotegut CA, Silver RM, Longo SA, Amon E, Cleary K, How HY, Novotny SR, Grobman WA, Whiteman VE, Wing DA, Scifres CM, Sibai BM. Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia. American Journal Of Obstetrics And Gynecology 2020, 223: 739.e1-739.e13. PMID: 32780999, DOI: 10.1016/j.ajog.2020.08.004.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntravenousAdolescentAdultAntithrombin ProteinsCesarean SectionDelivery, ObstetricDouble-Blind MethodFemaleFetal DistressGestational AgeHumansInfant, Premature, DiseasesInfant, Small for Gestational AgeMiddle AgedNeonatal SepsisPerinatal MortalityPre-EclampsiaPregnancyPregnancy Trimester, SecondPregnancy Trimester, ThirdProspective StudiesRecombinant ProteinsYoung AdultConceptsRecombinant human antithrombinPreterm preeclampsiaExpectant managementMorbidity scoreHuman antithrombinPlacebo-controlled clinical trialPlacebo-controlled evaluationPlacebo-controlled trialMedian gestational ageMaternal complicationsVersus PlaceboFetal outcomesMaternal outcomesPreterm deliveryEndothelial dysfunctionSecondary outcomesSingleton pregnanciesStandard therapyLoading dosePrimary outcomeWeeks' gestationGestational ageContinuous infusionClinical trialsSaline infusion
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