Search results for " randomized controlled trials"

showing 10 items of 36 documents

Efficacy and safety of human papillomavirus vaccination in HIV-infected patients: a systematic review and meta-analysis

2021

AbstractThe prophylactic vaccines available to protect against infections by HPV are well tolerated and highly immunogenic. People with HIV have a higher risk of developing HPV infection and HPV-associated cancers due to a lower immune response, and due to viral interactions. We performed a systematic review of RCTs to assess HPV vaccines efficacy and safety on HIV-infected people compared to placebo or no intervention in terms of seroconversion, infections, neoplasms, adverse events, CD4+ T-cell count and HIV viral load. The vaccine-group showed a seroconversion rate close to 100% for each vaccine and a significantly higher level of antibodies against HPV vaccine types, as compared to the …

0301 basic medicineCD4-Positive T-LymphocytesMaleDisease preventionHIV InfectionsAdolescent Adult Antibodies Viral CD4 Lymphocyte Count CD4-Positive T-Lymphocytes Female HIV Infections Humans Male Papillomavirus Infections Papillomavirus Vaccines Public Health Randomized Controlled Trials as Topic Risk Treatment Outcome Viral Load Virus Shedding Young Adult Patient SafetySettore MED/42 - Igiene Generale E ApplicataAntibodies Viral0302 clinical medicine030212 general & internal medicineViralRandomized Controlled Trials as TopicPublic healthMultidisciplinaryQHPV infectionRViral LoadAdolescent; Adult; Antibodies Viral; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; Female; HIV Infections; Humans; Male; Papillomavirus Infections; Papillomavirus Vaccines; Public Health; Randomized Controlled Trials as Topic; Risk; Treatment Outcome; Viral Load; Virus Shedding; Young Adult; Patient SafetyVirus SheddingTreatment OutcomeMedicineFemalePublic HealthPatient SafetyViral loadAdultRiskmedicine.medical_specialtyAdolescentScienceHPV vaccinesPlaceboAntibodiesArticle03 medical and health sciencesPapillomavirus VaccinesYoung AdultInternal medicinemedicineHumansPapillomavirus VaccinesSeroconversionViral sheddingAdverse effectbusiness.industryPapillomavirus InfectionsHealth caremedicine.diseaseCD4 Lymphocyte Count030104 developmental biologybusinessScientific Reports
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Frequency and prognostic impact of ALK amplifications and mutations in the European Neuroblastoma Study Group (SIOPEN) high-risk neuroblastoma trial …

2021

Purpose: In neuroblastoma (NB), the ALK receptor tyrosine kinase can be constitutively activated through activating point mutations or genomic amplification. We studied ALK genetic alterations in high-risk (HR) patients on the HR-NBL1/SIOPEN trial to determine their frequency, correlation with clinical parameters, and prognostic impact. Materials and methods: Diagnostic tumor samples were available from 1,092 HR-NBL1/SIOPEN patients to determine ALK amplification status (n = 330), ALK mutational profile (n = 191), or both (n = 571). Results: Genomic ALK amplification (ALKa) was detected in 4.5% of cases (41 out of 901), all except one with MYCN amplification (MNA). ALKa was associated with …

0301 basic medicineCancer ResearchPrognostic ImpactAnaplastic Lymphoma Kinase/genetics; Child Preschool; Clinical Trials Phase III as Topic; Europe; Female; Follow-Up Studies; Gene Amplification; Humans; Infant; Male; Mutation Rate; N-Myc Proto-Oncogene Protein/genetics; Neuroblastoma/genetics; Prognosis; Randomized Controlled Trials as Topic; Risk Factors; Survival RateEuropean Neuroblastoma Study GroupSIOPENRELAPSE03 medical and health sciencesNeuroblastoma0302 clinical medicineText miningNeuroblastomahemic and lymphatic diseasesREVEALSMedicine and Health SciencesKINASEMedicineHigh risk neuroblastomaHETEROGENEITYCRIZOTINIBSEGMENTAL CHROMOSOMAL ALTERATIONSACTIVATING MUTATIONSPEDIATRIC-PATIENTSbusiness.industryALK receptor tyrosine kinasePoint mutationREARRANGEMENTSCHEMOTHERAPYmedicine.diseaseDoenças Genéticas030104 developmental biologyALKOncology030220 oncology & carcinogenesisCancer researchbusiness
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Fruit and vegetable consumption and health outcomes: an umbrella review of observational studies

2019

The aim of this study was to provide a comprehensive evaluation of current evidence on fruit and vegetable consumption and health outcomes. A systematic search for quantitative syntheses was performed. Several criteria, including study design, dose-response relationship, heterogeneity and agreement of results over time, and identification of potential confounding factors, were used to assess the level of evidence. The strongest (probable) evidence was found for cardiovascular disease protection; possible evidence for decreased risk of colon cancer, depression and pancreatic diseases was found for fruit intake; and colon and rectal cancer, hip fracture, stroke, depression and pancreatic dise…

0301 basic medicineDatabases FactualColorectal cancerHealth BehaviorDiseasemeta-analysiCOLORECTAL-CANCER0302 clinical medicineRisk FactorsVegetablesMedicinevegetableSettore MED/49 - Scienze Tecniche Dietetiche ApplicateDepression (differential diagnoses)Randomized Controlled Trials as TopicMOLECULAR-MECHANISMSDepressionCOLON-CANCERConfoundingcohort study; evidence; Fruit; meta-analysis; umbrella review; vegetable; Food Sciencecohort study; evidence; Fruit; meta-analysis; umbrella review; vegetable; Cardiovascular Diseases; Colonic Neoplasms; Databases Factual; Depression; Diet Healthy; Health Behavior; Humans; Observational Studies as Topic; Pancreatic Diseases; Randomized Controlled Trials as Topic; Risk Factors; Fruit; VegetablesObservational Studies as TopicCardiovascular DiseasesMeta-analysisColonic NeoplasmsDiet HealthyCohort studyCANCER-RISKBLADDER-CANCER030209 endocrinology & metabolismDIETARY POLYPHENOLSDatabases03 medical and health sciencesLUNG-CANCEREnvironmental healthcohort studyHumansCORONARY-HEART-DISEASEFactualHealthy030109 nutrition & dieteticsumbrella reviewbusiness.industryevidencePancreatic DiseasesEvidence-based medicinemedicine.diseaseDietmeta-analysisFruitObservational studyDOSE-RESPONSE METAANALYSISbusinessGASTRIC-CANCERFood Science
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Therapeutic strategies for severe COVID-19: a position paper from the Italian Society of Infectious and Tropical Diseases (SIMIT)

2021

Abstract Scope Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become pandemic, reaching almost one million death worldwide. At present standard treatment for coronavirus disease 2019 (COVID-19) is not well defined because the evidence, either from randomized or observational studies, with conflicting results, has led to rapid changes in treatment guidelines. Our aim was to narratively summarize the available literature on the management of COVID-19 in order to combine current evidence and interpretation of the data by experts who are treating patients in the frontline setting. Methods The panel conducted a detailed review of the literature and eventual press rele…

0301 basic medicineMicrobiology (medical)medicine.medical_specialtyCoronavirus disease 2019 (COVID-19)030106 microbiologyCoronavirupractice guidelines as topiccoronavirusrandomized controlled trials as topicGuidelinesmedicine.disease_causemedicallaw.invention03 medical and health sciences0302 clinical medicinesocietiesRandomized controlled triallawPandemicitalymedicinepneumonia030212 general & internal medicineIntensive care medicinehumansSocieties MedicalCoronavirustherapySARS-CoV-2business.industryCOVID-19; Coronavirus; Pneumonia; SARS-CoV-2; TherapyStandard treatmentCOVID-19PneumoniaGeneral Medicinecovid-19; coronavirus; pneumonia; sars-cov-2; therapy; covid-19; humans; italy; randomized controlled trials as topic; sars-cov-2; societies medical; standard of care; practice guidelines as topicCOVID-19 Drug TreatmentCoronavirusClinical trialsars-cov-2Infectious Diseasescovid-19standard of carePosition paperObservational studyTherapyCoronavirus; COVID-19; Pneumonia; SARS-CoV-2; TherapybusinessHuman
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Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical…

2022

BACKGROUND: High intraoperative PEEP with recruitment manoeuvres may improve perioperative outcomes. We re-examined this question by conducting a patient-level meta-analysis of three clinical trials in adult patients at increased risk for postoperative pulmonary complications who underwent non-cardiothoracic and non-neurological surgery. METHODS: The three trials enrolled patients at 128 hospitals in 24 countries from February 2011 to February 2018. All patients received volume-controlled ventilation with low tidal volume. Analyses were performed using one-stage, two-level, mixed modelling (site as a random effect; trial as a fixed effect). The primary outcome was a composite of postoperati…

AdultLung Diseases*PEEP*postoperative pulmonary complicationsmechanical ventilationPositive-Pressure RespirationsurgeryAnesthesiology and Pain MedicinePostoperative ComplicationsTidal Volume*surgeryHumanspostoperative pulmonary complicationsPostoperative Period*mechanical ventilationmechanical ventilation; PEEP; postoperative pulmonary complications; surgery; Adult; Humans; Lung; Postoperative Complications; Postoperative Period; Randomized Controlled Trials as Topic; Tidal Volume; Lung Diseases; Positive-Pressure RespirationLungPEEPRandomized Controlled Trials as Topic
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"Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxa…

2010

BACKGROUND: No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. METHODS: We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = …

AdultMalemedicine.medical_specialtyMultivariate analysisColorectal cancerSettore MED/06 - Oncologia MedicaKaplan-Meier EstimateGastroenterologyDisease-Free SurvivalCapecitabineTreatment Outcome; Prognosis; Aged 80 and over; Male; Retrospective Studies; Randomized Controlled Trials as Topic; Middle Aged; Kaplan-Meier Estimate; Colorectal Neoplasms; Female; Disease-Free Survival; Humans; Quality of Life; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials Phase III as Topic; Aged; Adult; Health Status Indicators; Multicenter Studies as TopicFolinic acidQuality of lifeInternal medicineAntineoplastic Combined Chemotherapy Protocols80 and overmedicineOverall survivalHealth Status IndicatorsHumansMulticenter Studies as TopicClinical TrialsRadiology Nuclear Medicine and imagingneoplasmsmetastatic colorectal canceroxaliplatin physical functioning statusAgedRandomized Controlled Trials as TopicRetrospective StudiesAged 80 and overbusiness.industryHematologyGeneral MedicineMiddle AgedPrognosismedicine.diseaseSurgeryOxaliplatinPhase III as TopicTreatment OutcomeClinical Trials Phase III as TopicOncologyQuartileQuality of LifeFemaleColorectal Neoplasmsbusinessmedicine.drug
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Evidence of bias in randomized clinical trials of hepatitis C interferon therapies

2017

Introduction: Bias may occur in randomized clinical trials in favor of the new experimental treatment because of unblinded assessment of subjective endpoints or wish bias. Using results from published trials, we analyzed and compared the treatment effect of hepatitis C antiviral interferon therapies experimental or control. Methods: Meta-regression of trials enrolling naïve hepatitis C virus patients that underwent four therapies including interferon alone or plus ribavirin during past years. The outcome measure was the sustained response evaluated by transaminases and/or hepatitis C virus-RNA serum load. Data on the outcome across therapies were collected according to the assigned arm (exp…

Adultmedicine.medical_specialtyAlternative medicineAntiviral Agentslaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled trialBiaslawInterferonInternal medicinemedicineHumans030212 general & internal medicineSettore SECS-S/05 - Statistica SocialeRandomized Controlled Trials as TopicPharmacologyObserver Variationbusiness.industryGeneral MedicineHepatitis CMiddle Agedmedicine.diseaseHepatitis Cinterferon randomized controlled trials bias trial design favore armTreatment OutcomeResearch Design030220 oncology & carcinogenesisCase-Control StudiesPhysical therapyInterferonsbusinessmedicine.drug
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Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients

2016

Background Invasive fungal infections are important causes of morbidity and mortality among critically ill patients. Early institution of antifungal therapy is pivotal for mortality reduction. Starting a targeted antifungal therapy after culture positivity and fungi identification requires a long time. Therefore, alternative strategies (globally defined as 'untargeted antifungal treatments') for antifungal therapy institution in patients without proven microbiological evidence of fungal infections have been discussed by international guidelines. This review was originally published in 2006 and updated in 2016. This updated review provides additional evidence for the clinician dealing with s…

Adultmedicine.medical_specialtyAntifungal drugMycoseintensive care medicinelaw.invention03 medical and health sciencesImmunocompromised Hostcritically ill patient0302 clinical medicineRandomized controlled triallawInternal medicineAmphotericin BmedicineHumansAntifungal AgentPharmacology (medical)030212 general & internal medicineMED/41 - ANESTESIOLOGIAIntensive care medicineFluconazoleFluconazole [therapeutic use]Randomized Controlled Trials as Topicbusiness.industryfungal infectionMicafungin030208 emergency & critical care medicinePublication biasMycoses [mortalityClinical trialCritical Illness [mortality]; Amphotericin B [therapeutic use]; Antifungal Agents [therapeutic use]; Fluconazole [therapeutic use]; Immunocompromised Host; Mycoses [mortality; prevention & control]; Randomized Controlled Trials as Topic; Adult; HumansAntifungal Agents [therapeutic use]prevention & control]Relative riskMeta-analysisAmphotericin B [therapeutic use]AnidulafunginCritical IllneCritical Illness [mortality]businessmedicine.drugHuman
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Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: A systematic review and meta-analysis

2020

Background Bempedoic acid is a first-in-class lipid-lowering drug recommended by guidelines for the treatment of hypercholesterolemia. Our objective was to estimate its average effect on plasma lipids in humans and its safety profile. Methods and findings We carried out a systematic review and meta-analysis of phase II and III randomized controlled trials on bempedoic acid (PROSPERO: CRD42019129687). PubMed (Medline), Scopus, Google Scholar, and Web of Science databases were searched, with no language restriction, from inception to 5 August 2019. We included 10 RCTs (n = 3,788) comprising 26 arms (active arm [n = 2,460]; control arm [n = 1,328]). Effect sizes for changes in lipids and high-…

Apolipoprotein BPublication Ethics030204 cardiovascular system & hematologyCardiovascularGastroenterologyLipoprotein particleMedical and Health SciencesBiochemistrychemistry.chemical_compoundDatabase and Informatics Methods0302 clinical medicineMathematical and Statistical TechniquesAnticholesteremic Agents Apolipoproteins B Cholesterol Cholesterol LDL Clinical Trials Phase II as Topic Clinical Trials Phase III as Topic Dicarboxylic Acids Fatty Acids Humans Hypercholesterolemia Peptide Fragments Randomized Controlled Trials as TopicLipid and Blood Pressure Meta-Analysis Collaboration (LBPMC) Group and the International Lipid Expert PanelMedicine and Health SciencesDicarboxylic Acids030212 general & internal medicineDatabase SearchingResearch IntegrityRandomized Controlled Trials as Topicmedicine.diagnostic_testbiologyAnticholesteremic AgentsStatisticsFatty AcidsRDrugsGeneral MedicineMetaanalysisSerious Mental IllnessLipidsPhase III as TopicMental HealthCholesterolPhysical SciencesMedicineResearch Articlemedicine.medical_specialtyRMScience PolicyLipoproteinsHypercholesterolemiaBempedoic acid hypercholesterolemia lipid profile hsCRPResearch and Analysis MethodsLDL03 medical and health sciencesClinical Trials Phase II as TopicInternal medicineGeneral & Internal MedicinemedicineHumansClinical TrialsStatistical MethodsApolipoproteins BPharmacologyPlasma Proteinsbusiness.industryCholesterolPhase II as TopicStatinsBiology and Life SciencesProteinsOdds ratioCholesterol LDLConfidence intervalPeptide FragmentschemistryClinical Trials Phase III as Topicbiology.proteinUric acidCreatine kinaseLipid profilebusinessDigestive DiseasesMathematicsPLoS Medicine
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Metabolic effect of berberine-silymarin association: A meta-analysis of randomized, double-blind, placebo-controlled clinical trials.

2019

The aim of this study is to assess the impact of a combination of berberine and silymarin on serum lipids and fasting plasma glucose (FPG) through a systematic review of literature and meta-analysis of the available randomized, double-blind, placebo-controlled clinical trials (RCTs). A systematic literature search in SCOPUS, PubMed-Medline, ISI Web of Science, and Google Scholar databases was conducted up to October 2, 2018, in order to identify RCTs assessing changes in plasma concentrations of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and FPG during treatment with berberine and silymarin in combina…

Blood Glucosemedicine.medical_specialtysilymarinReviewsBlood lipidsberberine; cholesterol; fasting plasma glucose; meta-analysis; nutraceutical; silymarin; Berberine; Blood Glucose; Double-Blind Method; Fasting; Humans; Lipids; Randomized Controlled Trials as Topic; SilymarinReviewPlaceboGastroenterologymeta-analysiDouble blind03 medical and health scienceschemistry.chemical_compound0302 clinical medicineBerberineDouble-Blind MethodInternal medicineberberineMedicineHumansfasting plasma glucoseRandomized Controlled Trials as TopicPharmacology0303 health sciencesbusiness.industryCholesterolData synthesis030302 biochemistry & molecular biologycholesterolFastingLipidsClinical trialmeta-analysischemistrymeta‐analysis030220 oncology & carcinogenesisMetabolic effectsMeta-analysisnutraceuticalCardiology and Cardiovascular Medicinebusiness
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