Search results for "Phase 3"

showing 6 items of 6 documents

Effect on quality of life of cisplatin added to single-agent chemotherapy as first-line treatment for elderly patients with advanced non-small cell l…

2019

Abstract Objectives To evaluate the effect on quality of life (QOL) of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC) enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods Advanced NSCLC pts, >70 years old, performance status (PS) 0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional ana…

0301 basic medicinePulmonary and Respiratory MedicineQuality of lifeMaleCancer Researchmedicine.medical_specialtyLung NeoplasmsNauseamedicine.medical_treatmentRandomizedNSCLCPhase 303 medical and health sciences0302 clinical medicineQuality of lifeInternal medicineSurveys and QuestionnairesCarcinoma Non-Small-Cell LungAntineoplastic Combined Chemotherapy ProtocolsmedicineHumansSurveys and QuestionnaireLung cancerAgedNeoplasm StagingCisplatinAged 80 and overChemotherapyAntineoplastic Combined Chemotherapy ProtocolPerformance statusbusiness.industryAlopeciamedicine.diseaseDysphagiaLung Neoplasm030104 developmental biologyTreatment OutcomeOncology030220 oncology & carcinogenesisVomitingStomatitis AphthousFemalemedicine.symptomCisplatinbusinessElderly patientStomatitis Aphthoumedicine.drugHuman
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Biomarker analysis of the MITO2 phase III trial of first-line treatment in ovarian cancer: Predictive value of DNA-PK and phosphorylated ACC

2016

// Francesco Perrone 1,* , Gustavo Baldassarre 2,* , Stefano Indraccolo 3,* , Simona Signoriello 4 , Gennaro Chiappetta 1 , Franca Esposito 5 , Gabriella Ferrandina 6 , Renato Franco 1,15 , Delia Mezzanzanica 7 , Maura Sonego 2 , Elisabetta Zulato 3 , Gian F. Zannoni 6 , Vincenzo Canzonieri 2 , Giovanni Scambia 6 , Roberto Sorio 2 , Antonella Savarese 8 , Enrico Breda 9 , Paolo Scollo 10 , Antonella Ferro 11 , Stefano Tamberi 12 , Antonio Febbraro 13 , Donato Natale 14 , Massimo Di Maio 1,16 , Daniela Califano 1 , Giosue  Scognamiglio 1 , Domenica Lorusso 7 , Silvana Canevari 7 , Simona Losito 1 , Ciro Gallo 4,** and Sandro Pignata 1,** 1 Istituto Nazionale per lo Studio e la Cura dei Tumor…

0301 basic medicinemedicine.medical_specialtyLiposomal Doxorubicinovarian cancer; phase 3 clinical trial; predictive factors; pACC; DNA-PKDNA-Activated Protein KinaseDisease-Free Survivalpredictive factorDNA-PK03 medical and health scienceschemistry.chemical_compound0302 clinical medicineOvarian cancerPhase 3 clinical trialAntineoplastic Combined Chemotherapy ProtocolsOverall survivalMedicineHumansDNA-PK; ovarian cancer; pACC; phase 3 clinical trial; predictive factorsGynecologyOvarian NeoplasmsAdvanced ovarian cancerphase 3 clinical trialbusiness.industrySignificant differenceDNA-PK; Ovarian cancer; PACC; Phase 3 clinical trial; Predictive factors; Antineoplastic Combined Chemotherapy Protocols; DNA-Activated Protein Kinase; Disease-Free Survival; Female; Humans; Ovarian Neoplasms; Prognosismedicine.diseasePrognosisPredictive valuePACCCarboplatinhumanitiesFirst line treatmentovarian cancer030104 developmental biologyOncologychemistry030220 oncology & carcinogenesisFemalebusinessOvarian cancerPredictive factorsResearch PaperpACC
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Type I interferons as the potential mechanism linking mRNA COVID-19 vaccines to Bell's palsy

2021

Therapies - Sous presse. Epreuves corrigees par l'auteur. Disponible en ligne depuis le mardi 13 avril 2021

AdultMale2019-20 coronavirus outbreakCoronavirus disease 2019 (COVID-19)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)COVID-19 vaccines030226 pharmacology & pharmacyArticle03 medical and health sciencesPharmacovigilance0302 clinical medicineBell's palsyPhase 3 clinical trialsBell PalsymedicineType I interferonsHumansBell's palsyPharmacology (medical)Potential mechanismComputingMilieux_MISCELLANEOUSAgedCOVID-19 coronavirus disease 2019Vaccines SyntheticMessenger RNASARS-CoV-2business.industryCOVID-19Bell’s palsyMiddle Agedmedicine.diseaseVirologymRNA messenger RNA3. Good healthInterferon Type IFemale[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologiebusiness
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Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone.

2014

Aim The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and pioglitazone. Methods In this randomized, double-blind, phase 3 study, patients (N = 342) received canagliflozin 100 or 300 mg during a 26-week, placebo-controlled, core period and a 26-week, active-controlled extension in which placebo-treated patients were switched to sitagliptin 100 mg. Efficacy comparisons for canagliflozin versus placebo at week 26 are reported, with no comparisons versus sitagliptin at week 52 (sitagliptin used to maintain double-blind and control for safety). Safety data ar…

Blood GlucoseMaleendocrine system diseasesEndocrinology Diabetes and Metabolismphase 3 studyBlood PressureType 2 diabetesPharmacologyEndocrinologyGlucosidesWeight lossCanagliflozinCandidiasisSGLT2 inhibitorMiddle AgedDiuretics OsmoticLipidsMetforminMetforminTreatment OutcomePyrazinesDrug Therapy CombinationFemaletype 2 diabetesmedicine.symptomSGLT2 InhibitorGenital Diseases Malemedicine.drugmedicine.medical_specialtyUrologyThiophenesDouble-Blind MethodWeight LossInternal MedicinemedicineHumansHypoglycemic AgentsCanagliflozinthiazolidinedionesPioglitazonebusiness.industrySitagliptin Phosphatenutritional and metabolic diseasesType 2 Diabetes MellitusOriginal ArticlesTriazolesmedicine.diseaseBlood pressureDiabetes Mellitus Type 2businessPioglitazoneGenital Diseases FemaleDiabetes, obesitymetabolism
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The diagnosis and management of gastric cancer: Expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, B…

2011

Well-recognized experts in the field of gastric cancer discussed during the 12th European Society Medical Oncology (ESMO)/World Congress Gastrointestinal Cancer (WCGIC) in Barcelona many important and controversial topics on the diagnosis and management of patients with gastric cancer. This article summarizes the recommendations and expert opinion on gastric cancer. It discusses and reflects on the regional differences in the incidence and care of gastric cancer, the definition of gastro-esophageal junction and its implication for treatment strategies and presents the latest recommendations in the staging and treatment of primary and metastatic gastric cancer. Recognition is given to the ne…

Continuous infusionComputer assisted radiotherapyFolic acidFluorodeoxyglucose f 18Gimeracil plus oteracil potassium plus tegafurInfection controlIntensity modulated radiation therapyDocetaxelCancer stagingMetastatic gastric cancerRisk FactorsPrevalenceDrug fatalityOverall survivalNeoplasm MetastasisPriority journalddc:616Conference paperdigestive oral and skin physiologyFolinic acidHematologyPrognosisOxaliplatinNuclear magnetic resonance imagingBevacizumabSurvival RateOncologyCyanocobalaminPractice Guidelines as TopicDrug dose reductionFluorouracilEsophageal adenocarcinomaHumanPositron emission tomographymedicine.medical_specialtyNeutropeniaStomach cancerStomach neoplasmsMEDLINESide effectStomach adenocarcinomaPatient careIrinotecanHelicobacter infectionPrimary tumorEndoscopic echographyAdvanced cancerEndoscopic mucosal resectionComputer assisted tomographyStomach Neoplasms/*diagnosis/pathology/*therapymedicineHumansGenetic Predisposition to DiseaseGastrointestinal cancerPhase 3 clinical trial (topic)Intensive care medicineSurvival ratePlaceboCapecitabineEpirubicinCa 19-9 antigenStomach Neoplasms/diagnosis/pathology/therapyHelicobacter pyloribusiness.industryCancerTrastuzumabCardiovascular riskmedicine.diseaseCancer susceptibilitydigestive system diseasesSurgeryClinical trialMetastasis potentialExpert opinionMeta analysis (topic)Cancer adjuvant therapyCarcinoembryonic antigenLower esophagus sphincterCisplatinCaloric intakebusinessCancer incidenceRegional differencesAnnals of Oncology
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SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study

2021

Abstract Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18–49, 50–69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in su…

MaleCOVID-19 Vaccinesafe surgery; vaccination modelling; COVID-19Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]MULTICENTERComorbidity030230 surgery0302 clinical medicinephase 3 clinical trial (topic)Case fatality rateProspective StudiesSARS-CoV-2 Vaccination Safe surgeryCOVID-19/epidemiologySARS-CoV-2 ; vaccination ; safe surgeryeducation.field_of_studycase fatality rateVaccinationVaccinationAdolescent; Adult; Aged; COVID-19; COVID-19 Vaccines; Comorbidity; Elective Surgical Procedures; Female; Humans; Male; Middle Aged; Postoperative Complications; Preoperative Period; Prospective Studies; SARS-CoV-2; Vaccination; Young Adulthealth care policyElective Surgical Procedures030220 oncology & carcinogenesisvaccination modellingPreoperative PeriodCOVID-19; SARS-CoV-2; cancer; vaccination; outcome; mortality; infection; modellingCohort studyprospective studyHumanmedicine.medical_specialtyArticle03 medical and health sciencesSARS-CoV-2 vaccinationSDG 3 - Good Health and Well-beingCOVID-19 Vaccines/pharmacologyHumansVaccination/methodsElective surgeryeducationAgedScience & TechnologyElective Surgical Procedureadult; aged; Article; cancer grading; cancer surgery; case fatality rate; computer assisted tomography; elective surgery; female; follow up; health care policy; human; incidence; infection rate; infection risk; major clinical study; male; middle aged; mortality; outcome assessment; phase 3 clinical trial (topic); preoperative care; prospective study; sensitivity analysis; seroprevalence; Severe acute respiratory syndrome coronavirus 2; vaccination; young adult; COVID-19; COVID-19 Vaccines; Comorbidity; Elective Surgical Procedures; Postoperative Complications; Preoperative Period; SARS-CoV-2; Vaccination; surgery.Cura preoperatòriamajor clinical studymortalityinfectionProspective StudieincidenceSurgeryHuman medicinePostoperative Complication610 Medizin und GesundheitAcademicSubjects/MED00910Settore MED/18 - CHIRURGIA GENERALESettore MED/29 - CHIRURGIA MAXILLOFACCIALEcomputer assisted tomographyESTUDOS PROSPECTIVOSsurgerysafe surgeryPostoperative Complicationssensitivity analysisSevere acute respiratory syndrome coronavirus 2preoperative careVacunacióProspective cohort studyseroprevalenceIncidence (epidemiology)covidElective Surgical Procedures/methodsMiddle Agedcancer gradingCOVID vaccinationoutcome/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_beingSARS-CoV-2; vaccination; surgeryOriginal ArticleFemalecancer surgeryAcademicSubjects/MED00010Life Sciences & BiomedicineAdultCOVID-19 VaccinesAdolescentinternational prospective cohort studyPostoperative Complications/prevention & controlPopulationinfection rateSARS-CoV-2/immunologyNOmodellingYoung Adultmedicinefollow upcancerddc:610infection riskoutcome assessmentLS7_4business.industrySARS-CoV-2Number needed to vaccinatePreoperative careCOVID-193126 Surgery anesthesiology intensive care radiologySettore MED/18Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10]elective surgeryEmergency medicinebusiness[SDV.MHEP]Life Sciences [q-bio]/Human health and pathologyThe British Journal of Surgery
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