Search results for " placebo"

showing 9 items of 19 documents

Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial

2013

International audience; Boceprevir (BOC) added to peginterferon alfa-2b (PegIFN) and ribavirin (RBV) significantly increases sustained virologic response (SVR) rates over PegIFN/RBV alone in previously untreated adults with chronic hepatitis C genotype 1. We evaluate the relationship of incident anemia with triple therapy. A total of 1,097 patients received a 4-week lead-in of PegIFN/RBV followed by: (1) placebo plus PegIFN/RBV for 44 weeks (PR48); (2) BOC plus PegIFN/RBV using response-guided therapy (BOC/RGT); and (3) BOC plus PegIFN/RBV for 44 weeks (BOC/PR48). The management of anemia (hemoglobin [Hb]<10 g/dL) included RBV dose reduction and/or erythropoietin (EPO) use. A total of 1,080…

Male[SDV]Life Sciences [q-bio]MedizinGastroenterologyPolyethylene GlycolsPlaceboschemistry.chemical_compoundHemoglobins0302 clinical medicinehemic and lymphatic diseasesMedicine030212 general & internal medicineChronicSettore MED/12 - GastroenterologiaInterferon-alpha; Serine Proteinase Inhibitors; Proline; Recombinant Proteins; Hematinics; Humans; Ribavirin; Anemia; Antiviral Agents; Drug Therapy Combination; Erythropoietin; Hemoglobins; Adult; Treatment Outcome; Placebos; Polyethylene Glycols; Hepatitis C Chronic; Female; MaleAnemiaHepatitis CHepatitis CRecombinant Proteins3. Good health[SDV] Life Sciences [q-bio]Treatment OutcomeCombinationPeginterferon alfa-2b030211 gastroenterology & hepatologyDrug Therapy CombinationFemalemedicine.drugAdultmedicine.medical_specialtySerine Proteinase InhibitorsProlineAnemiaInterferon alpha-2PlaceboAntiviral Agentsprotease inhibitor03 medical and health sciencesDrug TherapyInternal medicineBoceprevirRibavirinHumansAdverse effectErythropoietinHepatologybusiness.industryRibavirinInterferon-alphaHepatitis C Chronicmedicine.diseaseSurgerychemistryErythropoietinHematinicsbusiness
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Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial …

2015

BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated.METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population …

Malemedicine.medical_specialtyAcute coronary syndromePopulationLIXisenatide610 Medicine & healthHypoglycemiaPlacebop38 Mitogen-Activated Protein Kinases11171 Cardiocentro Ticino2705 Cardiology and Cardiovascular Medicinelaw.inventionSettore MED/13 - EndocrinologiaAcute Coronary Syndrome; Aged; Cardiovascular Diseases; Double-Blind Method; Female; Glucagon-Like Peptide 1; Humans; Male; Middle Aged; Peptides; Placebos; Protein Kinase Inhibitors; Research Design; p38 Mitogen-Activated Protein Kinases; Cardiology and Cardiovascular MedicinePlacebosLixisenatidechemistry.chemical_compoundRandomized controlled trialDouble-Blind MethodlawGlucagon-Like Peptide 1Internal medicineJournal ArticlemedicineHumansComparative StudyMyocardial infarctionAcute Coronary SyndromeeducationProtein Kinase InhibitorsAgededucation.field_of_studybusiness.industryUnstable anginaResearch Support Non-U.S. Gov'tta3121Middle Agedmedicine.diseaseSurgeryMulticenter StudychemistryCardiovascular DiseasesResearch DesignRandomized Controlled TrialCardiologyFemaleCardiology and Cardiovascular MedicinebusinessPeptides
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Non-Celiac Wheat Sensitivity Diagnosed by Double-Blind Placebo-Controlled Challenge: Exploring a New Clinical Entity.

2012

Non-Celiac Wheat Sensitivity Diagnosed by Double-Blind Placebo-Controlled Challenge: Exploring a New Clinical Entity

Non-Celiac Wheat SensitivityPediatricsmedicine.medical_specialtySettore MED/09 - Medicina InternaHepatologybusiness.industryNon-celiac gluten sensitivityGastroenterologyDouble-Blind Placebo-Controlled Challengenutritional and metabolic diseasesfood and beveragesmedicine.diseasePlaceboFood hypersensitivitydigestive system diseasesDouble blindNon-Celiac Wheat Sensitivity; Double-Blind Placebo-Controlled Challenge;Severity of illnessmedicineDifferential diagnosisbusinessNon-celiac gluten sensitivityIrritable bowel syndromeWheat allergy
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Cognitive structuring and placebo effect

2017

Abstract In much of the research concerning the placebo phenomenon, the idea that placebo effects may vary in strength depending on a patient's personal characteristics or traits has been investigated. Findings regarding possible personality differences in placebo response, however, are conflicting and non-systematic. In this article a new theoretical attempt to explain the placebo phenomenon is offered. The authors postulate that the power of the placebo effect is moderated by the extent of use of cognitive structuring, which in turn is influenced by the interaction between the individuals' level of need for cognitive closure and their ability to achieve this state. To test this assumption…

Placebo responsemedia_common.quotation_subjectCognitionPlaceboStructuringCognitive structuring; Placebo effect; Individual differences; Need for closure; Ability to achieve cognitive structureDevelopmental psychology03 medical and health sciences0302 clinical medicineMoodPersonality030212 general & internal medicinePsychologyPractical implications030217 neurology & neurosurgeryGeneral Psychologymedia_commonClinical psychologyPersonality and Individual Differences
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The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial.

2014

BackgroundTiotropium, a once-daily long-acting anticholinergic bronchodilator, has demonstrated efficacy in patients with asthma who were symptomatic despite treatment with medium- to high-dose inhaled corticosteroids (ICS).ObjectiveThe objective of this study was to evaluate the efficacy and safety of once-daily tiotropium Respimat (5 μg or 2.5 μg), compared with placebo Respimat, as add-on therapy to low- to medium-dose ICS for adults with symptomatic asthma.MethodsA phase III, double-blind, placebo-controlled trial was conducted (NCT01316380). Adults with symptomatic asthma receiving low- to medium-dose ICS (200-400 μg budesonide or equivalent dose) and a pre-bronchodilator forced expira…

SpirometryBudesonideAdultMaleRespimatmedicine.drug_classSymptomaticAnticholinergicMildPlacebo03 medical and health sciences0302 clinical medicineBronchodilatorsAdrenal Cortex HormonesBronchodilatorControlAdministration InhalationImmunology and AllergyMedicineHumans030212 general & internal medicineTiotropium BromideBudesonideAnticholinergic; Asthma; Bronchodilators; Control; GINA; ICS; Mild; Respimat; Symptomatic; Tiotropium; Administration Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Bronchodilator Agents; Budesonide; Disease Progression; Drug Combinations; Female; Humans; Male; Placebo Effect; Spirometry; Tiotropium Bromide; Treatment Outcome; Immunology and AllergyAsthmamedicine.diagnostic_testbusiness.industryTiotropiumTiotropium bromidemedicine.diseasePlacebo EffectGINAAsthmarespiratory tract diseasesRespimatBronchodilator AgentsDrug CombinationsTreatment OutcomeInhalation030228 respiratory systemTolerabilityICSSpirometryAnesthesiaAdministrationDisease ProgressionFemalebusinessmedicine.drugThe journal of allergy and clinical immunology. In practice
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Trattamento induratio penis plastica: benefici e svantaggi dell'extra-corporeal shock therapy (ESWT). Studio prospettico randomizzato v/s placebo.

2011

extra-corporeal shock therapy (ESWT)Trattamento induratio penis plasticaStudio prospettico randomizzato v/s placebo.Settore MED/24 - Urologia
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OARSI/OMERACT Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee Osteoarthritis. An OMERACT 10 Special Inte…

2011

Objective.To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of “need for joint replacement surgery,” for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA).Methods.New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons’ indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA.…

medicine.medical_specialtyJoint replacementmedicine.medical_treatmentImmunologyPROGRESSIONOsteoarthritisPLACEBO-CONTROLLED TRIAL2-YEARArticlelaw.inventionRADIOGRAPHIC FEATURES03 medical and health sciencesDOUBLE-BLIND0302 clinical medicinePhysical medicine and rehabilitationRheumatologyRandomized controlled triallawSeverity of illnessPost-hoc analysismedicinePHYSICAL-FUNCTIONImmunology and Allergy030212 general & internal medicine030203 arthritis & rheumatologyHip surgery3-YEARbusiness.industry[SCCO.NEUR]Cognitive science/Neuroscience[SCCO.NEUR] Cognitive science/NeurosciencePAINASSOCIATIONmedicine.diseaseArthroplasty3. Good healthGLUCOSAMINE SULFATEOSTEOARTHRITIS SEVERITY PAIN FUNCTION STRUCTURE OUTCOME MEASURE placebo-controlled trial double-blind radiographic features glucosamine sulfate physical-function progression pain association 3-year 2-yearOrthopedic surgeryPhysical therapybusiness
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Meta-analysis of the placebo rates of clinical relapse and severe endoscopic recurrence in post-operative Crohn's disease

2008

Meta-analysis of the placebo rates of clinical relapse and severe endoscopic recurrence in postoperative Crohn's disease. Renna S, Cammà C, Modesto I, Cabibbo G, Scimeca D, Civitavecchia G, Mocciaro F, Orlando A, Enea M, Cottone M. Dipartimento di Medicina, Pneumologia e Fisiologia della Nutrizione Umana, Università di Palermo, Palermo, Italy. BACKGROUNDS &#38; AIMS: The benefit of therapy for prevention of postoperative recurrence of Crohn's disease (CD) is limited. Clinical relapse and severe endoscopic recurrence are the main outcomes in the evaluation of trials on prevention of recurrence. The aim of this meta-analysis was to focus on knowledge of the placebo rates of relapse and recurr…

medicine.medical_specialtyMEDLINEDiseasePlaceboEndoscopy Gastrointestinallaw.inventionCrohn DiseaseRandomized controlled triallawInternal medicineSecondary PreventionmedicineHumansPostoperative PeriodDigestive System Surgical ProceduresRandomized Controlled Trials as TopicCrohn's diseaseHepatologybusiness.industryGastroenterologyOdds ratioPrognosismedicine.diseaseConfidence intervalSurgeryMeta-analysisMeta-analysis placebo relapse severe endoscopic recurrencebusiness
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Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial

2022

Background and purpose: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials. Methods: This was a phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial. Participants diagnosed with definite, probable or probable laboratory-supported ALS were assigned to receive RNS60 or placebo administered for 24 weeks intravenously (375 ml) once a week and via nebul…

treatmentAmyotrophic Lateral Sclerosisplacebo-controlledNeurodegenerative DiseasesALS; clinical trial; placebo-controlled; randomized; treatmentclinical trialTreatment OutcomeNeurologyDouble-Blind MethodrandomizedQuality of LifeHumansSettore MED/26 - NeurologiaNeurology (clinical)ALSBiomarkers
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