Search results for "Double-Blind"

showing 10 items of 662 documents

Autologous dental pulp mesenchymal stem cells for inferior third molar post-extraction socket healing : a split-mouth randomised clinical trial

2018

Background Since the discovery of adult mesenchymal stem cells extensive research has been conducted to determine their mechanisms of differentiation and effectiveness in cell therapy and regenerative medicine. Material and Methods To assess the efficacy of autologous dental pulp mesenchymal stem cells delivered in a collagen matrix for post-extraction socket healing, a single-centre, double-blind, randomised, split-mouth, controlled clinical trial was performed. Both impacted mandibular third molars were extracted from 32 patients. Dental pulp was collected and dissociated; the resulting cell suspension, obtained by centrifugation, was incorporated into a resorbable collagen matrix and imp…

0301 basic medicineMolarAdultMaleAdolescentDentistryBone healingMesenchymal Stem Cell TransplantationBone resorptionMandibular second molar03 medical and health sciencesYoung AdultDouble-Blind MethodHounsfield scaleMedicineHumansTooth SocketAutograftsGeneral DentistryDental PulpPostoperative CareWound Healingbusiness.industryResearchMesenchymal stem cellInterdental consonant:CIENCIAS MÉDICAS [UNESCO]030104 developmental biologyOtorhinolaryngologyTooth ExtractionUNESCO::CIENCIAS MÉDICASSurgeryFemaleMolar ThirdOral SurgeryWound healingbusiness
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Schlafen-11 (SLFN11): a step forward towards personalized medicine in small-cell lung cancer?

2018

Purpose Both temozolomide (TMZ) and poly (ADP-ribose) polymerase (PARP) inhibitors are active in small-cell lung cancer (SCLC). This phase II, randomized, double-blind study evaluated whether addition of the PARP inhibitor veliparib to TMZ improves 4-month progression-free survival (PFS). Patients and Methods A total of 104 patients with recurrent SCLC were randomly assigned 1:1 to oral veliparib or placebo 40 mg twice daily, days 1 to 7, and oral TMZ 150 to 200 mg/m

0301 basic medicineOncologyMaleLung NeoplasmsDNA Mutational AnalysisPoly (ADP-Ribose) Polymerase-1Placebos0302 clinical medicineAntineoplastic Combined Chemotherapy ProtocolsPromoter Regions GeneticDNA Modification MethylasesAged 80 and overStandard treatmentNuclear ProteinsMiddle AgedNeoplastic Cells CirculatingImmunohistochemistryhumanitiesEditorialOncology030220 oncology & carcinogenesisFemaleNon small cellAdultmedicine.medical_specialtyMEDLINEAggressive disease03 medical and health sciencesText miningDouble-Blind MethodInternal medicinemedicineBiomarkers TumorTemozolomideHumansLung cancerneoplasmsAntineoplastic Agents AlkylatingAgedbusiness.industryTumor Suppressor ProteinsDNA Methylationmedicine.diseaseSmall Cell Lung Carcinomarespiratory tract diseases030104 developmental biologyDNA Repair EnzymesBenzimidazolesPersonalized medicinebusiness
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Protein misfolding, amyotrophic lateral sclerosis and guanabenz: Protocol for a phase II RCT with futility design (ProMISe trial)

2017

IntroductionRecent studies suggest that endoplasmic reticulum stress may play a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through an altered regulation of the proteostasis, the cellular pathway-balancing protein synthesis and degradation. A key mechanism is thought to be the dephosphorylation of eIF2α, a factor involved in the initiation of protein translation. Guanabenz is an alpha-2-adrenergic receptor agonist safely used in past to treat mild hypertension and is now an orphan drug. A pharmacological action recently discovered is its ability to modulate the synthesis of proteins by the activation of translational factors preventing misfolded protein accumula…

0301 basic medicineOncologyPathologyamyotrophic lateral sclerosisamyotrophic lateral sclerosis; motor neurone disease; neuromuscular disease; randomized clinical trial guanabenz; unfolded protein response; adrenergic alpha-2 receptor agonist s; age of onset; amyotrophic lateral sclerosis; disease progression; double-blind method; endoplasmic reticulum stress; guanabenz; humans; italy; medical futility; neuroprotective agents; proteostasis deficienciesamyotrophic lateral sclerosis; motor neurone disease; neuromuscular disease; randomized clinical trial guanabenz; unfolded protein response; Medicine (all)randomized clinical trial guanabenzHelsinki declaration0302 clinical medicineProtocolAdrenergic alpha-2 Receptor Agonists1506Amyotrophic lateral sclerosisAge of OnsetGuanabenzMedicine (all)amyotrophic lateral sclerosis; motor neurone disease; neuromuscular disease; randomized clinical trial guanabenz; unfolded protein responseNeurodegenerationamyotrophic lateral sclerosis; motor neurone disease; neuromuscular disease; randomized clinical trial guanabenz; unfolded protein response;amyotrophic lateral sclerosis; guanabenz; motor neurone disease; neuromuscular disease; randomized clinical trial; unfolded protein response; Adrenergic alpha-2 Receptor Agonists; Age of Onset; Amyotrophic Lateral Sclerosis; Disease Progression; Double-Blind Method; Endoplasmic Reticulum Stress; Guanabenz; Humans; Italy; Medical Futility; Neuroprotective Agents; Proteostasis DeficienciesGeneral Medicineunfolded protein responseEndoplasmic Reticulum StressRiluzoleNeuroprotective AgentsNeurologyTolerabilityItalyDisease Progression1713GuanabenzMedical Futilitymedicine.drugmedicine.medical_specialtyamyotrophic lateral sclerosis; motor neurone disease; neuromuscular disease; randomized clinical trial guanabenz; unfolded protein response; Adrenergic alpha-2 Receptor Agonists; Age of Onset; Amyotrophic Lateral Sclerosis; Disease Progression; Double-Blind Method; Endoplasmic Reticulum Stress; Guanabenz; Humans; Italy; Medical Futility; Neuroprotective Agents; Proteostasis Deficiencies; Medicine (all)Neuroprotection03 medical and health sciencesmotor neurone diseaseDouble-Blind MethodInternal medicinemedicineHumansProteostasis Deficienciesbusiness.industryAmbientaleneuromuscular diseaserandomized clinical trialmedicine.diseaseClinical trial030104 developmental biologybusiness030217 neurology & neurosurgery
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Efficacy and Safety of Zofenopril Versus Ramipril in the Treatment of Myocardial Infarction and Heart Failure: A Review of the Published and Unpublis…

2018

Zofenopril is a lipophilic, sulfhydryl group-containing angiotensin-converting enzyme (ACE)-inhibitor, characterized by wide tissue distribution, long duration of action, and pleiotropic effects on endothelial dysfunction. Its clinical efficacy and safety have been described in the four randomized controlled trials of the SMILE program, which globally enrolled more than 3600 patients in post-acute myocardial infarction (AMI) setting. The SMILE-4 study specifically selected patients with left ventricular dysfunction at admission, and compared the effects of zofenopril or ramipril in combination with acetylsalicylic acid (ASA). Zofenopril demonstrated its superiority over ramipril in reducing…

0301 basic medicineRamiprilmedicine.medical_specialtyCaptoprilPopulationMyocardial InfarctionCardiologyAngiotensin-Converting Enzyme InhibitorsHeart failureReviewAcute myocardial infarction030204 cardiovascular system & hematologylaw.inventionZofenopril03 medical and health scienceschemistry.chemical_compound0302 clinical medicineRandomized controlled trialDouble-Blind MethodRamiprillawInternal medicineAcute myocardial infarction; Angiotensin-converting enzyme inhibitors; Cardiology; Heart failure; Left ventricular dysfunction; Ramipril; Zofenopril; Pharmacology (medical)MedicineHumansPharmacology (medical)Myocardial infarctioneducationRandomized Controlled Trials as Topiceducation.field_of_studyLeft ventricular dysfunctionEjection fractionbusiness.industryGeneral Medicinemedicine.diseaseZofenopril030104 developmental biologyTreatment OutcomechemistryAngiotensin-converting enzyme inhibitorHeart failureCardiologyNumber needed to treatbusinessmedicine.drug
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Altilix® Supplement Containing Chlorogenic Acid and Luteolin Improved Hepatic and Cardiometabolic Parameters in Subjects with Metabolic Syndrome: A 6…

2019

The objective was to evaluate the effects of 6 months of supplementation with Altilix&reg

0301 basic medicineSettore MED/09 - Medicina Internacynaragenetic structuresPlacebo-controlled study030204 cardiovascular system & hematologySettore BIO/09 - FisiologiaGastroenterology0302 clinical medicineDiabetes mellitusimmune system diseasescardiovascular diseasehemic and lymphatic diseasesBrachial arteryLuteolinNutrition and Dieteticsdiabetes mellituFatty liverhemic and immune systemsDietary supplementsMetabolic syndromeCardiovascular diseasesLivertype 2diabetes mellitusChlorogenic Acidlcsh:Nutrition. Foods and food supplymedicine.medical_specialtyWaistlcsh:TX341-641chemical and pharmacologic phenomenaCynaraPlacebometabolic syndromedietary supplements03 medical and health sciencesDouble-Blind MethodInternal medicineDiabetes mellitusmedicine.arterymedicinebusiness.industrynon-alcoholic fatty liver diseasemedicine.diseasecardiovascular diseases030104 developmental biologydietary supplementSteatosisMetabolic syndromebusinessFood ScienceNon-alcoholic fatty liver disease
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Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placeb…

2018

Summary Background Antiangiogenic therapy has known activity in ovarian cancer. The investigator-initiated randomised phase 2 TRIAS trial assessed the multi-kinase inhibitor sorafenib combined with topotecan and continued as maintenance therapy for platinum-resistant or platinum-refractory ovarian cancer. Methods We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 trial at 20 sites in Germany. Patients (≥18 years) with platinum-resistant ovarian cancer previously treated with two or fewer chemotherapy lines for recurrent disease were stratified (first vs later relapse) in block sizes of four and randomly assigned (1:1) using a web-generated response system to topotec…

0301 basic medicineSorafenibAdultmedicine.medical_specialtyTime FactorsPerforation (oil well)Angiogenesis InhibitorsPlatinum CompoundsNeutropeniaPlaceboGastroenterologyDrug Administration Schedule03 medical and health sciences0302 clinical medicineMaintenance therapyDouble-Blind MethodInternal medicineGermanyAntineoplastic Combined Chemotherapy ProtocolsmedicineClinical endpointHumansProgression-free survivalProtein Kinase InhibitorsAgedOvarian Neoplasmsbusiness.industryMiddle AgedSorafenibmedicine.diseaseProgression-Free Survival030104 developmental biologyOncologyDrug Resistance Neoplasm030220 oncology & carcinogenesisDisease ProgressionTopotecanFemaleTopoisomerase I InhibitorsbusinessTopotecanmedicine.drugThe Lancet. Oncology
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Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial

2017

Objectives:The aim of the study was to evaluate the effects of infant formula supplemented with 2 human milk oligosaccharides (HMOs) on infant growth, tolerance, and morbidity. Methods:Healthy infants, 0 to 14 days old, were randomized to an intact-protein, cow's milk-based infant formula (control, n=87) or the same formula with 1.0g/L 2fucosyllactose (2FL) and 0.5g/L lacto-N-neotetraose (LNnT) (test, n=88) from enrollment to 6 months; all infants received standard follow-up formula without HMOs from 6 to 12 months. Primary endpoint was weight gain through 4 months. Secondary endpoints included additional anthropometric measures, gastrointestinal tolerance, behavioral patterns, and morbidit…

0301 basic medicinesafetyMalePediatricsmedicine.medical_specialtyMEDLINEOligosaccharidesWeight Gainlaw.inventionbronchitis03 medical and health scienceschemistry.chemical_compound2'-FucosyllactoseRandomized controlled trialDouble-Blind Method2fucosyllactose; bronchitis; lacto-N-neotetraose; safety; tolerancelawMulticenter trialmedicineAnimalsHumansLacto-N-neotetraoseRespiratory Tract Infectionslacto-N-neotetraose2′fucosyllactose030109 nutrition & dieteticstoleranceMilk Humanbusiness.industryGastroenterologyOriginal Articles: NutritionInfant Newbornfood and beveragesInfantProtective Factorsmedicine.diseaseInfant Formula030104 developmental biologyMilkchemistryInfant formulaPediatrics Perinatology and Child Health2'fucosyllactose bronchitis lacto-N-neotetraose safety toleranceBronchitisFemalemedicine.symptombusinessWeight gainFollow-Up Studies
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Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study.

2013

We previously described the isolation and characterization of three probiotic strains from the feces of exclusively breast-fed newborn infants: Lactobacillus paracasei CNCM I-4034, Bifidobacterium breve CNCM I-4035 and Lactobacillus rhamnosus CNCM I-4036. These strains were shown to adhere to intestinal mucus in vitro, to be sensitive to antibiotics and to resist biliary salts and low pH. In the present study, a multicenter, randomized, double-blind, placebo-controlled trial with 100 healthy volunteers in three Spanish cities was carried out to evaluate the tolerance, safety, gut colonization and immunomodulatory effects of these three probiotics. Volunteers underwent a 15-day washout perio…

ARN Bacterianoved/biology.organism_classification_rank.speciesPhysiologylcsh:Medicine:Phenomena and Processes::Biological Phenomena::Ecological and Environmental Phenomena::Environment::Ecosystem::Biodiversity::Biota::Microbiota [Medical Subject Headings]law.inventionFecesProbioticAntibioticslawLactobacillus:Phenomena and Processes::Physiological Phenomena::Nutritional Physiological Phenomena::Child Nutritional Physiological Phenomena::Infant Nutritional Physiological Phenomena::Breast Feeding [Medical Subject Headings]lcsh:Science:Chemicals and Drugs::Nucleic Acids Nucleotides and Nucleosides::Nucleic Acids::RNA::RNA Bacterial [Medical Subject Headings]BifidobacteriumMultidisciplinaryBifidobacterium brevebiologyLacticaseibacillus rhamnosusMicrobiotaHibridación in SituInterleukin-10:Organisms::Bacteria::Gram-Positive Bacteria::Lactobacillales::Lactobacillaceae::Lactobacillus [Medical Subject Headings]Breast FeedingBloodCytokinesFemaleResearch ArticleAdult:Anatomy::Fluids and Secretions::Feces [Medical Subject Headings]Lactobacillus paracasei:Organisms::Bacteria::Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Rods::Clostridium::Clostridium difficile [Medical Subject Headings]Microbiology:Chemicals and Drugs::Nucleic Acids Nucleotides and Nucleosides::Nucleic Acids::Nucleic Acid Probes::Oligonucleotide Probes [Medical Subject Headings]Double-Blind MethodLactobacillus rhamnosusHumansImmunologic Factors:Analytical Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Histocytological Preparation Techniques::Staining and Labeling::In Situ Hybridization [Medical Subject Headings]FecesSafety studiesved/biologyProbioticslcsh:RClostridium difficile:Organisms::Bacteria::Gram-Positive Bacteria::Actinobacteria::Bifidobacterium [Medical Subject Headings]biology.organism_classificationImmunoglobulin ALactobacilluslcsh:QInterleukin-4BifidobacteriumBreast feedingSondas de OligonucleótidosPLoS ONE
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Redox and autonomic responses to acute exercise-post recovery following Opuntia ficus-indica juice intake in physically active women

2021

Background: The aim of this study was to investigate if the supplementation with Opuntia ficus-indica (OFI) juice may affect plasma redox balance and heart rate variability (HRV) parameters following a maximal effort test, in young physically active women. Methods: A randomized, double blind, placebo controlled and crossover study comprising eight women (23.25 ± 2.95 years, 54.13 ± 9.05 kg, 157.75 ± 0.66 cm and BMI of 21.69 ± 0.66 kg/m2) was carried out. A juice containing OFI diluted in water and a Placebo solution were supplied (170 ml; OFI = 50 ml of OFI juice + 120 ml of water; Placebo = 170 ml beverage without Vitamin C and indicaxanthin). Participants consumed the OFI juice or Placebo…

Adult0301 basic medicineCactus pear juice supplementationOpuntia ficusTotal antioxidant capacityClinical nutritionmedicine.disease_causePlaceboYoung Adult03 medical and health scienceschemistry.chemical_compoundRedox balanceOxygen Consumption0302 clinical medicineAnimal scienceDouble-Blind MethodHigh frequencyHeart RatemedicineHumansHeart rate variabilityAutonomic nervous systemExerciseCross-Over StudiesNutrition and DieteticsSettore M-EDF/02 - Metodi E Didattiche Delle Attivita' SportiveVitamin Cbusiness.industryOpuntiaHydrogen Peroxide030229 sport sciencesCrossover studyFruit and Vegetable JuicesHydroperoxideHydroperoxides030104 developmental biologychemistryOxidative stressOxidative streFemalebusinessLow frequencyOxidation-ReductionIndicaxanthinSettore M-EDF/01 - Metodi E Didattiche Delle Attivita' MotorieOxidative stressResearch ArticleFood Science
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Short-term therapy for recurrent abortion using intravenous immunoglobulins: Results of a double-blind placebo-controlled Italian study

1997

It is still unclear whether i.v. immunoglobulins (Ig) can facilitate the reproductive prognosis of women who have suffered recurrent pregnancy loss. We report the results of a multicentre placebo-controlled study on the effect of Ig administration on pregnancy outcome in 46 women who had suffered at least three recurrent miscarriages. All were screened to exclude chromosomal or Müllerian abnormalities, the presence of antinuclear antibodies, lupus anticoagulant (LA) or elevated titres of anticardiolipin antibodies which may have revealed an underlying autoimmune problem. To avoid a selection bias towards ongoing pregnancies, i.v. Ig or placebo were administered between weeks 5 and 7 of gest…

AdultAbortion Habitualmedicine.medical_specialtyAnti-nuclear antibodyAbortionPlacebolaw.inventionDouble-Blind MethodRandomized controlled trialPregnancylawAntiphospholipid syndromemedicineHumansLupus anticoagulantPregnancyObstetricsbusiness.industryRehabilitationPregnancy OutcomeImmunoglobulins IntravenousObstetrics and Gynecologymedicine.diseaseSurgeryItalyReproductive MedicineGestationFemalebusiness
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