Search results for "Helsinki declaration"

showing 10 items of 13 documents

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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Redirected EBV-Specific Stem Cell-Memory and Central-Memory CD8+ T Lymphocytes Exhibit Effective and Sustained Antileukemic Immunity to Acute Myeloid…

2014

Abstract Introduction: Adoptive cellular therapy (ACT) of donor-derived cytolytic T lymphocytes (CTL) directed to leukemia or herpesvirus has proven promising to improve antiviral and antileukemic immunity in patients following allogeneic hematopoietic stem cell transplantation (AHSCT). However, durable clinical responses are often hampered by detrimental graft-versus host (GvH) reactivity and limited persistence of transferred, fully differentiated antileukemic effector T cells (TEFF). We thus explored memory and tumoricidal features of in vitro generated EBV-specific stem cell-memory T cells (TSCM) and central-memory T (TCM) cells, T cell-receptor (TCR) redirected to primary acute myeloid…

Adoptive cell transferbusiness.industryImmunologyCell BiologyHematologymedicine.diseaseBiochemistryHelsinki declarationCTL*LeukemiaInterleukin 21hemic and lymphatic diseasesImmunologyNSG mouseMedicineCytotoxic T cellbusinessCD8Blood
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Does being a Stranger make it Difficult to Cooperate?

2017

AbstractCompetition and cooperation are two somewhat opposed strategies for interpersonal social interaction that help us to achieve both individual and shared goals. The main aim of this study was to explore which type of social interaction (cooperative or competitive) is more stressful in a face-to-face same-sex dyad in healthy young participants (n = 178), considering outcome obtained in these tasks (positive or negative) and sex as moderating variables, and performance of the task alone as a control condition. Salivary cortisol (Csal) was measured in one sample obtained before task and four obtained after the task (+0, +15, +30 and +45 minutes after). Anxiety-state was assessed before a…

AdultMaleCompetitive BehaviorLinguistics and LanguageHydrocortisone050109 social psychologyAnxietyLanguage and LinguisticsElectronic mailHelsinki declarationTask (project management)Developmental psychologyYoung Adult03 medical and health sciencesInterpersonal relationship0302 clinical medicinemedicineHumansInterpersonal Relations0501 psychology and cognitive sciencesCooperative BehaviorSalivaGeneral PsychologySocial stress05 social sciencesSocial relationAnxietyFemalemedicine.symptomPsychologySocial psychologyStress Psychological030217 neurology & neurosurgeryDyadThe Spanish Journal of Psychology
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An Outbreak of Hepatitis C Virus Infection Among Transfused Thalassemia Patients: Root Cause Analysis, Phylogenetic Epidemiology and Antiviral Therapy

2021

Background: Occurrence of HCV infection is reduced by effective risk management procedures, but patient-to-patient transmission continues to be reported in healthcare settings. We report an outbreak of 11 patients with HCV acute hepatitis (seven new infections and four re-infections) among 128 thalassemia patients followed at a Hospital in Sicily. Methods All patients with acute hepatitis and known chronic infection were tested for HCV-RNA, HCV genotyping, and NS3, NS5A and NS5B HCV-genomic regions sequencing.  To identify transmission clusters we built phylogenetic trees for each gene employing Bayesian methods.  Findings All patients with acute hepatitis were infected with HCV genotype 1b…

Ledipasvirmedicine.medical_specialtyBlood transfusionSofosbuvirTransmission (medicine)business.industryHepatitis C virusmedicine.medical_treatmentmedicine.disease_causeHelsinki declarationchemistry.chemical_compoundChronic infectionchemistryInternal medicineEpidemiologymedicinebusinessmedicine.drugSSRN Electronic Journal
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Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic …

2016

[Purpose] TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer (mCRC) refractory or intolerant to standard therapies were evaluated in the phase 3 RECOURSE trial. Results of RECOURSE demonstrated significant improvement in overall survival (OS) and progression-free survival (PFS) with TAS-102 versus placebo [hazard ratio (HR) = 0.68 and 0.48 for OS and PFS, respectively; both P < 0.001]. The current analysis evaluates efficacy and safety of TAS-102 in the RECOURSE Spanish subgroup.

Male0301 basic medicineOncologyCancer ResearchPyrrolidinesColorectal cancerTrifluridineHelsinki declarationlaw.inventionTrifluridinechemistry.chemical_compound0302 clinical medicineRandomized controlled triallawMedicineAged 80 and overMetastatic colorectal cancerPalliative CareHazard ratioGeneral MedicineMiddle AgedPrognosisTAS-102Survival RateDrug CombinationsOncology030220 oncology & carcinogenesisDrug Therapy CombinationFemaleColorectal NeoplasmsFluoropyrimidineResearch Articlemedicine.drugAdultmedicine.medical_specialtyanimal structuresSubgroup analysisPlaceboAntiviral Agents03 medical and health sciencesDouble-Blind MethodInternal medicineHumansTipiracil hydrochlorideUracilAgedNeoplasm StagingTipiracilbusiness.industrymedicine.diseaseSurgery030104 developmental biologychemistrySpainbusinessThymineFollow-Up StudiesClinical and Translational Oncology
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The impact of diet during adolescence on the neonatal health of offspring: evidence on the importance of preconception diet. The HUNT study

2020

Background: Emerging evidence suggests that parents' nutritional status before and at the time of conception influences the lifelong physical and mental health of their child. Yet little is known about the relationship between diet in adolescence and the health of the next generation at birth. This study examined data from Norwegian cohorts to assess the relationship between dietary patterns in adolescence and neonatal outcomes. Methods: Data from adolescents who participated in the Nord-TrA¸ndelag Health Study (Young-HUNT) were merged with birth data for their offspring through the Medical Birth Registry of Norway (MBRN). Young-HUNT1 collected data from 8980 adolescents between 1995 and 19…

MaleAdolescentOffspringDeclarationMedicine (miscellaneous)030209 endocrinology & metabolismNorwegianHelsinki declaration03 medical and health sciences0302 clinical medicineEnvironmental healthHunt studyFood choiceneonatal outcomesFood QualityMedicineHumansInfant Health030212 general & internal medicineNeonatal healthadolescentsResearch ethicsbusiness.industrypreconceptionNorwayHUNT studyMental healthlanguage.human_languagenutritionNeonatal outcomesAdolescent BehaviorCohortlanguageFemalePreconception CarebusinessDemography
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PNPLA3 Rs738409 C&amp;gt;G Variant Predicts Liver-Related Outcomes in Patients with Non-Alcoholic Fatty Liver Disease

2019

Background: Patients with NAFLD are at higher risk of developing liver-related complications -liver decompensation(LD) and hepatocellular carcinoma (HCC), including death-. A single nucleotide polymorphism in PNPLA3 gene is associated with a higher prevalence of liver damage and HCC, but prospective date are not available. We aimed to assess whether the common rs738409 variant in PNPLA3 gene can predict the occurrence of liver-related events and death in a large cohort of NAFLD patients.   Methods: We considered 471 consecutive Italian individuals with histological diagnosis of NAFLD or clinical diagnosis of compensated NAFLD-related cirrhosis, prospectively followed for at least 6 months. …

medicine.medical_specialtyCirrhosisProportional hazards modelbusiness.industryFatty liverSingle-nucleotide polymorphismmedicine.diseaseGastroenterologyHelsinki declarationFibrosisInternal medicineHepatocellular carcinomamedicineDecompensationbusinessSSRN Electronic Journal
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Prognostic Impact of 3-HM Concentration in Patients with Alcoholic or Viral Cirrhosis

2018

The role of endotoxemia related to intestinal bacterial translocation in worsening liver disease is the subject of many studies, but its impact on cirrhosis mortality has not been well evaluated. In this study, 3-hydroxymyristate (3-HM) (specific lipid of lipopolysaccharides) was directly quantified by an innovative patented assay with the aim of assessing the impact on cirrhosis mortality. The 3-HM concentration was measured in 593 patients with alcoholic or viral cirrhosis in stable clinical condition. A Cox hazards regression model was used to evaluate association between 3-HM and its fractions bound or nor bound to lipoprotein and the mortality. The 3-HM concentration was increased in p…

medicine.medical_specialtyGastrointestinal bleedingCirrhosisbusiness.industryHazard ratiomedicine.diseaseConfidence intervalHelsinki declarationLiver diseaseInternal medicineAscitesmedicinemedicine.symptomComplicationbusinessSSRN Electronic Journal
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&lt;i&gt;PCSK9&lt;/i&gt; rs11591147 R46L Loss-of-Function Variant Protects Against Liver Damage in Individuals with NAFLD

2020

Background and Aims: The proprotein convertase subtilisin/kexin type 9 (PCSK9) plays a key role in cholesterol homeostasis, and its inhibition represents an effective therapy to lower LDL-C levels. In this study, we examined the impact of PCSK9 rs11591147 loss-of-function (LOF) variant on liver damage in a multicenter collection of patients at risk of nonalcoholic steatohepatitis (NASH), in clinical samples and experimental models. Methods: We considered 1,874 consecutive individuals at risk of NASH as determined by histology. The SNP rs11591147, encoding for the p.R46L variant of PCSK9, was genotyped by TaqMan assays. We also evaluated 1) PCSK9 mRNA hepatic expression in human liver, and 2…

medicine.medical_specialtyHuman liverbusiness.industryPCSK9Helsinki declarationFat accumulationInformed consentInternal medicineMedicinemedia_common.cataloged_instanceLiver damageEuropean unionbusinessPharmacogeneticsmedia_commonSSRN Electronic Journal
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GEMS, a GEnetic and Metabolic Staging predicting the outcome of non-alcoholic fatty liver disease

2021

Background and Aim: Non-alcoholic fatty liver disease(NAFLD) is an emergent cause of liver-related events(LRE). We have assessed the ability of a composite score based on clinical features, metabolic comorbidities and genetic background, to predict LRE. Methods: 546 consecutive patients with NAFLD were recruited and stratified according to FIB-4(low risk <1.3;intermedium-high risk ≥1.3). LRE were defined as occurrence of HCC or hepatic decompensation. Cox regression multivariate analysis was used to identify baseline variables associated with LRE. Results: Over a median follow-up of 73.8 months, 58 patients experienced LRE(only 1 in the cohort of patients with FIB-4 65 years(HR 17.96), plat…

medicine.medical_specialtyMultivariate analysisHepatologyProportional hazards modelbusiness.industryFatty liverGastroenterologyNon alcoholicDiseasemedicine.diseaseOutcome (game theory)GastroenterologyHelsinki declarationHepatocellular carcinomaDiabetes mellitusInternal medicineCohortMedicinebusinessTM6SF2Digestive and Liver Disease
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