Search results for " Randomized clinical trial"

showing 8 items of 8 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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Denosumab for bone health in prostate and breast cancer patients receiving endocrine therapy? A systematic review and a meta-analysis of randomized t…

2019

Highlights • Hormonal receptors positive breast tumor and prostate cancer are managed with endocrine therapies. • Endocrine therapies designed for breast and prostate cancer are often associated to serious adverse skeletal related events, such fractures. • Denosumab is a monoclonal anti-body binding RANKL which acts as inhibitor of osteoclasts activity, thus increasing bone mass. • Denosumab was showed to strongly prevent hormonal therapies-related skeletal issues. • Denosumab administration results safe in bone mass increase and reduction of fractures risk.

0301 basic medicineOncologyRCTs randomized clinical trialrandomized clinical trialslcsh:Diseases of the musculoskeletal systemSettore MED/06 - Oncologia MedicaOsteoporosisBMD bone mass densityReview Articleandrogen deprivation therapyADTlaw.inventionAndrogen deprivation therapyProstate cancerhazard ratio0302 clinical medicineRandomized controlled triallawHRMedicineBreastSAEsCancerProstateRANKLCIMD mean differencelcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogensRCTs randomized clinical trialsDenosumabOncology030220 oncology & carcinogenesisSAEs serious adverse eventsDenosumabmean differencemedicine.drugmedicine.medical_specialtylcsh:RC254-28203 medical and health sciencesBreast cancerRANKL receptor activator of nuclear factor-kB ligandBMDInternal medicineAdverse effectADT androgen deprivation therapyRCTsbusiness.industryMDmedicine.diseaseHR hazard ratioHormonereceptor activator of nuclear factor-kB ligandDiscontinuationCI confidence interval030104 developmental biologyFractureconfidence intervalADT androgen deprivation therapy; BMD bone mass density; Breast; CI confidence interval; Cancer; Denosumab; Fracture; HR hazard ratio; Hormone; MD mean difference; Prostate; RANKL receptor activator of nuclear factor-kB ligand; RCTs randomized clinical trials; SAEs serious adverse eventsserious adverse eventsbone mass densitylcsh:RC925-935businessJournal of Bone Oncology
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Network intervention analysis to assess the trajectory of change and treatment effects associated with the use of online guided self-help for anorexi…

2020

Aim The aim of this study was to use the innovative technique of Network Intervention Analysis (NIA) to examine the trajectory of symptom change associated with the use of a digital guided self-help intervention (RecoveryMANTRA) to augment treatment as usual in adult anorexia nervosa. Methods Self-reported eating disorder symptoms and mood (stress, anxiety and depression), work and social adjustment, motivation and treatment (Treatment as usual + RecoveryMANTRAand Treatment as usual) were included as nodes in the network and examined using NIA. Networks were computed at baseline (n = 88, 99), at end of treatment (6 weeks, n = 71, 75) and at 6- (n = 58, 63) and 12-month (n = 52, 63) follow-u…

Adultanorexia nervosa network intervention analysis outcome random ized clinical trial treatment effectsAnorexia Nervosaanorexia nervosa; network intervention analysis; outcome; randomized clinical trial; treatment effectsAnxietylaw.inventionSelf-helpRandomized controlled triallawIntervention (counseling)Settore M-PSI/08 - Psicologia ClinicaMedicineHumansBiological PsychiatryDepression (differential diagnoses)network intervention analysiMotivationbusiness.industrynetwork intervention analysistreatment effectsrandomized clinical trialAnxiety DisordersPsychiatry and Mental healthMoodAnorexia nervosa (differential diagnoses)outcomeAnxietyPshychiatric Mental Healthmedicine.symptomAugmentbusinessSocial AdjustmentClinical psychology
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Update I. A systematic review on the efficacy and safety of chloroquine/hydroxychloroquine for COVID-19

2020

Purpose To assess efficacy and safety of chloroquine (CQ)/hydroxychloroquine (HCQ) for treatment or prophylaxis of COVID-19 in adult humans. Materials and methods MEDLINE, PubMed, EMBASE and two pre-print repositories (bioRxiv, medRxiv) were searched from inception to 8th June 2020 for RCTs and nonrandomized studies (retrospective and prospective, including single-arm, studies) addressing the use of CQ/HCQ in any dose or combination for COVID-19. Results Thirty-two studies were included (6 RCTs, 26 nonrandomized, 29,192 participants). Two RCTs had high risk, two ‘some concerns’ and two low risk of bias (Rob2). Among nonrandomized studies with comparators, nine had high risk and five moderat…

ICU Intensive care unit;medicine.medical_treatmentCritical Care and Intensive Care MedicineRR Risk Ratio0302 clinical medicineChloroquineRCT Randomized clinical trialMedicineHCQ Hydroxychloroquine;Prospective StudiesProspective cohort studyChloroquine COVID-19 Hydroxychloroquine Mortality SARS-CoV-2ChloroquineECG Electrocardiogram;Rob2 Revised tool for Risk of Bias in randomized trials;CI Confidence interval;Coronavirus InfectionsPost-Exposure ProphylaxisHydroxychloroquinemedicine.drugmedicine.medical_specialtyCoronavirus disease 2019 (COVID-19)Pneumonia ViralMEDLINEContext (language use)Antiviral AgentsArticleWHO World Health OrganizationBetacoronavirus03 medical and health sciencesInternal medicineHumansMortalityCOVID-19 Coronavirus disease 2019;Post-exposure prophylaxisPandemicsRetrospective StudiesCQ Chloroquine;SARS-CoV-2ROBINS-I Risk of Bias in Non-randomized Studies of Interventions;business.industryCOVID-19030208 emergency & critical care medicineHydroxychloroquineRetrospective cohort studyHCWs Healthcare workers;NOS Newcastle Ottawa Scale;COVID-19 Drug Treatment030228 respiratory systembusinessHR Hazard Ratio;Journal of Critical Care
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E-PTFE (Gore-Tex) implant with or without low-dosage mitomycin-C as an adjuvant in penetrating glaucoma surgery: 2 year randomized clinical trial.

2008

Purpose: To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy. Methods: Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels – £21 and £17 mmHg – by Kaplan–Meier curves. Results: The postoperative IOP reduction was significant (P < 0.01) at th…

MaleIntraocular pressuremedicine.medical_specialtygenetic structuresmedicine.medical_treatmentMitomycinGlaucomaOcular HypotensionTrabeculectomyKaplan-Meier Estimatelaw.inventionRandomized controlled triallawpenetrating glaucoma surgerymedicineGlaucoma surgeryTrabeculectomyHumansPostoperative PeriodSurvival ratePolytetrafluoroethyleneIntraocular PressureE-PTFE (Gore-Tex)implantAgedDose-Response Relationship Drugbusiness.industryMitomycin CGlaucomaGeneral MedicineProstheses and ImplantsMiddle Agedmedicine.diseaserandomized clinical trialSurgerylow-dosage mitomycin-Cpenetrating glaucoma surgery; E-PTFE (Gore-Tex)implant; low-dosage mitomycin-C; randomized clinical trialOphthalmologyChemotherapy AdjuvantAnesthesiaFemaleImplantbusiness
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Sorafenib: from literature to clinical practice

2013

Sorafenib is considered the standard systemic therapy for hepatocellular carcinoma (HCC), in patients with well-preserved liver function (Child-Pugh A class) and advanced-stage HCC (BCLC-C) or in patients with HCC progressing after locoregional therapies, with a high grade of recommendation. The approval of sorafenib for this indication was grounded on the efficacy and the safety results reported by two international randomized, controlled trials, the SHARP and the Asia-Pacific studies. In addition, the efficacy and the safety of sorafenib in clinical practice are addressed by several field-practice experiences, including the multinational GIDEON study and the SOFIA study. Finally, further …

OncologyTime Factorsadverse eventPharmacologySystemic therapylaw.inventionTranslational Research Biomedicalobservational studieAntineoplastic AgentRandomized controlled trialRisk FactorslawMolecular Targeted TherapyHCCTranslational Medical Researchadverse events; clinical practice; observational studies; randomized clinical trials; sorafenib; Animals; Antineoplastic Agents; Carcinoma Hepatocellular; Evidence-Based Medicine; Humans; Liver Neoplasms; Neoplasm Staging; Niacinamide; Phenylurea Compounds; Protein Kinase Inhibitors; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Molecular Targeted Therapy; Translational Medical ResearchRandomized Controlled Trials as TopicEvidence-Based MedicineLiver NeoplasmsHematologyclinical practiceTreatment OutcomeOncologyLiver NeoplasmHepatocellular carcinomaHumanmedicine.drugNiacinamidePhenylurea CompoundSorafenibmedicine.medical_specialtyCarcinoma HepatocellularTime FactorProtein Kinase InhibitorAntineoplastic AgentsInternal medicinemedicineAnimalsHumansAdverse effectProtein Kinase InhibitorsneoplasmsNeoplasm StagingAnimalbusiness.industryPhenylurea CompoundsRisk FactorEvidence-based medicinerandomized clinical trialmedicine.diseasedigestive system diseasessorafenibObservational studyLiver functionbusiness
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Dosing fentanyl buccal tablet for breakthrough cancer pain: dose titration versus proportional doses.

2012

Abstract OBJECTIVES: The aim of this study was to compare the efficacy and safety of doses of fentanyl buccal tablet (FBT) proportional to doses of opioids used for background analgesia versus dose titration starting with the minimal dose for the management of breakthrough cancer pain (BTcP). METHODS: A total of 82 cancer patients with BTcP who were receiving strong opioids in doses of at least 60 mg of oral morphine equivalents and having acceptable background analgesia, were selected for a multicenter unblinded study. Forty-one patients were randomized to receive FBT in doses proportional to the daily opioid doses for four consecutive episodes of BTcP (group P). Forty-one patients underwe…

OralMaleDose titrationfentanyl buccal tabletAdministration OralOpioidDosing fentanylSettore MED/42 - Igiene Generale E ApplicataDose titrationlaw.inventionDose-Response RelationshipRandomized controlled triallawNeoplasmsFentanyl Buccal TabletMedicineHumansRapid onset opioidsDrug Dosage CalculationsCancer painAgedPain MeasurementAnalgesicsDose-Response Relationship DrugBreakthrough pain; Cancer pain; Dose titration; Fentanyl buccal tablet; Rapid onset opioids; Administration Oral; Aged; Analgesics Opioid; Breakthrough Pain; Dose-Response Relationship Drug; Female; Fentanyl; Humans; Male; Middle Aged; Neoplasms; Pain Measurement; Tablets; Titrimetry; Drug Dosage Calculations; Medicine (all)business.industryMedicine (all)Breakthrough PainTitrimetryCancerGeneral MedicineBuccal administrationfentanyl buccal tablet; breakthrough cancer pain; randomized clinical trialMiddle Agedmedicine.diseaserandomized clinical trialAnalgesics OpioidFentanylbreakthrough cancer painOpioidAnesthesiaAdministrationFemaleDrugbusinessCancer painmedicine.drugTabletsCurrent medical research and opinion
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An overview of randomized controlled trials on endovascular treatment for chronic cerebrospinal venous insufficiency in multiple sclerosis patients

2021

About ten years ago it was hoped that venous angioplasty for abnormal veins, primarily the internal jugular veins, will be a much awaited treatment for multiple sclerosis. Yet, a majority of randomized clinical trials on endovascular treatment for chronic cerebrospinal venous insufficiency did not reveal clinical efficacy of these procedures in multiple sclerosis patients. Still, a detailed analysis of these trials suggests that they were poorly designed, underpowered and endovascular techniques used were often far from being optimal. Nonetheless, even considering weak points of these trials, it can be concluded that venous angioplasty should not be used as a routine treatment modality in m…

chronic cerebrospinal venous insufficiency - internal jugular vein - multiple sclerosis - randomized clinical trialPhlebologie
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