Search results for "Randomized Clinical Trial"

showing 10 items of 23 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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Systematic review and meta-analysis on targeted therapy in advanced pancreatic cancer

2015

Abstract Aim A systematic review and meta-analysis from literature has been performed to assess the impact of targeted therapy in advanced pancreatic cancer. Methods By searching different literature databases and major cancer meetings proceedings, data from all randomized clinical trials designed to investigate molecular targeted agents in the treatment of advanced pancreatic cancer were collected. The time-frame between January 2007 and March 2015 was selected. Data on predefined end-points, including overall survival, progression-free survival in terms of Hazard Ratio and response-rate were extracted and analyzed by a random effects model. Pooled data analysis was performed according to …

0301 basic medicineOncologymedicine.medical_specialtyFunnel plotEndocrinology Diabetes and Metabolismmedicine.medical_treatmentAntineoplastic AgentsBioinformaticslaw.inventionTargeted therapy03 medical and health sciences0302 clinical medicineRandomized controlled triallawInternal medicineAntineoplastic Combined Chemotherapy ProtocolsHumansMedicineGenetic Predisposition to DiseaseMeta-analysiAdvanced pancreatic cancerHepatologybusiness.industryHazard ratioGastroenterologyCancerPancreatic cancerPublication biasmedicine.diseasePancreatic NeoplasmsClinical trial030104 developmental biology030220 oncology & carcinogenesisMeta-analysisRandomized clinical trialbusinessSignal TransductionPathwayPancreatology
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The Era of PARP inhibitors in ovarian cancer: “Class Action” or not? A systematic review and meta-analysis

2018

Abstract Introduction Carboplatin is the milestone of epithelial ovarian cancer (EOC) treatment, thus response to platinum is the major prognostic factor. Among platinum-sensitive patients, 40% carry a germline or somatic BRCA1/2 mutation. In this scenario a new class of drugs, the PARP inhibitors (PARPis), produced a significant improvement in long-term disease control. In order to make an aggregate evaluation of the impact of these agents, we performed a systematic review and meta-analysis. Patients and Methods Clinical trials were selected by searching “Pubmed” database and abstracts from major cancer meetings. We considered the January 2008 - April 2018 time frame. Progression free surv…

0301 basic medicineOncologymedicine.medical_specialtySettore MED/06 - Oncologia MedicaPoly (ADP-Ribose) Polymerase-1Poly(ADP-ribose) Polymerase Inhibitorslaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled triallawOvarian cancerInternal medicinemedicineHumansMeta-analysiProgression-free survivalAdverse effectOvarian Neoplasmsbusiness.industryHazard ratioHematologyPrognosisClinical trial030104 developmental biologyPARP inhibitorOncology030220 oncology & carcinogenesisMeta-analysisRelative riskCohortFemaleRandomized clinical trialMaintenance therapybusiness
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Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials

2005

Summary Background Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. Methods We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO g…

AdultMaleOncologymedicine.medical_specialtyLung NeoplasmsNeutropeniamedicine.medical_treatmentAntineoplastic AgentsNeutropenia.VinorelbineSeverity of Illness IndexCarcinoma Non-Small-Cell LungInternal medicinemedicineHumansLung cancerSurvival rateAgedProportional Hazards ModelsRandomized Controlled Trials as TopicAged 80 and overChemotherapyDose-Response Relationship Drugbusiness.industryStandard treatmentHazard ratioMiddle Agedrandomized clinical trialmedicine.diseaseGemcitabineSurgerySurvival Ratelandmark analysisnon-small-cell lung cancerItalyOncologychemotherapy-induced neutropeniaFemaleDrug MonitoringbusinessBiomarkersmedicine.drug
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Combination therapy with amantadine and interferon in naı̈ve patients with chronic hepatitis C: meta-analysis of individual patient data from six cli…

2003

Abstract Background/Aims In chronic hepatitis C, clinical trials evaluating the efficacy of amantadine (AMA) and interferon (INF) compared to INF monotherapy, have produced conflicting results. We performed a meta-analysis of the individual patient's data from previous studies. Methods Nine hundred and seventy-two patients from six European centres were evaluated by means of individual patient meta-analysis, using mixed models with centres and the centre–treatment interaction fitted as random variables. Results At the end of therapy, virological responses were 38.5% (95% CI 34.1–42.8) after INF and AMA, and 29.5% (95% CI 25.5–33.6) after INF alone (P=0.003). Sustained response occurred in 1…

AdultMalemedicine.medical_specialtyGenotypeCombination therapyHepacivirusAntiviral AgentsGastroenterologymeta-analysilaw.inventionchemistry.chemical_compoundPharmacotherapyRandomized controlled triallawInternal medicineparasitic diseasesAmantadinemedicinechronic hepatitis CHumansAgedRandomized Controlled Trials as TopictherapyDose-Response Relationship DrugHepatologybusiness.industryRibavirinAmantadineAlanine TransaminaseinterferonHepatitis CHepatitis C ChronicMiddle AgedViral Loadrandomized clinical trialmedicine.diseaseClinical trialTreatment OutcomechemistryImmunologyDrug Therapy CombinationFemaleInterferonsbusinessViral loadmedicine.drugJournal of Hepatology
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Peri‐implant marginal bone loss reduction with platform‐switching components: 5‐Year post‐loading results of an equivalence randomized clinical trial

2019

Abstract Aim To compare the clinical performance and marginal bone levels of implants restored with platform‐switching (PS) or platform‐matching (PM) abutments. Materials and Methods Adult patients missing two or more adjacent teeth in the posterior mandible received 2–4 CAMLOG SCREW‐LINE implants and were randomly allocated to the PM or PS group, receiving the corresponding prosthetic components from surgery onwards. Implants were conventionally loaded with single cemented crowns. Patients were followed annually for 5 years. Outcome measures were marginal bone level changes, implant survival, performance of the prosthetic components and clinical parameters plaque index, sulcus bleeding ind…

AdultPlaque indeximplantPlatform switchingPeriAlveolar Bone LossDentistryMandiblelaw.inventioncrestal bone preservation03 medical and health sciences0302 clinical medicineRandomized controlled triallawMedicineHumans030212 general & internal medicinestandardized radiographBone levelSurvival rateImplant DentistryCrownsbusiness.industryplatform switchingDental Implantation EndosseousDental Plaque IndexClinical performancebone levelDental Implant-Abutment Design030206 dentistryrandomized clinical trialTreatment Outcomeimplant successplatform matchPeriodonticsImplantDental Prosthesis Implant-SupportedbusinessImplant TherapyFollow-Up StudiesJournal of Clinical Periodontology
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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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Impact of abutment geometry on early implant marginal bone loss. A double‐blind, randomized, 6‐month clinical trial

2022

Objectives The objective of this study was to analyze the impact of the abutment width on early marginal bone loss (MBL). Material and Methods A balanced, randomized, double-blind clinical trial with two parallel experimental arms was conducted without a control group. The arms were “cylindrical” abutment and “concave” abutment. Eighty hexagonal internal connection implants, each with a diameter of 4 × 10 mm, were placed in healed mature bone. The main variable was the peri-implant tissue stability, which was measured as MBL at 8 weeks and 6 months. Results The final sample consisted of 77 implants that were placed in 25 patients. 38 (49.4%) were placed using the cylindrical abutment, and t…

Dental Implantsdental implantprostheses abutment widthDental Implantation EndosseousAlveolar Bone LossDental AbutmentsDental Implant-Abutment DesignUNESCO::CIENCIAS TECNOLÓGICASearly marginal bone lossrandomized clinical trialDental Implants Single-Toothsingle toothHumansOral SurgeryClinical Oral Implants Research
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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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