Search results for "clinical trial"

showing 10 items of 1656 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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Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast ca…

2017

Abstract Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Resul…

0301 basic medicineOncologyReceptor ErbB-2chemistry.chemical_compoundErbB-20302 clinical medicineDose-intensityExemestane80 and overNeoplasm MetastasisFulvestrantAged 80 and overeducation.field_of_studyAdvanced breast cancer Dose-intensity Everolimus Fulvestrant Hormone-receptor positiveAdvanced breast cancer; Dose-intensity; Everolimus; Fulvestrant; Hormone-receptor positive; Adult; Aged; Aged 80 and over; Androstadienes; Breast Neoplasms; Everolimus; Female; Follow-Up Studies; Humans; Middle Aged; Neoplasm Metastasis; Neoplasm Staging; Receptor ErbB-2; SurgeryGeneral MedicineMiddle AgedEverolimu030220 oncology & carcinogenesisAdvanced breast cancerFemaleAdvanced breast cancer; Dose-intensity; Everolimus; Fulvestrant; Hormone-receptor positive; SurgeryReceptormedicine.drugAdultmedicine.medical_specialtyPopulationSocio-culturaleBreast NeoplasmsHormone-receptor positive03 medical and health sciencesBreast cancerAdvanced breast cancer; Dose-intensity; Everolimus; Fulvestrant; Hormone-receptor positive; Adult; Aged; Aged 80 and over; Androstadienes; Breast Neoplasms; Everolimus; Female; Follow-Up Studies; Humans; Middle Aged; Neoplasm Metastasis; Neoplasm Staging; Receptor ErbB-2Internal medicinemedicineHumansEverolimusAdverse effecteducationAgedNeoplasm StagingGynecologyEverolimusFulvestrantbusiness.industryfungiCancermedicine.diseaseAndrostadienesClinical trial030104 developmental biologychemistrySurgerybusinessFollow-Up StudiesThe Breast
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Can KRAS and BRAF mutations limit the benefit of liver resection in metastatic colorectal cancer patients? A systematic review and meta-analysis.

2016

Clinical trials investigated the potential role of both KRAS and BRAF mutations, as prognostic biomarkers, in colorectal cancer (CRC) patients who underwent surgical treatment of CRC-related liver metastases (CLM), showing conflicting results. This meta-analysis aims to review all the studies reporting survival outcomes (recurrence free survival (RFS), and/or overall survival (OS)) of patients undergoing resection of CLM, stratified according to KRAS and/or BRAF mutation status. Background: Clinical trials investigated the potential role of both KRAS and BRAF mutations, as prognostic biomarkers, in colorectal cancer (CRC) patients who underwent surgical treatment of CRC-related liver metast…

0301 basic medicineOncologyendocrine system diseasesColorectal cancerLiver metastasimedicine.medical_treatmentColorectal Neoplasmmedicine.disease_cause0302 clinical medicineLiver metastasisHematologyTumorLiver NeoplasmsHematologyPrognosisSurvival RateOncologyLiver Neoplasm030220 oncology & carcinogenesisMeta-analysisKRASColorectal NeoplasmsHumanProto-Oncogene Proteins B-rafmedicine.medical_specialtyPrognostic biomarkerPrognosiResectionBRAFProto-Oncogene Proteins p21(ras)03 medical and health sciencesInternal medicineBRAF; Colorectal cancer; KRAS; Liver metastasis; Prognostic biomarker; Biomarkers Tumor; Colorectal Neoplasms; Humans; Liver Neoplasms; Mutation; Prognosis; Proto-Oncogene Proteins B-raf; Proto-Oncogene Proteins p21(ras); Survival Rate; Hepatectomy; Oncology; Hematology; Geriatrics and GerontologymedicineKRASBiomarkers TumorHepatectomyHumansneoplasmsSurvival ratebusiness.industrymedicine.diseaseColorectal cancerdigestive system diseasesClinical trial030104 developmental biologyMutationBRAF; Colorectal cancer; KRAS; Liver metastasis; Prognostic biomarker; Biomarkers; Tumor; Colorectal Neoplasms; Humans; Liver Neoplasms; Mutation; Prognosis; Proto-Oncogene Proteins B-raf; Proto-Oncogene Proteins p21(ras); Survival Rate; Hepatectomy; Oncology; Hematology; Geriatrics and GerontologyHepatectomyGeriatrics and GerontologybusinessBiomarkersCritical reviews in oncology/hematology
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Treatment of invasive fungal diseases in cancer patients—Revised 2019 Recommendations of the Infectious Diseases Working Party (AGIHO) of the German …

2020

Background Invasive fungal diseases remain a major cause of morbidity and mortality in cancer patients undergoing intensive cytotoxic therapy. The choice of the most appropriate antifungal treatment (AFT) depends on the fungal species suspected or identified, the patient's risk factors (eg length and depth of granulocytopenia) and the expected side effects. Objectives Since the last edition of recommendations for 'Treatment of invasive fungal infections in cancer patients' of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) in 2013, treatment strategies were gradually moving away from solely empirical therapy of presumed or possib…

0301 basic medicineOncologymedicine.medical_specialtyAntifungal Agents030106 microbiologyMedizinDermatologyNeutropeniaAspergillosis030207 dermatology & venereal diseases03 medical and health sciencesImmunocompromised Host0302 clinical medicineInternal medicineNeoplasmsmedicineHumansHematologybusiness.industryMucormycosisCancerGeneral MedicineGuidelineEvidence-based medicineHematologymedicine.diseaseClinical trialInfectious DiseasesHematologic NeoplasmsPractice Guidelines as TopicbusinessInvasive Fungal InfectionsAgranulocytosis
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Clinical pharmacokinetics and pharmacodynamics of ramucirumab in the treatment of colorectal cancer

2016

Colorectal cancer is the third most common cancer worldwide. The prognosis of colorectal cancer patients still remains dismal and half of them will develop metastatic disease. Angiogenesis plays an essential role in colorectal tumorigenesis, and the VEGF pathway is one of the targets that has been validated up to now. The use of antiangiogenics along with chemotherapy has become an accepted standard for colorectal cancer.This review discusses the efficacy and safety profile of ramucirumab, a fully human immunoglobulin G1 monoclonal antibody against the vascular endothelial growth factor receptor-2 (VEGFR-2), for the treatment of second-line metastatic colorectal cancer upon progression to f…

0301 basic medicineOncologymedicine.medical_specialtyBevacizumabAngiogenesisColorectal cancermedicine.medical_treatmentDrug Evaluation PreclinicalAngiogenesis InhibitorsDiseaseAntibodies Monoclonal HumanizedToxicologyRamucirumab03 medical and health scienceschemistry.chemical_compoundClinical Trials Phase II as Topic0302 clinical medicineInternal medicinemedicineAnimalsHumansRandomized Controlled Trials as TopicPharmacologyChemotherapyClinical Trials Phase I as TopicNeovascularization Pathologicbusiness.industryAntibodies MonoclonalCancerGeneral Medicinemedicine.diseaseVascular endothelial growth factorDisease Models Animal030104 developmental biologyClinical Trials Phase III as Topicchemistry030220 oncology & carcinogenesisColorectal Neoplasmsbusinessmedicine.drugExpert Opinion on Drug Metabolism & Toxicology
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GOLFIG Chemo-Immunotherapy in Metastatic Colorectal Cancer Patients. A Critical Review on a Long-Lasting Follow-Up

2019

Background: GOLFIG is a chemo-immunotherapy regimen established in preclinical models that combines gemcitabine + FOLFOX (fluoropyrimidine backbone coupled to oxaliplatin) poly-chemotherapy with low-dose s. c. recombinant interleukin-2 (rIL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF). Promising antitumor effects in metastatic colorectal cancer (mCRC) patients were obtained in previous phase II and III trials. Here we report the results of 15 years of follow-up. Methods: This is a multi-institutional retrospective analysis including 179 mCRC patients receiving GOLFIG regimen between June 2002 and June 2018. Sixty-two of them received the treatment as frontline (enrolled …

0301 basic medicineOncologymedicine.medical_specialtyCancer ResearchColorectal cancermedicine.medical_treatmentcolorectal cancerchemotherapylcsh:RC254-28203 medical and health sciences0302 clinical medicineFOLFOXInternal medicineMedicineAdverse effectOriginal ResearchChemotherapybusiness.industryHazard ratiolcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogensmedicine.diseasechemotherapy; colorectal cancer; GOLFIG; immunotherapy; metastatic; phase III clinical trial; real-world medicineGemcitabineOxaliplatinmetastaticRegimen030104 developmental biologyOncology030220 oncology & carcinogenesisGOLFIGphase III clinical trialimmunotherapyreal-world medicinebusinessmedicine.drug
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The role of chemotherapy in localized and locally advanced rectal cancer: A systematic revision

2017

Curative treatment of rectal cancer depends on an optimal surgical resection, with the addition of neoadjuvant radiotherapy (RT) with or without concomitant chemotherapy (ChT) in more advanced tumors. The role of adjuvant ChT is controversial and a more intensified neoadjuvant approach with the addition of ChT before or after RT, or even as single modality, is currently being explored in trials. A systematic review selecting randomised phase II and III trials on the role of ChT in localized rectal cancer was performed. Data show that neoadjuvant ChRT improves locoregional control in resected rectal cancer. Short-course RT (SCRT) could give similar outcomes to ChRT. The addition of oxaliplat…

0301 basic medicineOncologymedicine.medical_specialtyColorectal cancermedicine.medical_treatmentAntineoplastic Agents03 medical and health sciences0302 clinical medicineClinical Trials Phase II as TopicPreoperative chemoradiationInternal medicineMedicineCombined Modality TherapyHumansRadiology Nuclear Medicine and imagingRectal cancerNeoadjuvant therapyRandomized Controlled Trials as TopicChemotherapybusiness.industryRectal NeoplasmsGeneral MedicineAdjuvant chemotherapy; Preoperative chemoradiation; Rectal cancermedicine.diseaseCombined Modality TherapyNeoadjuvant TherapyOxaliplatinAdjuvant chemotherapyRadiation therapy030104 developmental biologyOncologyClinical Trials Phase III as Topic030220 oncology & carcinogenesisConcomitantRadiotherapy AdjuvantbusinessAdjuvantmedicine.drug
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JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatel…

2020

A Japan Society of Clinical Oncology (JSCO)-hosted expert meeting was held in Japan on 27 October 2019, which comprised experts from the JSCO, the Japanese Society of Medical Oncology (JSMO), the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the Taiwan Oncology Society (TOS). The purpose of the meeting was to focus on what we have learnt from both microsatellite instability (MSI)/deficient mismatch repair (dMMR) biomarkers in predicting the efficacy of anti-programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) immunotherapy, and the neurotrophic tyrosine receptor kinase (NTRK) gene fusions in predicting the efficacy of inhibitors o…

0301 basic medicineOncologymedicine.medical_specialtyConsensusTaiwanEntrectinibPembrolizumabMedical Oncology03 medical and health sciences0302 clinical medicineJapanInternal medicineNeoplasmsmedicineHumansIn patientTumor typeSolid tumourClinical Trials as Topicbusiness.industryMicrosatellite instabilityExpert consensusHematologymedicine.diseaseClinical trial030104 developmental biologyOncology030220 oncology & carcinogenesisMicrosatellite InstabilitybusinessAnnals of oncology : official journal of the European Society for Medical 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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