Search results for " Clinical Trials"

showing 10 items of 79 documents

Randomized clinical trial of prophylactic transanal irrigation

2019

Background Low anterior resection syndrome (LARS) is a frequent problem after rectal resection. Transanal irrigation (TAI) has been suggested as an effective treatment in patients who have developed LARS. This prospective RCT was undertaken to evaluate the effect of TAI as a prophylactic treatment to prevent symptoms of LARS. Methods Patients who had undergone ultralow rectal resection were randomized to start TAI on a daily basis, or to serve as a control with supportive therapy only after ileostomy closure. All patients were seen after 1 week, 1 month and 3 months, and the maximum number of defaecation episodes per day and night documented during follow‐up. Wexner score, LARS score and Sh…

MalePostoperative ComplicationsProctectomyRandomized Clinical TrialsRandomized Clinical TrialAnal CanalHumansFemaleMiddle AgedDefecationTherapeutic Irrigationhuman activitiesAgedBJS open
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Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multicenter, three-armed randomized…

2017

Depression is one of the most common mental disorders and will become one of the leading causes of disability in the world. Internet-based CBT programs for depression have been classified as well established following the American Psychological Association criteria for empirically supported treatments. The aim of this study is to analyze the cost effectiveness at 12-month follow-up of the Internet-based CBT program Smiling is fun with (LITG) and without psychotherapist support (TSG) compared to usual care. The perspective used in our analysis is societal. A sample of 296 depressed patients (mean age of 43.04 years; 76% female; BDI-II mean score = 22.37) from primary care services in four Sp…

MaleSpanish PeopleEconomicsPsychological interventionSocial SciencesSeverity of Illness Indexlaw.invention:Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings]Learning and Memory0302 clinical medicineHispanoamericanosEthnicitiesPsychologyAnálisis de intención de tratarlcsh:Sciencemediana edadancianoDepressionAntidepressantsadulto:Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care [Medical Subject Headings]Humanosadulto joven:Health Care::Health Care Quality Access and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic::Intention to Treat Analysis [Medical Subject Headings]Psicoterapia:Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks::Internet [Medical Subject Headings]medicine.medical_specialtyEvidence-based practiceGrupos control03 medical and health sciences:Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis [Medical Subject Headings]Drug TherapySeverity of illnessHumans:Persons::Persons::Age Groups::Adult [Medical Subject Headings]psicoterapiaAgedPharmacologyDepressive DisorderDepressive Disorder MajorInternetPrimary Health CareMood Disorderslcsh:RBiology and Life SciencesSonrisa030227 psychiatryHealth CareAnálisis costo-beneficio:Check Tags::Female [Medical Subject Headings]Economic evaluationlcsh:QPopulation GroupingsNeuroscienceGerontologyFinancial ManagementCost effectivenessCost-Benefit Analysishumanosadolescentelcsh:MedicineTrastorno depresivoRandomized controlled triallawDepresiónMedicine and Health Sciences030212 general & internal medicineMultidisciplinaryAdultoPharmaceuticsresultado del tratamientoFemeninoDrugsCost-effectiveness analysisMiddle AgedTelemedicineTreatment OutcomeSociedades científicasFemale:Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Communication::Nonverbal Communication::Facial Expression::Smiling [Medical Subject Headings]Estudios de seguimiento:Persons::Persons::Population Groups::Ethnic Groups::Hispanic Americans [Medical Subject Headings]telemedicinaResearch ArticleAdultAdolescent:Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research Design::Control Groups [Medical Subject Headings]:Psychiatry and Psychology::Behavioral Disciplines and Activities::Psychotherapy [Medical Subject Headings]Cost-Effectiveness AnalysisMEDLINEYoung Adulttrastorno depresivoAtención primaria de saludMental Health and PsychiatryIndirect CostsmedicineLearningíndice de gravedad de la enfermedadPrimary Care:Psychiatry and Psychology::Mental Disorders::Mood Disorders::Depressive Disorder [Medical Subject Headings]:Health Care::Health Care Economics and Organizations::Organizations::Societies::Societies Scientific [Medical Subject Headings]Cognitive Behavioral Therapybusiness.industryCognitive Psychology:Health Care::Health Care Quality Access and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Follow-Up Studies [Medical Subject Headings]Economic AnalysisPsychotherapyPeople and PlacesPhysical therapyCognitive Science:Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Behavioral Symptoms::Depression [Medical Subject Headings]businessFinance
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Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a …

2019

BackgroundThe World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a blended low-intensity psychological intervention applied using information and communication technologies (ICTs) for the treatment of …

MaleTecnología de la informaciónhumanosPsychological interventiondepresiónEnsayo clínico controlado aleatoriolaw.invention:Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings]dolor lumbarStudy Protocol0302 clinical medicineRandomized controlled triallawlcsh:PsychiatryDepresiónHealth careGlobal healthMedicine030212 general & internal medicineRandomized Controlled Trials as Topic:Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings]:Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings]:Diseases::Pathological Conditions Signs and Symptoms::Pathologic Processes::Disease Attributes::Chronic Disease [Medical Subject Headings]Depressionensayos clínicos controlados aleatorizados como asuntoMultimorbilidadadultoPrimary careLow back pain:Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care [Medical Subject Headings]Psychiatry and Mental healthdiabetes mellitus:Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks::Internet [Medical Subject Headings]:Diseases::Pathological Conditions Signs and Symptoms::Signs and Symptoms::Pain::Back Pain::Low Back Pain [Medical Subject Headings]Femalemedicine.symptomAdultmedicine.medical_specialtyenfermedad crónicalcsh:RC435-571:Check Tags::Male [Medical Subject Headings]03 medical and health sciencesInformation and communication technologies (ICTs)Atención primaria de saludIntervention (counseling)Humans:Persons::Persons::Age Groups::Adult [Medical Subject Headings]:Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings]InternetPrimary Health Carebusiness.industry:Diseases::Endocrine System Diseases::Diabetes Mellitus::Diabetes Mellitus Type 2 [Medical Subject Headings]Multimorbidity:Health Care::Health Care Facilities Manpower and Services::Health Personnel::Physicians::Physicians Primary Care [Medical Subject Headings]medicine.diseaseComorbidity030227 psychiatryClinical trial:Check Tags::Female [Medical Subject Headings]Diabetes Mellitus Type 2SpainChronic DiseasePhysical therapyRandomized controlled trial (RCT)business:Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Behavioral Symptoms::Depression [Medical Subject Headings]Low Back PainBMC psychiatry
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IMPACT OF SHORTENED DENTAL ARCH ON ORAL HEALTH-RELATED QUALITY OF LIFE.

2021

Abstract Background A shortened dental arch (SDA) is an established treatment concept for patients with missing molars. However, little is known regarding long-term course of oral health-related quality of life (OHRQoL) in patients with SDA and the benefits from replacement of missing molars. Aim Purpose of this multi-center randomized clinical trial was to assess OHRQoL over a period of 15 years in patients with molar replacement by a removable partial denture (RPD) compared to patients with a restored SDA without molar replacement. Design Patients at least 35 years of age with all molars missing in one jaw and at least the canine and one premolar present on each side were included. Patien…

MolarAdultOrofacial painDentistry610Oral Healthlaw.inventionDental ArchQuality of lifeRandomized controlled triallawSurveys and QuestionnairesPremolarmedicineOral rehabilitationHumansGeneral Dentistrybusiness.industryDental prosthesishumanitiesDental archmedicine.anatomical_structureDenture precision attachmentQuality of LifeDenture Partial RemovableRandomized clinical trialsmedicine.symptombusinessRemovable partial dentureThe journal of evidence-based dental practice
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Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series.

2014

Objective To analyze the feasibility of laparoscopic/robotic secondary cytoreductive surgery and hyperthermic intraperitoneal intra-operative chemotherapy (SCS + HIPEC) in a retrospective series of isolated platinum sensitive recurrent ovarian cancer. Methods We retrospectively evaluated a consecutive series of ovarian cancer patients with isolated platinum sensitive relapse. Isolated relapse was defined as the presence of a single nodule, in a single anatomic site. In all cases the presence of isolated relapse was assessed at pre-operative FDG-PET/CT scan, and confirmed with staging laparoscopy performed immediately before SCS + HIPEC. Results 84 women with platinum sensitive relapse recei…

OVARIAN CANEROrganoplatinum Compoundsmedicine.medical_treatmentdrug therapy/pathology/surgery/therapyCarcinoma Ovarian EpithelialMultimodal ImagingCohort StudiesObstetrics and gynaecologyNeoplasmsAntineoplastic Combined Chemotherapy ProtocolsInfusions ParenteralNeoplasms Glandular and EpithelialLaparoscopyadministration /&/ dosageTomographyRandomized Controlled Trials as TopicOvarian Neoplasmsmedicine.diagnostic_testObstetrics and GynecologyGlandular and EpithelialMiddle AgedDebulkingCombined Modality TherapyIsolated platinum sensitive relapseX-Ray ComputedOxaliplatinPhase III as TopicOncologyFemalediagnostic usemedicine.drugmedicine.medical_specialtyInfusionsAged Antineoplastic Combined Chemotherapy Protocols; administration /&/ dosage Cisplatin; administration /&/ dosage Clinical Trials; Phase II as Topic Clinical Trials; Phase III as Topic Cohort Studies Combined Modality Therapy Female Fluorodeoxyglucose F18; diagnostic use Humans Hyperthermia; Induced; methods Infusions; Parenteral Middle Aged Minimally Invasive Surgical Procedures Multimodal Imaging Neoplasms; Glandular and Epithelial; drug therapy/pathology/surgery/therapy Organoplatinum Compounds; administration /&/ dosage Ovarian Neoplasms; drug therapy/pathology/surgery/therapy Positron-Emission Tomography Radiopharmaceuticals; diagnostic use Randomized Controlled Trials as Topic Retrospective Studies Tomography; X-Ray Computed ocal; pathologyocalmethodsClinical Trials Phase II as TopicMinimally invasive surgeryOvarian cancerFluorodeoxyglucose F18ParenteralmedicineHumansMinimally Invasive Surgical ProceduresClinical TrialsHyperthermiaAgedRetrospective StudiesCisplatinChemotherapySeries (stratigraphy)HIPECbusiness.industryPhase II as TopicInducedHyperthermia Inducedmedicine.diseaseOxaliplatinSurgeryRoboticSettore MED/40 - GINECOLOGIA E OSTETRICIAClinical Trials Phase III as TopicPositron-Emission TomographyLaparoscopypathologyNeoplasm Recurrence LocalCisplatinRadiopharmaceuticalsbusinessOvarian cancerTomography X-Ray Computed
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Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations

2017

International audience; Patients with mantle cell lymphoma (MCL) usually respond to initial combination chemotherapy, but the disease inevitably relapses and often follows an aggressive course. Here, clinical study results published since 2008 for patients with relapsed/refractory MCL were reviewed to compare available evidence for treatment guidance. Most trials identified were non-randomized, phase II studies performed at a limited number of sites, and many evaluated MCL as one of multiple non-Hodgkin lymphoma subtypes. Additional randomized, comparative trials are needed. Treatment selection generally depends on patient need, age and fitness, time of relapse, and line of therapy. Combina…

OncologyCancer ResearchLymphomaDrug ResistanceLymphoma Mantle-Cell[ SDV.CAN ] Life Sciences [q-bio]/Cancerchemistry.chemical_compound0302 clinical medicineimmune system diseaseshemic and lymphatic diseasesAntineoplastic Combined Chemotherapy ProtocolsMedicineChemotherapy ; clinical trials ; mantle cell lymphoma ; molecular targeted therapyBortezomibCombination chemotherapyclinical trialChemotherapy; clinical trials; mantle cell lymphoma; molecular targeted therapy; Hematology; Oncology; Cancer ResearchHematologyTemsirolimusEuropeLocalOncology030220 oncology & carcinogenesisIbrutinibPractice Guidelines as TopicRituximabRituximabmedicine.drugmedicine.medical_specialtymolecular targeted therapymantle cell lymphoma03 medical and health sciencesClinical Trials Phase II as TopicInternal medicineHumansChemotherapyLenalidomideclinical trialsbusiness.industryPhase II as TopicMantle-Cellmedicine.diseaseClinical trialChemotherapy; clinical trials; mantle cell lymphoma; molecular targeted therapy; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials Phase II as Topic; Drug Resistance Neoplasm; Europe; Humans; Lymphoma Mantle-Cell; Neoplasm Recurrence Local; Practice Guidelines as Topic; RituximabNeoplasm RecurrencechemistryDrug Resistance NeoplasmNeoplasmMantle cell lymphomaNeoplasm Recurrence Localbusiness030215 immunology
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Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists

2010

Abstract Background Overall survival (OS) is the gold standard for the demonstration of a clinical benefit in cancer trials. Replacement of OS by a surrogate endpoint allows to reduce trial duration. To date, few surrogate endpoints have been validated in digestive oncology. The aim of this study was to draw up an ordered list of potential surrogate endpoints for OS in digestive cancer trials, by way of a survey among clinicians and methodologists. Secondary objective was to obtain their opinion on surrogacy and quality of life (QoL). Methods In 2007 and 2008, self administered sequential questionnaires were sent to a panel of French clinicians and methodologists involved in the conduct of …

OncologyCancer ResearchTime FactorsDigestive System Neoplasms[ SDV.CAN ] Life Sciences [q-bio]/Cancer0302 clinical medicineQuality of lifeSurveys and QuestionnairesMedicine030212 general & internal medicineMESH: Treatment OutcomeResponse rate (survey)MESH : Evidence-Based MedicineClinical Trials as TopicEvidence-Based MedicineMESH: Endpoint DeterminationMESH: Research DesignMESH : QuestionnairesMESH : Research Designlcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens3. Good healthMESH: Reproducibility of Resultsmedicine.anatomical_structureTreatment OutcomeOncologyResearch Design030220 oncology & carcinogenesisData Interpretation StatisticalMESH: Survival AnalysisMESH : Disease-Free SurvivalMESH : Endpoint DeterminationFranceMESH : Time FactorsResearch Articlemedicine.medical_specialtyMESH: Clinical Trials as TopicEndpoint DeterminationRectum[SDV.CAN]Life Sciences [q-bio]/CancerMESH : Treatment Outcomelcsh:RC254-282Disease-Free Survival03 medical and health sciences[SDV.CAN] Life Sciences [q-bio]/CancerInternal medicineGeneticsHumansMESH : Data Interpretation StatisticalMESH : FranceSurvival analysisMESH: Humansbusiness.industrySurrogate endpointMESH: Digestive System NeoplasmsMESH : Reproducibility of ResultsMESH: QuestionnairesMESH : HumansMESH: Time FactorsCancerReproducibility of ResultsMESH: Quality of LifeMESH : Quality of Lifemedicine.diseaseSurvival AnalysisMESH : Clinical Trials as TopicMESH: FranceLocalized diseaseEndpoint DeterminationMESH: Disease-Free SurvivalQuality of LifeMESH : Digestive System NeoplasmsMESH : Survival AnalysisbusinessMESH: Data Interpretation StatisticalMESH: Evidence-Based MedicineBMC Cancer
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PDCT-08. SUPERIOR OUTCOME FOR BRAF V600E PEDIATRIC GLIOMAS TREATED WITH TARGETED BRAF INHIBITION

2019

Abstract BACKGROUND Children with pediatric low grade glioma’s (PLGG) harboring BRAF V600E mutation have poor outcome due to relative resistance to chemo-radiation and higher risk of malignant transformation. However, the role of targeted BRAF inhibition in these tumors is poorly defined. METHODS We assembled an international cohort of children with BRAF V600E mutant gliomas treated with BRAF inhibition, from 29 centers participating in the PLGG taskforce, and collected response, survival and molecular parameters. RESULTS Sixty-seven patients were treated with BRAFi (56 PLGG and 11 high grade gliomas) for a median time of 17.4 months (6 – 61 months), with 13 PLGG treated upfront. Objective …

OncologyCancer Researchmedicine.medical_specialtyChemotherapyPediatric Clinical Trialsbusiness.industrymedicine.medical_treatmentmedicine.diseaseChemotherapy regimenDiscontinuationOncologyCDKN2AConcomitantInternal medicineGliomamedicineNeurology (clinical)Progression-free survivalbusinessProspective cohort studyNeuro-Oncology
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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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Non small cell lung cancer patients with ECOG PS2: unsolved questions and lessons from clinical trials

2005

In the last two decades the results of medical treatment of advanced non-small cell lung cancer (NSCLC) have constantly improved even if they are still far from being considered satisfactory. Today systemic cisplatin-based chemotherapy (CT) is able to increase survival and improve cancer-related symptoms in patients with advanced ‘wet’ stage III and metastatic stage IV NSCLC, but it not clear if the benefits of CT also apply to patients with poor performance status (PS) [1, 2]. PS is the most powerful independent prognostic factor in advanced NSCLC since it is a reliable measure of functional independence, ability to perform daily activities and work, and a strong predictor of survival and …

Oncologymedicine.medical_specialtyLung Neoplasmsbusiness.industryDrugs Investigationallung cancer performance status 2 chemotherapy best supportive careHematologymedicine.diseaseClinical trialRegimenOncologyQuality of lifeCarcinoma Non-Small-Cell LungInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicineHumansControlled Clinical Trials as TopicStage (cooking)Lung cancerbusinessAdverse effectSurvival rateSurvival analysisNeoplasm StagingAnnals of Oncology
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