Search

Your search keyword '"Hospital Clinic i Provincial de Barcelona (SCReN)"' showing total 7 results
Start Over Author "Hospital Clinic i Provincial de Barcelona (SCReN)"
7 results on '"Hospital Clinic i Provincial de Barcelona (SCReN)"'

1. Minimum information about tolerogenic antigen-presenting cells (MITAP): a first step towards reproducibility and standardisation of cellular therapies

Author

Lord, Phillip, Aguillon, Juan C, Anderson, Amy E, Appel, Silke, Benitez-Ribas, Daniel, Ten Brinke, Anja, Broere, Femke, Cools, Nathalie, Cuturi, Maria Cristina, Diboll, Julie, Geissler, Edward K, Giannoukakis, Nick, Gregori, Silvia, van Ham, S Marieke, Lattimer, Staci, Marshall, Lindsay, Harry, Rachel A, Hutchinson, James A, Isaacs, John D, Joosten, Irma, van Kooten, Cees, Lopez Diaz de Cerio, Ascension, Nikolic, Tatjana, Oral, Haluk Barbaros, Sofronic-Milosavljevic, Ljiljana, Ritter, Thomas, Riquelme, Paloma, Thomson, Angus W, Trucco, Massimo, Vives-Pi, Marta, Martinez-Caceres, Eva M, Hilkens, Catharien M U, LS Immunologie, dI&I RA-I&I I&I, School of Computing Science [Newcastle], Newcastle University [Newcastle], Institute of Cellular Medicine [Newcastle], Instituto de Ciencias Biomédicas [Santiago, Chile] (Facultad de Medicina), Broegelmann Research Laboratory [Bergen, Norway] (Department of Clinical Science), University of Bergen (UiB), Department of Immunology [Barcelona, Spain], Hospital Clinic i Provincial de Barcelona (SCReN)-Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [Barcelona, Spain] (CIBERehd), Department of Immunopathology [Amsterdam, The Netherlands], University of Amsterdam [Amsterdam] (UvA), Department of Infectious Diseases and Immunology [Utrecht, The Netherlands], Utrecht University [Utrecht]-WHO Collaborating Center for Campylobacter /OIE Reference Laboratory for Campylobacteriosis (Utrecht), Laboratory of Experimental Hematology [Wilrijk, Belgium] (Faculty of Medicine and Health Sciences), University of Antwerp (UA)-Vaccine & Infectious Disease Institute [Wilrijk, Belgium] (VAXINFECTIO), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Institut de transplantation urologie-néphrologie (ITUN), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Department of Surgery, Section of Experimental Surgery [Regensburg, Germany], University Hospital Regensburg, Institute of Cellular Therapeutics [Pittsburgh, PA, USA], Allegheny Health Network, Division of Regenerative Medicine, Stem Cells and Gene Therapy [Milan, Italy], IRCCS Ospedale San Raffaele [Milan, Italy]-S. Raffaele Scientific Institute-San Raffaele Telethon Institute for Gene Therapy [Milan, Italy] (SR-Tiget), Department of Laboratory Medicine [Nijmegen, the Netherlands], Radboud Proteomics Centre [Nijmegen, the Netherlands], Department of Nephrology [Leiden, The Netherlands], Leiden University Medical Center (LUMC), Area of Cell Therapy [Pamplona, Spain], University Clinic of Navarra - CUN [Pamplona, Spain], Department of Immunohematology and Blood Transfusion [Leiden, The Netherlands], Department of Immunology [Bursa, Turkey] (Faculty of Medicine), Uludağ Üniversitesi = Uludag University, Institute for the Application of Nuclear Energy [Belgrade, Serbia] (INEP), University of Belgrade [Belgrade], Regenerative Medicine Institute [Galway, Ireland], National University of Ireland [Galway] (NUI Galway), Thomas E. Starzl Transplantation Institute [Pittsburgh, PA, USA], University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE)-Pennsylvania Commonwealth System of Higher Education (PCSHE), Immunology Division [Badalona, Spain], Health Sciences Research Institute [Badalona, Spain]-Germans Trias i Pujol University Hospital [Badalona, Spain], CIBER of Diabetes and Associated Metabolic Diseases [Madrid, Spain] (CIBERDEM), Instituto de Salud Carlos III [Madrid] (ISC), Department of Cellular Biology, Physiology and Immunology [Barcelona, Spain], Autonomous University of Barcelona, A grant from the European Cooperation in Science and Technology (COST) for the AFACTT project (Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies, BM1305). COST is part of the EU Framework Programme Horizon 2020., ~, LS Immunologie, dI&I RA-I&I I&I, Uludağ Üniversitesi/Tıp Fakültesi/İmmünoloji Anabilim Dalı., Oral, Haluk Barbaros, K-7285-2012, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [Barcelona, Spain] (CIBERehd)-Hospital Clinic i Provincial de Barcelona (SCReN), San Raffaele Telethon Institute for Gene Therapy [Milan, Italy] (SR-Tiget)-IRCCS Ospedale San Raffaele [Milan, Italy]-S. Raffaele Scientific Institute, Germans Trias i Pujol University Hospital [Badalona, Spain]-Health Sciences Research Institute [Badalona, Spain], Germans Trias i Pujol University Hospital [Badalona, Barcelona, Spain] (GTPUH)-Health Sciences Research Institute [Badalona, Spain], Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Universitat Autònoma de Barcelona (UAB), and Le Bihan, Sylvie

Subjects
0301 basic medicine, Science & technology - other topics, Macrophage, 610 Medizin, lcsh:Medicine, Celltherapy, Dendritic cells, Computational Science, Cell therapy, 0302 clinical medicine, Autoimmune disease, Prevalence, Tolerogenicdendriticcells, Medicine, Disease, Antigen-presentingcells, Regulatorymacrophages, ddc:610, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Antigen presenting cell, General Neuroscience, Tolerogenic dendritic cells, Gold standard, General Medicine, 3. Good health, Program sustainability, General Agricultural and Biological Sciences, Engineering sciences. Technology, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Dendritic cell, Human, Translational Medicine, Minimuminformationmodel, Immunology, Antigen-presenting cells, Computational biology, Multidisciplinary sciences, Article, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Clinical Trials, Immune response, Minimum information model, Antigen-presenting cell, Transplantation, business.industry, lcsh:R, Translational medicine, Reporting guidelines, Regulatory macrophages, 030104 developmental biology, business, Tolerogenic antigen resenting cell, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Dendritic Cells, Mixed Lymphocyte Culture Test, Regulatory T Lymphocyte, Model, 030215 immunology
Abstract

Cellular therapies, with tolerogenic antigen-presenting cells (tolAPC) show great promise for the treatment of autoimmune diseases and for the prevention of destructive immune responses after transplantation The methodologies for generating tolAPC vary greatly between different laboratories, making it difficult to compare data from different studies; thus constituting a major hurdle for the development of standardised tolAPC therapeutic products. Here we describe an initiative by members of the tolAPC field to generate a minimum information model for tolAPC (MITAP), providing a reporting framework that will make differences and similarities between tolAPC products transparent. In this way, MITAP constitutes a first but important step towards the production of standardised and reproducible tolAPC for clinical application. This work was supported by a grant from the European Cooperation in Science and Technology (COST) for the AFACTT project (Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies; BM1305). COST is part of the EU Framework Programme Horizon 2020. peer-reviewed

Published
2016
Full Text
View/download PDF

2. Liver transplantation for patients with acute-on-chronic liver failure (ACLF) in Europe: Results of the ELITA/EF-CLIF collaborative study (ECLIS)

Author

Luca S. Belli, Christophe Duvoux, Thierry Artzner, William Bernal, Sara Conti, Paolo A. Cortesi, Sophie-Caroline Sacleux, George-Philippe Pageaux, Sylvie Radenne, Jonel Trebicka, Javier Fernandez, Giovanni Perricone, Salvatore Piano, Silvio Nadalin, Maria C. Morelli, Silvia Martini, Wojciech G. Polak, Krzysztof Zieniewicz, Christian Toso, Marina Berenguer, Claudia Iegri, Federica Invernizzi, Riccardo Volpes, Vincent Karam, René Adam, François Faitot, Liane Rabinovich, Faouzi Saliba, Lucy Meunier, Mickael Lesurtel, Frank E. Uschner, Costantino Fondevila, Baptiste Michard, Audrey Coilly, Magdalena Meszaros, Domitille Poinsot, Andreas Schnitzbauer, Luciano G. De Carlis, Roberto Fumagalli, Paolo Angeli, Vincente Arroyo, Rajiv Jalan, Raffaella Viganò, Chiara Mazzarelli, Andrea Lauterio, Alessandro Giacomoni, Francesca Donato, Pietro Lampertico, Luisa Pasulo, Stefano Fagiuoli, Michele Colledan, Maria Cristina Morelli, Giovanni Vitale, Damiano Patrono, Renato Romagnoli, Antonio Ottobrelli, Ioannis Petridis, Umberto Cillo, Giacomo Germani, Patrizia Burra, Philippe Bachellier, Pietro Addeo, Camille Besch, Francoise Faitot, Sophie Caroline Sacleux, Saliba Faouzi, Rene Adam, Didier Samuel, Celine Guichon, Stéfanie Faure, Josè Ursic-Bedoya, Jorde Colmenero, David Toapanta, María Hernández-Tejero, Carmen Vinaixa, Caroline den Hoed, Jubi E. de Haan, Andrea Della Penna, Frank Erhard Uschner, Martin Welker, Stefan Zeuzem, Wolf Bechstein, Nicolas Goossens, Joanna Raszeja-Wyszomirska, Dev Katarey, Banwari Agarwal, Surgery, Internal Medicine, Gastroenterology & Hepatology, Intensive Care, ASST Great Metropolitan Niguarda / ASST Grande Ospedale Metropolitano Niguarda [Milan, Italia], Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital de Hautepierre [Strasbourg], King‘s College London, Ospedale Multimedica Sesto San Giovanni, Università degli Studi di Milano-Bicocca = University of Milano-Bicocca (UNIMIB), Centre Hépato-Biliaire [Hôpital Paul Brousse] (CHB), Hôpital Paul Brousse-Assistance Publique - Hôpitaux de Paris, Physiopathologie et traitement des maladies du foie, Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi], Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Service d'Hépatologie [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Goethe-University Frankfurt am Main, European Foundation for Study of Chronic Liver Failure [Barcelona] (EF CLIF), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Azienda Ospedale Università di Padova = Hospital-University of Padua (AOUP), Universitätsklinikum Tübingen - University Hospital of Tübingen, Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Azienda Ospedaliero-Universitaria di Bologna, Azienda Ospedalerio - Universitaria Città della Salute e della Scienza di Torino = University Hospital Città della Salute e della Scienza di Torino, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Medical University of Warsaw - Poland, Geneva University Hospitals and Geneva University, Hospital Universitari i Politècnic La Fe = University and Polytechnic Hospital La Fe, Hospital Papa Giovanni XXIII (Hosp P Giovanni XXIII), Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Pôle des Pathologies Digestives Hépatiques et Transplantation [Hôpital Hautepierre-Strasbourg], Department of Physiopatology and Transplantation, University of Milan (DEPT), Università degli Studi di Milano = University of Milan (UNIMI), Ospedale S. Giovanni Battista-Molinette, Azienda Ospedaliera di Padova, Università degli Studi di Padova = University of Padua (Unipd), Hospital Clinic i Provincial de Barcelona (SCReN), University College London Hospitals (UCLH), Belli, L, Duvoux, C, Artzner, T, Bernal, W, Conti, S, Cortesi, P, Sacleux, S, Pageaux, G, Radenne, S, Trebicka, J, Fernandez, J, Perricone, G, Piano, S, Nadalin, S, Morelli, M, Martini, S, Polak, W, Zieniewicz, K, Toso, C, Berenguer, M, Iegri, C, Invernizzi, F, Volpes, R, Karam, V, Adam, R, Faitot, F, Rabinovich, L, Saliba, F, Meunier, L, Lesurtel, M, Uschner, F, Fondevila, C, Michard, B, Coilly, A, Meszaros, M, Poinsot, D, Schnitzbauer, A, De Carlis, L, Fumagalli, R, Angeli, P, Arroyo, V, Jalan, R, Fagiuoli, S, Goossens, Nicolas, and Salvy-Córdoba, Nathalie

Subjects
Male, 0301 basic medicine, Multi-drug resistant organisms, medicine.medical_treatment, Waiting list, Salvage therapy, Liver transplantation, Severity of Illness Index, MESH: Proportional Hazards Models, Cohort Studies, 0302 clinical medicine, MESH: Risk Factors, Risk Factors, Medicine, MESH: Cohort Studies, Acute-on-Chronic Liver Failure, MESH: Aged, High rate, MESH: Middle Aged, ddc:617, Hazard ratio, MESH: Acute-On-Chronic Liver Failure, Middle Aged, Prognosis, Predictive factors, Italy, Female, 030211 gastroenterology & hepatology, Adult, MESH: Liver Transplantation, medicine.medical_specialty, MESH: Prognosis, 03 medical and health sciences, MESH: Severity of Illness Index, Internal medicine, Humans, Acute on chronic liver failure, Renal replacement therapy, Aged, Proportional Hazards Models, Retrospective Studies, MESH: Humans, Hepatology, business.industry, MESH: Italy, MESH: Adult, MESH: Retrospective Studies, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Retrospective cohort study, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Multi-drug resistant organism, MESH: Male, 030104 developmental biology, Predictive factor, business, MESH: Female
Abstract

Background & Aims: Liver transplantation (LT) has been proposed as an effective salvage therapy even for the sickest patients with acute-on-chronic liver failure (ACLF). This large collaborative study was designed to assess the current clinical practice and outcomes of patients with ACLF who are wait-listed for LT in Europe. Methods: This was a retrospective study including 308 consecutive patients with ACLF, listed in 20 centres across 8 European countries, from January 2018 to June 2019. Results: A total of 2,677 patients received a LT: 1,216 (45.4%) for decompensated cirrhosis. Of these, 234 (19.2%) had ACLF at LT: 58 (4.8%) had ACLF-1, 78 (6.4%) had ACLF-2, and 98 (8.1%) had ACLF-3. Wide variations were observed amongst countries: France and Germany had high rates of ACLF-2/3 (27-41%); Italy, Switzerland, Poland and the Netherlands had medium rates (9-15%); and the United Kingdom and Spain had low rates (3-5%) (p 4 mmol/L (hazard ratio [HR] 3.14; 95% CI 1.37-7.19), recent infection from multidrug resistant organisms (HR 3.67; 95% CI 1.63-8.28), and renal replacement therapy (HR 2.74; 95% CI 1.37-5.51) were independent predictors of post-LT mortality. During the same period, 74 patients with ACLF died on the waiting list. In an intention-to-treat analysis, 1-year survival of patients with ACLF on the LT waiting list was 73% for ACLF-1 or-2 and 50% for ACLF-3. Conclusion: The results reveal wide variations in the listing of patients with ACLF in Europe despite favourable post-LT survival. Risk factors for mortality were identified, enabling a more pre-cise prognostic assessment of patients with ACLF. Lay summary: Acute-on-chronic liver failure (ACLF) is a severe clinical condition for which liver transplantation is an effective therapeutic option. This study has demonstrated that in Europe, referral and access to liver transplantation (LT) for patients with ACLF needs to be harmonised to avoid inequities. Post-LT survival for patients with ACLF was >80% after 1 year and some factors have been identified to help select patients with favourable outcomes. (C) 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All reserved.

Published
2021
Full Text
View/download PDF

3. EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies

Author

Ramos-Casals, M., Brito-Zeron, P., Bombardieri, S., Bootsma, H., De Vita, S., Dorner, T., Fisher, B. A., Gottenberg, J. -E., Hernandez-Molina, G., Kocher, A., Kostov, B., Kruize, A. A., Mandl, T., W. -F., Ng, Retamozo, S., Seror, R., Shoenfeld, Y., Siso-Almirall, A., Tzioufas, A. G., Vitali, C., Bowman, S., EULAR-Sjögren Syndrome Task Force Group: Sebastian A, Mariette X., Saraux, A, Vissink, A, Rasmussen, A, Hofauer, B, Armagan, B, Feijoo-Massó, C, Shiboski, Ch, Baldini, C, Vollenweider, C, Sene, D, Hammenfors, D, Isenberg, D, Danda, D, Bartoloni, E, Hospital Clinic i Provincial de Barcelona (SCReN), CELLEX-IDIBAPS Department of Autoimmune Diseases, Barcelona, H. CIMA-Sanitas, Barcelona, University of Pisa - Università di Pisa, University of Groningen [Groningen], Ospedale 'Santa Maria della Misericordia' = University Hospital 'Santa Maria della Misericordia', Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], University of Birmingham [Birmingham], Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Immunopathologie et chimie thérapeutique (ICT), Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - National Institute of Medical Science and Nutrition Salvador Zubiran [Mexico], University Hospital Basel [Basel], Bern University Hospital [Berne] (Inselspital), Transverse group for research in primary care [Barcelona], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat Politècnica de Catalunya [Barcelona] (UPC), University Medical Center [Utrecht], Skane University Hospital [Malmo], Lund University [Lund], Newcastle University [Newcastle], Newcastle Upon Tyne Hospitals NHS Foundation Trust, Universidad de Córdoba = University of Córdoba [Córdoba], Universidad Nacional de Córdoba [Argentina], Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), The Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Saint Petersburg University (SPBU), CAP Les Corts (CAPSBE), National and Kapodistrian University of Athens (NKUA), Santo Stefano Riabilitazione, University Hospitals Birmingham [Birmingham, Royaume-Uni], Centre National de la Recherche Scientifique (CNRS)-Institut de biologie moléculaire et cellulaire (IBMC), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), Rheumatology Unit, Cordoba (Institute University of Biomedical Sciences University of Cordoba (IUCBC), Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa, and Salvy-Córdoba, Nathalie

Subjects
MESH: Antirheumatic Agents, Autoimmune diseases, MESH: Hydroxychloroquine, Matemàtiques i estadística::Matemàtica aplicada a les ciències [Àrees temàtiques de la UPC], Azathioprine, Administration, Ophthalmic, MESH: Cyclosporine, 0302 clinical medicine, Adrenal Cortex Hormones, MESH: Muscarinic Agonists, Epidemiology, Immunology and Allergy, 030212 general & internal medicine, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, treatment, Anti-Inflammatory Agents, Non-Steroidal, 92 Biology and other natural sciences::92B Mathematical biology in general [Classificació AMS], [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, MESH: Anti-Inflammatory Agents, Non-Steroidal, MESH: Administration, Ophthalmic, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Sjogren's Syndrome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Antirheumatic Agents, Cyclosporine, Rituximab, MESH: Immunosuppressive Agents, MESH: Lubricant Eye Drops, sjøgren's syndrome, MESH: Saliva, Artificial, autoimmune diseases, Immunosuppressive Agents, medicine.drug, Hydroxychloroquine, medicine.medical_specialty, Biomatemàtica, Immunology, Muscarinic Agonists, General Biochemistry, Genetics and Molecular Biology, Lubricant Eye Drops, MESH: Adrenal Cortex Hormones, 03 medical and health sciences, Therapeutic approach, Rheumatology, medicine, Humans, Intensive care medicine, Glucocorticoids, Sjøgren's syndrome, Biomathematics, 030203 arthritis & rheumatology, MESH: Humans, business.industry, Abatacept, Saliva, Artificial, Evidence-based medicine, medicine.disease, Belimumab, Treatment, stomatognathic diseases, MESH: Sjogren's Syndrome, MESH: Glucocorticoids, business, Rheumatism
Abstract

International audience; The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.

Published
2019
Full Text
View/download PDF

4. Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries

Author

Gabriella Kardos, Xina Grählert, Margaret Cooney, Raquel Hernandez, György Blaskó, Anke Strenge-Hesse, Mariantonia Serrano, Wolfgang Kuchinke, Timothy O'Brien, Christine Kubiak, Fernando de Andres, Arrigo Schieppati, Christian Gluud, Jacques Demotes, Jean-Marc Husson, Hanna Johansson, Diana Winter, Siobhan Gaynor, Nuria Sanz, Steffen Thirstrup, Béatrice Barraud, German Kreis, Sebastian Geismann, Kate Whitfield, Charlotte Asker-Hagelberg, Lea Stankovski, Christian Libersa, Gabriele Dreier, Adeeba Asghar, Zsuza Temesvari, Karl-Heinz Huemer, BMC, Ed., Copenhagen Trial Unit (CTU), Copenhagen University Hospital (DCRIN), Koordinierungszentrum für klinische Studien MUW, ATCRIN, The Danish Medicines Agency, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Institut National de la Santé et de la Recherche Médicale (Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM), ECRIN Coordination Office, Coordinating Centre for Clinical Trials, Medical Faculty - Carl Gustav Carus, ZKS - Clinical Trials Center, University Medical Centre Freiburg, Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Network of Coordinating Centres for Clinical Trials (KKS Network), University of Cologne, Ministry of Health Social and Family Affairs, Medical Research Council, Ministry of Health, Medical Research Council-Hungarian ECRIN Committee (HECRIN), Molecular Medicine Ireland (MMI), Irish Clinical Research Infrastructure Network (ICRIN)-National University of Ireland [Galway] (NUI Galway), Farmacologiche Mario Negri (IRFMN), Instituto Superiore di Sanita (ISS), Spanish Medicines Agency and Medical Devices (AEMPS), Spanish Medicines Agency and Medical Devices [Madrid] (AEMPS), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska University Hospital (SweCRIN), NIHR Clinical Research Network Coordination Centre, and European Forum for Good Clinical Practice

Subjects
Compassionate Use Trials, medicine.medical_specialty, Biomedical Research, MESH: Clinical Trials as Topic, Alternative medicine, MEDLINE, Psychological intervention, Medicine (miscellaneous), Severe disease, Klinikai orvostudományok, 03 medical and health sciences, 0302 clinical medicine, Nursing, European Clinical Research Infrastructures Network (ECRIN), medicine, Humans, media_common.cataloged_instance, Pharmacology (medical), 030212 general & internal medicine, European union, 030304 developmental biology, media_common, Clinical Trials as Topic, lcsh:R5-920, 0303 health sciences, MESH: Humans, business.industry, MESH: Compassionate Use Trials, Research, MESH: Biomedical Research, compassionate use programmes, Compassionate Use, Orvostudományok, European Regulation 726/2004/EC, humanities, 3. Good health, Europe, Clinical research, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Europe, lcsh:Medicine (General), business, expanded access programmes
Abstract

Background 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. Methods The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). Results European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. Conclusions 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

Published
2010
Full Text
View/download PDF

5. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Author

Raquel Hernandez, Hanna Johansson, Béatrice Barraud, Jane Byrne, Gabriele Dreier, Fernando de Andres-Trelles, Wolfgang Kuchinke, Siobhan Gaynor, Christine Kubiak, Arrigo Schieppati, Adeeba Asghar, Zsuzsa Temesvari, Jacques Demotes-Mainard, Charlotte Asker-Hagelberg, Gabriella Kardos, Sue Bourne, György Blaskó, Xina Grählert, Margaret Cooney, Christian Gluud, Christian Libersa, Steffen Thirstrup, Kate Whitfield, Timothy O'Brien, Nuria Sanz, Ruth Grychtol, Karl-Heinz Huemer, Jean-Marc Husson, Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (INSERM), Departemento de Farmacologia (Medicina), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), KKS-Duesseldorf (KKSD), Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Medical University of Vienna (ATCRIN), Copenhagen Trial Unit (CTU), Copenhagen University Hospital-Rigshospitalet [Copenhagen], Copenhagen University Hospital, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, KKS, Medizinische Fakultät Carl Gustav Carus, ZKS - Clinical Trials Centre, University Medical Centre Freiburg, Hungarian ECRIN Committee, Ministry of Health Social and Family Affairs-Medical Research Council (HECRIN), National University of Ireland [Galway] (NUI Galway), Molecular Medicine Ireland (ICRIN), Istituto di Ricerche Farmacologiche Mario Negri (IRFMN), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska Trial Alliance, UK Clinical Research Collaboration, Education and Research Centre, Wythenshawe Hospital, UK Clinical Research Network, European Forum for Good Clinical Practice, ECRIN is a project funded by the EU Sixth and Seventh Framework Programmes., and BMC, Ed.

Subjects
Pathology, medicine.medical_specialty, Biomedical Research, Knowledge management, MESH: Clinical Trials as Topic, MEDLINE, Alternative medicine, Medicine (miscellaneous), 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Epidemiology, Humans, Medicine, Pharmacology (medical), MESH: Data Collection, 030212 general & internal medicine, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Clinical Trials as Topic, lcsh:R5-920, Data collection, MESH: Humans, business.industry, Data Collection, Research, Gyógyszerészeti tudományok, MESH: Biomedical Research, Orvostudományok, 3. Good health, Europe, Transplantation, Clinical trial, Clinical research, Multinational corporation, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Europe, InformationSystems_MISCELLANEOUS, business, lcsh:Medicine (General)
Abstract

Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.

Published
2009
Full Text
View/download PDF

6. 26RFa, a novel orexigenic neuropeptide, inhibits insulin secretion in the rat pancreas

Author

José Marco, Eva M. Egido, Nicolas Chartrel, Jérôme Leprince, Raquel Hernández, Hubert Vaudry, Ramona A. Silvestre, Hospital Clinic i Provincial de Barcelona (SCReN), Différenciation et communication neuronale et neuroendocrine (DC2N), Université de Rouen Normandie (UNIROUEN), and Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, Physiology, medicine.medical_treatment, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, MESH: Amino Acid Sequence, [CHIM.THER]Chemical Sciences/Medicinal Chemistry, MESH: Insulin Secretion, MESH: Neuropeptides, Biochemistry, MESH: Dose-Response Relationship, Drug, Mice, 0302 clinical medicine, Endocrinology, Insulin receptor substrate, Insulin Secretion, [SDV.BC.IC]Life Sciences [q-bio]/Cellular Biology/Cell Behavior [q-bio.CB], Insulin, MESH: Animals, 0303 health sciences, biology, Chemistry, MESH: Glucagon, Glucagon secretion, MESH: Pancreas, 3. Good health, MESH: Glucose, hormones, hormone substitutes, and hormone antagonists, medicine.drug, medicine.medical_specialty, endocrine system, MESH: Rats, Molecular Sequence Data, Neuropeptide, MESH: Insulin, In Vitro Techniques, Glucagon, 03 medical and health sciences, Cellular and Molecular Neuroscience, Orexigenic, Internal medicine, medicine, Animals, Humans, Amino Acid Sequence, Galanin, Rats, Wistar, Pancreas, MESH: Mice, 030304 developmental biology, MESH: In Vitro Techniques, MESH: Humans, MESH: Molecular Sequence Data, Dose-Response Relationship, Drug, Neuropeptides, MESH: Rats, Wistar, MESH: Male, Rats, Insulin receptor, Glucose, biology.protein, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, 030217 neurology & neurosurgery
Abstract

International audience; 26RFa is a novel orexigenic neuropeptide identified as the endogenous ligand of the orphan G protein-coupled receptor GPR103. GPR103 shares sequence identity with the receptors for neuropeptide-Y and galanin, two peptides known to inhibit insulin secretion. We have investigated the effect of 26RFa on insulin and glucagon secretion in the perfused rat pancreas. 26RFa dose-dependently reduced glucose-induced insulin release, inhibited the insulin responses to both arginine and exendin-4 and did not affect glucagon output. The inhibitory effect of 26RFa on exendin-4-induced insulin secretion was not observed in pancreata from pertussis toxin-treated rats, thus suggesting that 26RFa may inhibit insulin secretion, at least in part, via a pertussis toxin-sensitive G(i) protein coupled to the adenylyl cyclase system.

Published
2007
Full Text
View/download PDF

7. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Author

Jean-Marc Husson, Timothy O'Brien, Fernando de Andres, Charlotte Asker-Hagelberg, Béatrice Barraud, Nuria Sanz, Zsuza Temesvari, Karl-Heinz Huemer, Sue Bourne, Gabriele Dreier, German Kreis, Adeeba Asghar, Hanna Johansson, Jacques Demotes-Mainard, György Blaskó, Siobhan Gaynor, Xina Grählert, Arrigo Schieppati, Jane Byrne, Kate Whitfield, Gabriella Kardos, Christian Gluud, Margaret Cooney, Steffen Thirstrup, Wolfgang Kuchinke, Christine Kubiak, Sebastian Geismann, Christian Libersa, Copenhagen Trial Unit (CTU), Copenhagen University Hospital-Centre for Clinical Intervention Research-Danish Clinical Research Infrastructures Network, Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (INSERM), Education and Research Centre, Wythenshawe Hospital, Medizinische Universität Wien = Medical University of Vienna, Danish Medicines Agency, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, KKS, Medizinische Fakultät Carl Gustav Carus, Studienzentrum-Clinical Trials Unit, University Medical Centre Freiburg, KKS-Duesseldorf (KKSD), Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Ministry of Health Social and Family Affairs, Medical Research Council (HECRIN), National University of Ireland [Galway] (NUI Galway), Irish Clinical Research Infrastructures Network (ICRIN), Istituto di Ricerche Farmacologiche Mario Negri (IRFMN), Departemento de Farmacologia (Medicina), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska Trial Alliance, UK Clinical Research Collaboration, NIHR Clinical Research Network Coordination Centre, European Forum for Good Clinical Practice, ECRIN is a project funded by the EU Sixth and Seventh Framework Programmes., and BMC, Ed.

Subjects
Consumer Product Safety, bias, Biomedical Research, Device Approval, International Cooperation, Population, empirical-evidence, Medicine (miscellaneous), Accounting, Guidelines as Topic, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, education, Drug Approval, Health policy, education.field_of_study, lcsh:R5-920, business.industry, Gyógyszerészeti tudományok, Research, Health Policy, Orvostudományok, Drugs, Investigational, Directive, 3. Good health, Product (business), Europe, Clinical research, quality, Multinational corporation, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, randomized-trials, Government Regulation, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Guideline Adherence, business, lcsh:Medicine (General)
Abstract

Background In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Results Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. Conclusion The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.

Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results