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1. Predictive and prognostic value of total tumor load in sentinel lymph nodes in breast cancer patients after neoadjuvant treatment using one-step nucleic acid amplification: the NEOVATTL study

Author: M. Sancho, Begoña Vieites, M. D. Martín-Salvago, L. Alfaro, María Ángeles López-García, L. López-Vilaró, B. Fernández-Rodriguez, F. Villardell, Octavio Burgues, V. Peg, C.L. Ramirez-Tortosa, R. Rezola, Institut Català de la Salut, [Vieites B] Department of Pathology, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [López-García MÁ] Department of Pathology, Hospital Universitario Virgen del Rocío, Sevilla, Spain. CIBERONC (Centro de Investigación Biomédica en Red de Cáncer), Instituto de Salud Carlos III, Madrid, Spain. [Martín-Salvago MD, Ramirez-Tortosa CL] Department of Pathology, Hospital Universitario Materno-Infantil, Jaén, Spain. [Rezola R] Department of Pathology, Onkologikoa Kutxa Fundazioa, Donostia, Spain. [Sancho M] Department of Pathology, Hospital Universitario de Salamanca, Salamanca, Spain. [Peg V] Servei d’Anatomia Patològica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBERONC (Centro de Investigación Biomédica en Red de Cáncer), Instituto de Salud Carlos III, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: 0301 basic medicine, Oncology, Cancer Research, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Neoadjuvant systemic therapy, diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::biopsia::biopsia del ganglio linfático centinela [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Metastasis, Breast cancer, 0302 clinical medicine, OSNA, Nodes limfàtics - Biòpsia, Lymph node, Otros calificadores::/terapia [Otros calificadores], neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], medicine.diagnostic_test, General Medicine, Prognosis, Neoadjuvant Therapy, Tumor Burden, medicine.anatomical_structure, Lymphatic Metastasis, 030220 oncology & carcinogenesis, Female, Lymph, Sentinel Lymph Node, Nucleic Acid Amplification Techniques, Research Article, medicine.medical_specialty, Prognostic variable, Prognosi, Disease-free survival, Sentinel lymph node, Breast Neoplasms, Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Biopsy::Sentinel Lymph Node Biopsy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], 03 medical and health sciences, Predictive Value of Tests, Internal medicine, Biopsy, medicine, Humans, Retrospective Studies, Sentinel Lymph Node Biopsy, business.industry, diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Other subheadings::/therapy [Other subheadings], Nomogram, Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], medicine.disease, 030104 developmental biology, Mama - Càncer - Tractament, business, Total tumor load
Abstract: Objective To evaluate the predictive and prognostic value of total tumor load (TTL) in sentinel lymph nodes (SLNs) in patients with infiltrating breast cancer after neoadjuvant systemic therapy (NST). Methods This retrospective multicenter study used data from a Spanish Sentinel Lymph Node database. Patients underwent intraoperative SLN biopsy after NST. TTL was determined from whole nodes using a one-step nucleic acid amplification (OSNA) assay and defined as the total sum of CK19 mRNA copies in all positive SLNs. Cox-regression models identified independent predictive variables, which were incorporated into a nomogram to predict axillary non-SLN metastasis, and identified prognostic variables for incorporation into a disease-free survival (DFS) prognostic score. Results A total of 314 patients were included; most had no lymph node involvement prior to NST (cN0; 75.0% of patients). Most received chemotherapy with or without biologic therapy (91.7%), and 81 patients had a pathologic complete response. TTL was predictive of non-SLN involvement (area under the concentration curve = 0.87), and at a cut-off of 15,000 copies/µL had a negative predictive value of 90.5%. Nomogram parameters included log (TTL + 1), maximum tumor diameter and study-defined NST response. TTL was prognostic of disease recurrence and DFS at a cut-off of 25,000 copies/µL. After a 5-year follow-up, DFS was higher in patients with ≤ 25,000 copies/µL than those with > 25,000 (89.9% vs. 70.0%; p = 0.0017). Conclusions TTL > 15,000 mRNA copies/µL was predictive of non-SLN involvement and TTL > 25,000 mRNA copies/µL was associated with a higher risk of disease recurrence in breast cancer patients who had received NST.
Published: 2021
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2. Implementing Personalized Medicine in COVID-19 in Andalusia: An Opportunity to Transform the Healthcare System

Author: Dopazo, Joaquín, Maya-Miles, Douglas, García, Federico, Lorusso, Nicola, Calleja, Miguel Ángel, Pareja, María Jesús, López-Miranda, José, Rodríguez-Baño, Jesús, Padillo, Javier, Túnez, Isaac, Romero-Gómez, Manuel, [Dopazo,J, García,F, Lorusso,N, Calleja,MA, Pareja,MJ, López-Miranda,J, Rodríguez-Baño,J, Padillo,J, Túnez,I, Romero-Gómez,M] GT MP Covid-19. SGIDIS, Consejería de Salud y Familias, Junta de Andalucía, Spain. [Dopazo,J] Área de Bioinformática, Fundación progreso y Salud, Junta de Andalucía, Sevilla, Spain. [Dopazo,J] Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Madrid, Spain. [Maya-Miles,D, Romero-Gómez,M] Instituto de Biomedicina de Sevilla (HUVR/HUVM/CSIC/US), Sevilla, Spain. [Maya-Miles,D, Romero-Gómez,M] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. [García,F] Servicio de Microbiología, Hospital Universitario San Cecilio, Granada, Spain. [García,F] Instituto de Investigación Biosanitaria IBS, Granada, Spain. [Lorusso,N] Dirección General de Salud Pública, Consejería de Salud y Familias, Junta de Andalucía, Spain. [Calleja,MA] Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Pareja,MJ] Hospital Universitario de Valme, Sevilla, Spain. [López-Miranda,J, Túnez,I] Servicio de Medicina Interna, Hospital Universitario Reina Sofía, Córdoba, Spain. [López-Miranda,J, Túnez,I] Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain. [López-Miranda,J] Departamento de Ciencias Médicas y Quirúrgicas, Universidad de Córdoba, Córdoba, Spain. [Rodríguez-Baño,J] Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Rodríguez-Baño,J, Romero-Gómez,M] Departamento de Medicina, Universidad de Sevilla, Sevilla, Spain. [Padillo,J] Departamento de Cirugía, Universidad de Sevilla, Sevilla, Spain. [Padillo,J] Servicio de Cirugía General y Digestiva, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Túnez,I] Departamento de Bioquímica, Universidad de Córdoba, Córdoba, Spain. [Túnez,I] Secretaría General de Investigación, Desarrollo e Innovación en Salud, Consejería de Salud y Familias de la Junta de Andalucía, Sevilla, Spain. [Romero-Gómez,M] Servicio de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain, and The authors included in this review have received funding for two COVID-19 projects (COVID GWAs, Premed COVID-19) from the Consejería de Salud y Familias of the Andalusian Government. DMM‘s contract is supported by the Andalussian government (Proyectos Estratégicos Fondos Feder PE-0451-2018).
Subjects: Health Care::Health Services Administration::Patient Care Management::Delivery of Health Care [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research Design::Patient Selection [Medical Subject Headings], Epidemiology, Viral genome, Psychiatry and Psychology::Psychological Phenomena and Processes::Mental Processes::Thinking::Decision Making [Medical Subject Headings], Disciplines and Occupations::Health Occupations::Medicine::Public Health [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Epidemiología, Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNA::RNA, Viral [Medical Subject Headings], Medicina de precisión, Public health, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination [Medical Subject Headings], SARS CoV2, Precision medicine, Vaccination, Health care, Vacunación, Health Care::Environment and Public Health::Public Health::Disease Outbreaks::Epidemics::Pandemics [Medical Subject Headings], Personalized medicine, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings], Host genetics, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Asymptomatic Diseases::Asymptomatic Infections [Medical Subject Headings], Genoma viral, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis [Medical Subject Headings], Covid-19, Atención a la salud
Abstract: The COVID-19 pandemic represents an unprecedented opportunity to exploit the advantages of personalized medicine for the prevention, diagnosis, treatment, surveillance and management of a new challenge in public health. COVID-19 infection is highly variable, ranging from asymptomatic infections to severe, life-threatening manifestations. Personalized medicine can play a key role in elucidating individual susceptibility to the infection as well as inter-individual variability in clinical course, prognosis and response to treatment. Integrating personalized medicine into clinical practice can also transform health care by enabling the design of preventive and therapeutic strategies tailored to individual profiles, improving the detection of outbreaks or defining transmission patterns at an increasingly local level. SARS-CoV2 genome sequencing, together with the assessment of specific patient genetic variants, will support clinical decision-makers and ultimately better ways to fight this disease. Additionally, it would facilitate a better stratification and selection of patients for clinical trials, thus increasing the likelihood of obtaining positive results. Lastly, defining a national strategy to implement in clinical practice all available tools of personalized medicine in COVID-19 could be challenging but linked to a positive transformation of the health care system. In this review, we provide an update of the achievements, promises, and challenges of personalized medicine in the fight against COVID-19 from susceptibility to natural history and response to therapy, as well as from surveillance to control measures and vaccination. We also discuss strategies to facilitate the adoption of this new paradigm for medical and public health measures during and after the pandemic in health care systems. Yes
Published: 2021

3. Quantitative Analysis of Somatostatin and Dopamine Receptors Gene Expression Levels in Non-functioning Pituitary Tumors and Association with Clinical and Molecular Aggressiveness Features

Author: Eva Venegas-Moreno, Miguel A. Japón, Raúl M. Luque, Justo P. Castaño, David A. Cano, Pablo Remón-Ruiz, Noelia Gros-Herguido, Florinda Roldan, Alfonso Soto-Moreno, Alvaro Flores-Martínez, Ainara Madrazo-Atutxa, Eugenio Cárdenas-Valdepeñas, Ariel Kaen, M Carmen Vazquez-Borrego, Elena Dios, Universidad de Sevilla. Departamento de Medicina, [Flores-Martinez,Á, Venegas-Moreno,E, Dios,E, Remón-Ruiz,P, Gros-Herguido,N, Madrazo-Atutxa,A, Cano,DA, Soto-Moreno,A] Unidad de Gestión de Endocrinología y Nutrición, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain. [Vázquez-Borrego,MC, Castaño,JP, Luque,RM] Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain. [Vázquez-Borrego,MC, Luque,RM] Department of Cell Biology, Physiology and Immunology, University of Córdoba, Córdoba, Spain. [Vázquez-Borrego,MC, Luque,RM] Hospital Universitario Reina Sofía, Córdoba, Spain. [Vázquez-Borrego,MC, Luque,RM] CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Córdoba, Spain. [Japón,MA] Department of Pathology, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain. [Kaen,A, Cárdenas-Valdepeñas,E] Servicio de Neurocirugía, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Roldán,F] Servicio de Radiología, Hospital Universitario Virgen del Rocío, Sevilla, Spain., This work was supported by grants from the ISCIII-Subdirección General de Evaluación y Fomento de la Investigación co-funded with Fondos FEDER (PI16/00175 to A.S.-M. and D.A.C, PI16/00264 to R.M.L.), the Sistema Andaluz de Salud (A-0006-2017 and A-0055-2018 to A.S.-M, C-0015-2014 and RC-0006-2018 to D.A.C.), Ministerio de Ciencia, Innovación (BFU2016-80360-R to J.P.C., and PID2019-105564RB-I00 to R.M.L.) and Junta de Andalucía (BIO-0139 to J.P.C. and R.M.L.), and CIBERobn. CIBER is an initiative of Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad, Spain. Part of the analyses included in this study was carried out within the REMAH (‘Spanish molecular registry of pituitary adenomas’) project, supported by Novartis Oncology as well as by the Andalusian and Spanish Societies of Endocrinology and Nutrition (SAEDYN and SEEN, respectively).
Subjects: lcsh:Medicine, Agonistas de dopamina, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Immunologic Techniques::Immunohistochemistry [Medical Subject Headings], Somatostatin receptor, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, fluids and secretions, Invasion, Gene expression, dopamine receptor, Receptor, General Medicine, invasion, somatostatin receptor, Somatostatin, Receptores de somatostatina, Dopamine agonists, Dopamine receptor, Immunohistochemistry, hormones, hormone substitutes, and hormone antagonists, medicine.drug, medicine.medical_specialty, endocrine system, Receptores dopaminérgicos, 030209 endocrinology & metabolism, pituitary tumor, Article, Non-functioning pituitary tumors, 03 medical and health sciences, Dopamine, Internal medicine, parasitic diseases, medicine, Neoplasias hipofisarias, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Neurotransmitter Agents::Dopamine Agents::Dopamine Agonists [Medical Subject Headings], business.industry, Pituitary tumors, fungi, lcsh:R, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Genetic Techniques::Nucleic Acid Amplification Techniques::Polymerase Chain Reaction [Medical Subject Headings], Andalucía, medicine.disease, Endocrinology, Diseases::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Pituitary Neoplasms [Medical Subject Headings], non-functioning pituitary tumors, business, 030217 neurology & neurosurgery, Pituitary tumor
Abstract: The primary treatment for non-functioning pituitary tumors (NFPTs) is surgery, but it is often unsuccessful. Previous studies have reported that NFPTs express receptors for somatostatin (SST1-5) and dopamine (DRDs) providing a rationale for the use of dopamine agonists and somatostatin analogues. Here, we systematically assessed SST1-5 and DRDs expression by real-time quantitative PCR (RT-qPCR) in a large group of patients with NFPTs (n = 113) and analyzed their potential association with clinical and molecular aggressiveness features. SST1-5 expression was also evaluated by immunohistochemistry. SST3 was the predominant SST subtype detected, followed by SST2, SST5, and SST1. DRD2 was the dominant DRD subtype, followed by DRD4, DRD5, and DRD1. A substantial proportion of NFPTs displayed marked expression of SST2 and SST5. No major association between SSTs and DRDs expression and clinical and molecular aggressiveness features was observed in NFPTs ISCIII-Subdirección General de Evaluación y Fomento de la Investigación co-funded with Fondos FEDER PI16/00175 to A.S.-M. and D.A.C; PI16/00264 to R.M.L. Sistema Andaluz de Salud A-0006-2017 and A-0055-2018 to A.S.-M, C-0015-2014 and RC-0006-2018 to D.A.C. Ministerio de Ciencia, Innovación BFU2016-80360-R to J.P.C.; PID2019-105564RB-I00 to R.M.L. Junta de Andalucía BIO-0139 to J.P.C. and R.M.L. Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad, Spain
Published: 2020

4. Management of chronic liver disease-associated severe thrombocytopenia in Spain: a view from the experts

Author: Manuel Romero-Gómez, Alicia Gil Aguirre, José Luis Calleja-Panero, Raúl J. Andrade, Rafael Esteban, Maria Eva Mingot-Castellano, Rocío Muñoz-Peñín, Rafael Bañares, Javier Crespo, Roy Bentley, John Shepherd, Isidro Jarque, Shionogi, and [Calleja-Panero,JL] Department of Hepatology. Hospital Universitario Puerta de Hierro Majadahonda. Madrid, Spain. [Andrade,RJ] Digestive Diseases Clinical Management Unit. Instituto de Investigación Biomédica de Málaga-IBIMA. Hospital Universitario Virgen de la Victoria. Universidad de Málaga. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd. Málaga, Spain. [Bañares,J] Department of Hepatology. Hospital General Universitario Gregorio Marañón. Madrid, Spain. [Crespo,J] Department of Hepatology. Hospital Universitario Marqués de Valdecilla. Santander, Spain. [Esteban,R] Department of Hepatology. Hospital Universitario Vall d’Hebron. Barcelona, Spain. [Jarque,I] Department of Hematology. Hospital Universitari i Politècnic La Fe. Valencia, Spain. [Mingot-Castellano,EM] Department of Hematology. Hospital Universitario Virgen del Rocío. Sevilla, Spain. [Romero-Gómez,M] Department of Hepatology. Hospital Universitario Virgen del Rocío. Sevilla, Spain. [Muñoz-Peñín,R] Shionogi Inc. Madrid, Spain. [Bentley,R] Shionogi Inc. Florham Park. New Jersey, USA. [Gil,A] Omakase Consulting S.L. Barcelona, Spain.
Subjects: medicine.medical_specialty, Epidemiology, Terapéutica, MEDLINE, Delphi method, Platelet Transfusion, Lung injury, Chronic liver disease, Técnica Delfos, Delphi, Thrombo-poietin receptor agonists, Thrombopoietin receptor agonists, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Health care, medicine, Epidemiología, Humans, Intensive care medicine, Adverse effect, Platelet transfusion, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], business.industry, Transfusión de plaquetas, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Blood Transfusion::Blood Component Transfusion::Platelet Transfusion [Medical Subject Headings], Liver Diseases, Gastroenterology, Anemia, General Medicine, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Blood Platelet Disorders::Thrombocytopenia [Medical Subject Headings], medicine.disease, Trombocitopenia, Thrombocytopenia, Severe thrombocytopenia, Treatment, Plate-let transfusion, Diseases::Digestive System Diseases::Liver Diseases [Medical Subject Headings], Spain, business, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia [Medical Subject Headings]
Abstract: [Background] chronic liver disease (CLD) patients often present thrombocytopenia (TCP) and when severe, it may prevent them from undergoing necessary invasive procedures due to an increased bleeding risk. The lack of scientific evidence makes it impossible to determine key aspects of the current management and associated healthcare burden of these patients in Spain., [Purpose] to gain insight into the current situation of patients with CLD-associated severe TCP undergoing invasive procedures in Spain, based on the experience of clinical experts. Methods: national Delphi study involving 32 medical experts., [Results] the estimated prevalence of CLD-associated severe TCP is approximately 5,967, with an annual incidence of 1,148 new patients. Patients undergo a median of 1 (0-3) invasive procedures/year. Platelet transfusions (PTs) are the standard option to raise platelet counts and are associated with significant burden. The achievement of target platelet levels (≥ 50 x 109/l) after a transfusion is not routinely measured. The lack of effectiveness and short life span of transfused platelets can lead to procedure cancellations and bleeding events, which potentially affect patient outcomes. Adverse events occur in 1-25 % of patients, including mild (febrile and allergic reactions) and severe events (e.g., transfusion-related acute lung injury). Between 5-15 % of patients are unfit to receive PTs and approximately 3 % are treated off-label with thrombopoietin receptor agonists., [Conclusions] this study provides a snapshot of the current situation in Spain, highlighting that the current management is poorly standardized and suboptimal in some cases. The results suggest the benefit of developing a consensus document to address some of these shortcomings and to advance in the search for alternatives to PTs., This study was funded by Shionogi Inc.
Published: 2020

5. Rates and Predictors of Treatment Failure in Staphylococcus aureus Prosthetic Joint Infections According to Different Management Strategies: A Multinational Cohort Study—The ARTHR-IS Study Group

Author: Reinaldo, Espíndola, Venanzio, Vella, Natividad, Benito, Isabel, Mur, Sara, Tedeschi, Eleonora, Zamparini, Johannes G E, Hendriks, Luisa, Sorlí, Oscar, Murillo, Laura, Soldevila, Mathew, Scarborough, Claire, Scarborough, Jan, Kluytmans, Mateo Carlo, Ferrari, Mathias W, Pletz, Iain, Mcnamara, Rosa, Escudero-Sanchez, Cedric, Arvieux, Cecile, Batailler, Frédéric-Antoine, Dauchy, Wai-Yan, Liu, Jaime, Lora-Tamayo, Julia, Praena, Andrew, Ustianowski, Elisa, Cinconze, Michele, Pellegrini, Fabio, Bagnoli, Jesús, Rodríguez-Baño, Maria Dolores, Del Toro, Gabriella, Lindergard, Hospital Universitario Virgen Macarena [Séville], GlaxoSmithKline [Siena, Italy] (GSK), Hospital de la Santa Creu i Sant Pau, University of Bologna/Università di Bologna, Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Department of Orthopaedic Surgery and Trauma, Maxima MC, parent, IMIM-Hospital del Mar, Generalitat de Catalunya, Institut d'Investigació Biomèdica de Bellvitge [Barcelone] (IDIBELL), John Radcliffe Hospital [Oxford University Hospital], Amphia Ziekenhuis = Amphia Hospital [Breda, The Netherlands] (AZ=AH), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], Jena University Hospital [Jena], Norfolk and Norwich University Hospital, Hospital Universitario Ramón y Cajal [Madrid], Universidad de Alcalá - University of Alcalá (UAH), Hôpital Sud [CHU Rennes], CHU Pontchaillou [Rennes], Laboratoire de Biomécanique et Mécanique des Chocs (LBMC UMR T9406 ), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Gustave Eiffel, Centre Hospitalier Universitaire de Bordeaux (CHU de Bordeaux), Catharina Hospital, Hospital Universitario HM Sanchinarro [Madrid, Spain], Hospital Universitario Virgen del Rocío [Sevilla], North Manchester General Hospital, This work was supported by the Innovative Medicines Initiative Joint Undertaking (grant agreement No. 115523), COMBACTE-NET consortium (European Union FP7/2007–2013 and GlaxoSmithKline Biologicals SA, as EFPIA partner). European Development Regional Fund ‘‘A way to achieve Europe’’, Operative Program Intelligence Growth 2014-2020. The study sponsor is also funding the journal’s Rapid Service Fee., European Project: 115523,EC:FP7:SP1-JTI,IMI-JU-06-2012,COMBACTE(2013), European Commission, GlaxoSmithKline, European Federation of Pharmaceutical Industries and Associations, Red Española de Investigación en Patología Infecciosa, Instituto de Salud Carlos III, Ministerio de Ciencia, Innovación y Universidades (España), Espíndola, Reinaldo, Vella, Venanzio, Benito, Natividad, Mur, Isabel, Tedeschi, Sara, Zamparini, Eleonora, Hendriks, Johannes G E, Sorlí, Luisa, Murillo, Oscar, Soldevila, Laura, Scarborough, Mathew, Scarborough, Claire, Kluytmans, Jan, Ferrari, Mateo Carlo, Pletz, Mathias W, Mcnamara, Iain, Escudero-Sanchez, Rosa, Arvieux, Cedric, Batailler, Cecile, Dauchy, Frédéric-Antoine, Liu, Wai-Yan, Lora-Tamayo, Jaime, Praena, Julia, Ustianowski, Andrew, Cinconze, Elisa, Pellegrini, Michele, Bagnoli, Fabio, Rodríguez-Baño, Jesú, and Del Toro, Maria Dolores
Subjects: STAPHYLOCOCCUSAUREUS, Microbiology (medical), Staphylococcus aureus, Prosthetic joint infection, Infectious Diseases, Functional failure, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Clinical failure, Outcome
Abstract: [Introduction] Guidelines have improved the management of prosthetic joint infections (PJI). However, it is necessary to reassess the incidence and risk factors for treatment failure (TF) of Staphylococcus aureus PJI (SA-PJI) including functional loss, which has so far been neglected as an outcome., [Methods] A retrospective cohort study of SA-PJI was performed in 19 European hospitals between 2014 and 2016. The outcome variable was TF, including related mortality, clinical failure and functional loss both after the initial surgical procedure and after all procedures at 18 months. Predictors of TF were identified by logistic regression. Landmark analysis was used to avoid immortal time bias with rifampicin when debridement, antibiotics and implant retention (DAIR) was performed., [Results] One hundred twenty cases of SA-PJI were included. TF rates after the first and all surgical procedures performed were 32.8% and 24.2%, respectively. After all procedures, functional loss was 6.0% for DAIR and 17.2% for prosthesis removal. Variables independently associated with TF for the first procedure were Charlson ≥ 2, haemoglobin 30 kg/m2 and delay of DAIR, while rifampicin use was protective. For all procedures, the variables associated with TF were haemoglobin, [Conclusions] TF remains common in SA-PJI. Functional loss accounted for a substantial proportion of treatment failures, particularly after prosthesis removal. Use of rifampicin after DAIR was associated with a protective effect. Among the risk factors identified, anaemia and obesity have not frequently been reported in previous studies., [Trial registration] This study is registered at clinicaltrials.gov, registration no. NCT03826108., This work was supported by the Innovative Medicines Initiative Joint Undertaking (grant agreement No. 115523), COMBACTE-NET consortium (European Union FP7/2007–2013 and GlaxoSmithKline Biologicals SA, as EFPIA partner). R.E, L.S, O. M, R. E-S, J. L–T, J. P, J. R-B and MD. del T are members of the Spanish Network for Research in Infectious Diseases (REIPI), supported by Plan Nacional de I + D + i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001; 0002; 0005; 0009; 0011; 0015), co‐ financed by European Development Regional Fund “A way to achieve Europe”, Operative Program Intelligence Growth 2014‐2020.
Published: 2022
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6. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients

Author: Laurence Bigay-Game, Miguel Sampayo, Nicolas Girard, Laurent Greillier, Benjamin Besse, Javier de Castro, Jordi Remon, Sophie Cousin, R. Bernabé, Oscar Juan, Joaquin Mosquera, Silvia Novello, Centro Integral Oncologico Clara Campal, Unité de recherche de l'institut du thorax (ITX-lab), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Institut Curie [Paris], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Università degli studi di Torino = University of Turin (UNITO), Hospital Universitario La Paz, Service de pneumologie [Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hospital Universitario Virgen del Rocío [Sevilla], Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Nord [CHU - APHM], Institut Bergonié [Bordeaux], UNICANCER, Hospital Universitari i Politècnic La Fe = University and Polytechnic Hospital La Fe, Institut Gustave Roussy (IGR), and Université Paris-Saclay
Subjects: Pulmonary and Respiratory Medicine, Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Thymoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, Second-line, Pembrolizumab, Antibodies, Monoclonal, Humanized, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Immunotherapy, Lenvatinib, Pembrolizumab, Second-line, Thymic epithelial tumors, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Lenvatinib, Humans, Medicine, Thymic epithelial tumors, Lung cancer, Survival rate, Thymic carcinoma, business.industry, Phenylurea Compounds, Standard treatment, Cancer, Thymus Neoplasms, medicine.disease, chemistry, Quinolines, [SDV.IMM]Life Sciences [q-bio]/Immunology, Immunotherapy, business
Abstract: International audience; Thymic epithelial tumors are rare neoplastic proliferations of thymic epithelial cells. The aggressiveness of these malignancies increases as higher is the histologic subtype, being thymic carcinoma the most aggressive subtype, with a greater tendency to metastatic spread. In metastatic setting, there is no standard treatment after progression on platinum-based chemotherapy. In this scenario, monotherapy treatment either with lenvatinib, a multi-tyrosine kinase inhibitor with antiangiogenic properties, or pembrolizumab, an immune-checkpoint inhibitor, has reported clinical activity. Potential combination of both agents may have synergistic activity as reported in other cancer types. PECATI trial is a single-arm, investigator-initiated phase II study aiming to assess the activity and safety of the combination of lenvatinib and pembrolizumab in 43 patients with advanced B3-thymoma or thymic carcinoma who progressed on or after at least one previous line of platinum-based chemotherapy. The primary endpoint of the trial is 5-month progression-free survival rate and the secondary endpoints include overall response rate, duration of response, and overall survival.
Published: 2022
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7. Consenso de recomendaciones para la mejora de la coordinación asistencial inter e intra-centros en el abordaje de la hemofilia

Author: José Bruno Montoro-Ronsano, José Luis Poveda-Andrés, José Antonio Romero-Garrido, Sara García-Barcenilla, Iria González-Álvarez, Ramiro Núñez-Vázquez, Montserrat Rambla-Pérez, Inmaculada Soto-Ortega, Institut Català de la Salut, [Montoro-Ronsano JB] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Poveda-Andrés JL] Servicio de Farmacia Hospitalaria, Hospital Universitario y Politécnico La Fe, Valencia, Spain. [Romero-Garrido JA] Área de Hemoderivados, Servicio de Farmacia Hospitalaria, Hospital Universitario La Paz, Madrid, Spain. [García-Barcenilla S] Unidad de Coagulopatías Congénitas y Adquiridas, Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain. [González-Álvarez I] Unidad de Hematología Clínica, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Núñez-Vázquez R] Sección de Trombosis y Hemostasia, Servicio de Hematología, Unidad de Gestión Clínica de Hematología del Hospital Universitario Virgen del Rocío, Sevilla, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Pharmacology, administración de los servicios de salud::gestión de la atención al paciente::prestación sanitaria::telemedicina [ATENCIÓN DE SALUD], enfermedades hematológicas y linfáticas::enfermedades hematológicas::trastornos de la coagulación sanguínea::trastornos de la coagulación sanguínea hereditarios::hemofilia A [ENFERMEDADES], Decisió de grup, Health Services Administration::Patient Care Management::Delivery of Health Care::Telemedicine [HEALTH CARE], Telemedicina, Other subheadings::/therapy [Other subheadings], Hemofília - Tractament, Behavior and Behavior Mechanisms::Psychology, Social::Group Processes::Consensus [PSYCHIATRY AND PSYCHOLOGY], conducta y mecanismos de la conducta::psicología social::procesos de grupo::consenso [PSIQUIATRÍA Y PSICOLOGÍA], Hemic and Lymphatic Diseases::Hematologic Diseases::Blood Coagulation Disorders::Blood Coagulation Disorders, Inherited::Hemophilia A [DISEASES], Otros calificadores::/terapia [Otros calificadores]
Abstract: Hemofilia A; Equipo multidisciplinar; Telefarmacia Haemophilia A; Multidisciplinary care team; Telepharmacy Hemofilia A; Equip multidisciplinar; Telefarmàcia Objetivo definir las recomendaciones consensuadas para mejorar la coordinación asistencial entre Farmacia Hospitalaria, Hematología y Enfermería, inter e intra-centros, en la atención a los pacientes con hemofilia. Método se identificaron y valoraron las recomendaciones para la mejora de la coordinación asistencial en el abordaje de los pacientes con hemofilia, por parte de un panel multidisciplinar de profesionales con experiencia en este campo (Farmacia Hospitalaria, Hematología y Enfermería) y apoyado en la evidencia científica. La valoración de las recomendaciones identificadas se realizó por metodología de consenso Rand/UCLA (Delphi-adaptado) con base en su adecuación y, posteriormente, a su necesidad. En ambos casos, se empleó la escala ordinal de Likert. Los datos se analizaron estadísticamente a través de diferentes métricas. Resultados se identificaron 53 recomendaciones para la mejora de la coordinación asistencial entre Farmacia Hospitalaria, Hematología y Enfermería en el manejo del paciente con hemofilia, agrupadas en 8 ámbitos de actuación: i) Unidades de Hemofilia, centros de referencia y abordaje multidisciplinar; ii) papel de Hematología, Farmacia Hospitalaria y Enfermería en el recorrido asistencial de los pacientes con hemofilia; iii) telefarmacia y telemedicina; iv) monitorización farmacocinética; v) transición al régimen de paciente adulto; vi) educación sanitaria al paciente; vii) cirugía, urgencias e ingreso hospitalario; y viii) evaluación de los resultados. Todas las recomendaciones fueron valoradas por el panel de expertos externos como adecuadas y necesarias. Conclusiones el recorrido asistencial del paciente con hemofilia es complejo y depende de diversas variables. Además, requiere la implicación de distintos profesionales sanitarios que deben actuar de manera coordinada e integrada en todas las etapas de la vida del paciente, de manera adaptada a sus necesidades individuales. Las recomendaciones identificadas y consensuadas pueden suponer una mejora para la continuidad y calidad asistencial, pues facilitan la integración y coordinación de los profesionales implicados en el abordaje de esta enfermedad, especialmente de Farmacia Hospitalaria, Hematología y Enfermería. Objective Define consensus recommendations to improve care coordination between Hospital Pharmacy, Haematology and Nursing, inter- and intra-center, in the care of haemophilia patients. Method Recommendations for the improvement of care coordination in the management of haemophilia patients were identified and assessed by a multidisciplinary panel of professionals with experience in this field (Hospital Pharmacy, Haematology and Nursing) and supported by scientific evidence. The identified recommendations were assessed by Rand/UCLA consensus methodology (Delphi-adapted) based on their appropriateness and, subsequently, on their necessity. In both cases, it was used ordinal Likert scale. Data were statistically analysed through different metrics. Results Fifty-three recommendations for the improvement of care coordination between Hospital Pharmacy, Haematology and Nursing in the management of haemophilia patients were identified, grouped into eight areas of action: i) Haemophilia units, reference centers and multidisciplinary care; ii) Role of Haematology, Hospital Pharmacy and Nursing in the patient journey of haemophilia patients; iii) Telepharmacy and telemedicine; iv) Pharmacokinetic monitoring; v) Transition to adult patient regimen; vi) Patient health education; vii) Surgery, emergency room and hospital admission; and viii) Outcome evaluation. All recommendations were assessed as appropriate and necessary by the external expert panel. Conclusions Haemophilia patient journey is complex and depends on different variables. It also requires the involvement of different healthcare professionals who must act in a coordinated and integrated manner at all stages of the patient's life, adapted to their individual needs. On this matter, the identified and agreed recommendations may improve continuity and quality of care, as they facilitate the integration and coordination of the professionals involved in the management of this pathology, especially Hospital Pharmacy, Haematology and Nursing. Para la realización de este trabajo se ha contado con el patrocinio de CSL-Behring.
Published: 2023

8. Association of HLA-B*41:02 with Henoch-Schönlein Purpura (IgA Vasculitis) in Spanish individuals irrespective of the HLA-DRB1 status

Author: Ana Márquez, Ricardo Blanco, José A. Miranda-Filloy, Trinitario Pina, Manuel León Luque, Raquel López-Mejías, Francisca González Escribano, Begoña Ubilla, Fernanda Genre, Norberto Ortego-Centeno, Eva Galíndez-Aguirregoikoa, Javier Llorca, J. M. Blanco-Madrigal, Belén Sevilla Pérez, Santos Castañeda, Marta Conde-Jaldón, Maximiliano Aragües, Diego de Argila, Miguel A. González-Gay, Verónica Mijares, E. Rubio, Antonio Navas Parejo, Javier Martín, Lourdes Ortiz-Fernández, Sara Remuzgo-Martínez, J. Gonzalo Ocejo-Vinyals, Vanesa Calvo-Río, Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad (España), Red de Investigación en Inflamación y Enfermedades Reumáticas (España), [López-Mejías,R, Genre,F, Ubilla,B, Remuzgo-Martínez,S, Mijares,V, Pina,T, Calvo-Río,V, Blanco,R, González-Gay,MA] Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. [Sevilla Pérez,B, Ortego-Centeno,N] Medicine Department, Hospital Universitario San Cecilio, Granada, Spain. [Castañeda,S] Rheumatology Department, Hospital Universitario La Princesa, IIS-Princesa, Madrid, Spain. [Llorca,J] Epidemiology and Computational Biology Department, School of Medicine, University of Cantabria, and CIBER Epidemiología y Salud Pública (CIBERESP), IDIVAL, Santander, Spain. [Márquez,A] Institute of Parasitology and Biomedicine López-Neyra (IPBLN-CSIC). Systemic Autoimmune Diseases Unit, Hospital Clínico San Cecilio, Granada, Spain. [Miranda-Filloy,JM] Division of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain. [Navas Parejo,A] Nephrology Department, Hospital Universitario San Cecilio, Granada, Spain. [Conde-Jaldón,M, Ortiz-Fernández,L, González Escribano,F] Immunology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Argila,D, Aragües,M] Dermatology Department, IIS-IP, Hospital de la Princesa, Madrid, Spain. [Rubio,E, León Luque,M] Rheumatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Blanco-Madrigal,JM, and Galíndez-Aguirregoikoa,E] Rheumatology Department, Hospital Universitario de Basurto, Bilbao, Spain. [Ocejo-Vinyals,JG] Immunology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain. [Martín,J] Institute of Parasitology and Biomedicine López-Neyra, CSIC, Granada, Spain.
Subjects: Male, Henoch-Schonlein purpura, España, Adulto joven, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Genetic Techniques::Genetic Association Studies [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Preescolar, immune system diseases, hemic and lymphatic diseases, Immunology and Allergy, Masculino, Child, HLA-DRB1, Adolescente, Geographicals::Geographic Locations::Europe::Spain [Medical Subject Headings], Purpura, Schoenlein-Henoch, Cadenas HLA-DRB1, Antígenos HLA-B, Femenino, Predisposición genética a la enfermedad, HLA-B, Humanos, Purpura, Niño, Child, Preschool, Chemicals and Drugs::Biological Factors::Antigens::Antigens, Surface::Histocompatibility Antigens::HLA Antigens [Medical Subject Headings], Female, Estudios de seguimiento, medicine.symptom, Persons::Persons::Age Groups::Adult::Young Adult [Medical Subject Headings], Vasculitis, Research Article, IgA Vasculitis, Adolescent, Immunology, Púrpura de Schoenlein-Henoch, Diseases::Immune System Diseases::Hypersensitivity::Immune Complex Diseases::Purpura, Schoenlein-Henoch [Medical Subject Headings], Check Tags::Male [Medical Subject Headings], Human leukocyte antigen, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Membrane Proteins::Membrane Glycoproteins::Histocompatibility Antigens Class II::HLA-D Antigens::HLA-DR Antigens::HLA-DR beta-Chains::HLA-DRB1 Chains [Medical Subject Headings], Persons::Persons::Age Groups::Adolescent [Medical Subject Headings], Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Disease Susceptibility::Genetic Predisposition to Disease [Medical Subject Headings], Young Adult, Rheumatology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings], medicine, HLA-B Antigens, Humans, Persons::Persons::Age Groups::Child [Medical Subject Headings], Genetic Predisposition to Disease, Genetic Association Studies, Estudios de asociación genética, business.industry, medicine.disease, IgA vasculitis, Check Tags::Female [Medical Subject Headings], Spain, business, Persons::Persons::Age Groups::Child::Child, Preschool [Medical Subject Headings], Follow-Up Studies, HLA-DRB1 Chains
Abstract: López-Mejías, Raquel et al., [Introduction] A study was conducted to determine whether the human leukocyte antigen (HLA) B alleles are implicated in the susceptibility to Henoch-Schönlein purpura (HSP) in the largest series of Caucasian HSP patients ever assessed for genetic studies., [Methods] The study population was composed of 349 Spanish patients diagnosed with HSP fulfilling the American College of Rheumatology and the Michel et al. classification criteria, and 335 sex and ethnically matched controls. HLA-B phenotypes were determined by sequencing-based typing (SBT) and analyzed by chi-square or Fisher exact test., [Results] A statistically significant increase of HLA-B*41:02 allele in HSP patients when compared with controls was found (8.3% versus 1.5% respectively; P = 0.0001; OR (odds ratio) =5.76 [2.15-19.3]). These results remained statistically significant after adjusting for Bonferroni correction (P = 0.0028). An internal validation also confirmed the susceptibility effect on HSP associated with HLA-B*41:02 (OR = 5.70 [1.98-16.44]). Since a former study described an association between HLA-DRB1*01:03 and HSP susceptibility, we also evaluated the implication of HLA-B*41:02 independently of HLA-DRB1*01:03. Interestingly, the association remained statistically significant (P = 0.0004, OR = 4.97 [1.8-16.9]). No HLA-B association with specific HSP clinical features was found., [Conclusions] Our study indicates that HLA-B*41:02 is associated with the susceptibility to HSP in Spanish patients irrespective of HLA-DRB1 status., This study was supported by a grant from ‘Fondo de Investigaciones Sanitarias’ PI12/00193 (Spain). RLM is a recipient of a Sara Borrell postdoctoral fellowship from the Instituto de Salud Carlos III at the Spanish Ministry of Health (Spain) (CD12/00425). FG and BU are supported by funds from the RETICS Program (RIER) (RD12/0009/0013).
Published: 2015

9. The Added Value of Coronary Calcium Score in Predicting Cardiovascular Events in Familial Hypercholesterolemia

Author: Antonio Gallo, Leopoldo Pérez de Isla, Sybil Charrière, Alexandre Vimont, Rodrigo Alonso, Ovidio Muñiz-Grijalvo, José L. Díaz-Díaz, Daniel Zambón, Philippe Moulin, Eric Bruckert, Pedro Mata, Sophie Béliard, Denis Angoulvant, Sophie Beliard, Franck Boccara, Bertrand Cariou, Valérie Carreau, Alain Carrie, Sybil Charrieres, Yves Cottin, Mathilde Di Filippo, Pierre Henri Ducluzeau, Sonia Dulong, Vincent Durlach, Michel Farnier, Emile Ferrari, Dorota Ferrieres, Jean Ferrieres, Philippe Giral, Sophie Gonbert, Regis Hankard, Jocelyn Inamo, Olga Kalmykova, Michel Krempf, Julie Lemale, François Paillard, Noel Peretti, Agnes Perrin, Alain Pradignac, Jean Pierre Rabes, Vincent Rigalleau, François Schiele, Ariane Sultan, Patrick Tounian, René Valero, Bruno Verges, Cecile Yelnik, Olivier Ziegler, Rocío Aguado, Ma Pilar Álvarez-Baños, Rosa Argüeso, Francisco Arrieta, Miguel Ángel Barba, Marta Casañas, José María Cepeda, Raimundo De Andrés, Gonzalo Díaz-Soto, Jose Luis Díaz-Diaz, Marta Dieguez, Ceferino Faedo, Francisco Fuentes, Juan A. Garrido, Aurora González, Pablo González-Bustos, Ma Dolores Mañas, Marta Mauri, Juan Diego Mediavilla, Alfredo Michán, Pablo Miramontes, Ovidio Muñiz, Leire Pérez, Leopoldo Perez De Isla, Xavier Pintó, Manuel J. Romero, Patricia Rubio, Juan F. Sánchez Muñoz-Torrero, Jose I. Vidal-Pardo, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire d'Imagerie Biomédicale (LIB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain] (IdISSC), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Public Health Expertise [Paris, France], Hospital Universitario Virgen del Rocío [Sevilla], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Laboratoire d'Imagerie Biomédicale [Paris] (LIB), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Hospital Abente y Lago, Fundación Hipercolesterolemia Familiar, and ANR-16-RHUS-0007,CHOPIN,CHOPIN(2016)
Subjects: Adult, Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Coronary Artery Disease, Disease, Familial hypercholesterolemia, 030204 cardiovascular system & hematology, Risk Assessment, Sudden death, Cohort Studies, Hyperlipoproteinemia Type II, risk prediction, 03 medical and health sciences, 0302 clinical medicine, cardiovascular disease, genetic disease, Predictive Value of Tests, Risk Factors, Interquartile range, Internal medicine, Humans, Medicine, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Vascular Calcification, Stroke, coronary artery calcium, ComputingMilieux_MISCELLANEOUS, familial hypercholesterolemia, business.industry, Proportional hazards model, nutritional and metabolic diseases, Middle Aged, Atherosclerosis, medicine.disease, 3. Good health, Coronary Calcium Score, Cardiology, Calcium, Cardiology and Cardiovascular Medicine, business, coronary imaging, Cohort study
Abstract: International audience; ObjectivesThis study aimed at investigating the additional contribution of coronary artery calcium (CAC) score to SAFEHEART (Spanish Familial Hypercholesterolemia Cohort Study) risk equation (SAFEHEART-RE) for cardiovascular risk prediction in heterozygous familial hypercholesterolemia (HeFH).BackgroundCommon cardiovascular risk equations are imprecise for HeFH. Because of the high phenotype variability of HeFH, CAC score could help to better stratify the risk of atherosclerotic cardiovascular disease (ASCVD).MethodsREFERCHOL (French Registry of Familial Hypercholesterolemia) and SAFEHEART are 2 ongoing national registries on HeFH. We analyzed data from primary prevention HeFH patients undergoing CAC quantification. We used probability-weighted Cox proportional hazards models to estimate HRs. Area under the receiver-operating characteristic curve (AUC) and net reclassification improvement (NRI) were used to compare the incremental contribution of CAC score when added to the SAFEHEART-RE for ASCVD prediction. ASCVD was defined as coronary heart disease, stroke or transient ischemic attack, peripheral artery disease, resuscitated sudden death, and cardiovascular death.ResultsWe included 1,624 patients (mean age: 48.5 ± 12.8 years; men: 45.7%) from both registries. After a median follow-up of 2.7 years (interquartile range: 0.4-5.0 years), ASCVD occurred in 81 subjects. The presence of a CAC score of >100 was associated with an HR of 32.05 (95% CI: 10.08-101.94) of developing ASCVD as compared to a CAC score of 0. Receiving-operating curve analysis showed a good performance of CAC score alone in ASCVD prediction (AUC: 0.860 [95% CI: 0.853-0.869]). The addition of log(CAC + 1) to SAFEHEART-RE resulted in a significantly improved prediction of ASCVD (AUC: 0.884 [95% CI: 0.871-0.894] for SAFEHEART-RE + log(CAC + 1) vs AUC: 0.793 [95% CI: 0.779-0.818] for SAFEHEART-RE; P < 0.001). These results were confirmed also when considering only hard cardiovascular endpoints. The addition of CAC score was associated with an estimated overall net reclassification improvement of 45.4%.ConclusionsCAC score proved its use in improving cardiovascular risk stratification and ASCVD prediction in statin-treated HeFH.
Published: 2021
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10. Expert Consensus on Morphofunctional Assessment in Disease-Related Malnutrition. Grade Review and Delphi Study

Author: José Manuel García-Almeida, Cristina García-García, María D. Ballesteros-Pomar, Gabriel Olveira, Juan J. Lopez-Gomez, Virginia Bellido, Irene Bretón Lesmes, Rosa Burgos, Alejandro Sanz-Paris, Pilar Matia-Martin, Francisco Botella Romero, Julia Ocon Breton, Ana Zugasti Murillo, Diego Bellido, Institut Català de la Salut, [García-Almeida JM] Department of Endocrinology and Nutrition, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain. IBIMA, Instituto de Investigación Biomédica y Plataforma en Nanomedicina, BIONAND, Málaga, Spain. CIBEROBN, Centro de Investigación Biomédica en Red, Fisiopatología de la Obesidad y Nutrición, Madrid, Spain. Department of Endocrinology and Nutrition, Hospital Quirónsalud, Málaga, Spain. Facultad de Medicina, University of Málaga, Málaga, Spain. [García-García C] PhD Program in Biomedicine, Translational Research and New Health Technologies, Faculty of Medicine, University of Málaga, Málaga, Spain. Medical Director, Persan Farma, Las Palmas de Gran Canaria, Spain. [Ballesteros-Pomar] Department of Endocrinology and Nutrition, Complejo Asistencial Universitario de León, León, Spain. [Olveira G] IBIMA, Instituto de Investigación Biomédica y Plataforma en Nanomedicina, BIONAND, Málaga, Spain. Facultad de Medicina, University of Málaga, Málaga, Spain. Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga, Málaga, Spain. CIBERDEM, Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Málaga, Spain. Department of Medicine and Dermatology, University of Málaga, Málaga, Spain. [Lopez-Gomez JJ] Department of Endocrinology and Nutrition, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. [Bellido V] Department of Endocrinology and Nutrition, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Burgos R] Unitat de Suport Nutricional, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Nutrition and Dietetics, Desnutrició, Alimentació - Avaluació, malnutrition, Investigative Techniques::Epidemiologic Methods::Data Collection::Nutrition Assessment [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Delphi, clinical practice, GRADE, Ciencias de la información::análisis de sistemas::técnica Delfos [CIENCIA DE LA INFORMACIÓN], enfermedades nutricionales y metabólicas::trastornos nutricionales::desnutrición [ENFERMEDADES], técnicas de investigación::métodos epidemiológicos::recopilación de datos::evaluación nutricional [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Decisió, Presa de, morphofunctional assessment, Information Science::Systems Analysis::Delphi Technique [INFORMATION SCIENCE], Nutritional and Metabolic Diseases::Nutrition Disorders::Malnutrition [DISEASES], Food Science, feasibility
Abstract: Feasibility; Malnutrition; Morphofunctional assessment Factibilitat; Desnutrició; Avaluació morfofuncional Factibilidad; Desnutrición; Avaluació morfofuncional Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions. This study was supported by Persan Farma.
Published: 2023

11. A versatile and interoperable computational framework for the analysis and modeling of COVID-19 disease mechanisms

Author: Niarakis, Anna, Ostaszewski, Marek, Mazein, Alexander, Kuperstein, Inna, Kutmon, Martina, Gillespie, Marc, Funahashi, Akira, Acencio, Marcio, Hemedan, Ahmed, Aichem, Michael, Klein, Karsten, Czauderna, Tobias, Burtscher, Felicia, Yamada, Takahiro, Hiki, Yusuke, Hiroi, Noriko, Hu, Finterly, Pham, Nhung, Ehrhart, Friederike, Willighagen, Egon, Valdeolivas, Alberto, Dugourd, Aurelien, Messina, Francesco, Esteban-Medina, Marina, Pena-Chilet, Maria, Rian, Kinza, Soliman, Sylvain, Aghamiri, Sara, Puniya, Bhanwar, Naldi, Aurelien, Helikar, Tomas, Singh, Vidisha, Farinas Fernandez, Marco, Bermudez, Viviam, Tsirvouli, Eirini, Montagud, Arnau, Noel, Vincent, Ponce de Leon, Miguel, Maier, Dieter, Bauch, Angela, Gyori, Benjamin, Bachman, John, Luna, Agustin, Pinero, Janet, Furlong, Laura, Balaur, Irina, Rougny, Adrien, Jarosz, Yohan, Overall, Rupert, Phair, Robert, Perfetto, Livia, Matthews, Lisa, Rex, Devasahayam, Orlic-Milacic, Marija, Monraz Gomez, Luis, de Meulder, Bertrand, Ravel, Jean, Jassal, Bijay, Satagopam, Venkata, Wu, Guanming, Golebiewski, Martin, Gawron, Piotr, Calzone, Laurence, Beckmann, Jacques, Evelo, Chris, d'Eustachio, Peter, Schreiber, Falk, Saez-Rodriguez, Julio, Dopazo, Joaquin, Kuiper, Martin, Valencia, Alfonso, Wolkenhauer, Olaf, Kitano, Hiroaki, Barillot, Emmanuel, Auffray, Charles, Balling, Rudi, Schneider, Reinhard, Computational systems biology and optimization (Lifeware), Inria Saclay - Ile de France, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Laboratoire de recherche européen pour la polyarthrite rhumatoïde (GenHotel), Université d'Évry-Val-d'Essonne (UEVE)-Université Paris-Saclay, University of Luxembourg [Luxembourg], Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris sciences et lettres (PSL), Maastricht Centre for Systems Biology [Maastricht] (MaCSBio), Maastricht University [Maastricht], Ontario Institute for Cancer Research [Canada] (OICR), Ontario Institute for Cancer Research, Keio University, Luxembourg Centre For Systems Biomedicine (LCSB), University of Konstanz, Hochschule Mittweida - University of Applied Sciences, Kanagawa Institute of Technology, Heidelberg University Hospital [Heidelberg], National Institute for Infectious Diseases 'Lazzaro Spallanzani', Hospital Universitario Virgen del Rocío [Sevilla], Biomedicine Institute of Sevilla [Seville, Spain], University of Nebraska–Lincoln, University of Nebraska System, Norwegian University of Science and Technology [Trondheim] (NTNU), Norwegian University of Science and Technology (NTNU), Barcelona Supercomputing Center - Centro Nacional de Supercomputacion (BSC - CNS), Harvard Medical School [Boston] (HMS), Universitat Pompeu Fabra [Barcelona] (UPF), National Institute of Advanced Industrial Science and Technology (AIST), Humboldt University Of Berlin, Integrative Bioinformatics Inc [Mountain View], Department of Informatics and System Sciences (Sapienza University of Rome), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU), Yenepoya University, Janet Piñero, Laura I. Furlong: IMI2-JU grants, resources which are composed of financial contributions from the European Union’s Horizon 2020 Research and Innovation Programme and EFPIA [GA: 777365 eTRANSAFE], and the EU H2020 Programme [GA:964537 RISKHUNT3R], Project 001-P-001647—Valorisation of EGA for Industry and Society funded by the European Regional Development Fund (ERDF) and Generalitat de Catalunya, and Institute of Health Carlos III (project IMPaCT-Data, exp. IMP/00019), co-funded by the European Union, European Regional Development Fund (ERDF, 'A way to make Europe').
Subjects: SARS-CoV-2, disease maps, systems biology, dynamic models, systems medicine, large-scale community effort, [INFO.INFO-BI]Computer Science [cs]/Bioinformatics [q-bio.QM], mechanistic models
Abstract: The COVID-19 Disease Map project is a large-scale community effort uniting 277 scientists from 130 Institutions around the globe. We use high-quality, mechanistic content describing SARS-CoV-2-host interactions and develop interoperable bioinformatic pipelines for novel target identification and drug repurposing. Community-driven and highly interdisciplinary, the project is collaborative and supports community standards, open access, and the FAIR data principles. The coordination of community work allowed for an impressive step forward in building interfaces between Systems Biology tools and platforms. Our framework links key molecules highlighted from broad omics data analysis and computational modeling to dysregulated pathways in a cell-, tissue- or patient-specific manner. We also employ text mining and AI-assisted analysis to identify potential drugs and drug targets and use topological analysis to reveal interesting structural features of the map. The proposed framework is versatile and expandable, offering a significant upgrade in the arsenal used to understand virus-host interactions and other complex pathologies.
Published: 2022

12. Pathways systematically associated to Hirschsprung's disease

Author: Stanislas Lyonnet, Joaquín Dopazo, Francesca Lantieri, Claude Besmond, Raquel M. Fernández, Guillermo Antiñolo, Marta Bleda, Berta Luzón-Toro, Robert M.W. Hofstra, Stacey Arnold, Isabella Ceccherini, Yunia Sribudiani, Luz Garcia-Alonso, Aravinda Chakravarti, Salud Borrego, Betty Q. Doan, Department of Genetics, Reproduction and Fetal Medicine, Universidad de Sevilla-Institute of Biomedicine of Seville (IBIS)-Hospital Universitario Virgen del Rocío [Sevilla], Centre for Biomedical Network Research on Rare Diseases (CIBERER), Department of Computational Genomics, Centro de Investigación Príncipe Felipe (CIPF), Center for Complex Disease Genomics, Johns Hopkins University School of Medicine-McKusick-Nathans Institute of Genetic Medicine, Department of Medical Genetics, University of Groningen [Groningen], Génétique et épigénétique des maladies métaboliques, neurosensorielles et du développement (Inserm U781), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratorio di Genetica Molecolare, Istituto Gaslini, Functional Genomics Node (INB), This work was supported by the Instituto de Salud Carlos III (ISCIII), Spanish Ministry of Economy and Competitiveness, Spain (PI1001290), Spanish Ministry of Economy and Competitiveness (BIO2011-27069), GVA-FEDER (PROMETEO/2010/001) and Consejeria de Innovación Ciencia y Empresa de la Junta de Andalucia (CTS-7447). The CIBER de Enfermedades Raras is an initiative of the ISCIII, Spanish Ministry of Economy and Competitiveness. LG-A is supported by fellowship PFIS FI10/00020 from the ISCIII., BMC, Ed., Universidad de Sevilla / University of Sevilla-Institute of Biomedicine of Seville (IBIS)-Hospital Universitario Virgen del Rocío [Sevilla], Universidad de Sevilla. Departamento de Cirugía, Universidad de Sevilla-Hospital Universitario Virgen del Rocío [Sevilla]-Institute of Biomedicine of Seville (IBIS), Universidad de Sevilla-University Hospital Virgen del Rocio-Institute of Biomedicine of Seville (IBIS), Génétique et épigénétique des maladies métaboliques, neurosensorielles et du développement ( Inserm U781 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and CIPF
Subjects: Male, genetics/metabolism, Genome-wide association study, Disease, [SDV.GEN] Life Sciences [q-bio]/Genetics, VARIANTS, 0302 clinical medicine, Polymorphism (computer science), Genotype, Genetics(clinical), Pharmacology (medical), genetics, SUSCEPTIBILITY LOCUS, Hirschsprung's disease, Genetics (clinical), Genetics, Medicine(all), RISK, 0303 health sciences, Pathway-Based Analysis, General Medicine, Single Nucleotide, 3. Good health, Hirschsprung’s disease, Female, Genetic Predisposition to Disease, Genotype, Hirschsprung Disease, genetics/metabolism, Humans, Male, Polymorphism, Female, SET, Biology, Polymorphism, Single Nucleotide, 03 medical and health sciences, PROTEIN-INTERACTION NETWORK, medicine, Humans, Genetic Predisposition to Disease, Hirschsprung Disease, Polymorphism, GENOME-WIDE ASSOCIATION, Gene, COMMON, 030304 developmental biology, [SDV.GEN]Life Sciences [q-bio]/Genetics, Research, medicine.disease, GENE, Human genetics, DNA binding site, MODEL, [ SDV.GEN ] Life Sciences [q-bio]/Genetics, RET, 030217 neurology & neurosurgery
Abstract: Despite it has been reported that several loci are involved in Hirschsprung’s disease, the molecular basis of the disease remains yet essentially unknown. The study of collective properties of modules of functionally-related genes provides an efficient and sensitive statistical framework that can overcome sample size limitations in the study of rare diseases. Here, we present the extension of a previous study of a Spanish series of HSCR trios to an international cohort of 162 HSCR trios to validate the generality of the underlying functional basis of the Hirschsprung’s disease mechanisms previously found. The Pathway-Based Analysis (PBA) confirms a strong association of gene ontology (GO) modules related to signal transduction and its regulation, enteric nervous system (ENS) formation and other processes related to the disease. In addition, network analysis recovers sub-networks significantly associated to the disease, which contain genes related to the same functionalities, thus providing an independent validation of these findings. The functional profiles of association obtained for patients populations from different countries were compared to each other. While gene associations were different at each series, the main functional associations were identical in all the five populations. These observations would also explain the reported low reproducibility of associations of individual disease genes across populations., This work was supported by the Instituto de Salud Carlos III (ISCIII), Spanish Ministry of Economy and Competitiveness, Spain (PI1001290); Spanish Ministry of Economy and Competitiveness (BIO2011-27069), GVA-FEDER (PROMETEO/2010/001) and Consejeria de Innovación Ciencia y Empresa de la Junta de Andalucia (CTS-7447). The CIBER de Enfermedades Raras is an initiative of the ISCIII, Spanish Ministry of Economy and Competitiveness. LG-A is supported by fellowship PFIS FI10/00020 from the ISCIII.
Published: 2013
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13. Assessment of joint cartilage using image diagnostic techniques

Author: Cano Rodríguez, Antonio, Gómez Vázquez, Lidia, Morales Pérez, José Manuel, Encinas Tobajas, Víctor, Domecq Fernández de Bobadilla, Gabriel, [Cano Rodríguez,V, Morales Pérez,JM, and Encinas Tobajas,V] Servicio de Diagnóstico por la imagen. Hospital Universitario Virgen del Rocío. Sevilla. [Gómez Vázquez,L] Centro de Salud Nuestra Señora de la Paz. San Juan de Aznalfarache (Sevilla). [Domecq Fernández de Bobadilla,G] Servicio de Cirugía Ortopédica y Traumatología. Hospital Universitario Virgen del Rocío. Sevilla
Subjects: Anatomy::Tissues::Connective Tissue::Cartilage::Hyaline Cartilage [Medical Subject Headings], Cartílago Articular, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Magnetic Resonance Imaging [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging [Medical Subject Headings], Diagnóstico por Imagen, Anatomy::Musculoskeletal System::Cartilage::Hyaline Cartilage::Cartilage, Articular [Medical Subject Headings], Imagen por Resonancia Magnética, Cartílago hialino
Abstract: This article briefly reviews the composition of the hyaline cartilage and its ultrastructure. Subsequently, we offer a brief review of the role of imaging techniques in the assessment of this pathology. These include the most useful pulse sequences for the morphological assessment of cartilaginous injuries using MRI, as well as how these injuries appear in the images, at pre and post-surgical intervals. Lastly, we mention the developments in MRI that allow us to close in on the biochemical assessment of normal and pathological cartilage. Se presenta un breve descripción del cartílago hialino, su composición y ultraestructura. Posteriormente, se ofrece una breve revisión del papel de las técnicas de imagen en la evaluación de esta patología. Las secuencias de pulso son las más útiles para la evaluación morfológica de las lesiones cartilaginosas mediante resonancia magnética (RM), presentamos las imágenes que se pueden observar en los intervalos de pre y post-quirúrgicos. Por último, cabe mencionar los avances en la RM que nos permiten acercarnos a la evaluación bioquímica del cartílago normal y patológico. Yes
Published: 2013

14. Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice

Author: Monica Corral, Fernando Garicano, Pedro López, Begoña Campos Balea, Eva Muñoz-Couselo, Javier Medina, Guillermo Crespo, Analia Rodríguez Garzotto, Pilar Sancho, Mª del Carmen Álamo, Sebastian Ochenduszko, Juana Oramas, Institut Català de la Salut, [Álamo MC] Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Ochenduszko S] Oncology Department, Hospital Universitario Dr. Peset, Valencia, Spain. [Crespo G] Oncology Department, Hospital Universitario de Burgos, Burgos, Spain. [Corral M] Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. [Oramas J] Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. [Sancho P] Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Muñoz-Couselo E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Oncology, medicine.medical_specialty, Neoplasms::Neoplasms by Histologic Type::Neoplasms::Neoplasms by Histologic Type::Neoplasms::Neoplasms by Histologic Type::Nevi and Melanomas::Melanoma [DISEASES], Metastatic melanoma, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Other subheadings::Other subheadings::/drug therapy [Other subheadings], OncoTargets and Therapy, BRAF, chemistry.chemical_compound, Metàstasi, durable response, Internal medicine, Medicine, Pharmacology (medical), Routine clinical practice, Vemurafenib, cobimetinib, Original Research, Cobimetinib, business.industry, Melanoma - Tractament, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], humanities, clinical practice, chemistry, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], Avaluació de resultats (Assistència sanitària), vemurafenib, business, neoplasias::neoplasias por tipo histológico::neoplasias::neoplasias por tipo histológico::neoplasias::neoplasias por tipo histológico::nevos y melanomas::melanoma [ENFERMEDADES], medicine.drug, metastatic melanoma
Abstract: MÂª del Carmen Ãlamo,1 Sebastian Ochenduszko,2 Guillermo Crespo,3 MÃ³nica Corral,4 Juana Oramas,5 Pilar Sancho,6 Javier Medina,7 Fernando Garicano,8 Pedro LÃ³pez,9 BegoÃ±a Campos Balea,10 Analia RodrÃguez Garzotto,11 Eva MuÃ±oz-Couselo12,13 1Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain; 2Oncology Department, Hospital Universitario Dr. Peset, Valencia, Spain; 3Oncology Department, Hospital Universitario de Burgos, Burgos, Spain; 4Oncology Department, Hospital ClÃnico Universitario Lozano Blesa, Zaragoza, Spain; 5Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; 6Oncology Department, Hospital Universitario Virgen del RocÃo, Sevilla, Spain; 7Oncology Department, Hospital Universitario Virgen de la Salud, Toledo, Spain; 8Oncology Department, Hospital de Galdakao, Bizkaia, Spain; 9Oncology Department, Complejo Hospitalario General de JaÃ©n, JaÃ©n, Spain; 10Oncology Department, Hospital Lucus Augusti, Lugo, Spain; 11Medical Department and Strategy, Roche S.A, Madrid, Spain; 12Oncology Department, Hospital Universitario Vall dÂ´Hebron, Barcelona, Spain; 13VHIO Vall dâHebron Institute on Oncology, Barcelona, SpainCorrespondence: Eva MuÃ±oz-CouseloOncology Department, Hospital Universitario Vall dÂ´Hebron, Passeig de la Vall dâHebron, 119, Barcelona, 08035, SpainEmail emunoz@vhio.netBackground: The combination of BRAF and MEK inhibitors delays the onset of resistance and provides more sustained and dramatic responses in comparison with a BRAF inhibitor in monotherapy. The objective of the study was to evaluate the effectiveness of the combination therapy with vemurafenib/cobimetinib in terms of durability, and to describe differential characteristics in patients associated to durable responses in real-world settings.Patients and Methods: Retrospective, observational, cross-sectional, multicenter study involving 41 patients with advanced melanoma harboring a BRAFV600 mutation who initiated a combination therapy with vemurafenib/cobimetinib between May 2018 and March 2019. Participants were differentiated regarding the durability of the response: durable (complete response, CR, or a partial response, PR, for at least 12 months) and non-durable (stable disease, SD, progressive disease, PD, or CR/PR < 12 months). Secondary endpoints included treatment adherence, labor productivity, anxiety/depression, and safety profile.Results: During the combination therapy, 12 patients (29.3%) had a CR, 19 a PR (46.3%), 5 showed SD (12.2%), and 5 had PD. A total of 12 patients (29.3%) were considered as achieving a durable response and 29 (70.7%) as a non-durable one. Practically all sociodemographic and clinical characteristics were similar between patients. Body mass index was the only differential factor (with higher body mass index achieving a non-durable response). The treatment adherence was 100% in patients with durable response and 66.7% in those with non-durable.Conclusion: The combination treatment with vemurafenib/cobimetinib results in an important impact on long-term survival, leading to a steady CR in one-third of the patients.Keywords: vemurafenib, cobimetinib, BRAF, metastatic melanoma, durable response, clinical practice
Published: 2021

15. MAX Mutations Cause Hereditary and Sporadic Pheochromocytoma and Paraganglioma

Author: Patricia L. M. Dahia, Maurizio Castellano, Nicole Reisch, Carli M. J. Tops, N. Abermil, Marta Barontini, Graeme Eisenhofer, Sandra Bernaldo de Quirós, Salud Borrego, Álvaro Gómez-Graña, Nelly Burnichon, M. Giacchè, Mercedes Robledo, Emiliano Honrado, Giuseppe Opocher, Francesca Schiavi, Xavier Girerd, Elena Rapizzi, Lucía Inglada-Pérez, Esther Korpershoek, Henri J L M Timmers, Massimo Mannelli, Encarna B. Gomez-Garcia, Elisa Taschin, María-Dolores Chiara, Sara Bobisse, Alberto Cascón, Peggy Pierre, Carlos Suárez, Alexander P.A. Stegmann, Arjen R. Mensenkamp, Felix Beuschlein, Luigi Mori, Iñaki Comino-Méndez, Marinus J. Blok, Laurence Amar, Arnaud Murat, Macarena Ruiz-Ferrer, Ronald R. de Krijger, F Schillo, Frederik J. Hes, Karel Pacak, Nicole Paes Morales, Tonino Ercolino, Jacques W.M. Lenders, Rocío Letón, Miguel Urioste, Eleonora P M Corssmit, Isabelle Guilhem, Nan Qin, Anne-Paule Gimenez-Roqueplo, Giovanna Roncador, Pierre-François Plouin, Tamara Prodanov, Yves-Jean Bignon, Victoria M. Raymond, Jérôme Bertherat, Miguel Quesada-Charneco, Anna Merlo, Aguirre A. de Cubas, Philippe Chanson, Paris-Centre de Recherche Cardiovasculaire (PARCC - UMR-S U970), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de génétique [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Paris Descartes - Paris 5 (UPD5), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centro de Investigaciones Endocrinológicas, Hospital de Niños R. Gutiérrez, Service d'Endocrinologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre de Référence pour les Maladies Rares, Laboratoire de diagnostic génétique et moléculaire, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, Equipe de recherche sur les traitements individualisés des cancers (ERTICa), Université d'Auvergne - Clermont-Ferrand I (UdA), Clinical Genetics, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht]-Maastricht University [Maastricht], School for Oncology & Developmental Biology (GROW), Department of Genetics, Reproduction and Fetal Medicine, Universidad de Sevilla / University of Sevilla-Institute of Biomedicine of Seville (IBIS)-Hospital Universitario Virgen del Rocío [Sevilla], Centre for Biomedical Network Research on Rare Diseases (CIBERER), Récepteurs stéroïdiens : physiopathologie endocrinienne et métabolique, Université Paris-Sud - Paris 11 (UP11)-IFR93-Institut National de la Santé et de la Recherche Médicale (INSERM), Departments of Pathology, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Centre Hospitalier Universitaire [Rennes], Laboratoire de Neurosciences Cognitives [Marseille] (LNC), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Beijing Genomics Institute [Shenzhen] (BGI), Monoclonal antibodies unit, Centro Nacional de Investigaciones Oncológicas, Group of Human Genetics, Spanish National Cancer Research Center (CNIO), Familial Cancer Clinic, Veneto Institute of Oncology, IRCCS & Department of Medical and Surgical Sciences, Università degli Studi di Padova = University of Padua (Unipd), Carl Gustav Carus University Hospital, Hereditary Endocrine Cancer Group, Human Cancer Genetics Programme, MUMC+: DA KG Lab Centraal Lab (9), Klinische Genetica, Genetica & Celbiologie, RS: GROW - School for Oncology and Reproduction, Université Paris Descartes - Paris 5 (UPD5)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP]-Centre de Référence pour les Maladies Rares, Centre Jean Perrin, Maastricht University Medical Center (MUMC), Universidad de Sevilla-Hospital Universitario Virgen del Rocío [Sevilla]-Institute of Biomedicine of Seville (IBIS), Human Cancer Genetics Program, Spanish National Cancer Centre (CNIO), Universita degli Studi di Padova, Centro Nacional de Investigaciones Oncológicas, CNIO, Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR93-Université Paris-Sud - Paris 11 (UP11), Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), Pathology, Pediatrics, Clinical sciences, Medical Genetics, Paris-Centre de Recherche Cardiovasculaire ( PARCC - U970 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Hôpital Européen Georges Pompidou [APHP] ( HEGP ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Européen Georges Pompidou [APHP] ( HEGP ), Université Paris Descartes - Paris 5 ( UPD5 ), Hôpital Européen Georges Pompidou [APHP] ( HEGP ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]-Centre de Référence pour les Maladies Rares, Equipe de recherche sur les traitements individualisés des cancers ( ERTICa ), Université d'Auvergne - Clermont-Ferrand I ( UdA ), Maastricht University Medical Center (MUMC+), Universidad de Sevilla-University Hospital Virgen del Rocio-Institute of Biomedicine of Seville (IBIS), Université Paris-Sud - Paris 11 ( UP11 ) -IFR93-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Erasmus MC-University Medical Center, Laboratoire de Neurosciences Cognitives [Marseille] ( LNC ), Aix Marseille Université ( AMU ) -Centre National de la Recherche Scientifique ( CNRS ), Beijing Genomics Institute [Shenzhen] ( BGI ), and Beijing Genomics Institute
Subjects: Male, Pheochromocytoma, Genetics, Cancer Research, Basic Helix-Loop-Helix Leucine Zipper Transcription Factors/genetics, MESH : Germ-Line Mutation, Somatic cell, MESH: Basic Helix-Loop-Helix Leucine Zipper Transcription Factors, MESH : Aged, Adrenal Gland Neoplasms, MESH : Child, Preschool, medicine.disease_cause, Germline, MESH : Pheochromocytoma, 0302 clinical medicine, MESH: Aged, 80 and over, MESH : Child, Paraganglioma, MESH: Child, MESH: Germ-Line Mutation, MESH : Female, Child, Aged, 80 and over, MESH: Aged, 0303 health sciences, Mutation, MESH: Middle Aged, Cardiovascular diseases [NCEBP 14], Basic Helix-Loop-Helix Leucine Zipper Transcription Factors, MESH: Genetic Predisposition to Disease, MESH : Adult, Middle Aged, MESH : Paraganglioma, Phenotype, 3. Good health, Oncology, MESH: Young Adult, 030220 oncology & carcinogenesis, Child, Preschool, Female, MESH : Basic Helix-Loop-Helix Leucine Zipper Transcription Factors, Adult, MESH: Paraganglioma, Adolescent, MESH : Adrenal Gland Neoplasms, MESH : Male, MESH : Young Adult, Biology, 03 medical and health sciences, Young Adult, Germline mutation, SDG 3 - Good Health and Well-being, MESH : Adolescent, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, medicine, Adrenal Gland Neoplasms/genetics, Humans, MESH : Middle Aged, Genetic Predisposition to Disease, MESH: Pheochromocytoma, MESH : Aged, 80 and over, Germ-Line Mutation, 030304 developmental biology, Aged, MESH: Adolescent, MESH: Humans, Paraganglioma/genetics, Genetic heterogeneity, Translational research Genomic disorders and inherited multi-system disorders [ONCOL 3], MESH : Humans, Hormonal regulation [IGMD 6], MESH: Child, Preschool, MESH: Adult, medicine.disease, MESH: Adrenal Gland Neoplasms, MESH: Male, Pheochromocytoma/genetics, Cancer research, MESH : Genetic Predisposition to Disease, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: 11 pages, 2 figures, 2 tables.-- Burnichón, Nelly et al., Purpose: Pheochromocytomas (PCC) and paragangliomas (PGL) are genetically heterogeneous neural crest-derived neoplasms. Recently we identified germline mutations in a new tumor suppressor susceptibility gene, MAX (MYC-associated factor X), which predisposes carriers to PCC. How MAX mutations contribute to PCC/PGL and associated phenotypes remain unclear. This study aimed to examine the prevalence and associated phenotypic features of germline and somatic MAX mutations in PCC/PGL., Design: We sequenced MAX in 1,694 patients with PCC or PGL (without mutations in other major susceptibility genes) from 17 independent referral centers. We screened for large deletions/duplications in 1,535 patients using a multiplex PCR-based method. Somatic mutations were searched for in tumors from an additional 245 patients. The frequency and type of MAX mutation was assessed overall and by clinical characteristics., Results: Sixteen MAX pathogenic mutations were identified in 23 index patients. All had adrenal tumors, including 13 bilateral or multiple PCCs within the same gland (P < 0.001), 15.8% developed additional tumors at thoracoabdominal sites, and 37% had familial antecedents. Age at diagnosis was lower (P = 0.001) in MAX mutation carriers compared with nonmutated cases. Two patients (10.5%) developed metastatic disease. A mutation affecting MAX was found in five tumors, four of them confirmed as somatic (1.65%). MAX tumors were characterized by substantial increases in normetanephrine, associated with normal or minor increases in metanephrine., Conclusions: Germline mutations in MAX are responsible for 1.12% of PCC/PGL in patients without evidence of other known mutations and should be considered in the genetic work-up of these patients. ©2012 AACR.
Published: 2012
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16. Resultados materno-fetales de la gestación tras cirugía bariátrica

Author: González Navarro, I., Pereira Cunill, J.L., Serrano Aguayo, P., Morales Conde, S., Martos Martínez, J. M., García Luna, P. P., [González Navarro,I, Pereira Cunill,JL, Serrano Aguayo,P, and García Luna,PP] Unidad de Nutrición Clínica y Dietética, Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, España. [Morales Conde,S] Unidad de Cirugía Laparoscópica, Servicio de Cirugía General y Digestiva,Hospital Universitario Virgen del Rocío, Sevilla, España. [Martos Martínez,JM] Unidad de Cirugía Endocrina, Servicio de Cirugía General y Digestiva, Hospital Universitario Virgen del Rocío, Sevilla, España.
Subjects: Phenomena and Processes::Physiological Phenomena::Body Constitution::Body Weights and Measures::Body Size::Body Weight::Birth Weight [Medical Subject Headings], Roux-en-Y gastric bypass, Bypass gástrico, Obesidad, Named Groups::Persons::Age Groups::Infant::Infant, Newborn [Medical Subject Headings], Roux-en-Ygastric bypass, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings], Gestación, Pregnancy, Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], Phenomena and Processes::Physiological Phenomena::Nutritional Physiological Phenomena::Nutritional Status [Medical Subject Headings], Obesity, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Micronutrients::Vitamins [Medical Subject Headings], Phenomena and Processes::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Reproductive Physiological Processes::Reproduction::Pregnancy [Medical Subject Headings], Cirugía bariátrica, Bariatric surgery, Diseases::Female Urogenital Diseases and Pregnancy Complications::Pregnancy Complications [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Digestive System Surgical Procedures::Biliopancreatic Diversion [Medical Subject Headings], Derivación biliopancreática, Phenomena and Processes::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Reproductive Physiological Processes::Reproduction::Pregnancy::Pregnancy Outcome [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Bariatric Surgery::Gastric Bypass [Medical Subject Headings], Diseases::Nutritional and Metabolic Diseases::Nutrition Disorders::Overnutrition::Obesity [Medical Subject Headings], Biliopancreatic diversión, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Bariatric Surgery [Medical Subject Headings], Check Tags::Female [Medical Subject Headings], Anatomy::Embryonic Structures::Fetus [Medical Subject Headings], Biliopancreatic diversion
Abstract: English Abstract; Journal Article; BACKGROUND Obesity is the most frequent metabolic disease in the World, and is associated with several comorbidities. Bariatric procedures arise as a promising treatment when classical approach is ineffective. Half of the operated patients are reproductive-aged women and there is evidence that obesity is related to worse maternal and fetal outcomes. Because nutritional status is affected by bariatric surgery and is a vital component during pregnancy, the aim of our study is to asses the impact of bariatric surgery on pregnancy in these patients. MATERIAL AND METHODS We studied 10 women and 15 pregnancies following bariatric surgery between 2003 and 2009. The visits took place every three months by an obstetrician and an endocrinologist with experience in nutrition, recording clinical features and lab work. RESULTS We found iron deficiency in 80% of the pregnancies, vitamin D in 46,7%, vitamin A in 20%, vitamin E in 13,3% and vitamin B12 in 26,7%. There were no complications during pregnancy, except one case of gravidic hiperemesis. There were nine deliveries without malformations, three of them were small for gestational age newborns and one suffered aspiration pneumonia. There were three stillbirths and one preterm delivery with fetal death. CONCLUSIONS our results show fewer complications during pregnancy in these women than obese women and similar to general population. Yes Introducción: La obesidad es la enfermedad metabòlica más frecuente en el mundo y conlleva múltiples co-morbilidades, siendo la cirugía bariátrica (CB) una opción terapéutica cuando fallan las medidas clásicas. La mitad de los pacientes intervenidos son mujeres en edad fértil y está demostrado que la obesidad se asocia a peores resultados obstétricos y fetales. Dado que el estado nutricional se ve afectado por la CB y es un factor esencial para el adecuado desarrollo del embarazo, el objetivo de nuestro trabajo es valorar los efectos de la CB sobre la gestación en mujeres obesas intervenidas. Material y métodos: Seguimiento de 10 mujeres y 15 gestaciones tras CB durante el periodo 2003-2009. Se realizaron visitas trimestrales en consultas de Nutrición y Obstetricia, con evaluación clínica y de laboratorio en cada una. Resultados: Se evidenció deficiencia de hierro en el 80% de las gestaciones, de vitamina D en el 46,7%, de vitamina A en el 20%, de vitamina E en el 13,3% y de vitamina B12 en el 26,7%. No hubo complicaciones durante la gestación salvo un caso de hiperemesis gravidica. Hubo 9 partos de recién nacidos vivos sin malformaciones de los cuales 3 fueron recién nacidos pequeños para la edad gestacional (RNPEG) y uno presentó neumonía por aspiración de meconio. Hubo 3 abortos y un parto prematuro con feto muerto. Conclusiones: En nuestro grupo de estudio hubo menos complicaciones durante la gestación comparado con lo descrito en obesas no operadas y similares a la población general.
Published: 2011

17. Position statement of the Spanish Society of Paediatric Infectious Diseases on the introduction, implementation and assessment of antimicrobial stewardship programmes in paediatric hospitals

Author: Goycochea-Valdivia, Walter Alfredo, Melendo Perez, Susana, Aguilera Alonso, David, Escosa-García, Luis, Baquero-Artigao, Fernando, Sociedad Española de Infectología Pediátrica (SEIP). Grupo de Trabajo PROA, Martinez Campos, Leticia, Institut Català de la Salut, [Goycochea-Valdivia WA] Servicio de Infectología, Reumatología e Inmunología Pediátrica, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Melendo Pérez S] Unitat de Patologia Infecciosa i Immunodeficiències de Pediatria, Servei de Pediatria, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Aguilera-Alonso D] Sección de Enfermedades Infecciosas, Servicio de Pediatría, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Hospital Universitario Gregorio Marañón, Madrid. CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Escosa-Garcia L, Baquero-Artigao F] Servicio de Pediatría Hospitalaria, Enfermedades Infecciosas y Tropicales, Instituto de Investigación del Hospital Universitario La Paz (IdiPAZ), Madrid. CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Martínez Campos L] Unidad de Infectología Pediátrica, Hospital Universitario Torrecárdenas, Almería, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: infecciones bacterianas y micosis::infección::enfermedades transmisibles [ENFERMEDADES], administración de los servicios de salud::organización y administración::administración farmacéutica::utilización de medicamentos::revisión de la utilización de medicamentos::programas de optimización del uso de los antimicrobianos [ATENCIÓN DE SALUD], Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos [COMPUESTOS QUÍMICOS Y DROGAS], Hospitals, Pediatric, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Communicable Diseases, Anti-Bacterial Agents, Antimicrobial Stewardship, Anti-Infective Agents, Management of Technology and Innovation, Health Services Administration::Organization and Administration::Pharmacy Administration::Drug Utilization::Drug Utilization Review::Antimicrobial Stewardship [HEALTH CARE], Humans, Medicaments antibacterians - Ús terapèutic, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents [CHEMICALS AND DRUGS], Bacterial Infections and Mycoses::Infection::Communicable Diseases [DISEASES], Child, Malalties transmissibles - Tractament
Abstract: Pediatría; Resistencia antibiótica Paediatrics; Antimicrobial resistance Pediatria; Resistència antibiòtica In the past few years, antimicrobial resistance has increased, becoming a serious public health problem. The irrational use of antimicrobials is one of the main contributors to antimicrobial resistance. The paediatric population is not free from this problem, as antimicrobials are widely prescribed in this age group, often inappropriately. The introduction of antimicrobial stewardship programmes (ASPs) has proven crucial in curbing the emergence of antimicrobial resistance. At the international level, the need to develop specific paediatric ASPs has been recognised on account of the differences between adult and paediatric patients as concerns infection and approaches to diagnosis and treatment. For this reason, paediatric ASPs should be multidisciplinary programmes led by paediatric infectious disease specialists and use specific paediatric indicators (such as days of treatment, antimicrobial susceptibility patterns in the paediatric population, or clinical indicators) to help identify areas of improvement and develop effective targeted interventions. On the other hand, the support and leadership of the pertinent scientific societies are also essential. The purpose of this document is to present the position of the Sociedad Española de Infectología Pediátrica (SEIP, Spanish Society of Paediatric Infectious Diseases) concerning the implementation of paediatric ASPs in hospitals in Spain and to provide tools to facilitate their application in hospitals throughout the regional health care systems in the country. Durante los últimos años ha habido un aumento en la aparición de resistencias antimicrobianas, lo cual supone un grave problema de salud pública. El mal uso de antimicrobianos es un factor determinante en su desarrollo. La población pediátrica no queda exenta de dicha problemática ya que la prescripción de antibióticos en pediatría es elevada y en muchas ocasiones inadecuada. La incorporación de los programas de optimización de uso de antimicrobianos (PROA) ha resultado ser una medida crucial para disminuir el riesgo en la aparición de resistencias antibióticas. A nivel internacional se reconoce la necesidad de crear PROAs específicos en pediatría (PROA-P) debido a las diferencias existentes entre pacientes adultos y pediátricos en referencia a las infecciones, así como al abordaje tanto diagnóstico como terapéutico de las mismas. Por esta misma razón, los PROA-P deben ser programas multidisciplinares liderados por especialistas en infecciones pediátricas y trabajar con indicadores específicos pediátricos (DOT, patrones de sensibilidad antibiótica de población pediátrica, indicadores clínicos…) que permitan detectar puntos de mejora y establecer estrategias dirigidas eficaces. Por otro lado, es imprescindible el apoyo y liderazgo por parte de las distintas sociedades científicas implicadas. El objetivo de este documento es dar a conocer el posicionamiento de la Sociedad Española de Infectología Pediátrica (SEIP) sobre la implementación de los PROA pediátricos hospitalarios en nuestro territorio así como aportar herramientas que ayuden en la aplicación de dichos programas en los diferentes hospitales de las distintas regiones sanitarias del país.
Published: 2022

18. Use of sponge-assisted endoluminal vacuum therapy for the treatment of colorectal anastomotic leaks: expert panel consensus

Author: Willem A Bemelman, Alberto Arezzo, Tomasz Banasiewicz, Richard Brady, Eloy Espín-Basany, Omar Faiz, Rosa M Jimenez-Rodriguez, Institut Català de la Salut, [Bemelman WA] Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. [Arezzo A] Department of Surgical Sciences, University of Torino, Turin, Italy. [Banasiewicz T] Poznan University of Medical Sciences, Department of General, Endocrinological Surgery and Gastroenterological Oncology, Poznań, Poland. [Brady R] Newcastle Centre for Bowel Disease Research Group, Department of Colorectal Surgery, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK. [Espín-Basany E] Unitat de Cirurgia de Còlon i Recte, Servei de Cirurgia General i Digestiva, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Faiz O] St Mark’s Hospital, London, UK. [Jimenez-Rodriguez RM] Unidad de Coloproctología, Department of Surgery, Hospital Universitario Virgen del Rocío, Sevilla, Spain, Vall d'Hebron Barcelona Hospital Campus, Surgery, CCA - Cancer Treatment and Quality of Life, and Amsterdam Gastroenterology Endocrinology Metabolism
Subjects: Consensus, Còlon - Càncer - Cirurgia - Complicacions, Vacuum, Presa de decisions, Anastomotic Leak, Otros calificadores::Otros calificadores::/cirugía [Otros calificadores], General Medicine, Recte - Càncer - Cirurgia - Complicacions, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales [ENFERMEDADES], Psychological Phenomena::Mental Processes::Thinking::Decision Making::Consensus [PSYCHIATRY AND PSYCHOLOGY], Other subheadings::Other subheadings::/surgery [Other subheadings], Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Anastomotic Leak [DISEASES], Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [DISEASES], afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::fuga anastomótica [ENFERMEDADES], Humans, fenómenos psicológicos::procesos mentales::pensamiento::toma de decisión::consenso [PSIQUIATRÍA Y PSICOLOGÍA], Colorectal Neoplasms, Negative-Pressure Wound Therapy
Abstract: Background Anastomotic leaks represent one of the most significant complications of colorectal surgery and are the primary cause of postoperative mortality and morbidity. Sponge-assisted endoluminal vacuum therapy (EVT) has emerged as a minimally invasive technique for the management of anastomotic leaks; however, there are questions regarding patient selection due to the heterogeneous nature of anastomotic leaks and the application of sponge-assisted EVT by surgeons. Method Seven colorectal surgical experts participated in a modified nominal group technique to establish consensus regarding key questions that arose from existing gaps in scientific evidence and the variability in clinical practice. After a bibliographic search to identify the available evidence and sequential meetings with participants, a series of recommendations and statements were formulated and agreed upon. Results Thirty-seven recommendations and statements on the optimal use of sponge-assisted EVT were elaborated on and unanimously agreed upon by the group of experts. The statements and recommendations answer 10 key questions about the indications, benefits, and definition of the success rate of sponge-assisted EVT for the management of anastomotic leaks. Conclusion Although further research is needed to resolve clinical and technical issues associated with sponge-assisted EVT, the recommendations and statements produced from this project summarize critical aspects to consider when using sponge-assisted EVT and to assist those involved in the management of patients with colorectal anastomotic leaks.
Published: 2022

19. N-3 fatty acids, cancer and cachexia: a systematic review of the literature

Author: Colomer, Ramón, Moreno-Nogueira, José M, García-Luna, Pedro P, García-Peris, Pilar, García-de-Lorenzo, Abelardo, Zarazaga, Antonio, Quecedo, Luis, Llano, Juan del, Usán, Luis, Casimiro, César, [Colomer,R] Medical Oncology Service, Catalan Institute of Oncology, Girona, Spain. [Moreno-Nogueira,JM] Medical Oncology Service, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [García-Luna,PP] Clinical Nutrition Service, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [García-Peris,P] Clinical Nutrition Service, Hospital Universitario Gregorio Marañón, Madrid, Spain. [García-de-Lorenzo,A] Intensive Medicine Service, Hospital Universitario La Paz, Madrid, Spain. [Zarazaga,A] Surgery Service, Hospital Universitario La Paz, Madrid, Spain. [Quecedo,L, Llano,J del] Fundación Gaspar Casal, Madrid, Spain. [Usán,L, and Casimiro,C] Medical Department, Abbott Laboratories, Madrid, Spain.
Subjects: Cachexia, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Body Weight::Body Weight Changes::Weight Loss::Emaciation::Cachexia [Medical Subject Headings], Phenomena and Processes::Physical Phenomena::Time::Time Factors [Medical Subject Headings], Suplementos Dietéticos, Caquexia, EPA, n-3 fatty acids, Chemicals and Drugs::Lipids::Fats::Dietary Fats::Dietary Fats, Unsaturated::Fatty Acids, Omega-3::Eicosapentaenoic Acid [Medical Subject Headings], Health Care::Health Services Administration::Quality of Health Care::Quality Assurance, Health Care::Guidelines as Topic::Practice Guidelines as Topic [Medical Subject Headings], DHA, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Technology, Industry, Agriculture::Food and Beverages::Food::Dietary Supplements [Medical Subject Headings], Chemicals and Drugs::Lipids::Fats::Dietary Fats::Dietary Fats, Unsaturated::Fatty Acids, Omega-3 [Medical Subject Headings], Guías de práctica clínica como asunto, Cancer, Nutrition, Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings]
Abstract: Journal Article; Research Support, Non-U.S. Gov't; Review; Use of n-3 fatty acids (FA) has been reported to be beneficial for cancer patients. We performed a systematic review of the literature in order to issue recommendations on the clinical use of n-3 FA in the cancer setting. A systematic search was performed in MEDLINE, EMBASE, Cochrane and Healthstar databases. We selected clinical trials or prospective observational studies including patients with cancer and life expectancy >2 months, in which enteral supplements with n-3 FA were administered. Parameters evaluated individually were clinical (nutritional status, tolerance, survival and hospital stays), biochemical (inflammatory mediators), and functional (functional status, appetite and quality of life (QoL)). Seventeen studies met the inclusion criteria; eight were of high quality. The panel of experts established the following evidence: (1) oral supplements with n-3 FA benefit patients with advanced cancer and weight loss, and are indicated in tumours of the upper digestive tract and pancreas; (2) the advantages observed were: increased weight and appetite, improved QoL, and reduced post-surgical morbidity; (3) there is no defined pattern for combining different n-3 FA, and it is recommended to administer > 1.5 g/day; and (4) better tolerance is obtained administering low-fat formulas for a period of at least 8 weeks. All the evidences were grade B but for 'length of treatment' and 'advantage of survival' it was grade C. Our findings suggest that administration of n-3 FA (EPA and DHA) in doses of at least 1.5 g/day for a prolonged period of time to patients with advanced cancer is associated with an improvement in clinical, biological and QoL parameters. Yes
Published: 2007

20. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

Author: Agnes Nagy, Rene-Olivier Casasnovas, Sameer Bakhshi, Sharon Shacham, Juan-Manuel Sancho, Ronit Gurion, Josée M. Zijlstra, Jatin P. Shah, Miklos Egyed, Brian T. Hill, Krzysztof Warzocha, Gabriel Tremblay, Michael W. Schuster, Fritz Offner, Reda Bouabdallah, Dimitrios Tomaras, Paolo Caimi, Andre Goy, Priyanka Samal, Catherine Thieblemont, Joost S.P. Vermaat, Matthew Ku, Ulrich Jäger, John Kuruvilla, Nagesh Kalakonda, George A Follows, Eric Van Den Neste, Miguel Ángel Canales Albendea, Michael Kauffman, Nada Hamad, Fatima De la Cruz, Patrick Daniele, Marie Maerevoet, Theodoros Vasilakopoulos, Federica Cavallo, Sylvain Choquet, Karyopharm Therapeutics Inc., Newton, MA, U918, Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Amsterdam UMC, Addenbrooke's Hospital, Cambridge University NHS Trust, Leiden University Medical Center (LUMC), Institute of Translational Medicine, University of Liverpool, Hackensack University Medical Center [Hackensack], Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Catholique de Louvain = Catholic University of Louvain (UCL), Cleveland Clinic, Service d'Hémato-oncologie [CHU Saint-Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Turin, Hospital Universitario Virgen del Rocío [Sevilla], University Health Network, St Vincent's Hospital Melbourne [Australia], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Medizinische Universität Wien = Medical University of Vienna, University Hospitals Case Medical Center, Tel Aviv University [Tel Aviv], Institute of Hematology and Transfusion Medicine[Warsaw, Poland] (IHTM), Germans Trias i Pujol Hospital, Barcelona Autonomous University, Stony Brook University [SUNY] (SBU), State University of New York (SUNY), Ghent University Hospital, National and Kapodistrian University of Athens (NKUA), Semmelweis University [Budapest], Hospital Universitario La Paz, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, and UCL - (SLuc) Service d'hématologie
Subjects: Male, Oncology, Cancer Research, Health utility, FACT-Lym, patient reported outcomes, MESH: Patient Reported Outcome Measures, MESH: Aged, 80 and over, 0302 clinical medicine, Quality of life, Recurrence, Medicine and Health Sciences, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, health, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, General Medicine, Middle Aged, MESH: Drug Resistance, Neoplasm, 3. Good health, health-related quality of life, Hydrazines, EQ-5D-5L, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, health utility, Lymphoma, Large B-Cell, Diffuse, MESH: Hydrazines, Adult, disutility of adverse events, medicine.medical_specialty, diffuse large B-cell lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Refractory, Internal medicine, medicine, Humans, health state utility, selinexor, Patient Reported Outcome Measures, Aged, Health related quality of life, MESH: Humans, business.industry, MESH: Quality of Life, MESH: Adult, Triazoles, medicine.disease, MESH: Male, MESH: Recurrence, Lymphoma, MESH: Triazoles, utility, Drug Resistance, Neoplasm, Relapsed refractory, Quality of Life, MESH: Lymphoma, Large B-Cell, Diffuse, business, MESH: Female, Diffuse large B-cell lymphoma, Progressive disease, 030215 immunology
Abstract: Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT - Lymphoma (p = 3 adverse events and serious adverse events were not associated with clinically meaningful negative QoL impacts.
Published: 2021
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21. Pulmonologists' Opinion on the Use of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease Patients in Spain: A Cross-Sectional Survey

Author: Marc Miravitlles, Fernando González-Torralba, Cristina Represas-Represas, Xavier Pomares, Eduardo Márquez-Martín, Cruz González, Carlos Amado, Carles Forné, Soledad Alonso, Bernardino Alcázar, Miriam Barrecheguren, Juan María Jurado Mirete, Elsa Naval, Institut Català de la Salut, [Miravitlles M] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. CIBER de Enfermedades Respiratorias (CIBERES), ISCIII, Madrid, Spain. [González-Torralba F] Pneumology Department, Hospital Universitario del Tajo, Aranjuez, Spain. [Represas-Represas C] Pneumology Department, Hospital Álvaro Cunqueiro, Vigo, Spain. [Pomares X] CIBER de Enfermedades Respiratorias (CIBERES), ISCIII, Madrid, Spain. Pneumology Department, Corporació Sanitària Parc Taulí, Sabadell, Spain. [Márquez-Martín E] CIBER de Enfermedades Respiratorias (CIBERES), ISCIII, Madrid, Spain. Medical-Surgical Unit for Respiratory Diseases, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [González C] Pneumology Department, Hospital Clínico de Valencia, Valencia, Spain. [Barrecheguren M] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], International Journal of Chronic Obstructive Pulmonary Disease, Pulmons - Malalties obstructives - Tractament, Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], Enquestes, Pulmonary Disease, Chronic Obstructive, exacerbation, Adrenal Cortex Hormones, Administration, Inhalation, Other subheadings::Other subheadings::/adverse effects [Other subheadings], hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas de la corteza suprarrenal [COMPUESTOS QUÍMICOS Y DROGAS], COPD, Humans, Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones [CHEMICALS AND DRUGS], Respiratory Tract Diseases::Lung Diseases::Lung Diseases, Obstructive::Pulmonary Disease, Chronic Obstructive [DISEASES], withdrawal, técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], General Medicine, Pneumonia, Asthma, Corticosteroides - Efectes secundaris, enfermedades respiratorias::enfermedades pulmonares::enfermedades pulmonares obstructivas::enfermedad pulmonar obstructiva crónica [ENFERMEDADES], bronchodilators, Bronchodilator Agents, Cross-Sectional Studies, Pulmonologists, Spain, eosinophils, inhaled corticosteroids
Abstract: Marc Miravitlles,1,2 Fernando GonzÃ¡lez-Torralba,3 Cristina Represas-Represas,4 Xavier Pomares,2,5 Eduardo MÃ¡rquez-MartÃn,2,6 Cruz GonzÃ¡lez,7 Carlos Amado,8 Carles FornÃ©,9,10 Soledad Alonso,11 Bernardino AlcÃ¡zar,12 Miriam Barrecheguren,1 Juan MarÃa Jurado Mirete,13 Elsa Naval14 1Pneumology Department, Hospital Universitari Vall dâHebron, Vall dâHebron Institut de Recerca (VHIR), Vall dâHebron Barcelona Hospital Campus, Barcelona, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), ISCIII, Madrid, Spain; 3Pneumology Department, Hospital Universitario del Tajo, Aranjuez, Spain; 4Pneumology Department, Hospital Ãlvaro Cunqueiro, Vigo, Spain; 5Pneumology Department, CorporaciÃ³ SanitÃ ria Parc TaulÃ, Sabadell, Spain; 6Medical-Surgical Unit for Respiratory Diseases, Hospital Universitario Virgen del RocÃo, Sevilla, Spain; 7Pneumology Department, Hospital ClÃnico de Valencia, Valencia, Spain; 8Pneumology Department, Hospital Universitario MarquÃ©s de Valdecilla, Santander, Spain; 9Heorfy Consulting, Lleida, Spain; 10Basic Medical Sciences Department, University of Lleida, Lleida, Spain; 11Pneumology Department, Hospital Universitario de TorrejÃ³n, TorrejÃ³n de Ardoz, Spain; 12Pneumology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain; 13Scientific Department, GOC Health Consulting, Barcelona, Spain; 14Pneumology Department, Hospital Universitario de La Ribera, Alzira, SpainCorrespondence: Marc Miravitlles, Pneumology Department, Hospital Universitari Vall dâHebron, P. Vall dâHebron 119-129, Barcelona, 08035, Spain, Tel/Fax +34 932746083, Email marcm@separ.esIntroduction: Identifying the variables that guide decision-making in relation to the use of inhaled corticosteroids (ICS) can contribute to the appropriate use of these drugs. The objective of this study was to identify the clinical variables that physicians consider most relevant for prescribing or withdrawing ICS in COPD.Methods: A cross-sectional survey was conducted in Spain from November 2020 to May 2021. Therapeutic decisions on the use of ICS in 11 hypothetical COPD patient profiles were collected using an online survey answered by specialists with experience in the management of patients with COPD. Mixed-effects logistic regression was used to analyze the impact of patientsâ characteristics in the therapeutic decision for prescribing ICS or proceeding to its withdrawal.Results: A total of 74 pulmonologists agreed to collaborate in the survey and answered the questionnaire. The results showed great variability, with only 2 profiles achieving consensus for starting or withdrawing the treatment. The frequency and severity of exacerbations influenced the decision to prescribe ICS in a dose-response fashion (1 exacerbation odds ratio (OR) = 1.86, 95% confidence interval (CI) 1.02 to 3.43, two exacerbations OR = 11.6, 95% CI: 4.47 to 30.2 and three OR = 123, 95% CI: 25 to 601). Similarly, increasing blood eosinophils and history of asthma were associated with ICS use. On the other hand, pneumonia reduced the probability of initiating treatment with ICS (OR = 0.54 [0.29 to 0.98]). Lung function and dyspnea degree did not influence the clinicianâs therapeutic decision. The results for withdrawal of ICS were similar but in the opposite direction.Conclusion: In accordance with guidelines, exacerbations, blood eosinophils and history of asthma or pneumonia are the factors considered by pulmonologist for the indication or withdrawal of ICS. However, the agreement in prescription or withdrawal of ICS when confronted with hypothetical cases is very low, suggesting a great variability in clinical practice.Keywords: COPD, exacerbation, bronchodilators, inhaled corticosteroids, eosinophils, withdrawal
Published: 2022

22. Attendee Survey and Practical Appraisal of a Telegram®-Based Dermatology Congress During the COVID-19 Confinement

Author: F. Russo-de la Torre, J. Bernabeu-Wittel, Ignacio García-Doval, E. del Río de la Torre, Mario Linares-Barrios, Alejandro Martin-Gorgojo, and [Martin-Gorgojo,A] Servicio de ITS/Dermatología, Sección de Especialidades Médicas. Ayuntamiento de Madrid, Madrid, España. [Bernabeu-Wittel,J] Servicio de Dermatología, Hospital Universitario Virgen del Rocío, Sevilla, España. [Linares-Barrios,M] Servicio de Dermatología, Hospital Puerta del Mar, Cádiz, España. [Russo-de la Torre] Consulta de Dermatología. Algeciras (Cádiz), España. [García-Doval,I] Servicio de Dermatología. Complexo Hospitalario Universitario de Vigo, Vigo, España. [del Río-de la Torre,E] Clínica Dermalar. Santiago de Compostela, España.
Subjects: Male, Congresos como tema, Artículo Original, Distance education, Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks [Medical Subject Headings], Personal Satisfaction, computer.software_genre, Tecnología disruptiva, 030207 dermatology & venereal diseases, 0302 clinical medicine, Videoconferencing, Surveys and Questionnaires, Daily practice, Pandemic, Medicine, Disruptive technology, Online social networking, Information Science::Information Science::Communications Media::Telecommunications::Videoconferencing [Medical Subject Headings], Distance, 05 social sciences, Middle Aged, Clinical Practice, Private practice, Educación a distancia, Difusión de la innovación, Female, Original Article, Intervención basada en Internet, Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks::Internet::Social Media [Medical Subject Headings], Adult, Histology, Coronavirus disease 2019 (COVID-19), Physical Distancing, Congresses as topic, Dermatology, Redes sociales en línea, Information Science::Information Science::Communication::Diffusion of Innovation [Medical Subject Headings], Health Care::Health Care Economics and Organizations::Organizations::Congresses as Topic [Medical Subject Headings], Education, Pathology and Forensic Medicine, 03 medical and health sciences, 0502 economics and business, Humans, Anthropology, Education, Sociology and Social Phenomena::Education::Education, Distance [Medical Subject Headings], Pandemics, Aged, Medical education, SARS-CoV-2, business.industry, Disciplines and Occupations::Health Occupations::Medicine::Dermatology [Medical Subject Headings], COVID-19, Internet-based intervention, Diffusion of innovation, business, computer, 050212 sport, leisure & tourism, Dermatologists
Abstract: Introduction: The COVID-19 pandemic outbreak introduced dramatic changes in all our lives, daily practice, and medical conferences. In search of a tool to spread dermatologic knowledge during confinement, an online medical meeting was held on April 25th to 26th, 2020. In this study, we aimed to assess the characteristics, opinion and satisfaction of the attendees to a free-of-charge online congress. Secondarily, we intended to explain how this meeting was prepared. Material and Methods: Online survey administered to the attendees to an online congress organised via the Telegram® Messenger App. Its organisation and planning, which needed no financial support and was done by volunteer organisers, moderators and speakers, is described step by step. Results: The satisfaction of both speakers and attendees was very high. All participants considered that this format had a great present and future, and most of them rated it as superior to regular face-to-face meetings. Female gender and predominantly private practice favoured this opinion. Discussion: The COVID-19 pandemic has forced the cancellation of most scientific gatherings. This has been seen by some authors as an excellent opportunity, encouraging medical societies and organisations to lead the change to virtual meetings. Although confinement did not allow real contact, our online meeting showed it was possible to ensure interaction and participation between attendees, moderators and speakers. Dermatologists enjoyed some dermatologic science, even despite the extraordinary circumstances disrupting their daily clinical practice. Most of them felt they were participating in something new and compelling that many felt superior to traditional meetings. Yes Introducción: La pandemia de COVID-19 introdujo cambios drásticos en nuestras vidas. Tratando de encontrar una herramienta adecuada para la formación y el debate dermatológico durante el confinamiento, se celebró un congreso médico on-line durante los días 25 y 26 de abril del 2020. El objetivo del presente estudio fue evaluar las características, la opinión y el grado de satisfacción de los asistentes a dicho congreso. En segundo lugar, se buscó explicar cómo se organizó este formato de reunión. Material y métodos: Se entregó un cuestionario a los asistentes a un congreso on-line realizado a través de la aplicación Telegram® Messenger App. Se describió paso a paso su organización y planificación. No se necesitó apoyo financiero, ya que fue realizado de manera voluntaria. Resultados: El grado de satisfacción tanto de los ponentes como de los asistentes fue muy elevado. Todos los participantes consideraron que este formato tenía un gran presente y futuro. La mayoría lo calificó como superior a las reuniones presenciales tradicionales. Ser del sexo femenino y tener una práctica clínica predominantemente privada favorecieron esta opinión. Discusión: La pandemia obligó a cancelar la mayoría de las reuniones científicas presenciales. Esto fue visto por algunos autores como una excelente oportunidad para mejorar y liderar el cambio a las reuniones virtuales. Aunque el confinamiento no permitió un contacto real, nuestra reunión demostró que era posible asegurar la interacción entre los participantes. Los dermatólogos pudieron participar en una actividad formativa a pesar de que debido a las circunstancias se interrumpiera su actividad práctica diaria. La mayoría de los asistentes tuvieron la sensación de que esta era una actividad nueva y atractiva, que superaba incluso a las reuniones presenciales tradicionales.
Published: 2020
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23. Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Author: Joan Albanell, José Manuel Pérez-García, Miguel Gil-Gil, Giuseppe Curigliano, Manuel Ruíz-Borrego, Laura Comerma, Joan Gibert, Meritxell Bellet, Begoña Bermejo, Lourdes Calvo, Juan de la Haba, Enrique Espinosa, Alessandro Marco Minisini, Vanesa Quiroga, Ana Santaballa Bertran, Leonardo Mina, Beatriz Bellosillo, Federico Rojo, Silvia Menéndez, Miguel Sampayo-Cordero, Crina Popa, Andrea Malfettone, Javier Cortés, Antonio Llombart-Cussac, Institut Català de la Salut, [Albanell J] Medical Oncology Department, Hospital del Mar, Barcelona, Spain. Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. Centro de Investigacion Biomédica en Red de Oncología (CIBERONC-ISCIII), Madrid, Spain. Universitat Pompeu Fabra, Barcelona, Spain. GEICAM, Spain. [Pérez-García JM] International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey. [Gil-Gil M] GEICAM, Spain. Catalan Institute of Oncology, Breast Cancer Unit, Medical Oncology Department, IDIBELL, Barcelona, Spain. [Curigliano G] Istituto Europeo di Oncologia, IRCCS, Milano, Italy. University of Milano, Department of Oncology and Hemato-Oncology, Milano, Italy. [Ruíz-Borrego M] GEICAM, Spain. Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Comerma L] Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. Pathology Department, Hospital del Mar, Barcelona, Spain. [Bellet M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Cancer Research, Receptor, ErbB-2, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Medicaments antineoplàstics - Ús terapèutic, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Breast Neoplasms, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Piperazines, Càncer de mama, Mama --Tumors, Breast cancer, Clinical trials, Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Quimioteràpia, Antineoplastic Combined Chemotherapy Protocols, Humans, Càncer, neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], Biochemical markers, terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Oncology, Mama - Càncer - Tractament, Marcadors bioquímics, Female, Protocols clínics, Assaigs clínics
Abstract: Hormone receptor; Advanced breast cancer Càncer de mama avançat; Receptor hormonal Cáncer de mama avanzado; Receptor hormonal Purpose: To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor–positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Patients and Methods: The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immediately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percentage of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis. Results: Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6–53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2–27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8–6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71–282.9; P = 0.018). Conclusions: Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials. This work was supported by Pfizer. The authors would like to thank the patients, their caregivers, and their families for participating in this study and all investigators and site personnel. The BioPER study was conceived and designed by Medica Scientia Innovation Research (MEDSIR) in collaboration with Pfizer Inc., which funded the study and provided palbociclib. J. Albanell acknowledges CIBERONC CB16/12/00241, PI21/00002, funded by Instituto de Salud Carlos III (ISCIII) and co-funded by the European Union, Generalitat de Catalunya (2017 SGR 507).
Published: 2022

24. SEOM-SOGUG clinical guideline for localized muscle invasive and advanced bladder cancer (2021)

Author: Begoña P. Valderrama, Aránzazu González-del-Alba, Rafael Morales-Barrera, Ignacio Peláez Fernández, Sergio Vázquez, Cristina Caballero Díaz, Montserrat Domènech, Ovidio Fernández Calvo, Alfonso Gómez de Liaño Lista, José Ángel Arranz Arija, Institut Català de la Salut, [Valderrama BP] Medical Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [González-Del-Alba A] Medical Oncology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. [Morales-Barrera R] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Peláez Fernández I] Medical Oncology Department, Hospital Universitario de Cabueñes, Gijón, Asturias, Spain. [Vázquez S] Medical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain. [Caballero Díaz C] Medical Oncology Department, Hospital General Universitario de Valencia, Centro de Investigación Biomédica de Red en Cáncer (CIBERONC), Valencia, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Cancer Research, Muscle-invasive, Carcinoma, Transitional Cell, neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias de la vejiga [ENFERMEDADES], Muscles, Bladder cancer, General Medicine, Cystectomy, Quimioteràpia combinada, Neoadjuvant Therapy, Therapeutics::Combined Modality Therapy::Neoadjuvant Therapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Oncology, Urinary Bladder Neoplasms, Urothelial, Antineoplastic Combined Chemotherapy Protocols, Bufeta - Càncer - Tractament, Humans, terapéutica::tratamiento combinado::tratamiento neoadyuvante [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Neoplasm Invasiveness, Cisplatin, Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Urinary Bladder Neoplasms [DISEASES]
Abstract: Bladder cancer; Muscle-invasive; Urothelial Cáncer de vejiga; Invasivo muscular; Urotelial Càncer de bufeta; Invasió muscular; Urotelial Most muscle-invasive bladder cancer (BC) are urothelial carcinomas (UC) of transitional origin, although histological variants of UC have been recognized. Smoking is the most important risk factor in developed countries, and the basis for prevention. UC harbors high number of genomic aberrations that make possible targeted therapies. Based on molecular features, a consensus classification identified six different MIBC subtypes. Hematuria and irritative bladder symptoms, CT scan, cystoscopy and transurethral resection are the basis for diagnosis. Radical cystectomy with pelvic lymphadenectomy is the standard approach for muscle-invasive BC, although bladder preservation is an option for selected patients who wish to avoid or cannot tolerate surgery. Perioperative cisplatin-based neoadjuvant chemotherapy is recommended for cT2-4aN0M0 tumors, or as adjuvant in patients with pT3/4 and or pN + after radical cystectomy. Follow-up is particularly important after the availability of new salvage therapies. It should be individualized and adapted to the risk of recurrence. Cisplatin–gemcitabine is considered the standard first line for metastatic tumors. Carboplatin should replace cisplatin in cisplatin-ineligible patients. According to the EMA label, pembrolizumab or atezolizumab could be an option in cisplatin-ineligible patients with high PD-L1 expression. For patients whose disease respond or did not progress after first-line platinum chemotherapy, maintenance with avelumab prolongs survival with respect to the best supportive care. Pembrolizumab also increases survival versus vinflunine or taxanes in patients with progression after chemotherapy who have not received avelumab, as well as enfortumab vedotin in those progressing to first-line chemotherapy followed by an antiPDL1/PD1. Erdafitinib may be considered in this setting in patients with FGFR alterations. An early onset of supportive and palliative care is always strongly recommended.
Published: 2022
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25. Influence of early identification and therapy on long-term outcomes in early-onset MTHFR deficiency

Author: Yverneau, Mathilde, Leroux, Stéphanie, Imbard, Apolline, Gleich, Florian, Arion, Alina, Moreau, Caroline, Nassogne, Marie-Cécile, Szymanowski, Marie, Tardieu, Marine, Touati, Guy, Bueno, María, Chapman, Kimberly A, Chien, Yin-Hsiu, Huemer, Martina, Ješina, Pavel, Janssen, Mirian C H, Kölker, Stefan, Kožich, Viktor, Lavigne, Christian, Lund, Allan Meldgaard, Mochel, Fanny, Morris, Andrew, Pons, Mónica Ruiz, Porras-Hurtado, Gloria Liliana, Benoist, Jean-François, Damaj, Léna, Schiff, Manuel, E-HOD Consortium, CHU Pontchaillou [Rennes], AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Heidelberg University Hospital [Heidelberg], Service de Pédiatrie Médicale [Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Université Catholique de Louvain = Catholic University of Louvain (UCL), CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hospital Universitario Virgen del Rocío [Sevilla], Children’s National Health System [Washington, DC, USA], National Taiwan University [Taiwan] (NTU), University Children’s Hospital Zurich, Charles University [Prague] (CU), Radboud University Medical Center [Nijmegen], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Copenhagen University Hospital, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Manchester University NHS Foundation Trust (MFT), Hospital Universitario N.S. de Candelaria [Santa Cruz de Tenerife, Spain], Hôpital Robert Debré Paris, Hôpital Robert Debré, Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), European Union [739543], EU-project phase [2012 12 02], SOBI, Recordati Rare Disease Foundation, Aeglea, and Jonchère, Laurent
Subjects: newborn screening, [SDV]Life Sciences [q-bio], MTHFR deficiency, Infant, Newborn, neurodevelopmental outcome, Metabolic Disorders Radboud Institute for Molecular Life Sciences [Radboudumc 6], digestive system diseases, [SDV] Life Sciences [q-bio], Cohort Studies, homocystinuria, Psychotic Disorders, EHOD, Muscle Spasticity, Genetics, Humans, remethylation defects, Homocystinuria, Homocysteine, Genetics (clinical), Methylenetetrahydrofolate Reductase (NADPH2), Retrospective Studies
Abstract: Contains fulltext : 286882.pdf (Publisher’s version ) (Closed access) MTHFR deficiency is a severe inborn error of metabolism leading to impairment of the remethylation of homocysteine to methionine. Neonatal and early-onset patients mostly exhibit a life-threatening acute neurologic deterioration. Furthermore, data on early-onset patients' long-term outcomes are scarce. The aims of this study were (1) to study and describe the clinical and laboratory parameters of early-onset MTHFR-deficient patients (i.e., ≤3 months of age) and (2) to identify predictive factors for severe neurodevelopmental outcomes in a cohort with early and late onset MTHFR-deficient patients. To this end, we conducted a retrospective, multicentric, international cohort study on 72 patients with MTHFR deficiency from 32 international metabolic centres. Characteristics of the 32 patients with early-onset MTHFR deficiency were described at time of diagnosis and at the last follow-up visit. Logistic regression analysis was used to identify predictive factors of severe neurodevelopmental outcome in a broader set of patients with early and non-early-onset MTHFR deficiency. The majority of early-onset MTHFR-deficient patients (n = 32) exhibited neurologic symptoms (76%) and feeding difficulties (70%) at time of diagnosis. At the last follow-up visit (median follow-up time of 8.1 years), 76% of treated early-onset patients (n = 29) exhibited a severe neurodevelopmental outcome. Among the whole study population of 64 patients, pre-symptomatic diagnosis was independently associated with a significantly better neurodevelopmental outcome (adjusted OR 0.004, [0.002-0.232]; p = 0.003). This study provides evidence for benefits of pre-symptomatic diagnosis and appropriate therapeutic management, highlighting the need for systematic newborn screening for MTHFR deficiency and pre-symptomatic treatment that may improve outcome.
Published: 2022
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26. Clinical Implications of the Genetic Background in Pediatric Pulmonary Arterial Hypertension: Data from the Spanish REHIPED Registry

Author: Alejandro Cruz-Utrilla, Natalia Gallego-Zazo, Jair Antonio Tenorio-Castaño, Inmaculada Guillén, Alba Torrent-Vernetta, Amparo Moya-Bonora, Carlos Labrandero, María Elvira Garrido-Lestache Rodríguez-Monte, Alejandro Rodríguez-Ogando, María del Mar Rodríguez Vázquez Del Rey, Juana Espín, Beatriz Plata-Izquierdo, María Álvarez-Fuente, Antonio Moreno-Galdó, Pilar Escribano-Subias, María Jesús Del Cerro Marín, Institut Català de la Salut, [Cruz-Utrilla A] Pulmonary Hypertension Unit, ERN-Lung, Cardiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain. [Gallego-Zazo N, Tenorio-Castaño JA] Instituto de Genética Médica y Molecular (INGEMM), Hospital Universitario La Paz, Madrid, Spain. CIBERER, Centro de Investigación en Red de Enfermedades Raras, Instituto de Salud Carlos III, Madrid, Spain. ITHACA, European Reference Network on Rare Congenital Malformations and Rare Intellectual Disability, Brussels, Belgium. [Guillén I] Pediatric Cardiology Unit, Department of Pediatrics, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Torrent-Vernetta A, Moreno-Galdó A] CIBERER, Centro de Investigación en Red de Enfermedades Raras, Instituto de Salud Carlos III, Madrid, Spain. Unitat de Pneumologia Pediàtrica i Fibrosi Quística, Servei de Pediatria, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Moya-Bonora A] Pediatric Cardiology, Department of Pediatrics, Hospital Universitari i Politècnic La Fe, Valencia, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: enfermedades respiratorias::enfermedades pulmonares::hipertensión pulmonar [ENFERMEDADES], Catalysis, técnicas de investigación::métodos epidemiológicos::recopilación de datos::registros [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Inorganic Chemistry, Respiratory Tract Diseases::Lung Diseases::Hypertension, Pulmonary [DISEASES], Hipertensió pulmonar - Aspectes genètics, Other subheadings::Other subheadings::/genetics [Other subheadings], Humans, genetics, Familial Primary Pulmonary Hypertension, Registries, Physical and Theoretical Chemistry, Child, Molecular Biology, Spectroscopy, Pulmonary Arterial Hypertension, Otros calificadores::Otros calificadores::/genética [Otros calificadores], Organic Chemistry, heritable pulmonary arterial hypertension, General Medicine, Investigative Techniques::Epidemiologic Methods::Data Collection::Registries [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Computer Science Applications, Registres mèdics, pediatric pulmonary hypertension, pulmonary veno-occlusive disease, Pulmonary Veno-Occlusive Disease, Genetic Background
Abstract: Genetics; Heritable pulmonary arterial hypertension; Pediatric pulmonary hypertension Genética; Hipertensión arterial pulmonar hereditaria; Hipertensión pulmonar pediátrica Genètica; Hipertensió arterial pulmonar hereditària; Hipertensió pulmonar pediàtrica Background: Pulmonary arterial hypertension (PAH) is a severe and rare disease with an important genetic background. The influence of genetic testing in the clinical classification of pediatric PAH is not well known and genetics could influence management and prognosis. Objectives: The aim of this work was to identify the molecular fingerprint of PH children in the REgistro de pacientes con HIpertensión Pulmonar PEDiátrica (REHIPED), and to investigate if genetics could have an impact in clinical reclassification and prognosis. Methods: We included pediatric patients with a genetic analysis from REHIPED. From 2011 onward, successive genetic techniques have been carried out. Before genetic diagnosis, patients were classified according to their clinical and hemodynamic data in five groups. After genetic analysis, the patients were reclassified. The impact of genetics in survival free of lung transplantation was estimated by Kaplan–Meier curves. Results: Ninety-eight patients were included for the analysis. Before the genetic diagnoses, there were idiopathic PAH forms in 53.1%, PAH associated with congenital heart disease in 30.6%, pulmonary veno-occlusive disease—PVOD—in 6.1%, familial PAH in 5.1%, and associated forms with multisystemic disorders—MSD—in 5.1% of the patients. Pathogenic or likely pathogenic variants were found in 44 patients (44.9%). After a genetic analysis, 28.6% of the cohort was “reclassified”, with the groups of heritable PAH, heritable PVOD, TBX4, and MSD increasing up to 18.4%, 8.2%, 4.1%, and 12.2%, respectively. The MSD forms had the worst survival rates, followed by PVOD. Conclusions: Genetic testing changed the clinical classification of a significant proportion of patients. This reclassification showed relevant prognostic implications. This project was funded by project “Bases Genético-Moleculares de la Medicina de Precisión en la Hipertensión Arterial Pulmonar”. Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Gobierno de España. Co-funded by “Fondo Europeo de Desarrollo Regional, Programa Operativo Crecimiento Inteligente 2014–2020” (Award number: PI 18/01233). A.C.-U. holds a research-training contract “Rio Hortega” (CM20/00164) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). REHIPED is supported by unrestricted grants of Janssen and Ferrer.
Published: 2022

27. Best treatment option for patients with refractory aggressive B-cell lymphoma in the CAR-T cell era: real-world evidence from GELTAMO/GETH Spanish Groups

Author: Mariana Bastos-Oreiro, Antonio Gutierrez, Juan Luís Reguera, Gloria Iacoboni, Lucía López-Corral, María José Terol, Valentín Ortíz-Maldonado, Jaime Sanz, Luisa Guerra-Dominguez, Rebeca Bailen, Alberto Mussetti, Pau Abrisqueta, Rafael Hernani, Hugo Luzardo, Juan-Manuel Sancho, Javier Delgado-Serrano, Antonio Salar, Carlos Grande, Leyre Bento, Sonia González de Villambrosía, Daniel García-Belmonte, Anna Sureda, Antonio Pérez-Martínez, Pere Barba, Mi Kwon, Alejandro Martín García-Sancho, Institut Català de la Salut, [Bastos-Oreiro M] Hospita Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain. [Gutierrez A] Hospital Universitario Son Espases, Fundació Institut d'Investigació Sanitària Illes Balears (IdISBa), Palma de Mallorca, Spain. [Reguera JL] Hematology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Iacoboni G, Abrisqueta P, Barba P] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [López-Corral L] Hospital Universitario de Salamanca, Instituto de investigación biomédica de Salamanca (IDBAL), CIBERONC, Salamanca, Spain. [Terol MJ] Hematology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: CAR-T cell therapy, Limfomes, Cèl·lules B, T-Lymphocytes, Cellular therapy, Antigens, CD19, Immunology, Real world evidence (RWE), Scholar-1 criteria, Cèl·lules B - Tumors - Tractament, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell::Lymphoma, Large B-Cell, Diffuse [DISEASES], Humans, Immunology and Allergy, Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::Lymphocytes::T-Lymphocytes [ANATOMY], Refractory aggressive B cell lymphoma, standard of care (SOC), Otros calificadores::/terapia [Otros calificadores], Retrospective Studies, B cells, Receptors, Chimeric Antigen, Teràpia cel·lular, Other subheadings::/therapy [Other subheadings], scholar-1 criteria, refractory aggressive B cell lymphoma, Cèl·lules T, Standard of care (SOC), neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B::linfoma de células B grandes difuso [ENFERMEDADES], Lymphomas, Lymphoma, Large B-Cell, Diffuse, terapéutica::terapia biológica::tratamientos basados en células y tejidos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], real world evidence (RWE), células::células sanguíneas::leucocitos::leucocitos mononucleares::linfocitos::linfocitos T [ANATOMÍA]
Abstract: CAR-T cell therapy; Real world evidence; B cell lymphoma Terapia con células CAR-T; Evidencia del mundo real; Linfoma de células B Teràpia amb cèl·lules CAR-T; Evidència del món real; Limfoma de cèl·lules B Real-world evidence comparing the efficacy of chimeric antigen receptor (CAR) T-cell therapy against that of the previous standard of care (SOC) for refractory large B-cell lymphoma (LBCL) is scarce. We retrospectively collected data from patients with LBCL according to SCHOLAR-1 criteria treated with commercial CAR T-cell therapy in Spain (204 patients included and 192 treated, 101 with axicabtagene ciloleucel [axi-cel], and 91 with tisagenlecleucel [tisa-cel]) and compared the results with a historical refractory population of patients (n = 81) obtained from the GELTAMO-IPI study. We observed superior efficacy for CAR-T therapy (for both axi-cel and tisa-cel) over pSOC, with longer progression-free survival (PFS) (median of 5.6 vs. 4–6 months, p ≤ 0.001) and overall survival (OS) (median of 15 vs. 8 months, p < 0.001), independently of other prognostic factors (HR: 0.59 (95% CI: 0.44–0.80); p < 0.001] for PFS, and 0.45 [(95% CI: 0.31–0.64)] for OS). Within the CAR-T cohort, axi-cel showed longer PFS (median of 7.3 versus 2.8 months, respectively, p = 0.027) and OS (58% versus 42% at 12 months, respectively, p = 0.048) than tisa-cel. These differences were maintained in the multivariable analysis. On the other hand, axi-cel was independently associated with a higher risk of severe cytokine release syndrome and neurotoxicity. Our results suggest that the efficacy of CAR-T cell therapy is superior to pSOC in the real-world setting. Furthermore, axi-cel could be superior in efficacy to tisa-cel, although more toxic, in this group of refractory patients according to SCHOLAR-1 criteria.
Published: 2022

28. The Current Role of the Heavy/Light Chain Assay in the Diagnosis, Prognosis and Monitoring of Multiple Myeloma: An Evidence-Based Approach

Author: Ríos-Tamayo, Rafael, Puig, Noemí, Algarín, Macarena, García de Veas Silva, José Luís, Barbosa, Nuno, Encinas, Cristina, Hernández, José Ángel, Alonso, Rafael, Campos, María Luisa, Rodríguez, Teresa, Leivas, Alberto, Olivares, María José, Sánchez, María José, Paiva, Bruno, Lahuerta, Juan José, Martínez-López, Joaquín, [Ríos-Tamayo,R] Hematology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Ríos-Tamayo,R, Sánchez,MJ] Instituto de Investigación Biosanitaria de Granada (Ibs.GRANADA), Granada, Spain. [Ríos-Tamayo,R, Sánchez,MJ] Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. [Puig,N] Hematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC) CIBERONC, Salamanca, Spain. [Algarín,M, Barbosa,N, Campos,ML, Leivas,A] Scientific Department, The Binding Site Iberia, Barcelona, Spain. [García de Veas Silva,JL] Molecular Diagnosis Laboratory Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Encinas,C] Hematology Department, Hospital General Universitario Gregorio Marañón, IiGM, Madrid, Spain. [Hernández,JÁ] Hematology Department, Hospital Universitario Infanta Leonor, Madrid, Spain. [Alonso,R, Martínez-López,J] Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain. [Rodríguez,T, Olivares,MJ] Immunology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Sánchez,MJ] Registro de Cáncer de Granada, Escuela Andaluza de Salud Pública (EASP), Granada, Spain. [Sánchez,MJ] Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain. [Paiva,B] Clínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain. [Lahuerta,JJ, and Martínez-López,J] Instituto de Investigación del Hospital Universitario 12 de Octubre, Madrid, Spain.
Subjects: Cadenas ligeras de inmunoglobulina, Monitoring, Hevylite, Diagnóstico, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Blood Protein Disorders::Paraproteinemias [Medical Subject Headings], Mieloma múltiple, Pronóstico, Cadenas pesadas de inmunoglobulina, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Globulins::Serum Globulins::Immunoglobulins::Immunoglobulin Subunits::Immunoglobulin Light Chains [Medical Subject Headings], Prognosis, Heavy/light chain assay, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Procesamiento automatizado de datos, Multiple myeloma, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis [Medical Subject Headings], Diagnosis, Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis [Medical Subject Headings], Inmunoensayo, Monitorización del ambiente, Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma [Medical Subject Headings]
Abstract: Despite tremendous progress being made in recent years, multiple myeloma (MM) remains a challenging disease. The laboratory plays a critical role in the overall management of patients. The diagnosis, prognosis, clinical monitoring and evaluation of the response are key moments in the clinical care process. Conventional laboratory methods have been and continue to be the basis of laboratory testing in monoclonal gammopathies, along with the serum free light chain test. However, more accurate methods are needed to achieve new and more stringent clinical goals. The heavy/light chain assay is a relatively new test which can overcome some of the limitations of the conventional methods for the evaluation of intact immunoglobulin MM patients. Here, we report an update of the evidence accumulated in recent years on this method regarding its use in MM. Yes
Published: 2021

29. Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu

Author: García, M. J., Rivero, M., Miranda-Bautista, J., Bastón-Rey, I., Mesonero, F., Leo-Carnerero, E., Casas-Deza, D., Cagigas Fernández, C., Martin-Cardona, A., El Hajra, I., Hernández-Aretxabaleta, N., Pérez-Martínez, I., Fuentes-Valenzuela, E., Jiménez, N., Rubin de Célix, C., Gutiérrez, A., Suárez Ferrer, C., Huguet, J. M., Fernández-Clotet, A., González-Vivó, M., Del Val, B., Castro-Poceiro, J., Melcarne, L., Dueñas, C., Izquierdo, M., Monfort, D., Bouhmidi, A., Ramírez de la Piscina, P., Romero, E., Molina, G., Zorrilla, J., Calvino-Suárez, C., Sánchez, E., Núñez, A., Sierra, O., Castro, B., Zabana, Y., González-Partida, I., De la Maza, S., Castaño, A., Nájera-Muñoz, R., Sánchez-Guillén, L., Riat Castro, M., Rueda, J. L., Benítez, J. M., Delgado-Guillena, P., Tardillo, C., Peña, E., Frago-Larramona, S., Rodríguez-Grau. M. C., Plaza, R., Pérez-Galindo, P., Martínez-Cadilla, J., Menchén, L., Barreiro-De Acosta, M., Sánchez-Aldehuelo, R., De la Cruz, M. D., Lamuela, L. J., Marín, I., Nieto-García, L., López San Román, A., Herrera, J. M., Chaparro, M., Gisbert, J. P., Young Group of GETECCU, [García MJ, Rivero M] Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain. [Miranda-Bautista J] Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), and Departamento de Medicina, Universidad Complutense, Madrid, Spain. [Bastón-Rey I] Gastroenterology Department, Hospital Universitario Clínico de Santiago, Santiago de Compostela, Spain. [Mesonero F] Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Leo-Carnerero E] Gastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Delgado-Guillena P] Gastroenterology Department, Hospital General de Granollers, Granollers, Spain, Hospital General de Granollers, [Jose Garcia, Maria] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Rivero, Montserrat] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Castro, Beatriz] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Miranda-Bautista, Jose] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Menchen, Luis] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Marin, Ignacio] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Miranda-Bautista, Jose] Univ Complutense, Dept Med, Madrid 28009, Spain, [Menchen, Luis] Univ Complutense, Dept Med, Madrid 28009, Spain, [Marin, Ignacio] Univ Complutense, Dept Med, Madrid 28009, Spain, [Baston-Rey, Iria] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Calvino-Suarez, Cristina] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Barreiro-De Acosta, Manuel] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Nieto-Garcia, Laura] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Mesonero, Francisco] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Sanchez, Eugenia] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Sanchez-Aldehuelo, Ruben] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Lopez-San Roman, Antonio] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Leo-Carnerero, Eduardo] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Nunez, Andrea] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Dolores De la Cruz, Maria] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Manuel Herrera, Jose] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Casas-Deza, Diego] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Sierra, Olivia] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Javier Lamuela, Luis] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Cagigas Fernandez, Carmen] Hosp Univ Marques de Valdecilla, Dept Gen & Digest Surg, Colorectal Unit, Santander 39008, Spain, [Martin-Cardona, Albert] Hosp Univ Mutua Terrassa, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Terrassa 08221, Spain, [Zabana, Yamile] Hosp Univ Mutua Terrassa, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Terrassa 08221, Spain, [El Hajra, Ismael] Hosp Univ Puerta de Hierro, Gastroenterol Dept, Majadahonda 28220, Spain, [Gonzalez-Partida, Irene] Hosp Univ Puerta de Hierro, Gastroenterol Dept, Majadahonda 28220, Spain, [Hernandez-Aretxabaleta, Nerea] Hosp Univ Basurto, Gastroenterol Dept, Bilbao 48013, Spain, [De la Maza, Saioa] Hosp Univ Basurto, Gastroenterol Dept, Bilbao 48013, Spain, [Perez-Martinez, Isabel] Hosp Univ Cent Asturias, Inst Invest Sanitaria Principado Asturias ISPA 33, Dept Gastroenterol, Oviedo 33011, Spain, [Castano, Andres] Hosp Univ Cent Asturias, Inst Invest Sanitaria Principado Asturias ISPA 33, Dept Gastroenterol, Oviedo 33011, Spain, [Fuentes-Valenzuela, Esteban] Hosp Univ Rio Hortega, Gastroenterol Dept, Valladolid 47012, Spain, [Najera-Munoz, Rodrigo] Hosp Univ Rio Hortega, Gastroenterol Dept, Valladolid 47012, Spain, [Jimenez, Nuria] Hosp Gen Univ Elche, Gastroenterol Dept, Alicante 03203, Spain, [Rubin de Celix, Cristina] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Castro, Micaela Riat] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Chaparro, Maria] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Gisbert, Javier P.] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Gutierrez, Ana] Hosp Gen Alicante, Gastroenterol Dept, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Inst Invest Sanitaria & Biomed Alicante ISABIAL, Alicante 03010, Spain, [Suarez Ferrer, Cristina] Hosp Univ La Paz, Gastroenterol Dept, Madrid 28046, Spain, [Luis Rueda, Jose] Hosp Univ La Paz, Gastroenterol Dept, Madrid 28046, Spain, [Maria Huguet, Jose] Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia 46014, Spain, [Fernandez-Clotet, Agnes] Hosp Clin Barcelona, Gastroenterol Dept, Barcelona 08036, Spain, [Gonzalez-Vivo, Maria] Hosp del Mar, Gastroenterol Dept, Barcelona 08003, Spain, [Del Val, Blanca] Hosp Rafael Mendez, Gastroenterol Dept, Lorca 30817, Spain, [Castro-Poceiro, Jesus] Hosp St Joan Despi Moises Broggi, Gastroenterol Dept, Barcelona 08970, Spain, [Melcarne, Luigi] Hosp Univ Parc Tauli, Gastroenterol Dept, Sabadell, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona 08208, Spain, [Duenas, Carmen] Hosp Univ Caceres, Gastroenterol Dept, Caceres 10003, Spain, [Izquierdo, Marta] Hosp Univ Cabuenes, Gastroenterol Dept, Gijon 33203, Spain, [Monfort, David] Consorcio Sanitario Terrasa, Gastroenterol Dept, Barcelona 08227, Spain, [Bouhmidi, Abdel] Hosp Santa Barbara, Gastroenterol Dept, Puertollano 13500, Spain, [Ramirez De la Piscina, Patricia] Hosp Univ Vitoria Gasteiz, Gastroenterol Dept, Vitoria 01002, Spain, [Romero, Eva] Hosp Clin Univ Valencia, Gastroenterol Dept, Valencia 46010, Spain, [Molina, Gema] Hosp Arquitecto Marcide, Gastroenterol Dept, Ferrol 15405, Spain, [Zorrilla, Jaime] Hosp Univ Gregorio Maranon, Dept Colorectal & Gastrointestinal Surg, Madrid 28009, Spain, [Sanchez-Guillen, Luis] Hosp Gen Univ Elche, Dept Colorectal & Gastrointestinal Surg, Alicante 03203, Spain, [Manuel Benitez, Jose] Hosp Reina Sofia, Gastroenterol Dept, IMIBIC, Cordoba 14004, Spain, [Delgado-Guillena, Pedro] Hosp Gen Granollers, Gastroenterol Dept, Granollers 08042, Spain, [Tardillo, Carlos] Hosp Nuestra Sanora de la Candelaria, Gastroenterol Dept, Tenerife 38010, Spain, [Pena, Elena] Hosp Royo Villanova, Gastroenterol Dept, Zaragoza 50007, Spain, [Frago-Larramona, Santiago] Complejo Hosp Soria, Gastroenterol Dept, Soria 42005, Spain, [Carmen Rodriguez-Grau, Maria] Hosp Univ Henares, Gastroenterol Dept, Coslada 28002, Spain, [Plaza, Rocio] Hosp Univ Infanta Leonor, Gastroenterol Dept, Madrid 28031, Spain, [Perez-Galindo, Pablo] Complejo Hosp Univ Pontevedra, Gastroenterol Dept, Pontevedra 36071, Spain, [Martinez-Cadilla, Jesus] Hosp Alvaro Cunqueiro Vigo, Gastroenterol Dept, Vigo 36312, Spain, and Spanish Working Group in Crohn's Disease and Ulcerative Colitis (GETECCU)
Subjects: Gastroenterología y hepatología, Crohn’s disease, vedolizumab, medicine.medical_specialty, Crohns-disease, Cirurgia - Complicacions, Surgical complications, Productes biològics, Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases::Crohn Disease [DISEASES], Outcomes, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications [DISEASES], Crohn, Malaltia de, Lower risk, Inflammatory bowel disease, Article, ustekinumab, Vedolizumab, surgery, inflammatory bowel disease, Internal medicine, Ustekinumab, postoperative complications, Medicine, Risk factor, ulcerative colitis, Crohn's disease, preoperative therapy, business.industry, Postoperative infectious complications, Retrospective cohort study, General Medicine, anti-TNF, Metaanalysis, medicine.disease, Resection, mezclas complejas::productos biológicos [COMPUESTOS QUÍMICOS Y DROGAS], Ulcerative colitis, afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias [ENFERMEDADES], Gastrointestinal surgery, enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal::enfermedad de Crohn [ENFERMEDADES], Risk-factors, Ulcerative-colitis, Preoperative steroid use, Complex Mixtures::Biological Products [CHEMICALS AND DRUGS], business, medicine.drug
Abstract: Background: The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. Aims: To evaluate the impact of biologics on the risk of PC. Methods: A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered “exposed”. The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. Results: A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5, 95% CI: 1.2–2.0), urgent surgery (OR: 1.6, 95% CI: 1.2–2.2), laparotomy approach (OR: 1.5, 95% CI: 1.1–1.9) and severe anaemia (OR: 1.8, 95% CI: 1.3–2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2, 95% CI: 0.97–1.58), although it could be a risk factor for postoperative infections (OR 1.5, 95% CI: 1.03–2.27). Conclusions: Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.
Published: 2021

30. Relationship Between Different Resistance Mechanisms and Virulence in Acinetobacter baumannii

Author: Rafael López-Rojas, Jordi Vila, Sara Martí, Dora Rolo, Alix Pantel, Younes Smani, Paula Espinal, Jean-Philippe Lavigne, Jerónimo Pachón, European Society of Clinical Microbiology and Infectious Diseases, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Salud Carlos III, Instituto de Salud Global - Institute For Global Health [Barcelona] (ISGlobal), Virulence bactérienne et maladies infectieuses (VBMI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service de Microbiologie [CHU Caremeau, Nîmes], Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut d'Investigació Biomèdica de Bellvitge [Barcelone] (IDIBELL), CIBER Epidemiologia y Salud Pùblica [Madrid, Spain] (CIBERESP), Instituto de Salud Carlos III [Madrid] (ISC), Instituto de Biomedicina de Sevilla [Sevilla, Spain] (IBIS/HUVR), Universidad de Sevilla-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Hospital Universitario Virgen del Rocío [Sevilla], and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)
Subjects: Acinetobacter baumannii, Microbiology (medical), Immunology, Virulence, macromolecular substances, Multidrug resistance, Microbiology, Impermeability, Carbapenemase, carbapenemase, 03 medical and health sciences, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, polycyclic compounds, Caenorhabditis elegans, 030304 developmental biology, Pharmacology, 0303 health sciences, biology, 030306 microbiology, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, biochemical phenomena, metabolism, and nutrition, bacterial infections and mycoses, Carbapenemases, biology.organism_classification, 3. Good health, Multiple drug resistance, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, bacteria, MESH: Anti-Bacterial Agents / pharmacology, Acinetobacter Baumanii / genetics, Lipopolysaccharides / deficiency, Mutation
Abstract: [Aim] This study analyzed the virulence of several Acinetobacter baumannii strains expressing different resistance mechanisms using the Caenorhabditis elegans infection model., [Results] Strains susceptible/resistant to carbapenems (presenting class D (OXA-23, OXA-24), class B metallo-β-lactamase (MBL) (NDM-1), penicillin binding protein (PBP) altered and decreased expression of Omp 33–36 kDa) and isogenic A. baumannii strains susceptible/resistant to colistin (presenting loss of lipopolysaccharide (LPS) and pmrA mutations) were included to evaluate the virulence using the C. elegans infection model. The nematode killing assay, bacterial ingestion in worms, and bacterial lawn avoidance assay were performed with the Fer-15 mutant line. A. baumannii strains generally presented low virulence, showing no difference between carbapenem-resistant strains (expressing class D, MBLs, or altered PBP) and their isogenic susceptible strains. In contrast, the absence of the Omp 33–36 kDa protein in the knockout was associated with a decrease of virulence, and a significant difference was observed between colistin-resistant mutants and their susceptible counterpart when the mechanism of resistance was associated with the loss of LPS but not with its modification., [Conclusions] Resistance to carbapenems in A. baumannii associated with the production of OXA-type or NDM-type enzymes does not seem to affect their virulence in the C. elegans infection model. In contrast, the presence of Omp 33–36 kDa, and high level resistance to colistin related with the loss of LPS, might contribute with the virulence profile in A. baumannii., This work was supported by INSERM, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) under Research Grant (2013) to PE, the Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC) under travel grant to PE, and the Instituto de Salud Carlos III (ISCIII), Madrid, Spain under “Sara Borrell” Postdoctoral Contract CD12/00482 to DR and CD15/00017 to PE.
Published: 2019
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31. Economic impact of the first pass effect in mechanical thrombectomy for acute ischaemic stroke treatment in Spain: a cost-effectiveness analysis from the national health system perspective

Author: Eva González Diaz, Carlos Rodríguez-Paz, Andres Fernandez-Prieto, Mario Martínez-Galdámez, Rosa Martínez-Moreno, Joaquín Ortega Quintanilla, Alejandro Tomasello, Joaquín Zamarro, David Liebeskind, Osama O Zaidat, Nils H Mueller-Kronast, Institut Català de la Salut, [González Diaz E] Neurointerventional Radiology, Radiology Department, Cruces University Hospital, Barakaldo, Spain. [Rodríguez-Paz C] Neuroradiology Unit, Department of Radiology, Hospital Álvaro Cunqueiro, Vigo, Spain. [Fernandez-Prieto A] Neurointerventional Radiology, Radiology Department, Hospital Universitario La Paz, Madrid, Spain. [Martínez-Galdámez M] Neuroradiology Unit, University Clinical Hospital of Valladolid, Valladolid, Spain. [Martínez-Moreno R] Hospital Universitario Virgen de las Nieves, Granada, Spain. [Ortega Quintanilla J] Interventional Neuroradiology, Hospital Universitario Virgen del Rocío, Sevilla, Andalucía, Spain. [Tomasello A] Secció de Neuroradiologia Intervencionista, Servei de Radiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Interventional radiology, intervenciones quirúrgicas::procedimientos quirúrgicos cardiovasculares::procedimientos quirúrgicos vasculares::trombectomía [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Cost-Benefit Analysis, HEALTH ECONOMICS, Otros calificadores::Otros calificadores::/cirugía [Otros calificadores], General Medicine, Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Brain Ischemia [DISEASES], Other subheadings::Other subheadings::/surgery [Other subheadings], enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::isquemia cerebral [ENFERMEDADES], Brain Ischemia, Stroke, Isquèmia cerebral - Cirurgia, Vasos sanguinis - Cirurgia, Treatment Outcome, Neuroradiology, Spain, Surgical Procedures, Operative::Cardiovascular Surgical Procedures::Vascular Surgical Procedures::Thrombectomy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Humans, Cost-eficàcia, epidemiología y bioestadística::epidemiología::usos de la epidemiología::análisis de coste-eficiencia [SALUD PÚBLICA], Epidemiology and Biostatistics::Epidemiology::Uses of Epidemiology::Cost Efficiency Analysis [PUBLIC HEALTH], Thrombectomy, Ischemic Stroke
Abstract: ObjectiveThe mechanical thrombectomy (MT) benefit is related to the degree of reperfusion achieved. First pass effect (FPE) is defined as complete/near revascularisation of the large-vessel occlusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) after a single device pass. This study assessed the health benefit and economic impact of achieving FPE for acute ischaemic stroke (AIS) patients from the Spanish National Health System (NHS) perspective.DesignA lifetime Markov model was used to estimate incremental costs and health outcomes (measured in quality-adjusted life-years (QALYs)) of patients that achieve FPE. A subanalysis of the Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischaemic Stroke (STRATIS) registry was performed to obtain clinical outcomes. The base case included all patients that achieved at least a final mTICI ≥2 b, while the alternative scenario included all patients regardless of their final mTICI (0–3). Treatment costs were updated to reflect current practice based on expert panel consensus, while other acute and long-term costs were obtained from a previous cost-effectiveness analysis of MT performed in Spain. Sensitivity analyses were performed to assess the model’s robustness.SettingSpanish healthcare perspective.ParticipantsAIS patients in Spain.InterventionsFPE following MT.Outcome measuresThe model estimated QALYs, lifetime costs and net monetary benefit for the FPE and non-FPE group, depending on the inclusion of reperfusion groups and formal care costs.ResultsSTRATIS subanalysis estimated significantly better clinical outcomes at 90 days for the FPE group in all scenarios. In the base case, the model estimated lifetime cost saving per patient of €16 583 and an incremental QALY gain of 1.2 years of perfect health for the FPE group. Cost savings and QALY gains were greater in the alternative scenario (-€44 289; 1.75). In all scenarios, cost savings were driven by the long-term cost reduction.ConclusionAchieving FPE after MT can lead to better health outcomes per AIS patient and important cost savings for the Spanish NHS.
Published: 2022
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32. European Reference Network for rare adult solid cancers, statement and integration to health care systems of member states

Author: Blay, J-Y, Casali, P, Bouvier, C, Dehais, C, Galloway, I, Gietema, J, Halámková, J, Hindi, N, Idbaih, A, Kinloch, E, Klümpen, H-J, Kolarova, T, Kopeckova, K, Lovey, J, Magalhaes, M, Oselin, K, Piperno-Neumann, S, Ravnsbaek, A, Rogasik, M, Safwat, A, Scheipl, S, Seckl, M, Taylor, J, Temnyk, M, Trama, A, Urbonas, M, Wartenberg, M, Weinman, A, EURACAN Network, Oncology, CCA - Cancer Treatment and Quality of Life, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Léon Bérard [Lyon], University of Milan, Fondazione IRCCS Istituto Nazionale Tumori - National Cancer Institute [Milan], Royal Free Hospital [London, UK], Service de neurologie 2 [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), University Medical Center Groningen [Groningen] (UMCG), Masaryk Memorial Cancer Institute (RECAMO), Hospital Universitario Virgen del Rocío [Sevilla], University of Amsterdam [Amsterdam] (UvA), University Hospital Motol [Prague], National Institute of Oncology [Budapest, Hungary], Centro Hospitalar do Porto, North Estonia Medical Center, Institut Curie [Paris], Aarhus University Hospital, Karl-Franzens-Universität [Graz, Autriche], Charing Cross Hospital & Imperial College, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC), Kaunas University of Technology (KTU), EURORDIS-Rare Diseases Europe (Bureau de Paris), EURORDIS - Plateforme Maladies Rares [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and University of Graz
Subjects: Cancer Research, medicine.medical_specialty, Statement (logic), MEDLINE, [SDV.CAN]Life Sciences [q-bio]/Cancer, News, GUIDELINES, DIAGNOSIS, 03 medical and health sciences, 0302 clinical medicine, EURACAN Network, Health care, medicine, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, business.industry, Member states, 3. Good health, Oncology, 030220 oncology & carcinogenesis, Family medicine, SURVIVAL, Position paper, SARCOMA PATIENTS, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, BURDEN
Abstract: International audience
Published: 2021
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33. Empty spiracles homeobox genes EMX1 and EMX2 regulate WNT pathway activation in sarcomagenesis

Author: Daniel Otero-Albiol, Antonio Lucena-Cacace, Manuel P. Jiménez-García, Amancio Carnero, Ministerio de Ciencia, Innovación y Universidades (España), Agencia Estatal de Investigación (España), European Commission, Centro de Investigación Biomédica en Red Cáncer (España), Junta de Andalucía, Fundación Científica Asociación Española Contra el Cáncer, Ministerio de Educación, Cultura y Deporte (España), [Jimenez-García,MP, Otero-Albiol,D, Carnero,A] Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, Spain. [Jimenez-García,MP, Carnero,A] CIBER de Cancer, IS Carlos III, Madrid, Spain. [Lucena-Cacace,A] Present address: Department of Cell Growth and Differentiation, Center for iPS Cell Research and Application, Kyoto University, Kyoto, Japan. [Carnero,A] Instituto de Biomedicina de Sevilla/HUVR/CSIC, Hospital Universitario Virgen del Rocío, Sevilla, Spain., This work was supported by grants from the Ministerio de Ciencia, Innovación y Universidades (MCIU) Plan Estatal de I + D + I 2018, a la Agencia Estatal de Investigación (AEI) y al Fondo Europeo de Desarrollo Regional (MCIU/AEI/FEDER, UE): RTI2018-097455-B-I00, from AEI-MICIU/FEDER (RED2018-102723-T), from CIBER de Cáncer (CB16/12/00275), co-funded by FEDER from Regional Development European Funds (European Union), and from Consejeria de Salud (PI-0397–2017) and Consejeria of Economía, Conocimiento, Empresas y Universidad of the Junta de Andalucia (P18-RT-2501). Also especial thanks to the Fundacion AECC for supporting this work. MPJ-G was funded by a FPU contract from the Ministerio de Educacion (FPU13/00426).
Subjects: Cancer Research, Phenomena and Processes::Genetic Phenomena::Phenotype [Medical Subject Headings], beta Catenina, Carcinogenesis, EMX1, Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Connective and Soft Tissue::Sarcoma [Medical Subject Headings], Anatomy::Cells::Stem Cells::Neoplastic Stem Cells [Medical Subject Headings], medicine.disease_cause, b-catenin, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Anatomy::Cells::Cells, Cultured::Cell Line [Medical Subject Headings], Wnt Signaling Pathway, RC254-282, Cancer, Phenomena and Processes::Chemical Phenomena::Chemical Processes::Biochemical Processes::Signal Transduction::Wnt Signaling Pathway [Medical Subject Headings], EMX, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::DNA-Binding Proteins::Homeodomain Proteins [Medical Subject Headings], Cancer stem cells, Línea celular, Wnt signaling pathway, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Sarcoma, Diseases::Neoplasms::Neoplastic Processes::Carcinogenesis [Medical Subject Headings], Diseases::Neoplasms [Medical Subject Headings], Neoplasias, Cell biology, ARN, Phenotype, Oncology, Disciplines and Occupations::Natural Science Disciplines::Biological Science Disciplines::Biology::Computational Biology [Medical Subject Headings], Cell lines, Stem cell, Fenotipo, Regulatory genes, Vía de señalización Wnt, Wnt pathway, Biology, Transfection, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Transcription Factors [Medical Subject Headings], Factores de transcripción, Cancer stem cell, medicine, Humans, Phenomena and Processes::Genetic Phenomena::Genetic Processes::Gene Expression::Transcription, Genetic [Medical Subject Headings], Células madre neoplásicas, Homeodomain Proteins, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genes::Genes, Regulator [Medical Subject Headings], Genes reguladores, Research, fungi, Phenomena and Processes::Genetic Phenomena::Genetic Processes::Gene Expression Regulation::Epigenesis, Genetic [Medical Subject Headings], Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNA::RNA, Messenger [Medical Subject Headings], Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Cytoskeletal Proteins::Catenins [Medical Subject Headings], Catenin, Phenomena and Processes::Genetic Phenomena::Genetic Structures::Genome::Genome Components::Genes::Genes, Developmental::Genes, Homeobox [Medical Subject Headings], Homeobox, RNA, Ectopic expression, b‑catenin, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Genetic Techniques::Gene Transfer Techniques::Transfection [Medical Subject Headings], Transcription Factors
Abstract: [Background] Sarcomas are a very heterogeneous group of tumors with intrinsic developmental programs derived from the cell of origin. This implies a functional hierarchy inside tumors governed by sarcoma stem cells. Therefore, genetic and/or epigenetic changes profoundly affect the biology of sarcoma tumor stem cells. EMX genes are proposed to be transcription factors that are involved in the sarcomagenesis process, regardless of the neural or mesodermal embryological sarcoma origin. It has been shown that EMX1 or EMX2 overexpression reduces tumorigenic properties, while reducing the levels of these genes enhances these properties. Furthermore, it has been shown that EMX genes decrease the expression of stem cell regulatory genes and the stem cell phenotype. Taken together, these results indicate that the EMX1 and EMX2 genes negatively regulate these tumor-remodeling populations or sarcoma stem cells, acting as tumor suppressors in sarcoma., [Methods] Bioinformatic analysis, quantitative mRNA and protein expression analysis, cell models of sarcoma by ectopic expression of EMX genes. By cell biology methods we measured tumorigenesis and populations enriched on stem cell phenotypes, either in vitro or in vivo., [Results] In this work, we showed that the canonical Wnt pathway is one of the mechanisms that explains the relationships of EMX1/EMX2 and stem cell genes in sarcoma. The Wnt-EMX1/EMX2 relationship was validated in silico with sarcoma patient datasets, in vitro in primary derived sarcoma cell lines, and in vivo. EMX expression was found to negatively regulate the Wnt pathway. In addition, the constitutive activation of the Wnt pathway revers to a more aggressive phenotype with stem cell properties, and stemness gene transcription increased even in the presence of EMX1 and/or EMX2 overexpression, establishing the relationship among the Wnt pathway, stem cell genes and the EMX transcription factors., [Conclusions] Our data showed that Empty Spiracles Homeobox Genes EMX1 and EMX2 represses WNT signalling and activation of WNT pathway bypass EMX-dependent stemness repression and induces sarcomagenesis. These results also suggest the relevance of the Wnt/b-catenin/stemness axis as a therapeutic target in sarcoma., This work was supported by grants from the Ministerio de Ciencia, Innovación y Universidades (MCIU) Plan Estatal de I + D + I 2018, a la Agencia Estatal de Investigación (AEI) y al Fondo Europeo de Desarrollo Regional (MCIU/AEI/FEDER, UE): RTI2018-097455-B-I00; from AEI-MICIU/FEDER (RED2018-102723-T); from CIBER de Cáncer (CB16/12/00275), co-funded by FEDER from Regional Development European Funds (European Union); from Consejeria de Salud (PI-0397–2017) and Consejeria of Economía, Conocimiento, Empresas y Universidad of the Junta de Andalucia (P18-RT-2501). Also especial thanks to the Fundacion AECC for supporting this work. MPJ-G was funded by a FPU contract from the Ministerio de Educacion (FPU13/00426).
Published: 2021

34. Decision-making in suicidal behavior: A systematic review and meta-analysis

Author: Aina Sastre-Buades, María Luisa Barrigón, Adrián Alacreu-Crespo, Enrique Baca-García, Philippe Courtet, IIS‑Fundación Jiménez Diaz‑Autonoma University [Madrid, Spain], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), University of Zaragoza - Universidad de Zaragoza [Zaragoza], General Hospital of Villalba [Madrid], University Hospital Infanta Elena [Valdemoro], Universidad Catolica Del Maule, Universidad Autonoma de Madrid (UAM), and Hospital Universitario Virgen del Rocío [Sevilla]
Subjects: Cognitive Neuroscience, [SDV]Life Sciences [q-bio], Decision Making, Vulnerability, Suicide, Attempted, Neuropsychological Tests, Suicidal Ideation, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Iowa gambling task, Suicide attempt, Humans, Risk factor, Cognition, 030227 psychiatry, Suicide, Neuropsychology and Physiological Psychology, Suicidal behavior, Meta-analysis, Gambling, Trait, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Psychology, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Clinical psychology, Decision-making
Abstract: International audience; Impaired decision-making (DM) is well-known in suicidal behavior (SB). We aimed to review the evidence on DM and its mediating factors in SB and perform a meta-analysis on DM assessed using the Iowa Gambling Task (IGT). We conducted a search on databases of papers published on DM and SB up to 2020: 46 studies were included in the systematic review, and 18 in the meta-analysis. For meta-analysis, we compared DM performance between suicide attempters (SAs) and patients (PCs) or healthy controls (HCs). The systematic review showed that SAs have greater difficulties in all DM domains. The meta-analysis found worse IGT performance among SAs in comparison with PCs and HCs. A meta-regression did not find differences for age, gender, psychiatric disorder, and clinical status. Our findings indicate that SAs exhibited deficits in DM under conditions of risk though not ambiguity. Worse DM was independent of age, gender, psychiatric disorder, and suggested that DM impairment could be considered a cognitive trait of suicidal vulnerability, a risk factor and an attribute of SAs.
Published: 2021
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35. Disease burden and economic impact of diagnosed non‐alcoholic steatohepatitis in five European countries in 2018: A cost‐of‐illness analysis

Author: Lawrence Serfaty, Emmanuel Tsochatzis, Laurent Castera, Jorge Mestre-Ferrandiz, S. Cure, Victoria Higgins, Rachel Elliott, Manuel Romero-Gómez, Javier Crespo, Stephen D Ryder, A. Morgan, Vlad Ratziu, Philip N. Newsome, Vincenzo Atella, S. Hartmanis, Salvador Augustin, Lefteris Floros, Vincent Leroy, Victor de Lédinghen, Jeffrey V. Lazarus, Jérôme Boursier, Jörn M. Schattenberg, S. Vasudevan, Heike Bantel, A. Trylesinski, Elisabetta Bugianesi, Lynne Pezzullo, Alessio Aghemo, Achim Kautz, University Medical Center [Mainz], Instituto de Salud Global - Institute For Global Health [Barcelona] (ISGlobal), University of Birmingham [Birmingham], Hôpital de Hautepierre [Strasbourg], Humanitas University [Milan] (Hunimed), Vall d'Hebron University Hospital [Barcelona], Royal Free Hospital [London, UK], CHU Bordeaux [Bordeaux], Università degli studi di Torino (UNITO), Hospital Universitario Virgen del Rocío [Sevilla], Medizinische Hochschule Hannover (MHH), University of Nottingham, UK (UON), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Universitaire [Grenoble] (CHU), Marqués de Valdecilla University Hospital [Santander], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), PHMR Limited [London, UK], Università degli Studi di Roma Tor Vergata [Roma], Independent Economics Consultant [Madrid, Spain], University of Manchester [Manchester], Kautz5 [Köln, Germany], Deloitte [Canberra, Australia], Deloitte [Victoria, Australia], Intercept Pharmaceuticals [London, UK] (IP), Adelphi Real World [Cheshire, UK], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Università degli studi di Torino = University of Turin (UNITO), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and BOURGEAIS, Véronique
Subjects: economic impact, Adult, cost‐of‐illness analysis, non-alcoholic steatohepatitis (NASH), [SDV]Life Sciences [q-bio], Population, Psychological intervention, burden of disease, 03 medical and health sciences, 0302 clinical medicine, Cost of Illness, Non-alcoholic Fatty Liver Disease, Economic cost, healthcare resource utilisation, Germany, Health care, medicine, non‐alcoholic steatohepatitis (NASH), Humans, cost-of-illness analysis, Disease management (health), education, Socioeconomic status, Disease burden, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Hepatology, business.industry, medicine.disease, digestive system diseases, United Kingdom, 3. Good health, [SDV] Life Sciences [q-bio], Europe, Italy, Spain, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Original Article, Liver Disease and Public Health, France, Steatohepatitis, business, Demography
Abstract: BACKGROUND AND AIMS: Non-alcoholic steatohepatitis (NASH) is a chronic disease that can progress to end-stage liver disease (ESLD). A large proportion of early-stage NASH patients remain undiagnosed compared to those with advanced fibrosis, who are more likely to receive disease management interventions. This study estimated the disease burden and economic impact of diagnosed NASH in the adult population of France, Germany, Italy, Spain and the United Kingdom (UK) in 2018.METHODS: The socioeconomic burden of diagnosed NASH was estimated using cost-of-illness methodology applying a prevalence approach to estimate the number of adults with NASH and the attributable economic and wellbeing costs. Given undiagnosed patients do not incur costs in the study, the probability of diagnosis is central to cost estimation. The analysis was based on literature review, databases and consultation with clinical experts, economists and patient groups.RESULTS: The proportion of adult NASH patients with a diagnosis ranged from 11.9% to 12.7% across countries, which increased to 38.8% to 39.1% for advanced fibrosis (F3 to F4 compensated cirrhosis). Total economic costs were €8,548-19,546M. Of these, health system costs were €619-1,292M. Total wellbeing costs were €41,536-90,379M. The majority of the undiagnosed population (87.3% to 88.2% of total prevalence) was found to have early stage NASH which, left untreated, may progress to more resource consuming ESLD over time.CONCLUSIONS: This study found the majority of economic and wellbeing costs of NASH are experienced in late disease stages. Earlier diagnosis and care of NASH patients could reduce future healthcare costs.
Published: 2021
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36. European ‘NAFLD Preparedness Index’ — Is Europe ready to meet the challenge of fatty liver disease?

Author: Manuel Romero-Gómez, Patrizia Carrieri, Mattias Ekstedt, Shira Zelber-Sagi, Katja Novak, Vlad Ratziu, Quentin M. Anstee, Frank Tacke, Adam Palayew, Jeffrey V. Lazarus, Helena Cortez-Pinto, Giulio Marchesini, Instituto de Salud Global - Institute For Global Health [Barcelona] (ISGlobal), University of Barcelona, McGill University = Université McGill [Montréal, Canada], Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Linköping University (LIU), Alma Mater Studiorum University of Bologna (UNIBO), Istituto di ricovero e cura a carattere scientifico Azienda Ospedaliera Universitaria 'San Martino' (IRCCS AOU San Martino), University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Hospital Universitario Virgen del Rocío [Sevilla], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], University of Haifa [Haifa], Universidade de Lisboa (ULISBOA), Newcastle University [Newcastle], Lazarus J.V., Palayew A., Carrieri P., Ekstedt M., Marchesini G., Novak K., Ratziu V., Romero-Gomez M., Tacke F., Zelber-Sagi S., Cortez-Pinto H., Anstee Q.M., EASL International Liver Foundation, Gilead Sciences, Allergan Foundation, Bristol-Myers Squibb, Pfizer, Resoundant, Intercept Pharmaceuticals, Genfit, Ministerio de Ciencia, Innovación y Universidades (España), Instituto de Salud Carlos III, European Commission, Generalitat de Catalunya, NIHR Biomedical Research Centre (UK), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Universidade de Lisboa = University of Lisbon (ULISBOA), Repositório da Universidade de Lisboa, and Gestionnaire, Hal Sorbonne Université
Subjects: ESPEN, type 2 diabetes mellitus, EASL, European Association for the Study of the Liver, [SDV]Life Sciences [q-bio], Disease, Multiple joint correspondence analysi, WHO, 0302 clinical medicine, Non-alcoholic fatty liver disease, Liver health, Multiple joint correspondence analysis, Policy preparedness, Health policy, Metabolic-associated fatty liver disease, Non-alcoholic steatohepatitis, Europe, Multidisciplinary approach, EASD, European Association for the Study of Diabetes, European Association for the Study of Diabetes, Epidemiology, Immunology and Allergy, Medicine, European Association for the Study of Obesity, European Society of Clinical Nutrition and Metabolism, EEA, EASO, European Association for the Study of Obesity, media_common, Gastroenterology, NASH, food and beverages, ESPEN, European Society of Clinical Nutrition and Metabolism, 3. Good health, [SDV] Life Sciences [q-bio], 030220 oncology & carcinogenesis, Preparedness, 030211 gastroenterology & hepatology, Research Article, European Association for the Study of the Liver, EEA, European Economic Area, medicine.medical_specialty, NAFLD, non-alcoholic fatty liver disease, EASD, NASH, non-alcoholic steatohepatitis, multiple correspondence analysis, T2DM, Gastroenterology and Hepatology, EASL, World Health Organization, digestive system, WHO, World Health Organization, European Economic Area, 03 medical and health sciences, Environmental health, EU, European Union, NAFLD, Gastroenterologi, Internal Medicine, media_common.cataloged_instance, European Union, lcsh:RC799-869, European union, MCA, multiple correspondence analysis, Hepatology, business.industry, Public health, MCA, nutritional and metabolic diseases, non-alcoholic fatty liver disease, T2DM, type 2 diabetes mellitus, medicine.disease, Obesity, digestive system diseases, EASO, lcsh:Diseases of the digestive system. Gastroenterology, business, EU, Non-alcoholic steatohepatiti
Abstract: [Background & Aims] Non-alcoholic fatty liver disease (NAFLD), which is closely associated with obesity, metabolic syndrome, and diabetes, is a highly prevalent emerging condition that can be optimally managed through a multidisciplinary patient-centred approach. National preparedness to address NAFLD is essential to ensure that health systems can deliver effective care. We present a NAFLD Preparedness Index for Europe., [Methods] In June 2019, data were extracted by expert groups from 29 countries to complete a 41-item questionnaire about NAFLD. Questions were classified into 4 categories: policies/civil society (9 questions), guidelines (16 questions), epidemiology (4 questions), and care management (12 questions). Based on the responses, national preparedness for each indicator was classified into low, middle, or high-levels. We then applied a multiple correspondence analysis to obtain a standardised preparedness score for each country ranging from 0 to 100., [Results] The analysis estimated a summary factor that explained 71.3% of the variation in the dataset. No countries were found to have yet attained a high-level of preparedness. Currently, the UK (75.5) scored best, although falling within the mid-level preparedness band, followed by Spain (56.2), and Denmark (43.4), whereas Luxembourg and Ireland were the lowest scoring countries with a score of 4.9. Only Spain scored highly in the epidemiology indicator category, whereas the UK was the only country that scored highly for care management., [Conclusions] The NAFLD Preparedness Index indicates substantial variation between countries’ readiness to address NAFLD. Notably, even those countries that score relatively highly exhibit deficiencies in key domains, suggesting that structural changes are needed to optimise NAFLD management and ensure effective public health approaches are in place., [Lay summary] Non-alcoholic fatty liver disease (NAFLD), which is closely associated with obesity, metabolic syndrome, and diabetes, is a highly prevalent condition that can be optimally managed through a multidisciplinary patient-centred approach. National preparedness to address NAFLD is essential to allow for effective public health measures aimed at preventing disease while also ensuring that health systems can deliver effective care to affected populations. This study defined preparedness as having adequate policies and civil society engagement, guidelines, epidemiology, and care management. NAFLD preparedness was found to be deficient in all 29 countries studied, with great variation among the countries and the 4 categories studied., The original data collection was funded by the EASL International Liver Foundation with support from Gilead Sciences Europe Ltd., Allergan Pharmaceutical International Ltd., Bristol-Myers-Squibb Company, Pfizer Inc., and Resoundant Inc. The statistical analysis was funded by the EASL International Liver Foundation with support from Bristol-Myers-Squibb Company, Intercept, and Genfit. JVL is supported by a Spanish Ministry of Science, Innovation and Universities Miguel Servet grant (Instituto de Salud Carlos III/ESF, European Union [CP18/00074]) and further acknowledges institutional support from the Spanish Ministry of Science, Innovation and Universities through the ‘Centro de Excelencia Severo Ochoa 2019–2023’ Programme (CEX2018-000806-S), and support from the Government of Catalonia through the CERCA Programme. QMA and VR are members of the EPoS (Elucidating Pathways of Steatohepatitis) consortium funded by the Horizon 2020 Framework Program of the European Union under Grant Agreement 634413. QMA, VR, HCP, ME, and MRG are members of the LITMUS (Liver Investigation: Testing Marker Utility in Steatohepatitis) consortium funded by the IMI2 Program of the European Union under Grant Agreement 777377. QMA is a Newcastle NIHR Biomedical Research Centre investigator. AP, PC, GM, KN, FT, and SZS have no financial support statements to disclose., With funding from the Spanish government through the "Severo Ochoa Centre of Excellence" accreditation (CEX2018-000806-S).
Published: 2021
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37. Association between Radiotherapy and Risk of Cancer Associated Venous Thromboembolism: A Sub-Analysis of the COMPASS-CAT Study

Author: Maya Charafeddine, Grigorios T. Gerotziafas, Luis Jara-Palomares, Ismail Elalamy, Nour Moukalled, Sally Temraz, Ali T. Taher, American University of Beirut [Beyrouth] (AUB), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Universitaire de Cancérologie [Paris] (IUC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Service d'Hématologie biologique [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sechenov First Moscow State Medical University, Hospital Universitario Virgen del Rocío [Sevilla], Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III [Madrid] (ISC), Gestionnaire, Hal Sorbonne Université, Centre de Recherche Saint-Antoine (CRSA), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)
Subjects: Cancer Research, medicine.medical_specialty, pulmonary embolism, Anthracycline, medicine.medical_treatment, [SDV]Life Sciences [q-bio], venous thromboembolism, neoplasms, lcsh:RC254-282, Article, 03 medical and health sciences, 0302 clinical medicine, Median follow-up, Internal medicine, medicine, Clinical endpoint, risk factors, cardiovascular diseases, 030212 general & internal medicine, radiotherapy, Chemotherapy, business.industry, Cancer, equipment and supplies, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Radiation therapy, [SDV] Life Sciences [q-bio], Oncology, 030220 oncology & carcinogenesis, Cohort, Hormonal therapy, business
Abstract: Background: The role and effect of radiotherapy in the development of VTE has not been extensively explored, Methods: This is a post-hoc analysis from the COMPASS-CAT trial. Patients with breast, lung, colon or ovarian cancer, with early, locally advanced or metastatic disease and receiving chemotherapy were included. Primary endpoint was documented symptomatic VTE, Results: A total of 1355 patients were enrolled between November 2013 and November 2015. Of those, 194 patients were excluded because of missing data or the use of anticoagulation. Of the evaluable patients, 361 patients received radiotherapy (33.6%) At a median follow up of 6 months, 9.1% (n = 33) of patients receiving radiotherapy developed a VTE event (excluding those with missing data on follow up). After applying the competing risk model, radiotherapy remained significantly associated with increased risk for VTE (HR 2.47, 95% CI: 1.47–4.12, p = 0.001). Stratification analysis for the cohort that received radiotherapy revealed an increased risk of VTE in women compared to men (10.8% vs. 2.7%, p = 0.03), in those older than 50 (12.2% vs. 3.7%, p = 0.011), for patients receiving anthracycline chemotherapy (14.4% vs. 2.9%, p &lt, 0.001) and hormonal therapy (12.9% vs. 3.9%, 0.001), Conclusions: Analysis from the COMPASS-CAT revealed a significant correlation between radiotherapy and VTE in patients with cancer. Further studies are needed to better understand the potential cellular toxicity associated with radiotherapy.
Published: 2021
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38. Galactic spiral structure revealed by Gaia EDR3

Author: Morgan Fouesneau, D. J. Marshall, Rene Andrae, Vincenzo Ripepi, Ronald Drimmel, Yves Fremat, P. Ramos, Gisella Clementini, Alex Lobel, Tristan Cantat-Gaudin, M. Romero-Gómez, Laurent Chemin, E. Poggio, T. Muraveva, R. Blomme, E. Zari, F. Figueras, Ministerio de Ciencia, Innovación y Universidades (España), Universidad de Barcelona, German Centre for Air and Space Travel, European Commission, Agenzia Spaziale Italiana, Royal Observatory of Belgium [Brussels] (ROB), Institut de recherche en astrophysique et planétologie (IRAP), Institut national des sciences de l'Univers (INSU - CNRS)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Observatoire Midi-Pyrénées (OMP), Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Centre National de la Recherche Scientifique (CNRS), Hospital Universitario Virgen del Rocío [Sevilla], Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Observatoire Midi-Pyrénées (OMP), Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Institut de Recherche pour le Développement (IRD)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Centre National de la Recherche Scientifique (CNRS), ANR-18-CE31-0006,GaDaMa,Matière Noire Galactique(2018), and ANR-19-CE31-0017,SEGAL,Evolution séculaire des galaxies(2019)
Subjects: Cepheid variable, Perseus Arm, Position of the Sun, FOS: Physical sciences, Astrophysics, Astrophysics::Cosmology and Extragalactic Astrophysics, 01 natural sciences, Galaxy: disk, 0103 physical sciences, stellar content [Galaxy], Astrophysics::Solar and Stellar Astrophysics, Disc, Galaxy: structure, 010303 astronomy & astrophysics, Astrophysics::Galaxy Astrophysics, Physics, Galaxy: stellar content, Spiral galaxy, 010308 nuclear & particles physics, Astronomy and Astrophysics, Astrometry, Astrophysics - Astrophysics of Galaxies, Stars, Space and Planetary Science, Astrophysics of Galaxies (astro-ph.GA), [PHYS.ASTR]Physics [physics]/Astrophysics [astro-ph], disk [Galaxy], structure [Galaxy], Open cluster
Abstract: Using the astrometry and integrated photometry from the Gaia Early Data Release 3 (EDR3), we map the density variations in the distribution of young Upper Main Sequence (UMS) stars, open clusters and classical Cepheids in the Galactic disk within several kiloparsecs of the Sun. Maps of relative over/under-dense regions for UMS stars in the Galactic disk are derived, using both bivariate kernel density estimators and wavelet transformations. The resulting overdensity maps exhibit large-scale arches, that extend in a clumpy but coherent way over the entire sampled volume, indicating the location of the spiral arms segments in the vicinity of the Sun. Peaks in the UMS overdensity are well-matched by the distribution of young and intrinsically bright open clusters. By applying a wavelet transformation to a sample of classical Cepheids, we find that their overdensities possibly extend the spiral arm segments on a larger scale (~10 kpc from the Sun). While the resulting map based on the UMS sample is generally consistent with previous models of the Sagittarius-Carina spiral arm, the geometry of the arms in the III quadrant (galactic longitudes $180^\circ < l < 270^\circ$) differs significantly from many previous models. In particular we find that our maps favour a larger pitch angle for the Perseus arm, and that the Local Arm extends into the III quadrant at least 4 kpc past the Sun's position, giving it a total length of at least 8 kpc., 10 pages, 7 figures. Accepted for publication in A&A. The maps presented in this paper are publicly available in the form of a Jupyter Notebook at https://github.com/epoggio/Spiral_arms_EDR3.git
Published: 2021
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39. A multidisciplinary intervention to improve safety of antidiabetic prescriptions

Author: Ana Sánchez Pedrosa, Nerea Báez Gutiérrez, Héctor Rodríguez Ramallo, María del Carmen Saborido Cansino, [Rodríguez Ramallo,H, Báez Gutiérrez,N] Hospital Pharmacy Department, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Sánchez Pedrosa,A, and Saborido Cansino,MDC] Clinical Management Unit of Pharmacy, South-Seville Health Management Area, Seville, Spain.
Subjects: medicine.medical_specialty, Medicine (General), Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective Studies [Medical Subject Headings], Persons::Persons::Occupational Groups::Health Personnel::Pharmacists [Medical Subject Headings], Health Care::Health Care Quality, Access, and Evaluation::Delivery of Health Care::Delivery of Health Care, Integrated [Medical Subject Headings], Drug Prescriptions, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Chemicals and Drugs::Carbohydrates::Polysaccharides::Oligosaccharides::Trisaccharides::Acarbose [Medical Subject Headings], R5-920, Diabetes mellitus, Multidisciplinary approach, Intervention (counseling), Hipoglucemiantes, Prescripciones de medicamentos, Medicine, Humans, Hypoglycemic Agents, Medical prescription, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Prescription drugs, business.industry, Seguridad del paciente, Diseases::Endocrine System Diseases::Diabetes Mellitus::Diabetes Mellitus, Type 2 [Medical Subject Headings], General Medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cross-Sectional Studies [Medical Subject Headings], Patient safety, Antidiabetic, Diabetes Mellitus, Type 2, Family medicine, Persons::Persons::Occupational Groups::Health Personnel::Physicians::Physicians, Primary Care [Medical Subject Headings], Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Hypoglycemic Agents [Medical Subject Headings], Family Practice, business, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Prescriptions [Medical Subject Headings], Scientific Letter, Health Care::Health Care Facilities, Manpower, and Services::Health Services::Pharmaceutical Services::Prescriptions [Medical Subject Headings]
Abstract: Yes
Published: 2021

40. Expanding Indications of Liver Transplantation in Spain: Consensus Statement and Recommendations by the Spanish Society of Liver Transplantation

Author: Rodríguez-Perálvarez, Manuel, Gómez-Bravo, Miguel Ángel, Sánchez-Antolín, Gloria, De la Rosa, Gloria, Bilbao, Itxarone, Colmenero, Jordi, Spanish Society of Liver Transplantation (SETH) Consensus Panel, Institut Català de la Salut, [Rodríguez-Perálvarez M] Department of Hepatology and Liver Transplantation, Hospital Universitario Reina Sofía, IMIBIC, CIBERehd, Córdoba, Spain. [Gómez-Bravo MÁ] Department of Abdominal Surgery and Transplantation, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Sánchez-Antolín G] Department of Hepatology and Liver Transplantation, Hospital Universitario Rio Hortega, Valladolid, Spain. [De la Rosa G] Organización Nacional de Trasplantes, Madrid, Spain. [Bilbao I] Servei de Trasplantament de Fetge, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Colmenero J] Department of Hepatology and Liver Transplantation, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, and Universidad de Sevilla. Departamento de Cirugía
Subjects: medicine.medical_specialty, Donation programs, Carcinoma, Hepatocellular, Consensus, Waiting Lists, medicine.medical_treatment, MEDLINE, Alcoholic hepatitis, 030230 surgery, Liver transplantation, Fetge - Trasplantació - Espanya, Liver transplantation (LT), Scientific evidence, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, medicine, Humans, Grading (education), Societies, Medical, Transplantation, terapéutica::terapia biológica::tratamientos basados en células y tejidos::trasplante de tejidos::trasplante de hígado [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], localizaciones geográficas::Europa (continente)::España [DENOMINACIONES GEOGRÁFICAS], business.industry, Liver Neoplasms, virosis::hepatitis viral humana::hepatitis C [ENFERMEDADES], Virus Diseases::Hepatitis, Viral, Human::Hepatitis C [DISEASES], Hepatitis C, medicine.disease, Liver Transplantation, Geographic Locations::Europe::Spain [GEOGRAPHICALS], Spain, Donation, Family medicine, Hepatocellular carcinoma, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy::Tissue Transplantation::Liver Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], 030211 gastroenterology & hepatology, business
Abstract: Trasplantament de fetge; Hepatitis C; Consens Trasplante de hígado; Hepatitis C; Consenso Liver Transplantation; Hepatitis C; Consensus Background. The number of patients awaiting liver transplantation (LT) in Spain has halved from 2015 to 2019 due to the reduction of candidates with hepatitis C and the successful implementation of nonheart beating donation programs across the country. The Spanish Society for Liver Transplantation has committed to take advantage of this situation by developing consensus around potential areas to expand the current indications for LT. The consensus group was composed of 6 coordinators and 23 expert delegates, each one representing an LT institution in Spain. Methods. A modified Delphi approach was used to identify areas to expand indications for LT and to build consensus around paramount aspects, such as inclusion criteria and waitlist prioritization within each area. The scientific evidence and strength of recommendations were assessed by the “Grading of Recommendations Assessment, Development, and Evaluation” system. Results. The consensus process resulted in the identification of 7 potential areas to expand criteria in LT: recipient’s age, hepatocellular carcinoma, alcoholic hepatitis, acute-on-chronic liver failure, hilar and intrahepatic cholangiocarcinoma, and unresectable liver metastases of colorectal cancer. Conclusions. We present the main recommendations issued for each topic, together with their core supporting evidence. These recommendations may allow for expanding criteria for LT homogenously in Spain and may provide a guidance to other countries/institutions facing a similar scenario.
Published: 2021

41. Antimicrobial defined daily dose in neonatal population

Author: Villanueva-Bueno, Cristina, Montecatine-Alonso, Elena, Jiménez-Parrilla, Francisco, Fernández-Llamazares, Cecilia M, Manrique-Rodríguez, Silvia, Zamora-Flores, Elena, Dolz, Elisenda, Fernández-Polo, Aurora, Catillo-Salinas, Félix, Comuñas, Juanjo, Gallego-Fernández, Carmen, González-López, María, Gómez-Trevecedo Calvo, María-Teresa, Gázquez-Pérez, Rocío, Álvarez Del Vayo-Benito, Concepción, Gil-Navarro, Maria-Victoria, Paediatric Antimicrobial Defined Daily Dose Study Group (KiDDDs), Institut Català de la Salut, [Villanueva-Bueno C, Montecatine-Alonso E] Department of Pharmacy, Institute of Biomedicine of Seville (IBIS), Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Jiménez-Parrilla F] Department of Neonatology, Hospital Universitario Virgen del Rocío, Seville, Spain. [Fernández-Llamazares CM, Manrique-Rodríguez S] Department of Pharmacy, Hospital Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Research Network on Maternal and Child Health and Development II (Red SAMID II), Spanish Health Institute Carlos III, Madrid, Spain. [Zamora-Flores E] Neonatology Division, Department of Pediatrics, Gregorio Marañon Biomedical Research Institute, Gregorio Marañon University Hospital, Complutense University, Madrid, Spain. [Fernández-Polo A] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain. PROA-NEN Project, Barcelona, Spain. [Catillo-Salinas F, Comuñas J] Servei de Neonatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Microbiology (medical), medicine.medical_specialty, Cefepime, Population, Cefazolin, Neonatal antimicrobial prescription, Cloxacillin, Medicaments antiinfecciosos, Therapeutics::Drug Therapy::Drug Dosage Calculations [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Levofloxacin, Internal medicine, Antimicrobial consumption, medicine, Infants nadons, Neonatología, education, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents [CHEMICALS AND DRUGS], Otros calificadores::Otros calificadores::/administración & dosificación [Otros calificadores], education.field_of_study, business.industry, personas::Grupos de Edad::lactante::recién nacido [DENOMINACIONES DE GRUPOS], acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos [COMPUESTOS QUÍMICOS Y DROGAS], Persons::Age Groups::Infant::Infant, Newborn [NAMED GROUPS], Antimicrobial, Posologia, terapéutica::farmacoterapia::cálculos de dosificación de medicamentos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Defined daily dose, Consumo de antimicrobianos, Other subheadings::Other subheadings::/administration & dosage [Other subheadings], Prescripción de antimicrobianos en neonatos, Neonatology, business, Cefuroxime, medicine.drug
Abstract: [EN] Background: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates. Methods: Neonates (, [ES] Antecedentes: La dosis diaria definida de antimicrobianos (DDD), un método estandarizado para evaluar el consumo de antimicrobianos en la población adulta, tiene limitaciones que dificultan su uso en la población neonatal. Este estudio propone un diseño alternativo de la DDD aplicable a los recién nacidos. Métodos: Se incluyeron neonatos (< 1 mes) de 6 hospitales españoles durante un período de 12 meses. El peso y las semanas de edad gestacional de cada recién nacido fueron las variables recogidas. Las DDD (g) de cada antimicrobiano se calcularon multiplicando el peso obtenido por la dosis recomendada (mg/kg) del antimicrobiano para la indicación infecciosa más común seleccionada por el método Delphi. Resultados: Se incluyeron un total de 4.820 recién nacidos. La edad media fue de 36,72 semanas de edad gestacional y el peso medio fue de 2,687 kg. La DDD estandarizado (intravenoso; oral) para antimicrobianos seleccionados fueron: amoxicilina (0,08; 0,08), amoxicilina-ácido clavulánico (0,27; 0,08), ampicilina (0,27; x), cloxacilina (0,13; 0,13), penicilina G sódica (0,12), cefazolina (0,13), cefuroxima (0,27; x), cefotaxima (0,27), ceftazidima (0,27), ceftriaxona (0,13), cefepima (0,27) piperacilina-tazobactam (0,54), aztreonam (0,24), azitromicina (0,03; 0,03) clindamicina (0,04; 0,04), amikacina (0,04), gentamicina (0,01), metronidazol (0,04; 0,08), ciprofloxacina (0,04; 0,05), levofloxacina (x; x), fluconazol (0,02; 0,02), itraconazol (0,01; 0,01), fosfomicina (0,27). Antimicrobianos restringidos: meropenem (0,11), teicoplanina (0,02), vancomicina (0,08; 0,11), linezolid (0,08; 0,08), daptomicina (x), anfotericina B liposomal (0, 01). Conclusiones: Se ha diseñado un método útil para la medición de las DDD de antimicrobianos en neonatología para controlar el consumo de antimicrobianos en entornos hospitalarios. Debería validarse en estudios posteriores para incluirse en el diseño de los programas de administración de antimicrobianos neonatales en el futuro.
Published: 2021

42. MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention

Author: Belvís, Roberto, Irimia, Pablo, Pozo-Rosich, Patricia, González-Oria, Carmen, Cano, Antonio, Viguera, Javier, Sánchez, Belén, Molina, Francisco, Beltrán, Isabel, Oterino, Agustín, Cuadrado-Godia, Elisa, Gómez-Camello, Angel, Alberte-Woodward, Miguel, Jurado, Carmen, Oms, Teresa, Ezpeleta, David, de Terán, Javier Díaz, Morollón Sánchez-Mateos, Noemí, Latorre, Germán, Torres-Ferrús, Marta, Alpuente, Alicia, Lamas, Raquel, Toledano, Carlos, Leira, Rogelio, Santos, Sonia, Del Rio, Margarita Sanchez, Universitat Autònoma de Barcelona, Institut Català de la Salut, [Belvís R] Headache and Neuralgia Unit, Department of Neurology, Hospital de La Santa Creu I Sant Pau, 08025 Barcelona, Spain. [Irimia P] Clínica Universitaria de Navarra, Pamplona, Spain. [Pozo-Rosich P, Torres-Ferrús M, Alpuente A] Unitat de Cefalees, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Recerca en Cefalea i Dolor Neurològic, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [González-Oria C] Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Cano A] Hospital de Mataró, Barcelona, Spain. [Viguera J] Hospital Universitario Virgen de La Macarena, Sevilla, Spain, Vall d'Hebron Barcelona Hospital Campus, and Servicio de Neurología. Hospital Universitario de Fuenlabrada
Subjects: Monoclonal antibody, medicine.medical_specialty, Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores], Registry, enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos [ENFERMEDADES], Migraine Disorders, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Migranya - Tractament, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Other subheadings::Other subheadings::/prevention & control [Other subheadings], 0302 clinical medicine, Chronic Migraine, Internal medicine, medicine, Migranya - Prevenció, Humans, 030212 general & internal medicine, Registries, Adverse effect, Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders [DISEASES], Migraine, business.industry, General Medicine, Middle Aged, medicine.disease, Migraine with aura, Discontinuation, Europe, Anesthesiology and Pain Medicine, Tolerability, Spain, Concomitant, Cohort, Medicine, Female, Neurology (clinical), medicine.symptom, business, 030217 neurology & neurosurgery, Research Article, Erenumab, Preventive treatment
Abstract: Background Erenumab was approved in Europe for migraine prevention in patients with ≥ 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results. Methods Patients fulfilled the ICHD-3 criteria for migraine and had ≥ 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A > 50% reduction of MMDs after 12 weeks was considered as a response. Results We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A—BoNT/A—had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score p = 0.01), ≤ 5 prior preventive treatment failures (p = 0.026), absence of MOH (p = 0.039), and simultaneous BoNT/A treatment (p Conclusions In real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.
Published: 2021

43. Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Author: Jesús Rodríguez-Baño, Jerónimo Pachón, Jordi Carratalà, Pablo Ryan, Inmaculada Jarrín, María Yllescas, José Ramón Arribas, Juan Berenguer, Esther Aznar Muñoz, Pedro Gil Divasson, Patricia González Muñiz, Clara Muñoz Aguirre, Marta Díaz Menéndez, Fernando de la Calle Prieto, Marta Arsuaga Vicente, Elena Trigo Esteban, Ignacio Pérez Valero, Rosa de Miguel Buckley, Julen Cadiñaños Loidi, Beatriz Diaz Pollan, Luz Martín Carbonero, Juan Carlos Ramos Ramos, Belén Loeches Yagüe, Rocío Montejano Sánchez, Juan González García, Julio García Rodríguez, Margarita Ramírez, Isabel Gutiérrez, Francisco Tejerina, Teresa Aldámiz-Echevarría, Cristina Díez, Chiara Fanciulli, Leire Pérez-Latorre, Blanca Pinilla, Juan Carlos López, Ana Such Diaz, Elena Álvaro Alonso, Juan Torres Macho, Guillermo Cuevas Tascon, Eva Jiménez González de Buitrago, Fátima Brañas Baztán, Jorge Valencia de la Rosa, Mario Pérez Butragueño, Inés Fernández Jiménez, Gemma Muñiz Nicolás, Antonia Sepúlveda Berrocal, Alberto Gato Díez, María Pilar Toledano Sierra, María Paz García Butenegro, Ana Isabel Peláez Ballesta, Elena Morcillo Rodríguez, Isidoro Fernández Romero, Cristina Peláez Ballesta, María Isabel Guirado Torrecillas, Josune Goikoetxea Agirre, Elena Bereciartua Bastarrica, Laura Guio Carrión, Regino Rodríguez Álvarez, Marta Ibarrola Hierro, Isabel A. Pérez Hernández, Inés Pérez Zapata, Sergio Román Soto, Mohamed Kallouchi, Juan Ramón Domínguez Vicent, Rafae Silvariño Fernández, Jon Ugalde Espiñeira, Ainhoa Sanjuan López, Silvia García Martínez, Mikel Temprano Gogenola, Víctor Asensi, Silvia Suárez, Lucia Suárez, Carmen Yllera, María Rivas-Carmenado, Alberto Romero-Palacios, Jesús Ruiz Aragón, Patricia Jiménez Aguilar, Ma Luisa Fernández Ávila, Rosario Castilla Ortiz, Vanesa Alende Castro, Cristina Pérez García, Marta Fernández Morales, María Lorena María Valle Feijoo Begoña Rodríguez Ferreira, Joan Gómez-Junyent, Judit Villar-García, Inmaculada López-Montesinos, Itziar Arrieta-Aldea, Abora Rial-Villavecchia, Elisa García Vázquez, Aychel Elena Roura Piloto, Encarnación Moral Escudero, Alicia Hernández Torres, Helena Albendín Iglesias, David Vinuesa García, Clara Martínez Montes, Francisco Javier De la Hera Fernández, Francisco Anguita Santos, Andrés Ruiz Sancho, Vicens Díaz de Brito Fernández, Montserrat Sanmarti Vilamala, Sergio España Cueto, Daniel Molina Morant, Araceli González-Cuevas, Joel Elías Chara Cervantes, Guillem Policarpo Torres, Meritxell Ortega Montoliu, Mònica Angerri Nadal, Ariadna De Genover Gil, Eleni Patera, Rita Godoy Lorenzo, Evangelia Anna María Zioga, Virginia Isern Fernández, Carlos Enrique Sabbagh Fajardo, Ana Ferrer Ribera, Carlos Bea Serrano, Rosa Oltra Sempere, Sara Vela Bernal, Paloma Albiol Viñals, Miguel Pedromingo Kus, María Ángeles Garcinuño, Silvana Fiorante, Sergio Pérez Pinto, Alexandra de la Vega, María Carmen Fariñas Álvarez, Claudia González Rico, Francisco Arnaiz de las Revillas, Teresa Giménez, Jorge Calvo, Yolanda Meije Castillo, Alejandra Duarte Borges, Júlia Pareja Coca, Mercedes Clemente Presas, Xavier Sanz Salvador, Ma Teresa Pérez Rodríguez, Adrián Sousa, Alexandre Pérez González, Rebeca Longueira, Alejandro Araujo, Blanca Alonso Martínez, Laura García Escudero, Sara Lidia Kamel Rey, David Roa Alonso, Juan Pablo Avilés Parra, Iván Pelegrín Senent, Rosana Rouco Esteves Marques, Laia Raich Montiu, Jessica Souto Higueras, Manuel Alejandro Gálvez Bobadilla, Jorge Parra Ruiz, Violeta Ramos Sesma, Sara Velasco Fuentes, Laura García Pereña, Alfonso Lluna Carrascosa, Sergio Gilaberte Reyzábal, Mónica Liébana Gómez, Juan Salillas Hernando, Alberto Serrano Martínez, Miguel Torralba González de Suso, Patricia Martínez Martín, Isabel Rábago Lorite, Patricia González-Ruano Pérez, Beatriz Pérez-Monte Mínguez, Ángeles García Flores, Pere Comas Casanova, Andrea Martín Plata, Sergio Manuel Santana Báez, Oscar Sanz Peláez, Karim Mohamed Ramírez, José María Robaina Bordón, Helem Haydeé Vílchez Rueda, Melchor Riera Jaume, Gemma Mut Ramon, Meritxell Gavalda Manso, Lluis Planas Bibiloni, Laura Castelo Corral, Lucía Ramos Merino, Efrén Sánchez Vidal, María Rodríguez Mayo, Enrique Míguez Rey, José M. García de Lomas Guerrero, Javier De la Torre Lima, Ana Correa Ruiz, Fernando Fernández Sánchez, Nicolás Jiménez-García, José Luis Sierra-Monzón, Borja Gracia-Tello, María Hernández-Bonaga, Galadriel Pellejero, Marta Asín-Corrochano, Lucia Boix Palop, Esther Calbo, Cristina Badía, Beatriz Dietl, Gómez Lucía, Ángel Domínguez-Castellano, María José Ríos-Villegas, María D. del Toro, Zaira R. Palacios Baena, Elena Salamanca-Rivera, Elena Marín, Virginia Almadana, Salvador Pérez-Galera, Luisa González-Iglesias, Gabriela Abelenda-Alonso, Claudia Álvarez-Pouso, Francesc Escrihuela, Carlota Gudiol, Laia Lorenzo-Esteller, Jordi Niubó, Daniel Podzamczer, Miquel Pujol, Alexander Rombauts, Miguel Salvert Lletí, Ricardo Gil Sánchez, Marta Jiménez Escrig, Laura Parra Gómez, Mariona Tasias Pitarch, Marta Navarro Vilasaró, María Luisa Machado Sicilia, Aina Gomila Grange, Sonia Calzado Isbert, Nerea Carrasco Antón, Elizabet Petkova-Saiz, Alfonso Cabello Úbeda, Miguel Górgolas Hernández-Mora, Olga Sánchez-Pernaute, Carlos Dueñas Gutiérrez, Javier Martin Guerra, José Javier Castrodeza Sanz, Virginia Fernández Espinilla, Laura Rodríguez Fernández, Juan González-Moreno, Aroa Villoslada Gelabert, María Antonia Ribot Sanso, María Victoria Fernández-Baca, Almudena Hernández Milian, Miguel Ángel Morán Rodríguez, Zuriñe Ortiz de Zárate Ibarra, José Joaquin Portu Zapirain, Ester Saez de Adana Arroniz, Juan Carlos Gainzarain Arana, Olga Meca Birlanga, Ma Jesús del Amor Espín, Montserrat Viqueira González, Josefina García García, Onofre Martínez Madrid, Enrique Bernal Morell, Antonia Alcaraz, Ángeles Muñoz, Ignacio Pina, Vicente de la Rosa, Tamara Caínzos Romero, Sabela Sánchez Trigo, Ana Isabel Mariño Callejo, Hortensia Álvarez Díaz, Nieves Valcarce Pardeiro, Adriana Sánchez Serrano, Diana Piñar Cabezos, Eva Pilar García Villalba, Carmen Aguayo Jiménez, María Ruíz Campuzano, Virginia Naranjo Velasco, Marta Santos Peña, Juan Mora Delgado, Israel Sevilla Moreno, Cristina Lojo Cruz, Xabier Kortajarena Urkola, José Antonio Iribarren Loyarte, María Jesús Bustinduy Odriozola, Maialen Ibarguren Pinilla, Ignacio Álvarez Rodríguez, Francisco Javier Martínez Marcos, Francisco Javier Rodríguez Gómez, Isabel Asschert Agüero, Francisco Muñoz Beamud, Antonio José Ruiz Reina, Jara Llenas-García, Inmaculada González-Cuello, Elena Hellín-Valiente, Esther Martínez Birlanga, José Manuel Tafalla Torres, Jorge Calderón Parra, Gabriela Escudero López, Isabel Gutiérrez Martín, Ane Andrés Eisenhofer, Sonia García Prieto, Raquel Álvarez Franco, Daniel Roger Zapata, Blanca Martínez Cifre, Elena Aranda Rife, Irene Martín Rubio, André Barbosa Ventura, Javier Garrido, Concepción Gonzalo, Iván Piñero, Nieves de la Cruz Felipe, Eva Talavera García, Marta Lamata Subero, Paula Mendoza Roy, María Soledad García de Carlos, Justo Lajusticia Aisa, Lorea Arteche Eguizabal, Ainhoa Urrutia Losada, Saioa Domingo Echaburu, Pedro Ángel Cuadros Tito, Gurutz Orbe Narváez, Ma del Carmen Liébana Martos, Carolina Roldán Fontana, Carmen Herrero Rodríguez, Gaspar Duro Ruiz, Santiago Pérez Parra, Arantzazu Mera Fidalgo, Miquel Hortos Alsina, Ana Alberich Conesa, Lourdes Bladé Vidal, Nicolás Merchante Gutiérrez, Eva León Jiménez, Reinaldo Espíndola Gómez, María Erostarbe Gallardo, Pedro Martínez Pérez-Crespo, José Miguel Cisneros, Manuela Aguilar-Guisado, Teresa Aldabó, Claudio Bueno, Elisa Cordero-Matía, Ana Escoresca, Carmen Infante, Martín Guillermo, Sonsoles Salto, Francesca Gioia, Pilar Vizcarra, Jesús Fortún Abete, Pilar Martín Dávila, Santiago Moreno Guillén, José A. Oteo Revuelta, Concepción García-García, Paula Santibañez Sáenz, Cristina Cervera Acedo, José M. Azcona Gutiérrez, José María Reguera Iglesias, Antonio Plata Ciezar, Lucia Valiente de Santis, Beatriz Sobrino Diaz, Juan Diego Ruiz Mesa, Ministerio de Ciencia e Innovación, Fundación SEIMC/GeSIDA, Instituto de Salud Carlos III - ISCIII, European Regional Development Fund (ERDF/FEDER), Red Española de Investigación en SIDA, Red Española de Investigación en Patología Infecciosa, UAM. Departamento de Medicina, UAM. Departamento de Medicina Preventiva y Salud Pública y Microbiología, Universidad de Cantabria, SAM-COVID Study Group, [Rodríguez-Baño,J] Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Rodríguez-Baño,J, Pachón,J] Departamento de Medicina, Universidad de Sevilla, Spain. [Rodríguez-Baño,J, Pachón,J] Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain. [Pachón,J] Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Carratalà,J] Servei de Malalties Infeccioses, Hospital Universitari de Bellvitge, Barcelona, Spain. [Carratalà,J] Instituto de Investigación Biomédica de Bellvitge (IDIBELL), Barcelona, Spain. [Carratalà,J] Universitat de Barcelona, Barcelona, Spain. [Ryan,P] Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain. [Jarrín,I] Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain. [Yllescas,M] Fundación SEIMC/GeSIDA, Madrid, Spain. [Arribas,JR] Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain. [Arribas,JR] Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain. [Berenguer,J] Servicio de Microbiología Clínica y Enfermedades Infecciosas, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Berenguer,J] Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain., Ministerio de Ciencia e Innovación (España), Instituto de Salud Carlos III, Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF), Red de Investigación Cooperativa en Investigación en Sida (España), Red de Investigación Cooperativa en Investigación en Patología Infecciosa (España), Gilead Sciences, ViiV Healthcare, AbbVie Pharmaceuticals, Merck & Co, Janssen Biotech, Teva Pharmaceutical Industries, Ministerio de Ciencia, Innovación y Universidades (España), European Commission, Universidad de Sevilla. Departamento de Medicina, Instituto Carlos III (España), and Unión Europea
Subjects: 0301 basic medicine, Male, law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], chemistry.chemical_compound, 0302 clinical medicine, Organisms::Viruses::RNA Viruses::Nidovirales::Coronaviridae [Medical Subject Headings], Randomized controlled trial, law, Adrenal Cortex Hormones, Clinical endpoint, Medicine, 030212 general & internal medicine, Hospital Mortality, Health Care::Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Vital Statistics::Mortality [Medical Subject Headings], Adrenocortical hormones, Hazard ratio, General Medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Intubation::Intubation, Intratracheal [Medical Subject Headings], Middle Aged, Tocilizumab, Hospitalization, Infectious Diseases, Treatment Outcome, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections [Medical Subject Headings], Drug Therapy, Combination, Female, Cohort study, Microbiology (medical), medicine.medical_specialty, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections::Severe Acute Respiratory Syndrome [Medical Subject Headings], Combination therapy, Medicina, Hyperinflammatory state, 030106 microbiology, Estudios de cohortes, Antibodies, Monoclonal, Humanized, Article, 03 medical and health sciences, Internal medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings], Intubation, Intratracheal, Mortalitat, Humans, Corticosteroids, Mortality, Corticoesteroides, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], Aged, Proportional Hazards Models, Retrospective Studies, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Inflammation, business.industry, SARS-CoV-2, COVID-19, Odds ratio, Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones [Medical Subject Headings], Corticosteroides, COVID-19 Drug Treatment, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Propensity Score [Medical Subject Headings], chemistry, Spain, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies [Medical Subject Headings], Propensity score matching, Mortalidad, Monoclonal antibodies, business, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Inflammation [Medical Subject Headings], Anticossos monoclonals
Abstract: © 2020 The Author(s)., [Objectives]: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters., [Methods]: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs)., [Results]: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22–0.47; p < 0.001) for tocilizumab, 0.82 (0.71–1.30; p 0.82) for IHDC, 0.61 (0.43–0.86; p 0.006) for PDC, and 1.17 (0.86–1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02–0.17; p < 0.001)., [Conclusions]: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situation., IJ has received honoraria for participating in an advisory board from Gilead Sciences, and for educational activities from ViiV. JB has received research grants from AbbVie, Gilead Sciences, Merck, and ViiV, and honoraria for being a speaker or advisory board participation from AbbVie, Gilead Sciences, Janssen, Merck, and ViiV. JRA received fees for participating in an advisory board, being a speaker, and research grant support from Viiv, Janssen, Gilead, MSD, Teva, Alexa and Serono. PR is involved as speaker or advisory board participant for Gilead Sciences, AbbVie and ViiV. JR-B, JP, JC and MY have no conflicts of interest to declare. SAM-COVID was funded by Spanish Ministry of Science and Innovation, Instituto de Salud Carlos III (COV20/01031) co-funded by European Union (ERDF/ESF, “Investing in your future”) and Fundación SEIMC/GeSIDA. In addition, Juan Berenguer, Jesús Rodríguez-Baño, Inmaculada Jarrín, Jordi Carratalá, Jerónimo Pachón, and José R Arribas received funding for research from Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades – co- financed by European Development Regional Fund “A way to achieve Europe”, Operative program Intelligent Growth 2014–2020 through the networks: Spanish AIDS Research Network (RIS) [RD16/0025/0017 (JB), RD16/0025/0018 (JRA), RD16/0025/00XX (IJ)] and Spanish Network for Research in Infectious Diseases (REIPI)[RD16/0016/0001 (JRB), RD16/0016/0005 (JC), and RD16/0016/0009 (JP).
Published: 2021

44. Documento de revisión y actualización de la cefalea por uso excesivo de medicación (CUEM)

Author: Agustín Oterino, S. Díaz-Insa, M. Sánchez del Río, J.M. Láinez, R. Belvís, Rogelio Leira, Pablo Irimia, María L. Cuadrado, Guerrero-Peral Ál, Patricia Pozo-Rosich, Julio Pascual, C. González-Oria, M. Huerta, Sonia Santos-Lasaosa, G. Latorre, Jesús Porta-Etessam, Servicio de Neurología. Hospital Universitario de Fuenlabrada, Institut Català de la Salut, [González-Oria C] Unidad de Cefaleas, Servicio de Neurología, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Belvís R] Unidad de Cefaleas, Servicio de Neurología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Cuadrado ML] Departamento de Medicina, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain. [Díaz-Insa S] Unidad de Cefaleas, Servicio de Neurología, Hospital Universitario La Fe, Valencia, Spain. [Guerrero-Peral AL] Unidad de Cefaleas, Servicio de Neurología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. Instituto de Investigación de Salamanca (IBSAL), Salamanca, Spain. [Huerta M] Sección de Neurología, Hospital de Viladecans, Barcelona, Spain. [Pozo-Rosich P] Unitat de Cefalea, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Recerca en Cefalea, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas [ENFERMEDADES], Neurology, Chronic pain, Disease, Triptanes, Guideline, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], lcsh:RC346-429, 0302 clinical medicine, Tratamiento preventivo, Headache Disorders, Secondary, Deshabituación, Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders [DISEASES], Analgèsics - Efectes secundaris, Depression (differential diagnoses), Guía, Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Peripheral Nervous System Agents::Sensory System Agents::Analgesics [CHEMICALS AND DRUGS], Headache, acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::fármacos del sistema nervioso periférico::fármacos del sistema sensitivo::analgésicos [COMPUESTOS QUÍMICOS Y DROGAS], Dolor crònic, Systematic review, Ergot derivatives, Anxiety, Cefalea con uso excesivo de medicación, Ergóticos, Cefalàlgia - Tractament, medicine.symptom, Medication overuse, Detoxification, Preventive treatment, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], 03 medical and health sciences, Other subheadings::Other subheadings::/adverse effects [Other subheadings], medicine, Opioides, Intensive care medicine, lcsh:Neurology. Diseases of the nervous system, business.industry, Triptans, medicine.disease, Discontinuation, Opioids, Cefalàlgia, Neurology (clinical), business, 030217 neurology & neurosurgery, Cefaleas Secundarias, Medication overuse headache
Abstract: Tratamiento preventivo; Cefalea con uso excesivo de medicación; Opioides Tractament preventiu; Cefalea per ús excessiu de medicaments; Opioides Preventive treatment; Medication overuse headache; Opioids Introducción La cefalea con uso excesivo de medicación es una cefalea secundaria en la que el uso regular o frecuente de medicación analgésica produce un aumento de la frecuencia de una cefalea de base, pasando de episódica a crónica. La prevalencia de esta entidad está en torno al 1-2%, siendo más frecuente en mujeres entre 30 y 50 años con comorbilidades psiquiátricas como depresión o ansiedad y otros procesos de dolor crónico. Es importante conocer el manejo de esta entidad. Por este motivo, el Grupo de Estudios de Cefaleas de la Sociedad Española de Neurología ha pretendido realizar este documento de consenso sobre esta patología. Desarrollo Esta guía ha sido redactada por un grupo de expertos a partir de la revisión de la evidencia científica publicada y estableciendo recomendaciones prácticas para su adecuado manejo y tratamiento. El tratamiento de la cefalea con uso excesivo de medicación tiene varios pilares fundamentales y suele ser complejo: información y educación sobre el desarrollo de la cefalea con uso excesivo de medicación, tratamiento preventivo, suspensión del fármaco de uso frecuente y tratamiento de deshabituación. Es importante el seguimiento de pacientes con riesgo de recurrencias. Conclusiones Esperamos que este documento resulte de utilidad y permita su aplicación práctica en la consulta diaria y que sirva para actualizar y mejorar el conocimiento del manejo de esta patología. Introduction Medication overuse headache is a secondary headache in which the regular or frequent use of analgesics can increase the frequency of the episodes, causing the transition from episodic to chronic headache. The prevalence of medication overuse headache is approximately 1-2%, with higher rates among women aged 30-50 years and with comorbid psychiatric disorders such as depression or anxiety, or other chronic pain disorders. It is important to be familiar with the management of this disease. To this end, the Spanish Society of Neurology's Headache Study Group has prepared a consensus document addressing this disorder. Development These guidelines were prepared by a group of neurologists specialising in headache after a systematic literature review and provides consensus recommendations on the proper management and treatment of medication overuse headache. The treatment of medication overuse headache is often complex, and is based on 4 fundamental pillars: education and information about the condition, preventive treatment, discontinuation of the drug being overused, and treatment for withdrawal symptoms. Follow-up of patients at risk of recurrence is important. Conclusions We hope that this document will be useful in daily clinical practice and that it will update and improve understanding of medication overuse headache management.
Published: 2021

45. Miyoshi myopathy and limb girdle muscular dystrophy R2 are the same disease

Author: Moore, Ursula, Gordish, Heather, Diaz-Manera, Jordi, James, Meredith K, Mayhew, Anna G, Guglieri, Michela, Fernandez-Torron, Roberto, Rufibach, Laura E, Feng, Jia, Blamire, Andrew M, Carlier, Pierre G, Spuler, Simone, Day, John W, Jones, Kristi J, Bharucha-Goebel, Diana X, Salort-Campana, Emmanuelle, Pestronk, Alan, Walter, Maggie C, Paradas, Carmen, Stojkovic, Tanya, Mori-Yoshimura, Madoka, Bravver, Elena, Pegoraro, Elena, Lowes, Linda Pax, Mendell, Jerry R, Bushby, Kate, Straub, Volker, Jain COS Consortium, Newcastle University [Newcastle], Georgetown University [Washington] (GU), CIBER de Enfermedades Raras (CIBERER), Hospital de la Santa Creu i Sant Pau, Institut de Myologie, Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Max Delbrück Center for Molecular Medicine [Berlin] (MDC), Helmholtz-Gemeinschaft = Helmholtz Association, Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, The University of Sydney, National Institutes of Health [Bethesda] (NIH), Neurologie, maladies neuro-musculaires [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Washington University School of Medicine in St. Louis, Washington University in Saint Louis (WUSTL), Ludwig-Maximilians-Universität München (LMU), Hospital Universitario Virgen del Rocío [Sevilla], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Università degli Studi di Padova = University of Padua (Unipd), Abigail Wexner Research Institute, Nationwide Children's Hospital, Centre de référence des maladies rares neuromusculaires, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Universita degli Studi di Padova, Jain Foundation, and International Centre for Genomic Medicine in Neuromuscular Diseases
Subjects: 0301 basic medicine, Male, [SDV]Life Sciences [q-bio], Disease, Clinical trials methodology, 0302 clinical medicine, [185] Muscle disease, Child, Genetics (clinical), Muscle disease, Muscle Weakness, medicine.diagnostic_test, [21] Clinical trials methodology, Anatomy, Middle Aged, Magnetic Resonance Imaging, 3. Good health, Limb girdle weakness, Muscular Atrophy, Phenotype, Neurology, Child, Preschool, Disease Progression, Female, Function and Dysfunction of the Nervous System, Cohort study, Adult, Dysferlinopathy, Miyoshi myopathy, Adolescent, [54] Cohort study, Lower limb weakness, [16] Clinical neurology examination, 03 medical and health sciences, Young Adult, medicine, Humans, Clinical neurology examination, [176] All neuromuscular disease, business.industry, Infant, Newborn, Infant, Magnetic resonance imaging, medicine.disease, Clinical trial, Distal Myopathies, 030104 developmental biology, Muscular Dystrophies, Limb-Girdle, Pediatrics, Perinatology and Child Health, Neurology (clinical), business, 030217 neurology & neurosurgery, Limb-girdle muscular dystrophy, All neuromuscular disease
Abstract: The Jain COS Consortium., This study aims to determine clinically relevant phenotypic differences between the two most common phenotypic classifications in dysferlinopathy, limb girdle muscular dystrophy R2 (LGMDR2) and Miyoshi myopathy (MMD1). LGMDR2 and MMD1 are reported to involve different muscles, with LGMDR2 showing predominant limb girdle weakness and MMD1 showing predominant distal lower limb weakness. We used heatmaps, regression analysis and principle component analysis of functional and Magnetic Resonance Imaging data to perform a cross-sectional review of the pattern of muscle involvement in 168 patients from the Jain Foundation's international Clinical Outcomes Study for Dysferlinopathy. We demonstrated that there is no clinically relevant difference in proximal vs distal involvement between diagnosis. There is a continuum of distal involvement at any given degree of proximal involvement and patients do not fall into discrete distally or proximally affected groups. There appeared to be geographical preference for a particular diagnosis, with MMD1 being more common in Japan and LGMDR2 in Europe and the USA. We conclude that the dysferlinopathies do not form two distinct phenotypic groups and therefore should not be split into separate cohorts of LGMDR2 and MM for the purposes of clinical management, enrolment in clinical trials or access to subsequent treatments., The estimated $4 million USD needed to fund this study was provided by the Jain Foundation. Volker Straub was supported by an MRC strategic award to establish an International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) MR/S005021/1.
Published: 2021
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46. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study

Author: Marina Chiara Garassino, Byoung-Chul Cho, Joo-Hang Kim, Julien Mazières, Johan Vansteenkiste, Hervé Lena, Jesus Corral Jaime, Jhanelle E Gray, John Powderly, Christos Chouaid, Paolo Bidoli, Paul Wheatley-Price, Keunchil Park, Ross A Soo, Yifan Huang, Catherine Wadsworth, Phillip A Dennis, Naiyer A Rizvi, Luis Paz-Ares Rodriguez, Silvia Novello, Sandrine Hiret, Peter Schmid, Eckart Laack, Raffaele Califano, Makoto Maemondo, Sang-We Kim, Jamie Chaft, David Vicente Baz, Thierry Berghmans, Dong-Wan Kim, Veerle Surmont, Martin Reck, Ji-Youn Han, Esther Holgado Martin, Cristobal Belda Iniesta, Yuichiro Oe, Antonio Chella, Akhil Chopra, Gilles Robinet, Hector Soto Parra, Michael Thomas, Parneet Cheema, Nobuyuki Katakami, Wu-Chou Su, Young-Chul Kim, Juergen Wolf, Jong-Seok Lee, Hideo Saka, Michele Milella, Inmaculada Ramos Garcia, Anne Sibille, Takashi Yokoi, Eun Joo Kang, Shinji Atagi, Ernst Spaeth-Schwalbe, Makoto Nishio, Fumio Imamura, Nashat Gabrail, Remi Veillon, Sofie Derijcke, Tadashi Maeda, Dylan Zylla, Kendra Kubiak, Armando Santoro, Ma. Noemi Uy, Sarayut Lucien Geater, Antoine Italiano, Dariusz Kowalski, Fabrice Barlesi, Yuh-Min Chen, David Spigel, Busyamas Chewaskulyong, Ramon Garcia Gomez, Rosa Alvarez Alvarez, Chih-Hsin Yang, Te-Chun Hsia, Fabrice Denis, Hiroshi Sakai, Mark Vincent, Koichi Goto, Joaquim Bosch-Barrera, Glen Weiss, Jean-Luc Canon, Christian Scholz, Massimo Aglietta, Hirotsugu Kemmotsu, Koichi Azuma, Penelope Bradbury, Ronald Feld, Abraham Chachoua, Jacek Jassem, Rosalyn Juergens, Ramon Palmero Sanchez, Albert Malcolm, Nandagopal Vrindavanam, Kaoru Kubota, Cornelius Waller, David Waterhouse, Bruno Coudert, Zsuzsanna Mark, Miyako Satouchi, Gee-Chen Chang, Christian Herzmann, Arvind Chaudhry, Selvaraj Giridharan, Paul Hesketh, Norihiko Ikeda, Ralph Boccia, Nichola Iannotti, Missak Haigentz, John Reynolds, John Querol, Kazuhiko Nakagawa, Shunichi Sugawara, Eng Huat Tan, Tomonori Hirashima, Scott Gettinger, Terufumi Kato, Koji Takeda, Oscar Juan Vidal, Andrea Mohn-Staudner, Amit Panwalkar, Davey Daniel, Kunihiko Kobayashi, Guia Elena Imelda Ladrera, Clemens Schulte, Martin Sebastian, Marketa Cernovska, Helena Coupkova, Libor Havel, Norbert Pauk, Joginder Singh, Shuji Murakami, Tibor Csoszi, Gyorgy Losonczy, Allan Price, Ian Anderson, Mussawar Iqbal, Vamsee Torri, Erzsebet Juhasz, Saleem Khanani, Leona Koubkova, Benjamin Levy, Ray Page, Csaba Bocskei, Lucio Crinò, David Einspahr, Christopher Hagenstad, Necy Juat, Lindsay Overton, Mitchell Garrison, Zsuzsanna Szalai, IRCCS Istituto Nazionale dei Tumori [Milano], Yonsei University College of Medicine, CHA Bundang Medical Center, Service Pneumologie-Allergologie [CHU Toulouse], Pôle Clinique des Voies respiratoires [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), University Hospitals KU Leuven, Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospital Universitario Virgen del Rocío [Sevilla], H. Lee Moffitt Cancer Center and Research Institute, Carolina BioOncology Institute, Service de Pneumologie [CHI Créteil], CHI Créteil, IMRB - CEPIA/'Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health' [Créteil] (U955 Inserm - UPEC), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Azienda Ospedaliera San Gerardo, The Ottawa Hospital Research Institute, Centre for Rehabilitation Research and Development, 505 Smyth Road, Ottawa, ON, Canada, K1H 8M2., Samsung Medical Center Sungkyunkwan University School of Medicine, Institute Division of Hematology/Oncology, National University Hospital and National University Cancer Institute, AstraZeneca, Gaithersburg, MD, USA, AstraZeneca [Cambridge, UK], Columbia University [New York], Università degli studi di Torino = University of Turin (UNITO), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Department of Mathematics [Imperial College London], Imperial College London, Université libre de Bruxelles (ULB), Department of Microbiology, Chang Won National University, German Center for Lung Research, Università degli studi di Palermo - University of Palermo, Garassino, M, Cho, B, Kim, J, Mazieres, J, Vansteenkiste, J, Lena, H, Jaime, J, Gray, J, Powderly, J, Chouaid, C, Bidoli, P, Wheatley-Price, P, Park, K, Soo, R, Huang, Y, Wadsworth, C, Dennis, P, and Rizvi, N
Subjects: 0301 basic medicine, Oncology, Male, Durvalumab, Lung Neoplasms, Phases of clinical research, B7-H1 Antigen, 0302 clinical medicine, Antineoplastic Agents, Immunological, 4-Butyrolactone, Carcinoma, Non-Small-Cell Lung, Anaplastic lymphoma kinase, Anaplastic Lymphoma Kinase, Fatigue, Antibodies, Monoclonal, phase 2 study, gamma-Glutamyltransferase, Middle Aged, Progression-Free Survival, ErbB Receptors, ATLANTIS, Response Evaluation Criteria in Solid Tumors, Oncology, Durvalumab, non-small-cell lung cancer , ATLANTIS, phase 2 study, 030220 oncology & carcinogenesis, Cohort, Female, Immunotherapy, Diarrhea, medicine.medical_specialty, [SDV.CAN]Life Sciences [q-bio]/Cancer, Article, 03 medical and health sciences, Internal medicine, medicine, Humans, Progression-free survival, Aspartate Aminotransferases, Lung cancer, Aged, Performance status, business.industry, Pneumonia, medicine.disease, Injection Site Reaction, 030104 developmental biology, non-small-cell lung cancer, Mutation, business
Abstract: Background: Immune checkpoint inhibitors are a new standard of care for patients with advanced non-small-cell lung cancer (NSCLC) without EGFR tyrosine kinase or anaplastic lymphoma kinase (ALK) genetic aberrations (EGFR−/ALK−), but clinical benefit in patients with EGFR mutations or ALK rearrangements (EGFR+/ALK+) has not been shown. We assessed the effect of durvalumab (anti-PD-L1) treatment in three cohorts of patients with NSCLC defined by EGFR/ALK status and tumour expression of PD-L1. Methods: ATLANTIC is a phase 2, open-label, single-arm trial at 139 study centres in Asia, Europe, and North America. Eligible patients had advanced NSCLC with disease progression following at least two previous systemic regimens, including platinum-based chemotherapy (and tyrosine kinase inhibitor therapy if indicated); were aged 18 years or older; had a WHO performance status score of 0 or 1; and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Key exclusion criteria included mixed small-cell lung cancer and NSCLC histology; previous exposure to any anti-PD-1 or anti-PD-L1 antibody; and any previous grade 3 or worse immune-related adverse event while receiving any immunotherapy agent. Patients in cohort 1 had EGFR+/ALK+ NSCLC with at least 25%, or less than 25%, of tumour cells with PD-L1 expression. Patients in cohorts 2 and 3 had EGFR−/ALK− NSCLC; cohort 2 included patients with at least 25%, or less than 25%, of tumour cells with PD-L1 expression, and cohort 3 included patients with at least 90% of tumour cells with PD-L1 expression. Patients received durvalumab (10 mg/kg) every 2 weeks, via intravenous infusion, for up to 12 months. Retreatment was allowed for patients who benefited but then progressed after completing 12 months. The primary endpoint was the proportion of patients with increased tumour expression of PD-L1 (defined as ≥25% of tumour cells in cohorts 1 and 2, and ≥90% of tumour cells in cohort 3) who achieved an objective response, assessed in patients who were evaluable for response per independent central review according to RECIST version 1.1. Safety was assessed in all patients who received at least one dose of durvalumab and for whom any post-dose data were available. The trial is ongoing, but is no longer open to accrual, and is registered with ClinicalTrials.gov, number NCT02087423. Findings: Between Feb 25, 2014, and Dec 28, 2015, 444 patients were enrolled and received durvalumab: 111 in cohort 1, 265 in cohort 2, and 68 in cohort 3. Among patients with at least 25% of tumour cells expressing PD-L1 who were evaluable for objective response per independent central review, an objective response was achieved in 9 (12·2%, 95% CI 5·7–21·8) of 74 patients in cohort 1 and 24 (16·4%, 10·8–23·5) of 146 patients in cohort 2. In cohort 3, 21 (30·9%, 20·2–43·3) of 68 patients achieved an objective response. Grade 3 or 4 treatment-related adverse events occurred in 40 (9%) of 444 patients overall: six (5%) of 111 patients in cohort 1, 22 (8%) of 265 in cohort 2, and 12 (18%) of 68 in cohort 3. The most common treatment-related grade 3 or 4 adverse events were pneumonitis (four patients [1%]), elevated gamma-glutamyltransferase (four [1%]), diarrhoea (three [1%]), infusion-related reaction (three [1%]), elevated aspartate aminotransferase (two [
Published: 2020
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47. First-in-Human Phase I Study of Iadademstat (ORY-1001): A First-in-Class Lysine-Specific Histone Demethylase 1A Inhibitor, in Relapsed or Refractory Acute Myeloid Leukemia

Author: Salamero, Olga, Montesinos, Pau, Willekens, Christophe, Pérez-Simón, José Antonio, Pigneux, Arnaud, Récher, Christian, Popat, Rakesh, Carpio Segura, Cecilia del Carmen, Molinero, César, Mascaró, Cristina, Vila, Joaquim, Arévalo, M. Isabel, Maes, Tamara, Buesa, Carlos, Bosch José, Francesc Xavier, The University of Manchester, Universitat Autònoma de Barcelona, Institut Català de la Salut, [Salamero O, Carpio C, Bosch F] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Montesinos P] Hospital Universitari I Politécnic La Fe, València, Spain. Centro de Investigación Biomédica en Red de Cáncer, Instituto Carlos III, Madrid, Spain. [Willekens C] Institut Gustave Roussy, Villejuif Cedex, France. [Pérez-Simón JA] Hospital Universitario Virgen del Rocío, Sevilla, Spain. Instituto de Biomedicina de Sevilla (Insitituto de Biomedicina De Sevilla/Consejo Superior De Investigaciones Científicas/Centro de Investigación Biomédica en Red de Cáncer), Universidad de Sevilla, Sevilla, Spain. [Pigneux A] Centre Hospitalier Universitaire CHU Bordeaux, Hôpital du Haut Lévêque, Pessac, France. [Récher C] Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université Toulouse III Paul Sabatier, Toulouse, France, Vall d'Hebron Barcelona Hospital Campus, Ministerio de Economía y Competitividad (España), European Commission, Cancer Research UK, Centro para el Desarrollo Tecnológico Industrial (España), National Institute for Health Research (UK), University College London, and NIHR Biomedical Research Centre (UK)
Subjects: Adult, Male, Cancer Research, Myeloid, Lysine-Specific Histone Demethylase 1A, acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos [COMPUESTOS QUÍMICOS Y DROGAS], neoplasias::neoplasias por tipo histológico::leucemia::leucemia mieloide::leucemia mieloide aguda [ENFERMEDADES], Refractory, In vivo, Recurrence, hemic and lymphatic diseases, medicine, Hematologic Malignancy, Humans, Other subheadings::/therapeutic use [Other subheadings], Enzyme Inhibitors, Aged, Aged, 80 and over, Histone Demethylases, business.industry, Leucèmia mieloide aguda, Otros calificadores::/uso terapéutico [Otros calificadores], Myeloid leukemia, Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Myeloid::Leukemia, Myeloid, Acute [DISEASES], KDM1A, ORIGINAL REPORTS, Middle Aged, medicine.disease, In vitro, Leukemia, Leukemia, Myeloid, Acute, medicine.anatomical_structure, Oncology, Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors [CHEMICALS AND DRUGS], Cancer research, Female, business, Inhibidors enzimàtics - Ús terapèutic
Abstract: [Purpose] Iadademstat is a novel, highly potent, and selective inhibitor of LSD1 (KDM1A), with preclinical in vitro and in vivo antileukemic activity. This study aimed to determine safety and tolerability of iadademstat as monotherapy in patients with relapsed/refractory acute myeloid leukemia (R/R AML)., [Methods] This phase I, nonrandomized, open-label, dose-escalation (DE), and extension-cohort (EC) trial included patients with R/R AML and evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antileukemic activity of this orally bioavailable first-in-class lysine-specific demethylase 1 inhibitor., [Results] Twenty-seven patients were treated with iadademstat on days 1 to 5 (5-220 µg/m2/d) of each week in 28-day cycles in a DE phase that resulted in a recommended dose of 140 µg/m2/d of iadademstat as a single agent. This dose was chosen to treat all patients (n = 14) in an EC enriched with patients with MLL/KMT2A-rearranged AML. Most adverse events (AEs) were as expected in R/R AML and included myelosuppression and nonhematologic AEs, such as infections, asthenia, mucositis, and diarrhea. PK data demonstrated a dose-dependent increase in plasma exposure, and PD data confirmed a potent time- and exposure-dependent induction of differentiation biomarkers. Reductions in blood and bone marrow blast percentages were observed, together with induction of blast cell differentiation, in particular, in patients with MLL translocations. One complete remission with incomplete count recovery was observed in the DE arm., [Conclusion] Iadademstat exhibits a good safety profile together with signs of clinical and biologic activity as a single agent in patients with R/R AML. A phase II trial of iadademstat in combination with azacitidine is ongoing (EudraCT No.: 2018-000482-36)., Supported by Oryzon Genomics and IPT-2012-0673-010000 of the INNPACTO program of the Spanish Ministry of Economy and Competitiveness, with contribution of Fondo Europeo de Desarrollo Regional (FEDER) from the European Union and CDTI_CIIP-20131005/EUROSTAR_E18159. T.C.P.S. is supported by Cancer Research UK Grant No. C5759/A20971. R.P. is supported by the National Institute for Health Research, University College London Hospitals, Biomedical Research Centre.
Published: 2020

48. The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease

Author: Hardy, Timothy, Wonders, Kristy, Younes, Ramy, Aithal, Guruprasad P, Aller, Rocio, Allison, Michael, Bedossa, Pierre, Betsou, Fay, Boursier, Jerome, Brosnan, M Julia, Burt, Alastair, Cobbold, Jeremy, Cortez-Pinto, Helena, Day, Chris P, Dufour, Jean-Francois, Ekstedt, Mattias, Francque, Sven, Harrison, Stephen, Miele, Luca, Nasr, Patrik, Papatheodoridis, George, Petta, Salvatore, Tiniakos, Dina, Torstenson, Richard, Valenti, Luca, Holleboom, Adriaan G, Yki-Jarvinen, Hannele, Geier, Andreas, Romero-Gomez, Manuel, Ratziu, Vlad, Bugianesi, Elisabetta, Schattenberg, Jörn M, Anstee, Quentin M, LITMUS Consortium, Newcastle University [Newcastle], Università degli studi di Torino (UNITO), University of Nottingham, UK (UON), Universidad de Valladolid [Valladolid] (UVa), Cambridge University Hospitals - NHS (CUH), University of Cambridge [UK] (CAM), Integrated BioBank of Luxembourg (IBBL), Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Pfizer, Oxford University Hospitals NHS Trust, University of Oxford [Oxford], Universidade de Lisboa (ULISBOA), University of Bern, Linköping University (LIU), University of Antwerp (UA), Università cattolica del Sacro Cuore [Roma] (Unicatt), National and Kapodistrian University of Athens (NKUA), Università degli studi di Palermo - University of Palermo, University of Milan, University of Helsinki, University of Würzburg, Hospital Universitario Virgen del Rocío [Sevilla], Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), University Medical Center [Mainz], Newcastle Upon Tyne Hospitals NHS Foundation Trust, Vascular Medicine, ACS - Diabetes & metabolism, ACS - Amsterdam Cardiovascular Sciences, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, LITMUS Consortium, Innovative Medicines Initiative, European Commission, Department of Medicine, HUS Internal Medicine and Rehabilitation, Helsinki University Hospital Area, Hardy T., Wonders K., Younes R., Aithal G.P., Aller R., Allison M., Bedossa P., Betsou F., Boursier J., Brosnan M.J., Burt A., Cobbold J., Cortez-Pinto H., Day C.P., Dufour J.-F., Ekstedt M., Francque S., Harrison S., Miele L., Nasr P., Papatheodoridis G., Petta S., Tiniakos D., Torstenson R., Valenti L., Holleboom A.G., Yki-Jarvinen H., Geier A., Romero-Gomez M., Ratziu V., Bugianesi E., Schattenberg J.M., Anstee Q.M., Harrison, Seamus Conor [0000-0003-1480-1143], and Apollo - University of Cambridge Repository
Subjects: Liver Cirrhosis, PROGNOSIS, Cirrhosis, SCORING SYSTEM, [SDV]Life Sciences [q-bio], PROGRESSION, Disease, Biomarker, Cirrhosis, NAFLD, NASH, STEATOHEPATITIS, DEFINITIONS, Cohort Studies, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Nonalcoholic fatty liver disease, Pharmacology (medical), 030212 general & internal medicine, Longitudinal Studies, Registries, ComputingMilieux_MISCELLANEOUS, media_common, Pharmacology. Therapy, Fatty liver, Liver Neoplasms, NASH, General Medicine, 3. Good health, Liver, 317 Pharmacy, Cohort, 0305 other medical science, Cohort study, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Geriatrik, QUESTIONNAIRE, NAFLD, Biomarker, 610 Medicine & health, 03 medical and health sciences, medicine, STEATOSIS, media_common.cataloged_instance, Humans, ALGORITHM, European union, Intensive care medicine, 030505 public health, business.industry, CONSUMPTION, STAGING SYSTEM, medicine.disease, Diabetes Mellitus, Type 2, Geriatrics, 3121 General medicine, internal medicine and other clinical medicine, 3111 Biomedicine, Human medicine, Steatohepatitis, business
Abstract: © 2020 The Author(s)., Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. At present our understanding of pathogenesis, disease natural history and long-term outcomes remain incomplete. There is a need for large, well characterised patient cohorts that may be used to address these knowledge gaps and to support the development of better biomarkers and novel therapies. The European NAFLD Registry is an international, prospectively recruited observational cohort study that aims to establish a large, highly-phenotyped patient cohort and linked bioresource. Here we describe the infrastructure, data management and monitoring plans, and the standard operating procedures implemented to ensure the timely and systematic collection of high-quality data and samples. Already recruiting subjects at secondary/tertiary care centres across Europe, the Registry is supporting the European Union IMI2-funded LITMUS ‘Liver Investigation: Testing Marker Utility in Steatohepatitis’ consortium, which is a major international effort to robustly validate biomarkers that diagnose, risk stratify and/or monitor NAFLD progression and liver fibrosis stage. The European NAFLD Registry has the demonstrable capacity to support research and biomarker development at scale and pace., The European NAFLD Registry is supported by the LITMUS (Liver Investigation: Testing Biomarker Utility in Steatohepatitis) consortium funded by the European Union Innovative Medicines Initiative 2 (IMI2) Joint Undertaking under grant agreement 777377, which receives support from the Horizon 2020 Framework Program of European Union and EFPIA. It has also received support from the EPoS (Elucidating Pathways of Steatohepatitis) consortium funded by the Horizon 2020 Framework Program of the European Union under Grant Agreement 634413, the FLIP consortium funded by the Framework Program 7 of the European Union under grant agreement 241762, and an EASL Registry Grant from the European Association for the Study of the Liver.
Published: 2020
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49. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Author: Richard Leblanc, Marie-Laure Risse, Xavier Leleu, Ludek Pour, Chang-Ki Min, Marta Segura, Mehmet Turgut, Sandrine Schwab, Ross I. Baker, Thomas G. Martin, Marcelo Capra, Laure Malinge, Philippe Moreau, Mohamad Mohty, Meletios A. Dimopoulos, University of California [San Francisco] (UCSF), University of California, Centre hospitalier universitaire de Nantes (CHU Nantes), Murdoch University, University Hospital Brno, Catholic University of Korea, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire d'Hématologie et d'Immunologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Pathologies biliaires, fibrose et cancer du foie [CHU Saint-Antoine], Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hospital Universitario Virgen del Rocío [Sevilla], Ondokuz Mayis University, Hôpital Maisonneuve-Rosemont, Sanofi-Aventis R&D, SANOFI Recherche, Aixial Pharma, University of Athens Medical School [Athens], [Capra, Marcelo] Hosp Mae de Deus, Ctr Integrad Hematol & Oncol, Porto Alegre, RS, Brazil, [Martin, Thomas] Univ Calif San Francisco, Dept Med, San Francisco, CA 94143 USA, [Moreau, Philippe] Univ Nantes, Dept Hematol, Nantes, France, [Baker, Ross] Murdoch Univ, Perth Blood Inst, Perth, WA, Australia, [Pour, Ludek] Univ Hosp Brno, Dept Internal Med Hematol & Oncol, Brno, Czech Republic, [Min, Chang-Ki] Catholic Univ Korea, Catholic Hematol Hosp, Coll Med, Dept Hematol,Seoul St Marys Hosp, Seoul, South Korea, [Min, Chang-Ki] Catholic Univ Korea, Leukemia Res Inst, Coll Med, Seoul St Marys Hosp, Seoul, South Korea, [Leleu, Xavier] CHU, Serv Hematol & Therapie Cellulaire, Poitiers, France, [Leleu, Xavier] CIC INSERM 1402, Poitiers, France, [Mohty, Mohamad] Sorbonne Univ, Dept Hematol, Hop St Antoine, INSERM UMRS 938, Paris, France, [Reinoso Segura, Marta] Hosp Univ Virgen del Rocio, Seville, Spain, [Turgut, Mehmet] Ondokuz Mayis Univ, Dept Hematol, Fac Med, Samsun, Turkey, [LeBlanc, Richard] Univ Montreal, Hop Maisonneuve Rosemont, Montreal, PQ, Canada, [Risse, Marie-Laure] Sanofi Res & Dev, Vitry Sur Seine, France, [Schwab, Sandrine] Sanofi Res & Dev, Vitry Sur Seine, France, [Malinge, Laure] Aixial, Boulogne, France, [Dimopoulos, Meletios] Natl & Kapodistrian Univ Athens, Sch Med, Dept Clin Therapeut, Athens, Greece, and Sanofi
Subjects: Complications, Failure, Biochemistry, Dexamethasone, Bortezomib, chemistry.chemical_compound, 0302 clinical medicine, Reversibility, Antineoplastic Combined Chemotherapy Protocols, Open-label, Renal Insufficiency, Lenalidomide, Multiple myeloma, media_common, Isatuximab, 0303 health sciences, Hematology, 3. Good health, Safety profile, 030220 oncology & carcinogenesis, Multiple Myeloma, Oligopeptides, medicine.drug, medicine.medical_specialty, Phase-iii, Immunology, Urology, Renal function, Subgroup analysis, Antibodies, Monoclonal, Humanized, Pooled analysis, 03 medical and health sciences, Internal medicine, medicine, Humans, media_common.cataloged_instance, In patient, European union, Renal response, Staging system, 030304 developmental biology, Low-dose dexamethasone, business.industry, Cell Biology, medicine.disease, Carfilzomib, chemistry, business, Dialysis, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030215 immunology
Abstract: Introduction: Renal impairment (RI) is a common feature in multiple myeloma (MM) and an adverse predictor of survival. Anti-myeloma treatments that can also improve renal function in patients (pts) with MM are required. Isatuximab (Isa), a monoclonal CD38 antibody, is approved in combination with pomalidomide and dexamethasone (d), in the United States, the European Union, Canada, Australia, Switzerland, and Japan for the treatment of adult pts with relapsed/refractory MM who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. IKEMA (NCT03275285) was a randomized, open-label, multicenter, Phase 3 study that demonstrated the benefit of adding Isa to carfilzomib (K) plus d vs Kd in pts with relapsed MM. This subgroup analysis of IKEMA examined efficacy, renal response, and safety in pts with RI. Methods: Pts with 1-3 prior lines of therapy were randomized 3:2 and stratified by number of prior lines and revised international staging system (R-ISS) stage to receive Isa-Kd or Kd. The Isa-Kd arm received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks thereafter. Both arms received recommended doses of Kd. Treatment continued until disease progression or unacceptable adverse events. Interim efficacy analysis was planned when 65% of the total expected progression-free survival (PFS) events determined by an Independent Response Committee were observed. RI was defined as estimated glomerular filtration rate ([eGFR]; using the Modification of Diet in Renal Disease equation) Results: A total of 302 pts (179 Isa-Kd; 123 Kd) were randomized. Pts with baseline eGFR as low as 15 mL/min/1.73m² (severe RI) were allowed to enroll. more pts with RI in the Isa-Kd arm (26.1%) vs Kd (16.2%). As expected, elderly pts had more RI. The median age in years (range) was 67 (39-86) for Isa-Kd vs 69 (49-90) for Kd among RI pts, and 64 (37-81) for Isa-Kd vs 62 (33-78) for Kd among pts with no RI. In RI pts, 60.5% vs 72.2% pts had ≥2 prior lines of therapy, 11.6% vs 16.7% had R-ISS stage III, and 20.9% vs 27.8% had high risk cytogenetics, in Isa-Kd vs Kd, respectively. More RI pts were still on treatment at the cut-off date in Isa-Kd (55.8%) vs Kd (16.7%). Median PFS for RI pts was not reached for Isa-Kd vs 13.4 months for Kd (HR 0.27; 95% CI 0.11-0.66), and not reached for both study arms among pts with no RI (HR 0.63; 95% CI 0.39-1.00). The overall response rate, ≥very good partial response rate, and minimal residual disease negativity for RI pts was higher with Isa-Kd than Kd: 93.0% vs 61.1%, 79.1% vs 44.4%, and 30.2% vs 11.1%, respectively. CrR accessed in pts with eGFR Conclusions: The addition of Isa to Kd improved PFS and disease response in pts with RI, with a manageable safety profile, consistent with the benefit observed in the overall IKEMA study population. Also, more pts treated with Isa-Kd showed reversal of RI and durable renal responses compared with Kd. Finally, RI pts treated with Isa-Kd received twice the number of cycles and had a lower treatment discontinuation rate compared with Kd pts. Disclosures Martin: AMGEN: Research Funding; Sanofi: Research Funding; GSK: Consultancy; Seattle Genetics: Research Funding; Janssen: Research Funding. Moreau:Novartis: Honoraria; Sanofi: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Takeda: Honoraria. Baker:Sanofi: Research Funding. Leleu:Karyopharm: Honoraria; Sanofi: Honoraria; Novartis: Honoraria; AbbVie: Honoraria; Amgen: Honoraria; Oncopeptide: Honoraria; Incyte: Honoraria; Merck: Honoraria; Carsgen: Honoraria; Janssen: Honoraria; BMS-celgene: Honoraria; GSK: Honoraria. Mohty:Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Stemline: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau. Leblanc:Celgene: Research Funding; Celgene Canada; Janssen Inc.; Amgen Canada; Takeda Canada: Membership on an entity's Board of Directors or advisory committees. Risse:Sanofi: Current Employment. Malinge:AIXIAL: Consultancy. Schwab:Sanofi: Current Employment. Dimopoulos:BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau.
Published: 2020
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50. Management strategies for children with COVID-19: ESPR practical recommendations

Author: Anne Paterson, Jovan Lovrenski, Karen Rosendahl, Maria I. Argyropoulou, Amaka C. Offiah, Ola Kvist, Süreyya Burcu Görkem, Susan C. Shelmerdine, Seema Toso, Pablo Caro-Domínguez, Maria Raissaki, Owen J. Arthurs, Joost van Schuppen, Maria Beatrice Damasio, Franz Wolfgang Hirsch, Andrea Rossi, Philippe Petit, Radiology and Nuclear Medicine, [Raissaki,M] Department of Radiology, University Hospital of Heraklion, University of Crete, Crete, Greece. [Shelmerdine,SC, Arthurs,OJ] Department of Clinical Radiology, Great Ormond Street Hospital for Children, London, WC1N 3JH, UK. [Shelmerdine,SC, Arthurs,OJ] UCL Great Ormond Street Institute of Child Health, Great Ormond Street Hospital for Children, London, UK. [Shelmerdine,SC, and Arthurs,OJ] NIHR Great Ormond Street Biomedical Research Centre, London, UK. [Damasio,MB] U.O.C. Radiologia, Istituto Giannina Gaslini, Genoa, Italy. [Toso,S] Department of Diagnostics, Geneva Children’s Hospitals, Geneva, Switzerland. [Kvist,O] Department of Pediatric Radiology, Karolinska University Hospital, Stockholm, Sweden. [Lovrenski,J] Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia. [Lovrenski,J] Institute for Children and Adolescent Health Care of Vojvodina, Novi Sad, Serbia. [Hirsch,FW] Department of Pediatric Radiology, University of Leipzig, Leipzig, Germany. [Görkem,SB] Paediatric Radiology Department, Erciyes University School of Medicine, Children’s Hospital, Kayseri, Turkey. [Paterson,A] Department of Radiology, Royal Belfast Hospital for Sick Children, Belfast, UK. [Rossi,A] Neuroradiology Unit, Istituto Giannina Gaslini, Genoa, Italy. [Rossi,A] Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. [van Schuppen,J] Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. [Petit,P] Service d’imagerie pédiatrique et prénatale, Aix Marseille University, Hôpital de La Timone-Enfants, Marseille, France. [Argyropoulou,MI] Department of Clinical Radiology and Imaging, Medical School, University Hospital of Ioannina, Ioannina, Greece. [Offiah,AC] Academic Unit of Child Health, University of Sheffield, Sheffield, UK. [Offiah,AC] Department of Radiology, Sheffield Children’s NHS Foundation Trust, Sheffield, UK. [Rosendahl,K] Department of Radiology, University Hospital of North Norway, Tromsø, Norway. [Rosendahl,K] Department of Clinical Medicine, UiT the Arctic University of Norway, Tromsø, Norway. [Caro-Domínguez,P] Unidad de Radiología Pediátrica, Servicio de Radiodiagnóstico, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Subjects: Health Care::Environment and Public Health::Public Health::Public Health Practice::Communicable Disease Control::Infection Control [Medical Subject Headings], Pediatrics, 030218 nuclear medicine & medical imaging, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Personal hygiene, Disciplines and Occupations::Health Occupations::Medicine::Pediatrics [Medical Subject Headings], Pandemic, Infection control, General anaesthesia, 030212 general & internal medicine, Child, Children, Neuroradiology, Espr, Imaging protocol, Management, Radiology Nuclear Medicine and imaging, Preparedness, Child, Preschool, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging [Medical Subject Headings], Medical emergency, Coronavirus Infections, Radiology, Diagnostic Imaging, Adolescent, Pneumonia, Viral, Persons::Persons::Age Groups::Adolescent [Medical Subject Headings], 03 medical and health sciences, Betacoronavirus, Medical imaging, medicine, Humans, VDP::Medisinske Fag: 700, Radiology, Nuclear Medicine and imaging, Persons::Persons::Age Groups::Child [Medical Subject Headings], Pediatrics, Perinatology, and Child Health, Health Care::Health Services Administration::Patient Care Management [Medical Subject Headings], Personal protective equipment, Pandemics, Niños, Infection Control, business.industry, SARS-CoV-2, Infant, COVID-19, medicine.disease, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings], VDP::Medical disciplines: 700, Coronavirus, Disciplines and Occupations::Health Occupations::Medicine::Radiology [Medical Subject Headings], Pediatrics, Perinatology and Child Health, business
Abstract: During the outbreak of the COVID-19 pandemic, guidelines have been issued by international, national and local authorities to address management and the need for preparedness. Children with COVID-19 differ from adults in that they are less often and less severely affected. Additional precautions required in the management of children address their increased radiosensitivity, need for accompanying carers, and methods for dealing with children in a mixed adult-paediatric institution. In this guidance document, our aim is to define a pragmatic strategy for imaging children with an emphasis on proven or suspected COVID-19 cases. Children suspected of COVID-19 should not be imaged routinely. Imaging should be performed only when expected to alter patient management, depending on symptoms, preexisting conditions and clinical evolution. In order to prevent disease transmission, it is important to manage the inpatient caseload effectively by triaging children and carers outside the hospital, re-scheduling nonurgent elective procedures and managing symptomatic children and carers as COVID-19 positive until proven otherwise. Within the imaging department one should consider conducting portable examinations with COVID-19 machines or arranging dedicated COVID-19 paediatric imaging sessions and performing routine nasopharyngeal swab testing before imaging under general anaesthesia. Finally, regular personal hygiene, appropriate usage of personal protective equipment, awareness of which procedures are considered aerosol generating and information on how to best disinfect imaging machinery after examinations should be highlighted to all staff members. Electronic supplementary material The online version of this article (10.1007/s00247-020-04749-3) contains supplementary material, which is available to authorized users.
Published: 2020

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