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1. Risk prediction tools in cardiovascular disease prevention: A report from the ESC Prevention of CVD Programme led by the European Association of Preventive Cardiology (EAPC) in collaboration with the Acute Cardiovascular Care Association (ACCA) and the Association of Cardiovascular Nursing and Allied Professions (ACNAP)

Author: Xavier Rossello, Jannick AN Dorresteijn, Arne Janssen, Ekaterini Lambrinou, Martijn Scherrenberg, Eric Bonnefoy-Cudraz, Mark Cobain, Massimo F Piepoli, Frank LJ Visseren, Paul Dendale, null This paper is a co-publication betw, Centro Nacional de Investigaciones Cardiovasculares Carlos III [Madrid, Spain] (CNIC), Instituto de Salud Carlos III [Madrid] (ISC), Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), University Medical Center [Utrecht], Jessa Ziekenhuis [Hasselt], Cyprus University of Technology, Hasselt University (UHasselt), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Service de Cardiologie Lyon (Hôpital Louis Pradel [CHU - HCL]), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Imperial College London, University of Southern California (USC), Rossello, Xavier/0000-0001-6783-8463, Rossello, Xavier, Dorresteijn, Jannick A. N., JANSSEN, Arne, Lambrinou, Ekaterini, SCHERRENBERG, Martijn, Bonnefoy-Cudraz, Eric, Cobain, Mark, Piepoli, Massimo F., Visseren, Frank L. J., DENDALE, Paul, CarMeN, laboratoire, Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-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)
Subjects: Male, Time Factors, Epidemiology, [SDV]Life Sciences [q-bio], Allied Health Personnel, Disease, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Medical and Health Sciences, 0302 clinical medicine, prevention, Risk Factors, cardiovascular disease, Preventive Health Services, Advanced and Specialised Nursing, 030212 general & internal medicine, Cardiovascular nursing, Societies, Medical, Aged, 80 and over, biology, risk assessment, General Medicine, Middle Aged, Prognosis, Risk prediction, 3. Good health, [SDV] Life Sciences [q-bio], Preventive cardiology, Europe, Primary Prevention, Medical–Surgical Nursing, Cardiovascular Diseases, Practice Guidelines as Topic, Female, patient, Cardiology and Cardiovascular Medicine, Risk assessment, Algorithms, Adult, Cardiovascular Nursing, medicine.medical_specialty, Critical Care, Clinical Decision-Making, Cardiology, Decision Support Techniques, 03 medical and health sciences, Predictive Value of Tests, Health Sciences, Medical–Surgical, medicine, Humans, Medical history, Intensive care medicine, Association (psychology), Aged, Advanced and Specialized Nursing, patient Keywords Risk prediction, Acca, Models, Statistical, business.industry, biology.organism_classification, Lifetime risk, business, Forecasting
Abstract: Risk assessment and risk prediction have become essential in the prevention of cardiovascular disease. Even though risk prediction tools are recommended in the European guidelines, they are not adequately implemented in clinical practice. Risk prediction tools are meant to estimate prognosis in an unbiased and reliable way and to provide objective information on outcome probabilities. They support informed treatment decisions about the initiation or adjustment of preventive medication. Risk prediction tools facilitate risk communication to the patient and their family, and this may increase commitment and motivation to improve their health. Over the years many risk algorithms have been developed to predict 10-year cardiovascular mortality or lifetime risk in different populations, such as in healthy individuals, patients with established cardiovascular disease and patients with diabetes mellitus. Each risk algorithm has its own limitations, so different algorithms should be used in different patient populations. Risk algorithms are made available for use in clinical practice by means of - usually interactive and online available - tools. To help the clinician to choose the right tool for the right patient, a summary of available tools is provided. When choosing a tool, physicians should consider medical history, geographical region, clinical guidelines and additional risk measures among other things. Currently, the website is the only risk prediction tool providing prediction algorithms for all patient categories, and its implementation in clinical practice is suggested/advised by the European Association of Preventive Cardiology. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this paper was produced within the framework of the ESC Prevention of Cardiovascular Disease Programme which is led by the European Association of Preventive Cardiology (EAPC) in collaboration with the Acute Cardiovascular Care Association (ACCA) and the Association of Cardiovascular Nursing and Allied Professions (ACNAP). The ESC Prevention of Cardiovascular Disease Programme is supported by unrestricted educational grants. The authors received no financial support for the research, authorship, and/or publication of this article. Rossello, X (corresponding author), Ctr Nacl Invest Cardiovasc CNIC Carlos III, Melchor Fernandez Almagro 3, Madrid 28029, Spain. fjrossello@cnic.es
Published: 2020

2. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE) : an international, randomised, placebo-controlled trial

Author: P J Devereaux, Emmanuelle Duceppe, Gordon Guyatt, Vikas Tandon, Reitze Rodseth, Bruce M Biccard, Denis Xavier, Wojciech Szczeklik, Christian S Meyhoff, Jessica Vincent, Maria Grazia Franzosi, Sadeesh K Srinathan, Jason Erb, Patrick Magloire, John Neary, Mangala Rao, Prashant V Rahate, Navneet K Chaudhry, Bongani Mayosi, Miriam de Nadal, Pilar Paniagua Iglesias, Otavio Berwanger, Juan Carlos Villar, Fernando Botto, John W Eikelboom, Daniel I Sessler, Clive Kearon, Shirley Pettit, Mukul Sharma, Stuart J Connolly, Shrikant I Bangdiwala, Purnima Rao-Melacini, Andreas Hoeft, Salim Yusuf, P.J. Devereaux, Shrikant I. Bangdiwala, Stuart Connolly, John Eikelboom, Janice Pogue, Daniel I. Sessler, Sara Di Diodato, Zora Gasic, Louise J. Mastrangelo, Sarah H. Molnar, Jennifer L. Swanson, Makayla L. Tosh, Jennifer R. Wells, Rafael Diaz, Clara K. Chow, Beatriz Gonzales, Skarlet Vásquez, Petr Jansky, Radovan Dušek, Christian S. Meyhoff, Pierre Coriat, Maria Wittmann, Gerald Yonga, Nandini Mathur, Elena Seletti, German Malaga, Bernadette A. Tumanan-Mendoza, Maria Pamela A. Tagle, Bruce M. Biccard, Pablo Alonso-Coello, Ekaterine Popova, Martin Shields, Yannick Le Manach, Paul Moayyedi, Sander van Zanten, Edith Fleischmann, Amit Garg, Kamilu Karaye, Edward McFalls, Alben Sigamani, Emilie Belley-Côté, Grzegorz Biedroń, Flavia Borges, Steffan Frosi Stella, Christian Haarmark Nielsen, Darryl P. Leong, Jessica Spence, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Stephen S. Yang, Terence Yung, D. George Wyse, Davy Cheng, David E. Johnstone, George A. Wells, Philip Joseph, Ameen Patel, Krysten Gregus, Kelly Lawrence, Lindsay Doharris, David Conen, Jason Cheung, Jim Douketis, Douglas Wright, Spencer Wikkerink, William Dechert, Mohamed Panju, Khalid Azzam, Theodore Rapanos, Tomas Van Helder, Anjali Shroff, Jacqueline Hare, Biniam Kidane, Thang Nguyen, Larissa Leydier, Vanessa Bayaraa, Joel Parlow, Deborah A. DuMerton, Amar Thakrar, Jessica Shelley, Benoit Deligne, Roberta Daila Carling, Marko Mrkobrada, George K. Dresser, Michael J. Jacka, David Hornstein, Gerrit B. Winkelaar, Zoeb Hussain Haider, Pravina Prashant Lanjewar, Valsamma Varughese, Rajneesh Calton, Hemani Ahuja, Preetha George, Ambika Sharma, Keyur Sureshchandra Bhatt, Dhaval Odhavajibhai Mangukiya, Karshan Vira Nandaniya, Viral Vasantrai Parekh, Ashok Bhaskaran Pillai, Vidya P. Menon, Sanjay Channappa Desai, Ravinder Singh Sidhu, Sandeep Kumar Gupta, Robbie K. George, T.R. Gurunath, Leanne W. Drummond, Alexandra M. Torborg, Belinda S. Küsel, Prebashini Naidoo, Datshana P. Naidoo, Chantal Rajah, Zane Farina, Richard Peter von Rahden, Simphiwe Gumede, Chishala Chishala, Ettienne Coetzee, Robert A. Dyer, Johan Diedericks, Piotr Bielański, Bogusz Kaczmarek, Dorota Studzińska, Maciej Zaniewski, Marek Józef Libura, Tomasz Mikołaj Zacharias-Nalichowski, Aurelia A.S. Sega, Jakub Salwa, Mateusz Kózka, Jacek Górka, Anna Wludarczyk, Ilona Nowak-Kózka, Paweł Szczepan Grudzień, Jaroslaw W. Gucwa, Michał Piotr Słowiaczek, Paweł P.D. Dobosz, Ismail Gögenur, Jens Ravn Eriksen, Tine Borup, Tove Kirkegaard, Dan Isbye, Asger Sonne, Lars S. Rasmussen, Sofie Pedersen, Hannibal Troensegaard, Camilla L. Duus, Benedikte M. Halle, Ossian N. Gundel, Katrine F. Bernholm, Kristian Rønsholt Martinsen, Søren Pedersen, Theis S. Itenov, Elena Camio, Carles Vázquez, Silvia Matarin, Esther Cano, Jesús Álvarez-García, Inmaculada India, Aránzazu González-Osuna, Marc Vives, Elena Rosselló, Ana B. Serrano, Maurizio Turiel, Lorenzo Drago, Chiara Colombo, Federica Marra, Lucio Mos, Franco Arteni, Rosalba Lembo, Alessandro Ortalda, Simonetta Passarani, Zhirajr Mokini, Estevao Lanna Figueiredo, Gustavo Fonseca Werner, Joao Luiz Petriz, Lilia Nigro Maia, Ricardo R. Bergo, Dalton Bertolim Precoma, José Francisco Kerr Saraiva, Oscar Gomez Vilamajo, Eduardo Allegrini, Mariano Benzadón, Maria Leonor Parody, Ernesto A. Duronto, Adrián C. Ingaramo, Gustavo Adolfo Parra, Danny Novoa, Scott A. Miller, Sabu Thomas, Sudhakar P. Karlapudi, Mohamad H. Bourji, Subhash Banerjee, Anita Gupta, Isaac O. Opole, Michal Fischer, Victor Lecaros Mendoza, Eugenio Borja Reyes, Richard J. Pierson, Martin O. Shields, Vincent Piriou, Kai Zacharowski, Aida Rotta-Rotta, Main Paper, Sadeesh K. Srinathan, Prashant Rahate, Navneet Chaudhry, Bogani Mayosi, and Mike Sharma
Subjects: Male, medicine.medical_specialty, Myocardial Infarction, Placebo-controlled study, Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Antithrombins, Dabigatran, law.invention, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Internal medicine, medicine, Humans, Perioperative Period, Stroke, Aged, Aged, 80 and over, business.industry, Hazard ratio, Proton Pump Inhibitors, Thrombosis, Venous Thromboembolism, General Medicine, Perioperative, Placebo Effect, medicine.disease, Troponin, Clinical trial, Treatment Outcome, Female, business, Omeprazole, medicine.drug
Abstract: Summary Background Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. Methods In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Findings Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55–0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55–1·53; p=0·76). Interpretation Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication. Funding Boehringer Ingelheim and Canadian Institutes of Health Research.
Published: 2018

3. Method for prediction of acute hypotensive episodes

Author: Mantas Deimantavicius, Zenonas Navickas, Kristina Berskiene, Arminas Ragauskas, Vytautas Petkus, Alfonsas Vainoras, Ian Paper, Rimtautas Ruseckas, and Kauno technologijos universitetas
Subjects: medicine.medical_specialty, business.industry, ECG, Arterial hypotension, Neurointensive care, acute hypotensive episodes, complex systems, Blood pressure, Internal medicine, Intensive care, Cardiology, Medicine, ECG analysis, In patient, Electrical and Electronic Engineering, business
Abstract: Hypotension is type of secondary insult and it is related to poor outcome. The ability to predict adverse hypotensive events, where a patient’s arterial blood pressure drops to abnormally low levels, would be of major benefit to the fields of primary and secondary health care. The aim of the paper is to present the novel method for predicting of acute hypotensive episodes, based on ECG analysis by the complex system theory approach. 45 patients (in four neurointensive care facilities throughout Europe) data were selected for the analysis. 11 patients had EUSIG-defined hypotensive events. The method includes determining of time varying biomarkers corresponding to plurality of physiological processes in patient’s organism as a non-linear dynamic complex system and generating an acute hypotension prediction classifier. The calculations of biomarkers are based on complex system approach and algebraic matrix analysis of ECG parameters. The classifier is based on the comparison of biomarkers behaviour in 3D images. It is demonstrated that the presented method allows us to predict arterial hypotension events 40-50 minutes ahead with a sensitivity of 81 %, specificity 94 %. This result was obtained from prospective real-time data collection in a live clinical intensive care environment.
Published: 2016

4. Preliminary Evaluation of the Healthy Workplace Index

Author: Andrea Berndt, Mickey L. Parsons, Bruce Paper, and Jennifer A. Browne
Subjects: medicine.medical_specialty, Index (economics), business.industry, Physical therapy, medicine, Critical Care Nursing, business
Published: 2009

5. Tacrolimus monotherapy in membranous nephropathy: A randomized controlled trial

Author: Praga, M., Barrio, V., Juárez, G. Fernández, Luño, J., and For the GRUPO ESPAÑOL DE ESTUDIO DE LA NEFROPATÍA MEMBRANOSA (Members of the Group listed at the end of the paper)
Subjects: medicine.medical_specialty, Creatinine, Proteinuria, nephrotic syndrome, business.industry, Urology, membranous nephropathy, Renal function, Spontaneous remission, medicine.disease, Tacrolimus, Surgery, law.invention, chemistry.chemical_compound, Membranous nephropathy, chemistry, Randomized controlled trial, Nephrology, law, medicine, medicine.symptom, tacrolimus, business, Nephrotic syndrome
Abstract: Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.
Published: 2007

6. Multi-dimensional Context-Aware Adaptation for Web Applications

Author: Genaro Motti, Vivian, Vanderdonckt, Jean, Workshops, Doctoral Symposium, and Tutorials, Held at ICWE 2011, Paphos, Cyprus, June 20-21, 2011. Revised Selected Papers, and Louvain School of Management - Operations and Information
Subjects: Web standards, medicine.medical_specialty, Web development, business.industry, Computer science, Web engineering, Social Semantic Web, World Wide Web, Human–computer interaction, Web design, medicine, Web navigation, business, Web intelligence, Web modeling
Abstract: This tutorial presents the state-of-the-art of adaptation for web interfaces concerning multi-dimensionality and context-awareness. The specific goals include the presentation of: (i) fundamental concepts, as motivations, definitions and relevant context information; (ii) adaptation techniques for web applications, as methods, models, strategies and technologies; (iii) adaptable and adaptive web applications in scientific and commercial aspects.
Published: 2012

7. Becoming a partner in your healthcare

Author: R. Paper
Subjects: Receipt, Service (business), medicine.medical_specialty, business.industry, media_common.quotation_subject, Control (management), Hematology, General Medicine, Haemophilia, medicine.disease, Intimidation, Quality of life (healthcare), Nursing, Feeling, Health care, medicine, business, Psychiatry, Genetics (clinical), media_common
Abstract: Chronic disorders such as haemophilia and von Willebrand disease can rob people of a feeling of control over their lives. Added to this is often a feeling of confusion or intimidation when dealing with the healthcare system. People may begin to feel like victims of their disorders and of the healthcare system. The healthcare system defines people who are in receipt of care as patients. The word patient comes from the Latin word patiens, which means to suffer, endure, allow, permit or undergo. Even the term implies a sense of victimization. People who become partners in their care and view the receipt and delivery of healthcare as a service wherein they are the consumer and the doctor or clinician is the provider, will feel more in control and will likely have better outcomes than people who assume the more traditional role of 'patient'.
Published: 2002

8. Determination of the Physiological Effects of Unloaded Treadmill Exercise

Author: D. D. Kelsey, Julie M. Murray, Tinker D. Murray, Mark W. Paper, and Diana Hunter
Subjects: medicine.medical_specialty, Physical medicine and rehabilitation, business.industry, Medicine, Physical Therapy, Sports Therapy and Rehabilitation, Treadmill exercise, business
Published: 1993

9. Antenatal manifestation of congenital pancreatoblastoma in a fetus with Beckwith-Wiedemann syndrome

Author: G. P. e. l. i. z. z. o., . G. Conoscenti, Vesce, Fortunato, Guerrini, . P., Cavazzini AUTHOR CORRECTIONS: Two of the author names in the above paper, . L., published in the April issue of Prenatal Diagnosis, The correct names are Fortunato Vesce, were supplied e. r. r. o. n. e. o. u. s. l. y., and The authors would like to apologise for any inconvenience caused, Pietro G. u. e. r. r. i. n. i.
Subjects: congenital, hereditary, and neonatal diseases and abnormalities, Pediatrics, medicine.medical_specialty, Pathology, Pancreatic disease, Beckwith-Wiedemann Syndrome, Pregnancy, High-Risk, Pancreatoblastoma, Beckwith–Wiedemann syndrome, Prenatal diagnosis, Ultrasonography, Prenatal, Pregnancy, Neoplasms, medicine, complications/pathology/ultrasonography, Humans, Prenatal, Cyst, Tomography, Genetics (clinical), Ultrasonography, Fetus, business.industry, Infant, Newborn, Obstetrics and Gynecology, Infant, complications/surgery/ultrasonography, Neoplasms, Germ Cell and Embryonal, Middle Aged, medicine.disease, complications/pathology/ultrasonography, Female, Humans, Infant, Newborn, Maternal Age, Middle Aged, Neoplasms, Germ Cell and Embryonal, complications/surgery/ultrasonography, Pancreatic Neoplasms, complications/surgery/ultrasonography, Pregnancy, Pregnancy, High-Risk, Tomography, X-Ray Computed, Treatment Outcome, Ultrasonography, Newborn, Uniparental disomy, X-Ray Computed, Pancreatic Neoplasms, medicine.anatomical_structure, Treatment Outcome, Female, High-Risk, Pancreas, business, Tomography, X-Ray Computed, Maternal Age
Abstract: Antenatal detection of an isolated abdominal cyst was found to be a pancreatoblastoma in a female fetus with Beckwith-Wiedemann syndrome. Prenatal and post-natal features and management of this very rare tumour are discussed. Molecular investigation disclosed a mosaic paternal 11p15 uniparental disomy in the tumoral cells. The prognosis of a congenital pancreatoblastoma is good if complete surgical excision is achieved. However, the association with Beckwith-Wiedemann syndrome requires a prolonged follow-up because of the increased risk of developing malignant tumours.
Published: 2003

10. Gynaecological complications in women with bleeding disorders

Author: Paper R
Subjects: medicine.medical_specialty, business.industry, General surgery, Pregnancy Complications, Hematologic, Hemorrhage, Hematology, General Medicine, Coagulation Protein Disorders, Hemophilia A, Surgery, von Willebrand Diseases, Pregnancy, medicine, Humans, Female, business, Genital Diseases, Female, Genetics (clinical)
Published: 2000

11. Recognition of the critically III neonate with ductal-dependent cardiac lesions

Author: L Richard, M Paper, M Furman, A Weintraub, and D Fields
Subjects: Pathology, medicine.medical_specialty, business.industry, Emergency Medicine, Medicine, business
Published: 1999

12. Production of low molecular weight √-carrageenans and their effects on BFGF and on FBHE-cells

Author: Gerhard Franz, R. Hoffman, D. H. Paper, and M. Marchesan
Subjects: Cancer Research, medicine.medical_specialty, Hematology, Oncology, Chemistry, Internal medicine, medicine, General Medicine, Pharmacology
Published: 1995

13. √-and λ-carrageenan as new angiogenesis inhibitors

Author: R. Hoffman, H. Vogl, D. H. Paper, and Gerhard Franz
Subjects: Cancer Research, medicine.medical_specialty, Hematology, Oncology, Angiogenesis, Chemistry, Internal medicine, λ carrageenan, medicine, Cancer research, General Medicine
Published: 1995

14. A novel access to sulphated oligosaccharides with potential antiangiogenic effect

Author: D. H. Paper, A. Garna, Gerhard Franz, and G. Florian
Subjects: Cancer Research, medicine.medical_specialty, Hematology, Oncology, Antiangiogenic effect, business.industry, Internal medicine, medicine, Cancer research, General Medicine, business
Published: 1995

15. Activation of CD8-positive T-lymphocytes in autoimmune hepatitis and primary biliary cirrhosis

Author: K.-H.Meyer zum Büsehenfelde, H. Manns, B. Päper, and A.W. Lohse
Subjects: medicine.medical_specialty, Primary biliary cirrhosis, Hepatology, business.industry, Internal medicine, medicine, Autoimmune hepatitis, medicine.disease, business, Gastroenterology, CD8
Published: 1990

16. Age-dependent changes in tolerizability with rabbit gamma-globulin in the Biozzi high and low-responder lines of mice

Author: Katsuji Nakano, Short Papers, Brian H. Sabiston, and Bernhard Cinader
Subjects: Lipopolysaccharides, Aging, medicine.medical_specialty, Lipopolysaccharide, Immunology, Age dependent, Biology, T-Lymphocytes, Regulatory, law.invention, Mice, chemistry.chemical_compound, Immune system, law, Internal medicine, Immune Tolerance, medicine, Animals, Immunology and Allergy, B cell, Gamma globulin, Low responder, Endocrinology, medicine.anatomical_structure, Immunization, chemistry, Suppressor, Female, gamma-Globulins
Abstract: The antibody response to rabbit gamma-globulin (RGG) of high-responder, but not of low-responder Biozzi mice decreased with age. Injection with aggregate-freed RGG reduced the response of high-responder but not of low-responder mice to subsequent injections with aggregated RGG. This reduction in the antibody response, formed by high-responder mice, decreased with increasing age; aggregate-freed RGG appeared to sensitize 6-month-old low-responder mice to a subsequent injection with aggregated RGG. When animals, not pretreated with aggregate-freed RGG, were immunized with RGG and lipopolysaccharide (LPS), the immune response was greatly enhanced. The response of both pretreated low and high responders was substantially smaller than that of corresponding animals which were not given aggregate-freed RGG, prior to immunization. LPS revealed an inhibitory effect on low-responder mice of aggregate-freed RGG, which was not detected upon immunization with heat-aggregated RGG alone. The involvement of nonspecific suppressor cells and of B cell tolerance in low-responder mice is discussed.
Published: 1979

17. The migration of lymphocytes in the fetal lamb

Author: R.N.P. Cahill, D.C. Poskitt, John B. Hay, Short Paper, Iver Heron, and Z. Trnka
Subjects: Male, Pathology, medicine.medical_specialty, Time Factors, T-Lymphocytes, Immunology, Sheep fetus, Spleen, Thoracic Duct, Fetus, Antigen, Cell Movement, Pregnancy, Intestine, Small, medicine, Immunology and Allergy, Animals, Lymphocytes, Lung, Sheep, biology, Small intestine, Chromium Radioisotopes, medicine.anatomical_structure, Liver, embryonic structures, Fetal lamb, biology.protein, Female, Lymph, Antibody
Abstract: The migration of 51Cr-labeled autologous lymphocytes from intestinal or prescapular lymph was compared in fetal lambs and adult sheep. A subpopulation of lymphocytes present in intestinal lymph of adults which migrated to the small intestine was not found in fetal intestinal lymph. There were marked differences in the migration of fetal and adult lymphocytes to the lungs and liver. In spite of the absence of circulating antibodies or immunoglobulins and of extrinsic antigen in the immunologically virgin sheep fetus, the circulation of lymphocytes through the spleen and lymph nodes of fetal lambs was more intense than in the adult.
Published: 1979

18. CLINICAL MANIFESTATIONS AND THERAPY OF Isospora belli INFECTION IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME

Author: Steven R. Martin, De-Horvitz Ja, Johnso n, Harland S. Winter, Paper Jw, and Boncy M
Subjects: Isospora, Pediatrics, medicine.medical_specialty, Acquired immunodeficiency syndrome (AIDS), biology, business.industry, Pediatrics, Perinatology and Child Health, Gastroenterology, medicine, In patient, business, medicine.disease, biology.organism_classification
Published: 1987

19. Comparison of a Barcode-Based Smartphone Application to a Questionnaire to Assess the Use of Cleaning Products at Home and Their Association with Asthma Symptoms

Author: Lemire, Pierre, Temam, Sofia, Quinot, Catherine, Sévin, Etienne, Remacle, Sophie, Supernant, Karine, Dumas, Orianne, Le Moual, Nicole, Eyriey, E., Licinia, A., Vellement, A., Pin, Isabelle, Hofmann, P., Hullo, Églantine, Llerena, Catherine, Morin, X., Morlot, A., Lepeule, Johanna, Lyon-Caen, Sarah, Philippat, Claire, Quentin, Joane, Siroux, Valérie, Slama, Rémy, Faraldo, Beatrice, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, MGEN Foundation for Public Health [Paris] (FESP-MGEN), Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), EpiConcept [Paris], The Sepages Study Group., Fondation d’entreprise MGEN pour la santé publique (FESP MGEN), Anses-PNR-EST-2015-1-022/Ademe-1594C0091, Anses-PNR-EST-2017-1-101/Ademe-1762C0021 Seventh Framework Programme, FP7: FP7/2007-206, N308333-HELIX European Research Council, ERC: N 311765-E-DOHaD Agence Nationale de la Recherche, ANR: 14-CE21-0007-01, 19-CE36-0003-01, ANR 18-CE36-005, ANR-12-PDOC-0029-01, ANR-15-IDEX, ANR-15-IDEX-02 Institut National de la Santé et de la Recherche Médicale, Inserm Fondation de France: CLI-MATHES—00081169 Commissariat Général à l'Investissement, CGI Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail, ANSES: PNR-EST-2018-1-264 Agir pour les Maladies Chroniques, Acknowledgments: We acknowledge the role of SEPAGES cohort study group: E. Eyriey, A. Licinia, A. Vellement (Groupe Hospitalier Mutualiste, Grenoble), I. Pin, P. Hofmann, E. Hullo, C. Llerena (Grenoble University Hospital, La Tronche), X. Morin (Clinique des Cèdres, Echirolles), A. Morlot (Clinique Belledonne, Saint-Martin d’Hères), J. Lepeule, S. Lyon-Caen, C. Philippat, I. Pin, J. Quentin, V. Siroux, R. Slama (Inserm, CNRS, University Grenoble Alpes IAB research center). We thank A. Benlakhryfa, L. Borges, Y. Gioria, clinical research assistants, J. Giraud, M. Marceau, M.-P. Martin, nurses, E. Charvet, A. Putod, midwives, M. Graca, K. Gridel, C. Pelini, fieldworkers, K. Guichardet, A. Levanic, C. Martel, E. Quinteiro neuropsychologists, the sta↵ from Grenoble Center for Clinical Investigation (CIC): J.-L. Cracowski, C. Cracowski, E. Hodaj, D. Abry, N. Gonnet and A. Tournier. A warm thank you also to M. Althuser, S. Althuser, F. Camus-Chauvet, P. Dusonchet, S. Dusonchet, L. Emery, P. Fabbrizio, P. Ho↵mann, D. Marchal André, X. Morin, E. Opoix, L. Pacteau, P. Rivoire, A. Royannais, C. Tomasella, T. Tomasella, D. Tournadre, P. Viossat, E. Volpi, S. Rey, E. Warembourg and clinicians from Grenoble University Hospital for their support in the recruitment of the study volunteers. We also thank A. Buchet, S.F. Caraby, J.-N. Canonica, J. Dujourdil, E. Eyriey, P. Hofmann, M. Jeannin, A. Licina, X. Morin, A. Nicolas, and all midwives from the four maternity wards of Grenoble urban areas. We thank B. Chevolon, C. Cornes, A.S. Gauchez, D. Guergour, P. Faure, J. Arnaud for thyroid hormones assessment. We thank the team of L. Chaperod (EFS) for its implication on the immunological aspects of the project. We thank G. Uzu (IRD) and J.-L. Ja↵rezo (CNRS) for their implication on PM oxidative potential assessment. We thank F.-X. Leupert, O. Bonnet and L. Goirand for the access to the birth certificate database from the Conseil Général de l’Isère. Sépages biospecimens are stored at Grenoble University Hospital (CHU-GA) biobank (bb-0033-00069), we would like to thank the whole CRB team, led by P. Mossuz and P. Lorimier, and in particular the technicians for the huge work of biospecimens processing and pooling: W. Jayar and L. Than, as well as G. Schummer. The Internet platform for secured data collection was developed by Epiconcept Paris (E. Sevin, S. Ployart, A. Polaert). SEPAGES data are stored thanks to Inserm RE-CO-NAI platform funded by Commissariat Général à l’Investissement, with the implication of Sophie de Visme (Inserm DSI). Many thanks to M.A. Charles, RE-CO-NAI coordinator, for her support. Finally, and importantly, we would like to express our sincere thanks to participants of the SEPAGES study. The authors are grateful for the help received from Ines Taarit and Mathias Clément to update the cleaning products ingredients database., Funding: The cohort was supported by the European Research Council (consolidator grant N 311765-E-DOHaD, PI, R. Slama), by the European Community’s Seventh Framework Programme (FP7/2007-206, grant N308333-HELIX, PI, M. Vrijheid), by ANR, the French Research Agency (PAPER project ANR-12-PDOC-0029-01, PI, J. Lepeule, SHALCOH project, 14-CE21-0007-01, PI, R. Slama, GUMME project, PI, R. Slama, ETAPE ANR 18-CE36-005, PI, J. Lepeule, EDeN project 19-CE36-0003-01, SYMER project, ANR-15-IDEX-02, PI, U. Schlattner, Mobil’Air project, ANR-15-IDEX, PI, S. Mathy, supported by University Grenoble-3Alpes), by ANSES (CNAP and HYPAXE projects, PI C. Philippat, PENDORE project, PNR-EST-2018-1-264, PI, V. Siroux), by Plan Cancer (Canc’Air project, PI, P. Guénel), by Association de Recherche sur le Cancer (ARC, PI, P. Guénel), by AGIR pour les maladies chroniques (PI, R. Slama and PRENAPAR project, V. Siroux), and Fonds de Recherche pour la Santé Respiratoire (FRSR, PI, I. Pin) and by Fondation de France (CLI-MATHES—00081169, J. Lepeule). We acknowledge the support of ANSES, Inserm and AGIR pour les maladies chroniques, for SEPAGES feasibility study. The support of 'SCUSI 2017' Région Auvergne-Rhône-Alpes programme is also acknowledged. COBANET-Sepages project was support by Anses and Ademe (COBANET: Anses-PNR-EST-2015-1-022/Ademe-1594C0091, PI: N Le Moual, CRESPINET: Anses-PNR-EST-2017-1-101/Ademe-1762C0021, PI: N Le Moual). Pierre Lemire benefited from a PhD scholarship of the University of Paris-Sud/Paris-Saclay, France., The cohort was supported by the European Research Council (consolidator grant N 311765-E-DOHaD, PI, R. Slama), by the European Community?s Seventh Framework Programme (FP7/2007-206, grant N308333-HELIX, PI, M. Vrijheid), by ANR, the French Research Agency (PAPER project ANR-12-PDOC-0029-01, PI, J. Lepeule, and EDeN project 19-CE36-0003-01, SYMER project, ANR-15-IDEX-02, PI, U. Schlattner, Mobil?Air project, ANR-15-IDEX, PI, S. Mathy, supported by University Grenoble-3Alpes), by ANSES (CNAP and HYPAXE projects, PI C. Philippat, PENDORE project, PNR-EST-2018-1-264, PI, V. Siroux), by Plan Cancer (Canc?Air project, PI, P. Gu?nel), by Association de Recherche sur le Cancer (ARC, PI, P. Gu?nel), by AGIR pour les maladies chroniques (PI, R. Slama and PRENAPAR project, V. Siroux), and Fonds de Recherche pour la Sant? Respiratoire (FRSR, PI, I. Pin) and by Fondation de France (CLIMATHES?00081169, J. Lepeule). We acknowledge the support of ANSES, Inserm and AGIR pour les maladies chroniques, for SEPAGES feasibility study. The support of ?SCUSI 2017? R?gion Auvergne-Rh?ne-Alpes programme is also acknowledged. COBANET-Sepages project was support by Anses and Ademe (COBANET: Anses-PNR-EST-2015-1-022/Ademe-1594C0091, PI: N Le Moual
Subjects: medicine.medical_specialty, Health, Toxicology and Mutagenesis, [SDV]Life Sciences [q-bio], lcsh:Medicine, Smartphone application, Logistic regression, Article, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Environmental health, Epidemiology, Odds Ratio, medicine, Humans, 030212 general & internal medicine, Association (psychology), smartphone application, Asthma, household cleaning products, business.industry, lcsh:R, Public Health, Environmental and Occupational Health, Asthma symptoms, Odds ratio, asthma, medicine.disease, 3. Good health, 030228 respiratory system, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Smartphone, business, Kappa, Disinfectants
Abstract: International audience; Household disinfectant and cleaning products (HDCPs) assessment is challenging in epidemiological research. We hypothesized that a newly-developed smartphone application was more objective than questionnaires in assessing HDCPs. Therefore, we aimed to compare both methods, in terms of exposure assessments and respiratory health effects estimates. The women of the SEPAGES birth cohort completed repeated validated questionnaires on HDCPs and respiratory health and used an application to report HDCPs and scan products barcodes, subsequently linked with an ingredients database. Agreements between the two methods were assessed by Kappa coefficients. Logistic regression models estimated associations of HDCP with asthma symptom score. The 101 participants (18 with asthma symptom score ≥1) scanned 617 different products (580 with available ingredients list). Slight to fair agreements for sprays, bleach and scented HDCP were observed (Kappa: 0.35, 0.25, 0.11, respectively). Strength of the associations between HDCP and asthma symptom score varied between both methods but all odds ratios (OR) were greater than one. The number of scanned products used weekly was significantly associated with the asthma symptom score (adjusted-OR [CI 95%]: 1.15 [1.00–1.32]). This study shows the importance of using novel tools in epidemiological research to objectively assess HDCP and therefore reduce exposure measurement errors.
Published: 2021

20. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study

Author: François Jourda, Christophe Saint-Etienne, Luc Christiaens, Grégoire Rangé, Benoit Lattuca, Philippe Brunel, Paul Guedeney, Hervé Le Breton, Marie Hauguel-Moreau, Eric Vicaut, Anne Bellemain-Appaix, Jean-Louis Georges, Guillaume Cayla, Christophe Pouillot, Christophe Caussin, Gregory Ducrocq, Ziad Boueri, Farzin Beygui, Johanne Silvain, Thibault Lhermusier, Gilles Montalescot, Jean-Noël Labèque, Jean-Philippe Collet, Zuzana Motovska, Franck Boccara, Mohamad El Kasty, Raphaelle Dumaine, Jean-Guillaume Dillinger, Mikael Laredo, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases [IHU 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), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Service de cardiologie et de pathologie vasculaire [CHU 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), Service de cardiologie [Chartres], Les hôpitaux de Chartres [Chartres], Marqueurs cardiovasculaires en situation de stress (MASCOT (UMR_S_942 / U942)), Institut National de la Santé et de la Recherche Médicale (INSERM)-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)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC)-Université Sorbonne Paris Nord, Hôpital de Bastia, Service de Cardiologie [Hôpital privé Dijon Bourgogne], Hôpital privé Dijon Bourgogne, Clinique Sainte Clotilde, Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service de cardiologie [CHU de Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de cardiologie [Centre Hospitalier de la Côte Basque, Bayonne], Centre Hospitalier de la Côte Basque, CHU Toulouse [Toulouse], Centre Hospitalier de Versailles André Mignot (CHV), Cardiology Department, Centre Hospitalier d'Antibes Juan les Pins, Antibes, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [APHP], Institut Mutualiste de Montsouris (IMM), Hôpital d'Auxerre, Partenaires INRAE, Grand Hôpital de l'Est Francilien (GHEF), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Université Sorbonne Paris Nord, AstraZeneca France Novartis Daiichi-Sankyo Bristol-Myers Squibb, BMS Eli Lilly and Company Bayer AstraZeneca France Boston Scientific Corporation, BSC Abbott Laboratories Medtronic Biotronik Fédération Française de Cardiologie, FFC, The ALPHEUS and the Bio-ALPHEUS studies are funded by the Fond de dotation ACTION ( www.action-fonds.org ) and a grant from AstraZeneca . The Bio-ALPHEUS study is also funded by the Institute of Cardiometabolism and Nutrition . The first draft of the paper was developed by Dr Silvain and Dr Montalescot, and all authors subsequently contributed to its development and final content and are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents. AstraZeneca reviewed the manuscript and was allowed to make suggestions, but final content was determined by the authors., Dr Silvain reports receiving consulting and lecture or travel support from AstraZeneca, Bayer HealthCare SAS, Biotronik, BPI France, Boehringer Ingelheim France, CSL Behring SA, Gilead Science, Sanofi-Aventis France, Terumo France SAS, Abbott Medical France SAS, and Zoll and is a stockholder of Pharmaseeds. Dr Cayla reports speaker or congress fees and has received research grants/consultant fees/lectures fees from Amgen, AstraZeneca, Abbott, Bayer, Biotronik, Bristol-Myers Squibb, Pfizer, and Sanofi-Aventis. Dr Beygui reports receiving consulting and lecture fees from Astrazeneca, Bristol-Myers Squibb, Medtronic, Biosensors, Boston Scientific Institutional and research grants from Medtronic, Biosensors, Acist, and Boston scientific. Dr Rangé reports receiving speaker’s and/or consulting fees from Abbott. Dr Lattuca has received research grants from Biotronik, Boston Scientific, Daiichi-Sankyo, Fédération Française de Cardiologie, and Institute of CardioMetabolism and Nutrition, consultant fees from Daiichi-Sankyo and Eli Lilly, and lecture fees from AstraZeneca, Medtronic, and Novartis. Dr Collet reports receiving consulting and lecture fees from AstraZeneca, Bayer, Bristol-Myers Squibb, Fédération Française de Cardiologie, Lead-Up, Medtronic, MSD, Sanofi-Aventis, and WebMD. Dr Dillinger reports receiving consulting and lecture fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer, and Sanofi and grants from Bayer, Bristol-Myers Squibb/Pfizer, and Biosensors. Dr Boueri reports receiving consulting and lecture fees from Novartis and Astra Zeneca. Dr Boccara reports consulting or speaker fees from Amgen, Gilead, ViiV Healthcare, Amgen, Sanofi, MSD, and Servier outside the submitted work. Dr Christiaens reports consulting or speaker fees from Astra Zeneca. Dr Lhermusier reports consulting or speaker fees from Astra Zeneca, Boston Scientifics, and Abbott and a research grant from Astra Zeneca. Dr Georges reports consulting or speaker fees from AstraZeneca France, Sanofi-Aventis, Amgen, and Merck Sharpe and Dohme. Dr Bellemain-Appaix reports consulting or speaker fees from Astra Zeneca, Novartis, and Pfizer. Dr Saint-Etienne reports consulting or speaker fees from Abbott, Medtronic, Edwards, and Biotronik. Dr Motovska reports consulting or speaker fees from Astrazeneca. Dr Laredo reports fellowship grants from Medtronic, Biotronik, and Boston Scientific. Dr Ducrocq reports consulting or speaker fees from Amgen, Astra Zeneca, Bayer, BMS, Janssen, Sanofi, and Terumo, proctoring: Boston scientific, CEC: Novo Nordisk, and travel fees: Astra Zeneca, Bayer, and BMS. Dr Vicaut reports consulting or speaker fees from Abbott, Bristol Myers Squibb, Celgene, Edwards, Pfizer, Sanofi, and Novartis. Dr Montalescot reports consulting or speaker fees from Abbott, AIM group, Amgen, Actelion, American College of Cardiology Foundation, Astrazeneca, Axis-Santé, Bayer, Boston-Scientific, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Fréquence Médicale, ICOM, Idorsia, Elsevier, Fédération Française de Cardiologie, Fréquence Médicale, Institute of Cardiometabolism and Nutrition, Lead-Up, Menarini, Medtronic, MSD, Novo-Nordisk, Pfizer, Quantum Genomics, Sanofi-Aventis, SCOR global life, Servier, and WebMD. Other authors have no conflict of interest to report., 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Université Sorbonne Paris Nord, 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, 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)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Centre Hospitalier de la Côte Basque (CHCB), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier d'Auxerre (CHA), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord
Subjects: medicine.medical_specialty, Ticlopidine, medicine.medical_treatment, Myocardial Infarction, Coronary Disease, 030204 cardiovascular system & hematology, Coronary Angiography, Loading dose, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, cardiovascular diseases, Aged, Aspirin, business.industry, Percutaneous coronary intervention, medicine.disease, Clopidogrel, 3. Good health, Conventional PCI, Cardiology, Purinergic P2Y Receptor Antagonists, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Cardiology and Cardiovascular Medicine, business, Ticagrelor, Platelet Aggregation Inhibitors, medicine.drug
Abstract: International audience; Background: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. Methods: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). Conclusion: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.
Published: 2020

21. The association between sedentary behavior and sarcopenia among adults aged ≥65 years in low-and middle-income countries

Author: Louis Jacob, Lee Smith, Deepti Adlakha, Mark A. Tully, Nicole E Blackburn, Ai Koyanagi, Paolo Caserotti, Pinar Soysal, Nicola Veronese, Guillermo Felipe López Sánchez, Davy Vancampfort, Anglia Ruskin University (ARU), University of Ulster, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Queen's University [Belfast] (QUB), University of Southern Denmark (SDU), Università degli studi di Palermo - University of Palermo, Institució Catalana de Recerca i Estudis Avançats (ICREA), National Institute on Aging, NIA: 08-CN-0020, OGHA 04034785, R01‐AG034479, R21‐AG034263, Y1-AG-1005, Y1‐AG‐1005–01, YA1323– 08‐CN‐0020, This paper uses data from WHO?s Study on Global Ageing and Adult Health (SAGE). SAGE is supported by the U.S. National Institute on Aging through Interagency Agreements OGHA 04034785, YA1323? 08-CN-0020, Y1-AG-1005?01 and through research grants R01-AG034479 and R21-AG034263., Funding: This paper uses data from WHO’s Study on Global Ageing and Adult Health (SAGE). SAGE is supported by the U.S. National Institute on Aging through Interagency Agreements OGHA 04034785, YA1323– 08‐CN‐0020, Y1‐AG‐1005–01 and through research grants R01‐AG034479 and R21‐AG034263., SOYSAL, PINAR, Smith, L., Tully, M., Jacob, L., Blackburn, N., Adlakha, D., Caserotti, P., Soysal, P., Veronese, N., Sánchez, G.F.L., Vancampfort, D., and Koyanagi, A.
Subjects: Male, Sarcopenia, Health, Toxicology and Mutagenesis, [SDV]Life Sciences [q-bio], lcsh:Medicine, WORLD-HEALTH-ORGANIZATION, Logistic regression, Continuous variable, older adult, 0302 clinical medicine, Medicine, 030212 general & internal medicine, Gait, Public, Environmental & Occupational Health, Low- and middle-income countries, Hand Strength, Sedentary behavior, musculoskeletal system, 3. Good health, PREVALENCE, TIME, OBESITY, Older adults, Income, Female, Life Sciences & Biomedicine, medicine.medical_specialty, Environmental Sciences & Ecology, Article, Odds, SKELETAL-MUSCLE MASS, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Humans, OLDER-ADULTS, Aged, Science & Technology, business.industry, Public health, lcsh:R, Public Health, Environmental and Occupational Health, medicine.disease, body regions, PHYSICAL-ACTIVITY, Cross-Sectional Studies, Socioeconomic Factors, Ageing, Low and middle income countries, FAT, Sedentary Behavior, business, human activities, 030217 neurology & neurosurgery, Environmental Sciences, Demography, low- and middle-income countries, older adults, sarcopenia, sedentary behavior
Abstract: The present study aimed to assess the association between sedentary behavior and sarcopenia among adults aged &ge, 65 years. Cross-sectional data from the Study on Global Ageing and Adult Health were analyzed. Sarcopenia was defined as having low skeletal muscle mass and either a slow gait speed or a weak handgrip strength. Self-reported sedentary behavior was assessed as a continuous variable (hours per day) and also as a categorical variable (0&ndash, &lt, 4, 4&ndash, 8, 8&ndash, 11, &ge, 11 hours/day). Multivariable logistic regression was conducted to assess the association between sedentary behavior and sarcopenia. Analyses using the overall sample and country-wise samples were conducted. A total of 14,585 participants aged &ge, 65 years were included in the analysis. Their mean age was 72.6 (standard deviation, 11.5) years and 55% were females. Compared to sedentary behavior of 0&ndash, 4 hours/day, &ge, 11hours/day was significantly associated with 2.14 (95% CI = 1.06&ndash, 4.33) times higher odds for sarcopenia. The country-wise analysis showed that overall, a one-hour increase in sedentary behavior per day was associated with 1.06 (95% CI = 1.04&ndash, 1.10) times higher odds for sarcopenia, while the level of between-country heterogeneity was low (I2 = 12.9%). Public health and healthcare practitioners may wish to target reductions in sedentary behavior to aid in the prevention of sarcopenia in older adults.
Published: 2020

22. The use of genetic tests to diagnose and manage patients with myeloproliferative and myeloproliferative/myelodysplastic neoplasms, and related disorders

Author: Catherine Cargo, Mamta Garg, Adam J. Mead, Anna L. Godfrey, Nicholas C.P. Cross, and Paper, A British Society for Haematology Good Practice
Subjects: medicine.medical_specialty, Receptor, Platelet-Derived Growth Factor alpha, Oncogene Proteins, Fusion, Mutation, Missense, Severity of Illness Index, Receptors, Colony-Stimulating Factor, Humans, Point Mutation, Medicine, Eosinophilia, Genetic Testing, mRNA Cleavage and Polyadenylation Factors, Biological Products, Myeloproliferative Disorders, business.industry, Disease Management, Bone Marrow Examination, Exons, Hematology, Janus Kinase 2, Prognosis, Dermatology, Clone Cells, Proto-Oncogene Proteins c-kit, Molecular Diagnostic Techniques, Myelodysplastic Syndromes, medicine.symptom, Calreticulin, business, Receptors, Thrombopoietin, Forecasting
Published: 2021

23. The association between objective vision impairment and mild cognitive impairment among older adults in low- and middle-income countries

Author: Hans Oh, Ai Koyanagi, Guillermo F. López-Sánchez, Jae Il Shin, Yvonne Barnett, Lee Smith, Pinar Soysal, Louis Jacob, Laurie T. Butler, Nicola Veronese, Shahina Pardhan, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), National Institute on Aging, NIA: 08-CN-0020, OGHA 04034785, R01-AG034479, R21-AG034263, Y1-AG-1005, YA1323, This paper uses data from WHO?s Study on Global Ageing and Adult Health (SAGE). SAGE is supported by the U.S. National Institute on Aging through Interagency Agreements OGHA 04034785, YA1323?08-CN-0020, Y1-AG-1005?01 and through research grants R01-AG034479 and R21-AG034263., Smith, L., Shin, J.I., Jacob, L., López-Sánchez, G.F., Oh, H., Barnett, Y., Pardhan, S., Butler, L., Soysal, P., Veronese, N., Koyanagi, A., and SOYSAL, PINAR
Subjects: Male, Gerontology, China, Aging, medicine.medical_specialty, Visual acuity, genetic structures, Epidemiology, [SDV]Life Sciences [q-bio], Visual impairment, Vision impairment, Logistic regression, Odds, 03 medical and health sciences, 0302 clinical medicine, Prevalence, Humans, Medicine, Dementia, Cognitive Dysfunction, 030212 general & internal medicine, Association (psychology), Developing Countries, Aged, Low- and middle-income countries, business.industry, Mild cognitive impairment, medicine.disease, eye diseases, Smith L., Shin J. I. , Jacob L., López-Sánchez G. F. , Oh H., Barnett Y., Pardhan S., Butler L., Soysal P., Veronese N., et al., -The association between objective vision impairment and mild cognitive impairment among older adults in low- and middle-income countries.-, Aging clinical and experimental research, 2021, Vision impairment, Mild cognitive impairment, Older adults, Low- and middle-income countries, Epidemiology, Cross-Sectional Studies, Ageing, Older adults, Female, Geriatrics and Gerontology, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract: Aim: The association between visual impairment and mild cognitive impairment (MCI) has not been investigated to date. Thus, we assessed this association among older adults from six low- and middle-income countries (LMICs) (China, India, Ghana, Mexico, Russia, and South Africa) using nationally representative datasets. Methods: Cross-sectional, community-based data from the WHO Study on global AGEing and adult health (SAGE) were analyzed. Visual acuity was measured using the tumbling ElogMAR chart, and vision impairment (at distance and near) was defined as visual acuity worse than 6/18 (0.48 logMAR) in the better-seeing eye. The definition of MCI was based on the National Institute on Aging-Alzheimer’s Association criteria. Multivariable logistic regression was conducted. Results: Data on 32,715 individuals aged ≥ 50years [mean (SD) age 62.1 (15.6) years; 51.2% females] were analyzed. Compared to those without far or near vision impairment, those with near vision impairment but not far vision impairment (OR = 1.33; 95% CI = 1.16–1.52), and those with both far and near vision impairment (OR = 1.70; 95% CI = 1.27–2.29) had significantly higher odds for MCI. Only having far vision impairment was not significantly associated with MCI. Conclusions: Visual impairment is associated with increased odds for MCI among older adults in LMICs with the exception of far vision impairment only. Future longitudinal and intervention studies should examine causality and whether improvements in visual acuity, or early intervention, can reduce risk for MCI and ultimately, dementia. © 2021, The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.
Published: 2021

24. Metabolic perturbations prior to hepatocellular carcinoma diagnosis: Findings from a prospective observational cohort study

Author: Eva Ardanaz, Agnetha Linn Rostgaard-Hansen, Alessio Naccarati, Elisabete Weiderpass, Pekka Keski-Rahkonen, Rudolf Kaaks, Tilman Kühn, Anna Winkvist, Jośe Mariá Huerta, H. B. Bueno-De-Mesquita, Guri Skeie, Pietro Ferrari, Krasimira Aleksandrova, Gabriel Perlemuter, Augustin Scalbert, Olatz Mokoroa, Giovanna Tagliabue, Marc J. Gunter, Kim Overvad, José Ramón Quirós, Agneta Kiss, Marie-Christine Boutron-Ruault, Yahya Mahamat-Saleh, Talita Duarte-Salles, Nivonirina Robinot, Anne Tjønneland, Antonia Trichopoulou, Julie A. Schmidt, Christina C. Dahm, Roel Vermeulen, Rosario Tumino, Núria Sala, Joseph A. Rothwell, Sophia Harlid, Magdalena Stepien, Klas Sjöberg, Vivian Viallon, Neil Murphy, Anna Karakatsani, Salvatore Panico, Nicholas J. Wareham, María José Sánchez, Francesca Mancini, Domenico Palli, Mazda Jenab, Elio Riboli, Bodil Ohlsson, Kay-Tee Khaw, Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Institut National Du Cancer, INCa: 2014-1-RT-02-CIRC-1 Ministerie van Volksgezondheid, Welzijn en Sport, VWS Cancer Research UK, CRUK: C570/A16491 Ministerie van Volksgezondheid, Welzijn en Sport, VWS Ligue Contre le Cancer German Cancer Research Center, DKFZ Bundesministerium für Bildung und Forschung, BMBF Institut National de la Santé et de la Recherche Médicale, Inserm Kræftens Bekæmpelse, DCS National Research Council, NRC 6236 Hellenic Health Foundation, HHF Fondation Gustave Roussy European Commission, EC Centre International de Recherche sur le Cancer, CIRC Associazione Italiana per la Ricerca sul Cancro, AIRC RD06/0020 Deutsche Krebshilfe World Cancer Research Fund, WCRF Cancerfonden Medical Research Council, MRC: MR/M012190/1, This work was supported by the French National Cancer Institute (L'Institut National du Cancer, INCA) (grant number 2014-1-RT-02-CIRC-1, PI: M. Jenab). The coordination of EPIC is financially supported by the European Commission (DG-SANCO), and the International Agency for Research on Cancer. The national cohorts are supported by Danish Cancer Society (Denmark), Ligue Contre le Cancer, Institut Gustave Roussy, Mutuelle G?n?rale de l'Education Nationale, and Institut National de la Sant? et de la Recherche M?dicale (INSERM) (France), Deutsche Krebshilfe, Deutsches Krebsforschungszentrum (DKFZ), and Federal Ministry of Education and Research (Germany), Hellenic Health Foundation (Greece), Italian Association for Research on Cancer (AIRC), National Research Council, and AIRE-ONLUS Ragusa, AVIS Ragusa, Sicilian Government (Italy), Dutch Ministry of Public Health, Welfare and Sports (VWS), Netherlands Cancer Registry (NKR), LK Research Funds, Dutch Prevention Funds, Dutch ZON (Zorg Onderzoek Nederland), World Cancer Research Fund (WCRF), and Statistics Netherlands (the Netherlands), and Nordic Center of Excellence Programme on Food, Nutrition and Health (Norway), Health Research Fund (FIS), Regional Governments of Andaluc?a, Asturias, Basque Country, Murcia (No. 6236) and Navarra, and ISCIII RETIC (RD06/0020) and the Catalan Institute of Oncology (Spain), Swedish Cancer Society, Swedish Scientific Council, and Regional Government of Sk?ne and V?sterbotten (Sweden), Cancer Research UK (14136 for EPIC-Norfolk and C570/A16491 for EPIC-Oxford) and the Medical Research Council (1000143 for EPIC-Norfolk and MR/M012190/1 for EPIC-Oxford) (UK). The funding sources had no influence on the design of the study, the collection, analysis, and interpretation of data, the writing of the report, and or the decision to submit the paper for publication. Disclaimer: Where authors are identified as personnel of the International Agency for Research on Cancer/World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer/World Health Organization.
Subjects: Male, Oncology, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, prospective observational cohort, Glycocholic acid, [SDV.CAN]Life Sciences [q-bio]/Cancer, Mass Spectrometry, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Dehydroepiandrosterone sulfate, Internal medicine, Biomarkers, Tumor, medicine, Humans, Metabolomics, Prospective Studies, Aged, Hepatitis, business.industry, Liver Neoplasms, Cancer, Feeding Behavior, hepatocellular carcinoma, Middle Aged, medicine.disease, 3. Good health, European Prospective Investigation into Cancer and Nutrition, untargeted metabolomics, chemistry, Case-Control Studies, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Cohort, Female, business, Metabolic Networks and Pathways, Chromatography, Liquid, Cohort study
Abstract: International audience; Hepatocellular carcinoma (HCC) development entails changes in liver metabolism. Current knowledge on metabolic perturbations in HCC is derived mostly from case-control designs, with sparse information from prospective cohorts. Our objective was to apply comprehensive metabolite profiling to detect metabolites whose serum concentrations are associated with HCC development, using biological samples from within the prospective European Prospective Investigation into Cancer and Nutrition (EPIC) cohort (>520 000 participants), where we identified 129 HCC cases matched 1:1 to controls. We conducted high-resolution untargeted liquid chromatography-mass spectrometry-based metabolomics on serum samples collected at recruitment prior to cancer diagnosis. Multivariable conditional logistic regression was applied controlling for dietary habits, alcohol consumption, smoking, body size, hepatitis infection and liver dysfunction. Corrections for multiple comparisons were applied. Of 9206 molecular features detected, 220 discriminated HCC cases from controls. Detailed feature annotation revealed 92 metabolites associated with HCC risk, of which 14 were unambiguously identified using pure reference standards. Positive HCC-risk associations were observed for N1-acetylspermidine, isatin, p-hydroxyphenyllactic acid, tyrosine, sphingosine, l,l-cyclo(leucylprolyl), glycochenodeoxycholic acid, glycocholic acid and 7-methylguanine. Inverse risk associations were observed for retinol, dehydroepiandrosterone sulfate, glycerophosphocholine, γ-carboxyethyl hydroxychroman and creatine. Discernible differences for these metabolites were observed between cases and controls up to 10 years prior to diagnosis. Our observations highlight the diversity of metabolic perturbations involved in HCC development and replicate previous observations (metabolism of bile acids, amino acids and phospholipids) made in Asian and Scandinavian populations. These findings emphasize the role of metabolic pathways associated with steroid metabolism and immunity and specific dietary and environmental exposures in HCC development.
Published: 2020

25. The impact of diabetes on heart failure development: the cardio-renal-metabolic connection

Author: Paul Valensi, Jean-Michel Halimi, Erwan Donal, Sara Pinto, Gaëtan Prévost, Jonchère, Laurent, Service d'endocrinologie diabétologie, nutrition (Hôpital Jean Verdier), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Jean Verdier [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Sorbonne Paris Nord, Centre de Recherche en Nutrition Humaine d'Ile-de-France (CRNH-IDF), Institut de Veille Sanitaire (INVS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Institut National Agronomique Paris-Grignon (INA P-G)-CETAF-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Sorbonne Paris Nord, CHU Rouen, Normandie Université (NU), Service de néphrologie et immunologie clinique [CHRU Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], For this review paper the authors did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., Institut de Veille Sanitaire (INVS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Institut National Agronomique Paris-Grignon (INA P-G)-CETAF-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Sorbonne Paris Nord, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de néphrologie et immunologie clinique [CHRU Tours] (EA4245 UT), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université de Tours-Hôpital Bretonneau
Subjects: medicine.medical_specialty, GLP1-receptor agonists, Endocrinology, Diabetes and Metabolism, Population, heart failure, 030209 endocrinology & metabolism, Type 2 diabetes, urologic and male genital diseases, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Diabetes mellitus, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Renal Insufficiency, Chronic, education, Intensive care medicine, Contraindication, [SDV.IB] Life Sciences [q-bio]/Bioengineering, education.field_of_study, business.industry, Diabetes, General Medicine, medicine.disease, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, 3. Good health, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Natural history, Diabetes Mellitus, Type 2, Heart failure, [SDV.IB]Life Sciences [q-bio]/Bioengineering, business, SGLT2 inhibitors, chronic kidney disease, coronary artery disease, Kidney disease
Abstract: Heart failure (HF) and chronic kidney disease (CKD) are often associated in type 2 diabetes (T2D), aggravate each other and exert synergistic effects to increase the risk of cardiac and renal events. The risks of renal worsening in HF patients and HF in CKD patients need to be evaluated to tailor preventive therapy. The recent CV and renal trials enriched our knowledge about the natural history of HF and CKD in T2D and provided evidence for the benefit of sodium-glucose cotransporter 2 inhibitors (SGLT2is) in HF and renal decline prevention. SGLT-2is are the best choice in patients with HFrEF to improve CV prognosis and HF-related outcomes and also to prevent kidney-related outcomes, and in CKD patients to slow down renal failure and also reduce hospitalization for HF and CV death. In both situations the number of patients to treat in order to prevent such events in one patient is lower than in the general T2D population at high CV risk. GLP1-receptor agonists could be an alternative in a patient who is intolerant or has a contraindication to SGLT-2is. A tight collaboration between diabetologists, nephrologists and cardiologists should be encouraged for a holistic and effective strategy to reduce the burden of cardio-renal-metabolic interaction.
Published: 2021

26. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD® program in Spanish children with autism and preterm children with communication and/or socialization difficulties

Author: Fátima Valencia, Inmaculada Navas, Maria Elias, Laia Villalta, Marina Romero-González, Almudena Ramírez, Alexandra Garriz, Elena Urbiola, [Valencia,F, Urbiola,E, Garriz,A] Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Romero-González,M, Navas,I, Ramírez,A] Maternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain. [Romero-González,M, Ramírez,A] Department of Brain Health, CIMES, Faculty of Medicine-IBIMA, UMA, Málaga, Spain. [Elías,M, Villalta,L] Department of Psychiatry and Psychology, Hospital Sant Joan de Déu de Barcelona, L’Hospitalet de Llobregat, Spain. [Villalta,L] Children and Adolescent Mental Health Research Group, Research Institute Sant Joan de Déu, Esplugues de Llobregat, Spain., and This paper reports on independent research financially supported by the Alicia Koplowitz Foundation.
Subjects: Parents, Medicine (General), Information Science::Information Science::Communication [Medical Subject Headings], Autism Spectrum Disorder, Psychiatry and Psychology::Behavior and Behavior Mechanisms::Psychology, Social::Family::Family Relations::Parenting [Medical Subject Headings], Psychological intervention, Medicine (miscellaneous), Pilot Projects, law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Study Protocol, 0302 clinical medicine, Randomized controlled trial, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Multicenter Studies as Topic [Medical Subject Headings], law, Autistic children, Medicine, Multicenter Studies as Topic, Pharmacology (medical), Child, Child development, Randomized Controlled Trials as Topic, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings], Parenting, Communication, 05 social sciences, Pilot, Autism spectrum disorder, Child, Preschool, Premature Birth, 050104 developmental & child psychology, Clinical psychology, medicine.medical_specialty, Parenting intervention, Pilotos, Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Child Development Disorders, Pervasive::Autistic Disorder [Medical Subject Headings], ASD, Desarrollo infantil, 03 medical and health sciences, R5-920, Complex intervention, Intervention (counseling), Humans, 0501 psychology and cognitive sciences, Persons::Persons::Age Groups::Child [Medical Subject Headings], Autistic Disorder, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Pilot Projects [Medical Subject Headings], Infants autistes, business.industry, Public health, Trastorno del espectro del autismo, Socialization, medicine.disease, Mental health, Responsabilidad parental, Desenvolupament infantil, Preterm children, Spain, randomized controlled trial, Autism, Anthropology, Education, Sociology and Social Phenomena::Social Sciences::Sociology::Socialization [Medical Subject Headings], Diseases::Female Urogenital Diseases and Pregnancy Complications::Pregnancy Complications::Obstetric Labor Complications::Obstetric Labor, Premature::Premature Birth [Medical Subject Headings], business, Persons::Persons::Parents [Medical Subject Headings], Persons::Persons::Age Groups::Child::Child, Preschool [Medical Subject Headings], 030217 neurology & neurosurgery, Nacimiento prematuro
Abstract: Abstract Having access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group intervention that has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and social outcomes in children. The program has been recently adapted for families of children with autism or language delays (IY-ASLD®). This intervention has not yet been implemented in the Spanish Public Health System, where there is a scarcity of evidence-based interventions being offered to families with young children presenting neurodevelopmental problems. The main aims of this study are to determine the feasibility of implementing the IY-ASLD® program within Spanish Child Mental Health Services and to examine parents’ acceptability and satisfaction with the intervention. As a secondary objective, we aim to evaluate its preliminary effectiveness in terms of reducing parental stress and behavioral difficulties in their children. The FIRST STEPS study is a multicenter, pilot randomized controlled trial comparing the IY-ASLD® program with a treatment-as-usual (TAU) condition. Approximately 70 families of children with autism spectrum disorder (ASD) and preterm children with communication and/or socialization difficulties (aged 2–5 years) will be recruited. Families will be assessed prior to randomization and after the intervention. Due to the COVID-19 pandemic, the intervention will consist of 22 weekly online sessions (approximately 6 months). The FIRST STEPS pilot trial will demonstrate the feasibility and acceptability of reliably implementing the IY-ASLD® program within the Spanish Public Health System. The results of this study could represent the first step to inform policymakers in Spain when designing evidence-based healthcare pathways for families of children presenting ASD symptoms or neurodevelopmental difficulties at early stages. Trial registration ClinicalTrials.gov NCT04358484. Registered on 04 April 2020
Published: 2021

27. Statin Use and Skin Cancer Risk: A Prospective Cohort Study

Author: Trude Eid Robsahm, Agnès Fournier, Yahya Mahamat-Saleh, Reza Ghiasvand, Marina Kvaskoff, Manon Cairat, Marie-Christine Boutron-Ruault, Iris Cervenka, Marie Al Rahmoun, Gianluca Severi, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oslo University Hospital [Oslo], Cancer Registry of Norway, International Agency for Cancer Research (IACR), Università degli Studi di Firenze = University of Florence (UniFI), 2102 918823, NCT03285230, Centre International de Recherche sur le Cancer, CIRC, Agence Nationale de la Recherche, ANR: ANR-10-COHO-0006, Institut National de la Santé et de la Recherche Médicale, Inserm, Institut National Du Cancer, INCa: INCa_13539, Institut Gustave-Roussy, Mutuelle Générale de l'Education Nationale, MGEN, We are grateful to the study participants for their continued participation and to practitioners for providing pathology reports. We also thank all members of the E3N study group, particularly Rafika Cha?t, Ghizlane Bajawi-Esselma, Amandine Gelot, Marie Fangon, Pascale Gerbouin-R?rolle, Sabine Moreira-Faria, Nad?ge Senina, Sofiane Harizi, Lyan Hoang, Anita Kowal, and Camille Laplanche for their technical assistance. The E3N cohort from the French National Institute of Health and Medical Research (Inserm) was supported by the Mutuelle G?n?rale de l'Education Nationale, the Gustave Roussy Institute, and the French League against Cancer. E3N-E4N is also supported by the French National Research Agency under the Investment for the Future Program (ANR-10-COHO-0006) and by the French Ministry of Higher Education, Research and Innovation (subsidy for public service charges #2102 918823). MAR, YMS, and IC were supported by research scholarships from the French National Cancer Institute (MAR: INCa_13539), the Paris Ile-de-France region, and the French Ministry of Research, respectively. This study is listed at ClinicalTrials.gov as NCT03285230. The work reported in this paper was performed during Agn?s Fournier's term as a Visiting Scientist at the International Agency for Research on Cancer. Conceptualization: MK, AF, Data Curation: MAR, AF, Formal Analysis: MAR, Funding Acquisition: MAR, MK, AF, Investigation: MAR, MK, AF, Methodology: MK, AF, Project Administration: MK, AF, Resources: GS, MCBR, MK, AF, Software: MAR, AF, Supervision: MK, AF, Visualization: MAR, Validation: MK, AF, Writing - Original Draft Preparation: MAR, RG, TER, MK, AF, Writing - Review and Editing: MAR, RG, MC, YMS, IC, GS, MCBR, TER, MK, AF, Funding sources had no role in study design, collection, analysis, and interpretation of data, writing of the report, and the decision to submit the article for publication., ANR-10-COHO-0006,E4N,Etude Epidémiologique des Enfants de femmes de l'Education Nationale(2010), HAL UVSQ, Équipe, and Cohortes - Etude Epidémiologique des Enfants de femmes de l'Education Nationale - - E4N2010 - ANR-10-COHO-0006 - COHO - VALID
Subjects: Male, medicine.medical_specialty, Skin Neoplasms, [SDV]Life Sciences [q-bio], [SDV.CAN]Life Sciences [q-bio]/Cancer, Dermatology, Biochemistry, Cohort Studies, [SDV.CAN] Life Sciences [q-bio]/Cancer, Risk Factors, Internal medicine, Epidemiology, medicine, Humans, Basal cell carcinoma, Prospective Studies, Prospective cohort study, Melanoma, Molecular Biology, Proportional Hazards Models, Aged, 80 and over, business.industry, Hazard ratio, Cell Biology, [SDV.MHEP.DERM] Life Sciences [q-bio]/Human health and pathology/Dermatology, medicine.disease, Confidence interval, [SDV] Life Sciences [q-bio], Defined daily dose, Carcinoma, Basal Cell, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Carcinoma, Squamous Cell, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Skin cancer, business, Body mass index, [SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology
Abstract: International audience; Epidemiological studies on statin use in relation to skin cancer risk are scarce and yielded conflicting results. We explored this association in Etude Epidémiologique auprès de femmes de l'Education Nationale, a prospective cohort of French women born in 1925–1950. Health and lifestyle data were self-reported biennially and matched with drug reimbursement data, allowing the identification of participants’ statin use since 2004. Multivariable cause-specific hazards regression models adjusted for skin cancer risk factors estimated hazard ratios with 95% confidence intervals. Over 2004–2014, 455 cutaneous melanoma, 1,741 basal cell carcinoma, and 268 squamous cell carcinoma cases were ascertained among 62,473 women. Compared with never use, there were no associations between ever use of statins and melanoma (hazard ratio = 1.16, 95% confidence interval = 0.94–1.44) or squamous cell carcinoma (hazard ratio = 0.89, 95% confidence interval = 0.66–1.19) risks and a decrease in basal cell carcinoma risk with ever use of statins (hazard ratio = 0.89, 95% confidence interval = 0.79–0.996). We found no trend of increasing or decreasing risks with dose, duration of use, time since first use, or age at first use and no statistically significant effect modification by pigmentary traits or residential UVR exposure. Because of the limited number of studies evaluating the associations between the use of statins and the risks of melanoma, basal cell carcinoma, and squamous cell carcinoma, these findings would deserve further investigation in other settings.
Published: 2022

28. Family, social and cultural determinants of long-lasting insecticidal net (LLIN) use in Madagascar: secondary analysis of three qualitative studies focused on children aged 5–15 years

Author: Andry Andrianasolo, Ammy Fiadanana Njatosoa, Chiarella Mattern, Bakoly Rahaivondrafahitra, Christophe Rogier, Mauricette Andriamananjara, Aina Harimanana, Thomas Kesteman, Dolorès Pourette, Elliot Rakotomanana, Jocelyn Razafindrakoto, Emma Raboanary, Institut Pasteur de Madagascar, Réseau International des Instituts Pasteur (RIIP), Centre population et développement (CEPED - UMR_D 196), Institut de Recherche pour le Développement (IRD)-Université de Paris (UP), Unité de Recherche sur le Paludisme [Antananarivo, Madagascar], Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Oxford University Clinical Research Unit [Hanoi] (OUCRU), Population Services International Madagascar [Antananarivo], Population Services International [Washington], Ministère de la Santé Publique [Antananarivo, Madagascar], U.S. President’s Malaria Initiative [Antananarivo] (PMI), U.S. President's Malaria Initiative [Atlanta, GA,], Institut international des sciences sociales [Antananarivo] (IISS), Primum Vitare, The publication process of this paper has been funded by USAID through the Research, Innovation, Surveillance and Evaluation (RISE) programme., Institut de Recherche pour le Développement (IRD), and Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité)
Subjects: Male, medicine.medical_specialty, Mosquito Control, lcsh:Arctic medicine. Tropical medicine, Adolescent, lcsh:RC955-962, LLIN use, 030231 tropical medicine, [SHS.ANTHRO-BIO]Humanities and Social Sciences/Biological anthropology, Ethnic group, Qualitative property, [SHS]Humanities and Social Sciences, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, 0302 clinical medicine, Environmental health, parasitic diseases, medicine, Madagascar, Humans, lcsh:RC109-216, 030212 general & internal medicine, Children over five, Insecticide-Treated Bednets, Child, Disease burden, Research, Public health, [SHS.ANTHRO-SE]Humanities and Social Sciences/Social Anthropology and ethnology, medicine.disease, 3. Good health, Malaria, Infectious Diseases, Geography, Child, Preschool, Mosquito net, Female, Parasitology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Thematic analysis, Sociocultural factors, Qualitative research
Abstract: BackgroundAlthough it is accepted that long-lasting insecticidal net (LLIN) use is an effective means to prevent malaria, children aged 5 to 15 years do not appear to be sufficiently protected in Madagascar; the malaria prevalence is highest in this age group. The purpose of this research is to summarize recent qualitative studies describing LLIN use among the Malagasy people with a focus on children aged 5–15 years.MethodsQualitative data from three studies on malaria conducted between 2012 and 2016 in 10 districts of Madagascar were analysed. These studies cover all malaria epidemiological profiles and 10 of the 18 existing ethnic groups in Madagascar. A thematic analysis was conducted on the collected data from semi-structured interviews, direct observation data, and informal interviews.ResultsA total of 192 semi-structured interviews were conducted. LLINs are generally perceived positively because they protect the health and well-being of users. However, regional representations of mosquito nets may contribute to LLIN lower use by children over 5 years of age including the association between married status and LLIN use, which leads to the refusal of unmarried young men to sleep under LLINs; the custom of covering the dead with a mosquito net, which leads to fear of LLIN use; and taboos governing sleeping spaces for siblings of opposite sexes, which leads to LLIN shortages in households. Children under 5 years of age are known to be the most vulnerable age group for acquiring malaria and, therefore, are prioritized for LLIN use when there are limited supplies in households. In contrast, children over 5 years of age, who are perceived to be at less risk for malaria, often sleep without LLINs.ConclusionsPerceptions, social practices and regional beliefs regarding LLINs and vulnerability to malaria contribute to the nonuse of LLINs among children over 5 years of age in Madagascar. Modifying LLIN policies to account for these factors may increase LLIN use in this age group and reduce disease burden.
Published: 2021

29. A review of current treatment strategies for infective endocarditis

Author: Ines Lakbar, David Luque Paz, Pierre Tattevin, CHU Pontchaillou [Rennes], CHU Toulouse [Toulouse], ARN régulateurs bactériens et médecine (BRM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), This paper was not funded., Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
Subjects: 0301 basic medicine, Microbiology (medical), Oral treatment, medicine.medical_specialty, Prosthesis-Related Infections, Time Factors, empirical treatment, medicine.drug_class, [SDV]Life Sciences [q-bio], 030106 microbiology, Antibiotics, Heart Valve Diseases, review, Microbiology, antibiotics, 03 medical and health sciences, 0302 clinical medicine, enterococci, Virology, medicine, Endocarditis, Animals, Humans, 030212 general & internal medicine, Intensive care medicine, staphylococci, treatment, business.industry, HACEK, oral treatment, Endocarditis, Bacterial, medicine.disease, 3. Good health, Anti-Bacterial Agents, Empirical treatment, Infectious Diseases, streptococci, Infective endocarditis, Heart Valve Prosthesis, Treatment strategy, business
Abstract: International audience; Introduction Infective endocarditis is one of the most difficult-to-treat infectious diseases. Areas covered We restricted this review to the anti-infective treatment of the main bacteria responsible for infective endocarditis, i.e. staphylococci, streptococci, enterococci, and Gram-negative bacilli, including HACEK. Specific topics of major interest in treatment strategy are covered as well, including empirical treatment, oral switch, and treatment duration. We searched in the MEDLINE database to identify relevant studies, trials, reviews, or meta-analyses until May 2020. Expert opinion The use of aminoglycosides for the treatment of endocarditis has been dramatically reduced over the last 20 years. It should be administered once daily, and no longer than 2 weeks. For staphylococcal endocarditis, recent data reinforced the role of anti-staphylococcal penicillins, for methicillin-susceptible isolates (alternative, cefazolin), and vancomycin for methicillin-resistant isolates (alternative, daptomycin). For staphylococcal prosthetic-valve endocarditis, these treatments will be reinforced by the addition of gentamicin during the first 2 weeks, and rifampin throughout the whole treatment duration, i.e. 6 weeks. The optimal duration of antibacterial treatment is 4 weeks for most native valve endocarditis, and 6 weeks for prosthetic-valve endocarditis. The oral switch is safe in patients stabilized after the initial intravenous course.
Published: 2021

30. Prospective Cohort Study of Infective Endocarditis in People Who Inject Drugs

Author: David R. Murdoch, Nuria Fernández-Hidalgo, Eugene Athan, Juan M. Pericàs, José M. Miró, Tomáš Freiberger, Pierre Tattevin, Emanuele Durante-Mangoni, Francisco Nacinovich, Marta Hernández-Meneses, Vivian H. Chu, Zeina A. Kanafani, Jacob Strahilevitz, Jaume Llopis, Cristiane da Cruz Lamas, Margaret M. Hannan, University of Barcelona, Deakin University [Burwood], University of Otago [Dunedin, Nouvelle-Zélande], American University of Beirut [Beyrouth] (AUB), Masaryk University [Brno] (MUNI), Hadassah Hebrew University Medical Center [Jerusalem], Universitat Autònoma de Barcelona (UAB), CHU Pontchaillou [Rennes], ARN régulateurs bactériens et médecine (BRM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Duke University [Durham], This study was supported by the Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (# E26/202.782/2015 to Dr. Lamas), Red Española de Investigación en Patología Infecciosa (V-2003-REDC14A-O), and Fondo de Investigaciones Sanitarias de la Seguridad Social (FIS 00-0475) (Dr. Miro). Dr. Miro has received a personal 80:20 research grant from the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, for 2017 to 2021. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., Pericas, J. M., Llopis, J., Athan, E., Hernandez-Meneses, M., Hannan, M. M., Murdoch, D. R., Kanafani, Z., Freiberger, T., Strahilevitz, J., Fernandez-Hidalgo, N., Lamas, C., Durante-Mangoni, E., Tattevin, P., Nacinovich, F., Chu, V. H., Miro, J. M., and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
Subjects: Adult, Male, medicine.medical_specialty, Staphylococcus aureus, cardiac surgery, [SDV]Life Sciences [q-bio], infective endocarditi, Human immunodeficiency virus (HIV), 030204 cardiovascular system & hematology, Logistic regression, medicine.disease_cause, Global Health, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Risk Factors, Internal medicine, medicine, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Substance Abuse, Intravenous, Aged, Prosthetic valve, people who inject drug, Endocarditis, business.industry, Public health, Incidence, HIV, Middle Aged, medicine.disease, 3. Good health, Cardiac surgery, people who inject drugs, Infective endocarditis, opioid crisis, Female, infective endocarditis, opioid crisi, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract: International audience; Background - Infective endocarditis (IE) in people who inject drugs (PWID) is an emergent public health problem. Objectives - The purpose of this study was to investigate IE in PWID and compare it with IE in non-PWID patients. Methods - Two prospective cohort studies (ICE-PCS and ICE-Plus databases, encompassing 8,112 IE episodes from 2000 to 2006 and 2008 to 2012, with 64 and 34 sites and 28 and 18 countries, respectively). Outcomes were compared between PWID and non-PWID patients with IE. Logistic regression analyses were performed to investigate risk factors for 6-month mortality and relapses amongst PWID. Results - A total of 7,616 patients (591 PWID and 7,025 non-PWID) were included. PWID patients were significantly younger (median 37.0 years [interquartile range: 29.5 to 44.2 years] vs. 63.3 years [interquartile range: 49.3 to 74.0 years]; p
Published: 2021

31. Deciphering the Chemistry of Cultural Heritage: Targeting Material Properties by Coupling Spectral Imaging with Image Analysis

Author: Étienne Anheim, Loïc Bertrand, Pierre Gueriau, Mathieu Thoury, Serge X. Cohen, Photophysique et Photochimie Supramoléculaires et Macromoléculaires (PPSM), Institut de Chimie du CNRS (INC)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Ecole Normale Supérieure Paris-Saclay (ENS Paris Saclay), Institut photonique d'analyse non-destructive européen des matériaux anciens (IPANEMA), Muséum national d'Histoire naturelle (MNHN)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Centre National de la Recherche Scientifique (CNRS)-Ministère de la Culture (MC), Nestlé Institute of Health Sciences SA [Lausanne, Switzerland], Centre de Recherches Historiques (CRH), École des hautes études en sciences sociales (EHESS)-Centre National de la Recherche Scientifique (CNRS), and We thank Barbara Berrie (National Gallery of Art, Washington, D.C., U.S.) and Agnès Desolneux (Centre Borelli, ENS Paris-Saclay, CNRS) for their careful rereading of our manuscript. The authors are particularly grateful to the large number of colleagues with whom we have discussed these aspects over many years of common work and interaction. Our very special thanks go to Marie-Angélique Languille (today at the Centre de Recherche sur la Conservation des Collections, Paris) and Sophie David (PPSM). We thank all of our coauthors from the papers discussed and the many colleagues with whom we have discussed these ideas, including Demetrios Anglos, Julie Arslanoglu, Bernadette Bensaude-Vincent, Uwe Bergmann, Barbara Berrie, Catherine Brechignac, Gilles Celeux, Antoine Chambaz, Pierre Chastang, Cynthia Colmellere, Marie Cornu, Jean-Paul Demoule, Agnès Desolneux, Jean-Philippe Échard, Douglas Galante, Pierre Galtier, Claire Gervais, Denis Gratias, Agnès Grimaud, Charlotte Guichard, Ineke Joosten, Katrien Keune, Andrew King, Bertrand Lavédrine, Pierre Laszlo, Erwan Le Pennec, Pierre Levitz, Alain Lusson, Lara Maldanis, Pascal Massard, Cristian Mocuta, Lionel Moisan, Emmanuel (Manolis) Pantos, André Rassat, Matthieu Réfrégiers, Luc Robbiola, Laurent Romary, Isabelle Rouget, Jean-Pascal Rueff, Solenn Réguer, Clément Sanchez, Sebastian Schoeder, Marika Spring, Maartje Stols-Witlox, Matija Strlic, Caroline Tokarski, Edward Vicenzi, Laurence de Viguerie, Kees van der Beek, Robert van Langh, Philippe Walter, Sam Webb, and many friends, students, and colleagues. L.B. acknowledges the support of the Fondation des Treilles and its wonderful team for the organization of two seminars (in 2013 and 2014) that enabled the scope of this research program to be critically defined. The construction of the IPANEMA laboratory was funded by a CPER grant from the French Ministère de la recherche, de l’enseignement supérieur et de l’innovation and Région Île-de-France.
Subjects: medicine.medical_specialty, Data processing, Materials science, 010405 organic chemistry, Chemistry, media_common.quotation_subject, Hyperspectral imaging, General Medicine, General Chemistry, Ambiguity, 010402 general chemistry, 01 natural sciences, Data science, 0104 chemical sciences, Spectral imaging, Characterization (materials science), Cultural heritage, Identification (information), medicine, [CHIM]Chemical Sciences, Spatial analysis, media_common
Abstract: International audience; ConspectusThe chemical study of materials from natural history and cultural heritage, which provide information for art history, archeology, or paleontology, presents a series of specific challenges. The complexity of these ancient and historical materials, which are chemically heterogeneous, the product of alteration processes, and inherently not reproducible, is a major obstacle to a thorough understanding of their making and long-term behavior (e.g., fossilization). These challenges required the development of methodologies and instruments coupling imaging and data processing approaches that are optimized for the specific properties of the materials. This Account discusses how these characteristics not only constrain their study but also open up specific innovative avenues for providing key historical information. Synchrotron methods have extensively been used since the late 1990s to study heritage objects, in particular for their potential to provide speciation information from excitation spectroscopies and to image complex heritage objects and samples in two and three dimensions at high resolution. We examine in practice how the identification of key intrinsic chemical specificities has offered fertile ground for the development of novel synchrotron approaches allowing a better stochastic description of the properties of ancient and historical materials. These developments encompass three main aspects: (1) The multiscale heterogeneity of these materials can provide an essential source of information in the development of probes targeting their multiple scales of homogeneity. (2) Chemical alteration can be described in many ways, e.g., by segmenting datasets in a semiquantitative way to jointly inform morphological and chemical transformation pathways. (3) The intrinsic individuality of chemical signatures in artifacts triggers the development of specific strategies, such as those focusing on weak signal detection. We propose a rereading of the advent of these new methodologies for analysis and characterization and examine how they have led to innovative strategies combining materials science, instrument development, history, and data science. In particular, we show that spectral imaging and the search for correlations in image datasets have provided a powerful way to address what archeologists have called the uncertainty and ambiguity of the material record. This approach has implications beyond synchrotron techniques and extends in particular to a series of rapidly developing approaches that couple spectral and spatial information, as in hyperspectral imaging and spatially resolved mass spectrometry. The preeminence of correlations holds promise for the future development of machine learning methods for processing data on historical objects. Beyond heritage, these developments are an original source of inspiration for the study of materials in many related fields, such as environmental, geochemical, or life sciences, which deal with systems whose alteration and heterogeneity cannot be neglected.
Published: 2021

32. Relationship between Physical Activity, Oxidative Stress, and Total Plasma Antioxidant Capacity in Spanish Children from the GENOBOX Study

Author: María D. Mesa, Rosaura Leis, Augusto Anguita-Ruiz, Azahara I. Rupérez, Concepción M. Aguilera, Luis A. Moreno, Angel Gil, Francisco Jesus Llorente-Cantarero, Francisco Javier Aguilar-Gómez, Gloria Bueno, Rocío Vázquez-Cobela, Mercedes Gil-Campos, Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, [Llorente-Cantarero,FJ] Department of Specific Didactics, Faculty of Education, Maimónides Institute of Biomedicine Research of Córdoba (IMIBIC), University of Córdoba, Córdoba, Spain. [Llorente-Cantarero,FJ, Leis,R, Bueno,G, Anguita-Ruiz,A, Vázquez-Cobela,R, Moreno,LA, Gil,A, Aguilera,CM, Gil-Campos,M] CIBEROBN, (Physiopathology of Obesity and Nutrition) Institute of Health Carlos III (ISCIII), Madrid, Spain. [Aguilar-Gomez FJ, Gil-Campos,M] Metabolism and Investigation Unit, Reina Sofía University Hospital, Maimónides Institute of Biomedicine Research of Córdoba (IMIBIC), University of Córdoba, Córdoba, Spain. [Leis,R, Vázquez-Cobela,R] Unit of Investigation in Nutrition, Growth and Human Development of Galicia, Pediatric Department, University of Santiago de Compostela, Clinic University Hospital of Santiago, Instituto de Investigación Sanitaria de Santiago (IDIS), Santiago de Compostela, Spain. [Bueno,G] Pediatric Endocrinology Unit, Clinic University Hospital Lozano Blesa, Facultad de Medicina, Universidad de Zaragoza, Zaragoza, Spain. [Bueno,G, Rupérez,AI, Moreno,LA] GENUD Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria (IIS) Aragón, University of Zaragoza, Zaragoza, Spain. [Anguita-Ruiz,A, Mesa,MA, Aguilera,CM] Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology 'José Mataix', Center of Biomedical Research, University of Granada, Armilla, Granada, Spain. [Anguita-Ruiz,A, Aguilera,CM] Instituto de Investigación Biosanitaria ibs Granada, 18014 Granada, Spain., This research was funded by the Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica (I + D + I), Instituto de Salud Carlos III-Health Research Funding (FONDOS FEDER) (PI11/02042, PI11/02059, PI11/01425, and PI16/00871, PI16/01301, PI16/01205) and RETIC (Redes temáticas de investigación cooperativa) (Red SAMID RD12/0026/0015). The authors also acknowledge Instituto de Salud Carlos III for personal funding of A.A.R: Contratos i-PFIS: doctorados IIS-empresa en ciencias y tecnologías de la salud de la convocatoria 2017 de la Acción Estratégica en Salud 2013–2016 (IFI17/00048). Á.G. was funded by the Research Plan of the Vice-Rectorate of Research and Transfer of the University of Granada, Spain This paper will be included in F.J.A. doctorate, under the 'Biomedicine Program' at the University of Córdoba, Spain.
Subjects: Antioxidant, Isoprostane, 8-hydroxy-2′-deoxyguanosine, Physiology, medicine.medical_treatment, Clinical Biochemistry, Physical fitness, physical activity, medicine.disease_cause, Biochemistry, Acelerometría, chemistry.chemical_compound, 0302 clinical medicine, Accelerometry, oxidative stress, 030212 general & internal medicine, Isoprostane F2α, Plasma total antioxidant capacity, Phenomena and Processes::Metabolic Phenomena::Metabolism::Oxidative Stress [Medical Subject Headings], Health Care::Health Care Economics and Organizations::Organizations::International Agencies::United Nations::World Health Organization [Medical Subject Headings], Total plasma, plasma total antioxidant capacity, Estrés oxidativo, Ejercicio físico, isoprostane F2, Antioxidant capacity, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Chemistry Techniques, Analytical::Titrimetry::Colorimetry [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Immunologic Techniques::Immunoassay::Immunoenzyme Techniques::Enzyme-Linked Immunosorbent Assay [Medical Subject Headings], 8-Hidroxi-2'-Desoxicoguanosina, medicine.medical_specialty, Physical activity, Article, 03 medical and health sciences, Internal medicine, isoprostane F2α, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Protective Agents::Antioxidants [Medical Subject Headings], medicine, accelerometry, Pysical activity, Molecular Biology, Redox homeostasis, business.industry, lcsh:RM1-950, 030229 sport sciences, Cell Biology, 8-hydroxy-20-deoxyguanosine, Phenomena and Processes::Musculoskeletal and Neural Physiological Phenomena::Musculoskeletal Physiological Phenomena::Physical Fitness [Medical Subject Headings], lcsh:Therapeutics. Pharmacology, chemistry, Oxidative stress, business
Abstract: The World Health Organization has recommended performing at least 60 min a day of moderate-to-vigorous physical activity (MVPA) and reducing sedentarism in children and adolescents to offer significant health benefits and mitigate health risks. Physical fitness and sports practice seem to improve oxidative stress (OS) status during childhood. However, to our knowledge, there are no data regarding the influence of objectively-measured physical activity (PA) and sedentarism on OS status in children and adolescents. The present study aimed to evaluate the influence of moderate and vigorous PA and sedentarism on OS and plasma total antioxidant capacity (TAC) in a selected Spanish population of 216 children and adolescents from the GENOBOX study. PA (light, moderate, and vigorous) and sedentarism (i.e., sedentary time (ST)) were measured by accelerometry. A Physical Activity-Sedentarism Score (PASS) was developed integrating moderate and vigorous PA and ST levels. Urinary 8-hydroxy-20-deoxyguanosine (8-OHdG) and isoprostane F2 (F2-IsoPs), as markers of OS, were determined by ELISA; and TAC was estimated by colorimetry using an antioxidant kit. A higher PASS was associated with lower plasma TAC and urinary 8-OHdG and F2-IsoPs, showing a better redox profile. Reduced OS markers (8-OHdG and F2-IsoPs) in children with higher PASS may diminish the need of maintaining high concentrations of antioxidants in plasma during rest to achieve redox homeostasis., Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica (I + D + I), Instituto de Salud Carlos III-Health Research Funding (FONDOS FEDER) PI11/02042 PI11/02059 PI11/01425 PI16/00871 PI16/01301 PI16/01205, RETIC (Redes temáticas de investigación cooperativa) Red SAMID RD12/0026/0015, Instituto de Salud Carlos III European Commission IFI17/00048, Research Plan of the Vice-Rectorate of Research and Transfer of the University of Granada, Spain
Published: 2021

33. Physical functional performance and prognosis in patients with heart failure: a systematic review and meta-analysis

Author: Antonio Cuesta-Vargas, Ricardo Gómez-Huelgas, María Rosa Bernal-López, Iván José Fuentes-Abolafio, Brendon Stubbs, Luis M. Pérez-Belmonte, [Fuentes-Abolafio,IJ, Cuesta-Vargas,AI] Department of Physiotherapy, Faculty of Health Science, University of Malaga, The Institute of Biomedical Research in Malaga (IBIMA), Clinimetric Group FE-14, Malaga, Spain. [Stubbs,B] Physiotherapy Department, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK. [Stubbs,B] Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK. [Stubbs,B] Positive Ageing Research Intitute (PARI), Faculty of Health Social Care and Education, Anglia Ruskin University, Chelmsford, UK. [Pérez-Belmonte,LM, Bernal-López,MR, Gómez-Huelgas,R] Internal Medicine Department, Instituto de Investigación Biomédica de Malaga (IBIMA), Regional University Hospital of Málaga, Málaga, Spain. [Pérez-Belmonte,LM] Unidad de Neurofisiología Cognitiva, Centro de Investigaciones Médico Sanitarias (CIMES), Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Campus de Excelencia Internacional (CEI) Andalucía Tech, Málaga, Spain. [Pérez-Belmonte,LM] Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain. [Bernal-López,MR, Gómez-Huelgas,R] CIBER Fisio-patología de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain. [Cuesta-Vargas,AI] School of Clinical Sciences, Faculty of Health at the Queensland University of Technology, Brisbane, Queensland, Australia., and Brendon Stubbs is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR). Brendon Stubbs is part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust. Brendon Stubbs is also supported by the Maudsley Charity, King’s College London and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions. María Rosa Bernal-López was supported by 'Miguel Servet Type I' program (CP15/00028) from the ISCIII-Madrid (Spain), cofinanced by the Fondo Europeo de Desarrollo Regional-FEDER.
Subjects: Male, lcsh:Diseases of the circulatory (Cardiovascular) system, Hospitalización, Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Assessment [Medical Subject Headings], Walking, 030204 cardiovascular system & hematology, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Risk Factors, Physical functional performance, Hospitalisation, Medicine, 030212 general & internal medicine, Phenomena and Processes::Musculoskeletal and Neural Physiological Phenomena::Musculoskeletal Physiological Phenomena::Musculoskeletal Physiological Processes::Movement::Motor Activity::Exercise::Walking [Medical Subject Headings], Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Aged, 80 and over, Insuficiencia cardíaca, Pronóstico, Middle Aged, Prognosis, Cardiac surgery, Hospitalization, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Sensitivity and Specificity::Predictive Value of Tests [Medical Subject Headings], Meta-analysis, Female, Gait Analysis, Cardiology and Cardiovascular Medicine, Research Article, medicine.medical_specialty, Check Tags::Male [Medical Subject Headings], Walk Test, Functional tests, Heart failure, CINAHL, Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], Risk Assessment, 03 medical and health sciences, Predictive Value of Tests, Humans, In patient, Mortality, Aged, Angiology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Heart Function Tests::Exercise Test [Medical Subject Headings], business.industry, Diseases::Cardiovascular Diseases::Heart Diseases::Heart Failure [Medical Subject Headings], Persons::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings], Evidence-based medicine, medicine.disease, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Physical Examination::Gait [Medical Subject Headings], Functional Status, Check Tags::Female [Medical Subject Headings], lcsh:RC666-701, Persons::Persons::Age Groups::Adult::Aged::Aged, 80 and over [Medical Subject Headings], Mortalidad, Physical therapy, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis [Medical Subject Headings], Observational study, business, Rendimiento físico funcional
Abstract: Background Patients with Heart Failure (HF) show impaired functional capacities which have been related to their prognosis. Moreover, physical functional performance in functional tests has also been related to the prognosis in patients with HF. Thus, it would be useful to investigate how physical functional performance in functional tests could determine the prognosis in patients with HF, because HF is the leading cause of hospital admissions for people older than 65 years old. This systematic review and meta-analysis aims to summarise and synthesise the evidence published about the relationship between physical functional performance and prognosis in patients with HF, as well as assess the risk of bias of included studies and the level of evidence per outcome. Methods Major electronic databases, such as PubMed, AMED, CINAHL, EMBASE, PEDro, Web of Science, were searched from inception to March 2020 for observational longitudinal cohort studies (prospective or retrospective) examining the relationship between physical functional performance and prognosis in patients with HF. Results 44 observational longitudinal cohort studies with a total of 22,598 patients with HF were included. 26 included studies reported a low risk of bias, and 17 included studies showed a moderate risk of bias. Patients with poor physical functional performance in the Six Minute Walking Test (6MWT), in the Short Physical Performance Battery (SPPB) and in the Gait Speed Test showed worse prognosis in terms of larger risk of hospitalisation or mortality than patients with good physical functional performance. However, there was a lack of homogeneity regarding which cut-off points should be used to stratify patients with poor physical functional performance from patients with good physical functional performance. Conclusion The review includes a large number of studies which show a strong relationship between physical functional performance and prognosis in patients with HF. Most of the included studies reported a low risk of bias, and GRADE criteria showed a low and a moderate level of evidence per outcome.
Published: 2020

34. Assessing the impact of preventive mass vaccination campaigns on yellow fever outbreaks in Africa : a population-level self-controlled case-series study

Author: Arran Hamlet, Hanaya Raad, Tini Garske, Katy A. M. Gaythorpe, Kévin Jean, Daniel R Hogan, Tewodaj Mengistu, Judith E. Mueller, Mounia N. Hocine, Heather Whitaker, Laboratoire Modélisation, épidémiologie et surveillance des risques sanitaires (MESuRS), Conservatoire National des Arts et Métiers [CNAM] (CNAM), Pasteur-Cnam Risques infectieux et émergents (PACRI), Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM), Imperial College London, École des Hautes Études en Santé Publique [EHESP] (EHESP), Chercheur indépendant, Public Health England [London], This work was carried out as part of the Vaccine Impact Modelling Consortium (www.vaccineimpact.org), but the views expressed are those of the authors and not necessarily those of the Consortium or its funders. The funders were given the opportunity to review this paper prior to publication, but the final decision on the content of the publication was taken by the authors. Dr Jean, Mr Hamlet, Dr Gaythorpe, and Dr Garske acknowledge joint Centre funding from the UK Medical Research Council and Department for International Development (MR/R015600/1) and report grant from The Bill & Melinda Gates Foundation (grant number OPP1157270). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript, HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM), and Institut Pasteur [Paris] (IP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)
Subjects: medicine.medical_specialty, Disease surveillance, business.industry, Public health, 030231 tropical medicine, Yellow fever, Outbreak, medicine.disease, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Environmental health, Epidemiology, Pandemic, Cohort, medicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, 030212 general & internal medicine, business, [STAT.ME]Statistics [stat]/Methodology [stat.ME], Cohort study
Abstract: Introduction The Eliminate Yellow fever Epidemics (EYE) strategy was launched in 2017 in response to the resurgence of yellow fever in Africa and the Americas. The strategy relies on several vaccination activities, including preventive mass vaccination campaigns (PMVCs). However, by how much PMVCs are associated with a decreased risk of outbreak to occur has not yet been quantified. Methods and Findings We used the self-controlled case series (SCCS) method to assess the association between the occurrence of yellow fever outbreaks and the implementation of PMVCs at the province level in the African endemic region. As all time-invariant confounders are implicitly controlled for, the SCCS method is an alternative to classical cohort or case-control study designs when the risk of residual confounding is high, in particular confounding by indication. The location and dates of outbreaks were identified from international epidemiological records, and information on PMVCs was provided by coordinators of vaccination activities and international funders. The study sample consisted of provinces that were both affected by an outbreak and targeted for a PMVC between 2005 and 2018. We compared the relative incidence of outbreaks before and after the implementation of a PMVC. The sensitivity of our estimates to a range of assumptions was explored, and the results of the SCCS method were compared to those obtained through a retrospective cohort study design. We further derived the number of yellow fever outbreaks that have been prevented by PMVCs. The study sample consisted of 33 provinces from 11 African countries. Among these, outbreaks occurred during the pre-PMVC period in 26 (79%) provinces versus 7 (21%) occurring in the post-PMVC period. At the province level, the post-PMVC period was associated with a 86% reduction (95% Confidence interval 66% to 94%, p-value A limitation of our study is the fact that it does not account for potential time-varying confounders, such as changing environmental drivers of yellow fever or possibly improved disease surveillance. Conclusion In this study, we provide new empirical evidence of the high preventive impact of PMVCs on yellow fever outbreaks. This study illustrates that the SCCS method can be advantageously applied at the population level in order to evaluate a public health intervention. AUTHOR SUMMARY Why Was This Study Done? Yellow fever is a mosquito-borne vaccine-preventable disease that may cause large urban outbreaks, especially in tropical African regions. Since 2006, Preventive Mass Vaccination Campaigns (PMVCs) have been implemented in many African provinces. These are large scale vaccination campaigns targeting all or most age group in a specific area. The preventive impact PMVCs may have on the risk of yellow fever outbreak has not been quantified yet. What Did the Researchers Do and Find? We used the self-controlled case series (SCCS) method to assess the association between PMVCs and outbreak risk at the province level over 34 African countries between 2005 and 2018. Using this method, we compared pre- and post-PMVC period are compared within each province individually, thus controlling for all possible confounders that do not vary in time, especially the fact that provinces indicated for PMVCs are generally those considered at highest baseline risk of yellow fever (ie confounding by indication). At the province level, we estimated that implementation of PMVCs was associated with an 86% reduction (66% to 94%) in the risk of yellow fever outbreak. Results from a complete cohort analysis provided less reliable results than the SCCS method, likely because of confounding by indication that was not entirely controlled for by adjusting on known drivers of yellow fever. We further estimated that all PMVCs conducted between 2006 and 2018 in Africa may have reduced the total number of yellow fever outbreaks by 34% (22% to 45%). What Do These Findings Mean? These results provide new empirical evidence of the high preventive impact of PMVCs on yellow fever outbreaks. These results may encourage rapid re-scheduling of yellow fever PMVCs that have been postponed due to the COVID-19 pandemic. The SCCS design may be advantageously applied at the population level to assess the impact of public health interventions.
Published: 2020

35. Towards a European Health Union: Time to Level Up

Author: Alberto Alemanno, Ecole des Hautes Etudes Commerciales (HEC Paris), and HEC Paris Research Paper Series
Subjects: EU health, Public administration, 0302 clinical medicine, Emergency Regulation, 030212 general & internal medicine, 050207 economics, media_common, Precautionary principle, 050208 finance, 030503 health policy & services, 05 social sciences, Cost-benefit analysis, EU law, Risk regulation, 3. Good health, Risk vs risk, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law/K.K3.K32 - Environmental, Health, and Safety Law, [SHS.GESTION]Humanities and Social Sciences/Business administration, Health law, 0305 other medical science, Safety Research, tradeoffs, medicine.medical_specialty, Public health law, Economic policy, Supply chain, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law, 03 medical and health sciences, Politics, Blueprint, Political science, 0502 economics and business, medicine, media_common.cataloged_instance, European Union, European union, Worst-case scenarios, Risk Regulation, Suppression, business.industry, Public health, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law/K.K3.K33 - International Law, COVID-19, Consumer protection, Coronavirus, Agriculture, business, Law
Abstract: The European response to COVID-19 has revealed an inconvenient truth. Despite having integrated public health concerns across all its policies – be it agriculture, consumer protection, or security –, the Union cannot directly act to save people’s lives. Only member states can do so. Yet when they adopted unilateral measures to counter the spread of the virus, those proved not only ineffective but also disruptive on vital supply chains, by ultimately preventing the flow of essential goods and people across the Union. These fragmented efforts in tackling cross-border health threats have almost immediately prompted political calls for the urgent creation of a European Health Union. Yet this call raises more questions than answers. With the aim to offer a rigorous and timely blueprint to decision-makers and the public at large, this Special Issue of the European Journal of Risk Regulation contextualizes such a new political project within the broader constitutional and institutional framework of EU public health law and policy. By introducing the Special, this paper argues that unless the envisaged Health Union will tackle the root causes of what prevented the Union from effectively responding to COVID-19 – the divergent health capacity across the Union –, it might fall short of its declared objective of strengthening the EU’resilience for cross-border health threats.
Published: 2020

36. Current use of inotropes in circulatory shock

Author: Michael R. Pinsky, Maria Cronhjort, Thomas Kaufmann, Rupert M Pearse, Ludhmila Abrahão Hajjar, Daniel A. Reuter, Jean Louis Vincent, Daniel De Backer, Martin W. Dünser, Maurizio Cecconi, Xavier Monnet, Iwan C. C. van der Horst, Vanina Siham Kanoore Edul, Bernard Cholley, Claude Martin, Thomas Scheeren, Yasser Sakr, Philippe Vignon, Didier Payen, Olfa Hamzaoui, Bernd Saugel, E. Christiaan Boerma, Pierre Squara, Alexandre Mebazaa, Geert Koster, Djillali Annane, Andrea Morelli, Arnaldo Dubin, Marc Leone, Pierre Asfar, Mervyn Singer, Anthony C. Gordon, Jan Bakker, Antoine Vieillard-Baron, Giovanni Landoni, Michael Sander, Michelle S Chew, Jean-Louis Teboul, Simon T. Vistisen, Glenn Hernandez, Peter Radermacher, Jacques Duranteau, Bruno Levy, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), RS: Carim - V04 Surgical intervention, Intensive Care, MUMC+: MA Medische Staf IC (9), MUMC+: MA Intensive Care (3), University of Groningen [Groningen], University Medical Center Groningen [Groningen] (UMCG), New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU), Columbia University Medical Center (CUMC), Columbia University [New York], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Hôpital Raymond Poincaré [AP-HP], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Medical Centre Leeuwarden, Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed), Linköping University (LIU), 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), Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), Université Paris Cité (UPCité), Karolinska Institutet [Stockholm], Centre Hospitalier Interrégional Edith Cavell (CHIREC), Universidad Nacional de la Plata [Argentine] (UNLP), Johannes Kepler University Linz [Linz] (JKU), Kepler University Hospital, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Imperial College London, Universidade de São Paulo = University of São Paulo (USP), AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pontificia Universidad Católica de Chile (UC), Hospital Juan A. Fernandez [Buenos Aires, Argentina], Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University [Milan, Italie] (UniSR), Hôpital Nord [CHU - APHM], Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Département d’Anesthésie-Réanimation-SMUR [Hôpital Lariboisière], Hôpitaux Universitaire Saint-Louis, Lariboisière, Fernand-Widal, Centre de Référence de l’Hypertension Pulmonaire Sévère [CHU Le Kremlin Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Ecotaxie, microenvironnement et développement lymphocytaire (EMily (UMR_S_1160 / U1160)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Lariboisière-Fernand-Widal [APHP], William Harvey Research Institute, Barts and the London Medical School, Queen Mary University of London (QMUL), University of Pittsburgh Medical Center [Pittsburgh, PA, États-Unis] (UPMC), Universitätsklinikum Ulm - University Hospital of Ulm, University Medical Center Rostock, Jena University Hospital [Jena], Justus-Liebig-Universität Gießen = Justus Liebig University (JLU), Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), University College of London [London] (UCL), Clinique Ambroise Paré [Centres Médico-Chirurgicaux Ambroise Pré, Pierre Cherest, Hartmann], Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Centre d'Investigation Clinique de Limoges (CIC1435), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM), Université libre de Bruxelles (ULB), Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], Aarhus University Hospital, European Society of Intensive Care Medicine, ESICM, This work has received the endorsement of the European Society of Intensive Care Medicine. The authors would like to thank Hannah Wunsch and Anders Perner, who provided their expertise as experts but abstained from being listed as co-author of this paper., HAL UVSQ, Équipe, NIHR, Scheeren, T. W. L., Bakker, J., Kaufmann, T., Annane, D., Asfar, P., Boerma, E. C., Cecconi, M., Chew, M. S., Cholley, B., Cronhjort, M., De Backer, D., Dubin, A., Dunser, M. W., Duranteau, J., Gordon, A. C., Hajjar, L. A., Hamzaoui, O., Hernandez, G., Kanoore Edul, V., Koster, G., Landoni, G., Leone, M., Levy, B., Martin, C., Mebazaa, A., Monnet, X., Morelli, A., Payen, D., Pearse, R. M., Pinsky, M. R., Radermacher, P., Reuter, D. A., Sakr, Y., Sander, M., Saugel, B., Singer, M., Squara, P., Vieillard-Baron, A., Vignon, P., Vincent, J. -L., van der Horst, I. C. C., Vistisen, S. T., and Teboul, J. -L.
Subjects: Inotrope, PDE-inhibitors, Levosimendan, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, GUIDELINES, 0302 clinical medicine, Catecholamines, CARDIAC-OUTPUT SYNDROME, Septic shock, Inotropes, Cardiogenic shock, lcsh:Medical emergencies. Critical care. Intensive care. First aid, Acute circulatory failure, 3. Good health, [SDV] Life Sciences [q-bio], Shock (circulatory), Sepsis, Resuscitation, Vasoactive agents, Cardiac output, medicine.symptom, Life Sciences & Biomedicine, CRITICALLY-ILL PATIENTS, medicine.drug, medicine.medical_specialty, Anestesi och intensivvård, Medicina, Context (language use), VASOPRESSORS, 1117 Public Health and Health Services, 03 medical and health sciences, Critical Care Medicine, acute circulatory failure, cardiac output, cardiogenic shock, catecholamines, inotropes, levosimendan, resuscitation, sepsis, septic shock, vasoactive agents, General & Internal Medicine, Anesthesiology, medicine, Intensive care medicine, METAANALYSIS, Science & Technology, Anesthesiology and Intensive Care, business.industry, Research, 1103 Clinical Sciences, 030208 emergency & critical care medicine, lcsh:RC86-88.9, Guideline, medicine.disease, DYSFUNCTION, CARDIOGENIC-SHOCK, Dobutamine, business
Abstract: Background: Treatment decisions on critically ill patients with circulatory shock lack consensus. In an international survey, we aimed to evaluate the indications, current practice, and therapeutic goals of inotrope therapy in the treatment of patients with circulatory shock. Methods: From November 2016 to April 2017, an anonymous web-based survey on the use of cardiovascular drugs was accessible to members of the European Society of Intensive Care Medicine (ESICM). A total of 14 questions focused on the profile of respondents, the triggering factors, first-line choice, dosing, timing, targets, additional treatment strategy, and suggested effect of inotropes. In addition, a group of 42 international ESICM experts was asked to formulate recommendations for the use of inotropes based on 11 questions. Results: A total of 839 physicians from 82 countries responded. Dobutamine was the first-line inotrope in critically ill patients with acute heart failure for 84% of respondents. Two-thirds of respondents (66%) stated to use inotropes when there were persistent clinical signs of hypoperfusion or persistent hyperlactatemia despite a supposed adequate use of fluids and vasopressors, with (44%) or without (22%) the context of low left ventricular ejection fraction. Nearly half (44%) of respondents stated an adequate cardiac output as target for inotropic treatment. The experts agreed on 11 strong recommendations, all of which were based on excellent (> 90%) or good (81–90%) agreement. Recommendations include the indications for inotropes (septic and cardiogenic shock), the choice of drugs (dobutamine, not dopamine), the triggers (low cardiac output and clinical signs of hypoperfusion) and targets (adequate cardiac output) and stopping criteria (adverse effects and clinical improvement). Conclusion: Inotrope use in critically ill patients is quite heterogeneous as self-reported by individual caregivers. Eleven strong recommendations on the indications, choice, triggers and targets for the use of inotropes are given by international experts. Future studies should focus on consistent indications for inotrope use and implementation into a guideline for circulatory shock that encompasses individualized targets and outcomes., La lista completa de autores que integran el documento puede consultarse en el archivo., Facultad de Ciencias Médicas
Published: 2020

37. Clinical and epidemiological characteristics of 1420 European patients with mild‐to‐moderate coronavirus disease 2019

Author: Lechien, Jerome R., Chiesa‐Estomba, Carlos M., Place, Sammy, Van Laethem, Yves, Cabaraux, Pierre, Mat, Quentin, Huet, Kathy, Plzak, Jan, Horoi, Mihaela, Hans, Stéphane, Rosaria Barillari, Maria, Cammaroto, Giovanni, Fakhry, Nicolas, Martiny, Delphine, Ayad, Tareck, Jouffe, Lionel, Hopkins, Claire, Saussez, Sven, Blecic, Serge, De Siati, Daniele R., Leich, Pierre, Souchay, Christel, Rossi, Camelia, Journe, Fabrice, Hsieh, Julien, Ris, Laurence, El Afia, Fahd, Harmegnies, Bernard, Distinguin, Lea, Chekkoury‐Idrissi, Younes, Circiu, Marta, Lavigne, Philippe, Lopez Delgado, Irene, Calvo‐Henriquez, Christian, Falanga, Chiara, Coppee, Frederique, Le Bon, Serge Daniel, Rodriguez, Alexandra, Dequanter, Didier, Cornelis, Jean‐Philippe, Vergez, Sebastien, Koenen, Lukas, Giuditta, Mannelli, Molteni, Gabriele, Tucciarone, Manuel, Radulesco, Thomas, Khalife, Mohamad, Fourneau, Anne‐Francoise, Cherifi, Soraya, Manto, Mario, Michel, Justin, Mannelli, Giuditta, Cantarella, Giovanna, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Assistance Publique - Hôpitaux de Marseille (APHM), Laboratoire Parole et Langage (LPL), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), We would like to thank Bayesia (BayesiaLab?, Chang?, France) for the Network Analysis, Jean-Louis Vincent and Michel Van Haeverbeek for the review of the paper or their useful comments, the heads of the Hospitals, which have been involved in the study, for their help in the rapid conduction of the study and the agreement of ethics committees, the European Press/Media (i.e. Le Monde, La Libre, Le Soir, MediQuality, MedScape, and Le Specialiste) for their help in the spread of the information about the study, and FRMH & UMONS for the grant and the support., Lechien, J. R., Chiesa-Estomba, C. M., Place, S., Van Laethem, Y., Cabaraux, P., Mat, Q., Huet, K., Plzak, J., Horoi, M., Hans, S., Barillari, M. R., Cammaroto, G., Fakhry, N., Martiny, D., Ayad, T., Jouffe, L., Hopkins, C., Saussez, S., Blecic, S., De Siati, D. R., Leich, P., Souchay, C., Rossi, C., Journe, F., Hsieh, J., Ris, L., El Afia, F., Harmegnies, B., Distinguin, L., Chekkoury-Idrissi, Y., Circiu, M., Lavigne, P., Lopez Delgado, I., Calvo-Henriquez, C., Falanga, C., Coppee, F., Le Bon, S. D., Rodriguez, A., Dequanter, D., Cornelis, J. -P., Vergez, S., Koenen, L., Giuditta, M., Molteni, G., Tucciarone, M., Radulesco, T., Khalife, M., Fourneau, A. -F., Cherifi, S., Manto, M., Michel, J., Mannelli, G., and Cantarella, G.
Subjects: 0301 basic medicine, myalgia, Male, medicine, Original, [SDV]Life Sciences [q-bio], coronavirus, symptoms, Disease, epidemiological, 030204 cardiovascular system & hematology, patients, clinical, Olfaction Disorders, Taste Disorders, 0302 clinical medicine, Epidemiology, Sore throat, Prevalence, Nose, Age Factors, Headache, Middle Aged, 3. Good health, Europe, medicine.anatomical_structure, COVID-19, Female, patient, medicine.symptom, Symptom Assessment, Coronavirus Infections, Sex characteristics, Adult, medicine.medical_specialty, Pneumonia, Viral, 03 medical and health sciences, Betacoronavirus, Sex Factors, Throat, Internal medicine, Internal Medicine, Humans, Pandemics, covid‐19, rhinorrhea, business.industry, SARS-CoV-2, Bayes Theorem, Myalgia, coronaviru, 030104 developmental biology, business
Abstract: International audience; Background: The clinical presentation of European patients with mild-to-moderate COVID-19 infection is still unknown. Objective: To study the clinical presentation of COVID-19 in Europe. Methods: Patients with positive diagnosis of COVID-19 were recruited from 18 European hospitals. Epidemiological and clinical data were obtained through a standardized questionnaire. Bayesian analysis was used for analysing the relationship between outcomes. Results: A total of 1,420 patients completed the study (962 females, 30.7% of healthcare workers). The mean age of patients was 39.17 ± 12.09 years. The most common symptoms were headache (70.3%), loss of smell (70.2%), nasal obstruction (67.8%), cough (63.2%), asthenia (63.3%), myalgia (62.5%), rhinorrhea (60.1%), gustatory dysfunction (54.2%) and sore throat (52.9%). Fever was reported by 45.4%. The mean duration of COVID-19 symptoms of mild-to-moderate cured patients was 11.5 ± 5.7 days. The prevalence of symptoms significantly varied according to age and sex. Young patients more frequently had ear, nose and throat complaints, whereas elderly individuals often presented fever, fatigue and loss of appetite. Loss of smell, headache, nasal obstruction and fatigue were more prevalent in female patients. The loss of smell was a key symptom of mild-to-moderate COVID-19 patients and was not associated with nasal obstruction and rhinorrhea. Loss of smell persisted at least 7 days after the disease in 37.5% of cured patients. Conclusion: The clinical presentation of mild-to-moderate COVID-19 substantially varies according to the age and the sex characteristics of patients. Olfactory dysfunction seems to be an important underestimated symptom of mild-to-moderate COVID-19 that needs to be recognized as such by the WHO.
Published: 2020
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38. Retinal findings in pediatric patients with Usher syndrome Type 1 due to mutations in MYO7A gene

Author: Jaume Català-Mora, Olaia Subirà, Jesús Díaz-Cascajosa, J.M. Caminal, M. A. Claveria, Joan Prat, Natalia Coll-Alsina, Noel Padrón-Pérez, Christine Petit, Crystel Bonnet, L’Hospitalet de Llobregat [Barcelona, Spain], Hospital Sant Joan de Déu [Barcelona], Syndrome de Usher et autres atteintes rétino-cochléaires, Institut de la Vision, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), ED 515 - Complexité du vivant, Université Pierre et Marie Curie - Paris 6 (UPMC), Génétique et Physiologie de l'Audition, Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Chaire Génétique et physiologie cellulaire, Collège de France (CdF (institution)), This work received no funding, We thank the families HEALTH-F2-2010-242013 (TREATRUSH). We also thank Bradley Londres for editing and improving the use of English in this document and Dr. Anne Kurtenbach for her critical review and comments of this paper., Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), and Collège de France - Chaire Génétique et physiologie cellulaire
Subjects: Male, medicine.medical_specialty, Visual acuity, Adolescent, genetic structures, MYO7A, Usher syndrome, [SDV]Life Sciences [q-bio], Visual Acuity, Retina, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Ophthalmology, Medicine, Humans, Fluorescein Angiography, External limiting membrane, Child, Melanosome, Retrospective Studies, Retinal pigment epithelium, business.industry, Usher Syndrome Type 1, Retinal, medicine.disease, eye diseases, medicine.anatomical_structure, chemistry, Child, Preschool, Myosin VIIa, Mutation, 030221 ophthalmology & optometry, Female, sense organs, medicine.symptom, business, Usher Syndromes, 030217 neurology & neurosurgery, Tomography, Optical Coherence
Abstract: International audience; Purpose: To describe retinal alterations detected by swept-source optical coherence tomography (SS-OCT) in paediatric patients with Usher syndrome type 1 (USH1) and to compare these findings to previously published reports.Methods: Thirty-two eyes from 16 patients (11 males and 5 females) with a genetic diagnosis of USH1 because of MYO7A mutations underwent SS-OCT. Patients ranged in age from 4 to 17 years (mean, 11,13 ± 4,29). The subfoveal and macular area were analysed with SS-OCT at 1050 nm using 12 radial scans of 12.0 mm. Structural abnormalities were evaluated and correlated with best-corrected visual acuity (BCVA).Results: The most common qualitative retinal abnormality was external layer damage in macular area. Specific alterations included external limiting membrane loss/disruption (27 eyes; 84.4%), disruption of the Myoid zone (27 eyes; 84.4%); Ellipsoid zone disruption (28 eyes; 87.5%), and loss of the outer segments (29 eyes; 90.6%). The damage of the retinal pigment epithelium was divided according to the loss of the different layers: phagosome zone (30 eyes; 93.8%), melanosome zone (29 eyes; 90.6%) and mitochondria zone (0 eyes; 0%). The presence of cystoid macular oedema (CMO) was significantly correlated with alterations in photoreceptors. Disruption or absence of the myoid and ellipsoid zones of the photoreceptors were the only variables independently associated with decreased BCVA.Conclusions: The findings of this study suggest that the physiopathologic basis of early-stage Usher syndrome (USH) may be changes in the outer retinal layer, particularly the photoreceptors, which in turn may cause alterations-such as CMO-in the inner retinal layers. Accordingly, monitoring the condition of photoreceptors during follow-up may be advisable for the early detection of pathologic changes.
Published: 2020

39. Les professionnels de santé face à la pandémie de la maladie à coronavirus (COVID-19) : quels risques pour leur santé mentale ?

Author: Nefize Yalin, Frank Bellivier, Alessandro Colasanti, Bruno Étain, Tim Mantingh, Paul R. A. Stokes, Jean-Pierre Kahn, Chantal Henry, Marion Leboyer, Rashmi Patel, Allan H. Young, King‘s College London, Bethlem Royal Hospital [London], Brighton and Sussex Medical School (BSMS), Hôpitaux Universitaire Saint-Louis, Lariboisière, Fernand-Widal, Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Fondation FondaMental [Créteil], IMRB - 'Neuropsychiatrie translationnelle' [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), Hôpital Henri Mondor, Perception et Mémoire / Perception and Memory, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Psychothérapique de Nancy [Laxou] (CPN), This paper represents independent research supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Authors from France acknowledge the support provided by INSERM (Research Protocol C0829), Assistance Publique des Hôpitaux de Paris (Research Protocol GAN12)., Etain, Bruno, and Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)
Subjects: MESH: United Kingdom, Identification, MESH: Protective Devices, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, 0302 clinical medicine, MESH: Risk Factors, MESH: Bipolar Disorder, London, Medicine, MESH: Tobacco, Psychotic illness, MESH: Workload, education.field_of_study, MESH: Sleep Wake Disorders, Mania, Psychiatry and Mental health, Clinical Psychology, Characteristics, MESH: Stress Disorders, Post-Traumatic, MESH: Young Adult, Cohort, cardiovascular system, behavior and behavior mechanisms, France, medicine.symptom, MESH: Uncertainty, MESH: Occupational Diseases, medicine.medical_specialty, MESH: Pandemics, Clinical variables, MESH: Sleep, Bipolar disorder, Population, MESH: Social Support, MESH: Mania, Unipolar mania, behavioral disciplines and activities, 03 medical and health sciences, MESH: Infectious Disease Transmission, Patient-to-Professional, MESH: Severe Acute Respiratory Syndrome, mental disorders, Humans, MESH: SARS-CoV-2, education, Psychiatry, MESH: Work Schedule Tolerance, MESH: Helplessness, Learned, MESH: Humans, business.industry, MESH: Influenza Pandemic, 1918-1919, MESH: Retrospective Studies, MESH: London, medicine.disease, United Kingdom, MESH: Quantitative Trait Loci, MESH: Prospective Studies, 030227 psychiatry, MESH: France, Case register, MESH: Suicide, MESH: Pneumonia, Viral, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Matched group, RC0321, MESH: Resilience, Psychological, business, 030217 neurology & neurosurgery
Abstract: Background: Unipolar mania is a putative subtype of bipolar disorder (BD) in which individuals experience recurrent manic but not major depressive episodes. Few studies of unipolar mania have been conducted in developed countries and none in the UK. This study aimed to identify and characterise people with unipolar mania in the UK and France. \ud \ud Methods: People with unipolar mania were ascertained using a South London UK electronic case register and a French BD case series. Each unipolar mania group was compared to a matched group of people with BD who have experienced depressive episodes. \ud \ud Results: 17 people with unipolar mania were identified in South London and 13 in France. The frequency of unipolar mania as a percentage of the BD clinical population was 1.2% for the South London cohort and 3.3% for the French cohort. In both cohorts, people with unipolar mania experienced more manic episodes than people with BD, and in the French cohort were more likely to experience a psychotic illness onset and more psychiatric admissions. Treatment characteristics of people with unipolar mania were similar to people with BD except that the unipolar mania group was less likely to be treated with antidepressants. \ud \ud Limitations: The relatively small number of people with unipolar mania identified by this study limits its power to detect differences in clinical variables. \ud \ud Conclusions: People with unipolar mania can be identified in France and the UK, and they may experience a higher frequency of manic episodes but have similar treatment characteristics to people with BD.
Published: 2020

40. Evolution and characteristics of the use of valproate in women of childbearing age with bipolar disorder: Results from the FACE-BD cohort

Author: Nicolas Mazer, Christine Passerieux, Bruno Etain, Valerie Aubin, S Gard, Joséphine Loftus, Raoul Belzeaux, Pierre-Michel Llorca, F Poinso, Thomas Schwitzer, Ludovic Samalin, Paul Roux, Bruno Aouizerate, A. Pelletier, Ophélia Godin, Emmanuel Haffen, Emilie Olié, Caroline Dubertret, Raymund Schwan, Marion Leboyer, C. Henry, P. Courtet, Thierry Bougerol, Franck Bellivier, Mircea Polosan, L Encely, Djamila Bennabi, Fondation FondaMental [Créteil], Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Psychiatrie et Neurologie personnalisées [AP-HP Hôpital Henri-Mondor] (DHU PePsy), Hôpital Henri Mondor, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Psychiatrie et de Médecine Addictologique [AP-HP, GH Saint-Louis-Lariboisière-F.Widal], AP-HP Hôpitaux universitaires Saint-Louis, Lariboisière, Fernand-Widal, GHU Paris Psychiatrie et Neurosciences, Service de Psychiatrie [CHU Mondor], Institut de Neurosciences de la Timone (INT), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Laboratoire de recherches cliniques et en santé publique sur les handicaps psychique, cognitif et moteur (HANDIReSP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Hospitalier Princesse Grace de Monaco (CHPG), Monaco, Laboratoire de Neurosciences Intégratives et Cliniques - UFC (EA 481) (NEURO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), [GIN] Grenoble Institut des Neurosciences (GIN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Centre Psychothérapique de Nancy-Unité D, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Hôpital psychiatrique de Nancy, Nutrition et Neurobiologie intégrée (NutriNeuro), Université de Bordeaux (UB)-Institut Polytechnique de Bordeaux-Ecole nationale supérieure de chimie, biologie et physique-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Charles Perrens, Ministère des Affaires Sociales et de la Santé ANR-10-COHO-10-01 Institut National de la Santé et de la Recherche Médicale, Inserm Assistance Publique - Hôpitaux de Paris, AP-HP, This multicenter, cross-sectional study included patients recruited into the FACE-BD (FondaMental Academic Centers of Expertise for Bipolar Disorders) cohort between June 2009 and June 2018. The FACE-BD cohort is based on a French national network of 12 BD Expert Centers (Besançon, Bordeaux, Clermont-Ferrand, Créteil, Colombes, Grenoble, Marseille, Monaco, Montpellier, Nancy, Paris and Versailles). This network was set up by the FondaMental Foundation ( www.fondation-fondamental.org ) and funded by the French Ministry of Research and the French Ministry of Health to build an infrastructure and to provide resources to follow clinical cohorts and comparative-effectiveness research on a patient population. This cohort and the clinical variables have been extensively described in a previous paper ( Henry et al., 2015 )., This work was funded by AP-HP (Assistance Publique des Hôpitaux de Paris), by the Fondation FondaMental (RTRS Santé Mentale), by the Investissements d'Avenir program, by the ANR under reference ANR-11-IDEX-0004-02 and ANR-10-COHO-10-01, and by INSERM (Institut National de la Santé et de la Recherche Médicale). This funding source had no role in the study design, data collection, analysis, preparation of the manuscript, or decision to submit the manuscript for publication., Aix Marseille Université (AMU), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Neurosciences Intégratives et Cliniques - UFC (UR 481) (NEURO), and Centre hospitalier Charles Perrens [Bordeaux]
Subjects: Adult, Pediatrics, medicine.medical_specialty, Adolescent, Bipolar disorder, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Logistic regression, National cohort, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, medicine, Anticonvulsant, Humans, 030212 general & internal medicine, Medical prescription, Women of childbearing age, ComputingMilieux_MISCELLANEOUS, Valproate, business.industry, Valproic Acid, Middle Aged, medicine.disease, 3. Good health, Affect, Psychiatry and Mental health, Clinical Psychology, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Childbearing age, Cohort, Female, business, 030217 neurology & neurosurgery
Abstract: International audience; Background: Valproate is associated with teratogenic and neurodevelopmental effects. Several agencies have restricted the conditions of its prescription in bipolar disorders (BD). We aimed to assess the evolution of valproate prescription and the clinical profile of BD women of childbearing age receiving valproate. Methods: Based on a large national cohort, we included all BD women 16–50 years old. Sociodemographic, clinical and pharmacological data were recorded. Logistic regression analyses were used to describe variables associated with valproate prescription. Results: Of the 1018 included women 16–50 years old, 26.9% were treated with valproate with a mean daily dosage of 968 mg. The prevalence of BD women using valproate was 32.6% before May 2015 and 17.3% after May 2015 (p
Published: 2020

41. The European Response to COVID19: From Regulatory Emulation to Regulatory Coordination?

Author: Alberto Alemanno, Haldemann, Antoine, Groupement de Recherche et d'Etudes en Gestion à HEC (GREGH), Ecole des Hautes Etudes Commerciales (HEC Paris)-Centre National de la Recherche Scientifique (CNRS), and HEC Research Paper Series
Subjects: Risk analysis, medicine.medical_specialty, Scrutiny, Coronavirus disease 2019 (COVID-19), International trade, Precautionary principle, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law, Competence (law), 03 medical and health sciences, 0302 clinical medicine, Emergency Regulation, Political science, 050602 political science & public administration, medicine, media_common.cataloged_instance, 030212 general & internal medicine, European union, Worst-case scenarios, media_common, Emulation, Risk Regulation, Suppression, business.industry, Public health, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law/K.K3.K33 - International Law, 05 social sciences, Cost-benefit analysis, EU law, COVID-19, Articles, 0506 political science, Coronavirus, Flatten the Curve, Action (philosophy), Risk vs risk, JEL: K - Law and Economics/K.K3 - Other Substantive Areas of Law/K.K3.K32 - Environmental, Health, and Safety Law, [SHS.GESTION]Humanities and Social Sciences/Business administration, business, [SHS.GESTION] Humanities and Social Sciences/Business administration, Safety Research, Law, tradeoffs
Abstract: COVID-19 is a matter of common European interest since its very first detection on the continent. Yet this pandemic outbreak has largely been handled as an essentially national matter.This article makes a first attempt at unpacking how such fragmented, uncoordinated national responses to COVID19 came into being under the EU legal order. To do so, it systematizes the European response into separate stages. Phase 1 – the emergency – has been characterized by the adoption of national emergency risk management measures that, albeit country specific, were inspired by a common objective of pandemic suppression, i.e. to reduce disease transmission and thereby diminishing pressure on health services, under the by now well-known ‘flatten the curve’ imperative. Phase 2 – the lifting – is about the attempt at relaxing some of the national risk responses in a coordinated fashion to avoid creating negative spillovers or distortions – be they sanitary and/or financial – across the Union.The article argues that contrary to conventional wisdom the resulting uncoordinated EU response to Covid-19 shouldn’t be seen as the inevitable consequence of the EU’s limited competence in public health. Against this backdrop, it strives to define the regulatory policy framework that might be governing the next phases of the European risk management response to this pandemic as they will emerge from a widely undefined yet unescapable dialectic between the Union and its member states. Ultimately, it predicts that by testing the outer limits of the EU public health competence COVID-19 is set to go down in history as a major catalyst in the advancement of EU health emergency action.
Published: 2020

42. Otolaryngological complications of hypopharyngeal-esophageal multichannel intraluminal impedance-pH monitoring

Author: Francois Bobin, Jerome R. Lechien, Sven Saussez, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Foch [Suresnes], and C. Knuts (native speaker (United States)) for the proofreading of the paper. Published with written consent of the patient.
Subjects: Impedance–pH monitoring, Medicine (General), medicine.medical_specialty, Laryngology, [SDV]Life Sciences [q-bio], education, Case Report, complication, Case Reports, 030204 cardiovascular system & hematology, Ph monitoring, 03 medical and health sciences, Laryngopharyngeal reflux, R5-920, 0302 clinical medicine, medicine, otorhinolaryngologic diseases, Nose, health care economics and organizations, business.industry, pH monitoring, Reflux, General Medicine, respiratory system, medicine.disease, digestive system diseases, testing, 3. Good health, laryngopharyngeal, medicine.anatomical_structure, 030220 oncology & carcinogenesis, impedance, Medicine, lipids (amino acids, peptides, and proteins), Radiology, reflux, business
Abstract: Probe of pH study may kink in the esophagus leading to nasal symptoms during the removal.
Published: 2020

43. The coming age of flavonoids in the treatment of diabetic complications

Author: Gema Marín-Royo, Carmen Gomez-Guerrero, Lucas Opazo-Ríos, Luna Jimenez-Castilla, Jesús Egido, Teresa Caro-Ordieres, Juan Antonio Moreno, Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD), UAM. Departamento de Medicina, Instituto de Investigación Sanitaria Fundación Jiménez Díaz (ISS-FJD), [Caro-Ordieres,T] Research Discovery and Innovation Department, FAES FARMA, S.A, Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country, Leioa (Bizkaia), Spain. [Marín-Royo,G, Opazo-Ríos,L, Jiménez-Castilla,L, Gómez-Guerrero,C, Egido,J] Renal, Vascular and Diabetes Research Laboratory, IIS-Fundación Jiménez Díaz, Universidad Autonoma de Madrid, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Madrid, Spain. [Moreno,JA] Department of Cell Biology, Physiology and Immunology, University of Córdoba, Córdoba, Spain. [Moreno,JA] Maimonides Biomedical Research Institute of Cordoba (IMIBIC), University of Córdoba, Córdoba, Spain. [Moreno,JA] Hospital Universitario Reina Sofía, Córdoba, Spain., and This paper was not funded. The authors work has been supported by FEDER-ISCIII Funds (PI17/00130, PI17/01495), Spanish Ministry of Economy and Competitiveness (RTI2018-098788-B-100, DTS17/00203, DTS19/00093, RYC-2017-22369), Spanish Society of Cardiology (SEC), Spanish Society of Nephrology (SEN) and Spanish Society of Atherosclerosis (SEA). TCO is an employee of FAES Pharma. The authors (except JAM) have an ongoing research project in common with FAES Pharma on Flavonoids in diabetic complications under the auspices of the joint-RETOS Collaborations Project 2017 (RTC-2017-6089-1), program supported by Spanish Ministry of Economy and Competitiveness. No other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Subjects: medicine.medical_specialty, Microvascular complications, Nefropatías Diabéticas, Medicina, Terapéutica, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics [Medical Subject Headings], lcsh:Medicine, Diseases::Endocrine System Diseases::Diabetes Mellitus::Diabetes Complications::Diabetic Nephropathies [Medical Subject Headings], Review, Diabetic nephropathy, Therapeutics, Controlled studies, Chemicals and Drugs::Heterocyclic Compounds::Pyrans::Benzopyrans::Chromones::Flavonoids [Medical Subject Headings], Unmet needs, 03 medical and health sciences, Diabetes mellitus, 0302 clinical medicine, medicine, Flavonoides, Phenomena and Processes::Metabolic Phenomena::Metabolism::Oxidative Stress [Medical Subject Headings], Intensive care medicine, Diseases::Cardiovascular Diseases [Medical Subject Headings], Beneficial effects, Enfermedades Cardiovasculares, 030304 developmental biology, Flavonoids, Inflammation, 0303 health sciences, Inflamación, Diseases::Endocrine System Diseases::Diabetes Mellitus [Medical Subject Headings], business.industry, lcsh:R, Diabetes, General Medicine, medicine.disease, Cardiovascular disease, Clinical trial, Clinical research, Tolerability, Oxidative stress, 030220 oncology & carcinogenesis, business, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Inflammation [Medical Subject Headings], Estrés Oxidativo
Abstract: Diabetes mellitus (DM), and its micro and macrovascular complications, is one of the biggest challenges for world public health. Despite overall improvement in prevention, diagnosis and treatment, its incidence is expected to continue increasing over the next years. Nowadays, finding therapies to prevent or retard the progression of diabetic complications remains an unmet need due to the complexity of mechanisms involved, which include inflammation, oxidative stress and angiogenesis, among others. Flavonoids are natural antioxidant compounds that have been shown to possess anti-diabetic properties. Moreover, increasing scientific evidence has demonstrated their potential anti-inflammatory and anti-oxidant effects. Consequently, the use of these compounds as anti-diabetic drugs has generated growing interest, as is reflected in the numerous in vitro and in vivo studies related to this field. Therefore, the aim of this review is to assess the recent pre-clinical and clinical research about the potential effect of flavonoids in the amelioration of diabetic complications. In brief, we provide updated information concerning the discrepancy between the numerous experimental studies supporting the eficacy of flavonoids on diabetic complications and the lack of appropriate and well-designed clinical trials. Due to the well-described beneficial effects on different mechanisms involved in diabetic complications, the excellent tolerability and low cost, future randomized controlled studies with compounds that have adequate bioavailability should be evaluated as add-on therapy on well-established anti-diabetic drugs, This paper was not funded. The authors work has been supported by FEDER-ISCIII Funds (PI17/00130, PI17/01495), Spanish Ministry of Economy and Competitiveness (RTI2018-098788-B-100, DTS17/00203, DTS19/00093, RYC-2017-22369), Spanish Society of Cardiology (SEC), Spanish Society of Nephrology (SEN) and Spanish Society of Atherosclerosis (SEA). TCO is an employee of FAES Pharma. The authors (except JAM) have an ongoing research project in common with FAES Pharma on Flavonoids in diabetic complications under the auspices of the joint-RETOS Collaborations Project 2017 (RTC-2017-6089-1), program supported by Spanish Ministry of Economy and Competitiveness.
Published: 2020

44. Use of nonsteroidal anti-inflammatory drugs and breast cancer risk in a prospective cohort of postmenopausal women

Author: Agnès Fournier, Marc J. Gunter, Gianluca Severi, Manon Cairat, Laure Dossus, Marie Al Rahmoun, Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France, International Agency for Cancer Research (IACR), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Institut Gustave Roussy (IGR), Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), Ligue Contre le Cancer Mutuelle Générale de l'Education Nationale, MGEN Institut Gustave-Roussy Institut National de la Santé et de la Recherche Médicale, Inserm, Ligue Contre le Cancer (support for the E3N cohort and PhD fellowship to Manon Cairat). Acknowledgements Disclaimer, and The research was carried out using data from the Inserm (French National Institutes for Health and Medical Research) E3N cohort, which was established and maintained with the support of the Mutuelle Générale de l’Education Nationale (MGEN), Gustave Roussy, and the French League against Cancer (LNCC). We are grateful to the study participants for their continued participation and to medical practitioners for providing pathology reports. We also thank all members of the E3N-EPIC study group, in particular Rafika Chaït, Ghizlane Esselma, Marie Fangon, Pascale Gerbouin-Rérolle, Lyan Hoang, Roselyn Gomes and the data management team, and Amandine Gelot for data management and/or technical assistance. The work reported in this paper was performed during Agnès Fournier’s term as a Visiting Scientist at the International Agency for Research on Cancer.
Subjects: medicine.medical_specialty, Proton pump inhibitors, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Comorbidity, Lower risk, lcsh:RC254-282, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Risk Factors, Surveys and Questionnaires, Internal medicine, medicine, Humans, Medical history, Prospective Studies, Prospective cohort study, Aged, Proportional Hazards Models, 030304 developmental biology, 0303 health sciences, Aspirin, business.industry, Proportional hazards model, Incidence, Incidence (epidemiology), Anti-Inflammatory Agents, Non-Steroidal, Hazard ratio, Nonsteroidal anti-inflammatory drugs, Middle Aged, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Postmenopausal women, 3. Good health, Postmenopause, 030220 oncology & carcinogenesis, Female, France, business, Research Article, Cohort study
Abstract: BackgroundAlthough anti-inflammatory agents could theoretically have anticancer properties, results from cohort studies on nonsteroidal anti-inflammatory drugs (NSAIDs) and breast cancer (BC) risk are inconsistent.MethodsWe investigated the association between NSAID use and BC incidence in the French E3N prospective cohort, which includes 98,995 women born between 1925 and 1950 and insured by a health insurance plan that covers mostly teachers. Self-reported information on lifestyle and medical history has been collected biennially by questionnaires and matched with data from a drug reimbursement database covering the period 2004–2014. Women who self-reported current NSAID use in the 2000 or 2002 questionnaires or with at least two reimbursements in any previous 3-month period were defined as exposed to NSAIDs. Multivariable Cox regression models were used to estimate hazard ratios (HRs) for the association of NSAID use with BC risk.ResultsIn the current analysis, 62,512 postmenopausal women were followed between 2004 and 2014 (9 years on average, starting at a mean age of 63 years; 2864 incident BC). In multivariable models, there was no statistically significant association between NSAID use and BC risk [HR = 1.00 (0.92–1.08), compared with non-exposed women]. The NSAID-BC associations did not differ by NSAID types, BC subtypes, risk factors, and comorbidities, nor by duration and dose of use. However, a statistically significant interaction was observed by proton pump inhibitor (PPI) drug use (Pinteraction = 0.01) whereby a decreased risk of BC with NSAID use was only observed among women who also used PPI before.ConclusionOnly women who used NSAIDs after having used PPI had a lower risk of BC. This result is novel and requires replication in other studies.
Published: 2020

45. Long-term risk of stroke and its predictors in transient ischaemic attack patients in Germany

Author: Karel Kostev, Louis Jacob, Christian Tanislav, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), and The authors have received no financial support for the research, authorship and/or publication of this paper.
Subjects: Male, associated predictors, Cohort Studies, 0302 clinical medicine, general practices, Germany, Atrial Fibrillation, 030212 general & internal medicine, Stroke, Aged, 80 and over, Incidence, Hazard ratio, Age Factors, Atrial fibrillation, Middle Aged, stroke, 3. Good health, Neurology, Ischemic Attack, Transient, Hypertension, Cohort, Platelet aggregation inhibitor, Female, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Risk, medicine.medical_specialty, transient ischaemic attack, 03 medical and health sciences, Sex Factors, Diabetes mellitus, Internal medicine, parasitic diseases, medicine, Humans, long-term risk, In patient, cardiovascular diseases, Aged, Ischemic Stroke, business.industry, Anticoagulants, Protective Factors, medicine.disease, nervous system diseases, Long term risk, Neurology (clinical), business, Platelet Aggregation Inhibitors, 030217 neurology & neurosurgery
Abstract: International audience; Background and purpose: Little is known about the long-term association between transient ischaemic attack (TIA) and stroke. Therefore, the goal of this study was to analyze the long-term risk of stroke and associated predictors in a large cohort of TIA patients followed in general practices in Germany. Methods: This study included patients with an initial TIA diagnosis and subsequently followed up in one of 1262 general practices in Germany between January 2007 and December 2016 (N = 19 824 patients). The primary outcome of the study was the risk of ischaemic stroke within 10 years of the initial diagnosis of TIA. The secondary outcome was the identification of demographic, clinical and pharmaceutical variables significantly associated with stroke in TIA patients. Results: Within 10 years of the initial TIA diagnosis, 18.3% of individuals were diagnosed with stroke. Age was positively associated with stroke, with hazard ratios ranging from 1.88 in patients aged 51–60 years to 4.00 in those aged >80 years (reference group: patients aged ≤50 years). Furthermore, male sex, hypertension, diabetes mellitus, atrial fibrillation and ischaemic heart diseases had an additional impact on the risk of stroke. Finally, new oral anticoagulants, heparins, diuretics, angiotensin II receptor blockers and platelet aggregation inhibitors were identified as protective factors. Conclusions: In a cohort of almost 20 000 TIA patients, 18.3% were diagnosed with stroke within 10 years after the TIA index event. Several demographic, clinical and pharmaceutical variables significantly predicted the long-term risk of stroke in TIA patients.
Published: 2020

46. Consumption of Fish and ω-3 Fatty Acids and Cancer Risk: An Umbrella Review of Meta-Analyses of Observational Studies

Author: Hans Oh, Mingyang Song, Jae Il Shin, Ai Koyanagi, Louis Jacob, Andreas Kronbichler, Gaeun Kim, Michael Eisenhut, Eun Kyoung Choi, Sun Jae Jung, Lin Yang, Marco Solmi, Gwang Hun Jeong, Eunyoung Jung, Brendon Stubbs, Keum Hwa Lee, Eunyoung Cho, Joaquim Radua, Edward Giovannucci, NaNa Keum, Hyo Jin Seong, Nicola Veronese, Hyunbong Park, Lee Smith, Gabriele Gamerith, Giuseppe Grosso, Trevor Thompson, Elena Dragioti, Sarah E Jackson, Leandro Fórnias Machado de Rezende, Shuji Ogino, Jong Yeob Kim, Hans van Vliet, Sung Hwi Hong, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), South London and Maudsley NHS Foundation Trust National Institute for Health Research, NIHR NIHR Collaboration for Leadership in Applied Health Research and Care South London National Institutes of Health, NIH: R35 CA197735 Maudsley Charity King’s College London National Institutes of Health, NIH: R35 CA197735, KHL, HJS, GK, GHJ, and JYK contributed equally to this work. The authors report no funding received for this study. Author Disclosures: The authors report no conflicts of interest. BS is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR), is in part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust, and is also supported by the Maudsley Charity, King’s College London, and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. The time effort of SO was in part supported by US National Institutes of Health grant R35 CA197735. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions. Address correspondence to JIS (e-mail: shinji@yuhs.ac) or EKC (e-mail: ekchoi@yuhs.ac). Supplemental Table 1 is available from the 'Supplementary data'link in the online posting of the article and from the same link in the online table of contents at https://academic.oup.com/advances. Abbreviation used: ALA, α-linolenic acid, AMSTAR2, A Measurement Tool to Assess Systematic Reviews 2, CUP, Continuous Update Project, DPA, docosapentaenoic acid, GRADE, Grading of Recommendations Assessment, Development and Evaluation, HCC, hepatocellular carcinoma, NA, not assessable, PI, prediction interval, PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, WCRF/AICR, Word Cancer Research Fund/American Institute for Cancer Research., The time effort of SO was in part supported by US National Institutes of Health grant R35 CA197735., Lee, K.H., Seong, H.J., Kim, G., Jeong, G.H., Kim, J.Y., Park, H., Jung, E., Kronbichler, A., Eisenhut, M., Stubbs, B., Solmi, M., Koyanagi, A., Hong, S.H., Dragioti, E., De Rezende, L.F.M., Jacob, L., Keum, N., Van Der Vliet, H.J., Cho, E., Veronese, N., Grosso, G., Ogino, S., Song, M., Radua, J., Jung, S.J., Thompson, T., Jackson, S.E., Smith, L., Yang, L., Oh, H., Choi, E.K., Shin, J.I., Giovannucci, E.L., and Gamerith, G.
Subjects: Male, Risk, Oncology, medicine.medical_specialty, [SDV]Life Sciences [q-bio], BF, Medicine (miscellaneous), Review, Cohort Studies, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Breast cancer, ω-3 fatty acid, Meta-Analysis as Topic, Neoplasms, Internal medicine, Fatty Acids, Omega-3, medicine, Animals, Humans, cancer, 030212 general & internal medicine, ω-3 fatty acid, fish, cancer, umbrella review, meta-analysis, chemistry.chemical_classification, fish, Nutrition and Dietetics, umbrella review, business.industry, Endometrial cancer, Fishes, Fatty acid, Cancer, medicine.disease, R1, 3. Good health, meta-analysis, Observational Studies as Topic, chemistry, Case-Control Studies, 030220 oncology & carcinogenesis, Meta-analysis, Female, Skin cancer, business, Liver cancer, Food Science
Abstract: Multiple studies have suggested that ω-3 fatty acid intake may have a protective effect on cancer risk; however, its true association with cancer risk remains controversial. We performed an umbrella review of meta-analyses to summarize and evaluate the evidence for the association between ω-3 fatty acid intake and cancer outcomes. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews from inception to December 1, 2018. We included meta-analyses of observational studies that examined associations between intake of fish or ω-3 fatty acid and cancer risk (gastrointestinal, liver, breast, gynecologic, prostate, brain, lung, and skin) and determined the level of evidence of associations. In addition, we appraised the quality of the evidence of significant meta-analyses by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We initially screened 598 articles, and 15 articles, including 57 meta-analyses, were eligible. Among 57 meta-analyses, 15 reported statistically significant results. We found that 12 meta-analyses showed weak evidence of an association between ω-3 fatty acid intake and risk of the following types of cancer: liver cancer (n = 4 of 6), breast cancer (n = 3 of 14), prostate cancer (n = 3 of 11), and brain tumor (n = 2 of 2). In the other 3 meta-analyses, studies of endometrial cancer and skin cancer, there were no assessable data for determining the evidence levels. No meta-analysis showed convincing, highly suggestive, or suggestive evidence of an association. In the sensitivity analysis of meta-analyses by study design, we found weak associations between ω-3 fatty acid intake and breast cancer risk in cohort studies, but no statistically significant association in case-control studies. However, the opposite results were found in case of brain tumor risk. Although ω-3 fatty acids have been studied in several meta-analyses with regard to a wide range of cancer outcomes, only weak associations were identified in some cancer types, with several limitations. Considering the nonsignificant or weak evidence level, clinicians and researchers should cautiously interpret reported associations between ω-3 fatty acid consumption and cancer risks. Copyright © 2020 The Author(s) on behalf of the American Society for Nutrition.
Published: 2020

47. Risk factors for bronchiolitis hospitalization in infants: A French nationwide retrospective cohort study over four consecutive seasons (2009-2013)

Author: Jean-Christophe Rozé, Jean-Michel Hascoet, Jean-François Magny, Pierre-Henri Jarreau, Brigitte Fauroux, Elie Saliba, Michaël Schwarzinger, Sommeil-Vigilance-Fatigue et Santé Publique (VIFASOM (URP_7330)), Institut de Recherche Biomédicale des Armées (IRBA)-Université Paris Cité (UPCité), Unité Pédiatrique de Ventilation Non Invasive et de Sommeil [CHU Necker Enfants-Malades], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Maternité Régionale Adolphe Pinard [Nancy], Développement, Adaptation et Handicap. Régulations cardio-respiratoires et de la motricité (DevAH), Université de Lorraine (UL), Université Paris Cité (UPCité), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier universitaire de Nantes (CHU Nantes), Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Translational Health Economics Network [Paris] (THEN), Sorbonne Université (SU), The present study was supported by AbbVie France. Translational Health Economics (THEN) was responsible for data collection, preparation, and validation with external sources of information. THEN received payment from AbbVie for these activities. Writing charges were funded by AbbVie France, and AbbVie approved the decision to submit the paper for publication, but the corresponding author was ultimately responsible for submitting the manuscript for publication., HASCOET, JEAN-MICHEL, Service d'assistance respiratoire et sommeil de l'enfant [CHU Necker], Sommeil-Vigilance-Fatigue et Santé Publique (VIFASOM - EA 7330), Institut de Recherche Biomédicale des Armées (IRBA)-Université de Paris (UP), Regional Maternity [Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Université de Lorraine (UL), Université de Paris (UP), Department of Neonatal Medicine of Port-Royal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Cochin [AP-HP], Neonatal Intensive Care Unit of Port-Royal [Paris], Department of Neonatology [Paris], Department of Neonatology [Nantes], Department of Neonatology [Tours], Hôpital Gatien de Clocheville [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Université Paris Diderot - Paris 7 (UPD7), Université Sorbonne Paris Cité (USPC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
Subjects: Male, Pediatrics, Pulmonology, Epidemiology, Physiology, Cell Transplantation, Comorbidity, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Families, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine and Health Sciences, Morphogenesis, Blood and Lymphatic System Procedures, Birth Weight, 030212 general & internal medicine, Children, education.field_of_study, Multidisciplinary, Congenital Heart Defects, Hospitals, 3. Good health, Hospitalization, Physiological Parameters, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Bronchiolitis, Medicine, Female, France, Seasons, Infants, Research Article, medicine.medical_specialty, Down syndrome, Science, Population, Cardiology, Surgical and Invasive Medical Procedures, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, 030225 pediatrics, Internal medicine, Congenital Disorders, medicine, Humans, Birth Defects, education, Transplantation, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Omphalocele, business.industry, Body Weight, Infant, Biology and Life Sciences, Retrospective cohort study, medicine.disease, Health Care, Bronchopulmonary dysplasia, Age Groups, Health Care Facilities, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Medical Risk Factors, People and Places, Respiratory Infections, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Population Groupings, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Developmental Biology, Stem Cell Transplantation
Abstract: International audience; Objectives: Large studies are needed to update risk factors of bronchiolitis hospitalization. We performed a nationwide analysis of hospitalization rates for bronchiolitis over four consecutive bronchiolitis seasons to identify underlying medical disorders at risk of bronchiolitis hospitalization and assess their frequency.Methods: Data were retrieved from the French National Hospital Discharge database. Of all infants discharged alive from maternity wards from January 2008 to December 2013 in France (N = 3,884,791), we identified four consecutive cohorts at risk of bronchiolitis during the seasons of 2009–2010 to 2012–2013. The main outcome was bronchiolitis hospitalization during a season. Individual risk factors were collected.Results: Among infants, 6.0% were preterm and 2.0% had ≥1 chronic condition including 0.2% bronchopulmonary dysplasia (BPD) and 0.2% hemodynamically significant congenital heart disease (HS-CHD). Bronchiolitis hospitalization rates varied between seasons (min: 1.26% in 2010–2011; max: 1.48% in 2012–2013; p
Published: 2020

48. Potential of Aedes albopictus and Aedes aegypti (Diptera: Culicidae) to transmit yellow fever virus in urban areas in Central Africa

Author: Basile Kamgang, Aurelie P. Yougang, Theodel A. Wilson-Bahun, Armel N. Tedjou, Charles S. Wondji, Laurence Mousson, Anna-Bella Failloux, Marie Vazeille, Centre for Research in Infectious Diseases [Yaoundé] (CRID), Arbovirus et Insectes Vecteurs - Arboviruses and Insect Vectors, Institut Pasteur [Paris] (IP), Université de Yaoundé I, University Marien Ngouabi of Brazzaville (umng), Liverpool School of Tropical Medicine (LSTM), This study was supported by a Wellcome Trust Training Fellowship in Public Health and Tropical Medicine [grant number 204862/Z/16/Z] awarded to BK., We would like to thank the populations of different collection sites for their collaboration during the field works. BK, CSW and ABF designed the experiments. BK performed the research. MV and LM provided a technical help. ANT, APY, TAWB helped in mosquito collections, BK, CSW and ABF wrote the paper with contribution from all other authors., and Institut Pasteur [Paris]
Subjects: 0301 basic medicine, medicine.medical_specialty, Aedes albopictus, Epidemiology, 030106 microbiology, Immunology, wa_395, Mosquito Vectors, Aedes aegypti, Microbiology, Article, law.invention, 03 medical and health sciences, Aedes, law, Virology, Yellow Fever, Drug Discovery, parasitic diseases, medicine, Animals, Humans, qx_525, Africa, Central, Socioeconomics, yellow fever virus, vector competence, Central Africa, biology, Public health, Yellow fever, Outbreak, General Medicine, biology.organism_classification, medicine.disease, wc_530, 3. Good health, 030104 developmental biology, Infectious Diseases, Geography, Transmission (mechanics), Vector (epidemiology), [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Female, Parasitology
Abstract: International audience; Yellow Fever (YF) remains a major public health issue in Sub-Saharan Africa and South America, despite the availability of an effective vaccine. In Africa, most YF outbreaks are reported in West Africa. However, urban outbreaks occurred in 2016 in both Angola and the Democratic Republic of Congo (DRC), and imported cases were reported in Chinese workers coming back from Africa. In Central Africa, Cameroon and the Republic of Congo host a high proportion of non-vaccinated populations increasing the risk of urban outbreaks. The main vector is Aedes aegypti and possibly, Aedes albopictus, both being anthropophilic and domestic mosquitoes. Here, we provide evidence that both Ae. aegypti and Ae. albopictus in Cameroon and the Republic of Congo are able to transmit Yellow fever virus (YFV) with higher rates of infection, dissemination, and transmission for Ae. aegypti. We conclude that the potential of both Aedes species to transmit YFV could increase the risk of urban YF transmission and urge public health authorities to intensify their efforts to control domestic vectors, and extend vaccine coverage to prevent major YFV outbreak.
Published: 2019

49. Informal caregiving and physical activity among 204,315 adults in 38 low- and middle-income countries: A cross-sectional study

Author: Louis Jacob, Brendon Stubbs, Ai Koyanagi, Lee Smith, Davy Vancampfort, Sarah E Jackson, Josep Maria Haro, Jae Il Shin, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), ICA-CL-2017-03-001 Maudsley Charity Collaboration for Leadership in Applied Health Research and Care - Greater Manchester, CLAHRC GM National Institute for Health Research, NIHR King's College London Instituto de Salud Carlos III, ISCIII European Regional Development Fund, ERDF Collaboration for Leadership in Applied Health Research and Care - Greater Manchester, CLAHRC GM, and Ai Koyanagi's work is supported by the PI15/00862 project, integrated into the National R + D + I and funded by the ISCIII - General Branch Evaluation and Promotion of Health Research - and the European Regional Development Fund (ERDF-FEDER). Brendon Stubbs is supported by a Clinical Lectureship ( ICA-CL-2017-03-001 ) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR). Brendon Stubbs is part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust . Brendon Stubbs is also supported by the Maudsley Charity , King's College London and the NIHR South London Collaboration for Leadership in Applied Health Research and Care - Greater Manchester (CLAHRC) funding. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions.
Subjects: Male, STRESS, IMPACT, Cross-sectional study, Epidemiology, [SDV]Life Sciences [q-bio], Global Health, 01 natural sciences, 0302 clinical medicine, Prevalence, Medicine, 030212 general & internal medicine, Public, Environmental & Occupational Health, RISK, Low- and middle-income countries, HEALTH BEHAVIORS, OF-LIFE, ASSOCIATION, Multi-country study, FAMILY, PREVALENCE, 3. Good health, Caregivers, Informal caregiving, Female, Life Sciences & Biomedicine, MENTAL-HEALTH, Adult, medicine.medical_specialty, Physical activity, World health, 03 medical and health sciences, Medicine, General & Internal, General & Internal Medicine, Environmental health, Humans, 0101 mathematics, Developing Countries, Exercise, Poverty, Science & Technology, business.industry, DISABILITY, 010102 general mathematics, Public Health, Environmental and Occupational Health, Health Surveys, Cross-Sectional Studies, Low and middle income countries, business
Abstract: Data on the association between informal caregiving and physical activity (PA) levels are scarce, especially from low- and middle-income countries (LMICs). Furthermore, previous research has yielded conflicting results. Thus, we investigated this association in adults from 38 LMICs. Data from the World Health Survey (WHS), a cross-sectional, predominantly nationally representative survey conducted in 2002-2004, were analyzed. PA was assessed by the International Physical Activity Questionnaire and participants were dichotomized into those who do (≥150 min of moderate-to-vigorous PA per week) and do not (
Published: 2019

50. Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol

Author: Miguel Romero, José Suárez-de-Lezo, Concha Herrera, Manuel Pan, José López-Aguilera, Flor Baeza-Garzón, Francisco Javier Hidalgo-Lesmes, Olga Fernández-López, Juliana Martínez-Atienza, Eva Cebrián, Vanesa Martín-Palanco, Rosario Jiménez-Moreno, Rosario Gutiérrez-Fernández, Sonia Nogueras, Maria Dolores Carmona, Soledad Ojeda, Natividad Cuende, Rosario Mata, [Romero,M, Suárez-de-Lezo, Pan,M, López-Aguilera,J, Suárez-de-Lezo Jr,J, Baeza-Garzón,F, Hidalgo-Lesmes,FJ, Cebrián,E, Ojeda,S] Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain. [Herrera,C, Martín-Palanco,V, Jiménez-Moreno,R, Gutiérrez-Fernández,R, Nogueras,S, Carmona,MD] Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain. [Fernández-López,O, Martínez-Atienza,J, Cuende,N, Mata,R] Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health, Seville, Spain., and This paper presents an investigator-driven Clinical trial partially funded by research grant provided by the Regional Ministry of Health of Andalusia (Grant Reference Number salud-201600073587-tra).
Subjects: Male, lcsh:Diseases of the circulatory (Cardiovascular) system, Time Factors, Ensayo clínico controlado aleatorio, 030204 cardiovascular system & hematology, Cell therapy, Ventricular Function, Left, law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Study Protocol, Cardiomiopatía dilatada, 0302 clinical medicine, Randomized controlled trial, law, Dilated myocardiopathy, Multicenter Studies as Topic, 030212 general & internal medicine, Myocardial infarction, Diseases::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Cardiomyopathy, Dilated [Medical Subject Headings], Bone Marrow Transplantation, Randomized Controlled Trials as Topic, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings], Diseases::Cardiovascular Diseases::Vascular Diseases::Myocardial Ischemia::Myocardial Infarction [Medical Subject Headings], Ejection fraction, Middle Aged, Treatment Outcome, Disciplines and Occupations::Natural Science Disciplines::Science::Research::Biomedical Research [Medical Subject Headings], Female, Cardiology and Cardiovascular Medicine, Adult, Cardiomyopathy, Dilated, medicine.medical_specialty, Information Science::Information Science::Communications Media::Publications [Medical Subject Headings], Adolescent, Cell- and tissue-based therapy, Células de la médula ósea, Bone Marrow Cells, Placebo, Transplantation, Autologous, Young Adult, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Double-Blind Method, Tratamiento basado en trasplante de células y tejidos, Internal medicine, medicine, Humans, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy [Medical Subject Headings], Aged, Angiology, Anatomy::Cells::Bone Marrow Cells [Medical Subject Headings], business.industry, Consolidated Standards of Reporting Trials, Recovery of Function, medicine.disease, Interim analysis, Clinical trial, lcsh:RC666-701, Spain, Bone marrow mononuclear cells, business
Abstract: Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comite Coordinador de Etica en Investigacion Biomedica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Espanola de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013–002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013–002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.
Published: 2019

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