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1. Circulating 20S proteasome for assessing protein energy wasting syndrome in hemodialysis patients

Author: Marine Freist, Elodie Gentes, Carole Philipponnet, Mohamed Hadj Abdelkader, Bruno Pereira, Aurélien Piraud, Cyril Garrouste, Anne-Elisabeth Heng, Julien Aniort, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Emile Roux [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Néphrologie - Hémodialyses [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Dept Clin Nutr, Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Unité de Biostatistiques, Direction de la Recherche Clinique (DRCI)
Subjects: Male, 0301 basic medicine, dialyse, [SDV]Life Sciences [q-bio], medicine.medical_treatment, 030232 urology & nephrology, Muscle Proteins, Biochemistry, protéasome, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Gastroenterology, 0302 clinical medicine, Medicine and Health Sciences, 2. Zero hunger, Multidisciplinary, Protein energy wasting, Muscle Analysis, Middle Aged, C-Reactive Proteins, Muscle atrophy, atrophie musculaire, 3. Good health, Hospitalization, Bioassays and Physiological Analysis, Nephrology, Creatinine, Medicine, Female, patient, Hemodialysis, medicine.symptom, Research Article, Proteasome Endopeptidase Complex, medicine.medical_specialty, Science, Nutritional Status, Circulating Proteasome, Research and Analysis Methods, Protein-Energy Malnutrition, 03 medical and health sciences, Signs and Symptoms, Renal Dialysis, Internal medicine, Medical Dialysis, medicine, Humans, Mortality, Survival rate, Nutrition, Aged, Wasting Syndrome, business.industry, Biology and Life Sciences, Proteins, Protein Complexes, Proteasomes, medicine.disease, perte d'énergie, Patient Outcome Assessment, 030104 developmental biology, Proteasome, Clinical Medicine, Atrophy, Complication, business, Biomarkers, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Kidney disease
Abstract: International audience; Protein energy wasting (PEW) including muscle atrophy is a common complication in chronic hemodialysis patients. The ubiquitin proteasome system (UPS) is the main proteolytic system causing muscle atrophy in chronic kidney disease and proteasome 20S is the catalytic component of the UPS. Circulating proteasome 20S (c20S proteasome) is present in the blood and its level is related to disease severity and prognosis in several disorders. We hypothesized that c20S proteasome could be related with muscle mass, other PEW criteria and their evolution in hemodialysis patients. Stable hemodialysis patients treated at our center for more than 3 months were followed over 2 years. C20S proteasome assay was performed at baseline. Biological and clinical data were collected, muscle mass was assessed by multi-frequency bio-impedancemetry, and nutritional scores were calculated at baseline, 1 year and 2 years. Hospitalizations and mortality data were collected over the 2 years. Forty-nine patients were included. At baseline, the c20S proteasome level was 0.40 [0.26-0.55] mu g/ml. Low muscle mass as defined by a lean tissue index (LTI) < 10th in accordance with the International Society of Renal Nutrition and Metabolism guidelines was observed in 36% and PEW in 62%. Increased c20S proteasome levels were related with LTI at baseline (R = 0.43, p = 0.004) and with its 2 year-variation (R = -0.56, p = 0.003). Two-year survival rate was not different between higher and lower c20S proteasome values (78.9 vs 78.4%, p = 0.98 log-rank test). C20S proteasome is not a good marker for assessing nutritional status in hemodialysis patients and predicting patient outcomes.
Published: 2020

2. Stress management in obesity during a thermal spa residential programme (ObesiStress): protocol for a randomised controlled trial study

Author: Yves Boirie, Daniela M. Pfabigan, Omar Izem, Magalie Miolanne-Debouit, N. Farigon, Bruno Pereira, Laurie Mobdillon, Guillaume T. Vallet, Armand Abergel, Pascale Duché, Gil Boudet, Philippe Obert, Shihui Han, Elodie Chaplais, Daniel Courteix, Frédéric Dutheil, Audrey Vilmant, Martial Mermillod, Laboratoire de Psychologie Sociale et Cognitive - Clermont Auvergne (LAPSCO), Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Institut de Médecine du Travail, CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I (UdA), Laboratoire Développement, Adaptation et Handicap (DevAH), Unité de Biostatistiques [CHU Clermont-Ferrand] (Département de la recherche clinique et de l'innovation - DRCI), CHU Clermont-Ferrand, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Faculté des Sciences du SportFaculté des Sciences du Sport, UFR STAPS, Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Impact de l'Activité Physique sur la Santé (IAPS), Université de Toulon (UTLN), Service d'Hépato-Gastroentérologie [CHRU Clermont-Ferrand], Centre Hospitalier Universitaire de Clermont-Ferrand, Peking University [Beijing], PKU-IDG/McGovern Institute For Brain Research, Centre de recherche en économie de Grenoble (CREG), Université Pierre Mendès France - Grenoble 2 (UPMF)-Université Grenoble Alpes (UGA), Institut Universitaire de France (IUF), Ministère de l'Education nationale, de l’Enseignement supérieur et de la Recherche (M.E.N.E.S.R.), Physiopathologie des adaptations cardiovasculaires à l'Exercice, Avignon Université (AU), EA4278 Laboratoire de Pharm-Ecologie Cardiovasculaire (LaPEC), Nutrition clinique, Centre Hospitalier Universitaire Gabriel Montpied, nutrition clinique, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Université Clermont Auvergne (UCA), Centre National de la Recherche Scientifique (CNRS), Service Santé Travail Environnement, EA 3450, Université de Lorraine (UL), Département Recherche Clinique et Innovation, EA 3533, Laboratoire des Adaptations Métaboliques à l’Exercice en conditions Physiologiques et Pathologiques (AME2P), Laboratoire Impact de l’Activité Physique sur la Santé, Hépatologie Gastro-Entérologie, Centre Hospitalier Universitaire Estaing, UMR 6284, University Beijing, Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes (COMUE) (UGA), Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), EA 4278, laboratoire de Pharm-Ecologie Cardiovasculaire (LaPEC ), Biostatistiques, Danone Research, Unité de Nutrition Humaine - Clermont Auvergne (UNH), Université Clermont Auvergne (UCA)-Institut National de la Recherche Agronomique (INRA), Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Développement, Adaptation et Handicap. Régulations cardio-respiratoires et de la motricité (DevAH), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Ferrand (UFR STAPS - UBP), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Université Blaise Pascal - Clermont-Ferrand 2 (UBP), Service d'Hépatologie Gastro-entérologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Auvergne Rhone-Alpes University Hospital of Clermont-Ferrand European Regional Development Fund (Fonds Europeen de Developpement Economique et Regional), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Ferrand (UFR STAPS - UBP), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Université Blaise Pascal - Clermont-Ferrand 2 (UBP), and Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA)
Subjects: musculoskeletal diseases, Stress management, medicine.medical_specialty, obesity, Cardiovascular Medicine, Overweight, Body Mass Index, law.invention, 03 medical and health sciences, stress, 0302 clinical medicine, Quality of life, Randomized controlled trial, prevention, Heart Rate, law, Protocol, Humans, Medicine, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, 2. Zero hunger, business.industry, Public health, heart rate variability, Hyperthermia, Induced, General Medicine, Anthropometry, medicine.disease, Obesity, 3. Good health, spa bath, Body Composition, Quality of Life, Physical therapy, France, medicine.symptom, business, Body mass index, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Biomarkers, Stress, Psychological, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: IntroductionStress and obesity are two public health issues. The relationship between obesity and stress is biological through the actions of stress on the major hormones that regulate appetite (leptin and ghrelin). Many spa resorts in France specialise in the treatment of obesity, but no thermal spa currently proposes a specific programme to manage stress in obesity. The ObesiStress protocol has been designed to offer a new residential stress management programme. This thermal spa treatment of obesity implements stress management strategies as suggested by international recommendations.Methods and analysis140 overweight or obese participants with a Body Mass Index of >25 kg/m2 and aged over 18 years will be recruited. Participants will be randomised into two groups: a control group of usual practice (restrictive diet, physical activity and thermal spa treatment) and an intervention group with stress management in addition to the usual practice. In the present protocol, parameters will be measured on five occasions (at inclusion, at the beginning of the spa (day 0), at the end of the spa (day 21), and at 6 and 12 months). The study will assess the participants’ heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters.Ethics and disseminationThe ObesiStress protocol complies with the ethics guidelines for Clinical Research and has been approved by the ethics committee (CPP Sud-Est VI, Clermont-Ferrand - ANSM: 2016-A01774-47). This study aimed to highlight the efficacy of a 21-day thermal spa residential programme of stress management in obesity through objective measurements of well-being and cardiovascular morbidity. Results will be disseminated during several research conferences and articles published in peer-reviewed journals.Trial registration numberNCT03578757.
Published: 2019

3. Excision versus colorectal resection in deep endometriosis infiltrating the rectum:5-year follow-up of patients enrolled in a randomized controlled trial

Author: Horace Roman, Haitham Khalil, Lacramioara Aurelia Branduse, Valérie Bridoux, Emmanuel Huet, Jean-Jacques Tuech, Michael Bubenheim, Clotilde Hennetier, Gamétogenèse et Qualité du Gamète - ULR 4308 (GQG), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Université de Lille, Service de gynécologie et obstétrique [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Laboratoire d'éthique médicale et médecine légale (LEM), Université Paris Descartes - Paris 5 (UPD5), Service de chirurgie digestive [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Unité de biostatistiques [CHU Rouen], University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Gamétogenèse et Qualité du Gamète (GQG), Normandie Université (NU)-Normandie Université (NU)-Université de Lille, Droit et Santé-Université de Lille, Service de gynécologie et obstétrique [Rouen], Service de chirurgie digestive [Rouen], and Unité de biostatistiques [Rouen]
Subjects: Adult, medicine.medical_specialty, Endometriosis, Rectum, bladder dysfunction, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Pelvic Pain, law.invention, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, law, Recurrence, medicine, Clinical endpoint, Dysuria, Humans, Digestive System Surgical Procedures, colorectal resection, 030219 obstetrics & reproductive medicine, business.industry, Rehabilitation, Obstetrics and Gynecology, shaving, medicine.disease, Anus, 3. Good health, Surgery, medicine.anatomical_structure, Rectal Diseases, Treatment Outcome, digestive symptoms, Reproductive Medicine, 030220 oncology & carcinogenesis, Defecation, Female, France, disc excision, Segmental resection, medicine.symptom, business, Corrigendum, Colorectal Surgery, Follow-Up Studies
Abstract: STUDY QUESTION Is there a difference in functional outcomes and recurrence rate between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 5 years postoperatively? SUMMARY ANSWER No evidence was found that long-term outcomes differed when nodule excision was compared to rectal resection for deeply invasive endometriosis involving the bowel. WHAT IS KNOWN ALREADY Functional outcomes of nodule excision and rectal resection for deeply invasive endometriosis involving the bowel are comparable 2 years after surgery. Despite numerous previously reported case series enrolling patients managed for colorectal endometriosis, long-term data remain scarce in the literature. STUDY DESIGN, SIZE, DURATION From March 2011 to August 2013, we performed a two-arm randomized trial, enrolling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring >20 mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference. Among them, 55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre. Institute review board approval was obtained to continue follow-up to 10 years postoperatively. One patient requested to stop the follow-up 2 years after surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS Patients underwent either nodule excision by shaving or disc excision, or segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of randomization results. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were values taken from the Knowles–Eccersley–Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36). MAIN RESULTS AND THE ROLE OF CHANCE Fifty-five patients were enrolled. Among the 27 patients in the excision arm, two were converted to segmental resection (7.4%). One patient managed by segmental resection withdrew from the study 2 years postoperatively, presuming that associated pain of other aetiologies may have jeopardized the outcomes. The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively. For excision and resection, the primary endpoint was present in 44.4% versus 60.7% of patients (P = 0.29), respectively, while 55.6% versus 53.6% of patients subjectively reported normal bowel movements (P = 1). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 5 years postoperatively. Statistically significant improvement was observed shortly after surgery with no further improvement or impairment recorded 1–5 years postoperatively. During the 5-year follow-up, additional surgical procedures were performed in 25.9% versus 28.6% of patients who had undergone excision or resection (P = 0.80), respectively. LIMITATIONS, REASONS FOR CAUTION The presumption of a 40% difference concerning postoperative functional outcomes in favour of nodule excision resulted in a lack of power for demonstration of the primary endpoint difference. WIDER IMPLICATIONS OF THE FINDINGS Five-year follow-up data do not show statistically significant differences between conservative and radical rectal surgery for long-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum. STUDY FUNDING/COMPETING INTEREST(S) No specific funding was received. Patient enrolment and follow-up until 2 years postoperatively was supported by a grant from the clinical research programme for hospitals in France. The authors declare no competing interests related to this study. TRIAL REGISTRATION NUMBER This randomized study is registered with ClinicalTrials.gov, number NCT 01291576. TRIAL REGISTRATION DATE 31 January 2011. DATE OF FIRST PATIENT’S ENROLMENT 7 March 2011.
Published: 2019

4. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial

Author: Jean-Michel Constantin, Matthieu Jabaudon, Jean-Yves Lefrant, Samir Jaber, Jean-Pierre Quenot, Olivier Langeron, Martine Ferrandière, Fabien Grelon, Philippe Seguin, Carole Ichai, Benoit Veber, Bertrand Souweine, Thomas Uberti, Sigismond Lasocki, François Legay, Marc Leone, Nathanael Eisenmann, Claire Dahyot-Fizelier, Hervé Dupont, Karim Asehnoune, Achille Sossou, Gérald Chanques, Laurent Muller, Jean-Etienne Bazin, Antoine Monsel, Lucile Borao, Jean-Marc Garcier, Jean-Jacques Rouby, Bruno Pereira, Emmanuel Futier, Cayot Sophie, Godet Thomas, Guerin Renaud, Verlac Camille, Chabanne Russel, Cosserant Bernard, Blondonnet Raiko, Lautrette Alexandre, Eisenmann Nathanael, Muller Laurent, Massanet Pablo, Boutin Caroline, Barbar Saber, Roger Claire, Belafia Fouad, Cisse Moussa, Monnin Marion, Conseil Matthieu, Carr Julie, De Jong Audrey, Dargent Auguste, Andreu Pascal, Lebouvrier Thomas, Launey Yoann, Roquilly Antoine, Cinotti Raphael, Tellier Anne-Charlotte, Barbaz Mathilde, Cohen Benjamin, Lemarche Edouard, Bertrand Pierre-Marie, Arberlot Charlotte, Zieleskiewicz Laurent, Hammad Emmanuelle, Duclos Garry, Mathie Calypso, Dupont Herve, Veber Benoit, Orban Jean-Christophe, Quintard Hervé, Rimmele Thomas, Crozon-Clauzel Julien, Le Core Marinne, Grelon Fabien, Assefi Mona, Petitas Frank, Morel Jerome, Molliex Serge, Hadanou Nanadougmar, CHU Clermont-Ferrand, Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Le Mans (CH Le Mans), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de réanimation, Centre Hospitalier Universitaire de Nice (CHU Nice)-Hôpital St Roch, Département d'anesthésie-Réanimation-Samu, CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Unité de soins intensifs [Clermont Ferrand], CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Edouard Herriot Hospital, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU de Saint-Brieuc, Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Université de Montpellier (UM), Immunologie - Immunopathologie - Immunothérapie (I3), 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), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Génétique, Reproduction et Développement (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Department of Perioperative Medicine, CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [APHP], Hopital Général, Le Mans, 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 Clermont-Ferrand-Hôpital Gabriel Montpied, Hospital General Saint-Brieuc, Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Centre Régional de Lutte Contre le Cancer Jean Perrin, Centre hospitalier universitaire d'Amiens (CHU Amiens-Picardie), Service de réanimation adulte, département d'anesthésie-réanimation, CHU Clermont-Ferrand-Hôtel Dieu, Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), University Hospital of Clermont-Ferrand, Institut Pascal - Clermont Auvergne (IP), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Unité de biostatistiques, CHU Clermont-Ferrand-Hôpital Montpied, Génétique, Reproduction et Développement - Clermont Auvergne (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), MORNET, Dominique, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, ARDS, medicine.medical_treatment, [SDV]Life Sciences [q-bio], law.invention, Positive-Pressure Respiration, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Fraction of inspired oxygen, Intensive care, medicine, Prone Position, Tidal Volume, Humans, Single-Blind Method, 030212 general & internal medicine, Prospective Studies, Precision Medicine, Lung, Positive end-expiratory pressure, Tidal volume, ComputingMilieux_MISCELLANEOUS, Proportional Hazards Models, Mechanical ventilation, Respiratory Distress Syndrome, business.industry, Hazard ratio, Middle Aged, medicine.disease, Respiration, Artificial, 3. Good health, [SDV] Life Sciences [q-bio], Intensive Care Units, Editorial Commentary, Treatment Outcome, 030228 respiratory system, Female, France, business
Abstract: The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care.We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589.From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012.Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial.French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).
Published: 2019

5. The importance of jointly analyzing treatment administration and toxicity associated with targeted therapies: a case study of regorafenib in soft tissue sarcoma patients

Author: J.-P. Delord, Thomas Brodowicz, Bastien Cabarrou, M. Longue, Jennifer Wallet, H. Roche, Thomas Filleron, Jean Marie Boher, Nicolas Penel, Institut Claudius Regaud, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université médicale de Vienne, Autriche, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), This project was supported by the CAPTOR project: ANR-11-PHUC-0001., ANR-11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Université de Lille, LillOA, Pôle hospitalier Universitaire Cancer (PHUC) - Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région - - CAPTOR2011 - ANR-11-PHUC-0001 - PHUC - VALID, Unité de Biostatistiques [Toulouse] ( Institut Claudius Regaud / IUCT-O), Institut Universitaire du Cancer Toulouse - Oncopôle (IUCT)-Institut Claudius Regaud, Service de biostatistiques [CHU Lille] (Centre Oscar Lambret), Comprehensive Cancer Center [Vienna, Austria], Institute of Cancer Research [Vienna, Austria]-Medizinische Universität Wien = Medical University of Vienna, Département d'Oncologie Médicale [CHU Toulouse] (IUCT Oncopole - Institut Universitaire du Cancer), Centre hospitalier universitaire de Toulouse - CHU Toulouse-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de Biostatistiques [Institut Paoli-Calmettes] (Département de la Recherche clinique et de l'Innovation), Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Service d'oncologie médicale (CHRU Lille), ANR-11-PHUC-0001/11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, CHU Lille, Université de Lille, METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Centre Hospitalier Régional Universitaire [Lille] [CHRU Lille], and Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Subjects: 0301 basic medicine, Pyridines, medicine.medical_treatment, [SDV]Life Sciences [q-bio], toxicity analysis, Targeted therapy, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Molecular Targeted Therapy, Soft tissue sarcoma, Sarcoma, Hematology, Prognosis, targeted therapy, 3. Good health, Survival Rate, [SDV] Life Sciences [q-bio], Oncology, 030220 oncology & carcinogenesis, France, Mucositis, medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Drug-Related Side Effects and Adverse Reactions, prevalence, 03 medical and health sciences, Double-Blind Method, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Internal medicine, Regorafenib, medicine, dose adjustment, Humans, Adverse effect, Survival rate, Stomatitis, business.industry, Phenylurea Compounds, medicine.disease, Clinical trial, 030104 developmental biology, chemistry, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Follow-Up Studies
Abstract: International audience; Background: Different methods have been proposed to analyze adverse events (AEs) associated with targeted therapies. While these AEs lead to dose adjustments for many patients, conventional reporting methods do not take drug administration into consideration. This paper underlines the importance of jointly reporting AEs and drug administration using prevalence, and proposes a complementary approach to reporting. Patients and methods: The prevalence method estimates the probability of progression-free patients being in a particular health state (state 1: AEs with full dose; state 2: AEs with reduced dose; state 3: no AEs with reduced dose) at different time points. To take into account the impact of dose adjustments on efficacy, the weighted prevalence method can be used by assigning utility weights to the different health states. The benefit of these methods was illustrated using data from a phase II trial of regorafenib. Results: Only 4.6% of progression-free patients developed mucositis/stomatitis (grade 2) at 3 months. The prevalence of patients not experiencing this AE but whose dose was reduced or treatment interrupted was 58.1%. The weighted prevalence of the regorafenib toxicity profile and dose reduction was higher in the control arm. Conclusion: This case study confirms the importance of jointly analyzing AEs and drug administration. The weighted prevalence approach is an average score that incorporates the dimension of drug administration into AE assessment. This can be helpful for regulatory agencies as well as for clinicians to evaluate the benefit-risk ratio of therapies in their treatment choice. Clinical trial: NCT01900743.
Published: 2018

6. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin?

Author: Frédéric Dutheil, Yves Boirie, Ana Marques, Elodie Durand, Maria Livia Fantini, Franck Durif, Isabelle Rieu, Aurélien Mulliez, Groupe de sociologie politique et morale (GSPM), École des hautes études en sciences sociales (EHESS)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Psychologie Sociale et Cognitive - Clermont Auvergne (LAPSCO), Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), École d’Orthoptie - Clermont-Ferrand (EO - UdA), CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I (UdA), Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux - Clermont Auvergne (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne (UCA), CHU Clermont-Ferrand, Unité de Biostatistiques, Délégation Recherche Clinique & Innovation, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Groupe de sociologie politique et morale ( GSPM ), École des hautes études en sciences sociales ( EHESS ) -Centre National de la Recherche Scientifique ( CNRS ), Laboratoire de Psychologie Sociale et Cognitive - Clermont Auvergne ( LAPSCO ), Université Clermont Auvergne ( UCA ) -Centre National de la Recherche Scientifique ( CNRS ), École d’Orthoptie - Clermont-Ferrand ( EO - UdA ), CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I ( UdA ), Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux - Clermont Auvergne ( NPsy-Sydo ), CHU Clermont-Ferrand-Université Clermont Auvergne ( UCA ), Unité de Nutrition Humaine ( UNH ), Institut National de la Recherche Agronomique ( INRA ) -Université d'Auvergne - Clermont-Ferrand I ( UdA ) -Clermont Université, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université-Institut National de la Recherche Agronomique (INRA), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
Subjects: 0301 basic medicine, Blood Glucose, Male, Parkinson's disease, Dopamine, medicine.medical_treatment, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Administration, Oral, Neurodegenerative disease, [ SDV.NEU.SC ] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Cognitive Sciences, 0302 clinical medicine, Insulin, ComputingMilieux_MISCELLANEOUS, 2. Zero hunger, [SDV.NEU.PC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior, Diabetes, [SDV.NEU.SC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Cognitive Sciences, Parkinson Disease, Middle Aged, 3. Good health, Neurology, [ SDV.NEU.NB ] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, [ SCCO.NEUR ] Cognitive science/Neuroscience, Female, medicine.symptom, medicine.drug, medicine.medical_specialty, [ SDV.NEU.PC ] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior, 03 medical and health sciences, Internal medicine, Diabetes mellitus, medicine, Humans, Aged, Glucose Metabolism Disorders, Retrospective Studies, Autonomous nervous system, business.industry, [SCCO.NEUR]Cognitive science/Neuroscience, Dysautonomia, Metabolism, Glucose Tolerance Test, medicine.disease, 030104 developmental biology, Endocrinology, Autonomic Nervous System Diseases, Blood sugar regulation, Neurology (clinical), Geriatrics and Gerontology, business, Body mass index, 030217 neurology & neurosurgery
Abstract: Objective To detect changes in glucose regulation in moderate to advanced Parkinson's disease (PD) patients in response to oral glucose intake. Methods Blood glucose and insulin kinetics during a 75-g Oral Glucose Tolerance Test (OGTT) were compared between 50 PD patients and 50 healthy controls (CT) matched for body mass index (BMI), age and sex. Potential relationships between changes in glucose kinetics and clinical parameters were analyzed including Parkinson's disease severity and autonomic function using SCOPA-AUT (Scales for Outcomes in Parkinson's disease, Autonomic dysfunction). Results Blood glucose was significantly higher at T90 (p = 0.04) and T150 (p = 0.01) in PD patients compared to healthy matched controls. Moreover, the total area under time curve (AUC) for the blood glucose levels was significantly higher in PD patients compared to healthy controls (1187 ± 229 vs 1101 ± 201 mmol min.l-1; p = 0.05). Simultaneously, no significant increase of insulin levels was observed in PD patients compared to controls. Higher blood glucose levels were associated with higher BMI (p Conclusion Glucose control is impaired in moderate to advanced non-diabetic PD patients, due to impaired adaptive insulin response which may be a novel non-motor consequence of PD associated dysautonomia.
Published: 2018

7. First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicentre, parallel-group, open-label randomised trial

Author: Catherine Prost-Squarcioni, Pierre Vabres, Philippe Bernard, Maud Maho-Vaillant, Estelle Houivet, Laurent Misery, Saskia Ingen-Housz-Oro, Sébastien Debarbieux, Alain Dupuy, Marie-Laure Golinski, P. Musette, Jean-David Bouaziz, Sophie Duvert-Lehembre, Pascal Joly, Laurent Machet, Nicolas Dupin, Denis Jullien, Frédéric Caux, Marie Beylot-Barry, Sébastien Calbo, Vivien Hébert, Martine Avenel-Audran, Bruno Sassolas, Carle Paul, Olivier Dereure, Gaëlle Quéreux, Emmanuel Delaporte, Jacques Benichou, Catherine Picard-Dahan, Nathalie Beneton, Bruno Labeille, Marie-Aleth Richard, Michel D'Incan, Christophe Bedane, Frédérique Caillot, Thomas Vermeulin, Marina Alexandre, Service de Dermatologie [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Centre de référence sur les maladies bulleuses autoimmunes (Rouen), CHU Rouen, Service de dermatologie [Paris], Université Paris Diderot - Paris 7 (UPD7)-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), Unité de biostatistiques [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), University Hospital of St-Etienne, Department of Dermatology, Service de Dermatologie, Hôpital Bichat, AP-HP, Service de dermatologie (CHU de Toulouse), CHU Toulouse [Toulouse], Centre de Recherches en Oncologie biologique et Oncopharmacologie (CRO2), Institut National de la Santé et de la Recherche Médicale (INSERM)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Aix Marseille Université (AMU), Service de Dermatologie [AP-HP Hôpital Saint Louis, Paris], Université Paris Diderot - Paris 7 (UPD7)-Hopital Saint-Louis [AP-HP] (AP-HP), Service de dermatologie (CHU de Reims), Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Henri Mondor, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Equipe GAD (LNC - U1231), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Service de dermatologie (CHRU de Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de dermatologie [Nantes], Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Service de Dermatologie [Rennes] = Dermatology [Rennes], CHU Pontchaillou [Rennes], Service de Dermatologie, Centre Hospitalier Sud, Hospices Civils, Lyon, Département de Dermatologie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service de Dermatologie et Oncologie Cutanée [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Dermatologie [CHU Limoges], CHU Limoges, Service de dermatologie [CH Le Mans], Centre Hospitalier Le Mans (CH Le Mans), Service de dermatologie (Dermato - BREST), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Dermatologie, Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de dermatologie [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Service d'informatique biomédicale [Rouen], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Unité de biostatistiques [Rouen], Aix Marseille Université (AMU)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-AP-HP Hôpital Saint-Louis, Service de Dermatologie [Rennes], Service de dermatologie et oncologie cutanée (CHU Clermont Ferrand), CHRU Clermont Ferrand, Service de dermatologie (CH Le Mans), Hôpital Trousseau (Tours), Assistance publique - Hôpitaux de Paris (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]-Université Paris Diderot - Paris 7 ( UPD7 ), CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Centre Hospitalier Universitaire de Toulouse - CHU Toulouse (FRANCE), Centre de Recherches en Oncologie biologique et Oncopharmacologie ( CRO2 ), Aix Marseille Université ( AMU ) - Hôpital de la Timone [CHU - APHM] ( TIMONE ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris Diderot - Paris 7 ( UPD7 ) -AP-HP Hôpital Saint-Louis, Centre Hospitalier Universitaire de Reims ( CHU Reims ), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Université de Nantes ( UN ) -Centre hospitalier universitaire de Nantes ( CHU Nantes ), Centre Hospitalier Universitaire d'Angers, CH Le Mans, Service de dermatologie ( Dermato - BREST ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ), Département de Médecine Interne et Pneumologie [Brest] ( DMIP - Brest ), Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Dermatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Service Dermatologie [CHU Toulouse], Pôle Clinique des Voies respiratoires [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and CHU Henri Mondor [Créteil]
Subjects: 0301 basic medicine, Adult, Male, medicine.medical_specialty, Prednisolone, Follow-Up, Vulgaris, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Prednisone, law, Internal medicine, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Corticosteroids, Disease, Prospective Studies, Prospective cohort study, Adjuvant, Aged, business.industry, Standard treatment, General Medicine, Middle Aged, Mycophenolate-Mofetil, medicine.disease, 3. Good health, Surgery, Pemphigus, Regimen, 030104 developmental biology, Treatment Outcome, Combination, Rituximab, Female, Therapy, business, Single-Cycle, Intensity Score Absis, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, medicine.drug
Abstract: IF 44.002; International audience; Background High doses of corticosteroids are considered the standard treatment for pemphigus. Because long-term corticosteroid treatment can cause severe and even life-threatening side-effects in patients with this disease, we assessed whether first-line use of rituximab as adjuvant therapy could improve the proportion of patients achieving complete remission off-therapy, compared with corticosteroid treatment alone, while decreasing treatment side-effects of corticosteroids.Methods We did a prospective, multicentre, parallel-group, open-label, randomised trial in 25 dermatology hospital departments in France (Ritux 3). Eligible participants were patients with newly diagnosed pemphigus aged 18-80 years being treated for the first time (not at the time of a relapse). We randomly assigned participants (1: 1) to receive either oral prednisone alone, 1.0 or 1.5 mg/kg per day tapered over 12 or 18 months (prednisone alone group), or 1000 mg of intravenous rituximab on days 0 and 14, and 500 mg at months 12 and 18, combined with a short-term prednisone regimen, 0.5 or 1.0 mg/kg per day tapered over 3 or 6 months (rituximab plus short-term prednisone group). Follow-up was for 3 years (study visits were scheduled weekly during the first month of the study, then monthly until month 24, then an additional visit at month 36). Treatment was assigned through central computer-generated randomisation, with stratification according to disease-severity (severe or moderate, based on Harman's criteria). The primary endpoint was the proportion of patients who achieved complete remission off-therapy at month 24 (intention-to-treat analysis). This study is registered with ClinicalTrials.gov, number NCT00784589.Findings Between May 10, 2010, and Dec 7, 2012, we enrolled 91 patients and randomly assigned 90 to treatment (90 were analysed; 1 patient withdrew consent before the random assignment). At month 24, 41 (89%) of 46 patients assigned to rituximab plus short-term prednisone were in complete remission off-therapy versus 15 (34%) of 44 assigned to prednisone alone (absolute difference 55 percentage points, 95% CI 38.4-71.7; p
Published: 2017

8. Comparative acceptability and perceived clinical utility of monitoring tools: A nationwide survey of patients with inflammatory bowel disease

Author: Guillaume Bonnaud, François Lʼhopital, Florent Gonzalez, Florian Poullenot, Mathurin Fumery, Stéphane Nancey, Veronique Michalet, Stephane Mathieu, Marc Duruy, Anca Achim, Gilles Bommelaer, Fabrice Luneau, Mathurin Flamant, Alain Thevenin, Julien P. Genes, Jérôme Filippi, Laurent Peyrin-Biroulet, David Laharie, Anthony Buisson, Emmanuelle Cruzille, Caroline Trang-Poisson, Guillaume Bouguen, Elisa Sollellis, Bruno Pereira, Maria Nachury, Benjamin Pariente, Service de Hépato-Gastro-Entérologie, CHU Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Département de Gastroentérologie, Private Practice, Hôpital Européen [Fondation Ambroise Paré - Marseille], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Private Practice Endocrinologist, Hôpital de l'Archet 2, Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Médical Clermont Sud, Centre Hospitalier Universitaire de Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte - Clermont Auvergne (M2iSH), Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), and Unité de Biostatistiques
Subjects: Adult, Male, endoscopie, medicine.medical_specialty, Visual analogue scale, medicine.medical_treatment, acceptabilité, Colonoscopy, vidéo surveillance, Inflammatory bowel disease, Capsule Endoscopy, law.invention, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Capsule endoscopy, law, colonoscopy, inflammatory bowel disease, Internal medicine, Surveys and Questionnaires, acceptability, inflammation intestinale, Immunology and Allergy, Medicine, Humans, Prospective Studies, endoscopy, Ultrasonography, Venipuncture, medicine.diagnostic_test, business.industry, Gastroenterology, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Enema, medicine.disease, Inflammatory Bowel Diseases, Prognosis, Ulcerative colitis, monitoring tools, 3. Good health, utility, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, Perception, business, Biomarkers, Follow-Up Studies
Abstract: Background: Objective control of intestinal inflammation during inflammatory bowel disease (IBD) is becoming the main driver for medical treatment. However, the monitoring tools-related burden remains poorly investigated. We aimed to evaluate their comparative acceptability and utility according to patients with IBD. Methods: After a preliminary phase, the final questionnaire encompassing self-administered and physician questionnaires was prospectively and consecutively submitted to 916 patients with IBD from 20 public and private centers. Acceptability and utility visual analog scales (VAS) were expressed as median with interquartile range. Results: Regarding the group of patients with Crohn's disease (n = 618), venipuncture (VAS = 9.3 [8.8-9.7]) and ultrasonography (VAS = 9.3 [8.7-9.7]) were the most acceptable tools (P < 0.0001, for each comparison), whereas rectosigmoidoscopy was the least acceptable tool (VAS = 4.4 [1.2-7.3]) (P < 0.0001, for each comparison). Wireless capsule endoscopy (VAS = 8.5 [5.2-9.3]), magnetic resonance enterocolonography (VAS = 8.0 [5.0-9.2]), and stools collection (VAS = 7.7 [4.6-9.3]) were more acceptable than colonoscopy (VAS = 6.7 [4.3-8.9]) (P < 0.0001, for each comparison). The acceptability was assessed in 298 patients with ulcerative colitis for venipuncture (VAS = 9.4 [8.8-9.7]), stools collection (VAS = 8.1 [5.7-9.4]), colonoscopy (VAS = 7.5 [4.7-9.2]), and rectosigmoidoscopy (VAS = 6.7 [2.8-9.1]); (P < 0.001 for each comparison). All monitoring tools were considered as highly useful by patients with IBD. Decreased acceptability was related to embarrassment for the collection/transport of stools (60.7%), bowel cleansing (76.3%) for colonoscopy, abdominal discomfort (51.3%) and rectal enema (36.6%) for rectosigmoidoscopy, bowel distension (48.3%) for magnetic resonance enterocolonography, and potential capsule retention (21.4%) for wireless capsule endoscopy. Conclusions: Among the IBD monitoring tools, endoscopy demonstrated the lowest acceptability supporting the development of alternative modalities. Patients' information and examination conditions should be improved to ensure proper monitoring adherence.
Published: 2017

9. Impact of medication reconciliation at discharge on continuity of patient care in France

Author: Gilles Bommelaer, Sarah Talavera-Pons, Armand Abergel, Mélanie Van Hollebeke, Valérie Sautou, Anne Boyer, Aurélien Mulliez, Université Grenoble Alpes - UFR Pharmacie (UGA UFRP), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA), Service d'Hépatogastroentérologie, CHU Saint-Eloi, Université de Clermont-Ferrand, Université Grenoble Alpes (UGA), CHU Clermont-Ferrand, Unité de Biostatistiques, Délégation Recherche Clinique & Innovation, Institut de Chimie de Clermont-Ferrand - Clermont Auvergne (ICCF), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte - Clermont Auvergne (M2iSH), Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Knowledge Information and Web Intelligence (KIWI), Department of Complex Systems, Artificial Intelligence & Robotics (LORIA - AIS), Laboratoire Lorrain de Recherche en Informatique et ses Applications (LORIA), Institut National de Recherche en Informatique et en Automatique (Inria)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche en Informatique et en Automatique (Inria)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire Lorrain de Recherche en Informatique et ses Applications (LORIA), Institut National de Recherche en Informatique et en Automatique (Inria)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche en Informatique et en Automatique (Inria)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Hôpital Saint Eloi (CHRU Montpellier), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
Subjects: Male, medicine.medical_specialty, Prescription Drugs, Pharmaceutical Science, Pharmacy, Pilot Projects, Community Pharmacy Services, Toxicology, Pharmacists, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Medication Reconciliation, Professional Role, Health care, Chi-square test, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Medical prescription, Hospital pharmacy, Prospective cohort study, Hospital discharge, Aged, Pharmacology, business.industry, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, Continuity of Patient Care, Middle Aged, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Patient Discharge, 3. Good health, Family medicine, Continuity of treatment, Female, Medical emergency, France, business, Pharmacy Service, Hospital, Seamless care, Community pharmacy, Medication list
Abstract: International audience; Background Care transitions from hospital to community have been identified as risk points for the continuity of patient care. Without upstream information, the community pharmacist (CP) cannot ensure error-free drug dispensing. A hospital-to-community records transmission process would enable CPs to guarantee that all prescription drugs are ready to pick up at hospital discharge, and to improve their responses to patient health inquiries. Objective To evaluate the impact of a hospital-to-CP medication records scheme on post-discharge continuity of patient treatment. Setting A University Hospital Digestive Surgery Department. Method Prospective, single-center, randomized pilot study. Eligible adult Digestive Surgery department patients discharged home over a period of 4 months were included. The medication reconciliation procedure was the same in both arms of the study. For patients included in the intervention group, CPs were sent the discharge prescription, patient medication list, and clinical and biological data required for drug dispensing. At 7 ± 2 days post-discharge, the CPs were surveyed by questionnaire. Seamlessness of drug continuity, use of the discharge medication form, and CP satisfaction with the scheme were assessed. Main outcome measures Prevalence of medication shortages, i.e. CPs unable to supply the appropriate drugs at discharge, and CP satisfaction levels, analyzed using Chi squared test. Results 124 patients were included. Of 124 CPs surveyed, 104 returned a completed questionnaire. Analysis found medication shortage in 10 control-group patients and one intervention-group patient (p < 0.005), non-availability of the full prescription in 24 % of control-group patients and 6 % of intervention-group patients (p < 0.013). In terms of CP satisfaction, 96 % of the intervention-group CPs stated that they were satisfied with the new hospital-to-community liaison initiative, while just 24 % of control-group CPs were satisfied with the current level of hospital-to-community liaison. Mean hospital pharmacist time input required for this initiative was an estimated 21 min for the control group versus 35 min for the intervention group. Conclusion The results provide a strong rationale for embedding the process longer-term and extending it out to other healthcare services. A pre-project study is needed to define which service departments and patients groups should be given priority for this process initiative.
Published: 2016

10. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study

Author: Nguyen, Minh Vu Chuong, Romand, Xavier, Trocme, Candice, Courtier, Anaïs, Marotte, Hubert, Thomas, Thierry, Miossec, Pierre, Tebib, Jacques, Grange, Laurent, Toussaint, Bertrand, Gaudin, Philippe, Nourisson, Cynthia, Soubrier, Martin, Mulliez, Aurelien, Baillet, Athan, Bardin, Thomas, Combe, Bernard, Dougados, Maxime, Flipo, René-Marc, Ravaud, Philippe, Tournadre, Anne, Derambure, C., Dzangue-Tchoupou, G., Bérard, C., Vergne, N., Hiron, M., D’Agostino, M., Musette, P., Lequerré, Thierry, Ruyssen-Witrand, Adeline, Degboé, Yannick, Cantagrel, Alain, Nigon, D., Lukas, C., Scaramuzzino, S, Allanore, Y., Schaeverbeke, Thierry, Morel, J., Sibilia, Jean, Cambon-Thomsen, A., Dieudé, P., Constantin, A, Nocturne, G., Virone, A., Ng, Wan-Fai, Le Guern, V., Hachulla, E., Cornec, D., Daien, C., Bienvenu, B., Marcelli, C., Wendling, D., Amoura, Z., Dhote, R., Lavigne, C., Fior, R., Gottenberg, Jacques-Eric, Seror, R., Mariette, Xavier, Eble, V., Legallicier, B., Joly, P., Caron, F., Tamion, F., Ducrotté, P., Lévesque, H., Ménard, J.-F., Jouen, F., Guerrot, D., Marié, I., D'Agostino, Maria-Antonietta, Wakefield, Richard, Berner-Hammer, Hilde, Vittecoq, Olivier, Filippou, Georgios, Bálint, Péter, Möller, Ingrid, Iagnocco, Annamaria, Naredo, Esperanza, Ostergaard, Mikkel, Boers, Maarten, Gaillez, Corine, Van Holder, Karina, Le Bars, Manuela, Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Université Grenoble Alpes - UFR Médecine (UGA UFRM), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Thérapeutique Recombinante Expérimentale (TIMC-IMAG-TheREx), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Groupe de Recherche et d'Etude du Processus Inflammatoire (GREPI), Centre National de la Recherche Scientifique (CNRS)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service de Rhumatologie [Saint-Etienne], Hôpital de Bellevue-CHU Saint-Etienne, Service d'Endocrinologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Department of Immunogenomics, Mixed Unit HCL-BioMerieux, Hopital E. Herriot, Hospices Civils de Lyon (HCL), Service de Rhumatologie, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, Service de rhumatologie, CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Lapeyronie [Montpellier] (CHU), Service de rhumatologie [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Unité de Nutrition Humaine (UNH), Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université-Institut National de la Recherche Agronomique (INRA), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Laboratoire de Mathématiques Raphaël Salem (LMRS), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS), Service de rhumatologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices (PANTHER), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU), CHU Toulouse [Toulouse], Service de rhumatologie et réadaptation fonctionelle, CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], Hôpital Purpan [Toulouse], Centre de rhumatologie, CHU Purpan, Institut Cochin (IC UM3 (UMR 8104 / U1016)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Bordeaux [Bordeaux], Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Hôpital Bicêtre-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Institute of Cellular Medicine [Newcastle], Newcastle University [Newcastle], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Rhumatologie [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), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hôpital Avicenne [AP-HP], Hôpital Antoine Béclère, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Immuno-Rhumatologie Moléculaire, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA), CHU Le Kremlin-Bicêtre (Rheumatology Department), Department of Rheumatology, Service de Médecine Interne [CHU Rouen], Service de Néphrologie [Rouen], Laboratoire Interuniversitaire de Biologie de la Motricité (LIBM ), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Unité de biostatistiques [CHU Rouen], Physiopathologie et biothérapies des maladies inflammatoires et autoimmunes, Service de Dermatologie [Rouen], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], Academic Unit of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, Chapel Allerton Hospital, Rheumatology Unit [Siena], National Institute of Rheumatology and Physiotherapy, Instituto Poal de Reumatologia, Barcelona, Università degli studi di Torino (UNITO), Fundación Jiménez Díaz, Fundacion Jimenez Diaz [Madrid] (FJD), Center for Rheumatology and Spine Diseases, Copenhagen (Center for Rheumatology and Spine Diseases), VU University Medical Center [Amsterdam], Epidemiology and Data Science, Rheumatology, AII - Inflammatory diseases, Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Université Grenoble Alpes (UGA), Groupe de Recherche et d'Etudes du Processus Inflammatoire (GREPI), Université Joseph Fourier - Grenoble 1 (UJF), Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), CHU Saint-Etienne-Hôpital de Bellevue, Délégation à la recherche clinique et aux innovations (DRCI), CHU de Clermont-Ferrand, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière, CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Hôpital Claude Huriez-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de Nutrition Humaine - Clermont Auvergne (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA), Service de rhumatologie [Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Bicêtre, CHU Cochin [AP-HP], Service de Rhumatologie [CHRU de Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Hôpital avicenne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris 13 (UP13)-Hôpital Avicenne, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Médecine Interne [Rouen], Service d'Hépato-Gastroentérologie [Rouen], Unité de biostatistiques [Rouen], Normandie Université (NU)-Normandie Université (NU)-Hôpital Charles Nicolle [Rouen], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Ambroise Paré, fundacion Jimenez Diaz, VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest-Institut Brestois Santé Agro Matière (IBSAM), Università degli studi di Torino = University of Turin (UNITO), Service de Rhumatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de Rhumatologie [CHU Toulouse], Pôle Inflammation, infection, immunologie et loco-moteur [CHU Toulouse] (Pôle I3LM Toulouse), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Hôpital Charles Nicolle [Rouen], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Laboratoire de recherche européen pour la polyarthrite rhumatoïde (GenHotel - EA 3886), Université d'Évry-Val-d'Essonne (UEVE), and Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Avicenne
Subjects: Male, Genetics and Molecular Biology (all), Settore MED/16 - REUMATOLOGIA, [SDV]Life Sciences [q-bio], DMARDs (biologic), Severity of Illness Index, Biochemistry, Arthritis, Rheumatoid, 0302 clinical medicine, Disease Activity, Rheumatoid Arthritis, Ultrasonography, Rheumatology, Immunology, Biochemistry, Genetics and Molecular Biology (all), Immunology and Allergy, Rheumatoid, 030212 general & internal medicine, Prospective Studies, skin and connective tissue diseases, Prospective cohort study, ComputingMilieux_MISCELLANEOUS, Synovitis, biology, Doppler, Middle Aged, 3. Good health, Europe, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Combination, [SDV.IMM]Life Sciences [q-bio]/Immunology, Drug Therapy, Combination, Female, medicine.symptom, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, General Biochemistry, Genetics and Molecular Biology, Abatacept, 03 medical and health sciences, Drug Therapy, Predictive Value of Tests, Internal medicine, medicine, Humans, Aged, 030203 arthritis & rheumatology, business.industry, Arthritis, C-reactive protein, Ultrasonography, Doppler, Joint effusion, Clinical and Epidemiological Research, medicine.disease, Methotrexate, biology.protein, Physical therapy, Joints, business, Rheumatism, Biomarkers
Abstract: Objectives To study the responsiveness of a combined power Doppler and greyscale ultrasound (PDUS) score for assessing synovitis in biologic-naive patients with rheumatoid arthritis (RA) starting abatacept plus methotrexate (MTX). Methods In this open-label, multicentre, single-arm study, patients with RA (MTX inadequate responders) received intravenous abatacept (∼10 mg/kg) plus MTX for 24 weeks. A composite PDUS synovitis score, developed by the Outcome Measures in Rheumatology–European League Against Rheumatism (OMERACT–EULAR)-Ultrasound Task Force, was used to evaluate individual joints. The maximal score of each joint was added into a Global OMERACT–EULAR Synovitis Score (GLOESS) for bilateral metacarpophalangeal joints (MCPs) 2–5 (primary objective). The value of GLOESS containing other joint sets was explored, along with clinical efficacy. Results Eighty-nine patients completed the 24-week treatment period. The earliest PDUS sign of improvement in synovitis was at week 1 (mean change in GLOESS (MCPs 2–5): −0.7 (95% CIs −1.2 to −0.1)), with continuous improvement to week 24. Early improvement was observed in the component scores (power Doppler signal at week 1, synovial hyperplasia at week 2, joint effusion at week 4). Comparable changes were observed for 22 paired joints and minimal joint subsets. Mean Disease Activity Score 28 (C reactive protein) was significantly reduced from weeks 1 to 24, reaching clinical meaningful improvement (change ≥1.2) at week 8. Conclusions In this first international prospective study, the composite PDUS score is responsive to abatacept. GLOESS demonstrated the rapid onset of action of abatacept, regardless of the number of joints examined. Ultrasound is an objective tool to monitor patients with RA under treatment. Trial registration number NCT00767325.
Published: 2016

11. Pediatric-Like Acute Lymphoblastic Leukemia Therapy in Adults With Lymphoblastic Lymphoma: The GRAALL-LYSA LL03 Study

Author: Patrice Chevallier, Carlos Graux, Vahid Asnafi, Anne Moreau, Thomas Vermeulin, Jacques Benichou, Gilles Salles, Stephanie Seris, Josette Brière, Norbert Ifrah, Aline Tanguy-Schmidt, Stéphane Leprêtre, Elizabeth Macintyre, Marie-Christine Béné, Jean-Michel Picquenot, Aurore Touzart, Serge Bologna, Reda Bouabdallah, Valérie Tallon-Simon, Françoise Huguet, Emmanuel Raffoux, Thierry Lamy, Hervé Dombret, Groupe d'étude des proliférations lymphoïdes ( GPL ), Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Institut Necker Enfants-Malades (INEM) ( INEM - UM 111 (UMR 8253 / U1151) ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Hôpital Charles Nicolle [Tunis], Pharmacoepidemiologie et évaluation de l'impact des produits de santé sur les populations, Université Bordeaux Segalen - Bordeaux 2-Université de Rouen Normandie ( UNIROUEN ), HEMATOLOGIE, CRLCC Henri Becquerel, Service d'Hématologie Clinique [Nantes], Hôpital Hôtel Dieu-Centre hospitalier universitaire de Nantes ( CHU Nantes ), Centre de Recherche en Cancérologie / Nantes - Angers ( CRCNA ), CHU Angers-Centre hospitalier universitaire de Nantes ( CHU Nantes ) -Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Hôpital Laennec-Centre National de la Recherche Scientifique ( CNRS ) -Faculté de Médecine d'Angers, Laboratoire de Biologie Moléculaire de la Cellule ( LBMC ), École normale supérieure - Lyon ( ENS Lyon ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Service d'hématologie clinique, Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou, Service d'Hématologie [Nantes], Centre hospitalier universitaire de Nantes ( CHU Nantes ), Service d'hématologie biologique, Assistance publique - Hôpitaux de Paris (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Centre Hospitalier Universitaire de Purpan ( CHU Purpan ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Département d'Hematologie, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Service d'anatomo-pathologie [Paris], Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Cliniques Universitaires UCL de Mont-Godinne, Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ), The study was supported by a grant from the French Ministry of Health (Projet Hospitalier de Recherche Clinique of France [PHRC 2003 No. 13-2]). The Macintyre laboratory was supported by the Fondation de France, the Association de Recherche sur le Cancer, Cent pour Sang la Vie, and the Société Française des Cancers de l’Enfant. CHUGAI PHARMA France provided technical and financialsupport., Groupe d'étude des proliférations lymphoïdes (GPL), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Necker Enfants-Malades (INEM - UM 111 (UMR 8253 / U1151)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Innate Immunity and Immunotherapy (CRCINA-ÉQUIPE 7), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), CHU Pontchaillou [Rennes], Centre hospitalier universitaire de Nantes (CHU Nantes), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire d'Hématologie [Purpan], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Unité de biostatistiques [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Gvh et Gvl : Physiopathologie Chez l'Homme et Chez l'Animal, Incidence et Role Therapeutique, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Imagine - Institut des maladies génétiques (IMAGINE - U1163), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service hématologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Lymphocyte et cancer, IFR105-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université Bordeaux Segalen - Bordeaux 2-Université de Rouen Normandie (UNIROUEN), Hôpital Hôtel Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), Laboratoire de Biologie Moléculaire de la Cellule (LBMC), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UR)-Hôpital Pontchaillou, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Unité de biostatistiques [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Necker - Enfants Malades [AP-HP], Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou, Centre Hospitalier Universitaire de Purpan (CHU Purpan), Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire d'Angers ( CHU Angers ), PRES Université Nantes Angers Le Mans ( UNAM ), Centre Hospitalier Lyon Sud [CHU - HCL] ( CHLS ), Hospices Civils de Lyon ( HCL ), Université Toulouse III - Paul Sabatier ( UPS ), CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Imagine - Institut des maladies génétiques ( IMAGINE - U1163 ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Necker - Enfants Malades [AP-HP], IFR105-Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Bernardo, Elizabeth
Subjects: Male, Cancer Research, F-Box-WD Repeat-Containing Protein 7, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Phases of clinical research, Cell Cycle Proteins, Hematopoietic stem cell transplantation, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Gastroenterology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Central Nervous System Diseases, Recurrence, Antineoplastic Combined Chemotherapy Protocols, Prospective Studies, Young adult, Receptor, Notch1, Prospective cohort study, Hematopoietic Stem Cell Transplantation, Induction Chemotherapy, Middle Aged, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 3. Good health, Survival Rate, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.medical_specialty, Cyclophosphamide, Adolescent, Ubiquitin-Protein Ligases, [SDV.CAN]Life Sciences [q-bio]/Cancer, Disease-Free Survival, Maintenance Chemotherapy, 03 medical and health sciences, Young Adult, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, medicine, Humans, Survival rate, [ SDV ] Life Sciences [q-bio], L-Lactate Dehydrogenase, business.industry, F-Box Proteins, Lymphoblastic lymphoma, PTEN Phosphohydrolase, Induction chemotherapy, medicine.disease, Surgery, Consolidation Chemotherapy, ras Proteins, business, 030215 immunology
Abstract: Purpose This study evaluated the efficacy of pediatric-like acute lymphoblastic leukemia (ALL) therapy in adults with lymphoblastic lymphoma (LL). Patients and Methods This was a prospective phase II study in adults 18 to 59 years old with previously untreated LL. Patients were treated with an adapted pediatric-like ALL protocol, which included a corticosteroid prephase, a five-drug induction reinforced by sequential cyclophosphamide administration, dose-dense consolidation, late intensification, CNS prophylaxis, and a 2-year maintenance phase. Treatment response was assessed by computed tomography and optional positron emission tomography. Allogeneic hematopoietic stem cell transplant was offered to selected patients in first complete remission (CR) or unconfirmed CR. Results The study enrolled 148 patients (131 with T-lineage LL [T-LL] and 17 with B-lineage LL [B-LL]). A total of 119 patients with T-LL (90.8%) and 13 with B-LL (76.5%) reached CR/unconfirmed CR, including 26 with T-LL and two with B-LL who needed a second induction salvage course. Relapse occurred in 34 patients with T-LL and four with B-LL. In patients with T-LL, 3-year event-free survival was 63.3% (95% CI, 54.2% to 71.0%), disease-free survival was 72.4% (95% CI, 63.0% to 79.7%), and overall survival was 69.2% (95% CI, 60.0% to 76.7%). Multivariate analysis identified serum lactate dehydrogenase level and the NOTCH1/FBXW7/RAS/PTEN oncogene (a four-gene oncogenetic classifier) status but not positron emission tomography or hematopoietic stem cell transplant as independent prognostic factors for outcome in T-LL. Conclusion In adults with LL, an intensive pediatric-like ALL treatment protocol was associated with a good response rate and outcome. In patients with T-LL, the four-gene oncogenetic classifier and lactate dehydrogenase level were independent prognostic indicators.
Published: 2016

12. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke

Author: Nicolas Andant, Armand Bonnin, Emmanuel Coudeyre, Isabelle Hauret, Bruno Pereira, Claire Morel, Service de Médecine Physique et de Réadaptation, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Hôpital Corentin Celton [Issy-les-Moulineaux], Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université d'Auvergne - Clermont-Ferrand I (UdA), Centre Hospitalier Etienne Clémentel, Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université-Institut National de la Recherche Agronomique (INRA), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Descartes - Paris 5 (UPD5)-Hôpital Corentin Celton [Issy-les-Moulineaux], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université d'Auvergne (Clermont Ferrand 1) (UdA), Unité de Biostatistiques, Centre Hospitalier Universitaire de Clermont-Ferrand, Unité de Nutrition Humaine - Clermont Auvergne (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Descartes - Paris 5 ( UPD5 ) -Hôpitaux Universitaires Paris Ouest - Hôpital Corentin Celton [Issy-les-Moulineaux], Université d'Auvergne (Clermont Ferrand 1) ( UdA ), Unité de Nutrition Humaine - Clermont Auvergne ( UNH ), Université Clermont Auvergne ( UCA ) -Institut national de la recherche agronomique [Auvergne/Rhône-Alpes] ( INRA Auvergne/Rhône-Alpes ), and Coudeyre, Emmanuel
Subjects: Male, 030506 rehabilitation, Neurology, Palpation, essai clinique, 0302 clinical medicine, Clinical Protocols, gastrocnemius, Clinical endpoint, Protocol, Medicine, Single-Blind Method, Prospective Studies, Botulinum Toxins, Type A, Range of Motion, Articular, Stroke, Ultrasonography, Aged, 80 and over, Cross-Over Studies, medicine.diagnostic_test, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, electrostimulation, clinical trial, General Medicine, Middle Aged, Botulinum toxin, 3. Good health, Santé publique et épidémiologie, Treatment Outcome, Neuromuscular Agents, Muscle Spasticity, Female, France, patient, medicine.symptom, 0305 other medical science, Range of motion, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Modified Ashworth scale, Médecine humaine et pathologie, Hemiplegia, accident vasculaire cérébral, Injections, Intramuscular, Rehabilitation Medicine, 03 medical and health sciences, Young Adult, Physical medicine and rehabilitation, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Humans, Spasticity, Aged, soleus, business.industry, echography, medicine.disease, Physical therapy, Human health and pathology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: This work was supported by CHU Clermont-Ferrand, and IPSEN provided funding for the ultrasound; INTRODUCTION: Botulinum toxin injections are an effective treatment for limb spasticity following stroke. Different tracking techniques are used for this purpose: palpation, electrostimulation, electromyography and ultrasound. Yet very few studies have compared these different techniques, and none has successfully proved the superior efficacy of ultrasound-guided injections compared to another tracking method. The primary objective of our study was therefore to compare the efficacy of botulinum toxin injections depending on the tracking technique used: ultrasound versus electrostimulation. METHODS AND ANALYSIS: This is a clinical, single-centre, prospective, interventional, single-blind, crossover, randomised trial. In total, 30 patients aged between 18 and 80 years presenting with triceps surae spasticity (evaluated >1 on the modified Ashworth scale) associated with hemiplegia sequelae due to stroke will be included. The patients will be selected among those who attend for consultation the Physical Medicine and Rehabilitation Department of the Clermont-Ferrand University Hospital. One group will receive the abobotulinumtoxinA (BoNT-A) injection guided by electrostimulation then ultrasound, and the second group's botulinum toxin injections will be guided by ultrasound then electrostimulation. For each patient, the duration of study participation is 5 months. The primary end point is variation in passive ankle dorsiflexion range of motion at slow and high speeds (Tardieu scale) with the knee straight. ETHICS AND DISSEMINATION: This study received ethics approval form the CPP of Rhones-Alpes region. Results will be published in a peer-reviewed journal
Published: 2016

13. Fructose Malabsorption in Systemic Sclerosis

Author: Isabelle Marie, Philippe Ducrotté, Guillaume Gourcerol, Hervé Levesque, Jean-François Ménard, Anne-Marie Leroi, Service de Médecine Interne [Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Service de physiologie digestive, urinaire, respiratoire et de l'exercice [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Unité de biostatistiques [Rouen], CHU Rouen, Service d'Hépato-Gastroentérologie [Rouen], Service de Médecine Interne [CHU Rouen], Service de physiologie digestive, urinaire, respiratoire et de l'exercice [CHU Rouen], Normandie Université (NU)-Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de biostatistiques [CHU Rouen], Service d'Hépato-Gastroentérologie [CHU Rouen], and Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN)
Subjects: Adult, Male, medicine.medical_specialty, Malabsorption, Observational Study, Fructose malabsorption, Fructose, Gastroenterology, chemistry.chemical_compound, Malabsorption Syndromes, Risk Factors, Internal medicine, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Prospective Studies, skin and connective tissue diseases, ComputingMilieux_MISCELLANEOUS, Aged, 2. Zero hunger, Breath test, Intestinal permeability, Scleroderma, Systemic, Gastric emptying, medicine.diagnostic_test, integumentary system, business.industry, Fructose Intolerance, General Medicine, Middle Aged, medicine.disease, 3. Good health, Diet, Diarrhea, Endocrinology, chemistry, Breath Tests, Female, medicine.symptom, business, Research Article
Abstract: The deleterious effect of fructose, which is increasingly incorporated in many beverages, dairy products, and processed foods, has been described; fructose malabsorption has thus been reported in up to 2.4% of healthy subjects, leading to digestive clinical symptoms (eg, pain, distension, diarrhea). Because digestive involvement is frequent in patients with systemic sclerosis (SSc), we hypothesized that fructose malabsorption could be responsible for intestinal manifestations in these patients. The aims of this prospective study were to: determine the prevalence of fructose malabsorption, in SSc; predict which SSc patients are at risk of developing fructose malabsorption; and assess the outcome of digestive symptoms in SSc patients after initiation of standardized low-fructose diet. Eighty consecutive patients with SSc underwent fructose breath test. All SSc patients also completed a questionnaire on digestive symptoms, and a global symptom score (GSS) was calculated. The prevalence of fructose malabsorption was as high as 40% in SSc patients. We also observed a marked correlation between the presence of fructose malabsorption and: higher values of GSS score of digestive symptoms (P = 0.000004); and absence of delayed gastric emptying (P = 0.007). Furthermore, in SSc patients with fructose malabsorption, the median value of GSS score of digestive symptoms was lower after initiation of standardized low-fructose diet (4 before vs. 1 after; P = 0.0009). Our study underscores that fructose malabsorption often occurs in SSc patients. Our findings are thus relevant for clinical practice, highlighting that fructose breath test is a helpful, noninvasive method by: demonstrating fructose intolerance in patients with SSc; and identifying the group of SSc patients with fructose intolerance who may benefit from low-fructose diet. Interestingly, because the present series also shows that low-fructose diet resulted in a marked decrease of gastrointestinal clinical manifestations in SSc patients with fructose malabsorption, our findings underscore that fructose malabsorption may play a significant role in the onset of gastrointestinal symptoms in these patients. Finally, we suggest that fructose malabsorption may be due to reduced fructose absorption by enterocytes, impaired enteric microbiome, and decreased intestinal permeability.
Published: 2015

14. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC)

Author: David Sefrioui, Ludivine Beaussire, André Gillibert, France Blanchard, Emmanuel Toure, Céline Bazille, Anne Perdrix, Frédéric Ziegler, Alice Gangloff, Mélanie Hassine, Caroline Elie, Anne-Laure Bignon, Aurélie Parzy, Philippe Gomez, Caroline Thill, Florian Clatot, Jean-Christophe Sabourin, Thierry Frebourg, Jacques Benichou, Karine Bouhier-Leporrier, Marie-Pierre Gallais, Nasrin Sarafan-Vasseur, Pierre Michel, Frédéric Di Fiore, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU), Unité de biostatistiques [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Département de Pathologie [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), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Laboratoire de biochimie générale [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Centre hospitalier universitaire de Rouen, Hepatogastroenterologie, chu Elbeuf Les Feugrais, Hepatogastroenterology, Caen University Hospital, Caen., Department of Hepatogastroenterology, Caen University Hospital, Departement Hepatogastroenterologie, Centre Francois Baclesse, Caen, Medical Oncology, centre Frédéric Joliot, Département de génétique [CHU Rouen] (Centre Normandie de Génomique et de Médecine Personnalisée), Service d'Hépato-Gastroentérologie [CHU Rouen], and Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN)
Subjects: Adult, Male, Cell kinetics, Oncology, Cancer Research, medicine.medical_specialty, Scoring system, endocrine system diseases, Colorectal cancer, medicine.medical_treatment, Article, Circulating Tumor DNA, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], medicine, Humans, Antigens, Tumor-Associated, Carbohydrate, In patient, Prospective Studies, Neoplasm Metastasis, ComputingMilieux_MISCELLANEOUS, Aged, Aged, 80 and over, Chemotherapy, business.industry, Middle Aged, Neoplastic Cells, Circulating, medicine.disease, Survival Analysis, digestive system diseases, Carcinoembryonic Antigen, Up-Regulation, 3. Good health, Gene Expression Regulation, Neoplastic, 030220 oncology & carcinogenesis, Circulating DNA, Female, CA19-9, Colorectal Neoplasms, business, Progressive disease
Abstract: BACKGROUND: We previously reported that CEA kinetics are a marker of progressive disease (PD) in metastatic colorectal cancer (mCRC). This study was specifically designed to confirm CEA kinetics for predicting PD and to evaluate CA19-9, cell-free DNA (cfDNA), circulating tumour DNA (ctDNA) and circulating tumour cell (CTC) kinetics. METHODS: Patients starting a chemotherapy (CT) with pre-treatment CEA > 5 ng/mL and/or CA19.9 > 30 UI/mL were prospectively included. Samples were collected from baseline to cycle 4 for CEA and CA19-9 and at baseline and the sixth week for other markers. CEA kinetics were calculated from the first to the third or fourth CT cycle. RESULTS: A total of 192 mCRC patients were included. CEA kinetics based on the previously identified >0.05 threshold was significantly associated with PD (p
Published: 2021

15. Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

Author: Buisson, Anthony, Nancey, Stéphane, Manlay, Luc, Rubin, David, Hebuterne, Xavier, Pariente, Benjamin, Fumery, Mathurin, Laharie, David, Roblin, Xavier, Bommelaer, Gilles, Pereira, Bruno, Peyrin‐biroulet, Laurent, Vuitton, Lucine, Post-Op Study Grp, Ustek, Service d'Hépatologie Gastro-entérologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Service d'Hépatogastroentérologie [CHU Lyon-Sud], Hospices Civils de Lyon (HCL), The University of Chicago Medicine [Chicago], Servcie Hépato-gastroentérolgie et Nutrition clinique [CHU Nice], Centre Hospitalier Universitaire de Nice (CHU Nice), Service Gastro-entérologie adulte – Maladies de l’appareil digestif [CHU Lille], CHU Lille, Service d'Hépato Gastroenterologie [CHU Amiens-Picardie], CHU Amiens-Picardie, Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Service Gastroentérologie [CHU Bordeaux], Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux), Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de Gastro-Entérologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), 'Francois Aupetit' Association (AFA CrohnRCH), CHU Clermont-Ferrand (DRCI), Centre Hospitalier Universitaire de Lille (CHU Lille), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de l'Environnement Industriel et des Risques, Service de gastroentérologie [CHU Saint-Etienne], and Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)
Subjects: Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Azathioprine, Antibodies, Monoclonal, Humanized, Gastroenterology, ustekinumab, law.invention, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Gastrointestinal Agents, Randomized controlled trial, Recurrence, law, Internal medicine, Ustekinumab, Secondary Prevention, medicine, Clinical endpoint, Humans, postoperative recurrence, Propensity Score, Retrospective Studies, Crohn's disease, azathioprine, business.industry, Inflammatory Bowel Disease, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Bowel resection, medicine.disease, Control Groups, 3. Good health, Oncology, 030220 oncology & carcinogenesis, Cohort, Propensity score matching, Original Article, Female, 030211 gastroenterology & hepatology, business, Immunosuppressive Agents, medicine.drug
Abstract: International audience; Background: Preventing postoperative recurrence (POR) is a major concern in Crohn's disease (CD). While azathioprine is an option, no data is available on ustekinumab efficacy in this situation.Aims: We compared the effectiveness of ustekinumab versus azathioprine in preventing endoscopic POR in CD.Methods: We retrospectively collected data from all consecutive CD patients treated with ustekinumab after intestinal resection in 9 centers. The control group (azathioprine alone) was composed of patients who participated in a randomized controlled trial conducted in the same centers comparing azathioprine alone or in combination with curcumin. Propensity score analyses (inversed probability of treatment weighting = IPTW) were applied to compare the two groups. The primary endpoint was endoscopic POR (Rutgeerts' index ≥ i2) at 6 months.Results: Overall, 32 patients were included in the ustekinumab group and 31 in the azathioprine group. The propensity score analysis was adjusted on the main risk factors (smoking, fistulizing phenotype, prior bowel resection, resection length >30 cm and ≥2 biologics before surgery) and thiopurines or ustekinumab exposure prior to surgery making the two arms comparable (∣d∣ < 0.2). After IPTW, the rate of endoscopic POR at 6 months was lower in patients treated with ustekinumab compared to azathioprine (28.0% vs. 54.5%, p = 0.029). After IPTW, the rates of i2b-endoscopic POR (Rutgeerts' index ≥ i2b) and severe endoscopic POR (Rutgeerts' index ≥ i3) were 20.8% versus 42.5% (p = 0.066) and 16.9% versus 27.9% (p = 0.24), in the ustekinumab and azathioprine groups, respectively.Conclusion: Ustekinumab seemed to be more effective than azathioprine in preventing POR in this cohort of CD patients.
Published: 2021

16. Prognostic factors of paraneoplastic pemphigus

Author: Luc Thomas, Saskia Ingen-Housz-Oro, Sandy Léger, Gilles Chaumentin, Caroline Robert, Pierre-Jean Weiller, Philippe Courville, Fabienne Léonard, Pascal Joly, Laurent Machet, Stéphane Debarbieux, Estelle Houivet, M. Dandurand, Francis Carsuzaa, Jacqueline Chevrant-Breton, Jean-Philippe Arnault, François Aubin, Denis Jullien, Michel D'Incan, Gérard Guillet, Olivier Chosidow, Catherine Lok, Jean-Philippe Lacour, Vincent Ferranti, Danièle Gilbert, Damien Picard, Marie-Sylvie Doutre, I. Kupfer, Olivier Dereure, Jacques Benichou, Carle Paul, Béatrice Crickx, Emmanuel Delaporte, Jean-Michel Pignon, Ludovic Martin, Physiopathologie et biothérapies des maladies inflammatoires et autoimmunes, Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Littoral, Environnement, Télédétection, Géomatique (LETG-Angers), Littoral, Environnement, Télédétection, Géomatique UMR 6554 (LETG), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-Université d'Angers (UA)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université de Brest (UBO)-Université de Rennes 2 (UR2), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Géographie et d'Aménagement Régional de l'Université de Nantes (IGARUN), Université de Nantes (UN)-Université de Nantes (UN)-Université de Caen Normandie (UNICAEN), Université de Nantes (UN)-Université de Nantes (UN), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de Dermatologie, Hôtel-Dieu, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Department of Dermatology, Université d'Angers (UA), Service de dermatologie, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Service de Dermatologie, Centre Hospitalier Sud, Hospices Civils, Lyon, Protéines de défense des réponses immune et inflammatoire : identification, régulation et rôles physiopathologiques, Unité de biostatistiques [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Laboratoire d'Etudes Environnementales des Systèmes Anthropisés, Université d'Angers ( UA ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Hospices Civils de Lyon ( HCL ), Institut Gustave Roussy ( IGR ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Unité de biostatistiques [Rouen], and CHU Rouen-Université de Rouen Normandie ( UNIROUEN )
Subjects: Male, Erythema, Paraneoplastic Syndromes, Kaplan-Meier Estimate, Severity of Illness Index, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 030207 dermatology & venereal diseases, Antibodies, Monoclonal, Murine-Derived, 0302 clinical medicine, Adrenal Cortex Hormones, Neoplasms, Erythema multiforme, Aged, 80 and over, Univariate analysis, integumentary system, Mortality rate, Castleman disease, Hazard ratio, General Medicine, Middle Aged, Prognosis, 3. Good health, 030220 oncology & carcinogenesis, Female, medicine.symptom, Rituximab, Immunosuppressive Agents, Adult, medicine.medical_specialty, Dystonin, [SDV.CAN]Life Sciences [q-bio]/Cancer, Nerve Tissue Proteins, Dermatology, 03 medical and health sciences, medicine, Humans, Immunologic Factors, Protein Precursors, Aged, Autoantibodies, Proportional Hazards Models, Retrospective Studies, Erythema Multiforme, Mucous Membrane, Proportional hazards model, business.industry, Plakins, Membrane Proteins, medicine.disease, Cytoskeletal Proteins, Paraneoplastic pemphigus, Desmoplakins, Multivariate Analysis, business, Carrier Proteins, Pemphigus
Abstract: International audience; OBJECTIVE To identify the prognostic factors of overall survival in a series of patients with paraneoplastic pemphigus (PNP). DESIGN Multicenter retrospective cohort study. SETTING Twenty-seven dermatology departments in France. PATIENTS A total of 53 patients (31 men and 22 women; median age, 59 years; age range, 30-88 years) were diagnosed as having PNP between 1992 and 2010. MAIN OUTCOME MEASURES Overall Kaplan-Meier survival rates were estimated, and features associated with survival were assessed using univariate (log-rank test) and multivariate (Cox regression) analyses. RESULTS The study included 53 patients with PNP. Thirty-six patients (68%) died during the study. The 1-, 3-, and 5-year overall survival rates were 49%, 41%, and 38%, respectively. The main causes of death were infections (n = 21) and evolution of neoplasia (n = 6). In univariate analysis, the main detrimental prognostic factors identified were erythema multiforme-like skin lesions (P = .05) and histologic keratinocyte necrosis (P = .03). None of the 5 patients with Castleman disease died during the study. After adjustment for age and sex in multivariate analysis, erythema multiforme-like skin lesions remained predictive of fatal outcome, with a 2-fold increase in death rate (hazard ratio [HR], 2.3; 95% CI, 1.05-5.03; P = .04). The prognosis of patients with PNP was even poorer when erythema multiforme-like skin lesions were associated with severe skin or mucosal involvement at presentation (HR of death, 3.0; 95% CI, 1.01-8.92; P = .049). CONCLUSION Patients with PNP with erythema multiforme-like skin lesions and histologic keratinocyte necrosis, especially when associated with extensive lesions at presentation, are likely to have a more severe and rapid fatal outcome and should be managed very carefully.
Published: 2012

17. Cancer mortality study among French cement production workers

Author: Michel Aubier, Michel Rossignol, Jacques Benichou, William Dab, Alain Marconi, Lucien Abenhaim, Denis Zmirou-Navier, Danièle Luce, Philippe Clément, Chaire d'Hygiène et sécurité du travail, Conservatoire National des Arts et Métiers [CNAM] (CNAM), Laboratoire Modélisation, épidémiologie et surveillance des risques sanitaires (MESuRS), Department of Epidemiology, Biostatistics and Occupational Health [Montréal], McGill University = Université McGill [Montréal, Canada], Santé publique et épidémiologie des déterminants professionnels et sociaux de la santé, Epidémiologie, sciences sociales, santé publique (IFR 69), Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-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)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Unité de biostatistiques [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Lafarge Centre de Recherche [Lyon] (Lafarge LCR Lyon), Lafarge, Auteur indépendant, Physiopathologie et Epidemiologie de l'Insuffisance Respiratoire, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut National de la Santé et de la Recherche Médicale (INSERM), 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), Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lafarge France [Groupe Holcim], McGill University, Université Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Panthéon-Sorbonne (UP1)-Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Descartes - Paris 5 (UPD5)-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)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Unité de biostatistiques [Rouen], and Université de Lorraine (UL)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, Santé publique, MESH: Regression Analysis, MESH: Occupational Exposure, Cohort Studies, 0302 clinical medicine, Risk Factors, MESH: Risk Factors, Neoplasms, Medicine, MESH: Neoplasms, MESH: Incidence, MESH: Cohort Studies, Cancer, MESH: Aged, education.field_of_study, Public health, MESH: Middle Aged, Mortality rate, Incidence, Middle Aged, 030210 environmental & occupational health, Occupational Diseases, MESH: Young Adult, 030220 oncology & carcinogenesis, 8. Economic growth, Cohort, Regression Analysis, Female, France, Cohort study, Adult, MESH: Occupational Diseases, medicine.medical_specialty, Portland cement, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Young Adult, Occupational Exposure, MESH: Construction Materials, Humans, education, Aged, Retrospective Studies, [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, MESH: Humans, business.industry, Proportional hazards model, Construction Materials, Public Health, Environmental and Occupational Health, MESH: Adult, MESH: Retrospective Studies, Cement production, Confidence interval, MESH: Male, MESH: France, Standardized mortality ratio, Mortality study, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female, Demography
Abstract: International audience; PURPOSE: To analyse the mortality and its causes, especially cancer, among French cement production workers. METHODS: A cohort of all workers employed at least 1 year in one of the main four cement companies in France was assembled (9,118 workers, 122,124 person-years of follow-up between 1990 and 2005). A common job titles classification was used to analyse occupational risk factors. We conducted a standardized mortality ratio analysis based on age, gender and calendar-period-specific national mortality rates and explored the combined effect of job titles and duration through an internal Cox regression analysis. RESULTS: The number of deaths during the follow-up period was 430 (4.7%). Malignant neoplasm was the cause of 48.1% of deaths. Overall, a deficit in all-causes mortality (standardized mortality ratio (SMR): 0.68, 95% confidence interval (CI) 0.61-0.74) and in cancer mortality (SMR: 0.80, CI 0.69-0.92) was observed. Working in the quarry, yard and shipping sectors was associated with a 50% higher all-causes mortality risk in comparison with the administrative sector. CONCLUSIONS: This cohort study does not support previous observations that cement workers are at higher risk of cancer mortality than the general population. The length of follow-up should be increased, and specific exposures deserve analysis.
Published: 2011

18. Effect of high intensity interval training on body composition in women before and after menopause: a meta‐analysis

Author: Marcelo Luis Marquezi, Nathalie Boisseau, Florie Maillard, Marine Dupuit, Bruno Pereira, Antonio Herbert Lancha, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Escola de Educação Física e Esporte, Universidade de São Paulo (USP), Centre de Recherche en Nutrition Humaine Auvergne [CHU Clermont-Ferrand] (CRNH A), and Universidade de São Paulo = University of São Paulo (USP)
Subjects: Adult, medicine.medical_specialty, Physiology, ERGOMETRIA, High-Intensity Interval Training, Intra-Abdominal Fat, 030204 cardiovascular system & hematology, Overweight, Body weight, women, Interval training, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Weight Loss, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Medicine, Obesity, Aged, Nutrition and Dietetics, Postmenopausal women, business.industry, abdominal fat mass, Postmenopausal state, fat mass, General Medicine, Middle Aged, medicine.disease, Menopause, Meta-analysis, Body Composition, Physical therapy, Female, medicine.symptom, business, High-intensity interval training, 030217 neurology & neurosurgery
Abstract: International audience; New findings: What is the topic of this review? A meta-analysis of the efficacy of high intensity interval training (HIIT) in reducing weight, total fat mass (FM) and (intra)-abdominal FM in normal-weight and overweight/obese women before and after menopause. What advances does it highlight? HIIT programmes in women significantly decrease body weight and total and abdominal FM. Their effects are more evident in pre- than in postmenopausal women. Cycling HIIT seems more effective than running, especially in postmenopausal women, and training interventions longer than 8 weeks comprising three sessions a week should be promoted.Abstract: High-intensity interval training (HIIT) is a stimulating modality for reducing body weight and adipose tissue. The purpose of this meta-analysis was to assess the efficacy of HIIT in reducing weight, total fat mass (FM) and (intra)-abdominal FM in normal-weight and overweight/obese women before and after menopause. A structured electronic search was performed to find all publications relevant to our review. Stratified analyses were made of hormonal status (pre- vs. postmenopausal state), weight, HIIT modalities (cycling vs. running), programme duration (< or ≥8 weeks) and the methods used to measure body composition (dual-energy X-ray absorptiometry vs. computed tomography, Magnetic Resonance Imaging and others). A total of 38 studies involving 959 subjects were included. Our meta-analysis showed that overall HIIT programmes significantly decrease weight, total and abdominal FM in women. Both normal weight and overweight/obese women lost total FM after HIIT protocols whereas HIIT was only effective in decreasing abdominal FM in women with excess adiposity. When pre- and postmenopausal women were considered separately, the effect of HIIT on weight, total and abdominal FM were only significant before menopause. Cycling HIIT seemed more effective than running, especially in postmenopausal women, and training interventions longer than 8 weeks comprising three sessions were more efficient. HIIT is a successful strategy to lose weight and FM in normal weight and overweight/obese women. However, further studies are still needed to draw meaningful conclusions about the real effectiveness of HIIT protocols in postmenopausal women.
Published: 2020

19. Does legislative framework favors prescription of physical activity in primary care ? The French experience

Author: Martine Duclos, Lemlih Ouchchane, David Thivel, Lambert Celine, Marc Charles, CHU Clermont-Ferrand, Institut Pascal (IP), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne (UCA)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), and CHU Clermont-Ferrand-CHU Clermont-Ferrand
Subjects: medicine.medical_specialty, [SDV]Life Sciences [q-bio], Physical activity, Physical Therapy, Sports Therapy and Rehabilitation, Primary care, 03 medical and health sciences, primary care, 0302 clinical medicine, medicine, chronic disease management, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Medical prescription, Practice Patterns, Physicians', Exercise, Public health policy, ComputingMilieux_MISCELLANEOUS, exercise referral, public health policy, prescription, Primary Health Care, business.industry, Legislature, 030229 sport sciences, Exercise referral, female genital diseases and pregnancy complications, Chronic disease, Cross-Sectional Studies, Prescriptions, Family medicine, France, Element (criminal law), business
Abstract: International audience; Objective Regular physical activity (PA) is a key element in chronic disease management. We studied the effect of a recent legislative framework given to physical activity prescription (PAP) on practices, motivations, barriers, and needs for PAP in primary care among general practitioners (GP) of the Auvergne-Rhone-Alpes region, France.Methods Our cross-sectional survey used a self-administrated questionnaire through two recruitment methods: e-mail address (online group) and face-to-face (office group). Based on the data pertaining to demography, motivation scores, needs, and barriers, we analyzed the profiles of participating GPs.Results Among the 283 GPs, online participants (n = 250) were younger than office participants (n = 33) (46 +/- 11 vs. 51 +/- 12 years, p = 0.0083), and were physically more active (80% vs 51%, p = 0.0006). Regular PA was also critical in the profile of current prescribers (OR = 2.83 (95%CI [1.28, 7.00]), p = 0.015). The motivation score for PAP was high and equal in both groups (10.5 +/- 3.3 in a maximum of 15), but multiple barriers emerged, which demonstrated age-dependent variations in the score. Young GPs mostly identified self-imposed barriers (exercise referral, PAP training), while for older GPs these barriers were equally attributable to patients.Conclusion Although the legislative framework given to PAP in France was associated with a 12% increase in the number of prescribers, PA remains poorly prescribed in primary care, even among the most motivated physicians.
Published: 2022

20. Impact of Metastasis Surgery and Alkylating-Agent-Based Chemotherapy on Outcomes of Metastatic Malignant Phyllodes Tumors: A Multicenter Retrospective Study

Author: Jean-Yves Blay, Charles Honoré, Marick Laé, Audrey Monneur, Mehdi Brahmi, Fabien Reyal, Nicolas Isambert, Camille Chakiba, Esma Saada-Bouzid, Sophie Piperno-Neumann, Thomas Ryckewaert, Nelly Firmin, S. Thezenas, Christophe Sajous, Nicolas Penel, Sébastien Salas, Mathias Neron, Isabelle Ray-Coquard, François Bertucci, Florence Duffaud, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Unité de biostatistiques, CRLCC Val d'Aurelle - Paul Lamarque, Institut Curie [Paris], Département de recherche translationnelle, Département d'oncologie médicale, Institut Bergonié [Bordeaux], UNICANCER-UNICANCER, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Institut Gustave Roussy (IGR), Pôle chirurgical et interventionnel [Gustave Roussy], Centre de Recherche en Cancérologie de Marseille (CRCM), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Medical Oncology Unit, S. Camillo-Forlanini Hospital, Service d’Oncologie Médicale [Hôpital de la Timone - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Département d'oncologie médicale [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Centre Léon Bérard [Lyon], Service d'Oncologie Médicale, Département d'oncologie Médicale, Département de Recherche Translationnelle, Université de Lille-UNICANCER, Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)
Subjects: Adult, Male, Alkylating Agents, medicine.medical_specialty, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Breast Neoplasms, [SDV.BC]Life Sciences [q-bio]/Cellular Biology, Metastasis, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Phyllodes Tumor, Surgical oncology, medicine, Humans, Neoplasm Metastasis, Aged, Retrospective Studies, Aged, 80 and over, Chemotherapy, business.industry, Hazard ratio, Retrospective cohort study, Middle Aged, Prognosis, medicine.disease, Survival Analysis, Confidence interval, 3. Good health, Surgery, Radiation therapy, Oncology, Chemotherapy, Adjuvant, Surgical Procedures, Operative, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, France, Sarcoma, business
Abstract: Metastatic phyllodes tumors have poor prognosis with median overall survival of 11.5 months. The objective of this study is to identify prognostic factors and the best options for management of metastatic malignant phyllode tumors (MMPTs). A multicentric retrospective study, including cases of MMPT from 10 sarcoma centers, was conducted. The primary end-point was overall survival (OS), and the secondary end-point was the clinical benefit of chemotherapy (CBCT) rate. 51 MMPT patients were included. Median time from diagnosis to metastatic recurrence was 13 months. Management of MMPT consisted in surgery of the metastatic disease for 16 patients (31.3%), radiation therapy of the metastatic disease for 15 patients (31.9%), and chemotherapy for 37 patients (72.5%). Median follow-up was 62.1 months [95% confidence interval (CI) 31–80 months]. Median OS was 11.5 months (95% CI 7.5–18.7 months). On multivariate analysis, two or more metastatic sites [hazard ratio (HR) 2.81, 95% CI 1.27–6.19; p = 0.01] and surgery of metastasis (HR 0.33, 95% CI 0.14–0.78; p = 0.01) were independently associated with OS. The CBCT rate was 31.4% and 16.7% for the first and second lines. Polychemotherapy was not superior to single-agent therapy. Alkylating-agent-based chemotherapy, possibly associated with anthracyclines, was associated with a better CBCT rate than anthracyclines alone (p = 0.049). The results of this study emphasize the impact of the number of metastatic sites on survival of MMPT patients and the leading role of metastasis surgery in MMPT management. If systemic therapy is used, it should include alkylating agents, which are associated with a better clinical benefit.
Published: 2019

21. Assessment of anal sphincter distensibility following the STARR procedure: a pilot study

Author: Valérie Bridoux, Jean-Jacques Tuech, Chloé Melchior, Anne-Marie Leroi, Charlotte Desprez, Guillaume Gourcerol, Estelle Houivet, Service de physiologie digestive, urinaire, respiratoire et de l'exercice [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Service d'Hépato-Gastroentérologie [CHU Rouen], Service de chirurgie digestive [CHU Rouen], CHU Rouen, Unité de biostatistiques [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), and Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, medicine.medical_specialty, Anal Canal, Pilot Projects, 03 medical and health sciences, 0302 clinical medicine, Refractory, Surgical Stapling, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Medicine, Fecal incontinence, Rectal resection, Defecation, ComputingMilieux_MISCELLANEOUS, Medical treatment, business.industry, Rectocele, Recovery of Function, General Medicine, Middle Aged, Surgical correction, Dilatation, 3. Good health, Surgery, Treatment Outcome, Anal dilatation, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, medicine.symptom, business, Anal sphincter
Abstract: Aim: The STARR (Stapled Trans-Anal Rectal Resection) procedure consists of a surgical correction of symptomatic rectocele refractory to medical treatment, involving anal dilatation. The aim of the ...
Published: 2019

22. Creatine supplementation and VO 2 max: a systematic review and meta-analysis

Author: Marek Zak, Ukadike C. Ugbolue, Jean-Baptiste Bouillon-Minois, Damien Gras, Frédéric Dutheil, Charlotte Lanhers, Reza Bagheri, Emmanuel Coudeyre, Bruno Pereira, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, University of Isfahan, University of the West of Scotland (UWS), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, The Institute of Health Sciences, Collegium Medicum, The Jan Kochanowski University, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Pôle Urgences [CHU Clermont-Ferrand], Service Santé Travail Environnement [CHU Clermont-Ferrand], and WittyFit
Subjects: medicine.medical_specialty, Population, 030204 cardiovascular system & hematology, Creatine, Placebo, Placebo group, Industrial and Manufacturing Engineering, law.invention, ventilatory threshold, 03 medical and health sciences, chemistry.chemical_compound, Dietary supplement, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Medicine, education, endurance, education.field_of_study, cardiorespiratory fitness, VO2peak, business.industry, Cardiorespiratory fitness, 030229 sport sciences, General Medicine, 3. Good health, chemistry, Meta-analysis, Ventilatory threshold, business, human activities, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Food Science
Abstract: Although creatine supplementation is well-known to increase exercise performance in acute high-intensity exercises, its role in aerobic performance based on VO2max is more controversial. Thus, we performed a systematic review and meta-analysis on the effects of creatine supplementation on VO2max. PubMed, Cochrane, Embase, and ScienceDirect were searched for randomized controlled trials (RCTs) reporting VO2max in creatine supplementation and placebo groups before and after supplementation. We computed a random-effects meta-analysis on VO2max at baseline, within groups following supplementation, on changes on VO2max between groups, and after supplementation between groups. Sensitivity analyses and meta-regression were conducted. We included 19 RCTs for a total of 424 individuals (mean age 30 years old, 82% men). VO2max did not differ at baseline between groups (creatine and placebo). Participants in both groups were engaged in exercise interventions in most studies (80%). Using changes in VO2max, VO2max increased in both groups but increased less after creatine supplementation than placebo (effect size [ES] = -0.32, 95%CI = -0.51 to -0.12, p = 0.002). Comparisons after creatine supplementation confirmed a lower VO2max in the creatine group compared to the placebo group (ES= -0.20, 95%CI = -0.39 to -0.001, p = 0.049). Meta-analysis after exclusion from meta-funnel resulted in similar outcomes in a subgroup of young and healthy participants. Meta-regressions on characteristics of supplementation, physical training, or sociodemographic were not statistically significant. Creatine supplementation has a negative effect on VO2max, regardless of the characteristics of training, supplementation, or population characteristics.Supplemental data for this article is available online at https://doi.org/10.1080/10408398.2021.2008864 .
Published: 2021

23. Rheumatologic manifestations of sarcoidosis and increased risk of spondyloarthritis occurrence. A retrospective single center case-control study

Author: Thierry Lequerré, Stéphane Dominique, Julien Grosjean, Tiffany Deroualle, Francesco Monti, Olivier Vittecoq, Stéfan Jacques Darmoni, Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU), Unité de biostatistiques [CHU Rouen], Département d'Informatique Médicale (D2IM), Normandie Université (NU)-Normandie Université (NU), Laboratoire d'Informatique Médicale et Ingénierie des Connaissances en e-Santé (LIMICS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Sorbonne Paris Nord, and LEJEUNE, Emeline
Subjects: medicine.medical_specialty, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Sarcoidosis, business.industry, MEDLINE, Case-control study, [INFO] Computer Science [cs], medicine.disease, Single Center, Dermatology, Arthritis, Rheumatoid, Increased risk, Rheumatology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Case-Control Studies, Spondylarthritis, Humans, Medicine, [INFO]Computer Science [cs], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Retrospective Studies
Abstract: International audience; An association between sarcoidosis and spondyloarthritis (SpA) has already been reported. The prevalence of sacroiliitis in sarcoidosis was estimated between 6.6% and 23.4%. All patients with sacroiliitis were diagnosed with SpA according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. However, sacroiliac joint involvement has been described in sarcoidosis without associated SpA.This association led us to determine a clinical form of sarcoidosis predictive of SpA development and to evaluate their respective management.We conducted a retrospective, single-center, multiparameter, case-control study that enrolled patients with a sarcoidosis/SpA sequence, followed up between 1992 and 2018, who were randomly matched to patients with sarcoidosis without SpA development during the same period. Identification of patients was performed via a semantic query in the database of the Normandy Clinical Data Warehouse (NCDW). The diagnoses of sarcoidosis and SpA were based on ATS/ERS/WASOG and ASAS diagnostic and classification criteria, respectively. The number of events was gathered under one entity based on sarcoidosis organ involvement. The predictive effect of different variables, collected at the time of sarcoidosis diagnosis, on SpA occurrence was studied using conditional logistic regression models (PROC PHREG). This study has been approved by the local Institutional Review Board (E2020-91). Twenty-two patients with a sarcoidosis/SpA sequence were identified; 66 controls were selected. The proportion of organ involvement related to sarcoidosis was similar between the two groups except for rheumatologic manifestations. In cases, the mean (SD) delay to SpA diagnosis was 7.7 years [range 0–25]. The occurrence of SpA was significantly associated with the rheumatologic involvement of sarcoidosis (OR 6.42 95%CI [2.30–19.59] P < 0.01 after Bonferroni's correction). This association remained significant in our age- and sex-adjusted model (OR 5.36 95%CI [1.80–17.19] P < 0.05). No specific rheumatologic clinical picture could be identified, but axial involvement, corresponding to inflammatory back pain and alternating buttock pain, was more frequently observed in cases, resulting in a higher proportion of patients presenting a combined pattern of axial and peripheral involvement. SpA characteristics of patients with sarcoidosis developing SpA are summarized in Appendix A.
Published: 2021

24. Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial

Author: Bruno Pereira, Terry Guirado, David Thivel, Martine Duclos, Lore Metz, Audrey Bergouignan, Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions, Université Blaise Pascal - Clermont-Ferrand 2 (UBP), Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Grenoble Alpes (UGA), Dept Sport Med and Funct Explorat, CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Institut Pluridisciplinaire Hubert Curien (IPHC), Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS), University of Colorado Anschutz [Aurora], University Hospital of Clermont-FerrandI-SITE program of Clermont Auvergne University, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-CHU Saint-Etienne-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Grenoble Alpes (UGA), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-CHU Saint-Etienne-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Grenoble Alpes (UGA), Université de Strasbourg (UNISTRA)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS), and ROSSI, Sabine
Subjects: Medicine (General), medicine.medical_specialty, Physical fitness, Psychological intervention, Medicine (miscellaneous), Context (language use), Sitting, law.invention, Study Protocol, 03 medical and health sciences, R5-920, 0302 clinical medicine, Quality of life (healthcare), Sedentary behaviours, Randomized controlled trial, law, Humans, Multicenter Studies as Topic, Medicine, Aerobic exercise, Pharmacology (medical), 030212 general & internal medicine, Workplace, Exercise, Occupational Health, Randomized Controlled Trials as Topic, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Job strain, business.industry, Physical activity, Prevention, 030229 sport sciences, Physical therapy, Tertiary societies, France, Cycling workstation, Sedentary Behavior, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Background Sedentary behaviour (SB) and low levels of physical activity (PA) are predictors of morbidity and mortality. Tertiary employees spend a considerable amount of their daily time seated and new efficient strategies to both reduce sedentary time and increase physical activity are needed. In that context, the REMOVE study aims at evaluating the health effects of a 24-week cycling desk intervention among office workers. Methods A prospective, open-label, multicentre, two-arm parallel, randomized controlled trial (RCT) will be conducted in office-sitting desk workers. Office workers (N = 80) who have 0.8 full time equivalent hours (FTE) and 75% of this time in a sitting position will be recruited from tertiary worksites in Clermont-Ferrand, France. Subjects will be randomly assigned to one of the two following interventions: (i) PPM6: performance of two 30 min of cycling desk (using portable pedal exercise machine—PPM) per working day for 6 months or (ii) CTL_PPM3: 3 months with no intervention (control) followed by 3 months during which workers will be asked to complete two 30 min of PPM per working day. At baseline (T0), at 3 months (T1) and at 6 months (T2) after the start of the interventions, primary outcomes; 7-day PA and SB (3D-accelerometers), secondary outcomes; body composition (bioelectrical impedance), physical fitness (aerobic fitness, upper and lower limb strength), metabolic outcomes (fasting blood samples), self-perceived stress, anxiety, quality of life at work and job strain (questionnaires), tertiary outcomes; resting metabolic rate and cycling energy expenditure (indirect calorimetry) and eating behaviours (questionnaires) will be measured. An ergonomic approach based on observations and individual interviews will be used to identify parameters that could determine adherence. Discussion The REMOVE study will be the first RCT to assess the effects of cycling workstations on objectively measured PA and SB during working and non-working hours and on key physiological and psychological health outcomes. This study will provide important information regarding the implementation of such cycling workstations in office workers and on the associated potential health benefits. Trial registration ClinicalTrials.govNCT04153214. Registered on November 2019, version 1
Published: 2021

25. A case–control study investigating food addiction in Parkinson patients

Author: Yves Boirie, B. Debilly, F. Durif, Georges Brousse, P.-M. Llorca, A. Marques, Maria Livia Fantini, Philippe Derost, Isabelle Chéreau-Boudet, Ingrid de Chazeron, Céline Lambert, Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), TEVA Sante FranceAbbVieAllerganEisai Co LtdGedeon RichterJohnson & JohnsonJohnson & Johnson USAJanssen Biotech IncLundbeck CorporationOtsuka PharmaceuticalRecordattiSanofiTeva, and CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Male, medicine.medical_specialty, Neurology, Food addiction, Science, media_common.quotation_subject, Impulsivity, Article, Night eating syndrome, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Prevalence, Humans, Night Eating Syndrome, Medicine, Aged, media_common, Sex Characteristics, Multidisciplinary, business.industry, Dopaminergic, Case-control study, Parkinson Disease, Middle Aged, medicine.disease, 030227 psychiatry, 3. Good health, Eating disorders, Cross-Sectional Studies, Risk factors, Case-Control Studies, Impulsive Behavior, Female, Food Addiction, medicine.symptom, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, 030217 neurology & neurosurgery, Vigilance (psychology)
Abstract: Eating disorders (EDs) in patients with Parkinson’s disease (PD) are mainly described through impulse control disorders but represent one end of the spectrum of food addiction (FA). Although not formally recognized by DSM-5, FA is well described in the literature on animal models and humans, but data on prevalence and risk factors compared with healthy controls (HCs) are lacking. We conducted a cross-sectional study including 200 patients with PD and 200 age- and gender-matched HCs. Characteristics including clinical data (features of PD/current medication) were collected. FA was rated using DSM-5 criteria and the Questionnaire on Eating and Weight Patterns-Revised (QEWP-R). Patients with PD had more EDs compared to HCs (27.0% vs. 13.0%, respectively, p p = 0.001) and night eating syndrome (7.0% vs. 2.5% p = 0.03). In PD patients, FA was associated with female gender (p = 0.04) and impulsivity (higher attentional non-planning factor) but not with the dose or class of dopaminergic therapy. Vigilance is necessary, especially for PD women and in patients with specific impulsive personality traits. Counterintuitively, agonist dopaminergic treatment should not be used as an indication for screening FA in patients with PD.
Published: 2021

26. High‐dose chemotherapy followed by autologous stem cell rescue in Wilms tumors: French report on toxicity and efficacy

Author: Isabelle Pellier, Hélène Sudour-Bonnange, Marie-Dominique Tabone, Claudia Pasqualini, Christophe Bergeron, Gudrun Scheleirmacher, Frédérique Dijoud, Aurore Coulomb-L'Hermine, Xavier Muracciole, Anne Notz-Carrere, Claire Freycon, Magali Morelle, Cécile Boulanger, Manon Delafoy, Arnauld Verschuur, Sabine Irtan, Estelle Thebaud, Département de cancérologie de l'enfant et de l'adolescent [Gustave Roussy], Institut Gustave Roussy (IGR), Hôpital de la Timone [CHU - APHM] (TIMONE), Institut Curie [Paris], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire [Grenoble] (CHU), CHU Bordeaux [Bordeaux], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de radiothérapie - [Hôpital de la Timone - Hôpital Nord - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE)- Hôpital Nord [CHU - APHM], Hospices Civils de Lyon (HCL), Centre Léon Bérard [Lyon], Service d'Hématologie pédiatrique, Hôpital de la Timone, Marseille, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Département d'oncologie pédiatrique [Institut Curie, Paris], Service d'hématologie-immunologie-oncologie pédiatrique [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité d'oncologie pédiatrique [Centre Oscar Lambret, Lille], Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, Service d'oncologie pédiatrique [CHU Nantes], Service d'Onco-Hématologie Pédiatrique [CHU Grenoble], Service d'Hémato-oncologie Pédiatrique [CHU Bordeaux], CHU Bordeaux [Bordeaux]-Hôpital Pellegrin, Service d'Hématologie et Oncologie pédiatriques [CHRU Toulouse], Centre Hospitalier Régional Universitaire de Toulouse (CHRU Toulouse), Service d'Immunologie Hématologie et Oncologie pédiatriques [CHU Angers], PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service de chirurgie viscérale pédiatrique [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Service de pathologie [CHU Trousseau], Unité de Biostatistiques [Lyon], Centre Léon-Bérard : Centre de lutte contre le cancer de Lyon et Rhône-Alpes, and Département d'oncologie pédiatrique [Centre Léon Bérard, Lyon]
Subjects: Adult, Male, Oncology, medicine.medical_specialty, Autologous Stem Cell Rescue, Adolescent, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, Transplantation, Autologous, Wilms Tumor, Young Adult, 03 medical and health sciences, High dose chemotherapy, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Young adult, Child, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, Chemotherapy, business.industry, Stem Cells, Hematopoietic Stem Cell Transplantation, Wilms' tumor, Hematology, medicine.disease, Combined Modality Therapy, Kidney Neoplasms, 3. Good health, Respiratory failure, Child, Preschool, 030220 oncology & carcinogenesis, Pediatrics, Perinatology and Child Health, Toxicity, Cohort, Female, business, 030215 immunology
Abstract: International audience; BackgroundHeterogeneous data have been reported on high-dose chemotherapy (HDCT) with autologous stem cell rescue (ASCR) in Wilms tumors (WTs). We aimed to define its safety and efficacy in the French cohort, and to compare this management to current international recommendations.MethodsData prospectively collected from children, adolescents, and young adults with WT treated with HDCT/ASCR between 2000 and 2016 in French centers were retrospectively analyzed. Toxicity was reported according to CTCAE v4.03.ResultsFifty-four patients received HDCT/ASCR (first line, n = 13; recurrence, n = 41). Their median age at the time of ASCR was 5.3 years (range 2.2–21.6). Main nonhematological acute grades 3–4 toxicities were digestive and renal. No significant difference of toxicity rate was observed among HDCT regimens and schedules. Two patients died shortly after ASCR (renal and multiorgan failure), and one heavily pretreated patient died of late respiratory failure. The selection criteria applied to define those patients eligible for HDCT/ASCR retrospectively matched to those currently used in the International Society of Pediatric Oncology (SIOP) UMBRELLA protocol for 38 patients, with encouraging survival rates compared to published data. The objective response rate to HDCT was 21%, with a disease control rate after HDCT of 85%. After a median follow-up of 7 years, the 5-year event-free survival (EFS) and overall survival (OS) were 54% (95% CI: 32%–76%) and 62% (95% CI: 31%–82%) for frontline patients, and 57% (95% CI: 39%–71%) and 69% (95% CI: 52%–81%) at recurrence.ConclusionHDCT was feasible and showed encouraging results in well-defined settings. Data from the current prospective protocol will help to better evaluate HDCT impact on survival.
Published: 2021

27. Changes in cannabis consumption during the global covid-19 lockdown: The international COVISTRESS study

Author: Juliette Salles, Antoine Yrondi, Fouad Marhar, Nicolas Andant, Raimundo Avilés Dorlhiac, Binh Quach, Jiao Jiao, Samuel Antunes, Ukadike Chris Ugbolue, Julien Guegan, Karine Rouffiac, Bruno Pereira, The COVISTRESS Network, Maélys Clinchamps, Stéphanie Mestres, Cécile Miele, Valentin Navel, Lénise Parreira, Yves Boirie Jean-Baptiste Bouillon-Minois, Martine Duclos Maria Livia Fantini, Jeannot Schmidt, Stéphanie Tubert-Jeannin, Mickael Berthon, Pierre Chausse, Michael Dambrun, Sylvie Droit-Volet, Serge Guimond, Laurie Mondillon, Armelle Nugier, Pascal Huguet, Samuel Dewavrin, Geraldine Naughton, Amanda Benson, Claus Lamm, Karen Gbaglo, Vicky Drapeau, Benjamin Bustos, Gu Yaodong, Haifeng Zhang, Peter Dieckmann, Julien Baker, Yanping Duan, Gemma Gao, Wendy Y J Huang, Ka Lai Kelly Lau, Chun-Qing Zhang, Perluigi Cocco, Rosamaria Lecca, Monica Puligheddu, Michela Figorilli, Morteza Charkhabi, Reza Bagheri, Daniela Pfabigan, David Neto, Pedro Almeida, Maria João Gouveia, Pedro Quinteiro, Constanta Urzeala, Benoit Dubuis, Juliette Lemaignen, Andy Liu, Foued Saadaoui, Keri Kulik, Kuan-chou Chen, CHU Toulouse [Toulouse], Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Toulouse Neuro Imaging Center (ToNIC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], CHU de Toulouse, Pole d'anesthésie Réanimation, Hôpital Paule de Viguier, Toulouse F-31059, France, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Clermont-Ferrand, Universidad Finis Terrae, Hong Kong Baptist University (HKBU), Instituto Universitário de Ciências Psicológicas, Sociais e da Vida (ISPA), University of the West of Scotland (UWS), Service Santé Travail Environnement [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], WittyFit, COVISTRESS Network: Nicolas Andant, Maélys Clinchamps, Stéphanie Mestres, Cécile Miele, Valentin Navel, Lénise Parreira, Bruno Pereira, Karine Rouffiac, Yves Boirie Jean-Baptiste Bouillon-Minois, Martine Duclos Maria Livia Fantini, Jeannot Schmidt, Stéphanie Tubert-Jeannin, Mickael Berthon, Pierre Chausse, Michael Dambrun, Sylvie Droit-Volet, Julien Guegan, Serge Guimond, Laurie Mondillon, Armelle Nugier, Pascal Huguet, Samuel Dewavrin, Fouad Marhar, Geraldine Naughton, Amanda Benson, Claus Lamm, Karen Gbaglo, Vicky Drapeau, Raimundo Avilés Dorlhiac, Benjamin Bustos, Gu Yaodong, Haifeng Zhang, Peter Dieckmann, Julien Baker, Binh Quach, Jiao Jiao, Yanping Duan, Gemma Gao, Wendy Y J Huang, Ka Lai Kelly Lau, Chun-Qing Zhang, Perluigi Cocco, Rosamaria Lecca, Monica Puligheddu, Michela Figorilli, Morteza Charkhabi, Reza Bagheri, Daniela Pfabigan, Peter Dieckmann, Samuel Antunes, David Neto, Pedro Almeida, Maria João Gouveia, Pedro Quinteiro, Constanta Urzeala, Benoit Dubuis, Juliette Lemaignen, Andy Liu, Foued Saadaoui, Ukadike Chris Ugbolue, Keri Kulik, Kuan-Chou Chen, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Toulouse Mind & Brain Institut (TMBI), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT), Pôle Anesthésie Réanimation [CHU de Toulouse], Instituto Universitário de Ciências Psicológicas, Sociais e da Vida = University Institute of Psychological, Social and Life Sciences (ISPA), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Toulouse [Toulouse]
Subjects: cannabis, medicine.medical_specialty, media_common.quotation_subject, Population, RC435-571, [SHS.PSY]Humanities and Social Sciences/Psychology, Anger, Medisinske Fag: 700::Klinisk medisinske fag: 750::Psykiatri, barnepsykiatri: 757 [VDP], tobacco, lockdown, medicine, Economic impact analysis, hasj, Psychiatry, education, media_common, Original Research, Consumption (economics), education.field_of_study, rusmisbruk, biology, Addiction, COVID-19, Boredom, biology.organism_classification, 3. Good health, Psychiatry and Mental health, Feeling, cannabis (marijuana), [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Cannabis, addiction, medicine.symptom, Psychology
Abstract: International audience; Introduction: COVID-19 lockdown measures have been sources of both potential stress and possible psychological and addiction complications. A lack of activity and isolation during lockdown are among the factors thought to be behind the growth in the use of psychoactive substances and worsening addictive behaviors. Previous studies on the pandemic have attested to an increase in alcohol consumption during lockdowns. Likewise, data suggest there has also been a rise in the use of cannabis, although it is unclear how this is affected by external factors. Our study used quantitative data collected from an international population to evaluate changes in cannabis consumption during the lockdown period between March and October, 2020. We also compared users and non-users of the drug in relation to: (1) socio-demographic differences, (2) emotional experiences, and (3) the information available and the degree of approval of lockdown measures. Methods: An online self-report questionnaire concerning the lockdown was widely disseminated around the globe. Data was collected on sociodemographics and how the rules imposed had influenced the use of cannabis and concerns about health, the economic impact of the measures and the approach taken by government(s). Results: One hundred eighty two respondents consumed cannabis before the lockdown vs. 199 thereafter. The mean cannabis consumption fell from 13 joints per week pre-lockdown to 9.75 after it (p < 0.001). Forty-nine respondents stopped using cannabis at all and 66 admitted to starting to do so. The cannabis users were: less satisfied with government measures; less worried about their health; more concerned about the impact of COVID-19 on the economy and their career; and more frightened of becoming infected in public areas. The risk factors for cannabis use were: age (OR = 0.96); concern for physical health (OR = 0.98); tobacco (OR = 1.1) and alcohol consumption during lockdown (OR = 1.1); the pre-lockdown anger level (OR = 1.01); and feelings of boredom during the restrictions (OR = 1.1). Conclusion: In a specific sub-population, the COVID-19 lockdown brought about either an end to the consumption of cannabis or new use of the drug. The main risk factors for cannabis use were: a lower age, co-addictions and high levels of emotions. Methods: An online self-report questionnaire concerning the lockdown was widely disseminated around the globe. Data was collected on sociodemographics and how the rules imposed had influenced the use of cannabis and concerns about health, the economic impact of the measures and the approach taken by government(s).Results: One hundred eighty two respondents consumed cannabis before the lockdown vs. 199 thereafter. The mean cannabis consumption fell from 13 joints per week pre-lockdown to 9.75 after it (p < 0.001). Forty-nine respondents stopped using cannabis at all and 66 admitted to starting to do so. The cannabis users were: less satisfied with government measures; less worried about their health; more concerned about the impact of COVID-19 on the economy and their career; and more frightened of becoming infected in public areas. The risk factors for cannabis use were: age (OR = 0.96); concern for physical health (OR = 0.98); tobacco (OR = 1.1) and alcohol consumption during lockdown (OR = 1.1); the pre-lockdown anger level (OR = 1.01); and feelings of boredom during the restrictions (OR = 1.1).Conclusion: In a specific sub-population, the COVID-19 lockdown brought about either an end to the consumption of cannabis or new use of the drug. The main risk factors for cannabis use were: a lower age, co-addictions and high levels of emotions.
Published: 2021

28. Efficacy of lumbar immobilisation by rigid brace for chronic low back pain with Modic 1 changes (DICO): Protocol for a randomised study

Author: Charlotte Lanhers, Emmanuel Coudeyre, Alexandre Schmitt, Armand Bonnin, Laura Boutevilain, Agnes Lhoste, Paul Calmels, Bruno Pereira, Anna Goldstein, Nicolas Coste, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), CHU Clermont-Ferrand, Centre de Réadaptation Fonctionnelle NOTRE DAME, Centre médico-chirurgical de réadaptation des massues [Lyon], Hôpital d'Instruction des Armées Desgenettes, Service de Santé des Armées, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), and CHU Clermont-Ferrand-CHU Clermont-Ferrand
Subjects: Protocol (science), medicine.medical_specialty, Lumbar, business.industry, Rehabilitation, Physical therapy, medicine, Orthopedics and Sports Medicine, business, Brace, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Chronic low back pain
Abstract: Letter; International audience
Published: 2021

29. Signs and symptoms of intimate partner violence in women attending primary care in Europe, North America and Australia: a systematic review and meta-analysis

Author: Catherine Laporte, Philippe Vorilhon, Bruno Pereira, Gilles Lazimi, Aurélie Cabaillot, Mathilde Vicard-Olagne, Laure Rougé, Département de Médecine Générale [Clermont-Ferrand], Faculté de Médecine - Clermont-Auvergne (FM - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), Département de Médecine Générale, Université Paris Cité (UPCité), Université de Paris (UP), and VIGNAL, Alexine
Subjects: medicine.medical_specialty, education, Sexually Transmitted Diseases, Intimate Partner Violence, CINAHL, Anxiety, 01 natural sciences, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, 0101 mathematics, Depression (differential diagnoses), [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Primary Health Care, business.industry, Public health, 010102 general mathematics, Odds ratio, Confidence interval, 3. Good health, Europe, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Family medicine, Meta-analysis, Domestic violence, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, medicine.symptom, Family Practice, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Background Intimate partner violence (IPV) is a prevalent yet underdiagnosed health issue, and primary care practitioners are in a unique front-line position to provide care and counsel for the victims. Objective To identify the signs and symptoms of women exposed to IPV who attended primary care, regardless motive of consultation. Methods Systematic review and meta-analysis on Cochrane, PubMed, Embase and CINAHL between 1946 and 2020. Eligible studies had to be original quantitative research, on women aged >15 years, attending primary care settings in Europe, North America and Australia and interviewed on their status as victims of IPV and on their signs and symptoms. Results Of 1791 articles identified, 57 were selected. Associations were found between IPV and signs and symptoms of depression [19 studies: overall odds ratio (OR) = 3.59, 95% confidence interval (CI; 2.7–4.7, I2 = 94.6%)], anxiety [9 studies: overall OR = 2.19, 95% CI (1.75–2.73, I2 = 84%)], gynaecological and/or sexually transmitted infections [6 studies: overall OR = 2.82, 95% CI (2.1–3.8, I2 = 41%)] and combination of somatic symptoms [5 studies: standard mean deviation = 0.795, 95% CI (0.62–0.97, I2 = 0%)]. Conclusions Women exposed to IPV may present with clinical symptoms and signs other than bodily injury. Policy implications knowing these symptoms presented by women victims of IPV can help GPs identify and treat them. Systematic review registration PROSPERO CRD42018089857.
Published: 2021

30. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial

Author: Bruno Pereira, Lionel Camilleri, Mehdi Farhat, Christian Dualé, Pascal Chabrot, Enrica Dorigo, Kasra Azarnoush, Etienne Geoffroy, Andrea Innorta, Nicolas Dauphin, BMC, Ed., Service de chirurgie cardiaque, CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université-Institut National de la Recherche Agronomique (INRA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre d'Investigation Clinique [CHU Clermont-Ferrand] (CIC 1405), Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service de radiologie, French Ministry of Health, Edwards Lifesciences (Irvine, CA, USA), St. Jude Medical (Minneapolis, MN, USA), and Sorin Group (Saluggia, Italy), Institut National de la Recherche Agronomique (INRA)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Unité de biostatistiques, CIC - Clermont Ferrand, and Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Aortic valve, Time Factors, Medicine (miscellaneous), Hemodynamics, 030204 cardiovascular system & hematology, law.invention, Study Protocol, 0302 clinical medicine, Clinical Protocols, Aortic valve replacement, Randomized controlled trial, law, Pharmacology (medical), Prospective Studies, Cardiac skeleton, Prospective cohort study, Ultrasonography, Heart Valve Prosthesis Implantation, Stented pericardial aortic valves, Pericardial aortic valves, Hemodynamic performance, 3. Good health, Treatment Outcome, medicine.anatomical_structure, Research Design, Aortic Valve, Heart Valve Prosthesis, Aortic valve stenosis, Cardiology, Stents, France, medicine.medical_specialty, Prosthesis Design, 03 medical and health sciences, Internal medicine, medicine, Humans, Bioprosthesis, business.industry, Aortic Valve Stenosis, Gold standard (test), medicine.disease, Surgery, 030228 respiratory system, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Tomography, X-Ray Computed, business
Abstract: International audience; BackgroundAortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the 'gold standard' treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses.Methods and designFirst, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery.DiscussionThis prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient's morphological characteristics.Trial registrationClinicalTrials.gov Identifier: NCT01522352
Published: 2013

31. COVID‐19 lockdown consequences on body mass index and perceived fragility related to physical activity: A worldwide cohort study

Author: Urzeala, Constanta, Duclos, Martine, Chris Ugbolue, Ukadike, Bota, Aura, Berthon, Mickael, Kulik, Keri, Thivel, David, Bagheri, Reza, Gu, Yaodong, Baker, Julien, Andant, Nicolas, Pereira, Bruno, Rouffiac, Karine, Clinchamps, Maëlys, Dutheil, Frédéric, Mestres, Stéphanie, Miele, Cécile, Navel, Valentin, Parreira, Lénise, Boirie, Yves, Bouillon‐Minois, Jean‐Baptiste, Fantini, Maria Livia, Schmidt, Jeannot, Tubert‐Jeannin, Stéphanie, Chausse, Pierre, Dambrun, Michael, Droit‐Volet, Sylvie, Guegan, Julien, Guimond, Serge, Mondillon, Laurie, Nugier, Armelle, Huguet, Pascal, Dewavrin, Samuel, Marhar, Fouad, Naughton, Geraldine, Benson, Amanda, Lamm, Claus, Drapeau, Vicky, Avilés Dorlhiac, Raimundo, Bustos, Benjamin, Zhang, Haifeng, Quach, Binh, Duan, Yanping, Gao, Gemma, Huang, Wendy, Lau, Ka Lai Kelly, Zhang, Chun‐Qing, Jiao, Jiao, Chen, Kuan‐chou, Nasir, Hijrah, Cocco, Perluigi, Lecca, Rosamaria, Puligheddu, Monica, Figorilli, Michela, Charkhabi, Morteza, Pfabigan, Daniela, Dieckmann, Peter, Antunes, Samuel, Neto, David, Almeida, Pedro, Gouveia, Maria João, Quinteiro, Pedro, Dubuis, Benoit, Lemaignen, Juliette, Liu, Andy, Saadaoui, Foued, University of Physical Education and Sports from Bucharest (UNEFS), University of Bucharest (UniBuc), CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Ningbo University (NBU), University of the West of Scotland (UWS), University of Strathclyde [Glasgow], Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Indiana University of Pennsylvania, Pennsylvania State System of Higher Education (PASSHE), Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne (UCA)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), University of Isfahan, Hong Kong Baptist University (HKBU), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service Santé Travail Environnement [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], Psychoneuroimmunologie, nutrition et génétique, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Recherche Agronomique (INRA)-Centre National de la Recherche Scientifique (CNRS), Ningbo Dahongying University, Centre for Health and Exercise Science Research, Department of Sport, Physical Education and Health, Hong Kong Baptist University, Kowloon Tong, Hong Kong, Service Médecine du Sport et Explorations Fonctionnelles [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Université Clermont Auvergne (UCA), WittyFit, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Swinburne University of Technology (Hawthorn campus), University of Vienna [Vienna], Université Laval [Québec] (ULaval), Universidad Finis Terrae, Universidad de los Andes [Santiago] (UANDES), Hebei Normal University, Copenhagen Academy for Medical Education and Simulation (CAMES), National Taïwan Sport University, Università degli Studi di Cagliari = University of Cagliari (UniCa), University of Oslo (UiO), University of Stavanger, Instituto Universitário de Ciências Psicológicas, Sociais e da Vida = University Institute of Psychological, Social and Life Sciences (ISPA), Université de Genève = University of Geneva (UNIGE), University of Taipei, and King Abdulaziz University
Subjects: Gerontology, medicine.medical_specialty, Sports medicine, Coronavirus disease 2019 (COVID-19), Adolescent, Vulnerable populations, [SHS.PSY]Humanities and Social Sciences/Psychology, Body Mass Index, RC1200, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Fragility, RA0421, medicine, Humans, 030212 general & internal medicine, Young adult, Exercise, Aged, 2. Zero hunger, 030503 health policy & services, pandemic, Public Health, Environmental and Occupational Health, COVID-19, health, Original Articles, 3. Good health, Snowball sampling, vulnerable population, Communicable Disease Control, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Original Article, Female, medicine.symptom, 0305 other medical science, Psychology, Body mass index, Weight gain, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Cohort study, Follow-Up Studies
Abstract: International audience; Background: This paper is a follow-up study continuing the COVISTRESS network previous research regarding health-related determinants.Objective: The aim was to identify the main consequences of COVID-19 lockdown on Body Mass Index and Perceived Fragility, related to Physical Activity (PA), for different categories of populations, worldwide.Design: The study design included an online survey, during the first wave of COVID-19 lockdown, across different world regions.Setting and participants: The research was carried out on 10 121 participants from 67 countries. The recruitment of participants was achieved using snowball sampling techniques via social networks, with no exclusion criteria other than social media access.Main outcome measures: Body Mass Index, Physical Activity, Perceived Fragility and risk of getting infected items were analysed. SPSS software, v20, was used. Significance was set at P < .05.Results: Body Mass Index significantly increased during lockdown. For youth and young adults (18-35 years), PA decreased by 31.25%, for adults (36-65 years) by 26.05% and for the elderly (over 65 years) by 30.27%. There was a high level of Perceived Fragility and risk of getting infected for female participants and the elderly. Correlations between BMI, Perceived Fragility and PA were identified.Discussion and conclusions: The research results extend and confirm evidence that the elderly are more likely to be at risk, by experiencing weight gain, physical inactivity and enhanced Perceived Fragility. As a consequence, populations need to counteract the constraints imposed by the lockdown by being physically active.
Published: 2021

32. Changes in Plasma Soluble Receptor for Advanced Glycation End-Products Are Associated with Survival in Patients with Acute Respiratory Distress Syndrome

Author: Vincent Sapin, Emmanuel Futier, Jules Audard, Erwan Laroche, Raiko Blondonnet, Jean-Etienne Bazin, Laurence Roszyk, Bruno Pereira, Jean-Michel Constantin, Julie A. Bastarache, Lorraine B. Ware, Matthieu Jabaudon, Thomas Godet, CHU Clermont-Ferrand, Génétique, Reproduction et Développement (GReD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Vanderbilt University Medical Center [Nashville], Vanderbilt University [Nashville], Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Gestionnaire, Hal Sorbonne Université
Subjects: medicine.medical_specialty, ARDS, soluble RAGE, medicine.medical_treatment, [SDV]Life Sciences [q-bio], mechanical ventilation, Gastroenterology, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Glycation, law, Internal medicine, medicine, Receptor, Mechanical ventilation, Lung, Surrogate endpoint, business.industry, therapeutic response, 030208 emergency & critical care medicine, General Medicine, acute respiratory distress syndrome, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], joint modeling, medicine.anatomical_structure, 030228 respiratory system, Biomarker (medicine), Medicine, biomarker, business
Abstract: The plasma soluble receptor for advanced glycation end-products (sRAGE) is a marker of lung epithelial injury with prognostic value when measured at baseline in acute respiratory distress syndrome (ARDS). However, whether changes in plasma sRAGE could inform prognosis in ARDS remains unknown. In this secondary analysis of the Lung Imaging for Ventilator Setting in ARDS (LIVE) multicenter randomized controlled trial, which evaluated a personalized ventilation strategy tailored to lung morphology, plasma sRAGE was measured upon study entry (baseline) and on days one, two, three, four and six. The association between changes in plasma sRAGE over time and 90-day survival was evaluated. Higher baseline plasma sRAGE (HR per-one log increment, 1.53, 95% CI, 1.16–2.03, p = 0.003) and an increase in sRAGE over time (HR for each one-log increment in plasma sRAGE per time unit, 1.01, 95% CI, 1.01–1.02, p &lt, 10−3) were both associated with increased 90-day mortality. Each 100-unit increase in the plasma sRAGE level per unit of time increased the risk of death at day 90 by 1% in joint modeling. Plasma sRAGE increased over time when a strategy of maximal alveolar recruitment was applied in patients with focal ARDS. Current findings suggest that the rate of change in plasma sRAGE over time is associated with 90-day survival and could be helpful as a surrogate outcome in ARDS.
Published: 2021

33. Impairments in Food Oral Processing in Patients Treated for Tongue Cancer

Author: Isabelle Barthélémy, Martine Hennequin, Bruno Pereira, Arnaud Depeyre, Nathalie Pham-Dang, Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre de Recherche en Odontologie Clinique (CROC), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Male, medicine.medical_specialty, Reconstructive surgery, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Speech and Hearing, Postoperative Complications, 0302 clinical medicine, Tongue, Swallowing, Quality of life, Internal medicine, medicine, Humans, Postoperative Period, Mastication, ComputingMilieux_MISCELLANEOUS, Aged, 2. Zero hunger, business.industry, Gastroenterology, Cancer, 030206 dentistry, Middle Aged, Hepatology, medicine.disease, Deglutition, Tongue Neoplasms, 3. Good health, medicine.anatomical_structure, Otorhinolaryngology, 030220 oncology & carcinogenesis, Quality of Life, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Deglutition Disorders, business
Abstract: Patients surgically treated for oral cancer are affected by several underestimated deglutition disorders risk factors. This study aims to characterize the level of these food oral processing (FOP) impairments in a group of patients treated by surgery for tongue cancer. Twenty-seven consecutive patients surgically treated for tongue cancer were evaluated concerning their chewing capacity (Mastication-test), and responded to questions concerning their capacity to bite, chew and manipulate food with their tongue, and their quality of life. According to the Mastication-test, 16 patients suffered total FOP incapacities (TI group), characterized by high tumor stage, invasive carcinological surgery and necessity of reconstructive surgery; 12 patients were partially or not impaired (PI/NI-group). Tongue movement score and number of dental units were lower in the TI group than in the PI/NI-group. Subjective FOP criteria were clearly impaired in the TI group and correlated with a poor oral health-related quality of life. One year after surgery, there is a decrease in BMI for TI group patients while the PI group patients had a significant increase in BMI. All patients surgically treated for oral cancer suffered FOP impairments, but not with the same severity. Totally impaired subjects are at higher risk from long-term malnutrition. Functional evaluation of FOP should form part of the post-operative follow-up for all patients suffering from tongue cancer, using a quick combined evaluation of chewing efficiency, oral health quality of life and nutritional status.
Published: 2019

34. Artificial nutrition in patients with cancer has no impact on tumour glucose metabolism: Results of the PETANC Study

Author: Anne Fallières, Marie-Claude Eberlé, N. Flori, Hélène de Forges, Pierre Senesse, Julien Fraisse, Raphael Tetreau, Jean-Pierre Pouget, Sophie Guillemard, Pierre-Olivier Kotzki, Lore Santoro, Emmanuel Deshayes, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CRLCC Val d'Aurelle - Paul Lamarque, Unité de biostatistiques, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), and CCSD, Accord Elsevier
Subjects: Blood Glucose, Male, 0301 basic medicine, medicine.medical_specialty, Cachexia, [SDV.CAN]Life Sciences [q-bio]/Cancer, 030209 endocrinology & metabolism, Carbohydrate metabolism, Critical Care and Intensive Care Medicine, Gastroenterology, Enteral administration, Eating, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Fluorodeoxyglucose F18, Positron Emission Tomography Computed Tomography, Internal medicine, medicine, Humans, Prospective Studies, Nutritional support, Prospective cohort study, Aged, Cancer, Cancer staging, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, 030109 nutrition & dietetics, Nutrition and Dietetics, medicine.diagnostic_test, business.industry, Tumour growth, Middle Aged, medicine.disease, 3. Good health, Glucose, Parenteral nutrition, Head and Neck Neoplasms, Positron emission tomography, Female, (18)F-FDG PET/CT, business, Supportive care, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Summary Background & aims Nutrition support is recommended in cachexic patients with cancer. However, there is no clear evidence about its impact on tumour growth. Glycolysis, which is usually higher in cancer than normal cells, can be monitored by 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) imaging that is widely used for cancer staging and therapy efficacy assessment. Here, we used 18F-FDG PET/CT imaging to investigate whether artificial nutrition has an impact on tumour glucose metabolism in patients with cancer and cachexia. Methods This prospective study included ten patients with histologically proven head and neck or oesophageal cancer. All patients underwent 18F-FDG PET/CT imaging at baseline and after (parenteral and/or enteral) nutrition support on average for 7 days. Tumour glucose metabolism changes were evaluated using static (SUVmax, SUVmean and SULpeak) and dynamic (glucose metabolic rate and transport constant rates, k) parameters computed from the 18F-FDG PET/CT data. Results Artificial nutrition (median energy intake of 21.83 kcal/kg/day [13.16–45.90], protein intake of 0.84 g/kg/day [0.56–1.64]) was administered. Eight patients (80%) received enteral nutrition and two patients (20%) parenteral support. Comparison of 18F-FDG PET/CT parameters did not highlight any significant difference in tumour glucose metabolism before and after the period of nutrition support. Conclusions In cachexic patients with head and neck or oesophageal cancer, nutrition support administered according to the current guidelines shows no impact on tumour glucose metabolism, assessed by 18F-FDG PET/CT.
Published: 2019

35. Clinical interest of PD-L1 immuno-histochemistry expression as a predictive factor of Bacillus Calmette Guerin (BCG) efficacy in refractory high-risk non-muscle-invasive bladder cancer (NMIBC)

Author: Clara Delcourt, Andre Gillibert, François Xavier Nouhaud, Jacques Irani, Christian Pfister, Françoise Gobet, Pierre Gemival, Jean Christophe Sabourin, Sophie Ferlicot, Service d'urologie [Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Département de Pathologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Unité de biostatistiques [CHU Rouen], Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen]-CHU Rouen, and Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, PD-L1, Nephrology, medicine.medical_specialty, Urology, 030232 urology & nephrology, Clone (cell biology), Risk Assessment, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Gastroenterology, B7-H1 Antigen, Cohort Studies, 03 medical and health sciences, symbols.namesake, 0302 clinical medicine, Immune system, Adjuvants, Immunologic, Refractory, Predictive Value of Tests, Internal medicine, medicine, Humans, Neoplasm Invasiveness, BCG, Fisher's exact test, Aged, Retrospective Studies, Aged, 80 and over, Bladder cancer, biology, business.industry, Middle Aged, medicine.disease, Immunohistochemistry, 3. Good health, Predictive factor, Treatment Outcome, Urinary Bladder Neoplasms, 030220 oncology & carcinogenesis, BCG Vaccine, symbols, biology.protein, Female, business
Abstract: International audience; Objective: To assess PD-L1 expression in tumor (TC) and tumor infiltrating immune cells (IC) as a predictive factor of BCG therapy failure in high-risk NMIBC.Materials and methods: Patients treated with complete resection followed by bladder BCG instillation for high-risk NMIBC were included. Early recurrence (ER) was defined as tumor recurrence after BCG induction course. The association between ER and immuno-histochemistry PD-L1 (E1L3N clone) expression by tumors cells (TC) and tumor infiltrating immune cells (IC) was investigated using an exact Fisher test variant.Results: A total of 186 patients were included, of whom 38 (20.4%) were ER, 35 (18.8%) were positive for TC PD-L1 expression and 60 (32.3%) were positive for IC PD-L1. ER was not significantly (p = 0.97) more frequent in the TC PD-L1 ≥ 1% group (n = 7, 20.0%) than in the TC PD-L1-negative group (n = 31, 20.5%). Patients with IC PD-L1 negative had ER in 15 (19.2%) cases and patients with IC PD-L1 ≥ 1% had ER in 23 (21.3%) cases. PD-L1-positive expression for IC (threshold > 1%) was correlated with immune infiltrate density (95.2% dense immune infiltrate vs 47.2% low immune infiltrate, p < 0.05), with increased expression of PD-L1 by IC after BCG therapy (p = 0.006).Conclusion: No association was observed between immuno-histochemistry PD-L1 positivity and ER after BCG therapy. Nevertheless, the relationship between immune infiltrate and PD-L1 positivity confirmed the interest of assessing the immune infiltrate density to define tumor's profile.
Published: 2019

36. Prognostic impact of celiac lymph node involvement in patients after frontline treatment for advanced ovarian cancer

Author: Christophe Pomel, Laurence Gladieff, Alejandra Martinez, Carlos Martínez-Gómez, Martina Aida Angeles, G. Balague, Gwenael Ferron, Bastien Cabarrou, Institut Claudius Regaud, Unité de Biostatistiques [Toulouse] ( Institut Claudius Regaud / IUCT-O), Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Group of Intelligent and Cooperative Systems / Education,Media, Informatics and Culture (GSIC/EMIC), Universidad de Valladolid [Valladolid] (UVa), and Institut Universitaire du Cancer Toulouse - Oncopôle (IUCT)-Institut Claudius Regaud
Subjects: Celiac lymph nodes, Multivariate analysis, Databases, Factual, Kaplan-Meier Estimate, Disease, Carcinoma, Ovarian Epithelial, Peritoneal ovarian carcinomatosis, Gastroenterology, Cohort Studies, 0302 clinical medicine, Celiac Artery, Porta hepatis disease, Medicine, Ovarian Neoplasms, 030219 obstetrics & reproductive medicine, Cytoreduction Surgical Procedures, General Medicine, Middle Aged, Prognosis, Advanced epithelial ovarian cancer, 3. Good health, Treatment Outcome, medicine.anatomical_structure, Oncology, Lymphatic Metastasis, 030220 oncology & carcinogenesis, Female, France, Adult, medicine.medical_specialty, Upper abdominal procedures, [SDV.CAN]Life Sciences [q-bio]/Cancer, Risk Assessment, Disease-Free Survival, 03 medical and health sciences, Internal medicine, Humans, Neoplasm Invasiveness, In patient, Risk factor, Aged, Neoplasm Staging, Retrospective Studies, Porta hepatis, Analysis of Variance, Advanced ovarian cancer, business.industry, Celiac lymph node status, Survival Analysis, Multivariate Analysis, Peritoneal Cancer Index, Lymph Node Excision, Surgery, Lymph Nodes, business
Abstract: Introduction Completeness of cytoreduction is the most important prognostic factor in patients with advanced ovarian cancer (OC). Extensive upper abdominal surgery has allowed to increase the rate complete cytoreduction and the feasibility of resection of celiac lymph nodes (CLN) and porta hepatis disease in these patients has been demonstrated. The aim of our study was to assess the prognostic impact of CLN involvement in patients with primary advanced OC undergoing a complete cytoreductive surgery (CRS). Material and methods We designed a retrospective unicentric study. We reviewed data from patients who underwent CLN resection with or without porta hepatis disease resection, within upfront or interval complete CRS in the frontline treatment of advanced epithelial OC between January 2008 and December 2015. Patients were classified in two groups according to CLN status. Univariate and multivariate analyses were conducted. Survival rates were estimated using Kaplan-Meier method. Results Forty-three patients were included and positive CLN were found in 39.5% of them. The median disease-free survival in the group of patients with positive and negative CLN were 11.3 months and 25.8 months, respectively. In multivariable analysis, both CLN involvement and high peritoneal cancer index were independently associated with decreased disease-free survival. Computed tomography re-reading by an expert radiologist has good sensitivity for detection of positive CLN. Conclusion CLN involvement and high preoperative tumor burden are independently associated with decreased survival after complete cytoreduction for OC. CLN involvement is a marker of diffuse disease and an independent risk factor for early recurrent disease.
Published: 2019

37. Control of replication of hepatitis B and C virus improves patient and graft survival in kidney transplantation

Author: Marc Hazzan, Sébastien Dharancy, Christophe Legendre, Hélène Fontaine, Alain Duhamel, Nassim Kamar, Benjamin Legendre, Stanislas Pol, Corinne Antoine, Philippe Mathurin, Alexandre Louvet, Laurent Alric, Julien Labreuche, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Physiopathologie du système immunitaire (Inserm U1223), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pharmacochimie et Biologie pour le Développement (PHARMA-DEV), Institut de Recherche pour le Développement (IRD)-Institut de Chimie de Toulouse (ICT), Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université de Toulouse (UT)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT), Unité de biostatistiques, CRLCC Val d'Aurelle - Paul Lamarque, Physiopathologie des Maladies Inflammatoires de l'Intestin, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Service des Maladies de l'Appareil Digestif et de la Nutrition [CHRU Lille], Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Agence de la biomédecine [Saint-Denis la Plaine], Service Néphrologie et transplantation rénale Adultes [CHU Necker], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Néphrologie et Transplantation rénale [CHRU-lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de Néphrologie - Immunologie Clinique [Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-PRES Université de Toulouse, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut de Chimie de Toulouse (ICT-FR 2599), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Institut de Chimie du CNRS (INC)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Institut de Chimie du CNRS (INC)-Institut de Recherche pour le Développement (IRD), Unité fonctionnelle d’éthique et médecine légale [AP-HP Hôpital Necker Enfants malades], Hôpital Purpan [Toulouse], and CHU Toulouse [Toulouse]
Subjects: Male, 0301 basic medicine, MESH: Antiviral Agents / therapeutic use, Kidney transplant recipients, [SDV]Life Sciences [q-bio], MESH: Hepatitis B, Chronic / virology, Hepacivirus, Virus Replication, medicine.disease_cause, Gastroenterology, 0302 clinical medicine, Interferon, MESH: Hepatitis C, Chronic / virology, Kidney transplantation, Graft Survival, MESH: Hepatitis B virus / drug effects, virus diseases, Middle Aged, MESH: Kidney Transplantation / mortality, Hepatitis B, Prognosis, MESH: Case-Control Studies, MESH: Hepatitis C, Chronic / drug therapy, 3. Good health, MESH: Hepacivirus / drug effects, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, Hepatitis B virus, medicine.medical_specialty, MESH: Graft Survival, Hepatitis C virus, Antiviral Agents, Virus, 03 medical and health sciences, Hepatitis B, Chronic, MESH: Hepacivirus / physiology, Internal medicine, medicine, Humans, chronic hepatitis C, chronic hepatitis B, Hepatitis, Hepatology, business.industry, MESH: Adult, MESH: Hepatitis B virus / physiology, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Hepatitis C, Chronic, medicine.disease, Kidney Transplantation, 030104 developmental biology, MESH: Virus Replication / drug effects, Viral replication, Case-Control Studies, business, MESH: Female, MESH: Hepatitis B, Chronic / drug therapy
Abstract: International audience; Background & aims: Before antiviral therapy, kidney transplant recipients infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) had poor outcomes. Since the 90s, nucleos(t)ide analogues have been widely used in HBV-infected patients, while interferon-based therapy was rarely used in HCV-infected patients. The aim of this study was to assess the impact of HBV and HCV on patient and graft survival, according to viral replication status.Methods: Data from January 1993 to December 2010 were extracted from the French national database CRISTAL. A total of 31,433 kidney transplant recipients were included, of whom 575, 1,060 and 29,798 had chronic hepatitis B, C, or were not infected, respectively.Results: Ten-year survival was lower in HCV-infected (71.3%) than in HBV-infected (81.2%, p = 0.0004) or non-infected kidney transplant recipients (82.7%, p
Published: 2019

38. Palliative endoscopic drainage of malignant stenosis of biliary confluence: Efficiency of multiple drainage approach to drain a maximum of liver segments

Author: Marc Giovannini, Jean Philippe Ratone, Marine Gilabert, Christian Pesenti, Christophe Zemmour, Simon Launay, Fabrice Caillol, Erwan Bories, Dupuis, Christine, Unité d’échoendoscopie et d’endoscopie d’oncologie digestive [Institut Paoli-Calmettes, Marseille], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Unité de Biostatistiques [Institut Paoli-Calmettes] (Département de la Recherche clinique et de l'Innovation), and Département d’Oncologie Chirurgicale [Institut Paoli-Calmettes, Marseille]
Subjects: Male, medicine.medical_specialty, Constriction, Pathologic, ERCP, 03 medical and health sciences, Endoscopic drainage, 0302 clinical medicine, Cause of Death, Humans, Medicine, Endoscopy, Digestive System, Mortality, Drainage, hilar stenosis, Aged, Proportional Hazards Models, Aged, 80 and over, palliative biliary drainage, business.industry, Palliative Care, Gastroenterology, Original Articles, Middle Aged, biliary hilum stenting, medicine.disease, Surgery, Stenosis, ROC Curve, Oncology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, 030220 oncology & carcinogenesis, Confluence, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, 030211 gastroenterology & hepatology, Bile Ducts, EUS-guided biliary drainage of the liver hilum, business
Abstract: International audience; Background and aim:More than 50% of the liver should be drained in case of unresectable hilar liver stenosis; however, it remains unclear if the use of several types of drainage (endoscopic retrograde cholangiography and pancreatography, percutaneous-biliary drainage, endoscopic ultrasound biliary drainage (EUS-BD)), allowing better drainage, has an impact on survival. The aim of our study was to evaluate the percentage of liver drained and its correlation on survival whatever the drainage technique used.Patients and methods:This study was a retrospective analysis of a prospective registry of patients with malignant drainage stenosis of the hilum. The quality of drainage was evaluated based on the percentage of liver segments drained, which was calculated by dividing the number of liver segments drained by the total number of liver segments. Drainage could be achieved via an endoscopic, EUS-guided or percutaneous route not associated with the procedure.Results:Sixty patients (38 men) were included from January 2015 to July 2016. The mean patient age was 69.84 years. Stenosis was classified as type II for 17 (29%) patients, type III for 20 (34%) patients, and type IV for 22 (37%) patients. Histology revealed cholangiocarcinoma for 26 (43%) patients, metastatic disease from colorectal cancer for 15 (25%) patients and another cancer for 19 (32%) patients. The median survival time was five (2.3-12.3) months.The percentage of liver segments drained had a significant prognostic impact on overall survival regardless of the technique used to drain the liver. The percentage of liver segments drained was dichotomized based on a threshold value of 80%, resulting in two groups (
Published: 2019

39. Large International Validation of ABSIS and PDAI Pemphigus Severity Scores

Author: Hébert, Vivien, Boulard, Claire, Houivet, Estelle, Lehembre, Sophie, Borradori, Luca, Della, Rocco, Feliciani, Claudio, Fania, Luca, Zambruno, Giovanna, Camaioni, Diana, Didona, Biago, Marinovic, Branka, Schmidt, Enno, Schumacher, Nina, Hü Nefeld 10, Christian, Schanz, Stefan, Kern, Johannes, Hofmann, Silke, Bouyeure, Anne, Picard-Dahan, Catherine, Prost-Squarcioni, Catherine, Caux, Frederic, Alexandre, Marina, Ingen-Housz-Oro, Saskia, Bagot, Martine, Tancrede-Bohin, Emmanuelle, David Bouaziz, Jean, Franck, Nathalie, Vabres, Pierre, Labeille, Bruno, Richard, Marie, Delaporte, Emmanuel, Dupuy, Alain, D'Incan, Michel, Quereux, Gaelle, Skowro, François, Paul, Carle, Livideanu, Cristina, Beylot-Barry, Marie, Doutre, Marie, Avenel-Audran, Martine, Bedane, Christophe, Bernard, Philippe, Machet, Laurent, Maillard, Hervé, Jullien, Denis, Debarbieux, Sebastien, Sassolas, Bruno, Misery, Laurent, Abasq, Claire, Dereure, Olivier, Lagoutte, Philippe, Ferranti, Vincent, Werth, Victoria, Murrell, Dedee, Hertl, Michael, Benichou, Jacques, Joly, Pascal, Duvert Lehembre, Sophie, Della Torre, Rocco, Hünefeld, Christian, Kern, Johannes Steffen, Bouyeure, Anne Charlotte, Bouaziz, Jean David, Richard, Marie Aleth, D’Incan, Michel, Livideanu, Cristina Bulai, Doutre, Marie Sylvie, UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU), Pharmacoepidemiologie et évaluation de l'impact des produits de santé sur les populations, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Bordeaux Segalen - Bordeaux 2-Université de Rouen Normandie (UNIROUEN), Universität Bern [Bern], Molecular and Cell Biology Laboratory, IDI-IRCCS, Rome, Service de Dermatologie, Hôpital Bichat, AP-HP, Service de dermatologie [Paris], Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de dermatologie [Avicenne], Hôpital Avicenne-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris 13 (UP13), CHU Henri Mondor, Service de Dermatologie [AP-HP Hôpital Saint Louis, Paris], Université Paris Diderot - Paris 7 (UPD7)-AP-HP Hôpital Saint-Louis, Service de Dermatologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), University Hospital of St-Etienne, Department of Dermatology, Université Grenoble Alpes - UFR Pharmacie (UGA UFRP), Université Grenoble Alpes (UGA), Service de dermatologie (CHRU de Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de Dermatologie [Rennes], CHU Pontchaillou [Rennes], Imagerie Moléculaire et Stratégies Théranostiques - Clermont Auvergne (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, Service de dermatologie [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Département de Dermatologie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service de Dermatologie [CHU Limoges], CHU Limoges, Club Rhumatismes et Inflammation, Service de Dermatologie, Centre Hospitalier Sud, Hospices Civils, Lyon, Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de dermatologie (Dermato - BREST), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Génétique médicale et fonctionnelle du cancer et des maladies neuropsychiatriques, Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie et biothérapies des maladies inflammatoires et autoimmunes, Seventh Framework Programme, French Society of Dermatology, Centre Hospitalier Universitaire de Reims (CHU Reims), Immuno-Régulation dans les Maladies Auto-Immunes Inflammatoires et le Cancer - EA 7509 (IRMAIC), Université de Reims Champagne-Ardenne (URCA), CHU Rouen, Normandie Université (NU), Service de dermatologie [Rouen], Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Unité de biostatistiques [Rouen], Service de Dermatologie [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]-Université Paris Diderot - Paris 7 (UPD7), Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Avicenne, Institut Mondor de recherche biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), L'Oréal recherche et innovation, L'Oréal, Institut de Génétique et Développement de Rennes (IGDR), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-IFR140-Centre National de la Recherche Scientifique (CNRS), Service de Dermatologie, Hôtel-Dieu, Centre de Recherche en Cancérologie / Nantes - Angers (CRCNA), Centre hospitalier universitaire de Nantes (CHU Nantes)-Faculté de Médecine d'Angers-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Centre National de la Recherche Scientifique (CNRS)-Hôpital Laennec-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôtel-Dieu de Nantes, Université Toulouse III - Paul Sabatier (UPS), Immunodermatologie, Cytokines, Cancer - EA 7319 (ICA), Service de dermatologie (CHRU de Tours), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), INSERM U1234, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Hopital Saint-Louis [AP-HP] (AP-HP), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service de Dermatologie [Rennes] = Dermatology [Rennes], Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier )-Université de Montpellier (UM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rouen Normandie (UNIROUEN), Université Bordeaux Segalen - Bordeaux 2-Université de Rouen Normandie (UNIROUEN), Universität Bern [Bern] (UNIBE), IDI-IRCCS [Roma, Italy], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], CHU Henri Mondor [Créteil], Service de Dermatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Université de Toulouse (UT), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
Subjects: 0301 basic medicine, Autoimmune Bullous Skin Disorder Intensity Score, Intraclass correlation, [SDV]Life Sciences [q-bio], intraclass correlation coefficient, Autoimmunity, PV, Validation Studies as Topic, Severity of Illness Index, Biochemistry, PDAI, 0302 clinical medicine, Medicine, DLQI, Pemphigus foliaceus, Skin, integumentary system, Desmoglein 1, PGA, CI, 3. Good health, ABSIS, month, 030220 oncology & carcinogenesis, PF, medicine.medical_specialty, pemphigus vulgaris, [SDV.CAN]Life Sciences [q-bio]/Cancer, Dermatology, 03 medical and health sciences, Dermatology Quality of Life Index, Internal medicine, Severity of illness, Humans, In patient, pemphigus foliaceus, Molecular Biology, Autoantibodies, Pemphigus severity scores, ICC, business.industry, Pemphigus vulgaris, Cell Biology, medicine.disease, Confidence interval, Moderate extent, Pemphigus Disease Area Index, Pemphigus, 030104 developmental biology, confidence interval, Physician Global Assessment, business, [SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: IF 6.448 (2017); International audience; The Pemphigus Disease Area Index (PDAI) and Autoimmune Bullous Skin Disorder Intensity-Score (ABSIS) scores have been proposed to provide an objective measure of pemphigus activity. These scores have been evaluated only on already treated patients mainly with mild to moderate activity. The objective was to assess the interrater reliability of ABSIS and PDAI scores and their correlation with other severity markers in a large international study. Consecutive patients with newly diagnosed pemphigus were enrolled in 31 centers. Severity scores were recorded during a 24-month period by the same two blinded investigators. Serum was collected at each visit for ELISA measurement of anti-desmoglein antibodies. The intraclass correlation coefficient (ICC) and Spearman rank correlation coefficient were calculated. A total of 116 patients with pemphigus vulgaris (n = 84) or pemphigus foliaceus (n = 32) were included. At baseline, the ABSIS and PDAI ICCs were 0.90 (95% confidence interval [CI] = 0.85-0.93), and 0.91(95% CI = 0.87-0.94), respectively. The ICCs for PDAI were higher in moderate and extensive pemphigus (ICC = 0.82, 95% CI = 0.63-0.92 and ICC = 0.80, 95% CI = 0.62-0.90, respectively) than in patients with intermediate (significant) extent (ICC = 0.50, 95% CI = 0.27-0.68). Conversely, the ICCs for ABSIS were lower in patients with moderate extent (ICC = 0.44, 95% CI = 0.004-0.74) than in those with intermediate or extensive forms, (ICC = 0.69, 95% CI = 0.51-0.81 and ICC = 0.75, 95% CI = 0.51-0.88, respectively). During patients' follow-up, the ICCs of both ABSIS and PDAI scores remained higher than 0.70. ABSIS and PDAI skin (r = 0.71 and r = 0.75) but not mucosal (r = 0.32 and r = 0.37) subscores were correlated with the evolution of anti-DSG1 and anti-DSG3 ELISA values, respectively. ABSIS and PDAI scores are robust tools to accurately assess pemphigus activity.
Published: 2019

40. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women

Author: Chloé Robert, Marie-Caroline Michalski, Nadine Leconte, Manon Lecomte, Laurie Joumard-Cubizolles, David Cheillan, Karène Bertrand, Anne-Esther Breyton, Emmanuel Combe, Annie Durand, Mélanie Le Barz, Florent Joffre, Martine Laville, Corinne Malpuech-Brugère, Cécile Vors, Michèle Trauchessec, Lemlih Ouchchane, Charlotte Cuerq, Sandra Pesenti, Patrice Gaborit, Hubert Vidal, Eddy Cotte, Jocelyne Drai, Stéphanie Lambert-Porcheron, Emmanuelle Meugnier, Emmanuelle Loizon, Annick Bernalier-Donadille, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Institut des Corps Gras, (ITERG), Hospices Civils de Lyon, Unité Maladies Héréditaires du Métabolisme, Service de Biochimie et Biologie, Centre, Hospices Civils de Lyon, Unité de Nutrition Endocrinologie Métabolisme, Service de Biochimie, ACTALIA, Dairy Products and Technologies, Science et Technologie du Lait et de l'Oeuf (STLO), AGROCAMPUS OUEST, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Microbiologie Environnement Digestif Santé (MEDIS), Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, Service de Chirurgie Digestive, Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA), Université Grenoble Alpes (UGA)-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-CHU Grenoble-Hospices Civils de Lyon (HCL)-CHU Saint-Etienne-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, FUNDINGS. Agence Nationale de la Recherche, ANR-11-ALID-007-01, Regional Hospital Clinical Research Program (PHRCI-2014: VALOBAB, n°14-007), French Dairy Interbranch Organization (CNIEL), Groupe Lipides et Nutrition (GLN 2018-11-07), Hospices Civils de Lyon as sponsor., Giboulot, Anne, Actalia - division produits laitiers, Actalia [Saint-Lô], Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-INSTITUT AGRO Agrocampus Ouest, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-CHU Saint-Etienne-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Grenoble Alpes (UGA), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Grenoble Alpes (UGA)
Subjects: 0301 basic medicine, chemistry.chemical_compound, Feces, 0302 clinical medicine, Cheese, maladie cardiovasculaire, Gastrointestinal tract, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, food and beverages, General Medicine, Cardiovascular disease, 3. Good health, Sphingomyelins, Postmenopause, Postprandial, Cholesterol, Milk, 030220 oncology & carcinogenesis, lipide polaire, Female, lipids (amino acids, peptides, and proteins), Sphingomyelin, medicine.medical_specialty, Ceramide, sphingomyéline, Ceramides, 03 medical and health sciences, intestin, Internal medicine, medicine, Animals, Humans, Clinical Trials, Lipid rafts, Glycoproteins, business.industry, lipide du lait, ménopause, Metabolism, Lipid Droplets, Overweight, Lipid Metabolism, Diet, [SDV.AEN] Life Sciences [q-bio]/Food and Nutrition, 030104 developmental biology, Endocrinology, chemistry, Clinical Medicine, Glycolipids, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Chylomicron
Abstract: International audience; BACKGROUND. High circulating levels of ceramides (Cer) and sphingomyelins (SM) have been associated with cardiometabolic diseases. The consumption of whole-fat dairy products, which naturally contain such polar lipids (PL), is associated with health benefits, but the impact on sphingolipidome remains unknown. We investigated how milk PL supplementation impacts circulating and intestinal SM and Cer composition in association with improvement of cardiovascular markers.METHODS. In a 4 week-randomized double-blind controlled study, 58 postmenopausal women consumed daily a cream cheese containing 0, 3 or 5 g of milk PL. Postprandial metabolic explorations were performed before and after the supplementation. SM and Cer species were analyzed in serum, intestine-derived chylomicrons and feces. The ileal content of 4 ileostomy patients was also explored after milk PL intake in a crossover double-blind study.RESULTS. Milk PL consumption decreased serum atherogenic C24:1 Cer (Pgroup = 0.033), C16:1 (Pgroup = 0.007) and C18:1 (Pgroup = 0.003) SM species. Changes in serum C16+18 SM species were positively correlated with the reduction of total cholesterol (r = 0.706, P < 0.001), LDL-C (r = 0.666, P < 0.001) and ApoB (r = 0.705, P < 0.001). Milk PL decreased the concentration in chylomicrons of total SM (Pgroup < 0.0001) and of C24:1 Cer (Pgroup = 0.001). Saturated SM and Cer species, which are also the major species found in milk PL-enriched cheeses, increased in ileal efflux and feces. There was a marked increase in total fecal Cer after milk PL supplementation (Pgroup = 0.0002). Milk PL also modulated the abundance of some specific SM and Cer species in ileal efflux and feces, suggesting differential absorption and metabolization processes in the gut.CONCLUSION. These data demonstrate that milk PL supplementation decreases atherogenic SM and Cer species associated with an improvement of cardiovascular risk markers. Our findings bring new insights on sphingolipid metabolism in the gastrointestinal tract, especially Cer as such signaling molecules potentially participating in the beneficial effect of milk PL. ClinicalTrials.gov, NCT02099032, NCT02146339.
Published: 2021

41. Severe undernutrition increases bleeding risk on vitamin-K antagonists

Author: Christine Morand, Aurélien Lebreton, Damien Richard, Farès Moustafa, Aurélien Mulliez, Loic Dopeux, Frédéric Dutheil, Jeannot Schmidt, Yves Boirie, N. Farigon, E. Gentes, Dorian Teissandier, Pôle Urgences [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service de Nutrition Clinique [CHU Clermont-Ferrand], Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Service de Pharmacologie Médicale [CHU Clermont-Ferrand], Service d’Hématologie Biologique [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Centre de Ressources et Compétences des Maladies Hémorragiques Constitutionnelles [CHU Clermont-Ferrand] (CRC-MHC), CHU Estaing [Clermont-Ferrand], Australian Catholic University (ACU), Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS)
Subjects: 0301 basic medicine, Male, medicine.medical_specialty, Vitamin K, medicine.drug_class, Micronutriment, 030209 endocrinology & metabolism, Hemorrhage, Vitamin k, Critical Care and Intensive Care Medicine, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Atrial Fibrillation, medicine, micronutrient, Humans, Prospective Studies, Prospective cohort study, Plasma zinc, Aged, 2. Zero hunger, Aged, 80 and over, 030109 nutrition & dietetics, Nutrition and Dietetics, business.industry, Malnutrition, Bleeding, Anticoagulants, Nutritional status, Undernutrition, Vitamin K antagonist, medicine.disease, Micronutrient, 3. Good health, Case-Control Studies, Female, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Major bleeding, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Anticoagulant agent
Abstract: Summary Introduction Hemorrhage occurs in 7–10% of patients treated with vitamin K antagonist (VKA), with major bleeding in 1–3%. Impact of nutritional status on the bleeding risk of patients on anticoagulants is still poorly documented. Our study aimed to analyze the link between the nutritional status of patients on VKA and the occurrence of hemorrhagic events. We also analyzed micronutrients status. Methods A case–control, monocentric, and prospective study was conducted from August 2012 to October 2015. The case patients were those presenting with major bleeding and control patients those without any bleeding under VKA treatment. Results Overall, 294 patients under VKA treatment were paired according to age, gender, and index normalized ratio (INR). Out of these, 98 (33.3%) had major bleeding and 196 (66.7%) did not have any bleeding. Additionally, more than two-thirds of patients displayed undernutrition, which was more prevalent in bleeding than non-bleeding patients (OR = 1.85, CI95%: 1.07–3.21). There was a higher bleeding risk for those with severe undernutrition (OR = 2.66, CI95%: 1.58–4.46), with no difference found concerning moderate undernutrition. Bleeding patients had lower plasma-zinc concentrations than non-bleeding patients (9.4 ± 3.6 vs. 10.5 ± 3.7 μmol/L, p = 0.003); among them, there was a higher rate of patients with plasma zinc under 5 μmol/L (9% vs. 2%, p Conclusion Patients with undernutrition on VKA exhibit a significantly higher bleeding risk, which increases three-fold in case of severe undernutrition. The evaluation of nutritional status provides additional, valuable prognosis information prior to initiating VKA therapy. ClinicalTrials.gov number NCT 01742871.
Published: 2021

42. How Did the COVID-19 Confinement Period Affect Our Physical Activity Level and Sedentary Behaviors? Methodology and First Results From the French National ONAPS Survey

Author: Céline Lambert, David Thivel, Bruno Pereira, Martine Duclos, Benjamin Larras, Julien S. Baker, Jean-François Toussaint, Angelo Tremblay, Pauline Genin, Observatoire national de l’activité physique et de la sédentarité (ONAPS), Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions, Université Blaise Pascal - Clermont-Ferrand 2 (UBP), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Observatoire national de l'Activité Physique et de la santé (ONAPS), Institut de recherche biomédicale et d’épidémiologie du sport (IRMES - URP_7329), Institut national du sport, de l'expertise et de la performance (INSEP)-Université de Paris (UP), Centre d'Investigation en Médecine du sport (CIMS), Hôtel-Dieu-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Ningbo University (NBU), Hong Kong Baptist University (HKBU), Institut des Nutraceutiques et des Aliments Fonctionnels (INAF), Université Laval [Québec] (ULaval), Université Clermont Auvergne (UCA), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Dept Sport Med and Funct Explorat, CHU Clermont-Ferrand, Institut national du sport, de l'expertise et de la performance (INSEP)-Université Paris Cité (UPCité), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, Coronavirus disease 2019 (COVID-19), Population, Affect (psychology), Screen Time, lockdown, Young Adult, 03 medical and health sciences, Screen time, 0302 clinical medicine, Surveys and Questionnaires, Epidemiology, medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Young adult, Child, education, habits, Exercise, Aged, Sitting Position, education.field_of_study, [SHS.SPORT]Humanities and Social Sciences/Sport, business.industry, Public health, pandemic, public health, COVID-19, 030229 sport sciences, Middle Aged, Physical activity level, Communicable Disease Control, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, France, Sedentary Behavior, business, Demography
Abstract: Background: The French National Observatory for Physical Activity and Sedentary Behaviors conducted a national survey aiming to evaluate the potential effects of confinement on the population’s physical activity levels and sedentary behaviors. Methods: In close collaboration with the French Ministry of Sports and a selected expert committee, 3 different questionnaires investigating 3 subgroup populations were included in the survey: (1) children, (2) adolescents, and (3) adults. Results: Forty-two percentage of children, 58.7% of adolescents, 36.4% of adults, and 39.2% of older people had reduced physical activity levels. Particularly, active transportation and endurance practices showed a significant decrease, while domestic, muscular strengthening, and flexibility activities increased. Sitting time and screen time increased, respectively, in 36.3% and 62.0% of children, 25.5% and 69.0% in adolescents, 24.6% and 41.0% in adults, and 36.1% and 32.1% in seniors. Conclusion: The COVID-19 confinement period led to important modifications in individual movement behaviors at all ages, particularly favoring decreased physical activity and increased sedentariness. These findings suggest that the authors need to inform and encourage people to maintain and improve their physical activities and to change their sedentary time habits during postconfinement and during the period of a potential future lockdown.
Published: 2021

43. Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor therapy

Author: Luc Manlay, Gilles Boschetti, Bruno Pereira, Bernard Flourié, Michel Dapoigny, Maud Reymond, Elisa Sollelis, Claire Gay, Mathilde Boube, Anthony Buisson, Stéphane Nancey, Service d'Hépatologie Gastro-entérologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service d'Hépatogastroentérologie [CHU Lyon-Sud], Hospices Civils de Lyon (HCL), Centre International de Recherche en Infectiologie - UMR (CIRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Molé, Christine, Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, medicine.medical_specialty, medicine.medical_treatment, Antibodies, Monoclonal, Humanized, Gastroenterology, Vedolizumab, MESH: Ustekinumab* / therapeutic use, 03 medical and health sciences, 0302 clinical medicine, Refractory, Crohn Disease, Internal medicine, Ustekinumab, medicine, Clinical endpoint, Humans, Pharmacology (medical), 030212 general & internal medicine, MESH: Treatment Outcome, Crohn's disease, Hepatology, business.industry, MESH: Antibodies, Monoclonal, Humanized / therapeutic use, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Bowel resection, Odds ratio, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Treatment Outcome, MESH: Crohn Disease* / drug therapy, Monoclonal, 030211 gastroenterology & hepatology, MESH: Tumor Necrosis Factor Inhibitors, Tumor Necrosis Factor Inhibitors, business, medicine.drug
Abstract: International audience; Background The best option between vedolizumab and ustekinumab after anti-tumour necrosis factor (TNF) failure remains unclear in Crohn's disease.Aims To compare the short- and long-term effectiveness of vedolizumab and ustekinumab in Crohn's disease patients with prior anti-TNF exposure.Methods All Crohn's disease patients treated with ustekinumab or vedolizumab after exposure to at least one anti-TNF agent were included from two referral centres. Primary endpoint was corticosteroid-free clinical remission defined as Crohn's disease activity index 35 years old (OR = 0.41 [0.19-0.87]), with noncomplicated phenotype (OR=0.42 [0.18-0.96]), no prior bowel resection (OR = 0.49 [0.24-0.96]), and no steroids at baseline (OR=0.47 [0.23-0.97]).Conclusion Ustekinumab was more effective to achieve early and long-term effectiveness than vedolizumab in Crohn's disease patients who previously failed response to anti-TNF agents.
Published: 2021

44. The Early Impact of the COVID-19 Lockdown on Stress and Addictive Behaviors in an Alcohol-Consuming Student Population in France

Author: Valentin Flaudias, Oulmann Zerhouni, Bruno Pereira, Cheryl J. Cherpitel, Jordane Boudesseul, Ingrid de Chazeron, Lucia Romo, Sébastien Guillaume, Ludovic Samalin, Julien Cabe, Laurent Bègue, Laurent Gerbaud, Benjamin Rolland, Pierre-Michel Llorca, Mickael Naassila, Georges Brousse, CHU Clermont-Ferrand, Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Laboratoire Parisien de Psychologie Sociale (LAPPS), Université Paris 8 Vincennes-Saint-Denis (UP8)-Université Paris Nanterre (UPN), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Clinique, Psychanalyse, Développement (CliPsyD), Université Paris Nanterre (UPN), Clinique des maladies mentales et de l'encéphale (CMME - Service de psychiatrie), Hôpital Sainte-Anne-Université Paris Cité (UPCité), Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Laboratoire Inter-universitaire de Psychologie : Personnalité, Cognition, Changement Social (LIP-PC2S), Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry])-Université Grenoble Alpes (UGA), Institut Pascal (IP), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), RIQUOIR, GAELLE, CHU Clermont-Ferrand-Université Clermont Auvergne (UCA), Université Paris Nanterre (UPN)-Université Paris 8 Vincennes-Saint-Denis (UP8), Hôpital Sainte-Anne-Université de Paris (UP), Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de recherche en neurosciences de Lyon (CRNL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Boudesseul, Jordane
Subjects: medicine.medical_specialty, lcsh:RC435-571, LockDown, media_common.quotation_subject, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, purl.org/pe-repo/ocde/ford#5.01.00 [https], Protective factor, 030508 substance abuse, Alcohol, Stress, 03 medical and health sciences, chemistry.chemical_compound, Social support, 0302 clinical medicine, lcsh:Psychiatry, Stress (linguistics), Medicine, 030212 general & internal medicine, College students, Estrés, media_common, Original Research, Psychiatry, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, alcohol, Public health, Addiction, Psicología / Psicología social, Stressor, public health, COVID-19, Estudiantes universitarios, Coronavirus, Psychiatry and Mental health, chemistry, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, stressors, addiction, Worry, 0305 other medical science, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Clinical psychology
Abstract: Indexado en Scopus This study evaluated factors linked with perceived stress related to the COVID-19 pandemic and lockdown and addictive behaviors prior to and during lockdown in a sample of students who indicated engaging in alcohol consumption behaviors before lockdown. Methods: Cross-sectional study. French students from four universities participated in this study, and 2,760 students reported alcohol use. During the first week of lockdown, students reported their perceived levels of stress regarding COVID-19. Substance use and addictive behaviors were reported before and during lockdown, and media exposure, demographical, living conditions, and environmental stressors were reported during lockdown. Results: Women reported greater levels of stress (95% CI: 1.18 to 1.93, p < 0.001). Highly-stressed students also report less social support (95% CI: -1.04 to -0.39, p < 0.001) and were more likely to worry about the lockdown (95% CI: 0.27 to -0.65, p < 0.001). Alcohol-related problemswere more prevalent among the most stressed students (95% CI: 0.02 to 0.09, p = 0.004) as well as eating problems (95% CI: 0.04 to 0.36, p = 0.016) and problematic internet use (95% CI, 0.06 to 0.14, p < 0.001). Students reporting the highest levels of stress also indicated more compulsive eating during the previous seven days (95% CI, 0.21 to 1.19, p = 0.005). Conclusions: The level of stress was strongly related to four categories of variables: (i) intrinsic characteristics, (ii) addictive behaviors before lockdown, (iii) lockdown-specific conditions, and (iv) addictive behaviors during the lockdown. Several variables linked to COVID-19 were not directly linked with perceived stress, while perceived stress was found to correlate with daily life organization-related uncertainty and anticipated consequences of lockdown. Importantly, social support seems to be a protective factor on high level of stress. Este estudio evaluó los factores relacionados con el estrés percibido relacionado con la pandemia de COVID-19 y el encierro y las conductas adictivas antes y durante el encierro en una muestra de estudiantes que indicaron participar en comportamientos de consumo de alcohol antes del encierro. Métodos: estudio transversal. En este estudio participaron estudiantes franceses de cuatro universidades y 2.760 estudiantes informaron haber consumido alcohol. Durante la primera semana de encierro, los estudiantes informaron sobre sus niveles percibidos de estrés con respecto a COVID-19. Se informó el uso de sustancias y los comportamientos adictivos antes y durante el encierro, y se informó sobre la exposición a los medios, las condiciones demográficas, de vida y los factores estresantes ambientales durante el encierro. Resultados: las mujeres informaron mayores niveles de estrés (IC del 95%: 1,18 a 1,93, p
Published: 2021

45. Factors associated with anti-tumor necrosis factor effectiveness to prevent postoperative recurrence in Crohn's disease

Author: Neil Hyman, Russell D. Cohen, Bruno Pereira, Sushila Dalal, Roger D. Hurst, Lisa M. Cannon, Joel Pekow, Konstantin Umanskiy, David T. Rubin, Anthony Buisson, Atsushi Sakuraba, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Infection Inflammation et Interaction Hôtes Pathogènes [CHU Clermont-Ferrand] (3IHP ), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, The University of Chicago Medicine [Chicago], Unité de Biostatistiques [CHU Clermont-Ferrand], United States Department of Health & Human Services, United States Department of Health & Human Services [P30 DK042086], NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), Inflammatory Bowel Disease Center, Department of Surgery, and Molé, Christine
Subjects: medicine.medical_specialty, Combination therapy, ileocolonic resection, medicine.medical_treatment, Disease, Gastroenterology, Inflammatory bowel disease, combination therapy, surgery, 03 medical and health sciences, 0302 clinical medicine, inflammatory bowel disease, Internal medicine, medicine, Crohn's disease, business.industry, Hazard ratio, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Odds ratio, medicine.disease, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Confidence interval, 3. Good health, Immunosuppressive drug, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, business
Abstract: Background/Aims: We assessed the effectiveness of anti-TNF agents and its associated factors to prevent endoscopic and clinical postoperative recurrence (POR) in Crohn’s disease (CD). Methods: From a prospectively-maintained database, we retrieved 316 CD patients who underwent intestinal resection (2011–2017). Endoscopic (Rutgeerts index ≥ i2 at 6 months) and clinical (recurrence of symptoms leading to hospitalization or therapeutic escalation) POR were assessed. Results: In 117 anti-TNF-naïve patients, anti-TNF therapy was more effective than immunosuppressive agents (odds ratio [OR], 8.8; 95% confidence interval [CI], 1.8–43.9; P= 0.008) and no medication/5-aminosalicylates (OR, 5.2; 95% CI, 1.0–27.9; P= 0.05) to prevent endoscopic POR. In 199 patients exposed to anti-TNF prior to the surgery, combination with anti-TNF and immunosuppressive agents was more effective than anti-TNF monotherapy (OR, 2.32; 95% CI, 1.02–5.31; P= 0.046) to prevent endoscopic POR. Primary failure to anti-TNF agent prior to surgery was predictive of anti-TNF failure to prevent endoscopic POR (OR, 2.41; 95% CI, 1.10–5.32; P= 0.03). When endoscopic POR despite anti-TNF prophylactic medication (n = 55), optimizing anti-TNF and adding an immunosuppressive drug was the most effective option to prevent clinical POR (hazard ratio, 7.38; 95% CI, 1.54–35.30; P= 0.012). Anti-TNF therapy was the best option to prevent clinical POR (hazard ratio, 3.10; 95% CI, 1.09–8.83; P= 0.034) in patients with endoscopic POR who did not receive any biologic to prevent endoscopic POR (n = 55). Conclusions: Anti-TNF was the most effective medication to prevent endoscopic and clinical POR. Combination with anti-TNF and immunosuppressive agents should be considered in patients previously exposed to anti-TNF.
Published: 2021

46. Cardiometabolic efficacy of multidisciplinary weight loss interventions is not altered in adolescents with obesity initially diagnosed or with a persistent metabolic syndrome

Author: Valérie Julian, David Thivel, Yves Boirie, Ana R Damaso, Katharina Maruszczak, Piotr Matłosz, Marwa Khammassi, Frédéric Dutheil, Daniel Weghuber, Laurie Isacco, Bruno Pereira, Martine Duclos, Département d'Informatique [Jendouba] (Université de Jendouba), Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions, Université Blaise Pascal - Clermont-Ferrand 2 (UBP), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Federal University of Sao Paulo (Unifesp), Rzeszow University of Technology, Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Centre de Recherche en Nutrition Humaine Auvergne [CHU Clermont-Ferrand] (CRNH A), French National University institute (IUF) UGE-CAM group, Service Médecine du Sport et Explorations Fonctionnelles [CHU Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand]
Subjects: Blood Glucose, 0301 basic medicine, Pediatrics, medicine.medical_specialty, Weight loss, Adolescent, [SDV]Life Sciences [q-bio], Endocrinology, Diabetes and Metabolism, Blood Pressure, 030209 endocrinology & metabolism, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Multidisciplinary approach, medicine, Humans, Insulin, Child, ComputingMilieux_MISCELLANEOUS, 2. Zero hunger, 030109 nutrition & dietetics, Nutrition and Dietetics, medicine.diagnostic_test, business.industry, Physical activity, Pediatric obesity, Anthropometry, medicine.disease, Lipids, Obesity, Metabolic syndrome, Cardiometabolic impairments, Weight Reduction Programs, Blood pressure, Body Composition, Metabolome, Female, medicine.symptom, Lipid profile, business, Body mass index, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition
Abstract: International audience; The efficacy of weight loss interventions might be affected by the metabolic profile of adolescents with obesity. In this study, we hypothesized that the initial diagnosis of the MS, or its persistence after an intervention, will not reduce the efficacy of a 16-week multidisciplinary weight loss program. Ninety two adolescents (12-15 years; 62 girls) with obesity completed baseline anthropometric and body composition evaluation (DXA). Lipid profile, insulinemia, glycaemia and blood pressure were measured and metabolic syndrome (MS) diagnosed. The adolescents then followed a 4-month inpatient multidisciplinary weight management program. All measurements were performed before (T0) and after 4 months of intervention (T1). Body weight, body mass index (BMI) and percentage of fat mass (%FM) decreased significantly between T0 and T1 (P < .001), with no difference in fat-free mass (kg). All metabolic variables (except blood pressure) were improved. 47.6% of the whole sample presented with MS at baseline against 35.7% at T1. Body weight (P = 0.006), BMI (P = 0.0261), %FM (P = 0.0211), hip circumference (= 0.0131), BMI percentile (P = 0.0319), and diastolic blood pressure (P = 0.0365) showed a time x group interaction and their deltas (variations between T0 and T1) were significantly different between adolescents with and without MS at baseline. There was no significant difference between adolescents with persistent and nonpersistent MS except for Delta BMI percentile that deceased significantly more in the non persistent group (P = 0.0115). According to our results, the efficacy of weight loss interventions is not reduced in adolescents initially diagnosed with MS or different between those who present a persistent or nonpersistent MS after the intervention.
Published: 2021

47. Is constitutional thinness really different from anorexia nervosa? A systematic review and meta-analysis

Author: Mélina Bailly, Daniel Courteix, Bogdan Galusca, David Thivel, Yves Boirie, Audrey Boscaro, Natacha Germain, Léonard Féasson, Bruno Pereira, Julien Verney, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne (UCA)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Université Jean Monnet [Saint-Étienne] (UJM), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), and Université Jean Monnet - Saint-Étienne (UJM)
Subjects: Pediatrics, medicine.medical_specialty, Anorexia Nervosa, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Body composition, Constitutional thinness, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Thinness, Diabetes mellitus, Medicine, Humans, Weight gain resistance, business.industry, Human Growth Hormone, Leptin, Biochemical markers, Energy metabolism, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, medicine.disease, Appetite-regulating hormones, 3. Good health, Anorexia nervosa (differential diagnoses), Meta-analysis, Basal metabolic rate, Underweight, medicine.symptom, business, Luteinizing hormone, Energy Intake, Hormone
Abstract: International audience; A growing interest in constitutional thinness has been observed in the last decades, but the publications however cover various fields of study and report equivocal results. The present work systematically reviewed any clinical trials enrolling participants with constitutional thinness and bibliographic researches were performed between December 2018 and June 2020. From a total of 1 212 records initially identified, 402 records were removed as duplicates, 381 articles were excluded based on titles or abstracts and 390 references were excluded against eligibility criteria. Thirty-nine articles were finally included in the systematic review. The results showed that constitutionally thin people seem to be underweight but not underfat and present a fat-free mass as blunted as anorexic patients, despite being a little less underweight. The meta-analysis confirmed that constitutionally thin people present normal energy intake and revealed a trend toward a higher resting metabolic rate to fat-free mass ratio which suggests a highly metabolic fat-free mass. Contrary to patients with anorexia nervosa, constitutionally thin people present normal levels of insulin-like growth factor 1, estradiol, growth hormone, follicle-stimulating hormone, and luteinizing hormone. An intermediate level of leptin between anorexic and control participants was however observed in constitutional thinness. While all the studies reported normal free triiodothyronine and cortisol levels in constitutionally thin individuals, a higher fasting free triiodothyronine level (p = 0.033) and a lower 24 h mean cortisol level (p = 0.005) were observed for the first time. Present results give robust evidence that constitutionally thin people present an atypical phenotype highly different from anorexia nervosa.
Published: 2021

48. The Effect of TNF and Non-TNF-Targeted Biologics on Body Composition in Rheumatoid Arthritis

Author: Sandrine Malochet-Guinamand, Martin Soubrier, Marie Eva Pickering, Gaelle Vial, Sylvain Mathieu, Bruno Pereira, Marion Couderc, Céline Lambert, Anne Tournadre, CHU Clermont-Ferrand, Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Unité de Nutrition Humaine (UNH), and Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA)
Subjects: rheumatoid arthritis, medicine.medical_specialty, muscle, medicine.medical_treatment, Adipose tissue, lcsh:Medicine, Gastroenterology, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, fat, medicine, Mass index, 030212 general & internal medicine, 030203 arthritis & rheumatology, body composition, business.industry, lcsh:R, General Medicine, medicine.disease, 3. Good health, TNF inhibitor, Rheumatoid arthritis, Lean body mass, Tumor necrosis factor alpha, Composition (visual arts), Subcutaneous adipose tissue, business, biologic, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Rheumatoid arthritis (RA) is associated with a decrease in lean mass and stability or even an increase in fat and ectopic adipose tissue. A few data are available on body composition changes under treatment, and data are still controversial. Body composition was assessed before initiation of biologic disease-modifying antirheumatic drug (bDMARD) and after 6 and 12 months of stable treatment. Eighty-three RA patients were included (75% of women, mean age 58.5 &plusmn, 10.8 years) of whom 47 patients treated with TNF inhibitor (TNFi), 18 with non-TNF-targeted biologic (Non-TNFi), and 18 with conventional DMARD (cDMARD) alone. In the TNFi group, total lean mass, fat-free mass index, and skeletal muscle mass index significantly increased at 1 year. An increase in subcutaneous adipose tissue (SAT) without change for the visceral or body fat composition was associated. These changes were associated with an improvement in strength and walking test. In non-TNFi or cDMARD groups, no significant changes for body composition or muscle function were observed at 1 year. However, no significant differences for treatment x time interaction were noted between group treatments. In active RA patients starting first bDMARD, treatment with TNFi over 1 year was associated with favorable changes of the body composition and muscle function.
Published: 2021

49. Effect of the COVID-19 lockdown on Physical Activity and Sedentary Behaviors in French Children and Adolescents: new results from the ONAPS national survey

Author: Julien Bois, Alicia Fillon, Pierre Melsens, Céline Lambert, Angelo Tremblay, Camille Chambonnière, David Thivel, Martine Duclos, Pauline Genin, Bruno Pereira, Michèle Tardieu, Nicole Fearnbach, Benjamin Larras, Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne (UCA)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Observatoire national de l'Activité Physique et de la santé (ONAPS), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Pennington Biomedical Research Center, Louisiana State University (LSU), Université de Pau et des Pays de l'Adour (UPPA), Département de kinésiologie, Université Laval, Université Laval [Québec] (ULaval), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), and French National Observatory for Physical Activity and Sedentary Behaviors (ONAPS)
Subjects: Gerontology, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Physical activity, Sitting, Adolescents, Article, Sedentary behaviors, 03 medical and health sciences, Screen time, 0302 clinical medicine, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], 030212 general & internal medicine, Children, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Public health, Sitting time, 030205 complementary & alternative medicine, 3. Good health, Complementary and alternative medicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Psychology, Covid-19
Abstract: International audience; Introduction: In France March 14, 2020 a national lockdown was imposed in France for 55 days to prevent the spread of the Covid-19 and all schools were closed. This study aimed to investigate the effects of home confinement as a result of lockdown on the activity (physical activity and sedentary behaviors), and their determinants, on French children (6-10 years) and adolescents (11-17 years).Methods: The National Observatory for Physical Activity and Sedentary behaviors launched an online survey from April 1 st , to May 6 th , 2020 using popular social networks and websites. It compared the level of physical activity (PA), sitting and screen time before and during the lockdown and identified the impact of the initial PA (active vs. inactive), sedentary (high vs. low) profiles of the participants and the housing conditions.Results: 6,491 children were included in this study. Initially active children and adolescents decreased their PA more than those initially inactive (p>0.001), while those who met the sitting time recommendations increased more their sitting time during lockdown (p
Published: 2021

50. Preoperative REM sleep behavior disorder and subthalamic nucleus deep brain stimulation outcome in Parkinson disease 1 year after surgery

Author: Isabelle Benatru, Dominique Guehl, Philippe Derost, Stéphane Thobois, David Devos, Franck Durif, Elodie Durand, Mélissa Tir, Ouhaid Lagha-Boukbiza, Elodie Hainque, Elsa Besse-Pinot, Caroline Giordana, Jean-Christophe Corvol, B. Debilly, David Maltête, Tiphaine Rouaud, Sophie Drapier, Lucie Hopes, Bruno Pereira, Ana Marques, Cécile Hubsch, Maria Livia Fantini, Olivier Rascol, Alexandre Eusebio, Caroline Moreau, Anne-Sophie Rolland, Béchir Jarraya, Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Lille, Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Service de neurologie [Nantes], Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Institut de Neurosciences de la Timone (INT), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service de neurologie [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de Neurologie [CHU Rennes], CHU Pontchaillou [Rennes], Institut des Maladies Neurodégénératives [Bordeaux] (IMN), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Centre d'investigation clinique de Toulouse (CIC 1436), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d’Excellence en Maladies Neurodégénératives (NeuroToul), CHU Toulouse [Toulouse], Service de neurologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de Neurologie [Strasbourg], CHU Strasbourg-Hopital Civil, Service de Neurologie [CHU Nice], Hôpital Pasteur [Nice] (CHU)-Centre Hospitalier Universitaire de Nice (CHU Nice), Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559 (LNFP), Université de Picardie Jules Verne (UPJV), Institut des sciences cognitives Marc Jeannerod - Centre de neuroscience cognitive - UMR5229 (CNC), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Hôpital Foch [Suresnes], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Lille Neurosciences & Cognition - U 1172 (LilNCog (ex-JPARC)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Ministère des Affaires Sociales et de la Santé, The study was funded by the France Parkinson charity and French Ministry of Health (PHRC National 2012) and promoted by CHU Lille (coordinated by Pr Devos and Pr Corvol) with the support of the French network NS-PARK and supported by NS-PARK/F-CRIN and the Fédération de la Recherche Clinique du CHU de Lille., Marques, Ana, CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), CHU Clermont-Ferrand, École d’Orthoptie - Clermont-Ferrand (EO - UdA), CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I (UdA), Service de Neurologie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Service de neurologie et pathologie du mouvement, Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Hôpital de la Timone [CHU - APHM] (TIMONE), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Toulouse Neuro Imaging Center (ToNIC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Toulouse Mind & Brain Institut (TMBI), Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, Différenciation et communication neuronale et neuroendocrine (DC2N), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Centre Hospitalier Universitaire de Nice (CHU Nice), Centre Hospitalier Universitaire de Nancy (CHU Nancy), Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service NEUROSPIN (NEUROSPIN), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut du Cerveau = Paris Brain Institute (ICM), 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)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Toulouse Mind & Brain Institut (TMBI), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT), Institut des sciences cognitives Marc Jeannerod - Centre de neuroscience cognitive - UMR5229 (ISC-MJ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and Hôpital Guillaume-et-René-Laennec [Saint-Herblain]-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université de Nantes (UN)
Subjects: medicine.medical_specialty, Activities of daily living, Deep Brain Stimulation, REM Sleep Behavior Disorder, Disease, Risk Assessment, REM sleep behavior disorder, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Subthalamic Nucleus, Rating scale, medicine, Humans, Prospective Studies, 030212 general & internal medicine, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Prospective cohort study, business.industry, Subthalamic nucleus deep brain stimulation, Parkinson Disease, medicine.disease, 3. Good health, Surgery, Treatment Outcome, Preoperative Period, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Neurology (clinical), Neurosurgery, business, 030217 neurology & neurosurgery, Research Article
Abstract: Background and ObjectivesTo determine whether patients with Parkinson disease (PD) eligible for subthalamic nucleus deep brain stimulation (STN-DBS) with probable REM sleep behavior disorder (RBD) preoperatively could be more at risk of poorer motor, nonmotor, and quality of life outcomes 12 months after surgery compared to those without RBD.MethodsWe analyzed the preoperative clinical profile of 448 patients with PD from a French multicentric prospective study (PREDISTIM) according to the presence or absence of probable RBD based on the RBD Single Question and RBD Screening Questionnaire. Among the 215 patients with PD with 12 months of follow-up after STN-DBS, we compared motor, cognitive, psycho-behavioral profile, and quality of life outcomes in patients with (pre-opRBD+) or without (pre-opRBD–) probable RBD preoperatively.ResultsAt preoperative evaluation, pre-opRBD+ patients were older (61 ± 7.2 vs 59.5 ± 7.7 years; p = 0.02), had less motor impairment (Movement Disorder Society–sponsored version of the Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] III “off”: 38.7 ± 16.2 vs 43.4 ± 7.1; p = 0.03) but more nonmotor symptoms on daily living activities (MDS-UPDRS I: 12.6 ± 5.5 vs 10.7 ± 5.3; p < 0.001), had more psychobehavioral manifestations (Ardouin Scale of Behavior in Parkinson's Disease total: 7.7 ± 5.1 vs 5.1 ± 0.4; p = 0.003), and had worse quality of life (Parkinson's Disease Questionnaire–39: 33 ± 12 vs 29 ± 12; p = 0.03), as compared to pre-opRBD– patients. Both pre-opRBD+ and pre-opRBD– patients had significant MDS-UPDRS IV score decrease (−37% and −33%, respectively), MDS-UPDRS III “med ‘off’/stim ‘on’” score decrease (−52% and −54%), and dopaminergic treatment decrease (−52% and −49%) after surgery, with no between-group difference. There was no between-group difference for cognitive and global quality of life outcomes.ConclusionsIn patients with PD eligible for STN-DBS, the presence of probable RBD preoperatively is not associated with a different clinical outcome 1 year after neurosurgery.Trial Registration InformationNCT02360683.Classification of EvidenceThis study provides Class II evidence that in patients with PD eligible for STN-DBS, the presence of probable RBD preoperatively is not associated with poorer outcomes 1 year post surgery.
Published: 2021

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