title: A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

acronym: FACTSEP

summary: The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.

ReferenceCitation: Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD007280.

ReferenceCitation: Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. Review.

ReferenceCitation: Filippi M, Rocca MA, Colombo B, Falini A, Codella M, Scotti G, Comi G. Functional magnetic resonance imaging correlates of fatigue in multiple sclerosis. Neuroimage. 2002 Mar;15(3):559-67.

ReferenceCitation: Oken BS, Kishiyama S, Zajdel D, Bourdette D, Carlsen J, Haas M, Hugos C, Kraemer DF, Lawrence J, Mass M. Randomized controlled trial of yoga and exercise in multiple sclerosis. Neurology. 2004 Jun 8;62(11):2058-64.

ReferenceCitation: Pucci E, Branãs P, D'Amico R, Giuliani G, Solari A, Taus C. Amantadine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002818. Review.

ReferenceCitation: Krupp LB, Coyle PK, Doscher C, Miller A, Cross AH, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R. Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo. Neurology. 1995 Nov;45(11):1956-61.

ReferenceCitation: van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30.

ReferenceCitation: Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43.

ReferenceCitation: Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C. Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci. 2004 Mar 15;218(1-2):103-8.

ReferenceCitation: Wingerchuk DM, Benarroch EE, O'Brien PC, Keegan BM, Lucchinetti CF, Noseworthy JH, Weinshenker BG, Rodriguez M. A randomized controlled crossover trial of aspirin for fatigue in multiple sclerosis. Neurology. 2005 Apr 12;64(7):1267-9.

ReferenceCitation: Lebrun C, Alchaar H, Candito M, Bourg V, Chatel M. Levocarnitine administration in multiple sclerosis patients with immunosuppressive therapy-induced fatigue. Mult Scler. 2006 Jun;12(3):321-4.

ReferenceCitation: Pittion-Vouyovitch S, Debouverie M, Guillemin F, Vandenberghe N, Anxionnat R, Vespignani H. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci. 2006 Apr 15;243(1-2):39-45. Epub 2006 Jan 24.

ReferenceCitation: Debouverie M, Pittion S. [Fatigue and episodic exhaustion as a feature of multiple sclerosis]. Rev Neurol (Paris). 2006 Mar;162(3):295-7. French.

ReferenceCitation: Richardson BA, Flack VF. The analysis of incomplete data in the three-period two-treatment cross-over design for clinical trials. Stat Med. 1996 Jan 30;15(2):127-43.

ReferenceCitation: GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80.

ReferenceCitation: Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Stat Med. 2000 Apr 15;19(7):901-11.

ReferenceCitation: Graziano F, Bisonni R, Catalano V, Silva R, Rovidati S, Mencarini E, Ferraro B, Canestrari F, Baldelli AM, De Gaetano A, Giordani P, Testa E, Lai V. Potential role of levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients. Br J Cancer. 2002 Jun 17;86(12):1854-7.

ReferenceCitation: Plioplys AV, Plioplys S. Amantadine and L-carnitine treatment of Chronic Fatigue Syndrome. Neuropsychobiology. 1997;35(1):16-23.

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32.

ReferenceCitation: Montel SR, Bungener C. Coping and quality of life in one hundred and thirty five subjects with multiple sclerosis. Mult Scler. 2007 Apr;13(3):393-401. Epub 2007 Jan 29.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Malamud S, Culliney B, Lapin J, Portenoy RK, Esteban-Cruciani N. Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. J Pain Symptom Manage. 2006 Dec;32(6):551-9.

ReferenceCitation: Gramignano G, Lusso MR, Madeddu C, Massa E, Serpe R, Deiana L, Lamonica G, Dessì M, Spiga C, Astara G, Macciò A, Mantovani G. Efficacy of l-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 2006 Feb;22(2):136-45.

ReferenceCitation: Neri S, Pistone G, Saraceno B, Pennisi G, Luca S, Malaguarnera M. L-carnitine decreases severity and type of fatigue induced by interferon-alpha in the treatment of patients with hepatitis C. Neuropsychobiology. 2003;47(2):94-7.

ReferenceCitation: Rebouche CJ. Kinetics, pharmacokinetics, and regulation of L-carnitine and acetyl-L-carnitine metabolism. Ann N Y Acad Sci. 2004 Nov;1033:30-41. Review.

ReferenceCitation: Plioplys AV, Plioplys S. Serum levels of carnitine in chronic fatigue syndrome: clinical correlates. Neuropsychobiology. 1995;32(3):132-8.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Culliney B, Malamud S, Shaiova L, Fleishman S, Lapin J, Klein E, Lesage P, Portenoy R, Esteban-Cruciani N. L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis. Ann N Y Acad Sci. 2004 Nov;1033:168-76.

ReferenceCitation: Taglialatela G, Navarra D, Cruciani R, Ramacci MT, Alemà GS, Angelucci L. Acetyl-L-carnitine treatment increases nerve growth factor levels and choline acetyltransferase activity in the central nervous system of aged rats. Exp Gerontol. 1994 Jan-Feb;29(1):55-66.

location_facility:
University Hospital, Hospital Pasteur
University Hospital
University Hospital, Hospital Dupuytren
University Hospital, Hospital Pellegrin
University Hospital, Hospital Central
University Hospital, Hospital Laënnec


summary: The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Aubier M, Haughney J, Selroos O, van Schayck OC, Ekström T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17. Erratum in: Ther Adv Respir Dis. 2012 Aug;6(4):247.

ReferenceCitation: Haughney J, Aubier M, Jørgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.

ReferenceCitation: Aubier M, Buhl R, Ekström T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.

lead_sponsor: AstraZeneca

location_country:
Spain
Greece
Ireland
Italy
Netherlands
Finland
Russian Federation
United Kingdom
Sweden
France
Norway
Belgium
Iceland
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Ill-health Related Jobloss

acronym: jobloss

summary: The current study aimed to estimate the one-year incidence of unfitness for the job in an occupational health service, and to describe their aetiology and the characteristics of the unfit employees

study_start_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

lead_sponsor_type: academique


title: Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status

summary: Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duché P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.

ReferenceCitation: Thivel D, Isacco L, Montaurier C, Boirie Y, Duché P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.

ReferenceCitation: Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duché P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other

status_simplified: Unknown


title: Mechanism of DCs Dysfunction in Chronic HBV Infection

acronym: HepatoDC

summary: This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity

status: Recruiting

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

intervention_type: Biological

status_simplified: Ongoing


type: Other Grant/Funding Number

title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome

summary: The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

ReferenceCitation: Nève V, Sadik A, Petyt L, Dauger S, Kheniche A, Denjean A, Léger PL, Chalard F, Boulé M, Javouhey E, Reix P, Canterino I, Deken V, Matran R, Leteurtre S, Leclerc F. Whole pulmonary assessment 1 year after paediatric acute respiratory distress syndrome: prospective multicentre study. Ann Intensive Care. 2022 Aug 20;12(1):79. doi: 10.1186/s13613-022-01050-4.

lead_sponsor: University Hospital, Lille

location_country: France Belgium

location_facility: Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille

location_facility: Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,

location_facility: Hôpital Trousseau, Assistance Publique Hôpitaux de Paris


title: Development of an Artificial Intelligence Model of Image Recognition Through Images of Intravascular Catheters From Inpatients and Outpatients to Identify the Presence of Local Signs Associated With Infection

acronym: DeepCath

summary:
Deepcath is the first step to the introduction of artificial intelligence in catheter care. A better use of visualisation of catheter exit site should be used not only by the HCWs but also by the patients and their family.

A deep learning system able to detect visual abnormalities of the catheter exit site will be an helpful tools to develop a continuous follow-up of intravascular catheters.

ReferenceType: result

ReferenceCitation: Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.

ReferenceCitation: Timsit JF. Diagnosis and prevention of catheter-related infections. Curr Opin Crit Care. 2007 Oct;13(5):563-71. Review.

ReferenceCitation: Buetti N, Rickard CM, Timsit JF. Catheter dressings. Intensive Care Med. 2022 Aug;48(8):1066-1068. doi: 10.1007/s00134-022-06734-w. Epub 2022 May 27.

ReferenceCitation: Blot S, Ruppé E, Harbarth S, Asehnoune K, Poulakou G, Luyt CE, Rello J, Klompas M, Depuydt P, Eckmann C, Martin-Loeches I, Povoa P, Bouadma L, Timsit JF, Zahar JR. Healthcare-associated infections in adult intensive care unit patients: Changes in epidemiology, diagnosis, prevention and contributions of new technologies. Intensive Crit Care Nurs. 2022 Jun;70:103227. doi: 10.1016/j.iccn.2022.103227. Epub 2022 Mar 3.

ReferenceCitation: Buetti N, Mermel LA, Timsit JF. Routine catheter-tip cultures for assessing catheter-related bloodstream infections in randomised-controlled trials. Anaesth Crit Care Pain Med. 2022 Feb;41(1):101006. doi: 10.1016/j.accpm.2021.101006. Epub 2021 Dec 14.

ReferenceCitation: Buetti N, Abbas M, Pittet D, Chraiti MN, Sauvan V, De Kraker MEA, Boisson M, Teixeira D, Zingg W, Harbarth S. Lower risk of peripheral venous catheter-related bloodstream infection by hand insertion. Antimicrob Resist Infect Control. 2022 Jun 3;11(1):80. doi: 10.1186/s13756-022-01117-8.

lead_sponsor: Outcome Rea

location_facility:
CHU Grenoble Alpes
CHU Clermont-Ferrand
Hôpital Bichat - Claude-Bernard
Réseau RéPIAS SPIADI

intervention_type: Diagnostic Test


title: Evolution of Empathy and Emotional Intelligence During a Doctor-patient Relationship Training for 4th Year Medical Students

acronym: EMOREL

summary:
Background: Empathic skills of medical students decrease during their studies. Besides, communication skills training is French context. In this context doctor-patient relationship training was built at Paris Descartes University for the 4th year medical students. Implementation of this training aims at maintaining or even increasing empathic and emotional skills of students.

Objective: to evaluate effectiveness of this training on medical students skills, knowledge and attitudes.

Methodology: Interventional and longitudinal monocentric study Pre/post-test auto-assessment for

empathic skills score assessed with the Jefferson Scale of Physician Empathy- Medical Student Version (JSPE-MS)
emotional intelligence's score assessed with the Emotional Expressivity Scale (EES)
students' declarative knowledge of the doctor-patient relationship assessed with multiple choice question.

Post-test assessement for:

empathic skills assessed by simulated patients with CARE grid during the Objective Structured Clinical Examination (OSCE).
satisfaction auto-questionnaire.
socio-demographic and education data.

ReferenceType: background

ReferenceCitation: Parish JM. The Patient Will See You Now: The Future of Medicine is in Your Hands. J Clin Sleep Med. 2015 Mar 20. pii: jc-00119-15. [Epub ahead of print]

ReferenceCitation: Richard C, Lussier M-T. La communication professionnelle en santé: Erpi; 2016.

ReferenceCitation: Starfield B, Wray C, Hess K, Gross R, Birk PS, D'Lugoff BC. The influence of patient-practitioner agreement on outcome of care. Am J Public Health. 1981 Feb;71(2):127-31.

ReferenceCitation: Maguire P, Fairbairn S, Fletcher C. Consultation skills of young doctors: I--Benefits of feedback training in interviewing as students persist. Br Med J (Clin Res Ed). 1986 Jun 14;292(6535):1573-6. Erratum in: Br Med J (Clin Res Ed) 1986 Jul 5;293(6538):26.

ReferenceCitation: Beckman HB, Markakis KM, Suchman AL, Frankel RM. The doctor-patient relationship and malpractice. Lessons from plaintiff depositions. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

ReferenceCitation: Marvel MK, Epstein RM, Flowers K, Beckman HB. Soliciting the patient's agenda: have we improved? JAMA. 1999 Jan 20;281(3):283-7.

ReferenceCitation: Ormel J, Koeter MW, van den Brink W, van de Willige G. Recognition, management, and course of anxiety and depression in general practice. Arch Gen Psychiatry. 1991 Aug;48(8):700-6.

ReferenceCitation: Arborelius E, Bremberg S. What does a human relationship with the doctor mean? Scand J Prim Health Care. 1992 Sep;10(3):163-9.

ReferenceCitation: Beaulieu MD, Leclère H, Bordage G. Taxonomy of difficulties in general practice. Can Fam Physician. 1993 Jun;39:1369-75.

ReferenceCitation: Novel A-S. Baptiste Beaulieu : " J'ai parfois l'impression que ma vie passe sans moi ". Le Monde.27.03.2015

ReferenceCitation: DiMatteo MR, Haskard-Zolnierek KB, Martin LR. Improving patient adherence: a three-factor model to guide practice. Health Psychology Review. 2012;6(1):74-91.

ReferenceCitation: DiMatteo MR. The physician-patient relationship: effects on the quality of health care. Clin Obstet Gynecol. 1994 Mar;37(1):149-61. Review.

ipd_sharing: Yes

ipd_sharing_description: All data will be shared with research team.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Paris Descartes University, Sorbonne Paris City, Faculty of Medicine


title: Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells

summary:
From a cellular perspective, breast cancers appear to develop hierarchically from a small contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus, these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the proportion of CSCs before any treatment is correlated with chemoresistance and that a resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.

The Oscar Lambret Center proposes a monocentric prospective interventional study based on the cellular and molecular analysis of the tumor, serum and circulating cells, before, during and at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant to chemotherapy could lead to therapeutic solutions.

status: Terminated

primary_purpose: Basic Science

lead_sponsor: Centre Oscar Lambret

intervention_type: Procedure


title: Pilot Study to Assess Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

acronym: Lipiback

summary: This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.

primary_purpose: Prevention

lead_sponsor: Valbiotis

location_facility: Biofortis Mérieux NutriSciences Clinical Investigation Center

intervention_type: Dietary Supplement


title: Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke

acronym: NETs

summary: The purpose of the study was to investigate the correlation between the nucleosome concentration and the rate of recanalization after thrombolysis. All patients were admitted to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke care. The investigators included all patients treated or not by intravenous thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before admission.

design_allocation: Non-Randomized

ReferenceCitation: Holdenrieder S, Stieber P, Bodenmüller H, Fertig G, Fürst H, Schmeller N, Untch M, Seidel D. Nucleosomes in serum as a marker for cell death. Clin Chem Lab Med. 2001 Jul;39(7):596-605.

ReferenceCitation: Holdenrieder S, Stieber P, Chan LY, Geiger S, Kremer A, Nagel D, Lo YM. Cell-free DNA in serum and plasma: comparison of ELISA and quantitative PCR. Clin Chem. 2005 Aug;51(8):1544-6.

ReferenceCitation: Naggara O, Raymond J, Domingo Ayllon M, Al-Shareef F, Touzé E, Chenoufi M, Gerber S, Mellerio C, Zuber M, Meder JF, Mas JL, Oppenheim C. T2* "susceptibility vessel sign" demonstrates clot location and length in acute ischemic stroke. PLoS One. 2013 Oct 11;8(10):e76727. doi: 10.1371/journal.pone.0076727. eCollection 2013.

lead_sponsor: Centre Hospitalier St Anne


title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

summary: We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332). These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.

ReferenceCitation: Hurault de Ligny B, Toupance O, Lavaud S, Bauwens M, Peyronnet P, Le Meur Y, Ryckelynck JP, Jolly D, Leroux-Robert C, Touchard G. Factors predicting the long-term success of maintenance cyclosporine monotherapy after kidney transplantation. Transplantation. 2000 Apr 15;69(7):1327-32.

ReferenceCitation: Touchard G, Hauet T, Cogny Van Weydevelt F, Hurault de Ligny B, Peyronnet P, Lebranchu Y, Toupance O, N'Doye P, Busson M. Maintenance cyclosporin monotherapy after renal transplantation--clinical predictors of long-term outcome. Nephrol Dial Transplant. 1997 Sep;12(9):1956-60.

lead_sponsor: Poitiers University Hospital

location_facility:
Reims University Hospital
Caen university Hospital
Dupuytren University Hospital
Rouen University Hospital
Poitiers University hospital


title: Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology

acronym: MEM-TA

summary: The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.

lead_sponsor: University Hospital, Caen


title: Sentinel Patients : Value of an Information System Collecting Patient's Own Report on His Healthcare Management. Application to the Detection of Adverse Events After Hospital Discharge.

acronym: SENTIPAT

summary:
"Evolution of patient's health after hospital discharge is poorly documented. The investigators hypothesize that information of good quality on this concern might be accessible at a relatively low cost from patients, further referred to as sentinel patients, who would voluntary report their health evolution on a dedicated web site.

The SENTIPAT study presents as a proof of concept study. It will collect patient's health evolution during a post-hospital discharge period of 45 days. The study presents as a randomized trial comparing patients' reports issued from two different methods in a patient population returning home after hospital discharge and having at disposal an internet access at home:

in the " internet " arm, sentinel patients will be solicited to directly report their post-discharge health evolution on a website especially devoted for collecting these data while in the " telephone " arm, the same items will be collected through a telephone interview 45 days after hospital discharge. Investigations will focus on post-discharge adverse events and will include appearance/worsening of symptoms, healthcare resources utilization, quality of life, and patients' satisfaction."

primary_purpose: Health Services Research

ReferenceCitation: Açma A, Carrat F, Hejblum G. Comparing SF-36 Scores Collected Through Web-Based Questionnaire Self-completions and Telephone Interviews: An Ancillary Study of the SENTIPAT Multicenter Randomized Controlled Trial. J Med Internet Res. 2022 Mar 10;24(3):e29009. doi: 10.2196/29009.

ReferenceCitation: Feldman SF, Lapidus N, Cosnes J, Tiret E, Fonquernie L, Cabane J, Chazouilleres O, Surgers L, Beaussier M, Valleron AJ, Carrat F, Hejblum G. Comparing Inpatient Satisfaction Collected via a Web-Based Questionnaire Self-Completion and Through a Telephone Interview: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2017 Aug 23;19(8):e293. doi: 10.2196/jmir.7061.

ReferenceCitation: Couturier B, Carrat F, Hejblum G; SENTIPAT Study Group. Comparing Patients' Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2015 Jun 24;17(6):e158. doi: 10.2196/jmir.4379.


title: Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

acronym: tDCS-TOC

summary: It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

lead_sponsor: Centre Hospitalier Henri Laborit

location_facility:
CHU de Nantes
Centre Hospitalier Henri Laborit
C.H. Guillaume Regnier
Hospices Civils De Lyon

intervention_type: Device


type: Other Identifier

title: Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication

acronym: TENS-PAD

summary: Purpose: The investigators team recently carried out a proof of concept study testing the efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In this randomized study, the investigators found that TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class II PAD. From these encouraging results, the investigators now seek to assess the efficacy of an intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized controlled trial / double blinding.

ReferenceCitation: Besnier F, Sénard JM, Grémeaux V, Riédel M, Garrigues D, Guiraud T, Labrunée M. The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study. Trials. 2017 Aug 10;18(1):373. doi: 10.1186/s13063-017-1997-1.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

acronym: EDEX

summary: The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

ReferenceCitation: Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefèvre-Colau MM, Nizard R, Perrodeau É, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.


title: Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder

acronym: SOS

summary:
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.

The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.

Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.

Single blind multicentre randomised trial with parallel control groups.

Effectiveness study of a psychiatric care strategy.

location_facility:
Sainte-Anne Hospital, Paris
University Hosiptal, Lille
University Hospital, Brest
University Hospital, Caen


title: Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial

summary:
This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe dementia.

Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions for 6 weeks.

This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:

it will determine which of the of the three learning techniques (EL, MR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.

lead_sponsor: Department of Clinical Research and Innovation

intervention_type: Behavioral


title: Impact of the Diet Fertility : A Case-control Multicentric Study

acronym: ALIFERT

summary: This case-control multicentric study involving fertile and infertile couples aims at evaluating the impact on conception rate of nutritional parameters (biologic, clinic, anthropometric, and food questionnaire).

time_perspective: Cross-Sectional

ReferenceCitation: Bachelot G, Lévy R, Bachelot A, Faure C, Czernichow S, Dupont C, Lamazière A; Alifert Collaborative Group. Proof of concept and development of a couple-based machine learning model to stratify infertile patients with idiopathic infertility. Sci Rep. 2021 Dec 14;11(1):24003. doi: 10.1038/s41598-021-03165-3.

ReferenceCitation: Talla P, Faure C, Rigourd V, Czernichow S, Sermondade N, Lévy R, Dupont C; ALIFERT collaborative group. Is There an Association of Being Breastfed as an Infant and Fertility Status as an Adult? Breastfeed Med. 2021 May;16(5):414-418. doi: 10.1089/bfm.2020.0130. Epub 2021 Mar 30.

ReferenceCitation: Dupont C, Hulot A, Jaffrezic F, Faure C, Czernichow S, di Clemente N, Racine C, Chavatte-Palmer P, Lévy R; Alifert group. Female ponderal index at birth and idiopathic infertility. J Dev Orig Health Dis. 2020 Apr;11(2):154-158. doi: 10.1017/S2040174419000394. Epub 2019 Jul 16.

ReferenceCitation: Dupont C, Faure C, Daoud F, Gautier B, Czernichow S, Lévy R; ALIFERT collaborative group. Metabolic syndrome and smoking are independent risk factors of male idiopathic infertility. Basic Clin Androl. 2019 Jul 1;29:9. doi: 10.1186/s12610-019-0090-x. eCollection 2019.

ReferenceCitation: Faure C, Dupont C, Chavatte-Palmer P, Gautier B, Levy R; ALIFERT Collaborative Group. Are semen parameters related to birth weight? Fertil Steril. 2015 Jan;103(1):6-10. doi: 10.1016/j.fertnstert.2014.11.027.

ReferenceCitation: Faure C, Leveille P, Dupont C, Julia C, Chavatte-Palmer P; Alifert Group, Sutton A, Levy R. Are superoxide dismutase 2 and nitric oxide synthase polymorphisms associated with idiopathic infertility? Antioxid Redox Signal. 2014 Aug 1;21(4):565-9. doi: 10.1089/ars.2014.5831. Epub 2014 Feb 25.

location_facility: Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS


type: Registry Identifier

title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

acronym: BOSAS

summary:
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.


title: Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.

acronym: Morphine-Mida

summary:
Administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain.

In a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a validated numeric rating scale (NRS).

The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

ReferenceCitation: Auffret Y, Gouillou M, Jacob GR, Robin M, Jenvrin J, Soufflet F, Alavi Z. Does midazolam enhance pain control in prehospital management of traumatic severe pain? Am J Emerg Med. 2014 Jun;32(6):655-9. doi: 10.1016/j.ajem.2014.01.048. Epub 2014 Feb 4.

lead_sponsor: Centre Hospitalier de Cornouaille

location_facility: Centre Hpistalier Intercommunal de Cornouaille


title: Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)

summary:
Tobacco use is one of the world's leading preventable causes of disease and premature death, and the physician has a central role in detecting smokers and helping them to quit.

Tobacco use in the military undermines fitness, readiness and performance, and increases health care costs.

A study conducted on a French Army contingent on external operations in Afghanistan have shown an increase in tobacco use in situation of operational constraints (stress, shift work, etc.). However, another study conducted in Ivory Coast on a mobile gendarmerie squadron showed no significant difference.

Among the American firefighters who have been exposed to the 9/11 World Trade Center attacks, smoking have been shown to play an aggravating role in the recovery of lung function.

This study is aimed at assessing smoking prevalence in the Paris Fire Brigade, which is composed of young and healthy sportsmen and women who are exposed to strong operational constraints.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
Antenne médicale de Ménilmontant
Centre Médical de Champerret


title: Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Trial" HYPOREME

acronym: HYPOREME

summary:
Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage. The first is to increase the number of organs by developing harvesting from donors in a state of brain-death (BD) termed "expanded criteria donors" or from patients deceased from circulatory arrest.

Another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (DFG).

The development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in DGF reduction.

Therapeutic Hypothermia could to be an attractive care strategy for BD patients.

primary_purpose: Other

ReferenceCitation: Brulé N, Canet E, Péré M, Feuillet F, Hourmant M, Asehnoune K, Rozec B, Duveau A, Dube L, Pierrot M, Humbert S, Tirot P, Boyer JM, Martin-Lefevre L, Labadie F, Robert R, Benard T, Kerforne T, Thierry A, Lesieur O, Vincent JF, Lesouhaitier M, Larmet R, Vigneau C, Goepp A, Bouju P, Quentin C, Egreteau PY, Huet O, Renault A, Le Meur Y, Venhard JC, Buchler M, Michel O, Voellmy MH, Herve F, Schnell D, Courte A, Glotz D, Amrouche L, Hazzan M, Kamar N, Moal V, Bourenne J, Le Quintrec-Donnette M, Morelon E, Boulain T, Grimbert P, Heng AE, Merville P, Garin A, Hiesse C, Fermier B, Mousson C, Guyot-Colosio C, Bouvier N, Rerolle JP, Durrbach A, Drouin S, Caillard S, Frimat L, Girerd S, Albano L, Rostaing L, Bertrand D, Hertig A, Westeel PF, Montini F, Delpierre E, Dorez D, Alamartine E, Ouisse C, Sebille V, Reignier J. Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME). BMJ Open. 2022 Mar 28;12(3):e052845. doi: 10.1136/bmjopen-2021-052845.

lead_sponsor: Nantes University Hospital

location_facility:
CH Orléans
CHU Strasbourg
CHU Toulouse
CH La Roche sur Yon
CH Lorient
Hopital Saint Louis
Hopital de la Pitié Salpetriere
CHU Reims
CH de Dreux
Chu Clermont Ferrand
CHRU Nancy
CHU Rennes
CH Saint Malo
CH Morlaix
CHRU Saint-Etienne
CH Marne la Vallée (GHEF)
CHU Nice
CHRU Lille
Ch Cholet
CH Laval
CH Cornouaille
CHU Tours
CH Saint Nazaire
CHU de Lyon
CHU Poitiers
CHU Rouen
Hopital de la Timone
CH de Meaux (GHEF)
CH Vannes
CH Annecy Genevois
CH Bourges
CHU Grenoble
CHU de Bordeaux
CH Saint Brieuc
CH La Rochelle
Hopital Bicetre
CH Avignon
Nantes University Hospital
Hopital Henri Mondor
CH de Blois
CHU Caen
CHU Montpellier
CHU Brest
CHU Foch
CH Angouleme
CHU d'Angers
CH Le Mans
CHU de Dijon
CHU Amiens-Picardie
CHU Limoges
Hopital Necker
CHU Tenon
Hopital de la Conception
CH Saintes


title: Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial

summary:
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de nice - Anesthésie Réanimation
Institut Arnaut Tzanck


title: The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

acronym: OPTI-AGED

summary:
With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

primary_purpose: Supportive Care

ReferenceCitation: Molliex S, Passot S, Futier E, Bonnefoi M, Rancon F, Lemanach Y, Pereira B. Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol. BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Dijon
CHU LYON
CHU NICE
Chu Clermont-Ferrand
Hopital Central Strasbourg
Chu Rennes
Lyon Sud - CHU
Chu Marseille La Timone
Chu Grenoble
Chu Nancy
CHU LILLE - Huriez
CHU Amiens - Picardie
CHU CAEN
Ch Saint Louis-Lariboisiere
Ch Paris Pitie Salpetriere
Hopital Hautepierre Strasbourg
Ch Paris Bichat
Chu Saint Etienne
Ch Paris Beaujon
CHRU Lille - Salengro
Médipôle Lyon - Villeurbanne
Chu Montpellier
Chu Nimes
Chu Marseille Nord
Chu Toulouse
Chu Poitiers
CHU de Nantes
Chu Rouen
Ch Paris Saint Antoine


title: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain

summary: Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHu de Nîmes
University Hospital, Clermont Ferrand


acronym: ARCADE

title: Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.

type: EudraCT Number

source: euctr

ReferenceCitation: Frank M, Albuisson J, Ranque B, Golmard L, Mazzella JM, Bal-Theoleyre L, Fauret AL, Mirault T, Denarié N, Mousseaux E, Boutouyrie P, Fiessinger JN, Emmerich J, Messas E, Jeunemaitre X. The type of variants at the COL3A1 gene associates with the phenotype and severity of vascular Ehlers-Danlos syndrome. Eur J Hum Genet. 2015 Dec;23(12):1657-64. doi: 10.1038/ejhg.2015.32. Epub 2015 Mar 11.

ReferenceCitation: Faugeroux J, Nematalla H, Li W, Clement M, Robidel E, Frank M, Curis E, Ait-Oufella H, Caligiuri G, Nicoletti A, Hagege A, Messas E, Bruneval P, Jeunemaitre X, Bergaya S. Angiotensin II promotes thoracic aortic dissections and ruptures in Col3a1 haploinsufficient mice. Hypertension. 2013 Jul;62(1):203-8. doi: 10.1161/HYPERTENSIONAHA.111.00974. Epub 2013 Apr 29.

ReferenceCitation: Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7. Erratum in: Lancet. 2016 Aug 6;388(10044):564. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.

location_facility: CHU DE GRENOBLE - Hopital Albert Michallon

location_facility: AP-HP - Hopital Europeen Georges-Pompidou

location_facility: CHRU DE NANCY - Institut Lorrain du Coeur et des Vaisseaux

summary: This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.


title: Optimum and Stepped Care Standardised Antihypertensive Treatment With or Without Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis. ANDORRA TRIAL

acronym: ANDORRA

summary: The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting + standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration in patients with confirmed resistant hypertension (RH) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.

location_facility: Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

location_facility: Hopital Europeen Georges Pompidou (HEGP)


title: Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study

acronym: MESAJ

summary: Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Montpellier University Hospital, Arnaud de Villeneuve Hospital


title: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST

acronym: REAVIST

summary:
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.

lead_sponsor: Rennes University Hospital


title: Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis

acronym: AntibioCor

summary:
Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint) as compared to corticosteroids alone.

The project is based on an approach never tested in a randomized controlled trial in severe alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2 months). This approach is based on animal and human studies.Antibiotics are effective in animal models and in other circumstances characterized by liver failure such as gastrointestinal bleeding related to portal hypertension. The interest of studying this population is emphasized by the frequency of infections in these critically ill patients. Antibiotics will be administered before the development of any infection, as it is likely that these patients present with mesenteric bacterial adenitis without systemic signs of infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and treatment is given for 30 days.

ReferenceCitation: Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.

ReferenceCitation: Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

ReferenceCitation: Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009 Jun 25;360(26):2758-69. doi: 10.1056/NEJMra0805786. Review.

ReferenceCitation: Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V, Deltenre P, Mathurin P. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009 Aug;137(2):541-8. doi: 10.1053/j.gastro.2009.04.062. Epub 2009 May 13.

ReferenceCitation: Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Dharancy S, Texier F, Hollebecque A, Serfaty L, Boleslawski E, Deltenre P, Canva V, Pruvot FR, Mathurin P. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun;45(6):1348-54.

ReferenceCitation: Mathurin P, Louvet A, Duhamel A, Nahon P, Carbonell N, Boursier J, Anty R, Diaz E, Thabut D, Moirand R, Lebrec D, Moreno C, Talbodec N, Paupard T, Naveau S, Silvain C, Pageaux GP, Sobesky R, Canva-Delcambre V, Dharancy S, Salleron J, Dao T. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. JAMA. 2013 Sep 11;310(10):1033-41. doi: 10.1001/jama.2013.276300.

lead_sponsor: University Hospital, Lille

location_facility:
CHU Nantes
CHU d'Amiens
CHU de Caen
Centre Hospitalier
Centre hospitalier
Hôpital Paul Brousse (AH-HP)
CHU Poitiers
CHU Montpellier
Hôpital La Pitié (AP-HP)
CHU Pontchaillou
Hôpital Claude Huriez, CHU
CHU
CHU Grenoble
Hôpital Saint Antoine (AP-HP)
CHU de Besançon
Hôpital BEaujon (AP-HP)
CHU Nice
Hôpital Jean Verdier (AH-HP)


title: Controlled Education Of Patients After Stroke

acronym: CEOPS

summary: The main objective of the study is to compare the benefit of optimised follow-up by nursing personnel from the vascular neurology department, including therapeutic follow-up and an educational program directed to the patient and a caregiving member of his social circle, with that of a typical follow-up.

ReferenceCitation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11:CD001919. doi: 10.1002/14651858.CD001919.pub4. Review.

ReferenceCitation: Mendyk AM, Duhamel A, Bejot Y, Leys D, Derex L, Dereeper O, Detante O, Garcia PY, Godefroy O, Montoro FM, Neau JP, Richard S, Rosolacci T, Sibon I, Sablot D, Timsit S, Zuber M, Cordonnier C, Bordet R; on the behalf of Strokavenir network. Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial. Trials. 2018 Feb 22;19(1):137. doi: 10.1186/s13063-018-2483-0.

location_facility: Ch Intercommunal Compiègne-Noyon - Compiegne


title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

acronym: préOVNI

summary:
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.

The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.

lead_sponsor: University Hospital, Brest

location_facility: Hôpital Nord Ouest Villefranche Sur Saône


title: Brainstem Dysfunction in Ventilated and Deeply Sedated COVID-19 Critically Ill Patients: a Prospective Observational Study

acronym: BRAINSTEM-COV

summary: The purpose of this study is to determine the prevalence of brainstem dysfunction in critically ill ventilated and deeply sedated patients hospitalized in the Intensive Care Unit (ICU) for a SARS-CoV-s2 infection.

ReferenceCitation: Rohaut B, Porcher R, Hissem T, Heming N, Chillet P, Djedaini K, Moneger G, Kandelman S, Allary J, Cariou A, Sonneville R, Polito A, Antona M, Azabou E, Annane D, Siami S, Chrétien F, Mantz J, Sharshar T; Groupe d'Exploration Neurologique en Réanimation (GENER). Brainstem response patterns in deeply-sedated critically-ill patients predict 28-day mortality. PLoS One. 2017 Apr 25;12(4):e0176012. doi: 10.1371/journal.pone.0176012. eCollection 2017.

ReferenceCitation: Benghanem S, Cariou A, Diehl JL, Marchi A, Charpentier J, Augy JL, Hauw-Berlemont C, Gavaret M, Pène F, Mira JP, Sharshar T, Hermann B. Early Clinical and Electrophysiological Brain Dysfunction Is Associated With ICU Outcomes in COVID-19 Critically Ill Patients With Acute Respiratory Distress Syndrome: A Prospective Bicentric Observational Study. Crit Care Med. 2022 Jul 1;50(7):1103-1115. doi: 10.1097/CCM.0000000000005491. Epub 2022 Feb 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
HEGP
Hôpital Cochin


title: Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke

summary: Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.

ReferenceCitation: Rémy-Néris O, Le Jeannic A, Dion A, Médée B, Nowak E, Poiroux É, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.

location_facility:
Centre Bouffard Vercelli
CRF de Valmante
EMPR Le Normandy
CHU de Clermont-Ferrand
CHU de Toulouse
APHP - Hôpital La Salpétriere
CHU de Montpellier
CMRRF Kerpape
CHU de Rennes
CHU de Lyon
CRRRF
CH de Garches
CHU de Bordeaux
CHU de Reims
IRR de Nancy
CHU d'Amiens
CHU de Nantes
CHRU de Brest
CHU de Dijon
APHP - Hôpital Lariboisière
CHU de Nîmes
CHU de Limoges
CHRU de Lille


title: Effects of Albumin Administration in Septic Cirrhotic Patients With Child > 8 Unrelated to Spontaneous Bacterial Peritonitis on Renal Function and Survival: A Multicenter Randomized Controlled Trial Comparing Use and Non-use of Human Albumin (Vialebex ®)

acronym: ALB-CIRINF

summary:
Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites.

The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score > 8.

ReferenceCitation: Thévenot T, Bureau C, Oberti F, Anty R, Louvet A, Plessier A, Rudler M, Heurgué-Berlot A, Rosa I, Talbodec N, Dao T, Ozenne V, Carbonell N, Causse X, Goria O, Minello A, De Ledinghen V, Amathieu R, Barraud H, Nguyen-Khac E, Becker C, Paupard T, Botta-Fridlung D, Abdelli N, Guillemot F, Monnet E, Di Martino V. Effect of albumin in cirrhotic patients with infection other than spontaneous bacterial peritonitis. A randomized trial. J Hepatol. 2015 Apr;62(4):822-30. doi: 10.1016/j.jhep.2014.11.017. Epub 2014 Nov 21.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier régional Universitaire

location_facility: Centre Hospitalier Universitaire de Besançon


title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

acronym: PREPINTEST

summary: The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

ReferenceCitation: Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, Cellier C, Quénéhervé L; PREPINTEST working group. Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 Feb 1;117(2):327-335. doi: 10.14309/ajg.0000000000001597.

location_facility: Centre Hospitalier Universitaire de Nice


title: Evaluationof the Efficiency of a Resorbable Barrier Membrane for the Prevention of Abdominal and Peri-hepatic Adhesion in Patients With Colorectal Cancer Requiring Two-stage Surgery for the Resection of Hepatic Metastases

summary:
The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.

Eligible patients will be randomly assigned to one of 2 arms:

Seprafilm group (receiving resorbable barrier membrane during the first surgery)
No-treatment control group (without seprafilm barrier during the first surgery)

The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.

This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.

A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.

ReferenceCitation: Weibel MA, Majno G. Peritoneal adhesions and their relation to abdominal surgery. A postmortem study. Am J Surg. 1973 Sep;126(3):345-53.

ReferenceCitation: Adam R, Laurent A, Azoulay D, Castaing D, Bismuth H. Two-stage hepatectomy: A planned strategy to treat irresectable liver tumors. Ann Surg. 2000 Dec;232(6):777-85.

ReferenceCitation: Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51.

ReferenceCitation: Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80.

ReferenceCitation: Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. Erratum in: Dis Colon Rectum 1999 May;42(5):578.

ReferenceCitation: Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. Review.

ReferenceCitation: Ray NF, Denton WG, Thamer M, Henderson SC, Perry S. Abdominal adhesiolysis: inpatient care and expenditures in the United States in 1994. J Am Coll Surg. 1998 Jan;186(1):1-9.

ReferenceCitation: Lower AM, Hawthorn RJ, Ellis H, O'Brien F, Buchan S, Crowe AM. The impact of adhesions on hospital readmissions over ten years after 8849 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. BJOG. 2000 Jul;107(7):855-62.

ReferenceCitation: Lower AM, Hawthorn RJ, Clark D, Boyd JH, Finlayson AR, Knight AD, Crowe AM; Surgical and Clinical Research (SCAR) Group. Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland: an epidemiological study of 24 046 patients. Hum Reprod. 2004 Aug;19(8):1877-85. Epub 2004 Jun 3.

ReferenceCitation: Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30.

ReferenceCitation: Parker MC. Epidemiology of adhesions: the burden. Hosp Med. 2004 Jun;65(6):330-6. Review.

ReferenceCitation: Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005 Nov;99(2):301-8. Epub 2005 Aug 8.

ReferenceCitation: Bristow RE, Santillan A, Diaz-Montes TP, Gardner GJ, Giuntoli RL 2nd, Peeler ST. Prevention of adhesion formation after radical hysterectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier: a cost-effectiveness analysis. Gynecol Oncol. 2007 Mar;104(3):739-46. Epub 2006 Nov 13.

ReferenceCitation: Duron JJ. [Post-operative bowel obstruction. Part 2: Mechanical post-operative small bowel obstruction by bands and adhesions]. J Chir (Paris). 2003 Dec;140(6):325-34. Review. French.

ReferenceCitation: Duron JJ. [Post-operative bowel obstruction. Part 1: Intraperitoneal bands and adhesions--causes and prevention]. J Chir (Paris). 2003 Sep;140(4):211-9. Review. French.

ReferenceCitation: Cuervas-Mons V, Rimola A, Van Thiel DH, Gavaler JS, Schade RR, Starzl TE. Does previous abdominal surgery alter the outcome of pediatric patients subjected to orthotopic liver transplantation? Gastroenterology. 1986 Apr;90(4):853-7.

ReferenceCitation: Sandler AD, Azarow KS, Superina RA. The impact of a previous Kasai procedure on liver transplantation for biliary atresia. J Pediatr Surg. 1997 Mar;32(3):416-9.

ReferenceCitation: Ong TH. Prevention of intraabdominal adhesions in Kasai portoenterostomy. J Pediatr Surg. 2001 Nov;36(11):1613-4.

ReferenceCitation: Jaeck D, Bachellier P, Guiguet M, Boudjema K, Vaillant JC, Balladur P, Nordlinger B. Long-term survival following resection of colorectal hepatic metastases. Association Française de Chirurgie. Br J Surg. 1997 Jul;84(7):977-80.

ReferenceCitation: Rivoire M; ANAES. [Can initially non-respectable hepatic metastases be made resectable?]. Gastroenterol Clin Biol. 2003 Mar;27 Spec No 2:B18-9, B88-104. French.

ReferenceCitation: Al-Jaroudi D, Tulandi T. Adhesion prevention in gynecologic surgery. Obstet Gynecol Surv. 2004 May;59(5):360-7. Review.

ReferenceCitation: Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; Adhesion Study Group Steering Committee. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum. 2003 Oct;46(10):1310-9.

ReferenceCitation: Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG, Roberts PL, Smith LE, Sweeney SA, Moore M. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996 Oct;183(4):297-306.

ReferenceCitation: Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group. Fertil Steril. 1996 Dec;66(6):904-10.

ReferenceCitation: Salum MR, Lam DT, Wexner SD, Pikarsky A, Baig MK, Weiss EG, Nogueras JJ, Singh JJ. Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm) have possible short-term beneficial impact? Dis Colon Rectum. 2001 May;44(5):706-12.

ReferenceCitation: Tang CL, Seow-Choen F, Fook-Chong S, Eu KW. Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision: a prospective, randomized trial. Dis Colon Rectum. 2003 Sep;46(9):1200-7.

ReferenceCitation: Vrijland WW, Tseng LN, Eijkman HJ, Hop WC, Jakimowicz JJ, Leguit P, Stassen LP, Swank DJ, Haverlag R, Bonjer HJ, Jeekel H. Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trial. Ann Surg. 2002 Feb;235(2):193-9.

ReferenceCitation: Tingstedt B, Isaksson K, Andersson E, Andersson R. Prevention of abdominal adhesions--present state and what's beyond the horizon? Eur Surg Res. 2007;39(5):259-68. Epub 2007 May 10. Review.

ReferenceCitation: Oikonomakis I, Wexner SD, Gervaz P, You SY, Secic M, Giamundo P. Seprafilm: a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancer. Dis Colon Rectum. 2002 Oct;45(10):1376-80.

ReferenceCitation: Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, Uchida K, Inoue Y, Kobayashi M, Miki C, Yamamura T. Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today. 2005;35(11):940-5.

ReferenceCitation: Wieand HS. Randomized phase II trials: what does randomization gain? J Clin Oncol. 2005 Mar 20;23(9):1794-5. Epub 2005 Feb 7.

ReferenceCitation: Dixon WJ, Massey FJ. Introduction to statistical analysis. 4th Edition McGraw-Hill, 1983; 80-5.

ReferenceCitation: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.

ReferenceCitation: Dupré A, Lefranc A, Buc E, Delpero JR, Quenet F, Passot G, Evrard S, Rivoire M. Use of bioresorbable membranes to reduce abdominal and perihepatic adhesions in 2-stage hepatectomy of liver metastases from colorectal cancer: results of a prospective, randomized controlled phase II trial. Ann Surg. 2013 Jul;258(1):30-6. doi: 10.1097/SLA.0b013e3182854949.

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonié
Centre Val d'Aurelle Paul Lamarque
Centre Alexis Vautrin
Hôpital de La Croix Rousse
Institut Paoli Calmettes
CHU Clermont Ferrand
CHU La conception
Hôpital Charles Nicolle - CHU Rouen
Hôpital Antoine Béclère
Hôpital Cochin
Centre Léon Bérard
Hôpital Beaujon
CHU Grenoble
Hôpital de Brabois CHU
Institut Gustave Roussy
Centre Hospitalier Lyon Sud
CHU Nice-Hôpital de l'Archet II


title: Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

acronym: RHESO

summary: Even if most patients in palliative care units presented with well-recognized risks factors of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the efficacy and safety of antithrombotic prophylaxis in such a population is not established. Indeed, patients admitted in palliative care units were not included in trials evaluating the potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and is thus a life prolonging therapy which is viewed as counterintuitive to palliative care philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low Molecular Weight Heparin in palliative care units seems to increase particularly in patients with advanced malignancy. The identification of high hemorrhagic risks in palliative care patients could help the decision of antithrombotic prophylaxis initiation. For this, the investigators conducted a multicenter prospective longitudinal study.

location_facility: Hôpital Joseph Ducuing - CH Saint-Gaudens


title: Tolerance and Efficacy of Rituximab in Sjogren's Disease

acronym: TEARS

summary:
CLINICAL PHASE II INDICATION Sjogren's syndrome RATIONALE Sjögren's syndrome (SS) is an autoimmune disorder affecting 0.2% to 3% of the general population. Pharmacological treatment can improve the sicca symptoms, often transiently, but they are unable to modify the course of the disease.Open label studies suggested that low-dose rituximab produced acute and complete CD20 depletion in blood and tissue; was well tolerated without corticosteroid use; and significantly improved glandular and extra-glandular manifestations of pSS. Larger controlled studies are now warranted. Our hypothesis is that two infusions of 1000 mg of Rituximab may be better than placebo to treat patients suffering from pSS. To test this hypothesis, we propose to compare patients with recent and/or severe pSS treated with either Rituximab or placebo.

OBJECTIVES Primary objective : Evaluation of the efficacy defined as a 30% improvement between Day 1 and Week 24 in the values on 2 of the 4 VAS measuring global scores of the disease (activity of the disease including extra glandular manifestations), joint pain, fatigue, and the most disturbing dryness.Secondary objectives : Variations from baseline to week 24 of:

The 0-100-mm VAS scores for dry mouth, dry eyes, dry trachea, dry vagina, and dry skin; fatigue; pain; Tender and swollen joint counts; Tender points; Other systemic manifestation; Unstimulated salivary flow rate; Schirmer and van Bijsterveld scores (2-3); C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR); rheumatoid factor (RF); ANA; serum IgG, IgA, and IgM; complement; cryoglobulinemia; and counts of B and T cells; Evaluation of the safety of Rituximab during the study Evaluation of the improvement evaluated on VAS by the physician Evaluation of the disease activity scores as suggested by Bowman and Vitali Evaluation of Chisholm score, B cells characteristics and DNA microarray on labial accessory salivary gland (SG) biopsy samples, and salivary gland echography at inclusion and at week 24.

TRIAL DESIGN Multicenter, randomized, double-blind, placebo-controlled trial NUMBER OF SUBJECTS : 120

ReferenceCitation: Devauchelle-Pensec V, Pennec Y, Morvan J, Pers JO, Daridon C, Jousse-Joulin S, Roudaut A, Jamin C, Renaudineau Y, Roué IQ, Cochener B, Youinou P, Saraux A. Improvement of Sjögren's syndrome after two infusions of rituximab (anti-CD20). Arthritis Rheum. 2007 Mar 15;57(2):310-7.

ReferenceCitation: Cornec D, Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, Berthelot JM, Perdriger A, Puéchal X, Le Guern V, Sibilia J, Gottenberg JE, Chiche L, Hachulla E, Yves Hatron P, Goeb V, Hayem G, Morel J, Zarnitsky C, Dubost JJ, Saliou P, Pers JO, Seror R, Saraux A. Severe Health-Related Quality of Life Impairment in Active Primary Sjögren's Syndrome and Patient-Reported Outcomes: Data From a Large Therapeutic Trial. Arthritis Care Res (Hoboken). 2017 Apr;69(4):528-535. doi: 10.1002/acr.22974.

ReferenceCitation: Costa S, Schutz S, Cornec D, Uguen A, Quintin-Roué I, Lesourd A, Berthelot JM, Hachulla E, Hatron PY, Goeb V, Vittecoq O, Pers JO, Marcorelles P, Saraux A, Devauchelle-Pensec V. B-cell and T-cell quantification in minor salivary glands in primary Sjögren's syndrome: development and validation of a pixel-based digital procedure. Arthritis Res Ther. 2016 Jan 20;18:21. doi: 10.1186/s13075-016-0924-2.

ReferenceCitation: Jousse-Joulin S, Devauchelle-Pensec V, Cornec D, Marhadour T, Bressollette L, Gestin S, Pers JO, Nowak E, Saraux A. Brief Report: Ultrasonographic Assessment of Salivary Gland Response to Rituximab in Primary Sjögren's Syndrome. Arthritis Rheumatol. 2015 Jun;67(6):1623-8. doi: 10.1002/art.39088.

ReferenceCitation: Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, Berthelot JM, Perdriger A, Puéchal X, Le Guern V, Sibilia J, Gottenberg JE, Chiche L, Hachulla E, Hatron PY, Goeb V, Hayem G, Morel J, Zarnitsky C, Dubost JJ, Pers JO, Nowak E, Saraux A. Treatment of primary Sjögren syndrome with rituximab: a randomized trial. Ann Intern Med. 2014 Feb 18;160(4):233-42.

location_facility:
Hôpital Cochin APHP
CHU Clermont-Ferrand
CHU de Nantes
CHU Rouen
CHU Bichat
CHU de Strasbourg
CHU de Marseille
CHRU de LILLE
Hôpital SUD CHU Rennes
GH Le Havre
CHU de Brest
Ch Le Mans
AP-HP Bicêtre
Hopital LAPEYRONIE


title: Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

acronym: EVATEL

summary:
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.

The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.

location_facility: Service de Cardiologie - Hôpital Pasteur

location_facility: Service de Cardiologie - Hôpital Européen Georges Pompidou

location_facility: Département de Cardiologie - CHU de Nancy-Brabois

location_facility: Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou

location_facility: Service de Cardiologie - Hôpital de la Côte de Nacre

location_facility: Service de Cardiologie - CHU de Clermont-Ferrand

location_facility: Service de Cardiologie - Centre Hospitalier du Pays d'Aix

location_facility: Département de Cardiologie - CHU de Montpellier

location_facility: Service de Cardiologie - Institut du Thorax - Hôpital Laennec

location_facility: Service de Cardiologie B - Hôpital Trousseau

location_facility: Institut de Cardiologie - Hôpital de la Pitité Salpétrière

location_facility: Service de Cardiologie - CHU Jean Minjoz

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Rangueil

location_facility: Service médico-chirurgical de Cardiologie - CHU de Poitiers

location_facility: Service de Cardiologie - Hôpital Charles Nicolle

location_facility: Service de Cardiologie - CHU de Saint Etienne

location_facility: Service de Cardiologie -Hôpital de la Cavale Blanche

location_facility: Service de Cardiologie - Hôpital Lariboisière

location_facility: Service de Cardiologie - Hôpital Henri Mondor

location_facility: Service de cardiologie et Urgences cardiologiques - Hôpital Michallon

location_facility: Service de Cardiologie - Groupement Hospitalier Est de Lyon

location_facility: Département de Cardiologie - CHU de Reims

location_facility: Service de Cardiologie - CHU Timone Adultes

location_facility: Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux

location_facility: Service de Cardiologie - Hôpital de Hautepierre


title: Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

acronym: METASYNC

summary: The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

ReferenceCitation: Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2.

ReferenceCitation: Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62.

location_facility: Service de Chirurgie - Hôpital Jean Bernard

location_facility: Chirurgie générale viscérale et digestive - Hôpital Nord

location_facility: Chirurgie Viscérale Digestive - CH Chubert

location_facility: Département de Chirurgie - CRLCC Léon Bérard

location_facility: Centre Hépato-biliaire - Hôpital Paul Brousse

location_facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou

location_facility: Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz

location_facility: Chirurgie digestive, thoracique et cancérologie

location_facility: Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine

location_facility: Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine

location_facility: Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre

location_facility: Service d'Oncologie Digestive- CRLCC Eugène Marquis


title: Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

summary:
The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution.

These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.

The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.

primary_purpose: Diagnostic

ReferenceCitation: Kim TK, Choi BI, Hong HS, Choi BY, Han JK. Improved imaging of hepatic metastases with delayed pulse inversion harmonic imaging using a contrast agent SH U 508A: preliminary study. Ultrasound Med Biol. 2000 Nov;26(9):1439-44.

ReferenceCitation: Albrecht T, Blomley MJ, Burns PN, Wilson S, Harvey CJ, Leen E, Claudon M, Calliada F, Correas JM, LaFortune M, Campani R, Hoffmann CW, Cosgrove DO, LeFevre F. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology. 2003 May;227(2):361-70. Epub 2003 Mar 20.

ReferenceCitation: Quaia E, Bertolotto M, Forgács B, Rimondini A, Locatelli M, Mucelli RP. Detection of liver metastases by pulse inversion harmonic imaging during Levovist late phase: comparison with conventional ultrasound and helical CT in 160 patients. Eur Radiol. 2003 Mar;13(3):475-83. Epub 2002 Sep 26.

ReferenceCitation: Bernatik T, Becker D, Neureiter D, Hänsler J, Frieser M, Schaber S, Hahn EG, Strobel D. [Detection of liver metastases--comparison of contrast--enhanced ultrasound using first versus second generation contrast agents]. Ultraschall Med. 2003 Jun;24(3):175-9. German.

ReferenceCitation: Basilico R, Blomley MJ, Harvey CJ, Filippone A, Heckemann RA, Eckersley RJ, Cosgrove DO. Which continuous US scanning mode is optimal for the detection of vascularity in liver lesions when enhanced with a second generation contrast agent? Eur J Radiol. 2002 Mar;41(3):184-91.

ReferenceCitation: Leen E, Angerson WJ, Yarmenitis S, Bongartz G, Blomley M, Del Maschio A, Summaria V, Maresca G, Pezzoli C, Llull JB. Multi-centre clinical study evaluating the efficacy of SonoVue (BR1), a new ultrasound contrast agent in Doppler investigation of focal hepatic lesions. Eur J Radiol. 2002 Mar;41(3):200-6.

ReferenceCitation: Tranquart F, Bleuzen A, Tchuenbou J. [Contrast ultrasound imaging in focal liver lesions: diagnostic value and guidelines]. J Radiol. 2004 May;85(5 Pt 2):680-9. Review. French.

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Necker, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Beaujon, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris

location_facility: Service de Radiologie, Hôpital d'Enfants de Brabois


title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).

acronym: ExPress

summary: The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.

ReferenceCitation: Mercat A, Richard J, Brochard L. Comparison of two strategies for setting Peep in ALI/ARDS : EsPress Study.Intensive care med, 19th ESICM Annual Congress - Barcelona, Spain, 2006 Sep, Oral presentation 0365

ReferenceCitation: Diehl JL, Coolen N, Faisy C, Osman D, Prat G, Sebbane M, Nieszkowska A, Gervais C, Richard JC, Richecoeur J, Brochard L, Mercat A, Guérot E, Borgel D. Growth-arrest-specific 6 (GAS6) protein in ARDS patients: determination of plasma levels and influence of PEEP setting. Respir Care. 2013 Nov;58(11):1886-91. doi: 10.4187/respcare.02129. Epub 2013 Apr 9.

ReferenceCitation: Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Hôtel Dieu
University Hospital of Angers
René Dubos Hospital
Victor Dupouy Hospital
Hospital of Beauvais
Regional Hospital of Orleans
University Hospital of Bellevue
University Hospital of Bordeaux
Hospital of Dieppe
University Hospital of Hotel Dieu
Henri Mondor Hospital
Bon Secours Hospital
University Hospital of La Milètrie
Cavale Blanche Hospital
Saint Eloi Hospital
General Hospital of Avignon
Hospital of Nancy
University Hospital of Nimes
Le Kremlin Bicetre Hospital
Hautepierre Hospital
Robert Ballanger Hospital
Jacques Monod Hospital
University Hospital of Claude Huriez
Croix Rousse Hospital
Oloron Sainte Marie Hospital
Hospital group of Pitié-Salpêtrière
Charles Nicolle Hospital
Gustave Dron Hospital
Docteur Schaffner Hospital
South Hospital of Amiens
Departemental Hospital
General Hospital of Arras
European Hospital of Georges Pompidou
Saint Aubin Les Elbeuf Hospital
University Hospital of Jean Bernard
University Hospital of Amiens
Saint André Hospital
Hospital of Brive
Hospital Group of Pitié - Salpêtrière
Hospital of Dax
Bichat Claude Bernard Hospital
University Hospital of Rouen
Hospital of Soissons
General Hospital of Aix en Provence


title: Strategies for Suspected Pulmonary Embolism in Emergency Departments - SPEED Study

summary:
Aims: 1) To evaluate the effectiveness of two interventions aimed at improving the management of patients with suspected pulmonary embolism: Written guidelines and Computer-Assisted Decision Support (CADS). 2) To evaluate the impact of electronic reminders on the appropriateness of the treatment of patients with suspected PE

Design: Pragmatic, unblinded, cluster randomised controlled study.

Setting: 20 French Emergency Departments

Patients: Out patients suspected of having pulmonary embolism

Methods: Emergency physicians will prospectively complete a standardized electronic form on Personal Data Assistant (PDA), including patients' characteristics, the clinical probability if assessed, the diagnostic tests performed, the treatments initiated and the final diagnostic and therapeutic decisions. Patients will be interviewed at the end of a 3-month follow-up period using a standardized questionnaire.

The reference rate of appropriateness of the diagnostic management before intervention will be assessed in each centre. At the end of this preliminary period, the centres will be randomized in two fold two groups according to a factorial design with stratification on their reference level of appropriateness. Half of the centres will have written guidelines and half a Computer-Assisted Decision Support for the diagnosis of PE on the PDA. In each of these two main groups, half of the centres will have electronic reminders on their PDA concerning the treatment of PE.

Judgment criteria

Main : Rate of strategies considered as validated according to the results of the systematic review and meta-analysis.3

Secondary judgment criteria (diagnosis):

Rate of strategies considered as validated or acceptable according to the opinion of international advisors.
Rate of thromboembolic-events during a 3-month follow-up period in patients for whom pulmonary embolism will be ruled out
Costs of the diagnostic management

Secondary judgment criteria (treatment):

Delay between Emergency Department admission and the first dose of antithrombotic treatment in patients with high clinical probability of PE according to the Revised Geneva Score
Rate of inappropriate treatment according to international recommendations for patients with confirmed PE.

Number of patients: By estimating that the rate of appropriateness would be 55% in the "written guidelines" group, 1331 patients are necessary to highlight an absolute superiority of 15% in the "CADS" group (rate of conformity of 70%).

The number of patients will be adjusted at the end of the preliminary period according to the level of appropriateness before interventions considering that it will improve less than 5% in the "written guidelines" group.

ReferenceCitation: Roy PM, Colombet I, Durieux P, Chatellier G, Sors H, Meyer G. Systematic review and meta-analysis of strategies for the diagnosis of suspected pulmonary embolism. BMJ. 2005 Jul 30;331(7511):259. Review.

ReferenceCitation: Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.

location_facility:
H le Mans
H Compiegne
H Argenteuil
H Dreux
H Langres
H Chateauroux
UH Toulouse
UH Dijon
UH Caen
UH Grenoble
H Lons le Saunier
H Saint Nazaire
H Roanne
H Thouars
H Bethune
UH Ambroise Pare
H Chalons en Champagne
UH Nancy
UH Besançon
UH La Pitie Salpetriere


title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.

acronym: PACKING

summary:
Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.

ReferenceCitation: Delion P, Labreuche J, Deplanque D, Cohen D, Duhamel A, Lallié C, Ravary M, Goeb JL, Medjkane F, Xavier J; Therapeutic Body Wrap Study group. Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study. PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.

ReferenceCitation: Huang HF, Tian JL, Yang XT, Sun L, Hu RY, Yan ZH, Li SS, Xie Q, Tian XB. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: A meta-analysis. PLoS One. 2018 Jun 21;13(6):e0197868. doi: 10.1371/journal.pone.0197868. eCollection 2018.

location_facility: Etablissement Public de Santé Roger Prévot

location_facility: Etablissement Public de Santé Mentale Val de Lys-Artois


title: Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020

acronym: Covaé

summary: The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.

location_facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Percy


title: Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection SINBIOSE-H.

acronym: SINBIOSE-H

summary:
Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay.

Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm.

As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low.

We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases.

An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA.

The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.

location_facility:
CHU Nantes
CHU Clermont-Ferrand
CHU Caen
CHU Lille
CHU Bordeaux
CHU Toulouse
CHU Nancy
CHU Marseille
CHU Nice
Chu Saint-Etienne
CHU Amiens
CHU Dijon


title: MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis

acronym: CFMR-lung

summary: The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis

status: Active, not recruiting

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Armand-Trousseau
CHRU Bretonneau-Tours
Hopital Nord
Hôpital Foch
CHRU de Grenoble
Hopital Universitaire de la Timone
CHRU de Lille
Fondation Lenval
Hôpital Henri Mondor
University Hospital of Bordeaux
Hôpital Necker Enfant Malades