title: Therapeutic Process at Work in Multiple Family Therapy Groups for Anorexia Nervosa During Adolescence. An Exploratory Study.

acronym: QUALI-TMF-TCA

summary:
Anorexia nervosa is a characterised disorder which forms part of the wider spectrum of eating disorders. It is a common pathology, particularly in adolescence, with a complex, severe prognosis in both somatic and psychiatric terms, and significant psychosocial consequences, particularly for family relationships.

The treatment of anorexia requires a multidisciplinary team of specialists who can offer individual and family-based approaches. International recommendations highlight the encouraging results of family therapy in the treatment of anorexia nervosa in adolescence. Various types of family approach exist, including "Family Based Treatments", which are a specific but highly effective approach, particularly widespread in the United States. Multifamily therapy (MFT), which involves bringing several families together to address the problem of anorexia, has proved effective for several years now.

Since January 2019, multifamily therapy has been offered to adolescents aged 12 to 18 who are being followed at the Maison de Solenn-Maison des Adolescents at Cochin hospital, for anorexia nervosa, as well as their families.

Each group brings together 5 to 7 families and comprises 10 3-hour sessions, with 3 weeks between each session. 2 groups are offered per year. Multi-family therapy therefore involves 10 to 14 families per year. It complements the other approaches available in the department.

To be able to describe the therapeutic processes at work in multifamily groups in order to be able to better describe our therapeutic device and envisage possible modifications. These processes would be broken down into four areas: MFT and its effects on the anorexic symptom, MFT and its effects on the family, MFT as group therapy and ways of improving the MFT system.

location_facility: University Hospital Cochin, Maison des Adolescents - Youth Department (Maison de Solenn)


title: Comparing Epidemiological and Clinical Characteristics of Infantile Hemangioma With Minimal or Arrested Growth (IH-MAG) and Classic Infantile Hemangioma : a Retrospective Study

summary: Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

lead_sponsor_type: academique

status_simplified: Completed


title: Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study

summary:
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.

The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.

In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.

Our study is a declarative study on pregnant women in Lorraine.

time_perspective: Prospective

location_facility: Centre hospitalier régional universitaire de Nancy

intervention_type: Other


title: Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

summary: Curative treatment of peri hilar cholangiocarcinomas is R0 surgery and require major hepatectomy with biliary tract resection. These complexe procedures can lead to high morbidity and mortality. A severe alteration of nutritional status before the surgery might be a poor prognosis for survival.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.1007/s00268-015-2988-6.

ReferenceCitation: Golse N, Nunez J, Mazzotta A, Cano L, Bergeat D, Sulpice L, Jeddou H, Abdelrafee A, Sa Cunha A, Cherqui D, Adam R, Boudjema K, Vibert E. Personalized Preoperative Nomograms Predicting Postoperative Risks after Resection of Perihilar Cholangiocarcinoma. World J Surg. 2020 Oct;44(10):3449-3460. doi: 10.1007/s00268-020-05618-8.

ReferenceType: result

ReferenceCitation: Yugawa K, Itoh S, Kurihara T, Yoshiya S, Mano Y, Takeishi K, Harada N, Ikegami T, Soejima Y, Mori M, Yoshizumi T. Skeletal muscle mass predicts the prognosis of patients with intrahepatic cholangiocarcinoma. Am J Surg. 2019 Nov;218(5):952-958. doi: 10.1016/j.amjsurg.2019.03.010. Epub 2019 Mar 14.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

status_simplified: Unknown


title: Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19

acronym: CoCovSDRA

summary: Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.

ipd_sharing: Undecided

location_facility: Hopital Central, Service de Reanimation Medicale

intervention_type: Drug


title: Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19

acronym: MAGIC

summary:
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.

The objectives are :

To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
To show that active smokers are less infected with COVID-19 than non-smokers.
To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.

intervention_type: Diagnostic Test


title: Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

acronym: COSALE

summary:
Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.

To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.

The aim of this study is thus to:

show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
confirm the relationship between the diarrhoea and the infection with these viruses.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study

acronym: ACTIVHOP

summary:
The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.

This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.

study_type: Interventional

design_allocation: Randomized

collaborators: Association pour la promotion du sport chez l'enfant malade (APSEM)

location_facility: University Hospital, Children's Hospital


title: A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014

acronym: PMSIApp

summary:
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)

acronym: PRAM-TAVI

summary:
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications.

Intrinsic ventricular performance can be characterized using three parameters:

Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load.
Arterial elastance (Ea for Arterial Elastance) which represents the post-load
The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.

For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved.

Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions.

Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed.

TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI


title: Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

acronym: DELIRIUMTAVI

summary: Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure

intervention_type: Procedure


title: Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique

acronym: MARTIAL

summary: Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling

primary_purpose: Treatment

ReferenceCitation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.

ReferenceCitation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.

ReferenceCitation: Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.

ReferenceCitation: Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

ReferenceCitation: Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83. doi: 10.1016/s0161-6420(01)00856-9.


title: Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT

acronym: EDLIS

summary: Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12.033. Epub 2015 Jan 17.

ReferenceCitation: Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 Apr 8.

publisher_dissemination: SAGE Publications

ReferenceCitation: Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 Dec 3. No abstract available.

ReferenceCitation: Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec.

publisher_dissemination: Wolters Kluwer Health

intervention_type: Device


title: Design of an Organizational Infrastructure Pediatric Plan to Deal With Bronchiolitis Epidemics: Impact on Length of Stay and Quality of Care in a Tertiary Care Regional Hospital

acronym: OIPP

summary:
Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.

In this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.

This plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.

The study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.

ReferenceType: derived

ReferenceCitation: Lavilledieu D, Abassi H, Mercier G, Guiraud M, Chaffaut GD, Milesi C, Cambonie G, Gavotto A, Jeziorski E, Amedro P. Implementation of an organizational infrastructure paediatric plan adapted to bronchiolitis epidemics. J Infect Public Health. 2020 Feb;13(2):167-172. doi: 10.1016/j.jiph.2019.07.007. Epub 2019 Aug 2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_concat: HAL

unpaywall_oa_status: gold

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Five Hospital of the Alpine Region

acronym: PACAAP

summary: The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.

lead_sponsor: Centre Hospitalier Annecy Genevois


type: Other Identifier

title: Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education

acronym: ESSTIM

summary:
This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

primary_purpose: Prevention

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Région Nord-Pas de Calais, France

location_facility:
CH Douai
Victor Provo Hospital
CHRU, Hôpital Huriez
CH du Dr Schaffner
CH Hôpital Duchenne
Valenciennes hospital
CH Dunkerque


title: Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé

acronym: LIVERPAIN

summary:
According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023).

The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease.

The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain.

However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter.

The research will require a single consultation lasting between 15 and 45 minutes.

During the visit, the patient will be asked whether or not they are experiencing pain.

status: Recruiting

ReferenceCitation: Liu YB, Chen MK. Epidemiology of liver cirrhosis and associated complications: Current knowledge and future directions. World J Gastroenterol. 2022 Nov 7;28(41):5910-5930. doi: 10.3748/wjg.v28.i41.5910.

ReferenceCitation: Zhai M, Long J, Liu S, Liu C, Li L, Yang L, Li Y, Shu B. The burden of liver cirrhosis and underlying etiologies: results from the global burden of disease study 2017. Aging (Albany NY). 2021 Jan 12;13(1):279-300. doi: 10.18632/aging.104127. Epub 2021 Jan 12.

ReferenceCitation: Klinge M, Coppler T, Liebschutz JM, Dugum M, Wassan A, DiMartini A, Rogal S. The assessment and management of pain in cirrhosis. Curr Hepatol Rep. 2018 Mar;17(1):42-51. doi: 10.1007/s11901-018-0389-7. Epub 2018 Feb 22.

ReferenceCitation: Marchesini G, Bianchi G, Amodio P, Salerno F, Merli M, Panella C, Loguercio C, Apolone G, Niero M, Abbiati R; Italian Study Group for quality of life in cirrhosis. Factors associated with poor health-related quality of life of patients with cirrhosis. Gastroenterology. 2001 Jan;120(1):170-8. doi: 10.1053/gast.2001.21193.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

status_simplified: Ongoing


title: Non-COVID Patient-safety Incidents Reported by General Practitioners in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study.

acronym: PSI-RECORd-GP

summary:
The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by general practitioners in France.

HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) [Internet]. [cited 2020 Apr 7]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesirables-graves-associes-a-des-soins-eigs
Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.

ReferenceCitation: Fournier JP, Amelineau JB, Hild S, Nguyen-Soenen J, Daviot A, Simonneau B, Bowie P, Donaldson L, Carson-Stevens A. Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care. Eur J Gen Pract. 2021 Dec;27(1):142-151. doi: 10.1080/13814788.2021.1945029.

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: Informa

lead_sponsor: Nantes University Hospital


title: Non-COVID Patient-safety Incidents Reported by Primary Care Professionals in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study

acronym: PSI-RECORd-XP

summary:
The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by primary care professionals in France.

- HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) [Internet]. [cited 2020 Apr 7]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesirables-graves-associes-a-des-soins-eigs
- Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.


title: Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

summary: Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.

lead_sponsor: University Hospital, Strasbourg, France


title: Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

acronym: ANTALGIP

summary:
Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.

The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:

during the procedure
following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).

Secondary purposes are to compare easiness of 2 treatments and their adverse effects.

primary_purpose: Supportive Care


title: Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "

summary:
The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient.

The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.

A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability.

The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.

ReferenceCitation: Nakeeb A, Pitt HA, Sohn TA, Coleman J, Abrams RA, Piantadosi S, Hruban RH, Lillemoe KD, Yeo CJ, Cameron JL. Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann Surg. 1996 Oct;224(4):463-73; discussion 473-5. doi: 10.1097/00000658-199610000-00005.

ReferenceCitation: Bar-Meir S, Rotmensch S. A comparison between peroral choledochoscopy and endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1987 Feb;33(1):13-4. doi: 10.1016/s0016-5107(87)71476-x.

ReferenceCitation: Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Hafner M, Costamagna G, Deviere J, Neuhaus H, Caillol F, Giovannini M, Hassan C, Dumonceau JM. Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy. 2015 Aug;47(8):739-53. doi: 10.1055/s-0034-1392584. Epub 2015 Jul 6.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Georg Thieme

ReferenceCitation: Urakami Y, Seifert E, Butke H. Peroral direct cholangioscopy (PDCS) using routine straight-view endoscope: first report. Endoscopy. 1977 Mar;9(1):27-30. doi: 10.1055/s-0028-1098481.

ReferenceCitation: Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.

ReferenceCitation: Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.

ReferenceCitation: Rey JW, Hansen T, Dumcke S, Tresch A, Kramer K, Galle PR, Goetz M, Schuchmann M, Kiesslich R, Hoffman A. Efficacy of SpyGlass(TM)-directed biopsy compared to brush cytology in obtaining adequate tissue for diagnosis in patients with biliary strictures. World J Gastrointest Endosc. 2014 Apr 16;6(4):137-43. doi: 10.4253/wjge.v6.i4.137.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Baishideng Publishing Group Inc.

ReferenceCitation: Navaneethan U, Hasan MK, Lourdusamy V, Njei B, Varadarajulu S, Hawes RH. Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review. Gastrointest Endosc. 2015 Oct;82(4):608-14.e2. doi: 10.1016/j.gie.2015.04.030. Epub 2015 Jun 10.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Boyer J. [Endoscopic sphincterotomy and lithiasis of the common bile duct. Reality and perspectives]. Gastroenterol Clin Biol. 1993;17(4):241-3. No abstract available. French.

ReferenceCitation: Seelhoff A, Schumacher B, Neuhaus H. Single operator peroral cholangioscopic guided therapy of bile duct stones. J Hepatobiliary Pancreat Sci. 2011 May;18(3):346-9. doi: 10.1007/s00534-010-0360-7.

ReferenceCitation: Arnelo U, Siiki A, Swahn F, Segersvard R, Enochsson L, del Chiaro M, Lundell L, Verbeke CS, Lohr JM. Single-operator pancreatoscopy is helpful in the evaluation of suspected intraductal papillary mucinous neoplasms (IPMN). Pancreatology. 2014 Nov-Dec;14(6):510-4. doi: 10.1016/j.pan.2014.08.007. Epub 2014 Sep 27.

ReferenceCitation: Laquiere AE, Privat J, Fumex F, Grandval P, Lecomte L, Curel L, Belle A, Trottier-Tellier F, Urena-Campos R, Penaranda G, Boustiere C, Napoleon B. Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study. Scand J Gastroenterol. 2020 Nov;55(11):1381-1388. doi: 10.1080/00365521.2020.1832143. Epub 2020 Oct 23.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Hopital Saint Joseph
Hopital Mermoz
Centre Hospitalier Jacques Lacarin


title: Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation

acronym: SUBSTRATE-HD

summary: To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.

ReferenceCitation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

location_facility:
Hopital Saint Joseph
CHU
Institut Mutualiste de Montsouris


title: Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus

acronym: SPIRALE

summary:
Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in osteoarticular destruction and serious disability. When clinical symptoms (painful and swollen joints) occur, the innate and adaptive immune responses against self antigens have already been largely amplified. This might explain that even when RA patients are treated very early and aggressively, a remission of the disease can only be obtained in approximately half of them. This proportion of remission under treatment can only be achieved using treat to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of patients remain in remission after treatment discontinuation. Thus, despite the availability of 5 different types of biologics, there are still therapeutic unmet needs. However, a spontaneous, drug-free decrease of disease activity can be observed in a physiological condition, pregnancy. Although most of treatments of RA have to be discontinued during pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy, with frequent post-partum flares. The situation is the opposite with an increased risk of flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys, the brain, the heart, …). The course of the disease remains unpredictable for a given patient, and very few biomarkers are available to help clinicians to identify patients a risk of flares. Thus, safe therapeutic options remain limited, especially in patients with serious complications. A specific concern in SLE is the fact that the disease usually starts in women entering their sexual and reproductive life. Even with a stable condition (i.e : lupus without recent flares and no impaired renal or cardiac function) as it is medically recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.

We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those regarding the pattern and levels of microRNAs, could explain the clinical improvement and the risk of flares in RA and SLE, respectively. A better understanding of the underlying mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA and targeting them in SLE.

location_facility: Service de rhumatologie Hôpital de Hautepierre


title: Implementation of a Return Home With a Hospitalization at Home or With a Home Health Care Provider From the Services of Oncopneumology, Oncology and Hematology of University Hospital of Strasbourg: Observational, Prospective, Monocentric, Non-interventional Study. Advantages, Disadvantages, Limitations

summary:
Hospitalization at home is booming. It is designed to meet the demands of patients and their families to continue care at home. It partially solves the problem of the lack of places in the "long-term care" structures and allows to respond to a desire of the health policy to reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in the management of chronic patients. Nevertheless, at the moment a certain number of requests for hospitalization at home remain unsuccessful or their implementation is complicated. In addition, the number of home health care provider has increased significantly in recent years. According to the federation of home health care provider, the number of beneficiaries increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients per year.

The objective of the study is to analyze the factors participating in Implementation of a return home with a Hospitalization at home or a home health care provider during a return home project constructed with the patient and his / her relatives from the services of Oncology, oncology, hematology of the University Hospital of Strasbourg.


title: Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

acronym: ECHOPOG

summary: As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).

location_facility: Service Réanimation chirurgicale cardio-vasculaire - NHC


title: Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users

acronym: CAUSA MAP

summary:
This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of magnocellular system (visual event-related potential, visual ERP).

Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the temporal sensitivity of magnocellular system (visual event-related potential), on the dynamics of cortical visual processing during face perception test (visual event-related potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).

The ancillary study is a genetic analysis of a group of candidate genes that aims to identify biomarkers for changes in visual processing. This will allow to distinguish among more homogeneous and specific groups in future studies on larger cannabis user population. This ancillary study concerns all participants subject to their informed consent (facultative study).

primary_purpose: Other

ReferenceCitation: Bernardin F, Schwitzer T, Schwan R, Angioi-Duprez K, Ligier F, Bourion-Bedes S, Jansen C, Giersch A, Laprevote V. Altered central vision and amacrine cells dysfunction as marker of hypodopaminergic activity in treated patients with schizophrenia. Schizophr Res. 2022 Jan;239:134-141. doi: 10.1016/j.schres.2021.11.049. Epub 2021 Dec 7.

ReferenceCitation: Remy I, Schwitzer T, Albuisson E, Schwan R, Krieg J, Bernardin F, Ligier F, Lalanne L, Maillard L, Laprevote V. Impaired P100 among regular cannabis users in response to magnocellular biased visual stimuli. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Mar 8;113:110437. doi: 10.1016/j.pnpbp.2021.110437. Epub 2021 Sep 11.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

location_facility: Maison des Addictions - CHU de Nancy, Hôpital St Julien


title: Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure

acronym: INSPIRE

summary:
The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance, this relates to 50,000 patients in France, life expectancy is very limited, and quality of life is poor.

CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are not yet established. Recently, a chronic inflammatory condition has been quoted as a putative cause. This chronic inflammation would involve the molecular mechanisms leading to poor regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could explain a lack of protein synthesis.

It is now well established that respiratory rehabilitation, including a program of exercise reconditioning, increases tolerance to exercise and improve the quality of life. Besides the classical type of endurance exercises stimulating the cardio-respiratory system, it is suggested to add resistance exercises. Several studies have reported the benefit of this strategy but the link with intracellular molecular pathways has not been described; moreover, it is unknown whether the existence of an initial muscular atrophy influences the gain in muscle strength/mass.

primary_purpose: Basic Science

ReferenceCitation: Costes F, Gosker H, Feasson L, Desgeorges M, Kelders M, Castells J, Schols A, Freyssenet D. Impaired exercise training-induced muscle fiber hypertrophy and Akt/mTOR pathway activation in hypoxemic patients with COPD. J Appl Physiol (1985). 2015 Apr 15;118(8):1040-9. doi: 10.1152/japplphysiol.00557.2014. Epub 2015 Feb 19.

repository_institution: Maastricht University - Research Publications

publisher_dissemination: American Physiological Society

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

acronym: FEMCAT

summary: Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

ReferenceCitation: Abraham AG, Condon NG, West Gower E. The new epidemiology of cataract. Ophthalmol Clin North Am. 2006 Dec;19(4):415-25. doi: 10.1016/j.ohc.2006.07.008.

ReferenceCitation: Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

ReferenceCitation: Lamoureux EL, Fenwick E, Pesudovs K, Tan D. The impact of cataract surgery on quality of life. Curr Opin Ophthalmol. 2011 Jan;22(1):19-27. doi: 10.1097/ICU.0b013e3283414284.

ReferenceCitation: Hovding G, Natvik C, Sletteberg O. The refractive error after implantation of a posterior chamber intraocular lens. The accuracy of IOL power calculation in a hospital practice. Acta Ophthalmol (Copenh). 1994 Oct;72(5):612-6. doi: 10.1111/j.1755-3768.1994.tb07188.x.

ReferenceCitation: Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg. 2008 Mar;34(3):368-76. doi: 10.1016/j.jcrs.2007.10.031.

ReferenceCitation: Norregaard JC, Thoning H, Bernth-Petersen P, Andersen TF, Javitt JC, Anderson GF. Risk of endophthalmitis after cataract extraction: results from the International Cataract Surgery Outcomes study. Br J Ophthalmol. 1997 Feb;81(2):102-6. doi: 10.1136/bjo.81.2.102.

ReferenceCitation: Powell SK, Olson RJ. Incidence of retinal detachment after cataract surgery and neodymium: YAG laser capsulotomy. J Cataract Refract Surg. 1995 Mar;21(2):132-5. doi: 10.1016/s0886-3350(13)80499-3.

ReferenceCitation: Norregaard JC, Thoning H, Andersen TF, Bernth-Petersen P, Javitt JC, Anderson GF. Risk of retinal detachment following cataract extraction: results from the International Cataract Surgery Outcomes Study. Br J Ophthalmol. 1996 Aug;80(8):689-93. doi: 10.1136/bjo.80.8.689.

ReferenceCitation: Qatarneh D, Mathew RG, Palmer S, Bunce C, Tuft S. The economic cost of posterior capsule tear at cataract surgery. Br J Ophthalmol. 2012 Jan;96(1):114-7. doi: 10.1136/bjo.2010.200832. Epub 2011 Mar 1.

ReferenceCitation: Chatoux O, Touboul D, Buestel C, Balcou P, Colin J. [Crystalline lens photodisruption using femtosecond laser: experimental study]. J Fr Ophtalmol. 2010 Sep;33(7):472-80. doi: 10.1016/j.jfo.2010.06.008. French.

ReferenceCitation: Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022. Erratum In: J Cataract Refract Surg. 2011 Sep;37(9):1742.

ReferenceCitation: Palanker DV, Blumenkranz MS, Andersen D, Wiltberger M, Marcellino G, Gooding P, Angeley D, Schuele G, Woodley B, Simoneau M, Friedman NJ, Seibel B, Batlle J, Feliz R, Talamo J, Culbertson W. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010 Nov 17;2(58):58ra85. doi: 10.1126/scitranslmed.3001305.

ReferenceCitation: Masket S, Sarayba M, Ignacio T, Fram N. Femtosecond laser-assisted cataract incisions: architectural stability and reproducibility. J Cataract Refract Surg. 2010 Jun;36(6):1048-9. doi: 10.1016/j.jcrs.2010.03.027. No abstract available.

ReferenceCitation: Taketani F, Matuura T, Yukawa E, Hara Y. Influence of intraocular lens tilt and decentration on wavefront aberrations. J Cataract Refract Surg. 2004 Oct;30(10):2158-62. doi: 10.1016/j.jcrs.2004.02.072.

ReferenceCitation: Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.

ReferenceCitation: Schweitzer C, Brezin A, Cochener B, Monnet D, Germain C, Roseng S, Sitta R, Maillard A, Hayes N, Denis P, Pisella PJ, Benard A; FEMCAT study group. Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial. Lancet. 2020 Jan 18;395(10219):212-224. doi: 10.1016/S0140-6736(19)32481-X.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Schweitzer C, Hayes N, Brezin A, Cochener B, Denis P, Pisella PJ, Benard A; FEMCAT study group. Re: Abell et al.: Cost-effectiveness of femtosecond laser-assisted cataract surgery versus phacoemulsification cataract surgery (Ophthalmology 2014;121:10-6). Ophthalmology. 2014 Oct;121(10):e53-4. doi: 10.1016/j.ophtha.2014.05.025. Epub 2014 Jun 26. No abstract available.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Cochin
CHU de Tours
CHU de Brest
Hospices Civils de Lyon
CHU de Bordeaux


title: Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet

acronym: FERIplaq

summary:
Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms.

The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases.

The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.

status: Not yet recruiting

time_perspective: Other


title: Characterization of Molecular Signature Associated With T-cell Dysfunction Observed During Chronic HBV Infection

acronym: VHB-Roche

summary:
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. These complications are strongly related to the function of the immune system. Indeed, the persistence of HBV and the progression of liver disease are mainly due to the development of an ineffective immune response to HBV. Therefore, the clinical outcome depends on the complex interaction between HBV replication and adaptive immune responses.

The ultimate goal of antiviral treatments is the elimination of HBsAgHBs and the appearance of anti-HBs antibodies without detectable PCR replication. Current treatments are effective at lowering viral DNA levels, but they are not able to permanently eliminate chronic HBV infection, due to the persistence of cDNA in the nucleus of infected hepatocytes. This therapeutic goal is rarely achieved and new therapeutic approaches are needed. In this sense, Immunotherapy represents a very promising new therapeutic approach that could lead to the cure of chronic HBV infection. Indeed, HBV infection is characterized by a progressive depletion of T lymphocytes which results in a progressive loss of function, associated with a sustained positive regulation of inhibitory control molecules.

Thus, the objective of this study is to define the immune signature and the main control pathways associated with T-cell depletion in patients chronically infected with HBV, by analyzing immune cells isolated from these patients at phenotypic , transcriptional and functional levels

intervention_type: Biological


title: Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study

acronym: COVID-Aging

summary: In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.

status: Terminated


title: Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery

acronym: HYPER-CARDIO

summary: The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications


title: Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

acronym: StudentCov

summary: The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

lead_sponsor: Versailles Hospital

location_facility:
Toulouse University Hospital
Versailles hospital


title: Evaluation of Patient Analgesia After Bloc Serratus for the Management of Thoracic Trauma

acronym: TraumaThorax

summary:
Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis).

The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...).

The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology.

The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.

location_facility: Service de Réanimation chirurgicale_ Hôpital de Hautepierre


title: Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients Who Consulted in the Emergency Services of the University Hospitals of Strasbourg From September 2018 to March 2019

acronym: Influenza

summary: Seasonal influenza outbreaks contribute to the saturation of emergency services. Better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.


title: Does the Contact Between the Deep Surface of the Supraspinatus Muscle Tendon and the Posterior Superior Labrum Physiological ?

summary: The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.

location_facility: Service de chirurgie du membre supérieur Hautepierre 2


title: Evaluation of the Interest of 18F-FDG Positron Emission Tomography in the Management of Unexplained Fevers and Inflammatory Syndromes in Elderly Subjects

summary:
Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.

In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


title: Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer

acronym: MRI-TULSAP

summary:
Primary purpose :

Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer.

Primary Objective:

Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.

Secondary Objectives:

Biochemical response
Presence of any CSC on biopsy at 1- and 2-year follow-up
Radical treatment free survival
Adverse events, clinical tolerance
Urinary continence
Erectile function
Quality of life


title: Epidemiological Study on the Evolution of the Rate and Causes of Mortality in Geriatric SRH in the HUS

summary: In view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative


title: Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

acronym: CHOLEMRI

summary: Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management

location_facility: Service D'Orl Et de Chirurgie Cervico-Faciale


title: Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data

summary: The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.

location_facility: Service Des Maladies Vasculaires - Hta - Nhc


title: Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO

acronym: ECMOstase

summary: ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.

location_facility: Service de Réanimation médicale CHU Strasbourg


title: Cerebellum and Cortical Plasticity: the Case of Dystonia

acronym: CERDYS

summary:
Purpose

- Objective : Sensorimotor adaptation allows the modification of the motor command taking into account the errors detected during execution of prior movements. It involves a large cortico-subcortical network. Isolated lesions of this network do not systematically alter sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key structure for sensorimotor adaptation. However, the link between cerebellar and the cortical plasticity underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor adaptation is associated with dystonia but it is unclear whether it is a cause or consequence of dystonia. It has been hypothesized that the abnormal plasticity observed in dystonia could account for the associated alteration of sensorimotor adaptation.

Classically, basal ganglia dysfunction is considered to be crucial for dystonia pathogenesis. However, recent studies suggest that the involvement of the cerebellum may also be important in this setting. In primary dystonia, imaging studies showed abnormal cerebellar activation during sensorimotor adaptation tasks and neurophysiological studies demonstrated a decrease of cerebellar output.

The aim of this study is to investigate the role of the cerebellum in the cortical plasticity underlying sensorimotor adaptation both in healthy subjects (normal plasticity) and in dystonic patients (abnormal plasticity).

- Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral nerve and a cortical stimulation. This kind of stimulation has been designed to induce artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity is exacerbated and has lost its topographical specificity in dystonic patients.TMS using trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.

We will also assess the acute effect of the rTMS induced modulation of the cerebellar output on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task. This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on standardized videorecording and measurement of the performance at the task after each rTMS session (cTBS, iTBS, sham).

Finally, we will assess the variation of PAS effect on other parameters reflecting cortical excitability after each rTMS session (cTBS, iTBS, sham).

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

collaborators: Sree Chitra Tirunal Institute for Medical Sciences & Technology

location_facility: Hpôpital Pitié Sapétrière - U 975 Plate forme " Pole Exploration de l'homme : Gait, Equilibrium, Posture, and Movement "


title: Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies

acronym: MAHM

summary:
Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies


title: Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region

acronym: DICI-VIH

summary:
To reduce late HIV diagnosis that remains common in France, the national health agency has promoted non-targeted HIV screening in health care settings, including emergency departments (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at high-risk. Our findings, consistent with results from other international groups, suggest that a targeted strategy could be feasible, efficient and cost-effective with fewer tests required. However, the feasibility and the efficacy of this strategy remain unknown in France.

The main aim of the present study is to compare the efficacy of 2 strategies: 1) the combination of the nurse-driven HIV targeted screening and the current practice (physician-directed HIV diagnostic testing) versus 2) the current practice alone.

The strategies will be compared during 2 randomly assigned periods (cluster randomization and cross-over) in 8 EDs of metropolitan Paris.

During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years old, identified as high-risk by a self-administered questionnaire, not know to be HIV positive, not being seen for post-exposure prophylaxis or unstable medical illness, and accepting to participate by providing an informed consent.

In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious disease specialist will be arranged within the following 48 hours.

primary_purpose: Screening

ReferenceCitation: Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Cremieux AC; DICI-VIH (Depistage Infirmier CIble du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.

ReferenceCitation: Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Cremieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ANRS, Emerging Infectious Diseases

location_facility: Clinical Research Center (Centre de Recherche Clinique de l'Est Parisien, CRC-Est), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris (AP-HP)


title: French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

acronym: CALCIMIT

summary: The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

ReferenceCitation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2013 Mar;14(3):167-214. doi: 10.1714/1234.13659. No abstract available. Italian.

ReferenceCitation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; ACC/AHA Task Force Members. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 10;129(23):e521-643. doi: 10.1161/CIR.0000000000000031. Epub 2014 Mar 3. No abstract available. Erratum In: Circulation. 2014 Jun 10;129(23):e651. Circulation. 2014 Sep 23;130(13):e120. Dosage error in article text.

ReferenceCitation: Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988 Oct;60(4):299-308. doi: 10.1136/hrt.60.4.299.

ReferenceCitation: Abascal VM, Wilkins GT, Choong CY, Thomas JD, Palacios IF, Block PC, Weyman AE. Echocardiographic evaluation of mitral valve structure and function in patients followed for at least 6 months after percutaneous balloon mitral valvuloplasty. J Am Coll Cardiol. 1988 Sep;12(3):606-15. doi: 10.1016/s0735-1097(88)80045-7.

ReferenceCitation: Palacios IF. Percutaneous mitral balloon valvuloplasty. Does it really last as long and do as well as surgery? Adv Cardiol. 2002;39:100-13. doi: 10.1159/000058916. No abstract available.

ReferenceCitation: Iung B, Cormier B, Ducimetiere P, Porte JM, Nallet O, Michel PL, Acar J, Vahanian A. Immediate results of percutaneous mitral commissurotomy. A predictive model on a series of 1514 patients. Circulation. 1996 Nov 1;94(9):2124-30. doi: 10.1161/01.cir.94.9.2124.

ReferenceCitation: Dreyfus J, Cimadevilla C, Nguyen V, Brochet E, Lepage L, Himbert D, Iung B, Vahanian A, Messika-Zeitoun D. Feasibility of percutaneous mitral commissurotomy in patients with commissural mitral valve calcification. Eur Heart J. 2014 Jun 21;35(24):1617-23. doi: 10.1093/eurheartj/eht561. Epub 2014 Jan 6.

ReferenceCitation: Bouleti C, Iung B, Himbert D, Messika-Zeitoun D, Brochet E, Garbarz E, Cormier B, Vahanian A. Relationship between valve calcification and long-term results of percutaneous mitral commissurotomy for rheumatic mitral stenosis. Circ Cardiovasc Interv. 2014 Jun;7(3):381-9. doi: 10.1161/CIRCINTERVENTIONS.113.000858. Epub 2014 Apr 29.

ReferenceCitation: Palacios IF, Block PC, Wilkins GT, Weyman AE. Follow-up of patients undergoing percutaneous mitral balloon valvotomy. Analysis of factors determining restenosis. Circulation. 1989 Mar;79(3):573-9. doi: 10.1161/01.cir.79.3.573.

ReferenceCitation: Ben-Farhat M, Betbout F, Gamra H, Maatouk F, Ben-Hamda K, Abdellaoui M, Hammami S, Jarrar M, Addad F, Dridi Z. Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy. Am Heart J. 2001 Dec;142(6):1072-9. doi: 10.1067/mhj.2001.118470.

ReferenceCitation: Bouleti C, Iung B, Laouenan C, Himbert D, Brochet E, Messika-Zeitoun D, Detaint D, Garbarz E, Cormier B, Michel PL, Mentre F, Vahanian A. Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients. Circulation. 2012 May 1;125(17):2119-27. doi: 10.1161/CIRCULATIONAHA.111.055905. Epub 2012 Mar 28.

lead_sponsor: French Cardiology Society

lead_sponsor_type: industriel


title: Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior

acronym: MEGADOSE

summary:
Prescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of medication in Europe. A single source of information is rarely sufficient to measure such a complex phenomenon. This project entitled MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete efficiently the available data from the addictovigilance centres allowing the health authorities (French Drug Agency) to answer to the main general questions (What are the main prescription drug abused in France? What are the national trends in prescription drug abuse? What is the impact of a public health measure on prescription drug abuse). This project constitutes the opportunity of "extending" the application of our tool (the DS method) on a French national database with a minimal risk since this method has already been validated and applied on different geographic areas, on different drugs and at different levels of analysis. The project would also be integrated in routinely as a useful tool included in the addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of policy and practice interventions implemented by the French Drug Agency.

The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM related to drug misuse in particular: development and identification of systems and tools able to detect earlier misuse phenomenon; analysis of the impact of communications, guidelines, decisions to health authorities and patients

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


type: Registry Identifier

title: L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie

acronym: PEDUPARK

summary:
Although major progresses were realized during recent years, temporal cognition is still poorly understood. However, abnormal temporal cognition is an underestimated aspect of several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore, the interest of studying temporal cognition is double: firstly, it is an essential function necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc). Therefore, in this project, PD patients and healthy volunteers will be used as a model to study the role of dopamine in temporal expectation.

An expectation is an internal representation of an event that is likely to occur in the future. Temporal expectation builds-up as time elapses before the upcoming event. The role of temporal expectation in the oculomotor domain has often been studied using anticipatory eye movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the knowledge of the investigators, expectation and anticipation have so far been studied in experimental tasks where temporal information is essential but not voluntarily controlled. This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye movement adapts to the timing of the target, implicitly and without voluntary control of the subject. However, anticipatory movements can also be based on an explicit estimation of time, e.g. during music playing. In summary, timing can be based on cognitive (explicit) or automatic (implicit) processing. The originality of the behavioral task the investigators will use in this study is that it will require an explicit comparison of a memorized duration with elapsing time in order to anticipate target appearance. In this task, expectation of the upcoming event will build up on explicit temporal information.

Same PD patients will be tested under treatment ("ON") and without treatment ("OFF") to determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson patients will be included and among them only those receiving levodopa and/or dopa agonists three times daily at a stable dosis since 30 days.

the investigators hypothesize that eye movements latency will not linearly covary with objective time in "OFF" PD patients. In treated PD patients, a recovery of the linear relationship between subjective and objective time is expected. This would clearly demonstrate the role of dopamine in temporal expectation in humans.

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: ICM-IHU ICM


title: Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis

acronym: CAPISLA

summary:
Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone.

Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory.

No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.

lead_sponsor: University Hospital, Angers


title: Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation

acronym: SUPERMELD

summary:
The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.

The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.

The expected benefits of this search are twofold:

At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.

Public health plan:

Improving the equity of graft allocation system.
Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: SuperMELD

titre: Construction de nouveaux modèles mathématiques prédictifs de mortalité des cirrhotiques décompensés candidats à la greffe hépatique.

discipline_principale: hépatologie

nom_porteur: Duvoux

prenom_porteur: Christophe


title: Incidence of Covid-19 in School Children During the Pandemic Period in Nice

acronym: COVIDECOLE

summary:
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

lead_sponsor: Fondation Lenval


title: Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study

acronym: SPEED-COVID

summary: The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.

lead_sponsor: Centre Hospitalier Sud Essonne


title: Work on the Social Representation of Addiction Among Mental Health Professionals

summary: Our goal is to determine the representations of addiction among caregivers working in the field of mental health. We hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.


title: Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study

summary: Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.


title: Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study

acronym: HypoTAShoulder

summary:
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.

The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.

The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,

location_facility: Service D'Anesthesiologie - Reanimation Chirurgicale


title: Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease

summary:
The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.

This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.

The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.

These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.

location_facility: Service de Gériatrie Hôpital de la Robertsau


title: Survival Rates of Atients Wearing a Mobile Unicompartimental Knee Prosthesis for the Past 10 Years

summary:
The unicompartmental knee prosthesis has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models.

In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing unicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses and mobile-bearing prostheses

location_facility: Centre de Chirurgie Orthopédique et de la Main (CCOM)


title: Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection

summary: This non-interventional study aims to determine whether there is a correlation between the Fc receptor polymorphism (FcR) and the course of the disease following HIV infection.

location_facility: Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC