title: French Cohort of HIV Associated Lymphomas

acronym: ANRS CO16

summary:
The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
study the differentiation and activation of B-cell populations,
better understand the role of specific T cell responses in the control of EBV infection,
allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases

summary: The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a cohort of patients representative of the population treated under real-life conditions of use in France for up to 5 years.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Cardiovascular

location_facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.

lead_sponsor: University Hospital, Tours

intervention_type: Other

lead_sponsor_type: academique


type: Other Identifier

title: Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area

acronym: DESSEIN

summary:
Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.

Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.

The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.

These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.

ReferenceType: derived

ReferenceCitation: Ngô C, Dinut A, Bochaton A, Charreire H, Desprès C, Baffert S, Lécuru F, Chatellier G. From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer. BMC Public Health. 2019 Nov 4;19(1):1450. doi: 10.1186/s12889-019-7611-6.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hopitalier Victor Dupouy Argenteuil

location_facility: Centre Hospitalier Intercommunal Poissy Saint Germain en Laye

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: Institut Curie Hôpital René-Huguenin site Saint-Cloud


title: Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease

acronym: ItinerAir

summary:
The complex congenital cardiac malformations are a significant number of different diseases, each having specific natural histories. The interface with pulmonary arterial hypertension (HTAP) is high since the physiology of many of these disorders comprises alterations in pulmonary vasculature.

This observatory is a cohort of 400 patients enrolled in 3 years, older than one month, having been informed and have agreed to participate in the study and with congenital heart disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension confirmed by cardiac catheterization.

The main objectives of this report are to know

Incidence of congenital heart disease in HTAP France.
Describe the natural history of HTAP in a large population of patients Congenital heart disease in France
The characteristics of HTAP congenital heart disease
Having a cohort study

ReferenceType: background

ReferenceCitation: Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.

ReferenceCitation: Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.

ReferenceCitation: Barst RJ, Ivy DD, Foreman AJ, McGoon MD, Rosenzweig EB. Four- and seven-year outcomes of patients with congenital heart disease-associated pulmonary arterial hypertension (from the REVEAL Registry). Am J Cardiol. 2014 Jan 1;113(1):147-55. doi: 10.1016/j.amjcard.2013.09.032. Epub 2013 Oct 4.

ReferenceCitation: Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. Epub 2006 Feb 2.

ReferenceCitation: Fraisse A, Jais X, Schleich JM, di Filippo S, Maragnès P, Beghetti M, Gressin V, Voisin M, Dauphin C, Clerson P, Godart F, Bonnet D. Characteristics and prospective 2-year follow-up of children with pulmonary arterial hypertension in France. Arch Cardiovasc Dis. 2010 Feb;103(2):66-74. doi: 10.1016/j.acvd.2009.12.001. Epub 2010 Feb 11.

ReferenceCitation: van Loon RL, Roofthooft MT, Hillege HL, ten Harkel AD, van Osch-Gevers M, Delhaas T, Kapusta L, Strengers JL, Rammeloo L, Clur SA, Mulder BJ, Berger RM. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005. Circulation. 2011 Oct 18;124(16):1755-64. doi: 10.1161/CIRCULATIONAHA.110.969584. Epub 2011 Sep 26.

ReferenceCitation: Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. Epub 2006 Dec 19.

lead_sponsor: French Cardiology Society


title: Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis (DFPP) or Plasma Exchange (PE).

acronym: DFPP

summary:
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).

In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis.

After renal transplant, two main causes of the graft loss after the first years are death of patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).

Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.

DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and essentially eliminates higher molecular weights molecules including immunoglobulins comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma exchanges.

A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels, which will result in rapidly progressive renal failure, usually associated with a high rate of proteinuria.

Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5 years of renal transplantation.

Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).

The investigators of this study propose in the context of the active ABMR demonstrated by renal biopsy to evaluate in combination with rituximab, a new apheresis technique double Plasma filtration (DFPP) instead of plasma Exchange.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikić Ž, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, König F, Hidalgo LG, Oberbauer R, Halloran PF, Böhmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.

ReferenceCitation: Eskandary F, Wahrmann M, Mühlbacher J, Böhmig GA. Complement inhibition as potential new therapy for antibody-mediated rejection. Transpl Int. 2016 Apr;29(4):392-402. doi: 10.1111/tri.12706. Epub 2015 Nov 10. Review.

ReferenceCitation: Gatault P, Kamar N, Büchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

ReferenceCitation: Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.

ReferenceCitation: Hanafusa N, Kondo Y, Suzuki M, Nakao A, Noiri E, Fujita T. Double filtration plasmapheresis can decrease factor XIII Activity. Ther Apher Dial. 2007 Jun;11(3):165-70.

lead_sponsor: University Hospital, Grenoble

status_simplified: Unknown


title: Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals

acronym: GriCoVax

summary: Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

location_facility: Maternité Notre Dame de Bon Secours - GH Paris St Joseph


title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

acronym: DiabeNord

summary: The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.

primary_purpose: Diagnostic

ReferenceCitation: Croyal M, Wargny M, Chemello K, Chevalier C, Blanchard V, Bigot-Corbel E, Lambert G, Le May C, Hadjadj S, Cariou B. Plasma apolipoprotein concentrations and incident diabetes in subjects with prediabetes. Cardiovasc Diabetol. 2022 Feb 7;21(1):21. doi: 10.1186/s12933-022-01452-5.

ReferenceCitation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zaïr Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.

lead_sponsor: Nantes University Hospital

location_facility: Clinical Nutrition Center Naturalpha (CNCN)


title: Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel

acronym: URGO

summary:
There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

time_perspective: Retrospective


title: Impact of a Front-of-pack Nutrition Labelling on the Nutritional Quality of Purchases of Customers in Contract Catering - a Controlled Trial

summary: This controlled trial investigates the impact of the implementation of a front-of-pack nutrition label, namely Nutri-Score, on foods and beverages sold in a contract catering in France on the nutritional quality of purchases.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: University of Paris 13

location_facility: Equipe de Recherche en Epidémiologie Nutritionnelle

intervention_type: Behavioral


title: Epidemiology and Treatment of Multidrug-resistant (MDR TB) and Extensively Drug- Resistant (XDR TB) Tuberculosis in Strasbourg, France; a 10 Years Retrospective Study

summary: The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Maladies Infectieuses et Tropicales


title: Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

acronym: ANEUVISM

summary:
Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.

Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.

status: Terminated

lead_sponsor: University Hospital, Montpellier


title: Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France

acronym: ACUTE-FLOW

summary: French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR. Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied. The rate of delay in the management of non-elective surgery in France is not known. Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017). Optimizing the flow of non-elective surgery represents a major challenge. The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France. All patients requiring urgent surgical management (<72 hours) will be included. The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: < 1 hour; NEST 3: < 4 hours; NEST 4: < 12 hours; NEST 5: < 48 hours; NEST 6: < 72 hours). For each patient, the ratio between the observed time (actual Time To Surgery [aTTS] ) and the ideal time (ideal Time To Surgery [iTTS]) will be determined. The delay is identified by aTTS/iTTS ratio >1.

lead_sponsor: University Hospital, Lille

location_facility:
University Hospital
Clinique
Henri Mondor Hospital
Edouard Herriot Hospital
Hôpital sud
University hospital
Beaujon Hospital
HEGP


title: Adapted Physical Activity and Prevention of Cardiovascular Risk in Elderly People Living With HIV: Comparative Study of Two Cohortes, CHU Saint Etienne (France) and Mvog Ada District Hospital Yaoundé, Cameroon.

summary: A quasi-experimental and comparative study will be conducted in two different geographical areas (Europe-France and Africa-Cameroon) on a period of 18 months. All eligible adults aged 50 years and older presenting to one of the investigative centers (for HIV care) will be included in the study. The patients will be randomized in two parallel groups according to the 1:1 ratio, namely a control group A where patients continue the usual HIV management, and an intervention group B where in addition to the usual HIV management, patients will benefit from an adapted physical activity (APA) program for three months. An evaluation of heart rate variability, response to current treatment, gut microbiota profile and quality of life will be performed at the end of the APA session. Comparison between control group A and intervention group B will be performed. The acceptability of this program will also be evaluated.

primary_purpose: Health Services Research

lead_sponsor: Support and Education Technic Centre

location_country: Cameroon France

location_facility:
Mvog Ada district Hospital
CHU Saint-Etienne
CHU Saint étienne


title: Visual Exploration and Attention : Studies in Patients With Schizophrenia and Autism Spectrum Disorders

summary: The aim of the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each population being compared with matched controls. The explorations are designed to test two different hypotheses regarding the mechanisms of the visual perception difficulties of the two populations. Even though difficulties to extract the global form of objects have been described in both subjects with autism and schizophrenia, we will test two different hypotheses for the two populations. We will test the hypothesis that subjects with autism display an advantage for the processing of local information arising at an early level of processing, whereas disorders observed in patients with schizophrenia originate from attention disorders. The protocol includes three consecutive studies, each one being applied in each of the three populations.

time_perspective: Cross-Sectional

location_facility: Centre de Ressources Autisme Pôle adultes (68) - Espace Autisme 68

location_facility: Pôle départemental du Centre de Ressources Autisme pour adultes (67) - Etablissement public de santé Alsace-Nord (site de Brumath)

location_facility: INSERM U666 ; Pôle de Psychiatrie - Service de Psychiatrie Adulte- HUS

location_facility: Pôle régional du Centre de Ressources Autisme pour enfants et adolescents - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - Pôle de Psychiatrie - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - HUS


title: Observatoire Des Assistances Monoventriculaires Gauches du Grand Sud

acronym: SOFCAR

summary:
Chronic heart failure is a common disease. It is also a serious disease with a mortality of 50% at 5 years, representing a significant cost in terms of public health expenditure.

Heart transplantation represents the "gold standard" of care for terminal heart failure patients reached the end of the disease despite optimal medical and surgical management of their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3 years.

Long term LVAD are an innovative technology available for more than a decade, developed in part because of the shortage of cardiac grafts and high mortality among patients waiting for transplants due to an important pending.

This technique is used substantially only for ten to fifteen years in the world. Survival after implantation of latest devices reaches 80% at 1 year.

In France, this technique is intended for patients with terminal heart failure who ended different pharmacological and invasive therapeutic resources available.

Currently, academic centers that offer the possibility of long-term LVAD support are organized unicentric in order to centralize specialized care for these patients.

Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected to ensure an acceptable survival.

However, practices vary considerably from one center to another in particular regarding:

Implantation indications,
Pre-implantation patient assessment,
Monitoring,
Implementation of pharmacological treatments, particularly anticoagulants or betablockers.

ipd_sharing_description: ND


acronym: FIBROFRANCE

summary:
"Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and primary liver cancer) is 15,000 per year in France. These mortality increases, despite that advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10 years before the onset of complications and cancer. The main goals of the FIBROFRANCE project which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis screening in French people.

The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications among the 186 publications of our group since 1986 in the field of liver fibrosis. These publications included discovery and validation of non-invasive biomarkers (Poynard Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002, Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the biochemical and clinical part in connection with national and international networks. Several panels have been identified and the most predictive FibroTest has been patented (US Patent Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis and cancer.

FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL, EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France in chronic hepatitis C. Several factors of fibrosis progression can be present in the same subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic screenng strategy can be conducted without taking into account the Interdependence of the different risk factors. Three biomarkers of fibrosis-associated liver injuries have been developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts already used for diagnostic validation will be followed at long term for prognostic validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific risks of fibrosis progression imputable to steatosis and steatohepatitis.

ReferenceCitation: Maisonnasse P, Poynard T, Sakka M, Akhavan S, Marlin R, Peta V, Deckmyn O, Ghedira NB, Ngo Y, Rudler M, van der Werf S, Marot S, Thabut D, Sokol H, Housset C, Combes A, Le Grand R, Cacoub P. Validation of the Performance of A1HPV6, a Triage Blood Test for the Early Diagnosis and Prognosis of SARS-CoV-2 Infection. Gastro Hep Adv. 2022;1(3):393-402. doi: 10.1016/j.gastha.2021.12.009. Epub 2022 Feb 7.

ReferenceCitation: Poynard T, Deckmyn O, Rudler M, Peta V, Ngo Y, Vautier M, Akhavan S, Calvez V, Franc C, Castille JM, Drane F, Sakka M, Bonnefont-Rousselot D, Lacorte JM, Saadoun D, Allenbach Y, Benveniste O, Gandjbakhch F, Mayaux J, Lucidarme O, Fautrel B, Ratziu V, Housset C, Thabut D, Cacoub P. Performance of serum apolipoprotein-A1 as a sentinel of Covid-19. PLoS One. 2020 Nov 20;15(11):e0242306. doi: 10.1371/journal.pone.0242306. eCollection 2020.

ReferenceCitation: Poynard T, Peta V, Deckmyn O, Pais R, Ngo Y, Charlotte F, Ngo A, Munteanu M, Imbert-Bismut F, Monneret D, Housset C, Thabut D, Valla D, Boitard C, Castera L, Ratziu V; FLIP consortium, the FibroFrance Group, the EPIC-3 program and the QUID-NASH group. Performance of liver biomarkers, in patients at risk of nonalcoholic steato-hepatitis, according to presence of type-2 diabetes. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):998-1007. doi: 10.1097/MEG.0000000000001606.

ReferenceCitation: Poynard T, Peta V, Deckmyn O, Munteanu M, Moussalli J, Ngo Y, Rudler M, Lebray P, Pais R, Bonyhay L, Charlotte F, Thibault V, Fartoux L, Lucidarme O, Eyraud D, Scatton O, Savier E, Valantin MA, Ngo A, Drane F, Rosmorduc O, Imbert-Bismut F, Housset C, Thabut D, Ratziu V; HECAM-FibroFrance Group. LCR1 and LCR2, two multi-analyte blood tests to assess liver cancer risk in patients without or with cirrhosis. Aliment Pharmacol Ther. 2019 Feb;49(3):308-320. doi: 10.1111/apt.15082. Epub 2018 Dec 19.

ReferenceCitation: Munteanu M, Pais R, Peta V, Deckmyn O, Moussalli J, Ngo Y, Rudler M, Lebray P, Charlotte F, Thibault V, Lucidarme O, Ngo A, Imbert-Bismut F, Housset C, Thabut D, Ratziu V, Poynard T; FibroFrance Group. Long-term prognostic value of the FibroTest in patients with non-alcoholic fatty liver disease, compared to chronic hepatitis C, B, and alcoholic liver disease. Aliment Pharmacol Ther. 2018 Nov;48(10):1117-1127. doi: 10.1111/apt.14990. Epub 2018 Oct 17.

ReferenceCitation: Poynard T, Munteanu M, Charlotte F, Perazzo H, Ngo Y, Deckmyn O, Pais R, Mathurin P, Ratziu V; FLIP consortium, the FibroFrance-CPAM group; FibroFrance-Obese group. Impact of steatosis and inflammation definitions on the performance of NASH tests. Eur J Gastroenterol Hepatol. 2018 Apr;30(4):384-391. doi: 10.1097/MEG.0000000000001033.

ReferenceCitation: Poynard T, Pham T, Perazzo H, Munteanu M, Luckina E, Elaribi D, Ngo Y, Bonyhay L, Seurat N, Legroux M, Ngo A, Deckmyn O, Thabut D, Ratziu V, Lucidarme O; FIBROFRANCE-HECAM. Real-Time Shear Wave versus Transient Elastography for Predicting Fibrosis: Applicability, and Impact of Inflammation and Steatosis. A Non-Invasive Comparison. PLoS One. 2016 Oct 5;11(10):e0163276. doi: 10.1371/journal.pone.0163276. eCollection 2016.


title: Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

summary: Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

ReferenceCitation: Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36.

ReferenceCitation: Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prévention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2. Erratum in: Gut. 2012 Mar;61(3):472.

location_facility: Hôpital COCHIN Service d'Hépato-Gastro-Entérologie

intervention_type: Drug


title: Prevalence of Mental Disorder and Somatic Co-morbidities Among Asylum Seekers in Marseille

acronym: PREMENTADA

summary:
Introduction : World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. Thus, it recommends distinguishing refugees from asylum seekers. Asylum seekers are migrants who recently arrived in their host country and whose administrative situation is being examined. They do not have the same access to health care or the same rights as refugees.

In France in 2021, 78,372 major people filled a first asylum application, a 26.4% increase compared to 2020 Regarding the mental health of exiles, a literature review informs us that 31.5% of them suffer from post-traumatic stress disorder (PTSD), 31.5% from depression and 11.1% from anxiety disorders. However, these data are taken from studies that do not make a distinction between refugees and asylum seekers These missing data are a hindrance to the development of efficient strategies for the management of these populations within the health systems of Western countries.

The primary objective of this study was to describe the health status of asylum seekers who have recently arrived in their Western host country. The secondary objective was to investigate potential explanatory factors for the health status of asylum seekers.

Method: Single-center, cross-sectional, observational epidemiological study. The Refugee health screener (RHS15) questionnaire and the Cumulative Illness Rating Scale (CIRS) will be administered by a trained interviewer to each patient included on the day of their inclusion, in the asylum seekers reception platform (PADA).Potential use of tobacco, existence of an adapted treatment in case of a detected pathology and certain socio-demographic data will also be collected.

A telephone interpreting service will be used in the case of an allophone patient whose spoken language is not spoken by the interviewer. Each patient included will have an appointment to perform a standardised blood and urine sample.

Benefits : PREMENTADA study will provide a better understanding of the health status of the population of asylum seekers in France. As the existence of data is a prerequisite for evidence-based medicine, we notice the lack of previous studies specifically addressing this population in France.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

summary: The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

status: Recruiting

location_facility: Service médecine foetale-Hôpital Trousseau

intervention_type: Procedure

status_simplified: Ongoing


title: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)

acronym: AlgoDARPEF

summary: Pain is common following surgery in children. Currently, no recent review of pain profiles at home has been performed on pediatric population in France following general surgery in children. The aim of this study is to evaluate the duration and severity of pain felt by children using a mobile phone application. All children operated in the different centers and leaving home will be included in the study. Children's pain scores will be measured using PPMP-SF scale (Postoperative Pain Measure for Parents Short Form). Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected. The expected results are an inventory's objective observation of postoperative pain profiles at home following the different pediatric surgeries in France. The study will also highlight the different risk factors of postoperative pain (type of surgery, parental causes, reasons due to the child, medical causes).

ReferenceCitation: Walrave Y, Carles M, Evain JN, Ikonomoff T, Marie A, Ludot H, Bourdaud N, Kern D, Lejus-Bourdeau C, Orliaguet G, Rosello O, Ecoffey C, Savoldelli C, Perissier C, Delacquis M, Varé B, Donzeau D, Cousin C, Langlais E, Breaud J, Jonckheer K, Dadure C, De la Brière F; Association of French Pediatric Anaesthesia and Intensive Care Medicine (ADARPEF). A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Pain. 2022 Nov 1;163(11):2224-2231. doi: 10.1097/j.pain.0000000000002620. Epub 2022 Mar 1.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaaux Pédiatriques de Nice CHU-Lenval


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.

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.

ipd_sharing_description: NC


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


title: Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

summary:
For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th.

Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7).

In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak.

As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

ReferenceCitation: Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.

acronym: MEDIAGENE

summary:
More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.

Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.

The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.

Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.

primary_purpose: Prevention

lead_sponsor: University Hospital, Brest

location_facility:
Institut du Thorax Nantes
Hôpital La Timone Marseille
Hôpital Saint Philibert
CHU de la Côte de Nacre Caen
CHRU de Brest
Hôpital Sud Amiens
Faculté de médecine Toulouse

intervention_type: Genetic


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, Amélineau 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.


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.

study_start_date_type: Anticipated

status: Withdrawn


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).

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


title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).

acronym: CHECK-TOP

summary:
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.

The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.

The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.

In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.

To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.

The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.

This is a monocentric observational study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study

acronym: covid19 fai2r

summary:
Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.

This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.

ReferenceCitation: Truchetet ME, Drumez E, Barnetche T, Martin C, Devaux M, Goulenok T, Maria A, Schmidt J, Abdallah NA, Melki I, Hachulla E, Richez C. Outcome of COVID-19 in patients with rheumatic and inflammatory diseases treated with mycophenolic acid: data from the French RMD COVID-19 cohort. RMD Open. 2022 Sep;8(2). pii: e002476. doi: 10.1136/rmdopen-2022-002476.

ReferenceCitation: Avouac J, Drumez E, Hachulla E, Seror R, Georgin-Lavialle S, El Mahou S, Pertuiset E, Pham T, Marotte H, Servettaz A, Domont F, Chazerain P, Devaux M, Claudepierre P, Langlois V, Mekinian A, Maria ATJ, Banneville B, Fautrel B, Pouchot J, Thomas T, Flipo RM, Richez C; FAI2R/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors; FAIR/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases treated with rituximab: a cohort study. Lancet Rheumatol. 2021 Jun;3(6):e419-e426. doi: 10.1016/S2665-9913(21)00059-X. Epub 2021 Mar 25.

ReferenceCitation: FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2021 Apr;80(4):527-538. doi: 10.1136/annrheumdis-2020-218310. Epub 2020 Dec 2.


title: Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

acronym: FENTANYLIN

summary: The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Epidémiologie Des Gestes Douloureux ou Stressants Chez Les Nouveau-nés Pris en Charge Dans Les unités de réanimation néonatale et pédiatrique et Par Les équipes de SMUR de la région d'Ile de France

acronym: EPIPPAIN

summary:
Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years.

Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared.

The objectives of the present study are:

To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale.
To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011.
To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France.
To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units
To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units
To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results

ReferenceCitation: Carbajal R, Lode N, Ayachi A, Chouakri O, Henry-Larzul V, Kessous K, Normand A, Courtois E, Rousseau J, Cimerman P, Chabernaud JL. Premedication practices for tracheal intubation in neonates transported by French medical transport teams: a prospective observational study. BMJ Open. 2019 Nov 14;9(11):e034052. doi: 10.1136/bmjopen-2019-034052.

ReferenceCitation: Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfèvre C, Lagarde A, Sgaggero B, Guiot C, Goussot M, Huraux E, Nanquette MC, Butel C, Ferreira AM, Lacoste S, Séjourné S, Jolly V, Lajoie G, Maillard V, Guedj R, Chappuy H, Carbajal R. The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. 2016 May;57:48-59. doi: 10.1016/j.ijnurstu.2016.01.014. Epub 2016 Feb 8.

lead_sponsor: Hôpital Armand Trousseau

location_facility: Hôpital Armand Trousseau. Service de Réanimation Pédiatrique

location_facility: Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale

location_facility: Centre Hospitalier René Dubos. Service de réanimation néonatale

location_facility: Hôpital Victor Dupouy. Service de réanimation néonatale

location_facility: CHI Créteil. Service de réanimation néonatale

location_facility: Hôpital de Meaux. Service de réanimation néonatale

location_facility: Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale

location_facility: Hôpital Louis Mourier. Service de réanimation néonatale

location_facility: Hôpital du Sud Francilien. Service de réanimation néonatale

location_facility: Hôpital Robert Debré. Service de réanimation néonatale

location_facility: Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale

location_facility: CHI André Grégoire. Service de réanimation néonatale

location_facility: Hôpital Delafontaine. Service de réanimation néonatale

location_facility: Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale

location_facility: Hôpital Cochin-Port Royal. Service de médecine néonatale

location_facility: Hôpital Antoine Béclère. Service de réanimation néonatale


title: Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France

acronym: IDECAB

summary:
In the Somme region of France, cancer registry data showed an increasing incidence of oral cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve early detection for smokers will be assessed. This target population consults late (as 70% of oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative incentive strategy for screening among general practitioners based on unusual information vectors (tobacconist, local media).

The main objective of this study is a screening of oral cavity cancers in tobacco users aged 30-75 years in the Somme region of France.

ReferenceCitation: Bailey EE, Marghoob AA, Orengo IF, Testa MA, White VR, Geller AC. Skin cancer knowledge, attitudes, and behaviors in the salon: a survey of working hair professionals in Houston, Texas. Arch Dermatol. 2011 Oct;147(10):1159-65. doi: 10.1001/archdermatol.2011.184.

ReferenceCitation: Subramanian S, Sankaranarayanan R, Bapat B, Somanathan T, Thomas G, Mathew B, Vinoda J, Ramadas K. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India. Bull World Health Organ. 2009 Mar;87(3):200-6.

ReferenceCitation: Epstein JB, Silverman S Jr, Epstein JD, Lonky SA, Bride MA. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence and toluidine blue. Oral Oncol. 2008 Jun;44(6):538-44. Epub 2007 Nov 8. Erratum in: Oral Oncol. 2008 Jun;44(6):615.

ReferenceCitation: Hubert A, Lapôtre B, Raverdy N, Ganry O. Incidence et mortalité 2002-2004 Evolution de 1982 à 2004. Registre du Cancer de la Somme. Juin 2009. 138 p.

ReferenceCitation: Réseau Francim, service de biostatistique des hospices civils de Lyon. Survie des patients atteints de Cancer en France : étude des registres du réseau Francim, Paris 2007, springer, 406

ReferenceCitation: Reyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse

acronym: AdjuMel

summary: This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.

status: Active, not recruiting

lead_sponsor: Bristol-Myers Squibb


title: Optimized Rehabilitation After Anterior Cruciate Ligament Reconstruction at the First Step of Return to Sport

acronym: ORACL-Run

summary:
Following reconstruction of the anterior cruciate ligament (ACL), a standardized rehabilitation protocol is carried out by a physiotherapist. In France, a well-established rehabilitation consensus guides the first phase of 3 months postoperatively and patient compliance is generally excellent. The next phase should allow a return to sport (RTS) following a continuum depending on the objectives of the sport's patient, starting with a return to running activities (RTR) and a preparatory phase for a RTS which may be authorized at 6 months post-op.

This multicentre randomized control trial aims to evaluate the effectiveness of an individualized and optimized rehabilitation program guided by monthly assessments carried out by physiotherapists from the 3rd to the 6th month postoperatively to reduce the risk of new ACL injuries (operated or healthy knee), compared to standard management.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country: France Switzerland

location_facility:
Hôpital de la Tour
Medipole de Savoie
Hopital de La Croix Rousse
Clinique de La Sauvegarde
CHU de Saint-Etienne
Centre Hospitalier de Firminy


title: The Use of Complementary Medicine in Palliative/Supportive Care Centres in Lyon, France

summary:
Palliative care centres in Lyon, France as well as the disclosure of Complementary and Alternative Medicine and conventional healthcare use to conventional and Complementary and Alternative Medicine practitioners respectively.

These aims will be achieved through the following objectives:

Describe the prevalence of Complementary and Alternative Medicine practitioner and product use in the outpatient population of palliative care centres in Lyon, France
Describe the characteristics of Complementary and Alternative Medicine users the outpatient population of palliative care centres in Lyon, France
Estimate the Complementary and Alternative Medicine expenditure of the outpatient population of palliative care centres in Lyon, France
Describe the rates of disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France
Describe the reasons for disclosure or non-disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France

location_facility: Service E.M.S.P. Groupement Hospitalier Nord - Hôpital de la Croix-Rousse

location_facility: Centre de Soins Palliatifs Lyon-Sud Pavillon 1K - Centre Hospitalier Lyon-Sud

location_facility: USP de Charmettes - Croix rouge française


title: Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study

acronym: OSTEOPAL

summary:
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology

acronym: PEDONCOVID

summary: Since the description of the first cases of infection in December 2019 in the Hubei province in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged and caused a pandemic. This new virus is responsible for an infectious disease with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The first data concerned essentially the adult population and gave a clinical description of the disease. However, data is missing in the pediatric population. The first published studies indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the case of a child with leukemia recently described with the diagnosis of COVID-19, there is currently no data about pediatric patients with an oncology history or under chemotherapeutic drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a year in France. Malignant tumor or its treatment can affect self-immunity, which could favor SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to collect data about French children with a cancer and diagnosed with COVID-19.The analysis of the collected data will refine clinical characteristics of SARS-CoV-2 infection in this population. It will be critical for elaborating recommendations for the management of COVID-19 in children with cancer.

lead_sponsor: University Hospital, Caen


title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity

acronym: METHACAN

summary:
Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.

ReferenceCitation: Boesen K, Paludan-Müller AS, Gøtzsche PC, Jørgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2:CD012857. doi: 10.1002/14651858.CD012857.pub2. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

summary: We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

ReferenceCitation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.


type: Registry Identifier

title: RApid Fluid Volume EXpansion (RVE) in Critically Ill Patients With Acute Circulatory Failure After the Initial Phase of Resuscitation. A Single-center, Open-label, Randomized Study Comparing 3 Strategies of RVE in Orléans, France.

acronym: RAVEXO

summary: Rapid volume expansion using repeated intravenous fluid boluses is a very common intervention performed in the intensive care unit (ICU) in the early days of resuscitation of patients with shock. Once passed the initial phase of resuscitation, the fluid boluses administered fail to effectively increase the patients' cardiac output in about 50% of cases. Pulse pressure changes or stroke volume changes induced by a Passive Leg Raising (PLR) test have acceptable/good ability to predict fluid responsiveness (in terms of cardiac output change) and may be systematically used in patients with persistent shock with the aim of limiting the total amount of fluid administered to patients by avoiding undue fluid boluses. One may suppose that such a volume expansion management policy could impact morbidity and mortality of shocked patients. Among the predictive indices available in clinical practice, the PLR test has the advantages of being usable regardless of the patients' respiratory status and cardiac rhythm. Changes in left ventricular stroke volume during the PLR test perform better that changes in pulse pressure to predict fluid responsiveness. However, in counterpart, pulse pressure changes during PLR can be assessed without the need of other hemodynamic exploration such central venous pressure measurement or cardiac output monitoring. The investigators hypothesized that strategies using either stroke volume changes or pulse pressure changes induced by the PLR test to decide wether a fluid bolus clinically deemed indicated should or should not be administered, may limit the amount of fluid received by the patients during the first 5 days of shock, improve their oxygenation index, and shorten the time passed under mechanical ventilation, as compared to a "liberal" strategy (usual care) that does not use predictive indices of fluid responsiveness.

ReferenceCitation: Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. Erratum in: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe].

ReferenceCitation: Annane D, Sebille V, Duboc D, Le Heuzey JY, Sadoul N, Bouvier E, Bellissant E. Incidence and prognosis of sustained arrhythmias in critically ill patients. Am J Respir Crit Care Med. 2008 Jul 1;178(1):20-5. doi: 10.1164/rccm.200701-031OC. Epub 2008 Apr 3.

ReferenceCitation: Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive Care Med. 2007 Apr;33(4):575-90.

ReferenceCitation: Benes J, Chytra I, Altmann P, Hluchy M, Kasal E, Svitak R, Pradl R, Stepan M. Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14(3):R118. doi: 10.1186/cc9070. Epub 2010 Jun 16.

ReferenceCitation: Boulain T, Achard JM, Teboul JL, Richard C, Perrotin D, Ginies G. Changes in BP induced by passive leg raising predict response to fluid loading in critically ill patients. Chest. 2002 Apr;121(4):1245-52.

ReferenceCitation: Boulain T, Garot D, Vignon P, Lascarrou JB, Desachy A, Botoc V, Follin A, Frat JP, Bellec F, Quenot JP, Mathonnet A, Dequin PF; Clinical Research in Intensive Care and Sepsis Group. Prevalence of low central venous oxygen saturation in the first hours of intensive care unit admission and associated mortality in septic shock patients: a prospective multicentre study. Crit Care. 2014 Nov 6;18(6):609. doi: 10.1186/s13054-014-0609-7.

ReferenceCitation: Boulain T, Boisrame-Helms J, Ehrmann S, Lascarrou JB, Bougle A, Chiche A, Lakhal K, Gaudry S, Perbet S, Desachy A, Cabasson S, Geneau I, Courouble P, Clavieras N, Massanet PL, Bellec F, Falquet Y, Reminiac F, Vignon P, Dequin PF, Meziani F. Volume expansion in the first 4 days of shock: a prospective multicentre study in 19 French intensive care units. Intensive Care Med. 2015 Feb;41(2):248-56. doi: 10.1007/s00134-014-3576-1. Epub 2014 Dec 2.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility: Centre Hospitalier Régional d'Orléans, France


title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a Retinoic Acid Receptor Gamma (RARγ)-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

lead_sponsor: Clementia Pharmaceuticals Inc.

type: EudraCT Number

source: euctr

ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

location_facility: Hôpital Necker-Enfants Malades, Department of Genetics

summary:
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement.

In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP in France.


title: Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations

acronym: MARC

summary: Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.

lead_sponsor: Da Volterra

location_facility: Centre d'épidémiologie et de santé publique des armées


title: Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

summary: The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

lead_sponsor: NicOx

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Groupe Hospitalier La Pitié Salpêtrière-Charles Foix


title: Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.

summary:
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.

Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.

location_facility: Service Urgence et Réanimation Pédiatrique Hôpital Femme Mère Enfant Groupement Hospitalier Est


title: Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare

summary:
Primary lymphedema is a chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2015 on patients with primary lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. The investigators will combine concentration curves and concentration indices to assess the distributive effects.

ReferenceCitation: Mercier G, Pastor J, Clément V, Rodts U, Moffat C, Quéré I. Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema. PLoS One. 2019 May 8;14(5):e0216386. doi: 10.1371/journal.pone.0216386. eCollection 2019.

lead_sponsor: University Hospital, Montpellier


title: HIV Prevention in France : "Dat'AIDS Prevention"

summary: DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France including overseas, aiming to describe HIV prevention in every aspect including HIV screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure prophylaxis

lead_sponsor: DatAids

location_country: France Guadeloupe Martinique

location_facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

location_facility: Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille

location_facility: Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon

location_facility: Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille


title: Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists

acronym: DOSE RPW-CRI

summary:
The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.

The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry

acronym: LysoNeo

summary:
The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. Based on our previous pilot study (2011) assessing MCAD and PKU using tandem mass spectrometry-based method in Normandie region in which informed consents have been signed for all newborns (43,000) but we are expecting a great willingness to participate to this project. Thus, we are aiming to include 100,000 newborns, and the study will be continued until we reach at least this target.

The primary objective is to evaluate the epidemiology of MPS1 and Pompe disease using dried blood samples in the first cohort of neonates tested in France (Normandie region).

lead_sponsor: University Hospital, Rouen

location_facility:
Caen University Hospital
Rouen University Hospital


title: Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France

summary: After 7 then 13 valent pneumococcal conjugate vaccine implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Definition of the Target Population for Xarelto's New Indications in Connection With the VOYAGER PAD Study

acronym: PADELTO

summary:
This is a study to learn more about French patients who have peripheral artery disease (PAD) and who have had a revascularization procedure. With this procedure, doctors use surgery or a thin tube (called a catheter) to open a narrow or blocked blood vessel in the lower limbs.

In a previous Bayer trial called VOYAGER PAD, researchers studied Xarelto in participants with PAD who had recently had a revascularization procedure in their lower leg. The researchers studied how well Xarelto worked and how safe it was in these participants.

Based on the results of the VOYAGER PAD trial, the researchers in this study want to learn the number of patients with PAD who had a revascularization procedure in France from January 1st, 2016 to December 31st, 2019. This can help the researchers learn more about the target population (a specific group of people) who could potentially receive treatment with Xarelto.

Xarelto is available for doctors in France to prescribe to patients who have the following conditions:

to reduce the risk of another heart attack or of dying from a disease related to the heart or the blood vessels in adults with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) who have had an increase in certain cardiac blood tests
to reduce the risk of getting blot clots (atherothrombotic events) in adults at a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms
to prevent blood clots in the veins after a hip or knee replacement operation in adults
to prevent blood clots in brain (stroke) and other blood vessels in the body in adults who have a form of irregular heart rhythm called non-valvular atrial fibrillation
to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of the legs and/or lungs in adults
to treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs in full-term newborn babies, infants and toddlers, children and adolescents below 18 years following an initial treatment of at least 5 days with injectable medicines used to treat blood clots

All the patients in this study will have PAD in their lower leg. They will all have had a revascularization procedure during a hospital stay in France between January 1st, 2016 and December 31st, 2019. The researchers will collect the patients' health data from the French National Health Insurance (NHI) hospital discharge database (PMSI). The researchers will look at the health data from all patients with PAD who had a revascularization procedure and also patients who could have joined the VOYAGER PAD trial. This group will not include any patients who have health conditions other than PAD.

The researchers will review each patient's medical records until December 31st, 2019 or earlier if the patient has died. The researchers will also look at any previous medical records from the date of each patient's revascularization procedure back to January 1st, 2014. The researchers will use these medical records to look for any health conditions other than PAD that the patients may have had before their revascularization procedure after January 1st 2016.

The main question the researchers want to answer in this study is: how many patients with PAD had a revascularization procedure between January 1st, 2016 and December 31st, 2019?

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer


title: Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study

acronym: ADDICT-CCU

summary:
Background:

Illicit drug use is a growing issue in Europe and leading cause of acute cardiac events in patients admitted to intensive cardiac care units. Indeed, cardiovascular complications are one of the main causes of death due to illicit drug use. However, its prevalence in patients hospitalized in intensive cardiac care units is unknown.

Objectives:

This large multicenter prospective study will assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Eligibility:

Patient over 18 years old admitted to intensive Cardiac Care Unit (CCU) for any reason.
Without hospitalization for a planned interventional procedure.
Without hospitalization for more than 24 hours at any hospital facility before admission to the CCU.

Design:

Multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of illicit drug use in 40 centers throughout France.
Participants will be screened with a physical exam, medical history and addiction survey.
Participants will be screened for drug use by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) and for tobacco by standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK).
Participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.


title: Psychological Impact of Confinement on the Adult Population Followed in Outpatient Psychiatry at EPS Ville Evrard: Three-month Longitudinal Clinical Evaluation

acronym: IMPA

summary: This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.

lead_sponsor: Centre hospitalier de Ville-Evrard, France


title: Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018

acronym: IPNSAE

summary: This study aims to provide an estimate of the incidence of paraneoplastic neurological syndromes and autoimmune encephalitides in France between the years 2016 and 2018. The study will describe the incidence of antibody subtypes and regional variations.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes


title: Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool

acronym: DISPOSE

summary:
The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive, such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no single reference method to detect the H. pylori infection reliably and accurately. The specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at least two tests should agree when defining the H. pylori infection in children. Quantitative real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most reliable for H. pylori detection in adults and in children. In children, the reference method for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori antigen in stools could use a quick one-step immuno-chromatographic technique.

The aim of this study was to assess the performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the detection of H. pylori infection in children.

lead_sponsor: Lille Catholic University