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.

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

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.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories:
HAL
PubMed Central
medRxiv

repositories_concat: HAL;PubMed Central;medRxiv

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

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

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.

oa_colors: green hybrid

evidence: open (via page says license)

publisher_dissemination: Wolters Kluwer Health

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.

evidence: open (via crossref license)

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.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL


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.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

lead_sponsor_type: academique

status_simplified: Completed


title: Observational Study of Bilateral Upper Limb Amputees in France

acronym: ARMOBS

summary:
In France, there is currently no data to directly estimate the number of bilateral upper limb amputations, their characteristics and therapeutic care.

By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR) Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of amputees patients referred by orthopaedic centres in the United Kingdom , whose population's characteristics are similar to France) identified 395 incident cases of upper limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or related to diabetes. The population was relatively young, aged between 15 and 54 year old.

On this basis, the estimated number of new cases of bilateral upper limb amputations throughout France should therefore be about 40 incident cases over a 5-year period.

This observational study is aimed at collecting comprehensive and high quality data to describe the French population of bilateral upper limb amputees.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot

intervention_type: Other

status_simplified: Unknown


title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

acronym: Cartipatch

summary: Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Brest

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

location_facility: Orthopaedic surgery Departement Brest University Hospital

location_facility: Centre médico chirurgical de Dracy-Le-Fort

intervention_type: Procedure


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

ReferenceType: background

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.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: Other Grant/Funding Number

title: Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

acronym: FraLusoPark

summary:
Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is classically characterized by a symptomatic triad that includes rest tremor, akinesia and hypertonia and although the motor expression of the symptoms involves mainly the limbs, the muscles implicated in speech production are also subject to specific dysfunctions. Motor speech disorders, so-called dysarthria, can thus be developed by PD patients. The main objective of our project is to evaluate the physiological parameters (acoustics), perceptual markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree of impairment of such parameters should be associated with the pathology and be present universally in all patients, even if they speak different languages; that should be also the case of prosodic markers, whereas impairment of speech intelligibility may participate to the psychosocial impact in communication alteration.

PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60). Their global motor disability will be assessed with dedicated clinical rating scales, without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched volunteers will provide the normal reference for between-group comparisons. Along with the off and on medication clinical examinations, several speech tasks will be recorded. Moreover, speech organ functions will also be assessed during the same examination. The psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a posteriori, as well as the speech intelligibility evaluation, and both will strengthen the overall speech assessments. This global investigation will represent a unique opportunity to provide the most precise and reliable description of PD patients' speech and its impacts on intelligibility and quality of life. Challenging and interdisciplinary aspects are combined in our project, which original cross-linguistic approach involves an international collaboration definitely new in the field of motor speech disorders.

ReferenceType: derived

ReferenceCitation: Pinto S, Cardoso R, Sadat J, Guimaraes I, Mercier C, Santos H, Atkinson-Clement C, Carvalho J, Welby P, Oliveira P, D'Imperio M, Frota S, Letanneux A, Vigario M, Cruz M, Martins IP, Viallet F, Ferreira JJ. Dysarthria in individuals with Parkinson's disease: a protocol for a binational, cross-sectional, case-controlled study in French and European Portuguese (FraLusoPark). BMJ Open. 2016 Nov 17;6(11):e012885. doi: 10.1136/bmjopen-2016-012885.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Repositório Científico de Acesso Aberto de Portugal - Repositório Comum

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
comum.rcaap.pt

repositories_concat: HAL;PubMed Central;comum.rcaap.pt

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: Undecided

ipd_sharing_description: Undecided

lead_sponsor: Centre National de la Recherche Scientifique, France

collaborators: Instituto de Medicina Molecular João Lobo Antunes

location_country: Portugal France

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


title: Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities

acronym: PerceptR

summary: The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. To achieve this goal, a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCWs is proposed. This study will be planned in 60 different HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.

time_perspective: Cross-Sectional

ReferenceCitation: Vaillant L, Birgand G, Esposito-Farese M, Astagneau P, Pulcini C, Robert J, Zahar JR, Sales-Wuillemin E, Tubach F, Lucet JC; PerceptR Study group. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey. Antimicrob Resist Infect Control. 2019 Nov 12;8:173. doi: 10.1186/s13756-019-0625-0. eCollection 2019.

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

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

version: submittedVersion

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

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

repositories:
HAL
PubMed Central
spiral.imperial.ac.uk

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris


acronym: OFICE

summary:
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.

status: Recruiting

ReferenceCitation: Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.

repositories_concat: PubMed Central

ReferenceCitation: Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.

status_simplified: Ongoing


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.

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfevre C, Lagarde A, Sgaggero B, Guiot C, Goussot M, Huraux E, Nanquette MC, Butel C, Ferreira AM, Lacoste S, Sejourne 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.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Hôpital Armand Trousseau

location_facility: Hôpital de Meaux. Service de réanimation néonatale

location_facility: Hôpital Delafontaine. Service de réanimation néonatale

location_facility: Hôpital Antoine Béclère. Service de réanimation néonatale

location_facility: Hôpital Armand Trousseau. Service de Réanimation Pédiatrique

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

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

location_facility: Hôpital Louis Mourier. Service de réanimation néonatale

location_facility: CHI Créteil. Service de réanimation néonatale

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

location_facility: Hôpital Victor Dupouy. Service de réanimation néonatale

location_facility: Centre Hospitalier René Dubos. Service de réanimation néonatale

location_facility: Hôpital Robert Debré. Service de réanimation néonatale

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

location_facility: CHI André Grégoire. Service de réanimation néonatale

location_facility: Hôpital du Sud Francilien. Service de réanimation néonatale

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


type: Other Identifier

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.

primary_purpose: Prevention

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. doi: 10.2471/blt.08.053231.

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. doi: 10.1016/j.oraloncology.2007.08.011. 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

collaborators: Regional Observatory of Health and Social Issues in Picardie (OR2S)

collaborators: Association for the screening of diseases in Somme (Adema 80)


title: Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism

acronym: MOTHYRE

summary:
"Early paediatric Basedow disease is one of the rare endocrine diseases for which the Reference Centre for Rare Endocrine Growth Diseases, was approved by the Ministry of Health in 2005. In addition, the study will benefit from the expertise of public Health France (SFP). This study is therefore part of the missions of these partners (reference centre for endocrine growth diseases and Public Health France).

For several years, our group has been interested in defining the evolutionary profile of these patients. A national study on short- and long-term patient follow-up has already been conducted, which has been the subject of two international publications29,30, as well as a study on a specific clinical form of the disease 24. This work was made possible thanks to the collaboration of paediatric clinical centres within the Reference Centre and Competence Centre for Rare Endocrine Diseases Network. The present study planned in France will make it possible to accurately characterize the care pathway and the frequency of complications associated with it at the national level.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Le Moal J, Chesneau J, Goria S, Boizeau P, Haignere J, Kaguelidou F, Leger J. Spatiotemporal variation of childhood hyperthyroidism: a 10-year nationwide study. Eur J Endocrinol. 2022 Oct 3;187(5):675-683. doi: 10.1530/EJE-22-0355. Print 2022 Nov 1.

publisher_dissemination: Oxford University Press


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

lead_sponsor_type: industriel


title: Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia

acronym: ANI-LOOP

summary: Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.

lead_sponsor: University Hospital, Lille

intervention_type: Device


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: USP de Charmettes - Croix rouge française

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

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


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: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

summary: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

intervention_type: Drug


type: Registry Identifier

title: French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

acronym: DUPILAB

summary: This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number: 2500021
Investigational Site Number: 2500006
Investigational Site Number: 2500016
Investigational Site Number: 2500026


title: Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.

acronym: EFFICARD

summary:
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.

The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.

This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.

The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.

The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.

design_allocation: Non-Randomized

primary_purpose: Health Services Research


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: 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, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche 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. doi: 10.1001/jama.288.7.862. 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. doi: 10.1007/s00134-007-0531-4.

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. doi: 10.1378/chest.121.4.1245.

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: 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: Groupe Hospitalier La Pitié Salpêtrière-Charles Foix

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


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, Clement V, Rodts U, Moffat C, Quere 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.

repository_institution: Nottingham Trent Repository - Nottingham Trent University's Institutional Repository

version: acceptedVersion

evidence: oa repository (semantic scholar lookup)

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

publisher_dissemination: Public Library of Science

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: Guadeloupe Martinique France

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

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

location_facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

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

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

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

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


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).

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
University Hospital, Caen

location_facility:
Rouen University Hospital
Caen University Hospital


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

sponsor_collaborators:
Bayer
External supplier: HEVA


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: 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: 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.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation Coeur et Recherche


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.

study_start_date_type: Anticipated

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

sponsor_collaborators:
Lille Catholic University
Hôpital Cochin


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: Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry

acronym: ATLAS-FR

summary: The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

lead_sponsor: Stryker Neurovascular


title: A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France

acronym: PROACTIF

summary: The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France.

ReferenceCitation: Garin E, Pinaquy JB, Bailly C, Sengel C, Mariano-Goulart D, Edeline J, Blanc JF, Bouvier A, Tordo J, Rode A, Becker S, Sefrioui D, de Baere T, Somma C, Mastier C, Goupil J, Chevallier P, Regnault H, Vibert E, Manfredi S, Vicaut E, Patel B, Boucher E, Guiu B; PROACTIF registry group. Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France. Cardiovasc Intervent Radiol. 2022 Jan;45(1):1-11. doi: 10.1007/s00270-021-03002-0. Epub 2021 Nov 18.

oa_host_type: repository

repositories_concat: HAL

unpaywall_oa_status: green

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Biocompatibles UK Ltd

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Régional et Universitaire de Brest


title: Knowledges and Use of Cannabidiol in Older Adults Aged 65 Years and Over in France

summary: The use of non-medical cannabidiol (CBD) has been growing recently in France and in the world, in young but also older adults. Few data are available on the use of cannabidiol in older adults. A better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the CBD uptake in this population and avoid potential adverse events.

lead_sponsor: University Hospital, Toulouse


title: Ocular Biometric Measurements in Cataract Surgery Candidates in The South of France : a Multicenter Cross Sectional Study

summary: The investigators aimed to study ocular biometrics parameters and their association with age, gender and the prevalence of high myopia in a population of cataract surgery candidates in the South of France. The investigators also aimed to define proportion of an "usual eye" and know the rate of inhomogeneous eyes in our population.

ipd_sharing_description: NC


title: A Multi-Center Retrospective Chart Review Study Examining the Patient Characteristics, Treatment Patterns, Clinical Outcomes, and Burden of Illness Among Patients With Chronic Myeloid Leukemia in Third-line Treatment or With T315I Mutation in France (CML 3L+ & T315I)

summary: A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.

lead_sponsor: Novartis Pharmaceuticals


acronym: GRACE

summary: This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.

title: A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France

type: EudraCT Number

source: euctr


title: Descriptive and Prognostic Study of Arbovirus Infections in France, Based on a Hospital Cohort of Children and Adults With Suspected Arbovirose.

acronym: CARBO

summary: There are hundred of arbovirus which have been shown to cause disease in humans. Their most common clinical symptoms are algo-eruptive (dengue, chikungunya, zika), hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West Nile, Zika, dengue, Japanese encephalitis) or arthritic afflictions (Chikungunya, O'nyong nyong). Dengue is a mosquito-born viral disease caused by 4 different serotypes of virus. Dengue fever (DF) is defined by the sudden onset of fever with non-specific constitutional symptoms, recovery occurring spontaneously in 3 to 7 days. The infection can sometimes progress to dengue hemorrhagic fever (DHF) characterized by a transient increase in vascular permeability provoking a plasma leakage syndrome. DHF can be complicated by shock and internal hemorrhage. Other rarer complications include encephalitis, hepatitis, rhabdomyolysis and myocarditis. There is currently no way of predicting the outcome of DF or DHF and the WHO classification lacks sufficient sensitivity and specificity to recognize and guide the management of severe forms of dengue. The pathophysiology of these forms is also poorly known. Since 2000s, the French West Indies and Guiana have become hyperendemic for dengue with simultaneous circulation of the 4 serotypes, regular large outbreaks and severe dengue including fatalities. Chikungunya is a re-emerging virus causing massive epidemics in Africa, in the Indian Ocean and Southeast Asia. The first autochthonous cases were described in French Antilles in Nov 2013. The disease typically consists of an acute illness like dengue fever with abrupt onset of a high-grade fever followed by constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves in 4 to 6 weeks. However, severe clinical forms in early stage may appear and chronic clinical forms as incapacitating arthralgia which affect 40 to 60% of patients. In France, others arboviruses may cause severe emerging and re-emerging infectious diseases like Zika or West Nile. In non-immunized population these emerging diseases may cause outbreaks with specific severe clinical complications. The French interministerial mission on emerging infectious diseases coordinated by Professor Antoine Flahault, recommended such studies: large prospective multicenter cohort studies to characterize severe forms of arbovirus infections to seek predictive factors and to investigate the pathophysiology of the diseases.

ReferenceCitation: Bertolotti A, Thioune M, Abel S, Belrose G, Calmont I, Cesaire R, Cervantes M, Fagour L, Javelle E, Lebris C, Najioullah F, Pierre-Francois S, Roze B, Vigan M, Laouenan C, Cabie A; Chronic Chikungunya working group of University Medical Center of Martinique. Prevalence of chronic chikungunya and associated risks factors in the French West Indies (La Martinique): A prospective cohort study. PLoS Negl Trop Dis. 2020 Mar 12;14(3):e0007327. doi: 10.1371/journal.pntd.0007327. eCollection 2020 Mar.

evidence: oa repository (via page says license)

repository_normalized: bioRxiv

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repositories:
PubMed Central
bioRxiv

repositories_concat: PubMed Central;bioRxiv

repositories_institution:
Cold Spring Harbor Laboratory - bioRxiv
PubMed Central - Europe PMC

lead_sponsor: University Hospital Center of Martinique

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

location_country:
Réunion
Guadeloupe
French Guiana
Martinique
France

location_facility: Centre Hospitalier Universitaire de Martinique


title: Management of Osteoarticular Infection Due to Multidrug Resistant Mycobacterium Tuberculosis Strains in France

acronym: TboneR

summary: The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance strains (MDR IOATB). Given the lack of data regarding MDR IOATB, it may be helpful to study the diagnosis, medical treatment, surgical indications and prognosis of a cohort of MDR IOATB patients.


title: Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial

summary: Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

status: Not yet recruiting

lead_sponsor: Hotel Dieu University Hospital, France

intervention_type: Behavioral


title: Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study

acronym: DysM et SOC

summary: This study evaluates the relation between sens of coherence and primary dysmenorrhea. Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in Finistère (France).

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Lycée de l'Harteloire
Lycée Roz Glas
Lycée Brizeux
Lycée Jean-Marie Le Bris
Lycée du Léon
Lycée de l'Elorn


title: Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Peritoneal Carcinoma.

acronym: PIPAC-GRE

summary: The presence of peritoneal carcinomatosis indicates a neoplastic disease evolved. Without intervention, the prognosis is poor with survival of only a few months. Standard treatment is based on systemic chemotherapy, however, the pharmacokinetics of drug delivery to the peritoneum is poor, with limited efficacy compared to other metastatic sites such as the liver or lung. When the carcinomas are is resectable, selected patients can benefit from targeted therapeutic approaches combining peritonectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC), offering a significant improvement in survival. A new surgical technique has been developed for patients with unresectable Chemotherapy intraperitoneal aerosol spray (PIPAC). The objective is to improve the survival time, quality of life but can also make PC resectable and therefore accessible to complete excisional surgery. The cost of this treatment is not yet fully assessed in France. The main objective of this study is to assess the real cost of PIPAC in order to allow its dissemination.

lead_sponsor: University Hospital, Grenoble


title: Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France

acronym: MEDIP

summary:
Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from national population-based cohorts. The study aims to assess the frequency of different induction methods used in France from a prospective population-based cohort of women with an induced labor. Maternal, fetal and neonatal outcomes will be compared between the different induction methods. Moreover the adhesion to national clinical guidelines concerning the induction of labor will be studied from this population-based cohort.

Finally the women satisfaction will be assessed according to the induction method used.

ReferenceCitation: Blanc-Petitjean P, Schmitz T, Salome M, Goffinet F, Le Ray C; MEDIP Study Group. Target populations to reduce cesarean rates after induced labor: A national population-based cohort study. Acta Obstet Gynecol Scand. 2020 Mar;99(3):406-412. doi: 10.1111/aogs.13751. Epub 2019 Nov 19.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Jochum F, Le Ray C, Blanc-Petitjean P, Langer B, Meyer N, Severac F, Sananes N. Externally Validated Score to Predict Cesarean Delivery After Labor Induction With Cervi Ripening. Obstet Gynecol. 2019 Sep;134(3):502-510. doi: 10.1097/AOG.0000000000003405.

collaborators: Agence Nationale de sécurité du Médicament

location_facility: Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP


title: National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur

summary:
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.

The primary objective of this study is to evaluate the performance of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.

A total of 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.

status: Terminated

lead_sponsor: Hyprevention

location_facility:
Hôpital européen Georges-Pompidou
Hopital Tenon - AP-HP
CHU Toulouse
CHU Caen


title: Prospective, Single-center, Randomized, Open Label Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up, Strengthening an Obesity Program in Berry (FRANCE)

acronym: STROBERRY

summary: STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

primary_purpose: Supportive Care

lead_sponsor: Elsan


title: Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

acronym: LevoCV

summary: Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.

lead_sponsor: Central Hospital, Nancy, France


title: Strokecopilot: A Precision Medicine Tool in the Stroke Emergency

acronym: Strokecopilot

summary: Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service : Unité Neurovasculaire - CHU de Strasbourg - France


title: Assessment Using Microperimetry of the Risk of a Fellow Eye Progressing From Stage 3 to Stage 4 (AREDS Classification) Age-related Macular Degeneration (AMD)

acronym: PREVISION

summary:
Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central region of the retina responsible for discrimination between high spatial frequencies (reading), colour vision and the central visual field. The loss of visual acuity which occurs with the onset of AMD significantly affects patients' quality of life. In developed countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people suffer from this disease.

In the first stage of the disease it is known as age-related maculopathy (ARM). This early form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification) and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's progression.

It is therefore vital to adopt a strategy to assess the stage of the disease and provide the appropriate care management at the earliest possible stage. This is even more important for patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%.

Microperimetry is a promising new diagnostic method which combines measurements of light sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the functional assessment of retinal damage in patients with AMD, as it precisely correlates anatomical and functional modifications by measuring the loss of sensitivity and macular fixation. It has been shown that the more advanced the patient's AMD is, the further the parameters measured by microperimetry are from the norm.

The investigators want to assess the MAIA™ as a means of screening for AMD progression in patients with a high risk of progressing to a more advanced stage (patients presenting one eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS classification). The research hypothesis for our proposed study is that the parameters measured using microperimetry will already show abnormal results in the study eye prior to progressing to a more advanced stage of the disease. The use of these microperimetric parameters as predictor of progression would therefore make it possible to screen eyes likely to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide patients who need it with earlier follow-up, preventive treatment or adapted, personalized rehabilitation as appropriate.

sponsor_collaborators:
Hospices Civils de Lyon
Novartis


title: Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery

acronym: LipiDiet

summary:
Obesity is one of the greatest pandemics of the 21st century with 30 million new cases each year. In France each year, 60,000 bariatric surgery procedures are performed.

Many preoperative diets have been proposed in the literature with some studies giving positive results. But these diets are often strict and can have adverse effects on metabolism. Very few studies have described the PSMF diet. The hypothesis would be that this diet is associated with a reduction in liver volume with a reduction in steatosis.

location_facility: Service de chirurgie générale et digestive - CHU de Strasbourg - France


title: Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial

acronym: PASST

summary: Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.

ReferenceCitation: Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.

ReferenceCitation: Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.

ReferenceCitation: Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.

ReferenceCitation: Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.

ReferenceCitation: Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.

ReferenceCitation: Le Ray C, Rozenberg P, Kayem G, Harvey T, Sibiude J, Doret M, Parant O, Fuchs F, Vardon D, Azria E, Senat MV, Ceccaldi PF, Seco A, Garabedian C, Chantry AA; Groupe de Recherche en Obstetrique et Gynecologie. Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural. Am J Obstet Gynecol. 2022 Oct;227(4):639.e1-639.e15. doi: 10.1016/j.ajog.2022.07.025. Epub 2022 Jul 19.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: Essai PASST

titre: Alternative à la gestion intensive de la Phase Active du Second Stade du Travail : essai randomisé multicentrique

discipline_principale: autre

nom_porteur: LE RAY

prenom_porteur: Camille


title: Inter-Hospital Transfer to a Vascular Neurology Unit After Telethrombolysis in France Comté

acronym: TRATT

summary:
Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.

In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.

The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.

It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France).

ReferenceCitation: Nenert E, Pretalli JB, Bouamra B, Puyraveau M, Fehner L, Labourey JM, Desmettre T. Transfert interhospitalier vers une unité de neurologie vasculaire des accidents vasculaires cérébraux ischémiques téléthrombolysés : pertinence d'une médicalisation systématique ? Ann. Fr. Med. Urgence (2016).

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.

acronym: OLAF

summary: The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.


title: The Use of Chemsex (Drug Use in a Sexual Context) Among MSM (Men Who Have Sex With Men) and Transgender People in France, Whether or Not Taking PrEP, and Its Impact on PrEP Adherence

acronym: CONSUME

summary: This is a cross-sectional, single-center observational study conducted from October 2020 to March 2021 in Ile de France at the infectious disease of CHU Bichat (PrEP and CeGIDD(Free Center for Information, Screening and Diagnosis of Infections by Human Immunodeficiency Viruses, Viral Hepatitis and Sexually Transmitted Infections) consultation). It concerns adult subjects of male or transgender sex, of MSM (men having sex with men) or bi-sexual orientation. The data are collected by self-questionnaire evaluating the consumption of Chemsex (drug use in a sexual context) over the last 12 months, the existence or not of addiction treatment, the history of STIs (sexually transmitted infections) and adherence to PrEP (for subjects taking PrEP) during the last sexual intercourse (ANRS questionnaire, used in the PREVENIR study).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Chronic Kidney Disease - REAL Life Study in Alsace

acronym: CKD-REAL

summary:
Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry).

Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage.

Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.

location_facility: Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France


title: Molecular Characterization of Perivascular Epithelioid Cell Tumors

acronym: PEComesCells

summary: Perivascular epithelioid cell tumors (PEComas) are rare and are characterized by the expression of myomelanocytic markers. They are a complex family that includes angiomyolipomas, lymphangioleiomyomatoses and other soft tissue and visceral tumors. Due to the low prevalence of these tumors, the natural history is unclear; furthermore, a molecular classification integrating clinical, pathological and molecular parameters has not been described to date.

location_facility: Service d'Oncologie - CHU de Strasbourg - France


title: Project for the Liberation of Organizations in an University Hospital in France: A Randomized Controlled Study of the Impact at Two Years of an Intervention Program on the Empowerment of the Medical and Nursing Teams

acronym: CHRYSALIDE

summary: Health in France asks public hospitals to promote quality of working life (QWL), seen as a performance factor. Consistently with empowerment literature, they define QWL as giving workers mastery over their working life. The problem is, French hospitals follow a bureaucratic model, defined by a managerial culture of control and a stratified organization, which weakens mastery of their work, and hinders their commitment and performance. Main objective of CHRYSALIDE, is to create a managerial and organizational transition program of 1 year, and to test its effect at two years on workers empowerment in an university hospital Sub-Center (SC), in comparison with another SC from the same University Hospital Center (CHU) in a randomized controlled study design.

ReferenceCitation: Cougot B, Gillet N, Gauvin J, Caillet P, Fleury-Bahi G, Ollierou F, Armant A, Peltier A, Getz I, Bach-Ngohou K, Tripodi D, Moret L. Impact of empowering leadership on emotional exhaustion: A controlled interventional study in a large French university hospital complex. J Nurs Manag. 2022 Nov;30(8):4234-4250. doi: 10.1111/jonm.13829. Epub 2022 Oct 17.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Cougot B, Gauvin J, Gillet N, Bach-Ngohou K, Lesot J, Getz I, Deparis X, Longuenesse C, Armant A, Bataille E, Leclere B, Fleury-Bahi G, Moret L, Tripodi D. Impact at two years of an intervention on empowerment among medical care teams: study protocol of a randomised controlled trial in a large French university hospital. BMC Health Serv Res. 2019 Dec 3;19(1):927. doi: 10.1186/s12913-019-4724-7.

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

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

lead_sponsor: Nantes University Hospital

appel_a_projets: PREPS

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: CHRYSALIDE

titre: Projet de libération organisationnelle d'un pôle hospitalo-universitaire : étude contrôlée de l'impact à deux ans d'un programme d'intervention sur l'empowerment des équipes médico-soignantes.

discipline_principale: organisation des soins

nom_porteur: COUGOT

prenom_porteur: Baptiste


title: Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France

acronym: PrediLynch

summary:
Lynch Syndrome increases Endometrial Cancer Occurrence in women due to failure in MisMatch Repair System. Lifetime Cumulative risk of developing endometrial Cancer is approximatively 40% in women with Lynch Syndrome.

Endometrial cancer is the third women cancer in France. Many risk factors are known in general population. Lots of factors are related to over exposure to estrogen.

Data about influence of general risk factors in Women with Lynch Syndrome are poor. Recently, a cohort study appears to have shown a significant decrease in the risk of endometrial cancer with multiparity, the use of hormonal contraception and late menopause in Lynch women. The impact of weight and certain metabolic parameters on the occurrence of endometrial cancers remains poorly known to this day.

lead_sponsor: University Hospital, Lille


title: Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort, Montpellier, South of France

summary:
Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70% of the total.

Graft rejection is still the main cause of failure of this type of surgery, to the extent that nearly a third of all patients will in some way be affected by rejection in due course.

Numerous risk factors for rejection have been identified, whether related to the donor, the recipient, or the surgical procedure itself.

In addition, many of the studies performed have used univariate analysis only, and yet there is a strong case for multivariate analysis, given the wide range of factors that need to be examined.

This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty for a group of patients from Montpellier Hospital (France).

ReferenceCitation: Debourdeau E, Builles N, Couderc G, Boulhic J, Chamard C, Villain M, Babeau F, Daien V. Risk factors of rejection after penetrating keratoplasty: a retrospective monocentric study. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3627-3638. doi: 10.1007/s00417-022-05691-w. Epub 2022 May 12.

lead_sponsor: University Hospital, Montpellier


title: Quality of Care for Knee and Hip Osteoarthritis in Elderly Patients: a Multicentric Observational Study in France Using Quality Indicators Assessed by Questionnaire

acronym: QSAMISA

summary:
Introduction: Hip and knee osteoarthritis (OA) was ranked in 2010 as the eleventh highest contributor to global disability. In France in 2014, non-spinal OA was the leading self-reported cause of morbidity among adults over sixty-five years of age, with a prevalence of 49.5 per cent. OA is known to be the first cause of disability in activities of daily life and a risk factor of frailty among people over seventy-five years of age. Despite its major impact on the elderly population's quality of life and health, quality of care for OA in elderly patients remains understudied.

Objective: The study aims to assess the quality of care for knee and hip OA in patients aged 75 years and over.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR