acronym: REVOLMUCO

summary:
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.

This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.

For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.

All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.

In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.

So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.

A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier, Arnaud de Villeneuve


title: Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France

summary: The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: AstraZeneca

lead_sponsor_type: industriel

status_simplified: Completed


title: Qualitative and Functional Investigation of Lipids in Patients With SARS-CoV2 Infection - In Search of Atherogenic Sequelae

acronym: COVI-LIPI-D

summary:
Currently, the world is facing a SARS-CoV2 coronavirus epidemic, which is responsible for COVID-19. In France, this virus has already infected several million people and is responsible for the death of more than 127,000.

Infection is associated with a higher number of cardiovascular events (myocardial infarction, stroke, cardiac arrhythmia, thrombosis ...) in the short and medium term after infection. The long-term complications of this infection are not yet known and are the subject of research in France and in the world.

In order to investigate the possible long term sequelae of this virus infection, this research aims to evaluate the potential cholesterol abnormalities caused by COVID-19, which could play a significant role in the increase of cardiovascular risk in affected patients.

A total of 180 participants will be recruited in this study. They will be divided into four groups of participants that will be compared to one another:

30 participants who were infected with SARS-CoV2 with no or few signs and did not require hospitalization.
30 participants who were infected with SARS-CoV2 and whose severity of illness required hospitalization in a COVID unit
30 participants who were infected with SARS-CoV2 and required intensive care hospitalization due to severity of illness.
90 participants who were not infected with SARS-CoV2.

For each participant, the study will last approximately 1 hour, the time to fill out the consent forms, to answer a few questions about their current medical history and finally to take a blood sample for lipid measurements.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: Observational Study of the Use of the Service Giving Access to Teleconsultation in France by Telemedicine Companies

acronym: TELET

summary:
Teleconsultation is a telemedicine medical act carried out remotely via information and communication technologies. This medical procedure has been legal in France since 2010 and reimbursed by the National Health Insurance under certain conditions since 2018. In 2020, following the COVID-19 epidemic, the lockdowns and the extension of the scope of financial coverage, 17 million teleconsultations have been reimbursed.

To date, few scientific studies have been published in France to precisely describe the use of the service giving access to outpatient teleconsultation, in particular since the major increase in activity linked to the COVID-19 epidemic.

The objective is to describe the use of the service giving access to outpatient teleconsultation carried out in France by teleconsultation companies and compare the use of the teleconsultation service according to the medical density of the territory.

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Les Entreprises de Télémédecine


title: C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

summary:
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.

Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.

A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.

ipd_sharing: Yes

ipd_sharing_description: open to partnership

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Drug


acronym: TRANSTEP

summary:
Breast cancer is a major public health problem. In France, it is the leading cause of cancer death in women. According to the National Cancer Institute (INCA), approximately 49,000 new cases were diagnosed in 2012 in France.

It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior, biological and prognosis differ. Amongst these entities, the breast cancer triple negative (TN) is defined by the absence of expression of estrogen receptor and progesterone and the absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and occurs more frequently in young women. This is a very proliferative tumor phenotype with metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified molecular target, no targeted therapy has today shown benefit in terms of survival compared to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy treatment non-responder patients to treatment with low probability of pathologic complete response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective of this pilot, single-center, prospective study is a preliminary identification of recurrent genomic alterations among triple-negative tumors with early chemoresistance, identified by PET in the first cycle of neoadjuvant therapy.

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Other


title: Living Conditions After Non-Hodgkin's Lymphoma in France

acronym: LymphoVie 2

summary:
This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.

This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.

For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.

study_start_date_type: Anticipated

status: Not yet recruiting


title: Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes

summary: Purpose: Identification of the gene(s) involved in plasma membrane remodelling. Identification of the circulating markers affected by the defective membrane remodelling in a collection of families with unexplained provoked hemorrhages and evaluation of their prognosis value in the assessment of the hemostatic cellular response.Hypothesis: Scott syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type patients due to isolated membrane remodelling deficiency. Membrane remodelling is necessary for cellular hemostatic responses.

status: Terminated

lead_sponsor: University Hospital, Strasbourg, France

location_country: France Martinique

location_facility: Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Laboratoire d'Hématologie, Hôpital Robert Debré

location_facility: Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier

location_facility: Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman

location_facility: Hôpital Antoine Béclère, Service d'Hématologie Biologique

status_simplified: Unknown


title: Drug Wastage : Observational Study in Intensive Care Units in France

acronym: GAME-OVER

summary:
Environmental awareness leads medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare.

GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


type: Other Grant/Funding Number

title: Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (France)

summary: An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a hospital based clinical research center.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14.

lead_sponsor: University of Virginia

location_facility: Centre d'Investigation Clinique CHU Montipellier

intervention_type: Device


title: Vitamin D Status in Pregnant Women With Preeclampsia

acronym: FEPED

summary: Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia

ReferenceCitation: Salakos E, Rabeony T, Courbebaisse M, Taieb J, Tsatsaris V, Guibourdenche J, Senat MV, Haidar H, Jani JC, Barglazan D, Maisonneuve E, Haguet MC, Winer N, Masson D, Elie C, Souberbielle JC, Benachi A. Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study. Clin Nutr. 2021 Jan;40(1):79-86. doi: 10.1016/j.clnu.2020.04.028. Epub 2020 Apr 25.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Identifier

title: Heart Failure Educational and Follow up Platform

acronym: HELP

summary: Heart failure is a serious and common disease. HF is marked by a high rate of preventable hospitalizations through proper care. As such, it is a key target for telemedicine programs. However, currently published data are inconclusive. Investigators propose a multicenter randomized study of innovative telemedicine involving the usual patient monitoring daily weight monitoring, clinical signs and in one of three groups in our study of BNP testing in the patient's home all associated with a regular education reinforcement. The objective is to identify early cardiac decompensation to allow to treat ambulatory and thus prevent the occurrence of more serious events such as death or rehospitalization.

primary_purpose: Supportive Care

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

lead_sponsor: Centre Hospitalier René Dubos

location_facility:
Mutualiste Montsouris Institute
Centre Hospitalier René DUBOS
Turin Clinic
Poissy-Saint-Germain-en-Laye Hospital
Victor Dupouy Hospital
Orsay Hospital
Georges Pompidou University Hospital
Bernard Clinic
Versailles Hospital
Simone Veil Hospital
Meaux Hospital
Henri-Mondor Hospital
Sainte Marie Clinic
Sud francilien Hospital
Gonesse Hospital


title: The French Multiple Sclerosis Registry

acronym: OFSEP

summary:
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.

In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are

To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.

status: Unknown status

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer


title: Epidemiologic Study of Orthodontic Retention Practices in France

acronym: ORIF

summary: The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.

ipd_sharing_description: No IPD

lead_sponsor: Nantes University Hospital


title: Diagnostic Accuracy of the Circulating Cell-free DNA-based Epigenetic Biomarker mSEPT9 for Hepatocellular Carcinoma Detection Among Cirrhotic Patients: the SEPT9-CROSS Study

summary: Prospective evaluation of the circulating cell-free DNA-based epigenetic biomarker (mSEPT9) through a cross-sectional biomarker phase II design. The aim of the SEPT9-CROSS study is to assess the diagnostic accuracy of the plasma mSEPT9 biomarker in a large-scale study of 530 cirrhotic patients recruited in the Nancy University Hospital.

design_allocation: Non-Randomized

ipd_sharing_description: Final report, publication in a peer review journal. Main data and supplemental data.

location_facility: University Hospital of Nancy (CHRU de Nancy)

intervention_type: Diagnostic Test


title: Impact of Covid-19 in Congenital Heart Disease - COVID-CHD

acronym: COVID-CHD

summary:
The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer.

The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients.

CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today.

The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population.

This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France

ReferenceType: background

ReferenceCitation: Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. Epub 2007 Jan 8.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ipd_sharing: Undecided

ipd_sharing_description: NC


title: Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.

acronym: BREFORM

summary:
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.

Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.

primary_purpose: Other

lead_sponsor: Hôpital le Vinatier


title: Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.

acronym: CACIES

summary: CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

ReferenceCitation: Villa A, Molimard M, Bignon E, Martinez B, Rouyer M, Mathoulin-Pelissier S, Baldi I, Verdun-Esquer C, Canal-Raffin M. Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study. BMJ Open. 2019 Nov 10;9(11):e033040. doi: 10.1136/bmjopen-2019-033040.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Pellegrin
CHU de Toulouse
IUCT-Oncopole


title: Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians

acronym: Observ-MTEV

summary: In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of the Diagnostic Value of "Rapid" High Throughput Genome Sequencing Analysis in Diagnostic Emergency Situations

acronym: FASTGEN

summary:
Rare diseases (affecting less than one in 2,000 people) are a major public health issue. There are about 8,000 rare diseases and they affect more than 3 million people in France. Most of these diseases are diagnosed in children, and they are responsible for 10% of deaths before the age of 5. Up to 80% of these diseases are believed to be of genetic origin. New generation high throughput sequencing (HTS) technologies, which allow the study of an individual's entire genome, have emerged in recent years as a tool of choice for the study of rare diseases. Our team was the first in France to demonstrate the value of exome sequencing (ES: all coding regions (exons), representing 1% of the total genome size) in the diagnosis of severe diseases in pediatric patients, developmental anomalies and intellectual disability.

Although it represents a significant advance in the diagnosis of genetic diseases, ES provides a contributing result in only about 30% of cases in patients with no obvious clinical diagnosis and with normal CGH-array. Sequencing the entire genome (GS) promises to improve the ability to study the causes of genetic diseases, with an expected diagnostic rate of 50 to 60% through the concomitant identification of point variations, CNVs and structural variations. While some international teams have already implemented GS in the diagnosis of rare diseases, only two teams report the use of trio GS in emergency situations in the neonatal period, with a low yield for first-line diagnostic use (31 and 42% respectively). It is therefore essential that these preliminary results be compared with other studies before considering the deployment of GS in diagnostic, early detection or rapidly evolving emergency situations, such as neonatal resuscitation or pediatric neurological distress.


title: Initiative in LYon for Lung cAncer Screening Development - Prevalence Study

summary:
Screening at-risk subjects with low-dose computed tomography (CT) efficiently reduces lung cancer specific mortality. However screening efficiency relies on the at-risk population's criteria definition and its participation rate to the screening. In France, there are concerns regarding the participation rates to national cancer screening that are quite low (around 50% and 32% of the eligible population for breast cancer and colorectal cancer respectively). Before organizing national lung cancer screening it is then crucial to determine the factors impacting the at-risk subjects willingness to participate in lung cancer screening.

The Lyon University Hospital is the second biggest hospital in France with more than 23,000 employees distributed among more than 160 professions representing every level of education or working conditions. Its population is heterogeneous and wide enough to perform a prevalence study assessing the willingness to participate among the at-risk population.

ILYAD is a prospective study performed by anonymous questionnaires that will be submitted to the 23,000 employees of the Lyon University Hospital. The study main objective is to evaluate the at-risk population presence in the Lyon University Hospital population, as defined by NELSON criteria and selection criteria for lung cancer screening (PLCOm2012 scoring), and its willingness to participate to a lung-cancer screening with low-dose CT. This might help further efficient national lung cancer screening campaign organization.


title: Drug Wastage : Observational Study in the Operating Rooms of France

acronym: GAME OvBLOC

summary:
Environmental awareness is leading medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice this is not systematic. Moreover, data on drug wastage in the operating rooms by anesthesia department are rare.

The GAME-OvBLOC observational study aim to evaluate drug wastage in in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

ReferenceCitation: McGain F, Muret J, Lawson C, Sherman JD. Environmental sustainability in anaesthesia and critical care. Br J Anaesth. 2020 Nov;125(5):680-692. doi: 10.1016/j.bja.2020.06.055. Epub 2020 Aug 12. Review.

ReferenceCitation: Barbariol F, Deana C, Lucchese F, Cataldi G, Bassi F, Bove T, Vetrugno L, De Monte A. Evaluation of Drug Wastage in the Operating Rooms and Intensive Care Units of a Regional Health Service. Anesth Analg. 2021 May 1;132(5):1450-1456. doi: 10.1213/ANE.0000000000005457.

ReferenceCitation: Mankes RF. Propofol wastage in anesthesia. Anesth Analg. 2012 May;114(5):1091-2. doi: 10.1213/ANE.0b013e31824ea491. Epub 2012 Mar 13.

ReferenceCitation: Ramström H, Martini S, Borgendahl J, Ågerstrand M, Lärfars G, Ovesjö ML. Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use. Eur J Clin Pharmacol. 2020 Aug;76(8):1151-1160. doi: 10.1007/s00228-020-02885-1. Epub 2020 May 9.

location_facility: University Hospital of Bordeaux, Groupe Sud, Pôle médico-chirurgical Magellan

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer


title: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)

acronym: Epidol

summary:
Obstetric analgesia is a requirement of our times. The different applicable methods vary in effectiveness. The essential part is represented by epidural analgesia which remains one of the most effective methods. It is important to know other methods to respond to all requests. The applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in France.

The main objective is to describe the different techniques of anesthesia/analgesia actually used in France for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).

Secondary objectives will be multiple :

Describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale
Describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses
Describe the frequency of adverse events of birth


title: Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.

acronym: APACAM

summary:
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute.

Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer.

Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan.

However, it seems to be insufficiently proposed and prescribed in France at present.

CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse.

According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment."

Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life.

Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment.

With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival.

The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients.

They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI.

The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.

status: Withdrawn

location_facility: Service de Gynécologie-Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Effects of Progressive Interval Training on V02 Max in Chronic Heart Failure Patients

summary:
Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required.

A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually.

The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.


title: Survey for the Initial Treatment of Hypothyroidism in France

acronym: ORCHIDEE

summary: This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

acronym: CCF

summary: The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

time_perspective: Retrospective

ReferenceCitation: Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.

lead_sponsor: French Cardiology Society

location_facility: Georges Pompidou European Hospital (AP-HP)

location_facility: Lille Catholic Institute Hospital Group, Lille


title: Follow-up of Elderly Subjects With Falls Recruited in the Geriatric Departments of Several French Hospitals

acronym: PREMOB

summary:
Falls are the leading cause of accidental death among the elderly, with nearly 8,000 deaths per year in France, including more than 950 deaths on average per year in the Northwest interregion between 2006 and 2013. The incidence of falls increases with age. Falls are often the consequence of multiple factors: extrinsic and intrinsic. The WHO classifies these risk factors into 4 groups: environmental, socio-economic, behavioral and biological.

The best way to act to reduce falls is to identify the risk and severity factors (risk of fracture, risk of loss of autonomy, risk of death) in order to correct those that are modifiable.

On a national scale, the prevention of falls has been considered for many years as a major issue in health prevention [INPES 2005]. The management of elderly patients who fall has been the subject of recommendations for good practice by the French National Authority for Health (HAS) in 2009. These recommendations include the need to look for signs of geriatric severity of falls.

The SNDS National System of healthcare data brings together and links the main national health databases in France. Linking data from the PMSI (Programme de Médicalisation des Systèmes d'Information) and the National Inter-regime Information System of the French National Health Insurance with data from death certificates via the SNDS opens up unique perspectives for improving the quality of follow-up of these patients. Crossing data from the Fall assessment clinic (clinical data) and SNDS data will allow data completeness and will improve our knowledge of the care consumption of elderly fallers. In particular, we wish to determine the risk factors for unplanned hospitalizations of patients with falls.

This project aims to set up a common multicenter cohort of patients assessed during the day hospital for multidisciplinary fall assessment in 12 geriatric services: the university hospitals of Lille, Amiens-Picardie, Rouen, Caen, Tours, Strasbourg, Angers, Dijon, the GHICL and the hospitals of St Quentin, Valenciennes and Beauvais Data collection is currently being harmonized in all participating clinical departments. The databases of the SNDS and that of the fall day hospital assessment will be crossed. This will allow us to improve our knowledge of the follow-up of elderly fallers, the impact of risk factors (clinical, psychosocial, organizational, etc.) and their interactions, the effectiveness of specific management on the occurrence of falls, serious falls as well as the use of care. 1,000 elderly patients admitted in 12 French geriatric departements for a fall assessment will participate in the study.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021 and in 2022.

acronym: VACCIR

summary: the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

lead_sponsor: Centre Hospitalier Sud Francilien


title: A Multicentric Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures During Antenatal and Early Postnatal Periods and the Risk to Develop a Testicular Germ Cell Tumor During Adulthood

acronym: TESTIS

summary:
The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. Reliable data on environmental exposure during this critical period are sparse.The discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability.

We conduct a multicentric case-control study to assess this association. Cases and controls will be enrolled during a 18-month period. They will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances.

An optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls.

Mothers (or close relative) of cases and controls will also be contacted (with son's agreement). If they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances.

Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.

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ReferenceCitation: Dalgaard MD, Weinhold N, Edsgärd D, Silver JD, Pers TH, Nielsen JE, Jørgensen N, Juul A, Gerds TA, Giwercman A, Giwercman YL, Cohn-Cedermark G, Virtanen HE, Toppari J, Daugaard G, Jensen TS, Brunak S, Rajpert-De Meyts E, Skakkebæk NE, Leffers H, Gupta R. A genome-wide association study of men with symptoms of testicular dysgenesis syndrome and its network biology interpretation. J Med Genet. 2012 Jan;49(1):58-65. doi: 10.1136/jmedgenet-2011-100174. Epub 2011 Dec 3.

ReferenceCitation: Kanetsky PA, Mitra N, Vardhanabhuti S, Li M, Vaughn DJ, Letrero R, Ciosek SL, Doody DR, Smith LM, Weaver J, Albano A, Chen C, Starr JR, Rader DJ, Godwin AK, Reilly MP, Hakonarson H, Schwartz SM, Nathanson KL. Common variation in KITLG and at 5q31.3 predisposes to testicular germ cell cancer. Nat Genet. 2009 Jul;41(7):811-5. doi: 10.1038/ng.393. Epub 2009 May 31.

ReferenceCitation: Kratz CP, Han SS, Rosenberg PS, Berndt SI, Burdett L, Yeager M, Korde LA, Mai PL, Pfeiffer R, Greene MH. Variants in or near KITLG, BAK1, DMRT1, and TERT-CLPTM1L predispose to familial testicular germ cell tumour. J Med Genet. 2011 Jul;48(7):473-6. doi: 10.1136/jmedgenet-2011-100001. Epub 2011 May 26.

ReferenceCitation: Rapley EA, Turnbull C, Al Olama AA, Dermitzakis ET, Linger R, Huddart RA, Renwick A, Hughes D, Hines S, Seal S, Morrison J, Nsengimana J, Deloukas P; UK Testicular Cancer Collaboration, Rahman N, Bishop DT, Easton DF, Stratton MR. A genome-wide association study of testicular germ cell tumor. Nat Genet. 2009 Jul;41(7):807-10. doi: 10.1038/ng.394. Epub 2009 May 31.

ReferenceCitation: Turnbull C, Rapley EA, Seal S, Pernet D, Renwick A, Hughes D, Ricketts M, Linger R, Nsengimana J, Deloukas P, Huddart RA, Bishop DT, Easton DF, Stratton MR, Rahman N; UK Testicular Cancer Collaboration. Variants near DMRT1, TERT and ATF7IP are associated with testicular germ cell cancer. Nat Genet. 2010 Jul;42(7):604-7. doi: 10.1038/ng.607. Epub 2010 Jun 13.

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ReferenceCitation: Chia VM, Quraishi SM, Devesa SS, Purdue MP, Cook MB, McGlynn KA. International trends in the incidence of testicular cancer, 1973-2002. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1151-9. doi: 10.1158/1055-9965.EPI-10-0031.

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ReferenceCitation: Sonneveld DJ, Schaapveld M, Sleijfer DT, Meerman GJ, van der Graaf WT, Sijmons RH, Koops HS, Hoekstra HJ. Geographic clustering of testicular cancer incidence in the northern part of The Netherlands. Br J Cancer. 1999 Dec;81(7):1262-7.

ReferenceCitation: Walschaerts M, Muller A, Auger J, Bujan L, Guérin JF, Le Lannou D, Clavert A, Spira A, Jouannet P, Thonneau P. Environmental, occupational and familial risks for testicular cancer: a hospital-based case-control study. Int J Androl. 2007 Aug;30(4):222-9.

ReferenceCitation: Møller H. Work in agriculture, childhood residence, nitrate exposure, and testicular cancer risk: a case-control study in Denmark. Cancer Epidemiol Biomarkers Prev. 1997 Feb;6(2):141-4.

ReferenceCitation: Rajpert-De Meyts E. Developmental model for the pathogenesis of testicular carcinoma in situ: genetic and environmental aspects. Hum Reprod Update. 2006 May-Jun;12(3):303-23. Epub 2006 Mar 15. Review.

ReferenceCitation: McGlynn KA, Trabert B. Adolescent and adult risk factors for testicular cancer. Nat Rev Urol. 2012 Apr 17;9(6):339-49. doi: 10.1038/nrurol.2012.61. Review.

ReferenceCitation: Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. Review.

ReferenceCitation: Akre O, Richiardi L. Does a testicular dysgenesis syndrome exist? Hum Reprod. 2009 Sep;24(9):2053-60. doi: 10.1093/humrep/dep174. Epub 2009 May 14. Review.

ReferenceCitation: Hemminki K, Li X. Cancer risks in Nordic immigrants and their offspring in Sweden. Eur J Cancer. 2002 Dec;38(18):2428-34.

ReferenceCitation: Myrup C, Westergaard T, Schnack T, Oudin A, Ritz C, Wohlfahrt J, Melbye M. Testicular cancer risk in first- and second-generation immigrants to Denmark. J Natl Cancer Inst. 2008 Jan 2;100(1):41-7. Epub 2007 Dec 25.

ReferenceCitation: Béranger R, Le Cornet C, Schüz J, Fervers B. Occupational and environmental exposures associated with testicular germ cell tumours: systematic review of prenatal and life-long exposures. PLoS One. 2013 Oct 14;8(10):e77130. doi: 10.1371/journal.pone.0077130. eCollection 2013. Review.

ReferenceCitation: Cohn BA, Cirillo PM, Christianson RE. Prenatal DDT exposure and testicular cancer: a nested case-control study. Arch Environ Occup Health. 2010 Jul-Sep;65(3):127-34. doi: 10.1080/19338241003730887.

ReferenceCitation: Giannandrea F, Gandini L, Paoli D, Turci R, Figà-Talamanca I. Pesticide exposure and serum organochlorine residuals among testicular cancer patients and healthy controls. J Environ Sci Health B. 2011;46(8):780-7. doi: 10.1080/03601234.2012.597704.

ReferenceCitation: Hardell L, Bavel B, Lindström G, Eriksson M, Carlberg M. In utero exposure to persistent organic pollutants in relation to testicular cancer risk. Int J Androl. 2006 Feb;29(1):228-34. Epub 2005 Dec 20.

ReferenceCitation: Kardaun JW, Hayes RB, Pottern LM, Brown LM, Hoover RN. Testicular cancer in young men and parental occupational exposure. Am J Ind Med. 1991;20(2):219-27.

ReferenceCitation: Knight JA, Marrett LD. Parental occupational exposure and the risk of testicular cancer in Ontario. J Occup Environ Med. 1997 Apr;39(4):333-8.

ReferenceCitation: Kristensen P, Andersen A, Irgens LM, Bye AS, Sundheim L. Cancer in offspring of parents engaged in agricultural activities in Norway: incidence and risk factors in the farm environment. Int J Cancer. 1996 Jan 3;65(1):39-50.

ReferenceCitation: Nori F, Carbone P, Giordano F, Osborn J, Figà-Talamanca I. Endocrine-disrupting chemicals and testicular cancer: a case-control study. Arch Environ Occup Health. 2006 Mar-Apr;61(2):87-95.

ReferenceCitation: Rodvall Y, Dich J, Wiklund K. Cancer risk in offspring of male pesticide applicators in agriculture in Sweden. Occup Environ Med. 2003 Oct;60(10):798-801.

ReferenceCitation: Provost D, Cantagrel A, Lebailly P, Jaffré A, Loyant V, Loiseau H, Vital A, Brochard P, Baldi I. Brain tumours and exposure to pesticides: a case-control study in southwestern France. Occup Environ Med. 2007 Aug;64(8):509-14. Epub 2007 May 30.

ReferenceCitation: Chester G, Ward RJ. Occupational exposure and drift hazard during aerial application of paraquat to cotton. Arch Environ Contam Toxicol. 1984 Sep;13(5):551-63.

ReferenceCitation: Gunier RB, Ward MH, Airola M, Bell EM, Colt J, Nishioka M, Buffler PA, Reynolds P, Rull RP, Hertz A, Metayer C, Nuckols JR. Determinants of agricultural pesticide concentrations in carpet dust. Environ Health Perspect. 2011 Jul;119(7):970-6. doi: 10.1289/ehp.1002532. Epub 2011 Feb 17.

ReferenceCitation: Koch D, Lu C, Fisker-Andersen J, Jolley L, Fenske RA. Temporal association of children's pesticide exposure and agricultural spraying: report of a longitudinal biological monitoring study. Environ Health Perspect. 2002 Aug;110(8):829-33.

ReferenceCitation: Ward MH, Lubin J, Giglierano J, Colt JS, Wolter C, Bekiroglu N, Camann D, Hartge P, Nuckols JR. Proximity to crops and residential exposure to agricultural herbicides in iowa. Environ Health Perspect. 2006 Jun;114(6):893-7.

ReferenceCitation: Weppner S, Elgethun K, Lu C, Hebert V, Yost MG, Fenske RA. The Washington aerial spray drift study: children's exposure to methamidophos in an agricultural community following fixed-wing aircraft applications. J Expo Sci Environ Epidemiol. 2006 Sep;16(5):387-96. Epub 2005 Oct 12.

ReferenceCitation: Butte W, Heinzow B. Pollutants in house dust as indicators of indoor contamination. Rev Environ Contam Toxicol. 2002;175:1-46. Review.

ReferenceCitation: Zou B, Wilson JG, Zhan FB, Zeng Y. Air pollution exposure assessment methods utilized in epidemiological studies. J Environ Monit. 2009 Mar;11(3):475-90. doi: 10.1039/b813889c. Epub 2009 Feb 13. Review.

lead_sponsor: Centre Leon Berard

location_facility: CHU de Grenoble - Hôpital Couple Enfants


title: Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women

acronym: CASSANDRE

summary:
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.

Multicenter observational study on a cross-week comparative basis with men

ReferenceCitation: WRITING GROUP MEMBERS, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425.

ReferenceCitation: Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. Epub 2006 Mar 7.

ReferenceCitation: Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. Review.

ReferenceCitation: Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90.

ReferenceCitation: Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6.

ReferenceCitation: Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6.

ReferenceCitation: Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. Epub 2005 Feb 1.

ReferenceCitation: Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. Review.

ReferenceCitation: Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. Erratum in: JAMA. 2006 Feb 8;295(6):628.


title: Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old

summary: Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.

time_perspective: Other

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

intervention_type: Procedure


title: Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries

summary: The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation: an Observational, Prospective Study

acronym: REPERPSY

summary:
The fight against the scarcity of grafts is a major public health issue in France. Despite a very good success rate of transplants from brain-dead donors or living donors, the waiting time for transplantation continues to increase, leading to morbidity and mortality, as well as medical costs. Since 2005, the BioMedicine Agency has implemented a protocol authorizing kidney and liver samples taken from deceased donors after cardiac arrest (DDAC). This type of sampling has become a common practice in several regions of France and Europe. In case of DDAC, the sampling protocol poses a significant temporal constraint, since the patient must be taken within 6 hours after the cardiac arrest. This constraint leads to a specific organization of the announcement of the death and the request for non-opposition to the levy.

The brutal loss of a loved one is a potentially traumatic experience for family members. The manifestations of the pathological components of mourning such as post-traumatic stress disorder, anxio-depressive syndrome, pathological bereavement, are often expressed early in the first year after the death of the loved one. Families of organ donor patients probably represent a population at high risk for the expression of psychiatric conditions such as post-traumatic stress disorder or pathological bereavement. The limited time available to prepare relatives to make a decision could promote the expression of psychiatric morbidity in the short or medium term. The data on this new transplantation procedure and its psychological consequences are insufficient, and we consider that if a state of post-traumatic stress occurred in more than 50% of parents, the procedure of announcement would be reviewed. The purpose of this study is to test this hypothesis.

Most of the work on relatives of potential organ donors has focused on procedures for brain death. Most of this work has focused on characterizing the determinants of acceptance or refusal of organ donation in the family. The literature relating to the follow-up of relatives of a patient after organ donation is very poor: very few studies have focused on the psychological consequences and / or the psychological state of this population in the period post-death. In addition, very few qualitative and quantitative studies make it possible to evaluate the appearance of psychopathological manifestations related to the announcement of death simultaneously with a request for organ removal. This research, therefore, will make it possible to estimate the possible psychological impact on the bereaved family as well as an assessment of the psychological state. A mixed methodology (quantitative and qualitative) will make it possible to highlight explanatory factors of the quantitative results.

ReferenceCitation: Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30.

ReferenceCitation: Domínguez-Gil B, Haase-Kromwijk B, Van Leiden H, Neuberger J, Coene L, Morel P, Corinne A, Muehlbacher F, Brezovsky P, Costa AN, Rozental R, Matesanz R; European Committee (Partial Agreement) on Organ Transplantation. Council of Europe (CD-P-TO). Current situation of donation after circulatory death in European countries. Transpl Int. 2011 Jul;24(7):676-86. doi: 10.1111/j.1432-2277.2011.01257.x. Epub 2011 Apr 19.

ReferenceCitation: Fieux F, Losser MR, Bourgeois E, Bonnet F, Marie O, Gaudez F, Abboud I, Donay JL, Roussin F, Mourey F, Adnet F, Jacob L. Kidney retrieval after sudden out of hospital refractory cardiac arrest: a cohort of uncontrolled non heart beating donors. Crit Care. 2009;13(4):R141. doi: 10.1186/cc8022. Epub 2009 Aug 28.

ReferenceCitation: Eckenrod EL. Psychological/emotional trauma of donor families. Transplant Proc. 2008 May;40(4):1061-3. doi: 10.1016/j.transproceed.2008.03.048.

lead_sponsor: frederic ADNET


title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France

acronym: ARTEMIS

summary: The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.

lead_sponsor: Chugai Pharma France


title: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study

acronym: SourceCOVID

summary:
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.

Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.

ReferenceCitation: Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.

lead_sponsor: Weprom


title: Use and Misuse of Domperidone in Parkinson's Disease in France - Observational

acronym: DUMP-obs

summary:
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT.

Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days).

Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone.

The aim of this proposal is to conduct a cross sectional observational study performed in consecutive patients followed by the 24 PD expert centers of the NS Park network, general hospitals and private practice neurologists, to describe the actual use of domperidone in PD patients.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

acronym: PJPAP

summary:
Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work.

Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).

lead_sponsor: University Hospital, Brest


primary_purpose: Prevention

title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France

lead_sponsor: Sanofi Pasteur, a Sanofi Company

type: EudraCT Number

source: euctr

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

location_facility:
Investigational Site Number 2500002
Investigational Site Number 2500001

summary:
Primary Objective:

To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection.

Secondary Objective:

To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%).
To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).


title: Study of People's Profile Living in France Who Could be Interested in the Use of a Nanohydroxyapatite Toothpaste

summary:
Nano-hydroxyapatite is an interesting candidate to be a substitute for fluor in toothpastes or a complement to fluorides in order to prevent caries. The objective of this transversal descriptive study is to evaluate the profiles of people living in France who could be interested in using a nano-hydroxyapatite based toothpaste.

Participants in this transversal descriptive study have been chosen by a self-administered method. Before answering 16 questions, the participants were asked to watch a short video describing the main concepts to know about fluoridated toothpastes and nano-hydoxyapatite toothpastes. Pros and cons of each one them were mentioned. In order to compare the answers, pivot tables have been produced.

lead_sponsor: University Hospital, Montpellier


title: Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France

acronym: IPASTAPH

summary: S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.

lead_sponsor: Hospices Civils de Lyon


type: Registry Identifier

title: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III

acronym: PPSIII

summary: The aim of the present PPS3 study is (1) to assess the determinants of the regulation of heart rate and blood pressure variations and carotid properties (under different physiologic stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure variations and carotid properties to cardiovascular morbidity and mortality including sudden death during 10 years at least in healthy considered subjects.

ReferenceCitation: Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetière P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005 May 12;352(19):1951-8.

ReferenceCitation: Jouven X, Zureik M, Desnos M, Courbon D, Ducimetière P. Long-term outcome in asymptomatic men with exercise-induced premature ventricular depolarizations. N Engl J Med. 2000 Sep 21;343(12):826-33.

ReferenceCitation: Briet M, Bozec E, Laurent S, Fassot C, London GM, Jacquot C, Froissart M, Houillier P, Boutouyrie P. Arterial stiffness and enlargement in mild-to-moderate chronic kidney disease. Kidney Int. 2006 Jan;69(2):350-7.

ReferenceCitation: Kornet L, Hoeks AP, Janssen BJ, Houben AJ, De Leeuw PW, Reneman RS. Neural activity of the cardiac baroreflex decreases with age in normotensive and hypertensive subjects. J Hypertens. 2005 Apr;23(4):815-23.

ReferenceCitation: Empana JP, Sykes DH, Luc G, Juhan-Vague I, Arveiler D, Ferrieres J, Amouyel P, Bingham A, Montaye M, Ruidavets JB, Haas B, Evans A, Jouven X, Ducimetiere P; PRIME Study Group. Contributions of depressive mood and circulating inflammatory markers to coronary heart disease in healthy European men: the Prospective Epidemiological Study of Myocardial Infarction (PRIME). Circulation. 2005 May 10;111(18):2299-305. Epub 2005 May 2.

ReferenceCitation: Deraz O, Rangé H, Boutouyrie P, Chatzopoulou E, Asselin A, Guibout C, Van Sloten T, Bougouin W, Andrieu M, Vedié B, Thomas F, Danchin N, Jouven X, Bouchard P, Empana JP. Oral Condition and Incident Coronary Heart Disease: A Clustering Analysis. J Dent Res. 2022 May;101(5):526-533. doi: 10.1177/00220345211052507. Epub 2021 Dec 7.

ReferenceCitation: Lisan Q, Tafflet M, Charles MA, Thomas F, Boutouyrie P, Guibout C, Haba-Rubio J, Périer MC, Pannier B, Marques-Vidal P, Jouven X, Empana JP. Self-reported body silhouette trajectories across the lifespan and excessive daytime sleepiness in adulthood: a retrospective analysis. The Paris Prospective Study III. BMJ Open. 2018 Mar 27;8(3):e020851. doi: 10.1136/bmjopen-2017-020851.

ReferenceCitation: Simon M, Boutouyrie P, Narayanan K, Gaye B, Tafflet M, Thomas F, Guibout C, Périer MC, Pannier B, Jouven X, Empana JP. Sex disparities in ideal cardiovascular health. Heart. 2017 Oct;103(20):1595-1601. doi: 10.1136/heartjnl-2017-311311. Epub 2017 Jul 28.

ReferenceCitation: Empana JP, Perier MC, Singh-Manoux A, Gaye B, Thomas F, Prugger C, Plichart M, Wiernik E, Guibout C, Lemogne C, Pannier B, Boutouyrie P, Jouven X. Cross-sectional analysis of deprivation and ideal cardiovascular health in the Paris Prospective Study 3. Heart. 2016 Dec 1;102(23):1890-1897. doi: 10.1136/heartjnl-2016-309502. Epub 2016 Jun 27.

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

location_facility: Investigations Pré cliniques et Preventives de Paris


title: Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study

acronym: NUTRI-REAPED

summary:
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.

As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.

Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.

Secondary objectives:

Determine the children's nutritional status on admission.
Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
Describe the practices regarding nutritional care in each center.

Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.


title: Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use

acronym: CARMYN

summary: This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).

lead_sponsor: Centre Hospitalier le Mans