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.

lead_sponsor: University Hospital, Strasbourg, France

location_country: Martinique France

location_facility: Laboratoire d'Hématologie, Hôpital Robert Debré

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

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

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

location_facility: Hôpital Antoine Béclère, Service d'Hématologie Biologique


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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

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.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

sequence: first

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

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.

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

family: Du

full_name: Ronghui Du

given: Ronghui

family: Fan

full_name: Guohui Fan

given: Guohui

family: Liu

full_name: Ying Liu

given: Ying

full_name: Zhibo Liu

given: Zhibo

family: Xiang

full_name: Jie Xiang

given: Jie

family: Wang

full_name: Yeming Wang

given: Yeming

family: Song

full_name: Bin Song

given: Bin

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Guan

full_name: Lulu Guan

given: Lulu

family: Wei

full_name: Yuan Wei

given: Yuan

family: Li

full_name: Hui Li

given: Hui

full_name: Xudong Wu

given: Xudong

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Tu

full_name: Shengjin Tu

given: Shengjin

family: Zhang

full_name: Yi Zhang

given: Yi

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.


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. A Multicentric Stepped-wedge Randomized Control Trial.

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.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Hôpital le Vinatier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


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.

ReferenceType: derived

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.

apc_source: openAPC

family: Villa

full_name: Antoine Villa

given: Antoine

family: Molimard

full_name: Mathieu Molimard

given: Mathieu

family: Bignon

full_name: Emmanuelle Bignon

given: Emmanuelle

family: Martinez

full_name: Béatrice Martinez

given: Béatrice

family: Rouyer

full_name: Magali Rouyer

given: Magali

family: Mathoulin-Pelissier

full_name: Simone Mathoulin-Pelissier

given: Simone

family: Baldi

full_name: Isabelle Baldi

given: Isabelle

family: Verdun-Esquer

full_name: Catherine Verdun-Esquer

given: Catherine

family: Canal-Raffin

full_name: Mireille Canal-Raffin

given: Mireille

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility:
IUCT-Oncopole
Hôpital Pellegrin
CHU de Toulouse

status_simplified: Completed


title: Observatory of Unintentional Births Hospital Extras in Hérault

summary:
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.

For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.

status: Recruiting

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


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.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Genetic


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.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Satisfaction and the Quality of Life of Patients After Breast Reconstruction as Part of Breast Cancer. Comparison of Several Technics.

acronym: SQUARE

summary:
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy.

Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping.

Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction.

The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.

time_perspective: Retrospective

lead_sponsor: Institut Cancerologie de l'Ouest

lead_sponsor_type: industriel


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 440 cirrhotic patients recruited in the Nancy University Hospital.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: Yes

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

lead_sponsor: Central Hospital, Nancy, France

location_facility: University Hospital of Nancy (CHRU de Nancy)

intervention_type: Diagnostic Test


title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

acronym: TOSCANE

summary: Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.

status: Unknown status

primary_purpose: Treatment

intervention_type: Procedure

status_simplified: Unknown


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.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

family: Calinaud

full_name: Christine Calinaud

given: Christine

journal_name: BMC Health Services Research

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier René Dubos

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

intervention_type: Device


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: Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -

summary: Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

status: Active, not recruiting

primary_purpose: Prevention

location_facility:
CHU Angers
CHU Strasbourg
CHU Reims
CH Cannes
CHU Grenoble
CHU Brest


title: Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

summary: This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.

ReferenceCitation: Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liégeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.

ReferenceCitation: Mathelin C, Salvador S, Croce S, Andriamisandratsoa N, Huss D, Guyonnet JL. Optimization of sentinel lymph node biopsy in breast cancer using an operative gamma camera. World J Surg Oncol. 2007 Nov 17;5:132.

location_facility: Service de Gyynécologie-Obstétrique -Hôpital Civil


title: National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units

acronym: VACOVID-SENIOR

summary:
The COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. The management of the health crisis could take a new turn in 2021 with the arrival in France of vaccines against the SARS-CoV-2 virus.

The objectives of this vaccination campaign are to reduce the morbi-mortality attributable to COVID-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system.

However, the distrust of vaccination, traditionally strong in France, could have a negative impact on this strategy. While the President of the Republic announced on November 24, 2020 that vaccination against SARS-CoV-2 would not be made compulsory, almost one French person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more French people declare accepting to be vaccinated).

In view of the gradual vaccine supply schedule for the year 2021, the French National Authority for Health established at the end of 2020 a prioritization by vaccine availability phases. The critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to SARS-CoV-2.

For these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the SARS-CoV-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.

lead_sponsor: University Hospital, Angers


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


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: Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

summary: Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

lead_sponsor: University Hospital, Clermont-Ferrand


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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lead_sponsor: Centre Leon Berard

location_facility: CHU de Grenoble - Hôpital Couple Enfants


title: Detection of COPD in Primary Care

acronym: DISCO

summary:
Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people over 40 in France. COPD is responsible for a significant impairment of quality of life and was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.

However, about 75% of patients with COPD are not diagnosed. Spirometry is the only examination for the diagnosis of COPD. Patients identified at risk for COPD are insufficiently using spirometry and general practitioners (GPs) underestimate the severity of COPD when they do not practice spirometry in their patients. COPD is often diagnosed too late, the disease being discovered at the stage of complications requiring hospitalization. The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing a specialist performing spirometry, their reluctance to perform spirometry, and the insufficient involvement of general practitioners.

Currently in France, targeted screening for COPD and diagnosis in primary care is a major challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not indicate a systematic screening in the general population for COPD but advocate targeted screening of patients by five questions to identify risk factors and symptoms of COPD. The presence of at least one of these factors in an adult over the age of 40 requires spirometry.

Recent studies suggest the relevance of finding primary care variables for smoking and respiratory symptoms in order to identify new cases of COPD.

However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD in general practice has not been demonstrated. Moreover, the heterogeneity of the provision of care according to the territories limits a fast or easy access (distance) to the spirometry.

It is therefore necessary to evaluate in primary care the interest of a targeted screening of COPD and the interest of a coordination of care for the realization of a spirometry, in order to improve the rate of diagnosis of the disease.

primary_purpose: Screening

lead_sponsor: Rennes University Hospital


type: EudraCT Number

title: Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults:a Staggered Phase Ia/Ib, Randomised, Double-blind, Multi-Centre Trial

summary: The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults not previously exposed to the parasite P.falciparum and in healthy African adults exposed to the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria.

ReferenceCitation: Sirima SB, Durier C, Kara L, Houard S, Gansane A, Loulergue P, Bahuaud M, Benhamouda N, Nebié I, Faber B, Remarque E, Launay O; AMA1-DiCo Study Group. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1-DiCo malaria vaccine adjuvanted with GLA-SE or Alhydrogel® in European and African adults: A phase 1a/1b, randomized, double-blind multi-centre trial. Vaccine. 2017 Oct 27;35(45):6218-6227. doi: 10.1016/j.vaccine.2017.09.027. Epub 2017 Sep 22.

family: Sirima

full_name: S.B. Sirima

family: Durier

full_name: C. Durier

given: C.

family: Kara

full_name: L. Kara

given: L.

family: Houard

full_name: S. Houard

given: S.

family: Gansane

full_name: A. Gansane

given: A.

family: Loulergue

full_name: P. Loulergue

given: P.

family: Bahuaud

full_name: M. Bahuaud

given: M.

family: Benhamouda

full_name: N. Benhamouda

given: N.

family: Nebié

full_name: I. Nebié

given: I.

family: Faber

full_name: B. Faber

given: B.

family: Remarque

full_name: E. Remarque

given: E.

family: Launay

full_name: O. Launay

given: O.

family: Ouedraogo

full_name: E. Ouedraogo

family: Sanou

full_name: G. Sanou

given: G.

family: Gueguen

full_name: S. Gueguen

family: Lopez Perez

full_name: E. Lopez Perez

family: Ammour

full_name: K. Ammour

given: K.

family: Kocken

full_name: C. Kocken

family: Batteux

full_name: F. Batteux

given: F.

family: Tartour

full_name: E. Tartour

journal_name: Vaccine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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

location_country:
France
Burkina Faso

location_facility: CIC BT 505 de vaccinologie Cochin Pasteur

intervention_type: Biological


title: Development of a Serum Test for Colorectal Cancer Screening

acronym: COLODIAG pre

summary:
Colorectal cancer (CRC) is a major public health problem, with 44,872 new cases per year in France (3rd most common cancer), and 17,684 deaths (2nd cause of death from cancer).

Colorectal cancer screening is used to detect early-stage cancers and precancerous lesions (adenomas). Detecting the disease at an early stage enables curative treatment, which is less aggressive and less costly than treatment at an advanced stage.

Fecal occult blood screening has proven its effectiveness in the general population, with a 14% to 16% reduction in colorectal cancer mortality, and even a drop in incidence with 2nd generation immunological tests (FIT).

In France, organised colorectal cancer screening in the general population has been in place since 2009 and since 2015 has been based on the use of a quantitative immunological test (OC-Sensor®).

This test is offered every 2 years to men and women aged between 50 and 74 with an average risk of developing CRC, i.e. nearly 19.7 million people.

The disadvantages of the current screening test are:

Insufficient sensitivity, although the FIT is more sensitive than the old guaiac test, its sensitivity is not perfect.
Insufficient specificity: many colonoscopies are performed for nothing. This unjustifiably exposes many patients to endoscopic complications and incurs an unnecessary cost to society.
The participation rate in screening is too low. Colorectal cancer screening participation was 32.1% in 2017/2018, below the European minimum efficiency target of 45% and far below the 71% observed in our Dutch neighbours.

Several non-invasive alternatives for colorectal cancer screening are being explored and proposed. Among these techniques, serum protein assay has shown its interest in terms of screening for adenomas and colorectal cancers. The assay of 7 serum proteins (which will be the subject of a patent application in 2020), by ELISA test, is the subject of this study.

These results need to be confirmed in a prospective study, with comparison to the gold standard: total colonoscopy. If these results are confirmed, this would make it possible to develop a new non-invasive method of colorectal cancer screening, which would have several advantages over the current test: better sensitivity than the FIT (estimated at about 38% for the detection of advanced adenomas and 88% for colorectal cancers) which would limit the number of false negatives and decrease the number of colorectal cancers discovered at a late stage, a better specificity which would limit the number of false positives and decrease the number of unnecessary colonoscopies, a better participation in the screening test, and a reasonable cost with a technique that can be routinely performed in many centres.

Prior to this prospective clinical study, a pre-clinical calibration phase of the test (combined dosage of the 7 candidate proteins) is necessary, which is the subject of the present project.


title: Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking

acronym: APPLITABAC

summary:
Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage.

Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8% of smokers after 7 years of establishment in the USA).

An English study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("You smoke, you cough for more than 3 weeks, consult").

Regarding COPD, it is linked to tobacco in 85% of cases, affects 3.5 million French and is in 2013 the 4th leading cause of death in France. The evolution of COPD is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. COPD remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in France.

Dr DENIS has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial.

The Applitabac app takes this concept of symptom self-assessment by patients. By multiplying the number of symptoms analyzed compared to the English study, Applitabac should be able to increase the sensitivity of this early detection of COPD and increase the number of operable bronchial cancers and increase the chances of survival of patients.

ReferenceType: result

ReferenceCitation: Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.

name: Institut Inter-régional de Cancérologie Jean Bernard, Le Mans, France

family: Denis

full_name: Fabrice Denis

given: Fabrice

name: Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill

family: Basch

full_name: Ethan Basch

given: Ethan

family: Septans

full_name: Anne-Lise Septans

given: Anne-Lise

name: Thoracic and Digestive Oncology, CHU Nantes, Nantes, France

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

name: Service de pneumologie, Centre Hospitalier Universitaire, Angers, France

family: Urban

full_name: Thierry Urban

given: Thierry

family: Dueck

full_name: Amylou C. Dueck

given: Amylou C.

name: Normandie Université–CORIA, Rouen, France

family: Letellier

full_name: Christophe Letellier

given: Christophe

oa_colors: green other

ReferenceCitation: Ironmonger L, Ohuma E, Ormiston-Smith N, Gildea C, Thomson CS, Peake MD. An evaluation of the impact of large-scale interventions to raise public awareness of a lung cancer symptom. Br J Cancer. 2015 Jan 6;112(1):207-16. doi: 10.1038/bjc.2014.596. Epub 2014 Dec 2.

family: Ironmonger

full_name: L Ironmonger

given: L

family: Ohuma

full_name: E Ohuma

given: E

family: Ormiston-Smith

full_name: N Ormiston-Smith

given: N

family: Gildea

full_name: C Gildea

given: C

family: Thomson

full_name: C S Thomson

given: C S

family: Peake

full_name: M D Peake

given: M D

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via page says license)


title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins

summary: The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.

lead_sponsor: Biomatlante

location_facility: CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique

location_facility: CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie

location_facility: CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C

location_facility: Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière


title: Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

summary:
To investigate in a prospective way changes in Mucosal-Associated Invariant T (MAIT) cells frequency, phenotype and function in link with the gut microbiota, gut integrity and the presence of Coxsackie virus B in two cohorts of pediatric patients: patients with a high genetic risk of type 1 diabetes and pediatric patients with recently diagnosed T1D by comparison with control subjects

Tasks:

To measure blood MAIT cells frequency, phenotype and function in the three cohorts
To analyze gut microbiota and the presence of Coxsackie B enterovirus (CVB) and their impact on MAIT cell function
To evaluate gut integrity and analyze the gut mucosa
To integrate all the data obtained with T1D development and evolution

ReferenceCitation: Rouxel O, Da Silva J, Beaudoin L, Nel I, Tard C, Cagninacci L, Kiaf B, Oshima M, Diedisheim M, Salou M, Corbett A, Rossjohn J, McCluskey J, Scharfmann R, Battaglia M, Polak M, Lantz O, Beltrand J, Lehuen A. Cytotoxic and regulatory roles of mucosal-associated invariant T cells in type 1 diabetes. Nat Immunol. 2017 Dec;18(12):1321-1331. doi: 10.1038/ni.3854. Epub 2017 Oct 9. Erratum in: Nat Immunol. 2018 Jun 7;:.

ReferenceCitation: Rouland M, Beaudoin L, Rouxel O, Bertrand L, Cagninacci L, Saffarian A, Pedron T, Gueddouri D, Guilmeau S, Burnol AF, Rachdi L, Tazi A, Mouriès J, Rescigno M, Vergnolle N, Sansonetti P, Christine Rogner U, Lehuen A. Gut mucosa alterations and loss of segmented filamentous bacteria in type 1 diabetes are associated with inflammation rather than hyperglycaemia. Gut. 2021 Feb 16. pii: gutjnl-2020-323664. doi: 10.1136/gutjnl-2020-323664. [Epub ahead of print]

location_facility:
Hopital Necker enfants malades
Hopital privé d'Antony


title: Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

summary: Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).

status: Terminated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique

intervention_type: Drug


title: Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes

acronym: CARNet

summary:
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population.

However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding.

As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship.

The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period.

In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).

ReferenceCitation: Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94.

ReferenceCitation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum in: Ann Rheum Dis. 2010 Oct;69(10):1892.

ReferenceCitation: Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daurès JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.

ReferenceCitation: Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.

ReferenceCitation: Guillemin F, Brainçon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.

ReferenceCitation: Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.

ReferenceCitation: Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.

ReferenceCitation: Gossec L, Cantagrel A, Soubrier M, Berthelot JM, Joubert JM, Combe B, Czarlewski W, Wendling D, Dernis E, Grange L, Beauvais C, Perdriger A, Nataf H, Dougados M, Servy H. An e-health interactive self-assessment website (Sanoia(®)) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients. Joint Bone Spine. 2018 Dec;85(6):709-714. doi: 10.1016/j.jbspin.2017.11.015. Epub 2017 Dec 12.

family: Gossec

full_name: Laure Gossec

given: Laure

family: Cantagrel

full_name: Alain Cantagrel

given: Alain

family: Soubrier

full_name: Martin Soubrier

given: Martin

family: Berthelot

full_name: Jean-Marie Berthelot

given: Jean-Marie

family: Joubert

full_name: Jean-Michel Joubert

given: Jean-Michel

family: Combe

full_name: Bernard Combe

given: Bernard

family: Czarlewski

full_name: Wienia Czarlewski

given: Wienia

family: Wendling

full_name: Daniel Wendling

given: Daniel

family: Dernis

full_name: Emmanuelle Dernis

given: Emmanuelle

family: Grange

full_name: Laurent Grange

given: Laurent

family: Beauvais

full_name: Catherine Beauvais

given: Catherine

family: Perdriger

full_name: Aleth Perdriger

given: Aleth

family: Nataf

full_name: Henri Nataf

given: Henri

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Servy

full_name: Hervé Servy

given: Hervé

journal_name: Joint Bone Spine

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

version: submittedVersion

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

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

title: An e-health interactive self-assessment website (Sanoia®) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients

lead_sponsor: Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers

location_facility: University Hospital La Pitié Salpétrière

location_facility: University Hospital of Grenoble - Hôpital Sud


title: Pilot Study of the Impact of Rosuvastatin Administration on Residual Chronic Immune Activation Under Antiretroviral Therapy: CESAR (Crestor En Sus Des AntiRétroviraux)

acronym: CESAR

summary: Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4 and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio To study the relationship between the level of immune activation and the level of residual HIV replication in plasma To study the effect of Rosuvastatin administration on lipid profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
HEGP
St Antoine Hospital


title: Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood

acronym: CO19 COVERTE

summary:
Background: With the improvement of the prognosis for HIV-infected infants, thanks to the availability of antiretroviral therapies, young adults infected with HIV since birth are becoming an emerging group among the HIV-infected population. Morbidity, mortality and immunovirological evolution in these young adults need to be studied in a large population and compared to patients infected with HIV later in adulthood or to the general population in terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV and/or antiretroviral therapy, is particularly interesting in this population.

Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2 perinatally infected young adults: 1) To study the teenager to adult transition in terms of clinical and immunovirological status, schooling and professional integration, sexuality and reproductive life, transition from paediatrics to adult departments; 2) To study prognosis, morbidity and mortality according to age, infection stage at the time of antiretroviral initiation and therapeutic history; 3) To study the incidence and expression of adverse events and the potential link to antiretroviral therapies; 4) To study the markers of a potential premature ageing, from the metabolic, cardiovascular and immunological points of view.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems

acronym: observatory

summary: An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update. Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.

ReferenceCitation: Chambellan A, Chailleux E, Similowski T; ANTADIR Observatory Group. Prognostic value of the hematocrit in patients with severe COPD receiving long-term oxygen therapy. Chest. 2005 Sep;128(3):1201-8. Erratum in: Chest. 2006 Mar;129(3):831.

ReferenceCitation: Chailleux E, Laaban JP, Veale D. Prognostic value of nutritional depletion in patients with COPD treated by long-term oxygen therapy: data from the ANTADIR observatory. Chest. 2003 May;123(5):1460-6.

ReferenceCitation: Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. Review. French.

ReferenceCitation: Veale D, Chailleux E, Hoorelbeke-Ramon A, Reybet-Degas O, Humeau-Chapuis MP, Alluin-Aigouy F, Fleury B, Jonquet O, Michard P. Mortality of sleep apnoea patients treated by nasal continuous positive airway pressure registered in the ANTADIR observatory. Association Nationale pour le Traitement A Domicile de l'Insuffisance Respiratoire chronique. Eur Respir J. 2000 Feb;15(2):326-31.

ReferenceCitation: Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4.

ReferenceCitation: Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. Review. French.

ReferenceCitation: Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche


title: eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study

acronym: eDiagEPU

summary: In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

ReferenceCitation: Blavier F, Cosyns S, Dony N, Faron G, Parra J, Gucciardo L. Perception and knowledge of early pregnancy assessment units among perinatal practitioners in Europe. Int J Gynaecol Obstet. 2018 Dec;143(3):289-299. doi: 10.1002/ijgo.12661. Epub 2018 Sep 21.

name: Department of Obstetrics and Prenatal Medicine; Univeritair Ziekenhuis Brussel; Vrij Universiteit Brussel; Brussels Belgium

family: Blavier

full_name: Frédéric Blavier

given: Frédéric

name: Department of Gynecology; Univeritair Ziekenhuis Brussel; Vrij Universiteit Brussel; Brussels Belgium

family: Cosyns

full_name: Stefan Cosyns

given: Stefan

family: Dony

full_name: Noëlie Dony

given: Noëlie

family: Faron

full_name: Gilles Faron

given: Gilles

name: Faculty of Medicine; Univeritair Ziekenhuis Brussel; Vrij Universiteit Brussel; Brussels Belgium

family: Parra

full_name: José Parra

given: José

family: Gucciardo

full_name: Leonardo Gucciardo

given: Leonardo

journal_name: International Journal of Gynecology & Obstetrics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Program to Help Return Home Patients Hospitalized for Heart Failure, in a Cohort of Patients From the Hôpital Paris Saint-Joseph

summary:
The prevalence of heart failure is very high worldwide is between 1 and 2% in developed countries.

The French Federation of Cardiology estimates that a million people are affected in France. Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. In 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.

The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. The CPAM (Caisse Primaire d'Assurance Maladie) has set up since 2013 the PRADO-IC program (Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital.

A specially trained nurse visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity. It provides therapeutic education with reinforcement of hygieno-dietetic rules, warning signs, checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation.

The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.

ReferenceCitation: Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juillière Y, Alla F, Allemand H, Bauters C, Drici MD, Hagège A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up. Arch Cardiovasc Dis. 2013 Nov;106(11):570-85. doi: 10.1016/j.acvd.2013.08.002. Epub 2013 Oct 18.

family: Tuppin

full_name: Philippe Tuppin

given: Philippe

family: Cuerq

full_name: Anne Cuerq

given: Anne

family: de Peretti

full_name: Christine de Peretti

given: Christine

family: Fagot-Campagna

full_name: Anne Fagot-Campagna

family: Danchin

full_name: Nicolas Danchin

given: Nicolas

family: Juillière

full_name: Yves Juillière

given: Yves

family: Alla

full_name: François Alla

given: François

family: Allemand

full_name: Hubert Allemand

given: Hubert

family: Bauters

full_name: Christophe Bauters

given: Christophe

family: Drici

full_name: Milou-Daniel Drici

given: Milou-Daniel

family: Hagège

full_name: Albert Hagège

given: Albert

family: Jondeau

full_name: Guillaume Jondeau

given: Guillaume

family: Jourdain

full_name: Patrick Jourdain

given: Patrick

family: Leizorovicz

full_name: Alain Leizorovicz

given: Alain

family: Paccaud

full_name: Fred Paccaud

given: Fred

journal_name: Archives of Cardiovascular Diseases

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: First hospitalization for heart failure in France in 2009: Patient characteristics and 30-day follow-up

ReferenceCitation: Assyag P, Renaud T, Cohen-Solal A, Viaud M, Krys H, Bundalo A, Michel PL, Boukobza R, Bourgueil Y, Cohen A. RESICARD: East Paris network for the management of heart failure: absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation. Arch Cardiovasc Dis. 2009 Jan;102(1):29-41. doi: 10.1016/j.acvd.2008.10.013. Epub 2009 Feb 10.

family: Assyag

full_name: Patrick Assyag

family: Renaud

full_name: Thomas Renaud

given: Thomas

family: Cohen-Solal

full_name: Alain Cohen-Solal

family: Viaud

full_name: Magali Viaud

given: Magali

family: Krys

title: RESICARD: East Paris network for the management of heart failure: Absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735.

name: From the Advanced Heart Disease Section, Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: The Three-Phase Terrain of Heart Failure Readmissions


title: Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales

acronym: ELASTOGLI

summary:
Surgery for brain gliomas is usually guided by different imaging techniques including neuronavigation MRI and intraoperative ultrasound that do not allow visualization of the low-density peri-lesional tumor infiltration present in gliomas and from which the tumor recurs.

Another important aspect in the management of glial tumors is the histological grade. The appearance of new vessels (called neo-angiogenesis) is one of the crucial steps in the life of these tumors, which signifies the transition to anaplasia.

This neoangiogenesis is diagnosed during the anatomopathological analysis of the operative specimen, and may be suspected on preoperative MRI on the so-called infusion sequences.

The objective of this project is to evaluate the potential of two ultrasound modalities - elastography and ultrasensitive Doppler - in helping the surgical management of brain tumors. Ultrasound elastography measures cerebral elasticity and thus indirectly the degree of tumor infiltration; while ultrasensitive Doppler measures intratumoral vascularization, and could therefore help in the diagnosis of tumor anaplasia.

ReferenceCitation: Lima GLO, Dezamis E, Corns R, Rigaux-Viode O, Moritz-Gasser S, Roux A, Duffau H, Pallud J. Surgical resection of incidental diffuse gliomas involving eloquent brain areas. Rationale, functional, epileptological and oncological outcomes. Neurochirurgie. 2017 Jun;63(3):250-258. doi: 10.1016/j.neuchi.2016.08.007. Epub 2017 Feb 1.

family: Lima

full_name: G.L.O. Lima

family: Dezamis

full_name: E. Dezamis

given: E.

family: Corns

full_name: R. Corns

given: R.

family: Rigaux-Viode

full_name: O. Rigaux-Viode

given: O.

family: Moritz-Gasser

full_name: S. Moritz-Gasser

given: S.

family: Roux

full_name: A. Roux

given: A.

family: Duffau

full_name: H. Duffau

given: H.

family: Pallud

full_name: J. Pallud

given: J.

journal_name: Neurochirurgie

ReferenceCitation: Mahboob S, McPhillips R, Qiu Z, Jiang Y, Meggs C, Schiavone G, Button T, Desmulliez M, Demore C, Cochran S, Eljamel S. Intraoperative Ultrasound-Guided Resection of Gliomas: A Meta-Analysis and Review of the Literature. World Neurosurg. 2016 Aug;92:255-263. doi: 10.1016/j.wneu.2016.05.007. Epub 2016 May 10. Review.

family: Mahboob

full_name: Syed Mahboob

given: Syed

family: McPhillips

full_name: Rachael McPhillips

given: Rachael

family: Qiu

full_name: Zhen Qiu

given: Zhen

family: Jiang

full_name: Yun Jiang

given: Yun

family: Meggs

full_name: Carl Meggs

given: Carl

family: Schiavone

full_name: Giuseppe Schiavone

given: Giuseppe

family: Button

full_name: Tim Button

given: Tim

family: Desmulliez

full_name: Marc Desmulliez

given: Marc

family: Demore

full_name: Christine Demore

family: Cochran

full_name: Sandy Cochran

given: Sandy

family: Eljamel

full_name: Sam Eljamel

given: Sam

journal_name: World Neurosurgery

repository_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Ferraro N, Barbarite E, Albert TR, Berchmans E, Shah AH, Bregy A, Ivan ME, Brown T, Komotar RJ. The role of 5-aminolevulinic acid in brain tumor surgery: a systematic review. Neurosurg Rev. 2016 Oct;39(4):545-55. doi: 10.1007/s10143-015-0695-2. Epub 2016 Jan 27. Review.

ReferenceCitation: Coburger J, Merkel A, Scherer M, Schwartz F, Gessler F, Roder C, Pala A, König R, Bullinger L, Nagel G, Jungk C, Bisdas S, Nabavi A, Ganslandt O, Seifert V, Tatagiba M, Senft C, Mehdorn M, Unterberg AW, Rössler K, Wirtz CR. Low-grade Glioma Surgery in Intraoperative Magnetic Resonance Imaging: Results of a Multicenter Retrospective Assessment of the German Study Group for Intraoperative Magnetic Resonance Imaging. Neurosurgery. 2016 Jun;78(6):775-86. doi: 10.1227/NEU.0000000000001081.

name: Department of Neurosurgery, University of Ulm, Günzburg, Germany

name: Department of Neurosurgery, University of Erlangen, Erlangen, Germany

name: Department of Neurosurgery, University of Heidelberg, Heidelberg, Germany

name: Department of Neurosurgery, University of Schleswig-Holstein, Kiel, Germany

name: Department of Neurosurgery, University of Frankfurt, Frankfurt, Germany

name: Department of Neurosurgery, University of Tübingen, Tübingen, Germany

name: Department of Internal Medicine III, University of Ulm, Ulm, Germany

name: Institute for Epidemiology and Medical Biometrics, University of Ulm, Ulm, Germany

name: Department of Neuroradiology, University of Tübingen, Tübingen, Germany

name: Department of Neurosurgery, International Neuroscience Institute Hannover, Hannover, Germany

name: Department of Neurosurgery, Klinikum Stuttgart, Stuttgart, Germany

ReferenceCitation: Gerard IJ, Kersten-Oertel M, Petrecca K, Sirhan D, Hall JA, Collins DL. Brain shift in neuronavigation of brain tumors: A review. Med Image Anal. 2017 Jan;35:403-420. doi: 10.1016/j.media.2016.08.007. Epub 2016 Aug 24. Review.

ReferenceCitation: Chauvet D, Imbault M, Capelle L, Demene C, Mossad M, Karachi C, Boch AL, Gennisson JL, Tanter M. In Vivo Measurement of Brain Tumor Elasticity Using Intraoperative Shear Wave Elastography. Ultraschall Med. 2016 Dec;37(6):584-590. Epub 2015 Apr 15.


title: Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

acronym: VIGITRAUMA

summary:
A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard.

Control group will benefit from usual follow-up.

All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.

lead_sponsor: University Hospital, Lille

location_facility:
University Hospital, Lille
University Hospital, Amiens
University Hospital, Rouen
General Hospital, Saint-Quentin
University Hospital, Caen
General Hospital, Valenciennes
General Hospital, Boulogne sur Mer
General Hospital, Creil


title: Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District

acronym: PURPLE

summary:
This is an observational prospective multicenter study of patients admitted for acute dyspnea in an emergency department of the participating centers in the Lorraine district.

The primary objective is to assess the outcome of this population according to the cause of acute dyspnea as well as identify the predictors of this outcome, both overall and according to each acute dyspnea cause.

ReferenceCitation: Buessler A, Chouihed T, Duarte K, Bassand A, Huot-Marchand M, Gottwalles Y, Pénine A, André E, Nace L, Jaeger D, Kobayashi M, Coiro S, Rossignol P, Girerd N. Accuracy of Several Lung Ultrasound Methods for the Diagnosis of Acute Heart Failure in the ED: A Multicenter Prospective Study. Chest. 2020 Jan;157(1):99-110. doi: 10.1016/j.chest.2019.07.017. Epub 2019 Aug 2.

family: Buessler

full_name: Aurélien Buessler

given: Aurélien

family: Chouihed

full_name: Tahar Chouihed

given: Tahar

family: Duarte

full_name: Kévin Duarte

given: Kévin

family: Bassand

full_name: Adrien Bassand

given: Adrien

family: Huot-Marchand

full_name: Matthieu Huot-Marchand

given: Matthieu

family: Gottwalles

full_name: Yannick Gottwalles

given: Yannick

family: Pénine

full_name: Alice Pénine

given: Alice

family: André

full_name: Elies André

given: Elies

family: Nace

full_name: Lionel Nace

given: Lionel

family: Jaeger

full_name: Déborah Jaeger

given: Déborah

family: Kobayashi

full_name: Masatake Kobayashi

given: Masatake

family: Coiro

full_name: Stefano Coiro

given: Stefano

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

journal_name: Chest

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

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

lead_sponsor: Central Hospital, Nancy, France

location_facility: CH SAINT-DIE-DES-VOSGES - Service des Urgences

location_facility: CH Marie-Madeleine FORBACH - Service des Urgences

location_facility: CHR METZ-THIONVILLE- Hôpital de Mercy- Service des Urgences

location_facility: CHR METZ-THIONVILLE- Hôpital Bel-Air- Service des Urgences


title: Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

acronym: EMIBICI

summary: Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks' gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental examination. This extensive protocol testing may vary in clinical practice and interpretation of the results is rarely performed by multidisciplinary staff to establish cause of death. These findings are related to the fact that there are very few epidemiological studies to validate optimal protocol, no French recommendations on this subject, and a relative lack of pathologists with expertise in perinatal pathology. Only, one recent prospective study from the Netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may only be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, there are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in France may contribute to detection of the vast majority of severe chromosomal abnormalities and malformed fetuses and particularly those at risk of death. Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities. In fact in these two series, most deaths were related to placental diseases or fetal growth retardation. The hypothesis is that extensive protocol testing is not helpful in clinical practice and selective protocol testing focused on specific risk situations can be as efficient.

lead_sponsor: University Hospital, Rouen


title: Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps

acronym: PROCOPAD

summary: Since the beginning of the COVID-19 outbreak in France, nursing homes (NH) have been heavily affected. In this study, the investigators want to evaluate the factors associated with the occurrence of COVID-19 epidemic clusters within the nursing homes in the French Alps

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 Pandemic: Messages From Families Answering the ECHO French National Survey

acronym: ECHO

summary: During the COVID-19 pandemic, lockdown measures were established in France affecting the life course of children with disabilities. This study aimed at identifying the experiences, main difficulties and needs of these children and their parents during the lockdown period.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Brest


title: Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation

acronym: CERBois

summary:
The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.

Secondary purposes are:

Feasibility evaluation of identification of former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics in case of co-expositions (formaldehyde, chrome, nickel, leather)
Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test
Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases
Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program
Evaluation of information flow among different players
Assessment of costs induced by this targeted screening: direct medical costs (screened pathologies, induced additional examinations…) and indirect costs for company (duration of worker absence for transfer, medical and additional examinations).

location_facility: Centres de Consultations de Pathologies Professionnelles


title: Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage

acronym: HD-ROTEM

summary: Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures

acronym: DRAGET

summary:
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.

Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.

ReferenceCitation: Bonnemains L, Cherifi A, Girerd N, Odille F, Felblinger J. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies. BMJ Open. 2015 Oct 29;5(10):e008963. doi: 10.1136/bmjopen-2015-008963.

family: Bonnemains

full_name: Laurent Bonnemains

given: Laurent

family: Cherifi

full_name: Aboubaker Cherifi

given: Aboubaker

family: Odille

full_name: Freddy Odille

given: Freddy

family: Felblinger

full_name: Jacques Felblinger

given: Jacques

title: Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2quantification with MRI in comparison to myocardial biopsies

location_facility:
Hospices Civils de Lyon
CHU de Nantes
Groupe Hospitalier Pitié-Salpêtrière
CHU de Tours
CHU Bordeaux
Hopitaux Universitaires de Strasbourg
CHU Grenoble
CHRU Nancy Brabois
Hôpital Européen Georges Pompidou
CHU de Rennes


title: Adolescent Dysmenorrhea : Prevalence, Severity, Experience and Management in the Use of Medication in High School Girls in Ille-et-Vilaine

acronym: DAPsvs

summary:
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Primary dysmenorrhea is painful menstrual periods not due to other diseases, and often occurs soon after menarche. Secondary dysmenorrhea is due to an underlying pelvic abnormality, such as endometriosis.

Dysmenorrhea is the most common gynecological complaint. In many studies, the prevalence of primary dysmenorrhea varies between 34 % in 2010 in Egypt, 86.6% in 2002 in Switzerland, and 21% in 1999 in France.

Nowadays, physiopathology is better understood, which suggests that we have treatments Although dysmenorrhea is a common concern, many women never seek medical advice, even though treatments are easily available and simple.

In fact, despite the high prevalence, dysmenorrhea is undertreated and even disregarded by health professionals, and the girls themselves, who may accept it as a normal part of the menstrual cycle.

The pain occurs just before and/or during menstruation ; it can be mild to severe and is frequently associated with many other symptoms, like nausea, vomiting, headache, diarrhea, tiredness and has many consequences in wellbeing and school. Dysmenorrhea is known to be the first cause of absenteism from school, and appears to have many consequences and a real impact on women's daily activities, which is why it's a public health problem.

Because of the lack of recent studies in France, the aim of this study is to evaluate the prevalence of adolescent dysmenorrhea. We also assessed its severity, how adolescent girls experienced their menses, and how they manage their pain (seeking medical consultation, use of medication).

We used a self-assessment questionnaire in a cohort of high school girls, aged 15 to 19 years old, during April and May of 2019, in 8 private and public high schools in Ille-et-Vilaine.