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

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

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

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

family: Mercier

full_name: Gregoire Mercier

given: Gregoire

family: Pastor

full_name: Jenica Pastor

given: Jenica

family: Clément

full_name: Valerie Clément

given: Valerie

family: Rodts

full_name: Ulysse Rodts

given: Ulysse

family: Moffat

full_name: Christine Moffat

given: Christine

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

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

version: acceptedVersion

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

lead_sponsor: University Hospital, Montpellier


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

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

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: DatAids

location_country: Martinique France Guadeloupe

location_facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

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

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

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

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

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

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

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

lead_sponsor_type: industriel

status_simplified: Ongoing


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

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

ipd_sharing: Undecided

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne

intervention_type: Other


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

acronym: PADELTO

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

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

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

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

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

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

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

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

time_perspective: Retrospective

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

lead_sponsor: Bayer

intervention_type: Procedure


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

acronym: IMPA

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

time_perspective: Cross-Sectional

lead_sponsor: Centre hospitalier de Ville-Evrard, France

lead_sponsor_type: academique


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

acronym: IPNSAE

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

study_start_date_type: Anticipated

status: Unknown status

lead_sponsor: Hospices Civils de Lyon

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

status_simplified: Unknown


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

acronym: LysoNeo

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

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

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
Caen University Hospital


type: Other Identifier

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

acronym: ADDICT-CCU

summary:
Background:

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

Objectives:

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

Eligibility:

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

Design:

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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

acronym: ATLAS-FR

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

lead_sponsor: Stryker Neurovascular

intervention_type: Device


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

acronym: DISPOSE

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

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

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Lille Catholic University

status_simplified: Completed


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

acronym: PROACTIF

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

ReferenceType: derived

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

lead_sponsor: Boston Scientific Corporation

location_facility: Centre Hospitalier Régional et Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de St Etienne


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

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

ipd_sharing_description: NC


intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Treatment

acronym: GRACE

type: EudraCT Number

source: euctr

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

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


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

acronym: CARBO

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

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

family: Bertolotti

full_name: Antoine Bertolotti

given: Antoine

sequence: first

family: Thioune

full_name: Marême Thioune

given: Marême

sequence: additional

family: Abel

full_name: Sylvie Abel

given: Sylvie

family: Belrose

full_name: Gilda Belrose

given: Gilda

family: Calmont

full_name: Isabelle Calmont

family: Césaire

full_name: Raymond Césaire

given: Raymond

family: Cervantes

full_name: Minerva Cervantes

given: Minerva

family: Fagour

full_name: Laurence Fagour

given: Laurence

family: Javelle

full_name: Émilie Javelle

given: Émilie

family: Lebris

full_name: Catherine Lebris

given: Catherine

family: Najioullah

full_name: Fatiha Najioullah

given: Fatiha

family: Pierre-François

full_name: Sandrine Pierre-François

given: Sandrine

family: Rozé

full_name: Benoît Rozé

given: Benoît

family: Vigan

full_name: Marie Vigan

given: Marie

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

family: Cabié

full_name: André Cabié

given: André

name: the Chronic Chikungunya working group of University Medical Center of Martinique

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS Neglected Tropical Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

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

lead_sponsor: University Hospital Center of Martinique

location_country:
Guadeloupe
French Guiana
Réunion
France
Martinique

location_facility: Centre Hospitalier Universitaire de Martinique


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

acronym: DysM et SOC

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

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

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


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

acronym: TboneR

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


title: Prevalence, Risk Factors and Impact of Anal Incontinence in Patients Followed for Crohn's Disease

acronym: CRIA

summary:
Anal incontinence affects nearly 5% of the adult population in France. It is defined as the inability for a subject to retain matter and/or gas, outside of voluntary defecation episodes. It results in an uncontrolled loss of gas or stool through the anus. To quantify, anal incontinence clinical scores have been developed of which the most used is the Cleveland score (Jorge and Wexner). A Cleveland score ≥ 5 corresponds to anal incontinence.

Crohn's disease is a chronic inflammatory disease that can affect the entire digestive tract as well as the anus. It leads to destruction of the intestinal wall if not treated early.

The presence of ano-perineal involvement is a factor of severity and poor prognosis of Crohn's disease. The management of these ano-perineal lesions is particularly difficult because of the risks of destruction of the anal sphincter and recurrence of these lesions, as well as the consequences that they induce on anal continence, sexuality and quality of life.

The prevalence of anal incontinence in Crohn's disease has been assessed in three studies by self-questionnaires. In 2013, it was studied in a cohort of British patients followed for chronic inflammatory bowel disease (IBD) (Hemorrhagic rectocolitis or Crohn's disease). Of the 3264 patients who responded to this questionnaire (32.5% of the cohort), 74% claimed to have anal incontinence and in 40% of cases it occurred regularly or a few times. In a study of 184 patients treated at an IBD expert center in Sri Lanka, anal incontinence was reported to be 26%. Only 5 patients reported regular anal incontinence. Vollebregt et al specifically studied the prevalence of anal incontinence in patients followed for Crohn's disease in a Dutch expert center. Of the 325 responses (62%), 20% of patients reported having had an episode of anal incontinence in the last 4 weeks.

In these studies, the prevalence of anal incontinence varies according to the definition of anal incontinence (qualitative or quantitative estimate) and the population studied. No French study has been published on the prevalence of anal incontinence in Crohn's disease.

status: Not yet recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


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

acronym: MEDIP

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

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

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

name: Center of Research in Epidemiology and Statistics (CRESS) INSERM National Institute for Agricultural Research (INRA) Université de Paris Paris France

name: Department of Obstetrics and Gynecology, AP-HP Louis Mourier HospitalUniversité de Paris Colombes France

family: Blanc‐Petitjean

full_name: Pauline Blanc‐Petitjean

given: Pauline

name: Department of Obstetrics and Gynecology AP-HP Robert Debré HospitalUniversité de Paris Paris France

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

name: AP-HP Cochin HospitalClinical Research Unit‐Clinical Investigation Center (URC‐CIC) Paris Descartes Necker/Cochin Paris France

family: Salomé

full_name: Marina Salomé

given: Marina

name: AP-HP Cochin HospitalPort Royal Maternity UnitUniversité de Paris ParisF-75014France

family: Goffinet

full_name: François Goffinet

given: François

family: Le Ray

full_name: Camille Le Ray

given: Camille

journal_name: Acta Obstetricia et Gynecologica Scandinavica

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Target populations to reduce cesarean rates after induced labor: A national population‐based cohort study

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

family: Jochum

full_name: Floriane Jochum

given: Floriane

family: Blanc-Petitjean

full_name: Pauline Blanc-Petitjean

family: Langer

full_name: Bruno Langer

given: Bruno

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

family: Severac

full_name: François Severac

family: Sananes

full_name: Nicolas Sananes

journal_name: Obstetrics & Gynecology

oa_host_type: publisher

evidence: open (via free article)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Externally Validated Score to Predict Cesarean Delivery After Labor Induction With Cervical Ripening

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


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

acronym: PIPAC-GRE

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

lead_sponsor: University Hospital, Grenoble


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

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

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

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

status: Terminated

lead_sponsor: Hyprevention

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


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

acronym: TRATT

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

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

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

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

ReferenceType: result

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

lead_sponsor: Centre Hospitalier Universitaire de Besancon


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

acronym: PASST

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

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Supportive Care

ReferenceType: background

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

ReferenceCitation: Nordström L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8.

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

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

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


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

acronym: OLAF

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

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse


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

acronym: PREVISION

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

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

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

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

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


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

acronym: CONSUME

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

intervention_type: Behavioral


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

acronym: CHRYSALIDE

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

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

family: Cougot

full_name: Baptiste Cougot

given: Baptiste

family: Gauvin

full_name: Jules Gauvin

given: Jules

family: Gillet

full_name: Nicolas Gillet

family: Bach-Ngohou

full_name: Kalyane Bach-Ngohou

given: Kalyane

family: Lesot

full_name: Johan Lesot

given: Johan

family: Getz

full_name: Isaac Getz

given: Isaac

family: Deparis

full_name: Xavier Deparis

given: Xavier

family: Longuenesse

full_name: Claire Longuenesse

given: Claire

family: Armant

full_name: Anne Armant

given: Anne

family: Bataille

full_name: Emmanuelle Bataille

given: Emmanuelle

family: Leclere

full_name: Brice Leclere

given: Brice

family: Fleury-Bahi

full_name: Ghozlane Fleury-Bahi

given: Ghozlane

family: Moret

full_name: Leïla Moret

given: Leïla

family: Tripodi

full_name: Dominique Tripodi

given: Dominique

currency_apc_doaj: GBP

journal_name: BMC Health Services Research

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

repository_normalized: HAL

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


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

acronym: PrediLynch

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

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

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

lead_sponsor: University Hospital, Lille


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

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

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

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

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

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

lead_sponsor: University Hospital, Montpellier


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

acronym: QSAMISA

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

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

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

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France

acronym: COVIDICA

summary: To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.

lead_sponsor: Poitiers University Hospital

location_facility:
RANDRIAN Violaine
MOULIN Valérie
BOURGEOIS Hugues


title: Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa That Come for Their Annual/Biannual Check up at This Medical Rare Disease Reference Centers (MRDRC) of This Disease in France and Belgium

summary: Hereditary Epidermolysis Bullosa (EBH) are rare dermatologic diseases characterized by cutaneous and mucosa fragility. Oral manifestations of few small cohort have been published. The main objective of this multicentric cohort study first in Europe was to report the oral status of these patients that were consulted in the MRDRC of this disease in Nice (France), Toulouse (France) and Louvain (Belgium). Then a correlation between the oral characteristics and the EBH type will be made, in order to facilitate the management of patient care and the prevention program that can be established to improve their oral health.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Nice Hospital
Toulouse University


title: National, Multicentre, Prospective, Observational Study, to Evaluate the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

summary:
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.

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

A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Nouvelle Clinique de Tours Plus St Gatien


title: New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

acronym: NeoVie

summary:
Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest.

Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.

All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.

All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.

lead_sponsor: AbbVie

location_facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700

location_facility: Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie - 08 /ID# 223794

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776

location_facility: Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682

location_facility: Csapa Doaur Nevez de Ploermel /Id# 240583

location_facility: Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683

location_facility: Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Poitiers /ID# 239487

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie- LOGOS /ID# 221283

location_facility: Association Tremplin 17 - Saintes /ID# 218708

location_facility: CHRU de Nancy - Maison des addictions /ID# 221488

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703

location_facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516

location_facility: Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- CASANOVA /ID# 218705

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie - LANNION /ID# 238853

location_facility: Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793

location_facility: Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678

location_facility: CSAPA Danielle CASANOVA - MARSEILLE /ID# 240352

location_facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie-ANPAA 52 /ID# 218672


title: Qualitative Analysis Based on Medical Records of 300 Patients With Back Musculoskeletal Disorders Receiving a Physiotherapy Prescription From Primary Physicians in France

acronym: PresKi

summary:
"Prescription in France is a major act of medical activity and must be in accordance with the scientific evidence. The use of physiotherapy by primary physicians is becoming more and more frequent and involves the performance of a prescription given to the patients so that they can access to their care. The optimization of the use of this treatment is based on the respect of several legal and regulatory provisions allowing physiotherapists (PT) to offer the most appropriate treatment to the patient. Although these professionals can carry out a physiotherapy diagnosis and the objectives of care, as well as the choice of the acts and the techniques which seem to them the most appropriate. The performance of their treatment remains conditioned by the indication to physiotherapy and the anatomical region formulated by the prescription of the primary physicians. Primary physicians don't have the right to include their diagnostic hypothesis on the physiotherapy prescription. Therefore, they could transmit to the PT a supplementary report including all useful information for the PT which could influence the progress of the treatment.

It has been reported a frequent absence of diagnostic hypothesis formulated by the primary physicians to the PT to justify the indication to these treatment with the prescription. However, PT are led to formulate one or more diagnostic hypothesis following their clinical assessment. This can lead to questioning the interest of prescription for referring the patient from the primary physician to the PT.

The qualitative study by Panchout et al shows that 97.8% of the french private physiotherapists included treat patients with musculoskeletal disorders and 95.5% received those with back disorders. Back musculoskeletal disorders are the most common conditions reported from french private PT.

No French study has yet analyzed the quality of prescriptions formulated by primary physicians for private physiotherapists. Much foreign health systems have a different model of access to physiotherapy services compared to the French system, involving direct access physiotherapy for patients with musculoskeletal disorders. This care pathway gives patients the ability to refer themselves directly to a PT without having to see another health professional. Patients do not need a prescription in this model of access to physiotherapy care to use it.

Thus, in order to optimize the relevance of the use of physiotherapy for patients with back musculoskeletal disorders, we propose a prospective and cross-sectional observational study of 60 physiotherapists. The first aim of this study is to assess the relevance of the physiotherapy indication from primary care physicians for patients with back musculoskeletal disorders and consulting physiotherapists.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Consequences of the Abrupt Interruption of Physical and Rehabilitation Medicine Consultations During the Quarantine Period in France Between 2020 March 17th and May 11th

acronym: Handicall

summary:
Objectives This survey aims at reporting the immediate impact of the COVID-19 epidemic on outpatients followed in Physical and Rehabilitation Medicine (PRM). It focuses on the disruption of PRM healthcare services during the quarantine period in France between 2020 March 17th and May 11th and on its medical consequences.

Method This observational study was conducted in the PRM department of a French University Hospital. Outpatients whose PRM medical consultation had been cancelled were contacted by phone between April 9th, 2020 and May 7th, 2020. A structured questionnaire was fulfilled for each patient.

Demographical and medical data were recorded, including the disabling diseases motivating the PRM outpatients' follow-up. The necessity to perform an immediate phone consultation or to schedule an urgent consultation within the next 3 weeks constituted the main judgment criterion. Other recorded criteria were: the reason for this urgent need of a medical consultation, the access to other medical services during the quarantine period, the interruption of home-based rehabilitation services and its perceived consequences for the patients.


title: A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction

acronym: CRACK-ANT

summary: The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.

location_facility: Service de psychiatrie et addictologie - CHU de Fort-de-France

intervention_type: Genetic


title: Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France

acronym: AIDALZ

summary:
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.

Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.

Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.

Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.

Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.

lead_sponsor: Institut de Sante Publique, d'Epidemiologie et de Developpement

location_facility: ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)


lead_sponsor: Hoffmann-La Roche

location_facility: Hopital Claude Huriez; Internal Medicine

title: An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity.

summary: This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting disease activity. A maximum of 11 participants from six centers in France that participated in the WA28119 study will be enrolled. The entire study duration is anticipated to be approximately 160 weeks.


title: Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening

acronym: ISIRECC

summary:
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer

The project will be divided into 2 phases:

Objectives of the first phase:

Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
Fill in as completely as possible their colonoscopic history in the past 5 years,
Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).

Objective of the second phase:

Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours


title: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach

acronym: SEINE

summary:
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.

The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CH F Quesnay
GHEF site de Meaux
CH Argenteuil
CHI créteil
Hôpital Necker Enfants Malades
Robert debré hospital
Groupe Hospitalier Nord Essonne
CHU paris Sud site Antoine Béclère


title: Sources of the Variability of the Response to Fluindione in Elderly Patients (PREPA) [Etude Des Sources de variabilité de la réponse à la Fluindione Chez Les Personnes âgées de 80 Ans et Plus (PREPA) ]

summary:
We propose to study the pharmacokinetic (PK) and pharmacodynamic (PD) components of the response to fluindione, the main oral anticoagulant used in France, in patients over 80.

We expect to gain a better understanding of the role of age, nutritional status, genetic factors and drug interactions in the variability of the response to fluindione.

location_facility:
CHU d'Angers
Hôpital Bichat-Claude Bernard


title: Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France

summary:
ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.

As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.

The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.


title: A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

acronym: ORCHESTRA

summary:
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.

Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.

To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to detect change.

Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial hypertension (PAH).

Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.

lead_sponsor: Actelion

location_country: Italy France Spain

location_facility: Ambulatorio Scompenso Cardiaco e Trapiant

location_facility: Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare

location_facility: UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica

location_facility: Hospital Universitario Insular Gran Canarias


title: Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France

summary: The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care

time_perspective: Other

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service des Maladies Infectieuses et Tropicales


title: Non-antibiotic Primary Prevention of Low Urinary Tract Infections: Evaluation of the Knowledge and Practices of Patients in the General Practitioner's Office, Observational and Descriptive Study in the Former Auvergne Region in France.

summary:
3436/5000 Urinary tract infections are a real public health issue. The frequency of these infections in France is estimated between 6 and 8 million in primary care (1) which represents 15% of antibiotics prescribed in primary care. Approximately 40-50% of women have had at least one UTI during their lifetime. (4) There is also an ecological issue by increasing the resistance of bacteria to antibiotics. (6) (7) The goal is to assess patients' knowledge and understandings to improve primary prevention.

The secondary objective will be to identify the demographic, sociological and ethiologic factors that may influence the knowledge and behavior of patients consulting in general medicine concerning means of prevention of cystitis.

This exploratory descriptive study is carried out on the basis of an anonymous questionnaire distributed in waiting rooms of GP offices after drawing lots in the former Auvergne region with prior approval of doctors. The inclusion criterion is to be a woman aged 18 to 65, consultant in general medicine.

24 general practitioners will be drawn in proportion to the distribution by department of the former region of Auvergne.

The primary outcome measure is to assess patients' knowledge and behaviors about how to prevent cystitis from responses to questionnaire items

. The duration of the study will be 6 weeks. The questionnaire consists of a section on the characteristics of patients including age, BMI, socio-professional category, current treatments, medico-surgical antecedents of interest and the other part consisting of 16 questions. on preventative measures to avoid cystitis with simple answers divided into "did you know" and "do it yourself", two questions about ecology and two other questions about lifestyle and other preventive practices.

It will also be collected data on the selected doctors: age, location, gynecological acts associated with general medicine.

The statistical analysis will be carried out with the software Stata . All statistical tests will be carried out at the risk of error of the first kind α of 5%. Patients will be described according to the variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and treatments. These analyzes will be complemented by the usual statistical tests, for example Chi2 test or Fisher-exact test for the comparison of categorical and anova variables or Kruskal-Wallis test if necessary for the quantitative variables. It seems difficult to propose for this exploratory observational study an estimate of the number of necessary subjects sufficiently robust and relevant. Nevertheless, it has been agreed to include at least 800 patients to establish possible specific profiles associated with patient knowledge and behavior The protocol, the information and consent form and the questionnaire were submitted for opinion to the Protection to Persons Committee.

ReferenceCitation: François M, Hanslik T, Dervaux B, Le Strat Y, Souty C, Vaux S, Maugat S, Rondet C, Sarazin M, Heym B, Coignard B, Rossignol L. The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey. BMC Health Serv Res. 2016 Aug 9;16(a):365. doi: 10.1186/s12913-016-1620-2.

ReferenceCitation: Kunin CM. Urinary tract infections in females. Clin Infect Dis. 1994 Jan;18(1):1-10; quiz 11-2.

ReferenceCitation: Arpin C, Quentin C, Grobost F, Cambau E, Robert J, Dubois V, Coulange L, André C; Scientific Committee of ONERBA. Nationwide survey of extended-spectrum {beta}-lactamase-producing Enterobacteriaceae in the French community setting. J Antimicrob Chemother. 2009 Jun;63(6):1205-14. doi: 10.1093/jac/dkp108. Epub 2009 Mar 28.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue

summary: The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.

ReferenceCitation: Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network, Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.

name: Clinical Pharmacology Department Center for Evaluation and Information on Pharmacodependence – AddictovigilanceNantes University Hospital Nantes France

name: INSERM UMR 1246 SPHERE Methods in Patients‐Centered Outcomes and Health Research Nantes and Tours University Nantes France

family: Victorri‐Vigneau

full_name: Caroline Victorri‐Vigneau

given: Caroline

name: Addictology and Liaison‐Psychiatry Department Nantes University Hospital Nantes France

family: Laforgue

full_name: Edouard‐Jules Laforgue

given: Edouard‐Jules

family: Grall‐Bronnec

full_name: Marie Grall‐Bronnec

given: Marie

family: Guillou‐Landreat

full_name: Morgane Guillou‐Landreat

given: Morgane

family: Rousselet

full_name: Morgane Rousselet

family: Guerlais

full_name: Marylène Guerlais

given: Marylène

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Jolliet

full_name: Pascale Jolliet

given: Pascale

journal_name: Clinical Pharmacology & Therapeutics

lead_sponsor: Nantes University Hospital

location_facility:
CEIP Lyon
CEIP Caen
CEIP Montpellier
CEIP Nantes
CEIP Nancy
CEIP Grenoble
CEIP Paris
CEIP Bordeaux
CEIP Toulouse
CEIP Lille
CEIP Marseille


title: Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France

acronym: TX-COVID

summary: Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population

location_facility: Service de Néphrologie et Transplantation


title: Fertility and Temporality in Pediatric Oncology

acronym: FERTITOP

summary:
Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.

Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.

Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.

Patients & Methods:

300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.

Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
University Hospital of Dijon
University hospital of Strasbourg
University Hospital of Nancy, France
University Hospital of Besançon
University hospital of Reims


title: Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France

acronym: COV-OB-ICU

summary:
Disproportionate impact of COVID-19 in patients with obesity is now well established.

Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.

The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

location_facility: Centre hospitalo-universitaire régional de Nancy


title: Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

acronym: OPTIVIBE

summary: Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation of the Benefit/Risk Ratio of Restarting or Avoiding Antiplatelet Drugs in Patients Who Had a Spontaneous Intracerebral Hemorrhage While Treated With Antithrombotic Drugs : RESTART-FR Study

acronym: RESTART-Fr

summary:
RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ICH.

RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

ReferenceCitation: Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7.

family: Cheng

full_name: Xin Cheng

given: Xin

family: Dong

full_name: Qiang Dong

given: Qiang

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description: we plan to make IPD analysis with sister trial: RESTART UK


title: Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)

acronym: SERAP

summary: Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.


title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.

acronym: NOSOGRIPPE

summary:
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.

The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds

lead_sponsor: Hospices Civils de Lyon

location_facility: Infection Control unit. Edouard Herriot hospital Lyon - France


title: PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)

acronym: PITUICARE-Lyon

summary: The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

ReferenceCitation: Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.

family: Raverot

full_name: Gérald Raverot

given: Gérald

family: Dantony

full_name: Emmanuelle Dantony

family: Beauvy

full_name: Julie Beauvy

given: Julie

family: Vasiljevic

full_name: Alexandre Vasiljevic

given: Alexandre

family: Mikolasek

full_name: Sara Mikolasek

given: Sara

family: Borson-Chazot

full_name: Françoise Borson-Chazot

given: Françoise

family: Jouanneau

full_name: Emmanuel Jouanneau

given: Emmanuel

family: Roy

full_name: Pascal Roy

given: Pascal

family: Trouillas

full_name: Jacqueline Trouillas

given: Jacqueline

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

location_facility: Groupement Hospitalier Est, Lyon, France


title: Potential Interest of Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) for the Selection of Patients Proposed for Curative Treatment of a Hepatocellular Carcinoma

acronym: TOMIC

summary:
Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the second in terms of mortality. At an early stage, which is based on a low number and size of liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative treatment can be performed, i.e. liver transplantation, surgical resection, or thermo-ablation. These treatments can lead to severe complications, so patients benefiting from them must be carefully selected. The correct identification of all HCC lesions at the time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis but its field of exploration is limited to the upper abdominal area and its sensitivity decreases for nodules of less than two centimetres. Such lesions could actually be HCC that will cause early post-operative progression.

Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide prognostic information but impacts initial staging in less than 5% of cases. However, PET with fluorocholine (FCH), available in France since 2010, could detect intra- and extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting patient management (e.g. 52% of patients in a small case study).

FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC, combining in a single multimodality investigation the reference morphological imaging technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI is able to detect, in patients eligible for curative treatment, additional preoperative intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.

location_facility: HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie

location_facility: HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service de radiologie digestive

location_facility: CHU de Grenoble, Servide d'Hépato-gastro-entérologie


type: Registry Identifier

title: Does a Systematic Phone-call by a Medical Student/General Practitioner Team in Patients Suffering From a Chronic Condition During the COVID-19 Containment Period Impact One-month Hospitalization's Rate in France? A Cluster Randomized Trial

acronym: COVIQuest

summary:
Following the announcement of the containment of the population due to the COVID-19 epidemic on March 17, 2020 in France, a notable decrease in the number of consultations in general practice was reported. Patients no longer contact their general practitioner, including those with regular follow-up for one or more chronic conditions. This observation raised worries since it could lead to delay or failure in detecting decompensations / complications of these chronic conditions by a lack of recourse to care. Thus, an urgent message from the National Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the health professionals regarding the organization of care aside from COVID-19. The main recommendation was "that the personal physician or the corresponding specialist should contact the most fragile patients with chronic condition to ensure follow-up and detect any risk of decompensation ".

Such fragile patients are in great numbers, up to more than 200 for an average general practitioner. Therefore, although this recommendation is regarded as "essential in view of the health needs of the population", it will prove quite difficult to follow without the help of a skilled external assistance that can be quickly mobilized.

primary_purpose: Health Services Research

ipd_sharing_description: One-month-data can be shared, whereas 6-month data are not legally sharable (electronic health records).


title: Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma

acronym: EPOPA

summary:
Background:

Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.

Aim of the study:

To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

Primary study endpoint:

Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

ReferenceCitation: Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. Epub 2007 Feb 27.


title: The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients

acronym: CAROLE

summary:
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.

The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .

Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.

lead_sponsor: Saint-Louis Hospital, Paris, France


title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Advanced or Metastatic Lung Cancer in France From 2013

summary: The ESME AMLC Data Platform is a multi-center real life database using a retrospective data collection process in France over 36 sites. This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

ReferenceCitation: Robain M, Pérol M, Girard N, Debieuvre D, Coudert B, Madroszyk A, et al. Programme épidémio-stratégie médicoéconomique : une base nationale de données de vie réelle pour mieux comprendre la prise en charge du cancer bronchopulmonaire en France. Revue des Maladies Respiratoires. 2018 Jan;35:A106.

ReferenceCitation: Girard, N., M. Pérol, G. Simon, C. Audigier Valette, R. Gervais, D. Debieuvre, R. Schott, et al. " 90P - Real-world treatment patterns, clinical practice and outcomes for locally advanced, non resectable, non-small cell lung cancer from the French ESME Lung database ". Abstract Book of the European Lung Cancer Congress (ELCC) 10-13 April 2019, Geneva, Switzerland 30 (1 avril 2019): ii34. https://doi.org/10.1093/annonc/mdz067.006.

lead_sponsor: UNICANCER

location_facility: Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller

location_facility: Institut de cancérologie de l'Ouest - René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin

location_facility: Institut régional du Cancer Montpellier / Val d'Aurelle


title: Trisomy 21 in Adulthood. Evaluation of Health and Social State in Alsace (North-eastern France)

summary: Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability. Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10 liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with trisomy 21, as well as medical care, social and educational integration in childhood was the subject of much research and has led to remarkable progress in terms of health and medical care, it is not the same for the knowledge about adolescents and adults.Despite a more and more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a deterioration in health status, with a regression of acquired psychomotor skills, often attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well established that only a fraction of Down syndrome patients will develop this type of dementia. Too often a decline in general health, behavioral changes and decreased cognitive abilities are only attributed to the Down syndrome with an early dementia without looking for an underlying, potentially curable, disease.This study aims to better evaluate the health and social status of 100 adults with trisomy 21 in Alsace. The medical evaluation will include a comprehensive assessment of health status and quality of life conducted by the geneticist, a cardiac, sensory, hormonal, biological and radiological evaluation. A speech-language and psychomotor evaluation will also be conducted. A psychiatric consultation and a psychometric assessment will aim to assess cognitive function and to search for associated mood disorders.The expected results are to better know the natural history of trisomy 21 in adulthood, with the determination of the frequency of morbid events specific to adulthood, and also to improve the medical and paramedical care with the establishment of a monitoring program to prevent the occurrence of these morbid events.

ReferenceCitation: Dieudonné Y, Uring-Lambert B, Jeljeli MM, Gies V, Alembik Y, Korganow AS, Guffroy A. Immune Defect in Adults With Down Syndrome: Insights Into a Complex Issue. Front Immunol. 2020 May 8;11:840. doi: 10.3389/fimmu.2020.00840. eCollection 2020.

family: Dieudonné

full_name: Yannick Dieudonné

given: Yannick

family: Uring-Lambert

full_name: Beatrice Uring-Lambert

given: Beatrice

family: Jeljeli

full_name: Mohamed Maxime Jeljeli

given: Mohamed Maxime

family: Gies

full_name: Vincent Gies

given: Vincent

family: Alembik

full_name: Yves Alembik

given: Yves

family: Korganow

full_name: Anne-Sophie Korganow

given: Anne-Sophie

family: Guffroy

full_name: Aurélien Guffroy

given: Aurélien

journal_name: Frontiers in Immunology

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories:
HAL
PubMed Central
univOAK

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Guffroy A, Dieudonné Y, Uring-Lambert B, Goetz J, Alembik Y, Korganow AS. Infection risk among adults with down syndrome: a two group series of 101 patients in a tertiary center. Orphanet J Rare Dis. 2019 Jan 11;14(1):15. doi: 10.1186/s13023-018-0989-x.

family: Goetz

full_name: Joelle Goetz

given: Joelle


title: Sarcopenia Mechanism and Therapeutic

acronym: SAMANTHA

summary: Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. This sarcopenia is named secondary sarcopenia to distinguish it from the age-associated primary sarcopenia. During prolonged hospitalizations in intensive care, a significant loss of muscular mass and function is also observed. This acute sarcopenia or Intensive Care Unit-Acquired Weakness (ICU-AW) may persist for several months after discharge from hospital. In addition to the loss of autonomy, the reduction of muscle mass has important metabolic implications, ranging from insulin resistance to modification of myokines production. Sarcopenia greatly increases the morbidity and mortality of patients regardless of its cause. The aim of our project is to identify the molecular mechanisms implicated in sarcopenia from different origin. We will particularly focus our work on the metabolic properties, the proliferation/ differentiation and regeneration capacities of the satellite cells (adult muscle stem cells). These satellite cells will be purified from quadriceps biopsies of human volunteers recruited at CHU Montpellier. These satellite cells will also be used to test the ability of some wild aromatic plants from south of France to improve cell survival and differentiation. This will allow us to identify the molecular mechanisms involved in sarcopenia development and identify potential therapeutic molecules.

status: Withdrawn

lead_sponsor: University Hospital, Montpellier


title: Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

acronym: DHARMA

summary: Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.

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

location_facility: Service de Médecine néonatale, Hôpital de la Conception

intervention_type: Dietary Supplement


title: Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital

acronym: COLIGRAINE

summary: According to recent studies, we want to find evidences that infant colics could be a episodic symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The main purpose is to compare the presence of colics in infants between 60 days and 180 days of life and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents.