title: Pregnancy Denial and Attachment

acronym: Denial-attach

summary:
Described in the 1970's, pregnancy denial occurs as the un-consciousness of being pregnant for several months or throughout the entire period. Body transformations are most of the time not clearly noticeable. The prevalence of this symptom could represent 2 or 3 births over 1000. The definition of pregnancy denial remains unclear due to the different nosological classifications used. There is no international consensus. Encountered terminologies are different from on author to another: pregnancy denial, pregnancy negation. The difficulties to define properly pregnancy denial accurately reflect the clinic heterogeneity of our patients when practicing on a daily basis. As a result, it is difficult to find predictive factors: any women of childbearing age, regardless her age, parity or social professional category, can be subjected to pregnancy denial. Several publications report observations of case of denial of pregnancy, few retrospective studies were realized, only two studies were interested in the future of the child, and no prospective study was interested in the future of the relation mother - child. The denial of pregnancy questions the maternal psychic functioning. No link between psychiatric disorder and denial of pregnancy was until then established. Our various clinical meetings, with mothers having presented a denial of pregnancy and reporting a difficult personal history with many breaks and events susceptibly traumatic, brought us to emit the following hypothesis: an insecure attachment of the mother would participate or at least would facilitate in the construction of a denial of pregnancy. These mothers would have a difficult access, even impossible for the infantile experiences, the essential experiences in the psychic reorganizations of the pregnancy that prepare the woman to accept her new functions of mother. The investigators hypothesize that the attachment and the development of the child, as well as interactions mothers-babies are disturbed when the woman presents a denial of pregnancy.

The research will compare the maternal functioning in both constituted groups (group denial of pregnancy versus groups control), by estimating the type of maternal attachment, without omitting to look for a possible psychiatric pathology, and a personality problem at the mother.

From the questioning on the psychodynamic considerations of the denial of pregnancy, and also on the future of the dyade mother-baby, the investigators construct a national program of clinical research called "Attachment and pregnancy denial", with the participation of 13 centers in France. This research is a prospective cohort examination with main objectives: study the impact of the denial of pregnancy on the pattern of attachment of the child, on the interactions of dyads mother-child and on the early development of the child with a 20-month follow-up. It's a multicenter case-control study with 13 centers (Reims, Strasbourg, Besançon, Nancy, Toulouse, Amiens, Troyes, Toulon, Limoges, Ile-de-France, Lille, Bordeaux, Paris 18ème), to find the maternal risks factors associated to pregnancy denial (secondary objectives).

The main objectives of this study are: (i) studying the relationship between pregnancy denial and the attachment pattern of the child; (ii) studying the relationship between pregnancy denial and the early interactions of mother-infant dyads; (iii) studying the relationship between pregnancy denial and the early development of the child.

The secondary objectives of this study are: (i) studying the relationship between the duration period from the pregnancy announcement to the delivery and the early development of a child, including the attachment pattern of a child, the early interactions of mother-infant dyads, (ii) looking for the risk factors associated to pregnancy denial, including the type of attachment, the existence of a personality disorders and/or a psychiatric pathology

ReferenceCitation: Auer J, Barbe C, Sutter AL, Dallay D, Vulliez L, Riethmuller D, Gubler V, Verlomme V, Saad-Saint-Gilles S, Miton A, Tessier E, Parant O, Le Foll J, Bourgeois-Moine A, Viaux S, Dommergues M, Apter G, Belaisch-Allart J, Danion A, Nisand I, Graesslin O, Novo A, Eutrope J, Rolland AC. Pregnancy denial and early infant development: a case-control observational prospective study. BMC Psychol. 2019 Apr 11;7(1):22. doi: 10.1186/s40359-019-0290-3.

family: Auer

full_name: Julie Auer

given: Julie

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Sutter

full_name: Anne-Laure Sutter

given: Anne-Laure

family: Dallay

full_name: Dominique Dallay

given: Dominique

family: Vulliez

full_name: Laurianne Vulliez

given: Laurianne

family: Riethmuller

full_name: Didier Riethmuller

given: Didier

family: Gubler

full_name: Violaine Gubler

given: Violaine

family: Verlomme

full_name: Valérie Verlomme

given: Valérie

family: Saad-Saint-Gilles

full_name: Stéphanie Saad-Saint-Gilles

given: Stéphanie

family: Miton

full_name: Alain Miton

given: Alain

family: Tessier

full_name: Emmanuelle Tessier

given: Emmanuelle

family: Parant

full_name: Olivier Parant

given: Olivier

family: Le Foll

full_name: Julie Le Foll

family: Bourgeois-Moine

full_name: Agnès Bourgeois-Moine

given: Agnès

family: Viaux

full_name: Sylvie Viaux

given: Sylvie

family: Dommergues

full_name: Marc Dommergues

given: Marc

family: Apter

full_name: Gisèle Apter

given: Gisèle

family: Belaisch-Allart

full_name: Joëlle Belaisch-Allart

given: Joëlle

family: Danion

full_name: Anne Danion

family: Nisand

full_name: Israël Nisand

given: Israël

family: Graesslin

full_name: Olivier Graesslin

family: Novo

full_name: Alexandre Novo

given: Alexandre

family: Eutrope

full_name: Julien Eutrope

given: Julien


title: French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students (Enquête Nationale Sur le Dopage Intellectuel et Les Consommations de Substances Psychoactives Chez Les Jeunes étudiants)

acronym: ENQUETE-COSYS

summary: This descriptive and declarative study will help to find out consumption rates, all psychoactive substances taken together, among 18-25 year olds. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of cognitive performance).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Batisse A, Leger S, Vicaut E, Gerbaud L, Djezzar S. COgnitive enhancement and consumption of psychoactive Substances among Youth Students (COSYS): a cross-sectional study in France. Public Health. 2021 May;194:75-78. doi: 10.1016/j.puhe.2021.02.036. Epub 2021 Apr 14.

family: Batisse

full_name: A. Batisse

given: A.

sequence: first

family: Leger

full_name: S. Leger

given: S.

sequence: additional

family: Vicaut

full_name: E. Vicaut

given: E.

family: Gerbaud

full_name: L. Gerbaud

given: L.

family: Djezzar

full_name: S. Djezzar

bso_classification: Social sciences

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Public Health

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU Clermont-Ferrand - service de santé publique

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Prevalence of Enterobacteriaceae With Decreased Susceptibility to Carbapenems in Eastern Inter- Region

acronym: CARBAFREST

summary:
Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass by these enzymes which makes the molecules of last resort in serious infection. Recently the prevalence of enzymes hydrolysing carbapenem, the carbapenemases, was increasing in some countries. But these carbapenemases are not the only mechanism involved in a decreased susceptibility to carbapenems which is sometimes linked to the conjunction of several resistance mechanisms. Data available on the epidemic situation of this new resistance are essential for improving their detection, the management of infections in patients and prevent the occurrence of epidemic. In this context, the investigators propose a study in the North-East inter-region to estimate the prevalence of Enterobacteriaceae with decrease susceptibility to carbapenems and look for risk factors for infection with this type of bacteria. The study is conducted in five teaching hospitals (Besançon, Dijon, Nancy, Reims and Strasbourg) and two general hospitals (Colmar and Troyes) in North-Eastern France. For one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM) (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the Reims University Hospital. Among these strains 105 are randomly selected. The clinical study is conducted as follow: for each patient with CDSE isolate included in a center, 2 control patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.

Microbiological study : identification of isolates is performed using MALDI-TOF (Bruker Daltonics, Bremen, Germany). Antibiotic susceptibilities is determined by the disc diffusion method according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines (www.EUCAST.org) and extended-spectrum beta-lactamase (ESBLs) are detected by the double-disc synergy test and carbapenem minimal inhibitory concentrations (MICs to Imipenem, Ertapenem, Doripenem and Meropenem) determined using E-test® strips. Metallo-β-lactamase production was screened with the MβL Etest (bioMérieux, Marcy l'Etoile, France). Beta-lactamases detected using polymerase chain reaction (PCR). Carbapenemase-encoding genes (blaKPC, blaVIM, blaIMP, blaNDM, blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and blaOXA-48-like) were screened using multiplex PCRs and blaIMI and blaGES with simplex PCRs. All the blaOXA-48-like detected were subsequently sequenced. Genes blaTEM, blaSHV, blaCTX-M and blaOXA were detected by PCR using specific primers. Plasmid-mediated AmpC-type genes blaACC, blaFOX, blaMOX, blaDHA, blaCMY and blaMIR were screened using multiplex PCRs. All the beta-lactamases are sequenced. Mutations in the quinolone resistance determining region (QRDR) are identified by PCR and sequencing in the gyrA, gyrB, parC and parE genes. Qnr and qepA genes are detected by real-time PCR, aac(6')-Ib-cr by pyrosequencing and oqxAB by conventional PCR. Genotyping is performed with pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST).

Statistical analysis : qualitative variables are analysed with the Chi2 test and the two-tailed Fisher exact test. Quantitative variables are compared using the Mann-Whitney test. Then, a multivariate analysis is conducted: logistic regression with stepwise factors as explanatory variables with p <0.20 in the univariate analysis as input threshold and output set at 0.20.The results are considered statistically significant when P < 0.05.

Expected results : this study will give the proportion of the different species involved, of the carbapenemase in comparison to the other mechanisms, the level of resistance in MIC. Risk factors such as previous antibiotic treatment, underlying disease severity or clonal strain transmission will be evidenced, allowing to identify prevention control measure to implement.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceType: result

ReferenceCitation: Guillard T, Cholley P, Limelette A, Hocquet D, Matton L, Guyeux C, Lebreil AL, Bajolet O, Brasme L, Madoux J, Vernet-Garnier V, Barbe C, Bertrand X, de Champs On Behalf Of CarbaFrEst Group C. Fluoroquinolone Resistance Mechanisms and population structure of Enterobacter cloacae non-susceptible to Ertapenem in North-Eastern France. Front Microbiol. 2015 Oct 23;6:1186. doi: 10.3389/fmicb.2015.01186. eCollection 2015.

family: Guillard

full_name: Thomas Guillard

given: Thomas

family: Cholley

full_name: Pascal Cholley

given: Pascal

family: Limelette

full_name: Anne Limelette

given: Anne

family: Hocquet

full_name: Didier Hocquet

given: Didier

family: Matton

full_name: Lucie Matton

given: Lucie

family: Guyeux

full_name: Christophe Guyeux

given: Christophe

family: Lebreil

full_name: Anne-Laure Lebreil

given: Anne-Laure

family: Bajolet

full_name: Odile Bajolet

given: Odile

family: Brasme

full_name: Lucien Brasme

given: Lucien

family: Madoux

full_name: Janick Madoux

given: Janick

family: Vernet-Garnier

full_name: Véronique Vernet-Garnier

given: Véronique

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Bertrand

full_name: Xavier Bertrand

given: Xavier

family: de Champs on behalf of CarbaFrEst Group

full_name: Christophe de Champs on behalf of CarbaFrEst Group

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Microbiology

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

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Liapis E, Pantel A, Robert J, Nicolas-Chanoine MH, Cavalié L, van der Mee-Marquet N, de Champs C, Aissa N, Eloy C, Blanc V, Guyeux C, Hocquet D, Lavigne JP, Bertrand X; ONERBA. Molecular epidemiology of OXA-48-producing Klebsiella pneumoniae in France. Clin Microbiol Infect. 2014 Dec;20(12):O1121-3. doi: 10.1111/1469-0691.12727. Epub 2014 Jul 29.

family: Liapis

full_name: E. Liapis

family: Pantel

full_name: A. Pantel

family: Robert


title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa. SPICES Study Implementation Phase

summary:
Cardiovascular disease (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Three quarters of CVD deaths occur in developing countries (LDCs). According to estimates in 2030, CVD will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries. The lack of an adequate primary care network in developing countries limits the screening and treatment of people with CVRF. As a result, these people do not benefit from appropriate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Cardiovascular risk factor prevention measures (CVRF) have been shown to be effective. Interventions are possible on a large scale (policies against smoking and unfavorable eating habits, promoting physical activity, etc.). Actions are possible at the individual level, both in primary prevention (fight against the FDRCV) and secondary, where many treatments have proven their effectiveness. These interventions are effective and profitable from a macroeconomic point of view. It has been estimated that the cost for such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization (WHO) stresses the importance of the triad composed by the patient and his family, the community and health professionals. Results are possible only when these three components work together for the same purpose. Many studies show the benefit of people's involvement in care in rich and developing countries.

SPICES project builds on progress in HIV / AIDS treatment in sub-Saharan Africa (SSA) and chronic disease management through the Innovative Care for Chronic Conditions (ICCC Framework), WHO plan. With regard to HIV treatment, these interventions have proven to be effective and cost-effective in many SSA countries, both in terms of disease control and adherence. These data on communicable and infectious diseases seem to be transferable to non-communicable diseases.

These projects were born from the observation that the model of care of the rich countries (individual approach of the patient, centered on the hospital and the specialist with a regular clinical and paraclinical follow-up) could not be transposed to the developing countries, because the limitation of human, technical and financial resources. But also that this model was becoming more and more difficult to maintain in developed countries or resources become limited. New approaches need to be developed to increase the effectiveness of health systems.

A paradigm shift is needed to improve the control of CVD with greater cost-effectiveness.

The SPICES project incorporates the most up-to-date knowledge to improve the prevention and control of CVD in high-, middle- and low-income countries.

Rich countries and developing countries are therefore involved in the study. The selected sites are France, United Kingdom, Belgium, South Africa and Uganda.

Some main axes of the ICCC Framework will be developed in SPICES:

improve the efficiency of health professionals through the delegation of skills and appropriate training,
center care around the patient and his family and more generally his caregivers,
simplify the monitoring and treatment protocols,
support patients in their community and emphasize prevention, information and patient education.

A first step of observation in the various countries made it possible to make an inventory of fixtures and to target the most adapted interventions.

The following steps are the implementation of these interventions (delegation of skills, information campaign and screening, improve the availability of treatments, measure of strengthening of compliance, etc. ..) and their evaluation.

This study, carried out in France and integrated into the SPICES project, will test the best non-pharmacological interventions selected in the community and by the community.

status: Recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceCitation: Le Goff D, Barais M, Perraud G, Derriennic J, Aujoulat P, Guillou-Landreat M, Le Reste JY. Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa). BMC Public Health. 2021 Jul 19;21(1):1422. doi: 10.1186/s12889-021-11443-y.

family: Le Goff

full_name: Delphine Le Goff

given: Delphine

family: Barais

full_name: Marie Barais

given: Marie

family: Perraud

full_name: Gabriel Perraud

given: Gabriel

family: Derriennic

full_name: Jeremy Derriennic

given: Jeremy

family: Aujoulat

full_name: Paul Aujoulat

given: Paul

family: Guillou-Landreat

full_name: Morgane Guillou-Landreat

given: Morgane

family: Le Reste

full_name: Jean Yves Le Reste

given: Jean Yves

bso_classification: Medical research

currency_apc_doaj: GBP

journal_name: BMC Public Health

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

status_simplified: Ongoing


title: A Prospective Observational Autopsy Study of Neuropathology in Adults Intensive Care Unit Patients With COVID 19

summary: This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

ipd_sharing: Undecided

ipd_sharing_description: all individual patient data will be available upon request to the study official and after signing a data sharing agreement immediately after publication in a peer-reviewed journal

lead_sponsor: University of Versailles

intervention_type: Procedure


title: Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!

acronym: VITAE

summary:
In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.

This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.

ReferenceType: background

ReferenceCitation: Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4.

ReferenceCitation: Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497. Review.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CH Perrens - Equipe Addiction
MéRISP - Université U1219


title: The Brest Registry of Stroke

acronym: BREST

summary: The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.


title: Epidemiology and Outcomes of Critically Ill Patients With Covid 19: a French Single Centre Experience

summary: Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Registry Identifier

type: Other Identifier

title: Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies

acronym: Hemcancer

summary: Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.

primary_purpose: Basic Science

ReferenceCitation: Pierre FH, Martin OC, Santarelli RL, Taché S, Naud N, Guéraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and α-tocopherol suppress cured-meat promotion of chemically induced colon carcinogenesis in rats and reduce associated biomarkers in human volunteers. Am J Clin Nutr. 2013 Nov;98(5):1255-62. doi: 10.3945/ajcn.113.061069. Epub 2013 Sep 11.

family: Pierre

full_name: Fabrice HF Pierre

given: Fabrice HF

family: Martin

full_name: Océane CB Martin

given: Océane CB

family: Santarelli

full_name: Raphaelle L Santarelli

given: Raphaelle L

family: Taché

full_name: Sylviane Taché

given: Sylviane

family: Naud

full_name: Nathalie Naud

given: Nathalie

family: Guéraud

full_name: Françoise Guéraud

given: Françoise

family: Audebert

full_name: Marc Audebert

given: Marc

family: Dupuy

full_name: Jacques Dupuy

given: Jacques

family: Meunier

full_name: Nathalie Meunier

family: Attaix

full_name: Didier Attaix

given: Didier

family: Vendeuvre

full_name: Jean-Luc Vendeuvre

given: Jean-Luc

family: Mirvish

full_name: Sidney S Mirvish

given: Sidney S

family: Kuhnle

full_name: Gunter CG Kuhnle

given: Gunter CG

family: Cano

full_name: Noel Cano

given: Noel

family: Corpet

full_name: Denis E Corpet

given: Denis E

journal_name: The American Journal of Clinical Nutrition

oa_colors: green hybrid

evidence: open (via free pdf)

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

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine d'Auvergne


title: Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)

acronym: ETM

summary: A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.

lead_sponsor: Elsan

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery

acronym: SERAPHINE

summary: the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).

time_perspective: Retrospective

lead_sponsor: Nantes University Hospital

location_facility:
CHU Angers
CH Le Mans
CHU de Nantes


title: SCREENING FOR THE HEPATITIS C VIRUS BY TROD PAIRED WITH MAMMOGRAPHY AND MANAGEMENT OF CHRONIC HEPATITIS C IN WOMEN AGED 50 TO 74 IN THE AGGLOMERATION OF MONTPELLIER

acronym: Mammo'C

summary: In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. To answer the WHO objective of eliminating hepatitis C by 2030 and in France by 2025, we need to organize targeted screening. Women aged more than 50 years old, by their possible antecedents in life, are an exposed population. We propose to pair the already organized breast cancer screening with a hepatitis-screening test by rapid diagnostic orientation test (TROD) and evaluate the adherence of women in this paired screening. For women with positive TROD, a specialized care will be organized.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Montpellier

location_facility: Lapeyronie radiology ward (Montpellier University hospital)


type: Other Grant/Funding Number

title: Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life

acronym: THERAD

summary: Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.

primary_purpose: Supportive Care

ReferenceCitation: Villars H, Cantet C, de Peretti E, Perrin A, Soto-Martin M, Gardette V. Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD. Alzheimers Res Ther. 2021 Sep 12;13(1):152. doi: 10.1186/s13195-021-00896-3.

family: Villars

full_name: Hélène Villars

given: Hélène

family: Cantet

full_name: Christelle Cantet

given: Christelle

family: de Peretti

full_name: Eva de Peretti

given: Eva

family: Perrin

full_name: Amelie Perrin

given: Amelie

family: Soto-martin

full_name: Maria Soto-martin

given: Maria

family: Gardette

full_name: Virginie Gardette

given: Virginie

journal_name: Alzheimer's Research & Therapy

title: Impact of an educational programme on Alzheimer’s disease patients’ quality of life: results of the randomized controlled trial THERAD

ReferenceCitation: Villars H, Gardette V, Perrin A, Hein C, Elmalem S, de Peretti E, Zueras A, Vellas B, Nourhashémi F. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life. Alzheimers Res Ther. 2014 Oct 27;6(5-8):66. doi: 10.1186/s13195-014-0066-1. eCollection 2014.

full_name: Amélie Perrin

given: Amélie

family: Hein

full_name: Christophe Hein

given: Christophe

family: Elmalem

full_name: Sophie Elmalem

given: Sophie

family: Zueras

full_name: Audrey Zueras

given: Audrey

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Nourhashémi

full_name: Fati Nourhashémi

given: Fati

title: Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer’s disease patients’ quality of life

location_facility: CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie


title: Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes

acronym: CERADIAB

summary: Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: OBESITY, PHYSICAL INACTIVITY OR DIETARY FAT ? Role of Physical Activity in the Trafficking of Dietary Fatty Acids Varying in Length and Saturation Degree.

summary: Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors determine predisposition to obesity, but the most often mentioned idea is that environmental factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and explain the increased prevalence of obesity in our westernized societies. Since lipogenesis is negligible in humans, obesity represents the consequence of altered fat partitioning between oxidation and storage, likely due to a preferential directing of dietary fat towards adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind of such intervention but the scant data on dietary fat metabolism does not allow clear conclusions, in particular in obese subjects. One question concerns the impact of the type of fat eaten: the effects of physical inactivity may vary according to the length and saturation degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity, independently of its effect on energy balance, will favor a preferential trafficking towards adipose tissue, will modify the expression of genes implicated in fat oxidation and storage and partly correct the abnormalities observed in obese subjects, 2) effects of physical activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to 55, will undergo tests before and after 2 months of training at current recommendations to ascertain dietary fat partitioning using stable isotopes and to determine changes in gene expression with muscle and adipose tissue microbiopsies.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service des Explorations Fonctionelles Respiratoires et de l'Exercice - Hôpital Civil

location_facility: Service de Médecine Interne et de Nutrition - Hôpital de Hautepierre

intervention_type: Behavioral


title: Contribution of Body Composition Monitor (BCM) Among Patients Using Daily Home Dialysis With Low Dialysate Flow : French Study Cohort

acronym: VOLODIA

summary:
The fluid overload measured by the Body Composition Monitor (BCM Fresenius Medical Care) is a new independent risk factor of mortality.

This risk has already been described in intermittent hemodialysis patients and peritoneal dialysis patients but never evaluated in Daily Home Dialysis with low dialysate flow.

The investigator propose a first study measuring the state of hydration by impedancemetry (BCM) in this population.

The aim of this work is to to analyze hydration status in a representative sample of prevalent Daily Home Dialysis with low-flow Dialysate patients.

Secondary objectives are to identify associations between hydration status and patient characteristics and treatment practice in order to find out which conditions should alert the clinician to potential fluid overload, to compare these results with the peritoneal dialysis population and in center hemodialysis population, to evaluate the correlation between impedancemetry and blood pressure in this population, to assess the nutritional status and evaluation of a new method of measurement of kt / V based on impedancemetry, without recourse to a blood test.

ReferenceCitation: FHN Trial Group, Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh ML, Star RA, Kliger AS. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20. Erratum in: N Engl J Med. 2011 Jan 6;364(1):93.

ReferenceCitation: Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.

ReferenceCitation: Mathew A, McLeggon JA, Mehta N, Leung S, Barta V, McGinn T, Nesrallah G. Mortality and Hospitalizations in Intensive Dialysis: A Systematic Review and Meta-Analysis. Can J Kidney Health Dis. 2018 Jan 10;5:2054358117749531. doi: 10.1177/2054358117749531. eCollection 2018.

ReferenceCitation: Kjellstrand CM, Buoncristiani U, Ting G, Traeger J, Piccoli GB, Sibai-Galland R, Young BA, Blagg CR. Short daily haemodialysis: survival in 415 patients treated for 1006 patient-years. Nephrol Dial Transplant. 2008 Oct;23(10):3283-9. doi: 10.1093/ndt/gfn210. Epub 2008 May 5.

ReferenceCitation: Weinhandl ED, Liu J, Gilbertson DT, Arneson TJ, Collins AJ. Survival in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. J Am Soc Nephrol. 2012 May;23(5):895-904. doi: 10.1681/ASN.2011080761. Epub 2012 Feb 23.

ReferenceCitation: Raimann JG, Chan CT, Daugirdas JT, Depner T, Gotch FA, Greene T, Kaysen GA, Kliger AS, Kotanko P, Larive B, Lindsay R, Rocco MV, Chertow GM, Levin NW; Frequent Hemodialysis Network (FHN) Trial Group. The Effect of Increased Frequency of Hemodialysis on Volume-Related Outcomes: A Secondary Analysis of the Frequent Hemodialysis Network Trials. Blood Purif. 2016;41(4):277-86. doi: 10.1159/000441966. Epub 2016 Jan 21.

ReferenceCitation: Kaysen GA, Greene T, Larive B, Mehta RL, Lindsay RM, Depner TA, Hall YN, Daugirdas JT, Chertow GM; FHN Trial Group. The effect of frequent hemodialysis on nutrition and body composition: frequent Hemodialysis Network Trial. Kidney Int. 2012 Jul;82(1):90-9. doi: 10.1038/ki.2012.75. Epub 2012 Mar 28.

ReferenceCitation: Ipema KJ, Struijk S, van der Velden A, Westerhuis R, van der Schans CP, Gaillard CA, Krijnen WP, Franssen CF. Nutritional Status in Nocturnal Hemodialysis Patients - A Systematic Review with Meta-Analysis. PLoS One. 2016 Jun 20;11(6):e0157621. doi: 10.1371/journal.pone.0157621. eCollection 2016. Review.

ReferenceCitation: Weinhandl ED, Nieman KM, Gilbertson DT, Collins AJ. Hospitalization in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients. Am J Kidney Dis. 2015 Jan;65(1):98-108. doi: 10.1053/j.ajkd.2014.06.015. Epub 2014 Jul 29.

ReferenceCitation: Suri RS, Li L, Nesrallah GE. The risk of hospitalization and modality failure with home dialysis. Kidney Int. 2015 Aug;88(2):360-8. doi: 10.1038/ki.2015.68. Epub 2015 Mar 18.

ReferenceCitation: Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.

ReferenceCitation: Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.

ReferenceCitation: Jaber BL, Lee Y, Collins AJ, Hull AR, Kraus MA, McCarthy J, Miller BW, Spry L, Finkelstein FO; FREEDOM Study Group. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010 Sep;56(3):531-9. doi: 10.1053/j.ajkd.2010.04.019. Epub 2010 Jul 29.

ReferenceCitation: Cornelis T, Usvyat LA, Tordoir JH, Wang Y, Wong M, Leunissen KM, van der Sande FM, Kotanko P, Kooman JP. Vascular access vulnerability in intensive hemodialysis: a significant Achilles' heel? Blood Purif. 2014;37(3):222-8. doi: 10.1159/000362106. Epub 2014 Jun 5. Review.

ReferenceCitation: Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.

ReferenceCitation: Wabel P, Moissl U, Chamney P, Jirka T, Machek P, Ponce P, Taborsky P, Tetta C, Velasco N, Vlasak J, Zaluska W, Wizemann V. Towards improved cardiovascular management: the necessity of combining blood pressure and fluid overload. Nephrol Dial Transplant. 2008 Sep;23(9):2965-71. doi: 10.1093/ndt/gfn228. Epub 2008 May 5.

ReferenceCitation: Wieskotten S, Heinke S, Wabel P, Moissl U, Becker J, Pirlich M, Keymling M, Isermann R. Bioimpedance-based identification of malnutrition using fuzzy logic. Physiol Meas. 2008 May;29(5):639-54. doi: 10.1088/0967-3334/29/5/009. Epub 2008 May 7.

ReferenceCitation: Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.

ReferenceCitation: Zoccali C, Moissl U, Chazot C, Mallamaci F, Tripepi G, Arkossy O, Wabel P, Stuard S. Chronic Fluid Overload and Mortality in ESRD. J Am Soc Nephrol. 2017 Aug;28(8):2491-2497. doi: 10.1681/ASN.2016121341. Epub 2017 May 4.

ReferenceCitation: Hecking M, Moissl U, Genser B, Rayner H, Dasgupta I, Stuard S, Stopper A, Chazot C, Maddux FW, Canaud B, Port FK, Zoccali C, Wabel P. Greater fluid overload and lower interdialytic weight gain are independently associated with mortality in a large international hemodialysis population. Nephrol Dial Transplant. 2018 Oct 1;33(10):1832-1842. doi: 10.1093/ndt/gfy083.

ReferenceCitation: Jotterand Drepper V, Kihm LP, Kälble F, Diekmann C, Seckinger J, Sommerer C, Zeier M, Schwenger V. Overhydration Is a Strong Predictor of Mortality in Peritoneal Dialysis Patients - Independently of Cardiac Failure. PLoS One. 2016 Jul 14;11(7):e0158741. doi: 10.1371/journal.pone.0158741. eCollection 2016.

ReferenceCitation: Takahashi S. Future home hemodialysis - advantages of the NxStage System One. Contrib Nephrol. 2012;177:117-126. doi: 10.1159/000336944. Epub 2012 May 8.

ReferenceCitation: Benabed A, Henri P, Lobbedez T, Goffin E, Baluta S, Benziane A, Rachi A, van der Pijl JW, Bechade C, Ficheux M. [Low flux dialysate daily home hemodialysis: A result for the 62 first French and Belgian patients]. Nephrol Ther. 2017 Feb;13(1):18-25. doi: 10.1016/j.nephro.2016.06.007. Epub 2016 Nov 18. French.

ReferenceCitation: Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13.

ReferenceCitation: Wabel P, Chamney P, Moissl U, Jirka T. Importance of whole-body bioimpedance spectroscopy for the management of fluid balance. Blood Purif. 2009;27(1):75-80. doi: 10.1159/000167013. Epub 2009 Jan 23.

ReferenceCitation: Leypoldt JK, Kamerath CD, Gilson JF, Friederichs G. Dialyzer clearances and mass transfer-area coefficients for small solutes at low dialysate flow rates. ASAIO J. 2006 Jul-Aug;52(4):404-9.

ReferenceCitation: National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015. Review. Erratum in: Am J Kidney Dis. 2016 Mar;67(3):534.

ReferenceCitation: Wabel P, Chamney P, Moissl U (2007) Reproducibility of bioimpedance spectroscopy for the assessment of body composition and dry weight. J Am Soc Nephrol 18: A255

ReferenceCitation: Cole, K. S., & Cole, R. H. (1941). Dispersion and absorption in dielectrics I. Alternating current characteristics. The Journal of chemical physics, 9(4), 341-351.

ReferenceCitation: Moissl UM, Wabel P, Chamney PW, Bosaeus I, Levin NW, Bosy-Westphal A, Korth O, Müller MJ, Ellegård L, Malmros V, Kaitwatcharachai C, Kuhlmann MK, Zhu F, Fuller NJ. Body fluid volume determination via body composition spectroscopy in health and disease. Physiol Meas. 2006 Sep;27(9):921-33. Epub 2006 Jul 25.

ReferenceCitation: Chamney PW, Wabel P, Moissl UM, Müller MJ, Bosy-Westphal A, Korth O, Fuller NJ. A whole-body model to distinguish excess fluid from the hydration of major body tissues. Am J Clin Nutr. 2007 Jan;85(1):80-9.

lead_sponsor: University Hospital, Caen

status_simplified: Unknown


title: Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System

acronym: CCENDO

summary: The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

ReferenceCitation: Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. Review.

ReferenceCitation: Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17. Review.

ReferenceCitation: Engeli S, Böhnke J, Feldpausch M, Gorzelniak K, Janke J, Bátkai S, Pacher P, Harvey-White J, Luft FC, Sharma AM, Jordan J. Activation of the peripheral endocannabinoid system in human obesity. Diabetes. 2005 Oct;54(10):2838-43.

ReferenceCitation: Blüher M, Engeli S, Klöting N, Berndt J, Fasshauer M, Bátkai S, Pacher P, Schön MR, Jordan J, Stumvoll M. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes. 2006 Nov;55(11):3053-60.

ReferenceCitation: Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52.

location_facility: Haut Lévêque Hospital, Endocrine department


title: Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.

acronym: RISAROS

summary:
Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot

intervention_type: Drug


title: Antioxidant Signature in Adult Patients With Phenylketonuria (PKU) and Healthy Volunteers : Relationship With Metabolic Disturbances

acronym: StressOX-PCU

summary: To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim of the present study is to investigate oxidative stress in PKU with more comprehensive methods.The relationship between oxidative stress and metabolic disturbances (hyperPhenylalaninemia) will also be studied.

lead_sponsor: University Hospital, Tours


title: Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

acronym: VIBR-AVC

summary:
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.

The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.

This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.

lead_sponsor: Rennes University Hospital


title: Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy ( RALNOVO )

acronym: RALNOVO

summary:
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients.

Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir.

Secondary objectives

To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood
Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART
Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels
Identify virological responders may benefit from treatment intensification

primary_purpose: Diagnostic

intervention_type: Biological


title: Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants

acronym: HPAG

summary:
Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and policy makers, and a central question is how to improve the performance of screening during pregnancy in order to provide appropriate care. The recent recommendations and reporting of French results have raised awareness of the need to improve growth screening in France. Based on the existing literature, the hypothesis is that a greater investment in growth monitoring based on a more rigorous interpretation of information available from routinely implemented clinical assessment and ultrasound will allow for significant gains in detection. The current context provides the opportunity to evaluate the application of a training program for serial plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised charts. This intervention is consistent with French guidelines which support the monthly measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These guidelines were recently restated in the clinical practice recommendations issued by the French College of Obstetricians and Gynecologists.

The intervention tested in the trial will include training of professionals for standardization of SFH measurement, introduction of software, and recommendations for growth interpretation and referral examinations. Expected benefits are an increase in antenatal identification of growth restricted fetuses without an increase in the FP rate. Such a program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate antenatal care. This intervention could double the detection rate of SGA births from 20 to 40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be improved.

Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. The aim of the investigators is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.

primary_purpose: Other

ReferenceCitation: Ego A, Prunet C, Lebreton E, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. I - Methodology]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):155-64. doi: 10.1016/j.jgyn.2015.08.009. Epub 2015 Sep 28. French.

ReferenceCitation: Ego A, Prunet C, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. II - Comparison with existing curves and benefits of customization]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):165-76. doi: 10.1016/j.jgyn.2015.08.008. Epub 2015 Oct 1. French.

ReferenceCitation: Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.

ReferenceCitation: Ego A. [Definitions: small for gestational age and intrauterine growth retardation]. J Gynecol Obstet Biol Reprod (Paris). 2013 Dec;42(8):872-94. doi: 10.1016/j.jgyn.2013.09.012. Epub 2013 Nov 7. Review. French.

ReferenceCitation: Ego A, Subtil D, Grange G, Thiebaugeorges O, Senat MV, Vayssiere C, Zeitlin J. Customized versus population-based birth weight standards for identifying growth restricted infants: a French multicenter study. Am J Obstet Gynecol. 2006 Apr;194(4):1042-9.

lead_sponsor: University Hospital, Grenoble

location_facility: Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux

location_facility: Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille

location_facility: Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)

location_facility: Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre

location_facility: Department of Obstetrics and Gynecology, Caen University Hospital, Caen

location_facility: Department of Obstetrics and Gynecology, Tours University Hospital,

location_facility: Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital

location_facility: Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University

location_facility: Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg

location_facility: Department of Obstetrics and Gynecology, Rouen University Hospital

location_facility: Department of Obstetrics and Gynecology, Grenoble University Hospital

location_facility: Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon

location_facility: Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille

location_facility: Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)

location_facility: Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris

location_facility: Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal


title: Evaluation of a Parathyroid Hormone Suppression Test With Cinacalcet. Comparison: 1- With the Results of the Intravenous Calcium Suppression Test in Healthy Controls; 2- Between Healthy Controls and Patients With Primary Hyperparathyroidism.

summary: The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.

lead_sponsor: University Hospital, Rouen


title: Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery

acronym: MAGNOLIA

summary: Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Optimization of Drug Prescriptions in the Care Pathway for the Elderly, With the Final Objective of Reducing the Iatrogenic Risk.

acronym: IATROPREV

summary: The IATROPREV project is an organizational innovation experimentation project, carried out in Hauts-de-France by the University hospitals of Amiens and Lille, the ARS and the URPS Doctors and Pharmacists of Hauts-de-France and following to the social security financing law of 2018, allowing experimentation with new organizations in the health sector, according to article 51. The objectives of this course are to improve the relevance of prescription in elderly people with multiple drugs as well as, the coordination of care between the city and the hospital through the sharing of information and the establishment of multi-professional consultations between the various care actors.


title: Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)

summary:
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.

The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.

This include both children and adult subjects, subject without social security, and healthcare workers.

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

location_country:
French Guiana
France

location_facility: Centre d'investigation clinique 1406 CHU Grenoble

location_facility: Centre d'Investigation Clinique Hôpital Saint Louis

location_facility: Hôpital Cochin CIC 1417 Bâtiment Lavoisier

location_facility: Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou

location_facility: Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

location_facility: Centre Investigation Clinique 1433 CHRU de NANCY

location_facility: Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

location_facility: Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

location_facility: Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin

location_facility: Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

location_facility: Centre d'Investigation Clinique 1403 -CHU Lille

location_facility: Centre d'investigation clinique Infectiologie Hôtel-Dieu CHU Nantes

location_facility: Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

location_facility: Service de Maladies infectieuses et tropicales Centre hospitalier

location_facility: Département maladie infectieux CHU Saint Etienne

location_facility: Centre d'Investigation Clinique Ile de la Réunion CHU sud

location_facility: Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

intervention_type: Genetic


title: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

acronym: Cov-CONTACT

summary:
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

location_facility: Centre d'investigation clinique 1406 CHU Grenoble

location_facility: Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier


title: E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial

acronym: E-COMPARED

summary: To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU). Within the French context the TAU is considered as the traditional face to face CBT.

ReferenceCitation: Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Baños R, Chevreul K, Araya R, Cerga-Pashoja A, Cieślak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.

family: Kleiboer

full_name: Annet Kleiboer

given: Annet

family: Smit

full_name: Jan Smit

given: Jan

family: Bosmans

full_name: Judith Bosmans

given: Judith

family: Ruwaard

full_name: Jeroen Ruwaard

given: Jeroen

family: Andersson

full_name: Gerhard Andersson

given: Gerhard

family: Topooco

full_name: Naira Topooco

given: Naira

family: Berger

full_name: Thomas Berger

given: Thomas

family: Krieger

full_name: Tobias Krieger

given: Tobias

family: Botella

full_name: Cristina Botella

given: Cristina

family: Baños

full_name: Rosa Baños

given: Rosa

family: Chevreul

full_name: Karine Chevreul

given: Karine

family: Araya

full_name: Ricardo Araya

given: Ricardo

family: Cerga-Pashoja

full_name: Arlinda Cerga-Pashoja

given: Arlinda

family: Cieślak

full_name: Roman Cieślak

given: Roman

family: Rogala

full_name: Anna Rogala

given: Anna

family: Vis

full_name: Christiaan Vis

given: Christiaan

family: Draisma

full_name: Stasja Draisma

given: Stasja

family: van Schaik

full_name: Anneke van Schaik

given: Anneke

family: Kemmeren

full_name: Lise Kemmeren

given: Lise

family: Ebert

full_name: David Ebert

given: David

family: Berking

full_name: Matthias Berking

given: Matthias

family: Funk

full_name: Burkhardt Funk

given: Burkhardt

family: Cuijpers

full_name: Pim Cuijpers

given: Pim

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

location_facility: Hôpital de la conception Pôle Psychiatrie Centre


title: Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss

acronym: CMVP

summary: In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Representations and Acceptability of HIV Therapeutic Vaccine in a Cohort of HIV-1 Infected Outpatients Followed at Hospital : Multicentric Interventional Study Qualitative and Quantitative

acronym: RAVVIH

summary:
The main objective of the study is to assess the acceptability of a future therapeutic vaccine against HIV in patients living with HIV-1.

Secondary objectives concern the validation of a specific questionnaire for self-perception and acceptability of therapeutic vaccination against HIV-1 (RAVVIH), the development of a composite score for acceptability based on this questionnaire, and the analysis of critical factors related to: representations of vaccination in general, representations of therapeutic vaccination specific to HIV, perception of disease severity, health-related quality of life, doctor-patient relationship.

ReferenceCitation: Dimi S, Zucman D, Chassany O, Lalanne C, Prazuck T, Mortier E, Majerholc C, Aubin-Auger I, Verger P, Duracinsky M. Patients' high acceptability of a future therapeutic HIV vaccine in France: a French paradox? BMC Infect Dis. 2019 May 9;19(1):401. doi: 10.1186/s12879-019-4056-6.

family: Dimi

full_name: Svetlane Dimi

given: Svetlane

family: Zucman

full_name: David Zucman

family: Chassany

full_name: Olivier Chassany

given: Olivier

family: Lalanne

full_name: Christophe Lalanne

given: Christophe

family: Prazuck

full_name: Thierry Prazuck

given: Thierry

family: Mortier

full_name: Emmanuel Mortier

given: Emmanuel

family: Majerholc

full_name: Catherine Majerholc

given: Catherine

family: Aubin-Auger

full_name: Isabelle Aubin-Auger

given: Isabelle

family: Verger

full_name: Pierre Verger

given: Pierre

family: Duracinsky

full_name: Martin Duracinsky

given: Martin

journal_name: BMC Infectious Diseases

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

title: Patients’ high acceptability of a future therapeutic HIV vaccine in France: a French paradox?

lead_sponsor: Hopital Foch

location_facility: Centre Hospitalo-Universitaire Louis Mourier


title: Medico-economic Evaluation of Treatment With Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients With Severe Non-proliferative and Early Proliferative Diabetic Retinopathy

acronym: LIGHT

summary:
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.

Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)

acronym: PECV

summary:
Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

lead_sponsor: Lille Catholic University


title: A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.

summary: This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.


title: Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic

acronym: AUTONOMIC

summary:
This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

acronym: OXYNAT

summary:
Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation, that needs to be addressed for an adequate diagnosis and an optimal treatment.

If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it is necessary to search the various etiological conditions such as a critical congenital heart disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).

Newborn pulse oximetry screening identifies babies with critical congenital heart disease (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD) occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.

Early detection is beneficial because of acute collapse, if not resulting in death, is associated with a worse surgical and neurodevelopmental outcome.

Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical examination. Although antenatal detection rates have improved over recent years and can be as high as 70%-80% in some centers, this is not consistent. Indeed, in "Nouvelle Aquitaine" overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the "diagnostic gap' that is, increase the detection of babies who slip through the current screening net.

Several large European studies and a subsequent meta-analysis have shown that pulse oximetry screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to 0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary hypertension,...). As with CCHD, delayed recognition of these conditions can result in postnatal collapse and significant morbidity and mortality. It is also more useful to consider these conditions as secondary targets of screening and to remember they constitute 30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel. In Europe, implementation is advanced in such countries as North European Countries, and Switzerland. There isn't yet any European guidance. In France, the implementation is limited to local and transient experiments. The feasibility, usefulness and cost-effectiveness of routine pulse oximetry screening have not been evaluated so far. The French setting has two specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in contrast to a lot of other European countries, early discharge from the maternity ward before 48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed CCHD, but not saving babies from collapse.

- The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic newborns would allow to reduce the incidence of complications related to CCHDs as well as those related to non cardiac pathologies for a reasonable cost for the French Health Care System.

lead_sponsor: University Hospital, Bordeaux

location_facility: Maison de Santé Protestante de Bordeaux Bagatelle

location_facility: Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis


title: Transposition of the Mini-Mental State in Sign Language

acronym: MMS-LS

summary:
In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and according to very conservative estimates, about 44 000 deaf persons use the sign language. Additionally, the prevalence of dementia in France is close to 1% (850 000 dements for a total population of 65 millions). The prevalence of dementia in pre-lingual deaf adults has also been described and is between 1 and 1.4 /100 000 habitants.

The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the cognitive evaluation for the detection of mental disorders including dementia, and a consensual French version exists prepared by GRECO (Group of Research and Cognitive Assessments). However, to date, there are no simple, rapid and validated screening tests to study cognitive disorders in deaf persons who use the sign language. The only tests available allow a late diagnosis avoiding an optimal treatment of the patients.

location_facility: Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Hôpital de la Conception, Pôle psychiatrie Centre


title: Influence of Respiratory Quotient on Food Liking, Food Wanting, Macronutrient Selection and Food Consumption in Humans

summary:
The purpose of this study is to observe the influence of carbohydrate-to-fat balance on liking, wanting and food consumption in humans.

16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study. The sessions differed by the composition of the breakfast which was rich in carbohydrates (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4 foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast) were evaluated.

ReferenceCitation: Brondel L, Landais L, Romer MA, Holley A, Pénicaud L. Substrate oxidation influences liking, wanting, macronutrient selection, and consumption of food in humans. Am J Clin Nutr. 2011 Sep;94(3):775-83. doi: 10.3945/ajcn.111.017319. Epub 2011 Jul 27.

family: Brondel

full_name: L. Brondel

given: L.

family: Landais

full_name: L. Landais

family: Romer

full_name: M. A. Romer

given: M. A.

family: Holley

full_name: A. Holley

given: A.

family: Penicaud

full_name: L. Penicaud

journal_name: American Journal of Clinical Nutrition

oa_host_type: publisher

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University of Burgundy

location_facility: Centre des Sciences du Goût et de l'Alimentation


title: Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

acronym: DATOR

summary: Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.

ReferenceCitation: Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.

ReferenceCitation: Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

ReferenceCitation: Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. Epub 2007 Feb 20.

ReferenceCitation: Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


ReferenceCitation: Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.

family: Vinet

full_name: Agnès Vinet

given: Agnès

family: Morrissey

full_name: Christopher Morrissey

given: Christopher

family: Perez-Martin

full_name: Antonia Perez-Martin

given: Antonia

family: Goncalves

full_name: Aurélie Goncalves

given: Aurélie

family: Raverdy

full_name: Cécile Raverdy

given: Cécile

family: Masson

full_name: Delphine Masson

given: Delphine

family: Gayrard

full_name: Sandrine Gayrard

given: Sandrine

family: Carrere

full_name: Myriam Carrere

given: Myriam

family: Landrier

full_name: Jean-François Landrier

given: Jean-François

family: Amiot

full_name: Marie-Josèphe Amiot

given: Marie-Josèphe

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

acronym: VIDADO

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

type: EudraCT Number

source: euctr

title: Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial

summary: The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).


title: Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life

acronym: SPA-SEP

summary: Multiple Sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, with significant public health consequences. The benefit of spa treatments on the quality of life in this population has not been evaluated. The methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility: Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE


acronym: DIAVOY

summary:
Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs.

So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study

summary:
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.

lead_sponsor: Theraclion

location_facility:
Cochin Hospital
Hôpital Privé des Peupliers

intervention_type: Device


title: Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018

acronym: EIU

summary:
French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050.

The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions.

Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016.

Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations.

It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer


title: Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home

acronym: BRAZMAMAN

summary:
In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him.

A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.

lead_sponsor: University Hospital, Limoges


title: Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis

summary: In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.

ReferenceCitation: Orban JC, El-Mahjoub A, Rami L, Jambou P, Ichai C. Transcranial Doppler shortens the time between clinical brain death and angiographic confirmation: a randomized trial. Transplantation. 2012 Sep 27;94(6):585-8.

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes

location_facility: Centre Hospitalier Universitaire de Nice


title: A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation

acronym: DIABOLO

summary: The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

ReferenceCitation: Heming N, Faisy C, Urien S. Population pharmacodynamic model of bicarbonate response to acetazolamide in mechanically ventilated chronic obstructive pulmonary disease patients. Crit Care. 2011;15(5):R213. doi: 10.1186/cc10448. Epub 2011 Sep 14.

ReferenceCitation: Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92.

ReferenceCitation: Faisy C, Meziani F, Planquette B, Clavel M, Gacouin A, Bornstain C, Schneider F, Duguet A, Gibot S, Lerolle N, Ricard JD, Sanchez O, Djibre M, Ricome JL, Rabbat A, Heming N, Urien S, Esvan M, Katsahian S; DIABOLO Investigators. Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):480-8. doi: 10.1001/jama.2016.0019.

name: European Georges Pompidou Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Faisy

full_name: Christophe Faisy

given: Christophe

name: Nouvel Hôpital Civil, Medical Intensive Care Unit, Hôpitaux Universitaires de Strasbourg and EA 7293, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg University, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: André Mignot Hospital, Medico-Surgical Intensive Care Unit, Le Chesnay, France

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

name: Limoges University Hospital, Medical Intensive Care Unit, Limoges, France

family: Clavel

full_name: Marc Clavel

given: Marc

name: Rennes University Hospital, Medical Intensive Care Unit, Rennes, France

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

name: Le Raincy-Montfermeil Hospital, Medical Intensive Care Unit, Montfermeil, France

family: Bornstain

full_name: Caroline Bornstain

given: Caroline

name: Hautepierre Hospital, Strasbourg, Medical Intensive Care Unit, France

family: Schneider

full_name: Francis Schneider

given: Francis

name: Pitié-Salpêtrière Hospital, Department of Respiratory and Intensive Care Medicine, Paris, France

family: Duguet

full_name: Alexandre Duguet

given: Alexandre

name: Nancy University Hospital, Medical Intensive Care Unit, Nancy, France

family: Gibot

full_name: Sébastien Gibot

given: Sébastien

name: Angers University Hospital, Medical Intensive Care Unit, Angers, France

family: Lerolle

full_name: Nicolas Lerolle

given: Nicolas

name: Louis-Mourier Hospital, Medico-Surgical Intensive Care Unit, Colombes, France

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Tenon Hospital, Medico-Surgical Intensive Care Unit, Paris, France

family: Djibre

full_name: Michel Djibre

given: Michel

name: Poissy-Saint Germain Hospital, Medical Intensive Care Unit, Poissy, France

family: Ricome

full_name: Jean-Louis Ricome

given: Jean-Louis

name: Cochin Hospital, Medical Intensive Care Unit, Paris, France

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

family: Heming

full_name: Nicholas Heming

given: Nicholas

family: Urien

full_name: Saïk Urien

given: Saïk

family: Esvan

full_name: Maxime Esvan

given: Maxime

family: Katsahian

full_name: Sandrine Katsahian

journal_name: JAMA

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

location_facility: Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris


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

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

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

family: Kovatchev

full_name: Boris P. Kovatchev

given: Boris P.

family: Renard

full_name: Eric Renard

given: Eric

family: Cobelli

full_name: Claudio Cobelli

given: Claudio

family: Zisser

full_name: Howard C. Zisser

given: Howard C.

family: Keith-Hynes

full_name: Patrick Keith-Hynes

given: Patrick

family: Anderson

full_name: Stacey M. Anderson

given: Stacey M.

family: Brown

full_name: Sue A. Brown

given: Sue A.

family: Chernavvsky

full_name: Daniel R. Chernavvsky

given: Daniel R.

family: Breton

full_name: Marc D. Breton

given: Marc D.

family: Mize

full_name: Lloyd B. Mize

given: Lloyd B.

family: Farret

full_name: Anne Farret

given: Anne

family: Place

full_name: Jérôme Place

given: Jérôme

family: Bruttomesso

full_name: Daniela Bruttomesso

given: Daniela

family: Del Favero

full_name: Simone Del Favero

given: Simone

family: Boscari

full_name: Federico Boscari

given: Federico

family: Galasso

full_name: Silvia Galasso

given: Silvia

family: Avogaro

full_name: Angelo Avogaro

given: Angelo

family: Magni

full_name: Lalo Magni

given: Lalo

family: Di Palma

full_name: Federico Di Palma

family: Toffanin

full_name: Chiara Toffanin

given: Chiara

family: Messori

full_name: Mirko Messori

given: Mirko

family: Dassau

full_name: Eyal Dassau

given: Eyal

family: Doyle

full_name: Francis J. Doyle

given: Francis J.

title: Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas

location_facility: Centre d'Investigation Clinique CHU Montipellier


title: Epidemiologic Study of Orthodontic Retention Practices in France

acronym: ORIF

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

ipd_sharing_description: No IPD

lead_sponsor: Nantes University Hospital


title: To Promote Tobacco Free Life in the Dental Practice in France: Feasibility Study

acronym: TOBAFREE-DP

summary:
In France, 34% of the adult population is smoking every day. The links between smoking and the development of several chronic disorders is well established and smoking is directly implicated in most of the oral diseases such as cancers of the oral cavity. Thus, dentists have access to an area of the body that is actively affected and this gives them a central role in dispensing advice and support regarding smoking cessation.

Dentists often cite issues such as lack of time or education as a reason for why they do not offer support for smoking cessation. A brief intervention can increase smoking cessation by 30 to 100% (ie 1-3% in absolute value). The "5A" approach integrates and extends the brief intervention. It consists in Asking about smoking status, Advising smokers of the benefit of stopping, Assessing motivation to quit, Assisting smokers in their quit attempt, Arranging follow-up with stop-smoking services. For practitioners who do not have enough time, a "3A" approach might be acceptable (Ask, Advice and Act) by providing details of local stop smoking services and/or prescribing nicotine replacement therapy (NRT). This very brief advice can be delivered in less than one minute.

To investigators knowledge, the role of dentists in the French national tobacco-free program is not yet documented in France while since 2016, dentists can prescribe NRT with some products taken in charge by the French health insurance.

An intervention taking part in the continuing professional development will be developed so the dentists fell legitimate, motivated and competent to talk with their patients about their tobacco consumption and to assist them in their smoking cessation process. This intervention based on the 5/3A approach and prescription of NRT will include a specific training and provision of management kit, with communication tools and network for appropriate references.

Investigators hypothesize that 5/3A approach is feasible with adequate intervention in dental practices in France (dentists apply the approach to 90% of their patients) and that the format, the conditions, the barriers and the lever actions of its implementation are known.


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

acronym: Lymphorac

summary:
Lymphedema is a frequent and 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. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2014 on patients with 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. We will combine concentration curves and concentration indices to assess the distributive effects.

lead_sponsor: University Hospital, Montpellier

location_facility: Departement information Medicale CHU Montpellier