title: Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

acronym: PERCEPOLIS

summary:
Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)

Two sub-categories of phacoemulsification coexist :

Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)

ReferenceCitation: Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2021 Nov 3. doi: 10.1097/ICO.0000000000002822. [Epub ahead of print]

family: Perone

full_name: Jean-Marc Perone

given: Jean-Marc

family: Ghetemme

full_name: Cedric Ghetemme

given: Cedric

family: Zevering

full_name: Yinka Zevering

given: Yinka

family: Zaidi

full_name: Mohamed Zaidi

given: Mohamed

family: Ouamara

full_name: Nadia Ouamara

given: Nadia

family: Goetz

full_name: Christophe Goetz

given: Christophe

family: Lhuillier

full_name: Louis Lhuillier

given: Louis

journal_name: Cornea


title: Contribution of [18F] -FDG-PET / MRI in the Detection of the Absence of Complete Response After Neo-adjuvant Radiotherapy for Cancers of the Middle and Low Rectum for a Treatment Procedure With Rectal Savings

acronym: RECARHIA

summary:
Rectal cancer represents 14,000 new cases a year in France. At diagnosis, 70% of patients have a locally advanced tumors T3-T4 and / or N + evaluated mainly by rectal MRI. These patients will benefit from a neo-adjuvant treatment by radio-chemotherapy. The complete histologic response rate (ypT0N0) after this neo-adjuvant treatment ranged from 15 to 27% and improved recurrence-free survival, remotely relapse-free survival, overall survival, and decreased local recurrence rate. In the case of full response diagnosis after neoadjuvant chemoradiotherapy 3 theoretical solutions exist:

Total excision of the rectum and mesorectum (TME) This is the classic attitude with a low risk of local recurrence (5%) but functional complications occur in 25 to 60% of cases
A simple monitoring ("Watch and Wait") by MRI, biopsy, rectoscopy ... This strategy was initially proposed to elderly patients considered inoperable but it has also been proposed in younger patients, operable, with a view to decreasing morbidity and sequelae. This attitude poses a likely overall risk of local recidivism. However, this higher risk of recurrence may be the result of imperfect identification of ypT0N0 patients.
Local excision of the post-radiation scar also called closure lumpectomy with pathological analysis and possible secondary TME if no complete response. This last attitude has the advantage of allowing an anatomopathological verification of the treated lesion and to complete the treatment if necessary. In the case of ypT0 the local recurrence rate is low and in this case it is possible to consider rectal savings.

The choice of the last two attitudes is therefore based on the correct identification of patients in complete response. The performance of the diagnosis of no complete response after radiochemotherapy is therefore fundamental and is the subject of this project wich consist of comparing he diagnostic performance for the identification of a complete lack of response [18F] -FDG-PET / MRI ypT0N0 to that of the classic attitude (MRI) 6 to 9 weeks after the end of a neoadjuvant chemoradiotherapy treatment of low and mid-rectal cancers in patients in whom clinical and endoscopic examination favor a complete response.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Ongoing


title: From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

acronym: MODAP

summary: The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" [3]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research [4]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Gross-Goupil M, Escudier B. [Targeted therapies: sequential and combined treatments]. Bull Cancer. 2010;97:65-71. doi: 10.1684/bdc.2010.1071. French.

ReferenceCitation: Hoarau H, Giacomoni C, Etienne G, Fort MP, Mahon FX, Ceccaldi J, Reiffers J, Monnereau A. Expérience quotidienne des patients atteints de LMC traités par voie orale : déterminants des pratiques d'observance ?. Oncologie, 2012, n° 14, p. 609-612.

ReferenceCitation: Santucci R, Aatmani AE, Lescoute A, Levêque D, Serra S, Bergerat JP, Beretz L, Herbrecht R. [Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Bull Cancer. 2011 Feb;98(2):176-81. doi: 10.1684/bdc.2011.1308. French.

ReferenceCitation: Regnier Denois V, Poirson J, Nourissat A, Jacquin JP, Guastalla JP, Chauvin F. Adherence with oral chemotherapy: results from a qualitative study of the behaviour and representations of patients and oncologists. Eur J Cancer Care (Engl). 2011 Jul;20(4):520-7. doi: 10.1111/j.1365-2354.2010.01212.x. Epub 2010 Jul 23.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other

status_simplified: Completed


title: Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection

acronym: RIPI

summary: As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Prospective Comparative Study of Two Manual and Automated Oocyte Vitrification Systems: Randomization of Mature Oocytes in Vitro of In Vitro Fertilization Attempts With Micro-injection at the "Centre d'Assistance Médicale à la Procréation" of the Dijon University Hospital

acronym: Instruvit

summary:
In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that could potentially cause sterility. A clear improvement in survival rates since the early stages of slow freezing has been observed with vitrification but with fairly heterogeneous results Indeed, manual vitrification remains an operator-dependent technique with a long learning curve and which does not allow an oocyte survival rate of more than 70-80%.

The recent marketing of an automatic vitrification machine would make it possible to standardise the whole vitrification process from the contact/exchange of fluids to the sealing of the units, and thus potentially increase the oocyte survival rate. It seems to be in the best interest of women that their ability to conceive be preserved (probably for several years) with the technique that offers the best survival and reproducibility rates.

However, no studies have been conducted to assess the impact of such automation on oocyte survival.

For this reason the investigators wish to set up a comparative study between the routine, manual technique, and an automated technique (GAVI system), using immature oocytes, not suitable for fertilization, and usually discarded.

status: Unknown status

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Unknown


title: Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology and Rheumatology Departments of the University Hospital of Besançon

acronym: MISTIC

summary: Patients with chronic inflammatory diseases (CID) followed in gastroenterology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease [MC] and ulcerative colitis [RCH]), and chronic inflammatory rheumatic diseases (rheumatoid arthritis [RA] and spondyloarthritis [SpA] including psoriatic arthritis [PsA]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration

acronym: ONCO-EHPAD

summary:
According to data from the French National Cancer Institute (INCA), almost one third of the cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients management is an important part in oncology daily practice.

These last years, through the geriatric oncology development, collaboration between oncologists and geriatricians, the anti-cancer management and supportive care for elderly patients has evolved. The assessement of potential fragility helps to determine the cancers appropriate treatment plan.

Studies have shown that alterations in geriatric fields, found through Comprehensive Geriatric Assessment (CGA) are associated with poorer survival, increased risk of chemotherapy severe toxicity and autonomy loss.

Nursing home residents have often more frailties and functional problems than living at home elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home residents must have appropriate treatment to preserve as much as possible their quality of life.

Transversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille hospital propose to organize a personalized care course for nursing home residents with cancer to minimize the diagnostics delay, facilitate their management in oncology and maintain their quality of life.

Elderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological and geriatric assessment. Patient would be supported by UTOG and would have access to technical platform.

According to his cancer and nursing home location, the nearest reference center would be offered.

Treatment or course of action (monitoring, palliative care …) would be decided in onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit UCOG PACA west) and programmed and fast hospitalization would be organized in the reference center.

When returning in nursing homes, elderly patient would be revalued by EMGE to continue therapeutic management and personalized care plan. The aim of this management is to allow a shorter hospitalization and maintain the quality of life of frailty patient during cancer treatment.

study_start_date_type: Anticipated

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Couderc AL, Berbis J, Delalande G, Mugnier B, Courcier A, Bourriquen M, Rey D, Greillier L, Baciuchka M, Sudour P, Agnelli L, Nouguerede E, Fabries S, Villani P. Impact of care pathway for nursing home residents treated for cancer: ONCO-EHPAD study. Support Care Cancer. 2021 Jul;29(7):3933-3942. doi: 10.1007/s00520-020-05973-1. Epub 2021 Jan 3.

family: Couderc

full_name: Anne-Laure Couderc

given: Anne-Laure

sequence: first

family: Berbis

full_name: Julie Berbis

given: Julie

sequence: additional

family: Delalande

full_name: Géraldine Delalande

given: Géraldine

family: Mugnier

full_name: Bénédicte Mugnier

given: Bénédicte

family: Courcier

full_name: Anais Courcier

given: Anais

family: Bourriquen

full_name: Maryline Bourriquen

given: Maryline

family: Rey

full_name: Dominique Rey

given: Dominique

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Baciuchka

full_name: Marjorie Baciuchka

given: Marjorie

family: Sudour

full_name: Patrick Sudour

given: Patrick

family: Agnelli

full_name: Lauren Agnelli

given: Lauren

family: Nouguerede

full_name: Emilie Nouguerede

given: Emilie

family: Fabries

full_name: Stéphane Fabries

given: Stéphane

family: Villani

full_name: Patrick Villani

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Supportive Care in Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


type: Other Identifier

title: Evaluation of the Benefit of a Systematic Offer of Nurse-Driven SARS-Cov2 Screening by Rapid Testing in Emergency Departments in the Paris Metropolitan Area

acronym: DEPIST-COVID

summary:
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters.

Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population.

To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions.

The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy)

The strategies will be compared during two periods following a cluster-randomized two-period crossover design.

During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.

status: Not yet recruiting

primary_purpose: Screening


title: Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis

acronym: CEFIMPACT

summary:
Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of patients managed in general city medicine. The ceftriaxone, parenteral third-generation cephalosporin (C3G), occupies an important place in the antibiotic treatment of these infections: this is the recommended probabilistic treatment, and in some situations the treatment can be continued in its entirety via a Ceftriaxone monotherapy.

The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .

To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86% C3G resistance).

Thus, before considering randomized studies comparing the ecological impact of different molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise and rigorous evaluation of the ecological impact of the molecule reference in this indication.

The investigators propose a study to evaluate the impact on the digestive flora at 1 month of a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Drug


title: Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study

acronym: AmbuLUS

summary:
Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.

The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.

This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.

The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Caen

intervention_type: Diagnostic Test


type: Other Grant/Funding Number

title: Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea: Prospective Observational Multicenter Cohort Study

acronym: LEDA

summary:
LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective observational cohort multicenter clinical study. Project is carried out by Vilnius University together with a partner Lithuanian University of Health Sciences, in conjunction with a research protocol of international GREAT consortium (Global Research on Acute Conditions Team). The aim of this project is to find the specific novel biomarkers of acute heart failure (AHF), to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2) post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1 and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular mortality and rehospitalization.

During the project a sizeable national database (2000 Lithuanian patients) will be integrated into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters of right ventricular (RV) function are in the focus of the study. During the acute phase of heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period, along with standard echocardiography examination. The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality, as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region. Quantitative parameters of RV systolic function and deformation will be measured. It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations, cost and hospital length of stay without decrease in the quality of diagnostics and treatment. An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting.

ReferenceCitation: Kaur M, Sprague S, Ignacy T, Thoma A, Bhandari M, Farrokhyar F. How to optimize participant retention and complete follow-up in surgical research. Can J Surg. 2014 Dec;57(6):420-7.

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ReferenceCitation: Zannad F, Mebazaa A, Juillière Y, Cohen-Solal A, Guize L, Alla F, Rougé P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. Epub 2006 Mar 3.

ReferenceCitation: Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.

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ReferenceCitation: Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7.

ReferenceCitation: Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54.

ReferenceCitation: Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

name: AP-HP, Groupe Hospitalier Lariboisiere Saint Louis; INSERM U942 Paris 7 University Paris France

family: Logeart

full_name: Damien Logeart

given: Damien

name: AP-HP, Groupe Hospitalier Pitie Salpetriere; Paris 6 University Paris France

family: Isnard

full_name: Richard Isnard

given: Richard

name: AP-HP, Groupe Hospitalier Lariboisiere Saint Louis; Paris France

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

name: Centre Hospitalier Universitaire Minoz; Besançon France

family: Seronde

full_name: Marie-France Seronde

given: Marie-France

name: Centre Hospitalier Regional Universitaire de Lille; France

family: de Groote

full_name: Pascal de Groote

given: Pascal

name: AP-HP, Groupe Hospitalier Bichat Claude Bernard; INSERM U698 Paris 7 University Paris France

family: Jondeau

full_name: Guillaume Jondeau

given: Guillaume

name: Centre Hospitalier Universitaire Rangueil; Toulouse France

family: Galinier

full_name: Michel Galinier

given: Michel

name: French Society of Cardiology; Paris France

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

name: Centre Hospitalier Universitaire Pontchaillou; CIC-IT 804, LTSI INSERM U1099 Rennes France

family: Donal

full_name: Erwan Donal

given: Erwan

name: Hospices Civils de Lyon; Claude Bernard University; Lyon

family: Delahaye

full_name: François Delahaye

given: François

name: Centre Hospitalier Universitaire Brabois; Nancy France

family: Juilliere

full_name: Yves Juilliere

given: Yves

name: AP-HP, Hopital Henri Mondor; Créteil France

family: Damy

full_name: Thibaud Damy

given: Thibaud

name: Centre Hospitalier Rene Dubosc; Pontoise France

family: Jourdain

full_name: Patrick Jourdain

family: Bauer

full_name: Fabrice Bauer

given: Fabrice

name: Centre Hospitalier Universitaire; Dijon France

family: Eicher

full_name: Jean-Christophe Eicher

given: Jean-Christophe

name: Centre Hospitalier Universitaire; Grenoble France

family: Neuder

full_name: Yannick Neuder

given: Yannick

name: INSERM UMR1087, Université de Nantes, Centre Hospitalier Universitaire Nantes; Nantes France

family: Trochu

full_name: Jean-Noël Trochu

given: Jean-Noël

name: on behalf of the working group on Heart Failure of the French Society of Cardiology

journal_name: European Journal of Heart Failure

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

title: Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study

ReferenceCitation: Chioncel O, Ambrosy AP, Bubenek S, Filipescu D, Vinereanu D, Petris A, Christodorescu R, Macarie C, Gheorghiade M, Collins SP; Romanian Acute Heart Failure Syndromes study investigators. Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry. J Cardiovasc Med (Hagerstown). 2016 Feb;17(2):92-104. doi: 10.2459/JCM.0000000000000192.

ReferenceCitation: Bĕlohlávek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Exp Clin Cardiol. 2013 Spring;18(2):129-38.

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ReferenceCitation: Böhm M, Link A, Cai D, Nieminen MS, Filippatos GS, Salem R, Cohen Solal A, Huang B, Padley RJ, Kivikko M, Mebazaa A. Beneficial association of β-blocker therapy on recovery from severe acute heart failure treatment: data from the Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support trial. Crit Care Med. 2011 May;39(5):940-4. doi: 10.1097/CCM.0b013e31820a91ed.

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ReferenceCitation: Breidthardt T, Vanpoucke G, Potocki M, Mosimann T, Ziller R, Thomas G, Laroy W, Moerman P, Socrates T, Drexler B, Mebazaa A, Kas K, Mueller C. The novel marker LTBP2 predicts all-cause and pulmonary death in patients with acute dyspnoea. Clin Sci (Lond). 2012 Nov;123(9):557-66. doi: 10.1042/CS20120058.

ReferenceCitation: Mebazaa A, Gayat E, Lassus J, Meas T, Mueller C, Maggioni A, Peacock F, Spinar J, Harjola VP, van Kimmenade R, Pathak A, Mueller T, Tavazzi L, Disomma S, Metra M, Pascual-Figal D, Laribi S, Logeart D, Nouira S, Sato N, Parenica J, Deye N, Boukef R, Collet C, Van den Berghe G, Cohen-Solal A, Januzzi JL Jr; GREAT Network. Association between elevated blood glucose and outcome in acute heart failure: results from an international observational cohort. J Am Coll Cardiol. 2013 Feb 26;61(8):820-9. doi: 10.1016/j.jacc.2012.11.054. Epub 2013 Jan 16.

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ReferenceCitation: Seronde MF, Gayat E, Logeart D, Lassus J, Laribi S, Boukef R, Sibellas F, Launay JM, Manivet P, Sadoune M, Nouira S, Solal AC, Mebazaa A; Great network. Comparison of the diagnostic and prognostic values of B-type and atrial-type natriuretic peptides in acute heart failure. Int J Cardiol. 2013 Oct 9;168(4):3404-11. doi: 10.1016/j.ijcard.2013.04.164. Epub 2013 May 14.

ReferenceCitation: Shah R, Gayat E, Januzzi JL Jr, Sato N, Cohen-Solal A, diSomma S, Fairman E, Harjola VP, Ishihara S, Lassus J, Maggioni A, Metra M, Mueller C, Mueller T, Parenica J, Pascual-Figal D, Peacock WF, Spinar J, van Kimmenade R, Mebazaa A; GREAT (Global Research on Acute Conditions Team) Network. Body mass index and mortality in acutely decompensated heart failure across the world: a global obesity paradox. J Am Coll Cardiol. 2014 Mar 4;63(8):778-85. doi: 10.1016/j.jacc.2013.09.072. Epub 2013 Dec 4.

ReferenceCitation: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

name: Hofstra North Shore-LIJ School of Medicine; Hempstead NY USA

name: Academic Medical Center; Amsterdam the Netherlands

name: Janssen Research Development; LLC; Raritan NJ USA

name: People's Hospital of Peking University; Beijing China

name: Saint Louis Lariboisière Hospitals; Paris France

name: Thomas Jefferson Hospitals; Philadelphia PA USA

name: Dresden-Friedrichstadt Hospital; Dresden Germany

name: Duke University Medical Center; Durham NC USA

title: D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial

ReferenceCitation: Pang PS, Collins SP, Sauser K, Andrei AC, Storrow AB, Hollander JE, Tavares M, Spinar J, Macarie C, Raev D, Nowak R, Gheorghiade M, Mebazaa A. Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales. Acad Emerg Med. 2014 Jun;21(6):659-66. doi: 10.1111/acem.12390.

ReferenceCitation: Mebazaa A, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

name: From Université Paris Diderot, PRES Sorbonne Paris Cité and Department of Anesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, U942 Inserm, Paris, France (A.M.); Bayer HealthCare Pharmaceuticals Inc, Montville, NJ (T.E.S., Y.D.S.); Academic Medical Center, Amsterdam, The Netherlands (H.R.B.); Janssen Research & Development LLC, Raritan, NJ (L.H.); People’s Hospital of Peking University, Beijing, China (D.H.); Foothills Hospital, Calgary, Alberta, Canada (R.H....

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Predicting the Risk of Venous Thromboembolism in Patients Hospitalized With Heart Failure

ReferenceCitation: Vodovar N, Séronde MF, Laribi S, Gayat E, Lassus J, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Ishihara S, Cohen Solal A, Januzzi JL Jr, Richards AM, Launay JM, Mebazaa A; GREAT Network. Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure. Eur Heart J. 2014 Dec 21;35(48):3434-41. doi: 10.1093/eurheartj/ehu314. Epub 2014 Aug 24.

title: Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure

ReferenceCitation: Cohen-Solal A, Laribi S, Ishihara S, Vergaro G, Baudet M, Logeart D, Mebazaa A, Gayat E, Vodovar N, Pascual-Figal DA, Seronde MF. Prognostic markers of acute decompensated heart failure: the emerging roles of cardiac biomarkers and prognostic scores. Arch Cardiovasc Dis. 2015 Jan;108(1):64-74. doi: 10.1016/j.acvd.2014.10.002. Epub 2014 Nov 4. Review.

ReferenceCitation: Parissis JT, Andreoli C, Kadoglou N, Ikonomidis I, Farmakis D, Dimopoulou I, Iliodromitis E, Anastasiou-Nana M, Lainscak M, Ambrosio G, Mebazaa A, Filippatos G, Follath F. Differences in clinical characteristics, management and short-term outcome between acute heart failure patients chronic obstructive pulmonary disease and those without this co-morbidity. Clin Res Cardiol. 2014 Sep;103(9):733-41. doi: 10.1007/s00392-014-0708-0. Epub 2014 Apr 10.

ReferenceCitation: Legrand M, Mebazaa A, Ronco C, Januzzi JL Jr. When cardiac failure, kidney dysfunction, and kidney injury intersect in acute conditions: the case of cardiorenal syndrome. Crit Care Med. 2014 Sep;42(9):2109-17. doi: 10.1097/CCM.0000000000000404. Review.

ReferenceCitation: Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, Fiuzat M, Zannad F, Pitt B, O'Connor CM, Lam CSP. Patient selection in heart failure with preserved ejection fraction clinical trials. J Am Coll Cardiol. 2015 Apr 28;65(16):1668-1682. doi: 10.1016/j.jacc.2015.03.043. Review.

ReferenceCitation: Mebazaa A, Yilmaz MB, Levy P, Ponikowski P, Peacock WF, Laribi S, Ristic AD, Lambrinou E, Masip J, Riley JP, McDonagh T, Mueller C, deFilippi C, Harjola VP, Thiele H, Piepoli MF, Metra M, Maggioni A, McMurray J, Dickstein K, Damman K, Seferovic PM, Ruschitzka F, Leite-Moreira AF, Bellou A, Anker SD, Filippatos G. Recommendations on pre-hospital & early hospital management of acute heart failure: a consensus paper from the Heart Failure Association of the European Society of Cardiology, the European Society of Emergency Medicine and the Society of Academic Emergency Medicine. Eur J Heart Fail. 2015 Jun;17(6):544-58. doi: 10.1002/ejhf.289. Epub 2015 May 21. Review.

ReferenceCitation: Mebazaa A, Longrois D, Metra M, Mueller C, Richards AM, Roessig L, Seronde MF, Sato N, Stockbridge NL, Gattis Stough W, Alonso A, Cody RJ, Cook Bruns N, Gheorghiade M, Holzmeister J, Laribi S, Zannad F. Agents with vasodilator properties in acute heart failure: how to design successful trials. Eur J Heart Fail. 2015 Jul;17(7):652-64. doi: 10.1002/ejhf.294. Epub 2015 Jun 4. Review.

ReferenceCitation: Jaffe AS, Apple FS, Mebazaa A, Vodovar N. Unraveling N-terminal pro-B-type natriuretic peptide: another piece to a very complex puzzle in heart failure patients. Clin Chem. 2015 Aug;61(8):1016-8. doi: 10.1373/clinchem.2015.243626. Epub 2015 Jun 15.

ReferenceCitation: Gayat E, Caillard A, Laribi S, Mueller C, Sadoune M, Seronde MF, Maisel A, Bartunek J, Vanderheyden M, Desutter J, Dendale P, Thomas G, Tavares M, Cohen-Solal A, Samuel JL, Mebazaa A. Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure. Int J Cardiol. 2015 Nov 15;199:241-7. doi: 10.1016/j.ijcard.2015.07.039. Epub 2015 Jul 12.

ReferenceCitation: Vodovar N, Séronde MF, Laribi S, Gayat E, Lassus J, Januzzi JL Jr, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Cohen-Solal A, Richards AM, Launay JM, Mebazaa A; GREAT Network. Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure. JACC Heart Fail. 2015 Aug;3(8):629-36. doi: 10.1016/j.jchf.2015.03.011.

ReferenceCitation: Teixeira A, Parenica J, Park JJ, Ishihara S, AlHabib KF, Laribi S, Maggioni A, Miró Ò, Sato N, Kajimoto K, Cohen-Solal A, Fairman E, Lassus J, Mueller C, Peacock WF, Januzzi JL Jr, Choi DJ, Plaisance P, Spinar J, Mebazaa A, Gayat E; GREAT (Global Research on Acute Conditions Team) Network. Clinical presentation and outcome by age categories in acute heart failure: results from an international observational cohort. Eur J Heart Fail. 2015 Nov;17(11):1114-23. doi: 10.1002/ejhf.330. Epub 2015 Sep 30.

ReferenceCitation: Spinar J, Jarkovsky J, Spinarova L, Mebazaa A, Gayat E, Vitovec J, Linhart A, Widimsky P, Miklik R, Zeman K, Belohlavek J, Malek F, Felsoci M, Kettner J, Ostadal P, Cihalik C, Vaclavik J, Taborsky M, Dusek L, Littnerova S, Parenica J. AHEAD score--Long-term risk classification in acute heart failure. Int J Cardiol. 2016 Jan 1;202:21-6. doi: 10.1016/j.ijcard.2015.08.187. Epub 2015 Aug 28.

ReferenceCitation: Mebazaa A, Tolppanen H, Mueller C, Lassus J, DiSomma S, Baksyte G, Cecconi M, Choi DJ, Cohen Solal A, Christ M, Masip J, Arrigo M, Nouira S, Ojji D, Peacock F, Richards M, Sato N, Sliwa K, Spinar J, Thiele H, Yilmaz MB, Januzzi J. Acute heart failure and cardiogenic shock: a multidisciplinary practical guidance. Intensive Care Med. 2016 Feb;42(2):147-63. doi: 10.1007/s00134-015-4041-5. Epub 2015 Sep 14. Review.

ReferenceCitation: Parissis J, Farmakis D, Kadoglou N, Ikonomidis I, Fountoulaki E, Hatziagelaki E, Deftereos S, Follath F, Mebazaa A, Lekakis J, Filippatos G. Body mass index in acute heart failure: association with clinical profile, therapeutic management and in-hospital outcome. Eur J Heart Fail. 2016 Mar;18(3):298-305. doi: 10.1002/ejhf.489. Epub 2016 Jan 28.

ReferenceCitation: Harjola VP, Mebazaa A, Čelutkienė J, Bettex D, Bueno H, Chioncel O, Crespo-Leiro MG, Falk V, Filippatos G, Gibbs S, Leite-Moreira A, Lassus J, Masip J, Mueller C, Mullens W, Naeije R, Nordegraaf AV, Parissis J, Riley JP, Ristic A, Rosano G, Rudiger A, Ruschitzka F, Seferovic P, Sztrymf B, Vieillard-Baron A, Yilmaz MB, Konstantinides S. Contemporary management of acute right ventricular failure: a statement from the Heart Failure Association and the Working Group on Pulmonary Circulation and Right Ventricular Function of the European Society of Cardiology. Eur J Heart Fail. 2016 Mar;18(3):226-41. doi: 10.1002/ejhf.478. Review.

ReferenceCitation: Van Aelst LN, Čelutkienė J, Mebazaa A. Advanced heart failure: look right to prognosticate right! Eur J Heart Fail. 2016 May;18(5):573-5. doi: 10.1002/ejhf.533.

ipd_sharing_description: Individual participant data will be made available to other researchers via GREAT (Global REsearch on Acute Conditions Team) database

location_facility: Lithuanian University of Health Sciences


title: Pain in Patients With Cystic Fibrosis in Rouen University Hospital

acronym: MUCODOL

summary:
Objectif Principal

- To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.

Objectifs secondaires

To assess the relationship between pain and disease severity.
To assess the relationship between pain and the age of the patient.
To describe the pain locations.
To describe the use of pharmacological or nonpharmacological treatment.
To evaluate the procedural pain.

lead_sponsor: University Hospital, Rouen

intervention_type: Behavioral


title: Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients

acronym: RESTIT

summary:
Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.

To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.

In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.

The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session

primary_purpose: Treatment

lead_sponsor: CHU de Reims

intervention_type: Device


title: Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units

acronym: Co-PAP

summary:
Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.

Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.

Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.

The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.

The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


type: Registry Identifier

title: Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels

acronym: NEURORELAX

summary: This longitudinal study deals with the characterization of the electrophysiological and behavioral effects of alpha-based neurofeedback training on the brain networks involved in the relaxation process of healthy people.

primary_purpose: Basic Science

lead_sponsor: Centre National de la Recherche Scientifique, France

location_facility: Centre de Neuro-Imagerie de recherche (CENIR), ICM


title: Establishment of Normal Muscle Strength Measured by Hand-held Dynamometer and Muscle Mass Assessed by Ultrasonography for French Population

summary: Normal values for muscle strength using hand held dynamometer and muscle mass using echography are largely unknown. The objective of the present study is to establish normal values of these measurements in population living in France.

time_perspective: Other

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'exploration fonctionnelle Les Hôpitaux Universitaires de Strasbourg


title: Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

summary:
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.

Our project aims to study the performance and safety of personalized implants (personalized guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.

lead_sponsor: SLS France

location_country: Belgium France

location_facility:
Cabinet chirurgie Maxillo-faciale
Hôpital Villefranche sur Sâone
Cabinet Orhognatic

lead_sponsor_type: industriel


title: Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis

summary:
Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.

Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at 6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United Kingdom. The proportion of children with HS who develop renal disease is difficult to determine because the numbers reported in the literature are variable and depend greatly on the type of the reporting center, whether or not specialized in pediatric nephrology. Thus the proportion of renal disease varies from 20% to 100% of children with a HS.

The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions but histological classification is discussed and there is currently no consensus. Randomized studies are scarce and often do not allow to draw clear conclusions. A meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this study the definition of renal disease was very heterogeneous. The only classification of the HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI: pseudomesangiocapillary. However, this classification is questioned because it ignores other significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular and interstitial inflammation, the appearance of crescents (segmental or totally encompassing the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance in immunofluorescence.

There is currently no consensus on the criteria indicating the initiation of corticosteroid therapy whether oral or intra venous bolus. Some patients with severe clinical and / or histological initial presentation can evolve to remission spontaneously while others who have more moderate initial symptoms will evolve later to kidney failure. The management is therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before starting treatment (or in the days following the start of treatment), while in other centers's treatment decision is based on the biology resulting from the glomerular disease, kidney biopsy being performed possibly in a second time in case of failure of the initial treatment.

Principal objective of the study: assessment of the interest for the long term outcome of performing early a kidney biopsy (before the establishment of treatment or within 15 days after the start of treatment) in children with HSN compare to kidney biopsy performed later (depending on the response to initial therapy) or not performed.

Secondary objective: assessment of the impact of early kidney biopsy (before the establishment of treatment or within of 15 days after the start of treatment) on the initial treatment HSN : does it modify or not the treatment started right before it (decided on clinical and biological criteria).


title: Lorraine Registry of Multiple Sclerosis

acronym: RelSEP

summary: The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.

ReferenceCitation: Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19.

ReferenceCitation: Brissart H, Sauvée M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13.

ReferenceType: result

ReferenceCitation: El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. Epub 2012 Feb 21.

ReferenceCitation: Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4.

family: Becker

full_name: Madlyne Becker

given: Madlyne

family: Latarche

full_name: Clotilde Latarche

given: Clotilde

family: Roman

full_name: Emilie Roman

given: Emilie

family: Debouverie

full_name: Marc Debouverie

given: Marc

family: Malaplate-Armand

full_name: Catherine Malaplate-Armand

given: Catherine

family: Guillemin

full_name: Francis Guillemin

given: Francis

currency_apc_doaj: GBP

journal_name: BMC Neurology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

ipd_sharing: Yes

ipd_sharing_description: open to partnership

lead_sponsor: Central Hospital, Nancy, France

location_facility: CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy


title: Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode

acronym: THROMBO-GYN

summary: The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a multifactorial disease and the risk depends on the simultaneous presence of several triggers.

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Study of the Prevalence of Fabry Disease in French Dialysis Patients

acronym: FABRYDIAL

summary:
Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked mutation and characterized by an alpha-galactosidase A (GLA) deficiency. It causes globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency. Due to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other organs irreversible lesions, and to enhance the familial screening.

We aim to conduct a multicentric cross-sectional prevalence study in 5 areas (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving biologic collection and genetic diagnosis test. Our objective is to measure the prevalence of FD among dialysis patients. Eligible patients will be included after signing the informed consent.

In the five participating areas, all of the dialysis centers will be asked for involvement. Nominative data of the French renal epidemiology and information network (REIN) registry will enable first patients screening for eligibility among prevalent dialysis patients. If needed (insufficient or absent data in the REIN registry), data will be completed with medical files.

A blood drop will be collected during a hemodialysis session (or the monthly test for peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas screening in women will be established on the association of alpha-galactosidase activity and lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in order to confirm the diagnosis for women, and, for all, to offer familial testing. Results will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed with FD will be managed in accordance with the guidelines of the French National Authority for Health (F.N.A.H.).

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Pellegrin Tripode, Service de néphrologie-Dialyse, place Amélie Rabat Léon

location_facility: Hôpital Universitaire Carémeau, Service de Néphrologie, Place du Pr R. Debré

location_facility: Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval

location_facility: CHU d'Amiens, Site Sud, Service de néphrologie, D408

location_facility: Hôpital Necker, APHP Paris, Service de néphrologie-dialyse, 149 rue de Sèvres

intervention_type: Biological


title: Phonological Perception and Learning to Read : the Neuroanatomy of Reading in Congenitally Deaf Persons

summary: The aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.

intervention_type: Procedure


title: Modulation de l'excitabilité Des Aires Corticales Motrices Primaires Correspondant Aux hémi Diaphragmes à l'Aide de la tDCS (Transcranial Direct Current Stimulation)

summary: Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to modulate cerebral cortex excitability. It was shown that anodal stimulation increases cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the corticodiaphragmatic pathways. This preliminary study aims to test and validate the modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed before and after applications of three different modalities of tDCS (anodal, cathodal and placebo).

ReferenceCitation: Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. Epub 2005 Jan 5.

ReferenceCitation: Madhavan S, Stinear JW. Focal and bi-directional modulation of lower limb motor cortex using anodal transcranial direct current stimulation. Brain Stimul. 2010 Jan;3(1):42. doi: 10.1016/j.brs.2009.06.005.

ReferenceCitation: Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618. Review.

ReferenceCitation: Nitsche MA, Seeber A, Frommann K, Klein CC, Rochford C, Nitsche MS, Fricke K, Liebetanz D, Lang N, Antal A, Paulus W, Tergau F. Modulating parameters of excitability during and after transcranial direct current stimulation of the human motor cortex. J Physiol. 2005 Oct 1;568(Pt 1):291-303. Epub 2005 Jul 7.

ReferenceCitation: Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901.

ReferenceCitation: Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9.

ReferenceCitation: Roche N, Lackmy A, Achache V, Bussel B, Katz R. Impact of transcranial direct current stimulation on spinal network excitability in humans. J Physiol. 2009 Dec 1;587(Pt 23):5653-64. doi: 10.1113/jphysiol.2009.177550. Epub 2009 Oct 5.

ReferenceCitation: Sharshar T, Hopkinson NS, Jonville S, Prigent H, Carlier R, Dayer MJ, Swallow EB, Lofaso F, Moxham J, Polkey MI. Demonstration of a second rapidly conducting cortico-diaphragmatic pathway in humans. J Physiol. 2004 Nov 1;560(Pt 3):897-908. Epub 2004 Jul 22.

ReferenceCitation: Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41.

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

location_facility: Hôpitaux Universitaires Paris Ile de France Ouest - Hôpital Raymond poincaré


acronym: COFLUPREG

location_facility:
Maternité Necker-Brune
Maternité Port Royal
Maternité Saint Vincent de Paul

type: EudraCT Number

source: euctr

title: Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women

summary: The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.


title: Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study

summary:
This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.

Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.


title: Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model

acronym: OS-TUMOVASC

summary:
Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Its prognosis remains poor despite the emergence of new therapies, notably the Epithelial Growth Factor Receptor (EGFR) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of EGFR.

In addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. In addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (ADAURA trial). For this reason, we have proposed tests using TKIs on an in vitro platform based on organoid formation from tumour biopsies of NSCLC patients. This model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. In this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the INCA (4-6 weeks).

For non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. This model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.

status: Enrolling by invitation


title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia

summary: The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.

lead_sponsor: Danone Research


title: Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension

acronym: JAZ ART

summary:
Gardens and art represent public spaces and support venues of interactions and emotions, seeking not only a variety of conversational themes but also various cognitive skills such as mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly associated and made available to patients suffering from Alzheimer's disease, need to be evaluated.

MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive and emotional processes by means of interview analyses in Alzheimer patients and control subjects based on the " art, memory and life " garden.

SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer patients:

create assessment methods of:
the therapeutic efficacy of the design of the " art, memory and life " garden,
the perception of an artistic dimension in the living environment of those with Alzheimer's disease,
establish:
workshop applications using art and the garden for therapeutic purposes,
general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007, 2010, 2011) for the analysis of interactive behaviors and the assessment of parameters including esthetic appraisals, well-being, mnemonic and emotional processes (frequency and nature of these processes) as well as spatio-temporal orientation.

SECONDARY ENDPOINTS

Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE),
Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden,
Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations,
Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,
Score obtained with the specific assessment of emotional events scale (AES) for all subjects.

RESEARCH METHODOLOGY

Open, monocentric, controlled (group of healthy control subjects) study.

Population: 2 groups:

Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease: subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)" (CHU de Nancy, France) Group B "healthy control group": healthy volunteers

Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care management, notably: i) by determining the design, conception and layout of the gardens destined to these patients, ii) by developing the introduction of an artistic dimension to the design of such healing gardens and in their living environment, iii) by establishing workshop application perspectives using the contemplation of works of art and the garden for therapeutic purposes.

primary_purpose: Health Services Research


title: Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier

acronym: Légumineuses

summary: The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.

lead_sponsor: University Hospital, Montpellier

location_facility: Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier


title: Multicentre Retrospective Study on the Clinical and Epidemiological Characteristics and Therapeutic Management of Non-cholera Vibrio Infections

acronym: INFECTIVE

summary: The purpose of this study is to identify the epidemiological and clinical characteristics of patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019.

ReferenceCitation: Weis KE, Hammond RM, Hutchinson R, Blackmore CG. Vibrio illness in Florida, 1998-2007. Epidemiol Infect. 2011 Apr;139(4):591-8. doi: 10.1017/S0950268810001354. Epub 2010 Jun 14.

ReferenceCitation: Morris JG Jr. Cholera and other types of vibriosis: a story of human pandemics and oysters on the half shell. Clin Infect Dis. 2003 Jul 15;37(2):272-80. Epub 2003 Jul 3.

ReferenceCitation: Givens CE, Bowers JC, DePaola A, Hollibaugh JT, Jones JL. Occurrence and distribution of Vibrio vulnificus and Vibrio parahaemolyticus--potential roles for fish, oyster, sediment and water. Lett Appl Microbiol. 2014 Jun;58(6):503-10. doi: 10.1111/lam.12226. Epub 2014 Feb 27.

ReferenceCitation: Jones MK, Oliver JD. Vibrio vulnificus: disease and pathogenesis. Infect Immun. 2009 May;77(5):1723-33. doi: 10.1128/IAI.01046-08. Epub 2009 Mar 2. Review.

ipd_sharing_description:
Data will be made available with publication. Keyword are infection, non-cholera Vibrio, epidemiology The only available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.

Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Centre Hospitalier Départemental de la Vendée


title: Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.

acronym: CacheMire

summary: The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).

ReferenceCitation: Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. Review.

lead_sponsor: Chugai Pharma France


title: Longitudinal Description of Hemorrhoidal Pathology

acronym: DeLPH

summary: Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.


title: Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program

summary:
Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.

In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.

However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.

In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.

The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.

At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.


title: SENOMETRY : Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis

acronym: SENOMETRY

summary:
Primary purpose :

To develop a method to automatically extract and structure the information included in numerous medical records from breast cancer patients.

Secondary purpose :

With this procedure we can analyze the content of ten thousand anonymized textual medical records.

This information should enable us to explore many subjects, such as:

The impact of certain therapeutic procedures
The characteristics of sub-groups of patients
Pregnancy associated breast cancers
Risk factors


title: FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES

acronym: Focal HIFU for

summary: Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.


title: Impact of Parent's Presence in Neonatology

summary:
Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely.

Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents.

Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night.

The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard


title: Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson

acronym: ICEBERG

summary:
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.


title: Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

summary: It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


title: Feasibility and Effects of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization: a Controlled and Randomized Study

acronym: MUCAFOCSS

summary:
In France, home hospitalization services (HAD) are developing as an alternative to conventional hospitalization. In order to intervene at patients' home, a reason for referral must be defined. The most common one on the national territory is "complex dressing". Cares associated with these dressings can lead to symptoms such as pain and/or anxiety, and thus decrease the patient's quality of life. These two symptoms may be related, with the presence of one increasing the intensity of the other. Thus, drug treatments are often implemented as part of care, but may not be sufficient to relieve patients. Music has many interests in patients' pain and anxiety. MUSIC CARE© application allows the implementation of standardized musical interventions. It has been shown to be effective in reducing acute and chronic pain and anxiety in many clinical settings.

The aim of this study is to evaluate the feasibility of implementing MUSIC CARE© in the care of complex dressings at home and to confirm its effectiveness on the symptoms experienced by patients. In addition, attention will be paid to the impact of this standardized musical intervention on care time, medication use during care and patients' and caregivers' satisfaction.

lead_sponsor: Fondation Oeuvre de la Croix Saint-Simon


acronym: IDA-Adult

location_facility: Unité de Recherche Clinique et Immunologique

title: Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

summary:
Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.

This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.

The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.


title: Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study

acronym: SPIROKID

summary:
Objectives:

While a respiratory abnormality was found in 50% of pediatric renal transplant recipients in a study conducted in Belgium and the Netherlands in 2008, the respiratory status of transplanted children in France remains unknown. The primary objective of this study is to assess the prevalence of respiratory impairment and its characteristics in children with renal transplant. The secondary objective is to study its association with some potential risk factors such as immunosuppressive therapy or humoral immunodeficiency.

Methodology:

This interventional study aims to recruit the 385 children currently being followed by 5 French pediatric renal transplant centers between June 2018 and November 2019. A clinical and functional respiratory assessment will be carried out during the routine annual follow-up of the transplant recipient. Children with clinical signs of concern or abnormal spirometry will be referred to a respiratory specialist. Pharmacokinetic assays of immunosuppressant therapy and the exploration of humoral function will also be performed. The prevalence and type of respiratory abnormalities will be described. Logistic regression will be used to explore the association between potential risk factors and impaired respiratory function.

Expected results:

This study will be the first to evaluate the respiratory status of children with renal transplants in France. The prospective, multi- centered nature of the study, in addition to the large cohort size (which represents two thirds of children with renal transplants in France) will guarantee current, reliable, and representative data for the target population. We will provide new knowledge by precisely characterizing the type of lung injury and looking for potential risk factors. If our study confirms the high prevalence of pulmonary impairment in children with renal transplants, systematic monitoring of respiratory function may be recommended to enable early diagnosis and management. The expected individual and public health benefits would be significant by limiting the appearance of long-term, irreversible sequelae (such as non-cystic-fibrosis bronchiectasis) and improving the quality of life of these patients.

lead_sponsor: Nantes University Hospital

location_facility: Hôpital Universitaire Necker Enfants Malades


title: Northwest Inter Hospital Adult Congenital Heart Disease Observatory

acronym: CARL

summary: The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.

lead_sponsor: University Hospital, Caen