title: Clinical Implication of the Molecular Diagnostic Retinitis Pigmentosa Molecular Diagnostic Using High Throughput Sequencing (RP-SEQ-HD)

acronym: RP-SEQ-HD

summary:
The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading to severe low vision and is the leading cause of consultation in reference centers dedicated to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity (clinical, genetic and molecular), which made them unreachable by traditional molecular diagnostic sequencing technology by the large number of genes to be tested (> 190).

The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected possibilities of investigation and ultimately to improve the care of patients. This project aims to study the genetic and molecular epidemiology of an interregional french (grand EST) cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190 known genes (https://sph.uth.edu/retnet/).

This research will provide a molecular epidemiological cohort study compared to prior publications on the frequency of genes involved. The benefit for patients is important to: establish a mode of transmission of the disease and optimize genetic counseling (currently very empirical); establish phenotype-genotype correlations in the French population (very few studies to date) and from the data of international literature; identify patients likely to be included in future therapeutic protocols of research; identify patients with significant potential for future projects to identify new genes.

The primary purpose of the protocol is to use high throughput sequencing to identify pathogenic variants in genes involved in RP.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation

location_facility: Service d'Ophtalmologie, Hôpital Robert Debré, CHR

location_facility: Service d'Ophtalmologie CHU Hôpital Général

location_facility: Affections Rares en Génétique Ophtalmologique (CARGO) Hôpital Civil, Hôpitaux Universitaires de Strasbourg

acronyme: RP-SEQ-HD

titre: Etude de la rétinopathie pigmentaire : diagnostic moléculaire par séquençage haut-débit ciblé et conséquences cliniques.

discipline_principale: ophtalmologie , génétique

nom_porteur: MULLER

prenom_porteur: Jean


title: Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

summary: D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil

location_facility: Médecine interne, maladies tropicales et infectieuses Hôpital Civil

location_facility: Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg

location_facility: Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

acronym: DRONE

summary: This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

location_facility: Centre hospitalier de Belfort-Montbéliard

intervention_type: Biological


title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping

summary: Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

design_allocation: Randomized

primary_purpose: Prevention

location_facility: Service de Chirurgie Vasculaire, CHU le Bocage

location_facility: Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

location_facility: Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Chirurgie Vasculaire, CH Jean Minjoz

intervention_type: Procedure

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

type_etablissement: CH

acronyme: PRE-ISCH-AORTE

titre: Effets protecteurs du préconditionnement ischémique sur les fonctions cardiaque, rénale, pulmonaire et musculaire après clampage aortique

discipline_principale: autre

nom_porteur: LEJAY

prenom_porteur: Anne


title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

summary: Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).

location_facility: Chirurgie digestive et transplantation, Hôpital de Besançon

location_facility: CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)

location_facility: Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

intervention_type: Drug


title: Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

summary: Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

summary:
The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients.

efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration.
safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

ReferenceType: derived

ReferenceCitation: Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

location_facility: Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine

summary: USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

location_facility: Service de Rhumatologie - Hôpital de Hautepierre

location_facility: Service de Neuroradiologie - Hôpital Central

location_facility: Service de Radiologie 2 - Hôpital de Hautepierre


title: TWIST Human Gene and Cleft Lips and Palates

summary: This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

location_facility: Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

acronym: DISCO

summary: The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

status: Completed

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Beasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21.

ReferenceCitation: Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.

ReferenceCitation: Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.

ReferenceCitation: Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.

ReferenceCitation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

ReferenceCitation: Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.

ReferenceCitation: Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9.

ReferenceCitation: Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016.

ReferenceCitation: Thariat J, Creisson A, Chamignon B, Dejode M, Gastineau M, Hebert C, Boissin F, Topfer C, Gilbert E, Grondin B, Guennoc H, Mari V, Buzzo S, Saja D, Duboue N, Boulahssass R, Tosi A, Verne S, Ducray J, Benard-Thiery I, Ferrero JM. [Integrating patient education in your oncology practice]. Bull Cancer. 2016 Jul-Aug;103(7-8):674-90. doi: 10.1016/j.bulcan.2016.04.007. Epub 2016 Jun 7. French.

ReferenceCitation: Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133.

ReferenceCitation: Touillaud M, Fournier B, Perol O, Delrieu L, Maire A, Belladame E, Perol D, Perrier L, Preau M, Leroy T, Fassier JB, Fillol F, Pascal S, Durand T, Fervers B. Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2x2 factorial randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045448. doi: 10.1136/bmjopen-2020-045448.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: No

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Fondation ARC
National Cancer Institute, France
Fondation pour la Recherche Médicale
Cancéropôle Lyon Auvergne Rhône-Alpes
AG2R La Mondiale

location_facility:
CHRU Besançon
Centre Léon Bérard
Institut Sainte-Catherine

intervention_type: Device

status_simplified: Completed


title: Evaluation of the Long-term Efficacy and Safety of the Omega Loop Bypass Versus the Roux-en-Y Gastric Bypass on the Cohort of Patients Included in the Randomized Trial YOMEGA (DGOS 13-0037)

acronym: YOMEGA 5-7y

summary: Over the last 40 years, the Roux-en-Y Gastric Bypass (RYGB) has been the gold standard in the surgical management of morbid obesity. and is a validated bariatric procedure in France. Nevertheless, the RYGB remains a technically demanding procedure; thus and in order to overcome the complexity of this intervention, a simpler technique based on a single anastomosis at 200cm from the Treitz angle creating an omega loop (Mini Gastric Bypass - MGB or One Anastomosis Gastric Bypass-OAGB) has gradually spread around the worl without prior evaluation, . In 2018, the MGB was officially recognized by the International Federation of Bariatric Surgery (IFSO) as a standard procedure but not by the ASMBS American Society for Metabolic and Bariatric Surgery ; indeed, the OAGB remains controversial because considered by many surgeons at risk of biliary reflux and malnutrition.

status: Recruiting

time_perspective: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Chirurgie Générale - Hôpital Privé de la Loire

location_facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

location_facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - HEGP

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière

location_facility: Service de Chirurgie Digestive Hôpital Edouard Herriot

status_simplified: Ongoing


title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

summary: In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

lead_sponsor: French Innovative Leukemia Organisation

collaborators:
Schering SA
Novartis

sponsor_collaborators:
French Innovative Leukemia Organisation
Schering SA
Novartis

lead_sponsor_type: industriel


title: Using a Digital Mental Health Application in the Adolescent's Care Pathway.

acronym: TOGETHER

summary: Clinical experience has shown that adolescents have great difficulties in getting to mental health care centers. The investigators want to find a specific way to follow up with the adolescent public. This study sets up a digital mental health application offering a tele-consultation space, a chat space with mental health professionals, a forum space, a news and therapeutic education space. The objective of the study is to evaluate the acceptance of the digital tool by the adolescent between 11 and 18 years old. To do this, the investigators determine the number of connections to the tool during the 6 months of support.

primary_purpose: Other

lead_sponsor: Januel

location_facility: Etablissement Public de Santé de Ville-Evrard


title: Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

acronym: OPTIVACC

summary: In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CH de Montauban
CH du Bassin de Thau
CH de Bagnols sur Cèze
CHU de Toulouse
CH de Perpignan
CH Alès Cévennes
CHU de Nimes
CHU de Montpellier
CH Comminges Pyrénées

region: Occitanie

nom_etablissement: CHU NIMES

acronyme: OPTIVACC

titre: Prévention des infections à pneumocoques : impact d'une prise en charge collaborative médico-pharmaceutique structurée en vue d'améliorer la couverture vaccinale des patients à risque. Etude multicentrique randomisée en cluster avec permutation séquentielle (stepped-wedge).

discipline_principale: infectiologie  / pharmacie clinique

nom_porteur: DUBOIS

prenom_porteur: Florent


title: Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné

summary:
Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad.

For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market.

The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study.

It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.

lead_sponsor: University Hospital, Caen

location_facility: Centre hospitalier universitaire de CAEN

location_facility: Centre hospitalier Mémorial France Etats Unis


title: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

acronym: CALMET

summary:
Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases.

The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

lead_sponsor: University Hospital, Bordeaux

location_facility: CHRU de Strasbourg - Nouvel Hôpital Civil

location_facility: CHU de Brest - Hôpital La Cavale Blanche

location_facility: CHU de Bordeaux - Hôpital du Haut-Lévêque

location_facility: CHU de Grenoble - Hôpital Albert Michallon


title: Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort

acronym: RELEVANT

summary:
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.

time_perspective: Retrospective

sponsor_collaborators:
University Hospital, Caen
Biogen

location_facility: Department of Neurology, CHU Bobigny-Avicenne

location_facility: Department of Neurology, Percy Military Hospital

location_facility: Department of Neurology, CHU Toulouse Purpan


title: Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.

acronym: DeCOPO

summary:
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.

Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.

Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Hopital Saint Joseph
Hopital La Timone
Hopital Européen
Hopital Nord


title: Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score

acronym: ENHANCE

summary:
The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC.

Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy.

Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis.

Secondary Objectives:

Identify predictive factors for the response to adalimumab.
Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1).
Safety of the pCLE procedure

lead_sponsor: European Georges Pompidou Hospital


title: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

summary: This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

status: Active, not recruiting

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Switzerland
Austria
Belgium
United States
Spain
Czechia
Puerto Rico
France

location_facility:
Local Institution - 1414
Local Institution - 1910
Local Institution - 1302
Local Institution - 1427
Local Institution - 1422
Local Institution - 1425
Local Institution - 1506
Local Institution - 1305
Local Institution - 1912
Local Institution - 1504
Local Institution - 1408
Local Institution - 1605
Local Institution - 1101
Local Institution - 1908
Local Institution - 2107
Local Institution - 1409
Local Institution - 1434
Local Institution - 1404
Local Institution - 1907
Local Institution - 1203
Local Institution - 1433
Local Institution - 1202
Local Institution - 1407
Local Institution - 1606
Local Institution - 2203
Local Institution - 2002
Local Institution - 2103
Local Institution - 1003
Local Institution - 1418
Local Institution - 2101
Local Institution - 2102
Local Institution - 1802
Local Institution - 1426
Local Institution - 1905
Local Institution - 1402
Local Institution - 1201
Local Institution - 1403
Local Institution - 1423
Local Institution - 1703
Local Institution - 2106
Local Institution - 1301
Local Institution - 1904
Local Institution - 1601
Local Institution - 1602
Local Institution - 1412
Local Institution - 1103
Local Institution - 2201
Local Institution - 1435
Local Institution - 1436
Local Institution - 1428
Local Institution - 1406
Local Institution - 1702
Local Institution - 1102
Local Institution - 1902
Local Institution - 1416
Local Institution - 1413
Local Institution - 1405
Local Institution - 1421
Local Institution - 1417
Local Institution - 1424
Local Institution - 1401
Local Institution - 1603
Local Institution - 1607
Local Institution - 1801
Local Institution - 2202
Local Institution - 1303
Local Institution - 1430
Local Institution - 1432
Local Institution - 1604
Local Institution - 1002
Local Institution - 1419
Local Institution - 1915
Local Institution - 1803
Local Institution - 1501
Local Institution - 1502
Local Institution - 1913
Local Institution - 1006
Local Institution - 1503
Local Institution - 1909
Local Institution - 1304
Local Institution - 1307
Local Institution - 1901
Local Institution - 1415
Local Institution - 1429
Local Institution - 1906
Local Institution - 1804
Local Institution - 1431
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title: A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease

acronym: PROSIKA

summary:
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain.

The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

lead_sponsor: Santen SAS

location_country: Spain Poland France

location_facility: 5th MILITARY CLINICAL HOSPITAL IN KRAKOW

location_facility: El Instituto Ofalmológico Quirónsalud Zaragoza

location_facility: Klinika Okulistyki i Onkologii Okulistycznej


title: Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

acronym: Inspired

summary: Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators: Funding from DGOS (PHRC IR 2013 and PRME)

location_facility:
CHRU Lille
CHU Rouen


title: Evaluation of Length of Stay and Predisposing Factors of Late Discharge After Transfemoral Transcatheter Aortic Valve Implantation Using the SAPIEN-3 Prosthesis: A French Multicenter Prospective Observational Trial

acronym: FAST-TAVI

summary:
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.

While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.

Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.

lead_sponsor: University Hospital, Rouen

location_facility:
AP-HP Bichat - Claude Bernard Hospital
Rouen University Hospital
Brest University Hospital
Rennes University Hospital
Jacques Cartier Private Hospital


title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

acronym: PERFECTO

summary: The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU de Clermont-Ferrand
CHU de Toulouse
Bressollette
Institut A.Tzanck
CHU de Nimes
GHM de Grenoble
CHU Poitiers


summary:
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.

Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.

But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).

The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).

The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.

location_facility: Service Gynécologie Obstétrique et médecine de la reproduction


type: Other Identifier

title: High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial

acronym: CANULASTHM

summary: In France, over 2.5 million people suffer from asthma, including one-third of children. This is the chronic respiratory disease leading to the highest rate of hospitalization. The conventional oxygen delivery means in children are the non-rebreather face mask or low flow nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with acute respiratory failure, allowing to deliver a slight positive expiratory pressure while ensuring humidification and warming of the airways. Aerosol administration is also possible with excellent efficiency and without interrupting respiratory assistance. Physiological data and clinical studies in other pathologies suggest the interest of this technique during the asthma attack, but no comparative study currently exists in this indication. The HFNCs could have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather face mask sometimes not tolerated by the children. The investigators's hypothesis is that HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care units or continuous monitoring units (CMU).

location_facility:
CHU de Grenoble Alpes
CHU Arnaud de Villeneuve
CH Villefranche sur Saône,
CHU de Dijon
Hôpital Armand Trousseau
Hôpital Necker Enfants Malades
CHU de Nantes
CHU Strasbourg,
Hôpital Timone 2
Hôpital Bicêtre
Hôpital Femme-Mère-Enfant
CH Annecy Genevois
Hôpital Robert Debré
Chu Lenval

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: CanulAsthme

titre: Impact des canules nasales à haut débit dans l'asthme aigu grave chez les enfants

discipline_principale: anesthésiologie / réanimation

nom_porteur: POUYAU

prenom_porteur: Robin


title: Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.

acronym: CONCEPTION

summary: Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.

lead_sponsor: University Hospital, Toulouse

location_facility: APHP Hôpital Necker, Lactarium Régional d'Ile de France


title: Randomized Trial to Assess the Efficacy of a High-intensity Physical Activity Program on Renal Function Decline in High Risk Patients With Type 2 Diabetes

acronym: ACTIDIANE

summary:
Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy.

It has been shown that the trajectory of renal function (estimated glomerular filtration rate - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic patients. However the clinical use of this prognostic marker is not associated to date with a clear therapeutic intervention, effective in patients with type 2 diabetes identified with this biomarker.

In France, type 2 diabetes patients have twice less physical activity than non-diabetic persons. Recently, it has been published that physical activity was associated with an improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD study. It was demonstrated that high-intensity physical activity (HIPA) can have several additional advantages over moderate-intensity, on blood pressure improvement, and cardiovascular risk profile modification. In addition, this procedure was shown to be safe in patients with high cardiovascular risk.

We plan to perform a randomized intervention comparing a structured program of high-intensity physical activity (HIPA) vs standard recommendations for physical activity on renal function decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety and quality of life (secondary outcomes). Study participants will be patients with established type 2 diabetes and a high renal risk, identified by rapid renal function decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned to last for 2 years.

ipd_sharing_description: sharing policy is under the responsibility of the scientific committee who will organise this point Any request can be posted to the PI in the meantime.

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Universitaire de Nice

location_country: Belgium France

location_facility:
CHU Toulouse
Poitiers University Hospital
Hôpital Pitié Salpétrière
Caen University Hospital
Chu de Lyon
CH Chartres
CHU Dijon
CHU Nancy
Clermont Ferrand University Hospital
Besançon Hospital
Chu de Nice
CHU de TOURS
Bichat University Hospital
CHRU
CHU Strasbourg
CHG Sud Francilien
Bordeaux University Hospital
La Riboisière Hospital
Hospital of Liège
CHU Lille

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

acronyme: ACTIDIANE

titre: Essai randomisé pour évaluer l'efficacité d'un programme d'activité physique à haute intensité sur la fonction rénale de sujets diabétiques de type 2 à haut risque

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: HADJADJ

prenom_porteur: Samy


title: An International Field-Testing Study Of The Reliability And Validity Of A Patient Satisfaction Module (QLQ-SAT32) Assessing Cancer Patients' Perception Of The Quality Of Care Received Within The Hospital

summary:
RATIONALE: Questionnaires may help determine cancer patients' satisfaction with the quality of care they received in the hospital.

PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer patients' satisfaction with the quality of care they received in the hospital.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
France
United Kingdom
Belgium
Spain
Sweden

location_facility:
Institut Jules Bordet
Sahlgrenska University Hospital
Institut Bergonie
Bristol Royal Infirmary
Uppsala University Hospital
Centre Regional Francois Baclesse
Institut Gustave Roussy
Centre Paul Strauss
Institut Curie - Section Medicale
Centre Alexis Vautrin
Hospital De Navarra


title: SPICI: Strategic Treatment Pause of First-line Immune Check Point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in Good or Only One Adverse Prognostic Factor in Intermediate Risk Metastatic Renal Cell Carcinoma (mRCC) With an Objective Response: a Randomised, Non-inferiority Phase III Study

acronym: SPICI

summary:
The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response at 12 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI.

Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed.

location_facility: CH de la Cote Basque - Service d'Oncologie

location_facility: Institut Paoli-Calmettes - Service d'Oncologie

location_facility: Institut Régional du Cancer - Service d'Oncologie

location_facility: Hospices Civils de Lyon - Service d'Oncologie

location_facility: Centre Georges-François Leclerc - Service d'Oncologie

location_facility: Institut de cancérologie Strasbourg Europe - Service d'Oncologie

location_facility: Centre Antoine Lacassagne - Service d'Oncologie

location_facility: Centre Jean Perrin - Service d'Oncologie

location_facility: Institut Gustave Roussy - Service d'Oncologie

location_facility: AP-HP - Henri Mondor - Service d'Oncologie

location_facility: AP-HP - Hôpital Européen Georges Pompidou - Service d'Oncologie

location_facility: AP-HP - Hôpital Saint Louis - Service d'Oncologie

location_facility: Centre Leon Berard - Service d'Oncologie

location_facility: CHU de Saint-Etienne - Service d'Oncologie

location_facility: Polyclinique de Limoges - Service d'Oncologie

location_facility: Institut de Cancérologie de Lorraine - Service d'Oncologie

location_facility: Centre Eugène Marquis - Service d'Oncologie

location_facility: CHU Grenoble Alpes - Service d'Oncologie

location_facility: Centre François Baclesse - Service d'Oncologie

location_facility: CHU de la Réunion Site Sud - Service d'Oncologie

appel_a_projets: PHRCK

nom_etablissement: CHU DE BORDEAUX

acronyme: SPICI-GOOD MRCC

titre: SPICI-GOOD MRCC-PAUSE THERAPEUTIQUE DE MODULATEUR DE LA REPONSE IMMUNITAIRE ET ANTI ANGIOGENIQUE EN PREMIERE LIGNE CHEZ LES PATIENTS PRESENTANT UN CANCER DU REIN METASTATIQUE DU GROUPE PRONOSTIC FAVORABLE PRESENTANT UNE REPONSE OBJECTIVE: UNE ETUDE RANDOMISEE DE NON-INFERIORITE DE PHASE III

discipline_principale: cancer

nom_porteur: RAVAUD

prenom_porteur: Alain


title: Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident

acronym: INSPIRE

summary:
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.

The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).

lead_sponsor: Wandercraft

location_country: Luxembourg Belgium France

location_facility: Centre de Médecine Physique et de Réadaptation

location_facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape

location_facility: Hôpital La Musse, La Renaissance Sanitaire


title: Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study

acronym: TrOMaTho

summary: In France, the average incidence of thoracic trauma is 10,000 to 15,000 each year. These patients are at risk of early and late post traumatic respiratory complications as follows: pneumonia, Acute Respiratory Distress Syndrome (ARDS), hypoxemia. Main issues of thoracic trauma management were recently published by French anesthesiologist and intensivist experts. Non-invasive ventilation (NIV) was recommended in case of severe hypoxemia (PaO2/FiO2 < 200). In comparison to conventional oxygenation or mechanical ventilation, NIV reduced length of stay, incidence of complications and mortality in case of severe hypoxemia. For mild or moderate hypoxemic patients, no devices were tested to prevent respiratory complications. At the moment, low-flow oxygenation is administered to these patients in the absence of severe hypoxemia. Recently, many studies have found promising results with high-flow oxygenation delivered by nasal cannula. This device has many physiological advantages: wash out the naso-pharyngeal dead space, increase end expiratory lung volume, deliver a moderate or low level of Positive end-expiratory pressure (PEEP), improve work of breathing and confort. Several randomized controlled trials tested this device in many clinical settings, but there are no studies on its use after thoracic trauma. A comparative trial is needed to evaluate early prophylactic administration of high-flow oxygenation after thoracic trauma.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Kremlin Bicêtre university hospital (APHP)

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: TrOMaTho trial

titre: Post Traumatic early use of High flow Oxygenation for Management of Thoracic trauma: a randomized, open-label, parallel group, controlled trial

nom_porteur: VERMEERSCH

prenom_porteur: Veronique


title: Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

summary: Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.

ReferenceCitation: Barbe F, Hansen C, Badonnel Y, Legagneur H, Vert P, Boutroy MJ. Severe side effects and drug plasma concentrations in preterm infants treated with doxapram. Ther Drug Monit. 1999 Oct;21(5):547-52. doi: 10.1097/00007691-199910000-00011.

ReferenceCitation: Greze E, Benard M, Hamon I, Casper C, Haddad FE, Boutroy MJ, Hascoet JM. Doxapram Dosing for Apnea of Prematurity Based on Postmenstrual Age and Gender: A Randomized Controlled Trial. Paediatr Drugs. 2016 Dec;18(6):443-449. doi: 10.1007/s40272-016-0192-2.

publisher_dissemination: Springer-Nature

lead_sponsor: Jean Michel Hascoet

location_facility:
Maternite Regionale Universitaire
Hopital des Enfants


title: National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

summary:
The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa.

Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization.

The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

ReferenceCitation: Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8. doi: 10.1097/01.ta.0000171453.37949.b7.

ReferenceType: result

ReferenceCitation: Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001 Sep;51(3):431-8; discussion 438-9. doi: 10.1097/00005373-200109000-00002.

ReferenceCitation: Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care. 2006;10(6):R178. doi: 10.1186/cc5133.

ReferenceCitation: Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005 Jul;59(1):150-4. doi: 10.1097/01.ta.0000171470.39742.8e.

ReferenceCitation: Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Negrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. doi: 10.1016/j.annfar.2007.06.001. Epub 2007 Jul 16. French.

lead_sponsor: University Hospital, Grenoble

collaborators: Société Française d'Anesthésie et de Réanimation

location_facility:
ICHAI
COOK
FREYS
MARTIN
GARRIGUE
GUELON
Duranteau
AUDIBERT
LEFRANT
MIQUET
DEBIEN
Bleichner
LEPOUSE
Vinsiniti
Mateo A Loris
LAIGLE
SEDILLOT
OLIVIER
JAULT
YUNG
FAVIER
JOURNOIS
CHARBIT
LANGERON
MOREL
GARCIN
MEROUANI
NADJI
PEASE
BULEON
FLOCARD
LEBAS
MEAUDRE
CHUPIN
Nanadoumgar
DECLETY
GUITARD
SANTRE
DAVID


title: Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial

acronym: LombalgIP

summary:
Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.

Design: Pragmatic cluster randomized controlled trial

ReferenceCitation: Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020.

ReferenceCitation: Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.

ReferenceCitation: Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.

ReferenceCitation: Desmeules F, Roy JS, MacDermid JC, Champagne F, Hinse O, Woodhouse LJ. Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review. BMC Musculoskelet Disord. 2012 Jun 21;13:107. doi: 10.1186/1471-2474-13-107.

ReferenceCitation: Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.

ReferenceCitation: Kechichian A, Lafrance S, Matifat E, Dube F, Lussier D, Benhaim P, Perreault K, Filiatrault J, Rainville P, Higgins J, Rousseau J, Masse J, Desmeules F. Multimodal Interventions Including Rehabilitation Exercise for Older Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-analyses of Randomized Controlled Trials. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):34-49. doi: 10.1519/JPT.0000000000000279.

sponsor_collaborators:
University Hospital, Grenoble
TIMC-IMAG

location_facility: Maison de santé pluriprofessionnelle de Cran Gévrier

location_facility: Maison de santé pluriprofessionnelle de Voiron-Sud

location_facility: Pôle de santé interprofessionnel de Saint-Martin d'Hères

location_facility: Maison de santé pluriprofessionnelle de Moirans

location_facility: Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors

location_facility: Maison de santé pluriprofessionnelle des Hauts de Chambéry


title: Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study

acronym: CACAO

summary:
Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K antagonist (VKA) in real practice remain uncertain.

The few existing ambulatory studies did not answer all NOAC specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in France where warfarin is less frequently prescribed.

Therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between VKA and NOAC in primary care.

ReferenceCitation: Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22-30. doi: 10.1161/01.CIR.0000078464.82671.78.

ReferenceCitation: You JJ, Singer DE, Howard PA, Lane DA, Eckman MH, Fang MC, Hylek EM, Schulman S, Go AS, Hughes M, Spencer FA, Manning WJ, Halperin JL, Lip GYH. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e531S-e575S. doi: 10.1378/chest.11-2304.

ReferenceCitation: Mantilla CB, Horlocker TT, Schroeder DR, Berry DJ, Brown DL. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology. 2002 May;96(5):1140-6. doi: 10.1097/00000542-200205000-00017. Erratum In: Anesthesiology 2002 Aug;97(2):531.

ReferenceCitation: Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.

ReferenceCitation: Douketis J, Tosetto A, Marcucci M, Baglin T, Cosmi B, Cushman M, Kyrle P, Poli D, Tait RC, Iorio A. Risk of recurrence after venous thromboembolism in men and women: patient level meta-analysis. BMJ. 2011 Feb 24;342:d813. doi: 10.1136/bmj.d813.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.

ReferenceCitation: Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012 Aug 1;110(3):453-60. doi: 10.1016/j.amjcard.2012.03.049. Epub 2012 Apr 24.

ReferenceCitation: Adam SS, McDuffie JR, Ortel TL, Williams JW Jr. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review. Ann Intern Med. 2012 Dec 4;157(11):796-807. doi: 10.7326/0003-4819-157-10-201211200-00532.

ReferenceCitation: Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med. 2012 Mar 12;172(5):397-402. doi: 10.1001/archinternmed.2011.1666. Epub 2012 Jan 9.

ReferenceCitation: Larsen TB, Rasmussen LH, Skjoth F, Due KM, Callreus T, Rosenzweig M, Lip GY. Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol. 2013 Jun 4;61(22):2264-73. doi: 10.1016/j.jacc.2013.03.020. Epub 2013 Apr 3.

ReferenceCitation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

ReferenceCitation: Frappe P, Cogneau J, Gaboreau Y, Abenhaim N, Bayen M, Guichard C, Jacquet JP, Lacoin F, Liebart S, Bertoletti L, Bosson JL; CACAO study investigators. Anticoagulants' Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study. Ann Fam Med. 2020 Mar;18(2):131-138. doi: 10.1370/afm.2495.

evidence: open (via free pdf)

publisher_dissemination: Annals of Family Medicine

ReferenceCitation: Frappe P, Cogneau J, Gaboreau Y, Abenhaim N, Bayen M, Calafiore M, Guichard C, Jacquet JP, Lacoin F, Bertoletti L; CACAO study investigators. Areas of improvement in anticoagulant safety. Data from the CACAO study, a cohort in general practice. PLoS One. 2017 Apr 6;12(4):e0175167. doi: 10.1371/journal.pone.0175167. eCollection 2017.

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: CNGE IRMG Association

collaborators:
Floralis
University Hospital, Grenoble

sponsor_collaborators:
CNGE IRMG Association
Floralis
University Hospital, Grenoble

location_facility:
Office-based general practitioner
Office-based practitioner
Office-based general practioner


title: "Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"

acronym: FIXATUB

summary:
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.

Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.

There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.

The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hopitalier La Rochelle
Centre Hospitalier Le Mans
CH Saint-Nazaire
Groupe Hospitalier Bretagne Sud
Centre Hospitalier d'Angoulême
CHU La Réunion GHSR
CHU de Poitiers
CHI Poissy - Saint-Germain-en-Laye
Hôpital Nord Laennec
CHU de Tours
Centre Hospitalier Régional d'Orléans
CHU Nantes Hôtel Dieu
CH Victor Dupouy

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHD VENDEE

type_etablissement: EPSM

acronyme: FIXATUB

titre: Comparaison de deux méthodes de FIXAtions de sonde d'inTUBation en réanimation: bandes adhésives élastiques versus cordon dans une gaine plastique. Une étude contrôlée multicentrique randomisée, en cluster et en crossover. ETUDE FIXATUB

nom_porteur: ZINZONI

prenom_porteur: Vanessa


title: Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)

summary: The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)

ReferenceCitation: Pujol JL, Milleron B, Molinier O, Quoix E, Depierre A, Breton JL, Gervais R, Debieuvre D, Hominal S, Namouni F, Tonelli D. Weekly paclitaxel combined with monthly carboplatin in elderly patients with advanced non-small cell lung cancer: a multicenter phase II study. J Thorac Oncol. 2006 May;1(4):328-34.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

ReferenceCitation: Quoix E, Westeel V, Moreau L, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Sennelart H, Tredaniel J, Mennecier B, Morin F, Baudrin L, Milleron B, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique. Second-line therapy in elderly patients with advanced nonsmall cell lung cancer. Eur Respir J. 2014 Jan;43(1):240-9. doi: 10.1183/09031936.00048213. Epub 2013 Oct 10.

oa_host_type: publisher

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

location_facility:
CH - Pneumologie
CHU Besancon - Pneumologie
CHU
CHU - Pneumologie
Hôpital Tenon - Pneumologie


title: Study of Family COsegregation of Nucleotide VARiants in the Panel of Genes to Validate Their Use in Genetic Counseling

acronym: COVAR

summary: The aim of the COVAR project is to classify reliably a maximum of VUS of the French database in order to use them for the genetic counseling. The results obtained through this study will have a major impact on clinical management of the patients and their families conducting in some cases to propose a prophylactic surgery.

lead_sponsor: Institut Curie

location_country: Réunion Guadeloupe Martinique France

location_facility: Hopital de Hautepierre - Hôpital Universitaire

location_facility: Institut de Cancérologie Strasbourg Europe ICANS

location_facility: Institut Claudius Regaud - IUCT - Oncopole

intervention_type: Genetic


title: Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program

acronym: Post-ATU

summary:
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).

It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Bristol-Myers Squibb

location_facility:
Chu Amiens
Hôpitaux de Marseille
CH de PAU
Centre Léon Bérard de Lyon
Chu Clermont-Ferrand
Chu Toulouse
Ch Valence
CH du Mans
CHU de Grenoble
Chu Dijon
Institut Gustave Roussy
Hopital St andré-CHU DE Bordeaux
Chru Lille
AP-HP Hôpital Ambroise Paré
CHU de Rouen
Hospices Civils de Lyon: Lyon Sud
CHU NICE


title: RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

acronym: RACING-HF

summary: The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
Bayer

location_facility: Centre Hopsitalier Lucie et Raymond Aubrac


title: Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

acronym: MBRP

summary: Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Hopital Fernand Widal
Hôpital Corentin-Celton
Ssra Les Eumenides
Hopital Paul Brousse
CHU de Nimes
Hopital Des 4 Villes
CHU de Nantes

intervention_type: Behavioral

acronyme: MBRP

titre: Evaluation de l'efficacité du programme MBRP chez des patients présentant un trouble de l'usage de l'alcool.

discipline_principale: psychiatry

nom_porteur: LUQUIENS

prenom_porteur: Amandine


title: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial

summary:
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.

This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.

The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

lead_sponsor: Société des Produits Nestlé (SPN)

location_facility: Maternité Régionale Universitaire A. Pinard - CHRU Nancy

intervention_type: Dietary Supplement


title: National Prospective and Comparative Study on the Mode of Delivery of Twins

acronym: JUMODA

summary: The purpose of this study is to determine the best obstetrical practices for twin delivery.

ReferenceCitation: Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939. Erratum In: N Engl J Med. 2013 Dec 12;369(24):2364.

ReferenceCitation: Smith GC. Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762. doi: 10.1136/bmj.39176.426424.3a. No abstract available.

ReferenceCitation: Smith GC, Shah I, White IR, Pell JP, Dobbie R. Mode of delivery and the risk of delivery-related perinatal death among twins at term: a retrospective cohort study of 8073 births. BJOG. 2005 Aug;112(8):1139-44. doi: 10.1111/j.1471-0528.2005.00631.x.

ReferenceCitation: Smith GC, Pell JP, Dobbie R. Birth order, gestational age, and risk of delivery related perinatal death in twins: retrospective cohort study. BMJ. 2002 Nov 2;325(7371):1004. doi: 10.1136/bmj.325.7371.1004.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed).

acronym: Parpsych-Ed

summary: Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France. They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need. Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs. Theses also facilitate community support. One of them, early-interventions involve caregivers. Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.

study_start_date_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: GCS pour la recherche et la formation en sante mentale

location_facility:
EPSM Val de Lys
EPSM de Guadeloupe
Centre Hospitalier de Saint Denis
Fondation Bon Sauveur de la Manche
EPSM Barthélémy Durand
Centre Hospitalier Sainte Anne

appel_a_projets: PREPS

region: Hauts-de-France

nom_etablissement: EPSM LILLE METROPOLE

acronyme: ParpsychEd

titre: PARtenariats locaux entre le secteur de PSYCHiatrie infanto-juvénile et l'EDucation Nationale développant des interventions pluri-professionnelles: une recherche-action sur 10 sites

discipline_principale: psychiatrie / addictologie

nom_porteur: BONNETON

prenom_porteur: Sandrine


title: Phase II Randomized Trial Evaluating the Administration of Sorafenib or Pravastatin or Association Sorafenib-pravastatin or Best Supportive Care for the Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

acronym: PRODIGE 21

summary: The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients).

ReferenceCitation: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

ReferenceCitation: Taras D, Blanc JF, Rullier A, Dugot-Senant N, Laurendeau I, Vidaud M, Rosenbaum J. Pravastatin reduces lung metastasis of rat hepatocellular carcinoma via a coordinated decrease of MMP expression and activity. J Hepatol. 2007 Jan;46(1):69-76. doi: 10.1016/j.jhep.2006.06.015. Epub 2006 Jul 28.

ReferenceCitation: Kawata S, Yamasaki E, Nagase T, Inui Y, Ito N, Matsuda Y, Inada M, Tamura S, Noda S, Imai Y, Matsuzawa Y. Effect of pravastatin on survival in patients with advanced hepatocellular carcinoma. A randomized controlled trial. Br J Cancer. 2001 Apr 6;84(7):886-91. doi: 10.1054/bjoc.2000.1716.

ReferenceCitation: Lersch C, Schmelz R, Erdmann J, Hollweck R, Schulte-Frohlinde E, Eckel F, Nader M, Schusdziarra V. Treatment of HCC with pravastatin, octreotide, or gemcitabine--a critical evaluation. Hepatogastroenterology. 2004 Jul-Aug;51(58):1099-103.

ReferenceCitation: Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.

ReferenceCitation: Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

ReferenceCitation: Blanc JF, Khemissa F, Bronowicki JP, Monterymard C, Perarnau JM, Bourgeois V, Obled S, Abdelghani MB, Mabile-Archambeaud I, Faroux R, Seitz JF, Locher C, Senellart H, Villing AL, Audemar F, Costentin C, Deplanque G, Manfredi S, Edeline J; PRODIGE 21 collaborators. Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child-Pugh B cirrhosis. Hepatol Int. 2021 Feb;15(1):93-104. doi: 10.1007/s12072-020-10120-3. Epub 2021 Jan 9.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: univOAK

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

repository_normalized: HAL

repositories: HAL univOAK

repositories_concat: HAL;univOAK

unpaywall_oa_status: green

lead_sponsor: University Hospital, Bordeaux

collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Centre Régional de Lutte contre le Cancer Centre Paul Strauss

location_facility: CHU de Bordeaux, Hôpital du Haut Lévèque

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital civil

location_facility: Centre René Gauducheau CLCC Nantes Atlantique

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital Hautepierre


lead_sponsor: Genfit

summary: The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.

ReferenceCitation: Cariou B, Hanf R, Lambert-Porcheron S, Zair Y, Sauvinet V, Noel B, Flet L, Vidal H, Staels B, Laville M. Dual peroxisome proliferator-activated receptor alpha/delta agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects. Diabetes Care. 2013 Oct;36(10):2923-30. doi: 10.2337/dc12-2012. Epub 2013 May 28.

oa_colors: green hybrid

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

publisher_dissemination: American Diabetes Association

ReferenceCitation: Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

location_facility:
Site n°1
Site n°2

title: A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.

type: EudraCT Number

source: euctr


title: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

summary:
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.

Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).

This registry is opened in France and in Belgium

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: Impact of the Suicide Attempt on the Close Entourage: Traumatic Stress and Medico-economic Concerns, in Medium and Long Term

acronym: IMTAP

summary:
With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an important public health problem. For each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (Terra 2001). In term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide and 3.750.000 people (annually) touched by the "suicide attempt" of a close relative. It seems indeed important to have Public Health data on this cascade repercussion of the suicide attempt.

A suicide attempt propagates a suffering cascade on the various circles of the family and close entourage, which can be measured in term of traumatic stress and medico-economic impact.

Objective = To measure the medico-economic impact on the entourage, in the 3 months following the suicide attempt and at 1 year.

lead_sponsor: University Hospital, Lille

location_facility:
Le Vinatier Hospital
University Hospital, Nancy
University Hospital, Brest
University Hospital, Caen
University Hospital, Limoges
University Hospital, Nice
University Hospital, Angers
General Hospital, Quimper
EPSM Lille Metropole
University Hospital, Lille
Tenon Hospital, Paris
University Hospital, Clermont-Ferrand


type: Other Grant/Funding Number

title: The COMETE Network, Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card

acronym: COMETETACTIC

summary:
Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care.

The main objective of COMETE-TACTIC is to provide an easy-to-use "identity card" of the adrenal tumors that will allow a personalized "à la carte" management of the patient and, when indicated, to the indication of the most accurate molecular targeted therapy.

We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require,

the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers);
the implementation of the translational research projects based on the COMETE collection to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic biomarkers that could be used as non-invasive "liquid biopsies".

ReferenceCitation: Castro-Vega LJ, Letouze E, Burnichon N, Buffet A, Disderot PH, Khalifa E, Loriot C, Elarouci N, Morin A, Menara M, Lepoutre-Lussey C, Badoual C, Sibony M, Dousset B, Libe R, Zinzindohoue F, Plouin PF, Bertherat J, Amar L, de Reynies A, Favier J, Gimenez-Roqueplo AP. Multi-omics analysis defines core genomic alterations in pheochromocytomas and paragangliomas. Nat Commun. 2015 Jan 27;6:6044. doi: 10.1038/ncomms7044.

ReferenceCitation: Letouze E, Martinelli C, Loriot C, Burnichon N, Abermil N, Ottolenghi C, Janin M, Menara M, Nguyen AT, Benit P, Buffet A, Marcaillou C, Bertherat J, Amar L, Rustin P, De Reynies A, Gimenez-Roqueplo AP, Favier J. SDH mutations establish a hypermethylator phenotype in paraganglioma. Cancer Cell. 2013 Jun 10;23(6):739-52. doi: 10.1016/j.ccr.2013.04.018. Epub 2013 May 23.

ReferenceCitation: Assie G, Letouze E, Fassnacht M, Jouinot A, Luscap W, Barreau O, Omeiri H, Rodriguez S, Perlemoine K, Rene-Corail F, Elarouci N, Sbiera S, Kroiss M, Allolio B, Waldmann J, Quinkler M, Mannelli M, Mantero F, Papathomas T, De Krijger R, Tabarin A, Kerlan V, Baudin E, Tissier F, Dousset B, Groussin L, Amar L, Clauser E, Bertagna X, Ragazzon B, Beuschlein F, Libe R, de Reynies A, Bertherat J. Integrated genomic characterization of adrenocortical carcinoma. Nat Genet. 2014 Jun;46(6):607-12. doi: 10.1038/ng.2953. Epub 2014 Apr 20.

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

location_facility: Assistance Publique Hopitaux de Paris, Pitie Salpetriere

location_facility: Assistance Publique Hopitaux de Paris -HEGP

location_facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: Assistance Publique Hopitaux de Paris, Necker

location_facility: Assistance Publique Hopitaux de Pais, Hopital de Bicetre

location_facility: Assistance Publique Hopitaux de Paris, Cochin

appel_a_projets: PRTK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: COMETE-TACTIC

titre: Le réseau COMETE, en route vers une carte d'identité des cancers/tumeurs de la surrénale

nom_porteur: GIMENEZ-ROQUEPLO

prenom_porteur: Anne-Paule


title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years: A Randomized Controlled Trial

acronym: DILEMMA

summary: The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

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

acronyme: DILEMMA

titre: Défibrillateur automatique implantable en prévention primaire chez le patient âgé de plus de 75 ans: un essai contrôlé randomisé

discipline_principale: cardiologie

nom_porteur: MARIJON

prenom_porteur: Eloi


title: Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%

acronym: ROPI-LEVO

summary: This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

acronym: SENIOREA

summary:
Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome (e.g. hospital survival) of an ICU stay is improving in this population but little data have been published on long-term outcome. Beyond survival, outcome assessment in the elderly requires to evaluate several aspects of health: mental status, activity of daily living, pain, depression, frailty… referred by geriatrician as "comprehensive geriatric assessment' (CGA).

The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will be performed on the patients' site of living.

This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.

ReferenceCitation: Demiselle J, Duval G, Hamel JF, Renault A, Bodet-Contentin L, Martin-Lefevre L, Vivier D, Villers D, Lefevre M, Robert R, Markowicz P, Lavoue S, Courte A, Lebas E, Chevalier S, Annweiler C, Lerolle N. Determinants of hospital and one-year mortality among older patients admitted to intensive care units: results from the multicentric SENIOREA cohort. Ann Intensive Care. 2021 Feb 17;11(1):35. doi: 10.1186/s13613-021-00804-w.

lead_sponsor: University Hospital, Angers


title: Comparison of the Bilateral Transversus Abdominis Plane (TAP) Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study

summary: This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


acronym: PIK-ORL

lead_sponsor: Centre Leon Berard

summary: The aim of this study is to determine the activity, to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under platin and cetuximab-based chemotherapy.

ReferenceCitation: Graupera M, Guillermet-Guibert J, Foukas LC, Phng LK, Cain RJ, Salpekar A, Pearce W, Meek S, Millan J, Cutillas PR, Smith AJ, Ridley AJ, Ruhrberg C, Gerhardt H, Vanhaesebroeck B. Angiogenesis selectively requires the p110alpha isoform of PI3K to control endothelial cell migration. Nature. 2008 May 29;453(7195):662-6. doi: 10.1038/nature06892. Epub 2008 Apr 30.

ReferenceCitation: Schnell CR, Stauffer F, Allegrini PR, O'Reilly T, McSheehy PM, Dartois C, Stumm M, Cozens R, Littlewood-Evans A, Garcia-Echeverria C, Maira SM. Effects of the dual phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor NVP-BEZ235 on the tumor vasculature: implications for clinical imaging. Cancer Res. 2008 Aug 15;68(16):6598-607. doi: 10.1158/0008-5472.CAN-08-1044.

ReferenceCitation: Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. doi: 10.1056/NEJM199301213280306. No abstract available.

ReferenceCitation: Saranath D, Panchal RG, Nair R, Mehta AR, Sanghavi VD, Deo MG. Amplification and overexpression of epidermal growth factor receptor gene in human oropharyngeal cancer. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):139-43. doi: 10.1016/0964-1955(92)90043-z.

ReferenceCitation: Burtness B. The role of cetuximab in the treatment of squamous cell cancer of the head and neck. Expert Opin Biol Ther. 2005 Aug;5(8):1085-93. doi: 10.1517/14712598.5.8.1085.

sponsor_collaborators:
Centre Leon Berard
National Cancer Institute, France
Fondation ARC

location_facility:
Hôpital BEAUJON
Centre Léon Bérard
Hopital St André
Centre Antoine LACASSAGNE
Centre Val d'Aurelle - Paul Lamarque
Centre Oscar Lambret
Institut Gustave Roussy
Centre Hospitalier Lyon Sud
Institut Curie

title: A Phase II, Multicenter Trial Aiming to Evaluate the Clinical Interest of a Monotherapy With BKM120 , a Phosphoinositide 3-kinase (PI3K) Inhibitor in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive Under Platin and Cetuximab-based Chemotherapy


title: Responsiveness and Validation Study of MFM-20 in SMA Patients Treated With Nusinersen: Retro NusiMFM

acronym: RetroNusiMFM

summary:
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (MFM-20).

In order to show the possible use of MFM-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-20 and the validity of the scale in this population.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie et réanimation pédiatriques CHU Paris IdF Ouest - Hôpital Raymond Poincaré

location_facility: Service de neuropédiatrie et neurochirurgie de l'enfant Centre de Référence maladies neuromusculaires AOC CHU d'Angers

location_facility: Unité de Neurologie Pédiatrique Centre de Référence Maladies NeuroMusculaires Hôpital des Enfants CHU Toulouse

location_facility: Service de génétique médicale Pôle de Pédiatrie CHU Estaing

location_facility: Service de pédiatrie CHU de Saint-Etienne

location_facility: Hospices Civils de Lyon, Hôpital Femme Mère Enfant

location_facility: Institut I-Motion - Centre de recherche pédiatrique en pathologies neuromusculaires CHU Paris Est - Hôpital d'Enfants Armand-Trousseau


title: Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS

acronym: RUBIS

summary:
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).

Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. This explains why excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality.

A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL.

The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.

location_facility: neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France

location_facility: Neonatal intensive care unit, Hôpital femme-maternité

intervention_type: Diagnostic Test