title: STernectOmy Repair Efficiency of a Ceramic Implant

acronym: STOIC

summary:
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.

Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.

location_facility:
Saint George clinic
Reims university hospital
Limoges Hospital


type: EudraCT Number

title: Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.

acronym: PECS B&BS

summary: Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

location_facility: UH Montpellier - Hôpital Gui de Chauliac

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment

acronym: LUPUS CTL EBV

summary: EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Nantes University Hospital

location_facility:
Hopital La pitié Salpétriere
CHU de Nantes - Dermatologie
CHU de Nantes - Médecine interne

intervention_type: Biological

status_simplified: Ongoing


acronym: NEHAVI

summary:
The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne.

The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these children's lives from the perspectives of health, social sciences and environmental health

These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history).

This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.

status: Unknown status

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Limoges

location_facility:
Clinique des Emailleurs
Centre Hositalier de Saint Junien
HME

status_simplified: Unknown


title: Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)

acronym: PREDICCMI

summary: Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial disease (POAD). Despite progress in the revascularization procedures, half these patients experience amputation or death after one year. One issue is to identify these subjects because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a patient with POAD but no rest lower limb ischaemia), revascularization will not be necessary. Then it would be useful to develop a simple score to help the physician to improve diagnosis of CLI.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Limoges
CHU de Bordeaux
CHU de Toulouse

intervention_type: Other


title: Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

acronym: MMRD

summary: Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease

status: Recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire Hôtel-Dieu de Nantes


type: Other Identifier

title: Functional Significance of Complexity Measures in the Sensory-motor Behavior: Are There Potential Clinical Applications?

acronym: NEURO COMP

summary: The main objective of this study is to compare between groups the level of complexity of the estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1


title: Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

acronym: CaspoKin

summary:
Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.

The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
CHU de CLERMONT-FERRAND
Hôpital Saint-Louis


title: Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers

acronym: CYPREANE

summary: To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

primary_purpose: Diagnostic

location_facility: Laboratoire Immunologie et Immunogénétique


title: Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation

acronym: EPHEBE

summary:
Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains higher than 25%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.

The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation, while improving gas exchange.

ReferenceType: derived

ReferenceCitation: Diehl JL, Piquilloud L, Vimpere D, Aissaoui N, Guerot E, Augy JL, Pierrot M, Hourton D, Arnoux A, Richard C, Mancebo J, Mercat A. Physiological effects of adding ECCO(2)R to invasive mechanical ventilation for COPD exacerbations. Ann Intensive Care. 2020 Sep 29;10(1):126. doi: 10.1186/s13613-020-00743-y.

family: Diehl

full_name: J.-L. Diehl

sequence: first

family: Piquilloud

full_name: L. Piquilloud

given: L.

sequence: additional

family: Vimpere

full_name: D. Vimpere

given: D.

family: Aissaoui

full_name: N. Aissaoui

given: N.

family: Guerot

full_name: E. Guerot

given: E.

family: Augy

full_name: J. L. Augy

given: J. L.

family: Pierrot

full_name: M. Pierrot

given: M.

family: Hourton

full_name: D. Hourton

family: Arnoux

full_name: A. Arnoux

given: A.

family: Richard

full_name: C. Richard

given: C.

family: Mancebo

full_name: J. Mancebo

given: J.

family: Mercat

full_name: A. Mercat

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Université de Lausanne - SERVAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Physiological effects of adding ECCO2R to invasive mechanical ventilation for COPD exacerbations

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital de Bicetre, Hopitaux universitaires Paris Sud

intervention_type: Device


title: Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial

acronym: AlvéCare

summary: The main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard care (suturing for lower alveoli).

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

intervention_type: Procedure


title: Male Factor in Early Recurrent Pregnancy Loss : Study of Sperm DNA Fragmentation in Patients With Unexplained Recurrent Pregnancy Loss.

acronym: PARTHOM

summary: In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals' studies, several studies have underlined the importance of sperm quality for a normal embryo development. In human, epidemiological studies have demonstrated that several male risk factors have effects on development (male mediated development toxicology). However, few studies have explored sperm DNA fragmentation on embryo development but after in vitro fertilization. In natural pregnancy only rare studies have been performed but with different populations definitions and different methods of sperm exploration. In this context sperm DNA fragmentation exploration appears justified. The present study purpose to conduct a case - control study in order to research paternal role in RPL.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Toulouse

location_facility:
APHM
Chu Toulouse
Chu Bordeaux


title: Apport de l'échographie du Col Dans l'évaluation du Délai Induction Accouchement (DIA) Chez Des Patientes à Score de Bishop défavorable après déclenchement Par Dinoprostone Intravaginal

acronym: ECOLDIA

summary: Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.

primary_purpose: Prevention

lead_sponsor: University Hospital, Tours

location_facility:
University Hospital of Tours
University Hospital of Nantes
Hospital of Orleans


title: Improving Social Cognition for Adults With Autism Spectrum Disorder by the Serious Game JeStiMulE Versus Classic Video Game Stimulation Not Improving Social Cognition

summary:
The serious game "JeStiMulE" (Educational Game for Multisensory Stimulation of Children with developmental disorders), developed by the Autism Resources Center of Nice, was created to teach social cognition including emotion recognition in context, for children and adolescents with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of young people aged 6-17 years old with high and low levels of autism.

According to the recommendations of the 2011 HAS, disorders of social interactions are the most persistent troubles of the autistic triad in life.

It seems essential to us to be able to offer young adults with autism, rehabilitation methods adapted to their trouble, and to observe whether JeStiMulE could be one of them.

This study researches the effectiveness of the serious game JeStiMulE in the improvement social cognition for adults with autism versus controls.

The main goal is:

- Comparing the improvement in social cognition among adults with autism using the serious game JeStiMulE or not.

Two groups will be formed: a first one of fifteen adults with a diagnosis of autism objectified, this group will use JeStiMulE and will be compared to a control group of adults with autism, using another video game, not aimed to improve social cognition.

The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, including three modules each). The groups will be matched with their nonverbal IQ through Raven matrices and visual memory tasks (WAIS).

The control group will also be stimulated through a video game, not specialized in improving social cognition.

The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test: by the number of emotions recognized on faces, compared to the number of emotion presented through this test.

The secondary outcomes will be:

The rest of social cognition improvement by several tests (the theory of mind with the score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a self-administered questionnaire: EQ / AQ).
The impact on the quality of life, verbal fluency of emotional words, and the feedback from JeStiMulE players will also be seen as a secondary outcome.

primary_purpose: Other

lead_sponsor: Fondation Lenval

location_facility:
Hôpital Pasteur - CHU de Nice
Fondation Lenval
Hôpital psychiatrique de Sainte marie

lead_sponsor_type: industriel


title: Characterization of Bone Architectural Parameters Assessed by High-Resolution Peripheral Quantitative Computed Tomography in Post-menopausal Women Affected With Primary Hyperparathyroidism

acronym: MicrOs

summary: Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has shown that decreased microarchitectural parameters are associated with reduced bone strength independently of BMD. The purpose of this study is to characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.

location_facility:
Hopital Europeen Georges Pompidou
Hopital Cochin
Hopital Lariboisiere


title: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

acronym: HYDROPS

summary:
This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects
MR Perfusion Imaging will be assess in both cochlea as well
Primary auditory brain pathways will be evaluated through MR diffusion imaging

status: Terminated

ReferenceCitation: Eliezer M, Maquet C, Horion J, Gillibert A, Toupet M, Bolognini B, Magne N, Kahn L, Hautefort C, Attyé A. Detection of intralabyrinthine abnormalities using post-contrast delayed 3D-FLAIR MRI sequences in patients with acute vestibular syndrome. Eur Radiol. 2019 Jun;29(6):2760-2769. doi: 10.1007/s00330-018-5825-0. Epub 2018 Nov 9.

family: Eliezer

full_name: Michael Eliezer

given: Michael

family: Maquet

full_name: Charles Maquet

given: Charles

family: Horion

full_name: Julien Horion

given: Julien

family: Gillibert

full_name: André Gillibert

given: André

family: Toupet

full_name: Michel Toupet

given: Michel

family: Bolognini

full_name: Benoit Bolognini

given: Benoit

family: Magne

full_name: Nicolas Magne

given: Nicolas

family: Kahn

full_name: Laureline Kahn

given: Laureline

family: Hautefort

full_name: Charlotte Hautefort

given: Charlotte

family: Attyé

full_name: Arnaud Attyé

given: Arnaud

journal_name: European Radiology

lead_sponsor: University Hospital, Grenoble

location_facility:
Hôpital Charles Nicolle
GrenobleUniversityHospital
Hôpital Lariboisière


title: Metronomic Cyclophosphamide and Methotrexate Combined With Zoledronic Acid and Sirolimus in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma. A Phase Ib Study From the French Sarcoma Group

acronym: METZOLIMOS

summary: This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

family: Serra

full_name: Massimo Serra

given: Massimo

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Léon Bérard
Centre Oscar Lambret


title: Prevention of Post-exercise Muscle Fatigue Using a Non Invasive Ventilation and Effect on Exercise Training in Severe Patients With COPD. QUADRIVEND Study

acronym: QUADRIVEND

summary:
In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is severely impaired due to a ventilatory limitation, levelling off the intensity of exercise. This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity and the duration of every training session. In a preliminary study, the investigators showed that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps contractions (TlimQ).

The aim of this study is to determine the relationship between the prevention of post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of sessions) during a pulmonary rehabilitation programme. At the beginning of the training programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal workload) with and without IPS in random order. The training load was then monitored at every exercise session of the programme.

location_facility:
CHU de Saint-Etienne
CHU de Clermont-Ferrand
Clinique Cardio-pneumologique de Durtol


title: Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort

summary:
Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.

The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.

Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.

Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.

This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.

This work also will specify the evolution of different markers at the moment of thrust

location_facility: CHU Hôpital Nord - Service d'Hépato-Gastroentérologie

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie

location_facility: CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie


title: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

acronym: Coca-Colon

summary: The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

ReferenceCitation: Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.

family: Sefrioui

full_name: David Sefrioui

given: David

family: Beaussire

full_name: Ludivine Beaussire

given: Ludivine

family: Blanchard

full_name: France Blanchard

given: France

family: Toure

full_name: Emmanuel Toure

given: Emmanuel

family: Bazille

full_name: Céline Bazille

given: Céline

family: Perdrix

full_name: Anne Perdrix

given: Anne

family: Ziegler

full_name: Frédéric Ziegler

given: Frédéric

family: Gangloff

full_name: Alice Gangloff

given: Alice

family: Hassine

full_name: Mélanie Hassine

given: Mélanie

family: Elie

full_name: Caroline Elie

given: Caroline

family: Bignon

full_name: Anne-Laure Bignon

given: Anne-Laure

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: Gomez

full_name: Philippe Gomez

given: Philippe

family: Thill

full_name: Caroline Thill

family: Clatot

full_name: Florian Clatot

given: Florian

family: Sabourin

full_name: Jean-Christophe Sabourin

given: Jean-Christophe

family: Frebourg

full_name: Thierry Frebourg

given: Thierry

family: Benichou

full_name: Jacques Benichou

given: Jacques

family: Bouhier-Leporrier

full_name: Karine Bouhier-Leporrier

given: Karine

family: Gallais

full_name: Marie-Pierre Gallais

given: Marie-Pierre

family: Sarafan-Vasseur

full_name: Nasrin Sarafan-Vasseur

given: Nasrin

family: Michel

full_name: Pierre Michel

given: Pierre

family: Di Fiore

location_facility:
University Hospital
Centre François Baclesse
Centre Frédéric Joliot


title: Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation

acronym: RIO

summary: The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

name: INSERM Unit 1042; Grenoble Alpes University; Grenoble France

name: Physiology and Sleep Unit; Michallon University Hospital; Grenoble France

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

name: Pneumology Unit; Michallon University Hospital; Grenoble France

name: European Institute for Systems Biology and Medicine; EISBM; Lyon France

name: INSERM Unit 1055; Grenoble Alpes University; Grenoble France

family: Pison

full_name: Christophe Pison

given: Christophe

name: INSERM Unit 823; Grenoble Alpes University; La Tronche France

family: Vesin

full_name: Aurélien Vesin

given: Aurélien

name: Intensive Care and Pneumology Unit; Pitié-Salpêtrière University Hospital; Paris France

family: Gonzalez-Bermejo

full_name: Jesus Gonzalez-Bermejo

given: Jesus

name: Pneumology Unit; Saint-Etienne University Hospital; Saint Etienne France

family: Court-Fortune

full_name: Isabelle Court-Fortune

given: Isabelle

name: Intensive Care Unit, A; Michallon University Hospital; Grenoble France

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Respirology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility:
University Hospital
Hopital de La Pitie Salpetriere
Hopital Nord
Hopital de La Croix Rousse


title: EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)

summary: SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Neurology department - CHU Rangueil
Headache Emergency Center
Neurology department - La timone
Neurosurvery department


title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

summary: This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

lead_sponsor: Hoffmann-La Roche


title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

summary: The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.

location_facility:
CH Saint Nazaire
CHD La Roche-sur-Yon
University Hospital of Angers
Nantes University Hospital


lead_sponsor: Institut de Cancérologie de la Loire

acronym: RV-405 LAL

location_facility:
Hôpital Edouard Herriot
Hôpital Michallon
Institut de Cancerologie de la Loire
CHU de Clermont-Ferrand

source: euctr

title: A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Relapse After 2 Lines of Treatment

summary: The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).


title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis

acronym: CDCHC

summary:
Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.

ReferenceCitation: Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Féray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.

name: Institut des Maladies de l'Appareil Digestif; Hôtel-Dieu; Nantes France

family: Archambeaud

full_name: Isabelle Archambeaud

family: Auble

full_name: Hélène Auble

given: Hélène

name: Service d'Hépatologie; Hôpital Jean Verdier; Bondy; and INSERM U674; Université Paris 5; France

family: Nahon

full_name: Pierre Nahon

name: Cellule de Promotion à la Recherche Clinique; Hôtel-Dieu; Nantes France

family: Planche

full_name: Lucie Planche

given: Lucie

name: Centre Hépato-Biliaire and INSERM 785; Hôpital Paul Brousse; Villejuif France

family: Fallot

full_name: Guillaume Fallot

given: Guillaume

name: Hôpital de la Roche/Yon; Roche/Yon France

family: Faroux

full_name: Roger Faroux

given: Roger

family: Gournay

full_name: Jérôme Gournay

given: Jérôme

family: Samuel

full_name: Didier Samuel

given: Didier

name: Laboratoire de Génétique; Hôtel-Dieu; Nantes France

family: Kury

full_name: Sebastien Kury

given: Sebastien

name: Service d'hépatologie; Hôpital Henri Mondor; Créteil France

family: Féray

full_name: Cyrille Féray

given: Cyrille

journal_name: Liver International

location_facility:
Nantes UH
Paul Brousse UH
Jean Verdier UH
Rennes UH

intervention_type: Genetic


type: Other Grant/Funding Number

title: Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge

acronym: MSAJOY

summary:
Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including cerebellar impairment and poor response to dopatherapy. The objective of the study is to assess right-hand motor activation in MSA patients before and after an acute levodopa challenge and to compare these data with those obtained in patients with Parkinson Disease (PD) and healthy volunteers (HV).

Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included. rCBF measurements with H215O PET will be performed at rest and during a right hand movement. Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON condition and effect of levodopa on motor activation.

Hypothesis: MSA and PD patient should recruited different motor networks.

intervention_type: Radiation


title: Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol

acronym: CYTRAM

summary:
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.

O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.

The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).

The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

lead_sponsor: University Hospital, Caen

location_facility:
Private Clinic Saint-Martin
Créteil University Hospital
Rouen University Hospital
Caen University Hospital


title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

acronym: ATIM

summary: Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

primary_purpose: Supportive Care

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lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

location_facility: Hospices Civils de Lyon Service de Consultations et Traitements Dentaires

location_facility: Centre Léon Bérard Service de Chirurgie-Stomatologie


title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

acronym: Pétunia

summary: The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.

ReferenceCitation: Rozé JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

family: Barbarot

full_name: Sébastien Barbarot

given: Sébastien

family: Butel

full_name: Marie-José Butel

given: Marie-José

family: Kapel

full_name: Nathalie Kapel

given: Nathalie

family: Waligora-Dupriet

full_name: Anne-Judith Waligora-Dupriet

given: Anne-Judith

family: De Montgolfier

full_name: Inès De Montgolfier

given: Inès

family: Leblanc

full_name: Magali Leblanc

given: Magali

family: Godon

full_name: Nathalie Godon

family: Soulaines

full_name: Pascale Soulaines

given: Pascale

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

family: Rivero

full_name: Montserrat Rivero

given: Montserrat

family: Dupont

full_name: Christophe Dupont

bso_classification: Biology (fond.)

journal_name: British Journal of Nutrition

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

lead_sponsor: Sodilac

location_facility:
Hôpital Saint Vincent de Paul (AP-HP)
CHU d'Angers
Hôpital de la Pitié Salpétrière
CHU de Nantes

intervention_type: Dietary Supplement


title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

summary:
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).

The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.

Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.

Primary objective:

To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.

Secondary Objectives:

Overall survival.
Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
Histological and seric proteomic exploratory studies.

primary_purpose: Screening

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre Léon BERARD
Centre Antoine LACASSAGNE
Chu Font-Pre
Institut PAOLI-CALMETTES


title: Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)

acronym: RBHP 2008

summary:
Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.

Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Hôpital La Pitié Salpétrière
CHU Gabriel-Montpied
CHU Purpan
Hôpital Haut-Levêque


title: Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study

summary: Interleukin-2 (IL-2) was initially discovered and used as a stimulator of effector T lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to stimulate Treg and define potential clinical benefits

location_facility: Département des maladies du système nerveux et Centre d'investigation clinique - Groupe Hospitalier Pitié-Salpêtrière - AP-HP

location_facility: Centre d'investigation Clinique - Pitié salpêtrière

location_facility: Centre d'investigation clinique Biothérapie Immunologie (CIC-BTi) - Groupe Hospitalier Pitié-Salpêtrière - AP-HP


title: Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial

summary:
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.

This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.

The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.

location_facility: CHU de Nice - Service de chirurgie vasculaire


title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

acronym: PosoAnes

summary: The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

lead_sponsor: Hopital Foch

location_facility:
Hôpital Foch
Centre Hospitalier de Dreux
CHU Besançon
Hôpital Tenon


title: Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study

acronym: CALCECHO

summary: Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. Needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually followed by a corticosteroid injection in the subacromial bursae in order to prevent acute pain reaction due to the intervention. However, the relevance of this injection has never been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the needling and thus the body's natural calcium resorption processes. Finally, corticosteroids could have deleterious effect on the tendon structures and favour local infection. Our hypothesis is that corticosteroid have no significant effect on acute pain after needling and therefore should not been performed systematically after needling.

ReferenceCitation: Dumoulin N, Cormier G, Varin S, Coiffier G, Albert JD, Le Goff B, Darrieutort-Laffite C. Factors Associated With Clinical Improvement and the Disappearance of Calcifications After Ultrasound-Guided Percutaneous Lavage of Rotator Cuff Calcific Tendinopathy: A Post Hoc Analysis of a Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):883-891. doi: 10.1177/0363546521992359.

family: Dumoulin

full_name: Nicolas Dumoulin

given: Nicolas

name: Department of Rheumatology, CHU Rennes, Rennes, France.

family: Cormier

full_name: Grégoire Cormier

given: Grégoire

family: Varin

full_name: Stéphane Varin

given: Stéphane

name: Department of Rheumatology, CHD Vendée, La Roche-sur-Yon, France.

family: Coiffier

full_name: Guillaume Coiffier

family: Albert

full_name: Jean-David Albert

given: Jean-David

name: Department of Rheumatology, CHU Nantes, Nantes, France.

family: Le Goff

full_name: Benoit Le Goff

given: Benoit

family: Darrieutort-Laffite

full_name: Christelle Darrieutort-Laffite

given: Christelle

journal_name: The American Journal of Sports Medicine

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Darrieutort-Laffite C, Varin S, Coiffier G, Albert JD, Planche L, Maugars Y, Cormier G, Le Goff B. Are corticosteroid injections needed after needling and lavage of calcific tendinitis? Randomised, double-blind, non-inferiority trial. Ann Rheum Dis. 2019 Jun;78(6):837-843. doi: 10.1136/annrheumdis-2018-214971. Epub 2019 Apr 11.

full_name: Stephane Varin

given: Stephane

family: Planche

full_name: Lucie Planche

given: Lucie

family: Maugars

full_name: Yves Maugars

given: Yves

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
La Roche sur Yon Hospital
Rennes University hospital


title: Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery

acronym: CRPS-VITC

summary: Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Saint-Quentin
CHU Rouen
CHU Amiens


ReferenceCitation: Szostek AS, Boucher P, Subtil F, Zerzaihi O, Saunier C, de Queiroz Siqueira M, Merquiol F, Martin P, Granier M, Gerst A, Lambert A, Storme T, Chassard D, Nony P, Kassai B, Gaillard S. Determination of the optimal dose of ephedrine in the treatment of arterial hypotension due to general anesthesia in neonates and infants below 6 months old: the ephedrine study protocol for a randomized, open-label, controlled, dose escalation trial. Trials. 2021 Mar 12;22(1):208. doi: 10.1186/s13063-021-05155-2.

family: Szostek

full_name: A. S. Szostek

given: A. S.

family: Boucher

full_name: P. Boucher

given: P.

family: Subtil

full_name: F. Subtil

given: F.

family: Zerzaihi

full_name: O. Zerzaihi

given: O.

family: Saunier

full_name: C. Saunier

given: C.

family: de Queiroz Siqueira

full_name: M. de Queiroz Siqueira

given: M.

family: Merquiol

full_name: F. Merquiol

family: Martin

full_name: P. Martin

family: Granier

full_name: M. Granier

family: Gerst

full_name: A. Gerst

given: A.

family: Lambert

full_name: A. Lambert

family: Storme

full_name: T. Storme

given: T.

family: Chassard

full_name: D. Chassard

given: D.

family: Nony

full_name: P. Nony

family: Kassai

full_name: B. Kassai

given: B.

family: Gaillard

full_name: S. Gaillard

given: S.

journal_name: Trials

lead_sponsor: Hospices Civils de Lyon

acronym: EPHEDRINE

location_facility:
Hôpital Nord
Hospices Civils de Lyon
Hôpital d'Estaing

title: Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study.

summary:
The incidence of arterial hypotension under general anesthesia using sevoflurane is particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the initial mean blood pressure (mBP) is the definition of significant arterial hypotension in adults and children. In adults, intraoperative arterial hypotension is associated with an increase of intraoperative mortality and a certain neurological morbidity. In infants under 6 months of age, neurological disorders have been reported following general anesthesia. Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial hypotension.

Current management of hypotension uses vascular filling with crystalloids and vasopressive amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be used. Ephedrine is particularly interesting because of its action on both α and β receptors and its mode of administration: one dose and peripheral access.

Only one study is available in children from birth to adulthood; it demonstrates a lower hemodynamic response in infants than in adults, when administered a low dose of Ephedrine (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and the use of higher doses than those recommended.

The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine associated with a difference of proportion of newborns/infants in therapeutic success of 55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative arterial hypotension.

Secondary objectives:

Return to a mBP superior to 38mmHg post Ephedrine administration.
To assess occurrence of hypoxemic events during anesthesia.
To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6 months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24 months.


acronym: PCV

summary:
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: Centre Médical de la Rétine Maison Rouge


title: Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo

summary: The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study

acronym: CORTICODIAB

summary: The general objective is to precise the role of HPA axis activity in neuropsychological consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis is associated with higher scores of depression and changes in hippocampal volume and mean diffusion.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES

location_facility: Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque


title: Evaluation of the Efficacy and Tolerance of Honey-impregnated Dressings Versus Non-impregnated Dressings in the Local Management of Pressure Ulcers: A Randomized Single-blind Trial

acronym: MeliCare

summary: The main objective of this study is to document the effectiveness of a honey-based medical device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical device will be judged according to the evolution of the surface of the wound at the end of 12 weeks of treatment.

location_facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier


title: Sensory Approach of Food Modifications Led by Chemotherapy

summary: The aim of the present study was to evaluate the impact of chemotherapy on sensorial perception in lung cancer patients in comparison to a control group (individuals without lung cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients and 44 controls will be tested for olfactory and gustatory abilities before and after treatment (for patients) and for two sessions separated by the same duration for controls. Primary measure outcome will be to examine the impact of treatment on the perception of hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual changes and questionnaires on eating habits and behaviors, in order to examine the impact of treatment on odor, taste and food perception.

location_facility: Centre Hospitalier Lyon Sud - Service de Pneumologie

location_facility: Centre de Recherche en Nutrition Humaine


title: French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance

acronym: FACE

summary: The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.

status: Withdrawn

lead_sponsor: ResMed

location_facility:
CHU Bichat
CHU de Grenoble
CHU Henri Mondor


title: Asymmetry, Auditory Processing and Reading Skills in Phonological Dyslexic Children Compared to Average-reading Children

acronym: ASTRAUCOLE

summary: The hypothesis of central auditory processing disorders has been advanced to explain the anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast, in the subject-handed dyslexic, the efferent system tends to be right-lateralized or non-lateralized. However, after an audio-visual training, normal lateralization can appear. This maturation of the efferent system lateralization during reading acquisition seems to have a particular profile in dyslexics with phonological disorder, especially if it is persistent. This finding allows to consider new prognostic evaluation and speech therapy rehabilitation in the dyslexic child.

location_facility: Service d'Audiologie et Explorations Orofaciales Centre de Référence des Troubles des Apprentissages


title: Impact of Rational Control of Fluid Balance in the Intensive Care Unit.IRIHS-REA

acronym: IRIHS-REA

summary: Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid balance over a very short period of time. This positive fluid balance is the consequence of different organ failures (pulmonary, cardio-vascular, kidney…) or aggressive fluid resuscitation, which is mandatory in the early phase of ICU course. However recent data strongly suggest that an excessive fluid balance could be detrimental per se (increase of ICU morbidity or even mortality). There are controversies regarding the potential benefit of controlling this fluid balance with diuretics which are commonly used worldwide in various indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature data are lacking, regarding the possible advantages and drawbacks of diuretics in this indication. The aim of our study is to test an algorithm with furosemide to reduce fluid overload in severe ICU-patients.

ReferenceCitation: Cinotti R, Lascarrou JB, Azais MA, Colin G, Quenot JP, Mahé PJ, Roquilly A, Gaultier A, Asehnoune K, Reignier J. Diuretics decrease fluid balance in patients on invasive mechanical ventilation: the randomized-controlled single blind, IRIHS study. Crit Care. 2021 Mar 10;25(1):98. doi: 10.1186/s13054-021-03509-5.

family: Cinotti

full_name: Raphaël Cinotti

given: Raphaël

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Azais

full_name: Marie-Ange Azais

given: Marie-Ange

family: Colin

full_name: Gwenhaël Colin

given: Gwenhaël

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Mahé

full_name: Pierre-Joachim Mahé

given: Pierre-Joachim

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

family: Gaultier

full_name: Aurélie Gaultier

given: Aurélie

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Reignier

full_name: Jean Reignier

given: Jean

journal_name: Critical Care

location_facility:
Hôpital François Mitterand
CHU de Nantes
CHD Vendée


title: Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder

acronym: HYCORE

summary: The main objective of this study is to make a first evaluation of the relationship between metabolic abnormalities objectified by Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH) performed at rest at the onset of symptoms in patients with a first episode of motor conversion disorder and the persistence of a motor disability at 6 months measured by the modified Rankin score (mRS).

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac


title: Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.

summary: The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study

summary:
A prospective, open, multicenter, randomized III trial with two arms:

Arm A: Primary tumor resection , followed by chemotherapy
Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for resectable rectal adenocarcinoma with unresectable metastasis, treated either with the primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/- target therapy) alone.

ReferenceCitation: Cotte E, Villeneuve L, Passot G, Boschetti G, Bin-Dorel S, Francois Y, Glehen O; French Research Group of Rectal Cancer Surgery (GRECCAR). GRECCAR 8: impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis: a randomized multicentre study. BMC Cancer. 2015 Feb 12;15:47. doi: 10.1186/s12885-015-1060-0.

family: Cotte

full_name: Eddy Cotte

given: Eddy

name: The French Research Group of Rectal Cancer Surgery (GRECCAR)

family: Villeneuve

full_name: Laurent Villeneuve

given: Laurent

family: Passot

full_name: Guillaume Passot

given: Guillaume

family: Boschetti

full_name: Gilles Boschetti

given: Gilles

family: Bin-Dorel

full_name: Sylvie Bin-Dorel

given: Sylvie

family: Francois

full_name: Yves Francois

given: Yves

family: Glehen

full_name: Olivier Glehen

given: Olivier

journal_name: BMC Cancer

repository_institution: PubMed Central - Europe PMC

location_facility: Service de Chirurgie Générale et Digestive, CHRU Claude Huriez

location_facility: Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL

location_facility: Service d'Oncologie Médicale, Clinique du Cap-d'Or


title: Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"

acronym: KYPHOK

summary:
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.

This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.

Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.

The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Lariboisière-service de radiologie ostéoarticulaire

location_facility: Hôpital Henri Mondor - Service de Radiologie


title: Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture

acronym: PROME

summary:
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Amiens
UH Caen
Rouen University Hospital
UH Lille


title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

summary: This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche


acronym: ERBUS

summary:
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame


title: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

summary:
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).

The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.

We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.

Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.

Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.

Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.

The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.

The study will last 3 years. The number of patient to include is 280.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique


title: A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

summary: The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Regional - Dermatology


title: Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers

summary: The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs.

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille/ Centre d'investigation Clinique


title: Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma

acronym: PET-FETII

summary: Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample).

lead_sponsor: University Hospital, Toulouse

location_facility:
UHToulouse
Hôpital de la Pitié Salpétrière
CHU de CAEN


title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

summary: Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. The investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.

location_facility: Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille

location_facility: Service de Neurologie A, Hôpital Gabriel Montpied-BP


title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection

summary: The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

location_facility:
Urgences pédiatriques CHU de Caen
POSU pediatrique
Urgences pédiatriques
Urgences pédiatriques - CHU ROUEN


title: Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study

acronym: THERA

summary: Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter, non-randomised, single-arm, open-label, phase II trial.

lead_sponsor: Rennes University Hospital

location_facility:
CHRU de Lille
Groupe Hospitalier Lariboisière
Rennes University Hospital


ReferenceCitation: Bondia J, Dassau E, Zisser H, Calm R, Vehí J, Jovanovič L, Doyle FJ 3rd. Coordinated basal-bolus infusion for tighter postprandial glucose control in insulin pump therapy. J Diabetes Sci Technol. 2009 Jan;3(1):89-97.

ReferenceCitation: A. Farret, B. Catargi, J.P. Riveline, V. Melki, P. Schaepelynck, A. Sola, B. Guerci, H. Bertet, T. Mura, H. Chevassus, E. Renard : Étude randomisée contrôlée en cross-over comparant les effets sur le contrôle glycémique des bolus immédiats et combinés chez des patients diabétiques de type 1 traités par pompe à insuline portable. Diabetes & Metabolism, Volume 38, Supplement 2, March 2012, Page A6

ReferenceCitation: Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.

ReferenceCitation: Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.

ReferenceCitation: Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53.

ReferenceCitation: Etude Jubilé. SFD 2013

ReferenceCitation: Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2002 Mar 23;324(7339):705.

ReferenceCitation: Mudaliar SR, Lindberg FA, Joyce M, Beerdsen P, Strange P, Lin A, Henry RR. Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care. 1999 Sep;22(9):1501-6.

ReferenceCitation: Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf

ReferenceCitation: Melki.v, Cazals.l : Impact de la coordination des bolus et du débit de base sur le contrôle des glycémies postprandiales chez des diabétiques de type 1 traités par pompe externe (étude pilote). Poster accepté SFD 2014

acronym: COBOL

location_facility:
University Hospital Toulouse Rangueil
Saint-André Hospital
Lapeyronie Hospital

title: Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study

summary:
A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.

The aim of the investigators study is to assess if these results are confirmed in a clinical trial.

The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.


title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

summary: The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

lead_sponsor: Institut Claudius Regaud

location_facility:
Centre Hospitalier de Montauban
Centre Hospitalier de Castres
Centre Hospitalier Joseph Ducuing
Institut Claudius Regaud


title: Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9

summary: Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

ReferenceCitation: Martin JH, Begg EJ, Kennedy MA, Roberts R, Barclay ML. Is cytochrome P450 2C9 genotype associated with NSAID gastric ulceration? Br J Clin Pharmacol. 2001 Jun;51(6):627-30.

ReferenceCitation: Martínez C, Blanco G, Ladero JM, García-Martín E, Taxonera C, Gamito FG, Diaz-Rubio M, Agúndez JA. Genetic predisposition to acute gastrointestinal bleeding after NSAIDs use. Br J Pharmacol. 2004 Jan;141(2):205-8. Epub 2004 Jan 5.

location_facility: Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière

location_facility: : Service d'hépato-gastroentérologie, Hôpital Henri Mondor

location_facility: Service d'hépato-gastroentérologie, Hôpital Saint Antoine

location_facility: Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE


title: Phase II Study of the Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma

summary:
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years

The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test.

The other objective is to evaluate the toxicity

ReferenceCitation: Czuczman MS, Grillo-López AJ, White CA, Saleh M, Gordon L, LoBuglio AF, Jonas C, Klippenstein D, Dallaire B, Varns C. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol. 1999 Jan;17(1):268-76.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42.

ReferenceCitation: 44. Marcus R, et al. (2003). An International Multi-Centre, Randomized, Open-Label, Phase III Trial Comparing Rituximab Added to CVP Chemotherapy to CVP Chemotherapy Alone in Untreated Stage III/IV Follicular Non-Hodgkins Lymphoma. Blood, 102, issue 11, (abstract 87).

ReferenceCitation: O'Connor O, Wright J, Moskowitz CH et al. Promising Activity of the Proteasome Inhibitor Bortezomib (Velcade) in the Treatment of Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Session Type: Poster Session 517-II. Blood, Volume 102, issue 11, November 16, 2003 (abstract 2346)

lead_sponsor: Lymphoma Study Association

location_facility:
Hôpital Lyon Sud
Hôpital Henri Mondor
Institut Gustave Roussy
Hôpital Saint-Louis


title: A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

summary: The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Saint-André
Hôpital Gui de Chaudiac
Hôpital Saint-Antoine
Hôpital Necker
Hôpital Purpan
Hôpital Pierre Zobda-Quitman
Hôpial Bicêtre
Hôpital Bichat
Hôpital Pontchaillou
Hôpital Gustave Dron
Hôpital Gabriel Montpied
Hôpital du Bocage
Hôpital Avicenne
Hôpital Pitié-Salpêtrière
Centre hospitalier de Pernignan
Hôpital de l'Hotel Dieu
Hôpital Saint-Louis
Hôpital Bretonneau


title: Clinical and Medico-economic Assessment of Conventional Care Plus the "Autonom@Dom" Telemonitoring System Versus a Conventional Care Package Alone, for People With Heart Failure in Several French Structures.

summary: Heart failure is the principle cause of hospitalisation for people over 65. the assumption is that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation or rehospitalisation for heart failure (compared to a care package alone), This randomised controlled pilot study should assess the feasibility in terms of patient inclusion and follow-up.

ReferenceCitation: Maggioni AP, Greene SJ, Fonarow GC, Böhm M, Zannad F, Solomon SD, Lewis EF, Baschiera F, Hua TA, Gimpelewicz CR, Lesogor A, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial. Eur Heart J. 2013 Oct;34(40):3117-27. doi: 10.1093/eurheartj/eht342. Epub 2013 Sep 2.

ReferenceCitation: Gheorghiade M, Böhm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum in: JAMA. 2013 Apr 10;309(14):1461.

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

family: Böhm

full_name: Michael Böhm

given: Michael

family: Greene

full_name: Stephen J. Greene

given: Stephen J.

family: Fonarow

full_name: Gregg C. Fonarow

given: Gregg C.

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Baschiera

full_name: Fabio Baschiera

given: Fabio

family: Botha

full_name: Jaco Botha

given: Jaco

family: Hua

full_name: Tsushung A. Hua

given: Tsushung A.

family: Gimpelewicz

full_name: Claudio R. Gimpelewicz

given: Claudio R.

family: Jaumont

full_name: Xavier Jaumont

given: Xavier

family: Lesogor

full_name: Anastasia Lesogor

given: Anastasia

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

full_name: for the ASTRONAUT Investigators and Coordinators

given: for the

journal_name: JAMA

oa_colors: green hybrid

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Aliskiren on Postdischarge Mortality and Heart Failure Readmissions Among Patients Hospitalized for Heart Failure

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

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

family: Logeart

full_name: Damien Logeart

given: Damien

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

family: Isnard

full_name: Richard Isnard

given: Richard

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

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

name: Centre Hospitalier Universitaire Minoz; Besançon France

name: Centre Hospitalier Regional Universitaire de Lille; France

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

name: Centre Hospitalier Universitaire Rangueil; Toulouse France

name: French Society of Cardiology; Paris France

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

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

name: Centre Hospitalier Universitaire Brabois; Nancy France

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

name: Centre Hospitalier Rene Dubosc; Pontoise France

name: Centre Hospitalier Universitaire; Dijon France

name: Centre Hospitalier Universitaire; Grenoble France

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

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

ReferenceCitation: Jourdain P, Juillière Y; Steering and Working Group Committee Members of the French Task Force on Therapeutic Education in Heart Failure. Therapeutic education in patients with chronic heart failure: proposal for a multiprofessional structured programme, by a French Task Force under the auspices of the French Society of Cardiology. Arch Cardiovasc Dis. 2011 Mar;104(3):189-201.

ReferenceCitation: Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

ReferenceCitation: Jondeau G, Neuder Y, Eicher JC, Jourdain P, Fauveau E, Galinier M, Jegou A, Bauer F, Trochu JN, Bouzamondo A, Tanguy ML, Lechat P; B-CONVINCED Investigators. B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode. Eur Heart J. 2009 Sep;30(18):2186-92. doi: 10.1093/eurheartj/ehp323. Epub 2009 Aug 30.

location_facility:
Private Geriatric Hospital Magnolias
Hospital Group Mutualiste
University Hospital of Grenoble


title: Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes

acronym: BIOPARK

summary:
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and PSP remains an unmet need. Such biological markers are crucial for future disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in PD and MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling at two study visits (baseline and after 12 months). Major secondary objectives are (i) to assess potential associations between the biomarker and clinical measures of disease severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its correlation to disease severity and progression in PD, MSA and PSP.

location_facility:
CHU de Limoges
CHU de Bordeaux
CHU de Toulouse


title: Simultaneous Detection of Somatic Quantitative Molecular Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study

acronym: Code Barre

summary:
Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.

AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.

location_facility:
Chu Dijon
Chu Lille
Chu Hopitaux de Rouen


title: Study of the Impact of Chemo-induced Menopause on the Quality of Life in Young Women of Childbearing Age and Diagnosed With Non-metastatic Breast Cancer

acronym: MENOCOR

summary: Prospective multicenter study, Not on Health Products that evaluates up to 2 and a half years the impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age, diagnosed with non-metastatic breast cancer.

lead_sponsor: Centre Jean Perrin

location_facility: Centre de lutte contre le cancer - Centre Jean PERRIN


title: Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

summary:
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:

at meals, with CHO roughly assessed by the patient.
during and after physical activity sessions qualified as moderate by the patient.

Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.

primary_purpose: Health Services Research

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
Centre Hospitalier du Sud Francillien
University Hospital of Montpellier
University Hospital of Grenoble