title: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective

acronym: IPA

summary:
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.

The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).

In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.

The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.

location_facility:
CHU de Nantes
Centre Hospitalier Departemental Vendee


title: Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use

acronym: MobiCogIm

summary: 120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls will be administered a whole-brain imaging exam. The current research project constitutes a highly novel approach to understanding the pathophysiology of addiction through its combination of neuroimaging with state-of-the-art information concerning the real-time expression of risk factors.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Charles Perrens
CHU de Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Prospective Study for Diagnosis Utility of Array-CGH Screening in Case of Non Syndromic Congenital Heart Defect in Prenatal Diagnosis (CAPA)

acronym: CAPA

summary:
Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

location_facility:
St Brieuc University Hospital
Rennes University Hospital


status: Terminated

primary_purpose: Treatment

acronym: LET

intervention_type: Drug

title: Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

summary: The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.

status_simplified: Unknown


title: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

acronym: ATTRACT

summary: This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.

lead_sponsor: Poitiers University Hospital

location_facility:
Polyclinic of POITIERS
Poitiers University Hospital


type: Other Identifier

title: Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

acronym: FOX-TREG

summary: The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.

time_perspective: Cross-Sectional

intervention_type: Biological


title: Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy

acronym: TARCI

summary: The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.

primary_purpose: Supportive Care

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
Nouvelles cliniques Nantaises


title: Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

acronym: SPECTAbrain

summary:
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:

Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
Identify or validate new molecularly defined subgroups of tumors;
Investigate the prevalence of novel biomarkers to plan future clinical trials;
Enable exploratory/future research;
Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;

status: Withdrawn

study_completion_date_type: Anticipated

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

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

intervention_type: Genetic

lead_sponsor_type: industriel


title: Imaging of Intracerebral Inflammation in the Progressive Phase of Multiple Sclerosis

acronym: INFLASEP

summary: In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This new ligand for PBR displays several advantages compared to the existing reference compound PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in activated immune cells in the white matter. Progressive MS patients (secondary progressive and primary progressive) will be compared to relapsing-remitting patients and to healthy volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to document clinical disability and tissue injury. A clinical and radiological follow up will then be performed for a 2-year period. This study should help to understand the contribution of the intracerebral inflammation on the progression of disability and could provide a surrogate marker for further therapeutic trials in chronic progressive MS.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6). pii: e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.

ReferenceCitation: García-Lorenzo D, Lavisse S, Leroy C, Wimberley C, Bodini B, Remy P, Veronese M, Turkheimer F, Stankoff B, Bottlaender M. Validation of an automatic reference region extraction for the quantification of [(18)F]DPA-714 in dynamic brain PET studies. J Cereb Blood Flow Metab. 2018 Feb;38(2):333-346. doi: 10.1177/0271678X17692599. Epub 2017 Feb 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Saint Antoine Hospital
Pitie Salpetriere Hospital


title: Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population

summary:
Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part or the entire chorionic plate with penetration of chorionic villi in the myometrium and absence of the decidua basalis. This anomaly is associated with significant maternal morbidity and mortality as it may result in severe haemorrhage during the post-partum. It has been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal morbidity. In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to better outcomes, due to fewer emergency operations and less mass transfusions. Currently, the diagnosis of AIP is based on a combination of conventional B-mode ultrasound and MRI. However, prenatal diagnosis of AIP remains challenging and recent reports demonstrated it is achieved in only thirds of cases.

Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular rheological properties of these bubbles are similar to those of red blood cells and they remain entirely within the intravascular space. Previous studies have demonstrated that microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet approved for clinical use, CEUS offers the opportunity to analyze anatomical placental landmarks, improving the contrast between placenta and myometrium. In addition, quantification parameters related to the contrast enhancement have been proposed as objective indicators to estimate blood perfusion rates in the placental intervillous space.

The main objective of this study is to provide pre-clinical evaluation of CEUS for the diagnosis of AIP and to try to determine if AIP are characterised by differences in intervillous blood rheological properties. Conventional CEUS parameters will be: rise time, peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.

As this study is a pre-clinical evaluation, sample size calculation remains subjective and imprecise. For this reason, a sample size of 100 pregnant women to be included in this prospective study has been decided.

The potential impact of this study will be to propose a more reliable tool with both improved sensibility and specificity compared to the combination US/MRI and therefore to reduce the maternal worldwide burden of AIP.

lead_sponsor: University Hospital, Tours

location_facility:
CHU La Millétrie
University Hospital of Tours


title: Predictive Factors of the Autonomy Level Change Related to Memory Disorders

acronym: MEMORA

summary: The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.

status: Recruiting

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital des Charpennes

status_simplified: Ongoing


title: Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

acronym: MGM-Eval

summary: Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Institut Hospitalier Franco-Britannique

intervention_type: Device


title: Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility

acronym: CFC

summary: The purpose of this study is to determine whether cognitive disorders are a risk factor for a fracture after a fall independently of a bone fragility.

primary_purpose: Basic Science

ReferenceCitation: Langeard A, Pothier K, Chastan N, Marcelli C, Chavoix C, Bessot N. Reduced gait and postural stability under challenging conditions in fallers with upper limb fracture. Aging Clin Exp Res. 2019 Apr;31(4):483-489. doi: 10.1007/s40520-018-0992-z. Epub 2018 Jul 4.

ReferenceCitation: Langeard A, Pothier K, Morello R, Lelong-Boulouard V, Lescure P, Bocca ML, Marcelli C, Descatoire P, Chavoix C. Polypharmacy Cut-Off for Gait and Cognitive Impairments. Front Pharmacol. 2016 Aug 31;7:296. doi: 10.3389/fphar.2016.00296. eCollection 2016.

lead_sponsor: University Hospital, Caen

location_facility:
Dr Alain Daragon
University Hospital


title: Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections

summary: The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified

ReferenceCitation: Alexandre K, Réveillon-Istin M, Fabre R, Delbos V, Etienne M, Pestel-Caron M, Dahyot S, Caron F. Temocillin against Enterobacteriaceae isolates from community-acquired urinary tract infections: low rate of resistance and good accuracy of routine susceptibility testing methods. J Antimicrob Chemother. 2018 Jul 1;73(7):1848-1853. doi: 10.1093/jac/dky101.

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
Lbmr de Normandie


title: Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy

acronym: AuTop

summary:
Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries have no abnormal history. It is widely agreed that preterm delivery is often associated with bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the Nugent score, but it lacks the characteristics necessary for widespread use in the general population. It must be performed on a fresh swab, and any delay in transporting it can cause drying that makes the test difficult to perform.

The investigators have developed a rapid diagnostic tool for bacterial vaginosis using molecular biology based on a point of care model and obtained a patent (European Patent Office N° 2087134). In comparison with the reference techniques, our tool's performance has been excellent, in terms of specificity, sensitivity, and positive and negative predictive values. In particular, our work showed that 57% of the flora samples rated as intermediate on the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore identifies a homogeneous population of women with vaginal flora anomalies. The investigators recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006). Vaginal flora anomalies are therefore an important target for preventing preterm delivery.

primary_purpose: Screening

ReferenceCitation: Bretelle F, Fenollar F, Baumstarck K, Fortanier C, Cocallemen JF, Serazin V, Raoult D, Auquier P, Loubière S. Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial. Trials. 2015 Oct 19;16:470. doi: 10.1186/s13063-015-1000-y. Erratum in: Trials. 2016;17:83.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life

acronym: TOMOBREAST

summary: Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

status: Active, not recruiting

ReferenceCitation: Pasquier D, Bataille B, Le Tinier F, Bennadji R, Langin H, Escande A, Tresch E, Darloy F, Carlier D, Crop F, Lartigau E. Correlation between toxicity and dosimetric parameters for adjuvant intensity modulated radiation therapy of breast cancer: a prospective study. Sci Rep. 2021 Feb 11;11(1):3626. doi: 10.1038/s41598-021-83159-3.

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
Centre Léonard de Vinci


title: Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis

acronym: EDDRAPro

summary: The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.


title: Diagnostic and Prognostic Biomarkers for Acute Graft-versus-host Disease: a Prospective Single Centre Biological Study

acronym: PLASMA-INCA

summary: Validation of already described biomarkers on acute GVHD prediction and severity Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha, HGF

status: Unknown status


title: Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

acronym: MGM-PicRemi

summary:
Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a conventional MacIntosh laryngoscope.

Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that it modifies the anesthetic drugs requirement. .

ReferenceType: background

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

ReferenceCitation: Ing R, Liu N, Chazot T, Fessler J, Dreyfus JF, Fischler M, Le Guen M. Nociceptive stimulation during Macintosh direct laryngoscopy compared with McGrath Mac videolaryngoscopy: A randomized trial using indirect evaluation using an automated administration of propofol and remifentanil. Medicine (Baltimore). 2017 Sep;96(38):e8087. doi: 10.1097/MD.0000000000008087.

intervention_type: Procedure


title: Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly

summary:
The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication.

The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person.

The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Pôle de Gérontologie Hôpital de Cimiez CHU de Nice


title: Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections

summary:
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.

Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.

lead_sponsor: Diaxonhit

location_facility: Groupe hospitalier Diaconesses Croix Saint Simon


title: Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency

summary:
Anemia in patients with cancer is a common problem associated with an impaired quality of life.

Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements.

Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia.

Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency.

In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse


title: Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study

acronym: PERAM-QUAL

summary:
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units. There are few data concerning the fathers of preterm infants. However, the role of the father is identified in the literature as a key factor in the initiation and continuation of breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not identified but may be related to the father being in close and constant contact with the medical and paramedical staff. In fact, fathers are often first in contact with caregivers. They can be invested in the implementation of nursing care, skin to skin, as well as being asked to support the development of their child in the service and at home.

The aims of this study are to:

Analyze the beliefs, social representations and the experience of the fathers of premature infants hospitalized in intensive care unit concerning breastfeeding.
Analyze the factors facilitating and inhibiting the initiation and continuation of breastfeeding.
Consider strategies of care and support that can be used for the families of premature infants and of children born at term.
Explore the expectations of medical staff with regards to the management of children and families, their practices, identify the role attributed to the father.
Initiate and facilitate reflexivity of medical and paramedical staff about their respective practices

lead_sponsor: University Hospital, Brest

location_facility:
CH du Mans
CHRU de Brest


title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL FOR EVALUATING THE EFFICACY OF AB-LIFE PROBIOTIC PRODUCT ON THE LDL-CHOLESTEROL REDUCTION IN THE MODERATE HYPERCHOLESTEROLEMIA

summary: This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.

primary_purpose: Prevention

lead_sponsor: AB Biotics, SA

location_facility: Biofortis Naturalpha

intervention_type: Dietary Supplement


title: Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients

summary:
Hospital acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent influenza transmission in healthcare setting.

Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in the elderly population will not necessarily result in a total control of the incidence. Consequently, the prevention of influenza outbreaks in this vulnerable population must also include the reduction of the exposure to the influenza viruses, in particular thanks to the vaccination of HCW.

A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results suggest a protective effect but investigations, carried out on a more important sample are needed to validate the benefit of HCW vaccination.

The aim of this prospective multicentric cohort study is to estimate incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units.

ReferenceCitation: Amour S, Bénet T, Regis C, Robert O, Fontana L, Lina B, Pozzetto B, Berthelot P, Vanhems P. Effect of influenza vaccination among healthcare workers on hospital-acquired influenza in short-stay hospitalized patients: A multicenter pilot study in France. Infect Control Hosp Epidemiol. 2022 Apr 6:1-5. doi: 10.1017/ice.2022.68. [Epub ahead of print]

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot

location_facility: Centre Hospitalier Universitaire - Saint Etienne


type: Registry Identifier

title: Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma

acronym: OBAMAg

summary:
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma).

Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens
Centre d'ophtalmologie Victor Pauchet


title: Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans

summary:
For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.

Participation consists in accepting samples to be taken at the birth of the infant:

from the umbilical cord.
from the placenta.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de BESANCON
CHU de DIJON


title: Study of Intestinal Permeability in Patients With Anorexia Nervosa

acronym: PIANO

summary:
In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier preventing the passage of toxic substances from the intestinal lumen to the blood stream. Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract profoundly affect small bowel morphology and physiology. Many reports have described alterations of ion and nutrient transport, mucosal atrophy and modifications in the intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in severe starvation. These changes may dampen both the absorptive and the barrier functions of intestinal mucosa.

The assessment of intestinal permeability, by measuring the urinary excretion of substances that are not metabolised by human tissues and passively cross the intestinal epithelium, is a reliable and non invasive method to investigate the anatomo-functional integrity of the intestinal mucosa. Previous studies have shown an increase of permeability in malnourished humans . The increase of may also increase the risk for inappropriate passage of food antigens and other noxious substances across the mucosal barrier. To this regard, the enhanced susceptibility of malnourished subjects to systemic infections and postoperative sepsis has long been recognised.

Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours aiming to decrease body weight. Typically, women with anorexia nervosa restrict food ingestion up to severe starvation. These behaviours usually lead to malnutrition and a more or less prolonged absence of luminal nutrients in the gastrointestinal tract. Therefore, alterations in the integrity and functioning of intestinal mucosa are likely to occur in this condition. There is no information on intestinal permeability in patients with eating disorders. We hypothesised that, as it occurs in simple starvation and malnutrition, intestinal permeability should be increased in fasted undernourished people with anorexia nervosa and decrease after re feeding. Therefore, in the present study, we explored intestinal permeability of 23 subjects with anorexia nervosa by means of the lactulose-mannitol test and urinary sucralose excretion and compare them to 46 controls.

Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The origin of these auto-antibodies is still unknown , but some studies suggested a digestive origin. Moreover, modifications of intestinal flora have been described in patients with anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia nervosa is necessary. In this study, a comparaison of intestinal permeability and autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with anorexia nervosa.

location_facility:
CHU- Hôpitaux de Rouen
Hôpital de la Croix Rouge


title: Identification and First Validation of Early Non-invasive Biomarkers of Diabetic Nephropathy in Type I Diabetic Children

summary:
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. However, it is a late (because it permits to detect a renal disease already present), non-specific and low sensitive biomarker.

Therefore the main objective of this study is to identify early urinary biomarkers predictive of DN in children with type I diabetes, before the appearance of a microalbuminuria.

lead_sponsor: University Hospital, Toulouse

location_facility:
Purpan Children Hospital
Rangueil Hospital


title: Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.

acronym: QUIET

summary:
In spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. Anxiety and depression are especially frequent. They impact significantly morbidity and mortality. Especially because they are associated with poor therapeutic adherence and risks of infection and rejection. The inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. This results in an important deterioration in quality of life of patients.

The investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.

location_facility: Service de Psychiatrie d'Adultes Liaison/Consultation,

intervention_type: Behavioral


title: Feasibility of the Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail "La Santé" (Maison d'arrêt Paris La Santé)"

acronym: EPRIDIA

summary:
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.

The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".

location_facility:
Hôpital COCHIN
Maison d'Arrêt Paris La Santé (MAPLS)


title: Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training

acronym: ENERGETIC

summary: The aim of this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the efficacy of combined eccentric/concentric training on physical capacity and overall autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and muscular effort and tolerance.


title: Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants

summary:
Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. However, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. Treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. Several technologies and devices are developed around this LED and specially a compact system.

The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with conventional phototherapy (non-LED) and satisfaction of the parents and the professional staff about comfort of this new technology. The newborn infant is placed in a sleeper with the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the blue light. This one is generated by the module LED and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually.

The device is endowed with an hour counter to schedule the time of treatment. The energy illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².

lead_sponsor: Association Pédiatrique des Groupes d'Acuueil et de Recherche

location_facility:
Bicetre Hospital
hopital Antoine Béclère


title: Titration Morphinique autocontrôlée Par le Patient Par un Dispositif mécanique à Usage Unique Versus Administration Par l'infirmière Chez Les Patients Ayant Une Douleur aiguë sévère Aux Urgences.

acronym: TACIDOU

summary:
Intense acute pain is a common reason for Emergency admittance and its management is one of the major public health goals.

In the recommendations formalized experts, it is recommended to use a protocol titration with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg) repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.

Despite these specific recommendations and a broad awareness of the teams, management of pain remains to be improved, the major difficulty of morphine titration at the emergency department being the availability of paramedical personnel to perform revaluations and reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.

The investigators want to study the self-controlled morphine titration by the patient by a mechanical device for single use (efficacy/safety).

lead_sponsor: University Hospital, Angers

location_facility:
SCHOTTE Thibault
CHOUKROUN Jacques


title: Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation

acronym: EPI-AMELIE

summary: In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Carémeau
CHU de Montpellier - Hôpital Lapeyronie


title: Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.

acronym: VALOBAB-D

summary:
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.

Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.

The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.

The subjects will be taking three different test meals varying by their milk polar lipids content.

It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).

ReferenceCitation: Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugère C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10). pii: 146161. doi: 10.1172/jci.insight.146161.

ReferenceCitation: Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gésan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugère C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle


title: Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study

acronym: Closed Loop

summary: The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.

acronym: PapU-APV

summary: Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .

location_facility:
Hôpital Ferdinand Grall
CHRU de Brest


title: Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.

acronym: MUSE

summary:
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.

The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.


title: Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine

acronym: Medis

summary: The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

lead_sponsor: University Hospital, Grenoble

location_facility:
Hospital of Voiron
Grenoble University Hospital


title: Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly

acronym: Rev-EHPAD

summary: The main objective of the study is to show that the multidisciplinary review of drug prescriptions changes the adverse drug event (ADE) geriatric risk score (according to Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence for Dependent Elderly.

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


title: ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

summary: The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint-Etienne
CHU de Grenoble


title: The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome

acronym: SCA COP

summary: The main objective of our study is to evaluate the diagnostic value of copeptin testing in association with troponin HS testing during pre-hospital care (ambulance care) in the treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but not ST+.

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial

acronym: IMOOVE IT

summary: The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).


title: Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women

acronym: VALOBAB-C

summary:
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.

Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids.

The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.

It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).

location_facility: Université d'Auvergne-Laboratoire de Nutrition Humaine


title: Prospective Evaluation of Bulbar Function in Neuromuscular Patients

acronym: ORDEG

summary: The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility: Non invasive ventilation Unit - Necker Hospital

location_facility: Home Ventilation Unit, Raymond Poincare Hospital


title: Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.

acronym: ENDOTANIL

summary:
The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation.

The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.

ReferenceCitation: Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82.

ReferenceCitation: Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23.

ReferenceCitation: Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire


title: Randomized Assay Evaluating the Risk/Benefit of Early Versus Late Resumption of Anticoagulation in Patients With Major, Non-trauma Related Hemorrhage Occurring While on Anticoagulant Treatment for a High Risk of Thrombosis.

acronym: RATHER

summary:
In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is recommended in some situations, including when major hæmorrhage occurs. But withdrawing treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment withdrawal heightens the risk of thromboembolic events occurring, with potentially major consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients. Resumption of anticoagulation is therefore critical in patients at high risk for thromboembolic events.

However, in these patients having presented major hæmorrhage, resumption of anticoagulation heightens the risk of hæmorrhage recurrence. This risk is even higher when the original hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.

As far as investigators know, there is no data in the literature to rely on when the major hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high. When confronted with patients who need anticoagulation but have a high risk of hæmorrhage recurrence, the question of when treatment should be resumed has not been resolved. This is why investigators propose to conduct a randomised comparative study to evaluate two treatment strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of anticoagulation.

MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of anticoagulation in patients having presented with serious hæmorrhage while on curative-dose anticoagulants and facing a high thromboembolic risk.

location_facility: Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne


acronym: SiloMET

title: Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre hospitalier départemental Vendée
CH Loire Vendée Océan

summary:
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . "The abdominopelvic CT scan without injection of contrast is the examination of choice.

Current recommendations in the management of gallstone colic simply based on the joint use of analgesics , anti inflammatory drugs and control of water intake .

The mechanism of analgesic action of this treatment is a decrease in the pressure in the cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of urine . )

The expulsive medical therapy remains under evaluation. The French Association of Urology does not recommend at this time for lack of evidence deemed sufficient.

For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended (grade 1A) . However, there are less formal studies of their effectiveness .

Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for pelvic stones 4 to 10mm .


title: Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.

summary:
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the frequency and describe the different binding profiles in comparison with MRI data.

Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.

All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A high fat and low carbohydrate diet and an heparin injection will be prescribed to patients before this FDG PET.

Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be completed by a 12 months evaluation.

lead_sponsor: Nantes University Hospital

location_facility: West Cancerology Institute/Nantes UH : PET plateform


title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial

acronym: EMI II

summary: Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.

ReferenceCitation: Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1). pii: 1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

location_facility: Centre des maladies respiratoires et allergiques - Les Acacias


title: Self Assessment Vs. Expert for Fetal Ultra Sound Biometry Images

acronym: SAVE US

summary:
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective.

To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups.

One group assess their own images (self assessment). The other group has their images assessed by an expert. Images are audited via the internet in a standardized procedure that generates feedback with recommendation for change.

Three to 6 months later, participants are audited again. If the improvement in image quality turns to be the same in both groups, it will be likely that self assessment is indeed as effective as assessment by an expert reviewer - at least for professionals experienced in fetal ultrasound.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Collège Français d'échographie Foetale
Groupe Hospitalier Pitié Salpetrière


acronym: SWAD

title: Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults

ReferenceCitation: Dailly E, Allavena C, Grégoire M, Reliquet V, Bouquié R, Billaud E, Hernando H, Bouchez S, Deslandes G, Hall N, Jolliet P, Raffi F. Influence of nevirapine administration on the pharmacokinetics of dolutegravir in patients infected with HIV-1. J Antimicrob Chemother. 2015 Dec;70(12):3307-10. doi: 10.1093/jac/dkv245. Epub 2015 Aug 13.

location_facility:
Nantes University Hospital
La Roche-sur-Yon Hospital

summary: Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable regimen on the long-term. However this regimen comprises 2 pills per day. Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP) of high potency, higher genetic barrier to resistance, with a very good safety profile. The objective of this study is to evaluate the virologic safety (maintenance of virologic suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK) assessment will be performed in all patients in the first weeks after switch and 24-hours PK in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching to ABC/3TC/DTG.


title: Perineal Consequences of Twin Pregnancies According to Mode of Delivery

acronym: JUMODA-CP

summary:
This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.

The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?

summary:
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.

The aims of this retrospective study was :

To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

ReferenceCitation: Héraud N, Préfaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10.

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle La Solane


title: Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment

acronym: NEORIS

summary:
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.

The study will be divided into 3 parts:

Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

lead_sponsor: Jean Michel Hascoet

location_facility: M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)


title: Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier

acronym: CARBOXHYD

summary:
Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication with only a third of survivors . It is due to a series of phenomena involving microcirculation disorders . Cerebral oximetry is a new technique to evaluate the microcirculatory status . To this day it is used in cardiovascular surgery at risk of cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of action seem to change all the phenomena responsible for microcirculatory reperfusion disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C. However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.

The hypothesis of this study is that cerebral oximetry value will be different in patients subjected to two different levels of therapeutic hypothermia in the aftermath of an extra- hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying the benefit of this technique.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CH de Fréjus-Saint Raphael
CHU de Nice - Hôpital Saint Roch


title: Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment

acronym: TRICIDIA

summary:
This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.

In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de Besancon
CHU de Dijon


title: Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)

summary: The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.

lead_sponsor: Hopital Foch

location_facility:
Hopital Beaujon
Hopital Foch


title: RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)

summary: Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU de Rouen - Hôpitaux de Rouen
Head Dermatology Department


title: Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

acronym: DAG

summary: The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Comparison of the Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation of the Motor Cortex in Patients With Neuropathic Pain Due to Chronic Radiculopathy

summary: The present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Hôpital Henri Mondor, APHP
Hôpital Ambroise Paré


title: Comparability of Bispectral Index and NeuroSENSE in Aged Patients

summary:
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

location_facility:
Hopital Foch
Hopital Stell


title: Influence of Ketamine on a Closed-Loop Anesthesia System

acronym: LoopKeta

summary: The objective is to evaluate the sparing effect of ketamine on the dose of propofol.

location_facility:
Clinique Fontaine les Dijons
Hopital Foch


title: Are Sperm Head Vacuoles Associated With Sperm Nuclear Alterations?

acronym: VATES

summary:
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments.

The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations.

ReferenceCitation: Antinori M, Licata E, Dani G, Cerusico F, Versaci C, d'Angelo D, Antinori S. Intracytoplasmic morphologically selected sperm injection: a prospective randomized trial. Reprod Biomed Online. 2008 Jun;16(6):835-41.

ReferenceCitation: Auger J, Eustache F, Andersen AG, Irvine DS, Jørgensen N, Skakkebaek NE, Suominen J, Toppari J, Vierula M, Jouannet P. Sperm morphological defects related to environment, lifestyle and medical history of 1001 male partners of pregnant women from four European cities. Hum Reprod. 2001 Dec;16(12):2710-7.

ReferenceCitation: Bartoov B, Berkovitz A, Eltes F. Selection of spermatozoa with normal nuclei to improve the pregnancy rate with intracytoplasmic sperm injection. N Engl J Med. 2001 Oct 4;345(14):1067-8.

ReferenceCitation: Bartoov B, Berkovitz A, Eltes F, Kogosovsky A, Yagoda A, Lederman H, Artzi S, Gross M, Barak Y. Pregnancy rates are higher with intracytoplasmic morphologically selected sperm injection than with conventional intracytoplasmic injection. Fertil Steril. 2003 Dec;80(6):1413-9.

ReferenceCitation: Boitrelle F, Ferfouri F, Petit JM, Segretain D, Tourain C, Bergere M, Bailly M, Vialard F, Albert M, Selva J. Large human sperm vacuoles observed in motile spermatozoa under high magnification: nuclear thumbprints linked to failure of chromatin condensation. Hum Reprod. 2011 Jul;26(7):1650-8. doi: 10.1093/humrep/der129. Epub 2011 May 2.

ReferenceCitation: Bonduelle M, Van Assche E, Joris H, Keymolen K, Devroey P, Van Steirteghem A, Liebaers I. Prenatal testing in ICSI pregnancies: incidence of chromosomal anomalies in 1586 karyotypes and relation to sperm parameters. Hum Reprod. 2002 Oct;17(10):2600-14.

ReferenceCitation: Figueira Rde C, Braga DP, Setti AS, Iaconelli A Jr, Borges E Jr. Morphological nuclear integrity of sperm cells is associated with preimplantation genetic aneuploidy screening cycle outcomes. Fertil Steril. 2011 Mar 1;95(3):990-3. doi: 10.1016/j.fertnstert.2010.11.018. Epub 2010 Dec 4.

ReferenceCitation: Foresta C, Garolla A, Bartoloni L, Bettella A, Ferlin A. Genetic abnormalities among severely oligospermic men who are candidates for intracytoplasmic sperm injection. J Clin Endocrinol Metab. 2005 Jan;90(1):152-6. Epub 2004 Oct 27.

ReferenceCitation: Franco JG Jr, Baruffi RL, Mauri AL, Petersen CG, Oliveira JB, Vagnini L. Significance of large nuclear vacuoles in human spermatozoa: implications for ICSI. Reprod Biomed Online. 2008 Jul;17(1):42-5.

ReferenceCitation: Franco JG Jr, Mauri AL, Petersen CG, Massaro FC, Silva LF, Felipe V, Cavagna M, Pontes A, Baruffi RL, Oliveira JB, Vagnini LD. Large nuclear vacuoles are indicative of abnormal chromatin packaging in human spermatozoa. Int J Androl. 2012 Feb;35(1):46-51. doi: 10.1111/j.1365-2605.2011.01154.x. Epub 2011 Apr 28.

ReferenceCitation: Garolla A, Fortini D, Menegazzo M, De Toni L, Nicoletti V, Moretti A, Selice R, Engl B, Foresta C. High-power microscopy for selecting spermatozoa for ICSI by physiological status. Reprod Biomed Online. 2008 Nov;17(5):610-6.

ReferenceCitation: Hazout A, Dumont-Hassan M, Junca AM, Cohen Bacrie P, Tesarik J. High-magnification ICSI overcomes paternal effect resistant to conventional ICSI. Reprod Biomed Online. 2006 Jan;12(1):19-25.

ReferenceCitation: Oliveira JB, Massaro FC, Baruffi RL, Mauri AL, Petersen CG, Silva LF, Vagnini LD, Franco JG Jr. Correlation between semen analysis by motile sperm organelle morphology examination and sperm DNA damage. Fertil Steril. 2010 Oct;94(5):1937-40. doi: 10.1016/j.fertnstert.2010.01.042. Epub 2010 Mar 2.

ReferenceCitation: Perdrix A, Travers A, Chelli MH, Escalier D, Do Rego JL, Milazzo JP, Mousset-Siméon N, Macé B, Rives N. Assessment of acrosome and nuclear abnormalities in human spermatozoa with large vacuoles. Hum Reprod. 2011 Jan;26(1):47-58. doi: 10.1093/humrep/deq297. Epub 2010 Nov 18.

ReferenceCitation: Van Steirteghem A, Bonduelle M, Devroey P, Liebaers I. Follow-up of children born after ICSI. Hum Reprod Update. 2002 Mar-Apr;8(2):111-6. Review.

ReferenceCitation: Vanderzwalmen P, Hiemer A, Rubner P, Bach M, Neyer A, Stecher A, Uher P, Zintz M, Lejeune B, Vanderzwalmen S, Cassuto G, Zech NH. Blastocyst development after sperm selection at high magnification is associated with size and number of nuclear vacuoles. Reprod Biomed Online. 2008 Nov;17(5):617-27.

ReferenceCitation: Watanabe S, Tanaka A, Fujii S, Mizunuma H, Fukui A, Fukuhara R, Nakamura R, Yamada K, Tanaka I, Awata S, Nagayoshi M. An investigation of the potential effect of vacuoles in human sperm on DNA damage using a chromosome assay and the TUNEL assay. Hum Reprod. 2011 May;26(5):978-86. doi: 10.1093/humrep/der047. Epub 2011 Feb 28.

ReferenceCitation: Wilding M, Coppola G, di Matteo L, Palagiano A, Fusco E, Dale B. Intracytoplasmic injection of morphologically selected spermatozoa (IMSI) improves outcome after assisted reproduction by deselecting physiologically poor quality spermatozoa. J Assist Reprod Genet. 2011 Mar;28(3):253-62. doi: 10.1007/s10815-010-9505-5. Epub 2010 Nov 12.

location_facility: Laboratoire de spermiologie, CHRU de Lille

location_facility: Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen


title: Bicentric, Open and Pilot Study Evaluating the Efficiency and the Tolerance of the Photodynamic Therapy in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary Dystrophic Epidermolysis Bullosa

summary:
The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent spontaneous or posttraumatic bullous detachment. They are caused by mutations in the COL7A1 gene encoding for the collagen VII.

No curative treatment is avaible. The main cause of patients death is the development of squamous cell carcinoma, sometimes multiple and paticularly aggressive in repeated healing part. The photodynamic therapy (PDT) is one of technical reference of multiple actinic keratoses lesions for adults, which are also pre-epithelioma lesions. The PDT is well tolerated even by the elderly and requires only a single session.

The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa (DEB). The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing, and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa. The main evaluation criterion is the cutaneous biopsy before and after (M2) a PDT session of an epidermal dysplasia area. The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0, M2 and M4 (lesion area and healing time) and correlation histology / MC. Each patient with a suspicious lesion will be biopsied. In case of agreement for this protocol, there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment.

location_facility:
Saint Louis Hospital
Nice University Hospital


title: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

summary:
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

lead_sponsor: Gynesonics

location_facility: Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre


title: Validation of a New TSH Test for Early Screening of Hypothyroidism

summary:
The aim of this research project, which is realised with the partnership of the enterprise Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an earlier screening of hypothyroidism. A serum bank will be conserved in the "Centre de Biologie Sud" ("Groupement Hospitalier Lyon Sud").

The serum samples will be assayed locally for the usual medical support to patients and after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new diagnostic test. The results obtained from the two techniques will be compared.

The validation of this new TSH test represents a major advancement, since it could bring in the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic patients with subclinical hypothyroidism.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Hospitalier Lyon Sud
Centre Hospitalier de Chambéry


title: Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion

summary: The primary aim of this project is to get further knowledge on the effects of + Gz accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung perfusion and cardiovascular function in these conditions.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Department of Nuclear Medicine, Val-de-Grâce hospital

location_facility: Armed Forces Biomedical Research Institute


title: Neuropsychomotor Functions in Children With Autism Spectrum Disorder

summary: The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard results.

ReferenceCitation: Lasserre E, Vaivre-Douret L, Abadie V. Psychomotor and cognitive impairments of children with CHARGE syndrome: common and variable features. Child Neuropsychol. 2013 Sep;19(5):449-65. doi: 10.1080/09297049.2012.690372. Epub 2012 Jun 14.

lead_sponsor: Centre Hospitalier Esquirol

location_facility:
Centre Hospitalier esquirol
Centre de Ressources Autisme Limousin


title: Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial

acronym: DLMOF

summary:
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.

lead_sponsor: University Hospital, Tours

location_facility:
UH Tours
UH Montpellier


summary: Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately 35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated by computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the chemotherapy. The management of treatment for metastatic CRC need the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, the investigators will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9. The investigators carried out a microfluidic digital polymerase-chain-reaction (PCR) assay to measure the specific somatic genomic alterations in plasma to identify the circulating tumor DNA.

ReferenceCitation: Unseld M, Belic J, Pierer K, Zhou Q, Moser T, Bauer R, Piringer G, Gerger A, Siebenhüner A, Speicher M, Heitzer E, Prager GW. A higher ctDNA fraction decreases survival in regorafenib-treated metastatic colorectal cancer patients. Results from the regorafenib's liquid biopsy translational biomarker phase II pilot study. Int J Cancer. 2021 Mar 15;148(6):1452-1461. doi: 10.1002/ijc.33303. Epub 2020 Oct 16.

location_facility:
HEGP
Hopital Européen Georges Pompidou


title: Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.

acronym: DIAMS

summary:
Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of their optimal use in hemodialysis patients remain unsolved and little is known about their pharmacokinetics in this context. The current practice for prescribing aminoglycosides to these particular patients consists in giving after each hemodialysis session about half the dose usually given to patients with normal renal function.

However, theoretical considerations and emerging clinical data suggest that this may not be the most beneficial dosing regimen as efficient peak concentrations are often not attained and the occurrence of ototoxicity and nephrotoxicity is still frequent.

ReferenceType: result

ReferenceCitation: Franck B, Monchaud C, Saint-Marcoux F, Rérolle JP, Allard J, Allot V, Marquet P, Essig M, Woillard JB. Population pharmacokinetics of gentamicin in haemodialysis patients: modelling, simulations and recommendations. Eur J Clin Pharmacol. 2020 Jul;76(7):947-955. doi: 10.1007/s00228-020-02867-3. Epub 2020 May 1.

lead_sponsor: University Hospital, Limoges

location_facility: CHU LIMOGES - Laboratoire de Pharmacologie


title: A Prospective, Multicentre, Uncontrolled, Phase Ib/II Study of LY2780301 in Combination With Weekly Paclitaxel in HER2-negative Metastatic or Locally Advanced Breast Cancer in Patients With and Without PI3/AKT/S6 Pathway Activation. - TAKTIC-IPC 2012-008

acronym: TAKTIC

summary:
The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic breast cancer (MBC) is based on :

the medical need in this population with either hormonal-resistant or unsensitive and/or rapidly progressive disease
the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and drug resistance, including taxanes as well as its potential reversion by AKT inhibition
the high level of frequency of PI3K/AKT activation in HER2-negative MBC
the in vitro and in vivo preclinical activity of LY2780301, and its synergistic combination with various anticancer agents, including taxanes
the favourable profile of tolerance of LY2780301 in phase I trial

Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as the RP2D in phase I single agent trial.

Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.

ReferenceCitation: Sabatier R, Vicier C, Garnier S, Guille A, Carbuccia N, Isambert N, Dalenc F, Robert M, Levy C, Pakradouni J, Adelaïde J, Chaffanet M, Sfumato P, Mamessier E, Bertucci F, Goncalves A. Circulating tumor DNA predicts efficacy of a dual AKT/p70S6K inhibitor (LY2780301) plus paclitaxel in metastatic breast cancer: plasma analysis of the TAKTIC phase IB/II study. Mol Oncol. 2022 May;16(10):2057-2070. doi: 10.1002/1878-0261.13188. Epub 2022 Mar 30.

ReferenceCitation: Vicier C, Sfumato P, Isambert N, Dalenc F, Robert M, Levy C, Rezai K, Provansal M, Adélaïde J, Garnier S, Guille A, Carbuccia N, Popovici C, Charafe-Jauffret E, Chaffanet M, Birnbaum D, Pakradouni J, Bertucci F, Boher JM, Sabatier R, Gonçalves A. TAKTIC: A prospective, multicentre, uncontrolled, phase IB/II study of LY2780301, a p70S6K/AKT inhibitor, in combination with weekly paclitaxel in HER2-negative advanced breast cancer patients. Eur J Cancer. 2021 Dec;159:205-214. doi: 10.1016/j.ejca.2021.09.040. Epub 2021 Nov 12.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre Geroges François Leclerd
Institut Paoli-Calmettes


title: Endoscopic Injection of Botulinum Toxin in Patients With Hypercontractile Esophageal Motility Disorders: a Prospective, Randomized, Double-blind, Controlled Study

acronym: TIBOH

summary: This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to hypercontractile esophageal motility disorders.

ReferenceCitation: Mion F, Marjoux S, Subtil F, Pioche M, Rivory J, Roman S, Zerbib F. Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double-blind randomized sham-controlled study. Neurogastroenterol Motil. 2019 May;31(5):e13587. doi: 10.1111/nmo.13587. Epub 2019 Apr 11.

location_facility: Service d'Hépato-Gastro-Entérologie et Oncologie Digestive- Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot Pavillon H 5 - Hospices Civils de Lyon


title: Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment

summary: Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.

ReferenceCitation: Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.

location_facility:
Centre Hospitalier Esquirol
Centre Hospitalier Universitaire


title: Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL

acronym: LYMPHOQOL

summary: The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.

ReferenceCitation: Quéré I, Stasi E, Mestre S, Roessler J, Roccatello D, Moffatt C. International Camps for Children with Lymphedema and Lymphatic Anomalies: When Education Links with Psychosocial Research. Lymphat Res Biol. 2021 Feb;19(1):36-40. doi: 10.1089/lrb.2020.0095.

lead_sponsor: University Hospital, Montpellier


title: Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.

acronym: APANVADS

summary: The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).

location_facility: CHU LIMOGES - Explorations Fonctionnelles Respiratoires


title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus

acronym: HydroFlux

summary: Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Lille
CHU Amiens


title: Comparison and Reproducibility of Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods: Clinical Observation Versus Photography Versus the EOS Imaging System

acronym: CRESPEOS

summary: The main objective of this study is to describe for the first time the expansion reserve of the pelvic area (measurements using the EOS system) for each of the four morphotypes (Roussouly classification) commonly found in a population of healthy volunteers.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer

acronym: HYPOXProstat

summary:
With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation.

In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy.

If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed.
If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered.

This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.

ReferenceCitation: Rasey JS, Koh WJ, Evans ML, Peterson LM, Lewellen TK, Graham MM, Krohn KA. Quantifying regional hypoxia in human tumors with positron emission tomography of [18F]fluoromisonidazole: a pretherapy study of 37 patients. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):417-28.

ReferenceCitation: Bentzen SM. Theragnostic imaging for radiation oncology: dose-painting by numbers. Lancet Oncol. 2005 Feb;6(2):112-7.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
CHU Poitiers
ICO Rene Gauducheau


title: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease

acronym: F-IBDQ

summary: The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux