title: Assessment of Intestinal Barrier in Irritable Bowel Syndrome Patients : Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins ?

acronym: BISII

summary:
Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability.

We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.

primary_purpose: Screening


title: Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

acronym: OPTILTH

summary: Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Sarcopenia in Patients With Gastrointestinal Stromal Tumours

acronym: SARCO-GIST

summary:
The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor. Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is generally well-tolerated and known to improve performance status but up to 16% grades 3-4 toxicities, leading to at least 40% withdrawals, have been reported.

Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients included in phase 1 trials, suggesting that it should be considered an inclusion criterion for such studies. Sarcopenic patients had low performance status, shorter survival, more chemotherapy toxicities and post-operative infections, and longer post-operative hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell or hepatocellular carcinomas.

Computed tomography (CT) scans acquired during routine care have been validated as an accurate and robust imaging technique to evaluate sarcopenia in cancer patients.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Moryoussef F, Dhooge M, Volet J, Barbe C, Brezault C, Hoeffel C, Coriat R, Bouché O. Reversible sarcopenia in patients with gastrointestinal stromal tumor treated with imatinib. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):343-50. doi: 10.1002/jcsm.12047. Epub 2015 Jun 4.

lead_sponsor: CHU de Reims


title: Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases

summary: The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.

lead_sponsor: Hospices Civils de Lyon


title: A Prospective, Single-arm Study of the Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions Such as Fine Lines and for Improvement of Skin Quality

summary: This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA) injectable gel for filling fine lines, as measured by skin texture improvement, and for improvement of skin quality.

study_type: Interventional

primary_purpose: Treatment

lead_sponsor: Allergan

intervention_type: Device

lead_sponsor_type: industriel


title: Measurement of the Quality: Application to Lung Resection for Cancer Using a National PMSI Database

acronym: ResPul

summary: In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Procedure

status_simplified: Unknown


title: Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

acronym: CORISMAP

summary:
The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.

This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.

time_perspective: Cross-Sectional

ipd_sharing: No

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Opthalmologique A de Rothschild


primary_purpose: Prevention

acronym: ATG-CyGVHD

intervention_type: Drug

title: Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Del Pozo Martín Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31.

location_facility: Saint Antoine Hospital - Hematology Department

summary: The study is designed as a two arm randomized Phase II, multicenter trial comparing cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis in patients with hematologic malignancies undergoing reduced intensity conditioning hematopoietic stem cell transplantation.


title: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

acronym: SAOS

summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)

design_allocation: Non-Randomized

primary_purpose: Basic Science


acronym: HILARIUM

summary:
The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.

This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.

study_completion_date_type: Anticipated

lead_sponsor: Institut Paoli-Calmettes


title: Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

acronym: PERLYON

summary:
Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.

The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).


title: Postconditioning by Cyclosporin A in Pulmonary Transplantation

acronym: CsA Poumon

summary:
The morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF).

The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.

Ischemic postconditioning, has recently been described in experimental models of ischemia-reperfusion injury in the heart, and although not yet fully understood. Several studies suggest that the mitochondria play a central role in cellular survival mechanisms after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability transition pore (mPTP)).

Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in clinical phase II trials in reperfused myocardial infarction patients.

The hypothesis of this study is that the administration of CsA in transplanted patients (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s) from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and severity of PGF.

status: Withdrawn


type: Registry Identifier

title: Cerebral Bases Bodily Representations: Imaging Approach by Functional Magnetic Resonance, Cortical Stimulation Corticographie and Surgery Awake

acronym: EBA

summary:
Bring elements of understanding to the study of brain organization bodily representations. The body is organized into multiple, distinct levels of representation. The body schema is an unconscious and dynamic representation of his body, updated constantly, resulting from the convergence of multiple sensory information, which articulates with the motor systems to participate in the genesis of the action. The self-image corresponds to a more abstract representation of the body, covering symbolic and imaginary aspects drawn from the emotional life of the individual. Finally, the body of another person engages simultaneously shared and differential representational systems that allow understanding the actions of others while preserving the identity of the agent responsible for the action. These various bodies represented subtly interacting and participating in equilibrium, the self-awareness building as being curious, social and acting. Brain organization bodily representations remains a fundamental question still poorly explored that is of major scientific interest because of its influence on identity and social construction, and the serious repercussions that are their problems, also for the individual and society. This project aims to deepen this hypothesis using a methodology combining functional imaging and awake surgery. The richness of this project lies in the innovative methods of investigation, and in the plurality of disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams (clinical and research) grouped for wear.

The subjects enrolled in this study are all candidates in patients with awakened provided surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake neurosurgery is for patients with glial tumors, but also brain metastases and intra-parenchymal cavernomas. A first experimental session will be held in pre-operative period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a precise functional mapping of cortical structures, including lateral occipital, involved in body representation. The second experimental session will be conducted in the neurosurgical intervention, practiced one to four weeks later.

This dual approach that combines the functional stimulation of a cortical area (imaging) and functional inhibition (in surgery) allows you to make extremely robust scientific arguments about the causal relationships linking structure and function

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assitance Publique Hôpitaux de Marseille


title: Characterization of Immunosuppressive Signing of Cervical Cancer

summary:
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer.

The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.

status: Not yet recruiting

primary_purpose: Diagnostic

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Biological

status_simplified: Ongoing


title: Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.

acronym: MEG-SEEG

summary:
Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function.

The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient.

Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain.

The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements.

It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.


title: Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma

acronym: ctDNA MU

summary: Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

lead_sponsor: Institut Curie


title: Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)

summary: This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.

ReferenceCitation: Ngô C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lécuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie


title: Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography

acronym: AAA-angioCT

summary:
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.

The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.

The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.


title: Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures

acronym: LAXIMETRIE

summary: Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.

ipd_sharing: Undecided

lead_sponsor: Versailles Hospital


title: Assessment of Global Longitudinal Strain at Low Dose Anthracycline-based Chemotherapy for the Prediction of Subsequent Cardiotoxicity

acronym: Anthracardio

summary:
Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure treatment can potentially reverse cardiac dysfunction at the early stage of cardiac toxicity, early detection of AIC is crucial.

Transthoracic echocardiography is recommended for monitoring left ventricular function in patients receiving these molecules. In routine practice, left ventricular systolic function is mainly assessed by the left ventricular ejection fraction (LVEF), measured by two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience and is not sensitive enough to detect subclinical myocardial dysfunction.

To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed. This technique allows for a study of global and regional myocardial deformation, especially the longitudinal component, which appears to be the most sensitive one. Several studies have already emphasized the role of global longitudinal strain (GLS) to detect slight alterations in systolic function, especially in the setting of potentially cardiotoxic drugs and even after low to moderate doses of anthracyclines. A recent expert consensus paper strongly recommends GLS assessment for the detection of subclinical left ventricular dysfunction due to anthracycline therapy.

Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few data exist on the optimal timing to perform echocardiography.

The investigators hypothesized that very early measurement of GLS in the time course of anthracycline therapy could predict subsequent left ventricular systolic dysfunction.

The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.


title: Impact of Cataract Surgery on Keratoplasty Graft Survival

acronym: IGREC

summary:
The follow up time after keratoplasty now routinely exceeds multiple decades. It is common for keratoplasty patients to also undergo cataract surgery at a later date in their lives.

Keratoplasties and cataract surgery both result in local inflammation. This may influence the density of endothelial cells, and on average there is a loss of 10% in endothelial cells within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is required to maintain graft transparency. It may be therefore difficult to strike a balance between loss of visual acuity due to the cataract of to the loss of graft transparency over the long term.

The investigators aim to compare graft survival in patients with clear crystalline lens with and without cataract surgery.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


type: Other Identifier

title: Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia

summary: In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission.

lead_sponsor: Janssen-Cilag Ltd.


title: Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission: Functional MRI Study

acronym: Douleur IRMf

summary:
Crohn's disease goes along with an alteration of the quality of life, even in remission and has a negative impact on stress management linked to the pain and the health. Conversely, stress and psychological variables play a significant role in the pathogenesis of this disease. These interrelations reflects the link between the brain and the digestive tract, called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface, relaying in a bidirectional way, informations between the digestive tract and the central nervous system (CNS).

Visceral information can thus modulate the functionnement of CNS's areas involved in pain management but also in the management of emotional and cognitive behaviours. Yet, numerous work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a dysautonomia of the sympatho-vagal balance.

Human brain respond by advance before and during the application of a painful stimulus that enable the organism to regulate its nociceptive system in order to handle the aversive stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain awareness.

The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few studies exists about the differential role of certain or uncertain anticipation of the pain, despite the fact that they are associated to different emotional, cognitive and behavioral responses, and the effect of anticipation on painful visceral perception, have not yet been studied for parents in remission of Crohn's disease.

The main goal is to search during certain and uncertain visceral anticipation, induced by distension of an intra-rectal balloon for persons suffering from Crohn's disease in remission, compared to control subjects, with an MRI functional study

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lead_sponsor: University Hospital, Grenoble


title: Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia

summary:
Background:

Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).

The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.

Main aim:

The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.

Secondary objectives:

To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.

To separate an explicit response (motors responses) with an implicit response (eye tracking measures).

Methodology:

30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.

lead_sponsor: University Hospital, Lille


acronym: PerFAV

summary: Use of arteriovenous fistula for IV drug administration is controversial and often prohibited by nephrologists. However, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future. The aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.

lead_sponsor: University Hospital, Angers


title: Intestinal Stem Cells Characterization in Intestinal Organoid Culture From Inflammatory Bowel Disease and Intestinal Polyposis Patients

acronym: BIODIGE

summary: A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC.

status: Recruiting

primary_purpose: Other

ReferenceCitation: Moreau J, Mas E. Drug resistance in inflammatory bowel diseases. Curr Opin Pharmacol. 2015 Dec;25:56-61. doi: 10.1016/j.coph.2015.11.003. Epub 2015 Nov 29. Review.

lead_sponsor: University Hospital, Toulouse


title: High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial

acronym: OPTICAP

summary: The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.

lead_sponsor: University Hospital, Montpellier


summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and peripheral motor neurons, characterized by the rapidity of its evolution (median survival of 3 years). The pathophysiology of the disease is still poorly understood. Neuronal death results from several cellular mechanisms entangled, including mitochondrial dysfunction. The absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction causing the accumulation in the sodium and calcium cell causing neuronal death. These studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.

location_facility: Assistance Publique Hopitaux de Marseille


summary:
Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to life-threatening patients. Preliminary studies conducted on patients with drepanocytose disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in the supply and use of oxygen. To date, the translation of this metabolic remodeling in the muscle work is not known.

This project's main objective is to evaluate muscle function in drepanocytose attempted patients. We hypothesized that muscle remodeling associated with sickle cell disease have a functional impact on strength and muscle metabolism. The main objective is to characterize the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle cell patients (HbSS) oxygen saturation.

The strictly non-invasive approach proposed in this project will study the functional parameters of the muscle of sickle cell disease and the possible link with the clinical manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation and pH plays a major role.


summary: Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL


title: Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

acronym: MICROPB

summary:
Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in Europe. The incidence of the individual entities is slight significantly different within Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and South America. The most common of these disorders is the bullous pemphigoid.

A considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. To this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. Further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later.

At present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. Epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs.

Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. A clear association with certain HLA regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear IgA dermatosis the association with HLA antigens is less pronounced. Another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.

lead_sponsor: CHU de Reims


title: Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas

summary: Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


title: Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease

acronym: EPITHREGENCOPD

summary: Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling. The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.

ReferenceCitation: Perotin JM, Adam D, Vella-Boucaud J, Delepine G, Sandu S, Jonvel AC, Prevost A, Berthiot G, Pison C, Lebargy F, Birembaut P, Coraux C, Deslee G. Delay of airway epithelial wound repair in COPD is associated with airflow obstruction severity. Respir Res. 2014 Nov 27;15:151. doi: 10.1186/s12931-014-0151-9.


title: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD

acronym: OPTIFEL

summary:
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.

For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.

Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie

intervention_type: Dietary Supplement


title: Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

acronym: CAMAT

summary: The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


title: Elucidation of Sensory Characteristics and Food Preferences in the Elderly

acronym: AUPALESENS

summary: Malnutrition is a frequent problem in persons older than 65 years: the prevalence of malnutrition can reach 25 to 29% in persons living at home who require help, figures vary between 19 and 38% for those living in institutions, and finally, the prevalence of malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have attempted to explain modifications in attitudes, behaviour, the frequency of meals or nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this project is to test the hypothesis that perhaps it is not as much the capacity to perceive a smell or a taste that affects eating behaviour in the elderly as their ability to distinguish between smells or tastes on the one hand (perceptual processing), and their ability to correctly interpret a chemosensory signal on the other (cognitive processing).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer - Preliminary Validation of the Caregiver Objective Burden-Quality of Life (COBQoL) Questionnaire

acronym: APPACH

summary: Altered quality of life in patients with stage III or IV colon cancer is well known. At their sides, their spouse/partner must also cope with the suffering caused by the disease and the upheavals that it engenders, with the treatments, in the organization of their everyday life. The physical, emotional, social and financial impact of cancer in general and its treatment on care-givers has already been studied. However, there are no data concerning the "objective burden", that is to say the nature and the magnitude of the care weighing on the spouse of persons with colon cancer. Objective is to develop and validate a questionnaire that can be completed by the spouse/partner of patients with stage III or IV colon cancer so as to evaluate the burden of the disease in everyday life. It will allow medico-social professionals to identify spouses/partners in difficulty and the needs of patients so as to offer the best support.


title: Efficacy of Heat-shock Protein (HSP) Inhibitors in Myeloproliferative Syndromes (MPS): Fundamental Observational in Vitro Study Using Samples From a Collection

acronym: HSP-SMP

summary:
Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species and are characterized by their chaperone function, thanks to their ability to prevent aggregation and to promote the renaturation/break down of damaged proteins. Among other targets, they also chaperone JAK2, a key step that is deregulated in signalling in myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a potent cytoprotective action through their multiples inhibiting effects on apoptotic processes.

Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS cells.

However, in vitro studies of different cell models have shown the interest of HSP90 inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal models with results in terms of blood counts and overall survival. In addition, it seems that the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors. Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth, even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of several HSP inhibitors could be beneficial, and eventually present synergistic effects on the inhibition of tumour processes.


title: Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle

acronym: SEMINOMES

summary: By analogy with the mouse, the activity of control pathways for transposable elements (TE) in foetal primordial germinal cells could prove to be a determinant for fertility in adulthood in humans. Moreover, defects in the control of transposable elements (TE) could also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal instability and tumorigenesis. In this context, the aim is to analyse a specific type of adult germinal testicular cancers, seminomas. Directly related to our research interest, the histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent of germinal cells normally present in foetuses. The investigator postulates that these similarities could also extend to the biology of transposable elements (TE), and in particular to the initiation of the control of these elements. The management of seminomas requires surgery, orchiectomy, which consists of the total excision of the affected testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse the control pathways of transposable elements (TE) in tumour samples harvested from surgical pieces in comparison with adjacent healthy tissue. The results obtained in these tumour samples will be compared with those in normal foetal gonad samples.

intervention_type: Genetic


acronym: KTSS

title: Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)

lead_sponsor: Centre Hospitalier Departemental Vendee

summary:
The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.

Patients will be randomized in two arms:

catheter in position under sartorial (experimental group)
femoral catheter (control group)


title: Marqueurs de vulnérabilité Aux Jeux Pathologiques

acronym: GambleMMORe

summary: Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).

ReferenceType: result

ReferenceCitation: Giustiniani J, Gabriel D, Nicolier M, Monnin J, Haffen E. Neural Correlates of Successful and Unsuccessful Strategical Mechanisms Involved in Uncertain Decision-Making. PLoS One. 2015 Jun 18;10(6):e0130871. doi: 10.1371/journal.pone.0130871. eCollection 2015.


title: Pilot Project - Prospective Longitudinal Cohort of Patients Over 70 Years With Malignant Solid Tumors: Modification of Quality of Life Based on Objective Geriatric Tests

acronym: MEGERIA

summary:
The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment.

The analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.

primary_purpose: Supportive Care

lead_sponsor: Centre Antoine Lacassagne


title: Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.

acronym: PF-ECHO

summary: PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.


title: Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers

acronym: CANARI

summary: This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

lead_sponsor: Rennes University Hospital


title: Diagnosis Accuracy of Noninvasive Screening by PCR Digital for Down Syndrom

summary:
The main objective of this study is to estimate the intrinsic diagnostic qualities of the digital dPCR in the screening of T21 from a multicentrique sample of patients with pregnancies at high risk of T21 (risk > 1/250).

The profit expected from this technique is to propose to the encircled women a screening more successful than that of the screening combined(organized) of the 1st quarter, simple of realization and in a moderate cost. We thus propose here an original alternative(alternate) method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent technical improvements and his(her,its) advantages medical - economic allow to envisage a reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in most of the laboratories. This pilot project could serve for the later development of a study of clinical validation multicentrique of large scale(big turntable ladder).

ReferenceCitation: Cans C, Amblard F, Devillard F, Pison H, Jalbert P, Jouk PS. Population screening for aneuploidy using maternal age and ultrasound. Prenat Diagn. 1998 Jul;18(7):683-92.

ReferenceCitation: Coutton C, Abada F, Karaouzene T, Sanlaville D, Satre V, Lunardi J, Jouk PS, Arnoult C, Thierry-Mieg N, Ray PF. Fine characterisation of a recombination hotspot at the DPY19L2 locus and resolution of the paradoxical excess of duplications over deletions in the general population. PLoS Genet. 2013 Mar;9(3):e1003363. doi: 10.1371/journal.pgen.1003363. Epub 2013 Mar 21.

ReferenceCitation: Nadeau G, Coutton C, Amblard F, Michalowicz G, Frasca S, Fertin A, Devillard F, Satre V, Usson Y, Jouk PS. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring. Clin Chem Lab Med. 2013 Apr;51(4):e41-4.

ReferenceCitation: Coutton C, Bidart M, Rendu J, Devillard F, Vieville G, Amblard F, Lopez G, Jouk PS, Satre V. 190-kb duplication in 1p36.11 including PIGV and ARID1A genes in a girl with intellectual disability and hexadactyly. Clin Genet. 2013 Dec;84(6):596-9. doi: 10.1111/cge.12113. Epub 2013 Mar 25.

ReferenceCitation: Ben Khelifa M, Coutton C, Zouari R, Karaouzène T, Rendu J, Bidart M, Yassine S, Pierre V, Delaroche J, Hennebicq S, Grunwald D, Escalier D, Pernet-Gallay K, Jouk PS, Thierry-Mieg N, Touré A, Arnoult C, Ray PF. Mutations in DNAH1, which encodes an inner arm heavy chain dynein, lead to male infertility from multiple morphological abnormalities of the sperm flagella. Am J Hum Genet. 2014 Jan 2;94(1):95-104. doi: 10.1016/j.ajhg.2013.11.017. Epub 2013 Dec 19.


title: Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

acronym: MUEVELO

summary:
Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated.

The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock

The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on:

the duration between hemodynamic stability* and the removal of sedation
the duration between the removal of sedation and ICU discharge
the mechanical ventilation duration (invasive and noninvasive)

status: Terminated

lead_sponsor: University Hospital, Rouen


title: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer

acronym: COCA-MACS

summary:
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.

The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.


title: A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.

acronym: CXLMyopie

summary:
43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.

All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.

Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.


title: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study

acronym: enteroMRI-TSI

summary:
Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

intervention_type: Radiation


title: Characterization of Tissular T Follicular Helper Cells in IgG4-RD

summary:
IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. In this context, identification of new therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell compartment. In this context, this population could have an important contribution in the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.

TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This study is an exploratory prospective multicentric study. Thirty patients with a suspected diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. The results obtained in patients with a confirmed diagnosis of IgG4-RD (" IgG4-RD group ") will be compared to results of patients with another diagnosis (" control group "). Main objective of the study is to show by confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these cells and co-culture tests with autologous naive B cells. All these results will be compared between the " IgG4-RD group " and the " control group ". This study should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.

lead_sponsor: Assistance Publique Hopitaux De Marseille


acronym: ECUN

summary:
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.

The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.

Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.

The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.


title: Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study

acronym: MBCT

summary:
Mindfulness is both a natural resource of individuals present in all individuals in varying degrees characteristic ability of attention to the experience that unfolds moment by moment without judgment and a practice based on meditation, mindfulness exercises, which aims to enhance two central skills of mindfulness that are the presence and acceptanc. In the context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is recognized as effective in psychological suffering and relapse. The mechanisms implied in MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms, reduction of rumination is a major factor in the action of MBCT, especially for patients with less than three depressive relapses.

This exploratory research focuses on the impact of mindfulness functioning (mindfulness resource level at baseline) on the benefits of MBCT for patients with recurrent depressive disorder.

The objective is to assess whether the level of mindfulness resource of patients with recurrent depression is a factor contributing to the positive effect of a MBCT applied in add-on to conventional care.

This objective will be measured by comparing the clinical improvement of patients secondary to MBCT according to the initial categorization of the mindfulness resource.

Clinical improvement will be more important for patients characterized by a lower initial level of mindfulness resource.


acronym: AMIKACINE

title: Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population

summary:
The loss of skin barrier function after burn causes increased susceptibility to infections, which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics are one part of the therapeutic arsenal available to treat these infections. Pseudomonas aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this population of patients.

The use of dressings impregnated with amikacin is a common practice. Actually, there are no available data on local and systemic effects with this antibiotic. The study of tissue and plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this singular use of amikacin and improve the care of burn patients.

The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin after dermal administration and impregnated dressing to estimate the pharmacokinetic parameters and their variability in a burned population.

Secondary objectives are to assess on the one hand the relationship between the effectiveness of treatment and the concentration of antibiotic at the site of tissue infection, and on the other hand to assess the relationship between plasma concentration and the toxicity found of this treatment. We would like also to note the efficacy of the antibiotic treatment in terms of: need for repeat surgery (new skin graft), healing time and hospital length of stay.

Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the start of treatment.

The knowledge about the tissue concentrations obtained and a possible systemic absorption will then provide additional safety data and optimize the conditions of use of these dressings (dosage, frequency of administration) for effective treatment and safe.


title: Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

acronym: LAB-Card

summary: The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.

location_facility: Centre Hospitalier Régional Universitaire


title: Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study

acronym: ImSOLENCE

summary:
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.


title: Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

acronym: EVONAIL

summary:
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.

Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.

The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.

lead_sponsor: Institut de Cancérologie de Lorraine


summary: The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and fibrosis in its environment. This study aims to measure the influence of the tumor on his kidney Environment and fat and define molecular markers not influenced by renal tumor. The main objective is to compare the inflammation of the perirenal fat taken in two locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his own control. The secondary objective is to compare the degree of interstitial fibrosis of the renal cortex in the same sampling methods.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

acronym: ELASTOMAP

summary: The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.

ReferenceCitation: Mottet N, Aubry S, Vidal C, Boiteux G, Metz JP, Riethmuller D, Pazart L, Ramanah R. Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol. BMJ Open. 2017 Dec 26;7(12):e018130. doi: 10.1136/bmjopen-2017-018130.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


acronym: HIF

summary:
Burn injury with full-thickness skin damage that encompass large body surface areas can induce local and systemic perturbations that are costly in terms of human suffering as well as in strains on the health care system. Characterization of new major molecular biomarkers involved in this process creates significant diagnostic and therapeutic challenges.

Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric transcription factor comprising an α and a β subunit. It was shown that under normoxic conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a spectrum of target genes encoding multiple angiogenic growth factors and cytokines of potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative splicing have been identified.

The importance of HIF-1α in wound healing in animal models has been suggested by several studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in mice in case of burn wound skin that in the case of excisional cutaneous wound. Other studies have shown that the expression of HIF-1α was correlated with the extent and depth of the burns.

This study aims to improve the knowledge on the pathophysiological factors involved in the field of wound healing. The assumptions are based on results of studies done on mice, and this work aims to document these findings in humans.

Objective

The main objective of the study is to compare the variations of expression of HIF-1α measured in blood and skin tissue samples in three groups:

Subjects with major burn wounds involving more than 20% of the total body surface area;
Subjects with burn wounds smaller than 5% of total body surface area;
Subjects with a skin wound after a surgical procedure requiring a skin resection.

Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and to assess the correlation between the expression of HIF-1α and the kinetics of wound healing of the subject rated by evaluation of time of donor sites complete epithelialization.

Material and Methods

We propose to create three groups:

15 patients with extensive third degree burns involving more than 20% of the total body surface area;
15 patients with less extensive third degree burns, involving less than 5% of body surface area;
15 patients with post-surgical wounds with skin resection. Skin and tissue specimens will be collected three times: day 0, 7 and 14 from burned patients (with more than 20% of the total body surface area and less than 5% of body surface area). Samples of skin tissue will be collected within the skin resection from patients with post-surgical wounds at day 0, blood samples will be collected at day 0 and 14.


acronym: ReTransQol

summary:
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.

The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol


title: Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study

acronym: IDASPHERE

summary:
Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)

classical chemoembolization consists in injecting an emulsion of an anticancer agent in Lipiodol® via the hepatic artery
doxorubicin, an anthracycline, is the most frequently used drug in lipiodol chemoembolization (LCE)
however, less than half of HCC respond favourably to classical lipiodol chemoembolization (LCE) with doxorubicin/Lipiodol®

In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to achieve a more effective antitumor effect for the following reasons, recently pointed out by our team:

idarubicin is an anthracycline that penetrates tumour cells more quickly and is more cytotoxic than doxorubicin on hepatocellular carcinoma cell lines
idarubicin is injected in a solution of embolization microspheres of a diameter of (300-500µm), which all the progressive and controlled release of the anticancer drug, whereas the doxorubicin/Lipiodol® emulsion is unstable


title: Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

acronym: SACRE

summary: The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.


title: Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease

acronym: DATACOMT

summary:
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis.

Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms. The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).

The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.

To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.

Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP). All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.

The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS part 3.

If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


acronym: TEMP CORE BLOC

summary: Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.

ReferenceCitation: Boisson M, Alaux A, Kerforne T, Mimoz O, Debaene B, Dahyot-Fizelier C, Frasca D. Intra-operative cutaneous temperature monitoring with zero-heat-flux technique (3M SpotOn) in comparison with oesophageal and arterial temperature: A prospective observational study. Eur J Anaesthesiol. 2018 Nov;35(11):825-830. doi: 10.1097/EJA.0000000000000822.

lead_sponsor: Poitiers University Hospital