title: Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study

acronym: MYRIFIC

summary:
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.

The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).

Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.

The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.

Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months


title: Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement

acronym: ADIPOGEST

summary: ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).

summary: Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Procedure

status_simplified: Completed


title: Mechanisms of Auto-immune Encephalitis

acronym: MECANO

summary:
Neurological and psychiatric diseases are one of the major health problems worldwide. Decades of fundamental and clinical research have led to the model that these disorders results from synaptic imbalance between excitatory, inhibitory and modulatory systems in key brain structures. Although the network and neurotransmitter systems involved have been delineated, the mechanisms leading to improper neurotransmissions remain poorly understood. One major limitation lays in the difficulty to transpose the identified dysregulation in humans to relevant animal models in which molecular and cellular targets can be manipulated.

The amino-acid glutamate mediates the vast majority of excitatory neurotransmission in the mammalian brain. We know that the glutamatergic synapses can change their strength by regulating surface expression and dynamics of their postsynaptic receptors, through changes in receptor recycling and/or lateral diffusion. This synaptic plasticity underlies higher cognitive functions such as learning and memory and is likely compromised in several disease states. Regulating glutamate receptor number and function is thus of primary importance. New subcellular imaging technique rendered possible the study of receptor trafficking and receptor regulation in various conditions including pathological models opening new fundamental questions. Moreover, recent breakthroughs on glutamate receptor structure offer unprecedented clues on the molecular and structural mechanisms underpinning receptor dysfunction at the atomic level.

Recently, description of encephalitis associated with specific autoantibodies (Abs) directed against neuronal synaptic receptors or proteins (NSA-Abs) opens new lights in the pathophysiological mechanisms of some human brain disorders. The best example and the most frequent syndrome is the synaptic autoimmune encephalitis associated with autoantibodies against extracellular domains of the glutamatergic NMDA receptor (NMDAR-Abs). Classically, patients first present psychiatric symptoms with hallucinations and bizarre behavior before development of neurological symptoms such as seizures, dyskinesia, and autonomic instability. Despite the severity of neuropsychiatric symptoms, more than 80% of patients fully recover after immunomodulatory treatments and many arguments suggest a direct role of NMDAR-Abs in the symptoms. The investigators recently demonstrated that NMDAR-Abs directly modify, at the synaptic level, NMDAR lateral diffusion by disruption of the interaction between NMDAR and EphrinB2 receptor, a synaptic protein anchoring NMDAR at the synapse (Mikasova et al, Brain 2012; Dupuis et al, EMBOJ 2014). These data suggest that NMDAR-Abs could directly participate in the neuropsychiatric disorders observed in patients and that NMDAR dysfunctions could be directly responsible for the observed symptoms. Furthermore, these data suggest that other NSA-Abs directed against other synaptic proteins could explain specific neurological symptoms in patients with encephalitis that are not associated with NMDAR-Abs.

The aim of MECANO is to combine multidisciplinary approaches (clinical, immunological, and neurobiological ones) to identify new NSA-Abs, to characterize their specific pathological roles and to decipher acute and chronic NMDAR-Abs effects on biophysical and structural properties of the NMDA receptor, synaptic plasticity, neuronal morphology, and cognitive performance. This project should provide key insights onto the effects of patients' NSA-Abs on the cellular dynamic and regulation of synaptic proteins or receptors and on the molecular cascades activated during synapse dysfunction. The investigators will investigate how NSA-Abs binding alter receptor activity, modify surface receptor mobility and dynamically regulate the maturation of synapses and circuitries. For that purpose, The investigators will use a unique combination of high-resolution imaging (single nanoparticle tracking), receptor engineering, cellular electrophysiology, computational (structural modeling) and cellular and molecular biology approaches and finally behaviour assays. Based on both cutting-edge neurobiology and clinical expertise of autoimmune disorders, and strengthened by promising preliminary experiments, the MECANO project will likely open new avenues of fundamental research in the understanding of synaptic dysfunction and clinical research for the treatment of neuropsychiatric disorders.

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut NeuroMyoGène Équipe Synaptopathies et Autoanticorps (SynatAc) INSERM U1217 / UMR CNRS 5310

intervention_type: Other


acronym: Physios

summary:
The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation.

The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of "physios" program,

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study

acronym: SERENAT

summary: The main objective of this work is to explore the psychometric properties of scale of well-being at work called "Serenat" in order to validate it. Secondary objectives are to study the influence of socio-demographic characteristics of the subjects on the results of Serenat and to describe the results on subjects monitored among an adult psychiatric population.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Andrea H, Bültmann U, Beurskens AJ, Swaen GM, van Schayck CP, Kant IJ. Anxiety and depression in the working population using the HAD Scale--psychometrics, prevalence and relationships with psychosocial work characteristics. Soc Psychiatry Psychiatr Epidemiol. 2004 Aug;39(8):637-46.

ReferenceCitation: Stansfeld S, Candy B. Psychosocial work environment and mental health--a meta-analytic review. Scand J Work Environ Health. 2006 Dec;32(6):443-62. Review.

ReferenceCitation: Melchior M, Caspi A, Milne BJ, Danese A, Poulton R, Moffitt TE. Work stress precipitates depression and anxiety in young, working women and men. Psychol Med. 2007 Aug;37(8):1119-29. Epub 2007 Apr 4.

ReferenceType: derived

ReferenceCitation: Servant D, Drumez E, Raynal S, Demarty AL, Salembier A, Deschepper MH, Bizet MA, Pisanu-Zimny A, Culem JB, Labreuche J, Duhamel A, Vaiva G. [Elaboration and psychometric properties of a well-being scale at work. The Serenat study among employees in occupational medicine unit]. Rev Epidemiol Sante Publique. 2019 Sep;67(5):303-309. doi: 10.1016/j.respe.2019.05.011. Epub 2019 Jun 28. French.

family: Servant

full_name: D. Servant

given: D.

sequence: first

family: Drumez

full_name: E. Drumez

given: E.

sequence: additional

family: Raynal

full_name: S. Raynal

given: S.

family: Demarty

full_name: A.L. Demarty

family: Salembier

full_name: A. Salembier

given: A.

family: Deschepper

full_name: M.H. Deschepper

family: Bizet

full_name: M.A. Bizet

family: Pisanu-Zimny

full_name: A. Pisanu-Zimny

family: Culem

full_name: J.B. Culem

family: Labreuche

full_name: J. Labreuche

given: J.

family: Duhamel

full_name: A. Duhamel

family: Vaiva

full_name: G. Vaiva

given: G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Revue d'Épidémiologie et de Santé Publique

oa_host_type: publisher

evidence: open (author manuscript)

host_type: publisher

license_normalized: no license

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Élaboration et qualités psychométriques d’une échelle de bien-être au travail. Étude SERENAT auprès de salariés vus en médecine du travail

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille


summary:
Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a chronic disease with a recurrence rate of 30% at 10 years.

Reduce the risk of recurrence is a serious public health issue. For this it is necessary to identify patients at high risk of recurrence. However, until now, only 50% of recurrences are in the presence of known risk factors, suggesting that there are still yet unidentified risk factors.

The assumption behind this project is that there are specifically associated genetic polymorphisms to the risk of VTE recurrence.

The aim of our project is to identify these polymorphisms from genome-wide data MARTHA cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for approximately 500,000 polymorphisms.

The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be compared between cases and controls. The identification of these new genetic variants associated with VTE recurrence should allow us to improve the pathophysiological knowledge of the disease, reduce the frequency of episodes and focus research on new therapeutic approaches.

design_allocation: Non-Randomized

primary_purpose: Prevention

intervention_type: Biological


acronym: SHU

summary: The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia. One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

primary_purpose: Diagnostic


title: Prevention of Diseases Induced by Chlamydia Trachomatis

acronym: i-PREDICT

summary:
The main objective of the study is to determine whether early screening and treating young women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the cumulative incidence of pelvic inflammatory disease (PID) over 24 months.

As secondary objectives, the study aims

To determine the baseline prevalence and the incidence of Ct infection;
To improve knowledge on natural history of Ct infection in young women such as the rate and timing of progression to PID (at the beginning of the infection, at the end, throughout the course of infection), as well as the incidence of reinfections with Ct;
To investigate the relation between host immuno-genetic factors and the clearance, persistence and development of late complications (PID) as an explanation for the inter-individual heterogeneity in the susceptibility to and course of Ct infection.

status: Active, not recruiting

ReferenceCitation: Tamarelle J, Thiébaut ACM, Sabin B, Bébéar C, Judlin P, Fauconnier A, Rahib D, Méaude-Roufai L, Ravel J, Morré SA, de Barbeyrac B, Delarocque-Astagneau E; i-Predict study group. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial. Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.

apc_source: openAPC

family: Tamarelle

full_name: Jeanne Tamarelle

given: Jeanne

family: Thiébaut

full_name: Anne C. M. Thiébaut

given: Anne C. M.

family: Sabin

full_name: Bénédicte Sabin

given: Bénédicte

family: Bébéar

full_name: Cécile Bébéar

given: Cécile

family: Judlin

full_name: Philippe Judlin

given: Philippe

family: Fauconnier

full_name: Arnaud Fauconnier

given: Arnaud

family: Rahib

full_name: Delphine Rahib

given: Delphine

family: Méaude-Roufai

full_name: Layidé Méaude-Roufai

given: Layidé

family: Ravel

full_name: Jacques Ravel

given: Jacques

family: Morré

full_name: Servaas A. Morré

given: Servaas A.

family: de Barbeyrac

full_name: Bertille de Barbeyrac

given: Bertille

family: Delarocque-Astagneau

full_name: Elisabeth Delarocque-Astagneau

given: Elisabeth

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature


title: Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers

acronym: PHOTOFLUO

summary:
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.

This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.

primary_purpose: Health Services Research

lead_sponsor: Institut de Cancérologie de Lorraine

intervention_type: Device

lead_sponsor_type: industriel


title: Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery

acronym: ADRIATIC

summary:
Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.

There is a lack of data to determine wich route allows a longer analgesic effect.

This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.

primary_purpose: Treatment

ReferenceCitation: Marty P, Rontes O, Chassery C, Vuillaume C, Basset B, Merouani M, Marquis C, Bataille B, Chaubard M, Mailles MC, Ferré F, Delbos A. Perineural Versus Systemic Dexamethasone in Front-Foot Surgery Under Ankle Block: A Randomized Double-Blind Study. Reg Anesth Pain Med. 2018 Oct;43(7):732-737. doi: 10.1097/AAP.0000000000000769.

family: Marty

full_name: Philippe Marty

family: Rontes

full_name: Olivier Rontes

given: Olivier

family: Chassery

full_name: Clément Chassery

given: Clément

family: Vuillaume

full_name: Corine Vuillaume

given: Corine

family: Basset

full_name: Bertrand Basset

given: Bertrand

family: Merouani

full_name: Mehdi Merouani

given: Mehdi

family: Marquis

full_name: Constance Marquis

given: Constance

family: Bataille

full_name: Benoit Bataille

given: Benoit

family: Chaubard

full_name: Martine Chaubard

given: Martine

family: Mailles

full_name: Marie Claude Mailles

given: Marie Claude

family: Ferré

full_name: Fabrice Ferré

given: Fabrice

family: Delbos

full_name: Alain Delbos

given: Alain

journal_name: Regional Anesthesia and Pain Medicine

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran

acronym: DABI-SURV

summary:
Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF). This drug is at high risk for severe ADR and requires thus careful pharmacovigilance monitoring.

Primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with AF under the same treatment.

time_perspective: Retrospective


title: Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients

acronym: DEXDOR

summary:
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.

DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

summary: The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation

primary_purpose: Other

location_facility: Département d'ORL, Hôpital Edouard Herriot


acronym: CONCORDE

summary: Bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. In addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. Poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. Considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. Adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. This fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. However, this factor seems modifiable by better training of professionals. A team from Newcastle University in England has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. The investigators assume that this training will improve medication adherence among outpatients by trained professionals.

intervention_type: Behavioral


title: Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion

acronym: TsColEPS

summary: TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.


title: National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode

acronym: SECS

summary: This study aims at identifying predictors of suicidal behaviors in depressed subjects. Investigators will first compare demographic, clinical, and biological features of depressed recent suicide attempters (within one week) and depressed subjects without lifetime history of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of attempting suicide during a one year follow-up. A thorough evaluation of these patients will allow to identify the factors associated with suicidal risk and develop a simplified risk score that could be used in clinical settings to improve our practice.

lead_sponsor: University Hospital, Montpellier


title: SArcopenia Prevalence in Frail Older Adults: SAF Study

acronym: SAF

summary:
The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Radiation


acronym: MixMal

summary: Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more different malaria parasites lead to complex and potentially harmfull therapeutic problems. The aim of the study was to look at malaria smears between 2000 and 2008 and determine using PCR the frequency of mixed infections, and their distribution in the terrtory of French Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax. The Maroni river where Duffy negative populations live was largely devoid of vivax infections. These results suggest that mixed infections are frequent in french guiana except on the Maroni river which leads to practical implications for clinicians facing a patient with clinical malaria.

lead_sponsor: Centre Hospitalier de Cayenne


acronym: CAPADO

summary:
French Guiana is the French territory where the prevalence of HIV is highest. in order to determine the knowledge attitudes, beliefs, and practices among the target group of teenagers attending the public school system a survey was conducted in 2011. schools and classrooms were randomly selected, and a structured questionnaire was administered. Descriptive statistics were obtained and multivariate logistic regression was used to determine predictors of main outcomes such as age at first sex.

the results will be used to guide prevention of HIV and sexually transmitted infections though the school system.


title: Cervical Cancer in French Guiana: Screening Between 2006-2011. Description of the Population With Invasive Cervical Cancer Between 2003-2008

acronym: DepCol

summary: Given that cervical cancer is the second most frequent cancer among women in french guiana the aim of the study was to determine the screening rate among women living in French Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years. between 2006 and 2011 54% of women were screened. These baseline figures will allow to evaluate present efforts to increase the screening rate for this frequent cancer in French Guiana.


acronym: CAPMARONI

summary: The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which lies between French Guiana and Surinameaim of the study is to determine the knowledge, attitudes, behaviours, and practices on HIV in the population living along the French bank of the Maroni border. Descriptive statistics are computed from the tabulation of answers to a structured questionnaire. Multivariate logistic models were computed to determine predictors of key outcomes. These data will help taylor prevention intervention in this very particular area.


acronym: CAPProstit

summary: The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A standardized questionnaire was administered face to face to sex workers. Analysis of the questionnaires led to descriptive statistics. Multiple logistic regression models were computed to determine the predictors of condom use.


title: Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

summary:
Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. Surgical treatment is required to prevent infectious or functional complications. A recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. Surgical treatment is the only care option for recurrent cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are seen. Temporal bone CT is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high anatomical resolution and complex anatomy, temporal bone CT is usually displayed with Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .

Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and volume are still unknown and needs further investigations. The aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.

location_facility: Hôpital de La Timone - Assistance Publique Hôpitaux de Marseille


acronym: CATARIDE

summary:
This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia.

The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses.

In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique Adophe de Rothschild


title: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait in Patients With Cerebellar Ataxia Gene

summary:
Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and an ataxic gait. To date, no therapy is available for patients and physical therapy is essential and recommended. The evolution of the pathology causes a degradation of walking, increased instability and risk of falling. In one year, between 74% and 93% of patients reported having fallen at least once. Falls prevention by understanding the mechanisms affecting stability is a major issue in the management of these patients physiotherapy. The analysis of the literature, we assume that there exists a trio "fatigue - instability - energy expenditure" in which the three parameters would influence each other. To date, we do not have data to characterize these interrelationships and their evolution over time.

STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene. The secondary objectives are to study, after one year of development, the relationship between fatigue, instability, energy consumption, the number of falls, the severity of ataxia and quality of life.

CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration of patient recruitment will be 12 months and the total number of patients will be included in 15. The duration of participation in this study is 12 months for each patient. The anticipated duration of the study is 30 months. Development of the study: Patients included will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia according Scale for the assessment and rating of ataxia (SARA); measuring the quality of life through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before and after physical activity; quantified analysis of walking on walking track GAITRite® (with score calculation FAP and GVI) before and after physical activity; physical activity like walking on a treadmill (with measurement of maximal voluntary quadriceps by manual dynamometer before and after physical activity to ensure the induction of fatigue). Patients will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome, Italy) during walking analyzes GAITRite®.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?

acronym: MDSC

summary: Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.

lead_sponsor: University Hospital, Limoges


title: Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +

acronym: Immuno ALCL

summary: To study the correlation between the polymorphism of the main immunity genes and progression-free survival in ALCL of the child.

primary_purpose: Basic Science

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


acronym: COAGHEMO

summary: The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation state (prothrombin time) measured inside the therapeutical zone and thanks to a portable monitor. The values obtained at the point of care will be compared to the standard biological assessment.

lead_sponsor: University Hospital, Brest


title: Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study

acronym: ANIONCO

summary:
l'ANI (Analgesia Nociception Index

The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.

lead_sponsor: Hopital Foch


title: Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

acronym: PEACE

summary: This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation) Evaluation of Individual Genetic Susceptibility in Severe Gastro-enteritis Rotavirus: Role of HBGA Polymorphisms & Biotechnology Improvement of RVA Vaccines

acronym: Gastrovimc

summary: The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

lead_sponsor: Nantes University Hospital

intervention_type: Genetic


title: Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

acronym: ROTEMPredict

summary:
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

lead_sponsor: University Hospital, Caen


title: Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

acronym: CITRANS

summary:
In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.

Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.

location_facility: Centre Hospitalier Universitaire de Besançon


title: Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide

acronym: EMODES

summary:
Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability.

This trial will study two fMRI paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. Four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls.

The main goal will be to correlate fMRI activation during the two paradigms in subjects vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fMRI activations.

lead_sponsor: Rennes University Hospital


summary:
The deaf children showed deficits in speech processing and temporality. They badly apprehend temporal concepts and perceptions of deficit so the acoustic phenomena marking the time course linguistically. Their prediction capabilities and anticipation multisensory events are thereby affected, thus impacting their ability to adapt to multiple and complex interaction possibilities that arise during a conversation.The project aim it is to measure the impact of a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities of older deaf children 5 to 8 years and its impact on their language skills in a conversational task. A matched control group of age will be examined for each of the proposed tasks.

We first measure the capacity to anticipate a situation of language interaction. For this purpose, we will use an alternate naming paradigm with a virtual partner, already developed and tested in children with normal hearing. This paradigm approaches the conversational situation while allowing control of the time parameter of speech (speed of trade) and by controlling the bias (temporal) inherent linguistic programming difficulties of children in a spontaneous conversation situations .

Then we will couple behavioral measurements with measurements of eye movements and the electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task already developed for normal hearing children. This task will allow us firstly to analyze the anticipation level of speaking turns by analyzing eye movements (which "precedes" the speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of anticipatory processes and convergence in conversational interaction will also be studied using cortico-cortical coherence techniques to assess the dynamics of connectivity between remote networks (system here auditory and motor system).

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Epidémie de Chikungunya à l'île de La Réunion : Effet à Dix Ans de l'Infection Sur la qualité de Vie Dans la Cohorte TELECHIK

acronym: QoLCHIK

summary: QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


summary: The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP

acronym: SURV-SEP

summary:
The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: Body Perception and Complex Regional Pain Syndrome : a Case-control Study

acronym: SDRC

summary:
In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.

Does a local body image perturbation can affect the balanced of the global self-awareness?

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Etude de Validation de la Version française d'un Questionnaire " Ask Suicide-Screening Questions " (ASQ) Dans Une Population de Patients Adolescents Pris en Charge en unité d'Urgences pédiatriques

acronym: ASQ-Fr

summary: The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use of this brief valid screening instrument could assess the risk for suicide in pediatric patients and then improve the prevention of suicidal tendencies in this population.

location_facility: Centre Hospitalier Universitaire de La Réunion


title: Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy

acronym: NUTRINECK

summary: Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.

lead_sponsor: Centre Henri Becquerel


title: Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

acronym: NEUTROSTROKE

summary:
Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.

The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.

status: Recruiting

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

status_simplified: Ongoing


acronym: AIRWAY

summary:
Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.

The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.


title: Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination

acronym: Rotavirus

summary:
Epidemiological studies have shown the diversity of resistance genotypes and the evolution of their prevalence in the paediatric population. This large study conducted in a context of very low vaccination coverage will generate more precise data on the natural epidemiological evolution of rotavirus, notably the G9 genotype, which has appeared relatively recently.
This study will allow us to identify and document rare or unusual strains of human or animal origin. The complete genetic characterization of these strains will also make it possible to study their ability to recombine and to assess the risk of emergence. Among these still rare strains, the investigators are particularly monitoring G12 rotavirus, whose ability to recombine raises the risk of emergence.
For at least one of the centres taking part in the study, the paediatric population studied will be given strong vaccination coverage. It will be extremely interesting to compare the results obtained in the vaccinated population with non-vaccinated children to assess the impact of this vaccination on the distribution of rotavirus genotypes

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Understand the Behavior and the Knowledges of Patients Enrolled Into SIOUX Study

acronym: COM-Patient

summary: The purpose of this study is to contribute to the evaluation of SIOUX study by adding data about the choices of the observant patients, the mis-observant ones or the protocol deviations.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Caregivers Confronted With the Withdrawal of Artificial Nutrition at the End of Life: Perception and Experienced Difficulties

acronym: PERCEPAL

summary: Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.


title: The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

acronym: IA-AML

summary: Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.


title: MRI Sequences Optimization in Healthy Subjects

acronym: OSS-IRM

summary:
Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.

Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.

The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.

This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.

In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.


title: Predictive Interest of Serum Phosphorus Level in the Early Diagnosis of Acute Renal Insufficiency in Post-operative Immediate at Patients Having Benefited From a Cardiac Surgery.

acronym: PhosphoIRA

summary: Cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of renal function in this context. Consequently, the purpose of this study is to evaluate the predictibility of Ph to detect both AKI induction and in a second time, renal recovery.

lead_sponsor: University Hospital, Montpellier


title: Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation

acronym: BOTAN

summary: The first aim of the study is to obtain from chirurgical micro biopsy myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.


title: Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis

summary:
Breast cancers are among the cancers that metastasize the most to the skeleton. The appearance of bone metastasis, whether they are initials or during a relapse, is a turning point of the disease, due to the additional morbidity they imply (pain, pathologic fractures, hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the efficacy of this treatment in order to know whether to continue or change it depending on the response observed. But there is no consensus at this time on paraclinical examinations enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is formally validated and evaluation in routine practice remains subjective.

The main objective of our study is to determine if the PET-CT and the whole-body MRI are in agreement on the status of bone metastasis (stability, progression, partial response, complete response).

lead_sponsor: Centre Oscar Lambret


summary: Cell therapy appears to be an alternative to treat bone defects. Scientific advances have shown in animal models and in humans that mesenchymal stem cells were good candidates to support cellular bone regeneration after transplantation. However, their collection requires invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone regeneration has recently been identified in the nasal cavity, these cells are called "ecto-mesenchymal" cells. These stem cells have very similar biological characteristics of mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great potential for differentiation into osteoblast lineage. Given their properties and their ease of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells represent a nasal bone reconstruction interesting alternative in particular in indication of the cleft. They are directly and easily accessible in these children when conventional surgical reconstruction. The investigators propose in this study to validate a production method of stem cell called "ecto-mesenchymal" isolated from a biopsy of the nasal cavity of children with cleft lip and palate to be able to soon propose cell therapy innovative in this indication.


title: Register of Autoimmune Bullous Dermatoses

acronym: REGIBUL

summary:
Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal blisters.

The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological findings, including skin direct immunofluorescence.

Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.

lead_sponsor: CHU de Reims


title: Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction: a Multicentre Prospective Study

acronym: DYSPRED

summary: IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40% and up to 65% of the population concerned. However, the capacity of the various indices to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction have not been clearly defined. Measurement of parameters reflecting filling pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate cardiac function and estimate the filling reserve, but with no strong evidence. Right heart catheterization with determination of cardiac output by pulmonary thermodilution can also be used to measure the various parameters commonly used to predict the response to IV fluid therapy. Very few data are available with no reliable and clinically relevant data in this population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary thermodilution and right heart catheterization. Consequently, the capacity of the various indices of preload dependence to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction remains difficult to define.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease

acronym: ArthralgieMICI

summary: IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.


summary: This project aims to study the effect of haptic sensory information delivered at the hand using a cane in "light touch" or "light support" condition on postural stability and spatial and temporal gait parameters of elderly subjects with and without walking difficulties


title: Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial

acronym: VIDEOCLIP

summary: The aim of this study was to investigate the impact of multimedia information on epidural anesthesia. Pregnant women were randomly assessed to get a video information in addition to an oral and written information on epidural anesthesia. Maternal satisfaction concerning the quality of the information as well their anxiety and understanding of the procedure were assessed and compared in both groups.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial

summary: IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon


title: Neural Bases of Arithmetic Processing: MRIf Study in Adults and Children

summary: The aim of this study was to identify neural correlates involved in arthmetics processing in adults and children aged 8 to 14 with normal cognitive function. Brain area will be identified by functional magnetic resonance imaging (IRMf).

location_facility: Médecine nucléaire, Groupement Hospitalier Est, HCL


summary:
Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies.

Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field.

The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.


summary:
Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother. It is considered the equivalent of hemolytic disease of the newborn. The incidence of this disease is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic diagnosis requires the detection of anti-platelet antibodies with maternal determination of platelet phenotypes and genotypes of the two parents.

The objective of this work is to develop specific molecular tools to fetal platelet genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 , HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these results with those obtained from an invasive sampling of amniotic fluid.

This is a prospective study to assess the technical and diagnostic performance of a new molecular method noninvasive prenatal diagnosis of platelet genotyping.


acronym: EIVA

summary: The aim of the research is to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.

ReferenceCitation: Arraras JI, Greimel E, Sezer O, Chie WC, Bergenmar M, Costantini A, Young T, Vlasic KK, Velikova G. An international validation study of the EORTC QLQ-INFO25 questionnaire: an instrument to assess the information given to cancer patients. Eur J Cancer. 2010 Oct;46(15):2726-38. doi: 10.1016/j.ejca.2010.06.118. Epub 2010 Jul 30.

ReferenceType: result

ReferenceCitation: Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14.

ReferenceCitation: Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hôpital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.

family: Ferrand

full_name: Edouard Ferrand

given: Edouard

journal_name: Archives of Internal Medicine

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Circumstances of Death in Hospitalized Patients and Nurses' Perceptions<subtitle>French Multicenter Mort-a-l’Hôpital Survey</subtitle>

ReferenceCitation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

family: Temel

full_name: Jennifer S. Temel

given: Jennifer S.

family: Greer

full_name: Joseph A. Greer

given: Joseph A.

family: Muzikansky

full_name: Alona Muzikansky

given: Alona

family: Gallagher

full_name: Emily R. Gallagher

given: Emily R.

family: Admane

full_name: Sonal Admane

given: Sonal

family: Jackson

full_name: Vicki A. Jackson

given: Vicki A.

family: Dahlin

full_name: Constance M. Dahlin

given: Constance M.

family: Blinderman

full_name: Craig D. Blinderman

given: Craig D.

family: Jacobsen

full_name: Juliet Jacobsen

given: Juliet

family: Pirl

full_name: William F. Pirl

given: William F.

family: Billings

full_name: J. Andrew Billings

given: J. Andrew

family: Lynch

full_name: Thomas J. Lynch

given: Thomas J.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer

ReferenceCitation: Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.

name: All authors: Massachusetts General Hospital Cancer Center, Boston, MA.

publisher: American Society of Clinical Oncology (ASCO)

title: Effect of Early Palliative Care on Chemotherapy Use and End-of-Life Care in Patients With Metastatic Non–Small-Cell Lung Cancer

ReferenceCitation: Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.

title: Early Palliative Care in Advanced Lung Cancer

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

ReferenceCitation: Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.


title: Impact of a Sexology Consultation on Diabetes Disease Control of Type 2 Male Diabetics With Erectile Dysfunction: a Monocentric Randomised Comparative Study

acronym: RADOTES

summary:
Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients. The important frequency of these disorders and their consequences in term of quality of life have a strong contrast with the actual interest showed for them by the medical community.

Natural evolution of the disease and its management make that these disorders often occur little time after a therapeutic change. As a consequence, patients often accuse their medication to be responsible for the appearance of these disorders. This confusion, associated to false believes that may have the patients on their disease or their treatment, often leads to treatment discontinuation which has a deleterious effect on the disease evolution.

Educational therapy programs showed a positive impact on therapeutic adherence. Increasing patients' knowledge on their disease and treatments increases their therapeutic adherence and makes it easier to balance diabetes and therefore limits complications appearance.

Educational therapy programs concern today the disease, its process, its evolution, its treatments, their efficacy, their adverse effects but erection disorders are not specifically addressed.

This study aims to evaluate the impact of a sexology consultation on diabetes balance measured via HbA1c rate. This consultation aims at precising this particular symptom of erection disorders, without any medicine prescription. The aim is to explain to patients the different links between their symptoms, diabetes, medicines and themselves.


title: Suivi Prospectif Des Complications Infectieuses liées Aux PICC Lines en Milieu Tropical

acronym: Septi-PICC

summary: Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.


acronym: ReedPerinee

summary: The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)

lead_sponsor: Hopital Foch


title: Systematic Descriptive Experimental Ultrasound Study of Entheses and Small Joints of Hands and Feet in Patients Presenting an Atypical Form of Psoriasis

acronym: ECHOPSO

summary: Systematic study of the ultrasound infringements of tendons chest expanders of entheses the most involved in spondylarthropathies and small joints of hands and feet in expanding patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic rheumatism .

lead_sponsor: University Hospital, Brest


title: Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults

acronym: BELINDA

summary:
BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.

BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.

lead_sponsor: University Hospital, Lille


title: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003

summary:
In the perspective to better evaluate the efficacy of new treatment strategies for Alzheimer disease (AD), it appears important to develop experimental paradigms to precisely measure cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate drug efficacy profile.

The use of Electroencephalography (EEG) may be, therefore, a good candidate. The purpose of the present study is to use EEG to more precisely explore cognitive processes in healthy subjects, with a particular interest in episodic and working memory functions that are usually altered in both AD and Mild Cognitive Impairment (MCI) as well as to better understand underlying neural mechanisms involved in these processes.


type: Registry Identifier

title: Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease

summary:
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.

The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.

These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.

The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.

The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.


title: Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department

acronym: PCT-MI

summary:
Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1 for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells. Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other cytokines.

PCT is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker.

There are few data on the diagnostic use of PCT in an internal medicine department. The available studies yielded contradictory results and only one prospective study has been performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to establish whether PCT could distinguish infections from other inflammatory pathologies in patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been performed but featured small sample sizes and a retrospective design.

Of the various studies performed in internal medicine departments, none included patients presenting with a suspected bacterial infection (according to the clinician's interpretation) and lacking information on their bacterial status. In fact, these diagnoses are a core component of hospitalisation in internal medicine departments for fever or inflammatory syndrome. The investigators intend to include all patients, including those lacking information on their microbiological status).


summary:
Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy.

Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


acronym: SLICES

summary:
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.

It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.

The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.

location_facility: Fondation Opthalmologique A de Rothschild


title: Asymptomatic Obstructive Coronary Artery Disease (CAD) in Suppressed HIV-infected Patients ≥ 45 Years and 2 or More CV Risk Factors. Associations With Persistent Immune Activation and Microbial Translocation

summary: HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

ipd_sharing_description: NC


title: Study of the Role of Occupational Exposure to Pesticides in the Prognosis of Lymphomas Diffuse Large B Cell in

acronym: ProLyPhy

summary: The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Different biological models were used to understand the role of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and molecular level, on different signaling pathways. After metabolized by cytochrome P450, these compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR) causes the activation of signaling pathways involved in cell proliferation and survival. But deregulation of oxidative status does not in itself justify the specificity of the impact of pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the activation of signaling pathways by binding to transcription factors and others have immunomodulating properties.


title: Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis

summary: Identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.


title: Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe

acronym: CreoQol

summary:
The evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. The scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use.

Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions questionnaire ( EQ-5D) were widely validated in various populations, of which the population of the diabetics patients. Both scales have validated versions in French.

In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. One of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations.

Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and Reunion Island, adapting and validating these scales according to an identical procedure in Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French versions of these scales in their populations of type II diabetics patients.


title: Comparison of Atherothrombosis Markers From Aortic Atheroma in Diabetic and Non-diabetic Patients

acronym: MADI

summary: Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs) represent about 70% of leukocytes and may constitute a source of proteases and oxidants that favour plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque of non-diabetic versus type 2 diabetic patients. For this purpose, investigators will quantify the presence of cell-free DNA, that reflect the formation of neutrophil extracellular traps (NETs) in carotid endarterectomy samples.

location_facility: Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site


title: Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients

acronym: CritiDop

summary: The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Temozolomide Plus Bevacizumab Chemotherapy in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status (KPS<70)

acronym: ATAG

summary: The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.

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ReferenceCitation: Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Meneï P, Loiseau H, Bernier V, Honnorat J, Barrié M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35.

ReferenceCitation: Malmström A, Grønberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R; Nordic Clinical Brain Tumour Study Group (NCBTSG). Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012 Sep;13(9):916-26. Epub 2012 Aug 8.

ReferenceCitation: Wick W, Platten M, Meisner C, Felsberg J, Tabatabai G, Simon M, Nikkhah G, Papsdorf K, Steinbach JP, Sabel M, Combs SE, Vesper J, Braun C, Meixensberger J, Ketter R, Mayer-Steinacker R, Reifenberger G, Weller M; NOA-08 Study Group of Neuro-oncology Working Group (NOA) of German Cancer Society. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. Lancet Oncol. 2012 Jul;13(7):707-15. doi: 10.1016/S1470-2045(12)70164-X. Epub 2012 May 10.

ReferenceCitation: Gállego Pérez-Larraya J, Ducray F, Chinot O, Catry-Thomas I, Taillandier L, Guillamo JS, Campello C, Monjour A, Cartalat-Carel S, Barrie M, Huchet A, Beauchesne P, Matta M, Mokhtari K, Tanguy ML, Honnorat J, Delattre JY. Temozolomide in elderly patients with newly diagnosed glioblastoma and poor performance status: an ANOCEF phase II trial. J Clin Oncol. 2011 Aug 1;29(22):3050-5. doi: 10.1200/JCO.2011.34.8086. Epub 2011 Jun 27.

ReferenceCitation: Taal W, Oosterkamp HM, Walenkamp AM, Dubbink HJ, Beerepoot LV, Hanse MC, Buter J, Honkoop AH, Boerman D, de Vos FY, Dinjens WN, Enting RH, Taphoorn MJ, van den Berkmortel FW, Jansen RL, Brandsma D, Bromberg JE, van Heuvel I, Vernhout RM, van der Holt B, van den Bent MJ. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomised controlled phase 2 trial. Lancet Oncol. 2014 Aug;15(9):943-53. doi: 10.1016/S1470-2045(14)70314-6. Epub 2014 Jul 15.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96.

ReferenceCitation: Lou E, Peters KB, Sumrall AL, Desjardins A, Reardon DA, Lipp ES, Herndon JE 2nd, Coan A, Bailey L, Turner S, Friedman HS, Vredenburgh JJ. Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma. Cancer Med. 2013 Apr;2(2):185-95. doi: 10.1002/cam4.58. Epub 2013 Jan 24.

ReferenceCitation: Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WK, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733-40. doi: 10.1200/JCO.2008.19.8721. Epub 2009 Aug 31.

ReferenceCitation: Scott JG, Bauchet L, Fraum TJ, Nayak L, Cooper AR, Chao ST, Suh JH, Vogelbaum MA, Peereboom DM, Zouaoui S, Mathieu-Daudé H, Fabbro-Peray P, Rigau V, Taillandier L, Abrey LE, DeAngelis LM, Shih JH, Iwamoto FM. Recursive partitioning analysis of prognostic factors for glioblastoma patients aged 70 years or older. Cancer. 2012 Nov 15;118(22):5595-600. doi: 10.1002/cncr.27570. Epub 2012 Apr 19.

ReferenceCitation: Rosati G, Avallone A, Aprile G, Butera A, Reggiardo G, Bilancia D. XELOX and bevacizumab followed by single-agent bevacizumab as maintenance therapy as first-line treatment in elderly patients with advanced colorectal cancer: the boxe study. Cancer Chemother Pharmacol. 2013 Jan;71(1):257-64. doi: 10.1007/s00280-012-2004-x. Epub 2012 Oct 26.

ReferenceCitation: Cunningham D, Lang I, Marcuello E, Lorusso V, Ocvirk J, Shin DB, Jonker D, Osborne S, Andre N, Waterkamp D, Saunders MP; AVEX study investigators. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1077-1085. doi: 10.1016/S1470-2045(13)70154-2. Epub 2013 Sep 10.

ReferenceCitation: Biganzoli L, Di Vincenzo E, Jiang Z, Lichinitser M, Shen Z, Delva R, Bogdanova N, Vivanco GL, Chen Z, Cheng Y, Just M, Espié M, Vinholes J, Hamm C, Crivellari D, Chmielowska E, Semiglazov V, Dalenc F, Smith I. First-line bevacizumab-containing therapy for breast cancer: results in patients aged≥70 years treated in the ATHENA study. Ann Oncol. 2012 Jan;23(1):111-118. doi: 10.1093/annonc/mdr043. Epub 2011 Mar 28.

ReferenceCitation: Laskin J, Crinò L, Felip E, Franke F, Gorbunova V, Groen H, Jiang GL, Reck M, Schneider CP. Safety and efficacy of first-line bevacizumab plus chemotherapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer: safety of avastin in lung trial (MO19390). J Thorac Oncol. 2012 Jan;7(1):203-11. doi: 10.1097/JTO.0b013e3182370e02.

ReferenceCitation: Chauffert B, Feuvret L, Bonnetain F, Taillandier L, Frappaz D, Taillia H, Schott R, Honnorat J, Fabbro M, Tennevet I, Ghiringhelli F, Guillamo JS, Durando X, Castera D, Frenay M, Campello C, Dalban C, Skrzypski J, Chinot O. Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared with temozolomide-chemoradiation for unresectable glioblastoma: final results of the TEMAVIR study from ANOCEF†. Ann Oncol. 2014 Jul;25(7):1442-1447. doi: 10.1093/annonc/mdu148. Epub 2014 Apr 9.

family: Chauffert

full_name: B. Chauffert

given: B.

family: Feuvret

full_name: L. Feuvret

given: L.

family: Bonnetain

full_name: F. Bonnetain

given: F.

family: Taillandier

full_name: L. Taillandier

family: Frappaz

full_name: D. Frappaz

given: D.

family: Taillia

full_name: H. Taillia

given: H.

family: Schott

full_name: R. Schott

given: R.

family: Honnorat

full_name: J. Honnorat

given: J.

family: Fabbro

full_name: M. Fabbro

given: M.

family: Tennevet

full_name: I. Tennevet

given: I.

family: Ghiringhelli

full_name: F. Ghiringhelli

family: Guillamo

full_name: J.S. Guillamo

family: Durando

full_name: X. Durando

given: X.

family: Castera

full_name: D. Castera

family: Frenay

full_name: M. Frenay

family: Campello

full_name: C. Campello

given: C.

family: Dalban

full_name: C. Dalban

family: Skrzypski

full_name: J. Skrzypski

family: Chinot

full_name: O. Chinot

given: O.

ReferenceCitation: Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

title: Bevacizumab plus Radiotherapy–Temozolomide for Newly Diagnosed Glioblastoma

ReferenceCitation: Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

title: A Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma

ReferenceCitation: Fardet L, Fève B. Systemic glucocorticoid therapy: a review of its metabolic and cardiovascular adverse events. Drugs. 2014 Oct;74(15):1731-45. doi: 10.1007/s40265-014-0282-9. Review.

ReferenceCitation: Reyes-Botero G, Cartalat-Carel S, Chinot OL, Barrie M, Taillandier L, Beauchesne P, Catry-Thomas I, Barrière J, Guillamo JS, Fabbro M, Frappaz D, Benouaich-Amiel A, Le Rhun E, Campello C, Tennevet I, Ghiringhelli F, Tanguy ML, Mokhtari K, Honnorat J, Delattre JY. Temozolomide Plus Bevacizumab in Elderly Patients with Newly Diagnosed Glioblastoma and Poor Performance Status: An ANOCEF Phase II Trial (ATAG). Oncologist. 2018 May;23(5):524-e44. doi: 10.1634/theoncologist.2017-0689. Epub 2018 Feb 22.

name: Service de Neurologie 2 Mazarin, Groupe Hospitalier Pitié‐SalpêtrièreParisFrance

name: Department of Neuro‐Oncology, Hospices Civils de Lyon, Hôpital NeurologiqueLyonFrance

name: CNRS UMR 5310‐INSERM U1217 Institut Neuromyogene, Université Claude Bernard Lyon 1LyonFrance

name: Aix‐Marseille Université AP‐HMCHU Timone Service de Neuro‐OncologieMarseilleFrance

name: Institut Regional de Cancer MontpellierMontpellier France

name: Georges François Leclerc Cancer CenterDijon France

name: Université Paris VI Pierre et Marie CurieParis France


acronym: PROVIN

summary:
Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds.

Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects.

Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far.

The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated.

This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis

acronym: WheezSmart

summary: Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Nowadays, no available treatment shortens the course of bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value. The investigators developed a wheezing recognition algorithm from recorded respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of the present cross sectional, observational study are 1/ to further validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent analysis by two experienced pediatricians.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Robert Debré; service de Physiologie


acronym: CalciMo-TP

summary: The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.

status: Not yet recruiting

location_facility: Assistance Publique Hopitaux de Marseille


title: Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Medical Care

acronym: MUCODOULEUR

summary: The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.