title: Study Aiming to Collect Skin Samples of Diabetic Patients and Healthy Volunteers for Cellular Reprogramming, Within the Framework of New Therapeutic Strategies in Diabetes Treatment

summary: The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.

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


title: Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm)

acronym: ETOSA

summary: The couple of friction metal-polyethylene is regarded as the couple of reference in spite of the osteolysis induced by the wear of the polyethylene which remains the independent factor of long-term failure. This is all the more true as the patients are young, thus justifying the recourse to alternate couples of friction. The Metasul® couple was introduced on the French market under its current form in 1995 (year of its marking EC). The use of a couple of friction metal-metal (MM) is justified because it would be likely to improve longevity of the total arthroplasties of the active subjects by the reduction in osteolysis related to the wear of polyethylene. Various studies highlight evolutions different according to the types of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups "of cemented Weber type".

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


intervention_type: Genetic

acronym: Gene therapy for WAS

lead_sponsor: Genethon

summary: This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.

ReferenceType: derived

ReferenceCitation: Magnani A, Semeraro M, Adam F, Booth C, Dupre L, Morris EC, Gabrion A, Roudaut C, Borgel D, Toubert A, Clave E, Abdo C, Gorochov G, Petermann R, Guiot M, Miyara M, Moshous D, Magrin E, Denis A, Suarez F, Lagresle C, Roche AM, Everett J, Trinquand A, Guisset M, Bayford JX, Hacein-Bey-Abina S, Kauskot A, Elfeky R, Rivat C, Abbas S, Gaspar HB, Macintyre E, Picard C, Bushman FD, Galy A, Fischer A, Six E, Thrasher AJ, Cavazzana M. Long-term safety and efficacy of lentiviral hematopoietic stem/progenitor cell gene therapy for Wiskott-Aldrich syndrome. Nat Med. 2022 Jan;28(1):71-80. doi: 10.1038/s41591-021-01641-x. Epub 2022 Jan 24. Erratum In: Nat Med. 2022 Oct;28(10):2217.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

license_normalized: no license

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

sponsor_collaborators:
Genethon
Hôpital Necker-Enfants Malades

title: Phase I/II Clinical Trial of Haematopoietic Stem Cell Gene Therapy for the Wiskott-Aldrich Syndrome

type: EudraCT Number

source: euctr

lead_sponsor_type: industriel


title: Neuromodulation in Post Stroke Dysphagia

summary: The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


title: Phase I Clinical Study of AAV1-gamma-sarcoglycan Gene Therapy for Limb Girdle Muscular Dystrophy Type 2C

summary: The purpose of this trial is to study the evaluation of clinical safety and feasibility of gene therapy in patients with limb girdle muscular dystrophy type 2C (gamma-sarcoglycanopathy).

intervention_type: Biological


summary: The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.

enrollment_type: Anticipated

lead_sponsor: Laboratoires Thea

intervention_type: Drug


title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy

acronym: APCORD

summary: This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

ReferenceCitation: Peffault de Latour R, Chevret S, Jubert C, Sirvent A, Galambrun C, Ruggeri A, Gandemer V, Cornillon J, Rialland F, Dalle JH, Forcade E, Bruno B, Paillard C, Rorlich PS, Salmon A, Furst S, Sicre de Fontbrune F, Rubio MT, Bay JO, Mohty M, Larghero J, Gluckman E, Socie G; Francophone Society of Bone Marrow Transplantation and Cellular Therapy. Unrelated cord blood transplantation in patients with idiopathic refractory severe aplastic anemia: a nationwide phase 2 study. Blood. 2018 Aug 16;132(7):750-754. doi: 10.1182/blood-2018-01-829630. Epub 2018 May 14.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Glycemic and Insulinemic Index Determination of 2 Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix

acronym: IGNUT

summary: The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Basic Science

lead_sponsor: CRITT Bio-Industries

collaborators: BioFortis NUTRITIS

sponsor_collaborators:
CRITT Bio-Industries
BioFortis
NUTRITIS

intervention_type: Other

status_simplified: Unknown


summary: The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)

acronym: INAPEN

summary:
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .

Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care

ReferenceType: background

ReferenceCitation: Rapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr

ReferenceCitation: Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.

ReferenceCitation: Circulaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002

ReferenceCitation: Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9. doi: 10.1177/014860710302700101.

ReferenceCitation: Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5. doi: 10.1054/clnu.1999.0121.

ReferenceCitation: Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.

lead_sponsor: Centre Hospitalier de Meaux

intervention_type: Dietary Supplement


title: Randomized Phase II Trial Seeking the Most Promising Drug Association With Azacitidine- in Higher Risk Myelodysplastic Syndromes

acronym: AZA-PLUS

summary:
In order to improve the overall survival benefit observed with AZA in higher risk MDS, its combination with other active drugs in MDS must be tested.

Among drugs that have demonstrated to be active as a single agent in MDS and have preclinical potential additive or synergistic activity with AZA are Histone deacetylase (HDAC) inhibitors including Valproic acid, Lenalidomide and idarubicin. Phase I studies have already been conducted or are being conducted combining those agents to demethylating agents, showing a low toxicity profile and significant responses in high risk MDS. In this phase II randomized trial, we want to identify the most promising combination of Azacitidine and another drug (among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk MDS, by comparison to Azacitidine alone. Of note, based on efficacy and toxicity, one or several combinations may be stopped, and others, previously tested in phase I trials, included after protocol amendment.

study_start_date_type: Actual

ReferenceCitation: Jacob L, Uvarova M, Boulet S, Begaj I, Chevret S. Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials - an example in hemato-oncology. BMC Med Res Methodol. 2016 Jun 2;16:67. doi: 10.1186/s12874-016-0166-7.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold


title: Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease

acronym: MIREILLE

summary: The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee venom on motor symptoms of Parkinson's disease over a period of one year, also the potential effects of this treatment on disease progression compared to placebo (saline injections).

ReferenceCitation: Hartmann A, Mullner J, Meier N, Hesekamp H, van Meerbeeck P, Habert MO, Kas A, Tanguy ML, Mazmanian M, Oya H, Abuaf N, Gaouar H, Salhi S, Charbonnier-Beaupel F, Fievet MH, Galanaud D, Arguillere S, Roze E, Degos B, Grabli D, Lacomblez L, Hubsch C, Vidailhet M, Bonnet AM, Corvol JC, Schupbach M. Bee Venom for the Treatment of Parkinson Disease - A Randomized Controlled Clinical Trial. PLoS One. 2016 Jul 12;11(7):e0158235. doi: 10.1371/journal.pone.0158235. eCollection 2016. Erratum In: PLoS One. 2016;11(9):e0162937.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: Public Library of Science

ReferenceCitation: Maurice N, Deltheil T, Melon C, Degos B, Mourre C, Amalric M, Kerkerian-Le Goff L. Bee Venom Alleviates Motor Deficits and Modulates the Transfer of Cortical Information through the Basal Ganglia in Rat Models of Parkinson's Disease. PLoS One. 2015 Nov 16;10(11):e0142838. doi: 10.1371/journal.pone.0142838. eCollection 2015.

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

repository_normalized: HAL

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

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

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org


type: Other Identifier

title: Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation

summary:
The objective of this study is to estimate red blood cells (RBC) transfusion related to central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is performed in visceral, vascular and thoracic surgery units in the university hospital of Lille.

One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old, patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical care medicine recommendations.

After randomisation, patients will be eligible to receive RBC according to their level of Hb in the standard group and according to the Hb and ScvO2 in the optimization group. Patients without any disease are transfused if their Hb level is below 7g/dL; patients older than 60 years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion is performed if and only if the ScvO2 level is les than 70% when Hb is under the same threshold levels.

The primary aim of the study is to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative. Considering the randomisation and considering the 50 % reduction of the decisions of transfusion in the group optimization, the absolute blood savings is estimated 25 % for the whole population. Secondary end points include the number of side effects associated with transfusion or when avoiding transfusion, length of hospital stay, and hospital mortality as well as major adverse events.

lead_sponsor: University Hospital, Lille


title: A Multicenter Study Comparing the Results of Allogeneic Stem Cell Genoidentical in Children With Sickle Cell Anemia and Cerebral Vascular Disease Detected by Transcranial Doppler

acronym: DREPAGREFFE

summary: The aim of this study is to demonstrate that cerebral velocities assessed by transcranial doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program A multicenter, national, non-randomized, prospective study of paired cohort will be conducted, with 2 groups of exposed (SCT) and non-exposed (TP) patients.

ReferenceCitation: Bernaudin F, Verlhac S, Peffault de Latour R, Dalle JH, Brousse V, Petras E, Thuret I, Paillard C, Neven B, Galambrun C, Divialle-Doumdo L, Pondarre C, Guitton C, Missud F, Runel C, Jubert C, Elana G, Ducros-Miralles E, Drain E, Taieb O, Arnaud C, Kamdem A, Malric A, Elmaleh-Berges M, Vasile M, Leveille E, Socie G, Chevret S; DREPAGREFFE Trial Investigators. Association of Matched Sibling Donor Hematopoietic Stem Cell Transplantation With Transcranial Doppler Velocities in Children With Sickle Cell Anemia. JAMA. 2019 Jan 22;321(3):266-276. doi: 10.1001/jama.2018.20059.

oa_colors: green other

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarre C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Freard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socie G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15.

oa_host_type: closed

publisher_dissemination: Elsevier


title: Evaluation of the Prognostic Value of Monocytes and Lymphocyte Phenotyping, Along With Intracellular MCP-1 Expression, to Predict Preterm Delivery for Women Hospitalized for Threat of Preterm Labor Between 24 and 34 Weeks of Amenorrhea: PhenoMAP Study

acronym: PHENOMAP

summary:
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic fluid during labour and by the increase in the expression of its RNA messengers in the peripheral maternal blood. We have also shown that the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery compared with those with caesarean delivery prior the onset of labour.

OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery occurring within 7 days post admission. Secondary: to (1) compare the predictive values of these new markers with those currently used, e.g. quantification of fœtal fibronectin and assessment of cervical length and effacement, (2) Compare the respective proportions of monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine if a correlation exists between the activation markers expressed by maternal monocyte and lymphocyte subpopulations and the neonatal outcomes of preterm infants.

MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of amenorrhea and complicated PTL, will be prospectively included in the maternity wards of Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not deliver within the first 7 days; finally, another blood sample will be drawn upon discharge. After delivery, foetal membranes will be collected to characterize and compare the various monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the study of the level of activation of blood and foetal membrane cells will be performed using flow cytometry technique with suitable markers. The main judgment criteria will be the percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations ("inflammatory", "residents or patrollers" and "intermediates", according to CD14, CD16, CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed using the Mann and Witney test or ANOVA, after verification of the conditions of application. The comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a stepwise descending analysis.

TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte subpopulations in the maternal blood and in the foetal membranes might constitute an " immunological signature " of the labour and therefore validate the relevance of a predictive marker for clinicians.

EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte subpopulations in the maternal blood will allow to better characterise the immunological mechanisms occurring at the start of premature labour and to identity predictive markers of the preterm delivery, to validate prospectively in order to optimize the management of PTL

primary_purpose: Diagnostic

location_facility: Centre d'investigation clinique plurithématique


title: Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers

summary: The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.

lead_sponsor: Drugs for Neglected Diseases

sponsor_collaborators:
Drugs for Neglected Diseases
Sanofi


title: Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study

acronym: DEMENSTIM

summary:
Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.

The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.

ReferenceCitation: Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health


title: Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases

acronym: Emotion

summary:
Empathy, defined as the ability to understand others emotions, is a fundamental concept in social interactions. It is a psychological phenomenon involving various separable components : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the perspective of other people. Several neurological diseases with behavioral disorders may lead to impaired processing of social and/or emotional informations. These pathologies are likely to induce a lack of empathy that may result from impairments at different levels.

The objective is simply to study how others' emotions are understood and how this allows for regulation of personal behavior. This study is being carried out among patients seen for various health problems and who can make behavior changes. This study could help to understand some neurological diseases and thereby to identify them earlier and/or to better differentiate them.

ReferenceType: result

ReferenceCitation: Narme P, Mouras H, Roussel M, Devendeville A, Godefroy O. Assessment of socioemotional processes facilitates the distinction between frontotemporal lobar degeneration and Alzheimer's disease. J Clin Exp Neuropsychol. 2013;35(7):728-44. doi: 10.1080/13803395.2013.823911. Epub 2013 Aug 12.

publisher_dissemination: Informa

ReferenceCitation: Narme P, Mouras H, Roussel M, Duru C, Krystkowiak P, Godefroy O. Emotional and cognitive social processes are impaired in Parkinson's disease and are related to behavioral disorders. Neuropsychology. 2013 Mar;27(2):182-92. doi: 10.1037/a0031522.

publisher_dissemination: American Psychological Association (APA)

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Behavioral


title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.

summary:
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®

lead_sponsor: Erempharma

collaborators: Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME)

location_facility: Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose


title: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

acronym: MODEL MAKER

summary: Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.

time_perspective: Prospective

lead_sponsor: Rennes University Hospital


title: Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin

acronym: BocepreVIH

summary:
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.

The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.

ReferenceCitation: Poizot-Martin I, Bellissant E, Garraffo R, Colson P, Piroth L, Solas C, Renault A, Bourliere M, Halfon P, Ghosn J, Alric L, Naqvi A, Carrieri P, Molina JM; ANRS HC27 BOCEPREVIH Study Group. Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study. HIV Clin Trials. 2016 Mar;17(2):63-71. doi: 10.1080/15284336.2015.1135553. Epub 2016 Feb 11.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repositories_concat: HAL

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Rennes University Hospital
Merck Sharp & Dohme LLC


title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma

summary: Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

lead_sponsor: Institut Curie


title: A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma

summary: The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; GRECCAR Study Group*. Tailored Strategy for Locally Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results From a Multicenter, Randomized, Open-Label, Phase II Trial. Dis Colon Rectum. 2022 Aug 1;65(8):986-995. doi: 10.1097/DCR.0000000000002153. Epub 2022 Jul 5.

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Etude Des Troubles de l'Inhibition Cognitive Chez le Sujet âgé déprimé Suicidant

acronym: ETIC

summary: The purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

time_perspective: Cross-Sectional

ReferenceCitation: Richard-Devantoy S, Annweiler C, Le Gall D, Garre JB, Olie JP, Beauchet O. Cognitive inhibition in suicidal depressed elderly: a case-control pilot study. J Clin Psychiatry. 2011 Jun;72(6):871-2. doi: 10.4088/JCP.10l06797. No abstract available.

lead_sponsor: University Hospital, Angers


title: Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)

summary: This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.

lead_sponsor: Hoffmann-La Roche


title: Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft

acronym: TRACHBRONCAR

summary:
First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day morbidity and mortality rates of bronchial transplantation using cryopreserved aortic allograft in proximal lung cancer surgery. The investigators hypothesize that this stage 1-2 surgical innovation could be safe and effective in order to reduce the 90-day morbidity and mortality rates compared to those observed with pneumonectomy, especially when some factors are present: age > 70 years, right side, neoadjuvant chemoradiotherapy.
Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant or benign) lesions of the trachea requiring airway transplantation.

For these patients, resection followed by direct end to end anastomosis is not possible or at high risk.

primary_purpose: Other

ReferenceCitation: Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Venissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653.

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis


title: Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass

acronym: MICROCARD

summary: The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric microcirculatory function, using sublingual evaluation, in cardiac surgery.


title: Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

acronym: MEEKADEAU

summary: The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

summary:
Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV measurement has not been yet validated in thoracic surgery during one-lung ventilation. The modifications of intrathoracic pressure induced by one-lung ventilation may altered the capabilities of PPV to predict fluid responsiveness.This study was designed to assess the ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.

Methods: a prospective observational study. Thirty five patients undergoing a pulmonary resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid challenges with a 250 milliliters colloid solution in response to hemodynamic instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will be calculated from recorded artery pressure curve (PPVref) before and after each fluid challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will be recorded simultaneously before and after each fluid challenge.

Statistical analysis: receiver operating characteristic curve will be used to assess the PPV capability to predict fluid responsiveness. Correlation analysis will be achieved using a Pearson test or Spearman's rho test when necessary. Continuous data will compared using a Student t test or a Mann-Whitney test when necessary.

ipd_sharing: Undecided

location_facility: Thoracic surgery department, University Hospital of Lille


title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

summary: This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

lead_sponsor: Novo Nordisk A/S


title: Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

summary: The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.

ReferenceCitation: Lauque D, Maupas-Schwalm F, Bounes V, Juchet H, Bongard V, Roshdy A, Botella JM, Charpentier S. Predictive value of the heart-type fatty acid-binding protein and the Pulmonary Embolism Severity Index in patients with acute pulmonary embolism in the emergency department. Acad Emerg Med. 2014 Oct;21(10):1143-50. doi: 10.1111/acem.12484.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Toulouse


title: Injection of CD4 and CD8 + T Cells Anti-CMV or Anti-adenovirus for the Treatment of Viral Infections Occurring After Allogenic Hematopoietic Stem Cell Transplantation (HSCT)

acronym: CTLantiCMV

summary: The main purpose of this project is to evaluate the efficiency of the injection of CD4 and CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the first injection (adenovirus infection is not enough usual, especially in adults, to be used for the primary purpose and is measured in the secondary endpoints).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Biotherapy department, Hôpital Necker - Enfants Malades


title: Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)

summary:
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.

OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.

A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe


title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position

summary: The main objective of this study is to investigate the influence of seat type (straight chair versus "ergonomic" chair) on the sagittal alignment of the lumbo-pelvic complex in two different postures compared to standing for each individual in both a chronic-back-pain and a non-chronic-back-pain population.

ReferenceCitation: Vaucher M, Isner-Horobeti ME, Demattei C, Alonso S, Herisson C, Kouyoumdjian P, van Dieen JH, Dupeyron A. Effect of a kneeling chair on lumbar curvature in patients with low back pain and healthy controls: A pilot study. Ann Phys Rehabil Med. 2015 Jun;58(3):151-6. doi: 10.1016/j.rehab.2015.01.003. Epub 2015 May 5.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Elsevier - VU Research Portal

repository_institution: Vrije Universiteit Amsterdam - VU Research Portal

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

summary: The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.

primary_purpose: Prevention

ReferenceCitation: L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase

acronym: SAPA

summary:
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.

Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.

ReferenceCitation: Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.

lead_sponsor: University Hospital, Limoges


title: Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

summary: Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.

status: Withdrawn


title: Register and DNA Bank of Adult Extra-hospital Sudden Death

summary:
The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.

status: Terminated

lead_sponsor: Nantes University Hospital


title: Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients

acronym: PREST

summary: The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.


title: Comparison of the Hemoglobin Results Obtained With the "Orsense NBM-200MP" Device and the Clinical Laboratory

summary: The purpose of this study is to compare the hemoglobin results obtained with the "Orsense NBM-200MP" device and the Clinical Laboratory.

ReferenceCitation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.

lead_sponsor: Hopital Foch


title: Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study

summary: The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.


title: Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit

acronym: SAS-AVC

summary: The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

location_facility: PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK


title: Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years

acronym: HYPOPANX

summary: This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.

ReferenceCitation: Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/jocn.13848. Epub 2017 Jul 4.


title: Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

summary: The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

summary:
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.

The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.


title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)

acronym: FLORALI

summary:
The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

conventional oxygen therapy (O2 conventional)
high flow nasal oxygen therapy (O2-HFN)
association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Poitiers University Hospital


title: Calibration and Validation of MOTIONPOD(TM) for Physical Activity Evaluation in Free-living Adults

acronym: MOTIONPOD(TM)

summary:
In this study we propose 1) to develop a new multisensor monitoring system associating a tri-axial accelerometer and a magnetometer to measure physical activity in free-living adults, 2) to perform its calibration and assess its validity in a series of activity tasks in comparison with the measure of energy expenditure by indirect calorimetry as the criterion measure, and with existing physical activity monitors (cardiofrequencemetry and accelerometers used either alone or in combination). Briefly the subjects will perform a series of standardized activity tasks of different intensities and a 30-min free physical activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors. Physical activity energy expenditure will be measured using a metabolic gas analyser.

Data of the 30 first subjects will be used to develop new algorithms to identify the different activity tasks and to estimate the related energy expenditures. Data of the following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry and existing physical activity monitors

ReferenceCitation: Bastian T, Maire A, Dugas J, Ataya A, Villars C, Gris F, Perrin E, Caritu Y, Doron M, Blanc S, Jallon P, Simon C. Automatic identification of physical activity types and sedentary behaviors from triaxial accelerometer: laboratory-based calibrations are not enough. J Appl Physiol (1985). 2015 Mar 15;118(6):716-22. doi: 10.1152/japplphysiol.01189.2013. Epub 2015 Jan 15.

publisher_dissemination: American Physiological Society

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)


title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

acronym: CONFUCIUS

summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.

ReferenceCitation: Mouchoux C, Rippert P, Duclos A, Fassier T, Bonnefoy M, Comte B, Heitz D, Colin C, Krolak-Salmon P. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol. BMC Geriatr. 2011 May 18;11:25. doi: 10.1186/1471-2318-11-25.

location_facility: Hospices Civils de Lyon-Hôpital des Charpennes


title: Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique

acronym: EVATEM

summary: The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

ReferenceCitation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.

ReferenceCitation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Rouch I, Beauchet O, Krolak-Salmon P, Fantino B. Early detection of memory impairment in people over 65 years old consulting at Health Examination Centers for the French health insurance: the EVATEM protocol. BMC Geriatr. 2013 Jun 6;13:55. doi: 10.1186/1471-2318-13-55.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

publisher_dissemination: Springer


title: Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs

acronym: GAIT

summary: The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

ReferenceCitation: Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)


title: Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers

acronym: MERE

summary: The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.

ReferenceCitation: Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.

ReferenceCitation: Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.


title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial

acronym: COMEDRA

summary: The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).

ReferenceCitation: Gossec L, Soubrier M, Foissac F, Molto A, Richette P, Beauvais C, Ruyssen-Witrand A, Perdriger A, Chary-Valckenaere I, Mouterde G, Dernis E, Euller-Ziegler L, Flipo RM, Gilson M, Guis S, Mariette X, Pouplin S, Marhadour T, Schaeverbeke T, Sordet C, Fayet F, Dougados M. Screening for and management of comorbidities after a nurse-led program: results of a 3-year longitudinal study in 769 established rheumatoid arthritis patients. RMD Open. 2019 Jun 14;5(2):e000914. doi: 10.1136/rmdopen-2019-000914. eCollection 2019.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: univOAK

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

publisher_dissemination: British Medical Journal

ReferenceCitation: Tournadre A, Pereira B, Gossec L, Soubrier M, Dougados M. Impact of comorbidities on fatigue in rheumatoid arthritis patients: Results from a nurse-led program for comorbidities management (COMEDRA). Joint Bone Spine. 2019 Jan;86(1):55-60. doi: 10.1016/j.jbspin.2018.06.010. Epub 2018 Jul 17.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

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

ReferenceCitation: Ferreira RJO, Dougados M, Kirwan JR, Duarte C, de Wit M, Soubrier M, Fautrel B, Kvien TK, da Silva JAP, Gossec L; CoimbRA investigators, RAID investigators and COMEDRA investigators. Drivers of patient global assessment in patients with rheumatoid arthritis who are close to remission: an analysis of 1588 patients. Rheumatology (Oxford). 2017 Sep 1;56(9):1573-1578. doi: 10.1093/rheumatology/kex211.

repository_institution: University of Bristol - Bristol Research

publisher_dissemination: Oxford University Press

ReferenceCitation: Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.

evidence: open (via page says license)

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
French Society of Rheumatology
Roche Chugai


title: Plasma Abeta Peptides and the Risk of Alzheimer's Disease. Diagnostic Performance and Predictive and Prognostic Values of Measurements of Plasma Amyloid Peptides Concentrations for the Diagnosis of Alzheimer's Disease

acronym: BALTAZAR

summary:
The aim of this study is to examine the relationship between plasma putative biomarkers for Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound, truncated, sAPPα) and :

the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into Alzheimer's disease (AD),
the Alzheimer's disease progression rate.

ReferenceCitation: Duron E, Vidal JS, Grousselle D, Gabelle A, Lehmann S, Pasquier F, Bombois S, Buee L, Allinquant B, Schraen-Maschke S, Baret C, Rigaud AS, Hanon O, Epelbaum J. Somatostatin and Neuropeptide Y in Cerebrospinal Fluid: Correlations With Amyloid Peptides Abeta1-42 and Tau Proteins in Elderly Patients With Mild Cognitive Impairment. Front Aging Neurosci. 2018 Oct 1;10:297. doi: 10.3389/fnagi.2018.00297. eCollection 2018. Erratum In: Front Aging Neurosci. 2019 Feb 19;11:11.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

publisher_dissemination: Frontiers

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: BALTAZAR PlaTau

titre: Protéine tau plasmatique et biomarqueurs de la dégradation de l'APP (Amyloid precursor protein) pour le diagnostic et le pronostic de la maladie d'Alzheimer. Etude ancillaire à l'étude BALTAZAR (Biomarker of AmyLoïd pepTide and AlZheimer's diseAse Risk).

discipline_principale: neurologie

nom_porteur: HANON

prenom_porteur: Olivier


title: Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

summary: This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.

lead_sponsor: Danone Research

location_facility: Médecin-chef du Groupement Formation Instruction


title: Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?

summary:
After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Indeed, facial expression recognition, which is necessary to understand other's emotional state, requires a subclinical facial mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.

This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's disease )patients with emotional facial expression (EFE) recognition impairment, compared to healthy control subjects. We also want to know if this facial mimicry disorder is primary (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the mirror neuron systems that allows us to activate similar neural networks when observing and feeling a specific emotion)


title: Etude de l'adhérence et Des Effets Des Ateliers "équilibre Siel Bleu" Sur la Marche, la Cognition, l'Autonomie et l'indépendance Des Sujets Atteints d'Une Maladie d'Alzheimer, et Sur le Fardeau de l'Aidant Principal

acronym: SIELBLEU

summary: The purpose of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.


title: Study of the Pathophysiological Mechanisms Involved in Bleeding Events Observed in Patients With Lowe Syndrome

acronym: LOWE

summary:
Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of hemorrhagic events was found in a retrospective clinical survey, suggesting platelet dysfunction.

The main objective of the study is to confirm the presence of platelet dysfunction in Lowe syndrome and to characterize this abnormality.

ReferenceCitation: Egot M, Lasne D, Poirault-Chassac S, Mirault T, Pidard D, Dreano E, Elie C, Gandrille S, Marchelli A, Baruch D, Rendu J, Faure J, Flaujac C, Gratacap MP, Sie P, Gaussem P, Salomon R, Baujat G, Bachelot-Loza C. Role of oculocerebrorenal syndrome of Lowe (OCRL) protein in megakaryocyte maturation, platelet production and functions: a study in patients with Lowe syndrome. Br J Haematol. 2021 Mar;192(5):909-921. doi: 10.1111/bjh.17346. Epub 2021 Feb 2.

location_facility: Necker Enfants Malades Hospital, Genetic


title: Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

acronym: CoEnv

summary: Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.


title: French Kabuki Syndrome Network. Epidemiology, Management of Patients and Research by Array-CGH

acronym: Kabuki

summary:
Create a census for the duration of the search for French patients with SK

determining epidemiological and morphological parameters,
determine the true frequency of clinical symptoms and identify new ones,
identify complications of the disease to improve the care of patients in the hope of a better prognosis of the disease and
performing a radiological study by Voxel based morphometry MRI type (N. BODDAERT, HOPITAL Necker-Enfants Malades, Paris)

Perform genetic research to identify the genetic bases of SK using CGH-array (Comparative Genomic Hybridization )


title: Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

summary: The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

lead_sponsor: Association Recherche Méthodologie Evaluation Psychiatrique

location_facility: Centre Mémoire de Ressources et de Recherche


title: Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study

acronym: DURAPOP

summary: The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.

ReferenceCitation: Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farese M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON


title: Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

summary: The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.

lead_sponsor: Rennes University Hospital


title: Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

acronym: STIMALGI

summary:
The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.

A double blind clinical trial with two randomized parallel groups:

Placebo rTMS and rehabilitation exercise
Active rTMS and rehabilitation exercise

ReferenceCitation: Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.

ReferenceCitation: Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.

ReferenceCitation: Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.

ReferenceCitation: Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.

ReferenceCitation: Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. doi: 10.1016/s0987-7053(00)00240-9. French.

ReferenceCitation: Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.

ReferenceCitation: Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449-458. doi: 10.1002/acr.24118.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Fondation Apicil


title: Surfactant Treatment Compared to Nasal Continuous Positive Airway Pressure for the Management of Respiratory Distress Syndrome in the Newborn Between 35 and 41 Weeks of Gestation

acronym: ASPEN

summary: Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. The purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint is "survival with no oxygen treatment at 72 hours of life". The secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

acronym: DIABSCAN

summary: The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.

lead_sponsor: Association HGE CHU Bordeaux Sud

location_facility: Service Hepato-Gastroentérologie Hopital Haut-Leveque


title: Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations

acronym: AGNORIENT

summary: The area of the brain responsible of visuospatial processing data and more specifically the orientation of an object or image is located in parietal lobe, especially on the right side. A dysfunction of this region would result in a disorder of recognition of the orientation of objects and images that the investigators call orientation agnosia. Several isolated cases are reported in the literature but to the investigators knowledge deficit has never been systematically searched, or put into perspective compared to other neuropsychological deficits. Moreover, the precise location of the lesion responsible for such a disorder remains uncertain. The objectives of this study are (1) detect the existence of orientation agnosia in case of right parietal lesion, and (2) to improve the understanding of such a deficit allowing better management of this disorder.

primary_purpose: Screening

lead_sponsor: University Hospital, Rouen


title: Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)

summary: To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

lead_sponsor: ARCAGY/ GINECO GROUP

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


title: Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.

summary:
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

ReferenceCitation: Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.


acronym: DOLANS

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.

The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.

The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.

Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.

title: Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study

primary_purpose: Health Services Research


title: and Safety of METAZYM (Recombinant Human Arylsulfatase A or rhASA) for the Treatment of Patients With Late Infantile MLD Who Had Previously Hematopoietic Stem Cell Transplantation

acronym: Azylis

summary: There is currently no effective treatment for late infantile MLD once clinical symptoms are evident. METAZYM is a recombinant human arylsulfatase A developed for an intravenous ERT for the treatment of late infantile MLD. The overall objective of this study is to evaluate the efficacy and safety of intravenous rhASA treatment in a patient with late infantile MLD who had previously received hematopoietic stem cell transplantation (HCT).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
European Leukodystrophy Association
Zymenex A/S
Shire

location_facility: Department of Pediatric Endocrinology and Neurology, Saint Vincent de Paul Hospital


title: Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly Fit Patients With Poor Prognosis Acute Myeloid Leukemia.

summary:
Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia (AML).

The disease-free survival (DFS) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same LIA induction therapy

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Celgene Corporation


acronym: UCGI 25

lead_sponsor: UNICANCER

summary: This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

title: A Multicentric Randomized Phase II Trial Evaluating Dual Targeting of EGFR Using the Combination of Cetuximab and Afatinib Versus Cetuximab Alone in Patients With Chemotherapy Refractory wtKRAS Metastatic Colorectal Cancer


title: Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

summary:
The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works.

The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.

The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of the Efficiency of the Ultrasound Measure of the Thickness of the Lower Segment Associated With a Rule of Decision to Reduce the Foetal and Maternal Morbidity and Mortality in the Care of the Deliveries of the Women Having a History of Caesarian: a Pragmatic Randomized Trial : Lustrial

summary:
The rate of caesarians dramatically increased for 15 years. The main indication of caesarian became the iterative caesarian of principle because of a history of caesarian. Any attempt of reduction of the rate of caesarians should thus focus on the indications of iterative principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of the attempts of low way after caesarian is the concern generated by the risk of uterine break during the trial of labor. Yet, there is no reliable method to predict this risk of uterine break. A way of interesting research consists in estimating the potential profits of the echography of the scar lower segment. Indeed, the echography can be useful to determine the specific risk of uterine break of a patient by measuring the thickness of the lower segment of the womb.

The strong negative predictive value of the echography of the lower segment on the risk of uterine break should encourage the women encircled to accept a trial of labor. That is why, this examination associated with a rule of decision could help to decrease the rate of iterative elective caesarians and especially to decrease the mortality and the foetal and maternal morbidity connected to the trial of labor among the patients having a history of caesarian.

ReferenceCitation: Rozenberg P, Senat MV, Deruelle P, Winer N, Simon E, Ville Y, Kayem G, Porcher R, Perrodeau E, Desbriere R, Boutron I; Groupe de Recherche en Obstetrique et Gynecologie. Evaluation of the usefulness of ultrasound measurement of the lower uterine segment before delivery of women with a prior cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2022 Feb;226(2):253.e1-253.e9. doi: 10.1016/j.ajog.2021.08.005. Epub 2021 Aug 9.

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Rozenberg P, Deruelle P, Senat MV, Desbriere R, Winer N, Simon E, Ville Y, Kayem G, Boutron I; Groupe de recherche en obstetrique et gynecologie. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. Gynecol Obstet Fertil Senol. 2018 Apr;46(4):427-432. doi: 10.1016/j.gofs.2018.03.005. Epub 2018 Apr 4. French.


title: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

summary:
The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Natural Killer Cells Functions, Tumoral Escape to Immune System and Regulation of Natural Cytotoxixity Receptors in Haematological Malignancies

summary: The NK cells participate in the innate immunity against infectious agents or transformed cells that are recognized as "no self" by the absent, weak or abnormal expression of human leukocyte antigen (HLA) class I molecules. According to the "missing self hypothesis", a negative signal is delivered to NK cells when their inhibitory receptors are engaged by the specific HLA class I molecules. NK activation requires a positive signal delivered by the engagement of activating receptors, more particularly of the "Natural cytotoxicity receptors" or NCRs who are directly involved in the natural cytotoxicity of Natural Killer. The activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3 respectively. NKp46 and NKp30 are constitutively expressed on the surface of the NK, the expression of NKp44 is observed only after activation of cells NK. NK cells from most (80%) healthy donors express a high quantity of NCR on their surface, corresponding to the NCRbright phenotype while only 20 % present the NCRdull phenotype. In sharp contrast, most patients (80%) having leukaemia have the NCRdull while only 20 % patients have the NCRbright phenotype. The culture of NK from healthy donors ( NCRbright) with leukaemic cells result in decreased expression of the NKp30 while there is no difference on expression if these same NK are cultivated with cells from healthy donors. Moreover, study of AML patients showed that the NCRdull phenotype was acquired during leukemia development because it was observed its complete (for NKp46) or partial (for NKp30) reversibility in patients achieving complete remission (CR). Reversibility of the NCRdull phenotype after CR suggested that leukemia cells might be involved in NCR down-regulation. In line with these observations, we aim to study the mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors with leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of the NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If this hypothesis is be verified, we will study the regulation of NCR by focusing on the implication of genes NCR transcription factors via bio-informatic analysis of putative transcription factors fixation sequences in the promoters of these genes, followed by the verification of the capacity of identified sequences to bind transcription factors. Ultimately, we will verify the real implications of these transcription factors by studying the effect of their silencing by RNA interference experiments.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Evaluation of the Efficacy of a Mobile Phone Short Message Service on Post-fracture Management for Patients Who Consult to the Emergency Department

acronym: Ostéo-SMS

summary: The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.


title: Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.

acronym: IVNICTUS

summary: Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure

ReferenceCitation: Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372.

ReferenceCitation: Lemiale V, Mokart D, Resche-Rigon M, Pene F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Theodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E; Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie (GRRR-OH). Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1711-9. doi: 10.1001/jama.2015.12402.


title: Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque

acronym: CGRCard

summary:
The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.

Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.

However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Micro Array Analysis in Preeclampsia

summary:
Preeclampsia is a frequent pathology. His etiology is doubtful.

Targets :

The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.

Design:

Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).

The study of the transcriptional history of peripheral blood cells of 2patients groups:

A patient group with a preeclampsia before 34 SA
A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.

Results and perspectives

Obtain a transcriptionnal signature of preeclampsia
To identify new mechanism of the disease
Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.


title: A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male Subjects

summary: A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

ReferenceCitation: Gibbons JA, de Vries M, Krauwinkel W, Ohtsu Y, Noukens J, van der Walt JS, Mol R, Mordenti J, Ouatas T. Pharmacokinetic Drug Interaction Studies with Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1057-69. doi: 10.1007/s40262-015-0283-1.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Astellas Pharma Europe B.V.

sponsor_collaborators:
Astellas Pharma Europe B.V.
Medivation, Inc.


title: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.

acronym: NESTIS

summary: ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.

ReferenceCitation: Pioche M, Lepilliez V, Ciocirlan M, Rivory J, Miaglia C, Hervieu V, Poncet G, Valette PJ, Saurin JC, Ponchon T. Endoscopic submucosal dissection with the Nestis(R) jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 2012-A00272-41). Surg Endosc. 2016 Nov;30(11):5140-5146. doi: 10.1007/s00464-016-4827-8. Epub 2016 Mar 4.

lead_sponsor: Hospices Civils de Lyon


title: Nutritional Adaptation to Contemporary Sedentary Behaviors and Physical Exercise in Youth: Effect of Weight Status

summary: Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. To date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. The aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.

lead_sponsor: Université Blaise Pascal, Clermont-Ferrand


title: Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

acronym: MRKH

summary:
The principal objective is to assess the general health status and the sexual health status of women with Rokitansky syndrome having received a surgical or non surgical treatment.

The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To search a correlation between the anatomical result, the general and sexual quality of life. To compare the different techniques of medical follow-up in terms of anatomic results, general quality of life, sexual quality of life, complications and morbidities.

To evaluate social inclusion of these women with their family situation, social and professional category and their job.

At the same time, we propose an evaluation with a psychologist to study the impact of the announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.

ReferenceCitation: Cheikhelard A, Bidet M, Baptiste A, Viaud M, Fagot C, Khen-Dunlop N, Louis-Sylvestre C, Sarnacki S, Touraine P, Elie C, Aigrain Y, Polak M; French MRKH Study Group. Surgery is not superior to dilation for the management of vaginal agenesis in Mayer-Rokitansky-Kuster-Hauser syndrome: a multicenter comparative observational study in 131 patients. Am J Obstet Gynecol. 2018 Sep;219(3):281.e1-281.e9. doi: 10.1016/j.ajog.2018.07.015. Epub 2018 Jul 21.

location_facility: Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades


title: Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

acronym: SUFEMYO

summary: The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Novartis


title: TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

summary: safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

lead_sponsor: Hôpital Edouard Herriot


type: Other Grant/Funding Number

title: Learning Mechanisms of Food Preferences in 2-3 y. o. Toddlers in Nurseries

summary: The aim of this study is to understand the formation of food preferences from an early age.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


summary: To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

lead_sponsor: Centre Jean Perrin


summary: Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.