title: Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study

acronym: TEPvENDO

summary: The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.

ReferenceCitation: Duval X, Le Moing V, Tubiana S, Esposito-Farèse M, Ilic-Habensus E, Leclercq F, Bourdon A, Goehringer F, Selton-Suty C, Chevalier E, Boutoille D, Piriou N, Le Tourneau T, Chirouze C, Seronde MF, Morel O, Piroth L, Eicher JC, Humbert O, Revest M, Thébault E, Devillers A, Delahaye F, Boibieux A, Grégoire B, Hoen B, Laouenan C, Iung B, Rouzet F; AEPEI-TEPvENDO study group. Impact of Systematic Whole-body 18F-Fluorodeoxyglucose PET/CT on the Management of Patients Suspected of Infective Endocarditis: The Prospective Multicenter TEPvENDO Study. Clin Infect Dis. 2021 Aug 2;73(3):393-403. doi: 10.1093/cid/ciaa666.

name: University Paris Diderot, Paris 7, UFR de Médecine-Bichat, Paris, France

family: Duval

full_name: Xavier Duval

given: Xavier

name: Department of Infectious Diseases, University Hospital of Montpellier, Montpellier, France

family: Le Moing

full_name: Vincent Le Moing

given: Vincent

family: Tubiana

full_name: Sarah Tubiana

given: Sarah

name: Unité de Recherche Clinique, AP-HP, HUPNVS, Hôpital Universitaire Paris Nord-Val de Seine, Paris, France

family: Esposito-Farèse

full_name: Marina Esposito-Farèse

given: Marina

family: Ilic-Habensus

full_name: Emila Ilic-Habensus

given: Emila

name: Department of Cardiology, University Hospital of Montpellier, Montpellier, France

family: Leclercq

full_name: Florence Leclercq

given: Florence

name: Department of Nuclear Medicine, University Hospital of Montpellier, Montpellier, France

family: Bourdon

full_name: Aurélie Bourdon

given: Aurélie

name: Department of Infectious Diseases, University Hospital of Nancy, Nancy, France

family: Goehringer

full_name: François Goehringer

name: Department of Cardiology, University Hospital of Nancy, Nancy, France

family: Selton-Suty

full_name: Christine Selton-Suty

given: Christine

name: Department of Nuclear Medicine, University Hospital of Nancy, Nancy, France

family: Chevalier

full_name: Elodie Chevalier

name: Department of Infectious Diseases, CIC UIC 1413 INSERM, University Hospital of Nantes, Nantes, France

family: Boutoille

full_name: David Boutoille

given: David

name: Thorax Institute, INSERM, UMR 1087, University Hospital of Nantes, Nantes, France

name: Department of Nuclear Medicine, Nantes University Hospital, G. et R. Laennec Hospital, Nantes, France

family: Piriou

full_name: Nicolas Piriou

given: Nicolas

family: Le Tourneau

full_name: Thierry Le Tourneau

given: Thierry

name: University Hospital of Besançon, France, UMR CNRS 6249 Chrono-Environnement, Bourgogne University, Franche-Comté, Dijon, France

family: Chirouze

full_name: Catherine Chirouze

given: Catherine

name: Department of Cardiology, University Hospital of Besançon, Besançon, France

family: Seronde

full_name: Marie-France Seronde

given: Marie-France

name: Department of Nuclear Medicine, University Hospital of Besançon, Besançon, France

family: Morel

full_name: Olivier Morel

name: Department of Infectious Diseases, University Hospital of Dijon, INSERM CIC 1432, CHU Dijon, France

family: Piroth

full_name: Lionel Piroth

given: Lionel

name: Department of Cardiology, University Hospital of Dijon, Dijon, France

family: Eicher

full_name: Jean-Christophe Eicher

given: Jean-Christophe

name: Department of Nuclear Medicine, University Hospital of Dijon, Dijon, France

family: Humbert

full_name: Olivier Humbert

name: Infectious Diseases and Intensive Care Unit, University Hospital of Rennes France, INSERM U1230 CHU Rennes, France

name: INSERM CIC 1414, University Hospital of Rennes, France

family: Revest

full_name: Matthieu Revest

given: Matthieu

family: Thébault

full_name: Elise Thébault

name: Department of Nuclear Medicine, University Hospital of Rennes, France

family: Devillers

full_name: Anne Devillers

given: Anne

name: Department of Cardiology, University Hospital of Lyon, Lyon, France

family: Delahaye

full_name: François Delahaye

name: Department of Nuclear Medicine, University Hospital of Lyon, Lyon, France

name: Department of Infectious Diseases, University Hospital of Lyon, Lyon, France

name: Department of Nuclear Medicine, AP-HP, University Hospital of Bichat, Paris, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon


title: Fc Gamma RIIIA V/F158 Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) and Correlations With Treatment

acronym: Poly-ITP

summary:
Aims of the study : 1) To determine whether the presence of the V158 allele of Fc gammaRIIIA gene is associated with a better outcome of Immune Thrombocytopenia (ITP) in adults and especially with a higher response-rate to rituximab. 2) To analyze the impact of therapy and especially rituximab on some B and T cells autoreactive subsets in the peripheral blood.

Patients and Methods :

Inclusion criteria : age ≥ 18 years, primary ITP defined according to the recent consensual criteria (Rodeghiero F et al. Blood 2009), active ITP defined as an ITP with a platelet count < 50 x 109/L requiring treatment, informed consent. Main exclusion criteria : secondary ITP.

Blood samples (serum, plasma, DNA) will be collected in every patient at time of inclusion (pre-treatment) and then sequentially at 3, 6 and 12 months after inclusion in patients treated with rituximab or during the remission phase for other treatments for immunological studies. When a marrow analysis is indicated, some marrow specimens will also be collected and studied and if a patient will have to undergo a splenectomy as a standard of care, some spleen specimens will also be collected. Fc gamma RIIIA V/F158 polymorphism will be assessed by means of an allele-specific PCR. The sequential analysis of anti-platelets (anti-GpIIbIIIa) antibodies producing B cells will be performed by means of flow cytometry and ELISPOT analysis. T cells subsets will be harvested in presence of GpIIbIIIa immunodominant peptides and and cytokines expression will be measured on supernatants on days 2 and 11 in vitro by using Luminex technology in order to characterize and distinguish TH1, TH2, TH17, TFH and Tregs subsets.

The primary outcome will be the overall response rate 1 year after inclusion defined by a platelet count > 30 x 109/L with at least a two-fold increase of the initial (pre-treatment) count. For the patients treated with rituximab as a standard of care, based on the overall expected response-rate (40-50%) and based on preliminary data on FcgammaRIIIA V/F158 distribution, the inclusion of 85 patients should be sufficient to show an association of the V158 allele and the response (b risk 20% and a 5%). Responders and non responders will be compared by non parametrical tests, a multivariate analysis will be than performed using a logistic regression model. The immunological data B and T cells subsets) obtained in both the responders and the non responders will be compared over time (To, M3, M6 and M12) by non parametrical matched tests.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.

acronym: MABUL

summary:
Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.

The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

intervention_type: Device

status_simplified: Unknown


title: Usefulness of Extracorporeal Removal of sFlt-1 in Women With Severe Preeclampsia at Less Than 26 Weeks' Gestation

acronym: ADENA

summary:
Introduction Preeclampsia is a multifactorial disease that is responsible of important adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental models and circulates at elevated levels in human preeclampsia.

The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in women with very early severe preeclampsia at less than 26 weeks' gestation Patients and methods Phase II trial. Women with singleton pregnancy having severe preeclampsia at 23-256/7 weeks' gestation. Women under 18 years, with multiples, or severe fetal growth restriction (less than 5th centile), or abnormal fetal heart rate, or maternal complications (abruption, eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded from the study. After blood pressure and maternal stabilization, women are approached for information and if they agree, to sign the trial consent.

Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation.

Primary endpoint or success of the procedure: baby alive or alive at 6 months if hospitalized Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%, beta power; 90%. First step: number 8 patients. If success equal or less than 5, the study is stopped.

Second step: if success of 6 or more, the study is continued for 9 more patients.

Overall, a maximum of 17 patients will be included. The final success of extracorporeal removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months if hospitalized.

status: Terminated

ReferenceType: background

ReferenceCitation: Anedda S, Mura S, Marcello C, Pintus P. HELP LDL-apheresis in two cases of familial hypercholesterolemic pregnant women. Transfus Apher Sci. 2011 Feb;44(1):21-4. doi: 10.1016/j.transci.2010.12.004. Epub 2011 Jan 22.

ReferenceCitation: Belghiti J, Kayem G, Tsatsaris V, Goffinet F, Sibai BM, Haddad B. Benefits and risks of expectant management of severe preeclampsia at less than 26 weeks gestation: the impact of gestational age and severe fetal growth restriction. Am J Obstet Gynecol. 2011 Nov;205(5):465.e1-6. doi: 10.1016/j.ajog.2011.06.062. Epub 2011 Jun 24.

ReferenceCitation: Cashin-Hemphill L, Noone M, Abbott JF, Waksmonski CA, Lees RS. Low-density lipoprotein apheresis therapy during pregnancy. Am J Cardiol. 2000 Nov 15;86(10):1160, A10.

ReferenceCitation: Deis S, Rouzier R, Kayem G, Masson C, Haddad B. Development of a nomogram to predict occurrence of preeclampsia. Eur J Obstet Gynecol Reprod Biol. 2008 Apr;137(2):146-51. Epub 2007 Jul 31.

ReferenceCitation: Azizi M, Chedid A, Oudard S. Home blood-pressure monitoring in patients receiving sunitinib. N Engl J Med. 2008 Jan 3;358(1):95-7. doi: 10.1056/NEJMc072330.

ReferenceCitation: Chelbi ST, Veitia RA, Vaiman D. Why preeclampsia still exists? Med Hypotheses. 2013 Aug;81(2):259-63. doi: 10.1016/j.mehy.2013.04.034. Epub 2013 May 10.

ReferenceCitation: Eremina V, Sood M, Haigh J, Nagy A, Lajoie G, Ferrara N, Gerber HP, Kikkawa Y, Miner JH, Quaggin SE. Glomerular-specific alterations of VEGF-A expression lead to distinct congenital and acquired renal diseases. J Clin Invest. 2003 Mar;111(5):707-16.

ReferenceCitation: Haddad B, Masson C, Deis S, Touboul C, Kayem G; Collége national des gynécologues et obstétriciens; Société française de médecine périnatale; Société française de néonatalogie; Société française de anesthésie et de réanimation. [Criteria of pregnancy termination in women with preeclampsia]. Ann Fr Anesth Reanim. 2010 Apr;29(4):e59-68. doi: 10.1016/j.annfar.2010.02.019. Epub 2010 Mar 27. Review. French.

ReferenceCitation: Haddad B, Deis S, Goffinet F, Paniel BJ, Cabrol D, Siba BM. Maternal and perinatal outcomes during expectant management of 239 severe preeclamptic women between 24 and 33 weeks' gestation. Am J Obstet Gynecol. 2004 Jun;190(6):1590-5; discussion 1595-7.

ReferenceCitation: Kabbinavar F, Hurwitz HI, Fehrenbacher L, Meropol NJ, Novotny WF, Lieberman G, Griffing S, Bergsland E. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol. 2003 Jan 1;21(1):60-5.

ReferenceCitation: Levine RJ, Qian C, Maynard SE, Yu KF, Epstein FH, Karumanchi SA. Serum sFlt1 concentration during preeclampsia and mid trimester blood pressure in healthy nulliparous women. Am J Obstet Gynecol. 2006 Apr;194(4):1034-41.

ReferenceCitation: Maynard SE, Min JY, Merchan J, Lim KH, Li J, Mondal S, Libermann TA, Morgan JP, Sellke FW, Stillman IE, Epstein FH, Sukhatme VP, Karumanchi SA. Excess placental soluble fms-like tyrosine kinase 1 (sFlt1) may contribute to endothelial dysfunction, hypertension, and proteinuria in preeclampsia. J Clin Invest. 2003 Mar;111(5):649-58.

ReferenceCitation: Romero R, Nien JK, Espinoza J, Todem D, Fu W, Chung H, Kusanovic JP, Gotsch F, Erez O, Mazaki-Tovi S, Gomez R, Edwin S, Chaiworapongsa T, Levine RJ, Karumanchi SA. A longitudinal study of angiogenic (placental growth factor) and anti-angiogenic (soluble endoglin and soluble vascular endothelial growth factor receptor-1) factors in normal pregnancy and patients destined to develop preeclampsia and deliver a small for gestational age neonate. J Matern Fetal Neonatal Med. 2008 Jan;21(1):9-23. doi: 10.1080/14767050701830480.

ReferenceCitation: Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2. Review.

ReferenceCitation: Sugimoto H, Hamano Y, Charytan D, Cosgrove D, Kieran M, Sudhakar A, Kalluri R. Neutralization of circulating vascular endothelial growth factor (VEGF) by anti-VEGF antibodies and soluble VEGF receptor 1 (sFlt-1) induces proteinuria. J Biol Chem. 2003 Apr 11;278(15):12605-8. Epub 2003 Jan 21.

ReferenceCitation: Thadhani R, Kisner T, Hagmann H, Bossung V, Noack S, Schaarschmidt W, Jank A, Kribs A, Cornely OA, Kreyssig C, Hemphill L, Rigby AC, Khedkar S, Lindner TH, Mallmann P, Stepan H, Karumanchi SA, Benzing T. Pilot study of extracorporeal removal of soluble fms-like tyrosine kinase 1 in preeclampsia. Circulation. 2011 Aug 23;124(8):940-50. doi: 10.1161/CIRCULATIONAHA.111.034793. Epub 2011 Aug 1.

ReferenceCitation: Thadhani R, Mutter WP, Wolf M, Levine RJ, Taylor RN, Sukhatme VP, Ecker J, Karumanchi SA. First trimester placental growth factor and soluble fms-like tyrosine kinase 1 and risk for preeclampsia. J Clin Endocrinol Metab. 2004 Feb;89(2):770-5.


type: Other Identifier

title: Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder.

acronym: LONGIDEP

summary: Depression is a debilitating illness with a risk of developing a treatment resistant form. Currently, diagnosis is purely clinical with little features available to identify potentially adverse developments. Clinical features such as early onset age, prolonged episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of resistance to conventional treatments. According to neuroimaging knowledge about the pathophysiological mechanisms, involving front-limbic functional networks supporting the functions of emotional regulation and reward system, recent work has focused on the identification of neuroimaging biomarkers predicting therapeutic response. Among the regions of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions participating in the Default Mode Network Training (Medial prefrontal cortex, posterior cingulate cortex, inferior parietal lobe) are most frequently areas associated with the prediction of therapeutic response. Limitations most reported in these studies are the heterogeneity of experimental paradigms (resting state, cognitive or emotional functional tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms studied, different techniques (as that we consider remission (threshold score) or response (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment assessment and neuro), the identification of neuroimaging biomarkers in a population of patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical and reproducible image daily routine methodology appears to be a reliable way to correct the heterogeneity of conventionally published studies on the topic. This study aim to identify, in routine care, predictive clinical and neuroimaging markers of poor outcome in major depressive disorder.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

status_simplified: Ongoing


title: Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure at the Thermal Baths of Brides-les-Bains

acronym: Educatherm

summary:
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients.

The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.

design_allocation: Non-Randomized

lead_sponsor: Institut Pasteur de Lille

intervention_type: Behavioral


title: Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques

acronym: SALPOVA

summary:
Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.

The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.

primary_purpose: Prevention

lead_sponsor: Hospices Civils de Lyon


title: Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis

acronym: PEPS

summary: Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study

lead_sponsor: University Hospital, Toulouse


summary:
Context: Sport and physical activity during and after cancer treatment can improve fitness and social inclusion in adults. In children, although early studies show interesting results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children following a physical training program showed a significant improvement in endurance, muscle tone, overall self-esteem, sports skills and self-perceived strength. The investigators then want to evaluate the health of a group of children during treat cancer that physical activities adapted compared to children who did not practice.

Objective: Measuring the impact of physical activity program on health of children and adolescents with cancer with improved physical, psychological health, social reintegration and reduced time hospitalization.

Method and Design: The study plans to include 90 children from the pediatric hematology - oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18 months.

This is a randomized controlled open trial open with a stratified distribution. Children will be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. - Arm B (Control - Delayed Program): the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. Each child integrates the physical program for a period of one year.

Regardless of the randomization arm, the child performs the initial tests, the intermediate tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be performed at 3 and 9 months.

The physical activity program includes a minimum of 30 days of activities per 6 months (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.

The investigators aim at demonstrating a difference of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance publique hopitaux de marseille


title: Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)

acronym: PVCAFM

summary: the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.

ipd_sharing: Undecided

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

lead_sponsor_type: industriel


title: Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry

acronym: PROMET II

summary: The recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. In this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer patients.

location_facility: Hôpital Edouard Herriot - service d'urologie

intervention_type: Biological


title: Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition

summary: A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.

lead_sponsor: Nestlé


title: Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment

acronym: ALCAPONE

summary:
The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.

lead_sponsor: Centre Georges Francois Leclerc


acronym: PROSTRACK

summary: This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.

status: Suspended

primary_purpose: Health Services Research


title: The Associative Memory in Autism Spectrum Disorders Without Intellectual Disability

summary: The objective of this multidisciplinary project is to explore the deficit of associative memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has been evocated but has never been tested. Hence, the present project will include two complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared to a control group matched in chronological age and intellectual quotient. The first assessment is devoted to the study of associative memory and its EEG correlates and the second focused on the investigation of perceptual strategies related to associative memory using the technique of Eye-tracking. Both behavioral and imaging data would provide new insights on the relationship between perception and memory in ASD.

lead_sponsor: University Hospital, Caen


type: Registry Identifier

title: Prospective, Randomized, Controlled Trial Evaluating the Efficacy of a Lock-therapy With a Solution of Taurolidine/Citrate (TauroLock) vs Standard Saline Solution for the Primary Prevention of Catheter-related Infections (CLI) in Adult Patients Wtih a Non-hematological Cancer Treated With Intravenous Anti-tumor Therapy

acronym: ATAPAC

summary: The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of central venous catheter-associated bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor

ReferenceCitation: Quarello F, Forneris G. Prevention of hemodialysis catheter-related bloodstream infection using an antimicrobial lock. Blood Purif. 2002;20(1):87-92. Review.

ReferenceCitation: Allon M. Prophylaxis against dialysis catheter-related bacteremia with a novel antimicrobial lock solution. Clin Infect Dis. 2003 Jun 15;36(12):1539-44. Epub 2003 Jun 6.

ReferenceCitation: Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. Epub 2004 Feb 19.

ReferenceCitation: Mandolfo S, Borlandelli S, Elli A. Catheter lock solutions: it's time for a change. J Vasc Access. 2006 Jul-Sep;7(3):99-102. Review.

ReferenceCitation: Taylor C, Cahill J, Gerrish M, Little J. A new haemodialysis catheter-locking agent reduces infections in haemodialysis patients. J Ren Care. 2008 Sep;34(3):116-20. doi: 10.1111/j.1755-6686.2008.00027.x.

ReferenceCitation: Solomon LR, Cheesbrough JS, Ebah L, Al-Sayed T, Heap M, Millband N, Waterhouse D, Mitra S, Curry A, Saxena R, Bhat R, Schulz M, Diggle P. A randomized double-blind controlled trial of taurolidine-citrate catheter locks for the prevention of bacteremia in patients treated with hemodialysis. Am J Kidney Dis. 2010 Jun;55(6):1060-8. doi: 10.1053/j.ajkd.2009.11.025. Epub 2010 Mar 6.

ReferenceCitation: Filiopoulos V, Hadjiyannakos D, Koutis I, Trompouki S, Micha T, Lazarou D, Vlassopoulos D. Approaches to prolong the use of uncuffed hemodialysis catheters: results of a randomized trial. Am J Nephrol. 2011;33(3):260-8. doi: 10.1159/000324685. Epub 2011 Mar 2.

ReferenceCitation: Solomon LR, Cheesbrough JS, Bhargava R, Mitsides N, Heap M, Green G, Diggle P. Observational study of need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurolidine-citrate and heparin catheter locks in patients treated with hemodialysis. Semin Dial. 2012 Mar-Apr;25(2):233-8. doi: 10.1111/j.1525-139X.2011.00951.x. Epub 2011 Sep 15.

ReferenceCitation: Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11. Review.

ReferenceCitation: Touré A, Lauverjat M, Peraldi C, Boncompain-Gerard M, Gelas P, Barnoud D, Chambrier C. Taurolidine lock solution in the secondary prevention of central venous catheter-associated bloodstream infection in home parenteral nutrition patients. Clin Nutr. 2012 Aug;31(4):567-70. doi: 10.1016/j.clnu.2012.01.001. Epub 2012 Jan 28.

ReferenceCitation: Lebeaux D, Larroque B, Gellen-Dautremer J, Leflon-Guibout V, Dreyer C, Bialek S, Froissart A, Hentic O, Tessier C, Ruimy R, Pelletier AL, Crestani B, Fournier M, Papo T, Barry B, Zarrouk V, Fantin B. Clinical outcome after a totally implantable venous access port-related infection in cancer patients: a prospective study and review of the literature. Medicine (Baltimore). 2012 Nov;91(6):309-318. doi: 10.1097/MD.0b013e318275ffe1. Review.

ReferenceCitation: Zwiech R, Adelt M, Chrul S. A Taurolidine-Citrate-Heparin Lock Solution Effectively Eradicates Pathogens From the Catheter Biofilm in Hemodialysis Patients. Am J Ther. 2016 Mar-Apr;23(2):e363-8. doi: 10.1097/MJT.0b013e31828d4610.

ReferenceCitation: Shah CB, Mittelman MW, Costerton JW, Parenteau S, Pelak M, Arsenault R, Mermel LA. Antimicrobial activity of a novel catheter lock solution. Antimicrob Agents Chemother. 2002 Jun;46(6):1674-9.

ReferenceCitation: Torres-Viera C, Thauvin-Eliopoulos C, Souli M, DeGirolami P, Farris MG, Wennersten CB, Sofia RD, Eliopoulos GM. Activities of taurolidine in vitro and in experimental enterococcal endocarditis. Antimicrob Agents Chemother. 2000 Jun;44(6):1720-4.

ReferenceCitation: Simon A, Ammann RA, Wiszniewsky G, Bode U, Fleischhack G, Besuden MM. Taurolidine-citrate lock solution (TauroLock) significantly reduces CVAD-associated grampositive infections in pediatric cancer patients. BMC Infect Dis. 2008 Jul 29;8:102. doi: 10.1186/1471-2334-8-102.

ReferenceCitation: Dümichen MJ, Seeger K, Lode HN, Kühl JS, Ebell W, Degenhardt P, Singer M, Geffers C, Querfeld U. Randomized controlled trial of taurolidine citrate versus heparin as catheter lock solution in paediatric patients with haematological malignancies. J Hosp Infect. 2012 Apr;80(4):304-9. doi: 10.1016/j.jhin.2012.01.003. Epub 2012 Feb 18.

ReferenceCitation: Klek S, Szczepanek K, Hermanowicz A, Galas A. Taurolidine lock in home parenteral nutrition in adults: results from an open-label randomized controlled clinical trial. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):331-5. doi: 10.1177/0148607114525804. Epub 2014 Mar 6.

ReferenceCitation: Al-Amin AH, Sarveswaran J, Wood JM, Burke DA, Donnellan CF. Efficacy of taurolidine on the prevention of catheter-related bloodstream infections in patients on home parenteral nutrition. J Vasc Access. 2013 Oct-Dec;14(4):379-82. doi: 10.5301/jva.5000168. Epub 2013 Jul 1.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


type: EudraCT Number

title: Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

acronym: FLUOTECH

summary:
The sentinel node has a fundamental role in the management of early breast cancer.

Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.

So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.

Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

intervention_type: Drug


title: Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

acronym: Multimod'HCA

summary:
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.

Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.

The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.

lead_sponsor: University Hospital, Tours


title: Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement

acronym: PTGMass

summary:
During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.

lead_sponsor: University Hospital, Limoges


title: Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

summary: The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

lead_sponsor: Laboratoires Thea


title: Assessment of Coronary Flow Reserve by PET-H215O and FFR in Patients Suspected of Coroanry Artery Disease. a Comparative Study With Dynamic Acquisition Using CZT Camera and 99mcTc-mibi.

acronym: WATERDAY

summary: The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.


title: Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Central Blood Pressure in Essential Hypertension Patients Treated But Not Stabilized

summary: The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to the hypertension consultations for essential hypertension treated but not stabilized. The effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral cutaneous microcirculation and on the central arterial pressure.

lead_sponsor: Stendo

location_facility: Hôpital Lariboisière - Service de Physiologie Clinique - Explorations Fonctionnelles


title: Pain Neuromodulation in Adults With Autism Spectrum Disorder

acronym: DOUPA

summary: Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

lead_sponsor: University Hospital, Brest


title: Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors

acronym: UROVISIO

summary: Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

acronym: LICHENVIR

summary:
Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network.

The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown.

This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Raybaud H, Olivieri CV, Lupi-Pegurier L, Pagnotta S, Marsault R, Cardot-Leccia N, Doglio A. Epstein-Barr Virus-Infected Plasma Cells Infiltrate Erosive Oral Lichen Planus. J Dent Res. 2018 Dec;97(13):1494-1500. doi: 10.1177/0022034518788282. Epub 2018 Jul 13.

name: Université Côte d’Azur, EA 7354 MICORALIS, UFR Odontologie, Nice, France

name: Centre Hospitalier Universitaire de Nice, Pôle Odontologie, Nice, France

family: Raybaud

full_name: H. Raybaud

given: H.

sequence: first

family: Olivieri

full_name: C.V. Olivieri

sequence: additional

family: Lupi-Pegurier

full_name: L. Lupi-Pegurier

given: L.

name: Université Côte d’Azur, Centre Commun de Microscopie Appliquée, Nice, France

family: Pagnotta

full_name: S. Pagnotta

given: S.

family: Marsault

full_name: R. Marsault

given: R.

name: Centre Hospitalier Universitaire de Nice, Department of Pathology, Pasteur Hospital, Nice, France

family: Cardot-Leccia

full_name: N. Cardot-Leccia

given: N.

name: Centre Hospitalier Universitaire de Nice, Unité de Thérapie Cellulaire et Génique, Nice, France

family: Doglio

full_name: A. Doglio

given: A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Dental Research

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Epstein-Barr Virus–Infected Plasma Cells Infiltrate Erosive Oral Lichen Planus


acronym: PRUGNANCY

summary:
The link between precarious situations and health conditions are more described in previous study. Precarious situations are more frequent and complex especially in rural areas. There are recognized like a risk factor of complications during pregnancy and delivery. It's necessary to describe antenatal cares for rural women in precarious situations to prevent those situations, to understand their difficulties in order to reduce inequalities and health spending.

The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women and the strategies developed to overcome them. Recognized earlier precarious situations and valorized General Practitioners and restore them to the follow-up or parturient women.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Etude Des Troubles métaboliques Induits Par Une Course à Pied très Longue Distance, " La Diagonale Des Fous " de La Réunion / Metabolic Disorders in Ultramarathon Runners of the Madmen's Diagonal Race on Reunion Island

acronym: METARUN

summary: Acute consequences of ultramarathon running are still unknown as very little research has been done on the matter. The investigators will assess the consequences on the metabolism of runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of metabolites in systemic inflammatory response syndrome. The purpose of this study is to assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion Island every year in October.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

intervention_type: Procedure


acronym: MIGAT

summary:
MIGAT will develop and transfer software tools to assist ablation therapy of cardiac arrhythmias. The scientific background and objectives of MIGAT differ between atrial and ventricular arrhythmias, because the knowledge on structure-function relationships and the definition of ablation targets are different.

Hypothesis: The combination of body surface mapping and imaging will enable a comprehensive non-invasive assessment of cardiac arrhythmia mechanisms and localization, myocardial structural substrate, and cardiac anatomy, all of which should be of value to better define targets for ablation therapy. No software solution is currently available for multimodal data processing, fusion, and integration in 3-dimensional mapping systems to assist ablation. Because such a development requires a trans-disciplinary approach (cardiac electrophysiology, imaging, computer sciences), it is likely to emerge from an academic initiative.

Objectives: MIGAT will gather resources from the Liryc Institute (L'Institut de Rythmologie et Modélisation Cardiaque), the Inria (Institut National de Recherche en Informatique et en Automatique) and the University Hospital of Bordeaux to develop a computer-based solution with high expected impact on the daily management of cardiac electrical disorders. The research program will benefit from the MUSIC (Magnetom Avanto, Siemens, Erlangen, Germany) equipment recently funded as part of the "Investissement d'Avenir" program, and combining state-of-the-art electrophysiology and magnetic resonance imaging technology. MIGAT will involve software engineers, computer science researchers, cardiologists, radiologists and clinical research personnel with the following objectives:

Development of a multimodal data processing software to assist cardiac ablation
Optimization and Validation of the software in terms of user experience
Optimization and Validation of the software in terms of clinical performance
Optimization of software quality compatible with subsequent device certification and randomized-controlled evaluation

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

acronym: CAMPYTEST

summary: For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT which are really interesting tools to use since they allow a diagnosis in about 15 min, in comparison to different methods of detection even serology.


title: Study of the Immunogenicity of a Prime Boost Vaccination Strategy Combining Conjugated Anti-pneumococcal and Polysaccharide Anti-pneumococcal Vaccine Compared to Polysaccharide Anti -Pneumococcal Vaccine Alone in Patients With Sickle Cells Disease

acronym: DREVAC

summary:
Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle cells disease.

The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic in these patients. We want to evaluate whether a prime with a 13-valent pneumococcal conjugate vaccine (PCV), able to induce immunologic memory, would improve the immune response against SP polysaccharides (SPP).

Primary objective: To evaluate and compare the specific antibody response to a prime-boost vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4, to the administration of PSV alone at W4 in patients with sickle cells disease.

Secondary objectives: Evaluation and comparison of the specific antibody response to the thirteen pneumococcal serotypes shared by the PCV and PSV vaccines, 4 weeks after the single PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for patients from group 2. Evaluation of the duration of the specific antibody response at W24 and 96. Evaluation of the T CD4 lymphocyte response to the CRM 197 protein. Safety of the vaccines.

Study Design: Randomised, monocentric, controlled phase II study of the immunological efficacy of a prime boost strategy combining the sequential administration of the PCV and PSV, compared to the administration of the PSV alone. 180 adults patients with sickle cells disease will be included. The primary endpoint : proportion of responders at W8 to at least 10 of thirteen serotypes. Secondary endpoints : Proportion of responders at W8 according to 4 categories of responders: 5-7; 3-4; 2-1 and 0. Evaluation of the pneumococcal opsonophagocytic activity (OPA) at baseline and W8 for each serotype, defined as the proportion of patients with OPA > 1:8 geometric mean of the specific antibody titers proportion of patients who experienced an increase of specific antibody levels 1 g/ml. Evaluation of the priming effect of the PCV vaccine in the group 1. Duration of the specific antibody responses at week 24 and W96. CD4 T lymphocyte responses to the CRM 197 protein (proliferative and cytokine production) at weeks 0, 8 and 12. Safety of the vaccines frequency of Streptococcus pneumoniae infections.

Statistical Considerations: With a sample size of 180 patients, and a randomization ration of 1:1, the study will have a power of at least 90% to show a difference of 25% category between the group receiving PCV and PSV vs the group receiving PSV alone (two-sided type I error = 5%). The primary comparison between both groups will be performed using a Chi2 test for independent groups or a Fisher exact test where appropriate.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of Pharmacokinetic and Pharmacodynamic Variability of Prednisone, in Adults

acronym: Glucomad

summary: This is a monocentric study, in the Internal Medicine Service of Cochin Hospital, Paris. Our main objective is to determine the pharmacokinetic properties of prednisone, secondary objectives are to determine the covariates affecting the prednisone pharmacokinetics and the relationship between glucocorticoid exposition levels and their side effects. The investigators will use a prospective, observational, population pharmacokinetic approach. 100 patients starting a prednisone treatment >7,5mg/d for an expected period >3 months will be recruited and followed over 6 months.

ReferenceCitation: Czock D, Keller F, Rasche FM, Häussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. Review.

ReferenceCitation: Rollin C, Chosidow O, Diquet B, Dutreuil C, Herson S, Revuz J, Delchier JC. Comparative study of availability of prednisolone after intestinal infusion of prednisolone metasulfobenzoate and prednisone. Eur J Clin Pharmacol. 1993;44(4):395-9.

ReferenceCitation: Wald JA, Law RM, Ludwig EA, Sloan RR, Middleton E Jr, Jusko WJ. Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man. J Pharmacokinet Biopharm. 1992 Dec;20(6):567-89.


ReferenceCitation: McGovern L, Johnson JN, Paulo R, Hettinger A, Singhal V, Kamath C, Erwin PJ, Montori VM. Clinical review: treatment of pediatric obesity: a systematic review and meta-analysis of randomized trials. J Clin Endocrinol Metab. 2008 Dec;93(12):4600-5. doi: 10.1210/jc.2006-2409. Epub 2008 Sep 9. Review.

ReferenceCitation: Bray GA. Risks of obesity. Endocrinol Metab Clin North Am. 2003 Dec;32(4):787-804, viii. Review.

ReferenceCitation: Astrup A, Caterson I, Zelissen P, Guy-Grand B, Carruba M, Levy B, Sun X, Fitchet M. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res. 2004 Oct;12(10):1658-69.

ReferenceCitation: Toplak H, Hamann A, Moore R, Masson E, Gorska M, Vercruysse F, Sun X, Fitchet M. Efficacy and safety of topiramate in combination with metformin in the treatment of obese subjects with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Int J Obes (Lond). 2007 Jan;31(1):138-46. Epub 2006 May 16.

ReferenceCitation: Rosenstock J, Hollander P, Gadde KM, Sun X, Strauss R, Leung A; OBD-202 Study Group. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients. Diabetes Care. 2007 Jun;30(6):1480-6. Epub 2007 Mar 15.

acronym: TOBI

source: euctr

title: Topiramate and Severe Obesity in Children and Adolescents

summary: The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.


title: Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation

summary: The main objective of this pilot study is to investigate the protein / peptide plasma profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients with non-valvular atrial fibrillation to better understand the mechanisms of action of these molecules and perform exploratory analyses concerning proteins whose concentrations change after starting treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)

acronym: NEBULAMB

summary: Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.

lead_sponsor: Poitiers University Hospital


title: Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane

acronym: Propo-Faim

summary:
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.

The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.

ReferenceCitation: Besnier E, Perdrix A, Gillibert A, Selim J, Froëmer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compère V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.

family: Besnier

full_name: Emmanuel Besnier

given: Emmanuel

family: Perdrix

full_name: Anne Perdrix

family: Gillibert

full_name: André Gillibert

given: André

family: Selim

full_name: Jean Selim

given: Jean

family: Froëmer

full_name: Benoit Froëmer

given: Benoit

family: Ghemired

full_name: Antoine Ghemired

given: Antoine

family: Berby

full_name: Benoit Berby

family: Rives

full_name: Nathalie Rives

given: Nathalie

family: Dureuil

full_name: Bertrand Dureuil

given: Bertrand

family: Clavier

full_name: Thomas Clavier

given: Thomas

family: Compère

full_name: Vincent Compère

given: Vincent

journal_name: Canadian Journal of Anesthesia/Journal canadien d'anesthésie

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Rouen


title: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

acronym: CHEMODEX

summary: The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

ReferenceCitation: Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.

family: Martin

full_name: Elodie Martin

given: Elodie

family: Morel

full_name: Véronique Morel

given: Véronique

family: Joly

full_name: Dominique Joly

given: Dominique

family: Villatte

full_name: Christine Villatte

given: Christine

family: Delage

full_name: Noémie Delage

given: Noémie

family: Dubray

full_name: Claude Dubray

given: Claude

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

journal_name: Contemporary Clinical Trials

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Rationale and design of a randomized double-blind clinical trial in breast cancer: Dextromethorphan in chemotherapy-induced peripheral neuropathy


title: Improvement of the Post ICSI Pregnancy Outcome by Induction of the Acrosome Reaction Prior to ICSI

acronym: RA-ICSI

summary:
Introduction To get through the egg vestment and fertilize the oocyte, the spermatozoon uses its acrosomal enzymes. When Intracytoplasmic sperm microinjection (ICSI) is performed, the acrosomal enzymes are introduced with the spermatozoa inside the ooplasme.

The fate of these enzymes, that normally never enter the oocyte, is not known. But they impair the embryo development.

Indeed, although the ICSI outcome is satisfactory in humans, a series of studies in many species (mouse, hamster, cattle, and horse) demonstrate the deleterious effects of the introduction of acrosomal material in the oocyte cytoplasm, on embryo and fetal development. These studies have also shown two things:

The bigger the acrosome, the more deleterious are the effects of their introduction into the egg.
And that the induction of the acrosome reaction (AR) prior to ICSI significantly improves embryonic development and the number of babies born after embryo transfer as it is the case in the mouse. The microinjection of acrosome reacted sperm increases from 40 to 70 % the percentage of pups born per embryo transferred.

Hypothesis :

It is possible to improve ICSI outcome, in terms of babies born in human, by induction of the AR prior to microinjection.

After studying several techniques, we choose a physiologic technique for acrosome induction.

The induction of acrosome reaction prior to ICSI should improve in utero fetal development and decrease the rate of miscarriage and pregnancy arrest.

ReferenceCitation: Lacham-Kaplan O, Trounson A. Intracytoplasmic sperm injection in mice: increased fertilization and development to term after induction of the acrosome reaction. Hum Reprod. 1995 Oct;10(10):2642-9.

ReferenceCitation: Roldan ER. Better intracytoplasmic sperm injection without sperm membranes and acrosome. Proc Natl Acad Sci U S A. 2006 Nov 21;103(47):17585-6. Epub 2006 Nov 13.

ReferenceCitation: Morozumi K, Shikano T, Miyazaki S, Yanagimachi R. Simultaneous removal of sperm plasma membrane and acrosome before intracytoplasmic sperm injection improves oocyte activation/embryonic development. Proc Natl Acad Sci U S A. 2006 Nov 21;103(47):17661-6. Epub 2006 Nov 7.


type: Other Grant/Funding Number

title: Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Weight Heparin in Child-Pugh B Cirrhotic Patients: a Randomized Controlled Study

acronym: Childbenox

summary: Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients


title: Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx: the First Three Patients

acronym: RoboCurage ORL

summary:
The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety.

Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.


title: Outcome of Infants With Prenatal Corpus Callosum Agenesis

acronym: Dacci

summary: The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.

primary_purpose: Screening

ReferenceCitation: Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27. Review.

ReferenceCitation: Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gélot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.

ReferenceCitation: Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gélot A, Campistol I Plana J, van Bogaert P, André M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. Epub 2003 Jul 4.


title: Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child

acronym: NEMOST

summary:
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.

Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.

primary_purpose: Other

ReferenceCitation: Miladi L, Khouri N, Pradon J, Elie C, Treluyer JM. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.

family: Miladi

full_name: Lotfi Miladi

given: Lotfi

family: Khouri

full_name: Nejib Khouri

given: Nejib

family: Pradon

full_name: Jerome Pradon

given: Jerome

family: Elie

full_name: Caroline Elie

given: Caroline

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

journal_name: European Spine Journal


title: Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®

summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

lead_sponsor: W.L.Gore & Associates


title: Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.

acronym: SOON

summary:
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery.

More accurately the questions addressed are:

What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution
What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

status: Recruiting

ReferenceCitation: Guggino J, Coumes S, Wion N, Reche F, Arvieux C, Borel AL. Effectiveness and Safety of Bariatric Surgery in Patients with End-Stage Chronic Kidney Disease or Kidney Transplant. Obesity (Silver Spring). 2020 Dec;28(12):2290-2304. doi: 10.1002/oby.23001.

name: Endocrinology, Diabetology, Nutrition Grenoble Alpes University Hospital Grenoble France

family: Guggino

full_name: Jessica Guggino

given: Jessica

family: Coumes

full_name: Sandrine Coumes

given: Sandrine

family: Wion

full_name: Nelly Wion

given: Nelly

name: Digestive Surgery Grenoble Alpes University Hospital Grenoble France

name: CNRSUMR 5525TIMC‐IMAGDomaine de la Merci Grenoble France

family: Reche

full_name: Fabian Reche

given: Fabian

family: Arvieux

full_name: Catherine Arvieux

given: Catherine

name: Hypoxia Pathophysiology (HP2) INSERM U1042 Grenoble Alpes University Grenoble France

family: Borel

full_name: Anne‐Laure Borel

given: Anne‐Laure

journal_name: Obesity

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effectiveness and Safety of Bariatric Surgery in Patients with End‐Stage Chronic Kidney Disease or Kidney Transplant

lead_sponsor: University Hospital, Grenoble


title: LESCOD: "A Single Center, Prospective Study Aimed at Validating a Clinical Scale, Screening for Symptoms of Lewy Body Disease in Patients Incipient Dementia of the Alzheimer's and/or Lewy Body Type"

acronym: LESCOD

summary: Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value of both diagnostic criteria. To date there is still a need for a tool able to discriminate patients with pure DLB from those expressing common signs with both AD and DLB and those with pure AD. The purpose of this study is to validate a semi quantitative scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The investigators hypothesized that the score obtained may differentiate between AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a preliminary work preceding further studies correlating the LeSCoD score with functional imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies

lead_sponsor: Nantes University Hospital


title: Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study

acronym: EchoComp TVP

summary: The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.


title: Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery

acronym: PEPKIN

summary: Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac surgery. Classically, the treatment of these patients is based on manual chest physiotherapy. Our objective is to evaluate the interest of association of positive end expiratory delivery sessions with the EzPAP® device. We perform a prospective monocentric, open label trial. Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are included. They benefit from manual chest therapy and are randomised to receive or not positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of this treatment on atelectasis radiological score after 2 days of treatment. The secondary endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of ventilatory function, respiratory & cardiac rate, pain, inspiratory pressure (sniff test), patient satisfaction, duration of intensive care unit (ICU) and hospital stay.

primary_purpose: Supportive Care


title: A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF

acronym: PRECONCEPTIO

summary: A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.

location_facility: Hôpital Saint-Louis - Laboratoire MatriceLAb Innove


title: Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.

acronym: MICIMAB

summary: The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.

lead_sponsor: University Hospital, Toulouse


title: Parallel Randomised Open Blind Evaluation Study of the Efficacy of 20° Trendelenburg Position During 24 Hours After Epidural Blood Patch in the Treatment of Spontaneous Intracranial Hypotension

acronym: SIHT

summary: Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension

ReferenceCitation: Ferrante E, Arpino I, Citterio A, Wetzl R, Savino A. Epidural blood patch in Trendelenburg position pre-medicated with acetazolamide to treat spontaneous intracranial hypotension. Eur J Neurol. 2010 May;17(5):715-9. doi: 10.1111/j.1468-1331.2009.02913.x. Epub 2009 Dec 29.

ReferenceCitation: Sencakova D, Mokri B, McClelland RL. The efficacy of epidural blood patch in spontaneous CSF leaks. Neurology. 2001 Nov 27;57(10):1921-3.

location_facility: Lariboisiere Hospital - Centre Urgences Céphalées (CUC)


title: Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.

summary:
The clinical manifestations of pulmonary embolism vary greatly from the absence of specific clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by "lung superinfection", also called "pulmonary embolism superinfected" is common and represents up to 30% of initial clinical presentations; she been few evaluations in clinical research. The reality of the bacterial infection remains controversial and the clinical presentation often leads to the prescription of empirical antibiotic therapy, often unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.

Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism without actually clarified whether this was related to temperature with a pulmonary embolism or other associated cause. Murray et al estimated that greater than 38 ° C was explained by pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism is often low intensity (often less than 38.3) and of short duration, with a peak on the day of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in pulmonary embolism has not yet was completely clarified. It is suggested that a combination of several factors involved pyrogenic myocardial tissue necrosis and releasing pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or local superinfection.

Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in patients with community-acquired pneumonia. This is especially verified in patients admitted for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.

The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial infections febrile forms of EP to other causes.


title: Sequential Analysis in Patients With an Hemopathy

acronym: S-HEMO

summary:
Recent advances in hematology clearly illustrate that the simple "clonal" nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1).

These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones.

For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops.

In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effects of Injection Tinzaparin Prophylactic Dose (4,500 IU Anti-Xa) on Thrombin Generation in Patients With Multiple Myeloma, Lymphoma Patients and Patients Hospitalized for an Acute Medical Condition.

acronym: METRO B

summary:
In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in myeloma seems no more effective than that achieved with aspirin, while the effectiveness of the latter in the primary prevention of VTE has never been demonstrated regardless of the type of population considered. Meanwhile, a biological study showed that prophylactic doses of LMWH in patients with different types of cancer did not always optimal reduction of thrombin peak during the 24 hours following the injection of LMWH. These clinical and biological studies lead to the conclusion that patients with myeloma may be resistant to the usual doses of preventive LMWH, which may explain the failure of prevention.

Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is present in patient's biology and if this resistance is specific to myeloma in hematological cancers. For this, we propose to study the evolution of thrombin generation by Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in patients with impaired renal function, and has a greater anti-biological activity thrombotic than other LMWH.

To assess whether the observed pattern of thrombin generation is particularly multiple myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical patients hospitalized for acute heart and respiratory failure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More

summary:
The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.

So in the elderly, the noxious character of the pain is more pregnant than at the young adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to deteriorate the isolation and the dependence: the echo on the psychic state is frequent and the pain is a part of the cause of a confusional state. Finally, the presence of a pain distorts considerably the quality of life and can modify the state general as the desire of life.

The evaluation of the pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than with the real age. For that purpose, the investigators have first of all scale of self-assessment as the numerical scale which is adapted to estimate the acute and chronic pains but this scale presents a bias because, certain patients do not express spontaneously their pain and this one must be attentively looked for in case of modification of behavior.

So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within one minute a good quality evaluation whatever is the place of care) whose objective is the observation of the behavioral changes caused by the acute pain in elderly having communication disorders.

Due to the demographic evolution, emergency departments are more and more frequently a place of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all the passages in emergency department and 50 % of the patients hospitalized during the passage in the reception of Emergency department are elderly. Elderly care is difficult for a certain number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this context, the evaluation of the presence of pain and its care are difficult in particular at the elderly with communication disorders.

In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on 700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of analgesic while 13 % only had a real quotation of the pain.

The aim of the investigators study is to analyze if the systematic introduction of the scale Algoplus® in the evaluation of elderly during its entrance to emergency department could modify the prescription of analgesic.

time_perspective: Cross-Sectional


title: Effets de la kétamine en Association Avec le Rt-PA au Cours de l'Infarctus cérébral Aigu: étude Pilote contrôlée randomisée en Double Aveugle Avec critère de Jugement Radiologique

acronym: KETA

summary: KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to determine if co-administration of ketamine with recombinant of tissue type plasminogen activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered with placebo, decreases cerebral infarction growth in diffusion weighted imaging between admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen within 4.5 h of onset with middle cerebral artery or distal internal carotid artery occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have 80% power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be enrolled.

ReferenceCitation: Nicole O, Docagne F, Ali C, Margaill I, Carmeliet P, MacKenzie ET, Vivien D, Buisson A. The proteolytic activity of tissue-plasminogen activator enhances NMDA receptor-mediated signaling. Nat Med. 2001 Jan;7(1):59-64.

ReferenceCitation: Gakuba C, Gauberti M, Mazighi M, Defer G, Hanouz JL, Vivien D. Preclinical evidence toward the use of ketamine for recombinant tissue-type plasminogen activator-mediated thrombolysis under anesthesia or sedation. Stroke. 2011 Oct;42(10):2947-9. doi: 10.1161/STROKEAHA.111.620468. Epub 2011 Aug 4.

lead_sponsor: University Hospital, Caen


title: Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients

acronym: eCOPD

summary:
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

Multicentric Randomized Controlled Trial

Primary Objective:

To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance

Secondary Objectives:

To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV

lead_sponsor: ResMed


lead_sponsor: Hospices Civils de Lyon

acronym: INTUITION

location_facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse

title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Iodiopathic Choroidal Neovascularization in Young Patients

summary:
After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50 years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown. This is a rare and severe disease, which can lead to blindness.

ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not need as many injections as in AMD.

INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE) regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in case of CNV activity).


title: Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

summary: Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

ReferenceCitation: Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.

lead_sponsor: Cardialen, Inc.


title: Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study

acronym: PSYCNEP

summary: A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.

location_facility: Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré


title: Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia

summary: Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

lead_sponsor: University Hospital, Clermont-Ferrand


acronym: POPCUR

title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease

summary:
Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible for the anti-inflammatory effect of curcumin

Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of Crohn's disease post-operative recurrence.


title: A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration

acronym: SONOCLOUD

summary:
PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy.

STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.

ReferenceCitation: Asquier N, Bouchoux G, Canney M, Martin C, Law-Ye B, Leclercq D, Chapelon JY, Lafon C, Idbaih A, Carpentier A. Blood-brain barrier disruption in humans using an implantable ultrasound device: quantification with MR images and correlation with local acoustic pressure. J Neurosurg. 2019 Feb 1;132(3):875-883. doi: 10.3171/2018.9.JNS182001.

name: 1CarThera, Institut du Cerveau et de la Moelle épinière, Paris;

name: 2LabTAU, INSERM, Centre Léon Bérard, Université Lyon 1, Lyon;

family: Asquier

full_name: Nicolas Asquier

given: Nicolas

family: Bouchoux

full_name: Guillaume Bouchoux

given: Guillaume

family: Canney

full_name: Michael Canney

given: Michael

family: Martin

full_name: Cyril Martin

given: Cyril

name: 3AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière–Charles Foix, Service de Neuroradiologie, Paris;

family: Law-Ye

full_name: Bruno Law-Ye

family: Leclercq

full_name: Delphine Leclercq

given: Delphine

family: Chapelon

full_name: Jean-Yves Chapelon

given: Jean-Yves

family: Lafon

full_name: Cyril Lafon

name: 4Sorbonne Université, INSERM, CNRS, UMR S 1127, Institut du Cerveau et de la Moelle épinière, AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière–Charles Foix, Service de Neurologie, Paris;

family: Idbaih

full_name: Ahmed Idbaih

given: Ahmed

name: 5AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière–Charles Foix, Service de Neurochirurgie, Paris; and

name: 6Sorbonne Université, Faculté de Médecine Pierre et Marie Curie, Paris, France

family: Carpentier

full_name: Alexandre Carpentier

given: Alexandre

journal_name: Journal of Neurosurgery

publisher: Journal of Neurosurgery Publishing Group (JNSPG)

publisher_dissemination: American Association of Neurological Surgeons

ReferenceCitation: Goldwirt L, Canney M, Horodyckid C, Poupon J, Mourah S, Vignot A, Chapelon JY, Carpentier A. Enhanced brain distribution of carboplatin in a primate model after blood-brain barrier disruption using an implantable ultrasound device. Cancer Chemother Pharmacol. 2016 Jan;77(1):211-6. doi: 10.1007/s00280-015-2930-5. Epub 2015 Dec 8.

family: Goldwirt

full_name: Lauriane Goldwirt

given: Lauriane

family: Horodyckid

full_name: Catherine Horodyckid

family: Poupon

full_name: Joel Poupon

given: Joel

family: Mourah

full_name: Samia Mourah

given: Samia

family: Vignot

full_name: Alexandre Vignot

journal_name: Cancer Chemotherapy and Pharmacology

title: Enhanced brain distribution of carboplatin in a primate model after blood–brain barrier disruption using an implantable ultrasound device

location_facility: Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department


title: Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase

acronym: MARILYN

summary: The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.

lead_sponsor: Thuasne

location_facility: CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires


title: Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis

acronym: POST-IMAGE

summary: Primary objective: To describe the evolution of cerebral lesions in IE patients (number of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

location_facility: Groupe Hospitalier Bichat - Claude Bernard


title: Feasibility of Dexmedetomidine-based Sedation in Neurocritical Care Patients : a Pilot Study

summary:
This will be an open, prospective pilot study with pharmacological analysis. This study is designed to assess the efficacity and safety of dexmedetomidine-based sedation in two subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48 hours. Those with or at risk for intracranial hypertension requiring deep sedation and those requiring a light to moderate sedation for early neurological evaluation.

The main objective is to assess the feasability of dexmedetomidine infusion in terms of efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted to intensive care unit and requiring sedation and mechanical ventilation for a predictable duration greater than or equal to 48 hours. Secondary objectives include the study of hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid) drug concentration, opioates and co-hypnotic consumption.


acronym: PORTO

title: Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.

summary: The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.


title: Study of Pharmacokinetic Variability of Glucocorticoids in Children

acronym: GLUCOPED

summary: The purpose of this study is to determine individual susceptibility factors (drug interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual variability towards corticosteroids (prednisone, prednisolone, methylprednisolone, hydrocortisone) in children, which could establish a base for therapeutic monitoring.

ReferenceCitation: Bartoszek M, Brenner AM, Szefler SJ. Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy. Clin Pharmacol Ther. 1987 Oct;42(4):424-32.

ReferenceCitation: Hoffmeyer S, Burk O, von Richter O, Arnold HP, Brockmöller J, Johne A, Cascorbi I, Gerloff T, Roots I, Eichelbaum M, Brinkmann U. Functional polymorphisms of the human multidrug-resistance gene: multiple sequence variations and correlation of one allele with P-glycoprotein expression and activity in vivo. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3473-8.

ReferenceCitation: Jamroziak K, Młynarski W, Balcerczak E, Mistygacz M, Trelinska J, Mirowski M, Bodalski J, Robak T. Functional C3435T polymorphism of MDR1 gene: an impact on genetic susceptibility and clinical outcome of childhood acute lymphoblastic leukemia. Eur J Haematol. 2004 May;72(5):314-21.

ReferenceCitation: Gatti G, Perucca E, Frigo GM, Notarangelo LD, Barberis L, Martini A. Pharmacokinetics of prednisone and its metabolite prednisolone in children with nephrotic syndrome during the active phase and in remission. Br J Clin Pharmacol. 1984 Apr;17(4):423-31.

ReferenceCitation: Miller PF, Bowmer CJ, Wheeldon J, Brocklebank JT. Pharmacokinetics of prednisolone in children with nephrosis. Arch Dis Child. 1990 Feb;65(2):196-200.

ReferenceCitation: Petersen KB, Jusko WJ, Rasmussen M, Schmiegelow K. Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2003 Jun;51(6):465-73. Epub 2003 Apr 16.

ReferenceCitation: Faure C, André J, Pelatan C, Munck A, Giraud M, Cèzard JP, Jacqz-Aigrain E. Pharmacokinetics of intravenous methylprednisolone and oral prednisone in paediatric patients with inflammatory bowel disease during the acute phase and in remission. Eur J Clin Pharmacol. 1998 Sep;54(7):555-60.


title: A Phase I/II Monocentric Trial of Cellular Immunotherapy Based on Autologous Tolerogenic Dendritic Cells (ATDCs) Administration in Patients With Renal Insufficiency Receiving as First Transplantation a Kidney Transplant From a Living-donor.

acronym: ONEatDC

summary: To collect evidence of the safety of administering autologous tolerogenic dendritic cells (ATDC) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluationg cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression in transplant recipients.

ReferenceCitation: Geissler EK. The ONE Study compares cell therapy products in organ transplantation: introduction to a review series on suppressive monocyte-derived cells. Transplant Res. 2012 Sep 28;1(1):11. doi: 10.1186/2047-1440-1-11.

ReferenceCitation: Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Böger CA, Scottà C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Öllinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyó J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7. Erratum in: Lancet. 2020 Jun 27;395(10242):1972.

family: Sawitzki

full_name: Birgit Sawitzki

given: Birgit

family: Harden

full_name: Paul N Harden

given: Paul N

family: Reinke

full_name: Petra Reinke

given: Petra

family: Moreau

full_name: Aurélie Moreau

given: Aurélie

family: Hutchinson

full_name: James A Hutchinson

given: James A

family: Game

full_name: David S Game

given: David S

family: Tang

full_name: Qizhi Tang

given: Qizhi

family: Guinan

full_name: Eva C Guinan

given: Eva C

family: Battaglia

full_name: Manuela Battaglia

given: Manuela

family: Burlingham

full_name: William J Burlingham

given: William J

family: Roberts

full_name: Ian S D Roberts

given: Ian S D

family: Streitz

full_name: Mathias Streitz

given: Mathias

family: Josien

full_name: Régis Josien

given: Régis

family: Böger

full_name: Carsten A Böger

given: Carsten A

family: Scottà

full_name: Cristiano Scottà

given: Cristiano

family: Markmann

full_name: James F Markmann

given: James F

family: Hester

full_name: Joanna L Hester

given: Joanna L

family: Juerchott

full_name: Karsten Juerchott

given: Karsten

family: Braudeau

full_name: Cecile Braudeau

given: Cecile

family: James

full_name: Ben James

given: Ben

family: Contreras-Ruiz

full_name: Laura Contreras-Ruiz

given: Laura

family: van der Net

full_name: Jeroen B van der Net

given: Jeroen B

family: Bergler

full_name: Tobias Bergler

given: Tobias

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)