title: Accuracy of a Portable International Normalized Ratio Monitor in a Population Aged 75 Years Old and Over

acronym: AGINR

summary:
Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé.

The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem.

University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects.

Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply.

The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.

ReferenceCitation: Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.

ReferenceCitation: Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. doi: 10.1136/heart.86.5.516.

ReferenceCitation: Bazzan M, Montaruli B, Vaccarino A, Fornari G, Saitta M, Prandoni P. Presence of low titre of antiphospholipid antibodies in cancer patients: a prospective study. Intern Emerg Med. 2009 Dec;4(6):491-5. doi: 10.1007/s11739-009-0316-6. Epub 2009 Sep 26.

ReferenceCitation: Sene D, Piette JC, Cacoub P. Antiphospholipid antibodies, antiphospholipid syndrome and infections. Autoimmun Rev. 2008 Feb;7(4):272-7. doi: 10.1016/j.autrev.2007.10.001. Epub 2007 Oct 23.

ReferenceCitation: Quemeneur T, Lambert M, Hachulla E, Dubucquoi S, Caron C, Fauchais AL, Devulder B, Hatron PY. Significance of persistent antiphospholipid antibodies in the elderly. J Rheumatol. 2006 Aug;33(8):1559-62.

ReferenceCitation: Perry SL, Samsa GP, Ortel TL. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. Thromb Haemost. 2005 Dec;94(6):1196-202. doi: 10.1160/TH05-06-0400.

lead_sponsor: University Hospital, Caen

location_facility: Centre hospitalier régional universitaire de Rouen

location_facility: Centre hospitalier régional universitaire d'Amiens

location_facility: Centre hospitalier régional universitaire de Lille

location_facility: Centre hospitalier régional universitaire de Caen


title: Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)

acronym: FERTIPRESERVE

summary:
Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.

As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Renault L, Labrune E, Giscard d'Estaing S, Cuzin B, Lapoirie M, Benchaib M, Lornage J, Soignon G, de Souza A, Dijoud F, Fraison E, Pral-Chatillon L, Bordes A, Sanlaville D, Schluth-Bolard C, Salle B, Ecochard R, Lejeune H, Plotton I. Delaying testicular sperm extraction in 47,XXY Klinefelter patients does not impair the sperm retrieval rate, and AMH levels are higher when TESE is positive. Hum Reprod. 2022 Oct 31;37(11):2518-2531. doi: 10.1093/humrep/deac203.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ReferenceCitation: Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: The Endocrine Society

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin

location_facility: Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier)

location_facility: Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon

location_facility: Service de Biologie de la Reproduction - Hôpital de la Conception

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation

acronym: PAPILLO-PMA

summary:
The main objective of this study is to investigate the association between the presence of HPV infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction.

The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve


title: Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study

acronym: SWEETMAC

summary: The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)

primary_purpose: Diagnostic

ReferenceCitation: Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.

license: cc-by

license_normalized: cc-by

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Francois Baclesse

collaborators:
Fondation avenir
laboratoire Genzyme

sponsor_collaborators:
Centre Francois Baclesse
Fondation avenir
laboratoire Genzyme

location_facility:
Centre François BACLESSE
CHU
Hôpital Pitié-salpétrière
Hôpital Américain de Paris

lead_sponsor_type: industriel


title: Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease

acronym: METISCARDIO

summary: A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.

lead_sponsor: Resicard

collaborators: union nationale de formation et d'evaluation en medecine cardio-vasculaire

location_facility:
Hopital Saint Antoine
Clinique Turin
Institut Coeur Effort Sante
Centre Cardiologique Alfred Kastler

intervention_type: Behavioral


title: Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes

acronym: PIEB

summary:
Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.

To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Montpellier

location_facility:
Hôpital Mère Enfant
CHU Bicêtre
CHU of Montpellier
CHU d'Estaing

intervention_type: Device

status_simplified: Unknown


title: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial

acronym: EVADELA

summary:
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.

Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Maternité du CH d'Avranches-Granville
Port-Royal Maternity Hospital
bluets maternity Hospital
CHU côte de nacre

intervention_type: Other


title: Frequency of Abnormal Glucose Metabolism (Diabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose) in the Immediate Postpartum Period Following Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

acronym: DG Post-Partum

summary: The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

ReferenceCitation: Cosma V, Imbernon J, Zagdoun L, Boulot P, Renard E, Brunet C, Mares P, Rodier M, Kabani S, Demattei C, Guedj AM. A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus. Sci Rep. 2021 May 17;11(1):10430. doi: 10.1038/s41598-021-89679-2.

oa_colors: green gold

evidence: oa journal (via doaj)

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

unpaywall_oa_status: gold

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

intervention_type: Biological


title: Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy

acronym: LAMVIRE

summary: Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Pr Marolleau
Chu Rouen
Chru Lille
CHU CAEN


title: IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY

acronym: SENTIMAG

summary: The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Sysmex America, Inc.

location_facility:
Centre Oscar Lambret
Centre Eugène Marquis
Centre Alexis Vautrin
Institut Claudius Regaud


title: Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"

summary: Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint

location_facility:
Centre Paul Strauss
Centre François Baclesse
Centre Henri Becquerel
Institut Gustave Roussy


title: Melatonin Dose-effect Relation in Childhood Autism

acronym: MELADOSE

summary:
Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion.

Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder.

These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.

ReferenceType: background

ReferenceCitation: Tordjman S, Chokron S, Delorme R, Charrier A, Bellissant E, Jaafari N, Fougerou C. Melatonin: Pharmacology, Functions and Therapeutic Benefits. Curr Neuropharmacol. 2017 Apr;15(3):434-443. doi: 10.2174/1570159X14666161228122115.

lead_sponsor: Rennes University Hospital

collaborators: Centre Hospitalier Guillaume Régnier, RENNES

location_facility: Service de Psychiatrie de l'Enfant et de l'Adolescent - Hôpital de la Pitié-Salpêtrière

location_facility: Centre Hospitalier Spécialisé Henri Laborit

location_facility: Service de Psychothérapie de l'Enfant et de l'Adolescent - Hôpital Robert Debré

location_facility: Pôle de Psychiatrie de l'Enfant et de l'Adolescent - Centre Hospitalier Guillaume Régnier

intervention_type: Drug


title: A Prospective, Non Randomized, Open, Multicenter Trial to Evaluate Non Specific Symptoms and Quality of Life (SF 36) Before and After Surgery for Mild Primary Hyperparathyroidism

summary: The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.

lead_sponsor: Nantes University Hospital

location_facility:
Marseille University Hospital
Nantes University Hospital
Angers University Hospital
Limoges University Hospital


title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.

acronym: NMDA-Autism

summary: Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

ReferenceType: result

ReferenceCitation: Bonnet-Brilhault F, Alirol S, Blanc R, Bazaud S, Marouillat S, Thepault RA, Andres CR, Lemonnier E, Barthelemy C, Raynaud M, Toutain A, Gomot M, Laumonnier F. GABA/Glutamate synaptic pathways targeted by integrative genomic and electrophysiological explorations distinguish autism from intellectual disability. Mol Psychiatry. 2016 Mar;21(3):411-8. doi: 10.1038/mp.2015.75. Epub 2015 Jun 9.

lead_sponsor: University Hospital, Tours

location_facility: CHRU - Centre de Ressources Autisme (CRA)


title: Study of Serum Hepcidin Rate Variations During Menstrual Cycle

acronym: HEPMEN

summary:
Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.

The interpretation of hepcidin dosage results requires to know the physiological variations of this hormone.

This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

location_facility:
CHU Rennes
Chu Brest
CHU Nantes
Chru Tours


title: Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

summary: There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.

status: Terminated

location_facility:
UH Marseill
UH NCaremeau
Chirurgy Plastic Department
UH Lyon


title: Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure

summary: This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.

lead_sponsor: Fisher and Paykel Healthcare

location_facility:
Hôpital Henri Mondor
Hôpital La Pitie Salpetriere
Hôpital Bichat-Claude Bernard
Hôpital Louis Mourier


title: Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial

summary: The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.

ReferenceCitation: Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.

oa_colors: green other

evidence: open (via free pdf)

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse
Centre Hospitalier Charles Perrens
Chru Lille
Chu Montpellier


type: EudraCT Number

title: Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT.

acronym: FOLAGLI

summary: O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Centre Antoine Lacassagne
Hospices Civils de Lyon

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin


title: Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy

acronym: DOMOLIM

summary:
The growth of the elderly population is associated with the autonomy failure and the increase of dependence problems. Fall incidents are the third cause of chronic disablement in older persons and are one of the major risk factors for entering in dependence.

The recent progress in home technologies and medical care are opportunities to search how to apply these tools to reduce and prevent falling at home.

The purpose of this study is to evaluate the cost effectiveness of simple home automation pack coupled to teleassistance service for preventing home falls in frail elderly population.

1200 patients will be enrolled and randmosied within two arms:

home with automation pack coupled to teleassistance service
home without this technology

lead_sponsor: University Hospital, Limoges

location_facility:
CH Bourganeuf
CHU Limoges
CH Aubusson
CH de Gueret


title: Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple

acronym: KALICOU

summary: The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.

location_facility:
François Baclesse Center
Hospital
Gustave Roussy Institut
Oscar Lambret Center


summary: The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.

lead_sponsor: Pierre Fabre Medicament


title: Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria

acronym: VOTRAGE

summary:
This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly patients, selected according to the International Society of Geriatric Oncology (SIOG)classification (Group 2).

It is expected that a total number of 30 patients maximum will be enrolled in the study on 30 months : 18 months accrual - 12 months follow up.

Eligible patients will be enrolled into a standard 3+3 design with a starting dose of Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels will be explored.

Toxicity of the schedule will be assessed during the first cycle. Patients will receive study medication until disease progression. After treatment discontinuation, patients will be followed during one year.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Novartis

location_facility:
Hôpital Saint André
Centre François BACLESSE
Centre Léon BERARD
Institut Claudius REGAUD


title: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

acronym: TOMOSEIN

summary: This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

primary_purpose: Screening

location_facility:
Clinique des Dentellières
Centre Hospitalier - Pavillon Paul Gelé
Centre Hospitalier
Oscar Lambret Center


title: Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies

acronym: TLI-ATG

summary: Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities associated with the transplant. Consequently non-relapse mortality has been reduced, including in elderly patients with comorbidities. However, despite this benefit in terms of toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal and viral infections are always serious complications. The aim of our study is to check if a new modality of reduced intensity preparative regimen combining total lymphoid irradiation (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.

location_facility:
Besançon University Hospital
Lille University Hospital
Nantes University Hospital
Lyon University Hospital


title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

acronym: CARDIOMEGA

summary: The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.

lead_sponsor: University Hospital, Rouen

location_facility:
Mahes Hospital
Rangueil University Hospital
Rouen University Hospital
George Pompidou European Hospital

intervention_type: Dietary Supplement


title: Impact of Essure Tubal Sterilization Devices on the Endometrium

summary: The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

summary: Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de TOULOUSE
CHU de NICE
Fondation Lenval
CHU de TOURS


title: Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur

summary:
Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.

However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.

The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.

The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.

ReferenceCitation: Dor-Nedonsel E, Menard ML, Fernandez A, Sakarovitch C, Fontas E, Salle-Collemiche X, Poinso F, Tosello AL, Maria F, Manera V, Askenazy F, Thummler S. Early-Onset Schizophrenia in a paediatric population of French psychiatric and medico-social care centres: A cross sectional study. PLoS One. 2020 Jul 27;15(7):e0236241. doi: 10.1371/journal.pone.0236241. eCollection 2020.

publisher_dissemination: Public Library of Science

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes

location_facility: Service de psychiatrie de l'enfant et de l'adolescent

location_facility: Psychiatrie infanto-juvénile-Pôle femme-mère -enfant


title: Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence

summary:
Alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.

The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a greater extent in subjects who had remained abstinent at 6 months after withdrawal than in subjects who had relapse.

To verify if the BDNF serum levels variation is linked to the way that abstinence is installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its evolution in relation to alcohol consumption, and other clinical characteristics : depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity. Monitoring serum BDNF concentrations in link with other clinical data could help to characterize alcohol dependence profiles in clinical practice, help predict relapses, and assist in adjusting care to prevent difficulties in alcohol withdrawal.

ReferenceCitation: Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.

ReferenceCitation: Pareaud M, Girard M, Nubukpo P. Factors for Maintaining Abstinence at 2 and 6 Months After Alcohol Withdrawal. J Psychiatr Pract. 2021 Jan 21;27(1):2-13. doi: 10.1097/PRA.0000000000000522.

lead_sponsor: Centre Hospitalier Esquirol

location_facility:
Centre Hospitalier Esquirol
Clinique Saint Maurice
Centre Hospitalier de Vauclaire
Centre Hospitalier La Vallette


title: Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

acronym: NeuroScS

summary: Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.

ReferenceCitation: Launay D, Remy-Jardin M, Michon-Pasturel U, Mastora I, Hachulla E, Lambert M, Delannoy V, Queyrel V, Duhamel A, Matran R, De Groote P, Hatron PY. High resolution computed tomography in fibrosing alveolitis associated with systemic sclerosis. J Rheumatol. 2006 Sep;33(9):1789-801.

lead_sponsor: University Hospital, Lille

location_facility:
Lille University hosiptal
Amiens Launay
Rouen University hospital
Caen University Hospital


title: Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination

summary:
Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.

A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

lead_sponsor: Narcisse Zwetyenga

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Universitaire, Amiens

location_facility: Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital

location_facility: Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire

location_facility: Maxillo-Facial Surgery, Besancon Univestitary Hospital

location_facility: Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens


title: Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

acronym: MRTOX

summary: The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.

lead_sponsor: Centre Francois Baclesse

location_facility:
Clinique du Bois
CHU de NANCY
Centre François Baclesse
Centre Georges-François Leclerc


title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

acronym: AADAPT

summary:
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.

Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)

location_facility:
CHU de Nice
Hôpital Bicêtre
CHU de Rangueil
CHRU Tours Hôpital Bretonneau


title: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

summary:
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.

Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.

The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.

The 5 years relapse-free survival will also be estimated.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Institut Paoli-Calmettes
Centre Antoine Lacassagne
Hopital La Timone
Centre jean Perrin

intervention_type: Genetic


title: VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

acronym: VASO-AM

summary: This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

primary_purpose: Basic Science

ReferenceCitation: Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

publisher_dissemination: British Medical Journal

ReferenceCitation: Gagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.

publisher_dissemination: American Thoracic Society

lead_sponsor: University Hospital, Angers

location_facility:
Hopital Saint Antoine
CH Le Mans
CHU Poitiers
CHU Grenoble


title: Assessment of an Innovative Visual Analogue Scale of Pain (Pictorial VAS) Versus the Usual VAS (VAS) Among Deaf People

summary:
The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial VAS) versus the usual VAS (VAS) among Deaf People.

The assumption of this study is that pictorial VAS is more suited to Deaf people than usual VAS.

ReferenceCitation: Dagron J. [Deafness and recourse to help, starting the dialog]. Soins. 2001 Dec;(661):37-9. No abstract available. French.

ReferenceCitation: Dagron J .Les silencieux. Chroniques de vingt ans de médecine avec les Sourds. Editions : Presse Pluriel, Paris. 2008 ; 287 p.

ReferenceCitation: Delaporte Y. Chapitre 1 : Qui sont les Sourds, histoire d'un mot. In : Les Sourds, c'est comme ça. Editions de la Maison des sciences de l'homme, Paris 2002 ; 398 p.

ReferenceCitation: Gillot Dominique. Le Droit des Sourds. Juin 1998. (mis en ligne le date : http://www.sante.gouv.fr/).

ReferenceCitation: Loi n°2005-102 du 11 février 2005. Pour l'égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées.

ReferenceCitation: Circulaire ministérielle n°DHOS/E1/DGS/SD1B/SD1C/SD4A/2006/90 du 2 mars 2006. La Charte de la personne hospitalisée.

ReferenceCitation: Circulaire N°99-84 du 11.02.1999. (Relative à la mise en place de protocole de prise en charge de la douleur).

lead_sponsor: University Hospital, Grenoble

location_facility:
La Pitié-Salpêtrière
University Hospital


acronym: PACHIU

lead_sponsor: University Hospital, Tours

summary:
Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections, without reducing the rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.

The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.

ReferenceCitation: Dinh A, Hallouin-Bernard MC, Davido B, Lemaignen A, Bouchand F, Duran C, Even A, Denys P, Perrouin-Verbe B, Sotto A, Lavigne JP, Bruyere F, Grall N, Tavernier E, Bernard L. Weekly Sequential Antibioprophylaxis for Recurrent Urinary Tract Infections Among Patients With Neurogenic Bladder: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3128-3135. doi: 10.1093/cid/ciz1207.

location_facility: University Hospital, Pontchaillou / RENNES

location_facility: University Hospital, Raymond Poincaré / APHP

location_facility: University Hospital, St Jacques / NANTES

title: A Randomized, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder

source: euctr


acronym: HYPOSPADES

lead_sponsor: Hospices Civils de Lyon

summary:
Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.

A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.

The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.

ReferenceCitation: Gorduza D, Plotton I, Remontet L, Gay CL, El Jani M, Cheikhelard A, Blanc T, El Ghoneimi A, Leclair MD, Roy P, Pirot F, Mimouni Y, Gaillard S, Chatelain P, Morel Y, Kassai B, Mouriquand P. Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa231. doi: 10.1210/clinem/dgaa231.

location_facility: Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant

title: Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications.


title: Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

summary:
Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic blisters. Neonatal period and infancy are critical since this autonomic dominant affection usually improves with age. Cyclins seem to be efficient in some cases of EBS but are prohibited in children younger than 8 years old. Erythromycin can be a good alternative in this population due to its antibacterial and anti-inflammatory potential.

The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after 3 months of treatment.

Primary end point is the number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin.

It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3 months. Follow up for each patient is 5 months. The duration of the study is 1 year.

location_facility:
Hôpital Saint Eloi
CHU de Dijon
Hôpital Purpan
CHU de Nice - Hôpital de Cimiez


title: Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease

acronym: FAIR-AD

summary:
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.

Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.

Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.

Method: Prospective multicentric study. 65 patients expected to enter the study.

Primary outcome measure: Standard Uptake Volume ratios.

location_facility:
University Hospital of Lille
university hospital of CAEN
University Hospital of Toulouse
University Hospital of Tours


title: Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients

summary: The T and B cells repertoire diversity represent one of the immune defence level which controls the integrity of the organism and determines its ability to recognize and control infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR diversity could permit to better understand how lymphopenia act on overall survival and to improve detection of high risk patients who could benefit of adapted therapies for better care.

ReferenceCitation: Belbaraka R, Tredan O, Ray-Coquard I, Chvetzoff G, Bajard A, Perol D, Ismaili N, Ismaili M, Errihani H, Bachelot T, Rebattu P. Factors of interrupting chemotherapy in patients with Advanced Non-Small-Cell Lung Cancer. BMC Res Notes. 2010 Jun 10;3:164. doi: 10.1186/1756-0500-3-164.

ReferenceCitation: Ray-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23.

lead_sponsor: Centre Leon Berard

collaborators: The Biostatistics and Therapy Evaluation Unit

location_facility:
Hopital Privé Jean Mermoz
Hopital de la Croix Rousse
Centre Léon Bérard
CHLS


title: Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers

acronym: CYPREANE

summary: To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

location_facility: Laboratoire Immunologie et Immunogénétique


title: Immunomonitoring of Children With Neuroblastoma for the Development of Antitumor Immunotherapy Strategies

acronym: Immuneuro

summary:
Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About 50% of the cases present at diagnosis with factors of bad prognosis. During the last two decades, despite increased therapeutic intensity during induction and consolidation of high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in between 30 to 40% depending on studies.

Besides strategies of high-dose chemotherapy followed by autologous transplantation of hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or molecules obtained such gains of survival ever before.

Studying the immune system of children with neuroblastoma at diagnosis and during their treatment will help us to determine when we should test active or passive immunotherapy strategies. Moreover, this study would allow us to specify the cause of tumor immune tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.

This will be a multicentric, pilot, prospective, open, study that will not require unusual diagnostic interventions. This study will be transversal (all neuroblastoma stages included) in order to determine comparative criteria between low and high risk neuroblastoma. It will also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.

Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment.

ReferenceCitation: Marabelle A, Merlin E, Halle P, Paillard C, Berger M, Tchirkov A, Rousseau R, Leverger G, Piguet C, Stephan JL, Demeocq F, Kanold J. CD34+ immunoselection of autologous grafts for the treatment of high-risk neuroblastoma. Pediatr Blood Cancer. 2011 Jan;56(1):134-42. doi: 10.1002/pbc.22840.

ReferenceCitation: Bertrand A, Marec-Berard P, Raverot G, Trouillas J, Marabelle A. Cabergoline therapy of paraneoplastic Cushing syndrome in children. Pediatr Blood Cancer. 2010 Sep;55(3):589-90. doi: 10.1002/pbc.22581. No abstract available.

ReferenceCitation: Marabelle A, Bergeron C, Billaud G, Mekki Y, Girard S. Hemophagocytic syndrome revealing primary HHV-6 infection. J Pediatr. 2010 Sep;157(3):511. doi: 10.1016/j.jpeds.2010.02.064. Epub 2010 Apr 18. No abstract available.

ReferenceCitation: Marabelle A, Sapin V, Rousseau R, Periquet B, Demeocq F, Kanold J. Hypercalcemia and 13-cis-retinoic acid in post-consolidation therapy of neuroblastoma. Pediatr Blood Cancer. 2009 Feb;52(2):280-3. doi: 10.1002/pbc.21768.

ReferenceCitation: Marabelle A, Campagne D, Dechelotte P, Chipponi J, Demeocq F, Kanold J. Focal nodular hyperplasia of the liver in patients previously treated for pediatric neoplastic diseases. J Pediatr Hematol Oncol. 2008 Jul;30(7):546-9. doi: 10.1097/MPH.0b013e3181691709.

ReferenceCitation: Kanold J, Paillard C, Tchirkov A, Merlin E, Marabelle A, Lutz P, Rousseau R, Baldomero H, Demeocq F. Allogeneic or haploidentical HSCT for refractory or relapsed solid tumors in children: toward a neuroblastoma model. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S25-30. doi: 10.1038/bmt.2008.279.

ReferenceCitation: Kanold J, Merlin E, Halle P, Paillard C, Marabelle A, Rapatel C, Evrard B, Berger C, Stephan JL, Galambrun C, Piguet C, D'Incan M, Bordigoni P, Demeocq F. Photopheresis in pediatric graft-versus-host disease after allogeneic marrow transplantation: clinical practice guidelines based on field experience and review of the literature. Transfusion. 2007 Dec;47(12):2276-89. doi: 10.1111/j.1537-2995.2007.01469.x. Epub 2007 Aug 30.

location_facility:
Chu Grenoble - Hopital Nord
IHOP
Chu - Hopital Nord
Hopital D'Estaing


title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.

acronym: EPIC-FOP

summary: The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

ReferenceCitation: Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.

publisher_dissemination: American College of Physicians

lead_sponsor: University Hospital, Brest

location_facility:
Brest University Hospital
CHU Dijon de Bocage
Centre Hospitalier de Cornouaille
Army Hospital


title: Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

summary: The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

location_facility: Hôpital Guy de Chauliac, CHU de Montpellier

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

acronym: Coca-Colon

summary: The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

ReferenceCitation: Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.

location_facility:
Centre Frédéric Joliot
Centre François Baclesse
University Hospital


title: Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation

acronym: RIO

summary: The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

publisher_dissemination: Wiley

location_facility:
Hopital de La Croix Rousse
Hopital Nord
Hopital de La Pitie Salpetriere
University Hospital


title: EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)

summary: SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.

location_facility:
Neurosurvery department
Neurology department - La timone
Neurology department - CHU Rangueil
Headache Emergency Center


title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

summary: This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

lead_sponsor: Hoffmann-La Roche


title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

summary: The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.

lead_sponsor: Nantes University Hospital

location_facility:
University Hospital of Angers
CH Saint Nazaire
CHD La Roche-sur-Yon
Nantes University Hospital


acronym: RV-405 LAL

lead_sponsor: Institut de Cancérologie de la Loire

summary: The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).

sponsor_collaborators:
Institut de Cancérologie de la Loire
Celgene Corporation

location_facility:
Hôpital Michallon
Institut de Cancerologie de la Loire
CHU de Clermont-Ferrand
Hôpital Edouard Herriot

title: A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Relapse After 2 Lines of Treatment


title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis

acronym: CDCHC

summary:
Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.

ReferenceCitation: Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Feray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.

location_facility:
Jean Verdier UH
Paul Brousse UH
Nantes UH
Rennes UH


type: Other Grant/Funding Number

title: Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge

acronym: MSAJOY

summary:
Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including cerebellar impairment and poor response to dopatherapy. The objective of the study is to assess right-hand motor activation in MSA patients before and after an acute levodopa challenge and to compare these data with those obtained in patients with Parkinson Disease (PD) and healthy volunteers (HV).

Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included. rCBF measurements with H215O PET will be performed at rest and during a right hand movement. Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON condition and effect of levodopa on motor activation.

Hypothesis: MSA and PD patient should recruited different motor networks.

lead_sponsor: University Hospital, Toulouse


title: Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol

acronym: CYTRAM

summary:
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.

O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.

The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).

The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

lead_sponsor: University Hospital, Caen

location_facility:
Rouen University Hospital
Private Clinic Saint-Martin
Créteil University Hospital
Caen University Hospital


title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

acronym: ATIM

summary: Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

primary_purpose: Supportive Care

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ReferenceCitation: Birkfellner W, Solar P, Gahleitner A, Huber K, Kainberger F, Kettenbach J, Homolka P, Diemling M, Watzek G, Bergmann H. In-vitro assessment of a registration protocol for image guided implant dentistry. Clin Oral Implants Res. 2001 Feb;12(1):69-78. doi: 10.1034/j.1600-0501.2001.012001069.x.

ReferenceCitation: Brosky ME, Korioth TW, Hodges J. The anterior cantilever in the implant-supported screw-retained mandibular prosthesis. J Prosthet Dent. 2003 Mar;89(3):244-9. doi: 10.1067/mpr.2003.43.

ReferenceCitation: Casap N, Wexler A, Persky N, Schneider A, Lustmann J. Navigation surgery for dental implants: assessment of accuracy of the image guided implantology system. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):116-9. doi: 10.1016/j.joms.2004.06.028.

ReferenceCitation: Casap N, Wexler A, Tarazi E. Application of a surgical navigation system for implant surgery in a deficient alveolar ridge postexcision of an odontogenic myxoma. J Oral Maxillofac Surg. 2005 Jul;63(7):982-8. doi: 10.1016/j.joms.2005.03.015.

ReferenceCitation: Delannes M, Daly NJ, Bonnet J, Sabatier J, Tremoulet M. Fractionated radiotherapy of small inoperable lesions of the brain using a non-invasive stereotactic frame. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):749-55. doi: 10.1016/0360-3016(91)90695-z.

ReferenceCitation: Esser E, Wagner W. Dental implants following radical oral cancer surgery and adjuvant radiotherapy. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):552-7.

ReferenceCitation: Esser E, Neukirchen S, Wagner W. [Comparative studies of Branemark implants in the irradiated and not irradiated mandible]. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S125-9. doi: 10.1007/PL00014498. German.

ReferenceCitation: Fortin T, Coudert JL, Champleboux G, Sautot P, Lavallee S. Computer-assisted dental implant surgery using computed tomography. J Image Guid Surg. 1995;1(1):53-8. doi: 10.1002/(SICI)1522-712X(1995)1:13.0.CO;2-L.

ReferenceCitation: Fortin T, Champleboux G, Lormee J, Coudert JL. Precise dental implant placement in bone using surgical guides in conjunction with medical imaging techniques. J Oral Implantol. 2000;26(4):300-3. doi: 10.1563/1548-1336(2000)0262.3.CO;2.

ReferenceCitation: Fortin T, Champleboux G, Bianchi S, Buatois H, Coudert JL. Precision of transfer of preoperative planning for oral implants based on cone-beam CT-scan images through a robotic drilling machine. Clin Oral Implants Res. 2002 Dec;13(6):651-6. doi: 10.1034/j.1600-0501.2002.130612.x.

ReferenceCitation: Fortin T, Bosson JL, Coudert JL, Isidori M. Reliability of preoperative planning of an image-guided system for oral implant placement based on 3-dimensional images: an in vivo study. Int J Oral Maxillofac Implants. 2003 Nov-Dec;18(6):886-93.

ReferenceCitation: Fortin T, Isidori M, Blanchet E, Perriat M, Bouchet H, Coudert JL. An image-guided system-drilled surgical template and trephine guide pin to make treatment of completely edentulous patients easier: a clinical report on immediate loading. Clin Implant Dent Relat Res. 2004;6(2):111-9. doi: 10.1111/j.1708-8208.2004.tb00033.x.

ReferenceCitation: Ganslandt O, Mueller R, Mueller W, Borchert H, Grabenbauer GG. Simple invasive fixation device for fractionated stereotactic LINAC based radiotherapy. Acta Neurochir (Wien). 2003 Apr;145(4):289-94; discussion 294. doi: 10.1007/s00701-003-0002-9.

ReferenceCitation: Gill SS, Thomas DG, Warrington AP, Brada M. Relocatable frame for stereotactic external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):599-603. doi: 10.1016/0360-3016(91)90076-g.

ReferenceCitation: Gulizio MP, Agar JR, Kelly JR, Taylor TD. Effect of implant angulation upon retention of overdenture attachments. J Prosthodont. 2005 Mar;14(1):3-11. doi: 10.1111/j.1532-849X.2005.00005.x.

ReferenceCitation: Henderson LA, Frysinger RC, Yu PL, Bandler R, Harper RM. A device for feline head positioning and stabilization during magnetic resonance imaging. Magn Reson Imaging. 2001 Sep;19(7):1031-6. doi: 10.1016/s0730-725x(01)00423-4.

ReferenceCitation: Kamath R, Ryken TC, Meeks SL, Pennington EC, Ritchie J, Buatti JM. Initial clinical experience with frameless radiosurgery for patients with intracranial metastases. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1467-72. doi: 10.1016/j.ijrobp.2004.08.021.

ReferenceCitation: Kassaee A, Das IJ, Tochner Z, Rosenthal DI. Modification of Gill-Thomas-Cosman frame for extracranial head-and-neck stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1192-5. doi: 10.1016/s0360-3016(03)00774-0.

ReferenceCitation: Marunick MT, Leveque F. Osteoradionecrosis related to mastication and parafunction. Oral Surg Oral Med Oral Pathol. 1989 Nov;68(5):582-5. doi: 10.1016/0030-4220(89)90244-2.

ReferenceCitation: Medin PM, Solberg TD, De Salles AA, Cagnon CH, Selch MT, Johnson JP, Smathers JB, Cosman ER. Investigations of a minimally invasive method for treatment of spinal malignancies with LINAC stereotactic radiation therapy: accuracy and animal studies. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1111-22. doi: 10.1016/s0360-3016(01)02762-6.

ReferenceCitation: Parel SM, Triplett RG. Interactive imaging for implant planning, placement, and prosthesis construction. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):41-7. doi: 10.1016/j.joms.2004.05.207.

ReferenceCitation: Quinones-Hinojosa A, Ware ML, Sanai N, McDermott MW. Assessment of image guided accuracy in a skull model: comparison of frameless stereotaxy techniques vs. frame-based localization. J Neurooncol. 2006 Jan;76(1):65-70. doi: 10.1007/s11060-005-2915-z.

ReferenceCitation: Rosenberg I, Alheit H, Beardmore C, Lee KS, Warrington AP, Brada M. Patient position reproducibility in fractionated stereotactic radiotherapy: an update after changing dental impression material. Radiother Oncol. 1999 Feb;50(2):239-40. doi: 10.1016/s0167-8140(99)00002-x.

ReferenceCitation: Rosenthal SJ, Gall KP, Jackson M, Thornton AF Jr. A precision cranial immobilization system for conformal stereotactic fractionated radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Dec 1;33(5):1239-45. doi: 10.1016/0360-3016(95)02009-8.

ReferenceCitation: Scott TW, Beach JL, Mendiondo OA. A precision repeat localization head frame for fractionated stereotactic radiotherapy. Med Dosim. 1997 Spring;22(1):5-8. doi: 10.1016/s0958-3947(96)00148-3.

ReferenceCitation: Siessegger M, Schneider BT, Mischkowski RA, Lazar F, Krug B, Klesper B, Zoller JE. Use of an image-guided navigation system in dental implant surgery in anatomically complex operation sites. J Craniomaxillofac Surg. 2001 Oct;29(5):276-81. doi: 10.1054/jcms.2001.0242.

ReferenceCitation: Sudbrink SD. Computer-guided implant placement with immediate provisionalization: a case report. J Oral Maxillofac Surg. 2005 Jun;63(6):771-4. doi: 10.1016/j.joms.2005.02.011.

ReferenceCitation: Theodorou K, Kappas C, Tsokas C. A new non-invasive and relocatable immobilization frame for fractionated stereotactic radiotherapy. Radiother Oncol. 1998 Jun;47(3):313-7. doi: 10.1016/s0167-8140(98)00015-2.

ReferenceCitation: Van Steenberghe D, Malevez C, Van Cleynenbreugel J, Bou Serhal C, Dhoore E, Schutyser F, Suetens P, Jacobs R. Accuracy of drilling guides for transfer from three-dimensional CT-based planning to placement of zygoma implants in human cadavers. Clin Oral Implants Res. 2003 Feb;14(1):131-6. doi: 10.1034/j.1600-0501.2003.140118.x.

ReferenceCitation: Vrielinck L, Politis C, Schepers S, Pauwels M, Naert I. Image-based planning and clinical validation of zygoma and pterygoid implant placement in patients with severe bone atrophy using customized drill guides. Preliminary results from a prospective clinical follow-up study. Int J Oral Maxillofac Surg. 2003 Feb;32(1):7-14. doi: 10.1054/ijom.2002.0337.

ReferenceCitation: Wagner A, Wanschitz F, Birkfellner W, Zauza K, Klug C, Schicho K, Kainberger F, Czerny C, Bergmann H, Ewers R. Computer-aided placement of endosseous oral implants in patients after ablative tumour surgery: assessment of accuracy. Clin Oral Implants Res. 2003 Jun;14(3):340-8. doi: 10.1034/j.1600-0501.2003.110812.x.

ReferenceCitation: Watzinger F, Ewers R, Henninger A, Sudasch G, Babka A, Woelfl G. Endosteal implants in the irradiated lower jaw. J Craniomaxillofac Surg. 1996 Aug;24(4):237-44. doi: 10.1016/s1010-5182(96)80007-2.

ReferenceCitation: Weischer T, Schettler D, Mohr C. Implant-supported telescopic restorations in maxillofacial prosthetics. Int J Prosthodont. 1997 May-Jun;10(3):287-92.

ReferenceCitation: Weischer T, Mohr C. Ten-year experience in oral implant rehabilitation of cancer patients: treatment concept and proposed criteria for success. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):521-8.

ReferenceCitation: Weischer T, Mohr C. Implant-supported mandibular telescopic prostheses in oral cancer patients: an up to 9-year retrospective study. Int J Prosthodont. 2001 Jul-Aug;14(4):329-34.

ReferenceCitation: Widmann G, Widmann R, Widmann E, Jaschke W, Bale RJ. In vitro accuracy of a novel registration and targeting technique for image-guided template production. Clin Oral Implants Res. 2005 Aug;16(4):502-8. doi: 10.1111/j.1600-0501.2005.01131.x.

ReferenceCitation: Kooy HM, Dunbar SF, Tarbell NJ, Mannarino E, Ferarro N, Shusterman S, Bellerive M, Finn L, McDonough CV, Loeffler JS. Adaptation and verification of the relocatable Gill-Thomas-Cosman frame in stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 1994 Oct 15;30(3):685-91. doi: 10.1016/0360-3016(92)90956-i.

collaborators: French Academic Institution, Financial support: PHRC 2007

location_facility: Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

location_facility: Centre Léon Bérard Service de Chirurgie-Stomatologie

location_facility: Hospices Civils de Lyon Service de Consultations et Traitements Dentaires


title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

acronym: Pétunia

summary: The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.

ReferenceCitation: Roze JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An alpha-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.

lead_sponsor: Sodilac

location_facility:
Hôpital Saint Vincent de Paul (AP-HP)
Hôpital de la Pitié Salpétrière
CHU de Nantes
CHU d'Angers


title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

summary:
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).

The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.

Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.

Primary objective:

To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.

Secondary Objectives:

Overall survival.
Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
Histological and seric proteomic exploratory studies.

location_facility:
Centre Léon BERARD
Institut PAOLI-CALMETTES
Centre Antoine LACASSAGNE
Chu Font-Pre


title: Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)

acronym: RBHP 2008

summary:
Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.

Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Merz Pharmaceuticals

location_facility:
Hôpital Haut-Levêque
CHU Purpan
Hôpital La Pitié Salpétrière
CHU Gabriel-Montpied


title: Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.

summary:
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). However, healing of those wounds can be made hard because of soiling induced by urine and/or stool, which is unavoidable in case of wearing nappies.

Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery wound dressing is protected by the application of a waterproof band aid (like Tegaderm®) during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse changes it, causing unpleasantness in low age children (whose epidermal fragility is well known), and sometimes parents worry.

Moreover, those occlusive wound dressings avoid any control of the surgical wound during healing phase.

At the end of the wound-healing time, wound dressings are removed, causing discomfort for children and necessity of a qualified nurse staff at visit times.

Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture in children is made with 5/0) and has its own local antiseptic properties. It does not need to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age distinction) seem to be equivalent to conventional sutures. Finally, its application goes with time saving (in preoperative and during wound-healing phase) and increases comfort for patients.

The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond® (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the acquisition of continence, by a non-inferiority randomized multicentric prospective study.

Two patient groups will be studied, the sutures of one control group will be made with a conventional technique (intradermic surjet surgical suture), and one patient group will be sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality (short- and long-term cosmetic aspect) evaluated by the surgeon.

Two secondary criteria will be studied :

Parental satisfaction
Ease of clinical nursing management Each studied criteria will be evaluated by a numeric score.

collaborators: Centre Hospitalier Régional Universitaire Montpellier

collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2

location_facility: Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants

location_facility: Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie


title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

acronym: PosoAnes

summary: The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

lead_sponsor: Hopital Foch

location_facility:
CHU Besançon
Hôpital Foch
Centre Hospitalier de Dreux
Hôpital Tenon


title: Development and Validation of Fungal Extraction and Real -Time PCR Assay for the Diagnosis of Medically Important Fungal Infections in Blood Samples.

summary:
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit.

The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. For these reasons, the investigators decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, could contribute strongly to the decision of treating using antifungals, and should monitor the effectiveness and the optimization of antifungal prescriptions.

The investigators' objectives are: First, to validate an extraction method from blood infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood samples of patients (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow the investigators to determine the sensitivity, specificity and reproducibility, negative and predictive values.

Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice - 4 avenue Reine Victoria
CHU de Touloluse - hôpital de Rangueil
CAL
CHU de Rennes


title: Comparison of Two Tranexamic Acid Dose Regimens on Transfusion Needs During Cardiac Surgery With Cardiopulmonary Bypass

acronym: Exacylcardio

summary:
Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA would be as accurate for haemostatic efficacy as higher dose.

The primary objective of this tri-center, prospective, double-blinded, randomised trial is to compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the perioperative blood loss.

In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted.

Patients are divided in two groups: low and high risk surgery. Methods: After written informed consent, patients are randomly assigned to one of the two treatment groups. The low dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30 mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation, and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A blood salvage device will be systematically used. The triggers for transfusion will be: red blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen less than 1g/l . All patients will receive standard anaesthesia and perioperative care.

In 60 consecutive patients in the principal investigator center, 5 blood samples will allow to assess the plasmatic concentration of tranexamic acid at different time of the surgery procedure:

Baseline
5 min after the loading dose
10 min after the beginning of bypass
at the discontinuation of the infusion
1 hour after the discontinuation Plasmatic dosage will be assessed using a high performance liquid chromatography technique.

Patients will be stratified in two groups for the statistical analysis; low and high risk surgery. Analysis will be in intention to treat. 300 patients should be recruited in each group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20% (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion between patients receiving high dose TA regimen and those receiving low dose TA regimen, assuming a power of 80% and a two-tailed value less than 0.05.

ReferenceCitation: Grassin-Delyle S, Tremey B, Abe E, Fischler M, Alvarez JC, Devillier P, Urien S. Population pharmacokinetics of tranexamic acid in adults undergoing cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2013 Dec;111(6):916-24. doi: 10.1093/bja/aet255. Epub 2013 Jul 23.

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

location_facility: department of anesthesiology, Haut Leveque Hospital

location_facility: department of anaesthesiology, CHU Jean Minjoz

location_facility: department of anesthesiology, Bichat Hospital


title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

acronym: TOTEME

summary:
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.

ReferenceCitation: Kulkarni R, Bellamy E. Nickel-titanium shape memory alloy Memokath 051 ureteral stent for managing long-term ureteral obstruction: 4-year experience. J Urol. 2001 Nov;166(5):1750-4.

ReferenceCitation: Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72. doi: 10.1080/00365590510007720.

ReferenceCitation: Pariente JL, Conort P. [Biomaterials used in contact with the urinary tract for urine drainage: catheters and ureteric stents]. Prog Urol. 2005 Nov;15(5):897-906. No abstract available. French.

ReferenceCitation: Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4. doi: 10.1159/000020250.

ReferenceCitation: Kehinde EO, Rotimi VO, Al-Awadi KA, Abdul-Halim H, Boland F, Al-Hunayan A, Pazhoor A. Factors predisposing to urinary tract infection after J ureteral stent insertion. J Urol. 2002 Mar;167(3):1334-7.

ReferenceCitation: Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-J ureteral stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007 Jul;21(7):698-702. doi: 10.1089/end.2007.9949.

ReferenceCitation: Hubner WA, Plas EG, Stoller ML. The double-J ureteral stent: in vivo and in vitro flow studies. J Urol. 1992 Aug;148(2 Pt 1):278-80. doi: 10.1016/s0022-5347(17)36572-2.

ReferenceCitation: Poulsen AL, Schou J, Ovesen H, Nordling J. Memokath: a second generation of intraprostatic spirals. Br J Urol. 1993 Sep;72(3):331-4. doi: 10.1111/j.1464-410x.1993.tb00728.x.

ReferenceCitation: Laaksovirta S, Valimaa T, Isotalo T, Tormala P, Talja M, Tammela TL. Encrustation and strength retention properties of the self-expandable, biodegradable, self-reinforced L-lactide-glycolic acid co-polymer 80:20 spiral urethral stent in vitro. J Urol. 2003 Aug;170(2 Pt 1):468-71. doi: 10.1097/01.ju.0000076389.88489.af.

ReferenceCitation: Vaidyanathan S, Soni BM, Oo T, Sett P, Hughes PL, Singh G. Long-term result of Memokath urethral sphincter stent in spinal cord injury patients. BMC Urol. 2002 Nov 11;2:12. doi: 10.1186/1471-2490-2-12. Epub 2002 Nov 11.

ReferenceCitation: Perry MJ, Roodhouse AJ, Gidlow AB, Spicer TG, Ellis BW. Thermo-expandable intraprostatic stents in bladder outlet obstruction: an 8-year study. BJU Int. 2002 Aug;90(3):216-23. doi: 10.1046/j.1464-410x.2002.02888.x.

ReferenceCitation: Arya M, Mostafid H, Patel HR, Kellett MJ, Philp T. The self-expanding metallic ureteric stent in the long-term management of benign ureteric strictures. BJU Int. 2001 Sep;88(4):339-42. doi: 10.1046/j.1464-410x.2001.02322.x.

lead_sponsor: University Hospital, Bordeaux

location_facility: Department of Urology, University Hospital, Bordeaux

location_facility: Department of Urology, Hospices Civils de Lyon

location_facility: Department of Urology, University Hospital, Toulouse

location_facility: Department of Urology, University Hospital, Limoges


title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

acronym: ROTEM

summary:
Cardiac surgery is bleeding requiring transfusion surgery .

The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.

All these changes contribute to increase the need for transfusions during heart surgery.

The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.

100 pateinst (50 in each arm) should be included in this trial.

lead_sponsor: University Hospital, Limoges

collaborators: Laboratoire français de Fractionnement et de Biotechnologies

location_facility: Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale


title: Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors, Daily Physical Activity, Dietary Habits and Blood Glucose and Fatty Acids in Coronary Syndromes Patients

acronym: OLIMPIC

summary:
In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.

Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:

an inhospital short health educational program alone
an inhospital short health educational program combined to cardiac rehabilitation
a cardiac rehabilitation program alone

ReferenceCitation: De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. doi: 10.1016/s0195-668x(03)00347-6. No abstract available.

ReferenceCitation: AHA; ACC; National Heart, Lung, and Blood Institute; Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2006 May 16;47(10):2130-9. doi: 10.1016/j.jacc.2006.04.026. No abstract available.

ReferenceCitation: Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. doi: 10.1161/CIRCULATIONAHA.106.180945. Epub 2007 May 18.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Centre Médical de Chavanne
CH de Feurs
CHU de Saint-Etienne
CH de Firminy