title: Genetic Study on the Familial Forms of Intracranial Aneurysm

acronym: GAÏA

summary:
Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death.

Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of an IA in a given individual. Also, there is no pharmacological drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the management of patients with IA remains extremely challenging and still controversial.

Although the pathogenesis of IA has been the subject of many studies for the last decade, the mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant animal models of IA are not available.

Familial history of IA predisposes to IA formation and rupture and increasing evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance and penetrance.

This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and predictive tools of risk of IA.

The investigators propose to identify IA-causing variants by whole-exome sequencing in familial forms of the disease.

The investigators hypothesises that the functional analysis of the causal / susceptibility variants thus identified will provide clues to understanding the pathological mechanisms of IA formation, and the bases for developing diagnostic tools. This project aims at meeting this challenge. Based on preliminary data that already allowed to identify such a variant, and the combination of genetic and functional investigations, the specific objectives of this project are: - To identify IA-causing variants in familial forms of the disease by whole-exome sequencing; - To understand the function of these genes/ variants in the formation and rupture of IA by molecular and cellular approaches and generation of relevant animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.

ReferenceCitation: Canham PB, Finlay HM. Morphometry of medial gaps of human brain artery branches. Stroke. 2004 May;35(5):1153-7. doi: 10.1161/01.STR.0000124926.76836.df. Epub 2004 Mar 11.

ReferenceCitation: Rhoton AL Jr. Aneurysms. Neurosurgery. 2002 Oct;51(4 Suppl):S121-58. No abstract available.

ReferenceCitation: Rinkel GJ, Djibuti M, Algra A, van Gijn J. Prevalence and risk of rupture of intracranial aneurysms: a systematic review. Stroke. 1998 Jan;29(1):251-6. doi: 10.1161/01.str.29.1.251.

ReferenceCitation: Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0.

ReferenceCitation: Ronkainen A, Hernesniemi J, Ryynanen M. Familial subarachnoid hemorrhage in east Finland, 1977-1990. Neurosurgery. 1993 Nov;33(5):787-96; discussion 796-97. doi: 10.1227/00006123-199311000-00001.

ReferenceCitation: Zuurbier CCM, Bourcier R, Constant Dit Beaufils P, Redon R, Desal H; ICAN Investigators; Bor ASE, Lindgren AE, Rinkel GJE, Greving JP, Ruigrok YM. Number of Affected Relatives, Age, Smoking, and Hypertension Prediction Score for Intracranial Aneurysms in Persons With a Family History for Subarachnoid Hemorrhage. Stroke. 2022 May;53(5):1645-1650. doi: 10.1161/STROKEAHA.121.034612. Epub 2022 Feb 11.

ReferenceCitation: Bakker MK, van der Spek RAA, van Rheenen W, Morel S, Bourcier R, Hostettler IC, Alg VS, van Eijk KR, Koido M, Akiyama M, Terao C, Matsuda K, Walters RG, Lin K, Li L, Millwood IY, Chen Z, Rouleau GA, Zhou S, Rannikmae K, Sudlow CLM, Houlden H, van den Berg LH, Dina C, Naggara O, Gentric JC, Shotar E, Eugene F, Desal H, Winsvold BS, Borte S, Johnsen MB, Brumpton BM, Sandvei MS, Willer CJ, Hveem K, Zwart JA, Verschuren WMM, Friedrich CM, Hirsch S, Schilling S, Dauvillier J, Martin O; HUNT All-In Stroke; China Kadoorie Biobank Collaborative Group; BioBank Japan Project Consortium; ICAN Study Group; CADISP Group; Genetics and Observational Subarachnoid Haemorrhage (GOSH) Study investigators; International Stroke Genetics Consortium (ISGC); Jones GT, Bown MJ, Ko NU, Kim H, Coleman JRI, Breen G, Zaroff JG, Klijn CJM, Malik R, Dichgans M, Sargurupremraj M, Tatlisumak T, Amouyel P, Debette S, Rinkel GJE, Worrall BB, Pera J, Slowik A, Gaal-Paavola EI, Niemela M, Jaaskelainen JE, von Und Zu Fraunberg M, Lindgren A, Broderick JP, Werring DJ, Woo D, Redon R, Bijlenga P, Kamatani Y, Veldink JH, Ruigrok YM. Genome-wide association study of intracranial aneurysms identifies 17 risk loci and genetic overlap with clinical risk factors. Nat Genet. 2020 Dec;52(12):1303-1313. doi: 10.1038/s41588-020-00725-7. Epub 2020 Nov 16. Erratum In: Nat Genet. 2020 Dec 22;:

version: acceptedVersion

repository_institution: University of Oslo - Duo Research Archive

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ReferenceCitation: Bourcier R, Le Scouarnec S, Bonnaud S, Karakachoff M, Bourcereau E, Heurtebise-Chretien S, Menguy C, Dina C, Simonet F, Moles A, Lenoble C, Lindenbaum P, Chatel S, Isidor B, Genin E, Deleuze JF, Schott JJ, Le Marec H; ICAN Study Group; Loirand G, Desal H, Redon R. Rare Coding Variants in ANGPTL6 Are Associated with Familial Forms of Intracranial Aneurysm. Am J Hum Genet. 2018 Jan 4;102(1):133-141. doi: 10.1016/j.ajhg.2017.12.006.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

location_facility:
Nantes University Hospital
AP-HP, Henri Mondor hospital
Tours University Hospital
University Hospital Poitiers
Rouen University Hospital
Bordeaux University Hospital
University Hospital Rennes
CHD La Roche sur YON


title: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort

acronym: Pancreas-CGE

summary: This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire Robert Debré

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

acronym: FRACTION

summary: The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Steinmeyer Z, Gerard S, Filleron T, Lozano S, Brechemier D, Abellan Van Kan G, Mourey L, Cristol-Dalstein L, De Decker L, Rolland Y, Balardy L. Low lean mass and chemotherapy toxicity risk in the elderly: the Fraction study protocol. BMC Cancer. 2019 Nov 27;19(1):1153. doi: 10.1186/s12885-019-6377-7.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility: Institut du Cancer de Montpellier Val d'Aurelle

status_simplified: Completed


title: Implementation of a Screening Tool for Subjects With Benign Prostatic Enlargement/Obstruction to Identify Men >=50 Years Presenting in General Practice With Other Co-morbidities Who Should be Assessed for BPH

summary: This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may help a General Practitioners (GP) to identify subjects who may have BPH for further tests and improve the speed of referrals to specialists when this is appropriate. The utility of the screening tool will be compared to the validated tool in wide clinical use, the International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of this screening tool will be used for further investigation. All subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based upon screening results and lab tests which suggest that they are related to BPH and not other causes of such symptoms. The GP will phone the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it will be considered that the subject has completed the study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This assessment includes a DRE and a brief physical exam and review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for probable BPH to yield 500 subjects being referred to an urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit scheduling.

primary_purpose: Screening

ReferenceCitation: Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nephrol. 2022 Feb;74(1):85-92. doi: 10.23736/S2724-6051.20.03834-5. Epub 2020 Sep 29.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Spain
Russian Federation
France

lead_sponsor_type: industriel


title: Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face - Study PICAMEL

acronym: PICAMEL

summary:
Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma cells, limited to the epidermis. It is found most commonly on the head and neck of elderly persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin. However, the lesions can be large, and conventional surgery can be difficult, particularly on the face.

Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis and superficial dermis.

Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or a prolonged remission of non-invasive LM.

Because of the exploratory phase of this study (no case report and no clinical trial at the early phase of designing this study, only one case report at the time of submission of this form) the investigators will conduct an open label study limited to patients who are not eligible to, or who refuse surgical treatment of their LM.

The main objective of this study is to determine the proportion of patients with complete response (CR) obtained 2 months after one or two cycles (for patients who did not respond to the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head and neck).

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
Hôpital Pontchaillou
CHRU de Lille
CHU de Saint Etienne
Hôpital du Morvan
CHU de Nantes
AP-HP Hôpital Ambroise Paré
AP-HP Hopital Avicenne

intervention_type: Drug


title: Phase II Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life

summary:
Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing. As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy, concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven efficacy on locoregional control, anal sphincter preservation, progression-free survival and complete response rate higher than 80%.

Nevertheless, conventional radiotherapy frequently induces significant non-haematological toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.

Considering the numerous anatomic pelvic structures, ACC has become a localisation of interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.

However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose escalade did not show its interest: 60 Grays remains the standard.

Assuming the deleterious effect of increased overall treatment time on local control and survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the benefit of no irradiation break on ACC tumour control is of interest.

IMRT offers the possibility to deliver different doses to different target volumes simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results were observed with moderate doses and schedules delivering higher doses with short interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.

status: Active, not recruiting

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Accuray Incorporated

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

status_simplified: Ongoing


title: A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

acronym: PROTRACH

summary: The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Guitton C, Ehrmann S, Volteau C, Colin G, Maamar A, Jean-Michel V, Mahe PJ, Landais M, Brule N, Bretonniere C, Zambon O, Vourc'h M. Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial. Intensive Care Med. 2019 Apr;45(4):447-458. doi: 10.1007/s00134-019-05529-w. Epub 2019 Jan 21.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Springer-Nature

lead_sponsor: Nantes University Hospital

location_facility: Nantes University hospital, Hôpital Laennec, pneumology intensive care unit

location_facility: Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit

location_facility: Brest hospital, CHU La cavale Blanche, medical intensive care unit

location_facility: Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit

location_facility: CHD LES OUDOUAIRIES Service de réanimation polyvalente

location_facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

location_facility: Tours university hospital, hôpital Bretonneau, medical intensive care unit

intervention_type: Device

appel_a_projets: PHRCI

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: PROTRACH

titre: Etude prospective, multicentrique, randomisée, ouverte et contrôlée évaluant l'intérêt d'un système d'oxygénation à haut débit lors de la pré oxygénation pour l'intubation en Réanimation du malade non sévèrement hypoxémique

discipline_principale: autre

nom_porteur: ZAMBON

prenom_porteur: Olivier


title: Evaluation of Treatment Response With CHOI and RECIST Criteria and CT Texture Analysis in Patients With Metastatic Colorectal Cancer Treated With Regorafenib. A GERCOR Phase II Study

acronym: TEXCAN

summary:
The purpose of the study is to evaluate the performance of various tumor response criteria (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.

Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic texture analysis (CTTA)

ReferenceCitation: Rousseau B, Boukerma AK, Henriques J, Cohen R, Lucidarme O, Borg C, Tournigand C, Kim S, Bachet JB, Mazard T, Louvet C, Chibaudel B, Vernerey D, Andre T, Hulin A. Impact of trough concentrations of regorafenib and its major metabolites M-2 and M-5 on overall survival of chemorefractory metastatic colorectal cancer patients: Results from a multicentre GERCOR TEXCAN phase II study. Eur J Cancer. 2022 Jun;168:99-107. doi: 10.1016/j.ejca.2022.03.009. Epub 2022 Apr 27.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Lucidarme O, Wagner M, Gillard P, Kim S, Bachet JB, Rousseau B, Mazard T, Louvet C, Chibaudel B, Cohen R, Garcia-Larnicol ML, Gobert A, Henriques J, Andre T. RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study. Cancer Imaging. 2019 Dec 9;19(1):85. doi: 10.1186/s40644-019-0271-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Saint Antoine
CHU Jean Minjoz
ICM Val D'Aurelle
Hôpital Pitié Salpêtrière
Hôpitlal Henri Mondor
Institut Hospitalier Franco-Britannique
Insitut Mutualiste Montouris
CHRU Claude Huriez


title: EXpanded CELL ENdocardiac Transplantation (EXCELLENT)

acronym: EXCELLENT

summary: A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.

lead_sponsor: CellProthera

location_country:
United Kingdom
France

location_facility: Saint Bartholomew's Hospital W Smithfield,

location_facility: CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming

location_facility: CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel

location_facility: BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,

location_facility: Leeds University & Leeds Teaching Hospitals NHS Trust


type: Other Identifier

title: Evaluation of the Circulating Concentration of Olfactomédine 4 (OLFM4) in Women With a BRCA1 or 2 Gene Mutation or at High Risk of Developing Breast Cancer, According to the Imaging

summary: Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

status: Recruiting

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Instit de Cancérologie de l'Ouest
CHBA Hopital Chubert
CH
Institut de Cancerologie de l'Ouest
CHU Morvan
CHU Bretonneau
CHU La Mileterie

intervention_type: Biological

nom_etablissement: ICO - SITE PAUL PAPIN

type_etablissement: CLCC

titre: Évaluation de la concentration circulante de l'Olfactomédine 4 (OLFM4) chez des femmes présentant une mutation du gène BRCA1 ou 2 ou à haut risque de développer un cancer du sein, en fonction de l'imagerie

nom_porteur: AUGEREAU

prenom_porteur: Paule


title: Assessment of Food Practices by Residents in Nursing Homes, Study of Relationship Between Food Intake and Nutritional Status.

summary:
Nutrition is an essential component of health and a key determinant of aging and quality of life of individuals. Malnutrition in the elderly is now recognized as a public health problem affecting nearly half of residents in nursing homes. The fight against malnutrition requires to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve practices of care at the elderly, the impact of environmental and social aspects of food in nursing homes has been assessed. The social environment and interactions during the meals are now identified as effective ways to stimulate food intake and increase feelings of well-being in the elderly.

The objectives of the study are to characterize the appreciation of food and social interactions during the meals and to study the relationships between the quality of food practices and nutritional status of the residents in nursing homes to improve their quality of life.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Les Alizés
Castellane
La Vérandine
Les Volubilis
Les Acanthes
Les Althéas
Les Cristallines
Les Amandines


title: A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.

acronym: NETIFLOW

summary: The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.

ReferenceCitation: Homer JJ, England RJ, Wilde AD, Harwood GR, Stafford ND. The effect of pH of douching solutions on mucociliary clearance. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):312-5. doi: 10.1046/j.1365-2273.1999.00265.x.

ReferenceType: result

ReferenceCitation: Aarbiou J, Verhoosel RM, Van Wetering S, De Boer WI, Van Krieken JH, Litvinov SV, Rabe KF, Hiemstra PS. Neutrophil defensins enhance lung epithelial wound closure and mucin gene expression in vitro. Am J Respir Cell Mol Biol. 2004 Feb;30(2):193-201. doi: 10.1165/rcmb.2002-0267OC. Epub 2003 Jul 18.

ReferenceCitation: Adam P, Stiffman M, Blake RL Jr. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998 Jan-Feb;7(1):39-43. doi: 10.1001/archfami.7.1.39.

ReferenceCitation: Bardou O, Trinh NT, Brochiero E. Molecular diversity and function of K+ channels in airway and alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2009 Feb;296(2):L145-55. doi: 10.1152/ajplung.90525.2008. Epub 2008 Dec 5.

ReferenceCitation: Bernstein IL. Is the use of benzalkonium chloride as a preservative for nasal formulations a safety concern? A cautionary note based on compromised mucociliary transport. J Allergy Clin Immunol. 2000 Jan;105(1 Pt 1):39-44. doi: 10.1016/s0091-6749(00)90175-1.

ReferenceCitation: Bieger-Farhan AK, Nichani J, Willatt DJ. Nasal septal mucosal contact points: associated symptoms and sinus CT scan scoring. Clin Otolaryngol Allied Sci. 2004 Apr;29(2):165-8. doi: 10.1111/j.0307-7772.2004.00774.x.

ReferenceCitation: Boek WM, Keles N, Graamans K, Huizing EH. Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Laryngoscope. 1999 Mar;109(3):396-9. doi: 10.1097/00005537-199903000-00010.

ReferenceCitation: Braiman A, Priel Z. Efficient mucociliary transport relies on efficient regulation of ciliary beating. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):202-7. doi: 10.1016/j.resp.2008.05.010. Epub 2008 May 22.

ReferenceCitation: Britton J, Pavord I, Richards K, Wisniewski A, Knox A, Lewis S, Tattersfield A, Weiss S. Dietary magnesium, lung function, wheezing, and airway hyperreactivity in a random adult population sample. Lancet. 1994 Aug 6;344(8919):357-62. doi: 10.1016/s0140-6736(94)91399-4.

ReferenceCitation: Buchanan PJ, McNally P, Harvey BJ, Urbach V. Lipoxin A(4)-mediated KATP potassium channel activation results in cystic fibrosis airway epithelial repair. Am J Physiol Lung Cell Mol Physiol. 2013 Jul 15;305(2):L193-201. doi: 10.1152/ajplung.00058.2013. Epub 2013 May 17.

oa_host_type: closed

publisher_dissemination: American Physiological Society

ReferenceCitation: Burgel PR, Nadel JA. Roles of epidermal growth factor receptor activation in epithelial cell repair and mucin production in airway epithelium. Thorax. 2004 Nov;59(11):992-6. doi: 10.1136/thx.2003.018879.

ReferenceCitation: Campos J, Heppt W, Weber R. Nasal douches for diseases of the nose and the paranasal sinuses--a comparative in vitro investigation. Eur Arch Otorhinolaryngol. 2013 Nov;270(11):2891-9. doi: 10.1007/s00405-013-2398-z. Epub 2013 Feb 28.

publisher_dissemination: Springer

ReferenceCitation: Chen EY, Yang N, Quinton PM, Chin WC. A new role for bicarbonate in mucus formation. Am J Physiol Lung Cell Mol Physiol. 2010 Oct;299(4):L542-9. doi: 10.1152/ajplung.00180.2010. Epub 2010 Aug 6.

ReferenceCitation: Christopher K, Chang J, Goldberg J. Stimulation of cilia beat frequency by serotonin is mediated by a Ca2+ influx in ciliated cells of Helisoma trivolvis embryos. J Exp Biol. 1996;199(Pt 5):1105-13. doi: 10.1242/jeb.199.5.1105.

ReferenceCitation: Ciarallo L, Sauer AH, Shannon MW. Intravenous magnesium therapy for moderate to severe pediatric asthma: results of a randomized, placebo-controlled trial. J Pediatr. 1996 Dec;129(6):809-14. doi: 10.1016/s0022-3476(96)70023-9.

ReferenceCitation: Clark AB, Randell SH, Nettesheim P, Gray TE, Bagnell B, Ostrowski LE. Regulation of ciliated cell differentiation in cultures of rat tracheal epithelial cells. Am J Respir Cell Mol Biol. 1995 Mar;12(3):329-38. doi: 10.1165/ajrcmb.12.3.7873199.

ReferenceCitation: Clarke RW, Jones AS. Nasal airflow sensation. Clin Otolaryngol Allied Sci. 1995 Apr;20(2):97-9. doi: 10.1111/j.1365-2273.1995.tb00022.x. No abstract available.

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ReferenceCitation: Coraux C, Martinella-Catusse C, Nawrocki-Raby B, Hajj R, Burlet H, Escotte S, Laplace V, Birembaut P, Puchelle E. Differential expression of matrix metalloproteinases and interleukin-8 during regeneration of human airway epithelium in vivo. J Pathol. 2005 Jun;206(2):160-9. doi: 10.1002/path.1757.

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publisher_dissemination: Wiley

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location_facility: Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin

location_facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin

location_facility: ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil

location_facility: ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse

location_facility: Service ORL et Chirurgie cervico-faciale - CHRU Lille

location_facility: Service d'ORL et Chirurgie cervico faciale - CHRU Tours

location_facility: Service ORL et Chirurgie Cervico-faciale - CHRU Nancy

location_facility: Service d'oto-rhino-laryngologie - CHU de Nantes


title: Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

acronym: SUP-R

summary:
This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study.

Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).

The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.

design_allocation: Non-Randomized

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
University Hospital, Bordeaux

location_facility:
Institut Regional Du Cancer Montpellier
Institut Bergonie
Institut Claudius Regaud
CHU DE LIMOGES - Hôpital Dupuytren
Centre Leon Berard
CH RODEZ
CHU DE BORDEAUX - Hôpital Saint-André
Institut Paoli Calmettes


title: Etude Prospective Observationnelle Multicentrique Sur Volontaires Sains Des VALeurs de Pression Artérielle mesurées Sur Trois Sites alteRnAtIfS Des Membres inférieurs cOmparées au Site de référence

acronym: VALPARAISO

summary:
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial).

The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible .

We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm.

It is also assessing the impact of certain parameters on the primary endpoint:

Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures.
A parameter related to measurement: discomfort felt when the blood pressure outlet.
Exposure setting: smoking.

status: Available

study_type: Expanded Access

ReferenceCitation: Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.

ReferenceCitation: Block FE, Schulte GT. Ankle blood pressure measurement, an acceptable alternative to arm measurements. Int J Clin Monit Comput. 1996 Aug;13(3):167-71. doi: 10.1023/a:1016997232542.

ReferenceCitation: Sanghera S, North A, Abernethy S, Wrench I. Arm and ankle blood pressure during caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):24-7. doi: 10.1016/j.ijoa.2005.04.016. Epub 2005 Oct 26.

ReferenceCitation: Moore C, Dobson A, Kinagi M, Dillon B. Comparison of blood pressure measured at the arm, ankle and calf. Anaesthesia. 2008 Dec;63(12):1327-31. doi: 10.1111/j.1365-2044.2008.05633.x.

ReferenceCitation: Lakhal K, Macq C, Ehrmann S, Boulain T, Capdevila X. Noninvasive monitoring of blood pressure in the critically ill: reliability according to the cuff site (arm, thigh, or ankle). Crit Care Med. 2012 Apr;40(4):1207-13. doi: 10.1097/CCM.0b013e31823dae42.

lead_sponsor: Centre Hospitalier Sud Francilien

location_facility:
Nursing School of Longjumeau
Nursing School Tenon
SSSM of Essonne SDIS91
Sud Francilien Nursing School
Nursing School Foch
Nursing School Rambouillet
Nursing Scool Barthelemy Durand
Perray-Vaucluse Nursing School


title: Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer

acronym: LIBIL

summary: The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy

acronym: EXCIMAG

summary:
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.

Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.

The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).

A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.

100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.

The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.

status: Terminated

primary_purpose: Diagnostic

location_facility: Service de Neurologie Hôpital Henry Mondor

location_facility: Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer

location_facility: Département de Neurologie Hôpital Roger Salengro

location_facility: Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Laboratoire des explorations fonctionnelles, Hôtel Dieu


title: Effects of a Long-term Exercise Program on Functional Ability in People With Dementia Living in Nursing Homes: a Cluster Randomised Controlled Trial. The LEDEN Study

acronym: LEDEN

summary: This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).

primary_purpose: Supportive Care

location_facility: Résidence d'Automne de Notre Dame de Sanhilac


type: EudraCT Number

title: Effect And Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

summary:
Fecal incontinence is a frequent pathology which concerns 10% of the general population and severely alters patients quality of life. The cost of urinary and faecal incontinence has been estimated to be $16 billions a year. Several treatments exist depending on the aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and are not without side effects, particularly the sacral nerve stimulation (pain, infection, electrode displacement..).

The intravesical injections of botulinum toxin have been used for several years for the treatment of urinary incontinence with overactive bladder. Several randomized trials have demonstrated the efficacy of these injections in patients with neurological disorders and overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the detrusor muscle increase the compliance and the bladder capacity and delay the initial appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve afferents.

The botulinum toxin should play a role on motor afferents as well as on the sensory function of efferent nerves.

The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency episodes with improvement in quality of life, without any major side effects, in the patients included in this study. Nevertheless, the benefit of toxin injections are known to be temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it would be possible to schedule one to two injections a year because of the limited side-effects and invasiveness of the rectal injections.

lead_sponsor: University Hospital, Rouen

location_facility:
Hôpital des Diaconesses
Clinique des Cèdres
AP-HM Hôpital Nord
Rouen University Hospital
Hospices Civils de Lyon
AP-HP Hôpital Tenon
Rennes University Hospital
Bordeaux University Hospital

intervention_type: Procedure

appel_a_projets: PHRCN

region: Normandie

nom_etablissement: CHU ROUEN

acronyme: IFTOXINE

titre: Efficacité et tolérance des injections intra-rectales de toxine botulique type A pour le traitement de l'incontinence fécale : étude randomisée, contrôlée en double aveugle

discipline_principale: gastro-entérologie

nom_porteur: LEROI

prenom_porteur: Anne Marie


title: Randomized Clinical Trial Comparing High Flow Oxygen Delivery System (Optiflow) With Oxygen Therapy Under High-concentration Mask on Oxygenation of Patients Who Receive Sequential Non-Invasive Ventilation (NIV) Sessions

acronym: VNI-HD

summary:
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.

The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions

Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:

control group with conventional clinical management, oxygen therapy and sequential used of NIV
Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.

Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de réanimation - CH de la côte basque

location_facility: Réanimation Polyvalente - CH de Mont de Marsan

location_facility: Service de Réanimation Polyvalente - CHU de Toulouse

location_facility: Service de Réanimation Polyvalente - CH d'Agen

location_facility: Service de Réanimation - CH de Perigueux

location_facility: Service de Réanimation Polyvalente - CH de Libourne

location_facility: Service de réanimation médicale - CHU de Bordeaux

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: VNI-HD

titre: Essai clinique randomisé de l'oxygène haut débit (OPTIFLOW) comparé à l'oxygène standard en ventilation non invasive séquentielle

discipline_principale: réanimation

nom_porteur: HILBERT

prenom_porteur: Gilles


title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

summary: The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

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ReferenceCitation: Fastner G, Sedlmayer F, Merz F, Deutschmann H, Reitsamer R, Menzel C, Stierle C, Farmini A, Fischer T, Ciabattoni A, Mirri A, Hager E, Reinartz G, Lemanski C, Orecchia R, Valentini V. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis. Radiother Oncol. 2013 Aug;108(2):279-86. doi: 10.1016/j.radonc.2013.05.031. Epub 2013 Jul 2.

ReferenceCitation: Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.

ReferenceCitation: Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.

ReferenceCitation: Welzel G, Boch A, Sperk E, Hofmann F, Kraus-Tiefenbacher U, Gerhardt A, Suetterlin M, Wenz F. Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Radiat Oncol. 2013 Jan 7;8:9. doi: 10.1186/1748-717X-8-9.

ReferenceCitation: Sperk E, Welzel G, Keller A, Kraus-Tiefenbacher U, Gerhardt A, Sutterlin M, Wenz F. Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A. Breast Cancer Res Treat. 2012 Aug;135(1):253-60. doi: 10.1007/s10549-012-2168-4. Epub 2012 Jul 29.

ReferenceCitation: Grobmyer SR, Lightsey JL, Bryant CM, Shaw C, Yeung A, Bhandare N, Hitchingham B, Copeland EM 3rd. Low-kilovoltage, single-dose intraoperative radiation therapy for breast cancer: results and impact on a multidisciplinary breast cancer program. J Am Coll Surg. 2013 Apr;216(4):617-23; discussion 623-4. doi: 10.1016/j.jamcollsurg.2012.12.038. Epub 2013 Feb 14.

ReferenceCitation: Keshtgar MR, Williams NR, Bulsara M, Saunders C, Flyger H, Cardoso JS, Corica T, Bentzon N, Michalopoulos NV, Joseph DJ. Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomised controlled trial. Breast Cancer Res Treat. 2013 Aug;140(3):519-25. doi: 10.1007/s10549-013-2641-8. Epub 2013 Jul 23.

ReferenceCitation: Dubois JB, Gu SD, Hay MH, Gely S, Delard R, Joyeux H, Solassol C, Pujol H. Intra-operative radiation therapy (IORT) with 100 kV X photons. Experience on 170 patients. Pathol Biol (Paris). 1992 Nov;39(9):884-5. No abstract available.

ReferenceCitation: Lemanski C, Azria D, Gourgou-Bourgade S, Ailleres N, Pastant A, Rouanet P, Fenoglietto P, Dubois JB, Gutowski M. Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial. Radiat Oncol. 2013 Aug 1;8:191. doi: 10.1186/1748-717X-8-191.

ReferenceCitation: Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

ReferenceCitation: Azria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M. Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.

ReferenceCitation: Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.

ReferenceCitation: Rothkamm K, Beinke C, Romm H, Badie C, Balagurunathan Y, Barnard S, Bernard N, Boulay-Greene H, Brengues M, De Amicis A, De Sanctis S, Greither R, Herodin F, Jones A, Kabacik S, Knie T, Kulka U, Lista F, Martigne P, Missel A, Moquet J, Oestreicher U, Peinnequin A, Poyot T, Roessler U, Scherthan H, Terbrueggen B, Thierens H, Valente M, Vral A, Zenhausern F, Meineke V, Braselmann H, Abend M. Comparison of established and emerging biodosimetry assays. Radiat Res. 2013 Aug;180(2):111-9. doi: 10.1667/RR3231.1. Epub 2013 Jul 17.

ReferenceCitation: Templin T, Paul S, Amundson SA, Young EF, Barker CA, Wolden SL, Smilenov LB. Radiation-induced micro-RNA expression changes in peripheral blood cells of radiotherapy patients. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):549-57. doi: 10.1016/j.ijrobp.2010.12.061. Epub 2011 Mar 21.

ReferenceCitation: Park SH, Kim MJ, Park BW, Moon HJ, Kwak JY, Kim EK. Impact of preoperative ultrasonography and fine-needle aspiration of axillary lymph nodes on surgical management of primary breast cancer. Ann Surg Oncol. 2011 Mar;18(3):738-44. doi: 10.1245/s10434-010-1347-y. Epub 2010 Oct 2.

ReferenceCitation: MacNeill M, Arnott I, Thomas J. Fine needle aspiration cytology is a valuable adjunct to axillary ultrasound in the preoperative staging of breast cancer. J Clin Pathol. 2011 Jan;64(1):42-6. doi: 10.1136/jcp.2010.083063. Epub 2010 Nov 19.

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

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

location_facility:
Institut Bergonié
CHU La TIMONE
Centre Léon Bérard
Institut Paoli Calmette
ICM
Chu Brest
Institut de Cancérologie de l'Ouest
Centre George Francois Leclerc

appel_a_projets: PHRCK

region: Occitanie

nom_etablissement: ICM MONTPELLIER

acronyme: RE-IORT 01

titre: Essai de faisabilité évaluant la radiothérapie per-opératoire (RIOP) dans les rechutes locales du cancer du sein bénéficiant d'une seconde chirurgie conservatrice.

discipline_principale: radiation oncology

nom_porteur: LEMANSKI

prenom_porteur: Claire


type: Other Grant/Funding Number

title: Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.

acronym: FIVPHENOL

summary: Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

primary_purpose: Basic Science

ReferenceCitation: Corbel T, Gayrard V, Viguie C, Puel S, Lacroix MZ, Toutain PL, Picard-Hagen N. Bisphenol A disposition in the sheep maternal-placental-fetal unit: mechanisms determining fetal internal exposure. Biol Reprod. 2013 Jul 18;89(1):11. doi: 10.1095/biolreprod.112.106369. Print 2013 Jul.

ReferenceCitation: Leandri RD, Gachet A, Pfeffer J, Celebi C, Rives N, Carre-Pigeon F, Kulski O, Mitchell V, Parinaud J. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial. Andrology. 2013 Sep;1(5):692-7. doi: 10.1111/j.2047-2927.2013.00104.x. Epub 2013 Jun 21.

location_facility: CHRU Brest Hôpital Morvan, Service de Médecine de la Reproduction


acronym: LYRITUX

lead_sponsor: University Hospital, Tours

summary:
Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous studies, 25 to 50% of patients have an insufficient or absence of response to rituximab at week 24.

In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes, to monitor rituximab-treated RA patients.

ReferenceCitation: Melet J, Mulleman D, Goupille P, Ribourtout B, Watier H, Thibault G. Rituximab-induced T cell depletion in patients with rheumatoid arthritis: association with clinical response. Arthritis Rheum. 2013 Nov;65(11):2783-90. doi: 10.1002/art.38107.

location_facility:
Rhumatologie, CHRU de NANTES
Rhumatologie, CHRU de ROUEN
Rhumatologie / IPROS, CHR d'ORLEANS
Rhumatologie, CHRU de POITIERS
Rhumatologie, CHRU de TOURS
Rhumatologie, CHD LA ROCHE SUR YON
Rhumatologie, CHRU de BREST
Rhumatologie, CHR du MANS

title: Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

source: euctr

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: LYRITUX

titre: Relation entre la depletion des lymphocytes T et la réponse clinique au rituximab dans la polyarthrite rhumatoide

discipline_principale: rhumatologie

nom_porteur: MULLEMAN

prenom_porteur: Denis


title: Pharmacokinetics and Safety of Roledumab, a Fully Human Recombinant Monoclonal Anti-RhD Antibody, in RhD-negative Pregnant Woman Carrying an RhD-positive Foetus: a Phase IIb, Multicenter, Open-label Study

summary:
The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in RhD-negative pregnant women carrying an RhD-positive foetus.

To assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive fetus and newborns.

In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in RhD-negative pregnant women carrying an RhD-positive fetus and the immunogenicity of Roledumab will be assessed.

primary_purpose: Prevention

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
Croix-Rousse Maternity
University Hospital Center
Maison Blanche Hospital
Port-Royal Maternity
Poissy-Saint-Germain-en-Laye Hospital
Jeanne de Flandre Hospital
Paule de Viguier Hospital
Armand-Trousseau Hospital


title: PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone

acronym: PROPHY-VAP

summary:
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.

Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.

ReferenceCitation: Dahyot-Fizelier C, Frasca D, Lasocki S, Asehnoune K, Balayn D, Guerin AL, Perrigault PF, Geeraerts T, Seguin P, Rozec B, Elaroussi D, Cottenceau V, Guyonnaud C, Mimoz O; PROPHY-VAP Study group, ATLANREA group. Prevention of early ventilation-acquired pneumonia (VAP) in comatose brain-injured patients by a single dose of ceftriaxone: PROPHY-VAP study protocol, a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2018 Oct 18;8(10):e021488. doi: 10.1136/bmjopen-2018-021488.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: Poitiers University Hospital

location_facility:
University Hospital of Angers
University Hospital of Rennes
University Hospital of Nantes
CHU
Djilali ELAROUSSI
CHRU
University Hospital of Poitiers
Thomas GEERAERTS

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

acronyme: PROPHY-VAP

titre: Prévention de la pneumopathie acquise sous ventilation mécanique précoce par une dose unique de ceftriaxone chez les cérébro-lésés.

nom_porteur: PETITPAS

prenom_porteur: Franck


title: Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease

acronym: PneumoMICI

summary:
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.

Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital Jean Minjoz
CHU de Saint-Etienne
Hôpital de l'Archet II
Hôpital Saint-Eloi
CHU Amiens-Picardie
Hôpital Charles Nicolle
Centre Hospitalier Lyon Sud
APHP - Hôpital Cochin


title: Levetiracetam Efficacy and Safety as First-line Treatment of Neonatal Seizures Occuring in Hypoxic-ischemic Encephalopathy Context

summary: LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

ReferenceCitation: Favrais G, Ursino M, Mouchel C, Boivin E, Jullien V, Zohar S, Saliba E. Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1): study protocol of a phase II trial. BMJ Open. 2019 Jan 24;9(1):e022739. doi: 10.1136/bmjopen-2018-022739.

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

sponsor_collaborators:
University Hospital, Tours
Assistance Publique - Hôpitaux de Paris
Rennes University Hospital
Amiens University Hospital

location_facility: Service de réanimation néonatale et pédiatrique

location_facility: Service de réanimation et service néonatale

location_facility: Service de Pédiatrie néonatale et réanimation

titre: Lévétiracétam pour le traitement en première intention des crises convulsives du nouveau-né : étude de phase II

discipline_principale: neurologie

nom_porteur: FAVRAIS

prenom_porteur: Géraldine