acronym: SONOCAP

summary:
Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound (CEUS) using SonoVue® as contrast agent.

The software analyses the ascending phase of enhancement (wash-in) and calculates the mode and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis of cancer is based on the combination of these two parameters.

The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound (CEUS).

The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to peak, the transit time and the area under the enhancement curve (parameters not used by the VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral zone at contrast-enhanced ultrasound (CEUS).

The study will enroll patients referred for prostate biopsy. The US transrectal probe will be inserted and the local anesthesia performed as per the institution's standard of care protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g. based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will then be injected and the ultrasound enhancement of this plane will be recorded during 2 minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the recording is still on, so that it will be possible to calculate quantitative enhancement parameters at the exact location of the biopsy.

Then, the operator will choose a plane that is likely not to contain cancer in the opposite prostate lobe and the same process will be repeated with injection of the second half of the vial.

The rest of the biopsies will be performed as per the institution's standard of care protocol.

The two recordings will be sent to Bracco's Research center in Geneva in order to:

Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software results
Calculate the wash-out rate, the time to peak, the transit time and the area under the enhancement curve at the biopsy location.

The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy samples) will be processed and analysed at the institution's department of Pathology and their results will be blinded to the Bracco's Research center.

The correlation between the biopsy results, the VueBoxTM-Prostate software results and the wash-out rate, time to peak, transit time and area under the enhancement curve will be performed by the study investigator.

In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot

location_facility: CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes


type: EudraCT Number

title: Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers

summary: The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille/ Centre d'investigation Clinique

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma

acronym: PET-FETII

summary: Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample).

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital de la Pitié Salpétrière
CHU de CAEN
UHToulouse

status_simplified: Completed


title: Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation

acronym: Mus-IRA

summary: Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.

ReferenceType: derived

ReferenceCitation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Institut Gustave Roussy
Hôpital Louis Mourier
CHD Vendée

intervention_type: Behavioral

appel_a_projets: PHRIP

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: Mus IRA

titre: Musicothérapie en Réanimation : effet sur la tolérance et l'acceptation de la ventilation non-invasive au cours de l'insuffisance respiratoire aigue

discipline_principale: anesthésiologie / réanimation

nom_porteur: MESSIKA

prenom_porteur: Jonathan


type: Other Identifier

title: Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study

acronym: THERA

summary: Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter, non-randomised, single-arm, open-label, phase II trial.

status: Terminated

lead_sponsor: Rennes University Hospital

location_facility:
CHRU de Lille
Groupe Hospitalier Lariboisière
Rennes University Hospital

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: THERA

titre: Traitement du rhumatisme hémochromatosique réfractaire par Anakinra: une étude préliminaire de phase II.

discipline_principale: rhumatologie

nom_porteur: GUGGENBUHL

prenom_porteur: Pascal


title: Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.

acronym: MC Monitor

summary:
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.

Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).

"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.

The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.

The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.

lead_sponsor: Advanced Perfusion Diagnostics

sponsor_collaborators:
Advanced Perfusion Diagnostics
CEISO

location_facility: CHU Estaing - Service réanimation adultes

intervention_type: Device

lead_sponsor_type: industriel


acronym: COBOL

summary:
A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.

The aim of the investigators study is to assess if these results are confirmed in a clinical trial.

The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.

ReferenceType: background

ReferenceCitation: Bondia J, Dassau E, Zisser H, Calm R, Vehi J, Jovanovic L, Doyle FJ 3rd. Coordinated basal-bolus infusion for tighter postprandial glucose control in insulin pump therapy. J Diabetes Sci Technol. 2009 Jan;3(1):89-97. doi: 10.1177/193229680900300110.

ReferenceCitation: A. Farret, B. Catargi, J.P. Riveline, V. Melki, P. Schaepelynck, A. Sola, B. Guerci, H. Bertet, T. Mura, H. Chevassus, E. Renard : Étude randomisée contrôlée en cross-over comparant les effets sur le contrôle glycémique des bolus immédiats et combinés chez des patients diabétiques de type 1 traités par pompe à insuline portable. Diabetes & Metabolism, Volume 38, Supplement 2, March 2012, Page A6

ReferenceCitation: Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.

ReferenceCitation: Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

ReferenceCitation: Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

ReferenceCitation: Etude Jubilé. SFD 2013

ReferenceCitation: Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2002 Mar 23;324(7339):705. doi: 10.1136/bmj.324.7339.705.

ReferenceCitation: Mudaliar SR, Lindberg FA, Joyce M, Beerdsen P, Strange P, Lin A, Henry RR. Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care. 1999 Sep;22(9):1501-6. doi: 10.2337/diacare.22.9.1501.

ReferenceCitation: Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf

ReferenceCitation: Melki.v, Cazals.l : Impact de la coordination des bolus et du débit de base sur le contrôle des glycémies postprandiales chez des diabétiques de type 1 traités par pompe externe (étude pilote). Poster accepté SFD 2014

location_facility:
Saint-André Hospital
Lapeyronie Hospital
University Hospital Toulouse Rangueil

title: Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study

type: Other Grant/Funding Number

source: euctr

ipd_sharing: No

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

titre: Evaluation de l'efficacité clinique des bolus coordonnés chez des diabétiques de type 1 traités par pompe externe : étude randomisée, croisée, multicentrique.

discipline_principale: diabétologie

nom_porteur: MELKI

prenom_porteur: Vincent


title: Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

acronym: CTC-CEC-ADN

summary: Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility:
Institut Mutualiste Montsouris
Institut Curie

intervention_type: Procedure


title: Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial

acronym: EASY

summary:
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.

The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.

The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

nom_etablissement: HOPITAL FONDATION A DE ROTHSCHILD

type_etablissement: EBNL

acronyme: EASYTRIAL

titre: Embolectomie des occlusions sylviennes aigues chez les patients réfractaires ou non éligibles à l'alteplase. Un essai contrôlé-randomisé multicentrique " EASYTRIAL for Embolectomy of Acute SYlvian Thrombosis in Refractory or Ineligible patients to ALtepla

discipline_principale: neurologie

nom_porteur: LABEYRIE

prenom_porteur: Marc-Antoine


title: Indication and Response to Immunosuppressive Treatment in Membranous Nephropathy : Role of Anti-mouse PLA2R1 ELISA

acronym: SOURIS

summary: Membranous Nephropathy (MN) is an auto-immune kidney disease and a common cause of nephrotic syndrome. About 30% of MN patients progress to end-stage kidney disease (ESKD) while 30% undergo spontaneous remission. The phospholipase A2 receptor (PLA2R1) is the major auto-antigen in idiopathic MN. Anti-PLA2R1 autoantibodies are found during the active phase of MN. Predictors of disease progression include high titers of anti-PLA2R1 autoantibodies and serum creatinine levels at presentation, as well as decline in renal function during the first six months of follow-up. Investigators identified new prognostic factors in a cohort of 41 idiopathic MN patients with nephrotic syndrome and anti-PLA2R1 autoantibodies at the time of presentation. During a follow-up of at least 36 months, 21 patients had a persistent nephrotic syndrome (group A) and 20 showed partial or total remission (group R). We first measured the cross-reactivity of their sera at the time of presentation to human, rabbit and mouse recombinant PLA2R1 by western blot. All patients exhibited reactivity against human and rabbit PLA2R1, but only some of them did against mouse PLA2R1. These results suggest the presence of distinct epitopes that are differentially conserved among PLA2R1 orthologs.Investigators then set-up three parallel ELISAs using human, rabbit and mouse recombinant PLA2R1. All 41 MN patients showed activity in human and rabbit ELISAs at presentation but only 32 of them (78%) in mouse ELISA.They finally analyzed the association between anti-PLA2R1 titers at presentation in the different ELISAs and the subsequent clinical outcome. The mean anti-PLA2R1 activity was significantly different between group A and R in mouse ELISA but not in human and rabbit ELISA. Patients with anti-mouse PLA2R1 activity over 605 RU (relative unit)/ml showed a significantly lower survival without doubling of serum creatinine or ESKD , but patients in the highest tertile of anti-PLA2R1 activity in rabbit and human ELISA did not show a significant increased risk of renal failure progression. The results suggest that the specific detection of particular anti-PLA2R1 autoantibodies using the novel anti-mouse PLA2R1 ELISA can identify MN patients at risk for ESKD. The aim is to confirm these result on a prospective cohort.

primary_purpose: Basic Science

ReferenceCitation: Teisseyre M, Cremoni M, Boyer-Suavet S, Crepin T, Benzaken S, Zorzi K, Esnault V, Brglez V, Seitz-Polski B. Rituximab Immunomonitoring Predicts Remission in Membranous Nephropathy. Front Immunol. 2021 Oct 13;12:738788. doi: 10.3389/fimmu.2021.738788. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Nephrology Department, Nice University Hospital


title: Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or

acronym: BUCCODOR

summary:
The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or.

Participation in this study will last only as long as it takes to:

carry out a bucco-dental examination: evaluation of dental plaque and calculus
take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse)
complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de DIJON
CHS La Chartreuse
CH Semur-en-Auxois

intervention_type: Other


title: Clinical and Medico-economic Assessment of Conventional Care Plus the "Autonom@Dom" Telemonitoring System Versus a Conventional Care Package Alone, for People With Heart Failure in Several French Structures.

summary: Heart failure is the principle cause of hospitalisation for people over 65. the assumption is that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation or rehospitalisation for heart failure (compared to a care package alone), This randomised controlled pilot study should assess the feasibility in terms of patient inclusion and follow-up.

primary_purpose: Supportive Care

ReferenceCitation: Maggioni AP, Greene SJ, Fonarow GC, Bohm M, Zannad F, Solomon SD, Lewis EF, Baschiera F, Hua TA, Gimpelewicz CR, Lesogor A, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial. Eur Heart J. 2013 Oct;34(40):3117-27. doi: 10.1093/eurheartj/eht342. Epub 2013 Sep 2.

ReferenceCitation: Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.

oa_host_type: repository

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Jourdain P, Juilliere Y; Steering and Working Group Committee Members of the French Task Force on Therapeutic Education in Heart Failure. Therapeutic education in patients with chronic heart failure: proposal for a multiprofessional structured programme, by a French Task Force under the auspices of the French Society of Cardiology. Arch Cardiovasc Dis. 2011 Mar;104(3):189-201. doi: 10.1016/j.acvd.2010.12.003. No abstract available.

ReferenceCitation: Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.

ReferenceCitation: Jondeau G, Neuder Y, Eicher JC, Jourdain P, Fauveau E, Galinier M, Jegou A, Bauer F, Trochu JN, Bouzamondo A, Tanguy ML, Lechat P; B-CONVINCED Investigators. B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode. Eur Heart J. 2009 Sep;30(18):2186-92. doi: 10.1093/eurheartj/ehp323. Epub 2009 Aug 30.

lead_sponsor: University Hospital, Grenoble

collaborators: Medico-economic evaluation unit , University Hospital, Grenoble

location_facility:
Private Geriatric Hospital Magnolias
University Hospital of Grenoble
Hospital Group Mutualiste


title: Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes

acronym: BIOPARK

summary:
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and PSP remains an unmet need. Such biological markers are crucial for future disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in PD and MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling at two study visits (baseline and after 12 months). Major secondary objectives are (i) to assess potential associations between the biomarker and clinical measures of disease severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its correlation to disease severity and progression in PD, MSA and PSP.

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
CHU de Limoges
CHU de Toulouse

status_simplified: Ongoing


title: Simultaneous Detection of Somatic Quantitative Molecular Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study

acronym: Code Barre

summary:
Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.

AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.

lead_sponsor: University Hospital, Rouen

location_facility:
Chu Hopitaux de Rouen
Chu Dijon
Chu Lille

intervention_type: Genetic


title: Study of the Impact of Chemo-induced Menopause on the Quality of Life in Young Women of Childbearing Age and Diagnosed With Non-metastatic Breast Cancer

acronym: MENOCOR

summary: Prospective multicenter study, Not on Health Products that evaluates up to 2 and a half years the impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age, diagnosed with non-metastatic breast cancer.

lead_sponsor: Centre Jean Perrin

location_facility: Centre de lutte contre le cancer - Centre Jean PERRIN


title: Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

summary:
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:

at meals, with CHO roughly assessed by the patient.
during and after physical activity sessions qualified as moderate by the patient.

Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.

primary_purpose: Health Services Research

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

location_facility:
University Hospital of Grenoble
University Hospital of Montpellier
Centre Hospitalier du Sud Francillien


title: Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells , Prospective, Open, Multicenter Study

summary: The purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. The aim of our study was to describe the incidence of reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role in this target population.

ReferenceCitation: De Bolle L, Naesens L, De Clercq E. Update on human herpesvirus 6 biology, clinical features, and therapy. Clin Microbiol Rev. 2005 Jan;18(1):217-45. doi: 10.1128/CMR.18.1.217-245.2005.

ReferenceCitation: Boutolleau D, Duros C, Bonnafous P, Caiola D, Karras A, Castro ND, Ouachee M, Narcy P, Gueudin M, Agut H, Gautheret-Dejean A. Identification of human herpesvirus 6 variants A and B by primer-specific real-time PCR may help to revisit their respective role in pathology. J Clin Virol. 2006 Mar;35(3):257-63. doi: 10.1016/j.jcv.2005.08.002. Epub 2005 Sep 23.

ReferenceCitation: Yamanishi K, Okuno T, Shiraki K, Takahashi M, Kondo T, Asano Y, Kurata T. Identification of human herpesvirus-6 as a causal agent for exanthem subitum. Lancet. 1988 May 14;1(8594):1065-7. doi: 10.1016/s0140-6736(88)91893-4.

ReferenceCitation: Santoro F, Kennedy PE, Locatelli G, Malnati MS, Berger EA, Lusso P. CD46 is a cellular receptor for human herpesvirus 6. Cell. 1999 Dec 23;99(7):817-27. doi: 10.1016/s0092-8674(00)81678-5.

ReferenceCitation: Agut H. Deciphering the clinical impact of acute human herpesvirus 6 (HHV-6) infections. J Clin Virol. 2011 Nov;52(3):164-71. doi: 10.1016/j.jcv.2011.06.008. Epub 2011 Jul 22.

ReferenceCitation: Ljungman P, Wang FZ, Clark DA, Emery VC, Remberger M, Ringden O, Linde A. High levels of human herpesvirus 6 DNA in peripheral blood leucocytes are correlated to platelet engraftment and disease in allogeneic stem cell transplant patients. Br J Haematol. 2000 Dec;111(3):774-81.

ReferenceCitation: Ljungman P. Immune reconstitution and viral infections after stem cell transplantation. Bone Marrow Transplant. 1998 Apr;21 Suppl 2:S72-4.

ReferenceCitation: Agut H. [Acute human herpesvirus 6 (HHV-6) infections: when and how to treat?]. Pathol Biol (Paris). 2011 Apr;59(2):108-12. doi: 10.1016/j.patbio.2010.07.015. Epub 2010 Sep 15. French.

ReferenceCitation: Kamble RT, Clark DA, Leong HN, Heslop HE, Brenner MK, Carrum G. Transmission of integrated human herpesvirus-6 in allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Sep;40(6):563-6. doi: 10.1038/sj.bmt.1705780. Epub 2007 Jul 16.

ReferenceCitation: Lee SO, Brown RA, Razonable RR. Clinical significance of pretransplant chromosomally integrated human herpesvirus-6 in liver transplant recipients. Transplantation. 2011 Jul 27;92(2):224-9. doi: 10.1097/TP.0b013e318222444a.

ReferenceCitation: Moreau P, Facon T, Attal M, Hulin C, Michallet M, Maloisel F, Sotto JJ, Guilhot F, Marit G, Doyen C, Jaubert J, Fuzibet JG, Francois S, Benboubker L, Monconduit M, Voillat L, Macro M, Berthou C, Dorvaux V, Pignon B, Rio B, Matthes T, Casassus P, Caillot D, Najman N, Grosbois B, Bataille R, Harousseau JL; Intergroupe Francophone du Myelome. Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myelome 9502 randomized trial. Blood. 2002 Feb 1;99(3):731-5. doi: 10.1182/blood.v99.3.731.

ReferenceCitation: Leong HN, Tuke PW, Tedder RS, Khanom AB, Eglin RP, Atkinson CE, Ward KN, Griffiths PD, Clark DA. The prevalence of chromosomally integrated human herpesvirus 6 genomes in the blood of UK blood donors. J Med Virol. 2007 Jan;79(1):45-51. doi: 10.1002/jmv.20760.

ReferenceCitation: Ogata M. Human herpesvirus 6 in hematological malignancies. J Clin Exp Hematop. 2009 Nov;49(2):57-67. doi: 10.3960/jslrt.49.57.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: CHU Saint-Etienne - laboratoire de virologie


acronym: IPOI vs IPOP

summary: The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .

lead_sponsor: Poitiers University Hospital

location_facility:
Rouen University Hospital
Poitiers University Hospital
Bicêtre Hospital


title: Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

summary:
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.

Participation consists in taking one or several blood samples depending on the group patients/controls.

location_facility:
CHU de DIJON
CHU de BESANCON
CH de METZ


title: Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.

summary: Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium) allows to obtain a better forecast of preservation of the tooth without complication than the conventional technique with the creation of an apicale barrier in the MTA in 24 months.

primary_purpose: Other

lead_sponsor: University Hospital, Brest

location_facility:
Hôtel Dieu
CHRU de Brest - Pôle Organe des Sens
CHU de Rennes

acronyme: APICALE

titre: Infiltration articulaire postérieure cervicale dans la névralgie cervico-brachiale chronique par uncarthrose : protocole pour un essai pilote randomisé

discipline_principale: autre

nom_porteur: DASTE

prenom_porteur: Camille


title: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis

acronym: STIMASEP

summary: This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Ambroise Paré
CHU de Clermont-Ferrand
Hôpital Henri Mondor


title: Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries

acronym: Caries Species

summary: The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires

location_facility: CHRU de Montpellier - Hôpital La Colombière

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Biological


title: Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

acronym: IoxRea

summary: The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.

ReferenceCitation: Desgrouas M, Merdji H, Bretagnol A, Barin-Le Guellec C, Halimi JM, Ehrmann S, Salmon Gandonniere C. Kinetic Glomerular Filtration Rate Equations in Patients With Shock: Comparison With the Iohexol-Based Gold-Standard Method. Crit Care Med. 2021 Aug 1;49(8):e761-e770. doi: 10.1097/CCM.0000000000004946.

oa_host_type: closed

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Polyvalente, CHRU de Tours


title: Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.

acronym: PTI PARI

summary:
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.

location_facility:
CHU de METZ
CHU de Dijon
CHU de Besançon


title: Medical Telephone Triage of Emergency Calls for Thoracic Pain: Construction of a Probability Score for Acute Coronary Syndrome.

summary:
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis.

The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.

ReferenceType: result

ReferenceCitation: Reuter PG, Pradeau C, Huo Yung Kai S, Lhermusier T, Bourde A, Tentillier E, Combes X, Bongard V, Ducasse JL, Charpentier S. Predicting acute coronary syndrome in males and females with chest pain who call an emergency medical communication centre. Scand J Trauma Resusc Emerg Med. 2019 Oct 17;27(1):92. doi: 10.1186/s13049-019-0670-y.

lead_sponsor: University Hospital, Toulouse

location_facility:
Toulouse Hosital Center
Bordeaux Hospital Center
La Réunion Hospital center


title: Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial

acronym: SEPT'ECHO

summary:
The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.

Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.

Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.

Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.

However, MRI is expensive and not rapidly accessible.

Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.

The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.

The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.

lead_sponsor: Nantes University Hospital

location_facility:
CH Saint-Nazaire
CH La Roche-sur-Yon
CH de Nantes


title: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

acronym: PRO-COLLE

summary: Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.

ReferenceCitation: Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20.

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
Vitalitec

location_facility: Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant


title: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide

acronym: PRECHOL

summary:
Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. To know soon that the treatment is effective will be decisive for the oncologist, even more in palliative situation where second effects can't be imposed to patients.

In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new therapy. Moreover, the investigators suppose that we can assess an early stage if there is an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and expansive treatment.

The aim of this study is to assess if it is possible to determine early (6 weeks of treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or enzalutamide in post-docetaxel.

ReferenceCitation: Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

ReferenceCitation: Townsend DW. Dual-modality imaging: combining anatomy and function. J Nucl Med. 2008 Jun;49(6):938-55. doi: 10.2967/jnumed.108.051276. Epub 2008 May 15.

ReferenceCitation: Jadvar H. Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. J Nucl Med. 2011 Jan;52(1):81-9. doi: 10.2967/jnumed.110.077941. Epub 2010 Dec 13.

ReferenceCitation: de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. 11C-choline positron emission tomography for the evaluation after treatment of localized prostate cancer. Eur Urol. 2003 Jul;44(1):32-8; discussion 38-9. doi: 10.1016/s0302-2838(03)00207-0.

ReferenceCitation: Scattoni V, Picchio M, Suardi N, Messa C, Freschi M, Roscigno M, Da Pozzo L, Bocciardi A, Rigatti P, Fazio F. Detection of lymph-node metastases with integrated [11C]choline PET/CT in patients with PSA failure after radical retropubic prostatectomy: results confirmed by open pelvic-retroperitoneal lymphadenectomy. Eur Urol. 2007 Aug;52(2):423-9. doi: 10.1016/j.eururo.2007.03.032. Epub 2007 Mar 20.

ReferenceCitation: Rinnab L, Mottaghy FM, Blumstein NM, Reske SN, Hautmann RE, Hohl K, Moller P, Wiegel T, Kuefer R, Gschwend JE. Evaluation of [11C]-choline positron-emission/computed tomography in patients with increasing prostate-specific antigen levels after primary treatment for prostate cancer. BJU Int. 2007 Oct;100(4):786-93. doi: 10.1111/j.1464-410X.2007.07083.x.

ReferenceCitation: Giovacchini G, Picchio M, Coradeschi E, Bettinardi V, Gianolli L, Scattoni V, Cozzarini C, Di Muzio N, Rigatti P, Fazio F, Messa C. Predictive factors of [(11)C]choline PET/CT in patients with biochemical failure after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2010 Feb;37(2):301-9. doi: 10.1007/s00259-009-1253-3. Epub 2009 Sep 15.

ReferenceCitation: Giovacchini G, Picchio M, Briganti A, Cozzarini C, Scattoni V, Salonia A, Landoni C, Gianolli L, Di Muzio N, Rigatti P, Montorsi F, Messa C. [11C]choline positron emission tomography/computerized tomography to restage prostate cancer cases with biochemical failure after radical prostatectomy and no disease evidence on conventional imaging. J Urol. 2010 Sep;184(3):938-43. doi: 10.1016/j.juro.2010.04.084.

ReferenceCitation: Breeuwsma AJ, Pruim J, van den Bergh AC, Leliveld AM, Nijman RJ, Dierckx RA, de Jong IJ. Detection of local, regional, and distant recurrence in patients with psa relapse after external-beam radiotherapy using (11)C-choline positron emission tomography. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):160-4. doi: 10.1016/j.ijrobp.2009.04.090. Epub 2009 Sep 23.

ReferenceCitation: Heinisch M, Dirisamer A, Loidl W, Stoiber F, Gruy B, Haim S, Langsteger W. Positron emission tomography/computed tomography with F-18-fluorocholine for restaging of prostate cancer patients: meaningful at PSA < 5 ng/ml? Mol Imaging Biol. 2006 Jan-Feb;8(1):43-8. doi: 10.1007/s11307-005-0023-2.

ReferenceCitation: Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

ReferenceCitation: Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

ReferenceCitation: Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; Eastern Cooperative Oncology Group study EST 3886. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol. 2006 Jun;7(6):472-9. doi: 10.1016/S1470-2045(06)70700-8.

ReferenceCitation: Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

ReferenceCitation: Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.

ReferenceCitation: de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

ReferenceCitation: Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Ghent University - Ghent University Academic Bibliography

version: acceptedVersion

repository_institution: University of California - eScholarship University of California

version: submittedVersion

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

ReferenceCitation: Scher HI, Morris MJ, Basch E, Heller G. End points and outcomes in castration-resistant prostate cancer: from clinical trials to clinical practice. J Clin Oncol. 2011 Sep 20;29(27):3695-704. doi: 10.1200/JCO.2011.35.8648. Epub 2011 Aug 22.

ReferenceCitation: Colloca G. Prostate-specific antigen kinetics as a surrogate endpoint in clinical trials of metastatic castration-resistant prostate cancer: a review. Cancer Treat Rev. 2012 Dec;38(8):1020-6. doi: 10.1016/j.ctrv.2012.03.008. Epub 2012 Apr 12.

ReferenceCitation: Effert PJ, Bares R, Handt S, Wolff JM, Bull U, Jakse G. Metabolic imaging of untreated prostate cancer by positron emission tomography with 18fluorine-labeled deoxyglucose. J Urol. 1996 Mar;155(3):994-8.

ReferenceCitation: Fuccio C, Castellucci P, Schiavina R, Guidalotti PL, Gavaruzzi G, Montini GC, Nanni C, Marzola MC, Rubello D, Fanti S. Role of 11C-choline PET/CT in the re-staging of prostate cancer patients with biochemical relapse and negative results at bone scintigraphy. Eur J Radiol. 2012 Aug;81(8):e893-6. doi: 10.1016/j.ejrad.2012.04.027. Epub 2012 May 22.

ReferenceCitation: Beheshti M, Vali R, Waldenberger P, Fitz F, Nader M, Loidl W, Broinger G, Stoiber F, Foglman I, Langsteger W. Detection of bone metastases in patients with prostate cancer by 18F fluorocholine and 18F fluoride PET-CT: a comparative study. Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1766-74. doi: 10.1007/s00259-008-0788-z. Epub 2008 May 9.

ReferenceCitation: Fuccio C, Schiavina R, Castellucci P, Rubello D, Martorana G, Celli M, Malizia C, Profitos MB, Marzola MC, Pettinato V, Fanti S. Androgen deprivation therapy influences the uptake of 11C-choline in patients with recurrent prostate cancer: the preliminary results of a sequential PET/CT study. Eur J Nucl Med Mol Imaging. 2011 Nov;38(11):1985-9. doi: 10.1007/s00259-011-1867-0. Epub 2011 Jul 6.

ReferenceCitation: Guide pour la rédaction de protocoles pour la tomographie par émission de positons (TEP) à la [18F]-Fluorocholine ([18F]-FCH). Médecine Nucléaire. 2012;36(6):353-9.

ReferenceCitation: IRSN. Doses délivrées au patient en scannographie et en radiologie conventionelle - Résultats d'une enquête multicentrique en secteur public. Rapport DRPH/SER N°2010-12. 2010.

ReferenceCitation: Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.

location_facility: Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble

location_facility: Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste

location_facility: Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble


title: Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer

acronym: IriGen

summary: This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.

location_facility:
Clinique de la Châtaigneraie
CHU Estaing
Centre Jean Perrin


title: Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis

acronym: MICROPOLY

summary:
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.

The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation

acronym: BANNISTER

summary:
randomized double-blind controlled study in parallel groups

Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.

During this administration, non invasive ventilation for the patient will be continued.

ReferenceCitation: Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.

publisher_dissemination: Mary Ann Liebert Inc

location_facility: Service de Réanimation Médicale - CHR d'Orléans


title: Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. "NODIVEM" Study

acronym: NODIVEM

summary:
Solitary pulmonary nodule has become a major challenge in respiratory clinical practice. According to published guidelines, their management often requires close CT follow up, PET CT and invasive procedures to obtain a definite histology. In this context, innovative endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for the localization and sampling of peripheral lung nodules. However, these techniques are unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of the distal lung structures in real time.

This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral lung nodules and to differentiate benign from tumoral lesions.

Objective(s)

To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule
To demonstrate that confocal endoscopy can differentiate benign from malignant tumors

Experimental design:

Multicentric prospective controlled trial, conducted in three academic centers, specialized in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based confocal endo-microscopy.

Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted in the same catheter as used for the navigational bronchoscopy and confocal images will be recorded before sampling. An ancillary study using topical methylene blue as in situ will be conducted at the Rouen University Center.

An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal endo-microscopy analysis.

location_facility:
CHU Saint Etienne
CHU Toulouse
UHRouen


title: Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth

acronym: OASIS 2

summary: The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.

primary_purpose: Prevention

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve


title: Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

summary: Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.

ReferenceCitation: Pongan E, Freulon M, Delphin-Combe F, Dibie-Racoupeau F, Martin-Gaujard G, Federico D, Waissi A, Richard G, Jacqueline S, Fabre F, Trombert-Paviot B, Krolak-Salmon P, Laurent B, Rouch I. Initial and long-term evaluation of patients with Alzheimer's after hospitalization in cognitive and behavioural units: the EVITAL study design. BMC Psychiatry. 2014 Nov 15;14:308. doi: 10.1186/s12888-014-0308-6.

publisher_dissemination: Springer

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint Etienne
Hospices Civils de Lyon
CH Saint Jean de Dieu


title: Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)

acronym: IGRage

summary:
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.

TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Interne, Diabete et Maladies Métaboliques

location_facility: Servive de Médecine Interne (Pr S. Herson)


title: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer

acronym: HYPNOSEIN

summary:
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).

The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.

lead_sponsor: Institut Bergonié

location_facility:
Centre Oscar Lambret
Centre Paul Strauss
Institut Bergonié


title: Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.

acronym: MYLY

summary:
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.

This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.

sponsor_collaborators:
University Hospital, Brest
Teva Pharmaceuticals USA

location_facility:
Hôpital Pitié Salpêtrière
CHRU de Brest
CHU de Rennes Hôpital Pontchaillou


title: Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling: a Qualitative Study in 3 Physical Therapy and Rehabilitation Departments

acronym: EMCIQUAL

summary: The purpose of this study is to suggest system for improving patients' management through a detail analysis of physical therapy departments functioning

ReferenceCitation: Coudeyre E, Rannou F, Tubach F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. General practitioners' fear-avoidance beliefs influence their management of patients with low back pain. Pain. 2006 Oct;124(3):330-337. doi: 10.1016/j.pain.2006.05.003. Epub 2006 Jun 5.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.

ReferenceCitation: Poiraudeau S, Rannou F, Le Henanff A, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Revel M, Ravaud P. Outcome of subacute low back pain: influence of patients' and rheumatologists' characteristics. Rheumatology (Oxford). 2006 Jun;45(6):718-23. doi: 10.1093/rheumatology/kei231. Epub 2005 Dec 23.

ReferenceCitation: Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.

ReferenceCitation: Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

ReferenceCitation: Coudeyre E, Demaille-Wlodyka S, Poizat S, Burton K, Hamonet MA, Revel M, Poiraudeau S. Could a simple educational intervention modify beliefs about whiplash? A preliminary study among professionals working in a rehabilitation ward. Ann Readapt Med Phys. 2007 Oct;50(7):552-7, 545-51. doi: 10.1016/j.annrmp.2007.05.005. Epub 2007 Jun 18. English, French.

ReferenceCitation: Coudeyre E, Givron P, Vanbiervliet W, Benaim C, Herisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. doi: 10.1016/j.annrmp.2006.05.003. Epub 2006 May 26. French.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
University of Paris 5 - Rene Descartes

location_facility: CHU Raymond Poincaré- Groupement hospitalier universitaire Ouest


title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints

summary: To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

lead_sponsor: NeuroHealing Pharmaceuticals Inc.

collaborators: Michael J. Fox Foundation for Parkinson's Research

location_facility:
Hôpital de la Salpêtrière
Hôpital Paul de Viguier
Hôpital Haut Lévêque


title: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.

acronym: HRM RTSIO

summary: The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'hépato-gastroentérologie et oncologie digestive

location_facility: Institut des Maladies de l'Appareil Digestif (IMAD)

location_facility: Service d'Exploration Fonctionnelle Digestive


title: Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay

acronym: HOT

summary: The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.


title: Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

acronym: IPEC-GC

summary: If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen

ReferenceCitation: Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratte S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
FNLCC center Georges François Leclerc
University hospital of Besançon
Hospital of Belfort-Montbeliard


type: Registry Identifier

title: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

summary: The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.

lead_sponsor: Neptune

location_facility: Biofortis Naturalpha OPTIMED


title: Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.

acronym: MEDOC

summary:
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage.

Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.

It is necessary to achieve a large national multicenter study, to clarify the risk of post recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).

The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.

It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: EXPLORATION OF THE SOCIAL COGNITION IN ADOLESCENTS WITH A Dissociative Disorder OR AUTISM SPECTRUM

summary:
The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental disorders distinct origin who share common challenges to engage and maintain social relationships and mutual disturbances of affective contact. An important issue of research is to determine the cognitive and brain mechanisms underlying social disability in these two pathologies. Several lines of social cognition have been systematically explored: the perception of emotions, the ability to attribute intentionality and mental states to others (theory of mind), the understanding of social situations in different contexts. We made the observation today that research findings clearly in the field of autism and schizophrenic disorders that converge on common patterns neurocognitive abnormalities. Consequently, many programs support published today use the same therapeutic targets and the same tools in both pathologies. This raises two questions of science: (1) whether the disorders of social cognition reported in the field of autism and schizophrenia are "specific deficit" and not "specific condition", that is to say they are inherent social disadvantage whatever condition or (2) if these disorders of social cognition is a pattern common to autism and schizophrenia but are the result of specific neurocognitive mechanisms and different in each these pathologies. Systematic exploration of these issues is a current issue for understanding the pathophysiological borders between the two neurodevelopmental disorders but also to better define the potential targets of therapeutic strategies, psycho-educational and remediation of disorders of social cognition in autism and schizophrenia.

Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic disorder, autistic or healthy in the three areas of social cognition: perception of emotions, attribution of intentions to others (theory of mind) and style attribution. We shall constitute three population groups of patients, a group of patients meeting the diagnosis of schizophrenia, a group of patients with autism and a control group (healthy subjects).

collaborators: Centre Hospitalier d'Antibes Juans les Pins

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: VERVE* PROJECT: Study of the Acceptability of a Virtual Reality System on the Cognitive Stimulation of Patients With Alzheimer's Disease or Related Conditions. (*Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment)

acronym: VERVE

summary:
Virtual environments and information communication technologies (ICT) offer large perspectives in the field of assistive care and rehabilitation.

As potentially endless, the scenarios and environment used using 3D can provide immersive social and interactive context for enjoyable and therapeutic exercises in the aging population. In addition it is also possible to use this type of serious game and scenario in very easy to use devices such as lap top or tablet.

Social exclusion has many causes, Apathy as one of the most common behavioural disturbances found in old adults populations alters significantly social and emotional interaction.

Even though, progress in VR has been made over the past year, the presence of such technology in daily living space is still at the embryonic stage.

The European e-Inclusion policy stresses the importance of ICT in improving the quality of life in potentially disadvantaged groups, including older people and persons.

The VERVE project is developing ICT tools to support the treatment of people who are at risk of social exclusion due to apathy associated with a disability.

As people aged and autonomy worsen fear for safety and comfortable means to maintain social and Health Related Quality of Life (HRQL) status are public health issues.

Moreover, even though older adults would like to perform some activities such as walking in the streets some are reluctant to go out of their homes as the external environment is perceived as potentially unsafe.

Apathy, the most common behavioural symptoms in aging population is characterized by symptoms of reduced initiation and responsiveness to environmental interactions. The syndrome of Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting, loss of initiative and loss of interest. Apathy along with the nosological characteristics of dementia induces impairment in autonomy level and therefore dependence as cognitive impairments worsened.

The importance of stimulation could be related to the concept of engagement defined as the act of being occupied or involved with an external stimulus. Engaging older person with or without Alzheimer's disease and related disorders in appropriate activities has been shown to yield beneficial HRQL effects such increasing positive emotion, improving cognition, functional autonomy and quality of life.

Accordingly, enriched environments with high definition virtual representation of cities and activities of interest have the potentials not only to encourage patients to get active in a safe and interactive environment but also to create access to enjoyable and stimulating settings for the more severe patients.

The VR setting from VERVE proposed personalised and populated environments available on two different, but interlinked hardware platforms: 1/: standard gaming set-up in the home, nursing home or day hospital therapy group; and 2/ mobile tracked internet devices (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web technologies.

location_facility:
CHU de Nice
EHPAD Villa Hélios Saint Jean
EHPAD Valrose


acronym: TOCIDYS

summary: Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.

location_facility: Service de rhumatologie, Hôpital Lariboisière

location_facility: Service de Rhumatologie, Groupe Hospitalier Pellegrin

location_facility: Service de rhumatologie, Hopital Edouard Herriot, HCL

title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.


title: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

acronym: CESNA

summary: The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

location_facility:
University Hospital of Toulouse
University Hospital Toulouse
University Hospital


title: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

acronym: Pascal

summary: The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de la Croix Rousse
Hôpital Lariboisière
CHU Dijon


title: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

summary:
The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

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

location_facility:
University Hospital of Grenoble
University Hospital of Toulouse
Centre Hospitalier Sud Francilien


title: Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III

summary:
TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of RD94 in patients needing endodontic care, medical device class III.

SPONSOR:

SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 09/001

PRODUCT NAME: Biodentine™ (RD94)

MEDICAL DEVICE:

Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

lead_sponsor: Ascopharm Groupe Novasco

collaborators: AscoPharm is conducting the study under the responsibility of SEPTODONT

location_facility: Service d'Odontologie Hôpital Rothschild

location_facility: Cabinet de Chirurgie Dentaire rue Saint Didier

location_facility: Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière


title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

acronym: TENOR

summary:
Phase 1:

Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

Phase 2:

All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .

ReferenceCitation: Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Laporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15.

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Chugai Pharmaceutical

location_facility:
Brest University Hospital
CHR d'Orléans
Nantes University Hospital


title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

summary: Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Centre Oscar Lambret
Institut Gustave Roussy
Hopital Lariboisière


title: Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

summary: This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

status: Withdrawn

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

location_facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE


title: Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms

acronym: abl LMC

summary: The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.

summary: The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

lead_sponsor: Boehringer Ingelheim

location_facility:
INS Claudius Regaud
CTR René Gauducheau, Onco, St Herblain
CTR Georges-François Leclerc


acronym: HYDRAREA

summary: The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

lead_sponsor: University Hospital, Caen

location_facility:
Medical Intensive Care Unit
Intensive care unit
Surgical Intensive Care Unit


acronym: LYLO

summary: Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).

location_facility:
CHU de Bordeaux Hôpital Haut Lévêque
AP-HM
Lyon UniversityHospital


title: Living Conditions and Breast Cancer

summary: The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

location_facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique


title: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT

summary:
Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

location_facility:
Léon BERARD Center
Centre Georges François Leclerc
Oscar Lambret Center


title: Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants

summary:
Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance.

The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Lille
CHU Angers
CHU de Rennes


acronym: IDEALE

lead_sponsor: Novartis Pharmaceuticals

summary:
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.

ReferenceCitation: Thibault G, Paintaud G, Legendre C, Merville P, Coulon M, Chasseuil E, Ternant D, Rostaing L, Durrbach A, Di Giambattista F, Buchler M, Lebranchu Y. CD25 blockade in kidney transplant patients randomized to standard-dose or high-dose basiliximab with cyclosporine, or high-dose basiliximab in a calcineurin inhibitor-free regimen. Transpl Int. 2016 Feb;29(2):184-95. doi: 10.1111/tri.12688. Epub 2015 Oct 8.

title: Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in de Novo Adult Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose of Basiliximab of 40 or 80 mg in Combination With Cyclosporine Microemulsion, or a Cumulative Dose of 80 mg of Basiliximab Without Calcineurin Inhibitor, With Additional Follow-up of 12 Weeks


title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain

summary: The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Hôtel-Dieu CHU Nantes
Polyclinique de L'Europe
Ambroise Paré Hospital


title: Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment

acronym: OPTIVUS

summary: Coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

lead_sponsor: University Hospital, Toulouse

location_facility:
UH Bordeaux Haut-Lévêque
UH Limoges
UH Toulouse


title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

acronym: RoboProstate

summary:
The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).