title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia

summary: The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.

ReferenceCitation: Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32.


title: Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm

summary:
Purpose:

This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.

This study is non randomized, monocentric, and with a pharmacodynamic part.

Primary objective:

Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.

Secondary objectives:

Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

acronym: BMoS

summary:
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.

The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5.

ReferenceCitation: Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13.

ReferenceCitation: Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. French.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Creteil

intervention_type: Other

status_simplified: Unknown


title: Evaluation of Ischemic Preconditioning in Patients Undergoing Major Liver Resection With Intermittent Pedicular Clamping: A Multicentric Randomized Trial

acronym: HECLA

summary:
To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent portal triad Clamping (IPTC).

Summary Background Data: For sake of safety and to avoid excessive blood loss during parenchymal transection, vascular inflow occlusion is an effective trick but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is beneficial if liver resection is performed under IPTC has never been demonstrated in a randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.

ReferenceType: derived

ReferenceCitation: Scatton O, Zalinski S, Jegou D, Compagnon P, Lesurtel M, Belghiti J, Boudjema K, Lentschener C, Soubrane O. Randomized clinical trial of ischaemic preconditioning in major liver resection with intermittent Pringle manoeuvre. Br J Surg. 2011 Sep;98(9):1236-43. doi: 10.1002/bjs.7626. Epub 2011 Jul 11.

name: Department of Hepatobiliary Surgery and Liver Transplantation, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris (AP-HP), France

family: Scatton

full_name: O Scatton

given: O

sequence: first

name: Université Pierre et Marie Curie, Paris, France

family: Zalinski

full_name: S Zalinski

given: S

sequence: additional

name: Department of Biostatistics, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris (AP-HP), France

family: Jegou

full_name: D Jegou

given: D

name: Department of Hepatobiliary Surgery and Liver Transplantation, Hôpital Pontchaillou, Rennes, France

family: Compagnon

full_name: P Compagnon

given: P

name: Swiss Hepato-Pancreatico-Biliary Centre, Department of Surgery, University Hospital Zurich, Zurich, Switzerland

family: Lesurtel

full_name: M Lesurtel

given: M

name: Department of Hepatobiliary Surgery and Liver Transplantation, Hôpital Beaujon, AP-HP, Clichy, France

family: Belghiti

full_name: J Belghiti

given: J

family: Boudjema

full_name: K Boudjema

given: K

name: Department of Anaesthesia and Critical Care, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris (AP-HP), France

family: Lentschener

full_name: C Lentschener

given: C

family: Soubrane

full_name: O Soubrane

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

acronym: ARTE

summary:
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .

In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.

intervention_type: Device


type: Registry Identifier

type: Other Identifier

title: A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS

acronym: BONBIS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

study_start_date_type: Actual

status: Active, not recruiting

ReferenceCitation: Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60.

ReferenceCitation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. Epub 2007 Jun 18.

ReferenceCitation: EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group, Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. Epub 2006 Jun 26.

ReferenceCitation: Bijker N, Peterse JL, Duchateau L, Julien JP, Fentiman IS, Duval C, Di Palma S, Simony-Lafontaine J, de Mascarel I, van de Vijver MJ. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol. 2001 Apr 15;19(8):2263-71.

ReferenceCitation: Cutuli B, Cohen-Solal-le Nir C, de Lafontan B, Mignotte H, Fichet V, Fay R, Servent V, Giard S, Charra-Brunaud C, Lemanski C, Auvray H, Jacquot S, Charpentier JC. Breast-conserving therapy for ductal carcinoma in situ of the breast: the French Cancer Centers' experience. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):868-79.

ReferenceCitation: Cutuli B, Fourquet A, Luporsi E, Arnould L, Caron Y, Cremoux Pd, Dilhuydy JM, Fondrinier E, Fourme E, Giard-Lefevre S, Blanc-Onfroy ML, Lemanski C, Mauriac L, Sigal-Zafrani B, Tardivon A, This P, Tunon de Lara C, Kirova Y, Fabre N; Federation of French Cancer Centres (FNCLCC), et le groupe de travail SOR. [Standards, Options and Recommendations for the management of ductal carcinoma in situ of the breast (DCIS): update 2004]. Bull Cancer. 2005 Feb;92(2):155-68. French.

ReferenceCitation: Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43.

ReferenceCitation: Ernster VL, Barclay J, Kerlikowske K, Grady D, Henderson C. Incidence of and treatment for ductal carcinoma in situ of the breast. JAMA. 1996 Mar 27;275(12):913-8.

ReferenceCitation: Fine JP. Regression modeling of competing crude failure probabilities. Biostatistics. 2001 Mar;2(1):85-97.

ReferenceCitation: Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12;353(9169):1993-2000.

ReferenceCitation: Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18.

ReferenceCitation: Gagliardi G, Lax I, Söderström S, Gyenes G, Rutqvist LE. Prediction of excess risk of long-term cardiac mortality after radiotherapy of stage I breast cancer. Radiother Oncol. 1998 Jan;46(1):63-71.

ReferenceCitation: Ho AY, Atencio DP, Peters S, Stock RG, Formenti SC, Cesaretti JA, Green S, Haffty B, Drumea K, Leitzin L, Kuten A, Azria D, Ozsahin M, Overgaard J, Andreassen CN, Trop CS, Park J, Rosenstein BS. Genetic predictors of adverse radiotherapy effects: the Gene-PARE project. Int J Radiat Oncol Biol Phys. 2006 Jul 1;65(3):646-55.

ReferenceCitation: Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102.

ReferenceCitation: Omlin A, Amichetti M, Azria D, Cole BF, Fourneret P, Poortmans P, Naehrig D, Miller RC, Krengli M, Gutierrez Miguelez C, Morgan D, Goldberg H, Scandolaro L, Gastelblum P, Ozsahin M, Dohr D, Christie D, Oppitz U, Abacioglu U, Gruber G. Boost radiotherapy in young women with ductal carcinoma in situ: a multicentre, retrospective study of the Rare Cancer Network. Lancet Oncol. 2006 Aug;7(8):652-6.

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

ReferenceCitation: Solin LJ, Fourquet A, Vicini FA, Haffty B, Taylor M, McCormick B, McNeese M, Pierce LJ, Landmann C, Olivotto IA, Borger J, Kim J, de la Rochefordiere A, Schultz DJ. Mammographically detected ductal carcinoma in situ of the breast treated with breast-conserving surgery and definitive breast irradiation: long-term outcome and prognostic significance of patient age and margin status. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):991-1002.

ipd_sharing: No

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

acronym: PTTritux

summary:
Multicentric non-randomized phase II opened prospective study (10 centres involved).

Primary endpoint:

To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.

Secondary endpoints:

To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

ReferenceCitation: Benhamou Y, Paintaud G, Azoulay E, Poullin P, Galicier L, Desvignes C, Baudel JL, Peltier J, Mira JP, Pène F, Presne C, Saheb S, Deligny C, Rousseau A, Féger F, Veyradier A, Coppo P; French Reference Center for Thrombotic Microangiopathies. Efficacy of a rituximab regimen based on B cell depletion in thrombotic thrombocytopenic purpura with suboptimal response to standard treatment: Results of a phase II, multicenter noncomparative study. Am J Hematol. 2016 Dec;91(12):1246-1251. doi: 10.1002/ajh.24559. Epub 2016 Nov 8.

name: Service de Médecine Interne, CHU Charles NicolleRouen

name: Hôpital Saint‐Antoine, AP‐HPCentre de Référence des Microangiopathies Thrombotiques Paris, France

family: Benhamou

full_name: Ygal Benhamou

given: Ygal

name: Université François‐Rabelais de Tours, CNRS, GICC UMR 7292, CHRU de Tours, Laboratoire de Pharmacologie‐ToxicologieTours France

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

name: Hôpital Saint‐Louis, AP‐HPService de Réanimation MédicaleParis France

name: Université Paris Diderot, Sorbonne Paris CitéParis France

family: Azoulay

full_name: Elie Azoulay

given: Elie

name: Hôpital de Marseille ConceptionService d'HémaphérèseMarseille France

family: Poullin

full_name: Pascale Poullin

given: Pascale

name: Hôpital Saint‐Louis, AP‐HPService d'Immunologie CliniqueParis France

family: Galicier

full_name: Lionel Galicier

given: Lionel

family: Desvignes

full_name: Céline Desvignes

given: Céline

name: CHU Saint‐Antoine, AP‐HPService de Réanimation MédicaleParis France

name: Sorbonne Université, UPMC Univ Paris 06Paris France

family: Baudel

full_name: Jean‐Luc Baudel

given: Jean‐Luc

name: Urgences néphrologiques et transplantation rénale, Hôpital Tenon, AP‐HPParis France

family: Peltier

full_name: Julie Peltier

given: Julie

name: Hôpital Cochin, AP‐HPService de Réanimation PolyvalenteParis France

family: Mira

full_name: Jean‐Paul Mira

given: Jean‐Paul

family: Pène

full_name: Frédéric Pène

given: Frédéric

name: Hôpital SudService de Néphrologie—Médecine InterneAmiens France

family: Presne

full_name: Claire Presne

given: Claire

name: Service de Médecine interne 1, Hôpital La Pitié‐Salpêtrière, AP‐HPParis France

family: Saheb

full_name: Samir Saheb

given: Samir

name: Service de Médecine interne, CHU de Fort‐de France France

family: Deligny

full_name: Christophe Deligny

given: Christophe

name: Hôpital Saint‐Antoine, AP‐HPUnité de Recherche Clinique de l'Est Parisien (URC‐Est)Paris France

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

name: CHU Saint‐Antoine, AP‐HPService d'Immunologie et Hématologie biologiqueParis France

family: Féger

full_name: Frédéric Féger

name: Hôpital Lariboisière, AP‐HPService d'Hématologie BiologiqueParis France

family: Veyradier

full_name: Agnès Veyradier

given: Agnès

name: Inserm U1009, Institut Gustave RoussyVillejuif, Paris France

name: Hôpital Saint‐Antoine, AP‐HPService d'HématologieParis France

family: Coppo

full_name: Paul Coppo

given: Paul

journal_name: American Journal of Hematology

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley


title: Methodological Evaluation of Fluor 18 Labelled Fluoromisonidazole ([18F]-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) for Non Operated Glioblastoma

acronym: MISOGLIO

summary:
Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET using [18F]-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. The use of this radiotracer for brain tumours is very limited and there is no standard to acquire and quantify [18F]-FMISO uptake. So there is a need for a methodological evaluation of this PET tracer The purpose of this research is to define optimal parameters for acquisition and data exploitation to quantify [18F]-FMISO uptake and so predict clinical outcome in glioblastomas.

Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great interest to modify therapeutic strategies, including local dose escalation for radiotherapy or select chemotherapeutic agents with better impact in glioblastomas.

PET with appropriate radiotracers, especially [18F]-FMISO, enables non-invasive assessment of hypoxia. [18F]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any optimal acquisition protocol or standardized images quantification treatment. Thus, the interpretation of [18F]-FMISO PET images and the predictive value of [18F]-FMISO SUV (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma

summary:
Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

status: Terminated

ReferenceCitation: Kraeber-Bodere F, Pallardy A, Maisonneuve H, Campion L, Moreau A, Soubeyran I, Le Gouill S, Tournilhac O, Daguindau E, Jardel H, Morineau N, Bouabdallah K, Gyan E, Moles MP, Gressin R, Berthou C, Sadot S, Moreau P, Deau B, Bodet-Milin C, Cazeau AL, Garin E, Salaun PY, Vuillez JP, Gouilleux-Gruart V, Barbet J, Wegener WA, Goldenberg DM, Lamy T, Soubeyran P. Consolidation anti-CD22 fractionated radioimmunotherapy with (90)Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial. Lancet Haematol. 2017 Jan;4(1):e35-e45. doi: 10.1016/S2352-3026(16)30168-5. Epub 2016 Dec 8.

family: Kraeber-Bodere

full_name: Françoise Kraeber-Bodere

given: Françoise

family: Pallardy

full_name: Amandine Pallardy

given: Amandine

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

family: Campion

full_name: Loïc Campion

given: Loïc

family: Moreau

full_name: Anne Moreau

given: Anne

family: Soubeyran

full_name: Isabelle Soubeyran

given: Isabelle

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Daguindau

full_name: Etienne Daguindau

given: Etienne

family: Jardel

full_name: Henry Jardel

given: Henry

family: Morineau

full_name: Nadine Morineau

given: Nadine

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Moles

full_name: Marie-Pierre Moles

given: Marie-Pierre

family: Gressin

full_name: Remy Gressin

given: Remy

family: Berthou

full_name: Christian Berthou

given: Christian

family: Sadot

full_name: Sophie Sadot

given: Sophie

full_name: Philippe Moreau

given: Philippe

family: Deau

full_name: Bénédicte Deau

given: Bénédicte

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Cazeau

full_name: Anne-Laure Cazeau

given: Anne-Laure

family: Garin

full_name: Etienne Garin

family: Salaun

full_name: Pierre-Yves Salaun

given: Pierre-Yves

family: Vuillez

full_name: Jean-Philippe Vuillez

title: Consolidation anti-CD22 fractionated radioimmunotherapy with 90 Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial


title: Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects

summary: Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

lead_sponsor: Institut Straumann AG

location_facility: Hôtel-Dieu, Université Paris 7 Denis Diderot


title: A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.

summary:
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.

The secondary endpoints are:

To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.
To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.
To assess the safety of the combination of levofloxacin and rifampicin.
To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

design_allocation: Non-Randomized

lead_sponsor: Sanofi


title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

summary:
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

primary_purpose: Supportive Care

lead_sponsor: Centre Oscar Lambret

intervention_type: Dietary Supplement


title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

acronym: GENBPD

summary:
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:

a genome-wide association (GWA) study in VLBW neonates,
a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.


title: ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

acronym: ETOC

summary: The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

ReferenceCitation: Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hézode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.

family: Laird

full_name: Melissa E. Laird

given: Melissa E.

family: Mohsen

full_name: Amira Mohsen

given: Amira

family: Duffy

full_name: Darragh Duffy

given: Darragh

family: Mamdouh

full_name: Rasha Mamdouh

given: Rasha

family: LeFouler

full_name: Lenaig LeFouler

given: Lenaig

family: Casrouge

full_name: Armanda Casrouge

given: Armanda

family: El-Daly

full_name: Mai El-Daly

given: Mai

family: Rafik

full_name: Mona Rafik

given: Mona

family: Abdel-Hamid

full_name: Mohamed Abdel-Hamid

given: Mohamed

family: Soulier

full_name: Alexandre Soulier

given: Alexandre

family: Pawlotsky

full_name: Jean-Michel Pawlotsky

given: Jean-Michel

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Rosa

full_name: Isabelle Rosa

given: Isabelle

family: Renard

full_name: Philippe Renard

family: Mohamed

full_name: Mostafa K. Mohamed

given: Mostafa K.

family: Bonnard

full_name: Philippe Bonnard

family: Izopet

full_name: Jacques Izopet

given: Jacques

family: Mallet

full_name: Vincent Mallet

given: Vincent

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Albert

full_name: Matthew L. Albert

given: Matthew L.

family: Fontanet

full_name: Arnaud Fontanet

given: Arnaud

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

location_facility: Hôpital Tenon Service des Maladies Infectieuses


title: Study Aiming at Researching Diagnostic Markers for the Recognition of Precancerous States, Tracking, Follow-up, and the Identification of New Therapeutic Targets for Mesothelioma in Patients With Atypical Mesothelial Hyperplasia.

summary:
RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

lead_sponsor: University Hospital, Caen


title: Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer

summary:
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

lead_sponsor: Institut Curie


title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

summary:
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.


title: Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

summary:
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

acronym: METHADOSE

summary: The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

time_perspective: Cross-Sectional

ReferenceType: result

ReferenceCitation: Hajj A, Ksouda K, Peoc'h K, Curis E, Messali A, Deveaux LL, Bloch V, Prince N, Mouly S, Scherrmann JM, Lépine JP, Laplanche JL, Drici MD, Vorspan F. KCNH2 polymorphism and methadone dosage interact to enhance QT duration. Drug Alcohol Depend. 2014 Aug 1;141:34-8. doi: 10.1016/j.drugalcdep.2014.04.027. Epub 2014 May 14.

family: Hajj

full_name: Aline Hajj

given: Aline

family: Ksouda

full_name: Kamilia Ksouda

given: Kamilia

family: Peoc’h

full_name: Katell Peoc’h

given: Katell

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

family: Messali

full_name: Anne Messali

given: Anne

family: Deveaux

full_name: Laurence Labat Deveaux

given: Laurence Labat

family: Bloch

full_name: Vanessa Bloch

given: Vanessa

family: Prince

full_name: Nathalie Prince

given: Nathalie

family: Mouly

full_name: Stéphane Mouly

given: Stéphane

family: Scherrmann

full_name: Jean-Michel Scherrmann

family: Lépine

full_name: Jean-Pierre Lépine

given: Jean-Pierre

family: Laplanche

full_name: Jean-Louis Laplanche

given: Jean-Louis

family: Drici

full_name: Milou-Daniel Drici

given: Milou-Daniel

family: Vorspan

full_name: Florence Vorspan

given: Florence

journal_name: Drug and Alcohol Dependence

publisher_normalized: Elsevier

ReferenceCitation: Icick R, Peoc'h K, Ksouda K, Bloch V, Laplanche JL, Lépine JP, Bellivier F, Vorspan F. OPRM1 polymorphism and lifetime suicide attempts among stabilized, methadone-maintained outpatients. Psychiatry Res. 2014 Aug 15;218(1-2):259-60. doi: 10.1016/j.psychres.2014.04.035. Epub 2014 Apr 24.

family: Icick

full_name: R. Icick

given: R.

full_name: K. Peoc’h

given: K.

full_name: K. Ksouda

full_name: V. Bloch

given: V.

full_name: J.L. Laplanche

full_name: J.P. Lépine

family: Bellivier

full_name: F. Bellivier

given: F.

ReferenceCitation: Mouly S, Bloch V, Peoc'h K, Houze P, Labat L, Ksouda K, Simoneau G, Declèves X, Bergmann JF, Scherrmann JM, Laplanche JL, Lepine JP, Vorspan F. Methadone dose in heroin-dependent patients: role of clinical factors, comedications, genetic polymorphisms and enzyme activity. Br J Clin Pharmacol. 2015 Jun;79(6):967-77. doi: 10.1111/bcp.12576.

name: Université Paris Descartes; UMR-S1144 Paris F-75006 France

name: Université Paris Diderot; UMR-S1144 Paris F-75010 France

name: Unit of Therapeutic Research & Internal Medicine Department; Lariboisière-Saint Louis Hospital; Paris France

name: Laboratory of Biochemistry and Molecular Biology; Lariboisière-Saint Louis Hospital; Paris France

name: Laboratory of Pharmacology; Lariboisière-Saint Louis Hospital; Paris France

name: Psychiatric Unit, Assistance Publique-Hôpitaux de Paris (APHP); Lariboisière-Saint Louis Hospital; Paris France

journal_name: British Journal of Clinical Pharmacology

ReferenceCitation: Karsinti E, Fortias M, Dupuy G, Ksouda K, Laqueille X, Simonpoli AM, Touzeau D, Avril E, Orizet C, Belforte B, Coeuru P, Polomeni P, Icick R, Jarroir M, Bloch V, Scott J, Lépine JP, Bellivier F, Vorspan F. Anxiety disorders are associated with early onset of heroin use and rapid transition to dependence in methadone maintained patients. Psychiatry Res. 2016 Nov 30;245:423-426. doi: 10.1016/j.psychres.2016.04.064. Epub 2016 Jul 19.

ReferenceCitation: Marie-Claire C, Crettol S, Cagnard N, Bloch V, Mouly S, Laplanche JL, Bellivier F, Lepine JP, Eap C, Vorspan F. Variability of response to methadone: genome-wide DNA methylation analysis in two independent cohorts. Epigenomics. 2016 Feb;8(2):181-95. doi: 10.2217/epi.15.110. Epub 2016 Jan 21.

name: Inserm, UMR-S 1144, Paris, F-75006, France

name: Université Paris Descartes, UMR-S 1144, Paris, F-75006, France

name: Université Paris Diderot, Sorbonne Paris Cité, UMR-S 1144, Paris, F-75013, France

name: Unit of Pharmacogenetics & Clinical Psychopharmacology, Centre for Psychiatric Neurosciences, Department of Psychiatry, Lausanne University, Hospital of Cery, Prilly-Lausanne, Switzerland

name: Bioinformatics Platform Université Paris Descartes, Sorbonne Paris Cité, Paris, France

name: Psychiatry Department, Fernand Widal Hospital, Assistance Publique - Hôpitaux de Paris, France

ReferenceCitation: Icick R, Peoc'h K, Karsinti E, Ksouda K, Hajj A, Bloch V, Prince N, Mouly S, Bellivier F, Lépine JP, Laplanche JL, Vorspan F. A cannabinoid receptor 1 polymorphism is protective against major depressive disorder in methadone-maintained outpatients. Am J Addict. 2015 Oct;24(7):613-20. doi: 10.1111/ajad.12273. Epub 2015 Sep 1.

name: Department of Psychiatry and Addiction Medicine, Groupe Hospitalier Saint-Louis-Lariboisière-Fernand Widal; Assistance Publique-Hôpitaux de Paris (AP-HP); Paris France

name: Paris Descartes University; Paris France

name: Department of Biochemistry and Molecular Biology; Groupe Hospitalier Saint-Louis-Lariboisière-Fernand Widal, AP-HP; Paris France

name: Hospital Pharmacy; Groupe Hospitalier Saint-Louis-Lariboisière-Fernand Widal; AP-HP; Paris France

name: Department of Internal Medicine; Groupe Hospitalier Saint-Louis-Lariboisière-Fernand Widal; Assistance Publique-Hôpitaux de Paris (AP-HP); Paris France

ReferenceCitation: Icick R, Vorspan F, Karsinti E, Ksouda K, Lépine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.


summary: Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


summary: The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.

location_facility: Assistance Publique Hopitaux de Marseille


title: A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

acronym: RARE

summary: Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

ReferenceCitation: Hejblum G, Chalumeau-Lemoine L, Ioos V, Boëlle PY, Salomon L, Simon T, Vibert JF, Guidet B. Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study. Lancet. 2009 Nov 14;374(9702):1687-93. doi: 10.1016/S0140-6736(09)61459-8. Epub 2009 Nov 4.

family: Hejblum

full_name: Gilles Hejblum

given: Gilles

family: Chalumeau-Lemoine

full_name: Ludivine Chalumeau-Lemoine

given: Ludivine

family: Ioos

full_name: Vincent Ioos

given: Vincent

family: Boëlle

full_name: Pierre-Yves Boëlle

given: Pierre-Yves

family: Salomon

full_name: Laurence Salomon

given: Laurence

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Vibert

full_name: Jean-François Vibert

given: Jean-François

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

journal_name: The Lancet


title: Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

summary: The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.

primary_purpose: Basic Science


title: A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to see how they effect memory compared with tamoxifen citrate in treating postmenopausal women with breast cancer.


title: Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.

summary: The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis

ReferenceCitation: Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Bourgier C, Rivera S, Noël G, Clippe S, Mornex F, Hennequin C, Kramar A, Gourgou S, Pèlegrin A, Fenoglietto P, Ozsahin EM. Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial. EBioMedicine. 2015 Oct 25;2(12):1965-73. doi: 10.1016/j.ebiom.2015.10.024. eCollection 2015 Dec.

family: Azria

full_name: David Azria

given: David

family: Riou

full_name: Olivier Riou

given: Olivier

family: Castan

full_name: Florence Castan

family: Nguyen

full_name: Tan Dat Nguyen

given: Tan Dat

family: Peignaux

full_name: Karine Peignaux

given: Karine

family: Lemanski

full_name: Claire Lemanski

given: Claire

family: Lagrange

full_name: Jean-Léon Lagrange

given: Jean-Léon

family: Kirova

full_name: Youlia Kirova

given: Youlia

family: Lartigau

full_name: Eric Lartigau

given: Eric

family: Belkacemi

full_name: Yazid Belkacemi

given: Yazid

family: Bourgier

full_name: Céline Bourgier

given: Céline

family: Rivera

full_name: Sofia Rivera

given: Sofia

family: Noël

full_name: Georges Noël

given: Georges

family: Clippe

full_name: Sébastien Clippe

given: Sébastien

family: Mornex

full_name: Françoise Mornex

given: Françoise

family: Hennequin

full_name: Christophe Hennequin

given: Christophe

family: Kramar

full_name: Andrew Kramar

given: Andrew

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Pèlegrin

full_name: André Pèlegrin

given: André

family: Fenoglietto

full_name: Pascal Fenoglietto

given: Pascal

family: Ozsahin

full_name: Esat Mahmut Ozsahin

given: Esat Mahmut

currency_apc_doaj: USD

journal_name: EBioMedicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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


title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration

acronym: EPURE

summary: The TUNA is a known and already old technique. There exists, in the literature, a certain number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of prostate. This technique does not present the disadvantages of the surgery prostate sufferer on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it is the case in particular in the States Unis. The aim of the study which will be led by the AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24 hours.


title: "Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"

summary:
Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
Obtain data on the total body water content of healthy full term infants from BIA.

lead_sponsor: Nantes University Hospital


title: Les Cartes Sensori-motrices De La Parole : Corrélats Neuroanatomiques Des Systèmes De Perception Et De Production Des Voyelles Du Français

acronym: SPIM

summary: Speech develops through a co-structuring of auditory and motor representations, especially in the first years of life during language acquisition. In the present study, we will test by means of functional magnetic resonance imaging whether vowel perception and production might depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of this study will lead to a better understanding of whether both vowel perception and production are processed in the human brain and will provide important insight into brain-language relationships. Besides new theoretical perspectives on speech perception and production, this project might raise important questions concerning patients with speech disorders by identifying which aspects of speech perception and production are functionally linked.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Hepatic Mitochondrial Function in Sepsis

summary:
Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome.

The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.

study_start_date_type: Anticipated

status: Withdrawn

ReferenceCitation: Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23.

ReferenceCitation: Fredriksson K, Hammarqvist F, Strigård K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. Epub 2006 Jun 27. Erratum in: Am J Physiol Endocrinol Metab. 2007 Apr;292(4):E1240.

lead_sponsor: Professor C ICHAI


title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

summary:
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Effect of Deep Brain Stimulation of the Hypothalamus/ Fornix on Memory Impairment in Patients With Alzheimer's Disease

summary:
Alzheimer's Disease (AD) is the most common cause of dementia for which no treatment has shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.

The primary objectives of this prospective, non-controlled, pilot study are to evaluate the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing. Changes in behavioral and mood scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.

The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez


title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients

summary: The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

primary_purpose: Diagnostic

location_facility: Hepatogastroenterology, Hôpital l'Archet, CHU de Nice


title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

acronym: HITUPPAC-BIO

summary: The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

ReferenceCitation: Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010. Review.

family: Ferreira Da Silva

full_name: Ivan Rocha Ferreira Da Silva

given: Ivan Rocha

family: Frontera

full_name: Jennifer Ann Frontera

given: Jennifer Ann

journal_name: Cardiology Clinics

title: Targeted Temperature Management in Survivors of Cardiac Arrest


title: Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study

summary:
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.

PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

acronym: CATETEL

summary: There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

ReferenceCitation: Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. Review.

ReferenceCitation: Forestier F, Rossi H, Calderon J, Soubiron L, Bourdarias B, Janvier G. [Training for adult subclavian venous catheterization: use of real-time echography]. Ann Fr Anesth Reanim. 2002 Nov;21(9):698-702. French.

ReferenceCitation: Brooks AJ, Alfredson M, Pettigrew B, Morris DL. Ultrasound-guided insertion of subclavian venous access ports. Ann R Coll Surg Engl. 2005 Jan;87(1):25-7.


title: Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

summary: The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

lead_sponsor: Hôpital le Vinatier


title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

acronym: Laryngotest

summary: The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

ReferenceCitation: Buléon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gérard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.

family: Buléon

full_name: Clément Buléon

given: Clément

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Lesage

full_name: Anne Lesage

given: Anne

family: Grandin

full_name: Wilfried Grandin

given: Wilfried

family: Pouliquen

full_name: Emmanuel Pouliquen

given: Emmanuel

family: Flais

full_name: Frédéric Flais

given: Frédéric

family: Simonet

full_name: Thérèse Simonet

given: Thérèse

family: Gérard

full_name: Jean-Louis Gérard

given: Jean-Louis

family: Hanouz

full_name: Jean-Luc Hanouz

given: Jean-Luc

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

summary:
MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis.

The objectives of the current study are:

to develop an imaging protocol for MR Elastography of the kidneys;
To calculate the stiffness of normal kidneys;
To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.

ReferenceCitation: Rouvière O, Souchon R, Pagnoux G, Ménager JM, Chapelon JY. Magnetic resonance elastography of the kidneys: feasibility and reproducibility in young healthy adults. J Magn Reson Imaging. 2011 Oct;34(4):880-6. doi: 10.1002/jmri.22670. Epub 2011 Jul 18.

family: Rouvière

full_name: Olivier Rouvière

given: Olivier

family: Souchon

full_name: Rémi Souchon

given: Rémi

family: Pagnoux

full_name: Gaële Pagnoux

given: Gaële

family: Ménager

full_name: Jean-Michel Ménager

given: Jean-Michel

family: Chapelon

full_name: Jean-Yves Chapelon

given: Jean-Yves

journal_name: Journal of Magnetic Resonance Imaging

oa_colors: green hybrid

evidence: open (via free pdf)

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Magnetic resonance elastography of the kidneys: Feasibility and reproducibility in young healthy adults

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Urinary an Vascular Radiology, Hôpital E. Herriot


acronym: DOFAMILIA

summary: Decisions to limit and stop active therapeutics are common in the emergency unit. They are framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable obstinacy and care of the patient's pain in later life. The pain assessment is an issue for these patients whose in majority, are not communicating. Moreover, no specific tool and the teams in charge, not knowing the patient make the recognition and treatment of pain symptoms very complex. This is the potential interest of directly involving the family or the person of confidence in this management , the first step being the detection and evaluation of pain.

ReferenceCitation: Douplat M, Daoud K, Berthiller J, Schott AM, Potinet V, Le Coz P, Tazarourte K, Jacquin L. Poor Involvement of General Practitioners in Decisions of Withholding or Withdrawing Life-Sustaining Treatment in Emergency Departments. J Gen Intern Med. 2020 Jan;35(1):177-181. doi: 10.1007/s11606-019-05464-y. Epub 2019 Nov 4.

family: Douplat

full_name: Marion Douplat

given: Marion

family: Daoud

full_name: Khadidja Daoud

given: Khadidja

family: Berthiller

full_name: Julien Berthiller

given: Julien

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Potinet

full_name: Véronique Potinet

given: Véronique

family: Le Coz

full_name: Pierre Le Coz

given: Pierre

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Jacquin

full_name: Laurent Jacquin

given: Laurent

journal_name: Journal of General Internal Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: ER unit Hospital Edouard Herriot, Hospices Civils de Lyon


title: Evaluation of the Observance and the Tolerance of a Motor Training Program Combining With Repetitive tDCS Sessions on Walking Performance of Hemiplegic Stroke Patients at the Subacute Stage Post Stroke. ESTIMAH Study

acronym: ESTIMAH

summary:
Transcortical direct current stimulation (tDCS) is an emerging technique in the rehabilitation of hemiplegic patients after stroke.

This study aims to assess the observance and the tolerance of repeated tDCS stimulation over the primary motor cortex of the lower limb coupled to a motor training program, among hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind, study with two parallel groups of 15 subjects each. The study will analyze first, the patient's observance considered good if 75% of the patients completed the entire protocol duration and the tolerance through a questionnaire. The secondary end point will try to estimate, if possible, the effect size of the walking performance measured with the six-minute walk test and aerobic performance measured with VO2peak of this training program compared to the same program combine with placebo stimulations. These evaluations are performed before, during and after the rehabilitation program.

status: Recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Negative Predictive Value of Drug Provocation Tests to Beta-lactams

acronym: NPVDPT

summary: Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.

lead_sponsor: University Hospital, Montpellier

location_facility: Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier


title: Single-center, Open-label, Phase 1 Study Consisting of a Single-dose Pilot Phase and a Randomized, Two-way Crossover, Single-dose Main Phase to Investigate the Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Male Subjects

summary: The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

primary_purpose: Other

ReferenceCitation: Kaufmann P, Hurst N, Astruc B, Dingemanse J. Absolute oral bioavailability of selexipag, a novel oral prostacyclin IP receptor agonist. Eur J Clin Pharmacol. 2017 Feb;73(2):151-156. doi: 10.1007/s00228-016-2164-4. Epub 2016 Nov 24.

family: Kaufmann

full_name: Priska Kaufmann

given: Priska

family: Hurst

full_name: Noémie Hurst

given: Noémie

family: Astruc

full_name: Béatrice Astruc

given: Béatrice

family: Dingemanse

full_name: Jasper Dingemanse

given: Jasper

journal_name: European Journal of Clinical Pharmacology

lead_sponsor: Actelion


acronym: Shortystrap

summary: The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.

lead_sponsor: Rennes University Hospital


title: Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp

acronym: FIDEX

summary: Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


acronym: LabyDys

summary:
Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.

Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).

The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.

location_facility: Fondation Ophtalmique Adolphe de Rothschild


acronym: NEOSTEM

summary:
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future.

The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.

The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration


summary:
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols better adapted to the neurological impairment of each patient and to her/his specific recovery profile.

The goal of this project is to contribute identifying the factors that determine functional recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our research on two factors that contribute in a complementary way to motor control: 1) the processing of proprioceptive informations, and 2) the processing of movement-execution errors. In this purpose, we will combine psychophysical methods that allow to precisely quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More specifically, we will exploit experimental protocols that have been developed in basic research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely quantify motor and proprioceptive deficits in stroke patients. Then, we will link these behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI) completed by diffusion tensor images (DTI) in order to achieve a finer description of the cerebral lesions.

The present study will include two experimental parts, respectively centered on the proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution errors (Part 2).

Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present, deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in " proprioception for action " are more determinant than deficits in the conscious sense of position (classically tested in clinics). In this purpose, we will collect three sets of behavioral data, in chronic stroke patients and healthy control participants, respectively intended to assess a) motor deficits, b) troubles in conscious sense of position, and c) deficits in "proprioception for action". To better document the neuronatomical substrates of these different types of deficits. In this purpose, we will link the obtained behavioral data with the results of detailed analyses of the lesions of the tested stroke patients.

Anomalies in the processing of movement-execution errors in stroke patients : We will assess movement-execution error processing in stroke patients, in order to test the idea that anomalies in error processing might contribute to motor deficits in stroke patients. In this purpose, we will record an electrophysiological correlate (ERP) of movement-error processing during a motor adaptation task. We will analyse the relation between the modulation of this ERP and motor performance. We will also examine the relation between these two sets of data (behavioral and electrophysiological) and the behavioral data collected during the first part of the study (Proprioceptive deficits). This will provide us with insight into the relationship between proprioceptive deficits and cinematic error processing. As in the first part of the study, we will link the observed electrophysiological and behavioral anomalies with the results of a detailed analysis of the anatomical lesions of the tested patients.

primary_purpose: Prevention

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

acronym: IMPRIM

summary: Open-label, non-randomized, prospective, single center, observational, translational study


title: Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy

summary: Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.

time_perspective: Retrospective


title: Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation.

acronym: EPISTIM

summary:
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population.

Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy.

It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results.

This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.

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ReferenceCitation: Kahane P, Minotti L, Hoffmann D, Lachaux JP, Ryvlin P. Invasive EEG in the definition of the seizure onset zone: depth electrodes. In : Rosenow F, Lüders HO, eds. Handbook of Clinical Neurophysiology, Vol.3. Presurgical assessment of the epilepsies with clinical neurophysiology and functional imaging. Amsterdam : Elsevier BV, 2004 : 109-133.

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ReferenceCitation: Rosenberg DS, Mauguière F, Catenoix H, Faillenot I, Magnin M. Reciprocal thalamocortical connectivity of the medial pulvinar: a depth stimulation and evoked potential study in human brain. Cereb Cortex. 2009 Jun;19(6):1462-73. doi: 10.1093/cercor/bhn185. Epub 2008 Oct 20.

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ReferenceCitation: Téllez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005 May;128(Pt 5):1188-98. Epub 2005 Mar 9. Review.

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ReferenceCitation: Worrell GA, Parish L, Cranstoun SD, Jonas R, Baltuch G, Litt B. High-frequency oscillations and seizure generation in neocortical epilepsy. Brain. 2004 Jul;127(Pt 7):1496-506. Epub 2004 May 20.


title: Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy

acronym: REDIAGEN

summary:
Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these countries (and the gold-standard treatment, laser photocoagulation has proven to be effective in preventing vision loss at the end stage of eye disease due to proliferative diabetic retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for predictive factors of sight threatening stages of diabetic retinopathy has become more important.

Previous studies that have examined candidate predictive factors for diabetic eye disease have mostly focused on systemic risk factors leading to PDR. Among various clinical parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration, neuropathy and elevated triglycerides have been associated with PDR.

Some genetic factors may also account for the development of PDR and are prospectively considered in this study .

lead_sponsor: CHU de Reims

intervention_type: Genetic


summary:
ECMO (extra-corporeal membrane oxygenation) is a blood oxygenation technical and purification of carbon dioxide by means of an extracorporeal circulation using a pump (identical to those used in cardiac surgery) and a membrane permitting gas exchange. This technique is used for almost 40 years in the acute respiratory distress syndrome (ARDS) but benefited from many technology improvements over the past 10 years.

The circuit is now fully pre-heparin, not imposing obtaining activated partial thromboplastin time (aPTT) high. Centrifugal pumps limit the risk of intravascular hemolysis. The multi-perforated drainage cannula in place in femoral vein or jugular no longer need to maintain hypervolaemia to ensure sufficient flow.

The membrane ensuring gas exchange is now polymethylpentene. This hollow fiber system ensures the gas exchange.

In light of recent technical improvements, manufacturers indicate that the membranes can be used for 3 weeks. However, after a few days of use, fibrinoplaquettaires microthrombi form at the ECMO circuit, up from cannulas up to the oxygenator, decreasing membrane efficiency and imposing more early changes of the circuit. This hypercoagulable state was revealed through the study of classical plasma markers of coagulation. There is not so far from reliable predictive marker of thrombus formation, indicating a need to change the circuit.

The production of microparticles (MPs) is a characteristic of cells subjected to an activation or apoptosis. MPs are membrane Smaller fragments released into the extracellular milieu after rupture of the asymmetry of the distribution of membrane phospholipids and characterized by the presence of phosphatidylserine (PhtdSer) on their surface, as well as various antigens expressed by their cells of origin. The PhtdSer is a pro-coagulating surface on which are going to assemble the enzymes responsible for the formation of thrombin and increases proportionally the TF activity ultimately leading to fibrin polymerization in the vessels.

The vesiculation phenomenon exists in healthy subjects. In human pathology, many examples emphasize the fundamental role of MP in clotting or thrombosis. The PM generating fault is associated with bleeding disorders (Scott syndrome, dysvésiculation syndrome). Conversely, high circulating levels of MP are found in many thrombotic diseases (myocardial infarction, diabetes, antiphospholipid antibody syndrome, preeclampsia ...). Platelet and intense monocyte endothelial activation, observed in sepsis and severe trauma, is accompanied by the generation of procoagulant MP carriers of tissue factor (TF). These MP diffuse into the vascular compartment pathogenic potential may exacerbate inflammatory and thrombotic responses and play a leading role in triggering the DIC.

More recently, various studies have shown that the microparticles are not only activation markers or injury, but also cellular elements having a true pathogenic role. Because they contain or express on their surface various biological effector (adhesion molecules, tissue factor, inflammatory mediators or apoptogenic, growth factor ...) the microparticles are able to interact with their environment and modulate cellular very different way the properties of target cells. And platelet or leukocyte microparticles could actively participate in the thrombotic process by increasing adhesion of monocytes and endothelial cells, or by inducing endothelial procoagulant response.


title: Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans

summary:
This study is part of the french research program ANR NEMRO "MICROROBOTIC NASAL ENDOSCOPY BY OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES." Recent studies have shown a strong correlation between the decrease in olfactory faculties of patients and the presence of neurodegenerative diseases.

This possible relationship has created a need to inspect in detail the area of the nasal cavity that houses the olfactory function.

Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of patients, with a view to extract images through non invasive imaging probe, and hoping to identify early signs of degeneration the olfactory tissue. The robot developed will thus be able to navigate in the nasal cavity of patients, and to break into the olfactory slots, which will host the imaging phase.

The purpose of this study is therefore to collect data on the usual path of instruments (endoscope, for example) in this area, and future potential pathway of the robot. This collection made from Computed Tomography (CT) scans will define the clinical geometry of the target area and provide precisely the dimensional constraints needed to build the NEMRO robot .

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial

acronym: FUSAC

summary:
After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms.

Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.

location_facility: Fondation Opthalmologique A de Rothschild


title: Assessment of Patients' Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke

acronym: AVC-endovasc

summary:
This trial aims at collecting standardized data concerning the early neurological clinical recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.

Although this outcome is a major issue of patients' prognosis, it is rarely collected at this stage of their follow-up.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Long Term Follow-up After Embolization of Brain Arteriovenous Malformations

acronym: MAV-endovasc

summary: The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients.

ReferenceCitation: Baharvahdat H, Blanc R, Fahed R, Pooyan A, Mowla A, Escalard S, Delvoye F, Desilles JP, Redjem H, Ciccio G, Smajda S, Hamdani M, Mazighi M, Piotin M. Endovascular treatment as the main approach for Spetzler-Martin grade III brain arteriovenous malformations. J Neurointerv Surg. 2021 Mar;13(3):241-246. doi: 10.1136/neurintsurg-2020-016450. Epub 2020 Sep 28.

family: Baharvahdat

full_name: Humain Baharvahdat

given: Humain

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

family: Fahed

full_name: Robert Fahed

given: Robert

family: Pooyan

full_name: Ashkan Pooyan

given: Ashkan

family: Mowla

full_name: Ashkan Mowla

family: Escalard

full_name: Simon Escalard

given: Simon

family: Delvoye

full_name: François Delvoye

given: François

family: Desilles

full_name: Jean Philippe Desilles

given: Jean Philippe

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Ciccio

full_name: Gabriele Ciccio

given: Gabriele

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Hamdani

full_name: Mylène Hamdani

given: Mylène

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

family: Piotin

full_name: Michel Piotin

given: Michel

journal_name: Journal of NeuroInterventional Surgery

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Endovascular treatment as the main approach for Spetzler–Martin grade III brain arteriovenous malformations

ReferenceCitation: Baharvahdat H, Blanc R, Fahed R, Smajda S, Ciccio G, Desilles JP, Redjem H, Escalard S, Mazighi M, Chauvet D, Robert T, Sasannejad P, Piotin M. Endovascular Treatment for Low-Grade (Spetzler-Martin I-II) Brain Arteriovenous Malformations. AJNR Am J Neuroradiol. 2019 Apr;40(4):668-672. doi: 10.3174/ajnr.A5988. Epub 2019 Feb 21.

full_name: H. Baharvahdat

given: H.

full_name: R. Blanc

given: R.

full_name: R. Fahed

full_name: S. Smajda

given: S.

full_name: G. Ciccio

given: G.

full_name: J.-P. Desilles

full_name: H. Redjem

publisher: American Society of Neuroradiology (ASNR)

title: Endovascular Treatment for Low-Grade (Spetzler-Martin I–II) Brain Arteriovenous Malformations


title: Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program

summary:
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.

However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.

A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.

The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.


title: Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft

acronym: TTT-PT-DOP

summary:
Interventional , multicenter , comparative study. One eye receiving the cells and the contralateral eye as a negative control . If effectiveness following review of the primary endpoint and the advice of an independent expert committee , the experimental treatment will be offered to the patient to the contralateral eyelid.

Objective is to restore muscle function levator muscle of the upper eyelid by providing a registry of autologous myoblasts from a non- clinically affected muscle .

lead_sponsor: University Hospital, Caen

intervention_type: Biological


summary:
The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.


title: Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)

acronym: DOLUTECAPS

summary:
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).

While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.


summary: The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.

lead_sponsor: ONIRIS


title: Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study

acronym: PrehabPilote

summary: The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.

lead_sponsor: Hopital Foch


title: Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity

summary: Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.

ReferenceCitation: Vanhelst J, Vidal F, Drumez E, Béghin L, Baudelet JB, Coopman S, Gottrand F. Comparison and validation of accelerometer wear time and non-wear time algorithms for assessing physical activity levels in children and adolescents. BMC Med Res Methodol. 2019 Apr 2;19(1):72. doi: 10.1186/s12874-019-0712-1.

family: Vanhelst

full_name: Jérémy Vanhelst

given: Jérémy

family: Vidal

full_name: Florian Vidal

given: Florian

family: Drumez

full_name: Elodie Drumez

given: Elodie

family: Béghin

full_name: Laurent Béghin

given: Laurent

family: Baudelet

full_name: Jean-Benoît Baudelet

given: Jean-Benoît

family: Coopman

full_name: Stéphanie Coopman

given: Stéphanie

family: Gottrand

full_name: Frédéric Gottrand

given: Frédéric

currency_apc_doaj: GBP

journal_name: BMC Medical Research Methodology

license: cc-by

license_normalized: cc-by

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

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

repository_normalized: HAL

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

ReferenceCitation: Vanhelst J, Béghin L, Drumez E, Coopman S, Gottrand F. Awareness of wearing an accelerometer does not affect physical activity in youth. BMC Med Res Methodol. 2017 Jul 11;17(1):99. doi: 10.1186/s12874-017-0378-5.

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

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille