title: Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.

summary: Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

ReferenceCitation: de Truchis P, Assoumou L, Landman R, Mathez D, Le Dû D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

name: Hôpitaux Universitaires Paris-Ile de France-Ouest, Hôpital Raymond Poincaré APHP, Garches, Université Versailles-Saint-Quentin, France

family: de Truchis

full_name: Pierre de Truchis

given: Pierre

name: Sorbonne Universités, INSERM, UPMC Université Paris 06, Institut Pierre Louis d’Epidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France

name: Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat, Université Paris 7, Paris, France

name: IAME, UMR 1137, Université Paris Diderot, Sorbonne Paris Cité, AP-HP, Hôpital Bichat-Claude Bernard, Service de Maladies Infectieuses et Tropicales, Paris, France

family: Mathez

full_name: Dominique Mathez

family: Le Dû

full_name: Damien Le Dû

given: Damien

family: Bellet

full_name: Jonathan Bellet

given: Jonathan

family: Amat

full_name: Karine Amat

given: Karine

name: APHP, Hôpital Pitié-Salpétrière, Service Maladies Infectieuses et Tropicales, Paris, France

family: Katlama

full_name: Christine Katlama

given: Christine

name: Centre Hospitalier Universitaire Bretonneau, Tours, France

family: Gras

full_name: Guillaume Gras

given: Guillaume

name: APHP, Centre Hospitalier Universitaire Avicenne, APHP, Bobigny 93, France

family: Bouchaud

full_name: Olivier Bouchaud

given: Olivier

name: Université Paris Sorbonne-Diderot, EA 7334, APHP Hotel-Dieu, URC-ECO, Paris, France

family: Duracinsky

full_name: Martin Duracinsky

given: Martin

name: APHP Hôpital R Poincaré, Département de Pharmacologie, Inserm U-1173, Université Paris-Ile de France Ouest, Garches 92, France

family: Abe

full_name: Emuri Abe

given: Emuri

family: Alvarez

full_name: Jean-Claude Alvarez

given: Jean-Claude

name: INSERM U1043/CNRS5282, Université de Toulouse, CHU Purpan, Toulouse, France

family: Izopet

full_name: Jacques Izopet

given: Jacques

name: INSERM-ANRS, Agence Nationale pour la Recherche sur le Sida et les Hépatites, Paris, France

family: Saillard

full_name: Juliette Saillard

given: Juliette

family: Melchior

full_name: Jean-Claude Melchior

family: Leibowitch

full_name: Jacques Leibowitch

name: APHP, Hôpital Saint Antoine, Service Maladies Infectieuses, Paris, France

family: Perronne

full_name: Christian Perronne

given: Christian

family: Zamord

full_name: Irène Zamord

given: Irène

family: Goujard

full_name: Cécile Goujard

given: Cécile

family: Fourreau

location_facility:
Hôpital Le Bocage
Hôpital Necker
Hôpital Purpan
Hôpital Tenon
Hôpital Gui de Chauliac
Hôpital Bichat
Hôpital Raymond Poincaré
Hôpital Bretonneau
Hôpital Foch
Hôpital Avicenne
Hôpital Pitié-Salpêtrière
Hôpital Européen Georges Pompidou
Hôpital Saint-Antoine
Hôpital Meynard
Hôpital Bicêtre
Centre Hospitalier Sud Francilien
CHU Côte de Nacre


title: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

summary: Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
CHU Angers
CHU Limoges
AP-HP La Pitié Salpétrière
CHU Nantes
CHU Nancy
Centre Hospitalier Le Mans

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery

summary: The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: ARCAGY/ GINECO GROUP

intervention_type: Drug

lead_sponsor_type: industriel


title: Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases

summary:
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.

A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804.

ReferenceCitation: Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


summary: Pressure ulcers are a common and frustrating problem and their treatment is critical in elderly people. The interaction between external pressure and the skin vascular is central to the prevention of pressure ulcers. It is only through understanding of the physiology of cutaneous perfusion and its relation to external pressure or different stimuli that effective preventive measures to reduce skin beakdown can be adapted in clinical practice.

status: Unknown status

time_perspective: Other

lead_sponsor: University Hospital, Angers

intervention_type: Behavioral

status_simplified: Unknown


type: Other Identifier

title: Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects

summary:
Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :

to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Service d'Explorations et de Médecine Vasculaire University Hospital Center


title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT

acronym: PAIN-OUT

summary:
This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

What is the incidence of chronic post surgical pain (CPSP) in Europe?
What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
What are the difference in incidence and risk factors in different European countries?

ReferenceCitation: Fletcher D, Pogatzki-Zahn E, Zaslansky R, Meissner W; Pain Out Group. euCPSP: European observational study on chronic post-surgical pain. Eur J Anaesthesiol. 2011 Jun;28(6):461-2. doi: 10.1097/EJA.0b013e328344b4cd.

ReferenceType: derived

ReferenceCitation: Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.

family: Fletcher

full_name: Dominique Fletcher

given: Dominique

sequence: first

family: Stamer

full_name: Ulrike M. Stamer

given: Ulrike M.

sequence: additional

family: Pogatzki-Zahn

full_name: Esther Pogatzki-Zahn

given: Esther

family: Zaslansky

full_name: Ruth Zaslansky

given: Ruth

family: Tanase

full_name: Narcis Valentin Tanase

given: Narcis Valentin

family: Perruchoud

full_name: Christophe Perruchoud

given: Christophe

family: Kranke

full_name: Peter Kranke

given: Peter

family: Komann

full_name: Marcus Komann

given: Marcus

family: Lehman

full_name: Thomas Lehman

given: Thomas

family: Meissner

full_name: Winfried Meissner

given: Winfried

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

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: Chronic postsurgical pain in Europe

ReferenceCitation: Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206. Erratum in: Eur J Anaesthesiol. 2015 Mar;32(3):222.

family: Naef

full_name: Nadja Naef

given: Nadja

family: Porz

full_name: Rouven Porz

given: Rouven

family: Stuber

full_name: Frank Stuber

given: Frank

family: Leva

full_name: Brigitte Leva

given: Brigitte

lead_sponsor: European Society of Anaesthesiology

location_country:
Italy
Switzerland
France
Romania
Ireland
Belgium
Spain
Moldova, Republic of
Germany
United Kingdom
Ukraine

location_facility: Ensemble Hospitalier de la Cote in Morges

location_facility: University College Hospital NHS Foundation Trust

location_facility: Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''

location_facility: Central Universitty and Emergency Military Hospital "Dr. Carol Davila"


title: A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)

acronym: HALO

summary: Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

status: Terminated

lead_sponsor: Debiopharm International SA

location_country:
United Kingdom
France
Spain

location_facility: Institut de Cancérologie de l'Ouest- Institut René Gauduchau


title: Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.

summary: The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.

ReferenceCitation: Boudjemline Y, Schievano S, Bonnet C, Coats L, Agnoletti G, Khambadkone S, Bonnet D, Deanfield J, Sidi D, Bonhoeffer P. Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: a hybrid approach. J Thorac Cardiovasc Surg. 2005 Apr;129(4):831-7.

location_facility: NECKER HOSPITAL for Sick Children, 149 R. de SEVRES


ReferenceCitation: Ignatiadis M, Rack B, Rothé F, Riethdorf S, Decraene C, Bonnefoi H, Dittrich C, Messina C, Beauvois M, Trapp E, Goulioti T, Tryfonidis K, Pantel K, Repollet M, Janni W, Piccart M, Sotiriou C, Litiere S, Pierga JY. Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial. Eur J Cancer. 2016 Aug;63:97-104. doi: 10.1016/j.ejca.2016.04.024. Epub 2016 Jun 10. Review.

family: Ignatiadis

full_name: Michail Ignatiadis

given: Michail

family: Rack

full_name: Brigitte Rack

family: Rothé

full_name: Francoise Rothé

given: Francoise

family: Riethdorf

full_name: Sabine Riethdorf

given: Sabine

family: Decraene

full_name: Charles Decraene

given: Charles

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Dittrich

full_name: Christian Dittrich

given: Christian

family: Messina

full_name: Carlo Messina

given: Carlo

family: Beauvois

full_name: Melanie Beauvois

given: Melanie

family: Trapp

full_name: Elisabeth Trapp

given: Elisabeth

family: Goulioti

full_name: Theodora Goulioti

given: Theodora

family: Tryfonidis

full_name: Konstantinos Tryfonidis

given: Konstantinos

family: Pantel

full_name: Klaus Pantel

given: Klaus

family: Repollet

full_name: Madeline Repollet

given: Madeline

family: Janni

full_name: Wolfgang Janni

given: Wolfgang

family: Piccart

full_name: Martine Piccart

given: Martine

family: Sotiriou

full_name: Christos Sotiriou

given: Christos

family: Litiere

full_name: Saskia Litiere

given: Saskia

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

journal_name: European Journal of Cancer

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Germany
United Kingdom
Belgium
France

acronym: TREAT-CTC

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt

location_facility: Gemeinschaftspraxis Lorenz / Hecker / Wesche

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen

location_facility: Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

location_facility: Gemeinschaftspraxis Prof. Salat / Dr. Stötzer

location_facility: HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz

location_facility: Staedtische Kliniken Frankfurt Am Main-Hoechst

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: HELIOS Kliniken - HELIOS Klinik Rottweil

location_facility: Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: Gesellschaft für onkologische Studien, Praxismanagement und -Logistik

location_facility: St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG

location_facility: Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH

title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

summary:
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.

Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.


title: Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

summary:
This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.

By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.

The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceCitation: Tailor A, Jurkovic D, Bourne TH, Collins WP, Campbell S. Sonographic prediction of malignancy in adnexal masses using multivariate logistic regression analysis. Ultrasound Obstet Gynecol. 1997 Jul;10(1):41-7.

ReferenceCitation: MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. Review.

ReferenceCitation: Timmerman D, Bourne TH, Tailor A, Collins WP, Verrelst H, Vandenberghe K, Vergote I. A comparison of methods for preoperative discrimination between malignant and benign adnexal masses: the development of a new logistic regression model. Am J Obstet Gynecol. 1999 Jul;181(1):57-65.

ReferenceCitation: Kinkel K, Hricak H, Lu Y, Tsuda K, Filly RA. US characterization of ovarian masses: a meta-analysis. Radiology. 2000 Dec;217(3):803-11.

ReferenceCitation: Suren A, Osmers R, Kulenkampff D, Kuhn W. Visualization of blood flow in small ovarian tumor vessels by transvaginal color Doppler sonography after echo enhancement with injection of Levovist. Gynecol Obstet Invest. 1994;38(3):210-2.

ReferenceCitation: Ordén MR, Gudmundsson S, Kirkinen P. Contrast-enhanced sonography in the examination of benign and malignant adnexal masses. J Ultrasound Med. 2000 Nov;19(11):783-8. Erratum in: J Ultrasound Med 2001 Jan;20(1):20.

ReferenceCitation: Morel DR, Schwieger I, Hohn L, Terrettaz J, Llull JB, Cornioley YA, Schneider M. Human pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for ultrasound imaging. Invest Radiol. 2000 Jan;35(1):80-5.

lead_sponsor: University Hospital, Tours


title: A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study

summary: The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 30 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

lead_sponsor: MIVI Neuroscience, Inc.

location_facility:
Hôpital Purpan
CHU Bicetre Paris
CHU Urbains
CHU Pellegrin

intervention_type: Device

status_simplified: Ongoing


title: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

summary: The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and bronchoalveolar lavage (FO-BAL) in performing the etiological diagnosis of acute respiratory failure in cancer patients.

ReferenceCitation: Dunagan DP, Baker AM, Hurd DD, Haponik EF. Bronchoscopic evaluation of pulmonary infiltrates following bone marrow transplantation. Chest. 1997 Jan;111(1):135-41.

ReferenceCitation: White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7.

ReferenceCitation: Murray PV, O'Brien ME, Padhani AR, Powles R, Cunningham D, Jeanes A, Ashley S. Use of first line bronchoalveolar lavage in the immunosuppressed oncology patient. Bone Marrow Transplant. 2001 May;27(9):967-71.

ReferenceCitation: Azoulay E, Mokart D, Lambert J, Lemiale V, Rabbat A, Kouatchet A, Vincent F, Gruson D, Bruneel F, Epinette-Branche G, Lafabrie A, Hamidfar-Roy R, Cracco C, Renard B, Tonnelier JM, Blot F, Chevret S, Schlemmer B. Diagnostic strategy for hematology and oncology patients with acute respiratory failure: randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1038-46. doi: 10.1164/rccm.201001-0018OC. Epub 2010 Jun 25.

family: Azoulay

full_name: Élie Azoulay

given: Élie

family: Mokart

full_name: Djamel Mokart

given: Djamel

family: Lambert

full_name: Jérôme Lambert

given: Jérôme

family: Lemiale

full_name: Virginie Lemiale

given: Virginie

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

family: Vincent

full_name: François Vincent

given: François

family: Gruson

full_name: Didier Gruson

given: Didier

family: Bruneel

full_name: Fabrice Bruneel

given: Fabrice

family: Epinette-Branche

full_name: Géraldine Epinette-Branche

given: Géraldine

family: Lafabrie

full_name: Ariane Lafabrie

given: Ariane

family: Hamidfar-Roy

full_name: Rebecca Hamidfar-Roy

given: Rebecca

family: Cracco

full_name: Christophe Cracco

given: Christophe

family: Renard

full_name: Benoît Renard

given: Benoît

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

family: Blot

full_name: François Blot

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Schlemmer

full_name: Benoît Schlemmer

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Diagnostic Strategy for Hematology and Oncology Patients with Acute Respiratory Failure

location_facility: Service de Réanimation Médicale de l'Hôpital Saint-Louis


title: Long-term Iron Chelation in the Prevention of Secondary Remote Degeneration After Stroke

acronym: CHEL-IC

summary:
Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra).

MRI imaging methods such as the quantification of the transverse relaxation rate R2* provide highly correlated information to the histologically measured iron load

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Montpellier
CHU de Lille
CHU Bordeaux
CHU de Toulouse


title: Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy : a Randomized, Multicenter, Open-label Phase III Study

summary:
At present, it is recommended to continue immunotherapy until progression or unacceptable toxicity.

However, only a minority of patients benefits from a durable response and most see the disease progress despite several months of control under immunotherapy. Multimodal approaches have been developed to improve their prognosis.

This study, randomized, open-label study aims to evaluate the impact of addition of ablative radiotherapy on OS of patients with NSCLC and oligometastatic lesions and treated by immunotherapy in first line (potentially associated with chemotherapy) or beyond. Stereotactic radiotherapy will be performed on a maximum of 5 residual hypermetabolic lesions seen on 18F-FDG PET / CT, in patients responding to immunotherapy (or with a stable disease) for at least 6 months.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut de cancérologie de l'ouest
Chu de Brest
Centre François BACLESSE
Chu de Tours

intervention_type: Radiation


title: INterest of the Negative Predictive Value of Integrons in Choosing a Narrow-spectrum Empirical anTibiotic Treatment vs Usual Empirical Antibiotic Treatment for Urinary Tract infectionS in the PEDiatric Emergency Department

acronym: INVICTUS PED

summary: INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe urinary tract infection (UTI) with fever

primary_purpose: Basic Science

lead_sponsor: University Hospital, Limoges

location_facility:
Toulouse university Hospital
Montpellier university Hospital
Bordeaux university Hospital
Limoges university Hospital


title: Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial

acronym: SECOIA

summary:
Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.

Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.

If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.

Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).

Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.

The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Hopital Lariboisière
Hopital Henri Mondor
CHU Nantes
CHD Vendée


title: Relationship Between Resistance to the Tyrosine Kinase Inhibitor Osimertinib and Pharmacokinetics in Non-small Cell Lung Cancer: Toward an Individualization of the Treatment (RESISTYR)

acronym: RESISTYR

summary:
Osimertinib is a tyrosine kinase (TKI) inhibitor targeting EGF-R (epidermal growth factor receptor) and used in the management of patients with non-small cell lung cancer (NSCLC) with oncogenic drug addiction to EGF-R. The results of the FLAURA study justifies this 3rd generation TKI as the first line TKI of choice since an increase in overall survival of several months has been observed compared to TKIs of previous generations (erlotinib, gefitinib). However, the response to osimertinib is heterogeneous and some patients are poor responder. In addition, even when an initial response to ITK is observed, the natural history of the disease inevitably leads to the appearance of resistance mutations and loss of efficacy of osimertinib after a few months of treatment.In the hypothesis of a concentration-effect relationship, an underexposure (an insufficient plasma concentration) to osimertinib could lead to a suboptimal response by favoring the appearance of molecular resistance. By analogy with the mechanisms of resistance to anti-infectives, the systemic concentration of TKI may have to be maintained above a certain value throughout the treatment to reach an effective concentration in the tumor, in order to to prevent the selection of resistant clones. The value of this approach for optimizing treatment with TKI has been shown for this therapeutic class. This mechanistic hypothesis has been suggested several TKIs.

In addition, the association between pharmacokinetics of TKIs and the development of resistance has been reported in several pilot studies for dasatinib, erlotinib. Furthermore, a link between TKI concentration and ctDNA concentration was demonstrated in a pilot study by Garlan et al. in 11 patients treated for melanoma with vemurafenib.

The impact of the results of this study is important since the aims are to identify preemptive and predictive biomarkers of drug response and to increase mechanistic knowledge regarding risk factor of resistance to osimertinib. Finally, if the hypotheses evaluated in this translational research study are verified, therapeutic drug monitoring of TKI (and ctDNA analysis) would be immediately applicable in clinical practice since the technical tools are already available in the laboratories of most hospitals centers.

lead_sponsor: Rennes University Hospital

location_facility:
CH Bretagne Sud (Site du Scorff)
CH Saint Malo (Service de Pneumologie)
Chu de Rennes (Service Pneumologie)
CH Bretagne Atlantique

intervention_type: Diagnostic Test


title: fMRI Study of Grasping in Autistic Patients

summary: The aim of the study is to localise brain regions involved in objects recognition, in planification and adjustment of grasping, in prehension with and without eye control. The study is conducted in normal and autistic adults. We hypothesize different activations in these two populations.


title: An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

acronym: DRIP

summary:
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

ReferenceCitation: Van Herzeele C, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Predictive parameters of response to desmopressin in primary nocturnal enuresis. J Pediatr Urol. 2015 Aug;11(4):200.e1-8. doi: 10.1016/j.jpurol.2015.03.007. Epub 2015 May 21.

family: Van Herzeele

full_name: Charlotte Van Herzeele

given: Charlotte

family: Evans

full_name: Jonathan Evans

given: Jonathan

family: Eggert

full_name: Paul Eggert

given: Paul

family: Lottmann

full_name: Henri Lottmann

given: Henri

family: Norgaard

full_name: Jens Peter Norgaard

given: Jens Peter

family: Vande Walle

full_name: Johan Vande Walle

given: Johan

journal_name: Journal of Pediatric Urology

ReferenceCitation: Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Safety profile of desmopressin tablet for enuresis in a prospective study. Adv Ther. 2014 Dec;31(12):1306-16. doi: 10.1007/s12325-014-0173-1. Epub 2014 Dec 12.

family: De Bruyne

full_name: Pauline De Bruyne

given: Pauline

journal_name: Advances in Therapy

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Safety Profile of Desmopressin Tablet for Enuresis in a Prospective Study

ReferenceCitation: Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract. 2009 Jan;63(1):35-45. doi: 10.1111/j.1742-1241.2008.01956.x.

full_name: H. Lottmann

given: H.

family: Baydala

full_name: L. Baydala

given: L.

full_name: P. Eggert

given: P.

family: Klein

full_name: B. M. Klein

given: B. M.

full_name: J. Evans

given: J.

journal_name: International Journal of Clinical Practice

location_facility: Foundation Hospital Saint Joseph, 185, rue Raymond Losserand


title: A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

summary:
Ultrasound is a well-established imaging modality for the evaluation of breast disease.

The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.

SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.

Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.

ReferenceCitation: Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44.

ReferenceCitation: Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51.

ReferenceCitation: Watermann D, Madjar H, Sauerbrei W, Hirt V, Prömpeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.

ReferenceCitation: Martínez AM, Medina CJ, Bustos C, Hernández JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.

ReferenceType: result

ReferenceCitation: Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104.


type: EudraCT Number

title: Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Retroperitoneal Sarcomas

acronym: TORNADO

summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Institut Gustave Roussy
Centre Léon Bérard
Institut Curie


title: Variations of Hemispheric Lateralisation of Language Depending of Gender and Age.

summary: The purpose of this study is to determine whether gender and age modify cerebral activations during a silent word generation functional Magnetic Resonance task.


summary:
The purpose of this study is :

to look for changes induced by aging in a population of old subjects, during silent word generation tasks studied by fMRI.
to look for a possible link between these changes and alterations in language


title: Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

acronym: PFO-AF

summary: This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

status: Recruiting

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Grenoble
University Hospital Besancon
CHU Lyon - Hôpital Louis Pradel
CHU Dijon


title: Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients

acronym: ROBOLINK-e

summary: This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).

primary_purpose: Other

lead_sponsor: Association APPROCHE

location_facility:
IUR Clémenceau
CMRRF de Kerpape
CR Mulhouse
CMPR Côte d'Amour


title: Suicide Risk Within 30 Days After a Potentially Traumatic Event (PTE) in Patients Treated by a Medico-psychological Emergency Unit. Prospective Cohort Study

acronym: SCAR

summary:
The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, we will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

lead_sponsor: University Hospital, Grenoble

location_facility:
Geneste-Saelens
VIGNAUD Philippe
DELACHENAL Catherine
COURVOISIER Pierre


title: Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients: a Qualitative Evaluation of the Implementation

acronym: FORAIDMUCO

summary:
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.

Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.

Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.

lead_sponsor: Hospices Civils de Lyon

location_facility: CRCM Grenoble adulte - Hôpital Albert Michallon

location_facility: CRCM Lyon adulte - Centre hospitalier Lyon Sud

location_facility: CRCM Montpellier Mixte - Hôpital Arnaud de Villeneuve

location_facility: CRCM Rennes adulte - Hôpital Pontchaillou


title: Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study

acronym: GRADE

summary:
The study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation.

In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo.

During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

lead_sponsor: Lille Catholic University

location_facility:
CH Dunkerque-rheumatology
CHU Rouen-rheumatology
CH Béthune-rheumatology
CHU Caen-rheumatology


title: CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes

acronym: CUTADIAB

summary: The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department

location_facility: AP-HP, Cochin Hospital, Department of Diabetology

location_facility: AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition


title: PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

summary: Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI


title: Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure

summary: The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). The assumption tested is that a high level of PEP increases the impedance with the ejection of the right ventricle independently of the level of plate pressure. The effect on the right ventricular preload will be checked via the analysis of the respiratory variability of the diameter of the higher vena cava.

ReferenceCitation: Bouadma L, Lellouche F, Cabello B, Taillé S, Mancebo J, Dojat M, Brochard L. Computer-driven management of prolonged mechanical ventilation and weaning: a pilot study. Intensive Care Med. 2005 Oct;31(10):1446-50. Epub 2005 Aug 23.

ReferenceCitation: Lacherade JC, Auburtin M, Cerf C, Van de Louw A, Soufir L, Rebufat Y, Rezaiguia S, Ricard JD, Lellouche F, Brun-Buisson C, Brochard L. Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1276-82. Epub 2005 Aug 26.

ReferenceCitation: Mekontso Dessap A, Charron C, Devaquet J, Aboab J, Jardin F, Brochard L, Vieillard-Baron A. Impact of acute hypercapnia and augmented positive end-expiratory pressure on right ventricle function in severe acute respiratory distress syndrome. Intensive Care Med. 2009 Nov;35(11):1850-8. doi: 10.1007/s00134-009-1569-2. Epub 2009 Aug 4.

family: Mekontso Dessap

full_name: Armand Mekontso Dessap

given: Armand

family: Charron

full_name: Cyril Charron

given: Cyril

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Aboab

full_name: Jérôme Aboab

family: Jardin

full_name: François Jardin

given: François

family: Brochard

full_name: Laurent Brochard

given: Laurent

family: Vieillard-Baron

full_name: Antoine Vieillard-Baron

given: Antoine

journal_name: Intensive Care Medicine

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

location_facility: HOPITAL HENRI MONDOR Department of Neurosurgery


title: Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep

acronym: CONNECTOSOM

summary: The management of insomnia includes, as a first step, a healthy lifestyle, including physical activity at appropriate times, nutritional monitoring, reduced consumption of stimulants, bedtime and wake-up times that do not vary between weekdays and weekends, banning screens at least two hours before bedtime, etc. If all these conditions are met and insomnia persists, additionnal therapies may be offered. URGOTECH has developed a connected headband allowing to practice neurofeedback in complete autonomy in subjects reporting dissatisfaction with the quality of their sleep.

lead_sponsor: URGOTECH

location_facility:
Lille University Hospital
Hôpital Hôtel-Dieu - APHP
Pellegrin University Hospital
Grenoble Alpes University Hospital


title: Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.

acronym: ASCENSION

summary: This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED

ReferenceCitation: Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martín-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas López VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6.

ReferenceCitation: Wynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cézard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.

ReferenceCitation: Pigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Doré J, Ruemmele FM. Mucosal Healing and Bacterial Composition in Response to Enteral Nutrition Vs Steroid-based Induction Therapy-A Randomised Prospective Clinical Trial in Children With Crohn's Disease. J Crohns Colitis. 2019 Jul 25;13(7):846-855. doi: 10.1093/ecco-jcc/jjy207.

ReferenceCitation: Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.

ReferenceCitation: Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18. Review.

location_facility: CHU Caen Normandie - Service de Gastroentérologie pédiatrique

location_facility: Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique

location_facility: Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique

location_facility: Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique

intervention_type: Dietary Supplement


title: Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)- Comprising a Sleeve and a Sock - in Amputees Suffering From Rebellious Neuropathic Pain on the Residual Limb and / or Phantom Limb

acronym: KCC

summary:
Neuropathic pain is common in limb amputees and causes reductions in activity and participation as well as impaired quality of life. Some of these pains lead to the diagnosis of a responsible lesion and to precise and effective treatments (amputation neuroma pains, for example), whether they are etiological or symptomatic. Other pains of a neuropathic character remain totally or partially resistant to symptomatic treatment. Their appearance, intensity, duration and frequency vary depending on the amputee.

Old scientific data confirmed by modern imagery indicates a process of reorganization of cortical areas by multimodal afferents. This reconstruction, coherent or not of the body diagram, is at the genesis of sensations, normal or not, in the amputee.

Early plurimodal reassignment constitutes the founding principle of the rehabilitation of amputees: tactile afferents, visual afferents, motor afferents, proprioceptive afferents. Rehabilitation techniques and early fitting contribute to this reafferentation and to the functional integration of the fitting and to the quality of life of the amputee.

Scientific work by Katz et al, and experiences of amputees relieved by the application of local heat or stay in hot climatic zones show that the thermoregulation of the residual limb could be of interest.

It has been shown that these pain conditions are often related to a reduction in superficial blood flow to the distal part of the stump. The physiological response of the body to variations in outside temperature physiologically consists in the regulation of skin temperature. The goal seems to keep the body in a so-called "thermal neutrality" zone, substantially between 30 ° C and 33 ° C, by vasodilation or vasoconstriction of the superficial blood vessels depending on exposure to cold or heat.

An innovative medical device has been developed for a regulated thermal re-afferentation of the residual limb, during and outside the wearing of the prosthesis. The Connected Caloprosthesis Kit (CCK®) includes a connected sleeve put in place when wearing the prosthesis (interface between the skin and the socket) and a connected sock to put in place outside of wearing the prosthesis. These 2 devices include an autonomous heating and regulation process, which maintains the amputation stump in the area known as "skin thermal normality". This device is non-invasive. It includes a silicone sleeve and a heating sock for femoral or tibial amputee patients equipped with an expandable textile warmer, a flexible micro-temperature sensor and a 4-conductor extensible cable connected to a thermoregulation box worn as a belt which regulates the temperature of the stumps in the thermal neutrality zone between 30 and 33°C.

In order to assess the therapeutic effect of CCK®, given the heterogeneity of the population and the small number of patients eligible for the study, the Single Case Experimental Design (multiple baselines design) seems to us to be the methodology the most suitable: the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator. The methodology is defined a priori including systematic observations and repeated measurements at a defined frequency before, during, or even after the intervention introduced in a sequential and randomized manner. The data analysis can be individual and therefore patient-specific, but also group with the calculation of the size of the therapeutic effect and the calculation of significance.

This design therefore makes it possible to overcome the difficulties encountered during randomized controlled trials: having to have a large number of subjects necessary to show a significant difference in the medical device and to have a homogeneous population.

This methodology is therefore not a description of a clinical case but an alternative methodology to randomized controlled trials. In fact, it is considered by the Oxford Center for Evidence-Based Medicine 2011 to be level I, like the randomized controlled trials.

The proposed clinical study therefore has a dual objective: practical as a new treatment therapy by validating this medical device and theoretical, supporting the pathogenic model of painful sensations in amputees

lead_sponsor: Gregand Innovations

location_facility: Hôpital d'Instruction des Armées Percy -

location_facility: Institut Universitaire de Réadaptation Clemenceau


title: A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

summary: The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

ReferenceCitation: Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904.

lead_sponsor: Cordis Corporation


title: Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer

acronym: SIG-QOL

summary: The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

lead_sponsor: Nantes University Hospital

location_facility:
Angers University Hospital
Nantes University Hospital
Vendée Departmental Hospital
Caen University Hospital


title: Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

acronym: BOOST

summary:
Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time.

There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS.

The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging.

This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.

location_facility:
Hospital Foch
Lariboisière
Department Neurology Caen Hospital
Rothschild Foundation Hospital


title: Predictors of the Response to Adalimumab in Rheumatoid Arthritis

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. All those features lead to great disability. Because it represents a major problem of the public health care system, RA has been selected as one of the main objectives of the government for the next five years.

RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents. However, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. Moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the G4 region.

The purpose of the present research project is to determine potential predictive factors of the response to a new TNF-a blocker ie adalimumab. To address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays from blood mononuclear cells, and use of different imaging tools.

The criteria of judgement will be the clinical, structural and bone responses to those new agents.

This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period.

At the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will be prescribed only for the patients who are likely to respond to those drugs. Thus, this study should allow to elaborate theranostic algorithms. Such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.

ReferenceCitation: Golinski ML, Vandhuick T, Derambure C, Fréret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loët X, Vittecoq O, Lequerré T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFα inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.

family: Golinski

full_name: Marie-Laure Golinski

given: Marie-Laure

family: Vandhuick

full_name: Thibault Vandhuick

given: Thibault

family: Derambure

full_name: Céline Derambure

given: Céline

family: Fréret

full_name: Manuel Fréret

given: Manuel

family: Lecuyer

full_name: Matthieu Lecuyer

given: Matthieu

family: Guillou

full_name: Clément Guillou

given: Clément

family: Hiron

full_name: Martine Hiron

given: Martine

family: Boyer

full_name: Olivier Boyer

given: Olivier

family: Le Loët

full_name: Xavier Le Loët

given: Xavier

family: Vittecoq

full_name: Olivier Vittecoq

family: Lequerré

full_name: Thierry Lequerré

given: Thierry

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Ternant D, Ducourau E, Fuzibet P, Vignault C, Watier H, Lequerré T, Le Loët X, Vittecoq O, Goupille P, Mulleman D, Paintaud G. Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis. Br J Clin Pharmacol. 2015 Feb;79(2):286-97. doi: 10.1111/bcp.12509.

name: CNRS, UMR 7292; ‘Genetics, Immunotherapy, Chemistry and Cancer’; Université François Rabelais de Tours; Tours France

name: Laboratoire de pharmacologie-toxicologie; CHRU de Tours; Tours France

family: Ternant

full_name: David Ternant

given: David

name: Service de Rhumatologie; CHRU de Tours; Tours France

family: Ducourau

full_name: Emilie Ducourau

given: Emilie

family: Fuzibet

full_name: Piéra Fuzibet

given: Piéra

family: Vignault

full_name: Céline Vignault

name: Laboratoire d'Immunologie; CHRU de Tours; Tours France

family: Watier

full_name: Hervé Watier

given: Hervé

name: Université de Rouen; INSERM U905 & CIC/CRB0204; Rouen France

name: CHRU de Rouen; Service de Rhumatologie; Rouen France

journal_name: British Journal of Clinical Pharmacology

ReferenceCitation: Blache C, Lequerré T, Roucheux A, Beutheu S, Dedreux I, Jacquot S, Le Loët X, Boyer O, Vittecoq O. Number and phenotype of rheumatoid arthritis patients' CD4+CD25hi regulatory T cells are not affected by adalimumab or etanercept. Rheumatology (Oxford). 2011 Oct;50(10):1814-22. doi: 10.1093/rheumatology/ker183. Epub 2011 Jul 26.

title: Number and phenotype of rheumatoid arthritis patients’ CD4+CD25hi regulatory T cells are not affected by adalimumab or etanercept


title: A Randomized Study With the Sirolimus Coated Modified BX Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

acronym: RAVEL

summary: The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.

ReferenceCitation: Hoffmann R, Morice MC, Moses JW, Fitzgerald PJ, Mauri L, Breithardt G, Schofer J, Serruys PW, Stoll HP, Leon MB. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials. Heart. 2008 Mar;94(3):322-8. Epub 2007 Aug 29.

ReferenceCitation: Fajadet J, Morice MC, Bode C, Barragan P, Serruys PW, Wijns W, Constantini CR, Guermonprez JL, Eltchaninoff H, Blanchard D, Bartorelli A, Laarman GJ, Perin M, Sousa JE, Schuler G, Molnar F, Guagliumi G, Colombo A, Ban Hayashi E, Wülfert E. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation. 2005 Mar 1;111(8):1040-4. Epub 2005 Feb 21.

ReferenceCitation: Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MC; Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J. 2004 Jan;25(2):107-12.

ReferenceCitation: Regar E, Serruys PW, Bode C, Holubarsch C, Guermonprez JL, Wijns W, Bartorelli A, Constantini C, Degertekin M, Tanabe K, Disco C, Wuelfert E, Morice MC; RAVEL Study Group. Angiographic findings of the multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): sirolimus-eluting stents inhibit restenosis irrespective of the vessel size. Circulation. 2002 Oct 8;106(15):1949-56.

ReferenceCitation: Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803.

ReferenceCitation: Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. Epub 2007 Sep 17.

ReferenceCitation: Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. Epub 2007 Feb 12.


title: Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis

summary:
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.

The objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.

Safety will be assessed over a period of 12 months.

ReferenceCitation: Lablanche JM, Commeau P; Investigateurs du Registre BRIDGE. [BRIDGE registry (safety and efficacy registry Bx Cyper stent in the RevascularIzation of patients with siGnificative risk of rEstenosis): protocol description and preliminary results]. Ann Cardiol Angeiol (Paris). 2004 May;53 Suppl 1:29s-31s. French.

location_facility: Université de Lille, Hôpital cardiologique


title: Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

summary: This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.


title: Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count

summary:
The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.

The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.

The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.

location_facility: Antoine Beclere Hospital, Obstetrics and Gynaecology and Reproduction Medicine Service


title: Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX

summary: Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

ReferenceCitation: Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52.

ReferenceCitation: Denys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.

family: Denys

full_name: Pierre Denys

given: Pierre

family: Le Normand

full_name: Loïc Le Normand

given: Loïc

family: Ghout

full_name: Idir Ghout

given: Idir

family: Costa

full_name: Pierre Costa

family: Chartier-Kastler

full_name: Emmanuel Chartier-Kastler

given: Emmanuel

family: Grise

full_name: Philippe Grise

given: Philippe

family: Hermieu

full_name: Jean-François Hermieu

given: Jean-François

family: Amarenco

full_name: Gérard Amarenco

given: Gérard

family: Karsenty

full_name: Gilles Karsenty

given: Gilles

family: Saussine

full_name: Christian Saussine

given: Christian

family: Barbot

full_name: Frédéric Barbot

given: Frédéric

journal_name: European Urology

title: Efficacy and Safety of Low Doses of OnabotulinumtoxinA for the Treatment of Refractory Idiopathic Overactive Bladder: A Multicentre, Double-Blind, Randomised, Placebo-Controlled Dose-Ranging Study


title: Evaluation De l'Efficacité Du Rituximab (Mabthéra) Chez l'Adulte Atteint d'Un Purpura thrombopénique Auto-Immun Chronique Et sévère Et Candidat à La splénectomie

summary: The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a treatment by the rituximab a satisfactory response to one year, defined by a number of platelets higher than 50x109/L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment.

ReferenceCitation: Michel M, Chanet V, Galicier L, Ruivard M, Levy Y, Hermine O, Oksenhendler E, Schaeffer A, Bierling P, Godeau B. Autoimmune thrombocytopenic purpura and common variable immunodeficiency: analysis of 21 cases and review of the literature. Medicine (Baltimore). 2004 Jul;83(4):254-263. doi: 10.1097/01.md.0000133624.65946.40. Review.

ReferenceCitation: Godeau B, Porcher R, Fain O, Lefrère F, Fenaux P, Cheze S, Vekhoff A, Chauveheid MP, Stirnemann J, Galicier L, Bourgeois E, Haiat S, Varet B, Leporrier M, Papo T, Khellaf M, Michel M, Bierling P. Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study. Blood. 2008 Aug 15;112(4):999-1004. doi: 10.1182/blood-2008-01-131029. Epub 2008 May 7.

name: Médecine Interne, Hôpital Henri-Mondor, Assistance Publique–Hôpitaux de Paris, Université Paris 12, Créteil;

family: Godeau

full_name: Bertrand Godeau

given: Bertrand

name: Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris;

family: Porcher

full_name: Raphael Porcher

given: Raphael

name: Médecine Interne, Hôpital Jean-Verdier, Université Paris 13, Bondy;

family: Fain

full_name: Olivier Fain

given: Olivier

name: Université Paris Descartes, Hématologie, Hôpital Necker, Paris;

family: Lefrère

full_name: François Lefrère

given: François

name: Hématologie, Hôpital Avicenne, Université Paris 13, Bobigny;

family: Fenaux

full_name: Pierre Fenaux

name: Hématologie, Hôpital de la Cote-de-Nacre, Caen;

family: Cheze

full_name: Stéphane Cheze

given: Stéphane

family: Vekhoff

full_name: Anne Vekhoff

given: Anne

name: Médecine Interne, Hôpital Bichat, Paris;

family: Chauveheid

full_name: Marie-Paule Chauveheid

given: Marie-Paule

family: Stirnemann

full_name: Jerôme Stirnemann

given: Jerôme

name: Immunopathologie, Hôpital Saint-Louis, Paris;

family: Galicier

full_name: Lionel Galicier

given: Lionel

family: Bourgeois

full_name: Emmanuelle Bourgeois

given: Emmanuelle

family: Haiat

full_name: Stéphanie Haiat

given: Stéphanie

family: Varet

full_name: Bruno Varet

given: Bruno

family: Leporrier

full_name: Michel Leporrier

given: Michel

family: Papo

full_name: Thomas Papo

given: Thomas

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

family: Michel

full_name: Marc Michel

given: Marc

name: Établissement Français du Sang, Hôpital Henri-Mondor, Créteil, France

family: Bierling

full_name: Philippe Bierling

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology


title: Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection to a Conventional Anaesthesia by Infiltration on Temporary Molars

acronym: SLEEPER-ONE

summary:
Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt.

(FPS-R).

The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard.

Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints

Specific monitoring modalities added by research include :

Explanation of the study to each eligible child and his or her legal guardians
Gathering the informed consent of the child and his or her legal guardians
The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)
Data collection during the two care sessions (maximum 15 days apart)

It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Toulouse university Hospital
Lille University Hospital
paris university hospital (APHP)
Nice Hospital


title: Laparoscopy and COVID-19 Contamination

acronym: LAPCOV

summary: The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.

location_facility: AP-HP, Bicêtre Hospital, Anesthesia Department

location_facility: AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery

location_facility: AP-HP, Bicêtre Hospital, Urology Department

location_facility: AP-HP, Bicêtre Hospital, Gynecology department


title: Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

acronym: PRINCE

summary: This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.

lead_sponsor: University Hospital, Lille

location_facility:
CH Victor Provot
Clinique Teissier
Hop Calmette Chu Lille
Clcc Oscar Lambret Lille


title: Efficacy of Nicotine in Preventing COVID-19 Infection

acronym: NICOVID-PREV

summary:
The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units.

According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form.

Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR).

Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection.

However, the epidemic is progressing throughout French territory and new variants (in particular the "English B1. 1.7 variant of SARS-COV-2") much more contagious run a risk of accelerating the epidemic in the population. The anti-SARS-COV-2 vaccines recently launched (or being evaluated) represent great hope in this health crisis, but trials were only able to show their effectiveness on symptomatic forms of SARS-COV-2 infection. On the one hand, the vaccination compaign for the entire population requires many months,which leaves many unprotected subjects waiting. In addition, there is currently no evidence of a protective role of vaccines against asymptomatic forms of COVID-19 and therefore on SARS-COV-2 transmission. Finally, the nicotine patches may protect people in hight-risk areas/periods until they are vaccinated (if they accept it and are eligible for it) and in the post-vaccination weeks necessary for the effectiveness of the vaccine,which reinforces the importance of evaluating this alternative prevention strategy, in the context of the arrival of vaccines

location_facility: Groupe Hospitalier de la Région de Mulhouse Sud Alsace

location_facility: Hôpital Pitié Salpêtrière - Service de Médecine Interne


title: Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains

summary:
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

ReferenceCitation: Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dollé F, Condé F, Bottlaender M, Peschanski M, Kéravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78.

ReferenceCitation: Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6.


title: Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder

acronym: SOMMEPT

summary:
Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.

Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.

According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.

In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Hôpital d'Instruction des Armées Laveran


title: Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019. Study of Efficacy and Safety Based on Finisterian Data Compared to Data in the Literature.

acronym: BREIZH-PARPi

summary: Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. It is therefore necessary to assess and prevent the risk of relapse, in order to establish a diagnosis as early as possible, and thus set up the appropriate treatment. Poly-ADP-Ribose Polymerase (PARP) inhibitors such as OLAPARIB and NIRAPARIB are effective in maintenance to prevent the risk of relapse in patients with recurrent platinum-sensitive ovarian cancer, as proved by recent data from the medical literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy and safety of PARP inhibitors is the same in Finistère patients as in the scientific literature.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH des pays de Morlaix
Clinique Pasteur
CHIC


title: Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

acronym: CogniSo-TC

summary:
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.

2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
SAMSAH-UEROS Arceau Anjou
Ueros Ugecam
Raymond Poincaré Hospital
FAM la vie devant soi


title: Therapeutical Impact of a Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly

acronym: IRIDIA

summary:
Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.

in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.


title: Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

summary:
This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

ReferenceCitation: Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol. 1997 Dec;25(4):628-33. Erratum in: J Clin Gastroenterol 1998 Apr;26(3):231.

ReferenceCitation: Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82. Review.

ReferenceCitation: Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. Erratum in: Lancet 1998 Jan 17;351(9097):220.

ReferenceCitation: Lökken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42.

ReferenceCitation: Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33.


title: Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19.

acronym: SAMILCOV

summary:
Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).

Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.

In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.

An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.


title: Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

summary: the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.

ReferenceCitation: Wootla B, Christophe OD, Mahendra A, Dimitrov JD, Repessé Y, Ollivier V, Friboulet A, Borel-Derlon A, Levesque H, Borg JY, Andre S, Bayry J, Calvez T, Kaveri SV, Lacroix-Desmazes S. Proteolytic antibodies activate factor IX in patients with acquired hemophilia. Blood. 2011 Feb 17;117(7):2257-64. doi: 10.1182/blood-2010-07-296103. Epub 2010 Dec 3.

name: Centre de Recherche des Cordeliers, Université Pierre et Marie Curie, Paris, France;

name: Université Paris Descartes, Unité Mixte de Recherche S872, Paris, France;

family: Wootla

full_name: Bharath Wootla

given: Bharath

name: Inserm U770 and Université Paris-Sud, Le Kremlin-Bicêtre, France;

family: Christophe

full_name: Olivier D. Christophe

given: Olivier D.

family: Mahendra

full_name: Ankit Mahendra

given: Ankit

family: Dimitrov

full_name: Jordan D. Dimitrov

given: Jordan D.

family: Repessé

full_name: Yohann Repessé

given: Yohann

name: Inserm, U698, Université Paris 7, Paris, France;

family: Ollivier

full_name: Véronique Ollivier

given: Véronique

name: Université de Technologie de Compiègne, Centre National de la Recherche Scientifique, Unité Mixte de Recherche 6022, Génie Enzymatique et Cellulaire, Compiègne Cedex, France;

family: Friboulet

full_name: Alain Friboulet

given: Alain

name: Laboratoire d'Hématologie, Université de Caen, Caen, France;

family: Borel-Derlon

full_name: Annie Borel-Derlon

given: Annie

name: Rouen University Hospital, Rouen, France; and

family: Levesque

full_name: Hervé Levesque

given: Hervé

family: Borg

full_name: Jeanne-Yvonne Borg

given: Jeanne-Yvonne

family: Andre

full_name: Sebastien Andre

given: Sebastien

family: Bayry

full_name: Jagadeesh Bayry

given: Jagadeesh

name: Unité Mixte de Recherche S943, Paris, France

family: Calvez

full_name: Thierry Calvez

given: Thierry

family: Kaveri

full_name: Srinivas V. Kaveri

given: Srinivas V.

family: Lacroix-Desmazes

full_name: Sébastien Lacroix-Desmazes

given: Sébastien

lead_sponsor: University Hospital, Rouen


title: Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

summary:
Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death.

In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc.

The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.


title: Study of the COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector in 3 French Regions Facing the COVID-19 Epidemic With Varying Degrees of Intensity

acronym: SEROCO

summary:
Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers.

This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.

Since june 2020, all staff in French health establishments could benefit a serological test.

Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.

status: Active, not recruiting

lead_sponsor: University Hospital, Limoges

location_facility:
Ch Belfort
CHU de Limoges
CH Argenteuil - Service de Réanimation
CHU Dijon - Serve de Réanimation


title: Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte

acronym: HEMATOVAC

summary: The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal injection followed 2 months later by polysaccharide 23-valent vaccine injection. General practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 70% of the patients are non-responders to vaccination, according to their anti-pneumococcal immunoglobulin G titers and the opsonophagocytic activity. To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, the investigator will measure anti-pneumococcal serotype-specific immunoglobulin G titers and opsonophagocytic activity at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the 13-valent pneumococcal injection (corresponding to 1 month after the end of the combined strategy) using immunoglobulin G titers and opsonophagocytic activity. At different time points (day 0, 1 month after the 13-valent pneumococcal injection, the day of the injection of the polysaccharide 23-valent vaccine, one month after the injection of the polysaccharide 23-valent vaccine, 3-6 months after the polysaccharide 23-valent vaccine,9-12 months after the polysaccharide 23-valent vaccine), the immunological response to vaccination will be monitored using specific-serotype immunoglobulin G titers, opsonophagocytic activity, and total anti-pneumococcal Immunoglobulin. The investigator will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received by both acute myeloblastic leukemia and lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.

ipd_sharing_description: Undecided

lead_sponsor: Poitiers University Hospital

location_facility:
CHU Poitiers
CHU Bordeaux
CHU Limoges
CHU Tours