title: A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.

summary: A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.

ReferenceCitation: Malka D, Cervera P, Foulon S, Trarbach T, de la Fouchardière C, Boucher E, Fartoux L, Faivre S, Blanc JF, Viret F, Assenat E, Seufferlein T, Herrmann T, Grenier J, Hammel P, Dollinger M, André T, Hahn P, Heinemann V, Rousseau V, Ducreux M, Pignon JP, Wendum D, Rosmorduc O, Greten TF; BINGO investigators. Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol. 2014 Jul;15(8):819-28. doi: 10.1016/S1470-2045(14)70212-8. Epub 2014 May 19.

family: Malka

full_name: David Malka

family: Cervera

full_name: Pascale Cervera

given: Pascale

family: Foulon

full_name: Stéphanie Foulon

given: Stéphanie

family: Trarbach

full_name: Tanja Trarbach

given: Tanja

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Fartoux

full_name: Laetitia Fartoux

given: Laetitia

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: Viret

full_name: Frédéric Viret

given: Frédéric

family: Assenat

full_name: Eric Assenat

given: Eric

family: Seufferlein

full_name: Thomas Seufferlein

given: Thomas

family: Herrmann

full_name: Thomas Herrmann

family: Grenier

full_name: Julien Grenier

given: Julien

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Dollinger

full_name: Matthias Dollinger

given: Matthias

family: André

full_name: Thierry André

given: Thierry

family: Hahn

full_name: Philipp Hahn

given: Philipp

family: Heinemann

full_name: Volker Heinemann

given: Volker

family: Rousseau

full_name: Vanessa Rousseau

family: Ducreux

full_name: Michel Ducreux

given: Michel

family: Pignon

full_name: Jean-Pierre Pignon

given: Jean-Pierre

family: Wendum

full_name: Dominique Wendum

given: Dominique

family: Rosmorduc

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome

summary: Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: European Georges Pompidou Hospital

lead_sponsor_type: academique

status_simplified: Unknown


title: Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse

summary:
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.

status: Unknown status

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Institut de Recherche Clinique sur les Cancers et le Sang

intervention_type: Other

lead_sponsor_type: industriel


title: Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.

design_allocation: Non-Randomized

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

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

intervention_type: Drug


title: Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.

ReferenceType: derived

ReferenceCitation: Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

name: Department of Medical Oncology; University Hospital; Besançon France

name: INSERM, Unit 1098, University of Bourgogne- Franche Comté; Besançon France

name: Clinical Investigation Center 1431, EFS Bourgogne-Franche Comté; Besançon France

family: Jary

full_name: Marine Jary

given: Marine

sequence: first

name: CNRS, Unit 7292, University François-Rabelais; Tours France

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital; Tours France

family: Lecomte

full_name: Thierry Lecomte

sequence: additional

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital Robert Debré; Reims France

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Kim

full_name: Stefano Kim

given: Stefano

family: Dobi

full_name: Erion Dobi

given: Erion

family: Queiroz

full_name: Lise Queiroz

given: Lise

name: Department of Medical Oncology; Leclerc Anticancer Center; Dijon France

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

name: Department of Gastroenterology; University Hospital; Besançon France

family: Etienne

full_name: Hélène Etienne

given: Hélène

name: INSERM, Clinical Investigational Center CIC 1415; Tours France

family: Léger

full_name: Julie Léger

given: Julie

family: Godet

full_name: Yann Godet

given: Yann

family: Balland

full_name: Jérémy Balland

given: Jérémy

name: Department of Digestive Surgery and Liver Transplantation; University Hospital; Besançon France

family: Lakkis

full_name: Zaher Lakkis

given: Zaher

family: Adotevi

full_name: Olivier Adotevi

name: Methodological and Quality of Life in Oncology Unit; EA 3181, University Hospital; Besançon France

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Borg

full_name: Christophe Borg

given: Christophe

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Cancer

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hopital Jean Minjoz

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: PET Study of the Nicotinic Receptors in Human : Brain Distribution and Quantification

summary: The purpose of this study is to quantify the brain distribution of the nicotinic receptors in human volunteers and their alterations in patients suffering from neurological diseases such as Parkinson and Alzheimer diseases and familial epilepsy. This will be done using Postron Emission Tomography (PET) and a new radiotracer of the nicotinic receptors.

lead_sponsor: Commissariat A L'energie Atomique

location_facility: CEA, Service Hospitalier Frederic Joliot


title: Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area (SII) and Insula : an fMRI Study

summary:
The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown.

The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

status: Completed

ReferenceType: background

ReferenceCitation: Mazzola L, Isnard J, Mauguière F. Somatosensory and pain responses to stimulation of the second somatosensory area (SII) in humans. A comparison with SI and insular responses. Cereb Cortex. 2006 Jul;16(7):960-8. Epub 2005 Sep 21.

ReferenceCitation: Peyron R, Schneider F, Faillenot I, Convers P, Barral FG, Garcia-Larrea L, Laurent B. An fMRI study of cortical representation of mechanical allodynia in patients with neuropathic pain. Neurology. 2004 Nov 23;63(10):1838-46.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Neurologie - CHU de Saint-Etienne

status_simplified: Completed


design_allocation: Randomized

lead_sponsor: Novo Nordisk A/S

acronym: MIXING

type: EudraCT Number

source: euctr

title: A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous Mixing - The Paediatric MIXING Trial

summary: This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.


title: Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma

summary:
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery.

lead_sponsor: Centre Oscar Lambret


title: Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype in Young Patients. First Approach by Systematic Screening of Candidate Genes

acronym: Cariogene

summary: Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. To identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient.

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Genetic


title: Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.

summary:
RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.

summary:
RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.

PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.


title: Comparison of Administration of Tirofiban in the Ambulance or in the Cathlab in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

summary: In patients with acute myocardial infarction who are managed in the prehospital setting, and who will treated with primary angioplasty, we evaluate the benefit of an early administration of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early administration in the ambulance or administration in the cathlab. The primary endpoint is TIMI 2-3 flow in the first coronary opacification of the culprit artery.

ReferenceCitation: El Khoury C, Dubien PY, Mercier C, Belle L, Debaty G, Capel O, Perret T, Savary D, Serre P, Bonnefoy E; AGIR-2 Investigators. Prehospital high-dose tirofiban in patients undergoing primary percutaneous intervention. The AGIR-2 study. Arch Cardiovasc Dis. 2010 May;103(5):285-92. doi: 10.1016/j.acvd.2010.04.005. Epub 2010 Jun 17.

family: El Khoury

full_name: Carlos El Khoury

given: Carlos

family: Dubien

full_name: Pierre-Yves Dubien

given: Pierre-Yves

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Belle

full_name: Loic Belle

given: Loic

family: Debaty

full_name: Guilaume Debaty

given: Guilaume

family: Capel

full_name: Olivier Capel

family: Perret

full_name: Thibault Perret

given: Thibault

family: Savary

full_name: Dominique Savary

family: Serre

full_name: Patrice Serre

given: Patrice

family: Bonnefoy

full_name: Eric Bonnefoy

given: Eric

journal_name: Archives of Cardiovascular Diseases

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon


title: Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

summary: To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma

lead_sponsor: French Innovative Leukemia Organisation

intervention_type: Procedure


title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

summary: Interest of the use of pegylated liposomal doxorubicin (caélyx)


title: Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation

acronym: REVOLU

summary: During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.

primary_purpose: Supportive Care

ReferenceCitation: Fernández-Pérez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8.

ReferenceCitation: Gothard J. Lung injury after thoracic surgery and one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):5-10. Review.

ReferenceCitation: Slinger P. Pro: low tidal volume is indicated during one-lung ventilation. Anesth Analg. 2006 Aug;103(2):268-70.

ReferenceCitation: Sentürk M. New concepts of the management of one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):1-4. Review.

ReferenceCitation: Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. Review.

ReferenceCitation: Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9.

lead_sponsor: University Hospital, Bordeaux

location_facility: Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux


title: Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation

summary: Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

study_completion_date_type: Anticipated

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome

acronym: Proseva

summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2<150 with FiO2 > or = 0.6 and positive end-expiratory pressure > or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.

ReferenceCitation: Guérin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384.

ReferenceCitation: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

family: Guérin

full_name: Claude Guérin

given: Claude

family: Reignier

full_name: Jean Reignier

given: Jean

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Boulain

full_name: Thierry Boulain

given: Thierry

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Badet

full_name: Michel Badet

given: Michel

family: Mercat

full_name: Alain Mercat

given: Alain

family: Baudin

full_name: Olivier Baudin

given: Olivier

family: Clavel

full_name: Marc Clavel

given: Marc

family: Chatellier

full_name: Delphine Chatellier

given: Delphine

family: Jaber

full_name: Samir Jaber

given: Samir

family: Rosselli

full_name: Sylvène Rosselli

given: Sylvène

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Sirodot

full_name: Michel Sirodot

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Bengler

full_name: Christian Bengler

given: Christian

family: Richecoeur

full_name: Jack Richecoeur

given: Jack

family: Gainnier

full_name: Marc Gainnier

family: Bayle

full_name: Frédérique Bayle

given: Frédérique

family: Bourdin

full_name: Gael Bourdin

given: Gael

family: Leray

full_name: Véronique Leray

given: Véronique

title: Prone Positioning in Severe Acute Respiratory Distress Syndrome


title: Face Reconstruction by Allotransplantation of Composite Tissues

summary: To show the feasibility of face transplantation in patients

ReferenceCitation: Lantieri L, Grimbert P, Ortonne N, Suberbielle C, Bories D, Gil-Vernet S, Lemogne C, Bellivier F, Lefaucheur JP, Schaffer N, Martin F, Meningaud JP, Wolkenstein P, Hivelin M. Face transplant: long-term follow-up and results of a prospective open study. Lancet. 2016 Oct 1;388(10052):1398-1407. doi: 10.1016/S0140-6736(16)31138-2. Epub 2016 Aug 25.

family: Lantieri

full_name: Laurent Lantieri

given: Laurent

family: Grimbert

full_name: Philippe Grimbert

given: Philippe

family: Ortonne

full_name: Nicolas Ortonne

given: Nicolas

family: Suberbielle

full_name: Caroline Suberbielle

given: Caroline

family: Bories

full_name: Dominique Bories

given: Dominique

family: Gil-Vernet

full_name: Salvador Gil-Vernet

given: Salvador

family: Lemogne

full_name: Cédric Lemogne

given: Cédric

family: Bellivier

full_name: Frank Bellivier

given: Frank

family: Lefaucheur

full_name: Jean Pascal Lefaucheur

given: Jean Pascal

family: Schaffer

full_name: Nathaniel Schaffer

given: Nathaniel

family: Martin

full_name: Fréderic Martin

given: Fréderic

family: Meningaud

full_name: Jean Paul Meningaud

given: Jean Paul

family: Wolkenstein

full_name: Pierre Wolkenstein

given: Pierre

family: Hivelin

full_name: Mikael Hivelin

given: Mikael

journal_name: The Lancet


title: Impact of External Cooling in Septic Shock Patients

acronym: sepsis-cool

summary: The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

ReferenceCitation: Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.

family: Schortgen

full_name: Frédérique Schortgen

given: Frédérique

family: Charles-Nelson

full_name: Anaïs Charles-Nelson

given: Anaïs

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Bizouard

full_name: Geoffray Bizouard

given: Geoffray

family: Brochard

full_name: Laurent Brochard

family: Katsahian

full_name: Sandrine Katsahian

given: Sandrine

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

summary: The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen University Hospital, Direction de la Recherche et de l'Innovation,


title: Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.

acronym: APODOUL

summary: Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations. We suppose that painful symptoms could be related to the neurotransmitter deficit of PD. So, we would like to evaluate the involvement of dopaminergic system in nociceptive processing in PD patients. The objectives of this study is to assess and to compare the effect of a dopamine agonist administration on the nociceptive threshold and on the cerebral activity using positrons emission tomography (PET scan) in two groups of PD patients (in 16 painful PD patients and in 16 pain free PD patients). We hypothesise that dopamine agonist could normalise nociceptive threshold and cerebral activity which were both abnormal in PD patients. Moreover, we think that painful PD patients could be more improved by dopamine agonist than pain free PD patients.

lead_sponsor: University Hospital, Toulouse


title: A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer

summary: Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

lead_sponsor: ARCAGY/ GINECO GROUP


title: Lower Limb Mechanical Characteristics: Effect on Running Mechanics and Energetics

summary: Inter-individual variability in energetic cost of running may be partly explained by lower limbs mechanical characteristics. The transposition of muscle mechanical model with two components (contractile and elastic) to the whole lower limb mechanical behavior analysis during running. The main aim of present investigation is to study the effects of lower limb mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using a lower limb mechanical approach including both contractile and elastic components.Twenty healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through conditions, stride frequency, sole stiffness and subject's body weight will be changed to allow artificial variations in lower limb mechanical characteristics. Energetic and non-invasive mechanical measurements analysis will be performed to obtain energetic cost of running and to compute force, velocity and stiffness of lower limbs for each condition.

location_facility: Service de Physiologie clinique et de l'exercice - CHU Saint-Etienne


title: Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-Articular Steroid Injection in Acute Synovitis

summary: Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Rheumatology department, Hopital Archet I


title: Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates

summary:
Objective: To study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (OA) in the general population.

Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. A physical examination and knee or hip radiographs were offered when the screen was positive. A sample of individuals with negative screens was also examined. The diagnosis of hip/knee OA was based on either American College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic stage 2 or greater. Prevalence rates were estimated with correction for the performance of the screening procedure.

time_perspective: Other

location_facility: Rheumatology department, Nice University hospital


title: A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer

summary: To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

lead_sponsor: Sanofi


title: Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

summary: Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.

primary_purpose: Diagnostic

ReferenceCitation: Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004 Aug;19(8):1947-51. Epub 2004 May 25.

ReferenceCitation: Mariat C, Sánchez-Fueyo A, Alexopoulos SP, Kenny J, Strom TB, Zheng XX. Regulation of T cell dependent immune responses by TIM family members. Philos Trans R Soc Lond B Biol Sci. 2005 Sep 29;360(1461):1681-5. Review.

ReferenceCitation: Mariat C Degauque N et al. TIM-1 strengthens Th-1 polarization and weakens CD4+CD25 T cells. Am J Transplant 6(suppl 2): 557, 2006

location_facility: Nephrology Unit Hôpital Nord CHU de Saint-Etienne


title: Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product

summary: This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.


title: A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire

summary: validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.


title: Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation

summary: The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.

lead_sponsor: University Hospital, Montpellier

intervention_type: Device


title: Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

acronym: TRACE

summary: Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.


title: Mazindol in Children With Attention Deficit Hyperactivity Disorder Design Study to Explore the Effectiveness, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Doses of Mazindol.

acronym: MAZDAH

summary: This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.


title: Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a

acronym: BIRDFERON

summary: Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

ReferenceType: result

ReferenceCitation: Kötter I, Günaydin I, Zierhut M, Stübiger N. The use of interferon alpha in Behçet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. Review.


title: Evaluation of the French Version of Screening Questionnaires for Autism and Asperger Syndrome : Autism Spectrum Quotient (AQ) Empathy Quotient (EQ) and Systemizing Quotient (SQ)

summary:
Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has been developed in order to measure the degree of autistic traits in autistic adolescent with normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups of 10 questions assessing imagination, social skills, attention switching, attention to detail and communication skills. Each of these items scores 1 point if the respondent records abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.

The principal objective of this study is to evaluate the accuracy of the French version of Autism Spectrum Quotient questionnaire.

Secondary objectives are to:

Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those with classical autism or AS.

Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from autistic adolescents.

Define the threshold of positivity for the 3 questionnaires.

lead_sponsor: Groupe Francais d'Epidemiologie Psychiatrique


lead_sponsor: Eisai Limited

location_facility: Centre d'Investigation Clinique, Hospital Purpan

title: A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

summary: This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.


title: Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

acronym: EEPAB

summary: Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.


title: Medico Economic Evaluation of a Temporary (6 Months) Intra-gastric Balloon in Morbidly Obese Patients Before a Gastric By-pass. A Randomised Multicenter Study Comparing the Usual Strategy to Two Types of Gastric Balloon

acronym: BIGPOM

summary: To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.

ReferenceCitation: Fernandes M, Atallah AN, Soares BG, Humberto S, Guimarães S, Matos D, Monteiro L, Richter B. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004931. Review.


title: Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly

acronym: CNSLymphoma

summary:
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :

Methotrexate, procarbazine, vincristine and cytarabine
Methotrexate and temozolomide

ReferenceCitation: Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. Review.

ReferenceCitation: Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrié M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.

family: Omuro

full_name: Antonio Omuro

given: Antonio

family: Chinot

full_name: Olivier Chinot

given: Olivier

family: Taillandier

full_name: Luc Taillandier

given: Luc

family: Ghesquieres

full_name: Hervé Ghesquieres

given: Hervé

family: Soussain

full_name: Carole Soussain

given: Carole

family: Delwail

full_name: Vincent Delwail

given: Vincent

family: Lamy

full_name: Thierry Lamy

given: Thierry

family: Gressin

full_name: Rémy Gressin

given: Rémy

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

family: Soubeyran

full_name: Pierre Soubeyran

family: Huchet

full_name: Aymeri Huchet

given: Aymeri

family: Benouaich-Amiel

full_name: Alexandra Benouaich-Amiel

given: Alexandra

family: Lebouvier-Sadot

full_name: Sophie Lebouvier-Sadot

given: Sophie

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Touitou

full_name: Valérie Touitou

given: Valérie

family: Barrié

full_name: Maryline Barrié

given: Maryline

family: del Rio

full_name: Monica Sierra del Rio

given: Monica Sierra

family: Gonzalez-Aguilar

full_name: Alberto Gonzalez-Aguilar

given: Alberto

family: Houillier

full_name: Caroline Houillier

family: Delgadillo

full_name: Daniel Delgadillo

given: Daniel

family: Lacomblez

full_name: Lucette Lacomblez

given: Lucette

family: Tanguy

full_name: Marie Laure Tanguy

given: Marie Laure

family: Hoang-Xuan

full_name: Khê Hoang-Xuan

given: Khê


title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery

acronym: PROPENLAP

summary: National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

location_facility: Groupe Hospitalier Albert Chenevier Henri Mondor


title: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG

acronym: EPEGE

summary: Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea


title: Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.

summary: The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.

lead_sponsor: Ipsen


type: Other Identifier

title: A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.

summary: The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.

lead_sponsor: Bayer


title: Visual Impairment, Oscillopsia and Multiple Sclerosis

summary:
This study consists of two parts. The first part is a survey to examine vision-specific health-related quality of life in a cohort of patients with multiple sclerosis. We test visual impairment like visual acuity, visual field, colour discrimination, contrast sensitivity, eye movement. The aim of this part is to examine the association between responses to the quality of life scale and objective measures of visual impairment.

The second part is an open controlled study, in which we measure motion detection threshold in MS patients with oscillopsia due to pendular nystagmus and in a group of control subjects. The objective of this part is to determine whether patients with pendular nystagmus develop adaptation to oscillopsia using increased threshold of motion detection. We plan to test the effect of visuo-motor rehabilitation on this threshold in patients with oscillopsia due to pendular nystagmus.


title: Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI

summary: This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.

ReferenceCitation: Blanc-Durand P, Jégou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodéré F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.

family: Blanc-Durand

full_name: Paul Blanc-Durand

given: Paul

family: Jégou

full_name: Simon Jégou

given: Simon

family: Kanoun

full_name: Salim Kanoun

given: Salim

family: Berriolo-Riedinger

full_name: Alina Berriolo-Riedinger

given: Alina

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Kraeber-Bodéré

full_name: Françoise Kraeber-Bodéré

given: Françoise

family: Carlier

full_name: Thomas Carlier

given: Thomas

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Casasnovas

full_name: René-Olivier Casasnovas

given: René-Olivier

family: Meignan

full_name: Michel Meignan

given: Michel

family: Itti

full_name: Emmanuel Itti

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

ReferenceCitation: Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.

name: Université François-Rabelais de Tours, National Center for Scientific Research (CNRS), Genetics, Immunotherapy, Chemistry, and Cancer (GICC), UMR 7292, Tours, France;

family: Tout

full_name: Mira Tout

given: Mira

name: Department of Clinical Hematology, Centre Hospitalier Universitaire (CHU) Dijon, INSERM Lipids, Nutrition, Cancer (LNC) UMR 866, Dijon, France;

full_name: Olivier Casasnovas

given: Olivier

name: Lymphoma Study Association (LYSA) Imaging, Henri Mondor University Hospital, Créteil, France;

name: Department of Clinical Hematology, CHU Rennes, U917, Rennes 1 University, Rennes, France;

family: Lamy

full_name: Thierry Lamy

name: Department of Clinical Hematology, CHU Lille, Groupe de Recherches sur les formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Department of Hematology, Hospices Civils de Lyon, Université Claude Bernard Lyon-1, France;

family: Salles

full_name: Gilles Salles

given: Gilles

name: Department of Hematology and Cell Therapy, Clinical Investigations Center INSERM U1415, CHU Tours, Tours, France;

name: Lymphoid Malignancies Unit, Henri Mondor University Hospital, Assistance Publique – Hôpitaux de Paris and Universités Paris-Est Créteil (UPEC), Créteil, France;

family: Haioun

full_name: Corinne Haioun

given: Corinne

name: Department of Hematology, CHU Angers, Angers, France;

family: Mercier

full_name: Mélanie Mercier

given: Mélanie

name: Department of Hematology, CHU Nancy, Nancy, France;

family: Feugier

full_name: Pierre Feugier

given: Pierre

name: Lymphoma Academic Research Organization, CHU Lyon-Sud, Lyon, France;

name: Laboratory of Pharmacology-Toxicology, CHU Tours, Tours, France;

name: Department of Hematology, CHU Montpellier, Montpellier, France; and

name: University of Montpellier, CNRS UMR 5235, Montpellier, France

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

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

ReferenceCitation: Casasnovas RO, Meignan M, Berriolo-Riedinger A, Bardet S, Julian A, Thieblemont C, Vera P, Bologna S, Brière J, Jais JP, Haioun C, Coiffier B, Morschhauser F; Groupe d'étude des lymphomes de l'adulte (GELA). SUVmax reduction improves early prognosis value of interim positron emission tomography scans in diffuse large B-cell lymphoma. Blood. 2011 Jul 7;118(1):37-43. doi: 10.1182/blood-2010-12-327767. Epub 2011 Apr 25.

name: Centre Georges-Francois Leclerc, Dijon, France;

name: CHU Nancy, Vandoeuvre les Nancy, France;

name: Hopital Lyon Sud, Pierre Bénite, France; and

name: Hopital Claude Huriez and EA 4481 GRIIOT, Lille 2 University, Lille, France


title: 18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study

acronym: PETRA

summary:
Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha). Identification of RA patients who respond to biologics is a challenging goal to avoid unnecessarily, costly and potentially harmful treatment.

The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above 5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value) measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to measurement of clinical (total swollen and tender joints count) echographic (synovium thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C reactive protein).

lead_sponsor: University Hospital, Tours


title: Dynamic Changes in the Serum Anti-Müllerian Hormone Level During Low-Dose recFSH Administration Further Support Its Role in the Anovulation of Polycystic Ovary Syndrome

acronym: SOPK

summary: We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.

ReferenceCitation: Hamilton-Fairley D, Kiddy D, Watson H, Sagle M, Franks S. Low-dose gonadotrophin therapy for induction of ovulation in 100 women with polycystic ovary syndrome. Hum Reprod. 1991 Sep;6(8):1095-9.

lead_sponsor: University Hospital, Lille


title: A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

acronym: FLIRT

summary: This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

ReferenceCitation: Ratziu V, Charlotte F, Bernhardt C, Giral P, Halbron M, Lenaour G, Hartmann-Heurtier A, Bruckert E, Poynard T; LIDO Study Group. Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial. Hepatology. 2010 Feb;51(2):445-53. doi: 10.1002/hep.23270.

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Charlotte

full_name: Fréderic Charlotte

given: Fréderic

family: Bernhardt

full_name: Carole Bernhardt

given: Carole

family: Giral

full_name: Philippe Giral

given: Philippe

family: Halbron

full_name: Marine Halbron

given: Marine

family: LeNaour

full_name: Gilles LeNaour

family: Hartmann-Heurtier

full_name: Agnès Hartmann-Heurtier

given: Agnès

family: Bruckert

full_name: Eric Bruckert

given: Eric

family: Poynard

full_name: Thierry Poynard

given: Thierry

journal_name: Hepatology

title: Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: Results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial

lead_sponsor: Association pour la Recherche sur les Maladies Hépatiques Virales

location_facility: Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière


title: Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL

summary: A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel position. The researchers believe that improving the accuracy of tunnel position will lead to an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study on a series of 500 patients in two groups: group I (250 cases) using conventional instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).

ReferenceCitation: Beaufils P, Lerat JL. [Navigation for knee surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2006 Sep;92(5 Suppl):2S199-2S207. French.

ReferenceCitation: Plaweski S, Cazal J, Rosell P, Merloz P. Anterior cruciate ligament reconstruction using navigation: a comparative study on 60 patients. Am J Sports Med. 2006 Apr;34(4):542-52.

lead_sponsor: University Hospital, Grenoble


title: Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.

acronym: fradius

summary: Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.

ReferenceCitation: Marcheix PS, Dotzis A, Benkö PE, Siegler J, Arnaud JP, Charissoux JL. Extension fractures of the distal radius in patients older than 50: a prospective randomized study comparing fixation using mixed pins or a palmar fixed-angle plate. J Hand Surg Eur Vol. 2010 Oct;35(8):646-51. doi: 10.1177/1753193410364179. Epub 2010 Mar 17.

name: Department of Orthopaedic Surgery, Dupuytren University Hospital, Limoges, France

family: Marcheix

full_name: P.-S. Marcheix

family: Dotzis

full_name: A. Dotzis

given: A.

family: Benkö

full_name: P.-E. Benkö

family: Siegler

full_name: J. Siegler

given: J.

family: Arnaud

full_name: J.-P. Arnaud

family: Charissoux

full_name: J.-L. Charissoux

journal_name: Journal of Hand Surgery (European Volume)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Hospital, Limoges


title: Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease

acronym: ENTEROPARK

summary: The "core" of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.

ReferenceCitation: Lebouvier T, Neunlist M, Bruley des Varannes S, Coron E, Drouard A, N'Guyen JM, Chaumette T, Tasselli M, Paillusson S, Flamand M, Galmiche JP, Damier P, Derkinderen P. Colonic biopsies to assess the neuropathology of Parkinson's disease and its relationship with symptoms. PLoS One. 2010 Sep 14;5(9):e12728. doi: 10.1371/journal.pone.0012728.

family: Lebouvier

full_name: Thibaud Lebouvier

given: Thibaud

family: Neunlist

full_name: Michel Neunlist

given: Michel

family: Bruley des Varannes

full_name: Stanislas Bruley des Varannes

given: Stanislas

family: Coron

full_name: Emmanuel Coron

given: Emmanuel

family: Drouard

full_name: Anne Drouard

given: Anne

family: N'Guyen

full_name: Jean-Michel N'Guyen

given: Jean-Michel

family: Chaumette

full_name: Tanguy Chaumette

given: Tanguy

family: Tasselli

full_name: Maddalena Tasselli

given: Maddalena

family: Paillusson

full_name: Sébastien Paillusson

given: Sébastien

family: Flamand

full_name: Mathurin Flamand

given: Mathurin

family: Galmiche

full_name: Jean-Paul Galmiche

given: Jean-Paul

family: Damier

full_name: Philippe Damier

family: Derkinderen

full_name: Pascal Derkinderen

given: Pascal

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Colonic Biopsies to Assess the Neuropathology of Parkinson's Disease and Its Relationship with Symptoms

lead_sponsor: Nantes University Hospital

location_facility: CHU Nantes Gastro-enterologic and Neurologic Service


summary:
Goal of study:

To assess the tissular and plasma kinetics of ertapenem;

To determine the optimal dosages in the patients according to norepinephrine administration:

to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.

Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).

ReferenceCitation: Boyadjiev I, Boulamery A, Simon N, Martin C, Bruguerolle B, Leone M. Penetration of ertapenem into muscle measured by in vivo microdialysis in mechanically ventilated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3573-5. doi: 10.1128/AAC.00180-11. Epub 2011 May 16.

family: Boyadjiev

full_name: I. Boyadjiev

given: I.

family: Boulamery

full_name: A. Boulamery

family: Simon

full_name: N. Simon

given: N.

family: Martin

full_name: C. Martin

given: C.

family: Bruguerolle

full_name: B. Bruguerolle

given: B.

family: Leone

full_name: M. Leone

given: M.

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories:
CiteSeerX
PubMed Central

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Penetration of Ertapenem into Muscle Measured by In Vivo Microdialysis in Mechanically Ventilated Patients

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Département d'Anesthésie-Réanimation - CHU NORD


title: Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy

summary: Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

summary:
This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease.

The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields.

2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment

ReferenceCitation: Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Roux A, Perrot X; ADPHA study group. Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. J Alzheimers Dis. 2017;58(1):123-137. doi: 10.3233/JAD-160793.

name: Geriatric Medicine Unit, Lyon Sud Hospital, Hospices Civils de Lyon, Pierre Bénite, France

family: Nguyen

full_name: Marie-France Nguyen

given: Marie-France

name: University Claude Bernard Lyon 1, Faculty of Medicine Lyon Sud, Pierre Bénite, France

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

family: Adrait

full_name: Arnaud Adrait

given: Arnaud

name: Clinical Research Unit, Pole IMER, Hospices Civils de Lyon, Lyon, France

family: Gueugnon

full_name: Marine Gueugnon

given: Marine

family: Petitot

full_name: Charles Petitot

given: Charles

name: Department of Audiology, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France

family: Collet

full_name: Lionel Collet

given: Lionel

family: Roux

full_name: Adeline Roux

given: Adeline

name: Institute of Sciences and Techniques for Rehabilitation (ISTR), Lyon 1 University, University of Lyon, Lyon, France

family: Perrot

full_name: Xavier Perrot

given: Xavier

journal_name: Journal of Alzheimer's Disease

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer’s Disease and Hearing Loss: A Multicenter Controlled Randomized Trial

ReferenceCitation: Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792.

name: Geriatric Medicine Unit, Lyon Sud Hospital, Hospices Civils de Lyon, Lyon, Université Claude Bernard, Lyon1, France

name: Institute of Sciences and Techniques for Rehabilitation (ISTR), Université Claude Bernard, Lyon1, France

title: Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer’s Disease Patients and Their Caregivers?

lead_sponsor: Hospices Civils de Lyon


title: Prediction of Left Ventricular Remodelling in Patients Treated by Angioplasty in the Acute of Phase of a First Myocardial Infarction by Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT

summary: Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.

ReferenceCitation: Ernande L, Cachin F, Chabrot P, Durel N, Morand D, Boyer L, Maublant J, Lipiecki J. Rest and low-dose dobutamine Tc-99m-mibi gated-SPECT for early prediction of left ventricular remodeling after a first reperfused myocardial infarction. J Nucl Cardiol. 2009 Jul-Aug;16(4):597-604. doi: 10.1007/s12350-009-9098-5. Epub 2009 May 29.

family: Ernande

full_name: Laura Ernande

given: Laura

family: Cachin

full_name: Florent Cachin

given: Florent

family: Chabrot

full_name: Pascal Chabrot

family: Durel

full_name: Nicolas Durel

given: Nicolas

family: Morand

full_name: Dominique Morand

given: Dominique

family: Boyer

full_name: Louis Boyer

given: Louis

family: Maublant

full_name: Jean Maublant

given: Jean

family: Lipiecki

full_name: Janusz Lipiecki

given: Janusz

journal_name: Journal of Nuclear Cardiology

publisher_dissemination: Springer

publisher_group: Springer


title: A Multicenter, Phase 4, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Recombinant Alpha-Galactosidase A (Agalsidase Beta, FABRAZYME) in Heterozygous Females for Fabry Disease

acronym: HEART

summary: Fabry disease (OMIM 301500) is an X-linked inborn error of sphingolipid metabolism resulting from the deficiency of the lysosomal enzyme alpha-galactosidase A. Heterozygous females for Fabry disease may be symptomatic with cardiac, renal or cerebrovascular involvement. Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME). In contrast, no randomized, controlled study of the efficacy of recombinant alpha-galactosidase A has been reported in heterozygotes for Fabry disease.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de reference de la maladie de Fabry et des maladies hereditaires du tissu conjonctif. Assistance Publique - Hôpitaux de Paris


title: The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study

summary:
Design: paired trials without and with naps and bright light. Setting: Real driving on a private road circuit. Environmental controlled car. Participants: 9 shift workers on tree shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).

Intervention: Participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. During the baseline period, the subjects were told to manage their rest as they usually do in the real life. During the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.

ReferenceCitation: Léger D, Annesi-Maesano I, Carat F, Rugina M, Chanal I, Pribil C, El Hasnaoui A, Bousquet J. Allergic rhinitis and its consequences on quality of sleep: An unexplored area. Arch Intern Med. 2006 Sep 18;166(16):1744-8.

ReferenceCitation: Philip P, Taillard J, Moore N, Delord S, Valtat C, Sagaspe P, Bioulac B. The effects of coffee and napping on nighttime highway driving: a randomized trial. Ann Intern Med. 2006 Jun 6;144(11):785-91.

location_facility: Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame


title: Tramadol and Pain Sensitization

acronym: TRAMADOL

summary: Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.


acronym: Tropisétron

summary: A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.


title: Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus

acronym: ACOUSCO

summary: The purpose of this study is to determine whether chronic electrical stimulation of the primary auditory cortex is effective in the treatment of chronic, severe and intractable tinnitus

ReferenceCitation: Engelhardt J, Dauman R, Arné P, Allard M, Dauman N, Branchard O, Perez P, Germain C, Caire F, Bonnard D, Cuny E. Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up. Brain Stimul. 2014 Sep-Oct;7(5):694-700. doi: 10.1016/j.brs.2014.05.008. Epub 2014 Jun 4.

family: Engelhardt

full_name: Julien Engelhardt

given: Julien

family: Dauman

full_name: René Dauman

given: René

family: Arné

full_name: Pierre Arné

given: Pierre

family: Allard

full_name: Michèle Allard

given: Michèle

full_name: Nicolas Dauman

family: Branchard

full_name: Olivier Branchard

given: Olivier

family: Perez

full_name: Paul Perez

given: Paul

family: Germain

full_name: Christine Germain

given: Christine

family: Caire

full_name: François Caire

given: François

family: Bonnard

full_name: Damien Bonnard

given: Damien

family: Cuny

full_name: Emmanuel Cuny

given: Emmanuel

journal_name: Brain Stimulation

title: Effect of Chronic Cortical Stimulation on Chronic Severe Tinnitus: A Prospective Randomized Double-blind Cross-over Trial and Long-term Follow Up

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Pellegrin


title: Multicentric, Controlled and Randomised Open Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin Using Pharmacologic Measures of Ribavirin Exposition During Combination Peginterferon Alfa-2 and Ribavirin Treatment in Naive Patients With Chronic Hepatitis C of Genotype 1 on a First Combination Therapy

acronym: RIBAJUSTE

summary: The aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis C of genotype 1. "Reference" strategy corresponding to standards of care recommended by the French consensus conference versus "Test" strategy corresponding to adaptation strategy of ribavirin dose during the first week according to AUC (area under the curve) of ribavirin plasmatic concentration after the first intake (Day 0) of 600 mg


title: National, Multicenter, Prospective Study of Screening of Fabry Disease in a Population of Men Over 28 Days Old and Less Than 55 Years, Hospitalized for an Ischemic Stroke.

acronym: FIND

summary:
Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke.

The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke.

This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.

ReferenceCitation: Clavelou P, Besson G, Elziere C, Ferrier A, Pinard JM, Hermier M, Artigou JY, Germain DP. [Neurological aspects of Fabry's disease]. Rev Neurol (Paris). 2006 May;162(5):569-80. Review. French.


title: Constitution of a Standardized Neural Imaging Database in Healthy Subjects

summary:
MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric study, tissue study, study of connectivity).

Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).

These examinations routinely contribute to the clinical diagnosis and surveillance of many neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular pathology, brain tumors, etc.).

As a result of the original morphological and functional information they provide, these examinations are being increasingly included in clinical research protocols involving the brain.

The absolute or relative quantification of anomalies observed, however, can be obtained only after comparison to a database of normal subjects.

The creation of these databases is currently limited by their cost and strictly single center nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).

The aim of this multidisciplinary study is to constitute a standardized database of multimode neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in patients, at the scale of a group or an individual, for the diagnosis and surveillance of neurological diseases.

Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).

The strictly single center character of this study is explained by the variability of the physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to each center.

ReferenceCitation: Mairal E, Barberon B, Laine N, Coulange M, Guedj E. Reversible widespread brain (18)F-FDG PET hypometabolism in chronic fatigue syndrome treated by hyperbaric oxygen therapy. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1680-1681. doi: 10.1007/s00259-020-05122-0. Epub 2021 Jan 9.

family: Mairal

full_name: E. Mairal

given: E.

family: Barberon

full_name: B. Barberon

given: B.

family: Laine

full_name: N. Laine

given: N.

family: Coulange

full_name: M. Coulange

given: M.

family: Guedj

full_name: Eric Guedj

given: Eric

title: Reversible widespread brain 18F-FDG PET hypometabolism in chronic fatigue syndrome treated by hyperbaric oxygen therapy

ReferenceCitation: Didic M, Felician O, Gour N, Bernard R, Pécheux C, Mundler O, Ceccaldi M, Guedj E. Rhinal hypometabolism on FDG PET in healthy APO-E4 carriers: impact on memory function and metabolic networks. Eur J Nucl Med Mol Imaging. 2015 Sep;42(10):1512-21. doi: 10.1007/s00259-015-3057-y. Epub 2015 Apr 22.

family: Didic

full_name: Mira Didic

given: Mira

family: Felician

full_name: Olivier Felician

family: Gour

full_name: Natalina Gour

given: Natalina

family: Bernard

full_name: Rafaelle Bernard

given: Rafaelle

family: Pécheux

full_name: Christophe Pécheux

given: Christophe

family: Mundler

full_name: Olivier Mundler

family: Ceccaldi

full_name: Mathieu Ceccaldi

given: Mathieu

ReferenceCitation: Arthuis M, Micoulaud-Franchi JA, Bartolomei F, McGonigal A, Guedj E. Resting cortical PET metabolic changes in psychogenic non-epileptic seizures (PNES). J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1106-12. doi: 10.1136/jnnp-2014-309390. Epub 2014 Dec 2.

family: Arthuis

full_name: M Arthuis

given: M

family: Micoulaud-Franchi

full_name: J A Micoulaud-Franchi

given: J A

family: Bartolomei

full_name: F Bartolomei

given: F

family: McGonigal

full_name: Aileen McGonigal

given: Aileen

full_name: E Guedj

given: E

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ


title: A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient

acronym: Cyclamax

summary: The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

ReferenceCitation: Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassaï B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.

family: Cornu

full_name: Catherine Cornu

given: Catherine

family: Remontet

full_name: Laurent Remontet

given: Laurent

family: Noel-Baron

full_name: Florence Noel-Baron

given: Florence

family: Nicolas

full_name: Alain Nicolas

given: Alain

family: Feugier-Favier

full_name: Nathalie Feugier-Favier

given: Nathalie

family: Roy

full_name: Pascal Roy

given: Pascal

family: Claustrat

full_name: Bruno Claustrat

given: Bruno

family: Saadatian-Elahi

full_name: Mitra Saadatian-Elahi

given: Mitra

family: Kassaï

full_name: Behrouz Kassaï

given: Behrouz

currency_apc_doaj: GBP

journal_name: BMC Complementary and Alternative Medicine

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

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

lead_sponsor: Persee Medica

location_facility: Clinical Research Center- Hopital Cardiologique


title: Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

acronym: KETADOL

summary: Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.


title: Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

summary: Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

lead_sponsor: French Cardiology Society


title: Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

summary:
Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.

High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

ReferenceCitation: Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Béné MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucémies Airguës et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. Epub 2004 Jul 15.

lead_sponsor: French Innovative Leukemia Organisation


title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects

summary: To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B

acronym: VIHVAC-B

summary:
In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer.

However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.

ReferenceCitation: Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.

name: Université Paris Descartes, Sorbonne Paris Cité, Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Cochin, Paris, France2Institut National de la Santé et de la Recherche Medicale (INSERM), Clinical Investigation Center 1417, Paris, France3INSERM Fren

family: Launay

full_name: Odile Launay

given: Odile

family: Rosenberg

full_name: Arielle R. Rosenberg

given: Arielle R.

name: Hôpitaux Universitaires, Strasbourg, France

family: Rey

full_name: David Rey

given: David

family: Pouget

full_name: Noelle Pouget

given: Noelle

name: Institut Pasteur, INSERM U994, Paris, France

family: Michel

full_name: Marie-Louise Michel

given: Marie-Louise

name: INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, France7Centre Hospitalier Universitaire de Montpellier, Hôpital Gui de Chauliac, Université de Montpellier, Unité Mixte Internationale 233, Montpe

family: Reynes

full_name: Jacques Reynes

given: Jacques

name: Service des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire (CHU) Bordeaux, Unité Mixte de Recherche–Centre National de la Recherche Scientifique 5234, Bordeaux, France

family: Neau

full_name: Didier Neau

given: Didier

name: INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, France9Collège des Universitaires des Maladies Infectieuses et Tropicales, Paris, France

family: Raffi

full_name: Francois Raffi

given: Francois

name: INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, France10CHU and UMR 1347, Université de Bourgogne, Dijon, France

family: Piroth

full_name: Lionel Piroth

given: Lionel

name: Sorbonne Universités, Université Pierre-et-Marie-Curie, Université Paris 06, INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique (Unité Mixte de Recherche en Santé 1136), Paris, France11AP-HP, Hôpital Saint Antoine, Unité de Santé Publique,

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

name: for the ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group

journal_name: JAMA Internal Medicine

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdière N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.

journal_name: JAMA

title: Safety and Immunogenicity of 4 Intramuscular Double Doses and 4 Intradermal Low Doses vs Standard Hepatitis B Vaccine Regimen in Adults With HIV-1

lead_sponsor: ANRS, Emerging Infectious Diseases

intervention_type: Biological


title: Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS

acronym: STIC

summary: The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.

ReferenceCitation: Houeto JL, Karachi C, Mallet L, Pillon B, Yelnik J, Mesnage V, Welter ML, Navarro S, Pelissolo A, Damier P, Pidoux B, Dormont D, Cornu P, Agid Y. Tourette's syndrome and deep brain stimulation. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):992-5.

ReferenceCitation: Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20.

family: Welter

full_name: Marie-Laure Welter

given: Marie-Laure

family: Houeto

full_name: Jean-Luc Houeto

given: Jean-Luc

family: Thobois

full_name: Stéphane Thobois

given: Stéphane

family: Bataille

full_name: Benoit Bataille

given: Benoit

family: Guenot

full_name: Marc Guenot

given: Marc

family: Worbe

full_name: Yulia Worbe

given: Yulia

family: Hartmann

full_name: Andreas Hartmann

given: Andreas

family: Czernecki

full_name: Virginie Czernecki

given: Virginie

family: Bardinet

full_name: Eric Bardinet

given: Eric

family: Yelnik

full_name: Jerome Yelnik

given: Jerome

family: du Montcel

full_name: Sophie Tezenas du Montcel

given: Sophie Tezenas

family: Agid

full_name: Yves Agid

given: Yves

family: Vidailhet

full_name: Marie Vidailhet

given: Marie

family: Cornu

full_name: Philippe Cornu

given: Philippe

family: Tanguy

full_name: Audrey Tanguy

given: Audrey

family: Ansquer

full_name: Solène Ansquer

given: Solène

family: Jaafari

full_name: Nematollah Jaafari

given: Nematollah

family: Poulet

full_name: Emmanuel Poulet

given: Emmanuel

family: Serra

full_name: Giulia Serra

given: Giulia

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

family: Cuny

full_name: Emmanuel Cuny

family: Aouizerate

full_name: Bruno Aouizerate

family: Pollak

full_name: Pierre Pollak


acronym: KTHYPE

summary: The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).

study_start_date_type: Actual

primary_purpose: Other

ReferenceCitation: Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18.

family: Fusco

full_name: Nicolas Fusco

given: Nicolas

family: Bernard

full_name: Franck Bernard

given: Franck

family: Roelants

full_name: Fabienne Roelants

given: Fabienne

family: Watremez

full_name: Christine Watremez

given: Christine

family: Musellec

full_name: Hervé Musellec

given: Hervé

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Beloeil

full_name: Helene Beloeil

given: Helene

family: Ahmin

full_name: Mustapha Ahmin

given: Mustapha

family: Barthes

full_name: Sébastien Barthes

given: Sébastien

family: Boulon

full_name: Natacha Boulon

given: Natacha

family: Branchu

full_name: Patricia Branchu

given: Patricia

family: Copin-Eliat

full_name: Catherine Copin-Eliat

given: Catherine

family: Delahaye-Larralde

full_name: Séverine Delahaye-Larralde

given: Séverine

family: Fillatre

full_name: Pierre Fillatre

family: Donal

full_name: Charlotte Donal

given: Charlotte

family: Hugot

full_name: Pierre Hugot

family: Gauvrit

full_name: Cécile Gauvrit

given: Cécile

family: Guillou

full_name: Nicolas Guillou

family: Leroyer

full_name: Isabelle Leroyer

given: Isabelle

family: Pouliquen

full_name: Cassiopée Pouliquen

given: Cassiopée

family: Renault

full_name: Alain Renault

given: Alain

family: Rolland

full_name: Emilie Rolland

given: Emilie

family: Rousseau

full_name: Chloé Rousseau

given: Chloé

location_facility:
Centre Hospitalier Privé Saint Grégoire
CHU
Cliniques Universitaires Saint-Luc


title: Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea

acronym: SOMNYX

summary: Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.

lead_sponsor: Université de Montréal

location_country: Canada France

location_facility:
Université Montpellier
Groupe Hospitalier Pitie-Salpetriere
Université de Montréal


title: An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy

summary: The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.

lead_sponsor: ProTiP Medical

location_country: Belgium France

location_facility:
CHU Mont-Godinne
CHU Strasbourg
CHU Toulouse


title: A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors

summary: The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors

lead_sponsor: Oncoethix GmbH

location_facility:
Institut Claudius Regaud
Institut Jules Bordet
Hopital Beaujon - AP-HP


title: A Non-randomized, Open-label, Multi-centric Dose-finding Adaptive Phase I/IIa Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Repeated Intravenous IPP-204106N Administrations in Adult Patients With Advanced Solid Tumors

acronym: IP N02

summary:
The experimental plan will consist in:

The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the optimal and recommended dose of IPP-204106N using a Bayesian "with memory" design with combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of three patients. The Bayesian methodology allows updating information as the trial progresses and stopping the trial as soon as the information obtained is deemed to be sufficient. Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I clinical trial with N6L will be used to inform the prior distribution in the present study.

The decisional part, according to the results of the phase I portion of the study, will define the optimal dose recommended for the phase IIa portion of the study.

The phase IIa portion of the study will confirm the optimal dose, and is designed to evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient population treated at the recommended dose of IPP-204106N.

lead_sponsor: Elro Pharma

location_facility:
Centre Claudius Regaud
Institut Jules Bordet
Centre Georges François Leclerc


title: The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases

summary:
This is a prospective clinical study to assess the performance of the prosthesis according to a composite success criterion. The clinical and functional results and the patient's quality of life up to 24 months of follow-up will also be recorded.

Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.

lead_sponsor: Medicrea International

location_facility:
Clairval hospital
Tripode Hospital
CHR Namur


title: Randomized Double Blind Placebo Controlled Multicenter Study of the Efficacy and Safety of Repeated Administrations of Botulinum Toxin Type A (Botox) in the Treatment of Peripheral Neuropathic Pain

summary: Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.

ReferenceCitation: Attal N, de Andrade DC, Adam F, Ranoux D, Teixeira MJ, Galhardoni R, Raicher I, Üçeyler N, Sommer C, Bouhassira D. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2016 May;15(6):555-65. doi: 10.1016/S1474-4422(16)00017-X. Epub 2016 Mar 2.

family: Attal

full_name: Nadine Attal

given: Nadine

family: de Andrade

full_name: Daniel C de Andrade

given: Daniel C

family: Adam

full_name: Frédéric Adam

given: Frédéric

family: Ranoux

full_name: Danièle Ranoux

given: Danièle

family: Teixeira

full_name: Manoel J Teixeira

given: Manoel J

family: Galhardoni

full_name: Ricardo Galhardoni

given: Ricardo

family: Raicher

full_name: Irina Raicher

given: Irina

family: Üçeyler

full_name: Nurcan Üçeyler

given: Nurcan

family: Sommer

full_name: Claudia Sommer

given: Claudia

family: Bouhassira

full_name: Didier Bouhassira

given: Didier

journal_name: The Lancet Neurology

ipd_sharing: No

lead_sponsor: Hospital Ambroise Paré Paris

location_country: Brazil France

location_facility: Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP


title: A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors

summary: Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.

ReferenceCitation: Hollebecque A, Houédé N, Cohen EE, Massard C, Italiano A, Westwood P, Bumgardner W, Miller J, Brail LH, Benhadji KA, Soria JC. A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Eur J Cancer. 2014 Mar;50(5):876-84. doi: 10.1016/j.ejca.2013.12.006. Epub 2014 Jan 20.

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Houédé

full_name: Nadine Houédé

family: Cohen

full_name: Ezra E.W. Cohen

given: Ezra E.W.

family: Massard

full_name: Christophe Massard

given: Christophe

family: Italiano

full_name: Antoine Italiano

family: Westwood

full_name: Paul Westwood

given: Paul

family: Bumgardner

full_name: William Bumgardner

given: William

family: Miller

full_name: Joel Miller

given: Joel

family: Brail

full_name: Les H. Brail

given: Les H.

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

journal_name: European Journal of Cancer

lead_sponsor: Eli Lilly and Company

location_country:
United States
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.