title: Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc

acronym: EVA

summary:
Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for the patients when nonsurgical management has failed. However , it has shown out some drawbacks : pseudoarthrosis may appear in the short term, and junctional degeneration in the long term.

The replacement of the intervertebral disc by a prosthesis (arthroplasty) has been since a few years a major alternative therapeutic to the arthrodesis.: it demonstrates great functional results and less post-interventional complications. It is indicated to restore a normal function of the spine (motion is kept)and to avoid deterioration of the adjacent spinal segments over the long time.

In this clinical study, we will distinguish the cervical discal pathology and the lumbar discal pathology.

The purpose of this study is to analyze the results of the arthroplasty in terms of functional effects, quality of life, anatomical results and economical results.

location_facility: Service de Chirurgie CHU Hopital Antoine Béclère

location_facility: Service de Neurochirurgie CHU Saint-Etienne


acronym: Trans-Insulin

summary: The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Chardigny JM, Malpuech-Brugère C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sébédio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. Epub 2006 Apr 24.

ReferenceType: derived

ReferenceCitation: Tardy AL, Lambert-Porcheron S, Malpuech-Brugère C, Giraudet C, Rigaudière JP, Laillet B, Leruyet P, Peyraud JL, Boirie Y, Laville M, Michalski MC, Chardigny JM, Morio B. Dairy and industrial sources of trans fat do not impair peripheral insulin sensitivity in overweight women. Am J Clin Nutr. 2009 Jul;90(1):88-94. doi: 10.3945/ajcn.2009.27515. Epub 2009 May 27.

family: Tardy

full_name: Anne-Laure Tardy

given: Anne-Laure

sequence: first

family: Lambert-Porcheron

full_name: Stéphanie Lambert-Porcheron

given: Stéphanie

sequence: additional

family: Malpuech-Brugère

full_name: Corinne Malpuech-Brugère

given: Corinne

family: Giraudet

full_name: Christophe Giraudet

given: Christophe

family: Rigaudière

full_name: Jean-Paul Rigaudière

given: Jean-Paul

family: Laillet

full_name: Brigitte Laillet

given: Brigitte

family: LeRuyet

full_name: Pascale LeRuyet

given: Pascale

family: Peyraud

full_name: Jean-Louis Peyraud

given: Jean-Louis

family: Boirie

full_name: Yves Boirie

given: Yves

family: Laville

full_name: Martine Laville

given: Martine

family: Michalski

full_name: Marie-Caroline Michalski

given: Marie-Caroline

family: Chardigny

full_name: Jean-Michel Chardigny

given: Jean-Michel

family: Morio

full_name: Béatrice Morio

given: Béatrice

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Clinical Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine Auvergne

location_facility: Centre de Recherche en Nutrition Humaine Rhônes-Alpes

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Completed


title: Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

summary:
Primary Objective:

To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).

Secondary Objective:

To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine

enrollment_type: Actual

lead_sponsor: Sanofi Pasteur, a Sanofi Company

intervention_type: Biological


title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients

summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.

primary_purpose: Health Services Research

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_normalized: University of Melbourne - Minerva Access

version: publishedVersion

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.

name: Psychiatric Research Unit; Psychiatry of Region Zealand; Slagelse Denmark

name: Child and Adolescent Psychiatric Department; Region Zealand; Roskilde Denmark

name: Department of Psychology; University of Southern Denmark; Odense Denmark

family: Storebø

full_name: Ole Jakob Storebø

given: Ole Jakob

name: Department of Psychiatry and Psychotherapy; University Medical Center Mainz; Mainz Germany

family: Stoffers-Winterling

full_name: Jutta M Stoffers-Winterling

given: Jutta M

name: Department of Forensic Psychiatry, Center for Neurology; University Rostock; Rostock Germany

family: Völlm

full_name: Birgit A Völlm

given: Birgit A

name: Psychiatric Research Unit; Region Zealand Psychiatry; Slagelse Denmark

name: Department of Psychology, Faculty of Health Science; University of Southern Denmark; Odense Denmark

family: Kongerslev

full_name: Mickey T Kongerslev

given: Mickey T

family: Mattivi

full_name: Jessica T Mattivi

given: Jessica T

family: Jørgensen

full_name: Mie S Jørgensen

given: Mie S

family: Faltinsen

full_name: Erlend Faltinsen

given: Erlend

family: Todorovac

full_name: Adnan Todorovac

given: Adnan

name: Duncan MacMillan House; Nottinghamshire Healthcare NHS Foundation Trust; Nottingham UK

name: Institute of Mental Health; Department of Psychiatry & Applied Psychology; Nottingham UK

family: Sales

full_name: Christian P Sales

given: Christian P

family: Callesen

full_name: Henriette E Callesen

given: Henriette E

name: Leibniz Institute for Resilience Research (LIR); Mainz Germany

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

url: https://nottingham-repository.worktribe.com/916765/1/storeb psychol borderline protocol cochrane 2018.pdf

url_for_landing_page: https://nottingham-repository.worktribe.com/916765/1/Storeb Psychol borderline protocol Cochrane 2018.pdf

location_facility: Hopital Cochin Centre de recherche Clinique Paris Centre


title: Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY)

acronym: INSUREA

summary:
During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose imbalance is frequent and associated with increased mortality. These observations have resulted in the hypothesis that intensive insulin therapy designed to control blood glucose would improve the prognosis of patients admitted into the ICU. In a prospective, randomized, single center study in a surgical ICU during which the majority of patients had undergone cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110 mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality compared to a group with a glycemic objective of 200 mg/dl.

In a recent published article, the beneficial effect of intensive insulin therapy seems less obvious in a randomized single center study in a medical ICU. One of the potential factors limiting the impact of a therapeutic strategy like this one is the absence of achieving strict glycemic control for all patients on intensive insulin therapy. Additionally, the implementation of such a therapeutic strategy results in an increased risk of hypoglycemia, the consequences of which on morbidity remain unclear.

The aim of our study is to determine, in a mixed population of medical and surgical patients admitted to the ICU, requiring artificial ventilation with a expected duration above 48 hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a conventional glycemic control (<11mmol/l) on hospital mortality.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Treatment

lead_sponsor: Poissy-Saint Germain Hospital

location_facility: Medico-surgical ICU Louise Michel Hospital

location_facility: Medico-surgical ICU Poissy Saint Germain Hospital

intervention_type: Other

status_simplified: Unknown


title: Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

summary: Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients

lead_sponsor: Nestlé

location_facility:
Hopital A. BECLERE
Hopital Saint Antoine

lead_sponsor_type: industriel


title: Phase I Study of Safety and Pharmacokinetics of Pazopanib in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

summary: Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for disease assessment.

study_start_date_type: Actual

lead_sponsor: GlaxoSmithKline

intervention_type: Drug


title: Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.

summary: Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.

lead_sponsor: UCB Pharma


title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.

acronym: SNIPP

summary: There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.

ReferenceType: result

ReferenceCitation: Wisborg K, Henriksen TB, Jespersen LB, Secher NJ. Nicotine patches for pregnant smokers: a randomized controlled study. Obstet Gynecol. 2000 Dec;96(6):967-71.

ReferenceCitation: Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202. Review.

ReferenceCitation: Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.

family: Berlin

full_name: Ivan Berlin

given: Ivan

family: Singleton

full_name: Edward G. Singleton

given: Edward G.

family: Heishman

full_name: Stephen J. Heishman

given: Stephen J.

journal_name: Drug and Alcohol Dependence

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Berlin I, Grangé G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ. 2014 Mar 11;348:g1622. doi: 10.1136/bmj.g1622.

full_name: I. Berlin

given: I.

family: Grange

full_name: G. Grange

given: G.

family: Jacob

full_name: N. Jacob

given: N.

family: Tanguy

full_name: M.-L. Tanguy

journal_name: BMJ

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique


title: Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®

summary: Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.

status: Terminated

lead_sponsor: University Hospital, Rouen

location_facility: JOLY UH-rouen


title: Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

acronym: Drone-TH

summary: To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

lead_sponsor: Hopital Foch

location_facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon

location_facility: Dept of Anesthesia and Intensive Care, Hôpital H. Mondor

intervention_type: Device


title: AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial

acronym: AMBIZYGO

summary: Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

ReferenceCitation: Lanternier F, Poiree S, Elie C, Garcia-Hermoso D, Bakouboula P, Sitbon K, Herbrecht R, Wolff M, Ribaud P, Lortholary O; French Mycosis Study Group. Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis. J Antimicrob Chemother. 2015 Nov;70(11):3116-23. doi: 10.1093/jac/dkv236. Epub 2015 Aug 27.

family: Lanternier

full_name: F. Lanternier

given: F.

family: Poiree

full_name: S. Poiree

given: S.

family: Elie

full_name: C. Elie

given: C.

family: Garcia-Hermoso

full_name: D. Garcia-Hermoso

given: D.

family: Bakouboula

full_name: P. Bakouboula

given: P.

family: Sitbon

full_name: K. Sitbon

given: K.

family: Herbrecht

full_name: R. Herbrecht

given: R.

family: Wolff

full_name: M. Wolff

given: M.

family: Ribaud

full_name: P. Ribaud

family: Lortholary

full_name: O. Lortholary

given: O.

journal_name: Journal of Antimicrobial Chemotherapy

evidence: open (via free pdf)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

location_facility: Hôpital Necker - Service des Maladies Infectieuses et Tropicales


title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study

acronym: AMNIO

summary:
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.

Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.

ReferenceCitation: Benifla JL, Goffinet F, Darai E, Madelenat P. Antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure. Obstet Gynecol. 1994 Dec;84(6):1041-2.

ReferenceCitation: Bénifla JL, Goffinet F, Bascou V, Darai E, Proust A, Madelenat P. [Transabdominal amnio-infusion facilitates external version maneuver after initial failure. Six successful attempts]. J Gynecol Obstet Biol Reprod (Paris). 1995;24(3):319-22. French.

ReferenceCitation: Boucher M, Bujold E, Marquette GP, Vezina Y. The relationship between amniotic fluid index and successful external cephalic version: a 14-year experience. Am J Obstet Gynecol. 2003 Sep;189(3):751-4.

ReferenceCitation: Cheng M, Hannah M. Breech delivery at term: a critical review of the literature. Obstet Gynecol. 1993 Oct;82(4 Pt 1):605-18. Review.

ReferenceCitation: Collaris RJ, Oei SG. External cephalic version: a safe procedure? A systematic review of version-related risks. Acta Obstet Gynecol Scand. 2004 Jun;83(6):511-8. Review.

ReferenceCitation: Collea JV, Chein C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. Am J Obstet Gynecol. 1980 May 15;137(2):235-44.

ReferenceCitation: Fernandez CO, Bloom SL, Smulian JC, Ananth CV, Wendel GD Jr. A randomized placebo-controlled evaluation of terbutaline for external cephalic version. Obstet Gynecol. 1997 Nov;90(5):775-9.

ReferenceCitation: Fischer R. Breech Presentation. 2004. http://www.emedicine.com/med/topic3272.htm

ReferenceCitation: Fisk NM, Ronderos-Dumit D, Soliani A, Nicolini U, Vaughan J, Rodeck CH. Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. Obstet Gynecol. 1991 Aug;78(2):270-8.

ReferenceCitation: Flamm BL, Fried MW, Lonky NM, Giles WS. External cephalic version after previous cesarean section. Am J Obstet Gynecol. 1991 Aug;165(2):370-2.

ReferenceCitation: Gembruch U, Hansmann M. Artificial instillation of amniotic fluid as a new technique for the diagnostic evaluation of cases of oligohydramnios. Prenat Diagn. 1988 Jan;8(1):33-45.

ReferenceCitation: Gimovsky ML, Wallace RL, Schifrin BS, Paul RH. Randomized management of the nonfrank breech presentation at term: a preliminary report. Am J Obstet Gynecol. 1983 May 1;146(1):34-40.

ReferenceCitation: Gramellini D, Fieni S, Kaihura C, Faiola S, Vadora E. Transabdominal antepartum amnioinfusion. Int J Gynaecol Obstet. 2003 Nov;83(2):171-8.

ReferenceCitation: Gramellini D, Fieni S, Kaihura C, Piantelli G, Verrotti C. Antepartum amnioinfusion: a review. J Matern Fetal Neonatal Med. 2003 Nov;14(5):291-6. Review.

ReferenceCitation: Gramellini D, Fieni S, Piantelli G, Faiola S, Kaihura C, Verrotti C, Cavallotti D, Viola P, Bacchini G, Vadora E. [Amnioinfusion: techniques, indications, and controlled retrospective study of 55 cases]. Acta Biomed Ateneo Parmense. 2000;71 Suppl 1:325-9. Italian.

ReferenceCitation: Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83.

ReferenceCitation: Hellström AC, Nilsson B, Stånge L, Nylund L. When does external cephalic version succeed? Acta Obstet Gynecol Scand. 1990;69(4):281-5.

ReferenceCitation: Hofmeyr GJ, Gyte G. Interventions to help external cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004a. Chichester, UK: John Wiley & Sons, Ltd.

ReferenceCitation: Hofmeyr GJ, Hannah ME. Planned caesarean section for term breech delivery (Cochrane Review). In: The Cochrane Library, Issue 3, 2004b. Chichester, UK: John Wiley & Sons, Ltd

ReferenceCitation: Hofmeyr GJ, Kulier R. Cephalic version by postural management for breech presentation (Cochrane Review). In: The Cochrane Library, Issue 3, 2004c. Chichester, UK: John Wiley & Sons, Ltd.

ReferenceCitation: Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004d. Chichester, UK: John Wiley & Sons, Ltd

ReferenceCitation: Hofmeyr GJ. External cephalic version facilitation for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000184. Review. Update in: Cochrane Database Syst Rev. 2001;(4):CD000184.

ReferenceCitation: Hofmeyr GJ. External cephalic version for breech presentation before term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004e. Chichester, UK: John Wiley & Sons, Ltd.

ReferenceCitation: Hutton EK, Kaufman K, Hodnett E, Amankwah K, Hewson SA, McKay D, Szalai JP, Hannah ME. External cephalic version beginning at 34 weeks' gestation versus 37 weeks' gestation: a randomized multicenter trial. Am J Obstet Gynecol. 2003 Jul;189(1):245-54.

ReferenceCitation: Kotaska A. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ. 2004 Oct 30;329(7473):1039-42. Review. Erratum in: BMJ. 2004 Dec 11;329(7479):1385.

ReferenceCitation: Lansac J, Body G, Perrotin F, Marret H. Pratique de l'accouchement. Paris: Masson ; 2001, p. 365-369.

ReferenceCitation: Le Bret T, Grangé G, Goffinet F, Cabrol D. [External cephalic version: experience about 237 versions at Port-Royal maternity]. J Gynecol Obstet Biol Reprod (Paris). 2004 Jun;33(4):297-303. French.

ReferenceCitation: Lilford RJ, van Coeverden de Groot HA, Moore PJ, Bingham P. The relative risks of caesarean section (intrapartum and elective) and vaginal delivery: a detailed analysis to exclude the effects of medical disorders and other acute pre-existing physiological disturbances. Br J Obstet Gynaecol. 1990 Oct;97(10):883-92.

ReferenceCitation: Newman RB, Peacock BS, VanDorsten JP, Hunt HH. Predicting success of external cephalic version. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 1):245-9; discussion 249-50.

ReferenceCitation: Novakov-Mikić A, Stojić S, Bogavac M, Mandić A. [Amnionic infusion therapy in conditions with low amnionic fluid levels]. Med Pregl. 2003 Jan-Feb;56(1-2):33-7. Croatian.

ReferenceCitation: Perrotin F, Sauget S, Laffont M, Lansac J, Body G. Version par manœuvre externe: nouveaux apports techniques. In: Collège National des Gynécologues Obstétriciens Français. Mises à jour en Gynécologie Obstétrique - VIGOT Ed. - Paris, 2003;25:5-23

ReferenceCitation: Pritchard JA, MacDonald PC. Dystocia caused by abnormalities in presentation, position, or development of the fetus. Williams Obstetrics. Norwalk, CT: Appleton-Century-Crofts; 1980, p. 787-796.

ReferenceCitation: Rietberg CC, Elferink-Stinkens PM, Brand R, van Loon AJ, Van Hemel OJ, Visser GH. Term breech presentation in The Netherlands from 1995 to 1999: mortality and morbidity in relation to the mode of delivery of 33824 infants. BJOG. 2003 Jun;110(6):604-9.

ReferenceCitation: Royal College of Obstetricians and Gynaecologists Clinical Audit Unit. Effective procedures in maternity care suitable for audit. London: RCOG Press; 1997;4(7). Breech presentation at term, p. 32.

ReferenceCitation: Royal College of Obstetricians and Gynaecologists The management of breech presentation. 2001

ReferenceCitation: Lee D, Contreras M, Robson SC, Rodeck CH, Whittle MJ. Recommendations for the use of anti-D immunoglobulin for Rh prophylaxis. British Blood Transfusion Society and the Royal College of Obstetricians and Gynaecologists. Transfus Med. 1999 Mar;9(1):93-7.

ReferenceCitation: Shalev E, Battino S, Giladi Y, Edelstein S. External cephalic version at term--using tocolysis. Acta Obstet Gynecol Scand. 1993 Aug;72(6):455-7.

ReferenceCitation: Stuart IP. Term breech trial. Lancet. 2001 Jan 20;357(9251):228.

ReferenceCitation: Wagner A, Potin J, Himily V, Arbeille P, Perrotin F. The "Loss Of Resistance" Syringe: a useful tool for difficult amnioinfusion. Fetal Diagn Ther (submitted).

ReferenceCitation: Mousa HA. Re: Lédée et al. Management in intractable obstetric haemorrhage: an audit study on 61 cases. Eur J Obstet Gynecol Reprod Biol 2001;94:189-96. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):116-7.

ReferenceCitation: Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12. Review.

ReferenceCitation: Diguisto C, Winer N, Descriaud C, Tavernier E, Weymuller V, Giraudeau B, Perrotin F. Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018 Apr;31(8):993-999. doi: 10.1080/14767058.2017.1304909. Epub 2017 Mar 28.

name: Department of Obstetrics, Gynecology and Fetal Medicine, University Hospital of Tours, Tours, France;

name: Université François-Rabelais de Tours, Tours, France;

family: Diguisto

full_name: Caroline Diguisto

given: Caroline

name: Department of Obstetrics, Gynecology and Fetal Medicine, University Hospital of Nantes, Nantes, France;

family: Winer

full_name: Norbert Winer

given: Norbert

name: Department of Obstetrics, Gynecology, Centre Hospitalier Régional Orléans, Orléans, France;

family: Descriaud

full_name: Celine Descriaud

given: Celine

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Weymuller

full_name: Victoire Weymuller

given: Victoire

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Perrotin

full_name: Franck Perrotin

given: Franck

journal_name: The Journal of Maternal-Fetal & Neonatal Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: University Hospital, Tours

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital

intervention_type: Procedure


title: Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil

summary: Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.

ReferenceCitation: Wallet F, Clement HJ, Bouret C, Lopez F, Broisin F, Pignal C, Schoeffler M, Derre E, Charpiat B, Huissoud C, Aubrun F, Viale JP. Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 May;27(5):441-7. doi: 10.1097/EJA.0b013e3283365944.

family: Wallet

full_name: Florent Wallet

given: Florent

family: Clement

full_name: Henri Jacques Clement

given: Henri Jacques

family: Bouret

full_name: Carine Bouret

given: Carine

family: Lopez

full_name: Felix Lopez

given: Felix

family: Broisin

full_name: Françoise Broisin

given: Françoise

family: Pignal

full_name: Corine Pignal

given: Corine

family: Schoeffler

full_name: Mathieu Schoeffler

given: Mathieu

family: Derre

full_name: Edith Derre

given: Edith

family: Charpiat

full_name: Bruno Charpiat

family: Huissoud

full_name: Cyril Huissoud

given: Cyril

family: Aubrun

full_name: Frédéric Aubrun

given: Frédéric

family: Viale

full_name: Jean Paul Viale

given: Jean Paul

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hospices Civils de Lyon

location_facility: Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse


title: Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine

acronym: GEMCOL

summary: The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

design_allocation: Non-Randomized

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Leonard de Vinci
Centre Oscar Lambret


title: Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study

summary: The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml

ReferenceCitation: Morris DL, Sheng Y, Zhang Y, Wang YF, Zhu Z, Tombleson P, Chen L, Cunninghame Graham DS, Bentham J, Roberts AL, Chen R, Zuo X, Wang T, Wen L, Yang C, Liu L, Yang L, Li F, Huang Y, Yin X, Yang S, Rönnblom L, Fürnrohr BG, Voll RE, Schett G, Costedoat-Chalumeau N, Gaffney PM, Lau YL, Zhang X, Yang W, Cui Y, Vyse TJ. Genome-wide association meta-analysis in Chinese and European individuals identifies ten new loci associated with systemic lupus erythematosus. Nat Genet. 2016 Aug;48(8):940-946. doi: 10.1038/ng.3603. Epub 2016 Jul 11.

family: Morris

full_name: David L Morris

given: David L

family: Sheng

full_name: Yujun Sheng

given: Yujun

family: Zhang

full_name: Yan Zhang

given: Yan

family: Wang

full_name: Yong-Fei Wang

given: Yong-Fei

family: Zhu

full_name: Zhengwei Zhu

given: Zhengwei

family: Tombleson

full_name: Philip Tombleson

given: Philip

family: Chen

full_name: Lingyan Chen

given: Lingyan

family: Cunninghame Graham

full_name: Deborah S Cunninghame Graham

given: Deborah S

family: Bentham

full_name: James Bentham

given: James

family: Roberts

full_name: Amy L Roberts

given: Amy L

full_name: Ruoyan Chen

given: Ruoyan

family: Zuo

full_name: Xianbo Zuo

given: Xianbo

full_name: Tingyou Wang

given: Tingyou

family: Wen

full_name: Leilei Wen

given: Leilei

family: Yang

full_name: Chao Yang

given: Chao

family: Liu

full_name: Lu Liu

given: Lu

full_name: Lulu Yang

given: Lulu

family: Li

full_name: Feng Li

given: Feng

family: Huang

full_name: Yuanbo Huang

given: Yuanbo

family: Yin

full_name: Xianyong Yin

given: Xianyong

full_name: Sen Yang

given: Sen

family: Rönnblom

full_name: Lars Rönnblom

given: Lars

family: Fürnrohr

full_name: Barbara G Fürnrohr

given: Barbara G

family: Voll

repositories:
PubMed Central
Pure (Denmark)
kar.kent.ac.uk

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

ReferenceCitation: Schoindre Y, Jallouli M, Tanguy ML, Ghillani P, Galicier L, Aumaître O, Francès C, Le Guern V, Lioté F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Le Thi Huong D, Asli B, Kahn JE, Sailler L, Ackermann F, Papo T, Sacré K, Fain O, Stirnemann J, Cacoub P, Leroux G, Cohen-Bittan J, Hulot JS, Lechat P, Musset L, Piette JC, Amoura Z, Souberbielle JC, Costedoat-Chalumeau N; Group PLUS. Lower vitamin D levels are associated with higher systemic lupus erythematosus activity, but not predictive of disease flare-up. Lupus Sci Med. 2014 Jun 7;1(1):e000027. doi: 10.1136/lupus-2014-000027. eCollection 2014.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Morel N, Bachelot A, Chakhtoura Z, Ghillani-Dalbin P, Amoura Z, Galicier L, Aumaitre O, Piette JC, Pourrat J, Boutin D, Sacre K, Kahn JE, Duhaut P, Farge D, Francès C, Guettrot-Imbert G, Harlé JR, Lambotte O, Le Guern V, Sène D, Trad S, Vidal E, Sarrot-Reynauld F, Gompel A, Tanguy ML, Touraine P, Lacorte JM, Costedoat-Chalumeau N; PLUS group. Study of anti-Müllerian hormone and its relation to the subsequent probability of pregnancy in 112 patients with systemic lupus erythematosus, exposed or not to cyclophosphamide. J Clin Endocrinol Metab. 2013 Sep;98(9):3785-92. doi: 10.1210/jc.2013-1235. Epub 2013 Jul 5.

name: University Pierre and Marie Curie (UPMC) (N.M., Z.A., J.-C.P., D.B., D.S., N.C.-C.), Université Paris 6, Paris, France

name: Assistance Publique-Hôpitaux de Paris (AP-HP) (N.M., Z.A., J.-C.P., D.B., D.S., N.C.-C.), Hôpital Pitié-Salpêtrière, Centre de référence national pour le Lupus Systémique et le syndrome des Antiphospholipides, service de médecine interne, 75651 Paris Cedex 13, France

name: UPMC (A.B., Z.C., P.T.), Université Paris 6, Paris, France

name: AP-HP (A.B., Z.C., P.T.), Hôpital Pitié-Salpêtrière, service d'endocrinologie et médecine de la reproduction, Centre de Référence des Maladies Gynécologiques Médico-Chirurgicales Rares and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, 75651 Paris Cedex 13, France

name: UPMC (P.G.-D.), Université Paris 6, Paris, France

name: AP-HP (P.G.-D.), Hôpital Pitié-Salpêtrière, service d'immunologie, 75651 Paris Cedex 13, France

name: Université Paris Diderot (L.G.), Sorbonne Paris Cité, Paris, France

name: AP-HP (L.G.), Hôpital St Louis, service d'immunologie clinique, 75010 Paris, France

name: Université de Clermont-Ferrand (O.A., G.G.-I.), 63003 Clermont-Ferrand, France

name: Centre Hospitalier Universitaire (CHU) Clermont-Ferrand (O.A., G.G.-I.), Hôpital Gabriel Montpied, service de médecine interne, 63003 Clermont-Ferrand Cedex 1, France

name: Université Paul-Sabatier (J.P.), Toulouse, France

name: CHU Toulouse (J.P.), Hôpital Rangueil, service de néphrologie, TSA 50032, 31000 Toulouse, France

name: Université Paris-Diderot (K.S.), Sorbonne Paris-Cité, F-75205 Paris, France

name: AP-HP (K.S.), Hôpital Bichat Claude-Bernard, service de médecine interne, 75018 Paris, France

name: Hôpital Foch (J.-E.K.), service de médecine interne, 92150 Suresnes, France

name: CHU Amiens (P.D.), Hôpital Nord, service de médecine interne, 80000 Amiens, France

name: Université Paris Diderot (D.F.), Sorbonne Paris Cité, Paris, France

name: AP-HP (D.F.), Hôpital St Louis, service de médecine interne, 75010 Paris, France

name: UPMC (C.F.), Université Paris 6, Paris, France

name: AP-HP (C.F.), Hôpital Tenon, service de dermatologie allergologie, 75020 Paris, France

name: Hôpital de la Conception (J.-R.H.), Assistance Publique-Hôpitaux de Marseille, Service de médecine interne, 13385 Marseille cedex 5, France

name: Hôpital Bicêtre (O.L.), service de médecine interne, 94270 Le Kremlin Bicêtre, France

name: Université Paris-Descartes (V.L.G.), Paris, France

name: AP-HP (V.L.G.), Hôpital Cochin, service de médecine interne, 75014 Paris, France

name: AP-HP (S.T.), Hôpital Ambroise Paré, service de médecine interne, 92104 Boulogne-Billancourt cedex, France

name: Centre Hospitalier Régional Universitaire Dupuytren (E.V.), service de médecine interne, 92104 Boulogne-Billancourt cedex, France

name: Site Nord Hôpital A. Michallon (F.S.-R.), 38700 La Tronche, France

name: Université Paris-Descartes (A.G.), Paris, France

name: AP-PH (A.G.), Hôpital Cochin, service de gynécologie, 75014 Paris, France

name: UPMC (M.L.T.), Université Paris 6, Paris, France

name: AP-HP (M.L.T.), Hôpital Pitié-Salpêtrière, unité de recherche clinique, 75651 Paris Cedex 13, France

name: UPMC (J.-M.L.), Université Paris 6, Paris, France

name: AP-HP (J.-M.L.), Hôpital Pitié-Salpêtrière, service de biochimie, 75651 Paris Cedex 13, France

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Study of Anti-Müllerian Hormone and Its Relation to the Subsequent Probability of Pregnancy in 112 Patients With Systemic Lupus Erythematosus, Exposed or Not to Cyclophosphamide

ReferenceCitation: Costedoat-Chalumeau N, Galicier L, Aumaître O, Francès C, Le Guern V, Lioté F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacré K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

location_facility: Hopital la Pitié Salpétrière Assistance Publique


title: Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

summary: To compare Bispectral index and entropy during maintenance of anesthesia

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J. Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90.

ReferenceCitation: Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM. Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42.

ReferenceCitation: Aimé I, Gayat E, Fermanian C, Cook F, Peuch C, Laloë PA, Mantz J, Fischler M. Effect of age on the comparability of bispectral and state entropy indices during the maintenance of propofol-sufentanil anaesthesia. Br J Anaesth. 2012 Apr;108(4):638-43. doi: 10.1093/bja/aer457. Epub 2012 Jan 17.

family: Aimé

full_name: I. Aimé

given: I.

family: Gayat

full_name: E. Gayat

given: E.

family: Fermanian

full_name: C. Fermanian

given: C.

family: Cook

full_name: F. Cook

given: F.

family: Peuch

full_name: C. Peuch

family: Laloë

full_name: P.A. Laloë

family: Mantz

full_name: J. Mantz

given: J.

family: Fischler

full_name: M. Fischler

given: M.

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Effect of age on the comparability of bispectral and state entropy indices during the maintenance of propofol–sufentanil anaesthesia


title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion

summary: This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ipd_sharing: No


title: Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction

acronym: STIMUCO

summary: This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.

ReferenceCitation: Pin I, Grenet D, Scheid P, Domblides P, Stern M, Hubert D. [Specific aspects and care of lung involvement in adults with cystic fibrosis]. Rev Mal Respir. 2000 Aug;17(3 Pt 2):758-78. Review. French.

ReferenceCitation: de Meer K, Gulmans VA, van Der Laag J. Peripheral muscle weakness and exercise capacity in children with cystic fibrosis. Am J Respir Crit Care Med. 1999 Mar;159(3):748-54.

ReferenceCitation: Selvadurai HC, Allen J, Sachinwalla T, Macauley J, Blimkie CJ, Van Asperen PP. Muscle function and resting energy expenditure in female athletes with cystic fibrosis. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1476-80. Epub 2003 Sep 18.

ReferenceCitation: Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9.

ReferenceCitation: Elkin SL, Williams L, Moore M, Hodson ME, Rutherford OM. Relationship of skeletal muscle mass, muscle strength and bone mineral density in adults with cystic fibrosis. Clin Sci (Lond). 2000 Oct;99(4):309-14.

ReferenceCitation: de Meer K, Jeneson JA, Gulmans VA, van der Laag J, Berger R. Efficiency of oxidative work performance of skeletal muscle in patients with cystic fibrosis. Thorax. 1995 Sep;50(9):980-3.

ReferenceCitation: Moser C, Tirakitsoontorn P, Nussbaum E, Newcomb R, Cooper DM. Muscle size and cardiorespiratory response to exercise in cystic fibrosis. Am J Respir Crit Care Med. 2000 Nov;162(5):1823-7.

ReferenceCitation: Vivodtzev I, Decorte N, Wuyam B, Gonnet N, Durieu I, Levy P, Cracowski JL, Cracowski C. Benefits of neuromuscular electrical stimulation prior to endurance training in patients with cystic fibrosis and severe pulmonary dysfunction. Chest. 2013 Feb 1;143(2):485-493. doi: 10.1378/chest.12-0584.

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: Decorte

full_name: Nicolas Decorte

given: Nicolas

family: Wuyam

full_name: Bernard Wuyam

given: Bernard

family: Gonnet

full_name: Nicolas Gonnet

family: Durieu

full_name: Isabelle Durieu

family: Levy

full_name: Patrick Levy

given: Patrick

family: Cracowski

full_name: Jean-Luc Cracowski

given: Jean-Luc

full_name: Claire Cracowski

given: Claire

journal_name: Chest

title: Benefits of Neuromuscular Electrical Stimulation Prior to Endurance Training in Patients With Cystic Fibrosis and Severe Pulmonary Dysfunction

lead_sponsor: University Hospital, Grenoble

location_facility: Pneumology Department of Lyon University Hospital

location_facility: Pneumology Department of Grenoble University Hospital

intervention_type: Behavioral


title: Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil

summary: This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia.

ReferenceCitation: Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20.

ReferenceCitation: Necib S, Tubach F, Peuch C, LeBihan E, Samain E, Mantz J, Dahmani S; PROMIFLUNIL trial group. Recovery from anesthesia after craniotomy for supratentorial tumors: comparison of propofol-remifentanil and sevoflurane-sufentanil (the PROMIFLUNIL trial). J Neurosurg Anesthesiol. 2014 Jan;26(1):37-44. doi: 10.1097/ANA.0b013e31829cc2d6.

family: Necib

full_name: Skander Necib

given: Skander

family: Tubach

full_name: Florence Tubach

given: Florence

full_name: Clarisse Peuch

given: Clarisse

family: LeBihan

full_name: Eric LeBihan

given: Eric

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

full_name: Jean Mantz

given: Jean

family: Dahmani

full_name: Souhayl Dahmani

given: Souhayl

journal_name: Journal of Neurosurgical Anesthesiology

title: Recovery from Anesthesia after Craniotomy for Supratentorial Tumors

location_facility:
Centre Hospitalier Universitaire.
Hopital BEAUJON ASSISTANCE PUBLIQUE


type: Other Identifier

title: A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation

summary: This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

lead_sponsor: Eli Lilly and Company

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.


title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

summary: The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

lead_sponsor: Rennes University Hospital

location_facility: Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou

location_facility: Service des Maladies du Foie - Hôpital de Pontchaillou


title: Continuous Regional Analgesia After Total Knee Arthroplasty. Normal Saline or Dextrose 5% in Water as Fluid Medium for Pre-Placement Expansion in Order to Facilitate the Catheter Passing

summary: This prospective, comparative and double blind study is aimed to determine if normal saline or dextrose 5% in water will modify the stimulation during the insertion of the stimulating catheter used for continuous femoral and sciatic blocks in total knee replacement.

lead_sponsor: Nantes University Hospital

location_facility: Departemental Hospital of la Roche sur Yon


title: Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

summary:
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:

either a first episode of preterm labor stopped by acute tocolysis;
either a history of late miscarriage or premature delivery or uterine malformation or DES
either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

ReferenceCitation: Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9.

ReferenceCitation: Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssière C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstétrique et Gynécologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.

family: Winer

full_name: Norbert Winer

given: Norbert

family: Bretelle

full_name: Florence Bretelle

family: Senat

full_name: Marie-Victoire Senat

given: Marie-Victoire

family: Bohec

full_name: Caroline Bohec

given: Caroline

family: Deruelle

full_name: Philippe Deruelle

given: Philippe

family: Perrotin

full_name: Frank Perrotin

given: Frank

family: Connan

full_name: Laure Connan

given: Laure

family: Vayssière

full_name: Christophe Vayssière

given: Christophe

family: Langer

full_name: Bruno Langer

given: Bruno

family: Capelle

full_name: Marianne Capelle

given: Marianne

family: Azimi

full_name: Shohreh Azimi

given: Shohreh

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Rozenberg

full_name: Patrick Rozenberg

journal_name: American Journal of Obstetrics and Gynecology

location_facility:
CHI Poissy st Germain
Chi Poissy St Germain


title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

summary: Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.

ReferenceCitation: Mercadal L, Tezenas du Montcel S, Chonchol MB, Debure A, Depreneuf H, Servais A, Bassilios N, Assogba U, Allouache M, Prié D. Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial. Am J Nephrol. 2018;48(5):349-356. doi: 10.1159/000494338. Epub 2018 Nov 8.

family: Mercadal

full_name: Lucile Mercadal

given: Lucile

family: Tezenas du Montcel

full_name: Sophie Tezenas du Montcel

given: Sophie

family: Chonchol

full_name: Michel B. Chonchol

given: Michel B.

family: Debure

full_name: Alain Debure

given: Alain

family: Depreneuf

full_name: Hélène Depreneuf

given: Hélène

family: Servais

full_name: Aude Servais

given: Aude

family: Bassilios

full_name: Nader Bassilios

given: Nader

family: Assogba

full_name: Ubald Assogba

given: Ubald

family: Allouache

full_name: Mahmoud Allouache

given: Mahmoud

family: Prié

full_name: Dominique Prié

given: Dominique

journal_name: American Journal of Nephrology

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

location_facility: HOPITAL LA PITIE SALPETRIERE, service de Néphrologie


title: Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis

acronym: FIBROSTIC

summary: A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.

location_facility:
Hopital Saint-Antoine
Hopital Beaujon


title: Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial

summary: The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

ReferenceCitation: Martinez V, Cohen P, Pagnoux C, Vinzio S, Mahr A, Mouthon L, Sailler L, Delaunay C, Sadoun A, Guillevin L; French Vasculitis Study Group. Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: results of a multicenter, prospective, open-label study of twenty-two patients. Arthritis Rheum. 2008 Jan;58(1):308-17. doi: 10.1002/art.23147.

family: Martinez

full_name: Valérie Martinez

given: Valérie

family: Cohen

full_name: Pascal Cohen

given: Pascal

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

family: Vinzio

full_name: Stéphane Vinzio

given: Stéphane

family: Mahr

full_name: Alfred Mahr

given: Alfred

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Sailler

full_name: Laurent Sailler

given: Laurent

family: Delaunay

full_name: Claire Delaunay

given: Claire

family: Sadoun

full_name: Alain Sadoun

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

journal_name: Arthritis & Rheumatism

title: Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: Results of a multicenter, prospective, open-label study of twenty-two patients

location_facility:
Hopital Cochin
Hôpital COCHIN


title: Identifying Morphological and Biological Biomarkers of the Venous Thromboembolic Risk Risk Related to Aging

summary: Aging is an independent risk factor, without any clear explanation. The primary aim of the study is to depict the effect of aging on the coagulation fibrinolysis parameters and microparticles.

lead_sponsor: Hopital Lariboisière

location_facility:
Hopital Lariboisière
Hopital Lariboisiere


title: Biological Efficacy of Clopidogrel 600 mg Loading Dose Followed by 75 mg Maintenance Dose After Implantation of Drug-eluting Stents in Patients With Diabetes Mellitus or Metabolic Syndrome (SPACE)

acronym: SPACE

summary:
The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is recommended that all patients take an association of aspirin and clopidogrel for several months after DES implantation to reduce this risk. However, the biological efficacy of current antiplatelet therapies has not been studied prospectively and specifically in DM or MS patients.

Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600 mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo shear-induced platelet aggregation (SIPA), along with other assays measuring platelet activation and aggregation, in patients with DM, MS, or no DM/MS.

Patients with stable coronary artery disease and successful DES implantation in native coronary arteries will be eligible. They will be stratified at entry according to their metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance dose (chronic effects).

Study end-points:

A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.

B. Secondary biological end-points:

To compare the results of other tests of platelet aggregation/activation in DM vs. MS vs. no DM/MS patients.
To compare the acute (6-24 hours after clopidogrel loading dose) and chronic (4 months later) results of the above mentioned tests. These comparisons will be performed in the overall population and in each group (DM, MS, no DM/MS).

C. Secondary clinical end-points: To study the relationship between SIPA levels (and the other tests of platelet aggregation/activation) and the occurrence of:

Periprocedural myocardial infarctions
Major adverse cardiac events (cardiovascular death, myocardial infarction or ischaemia-driven target vessel revascularization) at 4 and 12 months after stent implantation.

We, the researchers at Assistance PUBLIQUE - HOPITAUX de Paris, anticipate our study may help improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients treated with DES.

primary_purpose: Diagnostic

ReferenceCitation: Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. Epub 2005 Mar 15.

ReferenceCitation: Serebruany VL, Steinhubl SR, Berger PB, Malinin AI, Bhatt DL, Topol EJ. Variability in platelet responsiveness to clopidogrel among 544 individuals. J Am Coll Cardiol. 2005 Jan 18;45(2):246-51.

ReferenceCitation: Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. Epub 2003 Jun 9.

ReferenceCitation: Kastrati A, Mehilli J, Schühlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Volmer C, Gawaz M, Berger PB, Schömig A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med. 2004 Jan 15;350(3):232-8.

ReferenceCitation: Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005 Apr 26;111(16):2099-106. Epub 2005 Mar 6.

ReferenceCitation: Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. Epub 2004 Jun 7. Erratum in: Circulation. 2011 Oct 25;124(17):e459. Bienart, Roy [corrected to Beinart, Roy].

ReferenceCitation: Ajzenberg N, Aubry P, Huisse MG, Cachier A, El Amara W, Feldman LJ, Himbert D, Baruch D, Guillin MC, Steg PG. Enhanced shear-induced platelet aggregation in patients who experience subacute stent thrombosis: a case-control study. J Am Coll Cardiol. 2005 Jun 7;45(11):1753-6.

location_facility: Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris

location_facility: Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris


title: Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children

summary: Memory is a cognitive function whose development is still poorly documented in children, but which is often disturbed in temporal epilepsy. There are no studies about the disorders of episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not involve this field and none are dedicated to children. The objectives of this project are to study the neuronal networks involved in episodic memory in normal children, as well as the disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and cerebral reorganization in epilepsy.

ReferenceCitation: Jambaqué I, Dellatolas G, Dulac O, Ponsot G, Signoret JL. Verbal and visual memory impairment in children with epilepsy. Neuropsychologia. 1993 Dec;31(12):1321-37.

ReferenceCitation: Hertz-Pannier L, Chiron C, Jambaqué I, Renaux-Kieffer V, Van de Moortele PF, Delalande O, Fohlen M, Brunelle F, Le Bihan D. Late plasticity for language in a child's non-dominant hemisphere: a pre- and post-surgery fMRI study. Brain. 2002 Feb;125(Pt 2):361-72.

location_facility: Service Hospitalier Frédéric Joliot (SHFJ)


title: National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2

summary: Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility:
Centre Hospitalier Lyon-sud
Centre Hosptalier Emile Roux


title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.

summary: The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
Institut Paoli-Calmettes


title: Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

summary: The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.

location_facility:
Institut Claudius Regaud
Centre Jean Perrin


title: Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

summary: The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis > 50%.

ReferenceCitation: Jacqueminet S, Barthelemy O, Rouzet F, Isnard R, Halbron M, Bouzamondo A, Le Guludec D, Grimaldi A, Metzger JP, Le Feuvre C. A randomized study comparing isotope and echocardiography stress testing in the screening of silent myocardial ischaemia in type 2 diabetic patients. Diabetes Metab. 2010 Dec;36(6 Pt 1):463-9. doi: 10.1016/j.diabet.2010.06.005. Epub 2010 Sep 15.

family: Jacqueminet

full_name: S. Jacqueminet

given: S.

family: Barthelemy

full_name: O. Barthelemy

given: O.

family: Rouzet

full_name: F. Rouzet

given: F.

family: Isnard

full_name: R. Isnard

given: R.

family: Halbron

full_name: M. Halbron

given: M.

family: Bouzamondo

full_name: A. Bouzamondo

given: A.

family: Le Guludec

full_name: D. Le Guludec

given: D.

family: Grimaldi

full_name: A. Grimaldi

family: Metzger

full_name: J.-P. Metzger

family: Le Feuvre

full_name: C. Le Feuvre

given: C.

journal_name: Diabetes & Metabolism

lead_sponsor: Société Française de Cardiologie

location_facility: Service de diabétologie - Pitié Salpêtrière


title: Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C Non 2 -3 Genotype naïve Patients Treated With a 12 Weeks Bitherapy of Peginterferon Alpha 2a-Ribavirin, and Followed by a Tritherapy of Peginterferon Alpha 2a-Ribavirin-Amantadine for 36 Weeks

acronym: CINAM

summary:
Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50 % of the patients remain relapsers or virological non responders. The main predictive factors of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological properties, particularly those of ribavirin requires complementary studies. This drug has a large distribution volume and its concentrations display large inter-individual variability. Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on BW and a single ribavirin time point serum concentration at steady state.

The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient

lead_sponsor: University Hospital, Limoges

location_facility:
Service d'Hépatogastroentérologie
Service d'Hépato-gastroentérologie


title: Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

summary: The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.

location_facility:
Service de réanimation Polyvalente
Service de Réanimation


title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

summary: This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

location_facility: Département de Médecine Physique et de Réadaptation, CHU Limoges


title: Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

summary: Patients presenting a deterioration of the general state (performance status [PS] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

ReferenceCitation: Moro-Sibilot D, Pluquet E, Zalcman G, Bréchot JM, Souquet PJ, Debieuvre D, Morin F, Morère JF. [What treatment for a patient of PS 2-3 with stage IV non-small cell lung cancer?]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S120-4. Review. French.

ReferenceCitation: Morère JF, Bréchot JM, Westeel V, Gounant V, Lebeau B, Vaylet F, Barlési F, Urban T, Souquet PJ, Debieuvre D, Baudrin L, Zalcman G, Morin F, Milleron B, Moro-Sibilot D. Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study). Lung Cancer. 2010 Dec;70(3):301-7. doi: 10.1016/j.lungcan.2010.03.003. Epub 2010 Apr 18.

family: Morère

full_name: Jean-François Morère

given: Jean-François

family: Bréchot

full_name: Jeanne-Marie Bréchot

given: Jeanne-Marie

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Gounant

full_name: Valerie Gounant

given: Valerie

family: Lebeau

full_name: Bernard Lebeau

given: Bernard

family: Vaylet

full_name: Fabien Vaylet

given: Fabien

family: Barlési

full_name: Fabrice Barlési

given: Fabrice

family: Urban

full_name: Thierry Urban

given: Thierry

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Baudrin

full_name: Laurence Baudrin

given: Laurence

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Morin

full_name: Franck Morin

given: Franck

family: Milleron

full_name: Bernard Milleron

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

journal_name: Lung Cancer

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
CHU Grenoble - pneumologie
CHU Avicenne - Oncologie


title: Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

summary: The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

location_facility:
Hopital Salpetriere
Hopital Lariboisiere


title: Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients, Co-infected or Not With HBV and/or HCV. HEP.A.VAC Study.

acronym: HEPAVAC

summary: Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

location_facility: CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin


title: A Phase II Study of Radiofrequency Ablation of Lung Tumors

summary: Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Bergonié
Institut Gustave Roussy


title: Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

summary:
To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
To assess the effect of a long term treatment with Genotonorm on bone mineralisation
To assess the effect of a long term treatment with Genotonorm on body composition

ReferenceCitation: David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

family: David

full_name: Hélène David

given: Hélène

family: Aupiais

full_name: Camille Aupiais

given: Camille

family: Louveau

full_name: Baptiste Louveau

given: Baptiste

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Jacqz-Aigrain

full_name: Evelyne Jacqz-Aigrain

given: Evelyne

family: Carel

full_name: Jean-Claude Carel

given: Jean-Claude

family: Simon

full_name: Dominique Simon

given: Dominique

evidence: open (via free article)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

lead_sponsor: Pfizer


title: Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

summary: This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

ReferenceCitation: Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.

family: Tao

full_name: Yungan Tao

given: Yungan

family: Auperin

full_name: Anne Auperin

given: Anne

family: Blanchard

full_name: Pierre Blanchard

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

family: Sun

full_name: Xu-Shan Sun

given: Xu-Shan

family: Rives

full_name: Michel Rives

given: Michel

family: Pointreau

full_name: Yoann Pointreau

given: Yoann

family: Castelli

full_name: Joël Castelli

given: Joël

family: Graff

full_name: Pierre Graff

family: Wong Hee Kam

full_name: Stéphanie Wong Hee Kam

given: Stéphanie

family: Thariat

full_name: Juliette Thariat

given: Juliette

family: Veresezan

full_name: Ovidiu Veresezan

given: Ovidiu

family: Heymann

full_name: Steve Heymann

given: Steve

family: Renard-Oldrini

full_name: Sophie Renard-Oldrini

given: Sophie

family: Lafond

full_name: Cédrik Lafond

given: Cédrik

family: Cornely

full_name: Alexandre Cornely

given: Alexandre

family: Casiraghi

full_name: Odile Casiraghi

given: Odile

family: Boisselier

full_name: Pierre Boisselier

family: Lapeyre

full_name: Michel Lapeyre

family: Biau

full_name: Julian Biau

given: Julian

family: Bourhis

full_name: Jean Bourhis

given: Jean

journal_name: Radiotherapy and Oncology

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

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

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre Alexis Vautrin
Institut Gustave Roussy


title: Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma

summary: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

location_facility:
Institut Gustave Roussy
CHU de Tours


title: Regional and Systemic Hemodynamic Effects of a Long-term Administration of Amlodipine in Patients With Chronic Heart Failure Treated With a Combination of Enalapril, Furosemide and Digoxin

summary: Patients with congestive heart failure are usually treated with a combination of an ACE inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients remain symptomatic despite an optimal treatment with these drugs. In patients who also have coronary heart disease, nitrates or some calcium-channel blockers could help to relieve symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure who remain symptomatic despite an optimal treatment.

ReferenceCitation: Elkayam U, Shotan A, Mehra A, Ostrzega E. Calcium channel blockers in heart failure. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):139A-144A. Review.

ReferenceCitation: Cohn JN, Johnson G, Ziesche S, Cobb F, Francis G, Tristani F, Smith R, Dunkman WB, Loeb H, Wong M, et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):303-10.

ReferenceCitation: Packer M, O'Connor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp AB, DeMets DL. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. N Engl J Med. 1996 Oct 10;335(15):1107-14.

location_facility: Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

location_facility: Service de Réanimation Médicale - Hôpital Raymond Poincaré


title: Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up.

summary: The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

location_facility:
Center Oscar Lambret
Institut claudius regaud


title: A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)

summary: Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.

ReferenceCitation: Delobel P, Saliou A, Nicot F, Dubois M, Trancart S, Tangre P, Aboulker JP, Taburet AM, Molina JM, Massip P, Marchou B, Izopet J; ANRS 106-Window Study Team. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One. 2011;6(6):e21655. doi: 10.1371/journal.pone.0021655. Epub 2011 Jun 27.

family: Delobel

full_name: Pierre Delobel

given: Pierre

family: Saliou

full_name: Adrien Saliou

given: Adrien

family: Nicot

full_name: Florence Nicot

given: Florence

family: Dubois

full_name: Martine Dubois

given: Martine

family: Trancart

full_name: Stéphanie Trancart

family: Tangre

full_name: Philippe Tangre

given: Philippe

family: Aboulker

full_name: Jean-Pierre Aboulker

given: Jean-Pierre

family: Taburet

full_name: Anne-Marie Taburet

given: Anne-Marie

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Massip

full_name: Patrice Massip

given: Patrice

family: Marchou

full_name: Bruno Marchou

given: Bruno

family: Izopet

full_name: Jacques Izopet

given: Jacques

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

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: Minor HIV-1 Variants with the K103N Resistance Mutation during Intermittent Efavirenz-Containing Antiretroviral Therapy and Virological Failure

ReferenceCitation: Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, Durand-Zaleski I; ANRS 106 Study Group. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):416-21. doi: 10.1097/QAI.0b013e31818a657c.

family: Charreau

full_name: Isabelle Charreau

given: Isabelle

family: Jeanblanc

full_name: Grégoire Jeanblanc

given: Grégoire

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

title: Costs of Intermittent Versus Continuous Antiretroviral Therapy in Patients With Controlled HIV Infection: A Substudy of the ANRS 106 Window Trial

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Service des Maladies Infectieuses et Tropicales Hopital Purpan


title: A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy

acronym: RESPINE

summary:
This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls.

This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy .

Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

status: Recruiting

lead_sponsor: University Hospital, Montpellier

location_facility:
APHP Cochin
CHU Saint Antoine
UH Montpellier

status_simplified: Ongoing


title: Multicenter Randomized Controlled Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth DECAT DEep CAries Treatment

acronym: DECAT

summary:
This clinical trial is a national multicenter randomized controlled trial performed in parallel groups aiming to validate a treatment that preserves pulp vitality of mature permanent posterior teeth through partial removal of carious tissue and restoring tooth structure using a simple filling in one session, thus delaying premature tooth aging.

Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type of excavation carried out (partial vs. complete caries removal) and secondly for the nature of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second randomization will not be carried out for teeth requiring endodontic treatment after the first randomization.

The study's primary objective will be to compare, at 1 year of follow-up, the efficacy (binary success criteria) of partial caries removal versus complete caries removal in occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars except third molars). Secondary objectives will include the comparison, at 1 year of follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another secondary objective will be to compare, at two and three years of follow-up, the efficacy of partial versus complete caries removal.

The primary outcome is the success of the caries removal protocol at one year, measured according to 5 FDI criteria, while the secondary outcome is the contribution of the functional and biological dimensions of the 5 FDI criteria items to determining success or failure of the treatment. The outcome of success will be the same for all objectives, primary and secondary.

ReferenceCitation: Villat C, Attal JP, Brulat N, Decup F, Doméjean S, Dursun E, Fron-Chabouis H, Jacquot B, Muller Bolla M, Plasse-Pradelle N, Roche L, Maucort-Boulch D, Nony P, Gritsch K, Millet P, Gueyffier F, Grosgogeat B. One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial. Trials. 2016 Aug 15;17:404. doi: 10.1186/s13063-016-1484-0.

family: Villat

full_name: Cyril Villat

given: Cyril

family: Attal

full_name: Jean-Pierre Attal

family: Brulat

full_name: Nathalie Brulat

given: Nathalie

family: Decup

full_name: Franck Decup

given: Franck

family: Doméjean

full_name: Sophie Doméjean

given: Sophie

family: Dursun

full_name: Elisabeth Dursun

given: Elisabeth

family: Fron-Chabouis

full_name: Hélène Fron-Chabouis

given: Hélène

family: Jacquot

full_name: Bruno Jacquot

family: Muller Bolla

full_name: Michèle Muller Bolla

given: Michèle

family: Plasse-Pradelle

full_name: Nelly Plasse-Pradelle

given: Nelly

family: Roche

full_name: Laurent Roche

given: Laurent

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Nony

full_name: Patrice Nony

family: Gritsch

full_name: Kerstin Gritsch

given: Kerstin

family: Millet

full_name: Pierre Millet

family: Gueyffier

full_name: François Gueyffier

given: François

family: Grosgogeat

full_name: Brigitte Grosgogeat

given: Brigitte

currency_apc_doaj: GBP

journal_name: Trials

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

location_facility: Service de consultations et traitements dentaires


title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema

acronym: ELEVATE

summary: This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

status: Active, not recruiting

ReferenceCitation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344. Review.

family: Agrawal

full_name: Abhinav Agrawal

given: Abhinav

journal_name: American Journal of Therapeutics

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
Netherlands
France
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie

location_facility: Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

location_facility: Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie