title: Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children

acronym: PREVOCAP

summary:
The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary complications.

In the paediatric population presenting with the PHT, one of every two children develops varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But the role of the VCE for examination of the other parts of digestive tract still needs to be evaluated.

For the esophagus, the VCE could allow the diagnosis without the need of general sedation. Recent studies have shown a good sensitivity and tolerance of this technique for the initial diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension, but it has not yet been validated for this indication.

The investigators hypothesize that the VCE could be used in children with similar results in term of efficacy, as for adults.

This prospective simple blind multicentre study (blind for the lecture of the capsule endoscopy record), will investigate the diagnostic value of the VCE compared to the conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and the control of esophageal varices in children.

If it is provided that the VCE is as efficient as it is for the adults, it could become a very interesting alternative to the conventional EGD because less expensive and less invasive. Moreover, this technique would be very useful as a means of early detection on the EV and/or their control.

ReferenceCitation: Cardey J, Le Gall C, Michaud L, Dabadie A, Talbotec C, Bellaiche M, Lamireau T, Mas E, Bridoux-Henno L, Viala J, Restier-Miron L, Lachaux A. Screening of esophageal varices in children using esophageal capsule endoscopy: a multicenter prospective study. Endoscopy. 2019 Jan;51(1):10-17. doi: 10.1055/a-0647-1709. Epub 2018 Sep 5.

publisher_dissemination: Georg Thieme

location_facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

location_facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP

location_facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes

location_facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille

location_facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP

location_facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux


title: A Prospective, Multicentric Observational Study Evaluating the Long Term Efficacy and Safety of the CODMAN TRUFILL®'s Line of Coils in the Endovascular Treatment of Intracranial Aneurysms

acronym: TRULINE

summary: The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Codman & Shurtleff

location_facility:
Hôpital Neurologique
CHU Clermont-Ferrand
CHU Pontchaillou
Hôpital Adullte La Timone
Clinique Clairval
Hopitaux Civils de Colmar
Fondation Rothschild

lead_sponsor_type: industriel

status_simplified: Completed


title: Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of Side Branches of de Novo Bifurcation Lesions in Native Coronary Arteries.

acronym: DEBSIDE

summary: The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.

study_type: Interventional

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Berland J, Lefevre T, Brenot P, Fajadet J, Motreff P, Guerin P, Dupouy P, Schandrin C; DEBSIDE trial investigators. DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015 Dec;11(8):868-76. doi: 10.4244/EIJV11I8A177.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: MINVASYS

sponsor_collaborators:
MINVASYS
European Cardiovascular Research Center

location_facility:
Pôle Santé République
CHU Nantes
Clinique Saint-Hilaire
CHU Clermont-Ferrand
Clinique Pasteur
Centre Cardiologique d'Evecquemont
Institut hospitalier Jacques Cartier

intervention_type: Device


type: Other Identifier

title: Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial

acronym: EMPIRICUS

summary: Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.

design_allocation: Randomized

ReferenceCitation: Timsit JF, Azoulay E, Schwebel C, Charles PE, Cornet M, Souweine B, Klouche K, Jaber S, Trouillet JL, Bruneel F, Argaud L, Cousson J, Meziani F, Gruson D, Paris A, Darmon M, Garrouste-Orgeas M, Navellou JC, Foucrier A, Allaouchiche B, Das V, Gangneux JP, Ruckly S, Maubon D, Jullien V, Wolff M; EMPIRICUS Trial Group. Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1555-1564. doi: 10.1001/jama.2016.14655.

oa_host_type: closed

publisher_dissemination: American Medical Association

ReferenceCitation: Timsit JF, Azoulay E, Cornet M, Gangneux JP, Jullien V, Vesin A, Schir E, Wolff M. EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial. Trials. 2013 Nov 21;14:399. doi: 10.1186/1745-6215-14-399.

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

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 - INSU

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of La Pitié Salpetrière

intervention_type: Drug

lead_sponsor_type: academique


title: Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)

acronym: VAPS REHAB

summary:
Background : The general experience with the Virtual Reality application approach suggests that this treatment concept is promising in stroke rehabilitation
Purpose : In shopping activity in a real supermarket and in simulated with the investigators virtual shopping simulation (VAP-S = virtual action planning supermarket), the investigators will compare people who had undergone a stroke who receive conventional rehabilitation or virtual training in VAP-S.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT

intervention_type: Other


title: CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer

summary: Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

primary_purpose: Diagnostic

ReferenceCitation: Cabel L, Berger F, Cottu P, Loirat D, Rampanou A, Brain E, Cyrille S, Bourgeois H, Kiavue N, Deluche E, Ladoire S, Campone M, Pierga JY, Bidard FC. Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial. Br J Cancer. 2021 Mar;124(7):1207-1213. doi: 10.1038/s41416-020-01227-3. Epub 2021 Jan 21.

oa_colors: green hybrid

evidence: open (via crossref license)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Helissey C, Berger F, Cottu P, Dieras V, Mignot L, Servois V, Bouleuc C, Asselain B, Pelissier S, Vaucher I, Pierga JY, Bidard FC. Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial. Cancer Lett. 2015 May 1;360(2):213-8. doi: 10.1016/j.canlet.2015.02.010. Epub 2015 Feb 17.

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: Institut Curie

location_facility:
Hopital Saint Louis
Centre Georges Francois Leclerc
Institut de Canacerologie de L'Ouest
Clinique Victor Hugo
Chu Limoges
Institut Rene Huguenin Curie
Institut Curie


title: Post-stroke Cognitive Impairment and Dementia: Frequency and Anatomical Correlates With the French Version of the National Institute of Neurological Disorders and Stroke (NINDS)-Canadian Stroke Network Battery

acronym: GRECogVASC

summary:
Projections from epidemiological studies suggest that, among the Western adult population, one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a North America working group which are under validation. It is essential to adapt these standard for French-speaking population, and especially to define cutoff scores of the cognitive battery to determine cognitive deficit.

The investigators propose a study coordinated by the University-Hospital of Amiens for french speaking centers. This study will investigate this battery with 906 controls to define the standards and 302 stroke affected patients to define the frequency and cognitive mechanisms. This step is essential for people to benefit from these new standards.

ReferenceType: background

ReferenceCitation: Godefroy O, Fickl A, Roussel M, Auribault C, Bugnicourt JM, Lamy C, Canaple S, Petitnicolas G. Is the Montreal Cognitive Assessment superior to the Mini-Mental State Examination to detect poststroke cognitive impairment? A study with neuropsychological evaluation. Stroke. 2011 Jun;42(6):1712-6. doi: 10.1161/STROKEAHA.110.606277. Epub 2011 Apr 7.

ReferenceCitation: Godefroy O, Just A, Ghitu A, Leclercq C, Garcia PY, Lamy C, Canaple S, Bugnicourt JM. The Rankin scale with revised structured interview: effect on reliability, grading of disability and detection of dementia. Int J Stroke. 2012 Feb;7(2):183. doi: 10.1111/j.1747-4949.2011.00743.x. No abstract available.

ReferenceType: result

ReferenceCitation: Godefroy O; GRECOG-VASC study group; Leclercq C, Bugnicourt JM, Roussel M, Moroni C, Quaglino V, Beaunieux H, Taillia H, Nedelec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F. Neuropsychological assessment and cerebral vascular disease: the new standards. Rev Neurol (Paris). 2013 Oct;169(10):779-85. doi: 10.1016/j.neurol.2013.07.009. Epub 2013 Aug 30.

ReferenceCitation: Godefroy O, Leclercq C, Roussel M, Moroni C, Quaglino V, Beaunieux H, Tallia H, Nedelec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F; GRECOG-VASC Neuropsychological Committee. French adaptation of the vascular cognitive impairment harmonization standards: the GRECOG-VASC study. Int J Stroke. 2012 Jun;7(4):362-3. doi: 10.1111/j.1747-4949.2012.00794.x. No abstract available.

ReferenceCitation: Godefroy O, Yaiche H, Taillia H, Bompaire F, Nedelec-Ciceri C, Bonnin C, Varvat J, Vincent-Grangette F, Diouf M, Mas JL, Canaple S, Lamy C, Arnoux A, Leclercq C, Tasseel-Ponche S, Roussel M, Barbay M; GRECogVASC Study Group. Who should undergo a comprehensive cognitive assessment after a stroke? A cognitive risk score. Neurology. 2018 Nov 20;91(21):e1979-e1987. doi: 10.1212/WNL.0000000000006544. Epub 2018 Oct 17.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Barbay M, Taillia H, Nedelec-Ciceri C, Bompaire F, Bonnin C, Varvat J, Grangette F, Diouf M, Wiener E, Mas JL, Roussel M, Godefroy O; GRECOG-VASC Study Group. Prevalence of Poststroke Neurocognitive Disorders Using National Institute of Neurological Disorders and Stroke-Canadian Stroke Network, VASCOG Criteria (Vascular Behavioral and Cognitive Disorders), and Optimized Criteria of Cognitive Deficit. Stroke. 2018 May;49(5):1141-1147. doi: 10.1161/STROKEAHA.117.018889. Epub 2018 Apr 11.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH La Rochelle
HIA Val de Grâce
CHU Saint Etienne
CHRU Lille
CHU Brest
CHU Dijon
CHU Amiens

intervention_type: Behavioral


title: Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination

summary: This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.

design_allocation: Non-Randomized

primary_purpose: Prevention

ReferenceCitation: Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Germany France

intervention_type: Biological


type: Registry Identifier

title: An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

acronym: HOSCAR

summary: This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy Poland Portugal Switzerland France

location_facility:
Novartis Investigative Site
Novarts Investigative Site


title: Development and Implementation of a Cancer Fatigue Education Program

summary:
The purpose of the present project is to develop, implement and evaluate a pilot regional patient education program on the management of one of the main side effects of chemotherapy in cancer patients, that is fatigue.

A carer (doctor or nurse) trained in educational techniques will be responsible for the patient. The carer will first identify modes of behavior and competences that the patient must acquire in order to optimize his/her management of fatigue ("educational diagnosis"). An education program, based on a contract of goals will be proposed after this diagnosis phase. The expected results are, in the short-term, a significant reduction in the mean level of fatigue in patients receiving chemotherapy who benefited from individual educational management. In the longer term, the aim is to evaluate the impact of this program on patient quality of life and use of healthcare structures in comparison with conventional management.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility:
PIVOT
CHOLLET
CLAVREUL
BLAY
ZANETTA
LAFONT
BACHELOT Thomas


acronym: SINTRA-REV

lead_sponsor: Fundación General de la Universidad de Salamanca

summary:
Trial Design:

This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.

Disease:

Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.

Total number of patients:

In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.

Calendar:

First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).

ReferenceCitation: Steensma DP, Tefferi A. The myelodysplastic syndrome(s): a perspective and review highlighting current controversies. Leuk Res. 2003 Feb;27(2):95-120. doi: 10.1016/s0145-2126(02)00098-x. Erratum In: Leuk Res. 2005 Jan;29(1):117.

ReferenceCitation: Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88. Erratum In: Blood 1998 Feb 1;91(3):1100.

ReferenceCitation: List AF. New approaches to the treatment of myelodysplasia. Oncologist. 2002;7 Suppl 1:39-49. doi: 10.1634/theoncologist.7-suppl_1-39.

ReferenceCitation: McHugh SM, Deighton J, Stewart AG, Lachmann PJ, Ewan PW. Bee venom immunotherapy induces a shift in cytokine responses from a TH-2 to a TH-1 dominant pattern: comparison of rush and conventional immunotherapy. Clin Exp Allergy. 1995 Sep;25(9):828-38. doi: 10.1111/j.1365-2222.1995.tb00025.x.

ReferenceCitation: Bellamy WT. Expression of vascular endothelial growth factor and its receptors in multiple myeloma and other hematopoietic malignancies. Semin Oncol. 2001 Dec;28(6):551-9. doi: 10.1016/s0093-7754(01)90023-5.

ReferenceCitation: Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. No abstract available.

ReferenceCitation: List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.

ReferenceCitation: List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292.

ReferenceCitation: List A, Gordon W, Dewald G, Bennett J, Giagounidis A, Raza A et al. Long-term clinical benefit of lenalidomide (Revlimid) treatment in patients with myelodysplastic syndrome and chromosome deletion 5q [Abstract]. Blood. 2006;108:251A.

ReferenceCitation: Mallo M, Cervera J et al. Prognostic impact of additional chromosomal aberrations to 5q- in patients with primary myelodysplastic syndromes. Oral comunication, 0906, 13th Congress of the European Hematology Association. Haematologica | 2008; 93(s1), pag. 360

ReferenceCitation: Fenaux P, Kelaidi C. Treatment of the 5q- syndrome. Hematology Am Soc Hematol Educ Program. 2006:192-8. doi: 10.1182/asheducation-2006.1.192.

ReferenceCitation: Kelaidi C, Eclache V, Fenaux P. The role of lenalidomide in the management of myelodysplasia with del 5q. Br J Haematol. 2008 Feb;140(3):267-78. doi: 10.1111/j.1365-2141.2007.06910.x.

ReferenceCitation: List, AF. Active treatment-improving outcomes in del 5q patients. Leukemia Research, (2007)31(Suppl. 1), S9.

location_facility: Centre Hospitalier Universitaire Brabois

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hospital General Universitario José Maria Morales Meseguer

location_facility: Hospital Universitari Germans Trias i Pujol (ICO Badalona)

location_facility: Instituto Catalán de Oncología de Gerona

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

title: Multicenter, Randomized, Double-blind, Phase III Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) With Alteration in 5q- and Anemia Without the Need of Transfusion.

type: EudraCT Number

source: euctr

location_country: Germany Spain France


title: Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum

acronym: MYCA

summary: The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.

ReferenceCitation: Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, You B. Non-pegylated liposomal doxorubicin (NPLD, Myocet(R)) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Gynecol Oncol. 2019 Jan;152(1):68-75. doi: 10.1016/j.ygyno.2018.10.043. Epub 2018 Nov 14.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre hospitalier privé de Saint Grégoire

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Centre Hospitalier General de Valenciennes

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne


title: Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.

summary: This study is divided into two stages. The first stage is a transversal study and corresponds to the recruitment of participants, which will last about two years. Three groups of gamblers will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC) and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up study), that consists on an annual follow-up evaluation. The main objective of the first stage of the study is to compare the characteristics of the three groups of gamblers on some socio-demographic and clinical data. These comparisons will allow us to identify, among all data, those that will be most likely to explain the evolution of the practice of gambling (appearance or resolution of a gambling problem), and recourse to specific care. These such isolated data will be tested in the second stage of the study, in order to determine those that are predictive factors of three steps of the gambling course of some gamblers : evolution of a controlled gambling practice into a problematic gambling practice, resolution of the problematic gambling practice without intervention of care, and first recourse to specific care.

primary_purpose: Other

ReferenceCitation: Guillou Landreat M, Chereau Boudet I, Perrot B, Romo L, Codina I, Magalon D, Fatseas M, Luquiens A, Brousse G, Challet-Bouju G, Grall-Bronnec M; JEU-Group. Problem and non-problem gamblers: a cross-sectional clustering study by gambling characteristics. BMJ Open. 2020 Feb 18;10(2):e030424. doi: 10.1136/bmjopen-2019-030424.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

publisher_dissemination: British Medical Journal

ReferenceCitation: Challet-Bouju G, Hardouin JB, Venisse JL, Romo L, Valleur M, Magalon D, Fatseas M, Chereau-Boudet I, Gorsane MA; JEU Group; Grall-Bronnec M. Study protocol: the JEU cohort study--transversal multiaxial evaluation and 5-year follow-up of a cohort of French gamblers. BMC Psychiatry. 2014 Aug 20;14:226. doi: 10.1186/s12888-014-0226-7.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
MILDT

location_facility:
Nantes University Hospital
Marseille University Hospital
Marmottan hospital
Clermont Ferrand university Hospital
Paul Brousse hospital
Bordeaux University Hospital
Louis Mourier hospital


title: Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

acronym: OPTIMA

summary: The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

ReferenceCitation: Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quere S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.

ReferenceCitation: Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.

lead_sponsor: Novartis


title: A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement

acronym: ONICO

summary: The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Pierre Fabre Dermo Cosmetique

sponsor_collaborators:
Pierre Fabre Dermo Cosmetique
Quanta Medical

location_facility:
Hopital Purpan
Cabinet Medical
Cabinet Médical

status_simplified: Unknown


title: Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study

acronym: COMPARE

summary:
Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear.

Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events.

Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.

lead_sponsor: University Hospital, Toulouse

location_facility:
Rangueil University Hospital
Bellevue University Hospital
Dupuytren University Hospital
Louis Pasteur Hospital
University Hospital


title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage

acronym: SPIRIT-ICU

summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.

status: Terminated

ReferenceCitation: Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.

lead_sponsor: Rennes University Hospital

location_facility: Surgical Intensive Care Unit - CHU de Rennes

location_facility: Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes


title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

ReferenceCitation: Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.

ReferenceCitation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.

ReferenceCitation: Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.

ReferenceCitation: Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Romania
Netherlands
Qatar
Switzerland
Spain
Monaco
Russian Federation
France


acronym: INTEGRA®

summary: Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

location_facility:
Universiy Hospital Bordeaux,
Saint Roch Hospital
University Hospital


title: Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial

acronym: AWARE

summary: The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.

ReferenceCitation: Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.

ReferenceCitation: Constantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebe P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.

ReferenceCitation: Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.

ReferenceCitation: De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appere-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7. doi: 10.1097/01.ccm.0000150268.04228.68.

ReferenceCitation: Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aube H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6. doi: 10.1097/01.ccm.0000282733.83089.4d.

ReferenceCitation: Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

ReferenceCitation: Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

ReferenceCitation: Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

ReferenceCitation: SRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

lead_sponsor: French Society for Intensive Care

sponsor_collaborators:
French Society for Intensive Care
University Hospital, Tours

location_facility:
CH d'Argenteuil
CHD Les Oudairies
CHR d'Orléans Hopital la Source
CH Germon et Gauthier
Institut Mutualiste Montsouris
Hopital Raymond Poincare
GHIRM
CH Leon Binet
CHRU de la Cavale Blanche
Hopital de la Timone
CHU Marseille Hopital Nord
Hopital Laennec
CHRU Bretonneau
Hopital Ambroise Pare
Hopital Jean Bernard
CHU d'Angers
Groupe Hospitalier Edouard Herriot
CHU Henri Mondor
CHU Kremlin-Bicetre
Hopital l'Archet
Institut Gustave Roussy
Hopital Privé d'Antony
CH de Pontoise
CH Poissy
CH Sud Francilien
Hopital Avicenne
Hopital Roger Salengro
Hopital Tenon
CH de Versailles
CH de la Région d'Annecy
CH de St-Brieuc
Hôpital Saint-Esprit
HIA Béjin
Hopital St Louis
CH St-Joseph St-Luc
CH de St-Malo
Hopital Delafontaine
CH Francois Miterrand
Hopital Notre-Dame de Bon Secours
CH de Meaux
Hopital St-Andre
Hopital Antoine Beclere
CH Princesse Grace

intervention_type: Procedure


title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

acronym: ANTALPED

summary: The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.

ReferenceCitation: Drouineau MH, Guenego E, Sebille-Rivain V, Vrignaud B, Balencon M, Blanchais T, Levieux K, Vabres N, Picherot G, Guen CG. Do abused young children feel less pain? Child Abuse Negl. 2017 Mar;65:248-254. doi: 10.1016/j.chiabu.2017.02.002. Epub 2017 Feb 11.

location_facility:
Angers university Hospital
nantes University Hospital
Ch Cholet
rennes university Hospital
GHH
CH Saint Nazaire
CHD les oudairies


title: Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)

acronym: THORN

summary:
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single, dual, or triple chamber).

The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate therapies (IT), and to take preventive actions in order to reduce the burden of these inappropriate therapies.

THORN is an observational epidemiologic, prospective and multicenter registry. The primary objective is to measure the relative proportion of patients experiencing at least one inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD patients.

ReferenceCitation: Perrin T, Boveda S, Defaye P, Rosier A, Sadoul N, Bordachar P, Klug D, Ritter P, Belhameche M, Babuty D, Mansourati J, Lazarus A, Deharo JC. Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry. Europace. 2019 Apr 1;21(4):607-615. doi: 10.1093/europace/euy284.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Clinique du Milénaire
CH de Troyes
CH de Haguenau
Clinique de la Sauvegarde
CH William-Morey
CH d'Aix en Provence
CHU Albert Michalon
CHI de Montfermeil
CH St Luc St Joseph
CH d'Angoulême
Chu Hôpital Charles Nicolle
CHU la Mileterie
CHU de Nancy
CH de Valence
CHRU Tours (Hôpital Trousseau)
CHU Nîmes
CHU de Dijon
CH de Lagny sur Marne
Clinique Ambroise Paré
CHU G. & R. Laënnec
Hôpital Militaire
CHRU de Lille
Hôpital Font Pré
CH Bretagne Atlantique
Clinique Saint Augustin
CH Robert Boulin
Hôpital La Timone
CH de Rodez
CH de Saint Brieuc
CH de Périgueux
CHG de Chateauroux
Institut Jacques Cartier
CH d'Avignon
Clinique Saint Pierre
CH de Valenciennes
Hôpital Albert Schweitzer
CH de Villefranche
CHU Clermont-Ferrand
Hôpital Nord
CH de DAX
CHU de Montpellier
Clinique Pasteur
Centre Hospitalier Sud Francilien
CHU la Cavale Blanche
CHU de St-Etienne
CH de Pau
CHU (Hôpital Pontchaillou)
CH de la Cote Basque
CH de Moulins
Hôpital Georges Pompidou
CH d'Angers
CHU Bordeaux
Clinique Saint Joseph
Clinique Lafourcade
Hôpital Cardiologique


title: Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

acronym: Nutrilock

summary:
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.

The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.

Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.

lead_sponsor: University Hospital, Rouen

location_facility:
UH of Grenoble
University Hospital of Rouen
APHP Beaujon Hospital
UH of Lyon
UH of Toulouse
UH of Lille
UH of Nice


title: Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, 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. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

summary:
Justification:

We have recently demonstrated that maternofetal alloimmunization was not limited to blood cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the placenta can induce neonatal membranous glomerulonephritis.

Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not yet fully understood; nevertheless the hypothesis of an incompatibility between mother and child is often mentioned. The aim of this project is to detect and study the cases of recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by tissular maternofetal alloimmunization.

Materials and methods:

Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or intervillositis will be included in this project. Mothers' sera will be studied by indirect immunofluorescence and Western Blot on placental biopsies from different origins and gestational ages. This stage will enable us to detect possible maternal allo-antibodies. After detecting and revealing antibodies, nature of the target antigen will be identified by immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will be followed by a mass spectrometry analysis of detected proteins.

Expected results:

This study will enable us:

to detect new cases of tissular maternofetal alloimmunization
to improve our knowledge of mechanisms leading to anomalies of placentation
to carry out a specific, preventive therapeutic approach for cases induced by tissular alloimmunization.

Key words:

Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.

lead_sponsor: University Hospital, Limoges

location_facility:
Toulouse University Hospital
LIMOGES University Hospital
Tenon Hospital
Saint Antoine Hospital
Trousseau Hospital
South Reunion Hospital
Bordeaux University Hospital


summary: Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

lead_sponsor: Société des Produits Nestlé (SPN)

location_facility:
CH Béziers
CHU Montpellier
CRLCC Léon Bérard
CH Perpignan
CHU Charles Nicolle
Institut Sainte-Catherine
CRLC Val d'Aurelle


title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients

acronym: POPVNI

summary:
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.

Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.

Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.

Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
HEGP
Hotel Dieu
hopital de Pontoise
Institut Mutualiste Montsouris
Hopital Du Bocage
CHU Larrey
CHU strasbourg


title: Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg

acronym: CELEST

summary:
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear.

ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.

CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle

ReferenceCitation: Fowkes FJ, Price JF, Fowkes FG. Incidence of diagnosed deep vein thrombosis in the general population: systematic review. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):1-5. doi: 10.1053/ejvs.2002.1778.

ReferenceCitation: Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000 May;83(5):657-60.

ReferenceCitation: Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.

ReferenceCitation: Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997 Jul-Aug;82(4):423-8.

ReferenceCitation: Gabriel F, Labios M, Portoles O, Guillen M, Corella D, Frances F, Martinez M, Gil J, Saiz C. Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis. Thromb Haemost. 2004 Aug;92(2):328-36. doi: 10.1160/TH03-11-0700.

ReferenceCitation: Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. doi: 10.1001/archinte.164.1.17.

ReferenceCitation: Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002 May 27;162(10):1144-8. doi: 10.1001/archinte.162.10.1144.

ReferenceCitation: Bergqvist D, Jendteg S, Johansen L, Persson U, Odegaard K. Cost of long-term complications of deep venous thrombosis of the lower extremities: an analysis of a defined patient population in Sweden. Ann Intern Med. 1997 Mar 15;126(6):454-7. doi: 10.7326/0003-4819-126-6-199703150-00006.

ReferenceCitation: Brandjes DP, Buller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, ten Cate JW. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997 Mar 15;349(9054):759-62. doi: 10.1016/S0140-6736(96)12215-7.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56. doi: 10.7326/0003-4819-141-4-200408170-00004.

ReferenceCitation: Milne AA, Ruckley CV. The clinical course of patients following extensive deep venous thrombosis. Eur J Vasc Surg. 1994 Jan;8(1):56-9. doi: 10.1016/s0950-821x(05)80121-5.

ReferenceCitation: Partsch H, Blattler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg. 2000 Nov;32(5):861-9. doi: 10.1067/mva.2000.110352.

ReferenceCitation: Kahn SR, Elman E, Rodger MA, Wells PS. Use of elastic compression stockings after deep venous thrombosis: a comparison of practices and perceptions of thrombosis physicians and patients. J Thromb Haemost. 2003 Mar;1(3):500-6. doi: 10.1046/j.1538-7836.2003.00098.x.

ReferenceCitation: Benko T, Cooke EA, McNally MA, Mollan RA. Graduated compression stockings: knee length or thigh length. Clin Orthop Relat Res. 2001 Feb;(383):197-203.

ReferenceCitation: Sajid MS, Tai NR, Goli G, Morris RW, Baker DM, Hamilton G. Knee versus thigh length graduated compression stockings for prevention of deep venous thrombosis: a systematic review. Eur J Vasc Endovasc Surg. 2006 Dec;32(6):730-6. doi: 10.1016/j.ejvs.2006.06.021. Epub 2006 Aug 23.

ReferenceCitation: Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.

ReferenceCitation: Arpaia G, Cimminiello C, Mastrogiacomo O, de Gaudenzi E. Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial. Blood Coagul Fibrinolysis. 2007 Mar;18(2):131-7. doi: 10.1097/MBC.0b013e328011f2dd.

ReferenceCitation: Roumen-Klappe EM, den Heijer M, van Rossum J, Wollersheim H, van der Vleuten C, Thien T, Janssen MC. Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome. J Thromb Thrombolysis. 2009 May;27(4):400-5. doi: 10.1007/s11239-008-0229-7. Epub 2008 May 15.

ReferenceCitation: Delluc A, Gouedard C, De Saint Martin L, Garcia C, Roguedas AM, Bressollette L, Misery L, Mottier D, Le Gal G. [Incidence, risk factors and skin manifestations of post-thrombotic syndrome: a four-year follow-up of patients included in the EDITH study]. Rev Med Interne. 2010 Nov;31(11):729-34. doi: 10.1016/j.revmed.2010.07.018. Epub 2010 Sep 29. French.

lead_sponsor: Laboratoires Innothera

collaborators:
University Hospital, Grenoble
Floralis

sponsor_collaborators:
Laboratoires Innothera
University Hospital, Grenoble
Floralis

location_facility:
HEGP
Hôpital St Joseph
Chu Angers
CH Pierre-Bénite
Centre Hospitalier d'Armentieres
CHRU Amiens
Chu Hotel Dieu
Hôpital du bocage
CHR Orléans
Chu Clermont-Ferrand
Chra Annecy
Cabinet
Chu Brest
CH de Chambéry
Ch Bourgoin-Jallieu
CH Mâcon
Chu Toulouse
CHU Gabriel Montpied
Hia Brest
Chu St Etienne
Clinique Victor PAUCHET
Chru Lille
Ch La Rochelle
Chu Grenoble
CHU
CH Armentières
Chu Montpellier
Ch Chalon Sur Saone
Hopital Saint Philibert


title: Multicentric Phase II Study of Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer, With :- Induction Chemotherapy by Cisplatin - Docetaxel- Concomitant Chemo-radiotherapy by Weekly Cisplatin - Docetaxel- Consolidation Chemotherapy by Docetaxel

acronym: BIB 01

summary: Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Sanofi

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Multicentric Phase II Study to Evaluate Feasibility and Efficacy of Association of Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response After One Year of Imatinib Mesylate Monotherapy

summary: Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.

sponsor_collaborators:
Institut Bergonié
Novartis

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers

acronym: BRONKINOU

summary: The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.

ReferenceCitation: Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. doi: 10.1002/14651858.CD004873.pub2.

ReferenceCitation: Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Association des Réseaux Bronchiolite

location_facility: Antoine Béclère Hospital - Pediatric Department


title: A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

acronym: REV-LEG

summary:
In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients.

If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

lead_sponsor: University Hospital, Bordeaux

location_facility: AP-HP Groupe hospitalier Bichat - Claude Bernard


title: End-of-life in French Intensive Care Units: Perception of the Quality of Dying and Experience of Physicians, Nurses and Relatives. Validation of the CAESAR Scale

acronym: CAESAR

summary:
The purpose of the study is to evaluate the quality of the dying process in french ICUs (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives.

Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (PTSD)).

location_facility: Réanimation chirurgicale Hôpital Saint-Louis

location_facility: Reanimation medicale, Hôpital Saint Louis

location_facility: Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière

location_facility: Service de réanimation médicale CHU CH Nicolle

location_facility: Réanimation Médicale Groupement Hospitalier Edouard Herriot

location_facility: Réanimation Polyvalente CH Bretagne Atlantique

location_facility: Service d'anesthésie et de réanimation Chu Timone

location_facility: Réanimation polyvalente GH Edouard Herriot

location_facility: Service de réanimation Hôpital Saint Joseph

location_facility: Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord

location_facility: Réanimation médico-chirurgicale CH de Roanne

location_facility: Réanimation Centre hospitalier Marc Jacquet

location_facility: Réanimation polyvalente CH Sud Francilien

location_facility: Réanimation médicale Hôpital de La Croix Rousse

location_facility: Réanimation polyvalente Hôpital Les Oudairies

location_facility: Réanimation médicale Centre hospitalier Pays d'Aix

location_facility: Service de réanimation polyvalente CH de Valenciennes

location_facility: Réanimation médicale CHU de la Cavale Blanche

location_facility: Réanimation Polyvalente Centre Hospitalier Victor Dupouy

location_facility: Réanimation médicale CHU de Nancy- Hôpital central

location_facility: Service de réanimation polyvalente CH de Saint Lô

location_facility: Réanimation médicale Hôpital Saint André

location_facility: Service de réanimation médicale Hôpital Victor Provo

location_facility: Réanimation Médico-Chirugicale CH Chambéry

location_facility: Service de réanimation polyvalente CHR - Hôpital de la Source

location_facility: Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu

location_facility: Réanimation polyvalente Centre hospitalier d'Angoulême

location_facility: Réanimation polyvalente Centre hospitalier de Versailles

location_facility: Service d'anesthésie et de réanimation Hôpital Nord

location_facility: Réanimation polyvalente Hôpital Roger Salengro

location_facility: Réanimation Centre Hospitalier Intercommunal André Grégoire

location_facility: réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau

location_facility: Réanimation Polyvalente Centre Hospitalier de Gonesse

location_facility: Service de réanimation médicale et toxicologique CHU Lariboisière

location_facility: Service de réanimation Institut Paoli Calmettes

location_facility: Service de réanimation médico-chirurgicale Institut Gustave Roussy


title: The Medical-financial Evaluation of Pre-therapeutic Screening by a Joint Phenotypic-pharmacogenetic Approach for Metabolic Fluoropyrimidine Enzyme Deficiency in Terms of Serious Toxicity Risk Prevention : a Multicentric Case Study

acronym: DPD côlon

summary: The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic screening of DPD deficiency for predicting toxicity to fluoropyrimidines.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
HEGP
Hôpital Purpan
Institut Claudius Regaud
ICO Paul Papin
CHU Hotel Dieu
CHU Jean Minjoz
Pôle Santé Léonard de Vinci
Centre Hospitalier
CHU Morvan
Centre Oscar Lambret
Centre Antoine Lacassagne
Centre d'oncologie de Gentilly
ICO René Gauducheau
CH Sarthe et Loir
CHU Côte de Nacre
Centre François Baclesse
CHU Trousseau
Hôpital Henri Mondor
Clinique des Cèdres
Centre Hospitalier du Haut Anjou
Centre Hospitalier Lyon Sud
Centre Hospitalier Les oudairies

intervention_type: Genetic


acronym: Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE

lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
PRIMARY OBJECTIVES

To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE

location_facility:
SPMSD Investigational Site 153
SPMSD Investigational Site 129
SPMSD Investigational Site 197
SPMSD Investigational Site 116
SPMSD Investigational Site 139
SPMSD Investigational Site 106
SPMSD Investigational Site 101
SPMSD Investigational Site 155
SPMSD Investigational Site 135
SPMSD Investigational Site 110
SPMSD Investigational Site 117
SPMSD Investigational Site 133
SPMSD Investigational Site 113
SPMSD Investigational Site 193
SPMSD Investigational Site 125
SPMSD Investigational Site 103
SPMSD Investigational Site 157
SPMSD Investigational Site 134
SPMSD Investigational Site 121
SPMSD Investigational Site 161
SPMSD Investigational Site 141
SPMSD Investigational Site 160
SPMSD Investigational Site 148
SPMSD Investigational Site 115
SPMSD Investigational Site 151
SPMSD Investigational Site 145
SPMSD Investigational Site 120
SPMSD Investigational Site 114
SPMSD Investigational Site 150
SPMSD Investigational Site 199
SPMSD Investigational Site 198
SPMSD Investigational Site 140
SPMSD Investigational Site 164
SPMSD Investigational Site 136
SPMSD Investigational Site 102
SPMSD Investigational Site 128
SPMSD Investigational Site 147
SPMSD Investigational Site 107
SPMSD Investigational Site 124
SPMSD Investigational Site 163
SPMSD Investigational Site 162
SPMSD Investigational Site 123
SPMSD Investigational Site 130
SPMSD Investigational Site 152
SPMSD Investigational Site 194

title: Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE


title: Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells

acronym: FLUMED

summary:
Rationale:

Classical antiviral therapies target viral proteins and are consequently subject to resistance. To counteract this limitation, alternative strategies have been developed that target cellular factors. We hypothesized that such an approach could also be useful to identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral diversity and because of the need to develop therapies against unpredictable viruses as recently underlined by the H1N1 pandemic. Gene-expression signature-based screening identified broadly effective influenza A antivirals. Midodrine showed great results in inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

The main objective of the study is to assess the efficacy of midodrine taken at usual recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus Influenza A.

Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3 5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic of viral replication; analysis of the frequency of emergence of mutants and associated resistance.

Methods:

This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years infected by influenza A virus. Nasopharyngeal washing will be performed at day 0 (randomization), 2, 3, 5 to show the viral replication evolution.

161 patients will be randomized as follows :

Arm 1 : Midodrine, 2.5 mg, 3 times a day
Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon area.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital D'Instruction des Armées Desgenettes


title: A 2-year Multicentre, EU, Exploratory Study Without Therapeutic Benefit in Patients With Knee Osteoarthritis to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis by Use of Clinical, Imaging, and Biochemical (Bio)Markers.

acronym: APPROACH

summary:
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Different phenotypes of OA may benefit from different types of treatment. Therefore, novel markers to identify selected phenotypes of osteoarthritis may encourage drug development.

Objective: To prospectively describe in detail pre-identified progressing phenotypes of patients with knee OA by use of conventional and novel clinical, imaging, and biochemical (bio)markers, and to validate and refine a predictive model for these (and new) progressing phenotypes based on these markers.

Study design: APPROACH is an exploratory, European, five-centre, 2-year prospective follow-up, cohort study, with extensive measurements. In this study patients are treated according to regular care by their own physician with no study related treatment prescribed. Study related diagnostic and/or monitoring procedures are applied to the patients.

Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.

Main study parameters/endpoints: Joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.

Secondary parameters: A multitude of (novel and conventional) clinical, imaging, and biochemical parameters related to osteoarthritis.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not have any direct benefit from their participation in this study other than that their OA is maximally diagnosed and followed in detail for up to 2 years (screening, baseline, 6 months, 12 months, 24 months).

ReferenceCitation: Roemer FW, Jansen M, Marijnissen ACA, Guermazi A, Heiss R, Maschek S, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Lafeber FPJG, Weinans HH, Wirth W. Structural tissue damage and 24-month progression of semi-quantitative MRI biomarkers of knee osteoarthritis in the IMI-APPROACH cohort. BMC Musculoskelet Disord. 2022 Nov 17;23(1):988. doi: 10.1186/s12891-022-05926-1.

repository_institution: Universidade Da Coruña - RUC

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

ReferenceCitation: Wirth W, Maschek S, Marijnissen ACA, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Roemer FW, Lafeber FPJG, Weinans HH, Jansen M. Test-retest precision and longitudinal cartilage thickness loss in the IMI-APPROACH cohort. Osteoarthritis Cartilage. 2023 Feb;31(2):238-248. doi: 10.1016/j.joca.2022.10.015. Epub 2022 Nov 3.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: van Helvoort EM, Jansen MP, Marijnissen ACA, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans HH, Widera P, Bacardit J, Welsing PMJ, Lafeber FPJG. Predicted and actual 2-year structural and pain progression in the IMI-APPROACH knee osteoarthritis cohort. Rheumatology (Oxford). 2022 Dec 23;62(1):147-157. doi: 10.1093/rheumatology/keac292.

ReferenceCitation: Angelini F, Widera P, Mobasheri A, Blair J, Struglics A, Uebelhoer M, Henrotin Y, Marijnissen AC, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Ladel C, Larkin J, Bay-Jensen AC, Bacardit J. Osteoarthritis endotype discovery via clustering of biochemical marker data. Ann Rheum Dis. 2022 May;81(5):666-675. doi: 10.1136/annrheumdis-2021-221763. Epub 2022 Mar 4.

oa_colors: green other

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: Leiden University - Leiden Repository

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

repository_institution: University of Oulu - University of Oulu Repository - Jultika

ReferenceCitation: van Helvoort EM, Welsing PMJ, Jansen MP, Gielis WP, Loef M, Kloppenburg M, Blanco F, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans H, Lafeber F, Eijkelkamp N, Mastbergen S. Neuropathic pain in the IMI-APPROACH knee osteoarthritis cohort: prevalence and phenotyping. RMD Open. 2021 Dec;7(3):e002025. doi: 10.1136/rmdopen-2021-002025.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Taylor J, Dekker S, Jurg D, Skandsen J, Grossman M, Marijnissen AK, Ladel C, Mobasheri A, Larkin J, Weinans H, Kanter-Schlifke I; APPROACH research consortium and APPROACH Principal Investigators. Making the patient voice heard in a research consortium: experiences from an EU project (IMI-APPROACH). Res Involv Engagem. 2021 May 10;7(1):24. doi: 10.1186/s40900-021-00267-0. Erratum In: Res Involv Engagem. 2022 Apr 19;8(1):15.

ReferenceCitation: van Helvoort EM, van Spil WE, Jansen MP, Welsing PMJ, Kloppenburg M, Loef M, Blanco FJ, Haugen IK, Berenbaum F, Bacardit J, Ladel CH, Loughlin J, Bay-Jensen AC, Mobasheri A, Larkin J, Boere J, Weinans HH, Lalande A, Marijnissen ACA, Lafeber FPJG. Cohort profile: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers. BMJ Open. 2020 Jul 28;10(7):e035101. doi: 10.1136/bmjopen-2019-035101.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

collaborators: Complexo Hospitalario Universitario de A Coruña

collaborators: Institut de Recherches Internationales Servier

location_facility:
Leiden University Medical Center
UMC Utrecht
Diakonhjemmet hospital
SERGAS
Saint-Antoine hospital, AP-HP


title: FIRE AND ICE II Trial Pilot

summary: The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

collaborators: genae associates (CRO), Antwerp, Belgium

location_facility: Cardioangiologisches Centrum Bethanien CCB

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck


title: Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

acronym: ACT SOLO

summary: This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

ReferenceCitation: Flipo RM, Maillefert JF, Chazerain P, Idier I, Coudert M, Tebib J. Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study. RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Hoffmann-La Roche


title: An Ambispective, Non Interventional Study of 2 Cohorts (Triple Negative or HR+) of Patients With HER2- Metastatic or Locally Advanced Breast Cancer Treated With Avastin® (Bevacizumab) 1st Line for at Least 12 Months and Without Progression for at Least 12 Months.

summary: This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.


lead_sponsor: Idorsia Pharmaceuticals Ltd.

summary: The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration

location_facility: Kleinwachau, Sächsisches Epilepsiezentrum Radeberg

title: A Phase 2a, Multi-center, Single-blind, Within-subject, Placebo-controlled Study to Assess the Pharmacodynamics of ACT-709478 in Subjects With Photosensitive Epilepsy


title: International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)

acronym: PRoVING

summary:
Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ) in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both complaining of Gas-Related Symptoms (GRS).

IGQ has been developed previously simultaneously in UK English, French and Spanish through qualitative research with subject interviews. The conceptual framework of the IGQ assesses both GRS and their impact on daily life. Similar concepts were identified for both subjects with IBS diagnosis and general population and complaining of gas-related symptoms.

The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17 items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26 items)

ReferenceCitation: Chassany O, Tugaut B, Marrel A, Guyonnet D, Arbuckle R, Duracinsky M, Whorwell PJ, Azpiroz F. The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life. Neurogastroenterol Motil. 2015 Jun;27(6):885-98. doi: 10.1111/nmo.12565. Epub 2015 Apr 6.

lead_sponsor: University Paris 7 - Denis Diderot

collaborators: EA 7334, Patient-Centered Outcomes Research

location_country:
Spain
United Kingdom
France

location_facility: Horta, Hospital Universitari Vall d'Hebron


title: Developing Tools for Assessing the Natural History of Ambulant and Non-ambulant DMD Individuals to Assist in Antisense-oligomer Clinical Trials

summary: Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding of DMD natural history. This study aim to assess the natural history of DMD through a composite assessment tool capable of capturing disease progression linking ambulant and non-ambulant phases of the disease.

ReferenceCitation: Trucco F, Ridout D, Domingos J, Maresh K, Chesshyre M, Munot P, Sarkozy A, Robb S, Quinlivan R, Riley M, Wallis C, Chan E, Abel F, De Lucia S, Hogrel JY, Niks EH, de Groot I, Servais L, Straub V, Ricotti V, Manzur A, Muntoni F; UK NorthStar Clinical Network and AFM Network. Genotype-related respiratory progression in Duchenne muscular dystrophy-A multicenter international study. Muscle Nerve. 2022 Jan;65(1):67-74. doi: 10.1002/mus.27427. Epub 2021 Oct 27.

publisher_dissemination: Wiley

ReferenceCitation: Catapano F, Scaglioni D, Maresh K, Ala P, Domingos J, Selby V, Ricotti V, Phillips L, Servais L, Seferian A, Groot I, Krom YD, Voit T, Verschuuren JJGM, Niks EH, Straub V, Morgan J, Muntoni F. Novel free-circulating and extracellular vesicle-derived miRNAs dysregulated in Duchenne muscular dystrophy. Epigenomics. 2020 Nov;12(21):1899-1915. doi: 10.2217/epi-2020-0052. Epub 2020 Nov 20.

publisher_dissemination: Future Science Ltd

lead_sponsor: University College, London

collaborators: Association Française contre les Myopathies (AFM), Paris

location_country:
United Kingdom
Netherlands
France

location_facility: Institut de Myologie, Groupe Hospitalier Pitié Salpêtrière

location_facility: Dubowitz Neuromuscular Centre, UCL-Institute of Child Health

location_facility: John Walton Muscular Dystrophy Research Centre, Newcastle University


title: Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension

acronym: ENSAT-HT

summary: The purpose of this study is to assess the validity and usefulness of omics signatures for improved identification and risk stratification of patients with endocrine hypertension and stratification of patients with primary hypertension.

lead_sponsor: Radboud University Medical Center

sponsor_collaborators:
Radboud University Medical Center
European Georges Pompidou Hospital
University of Turin, Italy
University of Padova
University of Glasgow

location_country:
Italy
Netherlands
United Kingdom
France

location_facility:
University of Torino
University of Glasgow
University of Padua
Raddboudumc
European Georges Pompidou Hospital


title: Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease

summary: Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

ReferenceCitation: Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.

lead_sponsor: Wolfson Medical Center

location_country: Israel Italy France

location_facility: Saint-Antoine Hospital, Universite Pierre et Marie Curie


title: Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study

summary: The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

time_perspective: Cross-Sectional

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
RTI Health Solutions

location_country:
Germany
Italy
United Kingdom
Spain
France


title: Phase II Trial of Linsitinib (Anti-IGF-1R/IR) in Patients With Relapsed and/or Refractory Ewing Sarcoma

acronym: LINES

summary: This is an international, multi-centre, single arm Bayesian designed phase 2 study to identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7 European centres. Each patient will be treated with single agent linsitinib, 600 mg orally once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue toxicity.

lead_sponsor: University of Oxford

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

location_country:
Germany
Italy
United Kingdom
Netherlands
France

location_facility: Pediatric Hematology and Oncology, University Hospital Münster

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Department of Clinical Oncology, Leiden University Medical Center


title: Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

acronym: (R-HAD)

summary: The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

lead_sponsor: Prof. Dr. M. Dreyling (co-chairman)

collaborators: Klinikum der Universitaet Muenchen, Grosshadern

collaborators: GELARC Service de Pharmacovigilance, Pierre Benite

location_facility: Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan

location_facility: Hôpital Henri Mondor, Service hématologie

location_facility: Clinique Victor Hugo, Service hématologie

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Klinikum der Universität zu Köln, Klinik I f. Innere Medizin

location_facility: Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin

location_facility: Schlossberg Klinik, Oberstaufen Internistische Onkologie

location_facility: Westpfalz-Klinikum GmbH, I. Medizinische Klinik

location_facility: Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital

location_facility: Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III

location_facility: Universitätsklinikum Ulm, Innere Medizin III

location_facility: Diakonie Klinikum Jung Stilling Krankenhaus

location_facility: Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie

location_facility: Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin

location_facility: Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie

location_facility: Asklepios Klinik St. Georg, Abteilung Hämatologie

location_facility: CH Sud Francilien de Corbeil, Service hématologie

location_facility: Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung

location_facility: Ammerland-Klinik GmbH, Klinik für innere Medizin

location_facility: Hôpital Jean Bernard, Service hématologie

location_facility: Diakonieklinikum Stuttgart, Medizinische Klinik II

location_facility: Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie

location_facility: Centre Hospitalier de la côte Basque, Service hématologie

location_facility: Hôpital Haut Lévêque, Service hématologie

location_facility: Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin

location_facility: Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie

location_facility: Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie

location_facility: UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK

location_facility: CHU Necker, Service d'hématologie - adulte

location_facility: Universitätsklinik Essen, Klinik für Hämatologie

location_facility: Mutterhaus der Borromäerinnen, Medizinische Abteilung

location_facility: Hôpital Albert Michallon, Service hématologie

location_facility: CH de Bretagne Atlantique, Service Hématologie

location_facility: LMU München - Klinikum Großhadern Medizinische Klinik III


lead_sponsor: UNICANCER

summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.

ReferenceCitation: Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest/Centre René Gauducheau

title: Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas

ipd_sharing_description: PD will not be shared at an individual level, they will be part of the study database including all enrolled patients


title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

acronym: RANBI

summary: Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

time_perspective: Retrospective

lead_sponsor: Allergan

location_country:
Germany
France
United Kingdom
Spain
Israel


lead_sponsor: Centre Leon Berard

summary: The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

ReferenceCitation: Seiwert, TC, clement, P. M, Del Campo, J, de Mont-Serrat, H., Thurm, H. C., Blackman, A. S., and Cohen, E. E. BIBW 2992 versus cetuximab in patients with metastatic or recurrent head and neck cancer (SCCHN) after failure of platinum-containing therapy with a cross-over period for progressing patients: Preliminary results of a randomized, open-label phase II study. Journal of Clinical Oncology 28(15 suppl). 2010.

ReferenceCitation: Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

ReferenceCitation: Carpenter G, Cohen S. Epidermal growth factor. J Biol Chem. 1990 May 15;265(14):7709-12. No abstract available.

ReferenceCitation: Mendelsohn J. Epidermal growth factor receptor inhibition by a monoclonal antibody as anticancer therapy. Clin Cancer Res. 1997 Dec;3(12 Pt 2):2703-7.

ReferenceCitation: Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol. 1995 Jul;19(3):183-232. doi: 10.1016/1040-8428(94)00144-i. No abstract available.

ReferenceCitation: Grandis JR, Tweardy DJ. TGF-alpha and EGFR in head and neck cancer. J Cell Biochem Suppl. 1993;17F:188-91. doi: 10.1002/jcb.240531027.

ReferenceCitation: Baselga J. New therapeutic agents targeting the epidermal growth factor receptor. J Clin Oncol. 2000 Nov 1;18(21 Suppl):54S-9S. No abstract available.

ReferenceCitation: Fan Z, Mendelsohn J. Therapeutic application of anti-growth factor receptor antibodies. Curr Opin Oncol. 1998 Jan;10(1):67-73. doi: 10.1097/00001622-199801000-00011.

ReferenceCitation: Milas L, Mason K, Hunter N, Petersen S, Yamakawa M, Ang K, Mendelsohn J, Fan Z. In vivo enhancement of tumor radioresponse by C225 antiepidermal growth factor receptor antibody. Clin Cancer Res. 2000 Feb;6(2):701-8.

ReferenceCitation: Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81. 2006.

ReferenceCitation: Gregoire V, Eisbruch A, Hamoir M, Levendag P. Proposal for the delineation of the nodal CTV in the node-positive and the post-operative neck. Radiother Oncol. 2006 Apr;79(1):15-20. doi: 10.1016/j.radonc.2006.03.009. Epub 2006 Apr 17.

ReferenceCitation: Lapeyre M, Henrot P, Alfonsi M, Bardet E, Bensadoun RJ, Dolivet G, Favrel V, Gallocher O, Giraud P, Graff P, Guerif S, Lagarde P, Lartigau E, Marchesi V, Pommier P, Rives M, Tortochaux J, Toussaint B, Verrelle P, Bourhis J, Calais G; Groupe Oncologie Radiotherapie Tete et Cou. [Propositions for the selection and the delineation of peritumoral microscopic disease volumes in oral cavity and oropharyngeal cancers (lymph nodes excluded)]. Cancer Radiother. 2005 Jun;9(4):261-70. doi: 10.1016/j.canrad.2005.03.005. Epub 2005 Apr 25. French.

ReferenceCitation: Gregoire V, Levendag P, Ang KK, Bernier J, Braaksma M, Budach V, Chao C, Coche E, Cooper JS, Cosnard G, Eisbruch A, El-Sayed S, Emami B, Grau C, Hamoir M, Lee N, Maingon P, Muller K, Reychler H. CT-based delineation of lymph node levels and related CTVs in the node-negative neck: DAHANCA, EORTC, GORTEC, NCIC,RTOG consensus guidelines. Radiother Oncol. 2003 Dec;69(3):227-36. doi: 10.1016/j.radonc.2003.09.011.

ReferenceCitation: Prescribing, Recording, and Reporting Intensity-Modulated Photon-Beam Therapy (IMRT)(ICRU Report 83) ICRU Report 83, Journal of the ICRU Vol. 10 No. 1. 2011.

ReferenceCitation: Chao KS, Majhail N, Huang CJ, Simpson JR, Perez CA, Haughey B, Spector G. Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. Radiother Oncol. 2001 Dec;61(3):275-80. doi: 10.1016/s0167-8140(01)00449-2.

sponsor_collaborators:
Centre Leon Berard
Boehringer Ingelheim

location_facility: Pôle Hospitalier Mutualiste- Centre Etienne Dolet

location_facility: Institut de Cancérologie de lorraine (ICL)

title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02


title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

summary: The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

lead_sponsor: University Hospital, Angers

location_facility:
Rehabilitation
Vascular Medicine
Vascular investigation