title: Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age

acronym: VPI

summary: Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).

ReferenceCitation: Shevell MI, Bodensteiner JB. Cerebral palsy: defining the problem. Semin Pediatr Neurol. 2004 Mar;11(1):2-4. Review.

ReferenceCitation: Hagberg B, Hagberg G, Beckung E, Uvebrant P. Changing panorama of cerebral palsy in Sweden. VIII. Prevalence and origin in the birth year period 1991-94. Acta Paediatr. 2001 Mar;90(3):271-7.

ReferenceCitation: Nelson KB. Can we prevent cerebral palsy? N Engl J Med. 2003 Oct 30;349(18):1765-9.

ReferenceCitation: Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. Review.

ReferenceCitation: Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23.

ReferenceCitation: Weisglas-Kuperus N, Koot HM, Baerts W, Fetter WP, Sauer PJ. Behaviour problems of very low-birthweight children. Dev Med Child Neurol. 1993 May;35(5):406-16. Review.

lead_sponsor: University Hospital, Toulouse

location_facility: CHIVA centre hospitalier du val d'Ariège


title: Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump

acronym: CGMIP

summary: During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM) in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will participate in two period of 3 months separated by a 3 months washout. During one period, they will use CGM to adapt their insulin therapy while during the other period, they will manage their diabetes with their usual capillary blood glucose meter. We except to observe an increase of time spent in glucose safe range when using CGM.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

location_facility:
UHMontpellier
CHU de Dijon
CHRU de Lille
Chu de Toulouse
CHU de Bordeaux
CHRU de Strasbourg
AP - Hôpitaux de Paris
Chu de Nancy
AP - Hôpitaux de Marseille
CH Sud Francilien

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Is Caffeine an Environmental Modifier in Huntington's Disease?

acronym: CrEAM-HD

summary: The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility:
CHU de Angers
CHU Pellegrin
CHU de Nancy
AH-HP La Pitié-Salpétrière
CHU de Amiens
CHU de Grenoble
CHU Montpellier
Hôpital Roger Salengro, CHRU
CHU Purpan
AH-HP, Hôpital Henri Mondor

status_simplified: Ongoing


title: Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)

acronym: COSMIC

summary:
As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a mortality rate of 20%, end-of-life care has become a daily responsibility. Among those deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where physicians, nurses and relatives must work together towards the most consensual decision. In this context, patients' relatives feel vulnerable and, in the months that follow the death, they are most likely to present symptoms that negatively affect their quality of life (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with caregivers is one of the most highly valued aspects of care that impacts on family members' experience during the patient's stay and after the patient's death. Improving communication during the end-of-life process in the ICU context is a necessity that has been put forward in palliative care and family-centered care guidelines.

This study aims to improve both communication skills and behaviour by giving precise recommendations to physicians (3 step strategy) in their direct contact with patients' relatives. A 3-step physician-driven support strategy is used, that consists in 3 meetings with the relative - one before, one during and one after the patient's death. The underlying hypothesis is that this strategy will improve communication in the end-of-life setting and thus should reduce post-ICU burden for family members, specifically the development of prolonged grief 6 months after the death.

status: Completed

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Kentish-Barnes N, Chevret S, Azoulay E. Guiding intensive care physicians' communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL). Trials. 2018 Dec 22;19(1):698. doi: 10.1186/s13063-018-3084-7.

family: Kentish-Barnes

full_name: Nancy Kentish-Barnes

given: Nancy

sequence: first

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

sequence: additional

family: Azoulay

full_name: Elie Azoulay

given: Elie

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Guiding intensive care physicians’ communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Réanimation médicale HEGP
Réanimation polyvalente René Dubos
Réanimation médico chirurgicale Tenon
Réanimation médicale Pitié Salpetriere
Réanimation polyvalente Sud Francilien
Anesthésie Réanimation Beaujon
Réanimation Médicale hôpital Cochin
Réanimation médicale
Réanimation chirurgicale HEGP
Réanimation médicale Bicetre

intervention_type: Behavioral

status_simplified: Completed


title: Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock

summary: Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its external validity is hampered by the numerous limits and the heterogeneity of the studies. To date, a pathophysiological link between LV diastolic dysfunction associated with septic shock and the water balance (reflecting volume overload) remains to establish. In addition, small size studies reported an excess of mortality in patients with septic shock who were diagnosed with a high cardiac output. However, no large cohort has yet confirmed the negative prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Nancy
Felix Guyon Hospital
CH d'Orleans
University Hospital
CHU de Poitiers
Aphp - Ambroise Paré


title: Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty

acronym: FAVABED

summary:
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.

Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate.

These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.

Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.

For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.

These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty.

These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.

The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de RENNES


title: Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent

acronym: PROGERAD

summary: The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.

primary_purpose: Other

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Clinique Mutualiste de l'Estuaire
Institut de Cancérologie de l'Ouest
Centre Catherine de Sienne
CHD
Hopital Henri Mondor
Centre Georges François Leclerc
Centre Hospitalier Bretagne Sud
Institut de Cancérologie de Loire
Clinique Armoricaine de Radiologie
CHP

intervention_type: Other

lead_sponsor_type: industriel


title: A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)

acronym: STERIMGLI

summary:
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.

The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.

Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:

Arm A (control arm): Radiation therapy alone
Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Regional Du Cancer de Montpellier

intervention_type: Radiation


title: Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

acronym: SCA-AAR

summary:
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.

the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

status: Unknown status

ReferenceCitation: Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.

family: Leclerc

full_name: Betty Leclerc

given: Betty

family: Salomon Du Mont

full_name: Lucie Salomon Du Mont

given: Lucie

family: Parmentier

full_name: Anne-Laure Parmentier

given: Anne-Laure

family: Besch

full_name: Guillaume Besch

given: Guillaume

family: Rinckenbach

full_name: Simon Rinckenbach

given: Simon

currency_apc_doaj: USD

journal_name: Medicine

license: cc-by-nc

license_normalized: cc-by-nc

evidence: open (via page says license)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Strasbourg
CHU
CH

intervention_type: Procedure


title: APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients

acronym: APPLE

summary: The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression.

status: Active, not recruiting

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

location_country: Jordan France Poland Spain Slovenia

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital A Coruna-Hospital Teresa Herrera

intervention_type: Drug


title: Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes

acronym: STABILOT

summary: The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

ReferenceType: background

ReferenceCitation: Barton FB, Rickels MR, Alejandro R, Hering BJ, Wease S, Naziruddin B, Oberholzer J, Odorico JS, Garfinkel MR, Levy M, Pattou F, Berney T, Secchi A, Messinger S, Senior PA, Maffi P, Posselt A, Stock PG, Kaufman DB, Luo X, Kandeel F, Cagliero E, Turgeon NA, Witkowski P, Naji A, O'Connell PJ, Greenbaum C, Kudva YC, Brayman KL, Aull MJ, Larsen C, Kay TW, Fernandez LA, Vantyghem MC, Bellin M, Shapiro AM. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care. 2012 Jul;35(7):1436-45. doi: 10.2337/dc12-0063.

ReferenceCitation: Beckwith J, Nyman JA, Flanagan B, Schrover R, Schuurman HJ. A health economic analysis of clinical islet transplantation. Clin Transplant. 2012 Jan-Feb;26(1):23-33. doi: 10.1111/j.1399-0012.2011.01411.x. Epub 2011 Feb 16.

ReferenceCitation: Bellin MD, Kandaswamy R, Parkey J, Zhang HJ, Liu B, Ihm SH, Ansite JD, Witson J, Bansal-Pakala P, Balamurugan AN, Papas KK, Sutherland DE, Moran A, Hering BJ. Prolonged insulin independence after islet allotransplants in recipients with type 1 diabetes. Am J Transplant. 2008 Nov;8(11):2463-70. doi: 10.1111/j.1600-6143.2008.02404.x. Epub 2008 Sep 19. Erratum in: Am J Transplant. 2010 May;10(5):1337. Papas, K [corrected to Papas, K K].

ReferenceCitation: Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96.

ReferenceCitation: Lablanche S, David-Tchouda S, Margier J, Schir E, Wojtusciszyn A, Borot S, Kessler L, Morelon E, Thivolet C, Pattou F, Vantyghem MC, Berney T, Benhamou PY. Randomised, prospective, medico-economic nationwide French study of islet transplantation in patients with severely unstable type 1 diabetes: the STABILOT study protocol. BMJ Open. 2017 Feb 20;7(2):e013434. doi: 10.1136/bmjopen-2016-013434.

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

family: David-Tchouda

full_name: Sandra David-Tchouda

given: Sandra

family: Margier

full_name: Jennifer Margier

given: Jennifer

family: Schir

full_name: Edith Schir

given: Edith

family: Wojtusciszyn

full_name: Anne Wojtusciszyn

given: Anne

family: Borot

full_name: Sophie Borot

given: Sophie

family: Kessler

full_name: Laurence Kessler

given: Laurence

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Thivolet

full_name: Charles Thivolet

given: Charles

family: Pattou

full_name: François Pattou

given: François

family: Vantyghem

full_name: Marie Christine Vantyghem

given: Marie Christine

family: Berney

full_name: Thierry Berney

given: Thierry

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

journal_name: BMJ Open

repository_institution: University of Geneva - Archive ouverte UNIGE

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
University Hospital of Lyon
University hospital of Strasbourg
University Hospital of Besançon
Grenoble University Hospital
University hospital of Lille
University hospital of Nancy
APHP
university hospital of Clermont Ferrand
University Hospital of Montpellier
university hospital of Nantes
University Hospital of Geneva


title: Cost Utility of Radical Surgery in Ovarian Cancer

acronym: CURSOC

summary: The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

primary_purpose: Health Services Research

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

family: Filleron

full_name: T. Filleron

given: T.

family: Lusque

full_name: A. Lusque

given: A.

family: Dalenc

full_name: F. Dalenc

given: F.

family: Ferron

full_name: G. Ferron

given: G.

family: Roche

full_name: H. Roche

given: H.

family: Martinez

full_name: A. Martinez

family: Jouve

full_name: E. Jouve

given: E.

journal_name: Contemporary Clinical Trials

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility: Hopital Nord-Ouest - Villefranche Sur Saone


title: Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

acronym: MODIMUCOR

summary:
This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including :

patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency),
patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

location_facility: Centre Hospitalier Régional Universitaire


title: Evidence of Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease: Family Studies and Relations With a Particular Genetic Profile and Serological. Comparison of Affected Individuals, Their Siblings and Healthy Controls.

acronym: MAGIC

summary: Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD.

time_perspective: Cross-Sectional

location_facility:
APHP Kremlin Bicêtre
Aphp Necker
cLERMONT fERRAND University Hospital
Nancy University Hospital
Hôpital Claude Huriez, CHRU
Rouen University Hospital
CHRU,Hôpital Jeanne de Flandres
Amiens University & Hospital
APHP Robert Debré
Aphp St Antoine


title: Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions

acronym: LIPA-DRAIN

summary:
Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections.

To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences.

It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs.

In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients.

The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery.

The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: HCL - Hôpital universitaire de la Croix Rousse

intervention_type: Biological


title: Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

acronym: ACRO-OPTIM

summary: The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

lead_sponsor: Ipsen

location_facility: Hopital Neuro-Cardiologique, Fédération d'Endocrinologie


title: Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy

acronym: HIST-RIC

summary:
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. This is true all the more as it is about a reconstruction by prosthesis because of the prothetic died risk of hull(shell).

Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought back(reported) by increase of the risk of local or remote relapse.

Two studies estimated afterward the feasibility of the mastectomy with immediate mammary reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar to the patients benefiting from the classic therapeutic plan.

During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is possible and that by prescribing the chemotherapy and the radiotherapy before immediate mammary reconstruction, the morbidity is acceptable.

It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative chemotherapy as regards the global survival.

On the other hand, the rate of histological answer, according to subgroups, is very different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-, Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.

The purpose of the investigators study is to estimate the rate of histological response during the inversion of therapeutic sequence to make sure of the oncologic safety(security), in particular by molecular subgroups, considering the heterogeneousness of the results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications is the references and will be used here, but the investigators can also use Symmans classification in addition.

The rate of local and metastatic second offenses(recurrences) will also be estimated.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Icm - Institut Regional Du Cancer de Montpellier


type: Registry Identifier

title: Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial

acronym: KPDP

summary:
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.

Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.

Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.

The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.

lead_sponsor: University Hospital, Tours

location_facility:
UH BREST
UH Marseille
UH of PARIS - Robert Debre Hospital
UH of PARIS - NECKER Hospital
UH of PARIS - KREMLIN BICETRE Hospital
Uh Limoges
UH Tours
Uh Nantes
Hospices civiles Lyon
Uh Angers


title: MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach

summary: This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.

time_perspective: Retrospective

ReferenceCitation: Sarsour K, Beckley-Kartey S, Melega S, Odueyungbo A, Kirchner P, Khalife N, Bangs J. Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card. Pharmacol Res Perspect. 2020 Jan 3;8(1):e00555. doi: 10.1002/prp2.555. eCollection 2020 Feb.

name: Genentech, Inc South San Francisco CA USA

family: Sarsour

full_name: Khaled Sarsour

given: Khaled

name: F. Hoffmann‐La Roche Ltd Basel Switzerland

family: Beckley‐Kartey

full_name: Senam Beckley‐Kartey

given: Senam

family: Melega

full_name: Simone Melega

given: Simone

name: Roche Products Ltd Mississauga ON Canada

family: Odueyungbo

full_name: Adefowope Odueyungbo

given: Adefowope

family: Kirchner

full_name: Petra Kirchner

given: Petra

family: Khalife

full_name: Natasha Khalife

given: Natasha

name: Joanne Bangs Ltd Letchworth Garden City Hertfordshire UK

family: Bangs

full_name: Joanne Bangs

given: Joanne

journal_name: Pharmacology Research & Perspectives

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Rituximab utilization for approved and off‐label nononcology indications and patients’ experiences with the Patient Alert Card

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Spain
Germany
United Kingdom

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Ospedaliera Universitaria Arcispedale S. Anna

location_facility: Hospital Clinico Universitario Valladolid

location_facility: CIRI - Centrum für Innovative Diagnostik und Therapie GmbH

location_facility: Rheumazentrum Ratingen - Studienambulanz

location_facility: Chu De Clermont Ferrand; Hopital Gabriel Montpied

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie

location_facility: Hospital Regional Universitario de Malaga; Servicio de Reumatologia

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia


title: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

acronym: iLOC

summary: The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.

ReferenceCitation: Soussain C, Choquet S, Blonski M, Leclercq D, Houillier C, Rezai K, Bijou F, Houot R, Boyle E, Gressin R, Nicolas-Virelizier E, Barrie M, Moluçon-Chabrot C, Lelez ML, Clavert A, Coisy S, Leruez S, Touitou V, Cassoux N, Daniau M, Ertault de la Bretonnière M, El Yamani A, Ghesquières H, Hoang-Xuan K. Ibrutinib monotherapy for relapse or refractory primary CNS lymphoma and primary vitreoretinal lymphoma: Final analysis of the phase II 'proof-of-concept' iLOC study by the Lymphoma study association (LYSA) and the French oculo-cerebral lymphoma (LOC) network. Eur J Cancer. 2019 Aug;117:121-130. doi: 10.1016/j.ejca.2019.05.024. Epub 2019 Jul 3.

family: Soussain

full_name: C. Soussain

given: C.

family: Choquet

full_name: S. Choquet

given: S.

family: Blonski

full_name: M. Blonski

given: M.

family: Leclercq

full_name: D. Leclercq

given: D.

family: Houillier

full_name: C. Houillier

family: Rezai

full_name: K. Rezai

given: K.

family: Bijou

full_name: F. Bijou

family: Houot

full_name: R. Houot

given: R.

family: Boyle

full_name: E. Boyle

family: Gressin

full_name: R. Gressin

family: Nicolas-Virelizier

full_name: E. Nicolas-Virelizier

family: Barrie

full_name: M. Barrie

family: Moluçon-Chabrot

full_name: C. Moluçon-Chabrot

family: Lelez

full_name: M.L. Lelez

family: Clavert

full_name: A. Clavert

family: Coisy

full_name: S. Coisy

family: Leruez

full_name: S. Leruez

family: Touitou

full_name: V. Touitou

given: V.

family: Cassoux

full_name: N. Cassoux

given: N.

family: Daniau

full_name: M. Daniau

family: Ertault de la Bretonnière

full_name: M. Ertault de la Bretonnière

family: El Yamani

full_name: A. El Yamani

family: Ghesquières

full_name: H. Ghesquières

family: Hoang-Xuan

full_name: K. Hoang-Xuan

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

title: Ibrutinib monotherapy for relapse or refractory primary CNS lymphoma and primary vitreoretinal lymphoma: Final analysis of the phase II ‘proof-of-concept’ iLOC study by the Lymphoma study association (LYSA) and the French oculo-cerebral lymphoma (LOC) network

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU de la Pitié Salpêtrière
CHRU de LILLE - Claude Huriez
Centre Léon Bérard
Hôpital René Huguenin Institut Curie
CHU d'ESTAING
CHU de la Timone
CHU de Grenoble
CHU Brabois
CHU de Rennes
Centre Henri Becquerel


title: Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III

acronym: DUMPING

summary: The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.

ReferenceType: result

ReferenceCitation: Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5.

ReferenceCitation: Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40.

ReferenceCitation: Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15.

ReferenceCitation: Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. Review.

ReferenceCitation: Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016.

family: Michaud

full_name: Laurent Michaud

given: Laurent

family: Sfeir

full_name: Rony Sfeir

given: Rony

family: Couttenier

full_name: Frédéric Couttenier

given: Frédéric

family: Turck

full_name: Dominique Turck

given: Dominique

family: Gottrand

full_name: Frédéric Gottrand

journal_name: Journal of Pediatric Surgery

ReferenceCitation: Holschneider P, Dübbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75.

ReferenceCitation: Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651.

family: Aumar

full_name: Madeleine Aumar

given: Madeleine

family: Chalouhi

full_name: Christel Chalouhi

given: Christel

family: Blanc

full_name: Sébastien Blanc

given: Sébastien

family: Thomassin

full_name: Nadège Thomassin

given: Nadège

family: Piloquet

full_name: Hugues Piloquet

given: Hugues

family: Gastineau

full_name: Swellen Gastineau

given: Swellen

family: Schneider

full_name: Anne Schneider

given: Anne

family: Krishnan

full_name: Usha Krishnan

given: Usha

family: Duvoisin

full_name: Gilles Duvoisin

given: Gilles

family: Coopman

full_name: Stéphanie Coopman

given: Stéphanie

journal_name: Journal of Pediatric Gastroenterology & Nutrition

location_facility: Hôpital Robert Debré ,Service de chirurgie viscérale et urologique

location_facility: Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques


title: Contribution of High-throughput Exome Sequencing in Fetopathology

acronym: FOETEX

summary:
This research concerns the contribution of a new examination, high-throughput exome sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently available examinations, the causes of polyformative syndromes, which correspond to the association of several congenital malformations with varying degrees of severity in different organs, remain unknown in a large number of cases.

High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous analysis of all of the coding parts of DNA. This examination has already shown its superior diagnostic capability in every post-natal diagnostic context, in particulier in infants with malformations associated or not with intellectual deficiency. Its contribution has not yet been studied in a large number of fetuses with polymalformations. To investigate the usefulness of HTES, we propose to carry out the examination in 100 fetuses with polymalformations, as well as the usual examinations including chromosomal microarray analysis and possibly the study of specific genes that may explain these malformations. A blood sample will be taken from both parents to allow interpretation of the results.

location_facility:
CHU de NANCY
CHU de Clermont-Ferrand
CHU de STRASBOURG (Hôpital Hautepierre)
CHU Montpellier
CHRU de Tours
CHU de DIJON
CH de Mulhouse (Hôpital Emile Muller)
CHRU de Reims (Hôpital Maison Blanche)
CHU de Rennes
CHU de Rouen


title: Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

acronym: AXIPAP

summary: Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment.

ReferenceCitation: Negrier S, Rioux-Leclercq N, Ferlay C, Gross-Goupil M, Gravis G, Geoffrois L, Chevreau C, Boyle H, Rolland F, Blanc E, Ravaud A, Dermeche S, Flechon A, Albiges L, Pérol D, Escudier B; GETUG collaborative group. Axitinib in first-line for patients with metastatic papillary renal cell carcinoma: Results of the multicentre, open-label, single-arm, phase II AXIPAP trial. Eur J Cancer. 2020 Apr;129:107-116. doi: 10.1016/j.ejca.2020.02.001. Epub 2020 Mar 5.

family: Negrier

full_name: Sylvie Negrier

given: Sylvie

family: Rioux-Leclercq

full_name: Nathalie Rioux-Leclercq

given: Nathalie

family: Ferlay

full_name: Céline Ferlay

given: Céline

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Geoffrois

full_name: Lionel Geoffrois

given: Lionel

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Boyle

full_name: Helen Boyle

given: Helen

family: Rolland

full_name: Frederic Rolland

given: Frederic

full_name: Ellen Blanc

given: Ellen

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Dermeche

full_name: Slimane Dermeche

given: Slimane

family: Flechon

full_name: Aude Flechon

given: Aude

family: Albiges

full_name: Laurence Albiges

given: Laurence

family: Pérol

full_name: David Pérol

given: David

family: Escudier

full_name: Bernard Escudier

given: Bernard

journal_name: European Journal of Cancer

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

lead_sponsor: Centre Leon Berard

location_facility:
ICL
Centre Geogres François Leclerc
Institut Claudius Regaud
ICO Paul Papin
Institut Paoli Calmettes
Centre Leon Berard
ICO - René Gauducheau
Gustave Roussy
Centre Francois Baclesse
Chu Bordeaux


title: Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk

acronym: MARCHE-DMD

summary: The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Brest

location_facility:
CH Le Mans
CHU de Nantes
CHRU
CHU
CHBA


title: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment

acronym: BCD

summary:
This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.

It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).

location_facility:
CHU Angers
CH de Lorient
CHRU Brest
CH Le Mans
CHR Orléans
CHU Tours
CHU Nantes
CHU La Roche sur Yon
CHU SUD Rennes
CH Vannes


title: Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas

acronym: IRIS

summary: To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

ReferenceCitation: Pépin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.

family: Pépin

full_name: Jean Louis Pépin

given: Jean Louis

family: Raymond

full_name: Nathalie Raymond

family: Lacaze

full_name: Olivier Lacaze

given: Olivier

family: Aisenberg

full_name: Nathalie Aisenberg

family: Forcioli

full_name: Jérôme Forcioli

given: Jérôme

family: Bonte

full_name: Eric Bonte

given: Eric

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Launois

full_name: Sandrine Launois

given: Sandrine

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

journal_name: Thorax

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

lead_sponsor: ONIRIS

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III

summary:
Primary Objective:

To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.

Secondary Objectives:

To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level.

To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse and mortality 30±2 days after treatment is started.

To document failures. To collect and follow up adverse events.

lead_sponsor: Sanofi

location_country: Tunisia France

location_facility:
Investigational Site Number :250031
Investigational Site Number :250015
Investigational Site Number :250034
Investigational Site Number :250001
Investigational Site Number :788002
Investigational Site Number :788014
Investigational Site Number :788007
Investigational Site Number :788011
Investigational Site Number :788004
Investigational Site Number :250029
Investigational Site Number :250022
Investigational Site Number :250032
Investigational Site Number :788009
Investigational Site Number :788005
Investigational Site Number :788001
Investigational Site Number :250004
Investigational Site Number :250023
Investigational Site Number :250010


title: Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.

acronym: BANQUISE

summary:
For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection has never been assessed.

The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample.

By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus.

The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Institut de cancérologie de l'Ouest - Angers

location_facility: Institut de cancérologie de l'Ouest - Nantes


title: Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase

acronym: EAP

summary: Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.

status: No longer available

study_type: Expanded Access

lead_sponsor: ERYtech Pharma

location_facility:
CHRU Lille - Hôpital Claude-Huriez
CHU Rouen - Hôpital des enfants
IHOP
Hôpital Saint Louis
Institut Universitaire du Cancer
CHU Saint Etienne Hôpital Nord
Hôpital BRETONNEAU
Hôpital de l'Archet 2
Hôpital Jean Minjoz - Batiment MEMCP
Hôpital Brabois Enfants


title: Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

acronym: CHANCE

summary:
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.

Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.

primary_purpose: Diagnostic

ReferenceCitation: Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.

ReferenceCitation: Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.

ReferenceCitation: Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4.

ReferenceCitation: Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.

ReferenceCitation: Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Färkkilä M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6.

ReferenceCitation: Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. Review.

ReferenceCitation: Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. Erratum in: Endoscopy. 2007 Mar;39(4):303.

ReferenceCitation: Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40.

ReferenceCitation: Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5.

ReferenceCitation: Dionisio P.M., Leighton J.A., Leontiadis G.I., Fleischer D.E., Hara A.K., Heigh R.I., Shiff A.D., Sharma V.K. Capsule Endoscopy (CE) has a Significantly Higher Diagnostic Yield in Patients with Suspected and Established Non-Stricturing Crohn's Disease (NSCD): A Meta Analysis. Gastrointest Endosc 2007;65:AB 369.

ReferenceCitation: van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33.

ReferenceCitation: D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

family: Colombel

full_name: Jean Frédéric Colombel

given: Jean Frédéric

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Mantzaris

full_name: Gerassimos J. Mantzaris

given: Gerassimos J.

family: Kornbluth

full_name: Asher Kornbluth

given: Asher

family: Rachmilewitz

full_name: Daniel Rachmilewitz

given: Daniel

family: Lichtiger

full_name: Simon Lichtiger

given: Simon

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Diamond

full_name: Robert H. Diamond

given: Robert H.

family: Broussard

full_name: Delma L. Broussard

given: Delma L.

family: Tang

full_name: Kezhen L. Tang

given: Kezhen L.

family: van der Woude

full_name: C. Janneke van der Woude

given: C. Janneke

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease

ReferenceCitation: Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464.

ReferenceCitation: Dubcenco E, Jeejeebhoy KN, Petroniene R, Tang SJ, Zalev AH, Gardiner GW, Baker JP. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005 Oct;62(4):538-44.

ReferenceCitation: Postgate AJ, Burling D, Gupta A, Fitzpatrick A, Fraser C. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008 Oct;53(10):2732-8. doi: 10.1007/s10620-008-0210-5. Epub 2008 Mar 5.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: France Spain

location_facility:
Hôpital Archet 2
Hôpital St Louis
CHU CAEN
CHU Clermont Ferrand
Hospital Clinic
Hôpital Huriez
Hôpital Brabois
Hôpital Hôtel Dieu
CHU Kremlin Bicêtre
CHU Amiens
Hôpital Beaujon


lead_sponsor: Novartis Pharmaceuticals

acronym: CONSTELLATION

source: euctr

title: A 24 Month Open-label, Multicenter, Phase IIIb Study of the Efficacy and Safety of Lucentis® (Ranibizumab 0,5mg) in Diabetic Patients With Visual Impairment Due to Macular Edema Evaluating a Spaced Out Follow-up After Intensive Loading Phase

summary: The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.


title: Essai de Phase IV, Multicentrique, Ouvert, Visant à Tester la différence d'efficacité du Natalizumab, Versus le Fingolimod, 2 médicaments Ayant Une AMM Pour le Traitement de la sclérose en Plaques

acronym: BEST-MS

summary: Under the escalation treatment strategy when a patient displays breakthrough disease parameters under first line therapy, MS physicians are allowed by the EMEA to switch for Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by randomized therapeutic trial. As both treatments have been tested versus placebo a common way to compare them is to look at their respective annualized relapse risk ratio decrease. Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since the placebo group had different behaviour in the 2 trials and the patients demographic features at baseline are also different. Therefore, it is right now totally impossible to compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it. Unfortunately this head-to-head comparison is not available and will not probably be done under the drug companies initiative. During the time of this study, we will perform a phase IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600 patients. Our primary end point will be disease free patients after 1 year of treatment. Further, this trial will allow us to collect new biological samples, useful for a validation our project main aim. Further these new samples will be obtained from 3 European countries, which is a must if we want to generalize our conclusion obtained from a French cohort. Cooperation at the European level is thus essential for the implementation of this project .

lead_sponsor: University Hospital, Toulouse

location_country: Germany France Spain

location_facility:
Chu La Timone
Chu Lille
CHU Nîmes
CHU Caen
Hôpital Vall D'Hebron
CHRU Strasbourg
CHU Bordeaux
Université de Muenter
CHU Besançon
CHU Nantes
CHU Nice
CHU Nancy


title: WEB French Observatory

summary: An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.

lead_sponsor: Sequent Medical, Inc

location_facility:
Hôpital Nord Laennec
CHU Beaujon
CHU Pellegrin
CHU La Miletrie
CHU Reims - Hôpital Maison-Blanche
Hôpital Neurologique Pierre Wertheimer
CHU Bretonneau
CHU Purpan
CHU Pontchailloux
CHU Côte de Nacre


title: Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

summary: Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.

ReferenceCitation: Jacot W, Cottu P, Berger F, Dubot C, Venat-Bouvet L, Lortholary A, Bourgeois H, Bollet M, Servent V, Luporsi E, Espié M, Guiu S, D'Hondt V, Dieras V, Sablin MP, Brain E, Neffati S, Pierga JY, Bidard FC. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019 Nov 14;21(1):121. doi: 10.1186/s13058-019-1215-z.

family: Jacot

full_name: William Jacot

given: William

family: Cottu

full_name: Paul Cottu

family: Berger

full_name: Frederique Berger

given: Frederique

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Venat-Bouvet

full_name: Laurence Venat-Bouvet

given: Laurence

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Bourgeois

full_name: Hugues Bourgeois

given: Hugues

family: Bollet

full_name: Marc Bollet

given: Marc

family: Servent

full_name: Veronique Servent

given: Veronique

family: Luporsi

full_name: Elisabeth Luporsi

given: Elisabeth

family: Espié

full_name: Marc Espié

family: Guiu

full_name: Severine Guiu

given: Severine

family: D’Hondt

full_name: Veronique D’Hondt

family: Dieras

full_name: Veronique Dieras

family: Sablin

full_name: Marie-Paule Sablin

given: Marie-Paule

family: Brain

full_name: Etienne Brain

given: Etienne

family: Neffati

full_name: Souhir Neffati

given: Souhir

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Bidard

full_name: Francois-Clement Bidard

given: Francois-Clement

journal_name: Breast Cancer Research

location_facility:
Institut Curie - Hôpital René HUGENIN
Centre Catherine de Sienne
Centre Oscar Lambret
Chu de Limoges
Institut de Cancérologie de Lorraine
Institut Curie
Institut de Cancérologie HARTMANN
Centre Val d'Aurelle - P. Lamarque
Clinique Victor Hugo
Chu Saint-Louis


title: Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia

acronym: VISMOLY

summary: The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).

location_facility:
CHU Haut Lévèque
CHU Dijon _ Hôpital d'Enfants
CHU Pontchaillou
CHU de Nantes _ Hôtel Dieu
CHRU de Lille _ Hôpital Huriez
Centre Henri Becquerel
Hôpital René Huguenin _ Institut Curie
Hôpital Henri MONDOR
Hôpital Saint-Louis
CH Lyon Sud


lead_sponsor: Nantes University Hospital

location_facility:
CHRU Dijon
Hôpital Saint-Antoine
CHRU - Hôpitaux de Brabois
Pole IUC Oncopole CHU
CHRU - Hôpital du Haut Lévêque
Centre hospitalier départemental Vendée
Centre Hospitalier Lyon sud
CHRU - Hôpital Bretonneau
Nantes University Hospital
CHRU - Hôpital Claude Huriez

type: EudraCT Number

title: Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years

summary:
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.


title: Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.

acronym: CILOVE

summary: This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancerologie de l'Ouest, site Paul Papin


title: Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.

acronym: DOREFA

summary:
Patients with retinal detachment do not always recover good visual function. Sometimes simple causes are responsible. Other causes can only be discovered thanks to high-resolution imaging provided by the latest generation of OCT.

This study is possible thanks to surgical teams who have a strong recruitment potential, with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS) to define more strict intervention criteria. The principal objective of this study is to better define with regard to time:

The onset of surgically curable or transient macular affections, and losses in visual acuity that can be qualified as "explained"
But above all to better understand the relationships between anatomical analyses obtained using OCT and autofluorescence and functional analysis using visual acuity and microperimetry.
In the near future, two techniques (OCT and microperimetry) will certainly become essential tools in the evaluation of macular function. Better understanding of these relationships is the first necessary step in any study concerning the therapeutic prevention of retinal lesions related to retinal detachment: This study will make it possible to define criteria for the evaluation of anatomical and functional recovery, their relationship with each other and finally their evolution over time. This is an essential first phase before possible therapies can be evaluated.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Role of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Patients Wih Leptomeningeal Metastasis of Breast Cancer. A Randomized Phase III Study.

acronym: DEPOSEIN

summary: The purpose of this study is to evaluate the impact of Depocyte® IT combined with the systemic standard treatment in terms of clinical and/or radiological neuromeningeal progression free survival (SSPN)

ReferenceCitation: Le Rhun E, Wallet J, Mailliez A, Le Deley MC, Rodrigues I, Boulanger T, Lorgis V, Barrière J, Robin YM, Weller M, Bonneterre J. Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer. Neuro Oncol. 2020 Apr 15;22(4):524-538. doi: 10.1093/neuonc/noz201.

name: University of Lille, INSERM, Lille, France

name: Neuro-oncology, General and Stereotaxic Neurosurgery service, University Hospital of Lille, Lille, France

name: Breast Cancer Department, Oscar Lambret Center, Lille, France

name: Department of Neurology & Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland

family: Le Rhun

full_name: Emilie Le Rhun

given: Emilie

name: Biostatistics Unit, Oscar Lambret Center, Lille, France

family: Wallet

full_name: Jennifer Wallet

given: Jennifer

family: Mailliez

full_name: Audrey Mailliez

given: Audrey

name: Center for Research in Epidemiology and Population Health (CESP, INSERM), Paris-Sud, Paris-Saclay University, Villejuif, France

family: Le Deley

full_name: Marie Cecile Le Deley

given: Marie Cecile

family: Rodrigues

full_name: Isabelle Rodrigues

given: Isabelle

name: Imaging Department, Oscar Lambret Center, Lille, France

family: Boulanger

full_name: Thomas Boulanger

given: Thomas

name: Department of Medical Oncology, Georges François Leclerc Center, Dijon, France

family: Lorgis

full_name: Veronique Lorgis

name: Department of Medical Oncology, Antoine Lacassagne Center, Nice, France

family: Barrière

full_name: Jerome Barrière

given: Jerome

name: Department of Pathology, Oscar Lambret Center, Lille, France

family: Robin

full_name: Yves Marie Robin

given: Yves Marie

family: Weller

full_name: Michael Weller

given: Michael

family: Bonneterre

full_name: Jacques Bonneterre

given: Jacques

journal_name: Neuro-Oncology

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire Groupe Sud


title: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire

acronym: QASICC-EVA

summary:
Background Patient satisfaction with or acceptance of care assessment is increasingly taken into account in oncology. Most cancer and other critically-ill patients require a totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir connected to a central venous catheter, which may or may not be valved. It is impossible to estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over 7 million CVCs were placed in the United States in both chronic and acute care. Although many patients fitted with a CVC are able to undertake activities which are hindered with other external vascular access devices, they are often physically or psychologically anxious about their device. To our knowledge, no validated questionnaire measuring patient acceptance of and satisfaction with their CVC has been reported in the literature. Based on these observations, the aim of our study was to develop and to validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC. QASICC is designed as a multi-dimensional, self-administered questionnaire comprising approximately 30 items related to the use, appearance and pros and cons of the device as well as quality of life as perceived by patients using one for treatment.

Objective The purpose of the study is to validate a French-language self-administered questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning their totally-implanted central venous catheter: confirmatory validation of questionnaire psychometric properties.

Study Design This is a prospective, multicenter, open study.

Primary Outcome Measures:

Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:

Items quality
Dimensional structure
Dimensional consistence
Measure accuracy
Measure reliability
Sensitivity to change

lead_sponsor: Centre Antoine Lacassagne

location_facility:
Chu La Timone
Centre Antoine Lacassagne
Centre Alexis Vautrin
Institut Jean Godinot
Centre Paul Strauss
Centre Rene Huguenin
Institut Claudius Regaud
Chu de Montpellier
Centre Paul Papin - Ico
Centre Francois Baclesse


title: Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder

acronym: PRESTHYM

summary: Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.

ReferenceCitation: Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Vérin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.

family: Millet

full_name: Bruno Millet

given: Bruno

family: Jaafari

full_name: Nematollah Jaafari

given: Nematollah

family: Polosan

full_name: Mircea Polosan

given: Mircea

family: Baup

full_name: Nicolas Baup

given: Nicolas

family: Giordana

full_name: Bruno Giordana

family: Haegelen

full_name: Claire Haegelen

given: Claire

family: Chabardes

full_name: Stephan Chabardes

given: Stephan

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Devaux

full_name: Bertrand Devaux

given: Bertrand

family: Yelnik

full_name: Jérome Yelnik

given: Jérome

family: Fossati

full_name: Philippe Fossati

given: Philippe

family: Aouizerate

full_name: Bruno Aouizerate

family: Krebs

full_name: Marie Odile Krebs

given: Marie Odile

family: Robert

full_name: Gabriel Robert

given: Gabriel

family: Jay

full_name: Thérèse Jay

given: Thérèse

family: Cornu

full_name: Philippe Cornu

family: Vérin

full_name: Marc Vérin

given: Marc

family: Drapier

full_name: Sophie Drapier

given: Sophie

full_name: Dominique Drapier

given: Dominique

family: Sauleau

full_name: Paul Sauleau

given: Paul

family: Peron

full_name: Julie Peron

given: Julie

family: Jeune

full_name: Florence Le Jeune

given: Florence Le

family: Naudet

full_name: Florian Naudet

given: Florian

family: Reymann

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

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

title: Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: Accumbens more promising than caudate

location_facility: Grenoble University Hospital (Nord Hospital)


title: Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer

acronym: CEOLE

summary: The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

primary_purpose: Supportive Care

ReferenceCitation: Poirier AL, Kwiatkowski F, Commer JM, D'Aillières B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.

family: Poirier

full_name: Anne-Lise Poirier

given: Anne-Lise

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Commer

full_name: Jean-Marie Commer

given: Jean-Marie

family: D'Aillières

full_name: Bénédicte D'Aillières

given: Bénédicte

family: Berger

full_name: Virginie Berger

given: Virginie

family: Mercier

full_name: Mariette Mercier

given: Mariette

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Antoine Lacassagne
Centre Alexis Vautrin
CHU Minjoz
Centre Oscar Lambret
Centre Hospitalier
Centre Georges François Leclerc
ICO Paul Papin
Institut Bergonié
Centre Val d'Aurelle Paul Lamarque
CHU


title: Clinical, Biological, Genetic and Functional Characterization of Rare Iron Overload Phenotypes Associated With Hepcidin Deficiency Except C282Y Homozygosity.

acronym: HEPCIDEF

summary: Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

lead_sponsor: Rennes University Hospital

location_facility:
Saint Eloi Hospital - CHU
CHRU - Huriez Hospital
Lyon Sud Hospital
Hospital Center
BP 86709
Emilie Muller Hospital
Hospital of conception
Limoges CHU
Kremlin-Bicêtre Hospital
Purpan CHU


title: Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

acronym: DIABSURG

summary: The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

lead_sponsor: University Hospital, Lille

location_facility:
Centre Hospitalier Regional D' Angers
University Hospital of Lille
Hopital Jeanne D'Arc Chu Nancy
Hu Pitie Salpetriere Aphp
Hopital Larrey Chu Toulouse
Ch Valenciennes
Hopital de Bois-Guillaume Chu Rouen
Hopital Lyon Sud - Hcl - Pierre Benite
Hu Ouest Site Ambroise Pare Aphp -
Hopital Lapeyronie Chu Montpellier


ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, Rombo L, Tan NC, Rouzier R, Friel D, De Muynck B, De Simoni S, Suryakiran P, Hezareh M, Folschweiller N, Thomas F, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.

ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HML, Lee BW, Rombo L, Tan NC, Rouzier R, De Simoni S, Suryakiran P, Hezareh M, Thomas F, Folschweiller N, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial. Vaccine. 2018 Jan 2;36(1):98-106. doi: 10.1016/j.vaccine.2017.11.034. Epub 2017 Nov 23.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

lead_sponsor: GlaxoSmithKline

location_country:
Singapore
Sweden
France
Hong Kong

acronym: HPV-071 PRI

ipd_sharing: Yes

title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

summary: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.


lead_sponsor: Centre Francois Baclesse

acronym: IgES

location_facility:
CHRU Lille
Centre Georges-François Leclerc
Centre François Baclesse
Centre Oscar Lambret
CHU Charles Nicolle
Centre Paul Strauss
Centre Henri Becquerel
CHU
Centre hospitalier

title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab

summary: The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.


summary:
Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.

lead_sponsor: Poitiers University Hospital

location_facility: CHU DE NANTES - Centre ambulatoire de Gérontologie clinique

location_facility: CHU Angers - service Gérontologie clinique


title: Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial

summary: Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Nice - Pasteur Hospital - Department of Thoracic Surgery

location_facility: CHU Grenoble - Department of Vascular and Thoracic Surgery

location_facility: Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse

location_facility: CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital

location_facility: Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery

location_facility: CHU Strasbourg - Service of Thoracic Surgery

location_facility: CHU Clermont Ferrand - Service of Thoracic Surgery

location_facility: CHU Marseille - Department of Thoracic Surgery


lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice - 4 avenue Reine Victoria
CHU de Dijon
CHU de Bordeaux
CH de Quimper
Clinique Mathilde
CHU de reims
Hôpital Sévigné
Clinique de Turin
CHU de Touloluse
Clinique Saint-jean Languedoc

title: Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

summary:
Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS.

Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.


title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial

summary:
Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.

Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.

ReferenceCitation: Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussière JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15.

family: Meurin

full_name: P Meurin

given: P

family: Lelay-Kubas

full_name: S Lelay-Kubas

given: S

family: Pierre

full_name: B Pierre

given: B

family: Pereira

full_name: H Pereira

given: H

family: Pavy

full_name: B Pavy

family: Iliou

full_name: M C Iliou

given: M C

family: Bussière

full_name: J L Bussière

given: J L

family: Weber

full_name: H Weber

family: Beugin

full_name: J P Beugin

given: J P

family: Farrokhi

full_name: T Farrokhi

given: T

family: Bellemain-Appaix

full_name: A Bellemain-Appaix

given: A

family: Briota

full_name: L Briota

given: L

family: Tabet

full_name: J Y Tabet

given: J Y

journal_name: Heart

lead_sponsor: French Cardiology Society

location_facility:
Clinique les Grands Près
Centre Dieulefit Santé
Hopital Corentin Celton
Maison du mineur
Centre Médical de Bligny
Clinique de Châtillon
Clinique Iris
Centre Hospitalier Loire Vendée Océan
Clinique de la mitterie
Bois Gibert


title: A Multicenter, Open-label, Randomized, Controlled, Two-arm Study to Assess Compliance With Daily Tablet Intake of Women on Treatment With the Oral Contraceptive SH T00186D/BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function Over 12 Months

summary: The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

lead_sponsor: Bayer


ReferenceCitation: Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taillé C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961.

family: Garcia

full_name: Gilles Garcia

given: Gilles

family: Magnan

full_name: Antoine Magnan

given: Antoine

family: Chiron

full_name: Raphaël Chiron

given: Raphaël

family: Contin-Bordes

full_name: Cécile Contin-Bordes

given: Cécile

full_name: Patrick Berger

given: Patrick

family: Taillé

full_name: Camille Taillé

given: Camille

family: Devouassoux

full_name: Gilles Devouassoux

family: de Blay

full_name: Frédéric de Blay

given: Frédéric

family: Couderc

full_name: Louis-Jean Couderc

given: Louis-Jean

family: Didier

full_name: Alain Didier

given: Alain

family: O'Callaghan

full_name: Dermot S. O'Callaghan

given: Dermot S.

family: Girodet

full_name: Pierre-Olivier Girodet

given: Pierre-Olivier

family: Bourdeix

full_name: Isabelle Bourdeix

given: Isabelle

family: Le Gros

full_name: Vincent Le Gros

given: Vincent

family: Humbert

full_name: Marc Humbert

given: Marc

journal_name: Chest

title: A Proof-of-Concept, Randomized, Controlled Trial of Omalizumab in Patients With Severe, Difficult-to-Control, Nonatopic Asthma

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Basic Science

acronym: NATAIR

title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy

summary: This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


lead_sponsor: Pfizer

location_country:
Italy
United Arab Emirates
France
Greece
Hungary
Spain
Turkey
Germany
United Kingdom

acronym: ReSPONSE

location_facility: SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika

location_facility: Gulhane Military Medical Academy, Faculty of Medicine

location_facility: Centre Hopitalier St Jacques (Place St Jacques)

location_facility: Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158

location_facility: Gulhane Askeri Tip Akademisi Tip Fakultesi

location_facility: Clinica Dermatologica - Universita' di Catania

location_facility: Papageorgiou General Peripheral Hospital of Thessaloniki

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio

location_facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie

location_facility: Klinik fuer Dermatologie, Allergologie und Venerologie

location_facility: Hospital General Universitario Alicante C/ Maestro Alonso, 1

location_facility: Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

title: Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment

summary:
This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.


title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

acronym: IRISS

summary: The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

ReferenceCitation: Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan Stroke Study. Stroke. 1995 Jan;26(1):14-20.

ReferenceCitation: EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. 1985 Nov 7;313(19):1191-200.

ReferenceCitation: Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16.

ReferenceCitation: Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. Epub 2006 Jan 23.

ReferenceCitation: Connors JJ 3rd, Wojak JC. Percutaneous transluminal angioplasty for intracranial atherosclerotic lesions: evolution of technique and short-term results. J Neurosurg. 1999 Sep;91(3):415-23.

ReferenceCitation: Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke. 2006 Apr;37(4):1016-20. Epub 2006 Feb 23.

ReferenceCitation: SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. Epub 2004 Apr 22.

ReferenceCitation: Wojak JC, Dunlap DC, Hargrave KR, DeAlvare LA, Culbertson HS, Connors JJ 3rd. Intracranial angioplasty and stenting: long-term results from a single center. AJNR Am J Neuroradiol. 2006 Oct;27(9):1882-92.

ReferenceCitation: Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. Epub 2007 Mar 29.

ReferenceCitation: Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Pride L, Purdy P, Welch B, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella DJ. Wingspan in-stent restenosis and thrombosis: incidence, clinical presentation, and management. Neurosurgery. 2007 Sep;61(3):644-50; discussion 650-1.

ReferenceCitation: Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.

ReferenceCitation: Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. Epub 2007 Jun 21. Review.

ReferenceCitation: Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Trial Investigators. Design, progress and challenges of a double-blind trial of warfarin versus aspirin for symptomatic intracranial arterial stenosis. Neuroepidemiology. 2003 Mar-Apr;22(2):106-17.

ReferenceCitation: Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.

lead_sponsor: Stryker Neurovascular

location_country: Germany France

location_facility:
CHU Toulouse
CHU Limoges
Höpital Gui de Chauliac
Universitätsklinikum Essen
Universitätsklinikum Heidelberg
Universitätsklinikum Dresden
CHU Reims
Groupe Hospitalier Pellegrin
Universitätsklinikum Erlangen
Fondation Rotschild
Hôpital Lariboisière
Universitätsklinikum Düsseldorf
Klinikum Augsburg
Asklepios Klinik Altona
Hôpital Saint-Roch
UKSH Campus Kiel
CHU Hôpital Guillaume et René Laënnec
Universitätsklinikum Freiburg
CHU Dijon-Hopital General


lead_sponsor: Ipsen

acronym: DECAPUB

location_facility:
Hôpital Archet II
Hôpital Hôtel Dieu (CHU)
Hôpital des Enfants
American Memorial Hospital
Hôpital Hautepierre
Hôpital Charles Nicolle
Hôpital de la Gespe
Hôpital Flaubert
Hôpital Robert Debré
Medical Centre

title: Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty

summary: The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.


title: EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware

acronym: EXPRESSO

summary: The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.

lead_sponsor: Biosense Webster EMEA

location_country: Germany Hungary France

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Clinique Pasteur - Unité de Cardiologie interventionnelle

location_facility: Hôpital Privé Jacques Cartier Service de Rhytmologie

location_facility: Hôpital Lariboisière Service de Rhytmologie

location_facility: Hôpital Les Franciscaines Service Rhythmologie


acronym: KinéSEP

title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

summary: Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.