title: Immunomonitoring of Children With Neuroblastoma for the Development of Antitumor Immunotherapy Strategies

acronym: Immuneuro

summary:
Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About 50% of the cases present at diagnosis with factors of bad prognosis. During the last two decades, despite increased therapeutic intensity during induction and consolidation of high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in between 30 to 40% depending on studies.

Besides strategies of high-dose chemotherapy followed by autologous transplantation of hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or molecules obtained such gains of survival ever before.

Studying the immune system of children with neuroblastoma at diagnosis and during their treatment will help us to determine when we should test active or passive immunotherapy strategies. Moreover, this study would allow us to specify the cause of tumor immune tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.

This will be a multicentric, pilot, prospective, open, study that will not require unusual diagnostic interventions. This study will be transversal (all neuroblastoma stages included) in order to determine comparative criteria between low and high risk neuroblastoma. It will also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.

Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment.

ReferenceCitation: Marabelle A, Merlin E, Halle P, Paillard C, Berger M, Tchirkov A, Rousseau R, Leverger G, Piguet C, Stephan JL, Demeocq F, Kanold J. CD34+ immunoselection of autologous grafts for the treatment of high-risk neuroblastoma. Pediatr Blood Cancer. 2011 Jan;56(1):134-42. doi: 10.1002/pbc.22840.

ReferenceCitation: Bertrand A, Marec-Berard P, Raverot G, Trouillas J, Marabelle A. Cabergoline therapy of paraneoplastic Cushing syndrome in children. Pediatr Blood Cancer. 2010 Sep;55(3):589-90. doi: 10.1002/pbc.22581.

ReferenceCitation: Marabelle A, Bergeron C, Billaud G, Mekki Y, Girard S. Hemophagocytic syndrome revealing primary HHV-6 infection. J Pediatr. 2010 Sep;157(3):511. doi: 10.1016/j.jpeds.2010.02.064. Epub 2010 Apr 18.

ReferenceCitation: Marabelle A, Sapin V, Rousseau R, Periquet B, Demeocq F, Kanold J. Hypercalcemia and 13-cis-retinoic acid in post-consolidation therapy of neuroblastoma. Pediatr Blood Cancer. 2009 Feb;52(2):280-3. doi: 10.1002/pbc.21768.

ReferenceCitation: Marabelle A, Campagne D, Déchelotte P, Chipponi J, Deméocq F, Kanold J. Focal nodular hyperplasia of the liver in patients previously treated for pediatric neoplastic diseases. J Pediatr Hematol Oncol. 2008 Jul;30(7):546-9. doi: 10.1097/MPH.0b013e3181691709.

ReferenceCitation: Kanold J, Paillard C, Tchirkov A, Merlin E, Marabelle A, Lutz P, Rousseau R, Baldomero H, Deméocq F. Allogeneic or haploidentical HSCT for refractory or relapsed solid tumors in children: toward a neuroblastoma model. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S25-30. doi: 10.1038/bmt.2008.279. Review.

ReferenceCitation: Kanold J, Merlin E, Halle P, Paillard C, Marabelle A, Rapatel C, Evrard B, Berger C, Stephan JL, Galambrun C, Piguet C, D'Incan M, Bordigoni P, Deméocq F. Photopheresis in pediatric graft-versus-host disease after allogeneic marrow transplantation: clinical practice guidelines based on field experience and review of the literature. Transfusion. 2007 Dec;47(12):2276-89. Epub 2007 Aug 30.

location_facility:
IHOP
Chu - Hopital Nord
Hopital D'Estaing
Chu Grenoble - Hopital Nord


title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.

acronym: EPIC-FOP

summary: The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.

ipd_sharing: No

lead_sponsor: University Hospital, Brest

location_facility:
Army Hospital
CHU Dijon de Bocage
Centre Hospitalier de Cornouaille
Brest University Hospital

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

summary: The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

study_start_date_type: Actual

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Hôpital Guy de Chauliac, CHU de Montpellier

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Other

status_simplified: Unknown


title: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

acronym: Coca-Colon

summary: The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

study_type: Interventional

primary_purpose: Diagnostic

ReferenceCitation: Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.

lead_sponsor: University Hospital, Rouen

location_facility:
Centre Frédéric Joliot
Centre François Baclesse
University Hospital


title: Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation

acronym: RIO

summary: The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

lead_sponsor: University Hospital, Grenoble

location_facility:
Hopital de La Pitie Salpetriere
Hopital de La Croix Rousse
University Hospital
Hopital Nord


title: EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)

summary: SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Headache Emergency Center
Neurology department - La timone
Neurosurvery department
Neurology department - CHU Rangueil

intervention_type: Device


title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

summary: This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug

lead_sponsor_type: industriel


title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

summary: The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.

lead_sponsor: Nantes University Hospital

location_facility:
CHD La Roche-sur-Yon
CH Saint Nazaire
University Hospital of Angers
Nantes University Hospital

intervention_type: Procedure


acronym: RV-405 LAL

title: A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Relapse After 2 Lines of Treatment

lead_sponsor: Institut de Cancérologie de la Loire

type: EudraCT Number

source: euctr

location_facility:
CHU de Clermont-Ferrand
Hôpital Michallon
Hôpital Edouard Herriot
Institut de Cancerologie de la Loire

summary: The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).


title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis

acronym: CDCHC

summary:
Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.

ReferenceCitation: Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Féray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.

location_facility:
Paul Brousse UH
Rennes UH
Jean Verdier UH
Nantes UH

intervention_type: Genetic


type: Other Grant/Funding Number

title: Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge

acronym: MSAJOY

summary:
Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including cerebellar impairment and poor response to dopatherapy. The objective of the study is to assess right-hand motor activation in MSA patients before and after an acute levodopa challenge and to compare these data with those obtained in patients with Parkinson Disease (PD) and healthy volunteers (HV).

Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included. rCBF measurements with H215O PET will be performed at rest and during a right hand movement. Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON condition and effect of levodopa on motor activation.

Hypothesis: MSA and PD patient should recruited different motor networks.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Toulouse

intervention_type: Radiation


title: Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol

acronym: CYTRAM

summary:
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.

O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.

The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).

The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

lead_sponsor: University Hospital, Caen

location_facility:
Caen University Hospital
Private Clinic Saint-Martin
Créteil University Hospital
Rouen University Hospital

intervention_type: Biological


title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

acronym: ATIM

summary: Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Beumer J 3rd, Roumanas E, Nishimura R. Advances in osseointegrated implants for dental and facial rehabilitation following major head and neck surgery. Semin Surg Oncol. 1995 May-Jun;11(3):200-7. Review.

ReferenceCitation: Birkfellner W, Solar P, Gahleitner A, Huber K, Kainberger F, Kettenbach J, Homolka P, Diemling M, Watzek G, Bergmann H. In-vitro assessment of a registration protocol for image guided implant dentistry. Clin Oral Implants Res. 2001 Feb;12(1):69-78.

ReferenceCitation: Brosky ME, Korioth TW, Hodges J. The anterior cantilever in the implant-supported screw-retained mandibular prosthesis. J Prosthet Dent. 2003 Mar;89(3):244-9.

ReferenceCitation: Casap N, Wexler A, Persky N, Schneider A, Lustmann J. Navigation surgery for dental implants: assessment of accuracy of the image guided implantology system. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):116-9.

ReferenceCitation: Casap N, Wexler A, Tarazi E. Application of a surgical navigation system for implant surgery in a deficient alveolar ridge postexcision of an odontogenic myxoma. J Oral Maxillofac Surg. 2005 Jul;63(7):982-8.

ReferenceCitation: Delannes M, Daly NJ, Bonnet J, Sabatier J, Tremoulet M. Fractionated radiotherapy of small inoperable lesions of the brain using a non-invasive stereotactic frame. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):749-55.

ReferenceCitation: Esser E, Wagner W. Dental implants following radical oral cancer surgery and adjuvant radiotherapy. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):552-7.

ReferenceCitation: Esser E, Neukirchen S, Wagner W. [Comparative studies of Brånemark implants in the irradiated and not irradiated mandible]. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S125-9. German.

ReferenceCitation: Fortin T, Coudert JL, Champleboux G, Sautot P, Lavallée S. Computer-assisted dental implant surgery using computed tomography. J Image Guid Surg. 1995;1(1):53-8.

ReferenceCitation: Fortin T, Champleboux G, Lormée J, Coudert JL. Precise dental implant placement in bone using surgical guides in conjunction with medical imaging techniques. J Oral Implantol. 2000;26(4):300-3.

ReferenceCitation: Fortin T, Champleboux G, Bianchi S, Buatois H, Coudert JL. Precision of transfer of preoperative planning for oral implants based on cone-beam CT-scan images through a robotic drilling machine. Clin Oral Implants Res. 2002 Dec;13(6):651-6.

ReferenceCitation: Fortin T, Bosson JL, Coudert JL, Isidori M. Reliability of preoperative planning of an image-guided system for oral implant placement based on 3-dimensional images: an in vivo study. Int J Oral Maxillofac Implants. 2003 Nov-Dec;18(6):886-93.

ReferenceCitation: Fortin T, Isidori M, Blanchet E, Perriat M, Bouchet H, Coudert JL. An image-guided system-drilled surgical template and trephine guide pin to make treatment of completely edentulous patients easier: a clinical report on immediate loading. Clin Implant Dent Relat Res. 2004;6(2):111-9.

ReferenceCitation: Ganslandt O, Mueller R, Mueller W, Borchert H, Grabenbauer GG. Simple invasive fixation device for fractionated stereotactic LINAC based radiotherapy. Acta Neurochir (Wien). 2003 Apr;145(4):289-94; discussion 294.

ReferenceCitation: Gill SS, Thomas DG, Warrington AP, Brada M. Relocatable frame for stereotactic external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):599-603.

ReferenceCitation: Gulizio MP, Agar JR, Kelly JR, Taylor TD. Effect of implant angulation upon retention of overdenture attachments. J Prosthodont. 2005 Mar;14(1):3-11.

ReferenceCitation: Henderson LA, Frysinger RC, Yu PL, Bandler R, Harper RM. A device for feline head positioning and stabilization during magnetic resonance imaging. Magn Reson Imaging. 2001 Sep;19(7):1031-6.

ReferenceCitation: Kamath R, Ryken TC, Meeks SL, Pennington EC, Ritchie J, Buatti JM. Initial clinical experience with frameless radiosurgery for patients with intracranial metastases. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1467-72.

ReferenceCitation: Kassaee A, Das IJ, Tochner Z, Rosenthal DI. Modification of Gill-Thomas-Cosman frame for extracranial head-and-neck stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1192-5.

ReferenceCitation: Marunick MT, Leveque F. Osteoradionecrosis related to mastication and parafunction. Oral Surg Oral Med Oral Pathol. 1989 Nov;68(5):582-5.

ReferenceCitation: Medin PM, Solberg TD, De Salles AA, Cagnon CH, Selch MT, Johnson JP, Smathers JB, Cosman ER. Investigations of a minimally invasive method for treatment of spinal malignancies with LINAC stereotactic radiation therapy: accuracy and animal studies. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1111-22.

ReferenceCitation: Parel SM, Triplett RG. Interactive imaging for implant planning, placement, and prosthesis construction. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):41-7.

ReferenceCitation: Quiñones-Hinojosa A, Ware ML, Sanai N, McDermott MW. Assessment of image guided accuracy in a skull model: comparison of frameless stereotaxy techniques vs. frame-based localization. J Neurooncol. 2006 Jan;76(1):65-70.

ReferenceCitation: Rosenberg I, Alheit H, Beardmore C, Lee KS, Warrington AP, Brada M. Patient position reproducibility in fractionated stereotactic radiotherapy: an update after changing dental impression material. Radiother Oncol. 1999 Feb;50(2):239-40.

ReferenceCitation: Rosenthal SJ, Gall KP, Jackson M, Thornton AF Jr. A precision cranial immobilization system for conformal stereotactic fractionated radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Dec 1;33(5):1239-45.

ReferenceCitation: Scott TW, Beach JL, Mendiondo OA. A precision repeat localization head frame for fractionated stereotactic radiotherapy. Med Dosim. 1997 Spring;22(1):5-8.

ReferenceCitation: Siessegger M, Schneider BT, Mischkowski RA, Lazar F, Krug B, Klesper B, Zöller JE. Use of an image-guided navigation system in dental implant surgery in anatomically complex operation sites. J Craniomaxillofac Surg. 2001 Oct;29(5):276-81.

ReferenceCitation: Sudbrink SD. Computer-guided implant placement with immediate provisionalization: a case report. J Oral Maxillofac Surg. 2005 Jun;63(6):771-4.

ReferenceCitation: Theodorou K, Kappas C, Tsokas C. A new non-invasive and relocatable immobilization frame for fractionated stereotactic radiotherapy. Radiother Oncol. 1998 Jun;47(3):313-7.

ReferenceCitation: Van Steenberghe D, Malevez C, Van Cleynenbreugel J, Bou Serhal C, Dhoore E, Schutyser F, Suetens P, Jacobs R. Accuracy of drilling guides for transfer from three-dimensional CT-based planning to placement of zygoma implants in human cadavers. Clin Oral Implants Res. 2003 Feb;14(1):131-6.

ReferenceCitation: Vrielinck L, Politis C, Schepers S, Pauwels M, Naert I. Image-based planning and clinical validation of zygoma and pterygoid implant placement in patients with severe bone atrophy using customized drill guides. Preliminary results from a prospective clinical follow-up study. Int J Oral Maxillofac Surg. 2003 Feb;32(1):7-14.

ReferenceCitation: Wagner A, Wanschitz F, Birkfellner W, Zauza K, Klug C, Schicho K, Kainberger F, Czerny C, Bergmann H, Ewers R. Computer-aided placement of endosseous oral implants in patients after ablative tumour surgery: assessment of accuracy. Clin Oral Implants Res. 2003 Jun;14(3):340-8.

ReferenceCitation: Watzinger F, Ewers R, Henninger A, Sudasch G, Babka A, Woelfl G. Endosteal implants in the irradiated lower jaw. J Craniomaxillofac Surg. 1996 Aug;24(4):237-44.

ReferenceCitation: Weischer T, Schettler D, Mohr C. Implant-supported telescopic restorations in maxillofacial prosthetics. Int J Prosthodont. 1997 May-Jun;10(3):287-92.

ReferenceCitation: Weischer T, Mohr C. Ten-year experience in oral implant rehabilitation of cancer patients: treatment concept and proposed criteria for success. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):521-8.

ReferenceCitation: Weischer T, Mohr C. Implant-supported mandibular telescopic prostheses in oral cancer patients: an up to 9-year retrospective study. Int J Prosthodont. 2001 Jul-Aug;14(4):329-34.

ReferenceCitation: Widmann G, Widmann R, Widmann E, Jaschke W, Bale RJ. In vitro accuracy of a novel registration and targeting technique for image-guided template production. Clin Oral Implants Res. 2005 Aug;16(4):502-8.

ReferenceCitation: Kooy HM, Dunbar SF, Tarbell NJ, Mannarino E, Ferarro N, Shusterman S, Bellerive M, Finn L, McDonough CV, Loeffler JS. Adaptation and verification of the relocatable Gill-Thomas-Cosman frame in stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 1994 Oct 15;30(3):685-91.

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

location_facility: Hospices Civils de Lyon Service de Consultations et Traitements Dentaires

location_facility: Centre Léon Bérard Service de Chirurgie-Stomatologie


title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

acronym: Pétunia

summary: The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.

ReferenceCitation: Rozé JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.

lead_sponsor: Sodilac

location_facility:
CHU de Nantes
Hôpital Saint Vincent de Paul (AP-HP)
CHU d'Angers
Hôpital de la Pitié Salpétrière

intervention_type: Dietary Supplement


title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

summary:
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).

The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.

Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.

Primary objective:

To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.

Secondary Objectives:

Overall survival.
Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
Histological and seric proteomic exploratory studies.

primary_purpose: Screening

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre Antoine LACASSAGNE
Institut PAOLI-CALMETTES
Centre Léon BERARD
Chu Font-Pre


title: Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)

acronym: RBHP 2008

summary:
Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.

Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Hôpital Haut-Levêque
CHU Purpan
CHU Gabriel-Montpied
Hôpital La Pitié Salpétrière


title: Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.

summary:
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). However, healing of those wounds can be made hard because of soiling induced by urine and/or stool, which is unavoidable in case of wearing nappies.

Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery wound dressing is protected by the application of a waterproof band aid (like Tegaderm®) during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse changes it, causing unpleasantness in low age children (whose epidermal fragility is well known), and sometimes parents worry.

Moreover, those occlusive wound dressings avoid any control of the surgical wound during healing phase.

At the end of the wound-healing time, wound dressings are removed, causing discomfort for children and necessity of a qualified nurse staff at visit times.

Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture in children is made with 5/0) and has its own local antiseptic properties. It does not need to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age distinction) seem to be equivalent to conventional sutures. Finally, its application goes with time saving (in preoperative and during wound-healing phase) and increases comfort for patients.

The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond® (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the acquisition of continence, by a non-inferiority randomized multicentric prospective study.

Two patient groups will be studied, the sutures of one control group will be made with a conventional technique (intradermic surjet surgical suture), and one patient group will be sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality (short- and long-term cosmetic aspect) evaluated by the surgeon.

Two secondary criteria will be studied :

Parental satisfaction
Ease of clinical nursing management Each studied criteria will be evaluated by a numeric score.

location_facility: Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2

location_facility: Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants


title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

acronym: PosoAnes

summary: The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

lead_sponsor: Hopital Foch

location_facility:
CHU Besançon
Hôpital Foch
Hôpital Tenon
Centre Hospitalier de Dreux


title: Development and Validation of Fungal Extraction and Real -Time PCR Assay for the Diagnosis of Medically Important Fungal Infections in Blood Samples.

summary:
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit.

The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. For these reasons, the investigators decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, could contribute strongly to the decision of treating using antifungals, and should monitor the effectiveness and the optimization of antifungal prescriptions.

The investigators' objectives are: First, to validate an extraction method from blood infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood samples of patients (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow the investigators to determine the sensitivity, specificity and reproducibility, negative and predictive values.

Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated.

location_facility:
CHU de Touloluse - hôpital de Rangueil
CAL
CHU de Rennes
CHU de Nice - 4 avenue Reine Victoria


title: Comparison of Two Tranexamic Acid Dose Regimens on Transfusion Needs During Cardiac Surgery With Cardiopulmonary Bypass

acronym: Exacylcardio

summary:
Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA would be as accurate for haemostatic efficacy as higher dose.

The primary objective of this tri-center, prospective, double-blinded, randomised trial is to compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the perioperative blood loss.

In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted.

Patients are divided in two groups: low and high risk surgery. Methods: After written informed consent, patients are randomly assigned to one of the two treatment groups. The low dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30 mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation, and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A blood salvage device will be systematically used. The triggers for transfusion will be: red blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen less than 1g/l . All patients will receive standard anaesthesia and perioperative care.

In 60 consecutive patients in the principal investigator center, 5 blood samples will allow to assess the plasmatic concentration of tranexamic acid at different time of the surgery procedure:

Baseline
5 min after the loading dose
10 min after the beginning of bypass
at the discontinuation of the infusion
1 hour after the discontinuation Plasmatic dosage will be assessed using a high performance liquid chromatography technique.

Patients will be stratified in two groups for the statistical analysis; low and high risk surgery. Analysis will be in intention to treat. 300 patients should be recruited in each group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20% (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion between patients receiving high dose TA regimen and those receiving low dose TA regimen, assuming a power of 80% and a two-tailed value less than 0.05.

ReferenceCitation: Grassin-Delyle S, Tremey B, Abe E, Fischler M, Alvarez JC, Devillier P, Urien S. Population pharmacokinetics of tranexamic acid in adults undergoing cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2013 Dec;111(6):916-24. doi: 10.1093/bja/aet255. Epub 2013 Jul 23.

location_facility: department of anesthesiology, Haut Leveque Hospital

location_facility: department of anesthesiology, Bichat Hospital

location_facility: department of anaesthesiology, CHU Jean Minjoz


title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

acronym: TOTEME

summary:
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.

ReferenceCitation: Kulkarni R, Bellamy E. Nickel-titanium shape memory alloy Memokath 051 ureteral stent for managing long-term ureteral obstruction: 4-year experience. J Urol. 2001 Nov;166(5):1750-4.

ReferenceCitation: Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72.

ReferenceCitation: Pariente JL, Conort P. [Biomaterials used in contact with the urinary tract for urine drainage: catheters and ureteric stents]. Prog Urol. 2005 Nov;15(5):897-906. Review. French.

ReferenceCitation: Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4.

ReferenceCitation: Kehinde EO, Rotimi VO, Al-Awadi KA, Abdul-Halim H, Boland F, Al-Hunayan A, Pazhoor A. Factors predisposing to urinary tract infection after J ureteral stent insertion. J Urol. 2002 Mar;167(3):1334-7.

ReferenceCitation: Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-J ureteral stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007 Jul;21(7):698-702.

ReferenceCitation: Hübner WA, Plas EG, Stoller ML. The double-J ureteral stent: in vivo and in vitro flow studies. J Urol. 1992 Aug;148(2 Pt 1):278-80.

ReferenceCitation: Poulsen AL, Schou J, Ovesen H, Nordling J. Memokath: a second generation of intraprostatic spirals. Br J Urol. 1993 Sep;72(3):331-4.

ReferenceCitation: Laaksovirta S, Välimaa T, Isotalo T, Törmälä P, Talja M, Tammela TL. Encrustation and strength retention properties of the self-expandable, biodegradable, self-reinforced L-lactide-glycolic acid co-polymer 80:20 spiral urethral stent in vitro. J Urol. 2003 Aug;170(2 Pt 1):468-71.

ReferenceCitation: Vaidyanathan S, Soni BM, Oo T, Sett P, Hughes PL, Singh G. Long-term result of Memokath urethral sphincter stent in spinal cord injury patients. BMC Urol. 2002 Nov 11;2:12. Epub 2002 Nov 11.

ReferenceCitation: Perry MJ, Roodhouse AJ, Gidlow AB, Spicer TG, Ellis BW. Thermo-expandable intraprostatic stents in bladder outlet obstruction: an 8-year study. BJU Int. 2002 Aug;90(3):216-23.

ReferenceCitation: Arya M, Mostafid H, Patel HR, Kellett MJ, Philp T. The self-expanding metallic ureteric stent in the long-term management of benign ureteric strictures. BJU Int. 2001 Sep;88(4):339-42.

lead_sponsor: University Hospital, Bordeaux

location_facility: Department of Urology, University Hospital, Toulouse

location_facility: Department of Urology, University Hospital, Limoges

location_facility: Department of Urology, Hospices Civils de Lyon

location_facility: Department of Urology, University Hospital, Bordeaux


title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

acronym: ROTEM

summary:
Cardiac surgery is bleeding requiring transfusion surgery .

The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.

All these changes contribute to increase the need for transfusions during heart surgery.

The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.

100 pateinst (50 in each arm) should be included in this trial.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Limoges

location_facility: Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale


title: Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors, Daily Physical Activity, Dietary Habits and Blood Glucose and Fatty Acids in Coronary Syndromes Patients

acronym: OLIMPIC

summary:
In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.

Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:

an inhospital short health educational program alone
an inhospital short health educational program combined to cardiac rehabilitation
a cardiac rehabilitation program alone

ReferenceCitation: De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomér K, Perk J, Pyörälä K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10.

ReferenceCitation: AHA; ACC; National Heart, Lung, and Blood Institute, Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2006 May 16;47(10):2130-9.

ReferenceCitation: Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. Epub 2007 May 18.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH de Firminy
Centre Médical de Chavanne
CHU de Saint-Etienne
CH de Feurs


title: Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"

acronym: KYPHOK

summary:
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.

This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.

Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.

The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Henri Mondor - Service de Radiologie

location_facility: Hôpital Lariboisière-service de radiologie ostéoarticulaire


title: Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture

acronym: PROME

summary:
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Amiens
UH Caen
UH Lille
Rouen University Hospital


title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

summary: This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


acronym: ERBUS

summary:
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame


title: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

summary:
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).

The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.

We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.

Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.

Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.

Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.

The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.

The study will last 3 years. The number of patient to include is 280.

primary_purpose: Prevention

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique


title: A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

summary: The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Regional - Dermatology


title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

summary:
Primary objective:

To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.

Secondary objectives:

To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

summary: Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. The investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.

lead_sponsor: Nantes University Hospital

location_facility: Service de Neurologie A, Hôpital Gabriel Montpied-BP

location_facility: Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille


title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection

summary: The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

location_facility:
Urgences pédiatriques
POSU pediatrique
Urgences pédiatriques - CHU ROUEN
Urgences pédiatriques CHU de Caen


title: Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

summary: There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Gustave Roussy
Centre Alexis Vautrin
Centre Francois Baclesse
Hôpital de la Croix Rousse


title: Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial

summary: The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.

ReferenceCitation: Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.

lead_sponsor: Poissy-Saint Germain Hospital

location_facility:
André Mignot Hospital
Poisyy Saint-Germain Hospital
Avignon Hospital
Poissy Saint-Germain Hospital


title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

summary: The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
Centre Hospitalier de Montauban
Centre Hospitalier de Castres
Centre Hospitalier Joseph Ducuing


title: Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

acronym: DNA-EVAL

summary:
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.

Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

location_facility: Service des Maladies Infectieuses et Tropicales


title: Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9

summary: Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

ReferenceCitation: Martin JH, Begg EJ, Kennedy MA, Roberts R, Barclay ML. Is cytochrome P450 2C9 genotype associated with NSAID gastric ulceration? Br J Clin Pharmacol. 2001 Jun;51(6):627-30.

ReferenceCitation: Martínez C, Blanco G, Ladero JM, García-Martín E, Taxonera C, Gamito FG, Diaz-Rubio M, Agúndez JA. Genetic predisposition to acute gastrointestinal bleeding after NSAIDs use. Br J Pharmacol. 2004 Jan;141(2):205-8. Epub 2004 Jan 5.

location_facility: : Service d'hépato-gastroentérologie, Hôpital Henri Mondor

location_facility: Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière

location_facility: Service d'hépato-gastroentérologie, Hôpital Saint Antoine

location_facility: Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE


title: Phase II Study of the Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma

summary:
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years

The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test.

The other objective is to evaluate the toxicity

ReferenceCitation: Czuczman MS, Grillo-López AJ, White CA, Saleh M, Gordon L, LoBuglio AF, Jonas C, Klippenstein D, Dallaire B, Varns C. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol. 1999 Jan;17(1):268-76.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42.

ReferenceCitation: 44. Marcus R, et al. (2003). An International Multi-Centre, Randomized, Open-Label, Phase III Trial Comparing Rituximab Added to CVP Chemotherapy to CVP Chemotherapy Alone in Untreated Stage III/IV Follicular Non-Hodgkins Lymphoma. Blood, 102, issue 11, (abstract 87).

ReferenceCitation: O'Connor O, Wright J, Moskowitz CH, Muzzy J, MacGregor-Cortelli B, Hamlin P, Straus D, Trehu E, Schenkein DP, Zelenetz AD. Promising activity of the proteasome inhibitor bortezomib (VELCADE) in the treatment of indolent non-Hodgkin's lymphoma and mantle cell lymphoma: ASH poster session 517-II. J Natl Compr Canc Netw. 2004 Nov;2 Suppl 4:S21-2.

lead_sponsor: Lymphoma Study Association

location_facility:
Hôpital Henri Mondor
Hôpital Saint-Louis
Hôpital Lyon Sud
Institut Gustave Roussy


title: A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

summary: The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Bretonneau
Hôpital Pierre Zobda-Quitman
Centre hospitalier de Pernignan
Hôpital Gabriel Montpied
Hôpital de l'Hotel Dieu
Hôpial Bicêtre
Hôpital Saint-Louis
Hôpital Gustave Dron
Hôpital Purpan
Hôpital Pontchaillou
Hôpital Saint-André
Hôpital Pitié-Salpêtrière
Hôpital Necker
Hôpital Avicenne
Hôpital du Bocage
Hôpital Gui de Chaudiac
Hôpital Bichat
Hôpital Saint-Antoine


title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)

acronym: HOME-PE

summary:
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.

The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.

An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.

The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.

The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).

The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

As regards the rate of patients eventually managed as outpatients.
As regards the rate of patients, in theory, eligible for outpatient care,

primary_purpose: Other

ReferenceCitation: Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28. Review.

ReferenceCitation: Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.

ReferenceCitation: Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galiè N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. Erratum in: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642.

ReferenceCitation: Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

ReferenceCitation: Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.

ReferenceCitation: Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.

lead_sponsor: University Hospital, Angers

location_country: Spain Switzerland France Belgium Netherlands

location_facility: Leiden University Medical Center Leiden,


status: Not yet recruiting

acronym: DICOV

title: Multicenter, Double-blind, Randomized, Placebo-controlled Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia - A Phase IIB, Proof of Concept Study

lead_sponsor: Hospices Civils de Lyon

study_start_date_type: Anticipated

location_facility: Maladies infectieuses et Tropicales CHU Grenoble Rhône-Alpes

location_facility: Clinique des Voies Respiratoires Hôpital Larrey

location_facility: Service de Pneumologie CHU Gabriel Montpied

location_facility: de Pneumologie Groupe Hospitalier du Havre Hôpital

location_facility: Médecine interne, CHMS, Hospices Civils de Lyon

location_facility: Clinique des bronches, de l'allergie et du sommeil Hôpital Nord

location_facility: Service des Maladies Infectieuses et du Voyageur Hôpital Gustave Dron

location_facility: Médecine Interne, Hôpital de la Croix- Rousse, HOSPICES CIVILS DE LYON

location_facility: Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière

location_facility: Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon

location_facility: Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne

location_facility: Service de Maladies infectieuses et tropicales

location_facility: Service de pneumologie, CHLS, Hospices Civils de Lyon

location_facility: Service de pneumologie Hôpital Haut-Leveque

summary:
SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative clinical benefit, particularly in the initial stages facilitating viral eviction. .

Based on the mechanism of action and the available data, diltiazem, administered in the first days post-infection, could facilitate viral eradication in these patients through the stimulation of the innate immune response of cells of the infected respiratory epithelium, actor in the fight against SARS-CoV-2.

In this context, the investigators propose the DICOV trial, to demonstrate the ability of diltiazem to reduce the viral load more rapidly, in patients hospitalized for COVID-19 hypoxemic pneumonia.

status_simplified: Ongoing


title: ANRS 175 RHIVIERA-01: Assessment of HIV Remission Upon Combination Antiretroviral Therapy (cART) Interruption in Early Treated Individuals From ANRS CO6 PRIMO Cohort Carrying the Major Histocompatibility Complex (MHC) B35/53Bw4TTC2 Genotype

summary:
The aim of the trial is to evaluate in ANRS CO6 PRIMO cohort participants if the presence of the MHC B35 (53) Bw4TTC2 genotype favors the control of HIV infection (defined by a viral load (VL) less than 400 cp/mL) after discontinuation of antiretroviral therapy (ART) initiated during primary HIV infection.

The trial will be a pilot "proof of concept", one arm, multicenter, nested in the ANRS CO6 PRIMO Cohort, in which the intervention is treatment interruption (of at least 6 months).

It is planned to include between 20 and 50 participants.

location_facility:
Hôpital Gabriel Montpied
CHI Villeneuve Saint Georges
Hôtel Dieu
Centre Hospitalier du Pays d'Aix
Hôpital Saint-André
Hôpital Avicenne
Hôpital Bretonneau
Hôpital Gui de Chauliac
Hôpital Gustave Dron
Hôpital de l'Hôtel-Dieu
Hôpital Saint-Louis
Hôpital Le Bocage
Hôpital Edouard HERRIOT
La Pitié Salpêtrière
Institut Pasteur
Hôpital Tenon
Hôpital de Purpan
CHD Vendée
Hôpital Lariboisière
Hôpital de Bicêtre
Hôpital Pierre Zobda-Quitman
Hôpital Raymond Poincaré
Hôpital de la Côte de Nacre
Hôpital PELLEGRIN
Hôpital de la Croix Rousse
Hôpital Sainte Marguerite
Hôpital Carémeau
Hôpitaux Universitaires de Strasbourg


title: Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') or or Authorisation for Early Access (AAP). A Prospective Cohort.

summary: This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') or authorisation for early access (AAP) delivered by the French drug agency (ANSM).

status: Recruiting

location_facility: Centre Hospitalier Sud Francilien - Hématologie

location_facility: Hôpital Universitaire Necker Enfants Malades

location_facility: Centre Hospitalier Sud Francilien - Néphrologie


title: A Randomized, Double-blind, Placebo-controlled Phase 2 (2a and 2b) Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia

acronym: POLYCOR

summary:
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3.

Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients.

A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans.

The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

ReferenceCitation: Gaborit B, Dailly E, Vanhove B, Josien R, Lacombe K, Dubee V, Ferre V, Brouard S, Ader F, Vibet MA, Le Thuaut A, Danger R, Flet L, Omnes A, Berly L, Chiffoleau A, Jobert A, Duvaux O, Raffi F; POLYCOR Trial Group. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study. Antimicrob Agents Chemother. 2021 Aug 17;65(9):e0123721. doi: 10.1128/AAC.01237-21. Epub 2021 Aug 17.

ReferenceCitation: Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, Lacombe K, Dubee V, Ader F, Ferre V, Vicaut E, Orain J, Le Bras M, Omnes A, Berly L, Jobert A, Morineau-Le Houssine P, Botturi K, Josien R, Flet L, Degauque N, Brouard S, Duvaux O, Poinas A, Raffi F; POLYCOR study group. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. Trials. 2021 Mar 9;22(1):199. doi: 10.1186/s13063-021-05132-9.

location_country: France Martinique Réunion

location_facility:
CHU Saint Etienne
CHR Orléans La Source
CHU Strasbourg
CHU Angers
CH Métropole Savoie
CH Sud Francilien
Hôpital FOCH
APHP - Hôpital Avicennes
CHU Reims
Hospices Civils Lyon
CHU Amiens Picardie
CHRU Nancy
CH de Mont de Marzan
CHU Nice
CHRU Lille
CH Cornouaille
CH Bretagne Atlantique
Hôpital Saint Antoine
CH de la Côte Basque
CHU Nîmes
CHD Vendée
APHP - Hôpital Tenon
CH René Dubos
CHU Nantes
CH Avignon
CH de La Rochelle
CHU Caen
Hôpital Privé d'Antony
CH Le Mans
CHU La Réunion
CHU Limoges
GHR Mulhouse Sud-Alsace
CHU Martinique
CH Colmar


title: Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

acronym: NeurofilMS

summary:
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: France Martinique

location_facility:
CHU de Rouen
Hopital Timone
CHU de Clermont Ferrand
CHU de Saint Etienne
CH de Poissy
CHU de Besancon
CHU de Nimes
CHU de Caen
CHU de Strasbourg
CHU de Toulouse
CHU de Lille
CHU de Montpellier
CHU de Rennes
CHU de Nice
CHU de Lyon
Hopital Pitie Salpetriere
CHU de Bordeaux
CHU d'Amiens
CHU de Potiers
Hopital Henri Mondor
CHU de Grenoble
Hopital Saint Antoine
CHU de Tours
CHU de Dijon
Fondation Rothschild
CHU de Limoges
CHU de Nancy
CHU de Martinique

intervention_type: Diagnostic Test


type: Other Identifier

title: French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort

acronym: RESPONSE

summary:
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.

To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

location_facility: Centre Hospitalier de Versailles Hôpital Andre Mignot


title: Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

acronym: ALLIANCE

summary: to evalute if therapeutic alliance is related to adherence in JIA

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Femme-Mère-Enfant - HCL
CH Mulhouse
CHU Poitiers
CHU Angers
CHU Bordeaux
CHRU Besançon
Hôpital Nord Franche Comté
CHU Rennes
Hôpital Bicêtre - APHP
CHU Nancy
CHRU Lille
CHU Nîmes
CHRU Strasbourg
CHRU Brest
Hôpital Necker-Enfants Malades - APHP
CHU Martinique
CHU Dijon


title: Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB

summary: This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

lead_sponsor: Hoffmann-La Roche


acronym: FIDEL

title: Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

ReferenceCitation: Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.

location_facility: Maternité Régionale Universitaire de Nancy

location_facility: CHU de Lille, Maternité Jeanne de Flandre

location_facility: Hôpital Saint-Joseph / Pôle Parents - Enfants

location_facility: Les Hôpitaux de Chartres (Hôpital Pasteur)

summary: The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.


title: Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)

acronym: OSICAT

summary:
Targeted population: Patients with heart failure causing hospitalization during the last twelve months.

Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required.

Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

ReferenceType: result

ReferenceCitation: Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartière L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.

lead_sponsor: CDM e-Health

location_facility: Centre Hospitalier d'Avignon - Hospital Henri Duffaut

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Pasteur

location_facility: Centre Hospitalier Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque

location_facility: Centre Hospitalier Universitaire d'Amiens de Picardie

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque

location_facility: Cabinet de Cardiologie - Pôle médical spécialisé

location_facility: Centre de réadaptation cardiovasculaire Midi-Gascogne

location_facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel

location_facility: Centre Hospitalier Intercommunal Castres-Mazamet


title: Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years.

acronym: D-Lay-MS

summary: The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).

status: Active, not recruiting

location_facility: MAILLART Elisabeth - La Pitié Salpétrière

location_facility: Fondation Ophtalmologique Adolphe Rothschild

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: CH de Cornouaille - Site Quimper - Hôpital Laennec

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Martinique - Hôpital Pierre Zobda-Quitman

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

acronym: PHRC CMV

summary: The investigators aim is to determine the incidence of cytomegalovirus resistance to antivirals in a cohort study. The patients are included at their first CMV active infection and are followed during two years thereafter. When criteria for suspected resistance are meet, blood and urine samples are collected for virus isolation and further resistance phenotype, and for resistance genotype determination. Results are compared with baseline samples. Clinical information such as treatment, immunosuppressive regimen and clinical evolution will be collected. Through this study, the investigators aim to organize a national network for the detection and identification of CMV resistant strains that will be useful when new therapeutics will be available.

ReferenceCitation: Germi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.

ReferenceCitation: Hantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.

lead_sponsor: University Hospital, Limoges

location_facility: Virologie - Hôpital La Pitié Salpétrière


title: Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study

summary:
TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier de Belfort Montbéliard

location_facility: Centre Hospitalier Intercommunal Alençon-Mamers


title: Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure Without Known Cardio Vascular or Renal Disease, Stratified on Blood Pressure Control.

acronym: PREVENTA

summary: Evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

summary:
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon

+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.

c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.


title: Study of the Therapeutic Response and Survival of Patients With Metastatic Colorectal Cancer (Stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®

acronym: ONCOGRAM

summary: Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity

ReferenceCitation: Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taïbi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®. Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.

location_facility:
Nimes University Hospital
CHU de TOURS
CHU d'AMIENS
Clinique des Cédres
Hospital Center
Centre Médical MGEN Alfred Leune
CH de BRIVE
CHU de Strasbourg
Limoges University Hospital
CHu de la Martinique
Clermont-Ferrand University Hospital
Bergonié Institut
CHU de POITIERS
CH de Saint Junien


title: Evaluation of the Frequency of Limitation of Activity, Depending on Gender and Age-group, in Patients With Persistent Asthma Consulting a General Practitioner

acronym: ASMAVIE

summary: Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner


title: Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not

acronym: SAISON

summary: To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not controlled) of asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is taken or not.


title: National Survey on GERD Patients (Adults and Children)

acronym: RGO à trav

summary: To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)


title: Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

acronym: ORHEO

summary: The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

ReferenceCitation: Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503. Erratum in: BMC Cancer. 2014;14:720.

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer


title: Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg

summary: The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

ReferenceCitation: Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

acronym: PREDICOM

summary: To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

ReferenceCitation: Sellem E, Rouland JF, Baudouin C, Bron A, Denis P, Nordmann JP, Renard JP. Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination. BMC Ophthalmol. 2010 Mar 26;10:10. doi: 10.1186/1471-2415-10-10.


title: Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.

summary: Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.

lead_sponsor: ATF Implants

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon