title: High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks

acronym: HAPI

summary: Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.

ReferenceCitation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbé V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.

family: Miguel-Montanes

full_name: Romain Miguel-Montanes

given: Romain

family: Hajage

full_name: David Hajage

given: David

family: Messika

full_name: Jonathan Messika

family: Bertrand

full_name: Fabrice Bertrand

given: Fabrice

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

family: Rafat

full_name: Cédric Rafat

given: Cédric

family: Labbé

full_name: Vincent Labbé

given: Vincent

family: Dufour

full_name: Nicolas Dufour

family: Jean-Baptiste

full_name: Sylvain Jean-Baptiste

given: Sylvain

family: Bedet

full_name: Alexandre Bedet

given: Alexandre

family: Dreyfuss

full_name: Didier Dreyfuss

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Use of High-Flow Nasal Cannula Oxygen Therapy to Prevent Desaturation During Tracheal Intubation of Intensive Care Patients With Mild-to-Moderate Hypoxemia*

lead_sponsor: Hôpital Louis Mourier


title: Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).

acronym: RHOKET

summary:
The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.

The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Sanofi

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children - 24 Months

summary: The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies in patients:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier


title: Acceptability, Safety, Pharmacokinetics and Effects on Blood Pressure of a Daily Dose of 0.025 to 0.135 Milligram Per Kilogram of S90652, a Paediatric Formulation of Perindopril, in 2-16 Years Old Hypertensive Children - 3 Month Study

summary: The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril given in hypertensive children


title: Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.

acronym: LECG

summary:
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.

The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

study_start_date_type: Actual

primary_purpose: Supportive Care

ipd_sharing: No

ipd_sharing_description: No sharing

lead_sponsor: Medtronic Bakken Research Center

intervention_type: Other


title: Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

acronym: URSONASH

summary:
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.

The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.

lead_sponsor: Axcan Pharma


title: Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament

summary: The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Beaujon Hospital

location_facility: Departement HPB surgery, Beaujon Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns

acronym: ARCHILACT

summary:
The optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns. Several short and long-term beneficial health effects were attributed to breastfeeding and have induced the increase of human milk in preterm newborns nutrition.

Whereas the chemical composition of infant formula has been optimized to mimic human milk, there is still a major difference between the structure of human milk and commercial infant formulas. It is well known in adult nutrition that the structure of emulsions influences their susceptibility to hydrolysis, such results have been obtained either on in vitro or in vivo studies.

Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.

The physical treatments apply to human milk or more generally to bovine milk to pasteurize or stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance induces whey proteins denaturation and the adsorption of protein aggregates on the surface of the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated lipase. These effects limit intragastric lipolysis in preterm newborns.

Conversely, reduction of milk globules size, by homogenisation of milk, increases the specific surface available for lipase adsorption and limits the lost of fat during enteral administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat absorption of preterm newborns.

The objective of this trial is to evaluate the effects of physical treatments (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk destructuration. This trial is conducted, in vivo, on preterm newborns.

ReferenceType: derived

ReferenceCitation: de Oliveira SC, Bellanger A, Ménard O, Pladys P, Le Gouar Y, Henry G, Dirson E, Rousseau F, Carrière F, Dupont D, Bourlieu C, Deglaire A. Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial. Clin Nutr ESPEN. 2017 Aug;20:1-11. doi: 10.1016/j.clnesp.2017.05.001. Epub 2017 May 15.

family: de Oliveira

full_name: Samira C. de Oliveira

given: Samira C.

sequence: first

family: Bellanger

full_name: Amandine Bellanger

given: Amandine

sequence: additional

family: Ménard

full_name: Olivia Ménard

given: Olivia

family: Pladys

full_name: Patrick Pladys

given: Patrick

family: Le Gouar

full_name: Yann Le Gouar

given: Yann

family: Henry

full_name: Gwénaële Henry

given: Gwénaële

family: Dirson

full_name: Emelyne Dirson

given: Emelyne

family: Rousseau

full_name: Florence Rousseau

given: Florence

family: Carrière

full_name: Frédéric Carrière

given: Frédéric

family: Dupont

full_name: Didier Dupont

given: Didier

family: Bourlieu

full_name: Claire Bourlieu

given: Claire

family: Deglaire

full_name: Amélie Deglaire

given: Amélie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Nutrition ESPEN

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: de Oliveira SC, Bellanger A, Ménard O, Pladys P, Le Gouar Y, Dirson E, Kroell F, Dupont D, Deglaire A, Bourlieu C. Impact of human milk pasteurization on gastric digestion in preterm infants: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):379-390. doi: 10.3945/ajcn.116.142539. Epub 2017 Jan 4.

full_name: Samira C de Oliveira

given: Samira C

family: Kroell

full_name: Florian Kroell

given: Florian

journal_name: The American Journal of Clinical Nutrition


type: Other Identifier

title: Anxiety of Patient and His Partner During Admission to Emergency Department

acronym: ANXURG

summary: Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Toulouse


title: Prognostic and Predictive Impact of Circulating Tumor DNA in Advanced and Localized Gastric Cancer Treatment

acronym: PLAGAST

summary:
The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. The management of treatment for gastric cancer needs the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.

Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy regimen.

lead_sponsor: Association des Gastroentérologues Oncologues


title: In Vivo Evaluation of the Nipro Elisio™ Dialyzer

summary: The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

lead_sponsor: Nipro Europe N.V.

intervention_type: Device


title: Multicenter, Controlled Parallel Groups Trial to Evaluate the Efficacy, Safety and Acceptability of OGT Oromucosal Spray Versus a Saliva Substitute in the Treatment of Xerostomia in Geriatrics

summary: The primary objective of the trial is to evaluate the efficacy, safety and clinical acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in comparison with a saliva substitute (European Medical Device).

ReferenceType: background

ReferenceCitation: Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75. Review.

lead_sponsor: Laboratoires CARILENE


title: MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting

summary: The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting

lead_sponsor: Hopital Jean Minjoz


title: Evolution of Visual Impairment During Pseudoxanthoma Elasticum

summary:
Pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000. There is a female preponderance with a sex-ratio of 2:1. PXE is transmitted according either to an autosomal dominant mode or to an autosomal recessive one. Mutations in the ABCC6 gene on chromosome 16p13.1 have recently been identified causing PXE. The elastic fibers slowly become mineralized mainly in the skin, the eyes, and the cardiovascular system. PXE is a multisystem disease that includes a spectrum of clinical manifestations affecting the skin, the eye or the cardiovascular system as well as other tissues. It can be responsible for severe and life threatening complications. Skin changes are usually the first manifestations and begin in early childhood. The vital prognosis of PXE depends on the severity of the cardiovascular lesions that could be responsible for sudden death in children and young adults.

Ocular manifestations are quite constant and include chorioretinal scarring, pigmentary changes or angioid streaks. The natural evolution of the angioid streaks leads to their enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages leaving macular scares. A self-monitoring is recommended since early treatment of subfoveal CNV is the only way to minimize their pejorative consequences. The gold standard treatment of the CNV consists in the photocoagulation. New therapeutics has been developed including photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be effective to reduce the immediate complications of a limited CNV. This evolution explains that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes. However, little is known about the age of occurrence of visual impairment in PXE patients. That is the reason why we decided to review the ophthalmologic status and visual history of our population of PXE patients according to their age.

time_perspective: Retrospective

ReferenceCitation: Pakalnis L, Makoroto J. Reproduction and the test tube baby. Can Nurse. 1977 Feb;73(2):34-8.

lead_sponsor: European Georges Pompidou Hospital


title: Randomized Prospective Multicenter Study of Non Invasive Ventilation Assessment for Weaning From Mechanical Ventilation in Patients With Chronic Respiratory Failure. NIV and Weaning (VENISE)Trial.

acronym: VENISE

summary:
The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of intensive care. Therefore, it could be interesting to use NIV for delivering effective ventilatory support and reduce the length of ETMV in ACRF patients still not capable to maintain spontaneous breathing. From the interesting but discordant results of two recent randomised controlled trial, a working group from the Société de Réanimation de Langue Française (SRLF) decided to perform a new prospective randomised controlled and multicenter trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning technique in ventilated ACRF patients. The methodology used compares three weaning strategies in parallel in ACRF patients considered difficult to wean : invasive conventional weaning (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV (group C). Based on the main end-point defined as the weaning success/failure rate, 208 patients from17 investigator centers are planned to be included. Results of the study will also allow to assess the respective impact of the three weaning strategies on the length of ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay and mortality.

Results of the VENISE trial should permit to improve the management of the difficult to wean ACRF patients and thus to contribute to more define the place of NIV among the weaning and prevention of re-intubation strategies in these patients.

ReferenceCitation: Girault C, Chajara A, Dachraoui F, Chambaretaud V, Hellot MF, Benichou J, Bonmarchand G; Groupe d'Etude VENISE. [VENISE: Non-invasive ventilation during mechanical ventilation weaning in chronic respiratory failure patients. A prospective randomised controlled and multicenter trial]. Rev Mal Respir. 2003 Dec;20(6 Pt 1):940-5. French.

ReferenceCitation: Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guérin C, Guiot P, Bénichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC.

family: Girault

full_name: Christophe Girault

given: Christophe

family: Bubenheim

full_name: Michael Bubenheim

given: Michael

family: Abroug

full_name: Fekri Abroug

given: Fekri

family: Diehl

full_name: Jean Luc Diehl

given: Jean Luc

family: Elatrous

full_name: Souheil Elatrous

given: Souheil

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Richecoeur

full_name: Jack Richecoeur

given: Jack

family: L'Her

full_name: Erwan L'Her

given: Erwan

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Capellier

full_name: Gilles Capellier

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

family: Besbes

full_name: Mohamed Besbes

given: Mohamed

family: Guérin

full_name: Claude Guérin

given: Claude

family: Guiot

full_name: Philippe Guiot

given: Philippe

family: Bénichou

full_name: Jacques Bénichou

given: Jacques

family: Bonmarchand

full_name: Guy Bonmarchand

given: Guy

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Noninvasive Ventilation and Weaning in Patients with Chronic Hypercapnic Respiratory Failure

lead_sponsor: University Hospital, Rouen

location_facility: Rouen University Charles Nicolle Hospital


title: Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

summary: The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

primary_purpose: Prevention

ReferenceCitation: Quintard H, Pavlakovic I, Mantz J, Ichai C. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study. Ann Intensive Care. 2012 Jul 16;2(1):29. doi: 10.1186/2110-5820-2-29.

family: Quintard

full_name: Hervé Quintard

given: Hervé

family: Pavlakovic

full_name: Isabelle Pavlakovic

given: Isabelle

family: Mantz

full_name: Jean Mantz

given: Jean

family: Ichai

full_name: Carole Ichai

given: Carole

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Review of the Paediatric Pleuropulmonary Blastoma French Series

acronym: PPB

summary:
Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were identified in 2009.

Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid. Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is possible from type 1 to type 2 or 3 in 10% of the cases.

Since 2009, DICER 1 mutations research is proposed systematically to all families.

PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can be difficult because of the proximity with congenital cystic adenomatoid malformation.

The French society of paediatric oncology recommends surgery at first instance. PPB type 1 remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy depends on the PPB type and the quality of the resection. There is a real interest to analyse the French series.

The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1 survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary invasion and quality of surgery.

Early local relapses are possible and late ones concern more often type 2 and 3 with more cerebral metastasis.

In 2009, the french cases were collected, but no update has been performed since. The aim of this retrospective review of the cases since 2000, is to audit the care of PPB patients in France and update the French rare tumour database.

Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion and PPB type 1. Radiological presentation is however overlapping. Another aim of this study will be to look for a predictive sign of type 1 PPB.

lead_sponsor: Rennes University Hospital

location_facility:
Montpellier University Hospital
Kremlin-Bicêtre Hospital
Lille University Hospital
Grenoble University Hospital
Lyon Universty Hospital
Curie Institute
Nice University Hospital
Marseille University Hospital
Réunion University Hospital
Tours University Hospital
Gustave Roussy Institute
Caen University Hospital
Angers University Hospital
Poitiers University Hospital
Nantes University Hospital
Bordeaux University Hospital
Toulouse University Hospital
Necher Hospital


title: Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial

acronym: SKIPA

summary: Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)

status: Recruiting

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Oximetrie Transcutanee et Ischemie Critique

acronym: CITRA

summary: Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

ipd_sharing: Undecided

ipd_sharing_description: Data available under reasonable request to the investigator


title: Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte

acronym: BREIZH-Cohorte

summary: The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

intervention_type: Biological


title: Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure

acronym: FIT-H

summary:
Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE during hormonal exposure, thrombophilia testing is often performed in order to adapt contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such practice is probably not accurate nor discriminent. Indeed, there are evidence that the impact of the familial history of VTE might be stronger than that of detectable inherited thrombophilia.

The "FIT-H" study is a cross-sectional study comparing the prevalence of previous venous thromboembolism in first-degree relatives of women (propositi) who had a first episode of venous thromboembolism in association with hormonal exposure with the prevalence of previous venous thromboembolism in first-degree relatives of women who did not have venous thromboembolism during a similar hormonal exposure.

The primary objective is to determine the association between the presence or the absence of VTE in young women during hormonal exposure and the presence or the absence of a previous episode of VTE in their first-degree relatives. Secondary objective is to determine the impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.


title: A One-year, Single-arm, Open-label, Multicenter Study Assessing the Anatomic Outcomes of Brolucizumab Assessed by OCT-A in Adult Patients With Neovascular Age Related Macular Degeneration

acronym: OCTOPUS

summary:
Neovascular age-related macular degeneration (nAMD) is characterized by the presence of choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.

The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter, double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and image CNV and vascular diseases of the retina was not included in previous brolcuizumab studies.

This single-arm, open-label, multicenter study is being performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD.

OCT-A will be used in this study to assess the morphological response of patients to brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week 12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to Week 48.

Approximately 428 adult patients will be screened and included in approximately 75 centers in France.

The maximum study duration for 1 patient is 48 weeks.

Patients will be required to attend 6 mandatory study visits: Screening/Baseline Visit (Day 1), Week 4, Week 8, Week 12, Week 16 and Week 48 visits. The timing of the interim visits between Week 16 and Week 48 will depend on the patient's injection regimen, i.e. every 8 weeks or every 12 weeks according to disease activity assessed by the investigator.

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals


title: Thromboembolic Risk Stratification by TRIP Score (Cast) to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or Casting.

acronym: CASTING

summary:
Non-surgical traumas to the lower limbs that require orthopedic immobilisation (plaster or splint) are a frequent reason for going to accident and emergency. Due to venous stasis caused by immobilisation, hypercoagulable states and vascular injuries brought on by the trauma, these patients are at risk of developing VTE. For this reason, it is current practice in France and Belgium for the majority of patients to receive a preventative anticoagulant treatment. However, the benefit of this treatment, which has a considerable cost, is controversial. Contrary to French recommendations, American recommendations from 2012 actually advise against systematic preventative medicine, with prevention appearing to be effective primarily in studies with restrictive inclusion criteria. The most significant randomised controlled study on the subject did not show the benefit of low-molecular-weight heparin (LMWH) on the rate of symptomatic VTE among 1,435 non-selected patients. Therefore, in 2017, the Cochrane meta-analysis concluded that stratification of the risk of thromboembolism is required.

For this purpose, in collaboration with the Dutch team of Nemeth et al. we have recently developed a risk stratification model that takes into consideration the patient's characteristics, the type of immobilisation and the severity of the trauma: the TRiP(cast) score. This score is applied retrospectively to a large cohort and demonstrates excellent prognostic performances (AUC (area under the curve) of 0.74). In addition, when using a <7 limits, it makes it possible to identify a large group of patients at very low risk of developing VTE (negative predictive value: 99.2%).

The aim of the CASTING study is to prospectively demonstrate the reliability and utility of the TRiP(cast) score by showing that patients with orthopaedic immobilisation of a lower limb who are not receiving preventative treatment on the basis of a TRiP(cast) score of <7 have a very low rate of symptomatic VTE, which allows for a significant reduction in prescriptions of anticoagulants in comparison with prior practices.

ReferenceCitation: Douillet D, Riou J, Thoma M, Moumneh T, Darsonval A, Trinh-Duc A, Hugli O, Chauvin A, Penaloza A, Roy PM. Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial. BMJ Open. 2021 Jun 28;11(6):e045905. doi: 10.1136/bmjopen-2020-045905.

family: Douillet

full_name: Delphine Douillet

given: Delphine

family: Riou

full_name: Jeremie Riou

given: Jeremie

family: Thoma

full_name: Maximilien Thoma

given: Maximilien

family: Moumneh

full_name: Thomas Moumneh

given: Thomas

family: Darsonval

full_name: Astrid Darsonval

given: Astrid

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

family: Hugli

full_name: Olivier Hugli

given: Olivier

family: Chauvin

full_name: Anthony Chauvin

given: Anthony

family: Penaloza

full_name: Andrea Penaloza

given: Andrea

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing_description: Individual participant data will not be available. The study protocol, the Statistical Analysis Plan, Informed consent form will be available immediately following publication. No end date.

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

acronym: FaisPLASTICITE

summary:
This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble


title: Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.

acronym: TETRAMINF

summary:
Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.

The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.

ReferenceCitation: Mateo S, Di Rienzo F, Reilly KT, Revol P, Delpuech C, Daligault S, Guillot A, Jacquin-Courtois S, Luauté J, Rossetti Y, Collet C, Rode G. Improvement of grasping after motor imagery in C6-C7 tetraplegia: A kinematic and MEG pilot study. Restor Neurol Neurosci. 2015;33(4):543-55. doi: 10.3233/RNN-140466.

lead_sponsor: Hospices Civils de Lyon

location_facility: Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine

location_facility: Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle

intervention_type: Behavioral


type: Registry Identifier

title: Assessment of Sense of Identity in Patients With a Diagnosis of Borderline Personality Disorder Through Autobiographical Memory and the Contents of Self-defining Memories, Compared to a Group of Healthy Individuals. A Pilot Study

acronym: MASB

summary:
One of the key features and long considered a fundamental element of Borderline Personality Disorder is the disruption of identity. Autobiographical memory is closely linked to the development and maintenance of a coherent, stable sense of self. It enables the individual to understand who he or she is. The investigators hypothesize that individuals diagnosed with Borderline Personality Disorder have a less coherent, stable sense of the self than healthy controls. The aim of the study is therefore to compare the sense of identity between a group of patients diagnosed with Borderline Personality Disorder and a group of healthy individuals (without Borderline Personality Disorder ).

This can be measured by evaluating the content of the self-defining memory using the Self-Defining Memory scale.

ReferenceCitation: Moffitt KH, Singer JA. Continuity in the Life Story: Self-Defining Memories, Affect, and Approach/Avoidance Personal Strivings. Journal of Personality.1994; 62(1), 21-43

ReferenceCitation: Singer, J. A., & Moffitt, K. H. An experimental investigation of specificity and generality in memory narratives. Imagination, Cognition and Personality. PsycINFO Database Record (1991-1992)11(3), 233-257.

ReferenceCitation: Bluck S, Alea N. Crafting the TALE: construction of a measure to assess the functions of autobiographical remembering. Memory. 2011 Jul;19(5):470-86. doi: 10.1080/09658211.2011.590500.

ReferenceCitation: Johnson MK, Foley MA, Suengas AG, Raye CL. Phenomenal characteristics of memories for perceived and imagined autobiographical events. J Exp Psychol Gen. 1988 Dec;117(4):371-6.

ReferenceCitation: Bernstein, D. P., Fink, L., Handelsman, L., & Foote, J. Childhood Trauma Questionnaire (CTQ) [Database record].(1994) APA PsycTests. https://doi.org/10.1037/t02080-000

ReferenceCitation: Spitzer, Robert L, Williams Janet BW, Gibbon Miriam, First Michael B, Structured Clinical Interview for DSM-III-R Axis II Disorders,(SCID-II), Washington, D.C.: American Psychiatric Press, Inc., 1990

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment

acronym: CHARTE-ODF

summary:
Dental occlusion is the reciprocal confrontation of the two dental arches. The child has two set of temporary and permanent teeth and passes through different stages of dentition during which dental, skeletal or functional abnormalities may appear.

Dental malocclusion is defined as an incorrect position of the teeth in the bone base, as well as the incoordination of the teeth of the opposite arches or the displacement of the maxillary and mandibular skeletal bases.

When a malocclusion is detected during clinical examination, patients are referred to an orthodontic specialist. The interception in orthodontics is carried out during a growing period; it consists of correcting or reducing malocclusions in evolution and eliminating the functional causes to prevent aggravation of skeletal and dental abnormalities.

An epidemiological study conducted in France on 789 children showed that 37.4% had at least one type of dental malocclusion. In 2010, a study of 5988 French children showed that 14% of them had received orthodontic treatment. These studies reveal a discrepancy between treatment needs and treatments conducted. In addition, certain dental malocclusions and skeletal disorders, such as lateral and anterior crossbite, require early orthodontic treatment in order to avoid aggravation of the occlusion disorder and induction of craniofacial growth disorders. Unfortunately these discrepancies are not always detected by the caregivers (pediatrician, general dentist, pediatric dentist).

A schematic representation of malocclusions in temporary and mixed dentition requiring orthodontic interception has been developed by the investigator's team to provide a simple visual means of identifying these dental and skeletal disorders in order to improve early screening by practitioners involved in the mandatory medical follow-up of children.

location_facility: Neurologie Pédiatrique - Hôpital Bicêtre

location_facility: Odontologie Pédiatrique - Hôpital Bretonneau

location_facility: Hôpital de jour pédiatrique - Hôpital Louis Mourier

location_facility: Service d'odontologie - Hôpital Bretonneau

location_facility: Endocrinologie et diabète de l'enfant - Hôpital Bicêtre

location_facility: Odontologie Pédiatrique - Hôpital Louis Mourier

location_facility: Servide d'odontologie - Hôpital Louis Mourier


type: EudraCT Number

title: Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock

acronym: THANE

summary:
The purpose of this study is :

- to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.

status: Active, not recruiting


title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)

acronym: SiMaT-B

summary:
Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.

Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.

ReferenceType: result

ReferenceCitation: Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan 30.

family: Cailhol

full_name: Lionel Cailhol

given: Lionel

family: Roussignol

full_name: Bruno Roussignol

given: Bruno

family: Klein

full_name: Rémy Klein

given: Rémy

family: Bousquet

full_name: Benjamin Bousquet

given: Benjamin

family: Simonetta-Moreau

full_name: Marion Simonetta-Moreau

given: Marion

family: Schmitt

full_name: Laurent Schmitt

given: Laurent

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Tap

full_name: Gérard Tap

given: Gérard

family: Birmes

full_name: Philippe Birmes

given: Philippe

journal_name: Psychiatry Research

title: Borderline personality disorder and rTMS: A pilot trial


title: Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep

acronym: SONAR

summary: Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).


title: Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

acronym: CLOWN-TOX

summary: In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers

ReferenceCitation: Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7.

ReferenceCitation: Hansen LK, Kibaek M, Martinussen T, Kragh L, Hejl M. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study. J Pain Res. 2011;4:297-300. doi: 10.2147/JPR.S23199. Epub 2011 Sep 21.

ReferenceCitation: Molenaers G, Schörkhuber V, Fagard K, Van Campenhout A, De Cat J, Pauwels P, Ortibus E, De Cock P, Desloovere K. Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency. Eur J Paediatr Neurol. 2009 Sep;13(5):421-9. doi: 10.1016/j.ejpn.2008.07.008. Epub 2008 Nov 1.

family: Molenaers

full_name: Guy Molenaers

given: Guy

family: Schörkhuber

full_name: Verena Schörkhuber

given: Verena

family: Fagard

full_name: Katrien Fagard

given: Katrien

family: Van Campenhout

full_name: Anja Van Campenhout

given: Anja

family: De Cat

full_name: Jos De Cat

given: Jos

family: Pauwels

full_name: Petra Pauwels

given: Petra

family: Ortibus

full_name: Els Ortibus

given: Els

family: De Cock

full_name: Paul De Cock

given: Paul

family: Desloovere

full_name: Kaat Desloovere

given: Kaat

journal_name: European Journal of Paediatric Neurology

oa_host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

title: Long-term use of botulinum toxin type A in children with cerebral palsy: Treatment consistency

ReferenceCitation: Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. Review.

ReferenceCitation: Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Rémy-Néris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys Rehabil Med. 2009 Dec;52(10):704-16. doi: 10.1016/j.rehab.2009.09.001. Epub 2009 Oct 6.

family: Brochard

full_name: S. Brochard

given: S.

family: Blajan

full_name: V. Blajan

given: V.

family: Lempereur

full_name: M. Lempereur

given: M.

family: Le Moine

full_name: P. Le Moine

given: P.

family: Peudenier

full_name: S. Peudenier

family: Lefranc

full_name: J. Lefranc

given: J.

family: Rémy-Néris

full_name: O. Rémy-Néris

given: O.

journal_name: Annals of Physical and Rehabilitation Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Bayon-Mottu M, Gambart G, Deries X, Tessiot C, Richard I, Dinomais M. Pain during injections of botulinum toxin in children: Influence of the localization technique. Ann Phys Rehabil Med. 2014 Dec;57(9-10):578-86. doi: 10.1016/j.rehab.2014.09.010. Epub 2014 Oct 8.

ReferenceCitation: Houx L, Dubois A, Brochard S, Pons C. Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children? Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.


title: Randomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid

acronym: RITUX-MMP

summary:
Mucous membrane pemphigoid (MMP) describes a group of chronic auto-immune bullous diseases (AIBD) of the basement membrane zone (BMZ), characterized by predominant or exclusive mucosal involvement, including oral, naso-pharyngeal, laryngo-tracheal, genital, oesophageal, anal and ocular mucous membranes. Circulating autoantibodies are directed against various antigens of the BMZ: BP180, laminin 332 and type 7 collagen. MMP is a rare disease with an incidence of 1.8 new cases/million inhabitants/year in France.

Scar formation which is secondary to initial inflammation, is a characteristic feature of MMP, leading to major disability (e.g blindness and oesophageal, anal, vaginal stenosis) and life-threatening situations (e.g. laryngeal stenosis leading to respiratory failure).

Dapsone is the first line treatment of mild/moderate forms of MMP. Dapsone is used both as initial treatment, and as maintenance therapy. However, severe forms of MMP can rapidly worsen leading to blindness, aphagia due to esophageal stenosis, respiratory failure due to tracheal or laryngeal stenosis, and urinary and sexual dysfunctions due to genital involvement. These patients are usually treated using immunosuppressive drugs. Indeed, corticosteroids (CS) are not recommended in MMP.

Cyclophosphamide was considered as the most effective immunosuppressant in severe forms of MMP, before the use of rituximab, an anti-CD20 monoclonal antibody (MAb).

Two series from our group have assessed the advantages and disadvantages of IV pulse and oral administration of cyclophosphamide in MMP. Oral administration seems more rapidly effective with 54% of complete remission (CR) after a median time of 24 weeks (16-52 weeks).

The results of 41 patients with severe types of MMP (including a French series of 20 patients) treated with rituximab have been published. Rate of CR after one and two cycles were 66% and 90%, respectively. Clinical improvement was rapid, since a decrease in disease activity was observed after 4 weeks of treatment in 64% of patients.

Our results and those of the literature suggest that rituximab might be more effective than cyclophosphamide, which has been considered as the gold standard of treatment in severe forms of disease, up to now.

location_facility:
Brest University Hospital
CH Le Mans
CHU Clermont Ferrand
APHP Avicennes
APHP Saint-Louis
CHU Montpellier
CHU Nantes
APHP Cochin
HCL
APHM La Timone
CHU Amiens
CHU saint-Etienne
CH Quimper
CH Argenteuil
APHP Pitié Salpétrière
CHU Dijon
CHU Bordeaux
APHP Henri Mondor
APHP Bichat
CHU Angers
CHU de Reims
CHU de Limoges
CHU Caen
CHU Tours
CHU Nice
CHU Lille
CHU Rennes


title: A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART)

acronym: NACRE

summary:
Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way.

The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility.

Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option.

When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery.

Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day.

The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids.

Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery.

5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility.

Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms.

The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.

lead_sponsor: ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO

location_country:
New Caledonia
France

location_facility: Centre Hospitalier Territorial Gaston Bourret

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Cmco - University Hospitals of Strasbourg


title: Prospective, Non-randomized, Single Center Clinical Study of Cervical Interbody Fusion Using a Viral-inactivated Allogeneic Graft

summary: This is a prospective, single arm, single center clinical study to evaluate efficacy and safety of a Supercritical CO2 viral-inactivated allogenic bone paste in cervical interbody fusion. Patient eligible for 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft after failure of well-conducted medical treatment will be screened for the study.

lead_sponsor: Biobank


title: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications

acronym: FAV ss ALR

summary:
Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. The primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis.

Local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. Multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics.

Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It enables an increased flow rate at an early time fistula and faster maturation.

However, studies included low numbers of patient or are non-randomized. They cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia .

This study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia

location_facility: Hopital Edouard Herriot - Service Anesthésie et Réanimation


title: Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.

summary: NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.

ReferenceCitation: Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

ReferenceCitation: Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE® dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

ReferenceCitation: Pasman W, Wils D, Saniez MH, Kardinaal A. Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. Eur J Clin Nutr. 2006 Aug;60(8):1024-34. Epub 2006 Feb 15.

ReferenceCitation: Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24.

lead_sponsor: Nealth Sarl

location_facility: Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

intervention_type: Dietary Supplement


title: Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.

summary:
Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones.
The objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months.
For this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.

ReferenceCitation: Nomura Y, Oohashi K, Watanabe M, Kasugai S. Increase in bone mineral density through oral administration of shark gelatin to ovariectomized rats. Nutrition. 2005 Nov-Dec;21(11-12):1120-6.

ReferenceCitation: Takeuchi Y, Nakayama K, Matsumoto T. Differentiation and cell surface expression of transforming growth factor-beta receptors are regulated by interaction with matrix collagen in murine osteoblastic cells. J Biol Chem. 1996 Feb 16;271(7):3938-44.

ReferenceCitation: Wu J, Fujioka M, Sugimoto K, Mu G, Ishimi Y. Assessment of effectiveness of oral administration of collagen peptide on bone metabolism in growing and mature rats. J Bone Miner Metab. 2004;22(6):547-53.

ReferenceCitation: Guillerminet F, Beaupied H, Fabien-Soulé V, Tomé D, Benhamou CL, Roux C, Blais A. Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Bone. 2010 Mar;46(3):827-34. doi: 10.1016/j.bone.2009.10.035. Epub 2009 Nov 4.

location_facility: CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE


title: Randomised Phase II/III Study, Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced, Unresectable and/or Metastatic Bile Duct Tumours

acronym: AMEBICA

summary:
Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their therapeutic management is complex and must be multidisciplinary in nature. Most of the time, an endoscopic or radiological biliary drainage is necessary before any tumour treatment.

Their prognosis is poor due to the fact that they are normally diagnosed late, which makes curative surgery impossible. A population study in the Côte d'Or region of France reported a survival rate at 5 years of approximately 10%.

For the locally advanced or metastatic forms, treatment has not been properly codified. With respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour (bile duct and pancreas tumours). Treatment with 5FU alone provides an objective response in approximately 10% of cases. In combination with mitomycin or carboplatin, the objective response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU has a better response rate (30%), but occurrences of different types of toxicity are more frequent.

More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50% of patients with a median survival period of 10 months. Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months.

The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced unresectable and/or metastatic bile duct cancer. The results were in favour of the combined treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 [0.52 - 0.80]). This combination is currently the reference first-line treatment.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre de radiothérapie et oncologie du Parc


title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer

summary: The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

lead_sponsor: AstraZeneca

location_facility:
Research SIte
Research Site


title: Finding Retinal Biomarkers in Alzheimer's Disease

acronym: FIREBALZ

summary:
CSF Alzheimer's disease (AD) biomarkers are the only one that reflect both Aβ and tau pathologies. There is increasing evidence for the presence of AD abnormalities in the retina of AD patients. Recent studies showed that they can be detected in living patients. Thus, retinal AD-linked abnormalities might be used as alternative diagnostic biomarkers for AD.

FIREBALZ study aims at identifying and validating retinal biomarkers for the diagnosis of Alzheimer's disease.

The study will include 160 patients in whom LP is indicated for assessment of CSF AD biomarkers according to French health authority (HAS) recommendations. Those patients will undergo a detailed neuro-ophtalmologic evaluation including retinal layers thickness evaluation (optical coherence tomography).

Univariate and multivariate analyses will be performed to test diagnostic properties of retinal parameters as compared to current diagnostic criteria including CSF biomarkers and logistic regression models will be used.

location_facility: Centre Mémoire de Ressources et de Recherche Paris Nord


title: Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study

acronym: E-MAC

summary: A seven-item simplified score (the MACOCHA score) has been validated to predict difficult tracheal intubation in intensive care unit patients. In the prehospital or in the emergency department settings, no such validated predictive score is available yet. The aim of the present study is to assess the feasibility the quick calculation of the MACOCHA score before emergent intubation, in the prehospital and emergency department contexts.

ReferenceCitation: De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRéa Network for the Frida-Réa Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

family: De Jong

full_name: Audrey De Jong

given: Audrey

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Terzi

full_name: Nicolas Terzi

family: Mongardon

full_name: Nicolas Mongardon

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

family: Constantin

full_name: Jean-Michel Constantin

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Leone

full_name: Marc Leone

given: Marc

family: Papazian

full_name: Laurent Papazian

given: Laurent

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Maziers

full_name: Nicolas Maziers

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Pradel

full_name: Gael Pradel

given: Gael

family: Jung

full_name: Boris Jung

given: Boris

family: Jaber

full_name: Samir Jaber

given: Samir

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

repository_normalized: HAL

title: Early Identification of Patients at Risk for Difficult Intubation in the Intensive Care Unit


title: International Clinical Outcome Study for Dysferlinopathy

acronym: Jain COS

summary:
The "Clinical Outcome Study for Dysferlinopathy" is being performed in centres in Europe (UK- Newcastle; Spain- Barcelona, Sevilla; Germany- Berlin, Munich; Italy- Padova; France- Paris, Marseille), USA (Charlotte, NC; Columbus, OH; Washington, DC; St.Louis, MO, Stanford CA), Japan (Tokyo) and Australia (Sydney). Oversight and funding for this study is being provided by the Jain Foundation, a non-profit foundation dedicated to finding therapies for dysferlinopathies(LGMD2b/Miyoshi). The aim of this "Clinical Outcome Study" is to determine the clinical outcome measures required for future clinical trials, characterize the disease progression of dysferlinopathy and collect biological samples for the identification of disease markers that are needed to non-invasively monitor the disease during clinical trials. Without this information, effective clinical trials cannot be performed.

This study is recruiting a large number of genetically confirmed dysferlinopathy patients aged 10 years or older, who are ambulant or non-ambulant. Participants will be assessed at 6 visits over 3 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard blood tests. Optionally, the participants can donate blood samples and a skin sample for use in the identification of disease markers and other approved research.

ReferenceCitation: Moore U, Jacobs M, James MK, Mayhew AG, Fernandez-Torron R, Feng J, Cnaan A, Eagle M, Bettinson K, Rufibach LE, Lofra RM, Blamire AM, Carlier PG, Mittal P, Lowes LP, Alfano L, Rose K, Duong T, Berry KM, Montiel-Morillo E, Pedrosa-Hernández I, Holsten S, Sanjak M, Ashida A, Sakamoto C, Tateishi T, Yajima H, Canal A, Ollivier G, Decostre V, Mendez JB, Sánchez-Aguilera Praxedes N, Thiele S, Siener C, Shierbecker J, Florence JM, Vandevelde B, DeWolf B, Hutchence M, Gee R, Prügel J, Maron E, Hilsden H, Lochmüller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Díaz-Manera J, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V; Jain COS Consortium. Assessment of disease progression in dysferlinopathy: A 1-year cohort study. Neurology. 2019 Jan 9. pii: 10.1212/WNL.0000000000006858. doi: 10.1212/WNL.0000000000006858. [Epub ahead of print]

family: Moore

full_name: Ursula Moore

given: Ursula

family: Jacobs

full_name: Marni Jacobs

given: Marni

family: James

full_name: Meredith K. James

given: Meredith K.

family: Mayhew

full_name: Anna G. Mayhew

given: Anna G.

family: Fernandez-Torron

full_name: Roberto Fernandez-Torron

given: Roberto

family: Feng

full_name: Jia Feng

given: Jia

family: Cnaan

full_name: Avital Cnaan

given: Avital

family: Eagle

full_name: Michelle Eagle

given: Michelle

family: Bettinson

full_name: Karen Bettinson

given: Karen

family: Rufibach

full_name: Laura E. Rufibach

given: Laura E.

family: Lofra

full_name: Robert Muni Lofra

given: Robert Muni

family: Blamire

full_name: Andrew M. Blamire

given: Andrew M.

family: Carlier

full_name: Pierre G. Carlier

given: Pierre G.

family: Mittal

full_name: Plavi Mittal

given: Plavi

family: Lowes

full_name: Linda Pax Lowes

given: Linda Pax

family: Alfano

full_name: Lindsay Alfano

given: Lindsay

family: Rose

full_name: Kristy Rose

given: Kristy

family: Duong

full_name: Tina Duong

given: Tina

family: Berry

full_name: Katherine M. Berry

given: Katherine M.

family: Montiel-Morillo

full_name: Elena Montiel-Morillo

given: Elena

family: Pedrosa-Hernández

full_name: Irene Pedrosa-Hernández

given: Irene

family: Holsten

full_name: Scott Holsten

given: Scott

family: Sanjak

full_name: Mohammed Sanjak

given: Mohammed

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

ReferenceCitation: Diaz-Manera J, Fernandez-Torron R, LLauger J, James MK, Mayhew A, Smith FE, Moore UR, Blamire AM, Carlier PG, Rufibach L, Mittal P, Eagle M, Jacobs M, Hodgson T, Wallace D, Ward L, Smith M, Stramare R, Rampado A, Sato N, Tamaru T, Harwick B, Rico Gala S, Turk S, Coppenrath EM, Foster G, Bendahan D, Le Fur Y, Fricke ST, Otero H, Foster SL, Peduto A, Sawyer AM, Hilsden H, Lochmuller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V; Jain COS Consortium. Muscle MRI in patients with dysferlinopathy: pattern recognition and implications for clinical trials. J Neurol Neurosurg Psychiatry. 2018 Oct;89(10):1071-1081. doi: 10.1136/jnnp-2017-317488. Epub 2018 May 7.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

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

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

ReferenceCitation: Moore UR, Jacobs M, Fernandez-Torron R, Jang J, James MK, Mayhew A, Rufibach L, Mittal P, Eagle M, Cnaan A, Carlier PG, Blamire A, Hilsden H, Lochmüller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Diaz-Manera J, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V. Teenage exercise is associated with earlier symptom onset in dysferlinopathy: a retrospective cohort study. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1224-1226. doi: 10.1136/jnnp-2017-317329. Epub 2018 Jan 29.

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

location_country:
Italy
France
Japan
Spain
United States
United Kingdom

location_facility: Department of Neurosciences, University of Padova

location_facility: National Center of Neurology and Psychiatry

location_facility: Neuromuscular Center at the Research Institute of Nationwide Children's Hospital

location_facility: Neurology & Pathology, Washington University, School of Medicine in St Louis

location_facility: Carolinas Medical Center, Neuroscience & Spine Institute, Dept of Neurology

location_facility: Hospital Universitario Virgen del Rocio, IBiS, Neurology Department

location_facility: Institute of Genetic Medicine, Newcastle University, International Centre for Life


title: Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease

acronym: EqualVENT

summary: This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery

acronym: NEVAL

summary:
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.

The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.

ReferenceCitation: Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28. Review.

ReferenceCitation: Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. Review.

ReferenceCitation: MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. Review.

ReferenceCitation: Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. Epub 2007 Sep 7. Review.

ReferenceCitation: Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.

ReferenceCitation: Chaouat M, Zakine G, Mimoun M. [Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. Review. French.

lead_sponsor: Symatese

location_facility: Centre François Xavier Michelet - CHU de Bordeaux


title: Acute and Medium-term Effects of Neuromuscular Electrical Multisite System (Kneehab®) on Cardiovascular Parameters and Induced Muscle Fatigue in Morbidly Obese Patients: Comparison With the Unidirectional Standard Device

acronym: StimobII

summary:
The study was designed to test the following hypotheses:

In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase in muscle strength during stimulated contractions than conventional unidirectional electrostimulation session (c-NMES).

In patients with severe obesity, a six-weeks m-NMES training program will enhance cardiovascular, metabolic and inflammatory parameters.

lead_sponsor: AGIR à Dom


title: A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.

summary:
Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of disease, and treatment is focused on delaying progression rather than eliminating all tumor burden. Local therapies, and specifically radiotherapy, have been directed at quality of life endpoints and not at improving survival. However, advances in imaging and systemic therapy have identified a population of 'oligometastatic' patients who have a lower burden of metastatic disease (usually ≤5 lesions), who may present an exception. This condition is hypothesized to occupy the hinterland between incurable metastatic disease and locoregional disease, where micrometastatic disease is assumed to exist and yet remain eradicable. Oligometastases can be detected using standard imaging but the sensitivity of these exams is very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely available in a large majority of cancer centres. More recently, PSMA PET imaging has been developed.

Since most oligometastases are now discovered at a time when conventional imaging is unable to detect metastases, we must rely on the literature regarding purely biochemically-relapsing prostate cancer patients. Three strategies have been explored: (i) observation until symptoms develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early intermittent ADT was superior in term of overall survival to observation in controlling metastatic prostate cancer, and this effect was similar in the biochemically-relapsing prostate cancer patient population.

This phase III study will explore the role of salvage pelvic IG-IMRT combined with intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first failure-free interval between the first and the second intermittent ADT courses.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Clinique Mutualiste de l'Estuaire
Centre Léon Bérard
Institut de Cancérologie de Montpellier
Institut Sainte Catherine
Hopital Privé du Confluent
Centre Oscar Lambret
ICL Lucien Neuwirth
Institut de Cancérologie de Bourgogne
Centre Jean Perrin
Centre Georges François Leclerc
Centre Azureen de Cancerologie
Clinique Pasteur
Centre Saint Yves
CHRU de Brest
Institut de Cancérologie
Institut Bergonie

intervention_type: Combination Product


title: Ultra-wide Fluorescein angiograpHy to Evaluate the Progression of Retinal ischeMia After aflibErcept Injections in patientS With Central Retinal Vein Occlusion in Real Life (HERMES Study)

acronym: HERMES

summary:
In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific.

With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.

ReferenceCitation: Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. Review.

ReferenceCitation: Hayreh SS. So-called "central retinal vein occlusion". I. Pathogenesis, terminology, clinical features. Ophthalmologica. 1976;172(1):1-13.

ReferenceCitation: Fujikawa M, Sawada O, Miyake T, Kakinoki M, Sawada T, Kawamura H, Ohji M. Correlation between vascular endothelial growth factor and nonperfused areas in macular edema secondary to branch retinal vein occlusion. Clin Ophthalmol. 2013;7:1497-501. doi: 10.2147/OPTH.S46817. Epub 2013 Jul 19.

ReferenceCitation: Noma H, Minamoto A, Funatsu H, Tsukamoto H, Nakano K, Yamashita H, Mishima HK. Intravitreal levels of vascular endothelial growth factor and interleukin-6 are correlated with macular edema in branch retinal vein occlusion. Graefes Arch Clin Exp Ophthalmol. 2006 Mar;244(3):309-15. Epub 2005 Aug 13.

ReferenceCitation: Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. Erratum in: Arch Ophthalmol 1997 Oct;115(10):1275.

ReferenceCitation: Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33.

ReferenceCitation: Opremcak EM, Rehmar AJ, Ridenour CD, Kurz DE. Radial optic neurotomy for central retinal vein occlusion: 117 consecutive cases. Retina. 2006 Mar;26(3):297-305.

ReferenceCitation: Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faÿsse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.

ReferenceCitation: Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. Arch Ophthalmol. 2009 Sep;127(9):1101-14. doi: 10.1001/archophthalmol.2009.234. Erratum in: Arch Ophthalmol. 2009 Dec;127(12):1648.

ReferenceCitation: Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.

ReferenceCitation: Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29.

ReferenceCitation: Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27. Erratum in: Ophthalmology. 2014 Nov;121(11):2293.

ReferenceCitation: Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: Centre Monticelli Paradis d'Ophtalmologie

location_facility: Centre d'exploration ophtalmologique de l'odéon


title: Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase

acronym: REMINARY

summary: As the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, INSEE projections). The possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. The possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. In this research project, we will use the principle of neurofeedback rehabilitation (EEG) based on motor imaging with a brain-computer interface. Feedback will consist of therapeutic video games.Here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

summary: To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

lead_sponsor: Laboratoires Thea


title: Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers

acronym: HYPO

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

lead_sponsor: IHU Strasbourg

location_facility: Clinical Investigation Center & Physiology and Functional Explorations unit at NHC


title: Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%

acronym: ROPI-LEVO

summary: This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Descriptive Study of Mental Activity in the Emergency Department of the Centre Hospitalier de Mayotte

acronym: URGPSYMAY

summary: Provide a description of patients admitted in the psychaitric department of the Mayotte Hospital

lead_sponsor: University Hospital, Montpellier


title: Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms

acronym: Barrel

summary: The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.

ReferenceCitation: Gory B, Blanc R, Turjman F, Berge J, Piotin M. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study. J Neurointerv Surg. 2018 Oct;10(10):969-974. doi: 10.1136/neurintsurg-2017-013602. Epub 2018 Feb 2.

family: Gory

full_name: Benjamin Gory

given: Benjamin

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

family: Turjman

full_name: Francis Turjman

given: Francis

family: Berge

full_name: Jérôme Berge

given: Jérôme

family: Piotin

full_name: Michel Piotin

given: Michel

journal_name: Journal of NeuroInterventional Surgery

oa_colors: green hybrid

evidence: open (via page says license)

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

summary: The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.

lead_sponsor: Bial - Portela C S.A.


title: Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy

summary: The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.

lead_sponsor: Air Liquide SA


type: Other Grant/Funding Number

title: The COMETE Network, Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card

acronym: COMETETACTIC

summary:
Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care.

The main objective of COMETE-TACTIC is to provide an easy-to-use "identity card" of the adrenal tumors that will allow a personalized "à la carte" management of the patient and, when indicated, to the indication of the most accurate molecular targeted therapy.

We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require,

the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers);
the implementation of the translational research projects based on the COMETE collection to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic biomarkers that could be used as non-invasive "liquid biopsies".

primary_purpose: Diagnostic

ReferenceCitation: Castro-Vega LJ, Letouzé E, Burnichon N, Buffet A, Disderot PH, Khalifa E, Loriot C, Elarouci N, Morin A, Menara M, Lepoutre-Lussey C, Badoual C, Sibony M, Dousset B, Libé R, Zinzindohoue F, Plouin PF, Bertherat J, Amar L, de Reyniès A, Favier J, Gimenez-Roqueplo AP. Multi-omics analysis defines core genomic alterations in pheochromocytomas and paragangliomas. Nat Commun. 2015 Jan 27;6:6044. doi: 10.1038/ncomms7044.

ReferenceCitation: Letouzé E, Martinelli C, Loriot C, Burnichon N, Abermil N, Ottolenghi C, Janin M, Menara M, Nguyen AT, Benit P, Buffet A, Marcaillou C, Bertherat J, Amar L, Rustin P, De Reyniès A, Gimenez-Roqueplo AP, Favier J. SDH mutations establish a hypermethylator phenotype in paraganglioma. Cancer Cell. 2013 Jun 10;23(6):739-52. doi: 10.1016/j.ccr.2013.04.018. Epub 2013 May 23.

ReferenceCitation: Assié G, Letouzé E, Fassnacht M, Jouinot A, Luscap W, Barreau O, Omeiri H, Rodriguez S, Perlemoine K, René-Corail F, Elarouci N, Sbiera S, Kroiss M, Allolio B, Waldmann J, Quinkler M, Mannelli M, Mantero F, Papathomas T, De Krijger R, Tabarin A, Kerlan V, Baudin E, Tissier F, Dousset B, Groussin L, Amar L, Clauser E, Bertagna X, Ragazzon B, Beuschlein F, Libé R, de Reyniès A, Bertherat J. Integrated genomic characterization of adrenocortical carcinoma. Nat Genet. 2014 Jun;46(6):607-12. doi: 10.1038/ng.2953. Epub 2014 Apr 20.

location_facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: Assistance Publique Hopitaux de Paris -HEGP

location_facility: Assistance Publique Hopitaux de Paris, Cochin

location_facility: Assistance Publique Hopitaux de Paris, Pitie Salpetriere

location_facility: Assistance Publique Hopitaux de Pais, Hopital de Bicetre

location_facility: Assistance Publique Hopitaux de Paris, Necker


lead_sponsor: Hospices Civils de Lyon

acronym: CLERANCE

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre hospitalier universitaire Côte de nacre

source: euctr

title: CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma

summary:
Hepatocellular carcinoma (HCC) is a common tumor (the 8th leading cause of cancer in France) and has a poor prognosis. It is the 3rd leading cause of cancer deaths in the world. In the early stages (low tumor mass), HCC can be treated for curative purposes by surgical resection, percutaneous ablation or liver transplantation. When the tumor mass is larger (> 3 nodules) but remains confined to the liver, the standard treatment is hepatic intra-arterial chemoembolization (TACE). In the event of failure of the latter or if the tumor dissemination progresses in the portal venous system or in the form of metastases, the systemic treatments are then indicated.

In 1st line, the reference treatment is a tyrosine kinase inhibitor (ITK) Sorafenib.

Cabozantinib obtained the European and French authorization (AMM) in November 2018 for its use in case of failure of Sorafenib in patients with HCC.

The main objective is the evaluation of the safety of Cabozantinib administered to patients with intermediate HCC ineligible for chemoembolization or advanced HCC after failure of Sorafenib and possibly another systemic anticancer line.


title: Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.

summary: Quantification and preferential sites of arterial wall calcification within the coronary and lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2 diabetics and Chronic Kidney disease.

lead_sponsor: University Hospital, Angers


ReferenceCitation: Graupera M, Guillermet-Guibert J, Foukas LC, Phng LK, Cain RJ, Salpekar A, Pearce W, Meek S, Millan J, Cutillas PR, Smith AJ, Ridley AJ, Ruhrberg C, Gerhardt H, Vanhaesebroeck B. Angiogenesis selectively requires the p110alpha isoform of PI3K to control endothelial cell migration. Nature. 2008 May 29;453(7195):662-6. doi: 10.1038/nature06892. Epub 2008 Apr 30.

ReferenceCitation: Schnell CR, Stauffer F, Allegrini PR, O'Reilly T, McSheehy PM, Dartois C, Stumm M, Cozens R, Littlewood-Evans A, García-Echeverría C, Maira SM. Effects of the dual phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor NVP-BEZ235 on the tumor vasculature: implications for clinical imaging. Cancer Res. 2008 Aug 15;68(16):6598-607. doi: 10.1158/0008-5472.CAN-08-1044.

ReferenceCitation: Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. Review.

ReferenceCitation: Saranath D, Panchal RG, Nair R, Mehta AR, Sanghavi VD, Deo MG. Amplification and overexpression of epidermal growth factor receptor gene in human oropharyngeal cancer. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):139-43.

ReferenceCitation: Burtness B. The role of cetuximab in the treatment of squamous cell cancer of the head and neck. Expert Opin Biol Ther. 2005 Aug;5(8):1085-93. Review.

lead_sponsor: Centre Leon Berard

acronym: PIK-ORL

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
Centre Hospitalier Lyon Sud
Centre Antoine LACASSAGNE
Institut Curie
Hopital St André
Institut Gustave Roussy
Hôpital BEAUJON
Centre Val d'Aurelle - Paul Lamarque

title: A Phase II, Multicenter Trial Aiming to Evaluate the Clinical Interest of a Monotherapy With BKM120 , a Phosphoinositide 3-kinase (PI3K) Inhibitor in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive Under Platin and Cetuximab-based Chemotherapy

summary: The aim of this study is to determine the activity, to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under platin and cetuximab-based chemotherapy.