title: Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

acronym: ECHOPP

summary: Parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. Only the indication of thoracic drainage has benefited from expert recommendations. However, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. Pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. This study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

ReferenceCitation: Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3.

ReferenceCitation: Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. Review.

ReferenceCitation: Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2:ii18-28.

ReferenceCitation: Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. Review.

ReferenceCitation: LeMense GP, Strange C, Sahn SA. Empyema thoracis. Therapeutic management and outcome. Chest. 1995 Jun;107(6):1532-7.

ReferenceCitation: Bober K, Swietliński J. Diagnostic utility of ultrasonography for respiratory distress syndrome in neonates. Med Sci Monit. 2006 Oct;12(10):CR440-6. Epub 2006 Sep 25.

ReferenceCitation: Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17. Review.

ReferenceCitation: Ramnath RR, Heller RM, Ben-Ami T, Miller MA, Campbell P, Neblett WW 3rd, Holcomb GW, Hernanz-Schulman M. Implications of early sonographic evaluation of parapneumonic effusions in children with pneumonia. Pediatrics. 1998 Jan;101(1 Pt 1):68-71.

ReferenceCitation: Xirouchaki N, Magkanas E, Vaporidi K, Kondili E, Plataki M, Patrianakos A, Akoumianaki E, Georgopoulos D. Lung ultrasound in critically ill patients: comparison with bedside chest radiography. Intensive Care Med. 2011 Sep;37(9):1488-93. doi: 10.1007/s00134-011-2317-y. Epub 2011 Aug 2.

family: Xirouchaki

full_name: Nektaria Xirouchaki

given: Nektaria

family: Magkanas

full_name: Eleftherios Magkanas

given: Eleftherios

family: Vaporidi

full_name: Katerina Vaporidi

given: Katerina

family: Kondili

full_name: Eumorfia Kondili

given: Eumorfia

family: Plataki

full_name: Maria Plataki

given: Maria

family: Patrianakos

full_name: Alexandros Patrianakos

given: Alexandros

family: Akoumianaki

full_name: Evaggelia Akoumianaki

given: Evaggelia

family: Georgopoulos

full_name: Dimitrios Georgopoulos

given: Dimitrios

journal_name: Intensive Care Medicine

ReferenceCitation: Tokuda Y, Matsushima D, Stein GH, Miyagi S. Intrapleural fibrinolytic agents for empyema and complicated parapneumonic effusions: a meta-analysis. Chest. 2006 Mar;129(3):783-90.

ReferenceCitation: Stavas J, vanSonnenberg E, Casola G, Wittich GR. Percutaneous drainage of infected and noninfected thoracic fluid collections. J Thorac Imaging. 1987 Jul;2(3):80-7.

ReferenceCitation: Sahn SA. Management of complicated parapneumonic effusions. Am Rev Respir Dis. 1993 Sep;148(3):813-17. Review.

ReferenceCitation: Taryle DA, Potts DE, Sahn SA. The incidence and clinical correlates of parapneumonic effusions in pneumococcal pneumonia. Chest. 1978 Aug;74(2):170-3.

ReferenceCitation: Pothula V, Krellenstein DJ. Early aggressive surgical management of parapneumonic empyemas. Chest. 1994 Mar;105(3):832-6.

ReferenceCitation: Saito T, Kobayashi H, Kitamura S. Ultrasonographic approach to diagnosing chest wall tumors. Chest. 1988 Dec;94(6):1271-5.

ReferenceCitation: Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313. Review.

family: Lichtenstein

full_name: Daniel A. Lichtenstein

given: Daniel A.

journal_name: Chest

title: BLUE-Protocol and FALLS-Protocol

ReferenceCitation: Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8.

ipd_sharing_description: the data will be collected on an electronic Ecrf, a single extraction is planned by the protocol, all the collected data will be analyzed centrally by the study cordernator,no data sharing is planned in the study

lead_sponsor: Central Hospital Saint Quentin

location_facility:
Saint-Quentin Hospital
CH Creteil
Chu Amiens
CH Pontoise


title: National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

summary: This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: ARCAGY/ GINECO GROUP

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)

acronym: CALYPSO

summary: This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months).

enrollment_type: Actual


title: Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.

summary: BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.

design_allocation: Non-Randomized

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_facility: Service de DermatologieHôpital Dupuytren


title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

acronym: UCPVax-Glio

summary:
Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide.

After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months.

There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM.

The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Bordeaux
Centre Georges François Leclerc
Hôpital Saint-Louis
CHU Besançon

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation Des méthodes de dépistage du Paragangliome héréditaire Chez Les Sujets prédisposés génétiquement

summary: Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

intervention_type: Procedure


summary: The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.

status: Unknown status

study_type: Observational

time_perspective: Prospective

status_simplified: Unknown


title: Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

summary: Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.

status: Suspended

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Device


title: Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study

acronym: METVI

summary: This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Dermatologie - Hôpital Saint-André

location_facility: Service de Dermatologie - CHU de Toulouse - Hopital Purpan


title: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit

summary: This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.


title: Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

summary: Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.

status: Terminated


type: Other Identifier

title: Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation: A Double-blind, Randomized; Placebo-controlled Trial

acronym: BifidoDigest

summary: This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation according to ROME III criteria. The hypothesis is that Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of stool frequency of at least 1 stool per week.

ipd_sharing: No

lead_sponsor: Danisco

location_facility:
CEN Nutriment
Eurofins Optimed
Biofortis Mérieux NutriSciences
Institut Pasteur de Lille

intervention_type: Dietary Supplement


title: Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan

summary:
The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.

This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.


title: Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

acronym: BICOLDER

summary: Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital Hotel Dieu
Hopital Gustave Dron
Bichat Hospital
Hopital Sainte Marguerite


title: Phase II Study of Imatinib (Glivec) Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT

summary: This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.


title: Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study

acronym: LYMphoNIGHT

summary:
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.

Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.

ReferenceType: background

ReferenceCitation: Quéré I, Presles E, Coupé M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

ReferenceCitation: Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.

ReferenceCitation: Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.

lead_sponsor: Thuasne

location_facility:
Ghr Mulhouse
Chu Toulouse
CHRU Tours
Chu Montpellier


title: A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

summary: This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3 acute leukemia, large B-cell lymphoma and non subclassified aggressive B-cell NHL


title: Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia

acronym: CROSS-TENS

summary: This study will compare 2 types of Transcutaneous Electrical Nerve Stimulation (TENS) to treat chronic neuropathic pain. TENS involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.

lead_sponsor: Lille Catholic University

location_facility:
CH Roubaix
GHICL
CHU Lille
CH Béthune


title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest

summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.

lead_sponsor: AfterROSC

location_facility:
CHU Cochin
CHU Nantes
CH Versailles
Hopital Privé Jacques Cartier

intervention_type: Diagnostic Test


title: Evaluation of the Performance and Safety of a Scintillating Lamp Developed to Improve the Reading of Dyslexic Patients

acronym: DysLight

summary: The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.

lead_sponsor: SATT Ouest Valorisation

location_facility:
Dr Laurence Derieux
Dr Hugo Peyre
Dr Catherine ALLAIRE
Dr Luc-Marie Virlet


title: Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)

acronym: CIMON

summary:
Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment.

Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness.

The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis.

Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients.

As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.

primary_purpose: Supportive Care

lead_sponsor: MaaT Pharma

location_facility:
CHU Angers
APHP St Antoine
IUCT
CHU Nice


title: Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

summary:
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).

Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.

Currently, one of the most common used procedure is a translated (lateraly) distal chevron associated with a release of the metatarsosesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct déformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.

Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.

The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up

status: Active, not recruiting

lead_sponsor: Klouche-Clinical-Research

location_facility:
Clinique du Parc Lyon
Clinique de l'Union
Clinique Lille sud
Clinique Mégival


title: Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors

acronym: FACPAR

summary: Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure

status: Withdrawn

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital FOCH
Institut Arthur Vernes
Fondation Adolphe De Rothschild
Hôpital Saint Joseph


title: Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities

acronym: ULD-Traumato

summary: The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been developed to reduce the dose of X-rays delivered to the patient. The general purpose of this study is to validate the ULD scanner in case of emergency trauma of the dorsolumbar spine, pelvis and / or extremities.

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Clinique de l'Union
Clinique du Parc
Centre Hospitalier Universitaire
Centre Hospitalier de Mont-de-Marsan


title: Phase III Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention

summary: The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.

ReferenceType: derived

ReferenceCitation: Quak E, Lasne Cardon A, Ciappuccini R, Lasnon C, Bastit V, Le Henaff V, Lireux B, Foucras G, Jaudet C, Berchi C, Grellard JM, Lequesne J, Clarisse B, Bardet S. Upfront F18-choline PET/CT versus Tc99m-sestaMIBI SPECT/CT guided surgery in primary hyperparathyroidism: the randomized phase III diagnostic trial APACH2. BMC Endocr Disord. 2021 Jan 7;21(1):3. doi: 10.1186/s12902-020-00667-5.

family: Quak

full_name: Elske Quak

given: Elske

sequence: first

family: Lasne Cardon

full_name: Audrey Lasne Cardon

given: Audrey

sequence: additional

family: Ciappuccini

full_name: Renaud Ciappuccini

given: Renaud

family: Lasnon

full_name: Charline Lasnon

given: Charline

family: Bastit

full_name: Vianney Bastit

given: Vianney

family: Le Henaff

full_name: Véronique Le Henaff

given: Véronique

family: Lireux

full_name: Barbara Lireux

given: Barbara

family: Foucras

full_name: Gauthier Foucras

given: Gauthier

family: Jaudet

full_name: Cyril Jaudet

given: Cyril

family: Berchi

full_name: Celia Berchi

given: Celia

family: Grellard

full_name: Jean-Michel Grellard

given: Jean-Michel

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Bardet

full_name: Stéphane Bardet

given: Stéphane

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Endocrine Disorders

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Eugène Marquis
CHU Brest
Centre François Baclesse
CHU


title: CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas

summary: This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.

ReferenceCitation: Thariat J, Bensadoun RJ, Etienne-Grimaldi MC, Grall D, Penault-Llorca F, Dassonville O, Bertucci F, Cayre A, De Raucourt D, Geoffrois L, Finetti P, Giraud P, Racadot S, Morinière S, Sudaka A, Van Obberghen-Schilling E, Milano G. Contrasted outcomes to gefitinib on tumoral IGF1R expression in head and neck cancer patients receiving postoperative chemoradiation (GORTEC trial 2004-02). Clin Cancer Res. 2012 Sep 15;18(18):5123-33. Epub 2012 Aug 1.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

intervention_type: Radiation


title: Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

summary: The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.


title: The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?

acronym: OPPRED

summary: Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.

primary_purpose: Other

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Hospital Dr Schaffner
Ch Germon Et Gauthier
Chu Amiens
CH Arras

intervention_type: Other


title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

acronym: BACHELOR

summary:
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included.

Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment.

No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion.

From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU Brest
Chu Tours
Chu Bordeaux
Ch Morlaix


title: Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

summary: The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.

primary_purpose: Prevention

lead_sponsor: Nantes University Hospital

location_facility: Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital)

location_facility: Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)

location_facility: Rheumatology department (Nantes University Hospital)

location_facility: Regional Hemophilia Treatment Centre (Nantes University Hospital)


title: Lacunar-Brain Infarction Cerebral Hyperactivity And Atorvastatin Trial. A Placebo-Controlled Trial Of High-Dose Atorvastatin In Patients With Cerebral Small Vessel Disease.

acronym: LA BICHAT

summary: The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.

ReferenceCitation: Lavallée PC, Labreuche J, Gongora-Rivera F, Jaramillo A, Brenner D, Klein IF, Touboul PJ, Vicaut E, Amarenco P; Lacunar-BICHAT Investigators. Placebo-controlled trial of high-dose atorvastatin in patients with severe cerebral small vessel disease. Stroke. 2009 May;40(5):1721-8. doi: 10.1161/STROKEAHA.108.540088. Epub 2009 Mar 12.

name: From INSERM U-698 and Department of Neurology and Stroke Centre (P.C.L., J.L., F.G.-R., A.J., D.B., P.J.T. P.A.), Bichat University Hospital, Denis Diderot University and Medical School, Paris, France; Neuroradiology Unit (I.F.K.), Department of Radiology, Bichat University Hospital, Denis Diderot University and Medical School, Paris, France; Department of Biostatistics and Clinical Research (E.V.), Fernand Widal University Hospital, Denis Diderot University and Medical School, Paris, France.

family: Lavallée

full_name: Philippa C. Lavallée

given: Philippa C.

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Gongora-Rivera

full_name: Fernando Gongora-Rivera

given: Fernando

family: Jaramillo

full_name: Arturo Jaramillo

given: Arturo

family: Brenner

full_name: David Brenner

given: David

family: Klein

full_name: Isabelle F Klein

given: Isabelle F

family: Touboul

full_name: Pierre-Jean Touboul

given: Pierre-Jean

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

journal_name: Stroke

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Placebo-Controlled Trial of High-Dose Atorvastatin in Patients With Severe Cerebral Small Vessel Disease

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


title: Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

summary: This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


summary:
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.

IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.

The study was powered to detect 10% difference in 3 year OS.


title: Combination Therapy Associating CPAP and Mandibular Advancement Device ( MAD) in Obstructive Sleep Apnea (OSA) Low CPAP Compliers: A Randomized Controlled Trial

acronym: PPC-OAM

summary:
The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypertensive patients in obstructive sleep apnea low CPAP compliers (less than 4 hours per night).

Hypertensive patients demonstrating low CPAP adherence will be selected during a screening visit; they will be then randomized to one of the three following arms: Education to CPAP ("CPAP only"), Treatment by a MAD ("MAD only") or a combination of both CPAP and MAD ("CPAP+MAD"). Mean systolic, diastolic, diurnal and nocturnal blood pressure will be assessed during 24-h Ambulatory Blood Pressure monitoring, before and after a 3-month treatment intervention. Biological laboratory parameters, patients reported outcomes (daytime sleepiness and Quality of Life), will also be evaluated before and after 3 months of treatment.

ReferenceType: result

ReferenceCitation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Kendzerska T, Gershon AS, Hawker G, Leung RS, Tomlinson G. Obstructive sleep apnea and risk of cardiovascular events and all-cause mortality: a decade-long historical cohort study. PLoS Med. 2014 Feb 4;11(2):e1001599. doi: 10.1371/journal.pmed.1001599. eCollection 2014 Feb.

family: Kendzerska

full_name: Tetyana Kendzerska

given: Tetyana

family: Gershon

full_name: Andrea S. Gershon

given: Andrea S.

family: Hawker

full_name: Gillian Hawker

given: Gillian

family: Leung

full_name: Richard S. Leung

given: Richard S.

family: Tomlinson

full_name: George Tomlinson

given: George

currency_apc_doaj: USD

journal_name: PLoS Medicine

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Obstructive Sleep Apnea and Risk of Cardiovascular Events and All-Cause Mortality: A Decade-Long Historical Cohort Study

ReferenceCitation: Bailly S, Destors M, Grillet Y, Richard P, Stach B, Vivodtzev I, Timsit JF, Lévy P, Tamisier R, Pépin JL; scientific council and investigators of the French national sleep apnea registry (OSFP). Obstructive Sleep Apnea: A Cluster Analysis at Time of Diagnosis. PLoS One. 2016 Jun 17;11(6):e0157318. doi: 10.1371/journal.pone.0157318. eCollection 2016.

family: Bailly

full_name: Sébastien Bailly

given: Sébastien

family: Destors

full_name: Marie Destors

given: Marie

family: Grillet

full_name: Yves Grillet

given: Yves

family: Richard

full_name: Philippe Richard

given: Philippe

family: Stach

full_name: Bruno Stach

given: Bruno

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: Timsit

full_name: Jean-Francois Timsit

given: Jean-Francois

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

ReferenceCitation: Lévy P, Kohler M, McNicholas WT, Barbé F, McEvoy RD, Somers VK, Lavie L, Pépin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. Review.

title: Obstructive sleep apnoea syndrome

ReferenceCitation: Bratton DJ, Gaisl T, Schlatzer C, Kohler M. Comparison of the effects of continuous positive airway pressure and mandibular advancement devices on sleepiness in patients with obstructive sleep apnoea: a network meta-analysis. Lancet Respir Med. 2015 Nov;3(11):869-78. doi: 10.1016/S2213-2600(15)00416-6. Epub 2015 Oct 20. Erratum in: Lancet Respir Med. 2015 Dec;3(12):e44.

ReferenceCitation: Pépin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Lévy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

ReferenceCitation: Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Comparison of Continuous Positive Airway Pressure and Valsartan in Hypertensive Patients with Sleep Apnea

ReferenceCitation: Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14. Review.

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Bratton DJ, Gaisl T, Wons AM, Kohler M. CPAP vs Mandibular Advancement Devices and Blood Pressure in Patients With Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. JAMA. 2015 Dec 1;314(21):2280-93. doi: 10.1001/jama.2015.16303. Review.

name: Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland2Zurich Center for Integrative Human Physiology, University of Zurich, Zurich, Switzerland3Center for Interdisciplinary Sleep Research, University of Zurich, Zurich, Switzerland

ReferenceCitation: Mokhlesi B, Hagen EW, Finn LA, Hla KM, Carter JR, Peppard PE. Obstructive sleep apnoea during REM sleep and incident non-dipping of nocturnal blood pressure: a longitudinal analysis of the Wisconsin Sleep Cohort. Thorax. 2015 Nov;70(11):1062-9. doi: 10.1136/thoraxjnl-2015-207231. Epub 2015 Aug 25.

location_facility:
Nouvelle Clinique Bel Air
Cabinet Médical
University Hospital Montpellier
University Hospital Grenoble


title: French Prospective Clinical Database of Colorectal Robotic Surgery

acronym: ROBOT CR

summary: Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

ReferenceCitation: Colombo PE, Bertrand MM, Alline M, Boulay E, Mourregot A, Carrère S, Quénet F, Jarlier M, Rouanet P. Robotic Versus Laparoscopic Total Mesorectal Excision (TME) for Sphincter-Saving Surgery: Is There Any Difference in the Transanal TME Rectal Approach? : A Single-Center Series of 120 Consecutive Patients. Ann Surg Oncol. 2016 May;23(5):1594-600. doi: 10.1245/s10434-015-5048-4. Epub 2015 Dec 29.

ReferenceCitation: Bertrand MM, Colombo PE, Mourregot A, Traore D, Carrère S, Quénet F, Rouanet P. Standardized single docking, four arms and fully robotic proctectomy for rectal cancer: the key points are the ports and arms placement. J Robot Surg. 2016 Jun;10(2):171-4. doi: 10.1007/s11701-015-0551-y. Epub 2015 Dec 8.

ReferenceCitation: Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH; Cooperative Clinical Investigators of the Dutch Colorectal Cancer Group. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.

ReferenceCitation: Chen SL, Steele SR, Eberhardt J, Zhu K, Bilchik A, Stojadinovic A. Lymph node ratio as a quality and prognostic indicator in stage III colon cancer. Ann Surg. 2011 Jan;253(1):82-7. doi: 10.1097/SLA.0b013e3181ffa780.

ReferenceCitation: Zhang X, Wei Z, Bie M, Peng X, Chen C. Robot-assisted versus laparoscopic-assisted surgery for colorectal cancer: a meta-analysis. Surg Endosc. 2016 Dec;30(12):5601-5614. Epub 2016 Jul 11. Review.

ReferenceCitation: Parc Y, Reboul-Marty J, Lefevre JH, Shields C, Chafai N, Tiret E. Factors influencing mortality and morbidity following colorectal resection in France. Analysis of a national database (2009-2011). Colorectal Dis. 2016 Feb;18(2):205-13. doi: 10.1111/codi.13099.

ReferenceCitation: Bege T, Lelong B, Esterni B, Turrini O, Guiramand J, Francon D, Mokart D, Houvenaeghel G, Giovannini M, Delpero JR. The learning curve for the laparoscopic approach to conservative mesorectal excision for rectal cancer: lessons drawn from a single institution's experience. Ann Surg. 2010 Feb;251(2):249-53. doi: 10.1097/SLA.0b013e3181b7fdb0.

ReferenceCitation: Poloniecki J, Valencia O, Littlejohns P. Cumulative risk adjusted mortality chart for detecting changes in death rate: observational study of heart surgery. BMJ. 1998 Jun 6;316(7146):1697-700. Erratum in: BMJ 1998 Jun 27;316(7149):1947.

ReferenceCitation: Guend H, Widmar M, Patel S, Nash GM, Paty PB, Guillem JG, Temple LK, Garcia-Aguilar J, Weiser MR. Developing a robotic colorectal cancer surgery program: understanding institutional and individual learning curves. Surg Endosc. 2017 Jul;31(7):2820-2828. doi: 10.1007/s00464-016-5292-0. Epub 2016 Nov 4.

ReferenceCitation: Bokhari MB, Patel CB, Ramos-Valadez DI, Ragupathi M, Haas EM. Learning curve for robotic-assisted laparoscopic colorectal surgery. Surg Endosc. 2011 Mar;25(3):855-60. doi: 10.1007/s00464-010-1281-x. Epub 2010 Aug 24.

ReferenceCitation: Bolsin S, Colson M. The use of the Cusum technique in the assessment of trainee competence in new procedures. Int J Qual Health Care. 2000 Oct;12(5):433-8.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du cancer de Montpellier


title: Effet Des Gestes de Revascularisation à l'étage Proximal

summary:
The whole study is divided in 4 parallel protocols. The first protocol estimates the reliability of the technique through test-retest recordings. The second protocol aims to prove that exercise Tcpo2 is efficient to estimate the benefit of proximal revascularisation on proximal and distal ischemia in patients suffering stage two lower extremity arterial disease. The third protocol aims at estimating with exercise tcpo2 the eventual apparison of proximal ischemia after aorto-bi-femoral bypasses. The last protocol is a transversal study of patients with aorto-bi-femoral bypasses aiming to analyse the presence of proximal and distal symptoms and ischemia.

The hypothesis for protocol 2 is that TcpO2 at exercise is significantly improved after surgery at the aortic and primary iliac artery. The hypothesis for protocols 3 and 4 relates on the hypothesis that a significant number of patients benefiting aorto-bi-femoral bypass suffer isolated proximal pain/ischemia after surgery.

Amendement to the project has been recently validated to study the neurologic and bone complication of chronic vascular ischemia

ReferenceCitation: Jaquinandi V, Picquet J, Bouyé P, Saumet JL, Leftheriotis G, Abraham P. High prevalence of proximal claudication among patients with patent aortobifemoral bypasses. J Vasc Surg. 2007 Feb;45(2):312-8.

ReferenceCitation: Jaquinandi V, Abraham P, Picquet J, Paisant-Thouveny F, Leftheriotis G, Saumet JL. Estimation of the functional role of arterial pathways to the buttock circulation during treadmill walking in patients with claudication. J Appl Physiol (1985). 2007 Mar;102(3):1105-12. Epub 2006 Nov 16.

ReferenceCitation: Ouedraogo N, Feuilloy M, Mahe G, Leftheriotis G, Saumet JL, Abraham P. Chest tcpO2 changes during constant-load treadmill walking tests in patients with claudication. Physiol Meas. 2011 Feb;32(2):181-94. doi: 10.1088/0967-3334/32/2/003. Epub 2010 Dec 22.

family: Ouedraogo

full_name: N Ouedraogo

given: N

family: Feuilloy

full_name: M Feuilloy

given: M

family: Mahe

full_name: G Mahe

given: G

family: Leftheriotis

full_name: G Leftheriotis

family: Saumet

full_name: J-L Saumet

given: J-L

family: Abraham

full_name: P Abraham

given: P

journal_name: Physiological Measurement

oa_host_type: repository

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

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

publisher: IOP Publishing

publisher_dissemination: IOP Publishing

publisher_group: IOP Publishing

publisher_normalized: IOP Publishing

title: Chest tcpO2changes during constant-load treadmill walking tests in patients with claudication

lead_sponsor: University Hospital, Angers


title: Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study

acronym: SNOW

summary: the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

lead_sponsor: Versailles Hospital

location_facility:
Hopital Nord Franche-Comte
Hopital Européèn Georges Pompidou
Ch Versailles
CHU Saint LOUIS


title: Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial

summary: This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP) treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.


title: Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial

summary: This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.


title: Evaluation of the Interest of Pulmonary Ultrasound in the Diagnosis and Early Detection of Acute Thoracic Syndrome in Hospitalized Children for Vaso-occlusive Sickle Cell Crisis: Multicenter Prospective Study

acronym: ECHO-STA

summary:
ATS (acute thoracic syndrome) refers to acute pulmonary involvement in a sickle cell patient. The diagnosis is based on the association of clinical signs (fever or respiratory symptoms) with a recent pulmonary infiltrate on the chest x-ray.

The main objective of the study is to evaluate the place of the pulmonary ultrasound for the diagnosis of ATS, in comparison with frontal chest x-ray.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Créteil


title: Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)

summary:
ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation.

Duration of therapy : 2 years.

lead_sponsor: Hospices Civils de Lyon


title: Constitution d'Une Cohorte Prospective de Sujets Sains et Malades et d'Une Collection de Ressources Biologiques associées Pour l'étude du système Immunitaire et de Ses déterminants Génétiques et Environnementaux"

acronym: CoSImmGEn

summary: CoSImmGEn is a protocol set up to respond to the current lack of healthy and sick population cohorts. Biological resources from these cohorts allow researchers to study the immune system and its genetic and environmental determinants. Those cohorts and collections are open not only to the Pasteurian community but also to the worldwide scientific community (both public and private) working in the field.

primary_purpose: Basic Science

ReferenceCitation: Iglesias MC, Briceno O, Gostick E, Moris A, Meaudre C, Price DA, Ungeheuer MN, Saez-Cirion A, Mallone R, Appay V. Immunodominance of HLA-B27-restricted HIV KK10-specific CD8(+) T-cells is not related to naïve precursor frequency. Immunol Lett. 2013 Jan;149(1-2):119-22. doi: 10.1016/j.imlet.2012.10.002. Epub 2012 Oct 13.

ReferenceCitation: Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.

ReferenceCitation: Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. The Milieu Intérieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.

ReferenceCitation: Monceaux V, Chiche-Lapierre C, Chaput C, Witko-Sarsat V, Prevost MC, Taylor CT, Ungeheuer MN, Sansonetti PJ, Marteyn BS. Anoxia and glucose supplementation preserve neutrophil viability and function. Blood. 2016 Aug 18;128(7):993-1002. doi: 10.1182/blood-2015-11-680918. Epub 2016 Jul 8.

ReferenceCitation: Urrutia A, Duffy D, Rouilly V, Posseme C, Djebali R, Illanes G, Libri V, Albaud B, Gentien D, Piasecka B, Hasan M, Fontes M, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Standardized Whole-Blood Transcriptional Profiling Enables the Deconvolution of Complex Induced Immune Responses. Cell Rep. 2016 Sep 6;16(10):2777-2791. doi: 10.1016/j.celrep.2016.08.011. Epub 2016 Aug 25.

ReferenceCitation: Hamimi C, David A, Versmisse P, Weiss L, Bruel T, Zucman D, Appay V, Moris A, Ungeheuer MN, Lascoux-Combe C, Barré-Sinoussi F, Muller-Trutwin M, Boufassa F, Lambotte O, Pancino G, Sáez-Cirión A; ANRS CO21 CODEX cohort. Dendritic Cells from HIV Controllers Have Low Susceptibility to HIV-1 Infection In Vitro but High Capacity to Capture HIV-1 Particles. PLoS One. 2016 Aug 9;11(8):e0160251. doi: 10.1371/journal.pone.0160251. eCollection 2016.

ReferenceCitation: Duffy D, Rouilly V, Braudeau C, Corbière V, Djebali R, Ungeheuer MN, Josien R, LaBrie ST, Lantz O, Louis D, Martinez-Caceres E, Mascart F, Ruiz de Morales JG, Ottone C, Redjah L, Guen NS, Savenay A, Schmolz M, Toubert A, Albert ML; Multinational FOCIS Centers of Excellence. Standardized whole blood stimulation improves immunomonitoring of induced immune responses in multi-center study. Clin Immunol. 2017 Oct;183:325-335. doi: 10.1016/j.clim.2017.09.019. Epub 2017 Sep 22.

ReferenceCitation: Piasecka B, Duffy D, Urrutia A, Quach H, Patin E, Posseme C, Bergstedt J, Charbit B, Rouilly V, MacPherson CR, Hasan M, Albaud B, Gentien D, Fellay J, Albert ML, Quintana-Murci L; Milieu Intérieur Consortium. Distinctive roles of age, sex, and genetics in shaping transcriptional variation of human immune responses to microbial challenges. Proc Natl Acad Sci U S A. 2018 Jan 16;115(3):E488-E497. doi: 10.1073/pnas.1714765115. Epub 2017 Dec 27.

ReferenceCitation: Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jönsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Publisher Correction: Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Jun;19(6):645. doi: 10.1038/s41590-018-0105-3.

ReferenceCitation: Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Intérieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.

family: Scepanovic

full_name: Petar Scepanovic

given: Petar

family: Alanio

full_name: Cécile Alanio

given: Cécile

family: Hammer

full_name: Christian Hammer

given: Christian

family: Hodel

full_name: Flavia Hodel

given: Flavia

family: Bergstedt

full_name: Jacob Bergstedt

given: Jacob

family: Patin

full_name: Etienne Patin

given: Etienne

family: Thorball

full_name: Christian W. Thorball

given: Christian W.

family: Chaturvedi

full_name: Nimisha Chaturvedi

given: Nimisha

family: Charbit

full_name: Bruno Charbit

family: Abel

full_name: Laurent Abel

given: Laurent

family: Quintana-Murci

full_name: Lluis Quintana-Murci

given: Lluis

family: Duffy

full_name: Darragh Duffy

given: Darragh

family: Albert

full_name: Matthew L. Albert

given: Matthew L.

family: Fellay

full_name: Jacques Fellay

given: Jacques

journal_name: Genome Medicine

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

ReferenceCitation: Kilens S, Meistermann D, Moreno D, Chariau C, Gaignerie A, Reignier A, Lelièvre Y, Casanova M, Vallot C, Nedellec S, Flippe L, Firmin J, Song J, Charpentier E, Lammers J, Donnart A, Marec N, Deb W, Bihouée A, Le Caignec C, Pecqueur C, Redon R, Barrière P, Bourdon J, Pasque V, Soumillon M, Mikkelsen TS, Rougeulle C, Fréour T, David L; Milieu Intérieur Consortium. Parallel derivation of isogenic human primed and naive induced pluripotent stem cells. Nat Commun. 2018 Jan 24;9(1):360. doi: 10.1038/s41467-017-02107-w.

ReferenceCitation: Belizna C, Stojanovich L, Cohen-Tervaert JW, Fassot C, Henrion D, Loufrani L, Nagy G, Muchardt C, Hasan M, Ungeheuer MN, Arnaud L, Alijotas-Reig J, Esteve-Valverde E, Nicoletti F, Saulnier P, Godon A, Reynier P, Chrétien JM, Damian L, Omarjee L, Mahé G, Pistorius MA, Meroni PL, Devreese K. Primary antiphospholipid syndrome and antiphospholipid syndrome associated to systemic lupus: Are they different entities? Autoimmun Rev. 2018 Aug;17(8):739-745. doi: 10.1016/j.autrev.2018.01.027. Epub 2018 Jun 6. Review.

ReferenceCitation: Belizna C, Pregnolato F, Abad S, Alijotas-Reig J, Amital H, Amoura Z, Andreoli L, Andres E, Aouba A, Apras Bilgen S, Arnaud L, Bienvenu B, Bitsadze V, Blanco P, Blank M, Borghi MO, Caligaro A, Candrea E, Canti V, Chiche L, Chretien JM, Cohen Tervaert JW, Damian L, Delross T, Dernis E, Devreese K, Djokovic A, Esteve-Valverde E, Favaro M, Fassot C, Ferrer-Oliveras R, Godon A, Hamidou M, Hasan M, Henrion D, Imbert B, Jeandel PY, Jeannin P, Jego P, Jourde-Chiche N, Khizroeva J, Lambotte O, Landron C, Latino JO, Lazaro E, de Leeuw K, Le Gallou T, Kiliç L, Limper M, Loufrani L, Lubin R, Magy-Bertrand N, Mahe G, Makatsariya A, Martin T, Muchardt C, Nagy G, Omarjee L, Van Paasen P, Pernod G, Perrinet F, Pïres Rosa G, Pistorius MA, Ruffatti A, Said F, Saulnier P, Sene D, Sentilhes L, Shovman O, Sibilia J, Sinescu C, Stanisavljevic N, Stojanovich L, Tam LS, Tincani A, Tollis F, Udry S, Ungeheuer MN, Versini M, Cervera R, Meroni PL. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome. Autoimmun Rev. 2018 Dec;17(12):1153-1168. doi: 10.1016/j.autrev.2018.05.012. Epub 2018 Oct 12. Review.

ReferenceCitation: Prigent J, Lorin V, Kök A, Hieu T, Bourgeau S, Mouquet H. Scarcity of autoreactive human blood IgA(+) memory B cells. Eur J Immunol. 2016 Oct;46(10):2340-2351. doi: 10.1002/eji.201646446. Epub 2016 Aug 25.

ReferenceCitation: Bouchet J, Del Río-Iñiguez I, Vázquez-Chávez E, Lasserre R, Agüera-González S, Cuche C, McCaffrey MW, Di Bartolo V, Alcover A. Rab11-FIP3 Regulation of Lck Endosomal Traffic Controls TCR Signal Transduction. J Immunol. 2017 Apr 1;198(7):2967-2978. doi: 10.4049/jimmunol.1600671. Epub 2017 Feb 24.

ReferenceCitation: Agüera-González S, Burton OT, Vázquez-Chávez E, Cuche C, Herit F, Bouchet J, Lasserre R, Del Río-Iñiguez I, Di Bartolo V, Alcover A. Adenomatous Polyposis Coli Defines Treg Differentiation and Anti-inflammatory Function through Microtubule-Mediated NFAT Localization. Cell Rep. 2017 Oct 3;21(1):181-194. doi: 10.1016/j.celrep.2017.09.020.

location_facility:
Institut Pasteur
Centre médical de l'Institut Pasteur
Hopital sainte Périne
Hôpital Tenon


title: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study

summary: The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.

location_facility:
Hôpital La Timone
CHU Nîmes
Nimes University hospital
AP-HM - Hopital Nord


title: Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact

acronym: IMAGE

summary: Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

ReferenceCitation: Mahr A, Batteux F, Tubiana S, Goulvestre C, Wolff M, Papo T, Vrtovsnik F, Klein I, Iung B, Duval X; IMAGE Study Group. Brief report: prevalence of antineutrophil cytoplasmic antibodies in infective endocarditis. Arthritis Rheumatol. 2014 Jun;66(6):1672-7. doi: 10.1002/art.38389.

name: Hôpital St. Louis, AP-HP, and Université Paris Diderot, Paris 7; Paris France

family: Mahr

full_name: Alfred Mahr

given: Alfred

name: Hôpital Cochin, AP-HP, and Université Paris Descartes, Paris 5; Paris France

family: Batteux

full_name: Frédéric Batteux

given: Frédéric

name: Hôpital Bichat-Claude Bernard, AP-HP, and Université Paris Diderot, Paris 7; Paris France

family: Tubiana

full_name: Sarah Tubiana

given: Sarah

family: Goulvestre

full_name: Claire Goulvestre

given: Claire

family: Wolff

full_name: Michel Wolff

given: Michel

family: Papo

full_name: Thomas Papo

given: Thomas

family: Vrtovsnik

full_name: François Vrtovsnik

given: François

family: Klein

full_name: Isabelle Klein

given: Isabelle

family: Iung

full_name: Bernard Iung

given: Bernard

name: Hôpital Bichat-Claude Bernard, AP-HP, Université Paris Diderot, Paris 7, and INSERM U738, CIC 007; Paris France

family: Duval

full_name: Xavier Duval

given: Xavier

journal_name: Arthritis & Rheumatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Brief Report: Prevalence of Antineutrophil Cytoplasmic Antibodies in Infective Endocarditis

ReferenceCitation: Iung B, Tubiana S, Klein I, Messika-Zeitoun D, Brochet E, Lepage L, Al-Attar N, Ruimy R, Leport C, Wolff M, Duval X; ECHO-IMAGE Study Group. Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study. Stroke. 2013 Nov;44(11):3056-62. doi: 10.1161/STROKEAHA.113.001470. Epub 2013 Sep 3.

name: From the Departments of Cardiology (B.I., D.M.-Z., E.B.), Biostatistic (S.T.), Radiology (I.K.), Cardiovascular Surgery (L.L., N.A.-A.), Microbiology (R.R.), Intensive Care (M.W.), and Infectious Disease (X.D.), AP-HP, Bichat Hospital, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, France (B.I., R.R., C.L., M.W., X.D.); INSERM Clinical Investigation Center 007, Paris, France (S.T., X.D.); and INSERM U738, Paris, France (C.L., X.D.).

family: Messika-Zeitoun

full_name: David Messika-Zeitoun

given: David

family: Brochet

full_name: Eric Brochet

given: Eric

family: Lepage

full_name: Laurent Lepage

family: Al-Attar

full_name: Nawwar Al-Attar

given: Nawwar

family: Ruimy

full_name: Raymond Ruimy

given: Raymond

family: Leport

full_name: Catherine Leport

given: Catherine

title: Determinants of Cerebral Lesions in Endocarditis on Systematic Cerebral Magnetic Resonance Imaging

ReferenceCitation: Iung B, Klein I, Mourvillier B, Olivot JM, Détaint D, Longuet P, Ruimy R, Fourchy D, Laurichesse JJ, Laissy JP, Escoubet B, Duval X; Study Group. Respective effects of early cerebral and abdominal magnetic resonance imaging on clinical decisions in infective endocarditis. Eur Heart J Cardiovasc Imaging. 2012 Aug;13(8):703-10. doi: 10.1093/ehjci/jes023. Epub 2012 Feb 14.

journal_name: European Heart Journal - Cardiovascular Imaging

ReferenceCitation: Duval X, Iung B, Klein I, Brochet E, Thabut G, Arnoult F, Lepage L, Laissy JP, Wolff M, Leport C; IMAGE (Resonance Magnetic Imaging at the Acute Phase of Endocarditis) Study Group. Effect of early cerebral magnetic resonance imaging on clinical decisions in infective endocarditis: a prospective study. Ann Intern Med. 2010 Apr 20;152(8):497-504, W175. doi: 10.7326/0003-4819-152-8-201004200-00006.

title: Effect of Early Cerebral Magnetic Resonance Imaging on Clinical Decisions in Infective Endocarditis

location_facility: Hôpital Bichat Claude Bernard, 46 rue Henri Huchard


title: Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

acronym: ACTIVEDO

summary: Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU de Montpellier
CHI de Haute-Saône
CHU de Nantes
CHU de Besançon


title: A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

summary: Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.

ReferenceCitation: Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8:CD007789. doi: 10.1002/14651858.CD007789.pub3.

name: Adult Emergency Department; Auckland City Hospital; Auckland New Zealand

family: Jones

full_name: Peter Jones

given: Peter

family: Lamdin

full_name: Rain Lamdin

given: Rain

name: Departments of Surgery and Paediatrics: Child and Youth Health; The University of Auckland; Auckland New Zealand

family: Dalziel

full_name: Stuart R Dalziel

given: Stuart R

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Merck Sharp & Dohme Corp.

location_facility: Laboratoires Merck Sharp & Dohme - Chibret


title: Balance Control and Maturation in Normal and Deaf Children Aged From 6 to 14 Years Old

summary:
Balance disorders in children are poorly known, underestimated, and rarely assessed. Technologies to assess balance in children are almost non-existent, apart from a few exceptions. Such technologies are routinely used in adults for some decades, and are of considerable contribution in the diagnosis and treatment of adults balance disorders.

The aim of this study is :

to assess objectively children balance disorders.
to provide technologies suitable for children balance assessement.
to study children balance disorders suffering from sensorineural hearing loss.

intervention_type: Behavioral


title: Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With RAS-mutated Metastatic Colorectal Cancer: a Dose-escalation, Phase I/II Trial

acronym: FOLFIRINOX-R

summary: Safety, tolerability and efficacy of regorafenib in combination with FOLFIRINOX in patients with RAS-mutated metastatic colorectal cancer: a dose-escalation, phase I/II trial

ReferenceCitation: Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Köhne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Österlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taïeb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.

ReferenceCitation: Modest DP, Ricard I, Heinemann V, Hegewisch-Becker S, Schmiegel W, Porschen R, Stintzing S, Graeven U, Arnold D, von Weikersthal LF, Giessen-Jung C, Stahler A, Schmoll HJ, Jung A, Kirchner T, Tannapfel A, Reinacher-Schick A. Outcome according to KRAS-, NRAS- and BRAF-mutation as well as KRAS mutation variants: pooled analysis of five randomized trials in metastatic colorectal cancer by the AIO colorectal cancer study group. Ann Oncol. 2016 Sep;27(9):1746-53. doi: 10.1093/annonc/mdw261. Epub 2016 Jun 29.

ReferenceCitation: Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

family: Mross

full_name: Klaus Mross

given: Klaus

family: Frost

full_name: Annette Frost

given: Annette

family: Steinbild

full_name: Simone Steinbild

given: Simone

family: Hedbom

full_name: Susanne Hedbom

given: Susanne

family: Büchert

full_name: Martin Büchert

given: Martin

family: Fasol

full_name: Ulrike Fasol

given: Ulrike

family: Unger

full_name: Clemens Unger

given: Clemens

family: Krätzschmar

full_name: Jörn Krätzschmar

given: Jörn

family: Heinig

full_name: Roland Heinig

given: Roland

family: Boix

full_name: Oliver Boix

given: Oliver

family: Christensen

full_name: Olaf Christensen

given: Olaf

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: A Phase I Dose–Escalation Study of Regorafenib (BAY 73–4506), an Inhibitor of Oncogenic, Angiogenic, and Stromal Kinases, in Patients with Advanced Solid Tumors

ReferenceCitation: Schmieder R, Hoffmann J, Becker M, Bhargava A, Müller T, Kahmann N, Ellinghaus P, Adams R, Rosenthal A, Thierauch KH, Scholz A, Wilhelm SM, Zopf D. Regorafenib (BAY 73-4506): antitumor and antimetastatic activities in preclinical models of colorectal cancer. Int J Cancer. 2014 Sep 15;135(6):1487-96. doi: 10.1002/ijc.28669. Epub 2014 Apr 17.

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

family: Grothey

full_name: Axel Grothey

given: Axel

family: Cutsem

full_name: Eric Van Cutsem

given: Eric Van

family: Sobrero

full_name: Alberto Sobrero

given: Alberto

family: Siena

full_name: Salvatore Siena

given: Salvatore

family: Falcone

full_name: Alfredo Falcone

given: Alfredo

family: Ychou

full_name: Marc Ychou

given: Marc

family: Humblet

full_name: Yves Humblet

given: Yves

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Mineur

ReferenceCitation: Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13.

ReferenceCitation: Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R, Hacker UT, Köhne CH, Kornacker M, Boix O, Lettieri J, Krauss J, Fischer R, Hamann S, Strumberg D, Mross KB. Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study. Ann Oncol. 2013 Jun;24(6):1560-7. doi: 10.1093/annonc/mdt056. Epub 2013 Mar 13.

ReferenceCitation: Leitinger B. Discoidin domain receptor functions in physiological and pathological conditions. Int Rev Cell Mol Biol. 2014;310:39-87. doi: 10.1016/B978-0-12-800180-6.00002-5. Review.

ReferenceCitation: Rammal H, Saby C, Magnien K, Van-Gulick L, Garnotel R, Buache E, El Btaouri H, Jeannesson P, Morjani H. Corrigendum: Discoidin Domain Receptors: Potential Actors and Targets in Cancer. Front Pharmacol. 2016 Sep 30;7:346. eCollection 2016.

ReferenceCitation: Gao H, Chakraborty G, Zhang Z, Akalay I, Gadiya M, Gao Y, Sinha S, Hu J, Jiang C, Akram M, Brogi E, Leitinger B, Giancotti FG. Multi-organ Site Metastatic Reactivation Mediated by Non-canonical Discoidin Domain Receptor 1 Signaling. Cell. 2016 Jun 30;166(1):47-62. doi: 10.1016/j.cell.2016.06.009.

ReferenceCitation: Jeitany M, Leroy C, Tosti P, Lafitte M, Le Guet J, Simon V, Bonenfant D, Robert B, Grillet F, Mollevi C, El Messaoudi S, Otandault A, Canterel-Thouennon L, Busson M, Thierry AR, Martineau P, Pannequin J, Roche S, Sirvent A. Inhibition of DDR1-BCR signalling by nilotinib as a new therapeutic strategy for metastatic colorectal cancer. EMBO Mol Med. 2018 Apr;10(4). pii: e7918. doi: 10.15252/emmm.201707918.

ReferenceCitation: Zopf D, Fichtner I, Bhargava A, Steinke W, Thierauch KH, Diefenbach K, Wilhelm S, Hafner FT, Gerisch M. Pharmacologic activity and pharmacokinetics of metabolites of regorafenib in preclinical models. Cancer Med. 2016 Nov;5(11):3176-3185. doi: 10.1002/cam4.883. Epub 2016 Oct 13.

ReferenceCitation: Mouliere F, El Messaoudi S, Gongora C, Guedj AS, Robert B, Del Rio M, Molina F, Lamy PJ, Lopez-Crapez E, Mathonnet M, Ychou M, Pezet D, Thierry AR. Circulating Cell-Free DNA from Colorectal Cancer Patients May Reveal High KRAS or BRAF Mutation Load. Transl Oncol. 2013 Jun 1;6(3):319-28. Print 2013 Jun.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

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

ReferenceCitation: Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, Mathonnet M, Pezet D, Ychou M. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038/nm.3511. Epub 2014 Mar 23.

ReferenceCitation: Thierry AR, El Messaoudi S, Mollevi C, Raoul JL, Guimbaud R, Pezet D, Artru P, Assenat E, Borg C, Mathonnet M, De La Fouchardière C, Bouché O, Gavoille C, Fiess C, Auzemery B, Meddeb R, Lopez-Crapez E, Sanchez C, Pastor B, Ychou M. Clinical utility of circulating DNA analysis for rapid detection of actionable mutations to select metastatic colorectal patients for anti-EGFR treatment. Ann Oncol. 2017 Sep 1;28(9):2149-2159. doi: 10.1093/annonc/mdx330.

ReferenceCitation: Tie J, Kinde I, Wang Y, Wong HL, Roebert J, Christie M, Tacey M, Wong R, Singh M, Karapetis CS, Desai J, Tran B, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as an early marker of therapeutic response in patients with metastatic colorectal cancer. Ann Oncol. 2015 Aug;26(8):1715-22. doi: 10.1093/annonc/mdv177. Epub 2015 Apr 7.

ReferenceCitation: Vidal J, Muinelo L, Dalmases A, Jones F, Edelstein D, Iglesias M, Orrillo M, Abalo A, Rodríguez C, Brozos E, Vidal Y, Candamio S, Vázquez F, Ruiz J, Guix M, Visa L, Sikri V, Albanell J, Bellosillo B, López R, Montagut C. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients. Ann Oncol. 2017 Jun 1;28(6):1325-1332. doi: 10.1093/annonc/mdx125.

ReferenceCitation: Thierry AR, Pastor B, Jiang ZQ, Katsiampoura AD, Parseghian C, Loree JM, Overman MJ, Sanchez C, Messaoudi SE, Ychou M, Kopetz S. Circulating DNA Demonstrates Convergent Evolution and Common Resistance Mechanisms during Treatment of Colorectal Cancer. Clin Cancer Res. 2017 Aug 15;23(16):4578-4591. doi: 10.1158/1078-0432.CCR-17-0232. Epub 2017 Apr 11.

ReferenceCitation: Adenis A, Mazard T, Fraisse J, Chalbos P, Pastor B, Evesque L, Ghiringhelli F, Mollevi C, Delaine S, Ychou M. FOLFIRINOX-R study design: a phase I/II trial of FOLFIRINOX plus regorafenib as first line therapy in patients with unresectable RAS-mutated metastatic colorectal cancer. BMC Cancer. 2021 May 17;21(1):564. doi: 10.1186/s12885-021-08312-7.

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

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle


title: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial

acronym: EVASTRAM

summary:
Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia.

The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Grenoble
Hospices Civils de Lyon
CHU Saint-Etienne
CHU Clermont-Ferrand


title: Comparison of the Cumulative Number of Oocytes Obtained With 2 Controlled Ovarian Hyperstimulations (COH) Within the Same Cycle With FertistartKit® (DUOSTIM) Versus 2 Conventional COH in Poor Ovarian Responders Undergoing IVF. Bistim Study

summary: During ovarian stimulation, all the follicles grow under the action of FSH, only the selected follicles and with the faster growth are taken. However during this stimulation, other smaller follicles are also recruited and sensitized, which may increase the selection of follicles available on the follicular wave following. In patients with weak reserve this potentiation has a great interest, and the sequence of 2 stimulations on the same cycle could make it possible to obtain a larger number of oocytes and embryos, thus giving a better chance of delivery than on 2 distinct cycles of stimulation. However, this is preliminary data that needs to be confirmed with a randomized controlled trial. In this population of poor prognosis, the use of FSH-associated LH activity may optimize the ovarian response to stimulation, particularly the combination containing placental HCG (Fertistartkit®) that obtaining a slightly higher number of oocytes than highly purified HMG (Menopur®).

location_facility:
Cabinet Médical Carré Saint Giniez
CHI Creteil
Polyclinique Saint Roch
Polyclinique Jean Villar


title: Evaluation of the Bladder Stimulation, a Non-invasive Technique of Urine Collection, in Infant Less Than 6 Months to Diagnose Urinary Tract Infection: a Randomized Multicenter Study

acronym: EEStiVeN

summary: Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants. Actually, the investigators don't have data on bacterial contamination rates for clean-catch midstream urine collections using this technique

ReferenceCitation: Demonchy D, Ciais C, Fontas E, Berard E, Bréaud J, Rohrlich PS, Dubos F, Fortier C, Desmontils J, Hérisse AL, Donzeau D, Haas H, Tran A. Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study ("EE-Sti.Ve.N"). Trials. 2019 Dec 27;20(1):783. doi: 10.1186/s13063-019-3914-2.

family: Demonchy

full_name: D. Demonchy

given: D.

family: Ciais

full_name: C. Ciais

given: C.

family: Fontas

full_name: E. Fontas

given: E.

family: Berard

full_name: E. Berard

family: Bréaud

full_name: J. Bréaud

given: J.

family: Rohrlich

full_name: P. S. Rohrlich

given: P. S.

family: Dubos

full_name: F. Dubos

given: F.

family: Fortier

full_name: C. Fortier

family: Desmontils

full_name: J. Desmontils

family: Hérisse

full_name: A. L. Hérisse

given: A. L.

family: Donzeau

full_name: D. Donzeau

family: Haas

full_name: H. Haas

given: H.

family: Tran

full_name: A. Tran

given: A.

journal_name: Trials

title: Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study (“EE-Sti.Ve.N”)

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator

acronym: EFAPAD

summary:
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease.

Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Imagerie Médicale Bachaumont Paris Centre

location_facility: JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur


title: Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests

summary: Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be enrolled.

ReferenceCitation: Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Bragança C, Billères X, Clotteau-Lambert MP, Fuster P, Thiercelin D, Debaty G, Ricard-Hibon A, Roux P, Espesson C, Querellou E, Ducros L, Ecollan P, Halbout L, Savary D, Guillaumée F, Maupoint R, Capelle P, Bracq C, Dreyfus P, Nouguier P, Gache A, Meurisse C, Boulanger B, Lae C, Metzger J, Raphael V, Beruben A, Wenzel V, Guinhouya C, Vilhelm C, Marret E. Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. N Engl J Med. 2008 Jul 3;359(1):21-30. doi: 10.1056/NEJMoa0706873.

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

given: Pierre-Yves

family: David

full_name: Jean-Stéphane David

given: Jean-Stéphane

family: Chanzy

full_name: Eric Chanzy

given: Eric

family: Hubert

full_name: Hervé Hubert

given: Hervé

family: Dubien

full_name: Pierre-Yves Dubien

family: Mauriaucourt

full_name: Patrick Mauriaucourt

given: Patrick

family: Bragança

full_name: Coralie Bragança

given: Coralie

family: Billères

full_name: Xavier Billères

given: Xavier

family: Clotteau-Lambert

full_name: Marie-Paule Clotteau-Lambert

given: Marie-Paule

family: Fuster

full_name: Patrick Fuster

family: Thiercelin

full_name: Didier Thiercelin

given: Didier

family: Debaty

full_name: Guillaume Debaty

given: Guillaume

family: Ricard-Hibon

full_name: Agnès Ricard-Hibon

given: Agnès

family: Roux

full_name: Patrick Roux

family: Espesson

full_name: Catherine Espesson

given: Catherine

family: Querellou

full_name: Emgan Querellou

given: Emgan

family: Ducros

full_name: Laurent Ducros

given: Laurent

family: Ecollan

full_name: Patrick Ecollan

family: Halbout

full_name: Laurent Halbout

family: Savary

full_name: Dominique Savary

given: Dominique

family: Guillaumée

full_name: Frédéric Guillaumée

given: Frédéric

family: Maupoint

full_name: Régine Maupoint

given: Régine

family: Capelle

full_name: Philippe Capelle

given: Philippe

family: Bracq

full_name: Cécile Bracq

given: Cécile

title: Vasopressin and Epinephrine vs. Epinephrine Alone in Cardiopulmonary Resuscitation


title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

summary: This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.


title: Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

acronym: PETEChIA

summary:
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.

No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU of POITIERS
CHU of MONTPELLIER
CHU of NICE
La Pité Salpêtrière

intervention_type: Biological


title: A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy

summary: This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.


title: POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

summary:
Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery.

It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.

ReferenceCitation: Confavreux C, Hutchinson M, Hours MM, Cortinovis-Tourniaire P, Moreau T. Rate of pregnancy-related relapse in multiple sclerosis. Pregnancy in Multiple Sclerosis Group. N Engl J Med. 1998 Jul 30;339(5):285-91.

ReferenceCitation: Confavreux C, Hutchinson M, Hours M, Cortinovis-Tourniaire P, Grimaud J, Moreau T. [Multiple sclerosis and pregnancy: clinical issues]. Rev Neurol (Paris). 1999 Mar;155(3):186-91. Review. French.

ReferenceCitation: Vukusic S, Hutchinson M, Hours M, Moreau T, Cortinovis-Tourniaire P, Adeleine P, Confavreux C; Pregnancy In Multiple Sclerosis Group. Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post-partum relapse. Brain. 2004 Jun;127(Pt 6):1353-60. Epub 2004 May 6. Erratum in: Brain. 2004 Aug;127(Pt 8):1912.

ReferenceCitation: Vukusic S, Ionescu I, El-Etr M, Schumacher M, Baulieu EE, Cornu C, Confavreux C; Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis Study Group. The Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis (POPART'MUS) trial: rationale, objectives and state of advancement. J Neurol Sci. 2009 Nov 15;286(1-2):114-8. doi: 10.1016/j.jns.2009.08.056. Epub 2009 Sep 15.

family: Vukusic

full_name: S. Vukusic

given: S.

family: Ionescu

full_name: I. Ionescu

given: I.

family: El-Etr

full_name: M. El-Etr

given: M.

family: Schumacher

full_name: M. Schumacher

family: Baulieu

full_name: E.E. Baulieu

family: Cornu

full_name: C. Cornu

given: C.

family: Confavreux

full_name: C. Confavreux

journal_name: Journal of the Neurological Sciences

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis (POPART'MUS) trial: Rationale, objectives and state of advancement


title: A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis

summary: This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.

ReferenceCitation: Fizazi K, Gravis G, Flechon A, Geoffrois L, Chevreau C, Laguerre B, Delva R, Eymard JC, Rolland F, Houede N, Laplanche A, Burcoveanu D, Culine S. Combining gemcitabine, cisplatin, and ifosfamide (GIP) is active in patients with relapsed metastatic germ-cell tumors (GCT): a prospective multicenter GETUG phase II trial. Ann Oncol. 2014 May;25(5):987-91. doi: 10.1093/annonc/mdu099. Epub 2014 Mar 4.

family: Fizazi

full_name: K. Fizazi

given: K.

family: Gravis

full_name: G. Gravis

given: G.

family: Flechon

full_name: A. Flechon

given: A.

family: Geoffrois

full_name: L. Geoffrois

given: L.

family: Chevreau

full_name: C. Chevreau

family: Laguerre

full_name: B. Laguerre

given: B.

family: Delva

full_name: R. Delva

given: R.

family: Eymard

full_name: J.C. Eymard

family: Rolland

full_name: F. Rolland

given: F.

family: Houede

full_name: N. Houede

given: N.

family: Laplanche

full_name: A. Laplanche

family: Burcoveanu

full_name: D. Burcoveanu

given: D.

family: Culine

full_name: S. Culine

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific


title: AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

acronym: AXONE-Acute

summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Rouen

location_facility:
Lille University Hospital
Bordeaux University Hospital
Rouen University Hospital
Rennes University Hospital


title: Assessment of a Functional Test to Detect Familial Mediterranean Fever

acronym: DEPIST-FMF

summary:
Familial Mediterranean Fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is due to mutations of the MEFV gene, encoding variants of the Pyrin inflammasome. Inflammasomes are protein complexes of innate immunity producing pro-inflammatory cytokines (interleukin-1β).

In vitro, preliminary results demonstrated that activation of the Pyrin inflammasome (measured by interleukin-1β concentration) by kinase inhibitors is significantly increased in FMF patients compared to subjects with a similar clinical picture, and healthy controls. In addition, a measure of cell death yielded significant results in differentiating patients from controls.

The investigators hypothesize that this fast and simple functional test can serve as a diagnostic tool for FMF.

location_facility: Service de Médecine Interne et pathologies vasculaires, Batiment 1B, Centre Hospitalier Lyon Sud

location_facility: Unité Inserm U1111 & Service de Médecine Interne, Hôpital de la Croix-Rousse

location_facility: Service de Médecine Interne, Pavillon O - Hopital Edouard Herriot

location_facility: Service de néphrologie et rhumatologie pédiatrique, Hôpital Femme Mère Enfant


lead_sponsor: University Hospital, Montpellier

acronym: LIDA-BII

location_facility:
CHU de Montpellier
CHU d'Angers
CHU de Nice
CHU de Dijon

type: EudraCT Number

source: euctr

title: Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.

summary: The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.


title: A Prospective Phase II Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer Who Achieve a Response or a Stabilization to Docetaxel-Estramustine

summary: This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.


title: Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients

summary:
Adequate sedation is of paramount importance to avoid stress and pain in mechanically ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and analgesic (opiate) drugs.
This combined sedation may not be sufficient in some instances.
The aim of this study is to evaluate whether addition of a third substance, ketamine, allows the achievement of better sedation and avoids the use of neuromuscular blocking agents.

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

ReferenceCitation: Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ. Sedation in the intensive care unit: a systematic review. JAMA. 2000 Mar 15;283(11):1451-9. Review.

ReferenceCitation: Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13.

location_facility: Service de Réanimation Médicale, Hôpital Louis Mourier