title: EWOC-1 Trial: Multicenter, Randomized Trial of Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer

summary:
The current standard of first-line chemotherapy in advanced ovarian cancer is the combination of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is feasible in selected elderly patients such as those included in prospective trials. These trials, however, include a minority of the elderly population. In wider selection of patients >70 years old, the standard carboplatin-paclitaxel regimen has been shown to induce an excess of toxicity and premature treatment stopping. For elderly patients thought to be vulnerable and at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel regimen, other options are used in routine practice. One option is to delete paclitaxel and treat elderly patients with carboplatin as a single agent. An alternative is to use the carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the MITO (Multicentre Italian Trial in Ovarian Cancer).

To date, there is no randomized trial which could give us some evidence of how to select patients who could benefit most of one or the other regimen described above. The 4th Ovarian Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy for elderly patients with ovarian cancer and the necessity of additional research in this population.

Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of elderly patients with advanced ovarian cancer included in a specific multicenter phase II trial. The best proportional hazard model fitting for overall survival identified the following geriatric covariates score as being poor survival risk factors: ADL score <6, IADL score <25, HADS score >14, albuminemia <35g/L and , lymphopenia <1G/L. GVS is the sum of these risk factors for each patient. Using a cut off of 3, the GVS identified a group of patients at high risk of severe toxicity, early cessation of treatment, unplanned hospitalization and adverse outcomes.

This international multicentre randomized phase II trial will compare the success rate of delivering 6 courses of chemotherapy with evidence of efficacy and without premature termination for progression, death or unacceptable toxicity of three different chemotherapy regimens in a selected population of elderly patients with a GVS ≥ 3:

Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks
Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks
Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 every 4 weeks)

The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the first step, then 58 more by arm (total=174) after interim analysis.

ReferenceCitation: Falandry C, Rousseau F, Mouret-Reynier MA, Tinquaut F, Lorusso D, Herrstedt J, Savoye AM, Stefani L, Bourbouloux E, Sverdlin R, D'Hondt V, Lortholary A, Brachet PE, Zannetti A, Malaurie E, Venat-Bouvet L, Trédan O, Mourey L, Pujade-Lauraine E, Freyer G; Groupe d'Investigateurs Nationaux pour l'Étude des Cancers de l'Ovaire et du sein (GINECO). Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin Plus Paclitaxel for Vulnerable Older Adult Women With Ovarian Cancer: A GINECO/GCIG Randomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):853-861. doi: 10.1001/jamaoncol.2021.0696. Erratum in: JAMA Oncol. 2021 Jun 1;7(6):945.

name: Groupe d’Investigateurs Nationaux pour l’Étude des Cancers de l’Ovaire et du sein (GINECO), Laboratoire CarMEN, INSERM U1060/INRA U1397, Université Lyon 1, INSA de Lyon, and Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France

family: Falandry

full_name: Claire Falandry

given: Claire

name: GINECO and Institut Paoli Calmettes, Marseille, France

family: Rousseau

full_name: Frédérique Rousseau

given: Frédérique

name: GINECO and Centre Jean Perrin, Clermont-Ferrand, France

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

name: GINECO and Institut de Cancérologie de la Loire, St Priest en Jarez, France

family: Tinquaut

full_name: Fabien Tinquaut

given: Fabien

name: Multicentre Italian Trials in Ovarian cancer (MITO) and Fondazione Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, and Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

name: Nordic Society of Gynecologic Oncology (NSGO), Odense University Hospital, Odense, and Zealand University Hospital, Roskilde, Denmark

family: Herrstedt

full_name: Jørn Herrstedt

given: Jørn

name: GINECO and Institut Jean Godinot, Reims, France

family: Savoye

full_name: Aude-Marie Savoye

given: Aude-Marie

name: GINECO and Centre Hospitalier Annecy Genevois, Pringy, France

family: Stefani

full_name: Laetitia Stefani

given: Laetitia

name: GINECO and Institut de Cancérologie de l’Ouest René Gauducheau, Saint Herblain, France

family: Bourbouloux

full_name: Emmanuelle Bourbouloux

given: Emmanuelle

name: GINECO and Groupe Hospitalier Paris Saint Joseph, Paris, France

family: Sverdlin

full_name: Robert Sverdlin

given: Robert

name: GINECO and Institut du Cancer de Montpellier, Montpellier, France

family: D’Hondt

full_name: Veronique D’Hondt

given: Veronique

name: GINECO and Hôpital Privé du Confluent, Nantes, France

family: Lortholary

full_name: Alain Lortholary

given: Alain

name: GINECO and Centre François Baclesse, Caen, France

family: Brachet

full_name: Pierre-Emmanuel Brachet

given: Pierre-Emmanuel

name: GINECO and Centre Hospitalier de Cholet, Cholet, France

family: Zannetti

full_name: Alain Zannetti

name: GINECO and Centre Hospitalier Intercommunal de Créteil, Créteil, France

family: Malaurie

full_name: Emmanuelle Malaurie

name: GINECO and Centre Hospitalier Universitaire Dupuytren, Limoges, France

family: Venat-Bouvet

full_name: Laurence Venat-Bouvet

given: Laurence

name: GINECO and Centre Léon Bérard, Lyon, France

name: GINECO and Institut Claudius Regaud, Toulouse, France

family: Mourey

full_name: Loïc Mourey

given: Loïc

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

name: GINECO and Centre Hospitalier Lyon-Sud, Lyon, France

family: Freyer

full_name: Gilles Freyer

given: Gilles

journal_name: JAMA Oncology

lead_sponsor: Hospices Civils de Lyon

location_country: Italy Sweden Finland France Denmark Canada

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Cholet

location_facility: Service d'Oncologie Médicale - Centre Azuréen de Cancérologie

location_facility: Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle

location_facility: Service d'Oncologie - Groupe Hospitalier Saint-Joseph

location_facility: Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy

location_facility: Service d'Oncologie Médicale - ICO Centre René Gauducheau

location_facility: Service d'Oncologie Médicale - Institut Claudius Regaud

location_facility: Service d'Oncologie multidisciplinaire - Hôpital Nord

location_facility: Service d'Oncologie Radiothérapie - Clinique de Valdegour

location_facility: Service d'Oncologie Médicale - Institut Paoli Calmettes

location_facility: Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans

location_facility: Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy

location_facility: Service d''Hématologie Oncologie - Hôpital André Mignot

location_facility: Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine

location_facility: Service d'Onco-Hématologie - Hôpital Fleyriat

location_facility: Service de Chimiothérapie - Centre Catherine de Sienne

location_facility: Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo

location_facility: Service d'Onco-Hématologie - Centre Antoine Lacassagne

location_facility: Centre CARIO - Hôpital Privé des Côtes d'Armor

location_facility: Servide d'Oncologie Médicale - Centre Jean Perrin

location_facility: Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire

location_facility: Service d'Oncologie Médicale - Institut Bergonié

location_facility: Service d'Oncologie Médicale - Centre Paul Strauss

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Service d'Oncologie Médicale - ICO Paul Papin

location_facility: Service d'Oncologie - Centre Hospitalier Alpes Leman

location_facility: Service d'Oncologie Service 2 B Nord - Centre Léon Bérard

location_facility: Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: Centro di Riferimento Oncologico - CRO,IRCCS

location_facility: Service de cancérologie clinique - Institut Sainte-Catherine

location_facility: Servide d'Oncologie Médicale - Institut Jean Godinot

location_facility: Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman

location_facility: Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin

location_facility: Service d'Uro-Gynécologie - Centre François Baclesse

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Perpignan

location_facility: Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis

location_facility: Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou

location_facility: Service d'Oncologie - Centre Hospitalier de Chambéry

location_facility: Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Sens

location_facility: Service d'Oncologie Médicale - Centre Georges François Leclerc

location_facility: Service de Médecine Interne et Oncologie Médicale - CH du Mans

location_facility: Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll

location_facility: Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan

location_facility: Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille

location_facility: Servide d'Oncologie Médicale - Hôpital Jean Minjoz

location_facility: service d'Oncologie Médicale - Centre Hospitalier Broussais

location_facility: Service d'Oncologie Médicale - Centre Hospitalier d'Alès

location_facility: Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil

location_facility: Service d'Oncologie Médicale - Hôpital des Diaconesses

location_facility: Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap


title: Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of In-Stent Restenosis Lesions in Native Coronary Arteries.

acronym: DEBREST

summary: The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: MINVASYS

location_facility:
Centre Hospitalier privé Saint-Martin
Clinique Saint-Pierre
Les Franciscaines
Clinique Saint-Martin
Centre Hospitalier d'Haguenau
Polyclinique les Fleurs
Centre cardiologique d'Evecquemont
Hôpital Privé d'Antony

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


type: Registry Identifier

title: Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

summary:
This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months.

If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Castellsagué X, Quintana MJ, Martínez MC, Nieto A, Sánchez MJ, Juan A, Monner A, Carrera M, Agudo A, Quer M, Muñoz N, Herrero R, Franceschi S, Bosch FX. The role of type of tobacco and type of alcoholic beverage in oral carcinogenesis. Int J Cancer. 2004 Feb 20;108(5):741-9.

ReferenceCitation: Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. Epub 2007 Sep 6. Review.

ReferenceCitation: Nagler R, Bahar G, Shpitzer T, Feinmesser R. Concomitant analysis of salivary tumor markers--a new diagnostic tool for oral cancer. Clin Cancer Res. 2006 Jul 1;12(13):3979-84.

ReferenceCitation: Tavassoli M, Brunel N, Maher R, Johnson NW, Soussi T. p53 antibodies in the saliva of patients with squamous cell carcinoma of the oral cavity. Int J Cancer. 1998 Oct 29;78(3):390-1.

ReferenceCitation: Peng G, Hakim M, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Tisch U, Haick H. Detection of lung, breast, colorectal, and prostate cancers from exhaled breath using a single array of nanosensors. Br J Cancer. 2010 Aug 10;103(4):542-51. doi: 10.1038/sj.bjc.6605810. Epub 2010 Jul 20.

ReferenceCitation: Mager DL, Haffajee AD, Devlin PM, Norris CM, Posner MR, Goodson JM. The salivary microbiota as a diagnostic indicator of oral cancer: a descriptive, non-randomized study of cancer-free and oral squamous cell carcinoma subjects. J Transl Med. 2005 Jul 7;3:27.

ReferenceCitation: Li Y, St John MA, Zhou X, Kim Y, Sinha U, Jordan RC, Eisele D, Abemayor E, Elashoff D, Park NH, Wong DT. Salivary transcriptome diagnostics for oral cancer detection. Clin Cancer Res. 2004 Dec 15;10(24):8442-50.

ReferenceCitation: El-Naggar AK, Mao L, Staerkel G, Coombes MM, Tucker SL, Luna MA, Clayman GL, Lippman S, Goepfert H. Genetic heterogeneity in saliva from patients with oral squamous carcinomas: implications in molecular diagnosis and screening. J Mol Diagn. 2001 Nov;3(4):164-70.

ReferenceCitation: Liao PH, Chang YC, Huang MF, Tai KW, Chou MY. Mutation of p53 gene codon 63 in saliva as a molecular marker for oral squamous cell carcinomas. Oral Oncol. 2000 May;36(3):272-6.

ReferenceCitation: Anker P, Lyautey J, Lederrey C, Stroun M. Circulating nucleic acids in plasma or serum. Clin Chim Acta. 2001 Nov;313(1-2):143-6.

ReferenceCitation: Li Y, Zhou X, St John MA, Wong DT. RNA profiling of cell-free saliva using microarray technology. J Dent Res. 2004 Mar;83(3):199-203.

ReferenceCitation: Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. Erratum in: Cancer. 2003 Nov 1;98(9):2000.

ReferenceCitation: Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3.

ReferenceCitation: Miekisch W, Schubert JK, Noeldge-Schomburg GF. Diagnostic potential of breath analysis--focus on volatile organic compounds. Clin Chim Acta. 2004 Sep;347(1-2):25-39. Review.

lead_sponsor: Centre Leon Berard

location_facility: Groupement Hospitalier Pitié Salpêtrière

location_facility: CHU Bordeaux - Groupe Hospitalier Pellegrin

lead_sponsor_type: academique

status_simplified: Unknown


title: Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study

summary:
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.

This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.

The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.

design_allocation: Randomized

lead_sponsor: Air Liquide Santé International

location_country: Italy Germany France Netherlands

location_facility: Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Klinikum Links der Weser - Senator-Wessling-Str. 1

location_facility: Academic Medical Center - University of Amsterdam

location_facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel

intervention_type: Drug


title: STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL)

summary: This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Lemonnier F, Safar V, Beldi-Ferchiou A, Cottereau AS, Bachy E, Cartron G, Fataccioli V, Pelletier L, Robe C, Letourneau A, Missiaglia E, Fourati S, Moles-Moreau MP, Delmer A, Bouabdallah R, Voillat L, Becker S, Bossard C, Parrens M, Casasnovas O, Cacheux V, Régny C, Camus V, Delfau-Larue MH, Meignan M, de Leval L, Gaulard P, Haioun C. Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma. Blood Adv. 2021 Jan 26;5(2):539-548. doi: 10.1182/bloodadvances.2020003081.

name: Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Unité Hémopathies Lymphoïdes, Créteil, France;

name: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France;

family: Lemonnier

full_name: François Lemonnier

given: François

sequence: first

name: Service d’Hématologie Clinique, Hospices Civils de Lyon, Pierre-Bénite, and Université Lyon 1, Lyon, France;

family: Safar

full_name: Violaine Safar

given: Violaine

sequence: additional

name: Département d’Hématologie et d’Immunologie Biologique, Hôpitaux Universitaires Henri Mondor, AP-HP, Créteil, France;

family: Beldi-Ferchiou

full_name: Asma Beldi-Ferchiou

given: Asma

name: Département de Médecine Nucléaire, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France;

family: Cottereau

full_name: Anne-Ségolène Cottereau

given: Anne-Ségolène

family: Bachy

full_name: Emmanuel Bachy

given: Emmanuel

name: Département d’Hématologie Clinique, Centre Hospitalo-Universitaire de Montpellier, Unité Mixte de Recherche–Centre National de Recherche Scientifique 5535, Université de Montpellier, Montpellier, France;

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

name: Département de Pathologie, Hôpitaux Universitaires Henri Mondor, Créteil, France;

family: Fataccioli

full_name: Virginie Fataccioli

given: Virginie

family: Pelletier

full_name: Laura Pelletier

given: Laura

family: Robe

full_name: Cyrielle Robe

given: Cyrielle

name: Institut de Pathologie, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland;

family: Letourneau

full_name: Audrey Letourneau

given: Audrey

family: Missiaglia

full_name: Edoardo Missiaglia

given: Edoardo

name: Service de Virologie, Département Prévention, Diagnostic et Traitement des Infections, Hôpitaux Universitaires Henri Mondor, AP-HP, Créteil, France;

family: Fourati

full_name: Slim Fourati

given: Slim

name: Service d’Hématologie, Centre Hospitalier Universitaire, Angers, France;

family: Moles-Moreau

full_name: Marie-Pierre Moles-Moreau

given: Marie-Pierre

name: Service d’Hématologie, Centre Hospitalier Universitaire, Reims, France;

family: Delmer

full_name: Alain Delmer

name: Service d’Hématologie, Institut Paoli-Calmette, Marseille, France;

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

name: Service d’Hématologie, Centre Hospitalier, Chalon, France;

family: Voillat

full_name: Laurent Voillat

given: Laurent

name: Service de Médecine Nucléaire, Centre de Lutte Contre le Cancer Becquerel, Rouen, France;

family: Becker

full_name: Stéphanie Becker

given: Stéphanie

name: Université de Nantes, Center Hospitalier Universitaire Nantes, Département de Pathologie, INSERM Centre de Recherche en Cancérologie et Immunologie Nantes Angers, Nantes, France;

family: Bossard

full_name: Céline Bossard

given: Céline

name: Département de Pathologie, Hôpital Haut-Lévêque, Pessac, INSERM U1053, Université de Bordeaux, Bordeaux, France;

family: Parrens

full_name: Marie Parrens

given: Marie

name: Service d’Hématologie, Centre Hospitalier Universitaire, Dijon, France;

family: Casasnovas

full_name: Olivier Casasnovas

given: Olivier

name: Service d’Hématologie, Centre Hospitalier Universitaire, Clermont Ferrand, France;

family: Cacheux

full_name: Victoria Cacheux

given: Victoria

name: Service d’Hématologie, Centre Hospitalier Universitaire, Grenoble, France;

family: Régny

full_name: Caroline Régny

given: Caroline

name: Département d’Hématologie, Centre Henri Becquerel, Rouen, France; and

family: Camus

full_name: Vincent Camus

given: Vincent

family: Delfau-Larue

name: LYSA Image, Hôpitaux Universitaires Henri Mondor, Créteil, France

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre hospitalier Chalon sur Saone William Morey

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Université Catholique de Louvain Saint Luc


title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

summary: The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

lead_sponsor: Coloplast A/S

location_country: Denmark France

location_facility:
CHU Sud
CH Le Mans
Clinique Mathilde
Cabilet Medical
Odense Universitets Hospital
CHU
Hôpital lariboisiere
Centre hospitalier intercommunal
CHD Les Oudairies
CHRU La Miletrie
Arhus Sygehus
Centre Hospitalier de Douai
Clinique Pasteur
Hôpital de Freyming
CH Cornouailles
HIA Sainte Anne
Hôpital Manchester
CHIVA
Hôpital de Saint Gaudens
CH
Hôpital Dupuytren
Cabinet Médical
Centre Hospitalier
Bispebjerg ^Hospital
Hôpital Corention Celton
Cabinet Medical
CHU Caremeau
CHRU Tours
Hôpital jacques Monod


title: Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy

acronym: CAPSCDEIS

summary: The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Belgium France

location_facility:
Chu Besancon
CHU LIEGE - Sart Tilman
Hopital Saint Louis
CHU CAEN
Hopital Lariboisiere
Hopital St Antoine
Chu Amiens
Gent University Hospital
Hopital Saint Andre
Ulb - Clinique Saint Luc
Hopital Beaujon
Chu Nantes
CHU NICE
Chu Rouen
Chu Saint Etienne
Chu Strasbourg
Chu Tours
Institut Mutualiste Montsouris (Imm)
Chru Lille
Hopital Georges Pompidou


title: Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.

summary: This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults. This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort analysis of approximately 200 subjects and 2) if study continuation criteria are met at this interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of 48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID and 2) a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir 1400mg/100mg QD.

ReferenceCitation: Ross LL, Robinson MD, Carosi G, et al. Impact of HIV subtype on response and resistance in antiretroviral-naïve adults comparing treatment with once daily versus twice daily Ritonavir boosted Fosamprenavir in combination with Abacavir/Lamivudine. [Drugs Ther Stud]. 2012;2(e1):

ReferenceCitation: Carosi G, Lazzarin A, Stellbrink H, et al. Efficacy and Safety of Fosamprenavir + Ritonavir (FPV/RTV) 700mg/100mg Twice Daily (BID) Versus FPV/RTV 1400mg/100mg Once Daily (QD) with ABC/3TC QD over 24 Weeks. Abstract H-1244, 48th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2008.

ReferenceCitation: Carosi, Lazzarin, Stellbrink, Moyle, Rugina, Staszewski, Givens, Ross, Granier, Ait-Khaled, Leather, Nichols. Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects. HIV Clin Trials. 2009 Nov-Dec;10(6):356-67. doi: 10.1310/hct1006-356.

family: Carosi

full_name: G. Carosi

given: G.

family: Lazzarin

full_name: A. Lazzarin

given: A.

family: Stellbrink

full_name: H. Stellbrink

given: H.

family: Moyle

full_name: G. Moyle

family: Rugina

full_name: S. Rugina

given: S.

family: Staszewski

full_name: S. Staszewski

family: Givens

full_name: N. Givens

given: N.

family: Ross

full_name: L. Ross

given: L.

family: Granier

full_name: C. Granier

given: C.

family: Ait-Khaled

full_name: M. Ait-Khaled

given: M.

family: Leather

full_name: D. Leather

given: D.

family: Nichols

full_name: W. G. Nichols

given: W. G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: HIV Clinical Trials

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir Administered with Abacavir/Lamivudine Once Daily in Antiretroviral-Naïve HIV-1–Infected Adult Subjects

ReferenceCitation: Hughes S, Cuffe RL, Lieftucht A, Garrett Nichols W. Informing the selection of futility stopping thresholds: case study from a late-phase clinical trial. Pharm Stat. 2009 Jan-Mar;8(1):25-37. doi: 10.1002/pst.323.

family: Hughes

full_name: Sara Hughes

given: Sara

family: Cuffe

full_name: Robert L. Cuffe

given: Robert L.

family: Lieftucht

full_name: Alfons Lieftucht

given: Alfons

family: Garrett Nichols

full_name: W. Garrett Nichols

given: W.

journal_name: Pharmaceutical Statistics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: ViiV Healthcare

location_country:
Italy
Switzerland
France
Romania
Belgium
Russian Federation
Spain
Germany
United Kingdom


title: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial

summary:
Background: Two recent systematic reviews of the literature and meta-analyses have suggested that colloids administration might be deleterious in critically ill patients.

Objective: To compare the effects on hospital mortality of crystalloids and colloids when given for fluid resuscitation in critically ill patients.

Setting: Adult intensive care units (ICUs) in several European countries.

Study design: A multinational, randomised, controlled trial performed on two parallel groups.

Intervention: Any type of crystalloids (control group) versus any type of colloids (including albumin).

Patients: All patients above the legal age of consent and hospitalised in an intensive care unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund patients, brain dead patients, and patients who have a known allergy to colloids or severe head injury or major burns (> 20% of body surface) or dehydration will not be included.

Primary endpoint: 28-day mortality.

Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90% probability (two-sided test).

ReferenceType: result

ReferenceCitation: Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declère AD, Preiser JC, Outin H, Troché G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Reignier J, Abroug F, Berger P, Clec'h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. doi: 10.1001/jama.2013.280502. Erratum in: JAMA. 2013 Mar 12;311(10):1071. Régnier, Jean [corrected to Reignier, Jean]; Cle'h, Christophe [corrected to Clec'h, Christophe].

family: Annane

full_name: Djillali Annane

given: Djillali

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effects of Fluid Resuscitation With Colloids vs Crystalloids on Mortality in Critically Ill Patients Presenting With Hypovolemic Shock

ReferenceCitation: Heming N, Elatrous S, Jaber S, Dumenil AS, Cousson J, Forceville X, Kimmoun A, Trouillet JL, Fichet J, Anguel N, Darmon M, Martin C, Chevret S, Annane D; CRISTAL Investigators. Haemodynamic response to crystalloids or colloids in shock: an exploratory subgroup analysis of a randomised controlled trial. BMJ Open. 2017 Oct 6;7(10):e016736. doi: 10.1136/bmjopen-2017-016736.

family: Heming

full_name: Nicholas Heming

given: Nicholas

family: Elatrous

full_name: Souheil Elatrous

given: Souheil

family: Jaber

full_name: Samir Jaber

given: Samir

family: Dumenil

full_name: Anne Sylvie Dumenil

given: Anne Sylvie

family: Cousson

full_name: Joël Cousson

given: Joël

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

family: Trouillet

full_name: Jean Louis Trouillet

given: Jean Louis

family: Fichet

full_name: Jérôme Fichet

given: Jérôme

family: Anguel

full_name: Nadia Anguel

given: Nadia

family: Darmon

full_name: Michael Darmon

given: Michael

family: Martin

full_name: Claude Martin

given: Claude

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

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

location_country:
France
Tunisia
Belgium
Canada
United Kingdom

location_facility:
Hôpital Henri Mondor
CH Dourdan
Hôpital la Pitié Salpétrière
CHRG d'Orléans
Hôpital T Sfar
Centre Hospitalier d'Annecy
Hôpital Général
CH MEAUX
Hôpital Hautepierre
CHU Brabois Nancy
CH Claude Galien
CHG de Bastia
Hôpital Bichat Claude Bernard
CH Pellegrin Tripode
Centre Hospitalier de Mulhouse
Centre Régional Léon Bernard
Centre Cardiologique du Nord
Chg Briancon
Homerton University Hospital
CH Joseph Imbert
Hôpital Claude Huriez
Hôpital Central
CHU de Bordeaux
CHU de Sherbrooke-Höpital Fleurimont
CH Victor Provo
Hôpital Charles LeMoyne
CHU de Poitiers
CHR
Hôtel Dieu
Hôpital Bicêtre
CHU Liege
Hôpital Saint Eloi
Hôpital Lariboisière
Hôpital TENON
CHU Toulouse
Hôpital A Mami
Chu Reims
Hôpital de FREYMING-MERLEBACH
Hôpital A. Mignot
Hôpital Charles Nicolle
Hôpital A. Beclere
Hôpital Corbeil Essonnes
Hôpital Avicenne
CH Dupuytren
Centre Hospitalier R. Dubos
CH d'Arpajon
CHG Valence
CHG de SOISSONS
CHR Bel Air
Hôpital Cavale Blanche
Hôpital Raymond Poincaré
CHI Saint Germain en Laye
HIA Percy
Hôpital Louis Pradel
Chu Bourguiba
Hôpital Saint Louis
Polyclinique de Gentilly
CH Mémorial SAINT LO
Hôpital Civil
Hôpital Central NANCY
Chu Lyon Sud
CHI Poissy
CH d'Angers
HEGP
CHU Rennes
Hôpital Erasme
Centre Hospitalier d'Etampes


title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

acronym: POP-A-RIX

summary: Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
ROSENCHER Nadia
BARRE Jeanne
PETIT Pierre-Yves
MAITRE Anne-Marie
PEGOIX Michel
BAYLOT Denis
CHARRET Françoise
ZUFFEREY Paul


title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

summary:
The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.

ReferenceCitation: Kraaijpoel N, Bleker SM, Meyer G, Mahé I, Muñoz A, Bertoletti L, Bartels-Rutten A, Beyer-Westendorf J, Porreca E, Boulon C, van Es N, Iosub DI, Couturaud F, Biosca M, Lerede T, Lacroix P, Maraveyas A, Aggarwal A, Girard P, Büller HR, Di Nisio M; UPE investigators. Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study. J Clin Oncol. 2019 Jul 10;37(20):1713-1720. doi: 10.1200/JCO.18.01977. Epub 2019 May 22.

name: Amsterdam UMC/University of Amsterdam, Amsterdam, the Netherlands

family: Kraaijpoel

full_name: Noémie Kraaijpoel

given: Noémie

family: Bleker

full_name: Suzanne M. Bleker

given: Suzanne M.

name: Hôpital Européen Georges-Pompidou, Paris, France

name: Université Paris Descartes, Paris, France

name: French Clinical Research Infrastructure Network, Saint-Étienne, France

family: Meyer

full_name: Guy Meyer

given: Guy

name: Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche S1140, Faculté de Pharmacie, Paris, France

name: Assistance Publique–Hôpitaux de Paris, Hôpital Louis Mourier, Colombes, France

family: Mahé

full_name: Isabelle Mahé

given: Isabelle

name: Hospital General Universitario Gregorio Marañon, Madrid, Spain

family: Muñoz

full_name: Andrés Muñoz

given: Andrés

name: Service de Médecine Vasculaire et Thérapeutique, CHU de St-Étienne, Saint-Étienne, France;

name: Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1059, Equipe Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, Saint-Étienne, France

name: Institut National de la Santé et de la Recherche Médicale, CIC-1408, Centre Hospitalier Universitaire Saint-Etienne, Saint-Étienne, France

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

name: Netherlands Cancer Institute, Amsterdam, the Netherlands

family: Bartels-Rutten

full_name: Annemarieke Bartels-Rutten

given: Annemarieke

name: Universitätsklinikum Carl Gustav Carus, Dresden, Germany

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

name: Gabriele D'Annunzio University, Chieti, Italy

family: Porreca

full_name: Ettore Porreca

given: Ettore

name: Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

family: Boulon

full_name: Carine Boulon

given: Carine

family: van Es

full_name: Nick van Es

given: Nick

family: Iosub

full_name: Diana I. Iosub

given: Diana I.

name: Centre Hospitalier Régionaux et Universitaire de Brest, Hôpital de la Cavale Blanche, Brest, France

family: Couturaud

full_name: Francis Couturaud

given: Francis

name: Hospital Vall d’Hebron, Barcelona, Spain

family: Biosca

full_name: Mercedes Biosca

given: Mercedes

name: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy

family: Lerede

full_name: Teresa Lerede

given: Teresa

name: Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren, Limoges, France

family: Lacroix

full_name: Philippe Lacroix

given: Philippe

name: Hull and York Medical School, Castle Hill, United Kingdom

family: Maraveyas

full_name: Anthony Maraveyas

given: Anthony

name: George Washington University School of Medicine, Veteran Affairs Hospital, Washington, DC

family: Aggarwal

full_name: Anita Aggarwal

given: Anita

name: Institut du Thorax Curie-Montsouris, Paris, France

name: Institut Mutualiste Montsouris, Paris, France

family: Girard

full_name: Philippe Girard

family: Büller

full_name: Harry R. Büller

given: Harry R.

name: University G D’Annunzio, Chieti-Pescara, Italy

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

lead_sponsor: G. d'Annunzio University

location_country:
Italy
Austria
Netherlands
Germany
France
Spain
United States
Canada

location_facility: Malattie Cardiovascolari e Nefrourologiche

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)

location_facility: Division of Hematology, University of Ottawa

location_facility: Montpellier et clinique du parc a Castelnau le nez

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Nuestra Sra del Prado Talavera de la Reina

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Clinical Division of Haematology, Department of Medicine I

location_facility: Division of Vascular Medicine, Department of Medicine, Technical University Dresden

location_facility: Universita degli Studi G. d'Annunzio Chieti e Pescara

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University hospital Centra La Cavale Blanche

location_facility: National Cancer Institute - Antonie van Leeuwenhoek hospital

location_facility: Hospital Universitario Insular de Gran Canarias


lead_sponsor: Ipsen

location_facility: Hôpital Paul Brousse 12 av Paul-Vaillant-Couturier

location_facility: Centre Hospitalier d'Orsay 4 place du Général Leclerc

location_facility: Hôpital Corentin Celton 4 parvis Corentin Celton

type: EudraCT Number

source: euctr

title: Effect of Oral EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, Randomised, Double-blind, Parallel Groups, Placebo-controlled Study

summary: The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.


title: A Prospective, Comparative, Multicenter, Randomized Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation

acronym: EPARGNE

summary: The use of tacrolimus in the long term as part of the immunosuppressive regimen after transplantation is associated to complications such as chronic nephrotoxicity, impaired glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The conversion from a tacrolimus based therapy to a sirolimus based therapy associated with mycophenolate mofetil could improve the incidence of such complications. The aim of this study is to assess the risk/benefit ratio of this switch performed in stable renal transplant recipient between 12 months and 36 months after transplantation. The incidence of a composite endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will be assessed 24 months after conversion.

lead_sponsor: University Hospital, Rouen

location_facility: UHAmiens UHAngers UHRouen UHLimoges UHNecker UHCaen UHTours UHRennes


title: Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy

acronym: PASS

summary: SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.

lead_sponsor: UCB Pharma

location_country:
Netherlands
France
Spain
Germany
United Kingdom


title: Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study

summary:
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.

The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.

However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. The investigators, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.

Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European [3, 4] and North-American guidelines [5] suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.

lead_sponsor: University Hospital, Geneva

location_country: France Switzerland

location_facility:
Antoine ELIAS
Grégoire LE GAL
Caroline BOHEC
Florence PARENT
Pierre-Marie ROY
Marc Righini
Isabelle QUERE
Guy MEYER
Jean-Christophe GRIS

intervention_type: Other


title: Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

summary: The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

design_allocation: Non-Randomized

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_facility:
Dr. Lambert
Dr. Hassoun
Dr. Duillet
Dr. Borg
Pr Gruel
Pr Schved
Pr Chambost
Dr. Rothschild

intervention_type: Biological


title: A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.

summary: This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.

status: Terminated

ReferenceCitation: Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.

name: Service d'Hématologie Clinique, Centre Hospitalier Universitaire (CHU) Hôtel Dieu, Université de Nantes, Centre d'Investigation Clinique en Cancerologie (CI2C) and Inserm U892, Nantes, France;

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: Service d'Hématologie/Biologie, CHU Hôtel-Dieu, Nantes, France;

family: Robillard

full_name: Nelly Robillard

given: Nelly

name: Service d'Hématologie, Institut Paoli-Calmette, Marseille, France;

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

name: Service d'Hématologie, Assistance Publique–Hopitaux de Paris (AP-HP), Hôpital Saint-Louis, Paris, France;

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

name: Service d'Hématologie, AP-HP, Hôpital Henri Mondor, Créteil, France;

family: Maury

full_name: Sebastien Maury

given: Sebastien

name: Service d'Hématologie, CHU, Hôpital A. Michallon, Grenoble, France;

family: Carras

full_name: Sylvain Carras

given: Sylvain

name: Service d'Hématologie, CHU, Clermont-Ferrand, France;

family: Chabrot

full_name: Cecile Chabrot

given: Cecile

name: Service d'Hématologie, Centre Hospitalier Regional Universitaire, Hôpital Hautepierre, Strasbourg, France;

family: Fohrer

full_name: Cecile Fohrer

name: Service d'Hématologie, CHU, Rennes, France;

family: Bernard

full_name: Marc Bernard

given: Marc

name: Service de Médecine Interne-Oncologie, HIA Sainte-Anne, Toulon, France;

family: Blade

full_name: Jean-Sebastien Blade

given: Jean-Sebastien

family: Etienne

full_name: Anne Etienne

given: Anne

family: Talmant

full_name: Pascaline Talmant

given: Pascaline

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

family: Guillaume

full_name: Thierry Guillaume

given: Thierry

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

name: Service d'Immunologie, CHU et Université de Nancy, Nancy, France; and

family: Bene

full_name: Marie-Christine Bene

given: Marie-Christine

name: Service d'Hématologie, CHU, Angers, France

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

family: Dombret

full_name: Herve Dombret

given: Herve

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Nantes University Hospital

location_facility:
Strasbourg University Hospital
Grenoble Hospital
Clermont-Ferrand University Hospital
Rennes University Hospital
St Louis Hospital
Institut Paoli Calmettes
Mondor Hospital
CHU


title: A Phase Ib Study of Ibrutinib Combined With R-DHAP or R-DHAOx in Patients With B-cell Lymphomas

acronym: BIBLOS

summary:
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).

During Part 1 Dose Escalation, the "3+3" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg.

The dose escalation will be performed for two types of associations in five separate groups :

Group A : ibrutinib D1-D21+ R-DHAP
Group B : ibrutinib D1-D21 R-DHAOx
Group Abis : ibrutinib D5-D18+ R-DHAP
Group Bbis : ibrutinib D5-D18 R-DHAOx

This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.

location_facility: Universite Catholique de Louvain Saint Luc

location_facility: Centre François Magendie - Hôpital du Haut Lévêque


title: Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme

acronym: EQUIP-ACS

summary: The main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-ST elevation acute coronary syndromes.

primary_purpose: Health Services Research

ReferenceCitation: Flather MD, Babalis D, Booth J, Bardaji A, Machecourt J, Opolski G, Ottani F, Bueno H, Banya W, Brady AR, Bojestig M, Lindahl B. Cluster-randomized trial to evaluate the effects of a quality improvement program on management of non-ST-elevation acute coronary syndromes: The European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS). Am Heart J. 2011 Oct;162(4):700-707.e1. doi: 10.1016/j.ahj.2011.07.027.

family: Flather

full_name: Marcus D. Flather

given: Marcus D.

family: Babalis

full_name: Daphne Babalis

given: Daphne

family: Booth

full_name: Jean Booth

given: Jean

family: Bardaji

full_name: Alfredo Bardaji

given: Alfredo

family: Machecourt

full_name: Jacques Machecourt

family: Opolski

full_name: Grzegorz Opolski

given: Grzegorz

family: Ottani

full_name: Filippo Ottani

given: Filippo

family: Bueno

full_name: Héctor Bueno

given: Héctor

family: Banya

full_name: Winston Banya

given: Winston

family: Brady

full_name: Anthony R. Brady

given: Anthony R.

family: Bojestig

full_name: Mats Bojestig

given: Mats

family: Lindahl

full_name: Bertil Lindahl

given: Bertil

journal_name: American Heart Journal

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Cluster-randomized trial to evaluate the effects of a quality improvement program on management of non–ST-elevation acute coronary syndromes: The European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS)

ReferenceCitation: Flather MD, Booth J, Babalis D, Bueno H, Steg PG, Opolski G, Ottani F, Machecourt J, Bardaji A, Bojestig M, Brady AR, Lindahl B. Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: the EQUIP-ACS project protocol and design. Trials. 2010 Jan 14;11:5. doi: 10.1186/1745-6215-11-5.

full_name: Marcus D Flather

given: Marcus D

full_name: Hector Bueno

given: Hector

family: Steg

full_name: Philippe G Steg

given: Philippe G

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

title: Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme E uropean QU ality I mprovement P rogramme for A cute C oronary S yndrome: The EQUIP-ACS project protocol and design

lead_sponsor: Royal Brompton & Harefield NHS Foundation Trust

location_country:
Italy
France
Poland
Spain
United Kingdom

location_facility: Ospedale Generale Provinciale di Macerata

location_facility: Centre Hospitalier de la region d'Annecy

location_facility: Cardiology dept. B, CHU Hopital G. Montpied


ReferenceCitation: Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.

family: Guigay

full_name: J. Guigay

given: J.

family: Fayette

full_name: J. Fayette

family: Dillies

full_name: A.F. Dillies

family: Sire

full_name: C. Sire

given: C.

family: Kerger

full_name: J.N. Kerger

family: Tennevet

full_name: I. Tennevet

given: I.

family: Machiels

full_name: J.P. Machiels

family: Zanetta

full_name: S. Zanetta

given: S.

family: Pointreau

full_name: Y. Pointreau

given: Y.

family: Bozec Le Moal

full_name: L. Bozec Le Moal

given: L.

family: Henry

full_name: S. Henry

family: Schilf

full_name: A. Schilf

given: A.

family: Bourhis

full_name: J. Bourhis

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

acronym: TPEx

location_facility: Clinique universitaire de Mont Godinne UCL

title: Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

summary: PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.


title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

summary: To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.

lead_sponsor: Eisai Limited

location_country:
Italy
Austria
France
Norway
Denmark
Germany
United Kingdom

location_facility: Universitatsklinikum Campus Virchow-Klinikum Wedding

location_facility: Avd. for nevrologi og klinisk nevrofysiologi

location_facility: Istituto Nazionale Neurologico Carlo Besta di Milano

location_facility: University Hospital of North Staffordshire Royal Infirmary

location_facility: Azienda Ospedaliero- Universitaria Policlinico di Catania


lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
centre Hospitalier Lyon Sud
Hopital Foch
Hôpital Simone Veil
Hopital Europeen Georges Pompidou
Centre René Huguenin
Hôpital Privé St Joseph
Hopital Bichat - Claude Bernard
Hopital Tenon

type: Other Identifier

title: Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.


title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

ReferenceCitation: Forster MD, Dillon MT, Kocsis J, Remenár É, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.

family: Forster

full_name: Martin D. Forster

given: Martin D.

family: Dillon

full_name: Magnus T. Dillon

given: Magnus T.

family: Kocsis

full_name: Judit Kocsis

given: Judit

family: Remenár

full_name: Éva Remenár

given: Éva

family: Pajkos

full_name: Gabor Pajkos

given: Gabor

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Greenberg

full_name: Jonathan Greenberg

given: Jonathan

family: Harrington

full_name: Kevin J. Harrington

given: Kevin J.

journal_name: European Journal of Cancer

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
France
Poland
Romania
Hungary
Belgium
Germany
United Kingdom

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Centre Hospitalier de Bordeaux - Hôpital Saint André

location_facility: Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: The Shrewsbury and Telford Hospital NHS Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: Centre de Cancerologie du Grand Montpellier


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

summary: The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

lead_sponsor: Janssen-Cilag International NV

location_country:
France
Bulgaria
Greece
Russian Federation
Germany


title: The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)

acronym: EARLYSTIM

summary:
Earlystim Study: Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 2 years. The primary outcome criterium: PDQ-39.

Post study Follow up studies: After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.

status: Active, not recruiting

ReferenceCitation: Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.

family: Schuepbach

full_name: W.M.M. Schuepbach

family: Rau

full_name: J. Rau

family: Knudsen

full_name: K. Knudsen

given: K.

family: Volkmann

full_name: J. Volkmann

family: Krack

full_name: P. Krack

given: P.

family: Timmermann

full_name: L. Timmermann

family: Hälbig

full_name: T.D. Hälbig

family: Hesekamp

full_name: H. Hesekamp

given: H.

family: Navarro

full_name: S.M. Navarro

family: Meier

full_name: N. Meier

given: N.

family: Falk

full_name: D. Falk

given: D.

family: Mehdorn

full_name: M. Mehdorn

given: M.

family: Paschen

full_name: S. Paschen

family: Maarouf

full_name: M. Maarouf

family: Barbe

full_name: M.T. Barbe

family: Fink

full_name: G.R. Fink

family: Kupsch

full_name: A. Kupsch

family: Gruber

full_name: D. Gruber

family: Schneider

full_name: G.-H. Schneider

family: Seigneuret

full_name: E. Seigneuret

given: E.

family: Kistner

full_name: A. Kistner

family: Chaynes

full_name: P. Chaynes

family: Ory-Magne

full_name: F. Ory-Magne

given: F.

family: Brefel Courbon

full_name: C. Brefel Courbon

family: Vesper

full_name: J. Vesper

repository_institution: University of Geneva - Archive ouverte UNIGE

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

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

title: Neurostimulation for Parkinson's Disease with Early Motor Complications

ReferenceCitation: Deuschl G, Schade-Brittinger C, Agid Y; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 May 23;368(21):2038. doi: 10.1056/NEJMc1303485.

ReferenceCitation: Dams J, Balzer-Geldsetzer M, Siebert U, Deuschl G, Schuepbach WM, Krack P, Timmermann L, Schnitzler A, Reese JP, Dodel R; EARLYSTIM-investigators. Cost-effectiveness of neurostimulation in Parkinson's disease with early motor complications. Mov Disord. 2016 Aug;31(8):1183-91. doi: 10.1002/mds.26740.

name: Department of NeurologyPhilipps‐University MarburgMarburg Germany

name: Department of Public Health, Health Services Research and HealthTechnology Assessment, UMIT–University for Health SciencesMedical Informatics and TechnologyHall i.T. Austria

name: Institute for Technology Assessment and Department of RadiologyMassachusetts General Hospital, Harvard Medical SchoolBoston Massachusetts USA

name: Department of Health Policy and ManagementHarvard Chan School of Public HealthBoston Massachusetts USA

name: Department of NeurologyChristian‐Albrechts‐University KielKiel Germany

name: Assistance‐Publique Hôpitaux de Paris; Centre d'Investigation Clinique 9503, Institut du Cerveau et de la Moelle épinière; Département de Neurologie, Université Pierre et Marie Curie–Paris 6 et INSERM, CHU Pitié‐Salpêtrière, Paris, France, and Movement Disorders Center, Department of NeurologyBern University Hospital and University of BernBern Switzerland

name: Department of Neurology, University Hospital INSERM Unite 836Grenoble Alpes UniversitySaint‐Martin‐d'Hères France

name: Department of NeurologyUniversity Hospital CologneCologne Germany

name: Institute of Clinical Neuroscience and Medical PsychologyHeinrich‐Heine University DuesseldorfDuesseldorf Germany

name: Department of Medical Sociology and Social MedicinePhilipps‐University MarburgMarburg Germany

name: Department of GeriatricsUniversity Duisburg-EssenEssen Germany

title: Cost‐effectiveness of neurostimulation in Parkinson's disease with early motor complications

ReferenceCitation: Lhommée E, Wojtecki L, Czernecki V, Witt K, Maier F, Tonder L, Timmermann L, Hälbig TD, Pineau F, Durif F, Witjas T, Pinsker M, Mehdorn M, Sixel-Döring F, Kupsch A, Krüger R, Elben S, Chabardès S, Thobois S, Brefel-Courbon C, Ory-Magne F, Regis JM, Maltête D, Sauvaget A, Rau J, Schnitzler A, Schüpbach M, Schade-Brittinger C, Deuschl G, Houeto JL, Krack P; EARLYSTIM study group. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol. 2018 Mar;17(3):223-231. doi: 10.1016/S1474-4422(18)30035-8.

ReferenceCitation: Schüpbach WM, Rau J, Houeto JL, Krack P, Schnitzler A, Schade-Brittinger C, Timmermann L, Deuschl G. Myths and facts about the EARLYSTIM study. Mov Disord. 2014 Dec;29(14):1742-50. doi: 10.1002/mds.26080. Epub 2014 Nov 14. Review.

name: Assistance-Publique Hôpitaux de Paris; Centre d'Investigation Clinique 9503, Institut du Cerveau et de la Moelle épinière; Département de Neurologie, Université Pierre et Marie Curie-Paris 6 et INSERM, CHU Pitié-Salpêtrière, Paris, France, and Movement Disorders Center, Department of Neurology, Bern University Hospital and University of Bern; Switzerland

name: Coordinating Center for Clinical Trials, Philipps-University; Marburg Germany

name: Service de Neurologie, CIC INSERM-1402, CHU de Poitiers et Université de Poitiers; Poitiers France

name: Department of Neurology; University Hospital; INSERM U836 Grenoble France

name: Department of Neurology; Institute of Clinical Neuroscience and Medical Psychology, Heinrich-Heine-University; Duesseldorf Germany

name: Department of Neurology; University of Cologne; Cologne Germany

name: Department of Neurology; University Hospital Schleswig-Holstein, Christian-Albrechts-University Kiel; Germany

ReferenceCitation: Deuschl G, Schüpbach M, Knudsen K, Pinsker MO, Cornu P, Rau J, Agid Y, Schade-Brittinger C. Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study. Parkinsonism Relat Disord. 2013 Jan;19(1):56-61. doi: 10.1016/j.parkreldis.2012.07.004. Epub 2012 Jul 28.

title: Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: Concept and standards of the EARLYSTIM-study

ReferenceCitation: Schuepbach WMM, Tonder L, Schnitzler A, Krack P, Rau J, Hartmann A, Hälbig TD, Pineau F, Falk A, Paschen L, Paschen S, Volkmann J, Dafsari HS, Barbe MT, Fink GR, Kühn A, Kupsch A, Schneider GH, Seigneuret E, Fraix V, Kistner A, Chaynes PP, Ory-Magne F, Brefel-Courbon C, Vesper J, Wojtecki L, Derrey S, Maltête D, Damier P, Derkinderen P, Sixel-Döring F, Trenkwalder C, Gharabaghi A, Wächter T, Weiss D, Pinsker MO, Regis JM, Witjas T, Thobois S, Mertens P, Knudsen K, Schade-Brittinger C, Houeto JL, Agid Y, Vidailhet M, Timmermann L, Deuschl G; EARLYSTIM study group. Quality of life predicts outcome of deep brain stimulation in early Parkinson disease. Neurology. 2019 Mar 5;92(10):e1109-e1120. doi: 10.1212/WNL.0000000000007037. Epub 2019 Feb 8. Erratum in: Neurology. 2019 Jun 11;92(24):1166.

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: University of Luxembourg - Open Repository and Bibliography

publisher: Ovid Technologies (Wolters Kluwer Health)

ipd_sharing_description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

location_facility: CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital

location_facility: Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex

location_facility: Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217

location_facility: "Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain

location_facility: Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577

location_facility: Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont

location_facility: Neurologische Klinik der Universität, Moorenstr. 5

location_facility: Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3

location_facility: Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031

location_facility: Neurologische Universitätsklinik Freiburg, Breisacher Str. 64

location_facility: Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin

location_facility: Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16

location_facility: Klinik und Poliklinik für Neurologie, Charite

location_facility: Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10

location_facility: Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15


title: Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock

acronym: COIITSS

summary: This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

ReferenceCitation: COIITSS Study Investigators, Annane D, Cariou A, Maxime V, Azoulay E, D'honneur G, Timsit JF, Cohen Y, Wolf M, Fartoukh M, Adrie C, Santré C, Bollaert PE, Mathonet A, Amathieu R, Tabah A, Clec'h C, Mayaux J, Lejeune J, Chevret S. Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):341-8. doi: 10.1001/jama.2010.2. Erratum in: JAMA. 2010 May 5;303(17):1698.

title: Corticosteroid Treatment and Intensive Insulin Therapy for Septic Shock in Adults

lead_sponsor: University of Versailles

location_facility:
hôpital Cochin
Hôpital Saint Louis
Hôpital Delafontaine
Hôpital Bichat Claude Bernard
Hôpital Avicenne
CHU Grenoble
Hôpital Jean Verdier
Hôpital central


title: Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

ReferenceCitation: Taieb J, Puig PL, Bedenne L. Cetuximab plus FOLFOX-4 for fully resected stage III colon carcinoma: scientific background and the ongoing PETACC-8 trial. Expert Rev Anticancer Ther. 2008 Feb;8(2):183-9. doi: 10.1586/14737140.8.2.183.

family: Taieb

full_name: Julien Taieb

given: Julien

family: Puig

full_name: Pierre Laurent Puig

given: Pierre Laurent

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

journal_name: Expert Review of Anticancer Therapy

ReferenceCitation: Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.

family: Tabernero

full_name: Josep Tabernero

given: Josep

family: Mini

full_name: Enrico Mini

given: Enrico

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Folprecht

full_name: Gunnar Folprecht

given: Gunnar

family: Van Laethem

full_name: Jean-Luc Van Laethem

given: Jean-Luc

family: Thaler

full_name: Josef Thaler

given: Josef

family: Bridgewater

full_name: John Bridgewater

given: John

family: Petersen

full_name: Lone Nørgård Petersen

given: Lone Nørgård

family: Blons

full_name: Hélène Blons

given: Hélène

family: Collette

full_name: Laurence Collette

given: Laurence

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Rougier

full_name: Philippe Rougier

given: Philippe

family: Salazar

full_name: Ramon Salazar

given: Ramon

family: Emile

full_name: Jean-François Emile

given: Jean-François

family: Laurent-Puig

full_name: Pierre Laurent-Puig

given: Pierre

ReferenceCitation: Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, André T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.

name: Sorbonne Université, Department of Medical Oncology, Saint-Antoine Hospital, AP-HP, Paris, France

name: Department of Health Science Research, Mayo Clinic, Rochester, MN

name: Sorbonne Paris Cité, Paris Descartes University Georges Pompidou European Hospital, Paris, France

name: Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA

name: WVU Cancer Institute, West Virginia University, Morgantown, WV

name: Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan

name: Department of Oncology, Mayo Clinic, Rochester, MN

name: Department of Medicine and University of Florida Shands Cancer Center, FL

name: Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France

name: Division of Hematology/Oncology, University of Pennsylvania, Philadelphia, PA

name: Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy

name: Department of Oncology, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy

name: University of Oxford, Oxford, United Kingdom

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.

ReferenceCitation: Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, André T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
CHU de Caen
Centre Hospitalier Yves Le Foll
Nouvelle Clinique Generale
Hopital Bichat - Claude Bernard
Hopital Duffaut
Hopital Tenon
CHU Pitie-Salpetriere
Hopital Robert Boulin


title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

summary: This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.

lead_sponsor: Bayer

location_country:
Italy
France
Spain
Germany
United Kingdom
Portugal


title: A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.

acronym: CAREL

summary: To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

lead_sponsor: Pfizer

intervention_type: Procedure


title: Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

acronym: PEPsy-CM

summary: The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Nîmes
CHU Saint Etienne
CHU de Montpellier
Centre Hospitalier Léon-Jean Grégory
CHU Nice
CH de la Conception
CH Saint Marie Clermont-Ferrand

status_simplified: Ongoing


title: A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

summary: This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

lead_sponsor: European Myeloma Network

location_country: Italy Netherlands France Greece Spain Germany

location_facility: A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U

location_facility: ASST Spedali Civili di Brescia - Ematologia

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: H. General Universitario Morales Meseguer

location_facility: Azienda Ospedaliera Universitaria di Udine

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona

location_facility: General Hospital of Athens"Euaggelismos"

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: A.O.U. Policlinico S. Martino - Ematologia

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)

location_facility: CHU Poitiers - Pôle régional de Cancérologie


title: Impact of a Nutritional, Sensory and Culinary Support on the Improvement of the Quality of Life Related to Meals in Patients With Cancer Cancer Patients Treated With Chemotherapy

summary:
Although it has been established that the perception of food and eating and cooking habits change during cancer and its treatment, quality of life related to meals, which is an indicator of the psychobiological and physiological well-being of patients in their relationship to food, has been little studied in the pathological context, and particularly in patients undergoing chemotherapy.

Beyond its biological role, food plays a significant psychobiological and social role, as shown by a series of qualitative studies based on interviews with patients. Following a cancer diagnosis, loss of appetite, difficulty in sharing a meal with the family, and reduced pleasure in eating disrupt the patient's relationship with his or her food.

Thus, side effects such as fatigue, nausea and vomiting, and alterations in taste and smell induced by chemotherapy will affect patients' eating behavior, increasing the risk of deteriorating their quality of life with food. As these side effects are less known and therefore less expected by patients, they often lack the information and tools necessary to understand them.

The present study proposes a support for cancer patients treated by chemotherapy in order to improve their quality of life related to meals, and thus keep the pleasure of eating and reduce the risks of malnutrition. This support will consist of a guide provided to patients, in which they will have information on the functioning of the sensory systems involved in the eating experience, advice and culinary tips to adapt foods to their sensory disorders, and recipes that can be adapted in mild (for patients with hypersensitivity to tastes/smells), accentuated (for patients with hypersensitivity to tastes/smells) and enriched (for patients at risk of denutrition) versions. In addition, their sensory abilities will be assessed at the beginning of the study by psychophysical tests, then between each chemotherapy via a telephone interview (self-reported sensory abilities), and they will benefit from orientation according to the test results.

This work will be a first action to improve the quality of life related to the meal by information, follow-up, and adaptation of the meals to the sensory performances of each patient.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Louis Pradel, Service pneumologie

location_facility: Hôpital Louis Pradel, Service gynécologie

location_facility: Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale

location_facility: Centre hospitalo-universitaire de Lyon Sud, service pneumologie

location_facility: Hôpital de la Croix Rousse, service pneumologie


title: Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

acronym: PROPERTY

summary:
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%. Clinically, CIPN is a mostly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration.

Due to its high prevalence among cancer patients, CIPN constitutes a major problem for both cancer patients and survivors as well as for their health care providers, especially because, at the moment, there is no single effective method of preventing CIPN; moreover, the possibilities of treating this syndrome are very limited.

The phycocyanin (PC), a biliprotein pigment and an important constituent of the blue-green alga Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress.

Study hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastro intestinal cancers including oesogastric, colo-rectal and pancreatic cancers. This trial will be a randomised placebo-controlled study.

primary_purpose: Prevention

location_facility:
Nantes Uh
DIJON UH
LYON UH
Chd La Roche Sur Yon
Mutaliste Clinic Saint Nazaire
Foch Suresnes Hosptial
Saint Gregoire Clinique


title: SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

acronym: SATORI

summary: Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

status: Recruiting

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital de la Salpétrière
CHU de LILLE
CHU de Marseille
CHU de Bordeaux
CHU de Tours
CHRU de Brest
CHU d'ANGERS


title: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department

acronym: HYPSEM

summary:
The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine.

Anteromedial dislocation is a very common Reason for admission in emergency department. Many methods for reduction have been described but there is no consensus on the optimum technique or sedation procedures.

Some pain medication and tranquilizers used during a shoulder dislocation management include hemodynamic, respiratory and behavioral adverse effects with the requirement of strengthened surveillance.

Hypnosis could provide to reduce sedative and analgesic use during the reduction of anteromedial dislocation.

The main objective of this study is to evaluate the efficacy of a hypnosis session for reducing the consumption of analgesic in patient throughout a reduction of shoulder dislocation.

The investigators also examine the effect of hypnosis on hemodynamic parameters, patient's pain, patient and practitioner satisfaction, sedative consumption, number of attempts for reduction and length of stay in the emergency department.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility: Hôpital Nord-Ouest Villefranche sur Saône

location_facility: CHR Fleyriat- Hôpital de Bourg en Bresse

location_facility: Groupement hospitalier Sud-Hôpital Lyon Sud

location_facility: Centre Hospitalier Saint Luc Saint Joseph


title: Interrupters of VAscular daMAge in Malignant Hypertension: Role of Inflammasome, Angiogenic and Vasoactive System

acronym: IVAMA

summary: The pathophysiology of malignant hypertension is poorly understood. The objective of this translational research project is to evaluate the relationship between activation of vasoactive systems (renin-angiotensin and endothelin systems), angiogenic signal deficiency (VEGF and sFlt-1) and the occurrence of malignant hypertension episodes in humans.

lead_sponsor: Centre Hospitalier de PAU

location_facility:
Hôpital Tenon
Hôpital Bichat
CHU de Bordeaux
CHU de Tours
Chu Rangueil
Hôpital Avicenne
Hôpital Européen Georges Pompidou


title: Efficacité du E-learning et du Jeu de rôle Pour la Formation Des Soignants Des EHPAD à l'Accompagnement de l'Agitation Dans Les Maladies neurodégénératives : Essai randomisé en Cluster

summary: This study will investigate the effects of "I-Learn cognition and behaviour" training in the care in agitation in patients with neurodegenerative diseases. This training for caregivers, aims to reduce agitation and psycho-behavioral disorders of patients living in nursing home. In addition, amount of psychotropic drugs prescribed, as well as the number of hospitalizations during the study will be assessed.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility:
EHPAD La Source
EHPAD La Bourdaisière
EHPAD Montconseil
EHPAD Résidence du Prévot
EHPAD Le Clos Saint-Vincent
Résidence Père Brottier
Maison Saint Michel


title: Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs

acronym: CUICUI-AHD

summary: Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Intensive Care Victor Dupouy Hospital
Intensive Care Longjumeau Hospital
Intensive Care Louis Mourier Hospital
Intensive Care Avicenne Hsopital
Intensive Care René Dubos Hospital
Intensive Care Bichat Hospital
Intensive Care Tours Hospital


title: Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study

acronym: CANNAPSYSTIM

summary: Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service Hospitalo-Universitaire d'Addictologie CHU de Dijon

location_facility: Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles

location_facility: CHU de Clermont-Ferrand Service de Psychiatrie

location_facility: CH Le Vinatier Service universitaire d'addictologie de Lyon

location_facility: CHU Pôle de Psychiatrie Neurologie et Rééducation

location_facility: CH Saint-Cyr-au-Mont-d'Or service de psychiatrie