type: Registry Identifier

title: Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia

acronym: ARTIX

summary: The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

lead_sponsor: Center Eugene Marquis

location_facility:
CRLCC Antoine Lacassagne
CHU Tours
Centre Paul Strauss
CRLCC Oscar Lambret
CHU de la Milétrie
Centre Eugene Marquis
CRLCC Henri Becquerel
Centre Léon Bérard
CRLCC Baclesse
Clinique Claude Bernard
Clinique Pasteur - Saint Esprit


title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy

summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Frenel JS, Kim JW, Aryal N, Asher R, Berton D, Vidal L, Pautier P, Ledermann JA, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Colombo N, Park-Simon TW, Tamura K, Sonke GS, Freimund AE, Lee CK, Pujade-Lauraine E. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol. 2022 Oct;33(10):1021-1028. doi: 10.1016/j.annonc.2022.06.011. Epub 2022 Jun 27.

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.

ReferenceCitation: Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18.

ReferenceCitation: Tjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23.

ReferenceCitation: Friedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17.

ReferenceCitation: Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. Erratum in: Lancet Oncol. 2017 Sep;18(9):e510.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: City Hospital Birmingham Cancer Trials Team

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Niigata University Medical and Dental Hospital

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Winthrop Gynecologic Oncology Associates

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: Klinikum rechts der Isar der Technischen Universität

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: Saitama Medical University International Medical Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliera Policlinico Di Modena

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: Women's Hospital, Zhejaing University School of Medicine

location_facility: Barcelona,H.de la Sta.Creu i S.Pau,Oncología

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation

summary: This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility:
Hopital La Pitié Salpétriere
CHU Clermont Ferrand - Hôpital Estaing
IUCT Oncopole
Hôpital Saint Antoine
CHU Brabois
Institut de Cancérologie Gustave Roussy
CHU de Dijon - Hôpital le Bocage
APHP - Hôpital Henri Mondor
CHU de Bordeaux - Hôpital Haut Lévêque
Hôpital Claude Huriez
Hôpital Saint Eloi
CHU de Nantes - Hôtel Dieu
Centre Hospitalier Lyon Sud
CH Liège
CHU de Rennes - Hôpital de Pontchaillou
APHP - Hôpital Saint Louis


title: Feasibility of New Biological and Histological Samples at Progression for Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

acronym: GFPC-REBIOP

summary:
Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 06
Site 20
Centre Hospitalier du Morvan
Hospital Saint Antoine
Hospital du Cluzeau
Site 04
Site 25
Centre François Baclesse
Centre Hospitalier Universitaire

intervention_type: Procedure

status_simplified: Completed


title: Optimal Control of Liver Metastases With Intravenous Cetuximab and Hepatic Artery Infusion of Three-drug Chemotherapy in Patients With Liver-only Metastases From Colorectal Cancer. A European Multicenter Phase II Trial

acronym: OPTILIV

summary: The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).

status: Unknown status

design_allocation: Non-Randomized

ReferenceCitation: Bouchahda M, Boige V, Smith D, Karaboué A, Ducreux M, Hebbar M, Lepère C, Focan C, Guimbaud R, Innominato P, Awad S, Carvalho C, Tumolo S, Truant S, De Baere T, Castaing D, Rougier P, Morère JF, Taieb J, Adam R, Lévi F; ARTBC International. Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. Eur J Cancer. 2016 Nov;68:163-172. doi: 10.1016/j.ejca.2016.09.011. Epub 2016 Oct 18.

ReferenceCitation: Lévi FA, Boige V, Hebbar M, Smith D, Lepère C, Focan C, Karaboué A, Guimbaud R, Carvalho C, Tumolo S, Innominato P, Ajavon Y, Truant S, Castaing D, De Baere T, Kunstlinger F, Bouchahda M, Afshar M, Rougier P, Adam R, Ducreux M; Association Internationale pour Recherche sur Temps Biologique et Chronothérapie (ARTBC International). Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV. Ann Oncol. 2016 Feb;27(2):267-74. doi: 10.1093/annonc/mdv548. Epub 2015 Nov 16.

lead_sponsor: Association pour la Recherche sur le Temps Biologique et la Chronothérapie

location_country: France Italy Portugal Belgium

location_facility: Azienda Ospedaliera S.Maria Degli Angeli

location_facility: Chronotherapy Unit, Medical Oncology Department, Paul Brousse Hospital

status_simplified: Unknown


title: Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

summary: Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).

ReferenceCitation: Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. doi: 10.1200/JCO.21.01815. Epub 2021 Nov 29.

location_country:
Portugal
Spain
Italy
Korea, Republic of
France
Singapore
Belgium
Germany

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Charité Medical School Campus Virchow-Klinikum

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta

location_facility: Universitätsklinikum Carl Gustav Carus der TU Dresden

location_facility: Hospital Universitario Dr. Peset de Valencia

location_facility: Charité Medical School Campus Benjamin Franklin

location_facility: UniversitätsKrebszentrum Göttingen - G-CCC

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Istituto di Ematologia "Saragnoli" Policlinico San'Orsola-Malpighi, Bologna

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Institut d'Hématologie de Basse-Normandie

location_facility: Universitätklinikum Freiburg Klinik für Innere medizin I

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera universitaria Careggi


title: French Biological Observatory on Lung Cancer in Never Smokers

acronym: BioCAST

summary: Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT), focuses on this entity. It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a large French cohort composed by cases newly diagnosed in participating centres (around to 1000 patients expected). The clinical component of the study is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to provide concrete answers to clinicians and patients questions about this new and frequent entity.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Couraud S, Labonne S, Missy P, Morin F, Tran Q, Deroy A, Milleron B, Blanché H, Zalcman G, Souquet PJ; les membres du Groupe de travail " non-fumeurs de l'IFCT ". [Lung cancer in never smokers: a French national cohort (BioCAST/IFCT-1002)]. Rev Mal Respir. 2013 Sep;30(7):576-83. doi: 10.1016/j.rmr.2013.03.006. Epub 2013 May 18. French.

ReferenceType: result

ReferenceCitation: Couraud S, Debieuvre D, Moreau L, Dumont P, Margery J, Quoix E, Duvert B, Cellerin L, Baize N, Taviot B, Coudurier M, Cadranel J, Missy P, Morin F, Mornex JF, Zalcman G, Souquet PJ; BioCAST/IFCT-1002 study investigators. No impact of passive smoke on the somatic profile of lung cancers in never-smokers. Eur Respir J. 2015 May;45(5):1415-25. doi: 10.1183/09031936.00097314. Epub 2015 Mar 5.

ReferenceCitation: Couraud S, Souquet PJ, Paris C, Dô P, Doubre H, Pichon E, Dixmier A, Monnet I, Etienne-Mastroianni B, Vincent M, Trédaniel J, Perrichon M, Foucher P, Coudert B, Moro-Sibilot D, Dansin E, Labonne S, Missy P, Morin F, Blanché H, Zalcman G; French Cooperative Intergroup IFCT. BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers. Eur Respir J. 2015 May;45(5):1403-14. doi: 10.1183/09031936.00097214. Epub 2015 Feb 5.

ReferenceCitation: Couraud S, Vaca-Paniagua F, Villar S, Oliver J, Schuster T, Blanché H, Girard N, Trédaniel J, Guilleminault L, Gervais R, Prim N, Vincent M, Margery J, Larivé S, Foucher P, Duvert B, Vallee M, Le Calvez-Kelm F, McKay J, Missy P, Morin F, Zalcman G, Olivier M, Souquet PJ; BioCAST/IFCT-1002 investigators. Noninvasive diagnosis of actionable mutations by deep sequencing of circulating free DNA in lung cancer from never-smokers: a proof-of-concept study from BioCAST/IFCT-1002. Clin Cancer Res. 2014 Sep 1;20(17):4613-24. doi: 10.1158/1078-0432.CCR-13-3063. Epub 2014 Jul 10.

ReferenceCitation: Paris C, Do P, Mastroianni B, Dixmier A, Dumont P, Pichon E, Chouaid C, Coudert B, Foucher P, Fraboulet S, Locatelli-Sanchez M, Baize N, Dansin E, Moreau L, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; BioCAST/IFCT-1002 study investigators; to the BioCAST/IFCT- 1002 study. Association between lung cancer somatic mutations and occupational exposure in never-smokers. Eur Respir J. 2017 Oct 26;50(4). pii: 1700716. doi: 10.1183/13993003.00716-2017. Print 2017 Oct.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuses


type: Other Identifier

title: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)

acronym: ENDOFERT

summary: The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)

lead_sponsor: University Hospital, Lille

location_facility:
CHU
Hôpital Jeanne de Flandres, CHRU
AP-HP, Hôpital Tenon

lead_sponsor_type: academique


title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

acronym: PEPsy

summary: Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HÔPITAL Edouard Herriot
Chu Grenoble
Chu Saint Etienne
Chu Clermont-Ferrand
Chu Le Vinatier


title: Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

acronym: AMPAMAVIR

summary: Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.

primary_purpose: Screening

location_facility:
Hôpital Jean VERDIER
CHU de CLERMONT-FERRAND
CHU de BORDEAUX
CHU de SAINT-ETIENNE
Hôpital BICHAT

intervention_type: Other


title: Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome

acronym: EPO

summary: Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

status: Terminated

lead_sponsor: Rennes University Hospital

location_facility:
Laval Hospital
Saint-Malo Hospital
Rennes University Hospital
Yves Le Foll Hospital
Bretagne Atlantic Hospital


title: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

acronym: HEMIMARCHE

summary: The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.

primary_purpose: Supportive Care

location_facility: Groupe hospitalier Pellegrin CHU Bordeaux

location_facility: Institut Régional de médecine physique et de Réadaptation

location_facility: Centre Régional de Réeducation et de Réadaptation Fonctionnelle

intervention_type: Behavioral


title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor

summary:
The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_facility:
UH of Lyon
UH of Besancon
UH of Rennes
UH of Montpellier
UH of Angers


title: Open, Non Controlled, Multicenter, First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Preliminary Antitumor Activity of GM102 in Patients With Advanced Pretreated Gynecological Cancer

summary: First in Human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose.

ReferenceCitation: Prat M, Le Naour A, Coulson K, Lemée F, Leray H, Jacquemin G, Rahabi MC, Lemaitre L, Authier H, Ferron G, Barret JM, Martinez A, Ayyoub M, Delord JP, Gladieff L, Tabah-Fisch I, Prost JF, Couderc B, Coste A. Circulating CD14(high) CD16(low) intermediate blood monocytes as a biomarker of ascites immune status and ovarian cancer progression. J Immunother Cancer. 2020 Jun;8(1). pii: e000472. doi: 10.1136/jitc-2019-000472.

lead_sponsor: GamaMabs Pharma

location_country:
France
United Kingdom
Belgium

location_facility: Institut Universitaire Cancer Toulouse - Oncopole


title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

summary: The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

ipd_sharing: Undecided

lead_sponsor: Vascutek Ltd.

location_facility: Centre Hospitalier Universitaire - Hopital Michallon

location_facility: Centre Hospitalalier Universitaire - Hopital Brabois

location_facility: Centre Hospitalier Universitaire - Hopital Civil


title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy

summary: The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.

lead_sponsor: AB Science

location_country:
United States
France

location_facility: Froedtert & Medical College of Wisconsin-CLCC


title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma

acronym: ART-ORL

summary:
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).

This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .

The number of patients required in this study is: 300:

Number of patients treated with tomotherapy: 120
Number of patients treated with dynamic arctherapy RapidArc: 120
Number of patients treated with dynamic arctherapy Vmat: 60

This is a prospective; multicentric and non randomized study.

ReferenceCitation: Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.

ReferenceCitation: Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequéant B, Gallocher O, Alfonsi M, Bardet É, Rives M, Calugaru V, Chajon E, Noël G, Mecellem H, Pérol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Alexis Vautrin
Intitut Curie
Centre Privé de Radiothérapie de Metz
Centre Paul STRAUSS
Centre Léon Bérard
Centre Oscar Lambret
Centre René GAUDUCHEAU
Groupe Oncorad Garonne
Institut Claudius Regaud
Hôpital Eurppéen Geoges POMPIDOU
Centre Eugène Marquis
Institut BERGONIE
Centre Val d'Aurelle
Institut Sainte Catherine

intervention_type: Radiation


type: EudraCT Number

title: A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers

summary: This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

primary_purpose: Other

lead_sponsor: InFlectis BioScience

location_facility: Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)


title: Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)

acronym: EFIRTES

summary:
The present study was designed to assess the efficacy of infliximab in a 2-period study :

An initial period with comparison of infliximab versus placebo and allowing the determination of the primary criteria
Then an extension period in which the 2 arms will receive infliximab (in the placebo group : 5 perfusions and in the experimental group 3 supplemental perfusions). Finally, the 2 groups will receive 5 injections of infliximab There is little evidence in the literature of when and how infliximab should be administered in sarcoidosis. We hypothesized, from our personal experience in 30 cases (18 of which were reported in a retrospective trial (14), that infliximab would have a very quick activity. So it appeared reasonable to evaluate the primary criterion at 6 weeks after initiation of the treatment.

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital de la Timone- service de Médecine Internne

location_facility: Hopital Claude Huriez- service de Médecine Interne

location_facility: CHU Hotel Dieu - service de Médecine Interne

location_facility: Nouvel Hopital Civil- service de Médecine Interne

location_facility: Hopital Avicenne - service de pnaumologie

location_facility: Hopital de la Croix Rousse- service de Médecine Interne

location_facility: Hopital Henri Mondor- service de Médecine Interne

location_facility: GH la Pitié Salpêtrière. Service de Médecine interne


title: Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.

summary: To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

ReferenceCitation: Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. Review. French.

ReferenceCitation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77.

ReferenceCitation: Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancérologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.

location_facility: APHP - CHU Avicenne - Oncologie Medicale


title: Pacemaker Remote Electrogram Monitoring Study (PREMS)

acronym: PREMS

summary:
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.

PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Polyclinique du Parc
CH Pierre Oudot
Hôpitaux du Léman
Clinique Belledonne
HIA Saint Anne
Clinique Bon Secours
CH de Bastia
Clinique Axium
CH de Castres
CH de Saint Malo
CH de Roanne
Hôpital Privé Paul d'Egine
Hôpital Sainte Musse CHI
CH André Mignot
Polyclinique Nord Aquitaine
CHG de Longjumeau
CH des Broussailles
CH Val d'Ariège
CH d'Annecy
CH d'Antibes
Clinique de Saint Georges de Didonnes
Clinique Clairval
CH St Luc St Joseph
CHU Hôpital Charles Nicolle
Cabinet de cardiologie
CH de Chartres
CH d'Aurillac
CH de Nevers
CH Léon Binet
Clinique de l'Anjou
Clinique Saint Vincent
CH de Chambéry
Polyclinique Sevigné
CH Paul Morel
CH de Niort
Cabinet de Cardiologie
Clinique de la Marche
CH de Blois
CH de Douarnenez
Cabinet Descartes
CH de Valence
CH Annonay
HPOP
Clinique du Mousseau
Polyclinique Saint Laurent
CHG Villefranche
CH Montbrison
Clinique des Dômes


title: A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

acronym: NEORAD

summary:
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma

An open-label, exploratory, single-arm, multicenter trial.

Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy.

Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Hôpital Européen Georges Pompidou - Service d'oncologie médicale

location_facility: Fôpital d'Instruction des Amées du Val de Grâce

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles

acronym: COMeBACk

summary:
The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.

The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).

location_facility: Lille University Hospital & EPIMAD Registry

intervention_type: Biological


title: A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.

acronym: ER-One

summary: The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.

lead_sponsor: Institut Curie

location_facility:
AP-HP Hôpital Tenon
Centre Jean Perrin
Institut de Cancérologie de Lorraine
Institut Claudius Régaud UICT
Institut Curie


title: A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

acronym: RADIOSARP

summary: A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.

ReferenceCitation: Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22. Review.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Institut du Cancer de Montpellier
Centre Léon Bérard
Centre Oscar Lambret
Institut Claudius Regaud - IUCT


title: Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

summary: A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

location_country:
United Kingdom
Spain
Russian Federation
France
Czechia

location_facility: Hammersmith Hospital Imperial College Healthcare Nhs Trust


title: An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia

summary: The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)

lead_sponsor: Santaris Pharma A/S

location_country:
Denmark
United States
United Kingdom
France

location_facility: Service d'HématologieCentre Hospitalier Lyon-Syd

location_facility: Holden Comprehensive Cancer Center, Univ. of Iowa

location_facility: MRC Toxicology Unit, University of Leicester


title: International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.

acronym: NEXT

summary: The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

ReferenceCitation: Carrié D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25.

lead_sponsor: CID - Carbostent & Implantable Devices

location_country: Germany France Italy Belgium

location_facility:
Medizinisches Versorgungszentrum
Istituto di Fisiologia Clinica del CNR
Krankenhaus der Barmherzigen Brüder
Ziekenhuis Oost Limburg
Academisch Ziekenhuis Middelheim
Clinique Saint-Hilaire
Hôpital de Rangueil
Azienda Ospedaliera Careggi
Ospedale S. Camillo
Clinique les Franciscaines
Institut Mutualiste Montsouris

intervention_type: Device


title: Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

summary: NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

lead_sponsor: Theradial

location_country: France Monaco

location_facility:
CH Saint Quentin
Ch Annonay
Aura Paris Plaisance
Ch La Rochelle
Ch Besancon
Ch Toulouse Larrey
CHPM Monaco
Ch Metz-Thionville
CH Saint Brieuc
Ch Chartres
Chru Tours
CH MEAUX


title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

acronym: ACROHNEM

summary: This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

ReferenceCitation: Foligné B, Plé C, Titécat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6). pii: E577. doi: 10.3390/cells8060577.

lead_sponsor: University Hospital, Lille

location_facility:
Centre Hospitalier de Boulogne
CHRU, Hôpital Claude Huriez
Centre hospitalier
Centre Hospitalier,
Centre Hospitalier Dunkerque


title: Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer

summary:
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.

There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.

The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.

It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.

Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery

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

location_country: Spain Austria Switzerland France Belgium Netherlands

location_facility: CHU Saint-Etienne - CHU de Saint-Etienne - Hopital Nord

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

location_facility: Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan


title: Study of the Impact of the Stage of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors (ITK) in Patients Treated for Metastatic Kidney Cancer

acronym: IREKI

summary: The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.

ReferenceCitation: van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev. 2009 Dec;35(8):692-706. doi: 10.1016/j.ctrv.2009.08.004. Epub 2009 Sep 5. Review.

ReferenceCitation: Hendrayana T, Wilmer A, Kurth V, Schmidt-Wolf IG, Jaehde U. Anticancer Dose Adjustment for Patients with Renal and Hepatic Dysfunction: From Scientific Evidence to Clinical Application. Sci Pharm. 2017 Feb 27;85(1). pii: E8. doi: 10.3390/scipharm85010008.

ReferenceCitation: Verheijen RB, Bins S, Mathijssen RH, Lolkema MP, van Doorn L, Schellens JH, Beijnen JH, Langenberg MH, Huitema AD, Steeghs N; Dutch Pharmacology Oncology Group. Individualized Pazopanib Dosing: A Prospective Feasibility Study in Cancer Patients. Clin Cancer Res. 2016 Dec 1;22(23):5738-5746. Epub 2016 Jul 28.

ReferenceCitation: Lacy S, Yang B, Nielsen J, Miles D, Nguyen L, Hutmacher M. A population pharmacokinetic model of cabozantinib in healthy volunteers and patients with various cancer types. Cancer Chemother Pharmacol. 2018 Jun;81(6):1071-1082. doi: 10.1007/s00280-018-3581-0. Epub 2018 Apr 23.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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

location_facility: CHU de Nîmes, Institut de Cancérologie du Gard

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole


title: Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation

summary: The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Oscar Lambret
Centre François Baclesse
Institut de Cancérologie de l'Ouest
Centre Henri Becquerel


title: Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial

acronym: RANSPRE

summary: The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.

location_facility: Hôpital de la conception et de la Timone


title: Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

acronym: DELTASCREEN

summary: The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

ipd_sharing_description: data will be available upon request to the principal investigator

lead_sponsor: Societe Française de Medecine d'urgence

location_country: France Spain Belgium

location_facility:
Hopital Pitié-Salpêtrière
CHU Strasbourg
Saint Antoine
Hopital Europeen Georges Pompidou
Lariboisière
Cliniques St Luc
Cochin
Hopital Tenon
CHU Nimes
Hospital Clinic


title: The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial

acronym: ManEq

summary: Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

primary_purpose: Prevention

ReferenceCitation: Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.

lead_sponsor: EZUS-LYON 1


title: A Double-Blind, Placebo-controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophysiological, and Clinical Markers in Patients With Friedreich's Ataxia

acronym: FRAMES

summary: Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's Ataxia

lead_sponsor: Minoryx Therapeutics, S.L.

location_country: Germany France Spain Belgium

location_facility: ICM, Groupe Hospitalier Pitié Salpêtrière


acronym: SALUTOX

title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

lead_sponsor: Direction Centrale du Service de Santé des Armées

source: euctr

location_facility: Institut Universitaire de Réadaptation Clémenceau

summary: The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.


title: A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

summary: The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

ReferenceCitation: Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3). pii: e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

lead_sponsor: AB Science

location_country: Poland Spain Greece France Romania Germany Bulgaria

location_facility: "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment


title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit

summary: The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.

location_country:
Spain
Italy
Russian Federation
United States
France
Germany
Czechia

location_facility: N.N.Blokhin Russian Cancer Research Centre

location_facility: Klinik und Poliklinik für Hautkrankheiten


title: Bivalirudin Infusion for Ventricular Infarction Limitation

acronym: BIVAL

summary: The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of the damage done to the heart muscle in participants who suffered a heart attack, compared to the comparator treatment (heparin).

ReferenceCitation: Alderman EL, Stadius M. The angiographic definitions of the Bypass Angioplasty Revascularization Investigation. Coronary Artery Disease 1992;3: 1189-1207

ReferenceCitation: Graham MM, Faris PD, Ghali WA, Galbraith PD, Norris CM, Badry JT, Mitchell LB, Curtis MJ, Knudtson ML; APPROACH Investigators (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease. Validation of three myocardial jeopardy scores in a population-based cardiac catheterization cohort. Am Heart J. 2001 Aug;142(2):254-61.

ReferenceCitation: Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002.

ReferenceCitation: Lowe JE, Reimer KA, Jennings RB. Experimental infarct size as a function of the amount of myocardium at risk. Am J Pathol. 1978 Feb;90(2):363-79.

ReferenceCitation: Ortiz-Pérez JT, Meyers SN, Lee DC, Kansal P, Klocke FJ, Holly TA, Davidson CJ, Bonow RO, Wu E. Angiographic estimates of myocardium at risk during acute myocardial infarction: validation study using cardiac magnetic resonance imaging. Eur Heart J. 2007 Jul;28(14):1750-8. Epub 2007 Jun 22.

ReferenceCitation: Reimer KA, Ideker RE, Jennings RB. Effect of coronary occlusion site on ischaemic bed size and collateral blood flow in dogs. Cardiovasc Res. 1981 Nov;15(11):668-74.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Basic structure-function relations of the epicardial coronary vascular tree. Basis of quantitative coronary arteriography for diffuse coronary artery disease. Circulation. 1992 Jun;85(6):1987-2003.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Measurement from arteriograms of regional myocardial bed size distal to any point in the coronary vascular tree for assessing anatomic area at risk. J Am Coll Cardiol. 1993 Mar 1;21(3):783-97.

ReferenceCitation: Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8.

lead_sponsor: The Medicines Company

location_country: Netherlands France

location_facility:
VUMC Amsterdam
Erasmus Medical Center
Hopital Ambroise Paré
Hospital Lariboisière


title: A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy

acronym: TERMATEP

summary:
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.

The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.

location_facility:
CHU Rouen
CHU
Centre Henri Becquerel
Institut Claudius Regaud
Centre François Baclesse


title: Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

acronym: HDENO

summary:
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

on bone mineral density (femoral T-score) at 24 months
on bone mineral density evolution (femoral T-score) after 24 months of follow-up
on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
the tolerance after 24 months of follow-up

ReferenceCitation: Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7:CD013424. doi: 10.1002/14651858.CD013424.pub2.

lead_sponsor: University Hospital, Montpellier

location_facility:
Clinique Médipole Cabestany
CHL Castelnau Le Lez
CHU Nice, Nephrology department
CH Perpignan, Nephrology department
AIDER
AP-HM, Nephrology department
CHU Montpellier, Nephrology department
CHU Lyon Sud, Nephrology department
CHU Nimes, Nephrology department


title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

summary: To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

location_facility: CHU Montpellier, Endocrinology department

location_facility: CHU Montpellier, Internal medicine department


title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

summary: The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

lead_sponsor: Phenox GmbH

location_country:
Poland
Romania
United Kingdom
Italy
Russian Federation
Argentina
France
Belgium
Germany
Bulgaria

location_facility: Ospedale Bellaria Carlo Alberto Pizzardi

location_facility: Federal Almazov North-West Medical Research Centre

location_facility: Hôpital Gui de Chauliac (CHU Montpellier)

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu


title: Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées

acronym: PREFIX

summary: Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.

ReferenceCitation: Pasquier E, de Saint Martin L, Bohec C, Chauleur C, Bretelle F, Marhic G, Le Gal G, Debarge V, Lecomte F, Denoual-Ziad C, Lejeune-Saada V, Douvier S, Heisert M, Mottier D. Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial. Blood. 2015 Apr 2;125(14):2200-5. doi: 10.1182/blood-2014-11-610857. Epub 2015 Jan 30.

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Régional Universitaire de Caen


title: Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

summary: The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

ReferenceCitation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10:CD006008. doi: 10.1002/14651858.CD006008.pub5. Review.

lead_sponsor: Coloplast A/S

location_country: Denmark Sweden France Norway Germany

location_facility: Hôpital Léon Berard, Rehabilitation clinic,

location_facility: University Heidelberg, Neuro-Urology clinic,

location_facility: St. Olavs Hospital HF, Neurologi clinic,

location_facility: Hôpital Henry Gabrielle, Urology clinic,

location_facility: Hôpital Raymond Poincaré, Urology clinic

location_facility: Hôpital Tenon, Neuro-Urology and perineal explorations department,

location_facility: PrivatHospitalet Danmark, privat hospital,


title: A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation

summary:
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.

Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
United Kingdom
Italy
Austria
Switzerland
Hungary
France
Israel
Belgium
Germany
Czechia

location_facility: Ospedale SS. Antonio e Biagio e Cesare Arrigo


title: A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

summary: The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

location_country:
Greece
Russian Federation
Tunisia
Ukraine
India
France
Belgium
Slovakia

location_facility:
Hospital AZ Sint-Jan
Center of Surgical Innovations
General University Hospital of Patras
Omsk Clinical oncology dispensary Omsk
Sanjeevani CBCC USA Cancer Hospital
Institut Salah Azaiez de Cancerologie
National Oncology Institute
Polyclinique de Limoges site CHENIEUX
Centre Hospitalier de Longjumeau


title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass

acronym: YOMEGA

summary:
Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.

More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.

By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery

Hypothesis :

The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.

ReferenceCitation: Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6. Erratum in: Lancet. 2019 Mar 30;393(10178):1298.

lead_sponsor: Hospices Civils de Lyon

location_facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

location_facility: Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

location_facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

location_facility: Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

location_facility: Service de Chirurgie Générale - Hôpital Privé de la Loire

location_facility: Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière


title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

acronym: SOLSTICE

summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Sweden
Slovakia
Brazil
Hungary
Germany
Bulgaria
Denmark
Ireland
Latvia
Estonia
France
Netherlands

location_facility: Semmelweis University Radiology and Oncotherapy Clinic

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Hospital General Universitario Alicante Servicio de Oncología

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

location_facility: Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos

location_facility: Ustredna vojenska nemocnica Ruzomberok Klinika radiacnej a klinickej onkologie

location_facility: "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

location_facility: Spitalul Clinic "Coltea" Sectia Oncologie Medicala

location_facility: National Institute of Cancer Abdominal Oncology Department

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: Cork University Hospital Department of Medical Oncology

location_facility: "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology

location_facility: Moscow City Oncology Hospital # 62 chemotherapy department

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica

location_facility: State Research Institution of Oncology of Tomsk Chemotherapy

location_facility: Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

location_facility: Aberdeen Royal Infirmary Oncology Department

location_facility: Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.

location_facility: Albert Schweitzer Ziekenhuis Interne Geneeskunde

location_facility: Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

location_facility: Hospital de la Santa Creu I Sant Pau Oncología Medica

location_facility: Kursk Regional Clinical Oncology Dispensary Oncology Department

location_facility: Regional Clinical Oncological Dispensary Department of Oncology

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: Institute of Medical Radiology of S.P. Grygoryev of AMS UKR

location_facility: Med. Universität Graz Klinische Abteilung für Onkologie

location_facility: S.C ONCOMED S.R.L Departament Oncologie Medicala

location_facility: "Complex oncology center - Burgas" EOOD Department of medical oncology

location_facility: Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

location_facility: Odesa Regional Oncology Dispensary Day patient Department

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

location_facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi

location_facility: 1st Floor East Wing Medical OncologyFulham Palace RoadHammersmith

location_facility: Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy

location_facility: Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: St George Hospital St George Hospital Cancer Care Centre

location_facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

location_facility: Hospital Quirónsalud Valencia Servicio de Oncología Médica

location_facility: Fakultni nemocnice Ostrava Klinika onkologicka

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology

location_facility: Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica

location_facility: Centrul de Oncologie Sf Nectarie Oncology Department

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: "Spec. hospital for active treatment of oncology dis." EOOD Department of medical oncology and palliative care

location_facility: Hospital Beatriz Ângelo Serviço de oncologia medic

location_facility: M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

location_facility: Sarah Cannon Research Institute UK Clinical Trials

location_facility: Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica

location_facility: Glan Clwyd Hospital North Wales Cancer Treatment Centre

location_facility: Blacktown Hospital Cancer and Haematology Centre

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa

location_facility: Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

location_facility: Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

location_facility: Norrlands Universitetssjukhus Cancercentrum Umea

location_facility: Royal Marsden Hospital Department of Medicine

location_facility: Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)

location_facility: Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

location_facility: CHU Jean Minjoz Service d'oncologie médicale

location_facility: Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

location_facility: Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely

location_facility: Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

location_facility: Hospital CUF Infante Santo Oncology Department

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

location_facility: Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: P. Stradins Clinical University Hospital

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: Odense Universitetshospital Onkologisk Afdeling R

location_facility: Riga East Univerity Hospital Oncology Centre of Latvia

location_facility: Omsk Clinical Oncologic Dispensary Chemotherapy

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

location_facility: S.C Oncolab S.R.L Sectia Oncologie Medicala

location_facility: Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V

location_facility: Nemocnica s poliklinikou Stefana Kukuru, Michalovce, a.s Oddelenie okologie a radioterapie

location_facility: Hospital Virgen de las Nieves Unidad de Oncología Médica

location_facility: Ospedale San Carlo U.O. Oncologia Medica

location_facility: HOSPITAL DE BRAGA Medical Oncology Department

location_facility: H. Universitario La Paz Oncología Médica

location_facility: Europejskie Centrum Zdrowia Otwock Oddzial Onkologii Klinicznej

location_facility: HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

location_facility: "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology

location_facility: Hospital Universitario Miguel Servet Servicio de Oncología

location_facility: "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

location_facility: Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA

location_facility: SBIH of YR "Clinical oncology hospital" chemotherapy department

location_facility: Rostov Research Institute of Oncology Chemotherapy department

location_facility: Kyiv City Clinical Oncology Centre Chemotherapy Department #2

location_facility: SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)

location_facility: Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: H. Valle de Hebrón Servicio de Oncología - (VHIR)

location_facility: Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa

location_facility: "Complex Ongology Center - Vratsa" EOOD Department of Medical oncology

location_facility: Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

location_facility: Aalborg Universitetshospital, Syd Onkologisk Afdelin

location_facility: East Tallinn Central Hospital Center of Oncology

location_facility: Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative car

location_facility: University Headache Clinic Outpatient oncology clinic

location_facility: Lanssjukhuset Ryhov Onkologiska kliniken

location_facility: Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

location_facility: Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

location_facility: Clinical Oncology Dispensary No.1 Chemotherapy Department

location_facility: Lviv Regional Oncology Center Chemotherapy department

location_facility: Fakultni nemocnice Olomouc Onkologicka klinika

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Arkhangelsk Clinical Oncology Dispensary chemotherapy department

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: University Hospitals Bristol Bristol Haematology & Oncology Centre

location_facility: Fundación COIR Centro Oncológico de Interación Regional

location_facility: Hospital de Base Centro Integrado de Pesquisa

location_facility: Frankston Private Peninsula and Southeast Oncology Group

location_facility: Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale

location_facility: Leicester Royal Infirmary The HOPE Clinical Trials Unit

location_facility: CHU Morvan Institut de Cancérologie et d'Hématologie

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: Hospital A C Camargo Unidade de Pesquisa Clinica

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: Hospital São Rafael Centro Intergrado de Pesquisa

location_facility: Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: H. Clínico San Carlos Servicio de Oncología Médica

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Ordensklinikum Linz Barmherzige Schwestern Interne I

location_facility: Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

location_facility: Adventist HealthCare Integrated Cancer Centre

location_facility: MHAT Serdika EOOD Department of Medical Oncology

location_facility: Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

location_facility: Narodny onkologicky ustav Oddelenie klinickej onkologie

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: Podillia Regional Oncology Centre Chemotherapy Department

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: North Estonia Medical Centre Foundation Oncology and Haematology clinic

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

location_facility: Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling

location_facility: Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

location_facility: Hospital Universitario Marqués de Valdecilla Oncología médica

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio Institute of Biomedical Sciences Abel Salazar

location_facility: JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

location_facility: Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii

location_facility: Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

location_facility: National Medical Research Center of Oncology N.N. Petrova

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department

location_facility: Centro de Oncología e Investigación de Buenos Aires COIBA


title: Evaluation of Tele-expertise for Inmates With a Dermatological Lesion

acronym: TLM-Inmates

summary: The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation

time_perspective: Retrospective

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Zarca K, Charrier N, Mahé E, Guibal F, Carton B, Moreau F, Durand-Zaleski I. Tele-expertise for diagnosis of skin lesions is cost-effective in a prison setting: A retrospective cohort study of 450 patients. PLoS One. 2018 Sep 24;13(9):e0204545. doi: 10.1371/journal.pone.0204545. eCollection 2018.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
UCSA Osny
UCSA Meaux
UCSA Villepinte
UCSA Réau
UCSA Nanterre


title: Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units

summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.

location_facility:
Résidence de l'Orge
Résidence Notre Dame d'Espérance
Résidence Les Tisserins
Résidence La Gentilhommière
Le Centenaire


title: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults

acronym: NUTRIMEMO

summary: Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms) placebo-controlled design.

lead_sponsor: Nutrimemo Consortium

location_facility: Universitary Hospital Center - USR 3413 SANPSY

intervention_type: Dietary Supplement


title: Phase 3 Study to Compare Oral Masitinib to Placebo in Treatment of Patients With Smouldering or Indolent Severe Systemic Mastocytosis, Unresponsive to Optimal Symptomatic Treatment

ReferenceCitation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmérini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

location_country:
Germany
United States
France

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre de référence de Mastocytose (CEREMAST)

summary: The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.


title: Improve the Survival Without Morbidity of Extremely Preterm Infants: A Stepped-wedge Cluster-randomized Trial

acronym: PREMEX

summary:
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery.

Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery.

The follow-up collected for this study will take place:

At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents

At the child's discharge from the hospital, or if he or she dies in the hospital:

Collection of clinical data (principal endpoint) from data in the medical file.
Data to measure practices and adherence to the intervention will be collected

When the child reaches the corrected age of 2 years:

a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness..
Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, the ASQ (Ages and Stages Questionnaire), which the parents will complete.

primary_purpose: Health Services Research

ReferenceCitation: Lamau MC, Ruiz E, Merrer J, Sibiude J, Huon C, Lepercq J, Goffinet F, Jarreau PH. A new individualized prognostic approach to the management of women at risk of extreme preterm birth in France: Effect on neonatal outcome. Arch Pediatr. 2021 Jul;28(5):366-373. doi: 10.1016/j.arcped.2021.04.005. Epub 2021 May 28.


title: Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: A Pilot Diagnostic Accuracy Study

acronym: MPO-MDS-PILOT

summary:
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective hematopoiesis.

The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence of disease is lower than 20% in subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms.

An objective assay is highly desirable for accurately ruling out MDS based on peripheral blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in patients with negative results.

Few studies have investigated the value of peripheral blood flow cytometric analysis for the diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these studies lacked replication of their results, used a case-control design, which was prone to spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited sample sizes.

Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is an enzyme synthetized during myeloid differentiation that constitutes the major component of neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS is still lacking, to our knowledge.

In this study, the investigators hypothesize that flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine practice.

In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. Flow cytometry analysis of peripheral blood neutrophil myeloperoxidase expression will not require additional blood sample. A test result will have no impact on patient management. No follow-up visits are planned in this cross-sectional study.

time_perspective: Cross-Sectional

ReferenceCitation: Raskovalova T, Scheffen L, Jacob MC, Vettier C, Bulabois B, Szymanski G, Chevalier S, Gonnet N, Park S, Labarère J. Comparative diagnostic accuracy between simplified and original flow cytometric gating strategies for peripheral blood neutrophil myeloperoxidase expression in ruling out myelodysplastic syndromes. PLoS One. 2022 Nov 18;17(11):e0276095. doi: 10.1371/journal.pone.0276095. eCollection 2022.

ReferenceCitation: Raskovalova T, Jacob MC, Bulabois CE, Mariette C, Scheffen L, Park S, Labarère J. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for ruling out myelodysplastic syndromes: a prospective validation study. Ann Hematol. 2021 May;100(5):1149-1158. doi: 10.1007/s00277-021-04446-7. Epub 2021 Feb 10.

ipd_sharing_description: The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Universitaire Estaing

intervention_type: Diagnostic Test


title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

summary: Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

lead_sponsor: Zimmer Biomet

location_facility:
Polyclinique de Hénin Beaumont
CHU Hôpital Sud
Polyclinique de Riaumont
Clinique Saint Andre
CHU Pellegrin Tripode
CHU Amiens


title: Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

acronym: CAESAR

summary: The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

ReferenceCitation: Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7:CD002251. doi: 10.1002/14651858.CD002251.pub4.

ReferenceCitation: Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aimé M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.

lead_sponsor: Fresenius Kabi

location_facility: Hopital Caremeau, CHU, Service Anesthesie

location_facility: Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale

location_facility: Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation

location_facility: Hôpital Armand-Trousseau, Service d'anesthésie-réanimation

location_facility: Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre

location_facility: Unité d'anesthésie - Maternité Paule de Viguier

location_facility: CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation

location_facility: Hopital Robert Debre, CHU, Service Anesthesie

location_facility: Hopital Hautepierre, CHU, Service Reanimation Chirurgicale

location_facility: Hopital de l'Archet, Service Anesthesie-Reanimation

location_facility: Höpital Louis-Mourier - Service d'Anesthesie


title: Exploration of Sensory-motor Representations in Children of Typical Development Aged 5 to 8

acronym: IMOT

summary: Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Hôpital Saint Vincent
Hospital Sambre Avesnois
Psychomotor therapist' offices
Hospital Dr Schaffner