title: A Multicenter, Open, Phase II Study to Estimate the Activity and Safety of Caspofungin (CASP) in the First-Line Treatment of Probable and Proven Invasive Aspergillosis (IA) in Patients With Hematological Malignancies (HM) or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

summary:
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

ReferenceCitation: Viscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients. J Antimicrob Chemother. 2009 Dec;64(6):1274-81. doi: 10.1093/jac/dkp355. Epub 2009 Oct 19.

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

location_country: Germany Italy Slovakia Switzerland Belgium Turkey France

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Hacettepe University - Faculty of Medicine


title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced/Metastatic Urothelial Tract Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.

status: Completed

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

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

location_country: France Italy Netherlands Switzerland Belgium Spain Israel

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. doi: 10.1016/j.critrevonc.2006.07.008. Epub 2006 Nov 20.

ReferenceType: result

ReferenceCitation: Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. doi: 10.1016/j.ejca.2005.12.011. Epub 2006 Mar 7.

location_country:
France
Italy
United Kingdom
Netherlands
Austria
Switzerland
Spain
Greece
Israel

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Mario Negri Institute for Pharmacological Research

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research


title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.

ReferenceCitation: Briasoulis E, Pavlidis N, Terret C, Bauer J, Fiedler W, Schoffski P, Raoul JL, Hess D, Selvais R, Lacombe D, Bachmann P, Fumoleau P. Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group. Eur J Cancer. 2003 Nov;39(16):2334-40. doi: 10.1016/s0959-8049(03)00629-4.

location_country: Germany France Denmark Netherlands Switzerland Greece Israel

location_facility: Haemato-Onkologische Praxis und Tagesklinik

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Herlev Hospital - University Hospital of Copenhagen


title: Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

acronym: EXTRACT

summary: The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

study_start_date_type: Actual

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Hong Kong
Canada
France

location_facility: University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower

location_facility: Centre Hospitalier Regional de la Reunion

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Centre Hospitalier de la Region d'Annecy


title: A Phase II Open-label Study Evaluating Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

summary: This is a multicenter, prospective, single arm, non-randomized, open-label, phase 2 clinical study to evaluate safety and efficacy of valemetostat tosylate (DS-3201b) in patients with relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven cohorts. Up to 141 patients will be enrolled in 6 different cohorts (40 patients with aggressive B-cell lymphoma, 41 with follicular lymphoma (FL), 20 with Mantle Cell Lymphoma (MCL) and 20 with other indolent lymphomas, and 20 patients with Hodgkin lymphoma (HL)). FL patients with EZH2 mutant (gain of function mutations) will be enrolled in the cohort 2bis. At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the cohort 1. The primary endpoint is the overall response rate (ORR) determined by investigator assessment.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Service des Maladies du Sang - CHRU de Lille

status_simplified: Ongoing


title: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

acronym: Epis-AKI

summary:
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Weiss R, Saadat-Gilani K, Kerschke L, Wempe C, Meersch M, Zarbock A; EPIS-AKI Investigators. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial. BMJ Open. 2021 Dec 30;11(12):e055705. doi: 10.1136/bmjopen-2021-055705.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repository_institution: Università degli Studi di Trento - Institutional Research Information System

repository_institution: University of Zurich - Zurich Open Repository and Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital Muenster

sponsor_collaborators:
University Hospital Muenster
Baxter Healthcare Corporation

location_country:
Germany
Italy
Russian Federation
North Macedonia
Slovenia
Malta
United States
Saudi Arabia
Spain
Turkey
Libyan Arab Jamahiriya
Palestinian Territory, occupied
Egypt
France

location_facility: Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza

location_facility: Health Sciences University Medical School

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

location_facility: Hospital Universitario Funcacion Alcorcón

location_facility: Izmir Democracy University School of Medicine

location_facility: Centre de Lutte contre le Cancer Francois Baclesse

location_facility: Suleyman Demirel University School of Medicine

location_facility: Hospital Cliínico Universitario Virgen de las Nieves

lead_sponsor_type: academique


type: EudraCT Number

title: Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

acronym: EBIN

summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

status: Active, not recruiting

ipd_sharing_description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

location_country:
Finland
Italy
Germany
Poland
United Kingdom
Denmark
Netherlands
Spain
France

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: CHU de Dijon - Centre Georges-François-Leclerc

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: East & North Hertfordshire NHS Trust - East and North Hertfordshire NHS Trust - Mount Vernon Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: CHU de Poitier - Centre Hospitalier Universitaire De Poitiers

location_facility: University Hospitals Copenhagen - Herlev Hospital - University Copenhagen

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Universita Degli Studi Di Siena -Policlinico "le Scotte"

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

location_facility: Helsinki University Central Hospital - Dept of Oncology

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino


title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin

summary: This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

ReferenceCitation: Laterre PF, Pickkers P, Marx G, Wittebole X, Meziani F, Dugernier T, Huberlant V, Schuerholz T, Francois B, Lascarrou JB, Beishuizen A, Oueslati H, Contou D, Hoiting O, Lacherade JC, Chousterman B, Pottecher J, Bauer M, Godet T, Karakas M, Helms J, Bergmann A, Zimmermann J, Richter K, Hartmann O, Pars M, Mebazaa A; AdrenOSS-2 study participants. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. doi: 10.1007/s00134-021-06537-5. Epub 2021 Oct 4.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Springer-Nature

ReferenceCitation: Geven C, Blet A, Kox M, Hartmann O, Scigalla P, Zimmermann J, Marx G, Laterre PF, Mebazaa A, Pickkers P. A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2). BMJ Open. 2019 Feb 19;9(2):e024475. doi: 10.1136/bmjopen-2018-024475.

repository_institution: PubMed Central - Europe PMC

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

repositories_institution:
PubMed Central - Europe PMC
Radboud University - Radboud Repository

lead_sponsor: Adrenomed AG

location_country: Germany Netherlands Belgium France

location_facility: Hôpital Saint-Louis, Service d'Anesthésie-Réanimation

location_facility: Clinique Universitaire Saint-Luc (UCL Bruxelles)

location_facility: Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie

location_facility: Gelderse Vallei Hospital, Department of Intensive Care

location_facility: Antwerp University Hospital (UZA), Critical Care Medicine

location_facility: Medisch Spectrum Twente, Department of Intensive Care

location_facility: Groupe Jolimont, Hospitalier de Jolimont

location_facility: Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes

location_facility: Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale

location_facility: Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin

location_facility: Medical Intensive Care Medicine, Centre hospital - universitaire

location_facility: AP-HP, Hopital Louis Mourier, Réanimation Médicale

location_facility: Hôpital Lariboisière, Réanimation Médicale et Traumatologique

location_facility: University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine

location_facility: Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care

location_facility: Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

location_facility: Zuyderland Medical Center, Department of Intensive Care

location_facility: CHRU Bretonneau, Medecine Intensive Réanimation

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin

location_facility: Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale

location_facility: Hôpital Lariboisière, Dept. d'Anesthesie

location_facility: CHU de Nantes; Medicine Intensive Reanimation

location_facility: Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin

intervention_type: Biological


lead_sponsor: University Hospital, Lille

summary:
This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.

There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.

sponsor_collaborators:
University Hospital, Lille
Janssen, LP
Intergroupe Francophone du Myelome

location_facility: Sce Hématologie Thérapie Cellulaire CHU Limoges

location_facility: Onco-hématologie CHRU Hôpital Bretonneau

location_facility: Service d'Hématologie Clinique Institut de Cancérologie Lucien Neuwirth

location_facility: Médecine interne Centre hospitalier départemental

location_facility: Service Hématologie Centre Hospitalier Yves le Foll

location_facility: Unité de Recherche Clinique - CH Périgueux

location_facility: Département d'Hématologie et Oncologie Hôpitaux Universitaires de Strasbourg

location_facility: service hématologie CH Bretagne Atlantique

location_facility: Hôpital du Haut Lévêque Centre François Magendie

location_facility: Clinique - ICH CHU de Brest Hôpital Morvan

title: A Multicenter Open Label Phase II Study of Daratumumab in Combination With Dexamethasone in Multiple Myeloma Resistant or Refractory to Bortezomib and Lenalidomide and Pomalidomide - an IFM 2014-04 Study

source: euctr


title: A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin

acronym: PVAB

summary: This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility: Centre Hospitalier Annecy-Genevois - Site d'Annecy

location_facility: CHR de Metz-Thionville - Hôpital de Mercy

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

location_facility: CHU de Grenoble - Hôpital Albert Michallon


acronym: CIRCUS

lead_sponsor: Hospices Civils de Lyon

summary: Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.

ReferenceCitation: Cung TT, Morel O, Cayla G, Rioufol G, Garcia-Dorado D, Angoulvant D, Bonnefoy-Cudraz E, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Claeys MJ, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, De Poli F, Morice MC, Ider O, Dubois-Rande JL, Unterseeh T, Le Breton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Elmer E, Hansson MJ, Bergerot C, Boussaha I, Jossan C, Derumeaux G, Mewton N, Ovize M. Cyclosporine before PCI in Patients with Acute Myocardial Infarction. N Engl J Med. 2015 Sep 10;373(11):1021-31. doi: 10.1056/NEJMoa1505489. Epub 2015 Aug 30.

ReferenceCitation: Bochaton T, Claeys MJ, Garcia-Dorado D, Mewton N, Bergerot C, Jossan C, Amaz C, Boussaha I, Thibault H, Ovize M. Importance of infarct size versus other variables for clinical outcomes after PPCI in STEMI patients. Basic Res Cardiol. 2019 Dec 12;115(1):4. doi: 10.1007/s00395-019-0764-8.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Mewton N, Cung TT, Morel O, Cayla G, Bonnefoy-Cudraz E, Rioufol G, Angoulvant D, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, Morice MC, Monassier JP, Ider O, Dubois-Rande JL, Unterseeh T, Lebreton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Hansson MJ, Elmer E, Boussaha I, Jossan C, Torner A, Claeys M, Garcia-Dorado D, Ovize M; CIRCUS Study Investigators. Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial). Am Heart J. 2015 Jun;169(6):758-766.e6. doi: 10.1016/j.ahj.2015.02.020. Epub 2015 Mar 13.

oa_host_type: repository

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

repository_normalized: HAL

version: acceptedVersion

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

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

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_facility: Hôpitaux Universitaires, Nouvel Hôpital Civil

location_facility: Hopital Louis Pradel, Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire d'Angers

title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

location_country: Spain Belgium France


type: Registry Identifier

title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

acronym: INIS

summary: The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

location_country:
Ireland
Norway
United Kingdom
Denmark
Sweden
Greece
France


title: Kuvan® Adult Maternal Pediatric European Registry

acronym: KAMPER

summary:
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.

Kuvan® received marketed authorisation in Europe in December 2008 and is now available in several European countries for the treatment of Hyperphenylalaninemia (HPA).

The primary objective is to assess the long-term safety in subjects treated with Kuvan®.

Secondary objectives are to provide additional information regarding:

Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency).
Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are receiving treatment with Kuvan®.
Progress and outcome of pregnancy for women with HPA who become pregnant while receiving treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).
Assessment of adherence to diet and to Kuvan®.
Assessment of long-term sensitivity to Kuvan®treatment.

lead_sponsor: BioMarin Pharmaceutical

location_country: Germany Italy Portugal Slovakia Sweden Netherlands Austria Spain France

location_facility:
Research Site - Policlinico Federico
Research Site
Research Site - Necker
Research Site - Armand Trousseau
Research Site - Ospedale Annunziata


acronym: BIBF 1120 vs Bevacizumab in  CRC

lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.

location_facility: 1199.51.32005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34007 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32006 Boehringer Ingelheim Investigational Site

title: A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

location_country: Germany Italy Belgium Spain France


lead_sponsor: Ferring Pharmaceuticals

summary: The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

ReferenceCitation: Abrahamsson PA, Boccon-Gibod L, Morote J, de Jong IJ, Malmberg A, Neijber A, Albers P. Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy. Eur Urol Focus. 2017 Oct;3(4-5):470-479. doi: 10.1016/j.euf.2015.12.008. Epub 2016 Jan 22.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Boccon-Gibod L, Albers P, Morote J, van Poppel H, de la Rosette J, Villers A, Malmberg A, Neijber A, Montorsi F. Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer. Eur Urol. 2014 Oct;66(4):655-63. doi: 10.1016/j.eururo.2014.05.037. Epub 2014 Jun 18.

location_facility: Azienda Policlinico Universitario G. Martino

location_facility: Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Gemeinschaftspraxis Dres. Rudolph, Wörner

location_facility: Praxisgemeinschaft f. Onkologie & Urologie

location_facility: Erasme Hospital, University Clinics of Brussels

location_facility: Hospital Universitario Principe de Asturias

title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

location_country: Germany Italy Netherlands Belgium Spain France


title: Biventricular Tachycardias Outcome Trial

acronym: BITAC

summary:
This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

lead_sponsor: LivaNova

location_country:
Germany
Italy
Portugal
United Kingdom
Sweden
Belgium
Spain
Canada
France

location_facility: Universitatsklinik Med. Klinik Heidelberg

intervention_type: Device


title: Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.

summary: The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

ReferenceCitation: Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.

lead_sponsor: Ipsen

location_country: Netherlands Belgium France

location_facility: Centre de Radiothérapie et Oncologie Médicale


title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)

acronym: VENUS

summary: Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

ipd_sharing: Undecided

ipd_sharing_description: Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry

lead_sponsor: European Association of Urology Research Foundation

location_country:
Germany
United Kingdom
Netherlands
Belgium
Spain
Czechia
France

location_facility: University of Rennes, Department of Urology

location_facility: Marqués de Valdecilla University Hospital

intervention_type: Other


acronym: BI 6727 randomised phase II trial in ovarian cancer

summary:
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)

ReferenceCitation: Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: 1230.18.3308A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3310A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3315A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3301A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42103 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34006 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3309A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3314A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3305A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3311A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3313A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3307A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34007 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3322A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3312A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3320A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3321A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3302A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42101 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32003 Boehringer Ingelheim Investigational Site

title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy

location_country: France Slovakia Belgium Spain Sweden


title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)

acronym: TRacKING

summary:
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.

This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.

lead_sponsor: Centre Leon Berard

location_country:
Germany
Italy
Poland
Slovenia
United Kingdom
Denmark
Netherlands
Austria
Spain
Czechia
France

location_facility: Universitätsklinikum Tübingen Medizinische Universitätsklinik;

location_facility: "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"

location_facility: "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM)

location_facility: Maria Sklodowska Curie National Research Institute of Oncology

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"

location_facility: Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna

location_facility: Complejo Hospitalario regional Virgen del Rocio

location_facility: University College London NHS Foundation Trust

location_facility: "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"

location_facility: University Hospital Würzburg (UniversitätsKlinikum Würzburg)

location_facility: Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)

location_facility: "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"

location_facility: Mannheim University Medical Center (UniversitatsMedizin Mannheim)

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino


acronym: POLAR

lead_sponsor: ETOP IBCSG Partners Foundation

summary:
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs.

During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection.

It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial.

The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return.

ReferenceCitation: Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.

ReferenceCitation: Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035.

ReferenceCitation: Borner M, Bacchi M, Goldhirsch A, Greiner R, Harder F, Castiglione M, Jungi WF, Thurlimann B, Cavalli F, Obrecht JP, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol. 1994 Oct;12(10):2071-7. doi: 10.1200/JCO.1994.12.10.2071.

ReferenceCitation: Aebi S, Gelber S, Anderson SJ, Lang I, Robidoux A, Martin M, Nortier JW, Paterson AH, Rimawi MF, Canada JM, Thurlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

ReferenceCitation: Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Canada JM, Thurlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14.

ReferenceCitation: Migliaccio I, Di Leo A, Malorni L. Cyclin-dependent kinase 4/6 inhibitors in breast cancer therapy. Curr Opin Oncol. 2014 Nov;26(6):568-75. doi: 10.1097/CCO.0000000000000129.

ReferenceCitation: Wardell SE, Ellis MJ, Alley HM, Eisele K, VanArsdale T, Dann SG, Arndt KT, Primeau T, Griffin E, Shao J, Crowder R, Lai JP, Norris JD, McDonnell DP, Li S. Efficacy of SERD/SERM Hybrid-CDK4/6 Inhibitor Combinations in Models of Endocrine Therapy-Resistant Breast Cancer. Clin Cancer Res. 2015 Nov 15;21(22):5121-5130. doi: 10.1158/1078-0432.CCR-15-0360. Epub 2015 May 19.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

ReferenceCitation: Turner NC, Huang Bartlett C, Cristofanilli M. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Oct 22;373(17):1672-3. doi: 10.1056/NEJMc1510345. No abstract available.

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Pfizer

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Groupe hospitalier de Bretagne Sud, Hôpital du Scorff

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Instituto Catalan de Oncologia L´Hospitalet

location_facility: AOU Maggiore Della Carita, University of Eastern Piedmont

location_facility: Hospital General Universitario de Alicante

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: MUW - Universitätsklinik für Innere Medizin

location_facility: Medizinische Universität Innsbruck - Univ.-Klinik f. Frauenheilkunde

title: A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

type: Other Identifier

location_country: Italy Hungary Switzerland Austria Spain France


title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

acronym: PSO-TOP

summary: A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.

ReferenceCitation: Reich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.

ReferenceCitation: Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.

oa_colors: green hybrid

evidence: open (via crossref license)

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

lead_sponsor: Kristian Reich, MD

sponsor_collaborators:
Kristian Reich, MD
LEO Pharma

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Spain
France


title: Exploratory Evaluation of Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients Treated With HAART (CD4+ ≥ 200 Cells mm3): An Open Labeled, Non-comparative Study

summary: Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

ReferenceCitation: Saiag P, Bauhofer A, Bouscarat F, Aquilina C, Ortonne JP, Dupin N, Mougin C. Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study. Br J Dermatol. 2009 Oct;161(4):904-9. doi: 10.1111/j.1365-2133.2009.09210.x. Epub 2009 May 15.

lead_sponsor: MEDA Pharma GmbH & Co. KG

sponsor_collaborators:
MEDA Pharma GmbH & Co. KG
ORION Sante

location_facility: Service de Dermatologie Hôpital de l'Archet II

location_facility: Service de Dermatologie Groupe Hospitalier La Grave

location_facility: Service de Maladies Infectieuses Hôpital de la Conception

location_facility: Service de Dermatologie, Hôpital Ambroise Paré

location_facility: Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard

location_facility: Service de Dermatologie Centre Hospitalier de Valence

location_facility: Service de Dermatologie CHU Saint-Pierre

location_facility: Service de Dermatologie et Vénéréologie Hôpital Saint Jacques

location_facility: Service Dermatologie Hopital COCHIN - Pavillon Tarnier

location_facility: Service Dermatologie C.H. François Rabelais (César de Paepe)

location_facility: Départment de Gynécologie-Obstétrique CHU Saint-Pierre


acronym: IROCAS

lead_sponsor: UNICANCER

summary: The trial is a phase III, multicenter, open-labeled randomized trial comparing the association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

ReferenceCitation: Bennouna J, Andre T, Campion L, Hiret S, Miglianico L, Mineur L, Touchefeu Y, Artru P, Asmis T, Bouche O, Borde F, Kavan P, Lam YH, Rajpar LS, Emile JF, Jouffroy C, Gill S, Taieb J. Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer-A UNICANCER GI-PRODIGE Trial. Clin Colorectal Cancer. 2019 Mar;18(1):e69-e73. doi: 10.1016/j.clcc.2018.09.011. Epub 2018 Oct 19.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

sponsor_collaborators:
UNICANCER
Canadian Cancer Trials Group
GONO GROUP

location_facility: The PEI Cancer Treatment Centre Queen Elizabeth Hospital

location_facility: Institut de Cancérologie de l'Ouest -site Paul Papin

location_facility: Institut de Cancérologie de l'Ouest -site René Gauducheau

location_facility: Hospices civils de Lyon - Hôpital Edouard Herriot

location_facility: Centre hospitalier de l'Université de Montréal

title: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_country: Canada France

collaborators:
Canadian Cancer Trials Group
GONO GROUP


title: A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)

acronym: TRIPTOCARE LT

summary: The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

location_country:
Lithuania
United Kingdom
Denmark
Romania
Netherlands
Latvia
France

location_facility:
Medical Center
Bristol Royal Infirmary
Hôpital Pellegrin
CHU Pasteur
Frederiksbergs Hospital
Center of Oncology
Herlev University Hospital
University Hospital
University Hospital Coventry
Fredericia Sygehus
Sc E-Uro Srl
Hôpital Henry Gabrielle
Ulster hospital
Academisch Medisch Centrum
Odense Universitets Hospital
CHU Henri Mondor
Addenbrookes Hospital
University Oncological Institute
Clinique Beau Soleil
CHU Nantes
Private practice
Oncomed
Leicester General Hospital
Hôpital Nord
University Hospital Wales
Institut Mutualiste Monsouris
Chru Lille
Lister Hospital
Hôpital Val de Grâce
Clinique Rhône Durance
Medical University Clinics
Hôpital Foch
Nottingham City Hospital
P.Stradins Clinical University Hospital
Diaconessenhuis


title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

acronym: MUSIC

summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

ReferenceCitation: Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hebuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1.

oa_host_type: publisher

ReferenceCitation: Hebuterne X, Lemann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault E, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23.

lead_sponsor: UCB Pharma

location_country: Germany Belgium France


acronym: SEPCELL

lead_sponsor: Tigenix S.A.U.

summary:
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.

ReferenceCitation: Laterre PF, Sanchez-Garcia M, van der Poll T, de la Rosa O, Cadogan KA, Lombardo E, Francois B. A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. BMC Pulm Med. 2020 Nov 25;20(1):309. doi: 10.1186/s12890-020-01324-2.

license: cc-by

license_normalized: cc-by

sponsor_collaborators: Centre Hospital Regional Universitaire de Limoges

sponsor_collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

sponsor_collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_facility: Centre Hospitalier Départemental les Oudairies

location_facility: Azienda Ospedaliera San'Andrea. UOC Anestesia e Terapia Intensiva

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Klaipėda Republican Hospital, The Pulmonology and Allergology Department

location_facility: St. Olavs Hospital, Department of Intensive care Clinical Immunology and Infectious Disease

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Centre Hospitalier Universitaire de Limoges - CHU Dupuytren

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Centre Hospitalier Departemental les Ouidairies

location_facility: Hospital Universitari de Tarragona Joan XXIII

title: A Phase Ib/IIa, Randomised, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess the Safety and Efficacy of Expanded Cx611 Allogeneic Adipose-derived Stem Cells (eASCs) for the Intravenous Treatment of Adult Patients With Severe Community-acquired Bacterial Pneumonia and Admitted to the Intensive Care Unit

location_country: Italy Lithuania Norway Belgium Spain France


title: A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

status: Unknown status

lead_sponsor: Bellus Health Inc. - a GSK company

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
France

location_facility: Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie

location_facility: Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge

location_facility: Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon

location_facility: Memory Clinic UMC St Radboud - Alzheimer Centre

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Kingshill Research Centre - Victoria Hospital

location_facility: Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg

location_facility: Dept. of Neurosciences TCR - University of Modena and Reggio Emilia

location_facility: Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària

location_facility: Hospital Universitario Ramón y Cajal - Unidad de Geriatria

location_facility: Glasgow Memory Clinic - Golden Jubilee National Hospital

location_facility: CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique

location_facility: Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center

location_facility: Memory Clinic University Hospital Gasthuisberg, Neurology Department

location_facility: Memory Assessment Centre - Moorgreen Hospital

location_facility: Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy

location_facility: Hôpital Hôtel Dieu - Consultation de Gérontologie

location_facility: Hospital Santa Creu i Sant Pau, Servicio de Neurología, Unitad de Memoria

location_facility: Neuropsychiatric Clinic - University Hospital MAS

location_facility: Research Institute for Care of Elderly - St Martin's Hospital

location_facility: Department of Neuroscience - Section of Neurology - University of Pisa

location_facility: Fundaciò ACE- Institut Català de Neurociències Aplicades

location_facility: Memory Clinic -Geriatric Centre - Academic Hospital

location_facility: Memory Centre, Polycliniques Brull, CHU de Liège

location_facility: Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz

location_facility: Wales College of Medicine - Llandough Hospital

location_facility: San Martino Hospital - Padiglione Specialita' Fondi

location_facility: Centre Mémoire de Ressources et de Recherche Hôpital Pasteur

location_facility: Hôpital Sainte Marguerite Service de neuro-geriatrie

location_facility: Hospital del Mar- Servicio de Neurologia

location_facility: Memory Clinic - Neuropsychology Center - University Hospital

location_facility: IRCCS Centro San Giovanni di Dio- Fatebenefratelli

location_facility: Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie

location_facility: University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion (Del) 5q[31] Cytogenetic Abnormality

summary: The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).

ReferenceCitation: Fenaux, Pierre, Giagounidis, Aristotle, Selleslag, Dominik, Beyne-Rauzy, Odile, Mufti, Ghulam J, Mittelman, Moshe, Muus, Petra, te Boekhorst, Peter, Sanz, Guillermo, del Canizo, Consuelo, Guerci-Bresler, Agnes, Schlegelberger, Brigitte, Aul, Carlo, Kreipe, Hans, Goehring, Gudrun, Knight, Robert, Francis, John, Fu, Tommy, Hellstrom-Lindberg, Eva. RBC Transfusion Independence and Safety Profile of Lenalidomide 5 or 10 mg in Pts with Low- or Int-1-Risk MDS with Del5q: Results From a Randomized Phase III Trial (MDS-004). ASH Annual Meeting Abstracts 2009 114: 944.

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D. L., Beyne-Rauzy, O., Mittelman, M., Muus, P., Knight, R. D., Fu, T., Hellstrom-Lindberg, E., The MDS-004 Len del(5q) Study Group. Safety of lenalidomide (LEN) from a randomized phase III trial (MDS-004) in low-/int-1-risk myelodysplastic syndromes (MDS) with a del(5q) abnormality. J Clin Oncol (Meeting Abstracts) 2010 28: 6598

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D., Knight, R., Fu, T., Hellström-Lindberg, E. Effect of baseline EPO and prior erythropoiesis stimulating agents on RBC transfusion independence in Low-/Int-1-Risk MDS with del 5q treated with lenalidomide: A randomized phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:125, abs. 0311.

ReferenceCitation: Brandenburg, N., Fu, T., Revicki, D., Knight, R., Muus, P., Fenaux, P. Impact of lenalidomide on health-related quality of life in patients with RBC transfusion-dependent low- or int-1-risk myelodysplastic syndromes with del 5q: a randomized Phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:127, abs. 0316

ReferenceCitation: Fenaux, P., Giagounidis, A., Beyne-Rauzy, O., Mufti, G., Mittelman, M., Muus, P., te Boekhorst, P., Sanz, G., Cazzola, M., Backstrom, J., Fu, T., Hellström-Lindberg, E. Prognostic Factors of Long-Term Outcomes In Low- or Int-1-Risk MDS with del5q Treated with Lenalidomide (LEN): Results From a Randomized Phase 3 Trial (MDS-004). Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 4027.

ReferenceCitation: Brandenburg, N., Yu, R., Revicki, D. Reliability and Validity of the FACT-AN In Patients with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 3827.

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mittelman M, Muus P, Nimer SD, Hellstrom-Lindberg E, Powell BL, Guerci-Bresler A, Sekeres MA, Deeg HJ, Del Canizo C, Greenberg PL, Shammo JM, Skikne B, Yu X, List AF. Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q). J Hematol Oncol. 2017 Jun 26;10(1):131. doi: 10.1186/s13045-017-0491-2.

ReferenceCitation: Saft L, Karimi M, Ghaderi M, Matolcsy A, Mufti GJ, Kulasekararaj A, Gohring G, Giagounidis A, Selleslag D, Muus P, Sanz G, Mittelman M, Bowen D, Porwit A, Fu T, Backstrom J, Fenaux P, MacBeth KJ, Hellstrom-Lindberg E. p53 protein expression independently predicts outcome in patients with lower-risk myelodysplastic syndromes with del(5q). Haematologica. 2014 Jun;99(6):1041-9. doi: 10.3324/haematol.2013.098103. Epub 2014 Mar 28.

repository_institution: Semmelweis University - Semmelweis University Repository

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Canizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lubbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellstrom-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.

ReferenceCitation: Gohring G, Giagounidis A, Busche G, Hofmann W, Kreipe HH, Fenaux P, Hellstrom-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.

lead_sponsor: Celgene Corporation

sponsor_collaborators:
Celgene Corporation
ICON Clinical Research

location_country:
Germany
Italy
France
United Kingdom
Sweden
Netherlands
Belgium
Spain
Israel

location_facility: University of Pavia Division of Hematology

location_facility: CHU Nancy Hematologie et Medecine interne

location_facility: SU/Sahlgrenska Section of Hematology & Coagulation

location_facility: CHU Nantes Hematologie et Medicine interne

location_facility: John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine

location_facility: CHU d'Angers Service des Maladies du Sang

location_facility: Centre Henri Becquerel Service d'Hematologie Clinique

location_facility: Department of Medicine University Hospital

location_facility: CHU Purpan, Place du Dr Baylac, Pavillon des Médecines

location_facility: Korolinska Institutet Department of Hematology

location_facility: Central Manchester and Manchester Children's University Hospitals NHS Trust

location_facility: Centre Jean Bernhard Service Onco-Hematologie

location_facility: University Hospital of Wales, Dept of Haematology

location_facility: CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines


title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

summary: Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.

status: Terminated

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
France


title: "Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery: A Multicenter Stepped-wedge, Cluster-randomized Clinical Trial

acronym: PEFLA

summary:
Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist that have been correlated with poor patient outcomes.

Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements.

To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country:
Germany
Belgium
United States
Canada
France

location_facility: University of California Los Angeles (UCLA)

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Centre hospitalier universitaire de NANCY

intervention_type: Procedure


title: Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

acronym: SIRCCA

summary: The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

lead_sponsor: Sirtex Medical

location_country:
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
France

location_facility: Hammersmith Hospital Imperial College Healthcare NHS Trust

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust


title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

summary: This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

ReferenceCitation: Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.

repository_institution: University of Melbourne - Minerva Access

publisher_dissemination: Wiley

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Italy
Germany
France


title: A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

summary: The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

ReferenceCitation: Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.

publisher_dissemination: SAGE Publications

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United Kingdom
United States
Spain
Greece
Puerto Rico
France

location_facility:
Local Institution
University Gastroenterology
Scti Research Foundation
Umass Memorial Medical Center
Metropolitan Research


title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

acronym: REFINE

summary: The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

lead_sponsor: Biogen

location_country: Germany Italy Belgium Spain France


title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

lead_sponsor: Enlivex Therapeutics Ltd.

location_country: France Netherlands Belgium Spain Greece Israel

location_facility: General University Hospital Gregorio Maranon

location_facility: University Hospital Arnau de Vilanova of Lleida

location_facility: University Hospital Joan XXIII of Tarragona


title: Is the Endoscopic Remission Evaluation, Using the CREDO 1 Index / Score in CD Patients in Clinical Remission at Baseline, Predictive of Sustained Clinical Remission Using a 2-year Follow up: a Multicenter Prospective Cohort Study

summary:
The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation, the predictive value of this remission evaluation needs to be tested in different settings to valorise its usefulness in clinical practice and in clinical trials.

CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2 years.

The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening period to include a patient is two weeks. Patients will be followed up to week 104.

primary_purpose: Other

ipd_sharing_description: ND

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

collaborators:
AbbVie
Biogen
Celgene
Gilead Sciences
Roche Pharma AG
Takeda

location_country: Belgium France

location_facility:
CHU Estaing - Clermont Ferrand
CHRU de Lille - Hôpital C. Huriez
Hôpital Saint Antoine
AZ Sint Lucas Gent
CHU Bordeaux - Hôpital Haut Lévêque
CHU Besançon - Hôpital Jean Minjoz
UZ Leuven
CHU Nancy - Hôpital Barbois
Leuven University Hospital
CHU Nantes - Hôtel Dieu
CHU de Nice - Hôpital de l'Archet 2
CHU Liège
APHP- Hopital BEAUJON
CHU Montpellier - Hôpital Saint Eloi

intervention_type: Diagnostic Test


title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)

acronym: TICOSPA

summary: This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

ReferenceCitation: Molto A, Lopez-Medina C, Van den Bosch FE, Boonen A, Webers C, Dernis E, van Gaalen FA, Soubrier M, Claudepierre P, Baillet A, Starmans-Kool M, Spoorenberg A, Jacques P, Carron P, Joos R, Lenaerts J, Gossec L, Pouplin S, Ruyssen-Witrand A, Sparsa L, van Tubergen A, van der Heijde D, Dougados M. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis. 2021 Nov;80(11):1436-1444. doi: 10.1136/annrheumdis-2020-219585. Epub 2021 May 6.

evidence: open (via page says license)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Leiden University - Leiden Repository

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_country: Netherlands Belgium France

location_facility:
Reumatologie Medizorg
Chu Grenoble
Hopital de La Pitie Salpetriere
Chu Gabriel Montpied
AZ Alma
Ch Mulhouse
UMCG
Chu Toulouse
Jessa Ziekenhuis
UZ GENT
LUMC
Hopital Lapeyronnie
Maastricht UMC
Hopital Cochin
Hopital Henri Mondor
Zuyderland MC
Chu Rouen
Chu Le Mans


title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period

summary: This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

ReferenceCitation: Wijsenbeek MS, Bendstrup E, Valenzuela C, Henry MT, Moor CC, Jouneau S, Fois AG, Moran-Mendoza O, Anees S, Mirt M, Bengus M, Gilberg F, Kirchgaessler KU, Vancheri C. Disease Behaviour During the Peri-Diagnostic Period in Patients with Suspected Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2021 Jul;38(7):4040-4056. doi: 10.1007/s12325-021-01790-y. Epub 2021 Jun 11.

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

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

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

ReferenceCitation: Wijsenbeek M, Bendstrup E, Valenzuela C, Henry MT, Moor C, Bengus M, Perjesi A, Gilberg F, Kirchgaessler KU, Vancheri C. Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2019 Jan;36(1):232-243. doi: 10.1007/s12325-018-0845-3. Epub 2018 Nov 30.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repository_institution: University College Cork - Cork Open Research Archive

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

location_country:
Ireland
Italy
Netherlands
Canada
Russian Federation
France

location_facility: Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare

location_facility: SBIH at Vladimir Region "Regional Clinical Hospital"

location_facility: Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia

location_facility: Hopital Arnaud De Villeneuve; Pneumologie A

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere

location_facility: SBI at Rostov Region "Regional Clinical Hospital #2"

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

location_facility: Kingston Health Sciences Centre; research Kingston General Health Research Institute

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia

location_facility: Ospedale Policlinico S. Matteo; S.C. Pneumologia

location_facility: SBIH "Chelyabinsk Regional Clinical Hospital"

location_facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale


lead_sponsor: GlaxoSmithKline

summary:
This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of belimumab/ rituximab co-administration and of belimumab monotherapy; and to evaluate whether either co-administration therapy or belimumab monotherapy has a substantive effect on disease activity.

This study will consist screening period, double blind treatment period, a general follow-up period and individualized follow-up period. Approximately 70 subjects will be recruited into the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24, interim analyses and sample size re-estimation will be conducted. The total number of subjects randomized may increase following sample size re-estimation up to a maximum of 120 recruited into the study.

Subjects in all arms will receive investigational product (IP) until Week 52 (completion of the treatment phase). All subjects will enter a 16-week general follow-up period after the Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the treatment phase visits prior to Week 52.

After completing the general follow-up period, subjects with cluster of differentiation (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of baseline, if baseline value was below lower limit of normal [LLN]) will enter an individualized safety follow-up phase and return to the clinic for visits every 12 weeks with monthly calls between visits to evaluate subjects for any serious adverse events (SAEs) related to IP or study participation, fatal SAEs, and designated adverse event of special interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and to check concomitant medications.

The total duration of participation of a subject in this study will be approximately up to a maximum of 2 years (i.e., up to Week 104).

ReferenceCitation: Raymond K, Maher S, Saucier CD, O'Connor M, Yarlas A, Kosinski M, Chen WH, Gairy K. Validation of the PROFAD-SSI-SF in Patients with Primary Sjogren's Syndrome with Organ Involvement: Results of Qualitative Interviews and Psychometric Analyses. Rheumatol Ther. 2023 Feb;10(1):95-115. doi: 10.1007/s40744-022-00493-2. Epub 2022 Oct 13.

title: A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Germany
Italy
Norway
Argentina
United Kingdom
Sweden
Netherlands
Spain
Canada
France


title: A Multicenter Randomized, Open-Label Phase II/III Study, To Compare The Efficacy Of NBTXR3, Implanted As Intratumor Injection And Activated By Radiotherapy, Versus Radiotherapy Alone In Patients With Locally Advanced Soft Tissue Sarcoma Of The Extremity And Trunk Wall

summary:
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.

ReferenceCitation: Bonvalot S, Rutkowski PL, Thariat J, Carrere S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baere T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Verges R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovee JVMG, Le Pechoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8. Erratum In: Lancet Oncol. 2019 Sep;20(9):e468.

lead_sponsor: Nanobiotix

sponsor_collaborators: Nanobiotix PharmaEngine

location_country:
Germany
Italy
Poland
Hungary
Hong Kong
Norway
Australia
Romania
Belgium
Spain
South Africa
Philippines
France

location_facility: Centre Regional de Lutte Contre Le Cancer Paul Lamarque

location_facility: Capital Region Cancer Service, Canberra Hospital

location_facility: Spitalului Universitar de Urgenta Militar Central

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: START MADRID, Hospital Universitario Madrid Norte Sanchinarro

location_facility: Medical Centre, Hungarian Defence Forces

location_facility: START MADRID, Hospital Fundacion Jimenez Diaz


title: Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

summary: The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.

lead_sponsor: sigma-tau i.f.r. S.p.A.

sponsor_collaborators:
sigma-tau i.f.r. S.p.A.
PRA Health Sciences

location_country: Germany Lithuania Poland Hungary Austria Latvia Spain France

location_facility: Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

location_facility: Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie

location_facility: Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

location_facility: Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

location_facility: Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

location_facility: Paula Stradina Clinical University Hospital Gastroenterology Centre

location_facility: Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

location_facility: Semmelweis Egyetem II. sz. Belgyógyászati Klinika

location_facility: Centro Medico Teknon Servicio de Aparato Disgestivo

location_facility: Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

location_facility: Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

location_facility: Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

location_facility: Hospital Universitario La Paz Servico de Gastroenterologia

location_facility: Fundación Hospital de Alcorcón Servicio de Gastroenterología

location_facility: Hospital Universitario Marques de Valdecilla Servicio de Digestivo

location_facility: Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

location_facility: Gastroenterologische Fachpraxis am Germania Campus

location_facility: Universitätsmedizin Mannheim II. Medizinische Klinik

location_facility: Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

location_facility: Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

location_facility: ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

location_facility: Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

location_facility: Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

location_facility: Corporació Sanitaria Parc Taulí Servicio de Digestivo

location_facility: Klaipedos jurininku ligonine Diagnostikos skyrius

location_facility: Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

location_facility: Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

location_facility: Hôpital Nord - Dept. of Gastroenterology

location_facility: Hôpital Rangueil Service de gastro-enterologie

location_facility: Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

location_facility: Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

location_facility: Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

location_facility: Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

location_facility: Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

location_facility: Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

location_facility: Hôpital Brabois Service de gastro-enterologie