title: European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS)

acronym: EPAD-LCS

summary:
Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease at its very earliest stages when in theory treatments are most likely to be successful in preventing further spread of the disease in the brain and causing dementia. The aim of EPAD programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide subjects for the EPAD trial as well as data to improve understanding of disease before dementia develops.

The Investigators will approach a broad range of people over the age of 50 who have previously taken part in various research studies and consented to being recontacted for further research. Participants will be asked questions to assess their memory and other cognitive function. The participants will also undertake a brain scan, provide a sample of spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may change in Alzheimer's disease. The Investigators will then follow these participants until December 2019 repeating these tests annually. This will be called the EPAD Longitudinal Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the Investigators understand more about what happens to people before dementia develops, and to help recruit people more quickly into the EPAD trials of new medications or other interventions expected to prevent dementia.

People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention studies to see if interventions can modify the probability of developing dementia or cognitive problems (this will be subject to separate ethics approval and consent). Together EPAD LCS and EPAD PoC make up the full EPAD Programme.

ReferenceCitation: Vermunt L, Muniz-Terrera G, Ter Meulen L, Veal C, Blennow K, Campbell A, Carrie I, Delrieu J, Fauria K, Huesa Rodriguez G, Ingala S, Jenkins N, Molinuevo JL, Ousset PJ, Porteous D, Prins ND, Solomon A, Tom BD, Zetterberg H, Zwan M, Ritchie CW, Scheltens P, Luscan G, Brookes AJ, Visser PJ; IMI-EPAD collaborators. Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings. Alzheimers Res Ther. 2020 Jan 6;12(1):8. doi: 10.1186/s13195-019-0576-y.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Solomon A, Kivipelto M, Molinuevo JL, Tom B, Ritchie CW; EPAD Consortium. European Prevention of Alzheimer's Dementia Longitudinal Cohort Study (EPAD LCS): study protocol. BMJ Open. 2019 Feb 19;8(12):e021017. doi: 10.1136/bmjopen-2017-021017.

publisher_dissemination: British Medical Journal

ipd_sharing_description: EPAD is an Innovative Medicines Initiative (IMI) project with open access to data.

lead_sponsor: University of Edinburgh

sponsor_collaborators:
University of Edinburgh
Innovative Medicines Initiative

location_country:
Italy
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
Greece
France

location_facility: CHU Gui de Chauliac Département de Neurologie

location_facility: Greater Manchester Clinical Research Network

location_facility: Unidade Deterioro Cognitivo, Servicio de Neurologia, Hospital Universitario

location_facility: University of Cambridge; Department of Clinical Neurosciences

location_facility: VUmc Alzheimer Center and Alzheimer Research Center

location_facility: Hôpital Universitaire de la Pitié Salpêtrière

location_facility: Toulouse University Hospital / Gérontopôle-Research Clinical Center

location_facility: Univerita di Perugia, Centro Disturbi della Memoria, Clinica Neurologica

location_facility: Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal

location_facility: Cliniques Universitaires Saint-Luc ASBL, Neurology Department

location_facility: Glasgow Clinical Research Facility; NHS Greater Glasgow and Clyde

location_facility: CMRR du CHRU de Lille Hôpital Roger Salengro

location_facility: University of Oxford, Department of Psychiatry

location_facility: IRCCS San Giovanni di Dio - Fatebenefratelli

location_facility: Fundacion ACE, Institut Catala de Neurocienies Aplicades

location_facility: Fundacion CITA-alzheimer Fundazioa, Center for Research and Advanced Therapies

location_facility: Neuropsychiatric Research Unit, Sahlgrenska University Hoospital

location_facility: CMRR- Hôpital Laënnec Nord - CIC Neurologie / CHU de Nantes

location_facility: Centre Leenaards de la memoire- CHUV, Department of Neurosciences cliniques

location_facility: National and Kapodistran, University of Athens, 1st Department of Neurology, Aeginition Hospital

location_facility: University of Edinburgh, Centre for Dementia Prevention


title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

acronym: EBC MAIN

summary: The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ipd_sharing: No

lead_sponsor: European Cardiovascular Research Center

sponsor_collaborators:
European Cardiovascular Research Center
Medtronic

location_country:
Germany
Italy
United Kingdom
Denmark
Latvia
Spain
Serbia
France

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: University of Catania - Ferrarotto Hospital

location_facility: Pauls Stradins Clinical University Hospital

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

type: Other Identifier

title: An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985 (Vanucizumab), and in Combination With Atezolizumab, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country: Spain Belgium France

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Centre Leon Berard; Departement Oncologie Medicale

intervention_type: Biological

status_simplified: Completed


intervention_type: Drug

summary: Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years

ReferenceCitation: Bertini E, Dessaud E, Mercuri E, Muntoni F, Kirschner J, Reid C, Lusakowska A, Comi GP, Cuisset JM, Abitbol JL, Scherrer B, Ducray PS, Buchbjerg J, Vianna E, van der Pol WL, Vuillerot C, Blaettler T, Fontoura P; Olesoxime SMA Phase 2 Study Investigators. Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jul;16(7):513-522. doi: 10.1016/S1474-4422(17)30085-6. Epub 2017 Apr 28. Erratum In: Lancet Neurol. 2017 Aug;16(8):584.

oa_host_type: repository

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

host_type: repository

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

version: submittedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;air.unimi.it

unpaywall_oa_status: green

publisher_dissemination: Elsevier

sponsor_collaborators: Association Française contre les Myopathies (AFM), Paris

location_facility: Bambino Gesu' Research Children's Hospital

location_facility: Policlinico Universitario "Agostino Gemelli",

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

title: Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.

source: euctr

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
France


title: A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

summary: The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
Belgium
France

location_facility: Prof. Claude Desnuelle, Hopital 1-Archet 1

location_facility: Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

location_facility: Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm

location_facility: Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

location_facility: Prof. Philippe Couratier, Hopital Duruytren

location_facility: Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: Dr. Chris McDermott, Royal Hallamshire Hospital

location_facility: Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil

location_facility: Prof. Douglas Mitchell, Royal Preston Hospital

location_facility: Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

location_facility: Prof. Vincent Meininger, Hopital LaPitie Salpetriere

location_facility: Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz

location_facility: Prof. Nigel Leigh, Academic Neuroscience Centre

location_facility: Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Prof. Leonard H Van Den Berg, University Medical Center Utrecht

location_facility: Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

location_facility: Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette


title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.

ReferenceCitation: Onady GM, Stolfi A. Drug treatments for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD004730. doi: 10.1002/14651858.CD004730.pub5.

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Wiley

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Staab D, Hebestreit A, Naehrlich L, Nickolay T, Prinz N, Holl RW; CFRD Study Group. Repaglinide versus insulin for newly diagnosed diabetes in patients with cystic fibrosis: a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Feb;6(2):114-121. doi: 10.1016/S2213-8587(17)30400-X. Epub 2017 Dec 5. Erratum In: Lancet Diabetes Endocrinol. 2019 Apr;7(4):e4.

oa_host_type: closed

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Kronfeld K, Honer M, Holl RW; CFRD Study group. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus. BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

publisher_dissemination: Springer

ReferenceCitation: Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Mukoviszidose Institut gGmbH

sponsor_collaborators:
Mukoviszidose Institut gGmbH
Novo Nordisk A/S
Mucoviscidose-ABCF2
Assistance Publique - Hôpitaux de Paris

location_country: Germany Italy Austria France

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Klinik für Kinder und Jugendliche Erlangen

location_facility: Universitätsklinik für Kinder- und Jugendmedizin

location_facility: APHP, CRCM pediatrique, Hopital Robert Debre

location_facility: Klinik und Poliklinik für allgemeine Kinderheilkunde

location_facility: Klikum der Universität Heidelberg, Kinderklinik

location_facility: CRCM adultes, Centre Hospitalier Lyon Sud

location_facility: Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum

location_facility: Medizinische Hochschule Hannover, Abt. Kinderheilkunde

location_facility: Med. Klinik II, Allergologie und Pneumologie


title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

summary: Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

primary_purpose: Prevention

ReferenceCitation: Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Sweden
Netherlands
Spain
Estonia
Russian Federation
France


title: Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

ReferenceType: result

ReferenceCitation: Kruit WH, Suciu S, Dreno B, et al.: Immunization with recombinant MAGE-A3 protein combined with adjuvant systems AS15 or AS02B in patients with unresectable and progressive metastatic cutaneous melanoma: A randomized open-label phase II study of the EORTC Melanoma Group (16032- 18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9065, 2008.

ReferenceCitation: Louahed J, Gruselle O, Gaulis S, et al.: Expression of defined genes identified by pretreatment tumor profiling: association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032-18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9045, 2008.

ReferenceCitation: Kruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol. 2013 Jul 1;31(19):2413-20. doi: 10.1200/JCO.2012.43.7111. Epub 2013 May 28.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

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

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Regional et Universitaire de Lille


title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

summary:
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.

ReferenceCitation: Ray-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065.

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

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Meyerstein Institute of Oncology at University College of London Hospitals

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Royal Marsden NHS Foundation Trust - London


title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

acronym: EUROCOV

summary: This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

publisher_dissemination: American Medical Association

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

oa_colors: green other

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum In: JAMA. 2020 Apr 21;323(15):1510.

lead_sponsor: European Society for Emergency Medicine (EUSEM) Research Network

location_country: Finland Italy Greece Croatia France


title: Wright Foot & Ankle Post-Market Observational Study

summary: WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

status: Terminated

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Stryker Trauma GmbH

location_country:
United States
United Kingdom
Germany
France

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust


title: Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

summary: The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

ReferenceCitation: Bagot M, Porcu P, Marie-Cardine A, Battistella M, William BM, Vermeer M, Whittaker S, Rotolo F, Ram-Wolff C, Khodadoust MS, Bensussan A, Paturel C, Bonnafous C, Sicard H, Azim HA Jr, Kim YH. IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial. Lancet Oncol. 2019 Aug;20(8):1160-1170. doi: 10.1016/S1470-2045(19)30320-1. Epub 2019 Jun 25.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repositories_concat: HAL

lead_sponsor: Innate Pharma

location_country:
United States
United Kingdom
Netherlands
France

location_facility:
Hôpital Saint-Louis
Ohio State University
Guy's Hospital
Leiden University Medical Center
Stanford Cancer Center


lead_sponsor: CymaBay Therapeutics, Inc.

summary: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).

location_facility: Endocrinologie metabolisme et prevention cardiovasulaire, Institut E3M et IHU cardiometabolique (ICAN), Hôpital Pitié Salpêtrière

title: A 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

location_country: Canada Netherlands Norway France


title: Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

summary:
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

Investigate whether physicians have received any educational material related to Diane-35 or its generics
Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
Contraindications relevant to thromboembolism
Risk factors for thromboembolism
Signs and symptoms of thromboembolism

time_perspective: Other

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
RTI Health Solutions

location_country:
Netherlands
Austria
Spain
Czech Republic
France


title: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

acronym: CHRA

summary: This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.

status: Active, not recruiting

lead_sponsor: Smith & Nephew, Inc.

location_country:
United Kingdom
Australia
Sweden
France

location_facility:
Danderyd Hospital
Barwon Health
Institut Nices
Wrightington Hospital
Brisbane Hand & Upper Limb Clinic

status_simplified: Ongoing


title: A Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Biological Activity of ATYR1940 in Adult Patients With Molecularly Defined Genetic Muscular Dystrophies

summary: The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies

lead_sponsor: aTyr Pharma, Inc.

location_country:
United States
Italy
Netherlands
France


title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

summary: This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.

ReferenceCitation: Yap TA, Winter JN, Giulino-Roth L, Longley J, Lopez J, Michot JM, Leonard JP, Ribrag V, McCabe MT, Creasy CL, Stern M, Pene Dumitrescu T, Wang X, Frey S, Carver J, Horner T, Oh C, Khaled A, Dhar A, Johnson PWM. Phase I Study of the Novel Enhancer of Zeste Homolog 2 (EZH2) Inhibitor GSK2816126 in Patients with Advanced Hematologic and Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7331-7339. doi: 10.1158/1078-0432.CCR-18-4121. Epub 2019 Aug 30.

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

location_country:
United States
United Kingdom
France


title: A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy

summary: Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination

ReferenceCitation: Rodon J, Curigliano G, Delord JP, Harb W, Azaro A, Han Y, Wilke C, Donnet V, Sellami D, Beck T. A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget. 2018 Aug 3;9(60):31709-31718. doi: 10.18632/oncotarget.25854. eCollection 2018 Aug 3.

evidence: open (via page says license)

repositories_concat: PubMed Central;air.unimi.it

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher_dissemination: Impact Journals, LLC

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Italy
Spain
France

location_facility:
Horizon Oncology Center BioAdvance
Novartis Investigative Site
Highlands Oncology Group


acronym: Determination of MTD of volasertib  in paediatric patients with advanced cancer

lead_sponsor: Boehringer Ingelheim

summary: The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients

location_facility:
INS Curie
Universitätsklinikum Köln (AöR)
University Hospital Motol
UNIV UZ Gent
Osp. Pediatrico Bambin Gesù

title: Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known

location_country: Germany Italy Belgium Czechia France


title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

summary: This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.

location_facility: Dana Farber Cancer Institute DFCI - Brookline


title: Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors

summary:
Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR566658

Secondary Objectives:

To characterize the safety profile of SAR566658
To evaluate the pharmacokinetic profile of SAR566658
To assess the potential immunogenicity of SAR566658
To assess preliminary antitumor activity
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
To assess safety in the alternative schedules of SAR566658 administration

lead_sponsor: Sanofi

location_country:
United States
Spain
France

location_facility:
Investigational Site Number 724001
Investigational Site Number 724002
Investigational Site Number 250001
Investigational Site Number 840002
Investigational Site Number 840001


title: A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo

summary: Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.

primary_purpose: Other

lead_sponsor: Pfizer

location_country:
United Kingdom
Austria
Belgium
France


title: Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
Switzerland
France

location_facility: University Hospital of Basel, Clinic of Pneumology

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Washington University School of Medicine


title: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

summary:
Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

ReferenceCitation: Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.

ReferenceCitation: Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.

lead_sponsor: Deep Breeze

location_country:
United States
Japan
Germany
France

location_facility: National Jewish Medical and Research Center

intervention_type: Other


title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

acronym: SELECT-AMI

summary: An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).

lead_sponsor: Jozef Bartunek

sponsor_collaborators:
Jozef Bartunek
King's College London

location_facility:
CHU ST-Pierre
Catharina Ziekenhuis
King's College University Hospital
OLVZ Aalst
Hôpital Cardiologique


title: The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg

acronym: DESTINY

summary: The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.

ReferenceCitation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

lead_sponsor: Flanders Medical Research Program

location_country: Germany Belgium France

location_facility:
Herzzentrum
Polyclinique Les Fleurs
Herz-zentrum Bad Krozingen
Imelda Hospital
AZ Sint-Blasius


title: Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

summary:
The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

lead_sponsor: LEO Pharma

location_country:
Germany
United Kingdom
Denmark
Canada
France

location_facility: Hørsholm Hospital, Dermatological Department

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

location_facility: Monklands Hospital, Department of Dermatology


title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

location_country:
United States
Italy
Germany
France


title: The Nosology and Etiology of Leukodystrophies of Unknown Cause

summary:
Leukodystrophy is a disease of the white matter of the brain. White matter is the portion of the brain responsible for conducting electrical impulses from one area of the brain to the other. Insulating cells called myelin cover the brain and nerve cells in the white matter. If myelin becomes damaged electrical information cannot be transferred properly.

Many patients suffering from leukodystrophies do not fit the description of any of the defined types of leukodystrophies and are therefore considered to have a leukodystrophy of unknown cause.

The purpose of this study is to define groups of patients with leukodystrophies and to work toward finding the cause of the disorders. In order to do this, researchers will analyze patients with leukodystrophies of unknown causes. Patients will undergo clinical, neurophysiologic, biochemical, and genetic examinations and tests.

Researchers believe that by studying these patients and their disorders they will be able to better understand the causes of myelin destruction, and eventually lead to effective treatments for these disorders.

ReferenceCitation: Aicardi J. The inherited leukodystrophies: a clinical overview. J Inherit Metab Dis. 1993;16(4):733-43. doi: 10.1007/BF00711905.

ReferenceCitation: Schiffmann R, Moller JR, Trapp BD, Shih HH, Farrer RG, Katz DA, Alger JR, Parker CC, Hauer PE, Kaneski CR, et al. Childhood ataxia with diffuse central nervous system hypomyelination. Ann Neurol. 1994 Mar;35(3):331-40. doi: 10.1002/ana.410350314.

ReferenceCitation: Schiffmann R, Tedeschi G, Kinkel RP, Trapp BD, Frank JA, Kaneski CR, Brady RO, Barton NW, Nelson L, Yanovski JA. Leukodystrophy in patients with ovarian dysgenesis. Ann Neurol. 1997 May;41(5):654-61. doi: 10.1002/ana.410410515.

ReferenceCitation: McNeill N, Nasca A, Reyes A, Lemoine B, Cantarel B, Vanderver A, Schiffmann R, Ghezzi D. Functionally pathogenic EARS2 variants in vitro may not manifest a phenotype in vivo. Neurol Genet. 2017 Jul 14;3(4):e162. doi: 10.1212/NXG.0000000000000162. eCollection 2017 Aug.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

location_country:
United States
Israel
Netherlands
France

location_facility: Academiseh Ziuekenhuis Vrije Universiteit

location_facility: Institut National de la Sante' et de la Recherche Medicale


title: A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults

acronym: CaboCombo

summary: The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

status: Recruiting

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country:
Italy
United Kingdom
Belgium
Korea, Republic of
Saudi Arabia
Greece
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Finisterien de Radiotherapie et d'Oncologie

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Centre Hospitalier intercommunal Saint Raphaël Frejus

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

location_facility: Institut Ste Catherine - Institut du Cancer Avignon Provence

location_facility: Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz

location_facility: Groupe Hospitalier Saint-André (Bordeaux)

location_facility: Centre de Lutte Contre le Cancer Jean PERRIN

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: P.O Santa Maria delle Grazie, ASL Napoli 2 Nord

location_facility: PU A.Gemelli, Università Cattolica del Sacro Cuore

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ospedale "Santa Maria delle Croci" di Ravenna

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Centre d'Urologie Site Médipole - Centre Catalan d'Urologie

location_facility: IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Papageorgiou General Hosp of Thessaloniki

location_facility: Centre Hospitalier Universitaire (CHU) de Angers

location_facility: Centre Hospitalier Universitaire (CHU) Henri Mondor

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Edinburgh Cancer Centre, Western General Hospital

location_facility: Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori

location_facility: Groupe Hospitalier De La Rochelle - Ré - Aunis


acronym: TEDOVA

lead_sponsor: ARCAGY/ GINECO GROUP

summary:
The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible).

Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).

sponsor_collaborators:
ARCAGY/ GINECO GROUP
OSE Immunotherapeutics
Merck Sharp & Dohme LLC

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: CHU Grenoble-Alpes - Site Nord (La Tronche)

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Centre d'Oncologie et de Radiothérapie 37

location_facility: CHU de Saint-Etienne - Pôle de Cancérologie

title: Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI®) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy


title: TRI-FR : Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders

acronym: TRI-FR

summary:
Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders.

This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk.

The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention.

A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery.

The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients.

For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality ~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.

ReferenceCitation: Donal E, Leurent G, Iung B. Are We Right to Believe in the Value of Transcatheter Treatment of Secondary Tricuspid Regurgitation? J Am Coll Cardiol. 2021 Jan 26;77(3):240-242. doi: 10.1016/j.jacc.2020.11.037. No abstract available.

lead_sponsor: Rennes University Hospital

location_country: Belgium France

location_facility: CHU Bordeaux - Hôpital Cardiologique du Haut-Lévêque

location_facility: CHU Nantes - Hôtel Dieu et Hôpital Nord Laennec

location_facility: Hospices Civils de Lyon Groupement Hospitalier EST

location_facility: Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

intervention_type: Procedure

lead_sponsor_type: academique

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: TRI-FR

titre: Etude multicentrique randomisée évaluant le système de clip percutané tricuspide (TRICLIP ) dans le traitement des insuffisances tricuspides secondaires

discipline_principale: cardiology

nom_porteur: DONAL

prenom_porteur: Erwan


acronym: SOREGATT

lead_sponsor: UNICANCER

summary: A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer

location_facility: APHP - Hôpital Européen Georges Pompidou

location_facility: Association Hôpital Saint Joseph de Marseille

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

title: A Randomized, Phase II Study Comparing the Sequences of Regorafenib and Trifluridine/Tipiracil, After Failure of Standard Therapies in Patients With Metastatic Colorectal Cancer


title: Evaluation of the Impact of the Update Multiple Myeloma Criteria on the Natural History of Smoldering Myeloma in Order to Establish New Recommendations About Follow-up and Prognostic Evaluation of Smoldering Myeloma (CARRISMM)

acronym: CARRISMM

summary: This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

primary_purpose: Screening

lead_sponsor: Intergroupe Francophone du Myelome

location_country: Monaco Belgium France

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Centre de Recherche Clinique / GHT des Landes

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut Bergonié - Pavillon Saint Genès - 1er étage

location_facility: CH Bretagne Atlantique Vannes et Auray - P. Chubert

location_facility: CHV André Mignot - Université de Versailles

location_facility: Centre Hospitalier de Quimper Cornouaille

location_facility: CHU Carémeau, Institut de Cancérologie du Guard

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: CHRU Hôpital Bretonneau - Centre Henry Kaplan

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie


title: Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2

summary: The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft

primary_purpose: Diagnostic

ReferenceCitation: Rubio MT, Bouillie M, Bouazza N, Coman T, Trebeden-Negre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4- invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
SATT
SNC Graft Versus Host Disease
Imagine Institute
Axonal-Biostatem
CERBA laboratory

location_facility: Institut Universitaire du Cancer de Toulouse

intervention_type: Diagnostic Test


title: Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

acronym: NURSIE

summary:
Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

lead_sponsor: French Society for Intensive Care

location_country: Luxembourg Switzerland Belgium France

location_facility:
CH de la Dracénie
CHU Charleroi
CHU Toulouse
CHU Nimes
CHU Nice
CHU Marseille
CHU Ambroise Paré
CHR Orléans
Centre Hospitalier Emile Mayrisch
Hopital Civil Marie Curie
CHU Nantes
CH Sud Francilien
Hopital Europeen George Pompidou
CH Andre Migniot
Hopital Jeanne De Flandre
CH de Dax
CHU Necker Enfant Malade
Hopital de Bruxelles
CHRU Lille
CHU La Pitié Salpétrière
CHU Strasbourg
CHU Lariboisière
Hopital de la Tour
CHU Besançon
CH Valence
CHI Lucie & Raymond Aubrac


title: A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.

summary: This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut Jules Bordet - Centre des tumeurs de l'ULB


title: A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)

acronym: IRMYG

summary: Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country: Algeria Lebanon Belgium France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire d'Angers


title: A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP

acronym: Epi-RCHOP

summary:
Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21.

Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients :

DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab

ReferenceCitation: Sarkozy C, Morschhauser F, Dubois S, Molina T, Michot JM, Cullieres-Dartigues P, Suttle B, Karlin L, Le Gouill S, Picquenot JM, Dubois R, Tilly H, Herbaux C, Jardin F, Salles G, Ribrag V. A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features. Clin Cancer Res. 2020 Jul 1;26(13):3145-3153. doi: 10.1158/1078-0432.CCR-19-3741. Epub 2020 Mar 2.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

acronym: SOURCE 3

summary:
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

ReferenceCitation: Tarantini G, Nai Fovino L, Le Prince P, Darremont O, Urena M, Bartorelli AL, Vincent F, Hovorka T, Alcala Navarro Y, Dumonteil N, Ohlmann P, Wendler O. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020 Jul;13(7):e008972. doi: 10.1161/CIRCINTERVENTIONS.120.008972. Epub 2020 Jun 25.

oa_colors: green hybrid

ReferenceCitation: Fernandez-Santos S, Theron A, Pibarot P, Collart F, Gilard M, Urena M, Hovorka T, Kahlert P, Zamorano Gomez JL. Valve hemodynamic performance and myocardial strain after implantation of a third-generation, balloon-expandable, transcatheter aortic valve. Cardiol J. 2020;27(6):789-796. doi: 10.5603/CJ.a2019.0049. Epub 2019 May 20.

publisher_dissemination: VM Media SP. zo.o VM Group SK

ReferenceCitation: Tarantini G, Lefevre T, Terkelsen CJ, Frerker C, Ohlmann P, Mojoli M, Eltchaninoff H, Pinaud F, Redwood S, Windecker S. One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk. Circ Cardiovasc Interv. 2019 Jan;12(1):e006724. doi: 10.1161/CIRCINTERVENTIONS.118.006724.

ReferenceCitation: Frank D, Abdel-Wahab M, Gilard M, Digne F, Souteyrand G, Caussin C, Collart F, Letocart V, Wohrle J, Kuhn C, Hovorka T, Baumgartner H. Characteristics and outcomes of patients </= 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry. Clin Res Cardiol. 2019 Jul;108(7):763-771. doi: 10.1007/s00392-018-1404-2. Epub 2018 Dec 14.

publisher_dissemination: Springer-Nature

ReferenceCitation: Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Neumann FJ, Tarantini G, Zamorano JL, Vahanian A. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017 Sep 21;38(36):2717-2726. doi: 10.1093/eurheartj/ehx294.

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

repository_normalized: dnet

repositories:
PubMed Central
dnet
www.research.unipd.it

lead_sponsor: Edwards Lifesciences

location_country:
Finland
Italy
Germany
Slovakia
United Kingdom
Denmark
Netherlands
Switzerland
Spain
France

location_facility: Centre Cardiologique du Nord - Saint-Denis

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen

location_facility: Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson

location_facility: Azienda A.R.N.A.S. Ospedale Civico di Palermo

location_facility: Narodny ustav srdcovych a cievnych chorob, a. s.

location_facility: Evangelisches Klinikum Niederrhein Herzzentrum Duisburg

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Staedtisches Klinikum Karlsruhe GmbH (SKK)

location_facility: Institut Hospitalier Jacques Cartier Massy

location_facility: Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG


summary: The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Medicament


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

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

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

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

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

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

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

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

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;sdu.dk

lead_sponsor: Hospices Civils de Lyon

location_country: Finland Italy Denmark Sweden Canada France

location_facility: Service d'Oncologie Médicale - Institut Paoli Calmettes

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

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

location_facility: Service d'Oncologie - Centre Hospitalier de Chambéry

location_facility: Service d'Onco-Hématologie - Hôpital Fleyriat

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

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

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

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

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

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

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

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

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

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

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

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

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

location_facility: Service de cancérologie clinique - Institut Sainte-Catherine

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

location_facility: Service d'Oncologie - Centre Hospitalier Alpes Leman

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

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

location_facility: Servide d'Oncologie Médicale - Institut Jean Godinot

location_facility: Service d'Oncologie Médicale - ICO Paul Papin

location_facility: Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan

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

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

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

location_facility: Service d'Oncologie Médicale - Hôpital des Diaconesses

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

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

location_facility: Servide d'Oncologie Médicale - Centre Jean Perrin

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

location_facility: Service d'Oncologie multidisciplinaire - Hôpital Nord

location_facility: service d'Oncologie Médicale - Centre Hospitalier Broussais

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

location_facility: Service d'Oncologie Radiothérapie - Clinique de Valdegour

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

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

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

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

location_facility: Service d'Oncologie Médicale - Institut Claudius Regaud

location_facility: Centro di Riferimento Oncologico - CRO,IRCCS

location_facility: Service d'Oncologie Médicale - Centre Paul Strauss

location_facility: Service d'Oncologie Médicale - Institut Bergonié

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

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

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

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

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

location_facility: Servide d'Oncologie Médicale - Hôpital Jean Minjoz

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

location_facility: Service de Chimiothérapie - Centre Catherine de Sienne


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

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

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

evidence: open (via free article)

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

publisher_dissemination: American Society of Hematology

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre hospitalier Chalon sur Saone William Morey


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

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

lead_sponsor: Coloplast A/S

location_country: Denmark France

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


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

acronym: CAPSCDEIS

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

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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


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

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

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

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

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

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

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

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


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

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

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

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

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

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

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

Primary endpoint: 28-day mortality.

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

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: University of Versailles

sponsor_collaborators:
University of Versailles
Assistance Publique - Hôpitaux de Paris

location_country:
United Kingdom
Tunisia
Belgium
Canada
France

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


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

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

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

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

lead_sponsor: G. d'Annunzio University

location_country:
Germany
Italy
Netherlands
Austria
United States
Spain
Canada
France

location_facility: Hospital Universitario Insular de Gran Canarias

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

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

location_facility: Hospital Nuestra Sra del Prado Talavera de la Reina

location_facility: Division of Hematology, University of Ottawa

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Montpellier et clinique du parc a Castelnau le nez

location_facility: Clinical Division of Haematology, Department of Medicine I

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)

location_facility: National Cancer Institute - Antonie van Leeuwenhoek hospital

location_facility: University hospital Centra La Cavale Blanche

location_facility: Malattie Cardiovascolari e Nefrourologiche


title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

summary:
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

lead_sponsor: Forest Laboratories

location_country:
Germany
Italy
Poland
Hungary
Netherlands
Belgium
Spain
Russian Federation
France

location_facility: Klinkum Lippe-Detmold Med. Klink II-Kardiologie

location_facility: Myocardial Infarction Department St Petersburg Hospital, No. 28

location_facility: Instytut Kardiologii CMUJ Klinika Choroby Wiencowej

location_facility: County Hospital, Dept. of Internal Medicine I.

location_facility: Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii

location_facility: Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou

location_facility: Fundacion Jimenez Diaz Cardiology Service

location_facility: Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum

location_facility: Franz-Volhard-Klinik Abteilung fur Elektrophysiologie

location_facility: Service de Cardiologie A Hopital Cardiologique

location_facility: Cardiology Department Moscow Sechenov Medical Academy

location_facility: Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51

location_facility: Osp. Civile di Piacenza-Div. di Cardiologia

location_facility: Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia

location_facility: Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie

location_facility: Myocardial Infarction Department St Petersburg Hodpital, No. 29

location_facility: Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie

location_facility: Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11

location_facility: Cardiology Department, State Research Institute

location_facility: National Institiute of Pulmonology, Dept. of Cardiology

location_facility: Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1

location_facility: Oddizial Kardiologii Szpital Wojewodzki nr 2

location_facility: Department of Internal Medicine (DIMI) University of Genova

location_facility: Oddizial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Department of Cardiology No. 3 Pokrovskiy Hospital

location_facility: S. Paolo Hospital University of Milan Department of Cardiology

location_facility: Academisch Ziekenhuis Maastricht Afdeling Cardiologie

location_facility: I Klinika Chorob Serca Instytut Kardiologii AM

location_facility: Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies

location_facility: Service de Cardiologie Hopital Lariboisiere

location_facility: Gornoslaskie Centrum Medyczne I Klinika Kardiologii

location_facility: Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny

location_facility: Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela

location_facility: Medizinische Klinik und Poliklinik Innere Medizin C

location_facility: Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii

location_facility: Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie

location_facility: Department Cardiology Canisius Wilhelmina Hospital

location_facility: Universitate zu Koeln Klinik III fur Innere Medizin

location_facility: Cardiology Unit University of Naples "Frederico II"

location_facility: Cardiology Division Hospital "Santa Croce e Carle"

location_facility: Reinhard-Nieter-Krankenhaus Med. Klinik 1

location_facility: Cardiology Department St. Petersburg State Pavlov Medical University

location_facility: Wojewodzki Szpital Zespolony Oddzial Kardilolgii

location_facility: Gottsegen Gyorgy National Institute of Cardiology

location_facility: Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie

location_facility: Klinika Kardiologii IV Wojskowy Szpital Kliniczny

location_facility: Myocardial Infarction Department St Elizabeth Hospital

location_facility: Medizinische Universitats-und Ploiklinik Innere Medizin 3

location_facility: Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie

location_facility: Servizio di Cardiologia Azienda Ospedaliera S. Anna

location_facility: Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia

location_facility: Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva

location_facility: Klinik am See REHA-Zentrum fur Herz und Kreislauf

location_facility: Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie

location_facility: Szent Imre Hospital, Dept. of Internal MedicineI.

location_facility: Ospedale Civile Umberto I Cardiology Division

location_facility: Hospital Valle de Hebron Servicio de Cardiologia

location_facility: Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48

location_facility: Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute

location_facility: Semmelweis University, Dept. of Internal Medicine III.

location_facility: Hospital Civil De Basurto Cardiology Service

location_facility: Radomski Szpital Specjalistyczny Oddzial Kardiologii

location_facility: County Hospital, Dept. of Internal Medicine

location_facility: Hospital Universitario De Getafe Cardiology Service

location_facility: Hospital Clinico Universitario San Carlos Servicio de Cardiologia

location_facility: Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29

location_facility: Department of Emergency Cardiology Russian Cardiology Research Centre

location_facility: Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie

location_facility: Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64

location_facility: Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I

location_facility: Hospital Universitari San Juan Servicio di Cardiologia

location_facility: St Elisabeth Ziekenhuis Afdeling Cardiologie

location_facility: Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4

location_facility: Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii

location_facility: Cardiology Department St Petersburg Hospital No. 2

location_facility: Service de Cardiologie Hopital Saint Philibert

location_facility: Kerckhhoff-Klinik Abteilung Klinische Pharmakologie

location_facility: Divisione di Cardiologia Ospedale Civile

location_facility: Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan

location_facility: Oddzial Kardiologii Wojewodzkie Centrum Medyczne

location_facility: Service de cardiologie Hopitaux de Brabois/CHRU Nancy

location_facility: Oddzial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Cardiology Department, Moscow Clinical Hospital No. 59

location_facility: Cardiology Department Alexandrovskiy Hospital

location_facility: Centre Hospitalier General Hospital De Girac

location_facility: Toldi Ferenc Hospital, Dept. of Internal Medicine II.

location_facility: Cardiology Department, St Petersburg Hospital, No. 15

location_facility: Medizinische Klinik und Poliklnik Innere Medizin C

location_facility: Cardiologie CHRU St Etienne/Hopital Nord

location_facility: Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50

location_facility: Clinique Generale Saint Jean Service de cardiologie

location_facility: Cardilolgie Hopital Guillaume et Rene Laennec

location_facility: Erzgebirgskrankenhaus Klinik fur Innere Medizin

location_facility: Cardiovascular Disease Unit University of Bari-Ploiclinico

location_facility: Markusovszky Hospital, Dept. of Internal Medicine III.


title: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.

acronym: FIRST

summary:
The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms.

All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study.

The patient's inclusion and follow up in the study will occur as part of their usual standard of care.

lead_sponsor: Balt Extrusion

location_country: Germany Italy Israel Netherlands Austria Belgium Spain Croatia France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Centre Hospitalier Universitaire Clermont Ferrand

location_facility: Hospices Civils de Lyon - Hôpital Neurologique