title: A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients With Low On-treatment HBsAg Level

acronym: SALMONS

summary: The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.

study_start_date_type: Anticipated

primary_purpose: Other

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country: Germany Italy Portugal Denmark Spain Greece France

location_facility: Centro Hospitalar de Trás os Montes e Alto Douro- Vila Real

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: Azienda Ospedaliero Universitaria Pisana

intervention_type: Other


title: A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)

summary: This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Vir Biotechnology, Inc.

location_country:
Germany
Italy
Moldova, Republic of
New Zealand
United Kingdom
Romania
Netherlands
Bulgaria
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up

summary: The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.

lead_sponsor: Cousin Biotech

location_country: Spain Belgium France

location_facility: Hospital Viamed Santa Ángela de la Cruz en Sevilla

location_facility: Hôpital Lyon Sud, Hospices Civils de Lyon

intervention_type: Device


type: EudraCT Number

type: Other Identifier

title: A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients

summary: The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United Kingdom
Spain
Turkey
Taiwan
Czechia
Canada
France

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano

location_facility: Istanbul University Cerrahpasa Medical Faculty


title: A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide and Tislelizumab in Induction and With Tislelizumab in Maintenance Treatment Phase

summary: This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and tislelizumab in induction treatment and with tislelizumab in maintenance treatment in newly diagnosed patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Spain
Germany
France

location_facility: Georgetown University Lombardi Cancer Center


title: TENDyne European expeRience Registry

acronym: TENDER

summary: TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

study_type: Observational

time_perspective: Prospective

lead_sponsor: LMU Klinikum

location_country:
Germany
Italy
Norway
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
France

location_facility:
UZ Leuven
Inselspital Bern
CHU Rennes
Universitaetsklinikum Regensburg
Hospital Clinico Valladolid
CHU de Lille
Universitaetsklinikum Wien
Universitaetsklinikum Bonn
University Hospital of Vigo
Royal Brompton London
University hospital Oslo
Universitaetsklinikum Tuebingen
Universitätsklinikum Frankfurt
University Hospital of Pisa
Herz- und Diabeteszentrum NRW
University hospital Madrid
Herzentrum Leipzig
Puerto de Hierro Madrid
Karolinska University Stockholm
Clinique Pasteur
UKE Hamburg
Universitaetsspital Basel
ICH - Istituto Clinico Humanitas
CHU de Bordeaux
Universitaetsklinikum Linz
Universitätsmedizin Mainz
DHZ München
Universitaetsklinikum Koeln
Deutsches Herzzentrum Berlin
Robert-Bosch-Krankenhaus Stuttgart


title: Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

acronym: SOCRATES

summary: The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

lead_sponsor: FCRE (Foundation for Cardiovascular Research and Education)

location_country: Germany Italy Netherlands Austria Belgium Switzerland Spain France

location_facility: University of Bologna, IRCCS S. Orsola Hospital,

location_facility: Inselspital Bern, Universitätsklinik für Gefässchirurgie

location_facility: Hospital Ottakring, Institute for Vascular Surgery

location_facility: Vascular Endovascular Surgery University of Perugia;

location_facility: Hospices Civils de lyon - Hôpital Edouard Herriot

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert

location_facility: IRCCS Ospedale San Raffaele, Chirurgia Vascolare

location_facility: Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde


title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.

lead_sponsor: Incyte Biosciences International Sàrl

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

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Hospital Infantil Unversitario Nino Jesus

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Royal Hospital For Sick Children Yorkhill Glasgow

location_facility: L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

location_facility: Alder Hey Childrens Nhs Foundation Trust

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Princess Maxima Center For Pediatric Oncology

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Centre Hospitalier Universitaire de Poitiers


title: PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK

acronym: TTRACK

summary: The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Slovenia
Italy
Portugal
Slovakia
United Kingdom
Romania
Australia
Austria
Spain
France

location_facility: Centro Hospitalar de Lisboa Central, E.P.E.

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie

location_facility: Inherited Cardiovascular Diseases - Cardiology Institute

location_facility: University Medical Centre Ljubljana - Department of Cardiology

location_facility: East Slovak Institute of Cardiovascular Diseases

location_facility: The Heart Hospital - University College London Hospitals Nhs Foundation Trust

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Cardiomyopathy Unit, Department of Cardiology

location_facility: Hopital Henri Mondor, Service de Pharmacologie Clinique

intervention_type: Diagnostic Test

status_simplified: Completed


title: Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.

acronym: LiverScreen

summary: Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

status: Enrolling by invitation

ReferenceType: derived

ReferenceCitation: Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6. Erratum In: BMC Public Health. 2023 May 22;23(1):923.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Judit Pich Martínez

location_country:
Germany
United Kingdom
Denmark
Netherlands
Spain
Croatia
France

location_facility: Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers

status_simplified: Unknown


title: A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

summary: This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with < 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.

lead_sponsor: Transgene

sponsor_collaborators:
Transgene
Bristol-Myers Squibb

location_country:
United States
Hungary
Belgium
France

location_facility: Budapest Mulhouse Charlotte Libramont Szekesfehervar Strasbourg Créteil Rennes Nashville


title: Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury - (NOSTRA Phase III Trial): A Confirmatory, Placebo-controlled, Randomised, Double Blind, Multi-centre Study

acronym: NOSTRA-III

summary: This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome in patients with moderate and severe traumatic brain injury. Half of the participants will receive Ronopterin (VAS203), while the other half will receive placebo.

ReferenceType: background

ReferenceCitation: Stover JF, Belli A, Boret H, Bulters D, Sahuquillo J, Schmutzhard E, Zavala E, Ungerstedt U, Schinzel R, Tegtmeier F; NOSTRA Investigators. Nitric oxide synthase inhibition with the antipterin VAS203 improves outcome in moderate and severe traumatic brain injury: a placebo-controlled randomized Phase IIa trial (NOSTRA). J Neurotrauma. 2014 Oct 1;31(19):1599-606. doi: 10.1089/neu.2014.3344. Epub 2014 Jul 28.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Tegtmeier F, Schinzel R, Beer R, Bulters D, LeFrant JY, Sahuquillo J, Unterberg A, Andrews P, Belli A, Ibanez J, Lagares A, Mokry M, Willschke H, Fluh C, Schmutzhard E; NOSTRA Investigators. Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study. Trials. 2020 Jan 14;21(1):80. doi: 10.1186/s13063-019-3965-4. Erratum In: Trials. 2020 Feb 12;21(1):172.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

ipd_sharing: Undecided

lead_sponsor: veriNOS operations GmbH

sponsor_collaborators:
veriNOS operations GmbH
ICON plc

location_country:
Germany
United Kingdom
Austria
Spain
France

location_facility: Universitätsklinikum Schleswig-Holstein Klinik für Neurochirurgie

location_facility: Universitätsklinikum Jena Klinik und Poliklinik für Neurochirurgie

location_facility: Universitätsklinikum Leipzig Klinik und Poliklinik für Neurochirurgie

location_facility: Universitätsklinikum Düsseldorf Neurochirurgische Klinik

location_facility: Southampton University Hospital Division of Clinical Neurosciences

location_facility: Medizinische Hochschule Hannover Klinik für Neurochirurgie

location_facility: Universitätsklinikum Göttingen Klinik für Neurochirurgie

location_facility: Allgemeines Krankenhaus Celle Neurotraumatologie

location_facility: Vall d'Hebron University Hospital Department of Neurosurgery

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Neurochirurgie

location_facility: Pôle Anesthésie Réanimation Douleur Urgence

location_facility: Hôpital Pellegrin Service de réanimation traumatologique et chirurgicale

location_facility: Klinik für Neurochirurgie Universität Frankfurt

location_facility: Klinik für Allgemeine Anästhesie und Intensivmedizin AKH Wien

location_facility: Berufsgenossenschaftliche Kliniken Bergmannsheil Klinik für Neurochirurgie

location_facility: Neurologie und Neurochirurgie Medizinische Universität Innsbruck

location_facility: Berufsgenossenschaftliche Kliniken Bergmannstrost Halle Klinik für Neurochirurgie


title: A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome

summary: The aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with Down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Spain
France

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social

location_facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

location_facility: CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale

location_facility: IMIM, Human Pharmacology and Clinical Neurosciences,

location_facility: CHU de Saint Etienne; Service de Génétique


title: Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries

summary: The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

status: Terminated

lead_sponsor: Stryker Neurovascular

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

location_facility: Karolinska University Hospital in Solna, Department of Neuroradiology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust


title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

acronym: SPECTAlung

summary: SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

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

location_country:
Ireland
Italy
Poland
Slovenia
United Kingdom
Switzerland
Belgium
Spain
France

location_facility: Royal Marsden Hospital - Kingston Hospital

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

intervention_type: Genetic


title: Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

summary:
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.

This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

time_perspective: Retrospective

lead_sponsor: SuperSonic Imagine

collaborators: Johann Wolfgang Goethe University Hospital

location_country:
Germany
Italy
Hong Kong
Denmark
Romania
Belgium
China
Greece
France

location_facility: Chinese University of Hong Kong - Prince of Wales Hospital


title: A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors

summary: This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.

lead_sponsor: Bayer

location_country:
United Kingdom
Belgium
France


lead_sponsor: Celgene

summary: The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumors.

ReferenceCitation: Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.

ReferenceCitation: Amoroso L, Castel V, Bisogno G, Casanova M, Marquez-Vega C, Chisholm JC, Doz F, Moreno L, Ruggiero A, Gerber NU, Fagioli F, Hingorani P, Melcon SG, Slepetis R, Chen N, le Bruchec Y, Simcock M, Vassal G. Phase II results from a phase I/II study to assess the safety and efficacy of weekly nab-paclitaxel in paediatric patients with recurrent or refractory solid tumours: A collaboration with the European Innovative Therapies for Children with Cancer Network. Eur J Cancer. 2020 Aug;135:89-97. doi: 10.1016/j.ejca.2020.04.031. Epub 2020 Jun 15.

publisher_dissemination: Elsevier

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

publisher_dissemination: Informa

location_facility: l'Azienda Ospedaliera Regina Margherita - Sant Anna

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

location_facility: Unidad de Oncologia Pediatrica, Hospital Universitario la Fe

title: A Phase 1/2, Multicenter, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors.

source: euctr

location_country:
Italy
United Kingdom
Switzerland
United States
Spain
Canada
France


title: Non-Interventional Study Among Users Of LoFric Origo

summary:
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale

Secondary objectives:

To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale
To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale
To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.

Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.

Medical Device: LoFric Origo

Study Variable(s):

Primary variable: Use or No use of LoFric Origo after 8 weeks.
Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.

lead_sponsor: Wellspect HealthCare

location_country:
Norway
United Kingdom
Switzerland
Netherlands
Belgium
France

location_facility: Centre de Traumatologie et de Readaptation

location_facility: Stavanger Universitetssjukehus, Urologisk poliklinikk

location_facility: Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales

location_facility: National Hospital for Neurology and Neurosurgery Queens Square

location_facility: Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie

location_facility: Sunnaas Sykehus HF Urodynamisk laboratorium

location_facility: Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk

location_facility: University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital

location_facility: Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie

location_facility: Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman

location_facility: Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique

location_facility: Akershus Universitetssykehus HF Urologisk poliklinikk


title: A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)

acronym: TOSCA

summary: Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

primary_purpose: Basic Science

ReferenceCitation: Stuve O, Cataldi F, Pradhan V, Gorelick KJ. Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post-lumbar puncture headache. J Neuroimmunol. 2017 Sep 15;310:69-71. doi: 10.1016/j.jneuroim.2017.06.011. Epub 2017 Jun 30.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

lead_sponsor: Shire

location_country: Germany Netherlands Austria Belgium France

location_facility: Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und

location_facility: Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum,

intervention_type: Procedure


title: A Multicenter, Two Part, Randomized, Parallel Group, Placebo and Sitagliptin Controlled Study to Evaluate the Safety and Efficacy of GSK256073 Administered Once or Twice Daily for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

summary: The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

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:
United States
Spain
United Kingdom
France


title: Study of GSK2241658A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary: The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma.

ReferenceCitation: American Joint Committee on Cancer. 2002. Cancer staging manual. Sixth edition. Springer editions.

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

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Austria
Switzerland
France

intervention_type: Biological


title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies

summary: Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies

location_country:
United States
Germany
France


title: A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

summary: This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
Spain
France


title: A Phase I/II, Open-label, Non-controlled, Escalating Dose, Multicentre Clinical Trial Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of MP0112 Injected Intravitreally in Patients With Wet Age Related Macular Degeneration (AMD)

summary: The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with wet Age Related Macular Degeneration.

ReferenceCitation: Souied EH, Devin F, Mauget-Faysse M, Kolar P, Wolf-Schnurrbusch U, Framme C, Gaucher D, Querques G, Stumpp MT, Wolf S; MP0112 Study Group. Treatment of exudative age-related macular degeneration with a designed ankyrin repeat protein that binds vascular endothelial growth factor: a phase I/II study. Am J Ophthalmol. 2014 Oct;158(4):724-732.e2. doi: 10.1016/j.ajo.2014.05.037. Epub 2014 Jun 5.

oa_colors: green hybrid

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

repository_institution: Masarykiana Brunensis Universitas - Veřejné služby Informačního systému

lead_sponsor: Allergan

sponsor_collaborators:
Allergan
Molecular Partners AG

location_country:
France
Switzerland
Czech Republic

location_facility:
Hopitaux Universitaires
Centre Paradis-Monticelli
Inselspital
Centre Rabelais
Hopital Intercommunual de Creteil
Fakultni Nemocnice Olomouc
Ustrendi Vojenska Nemocnice
Fakultni Nemocnice Brno


title: A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS

summary: To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Poland
Belgium
Spain
Russian Federation
France

location_facility: Hospital Universitario Ntra Sra de la Candelaria

location_facility: Klinikum Osnabrück Klinik für Neurologie

location_facility: Universitätsklinikum Charité, Campus Mitte

location_facility: City hospital # 9 Str. B. Gornaya 43, Saratov

location_facility: Medical University of Gdansk Ul. Nowe Ogrody 1-6

location_facility: CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: CHU Clermont Ferrand-Hôpital Gabriel Montpied-

location_facility: Moscow regional institute of clinical research named after M.F. Vladimirsky

location_facility: Institute of Human Brain, str. Acad. Pavlov, St-Petersburg

location_facility: State Medical University named after I.P. Pavlov

location_facility: Upper Silezian Medical Center SAM Ul Ziolowa 45/47

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf

location_facility: hospital # 33 pr. Lenina 54, Nizniy Novgorod


lead_sponsor: Horizon Pharma USA, Inc.

summary: Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.

ReferenceCitation: Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9. doi: 10.1016/j.jpeds.2006.01.050.

ReferenceCitation: Fidler MC, Barshop BA, Gangoiti JA, Deutsch R, Martin M, Schneider JA, Dohil R. Pharmacokinetics of cysteamine bitartrate following gastrointestinal infusion. Br J Clin Pharmacol. 2007 Jan;63(1):36-40. doi: 10.1111/j.1365-2125.2006.02734.x.

ReferenceCitation: Levtchenko EN, van Dael CM, de Graaf-Hess AC, Wilmer MJ, van den Heuvel LP, Monnens LA, Blom HJ. Strict cysteamine dose regimen is required to prevent nocturnal cystine accumulation in cystinosis. Pediatr Nephrol. 2006 Jan;21(1):110-3. doi: 10.1007/s00467-005-2052-0. Epub 2005 Oct 27.

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (formerly Children's Memorial Hospital)

location_facility: Radboud University Nijmegen Medical Center

title: A Randomized, Crossover Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients With Nephropathic Cystinosis

location_country:
United States
Netherlands
France


title: A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

summary: Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Spain
Czechia
Ukraine
Russian Federation
France

location_facility: Russian Oncology Research Centre n.a. Blokhin, RAMS

location_facility: Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia

location_facility: Institute for Cancer Research and Treatment - IRCC

location_facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin

location_facility: St-Petersburg State Institution of Public Health

location_facility: Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie


title: A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

acronym: SUMMIT

summary: The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

ReferenceType: result

ReferenceCitation: Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.

oa_host_type: repository

repository_institution: University of Twente - University of Twente Research Information

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: SAGE Publications

lead_sponsor: Vericel Corporation

location_country:
Poland
Norway
United Kingdom
Sweden
Netherlands
Czechia
France

location_facility: Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet

location_facility: Hopital d'instruction des armees Robert Picque

location_facility: The South West London Elective Orthopaedic Centre (SWLEOC)

location_facility: Regional Hospital of Traumatologic Surgery

location_facility: Nuffield Dept. of Orthopaedic Surgery, University of Oxford


title: A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease

acronym: MermaiHD

summary: The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.

ReferenceCitation: de Yebenes JG, Landwehrmeyer B, Squitieri F, Reilmann R, Rosser A, Barker RA, Saft C, Magnet MK, Sword A, Rembratt A, Tedroff J; MermaiHD study investigators. Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Dec;10(12):1049-57. doi: 10.1016/S1474-4422(11)70233-2. Epub 2011 Nov 7.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Germany
Italy
Portugal
United Kingdom
Austria
Belgium
Spain
France

location_facility: Institute of Human Genetics, Centre for Life, Central Parkway

location_facility: Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park

location_facility: Department of Clinical Genetics, St Mary's Hospital, Hathersage Road

location_facility: LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz

location_facility: Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5

location_facility: Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22

location_facility: Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria

location_facility: Academic Neurology Unit, E Floor Medical School Beech Hill Road

location_facility: Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1

location_facility: Churchill Hospital, Old Road, Headington

location_facility: University Hospital of Coimbra, Av. Rissaya Barreto

location_facility: Innsbruck Medical University, Anichstraße 35

location_facility: Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74

location_facility: Hospital Universitario La Fe, Avda. Campanar 21,

location_facility: Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz

location_facility: R&D Headquarters, Barberry Centre, 25 Vincent Drive

location_facility: Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie

location_facility: Cambridge Centre for Brain repair, Cambridge University

location_facility: Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21

location_facility: Hôpital Purpan, Place Docteur-Baylac, Bâtiment F

location_facility: First Floor Argyll House, Fosterhill, Cornhill Road

location_facility: SE Scotland Genetic Service, Western General Hospital, Crewe Road

location_facility: Hospital Clinic of Barcelona, Calle Villarroel, 170

location_facility: St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56

location_facility: Hôpital Nord, CHU d'Amiens, Service de Neurologie

location_facility: Hospital Ramon y Cajal, Carretera Colemenar km 9.100


title: A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

summary: This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Switzerland
United States
Spain
Canada
France


title: Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity

acronym: NT-Spin

summary: This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Germany
Italy
Portugal
United Kingdom
Switzerland
Austria
Spain
France


title: A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

summary: This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

location_country: Germany Norway Denmark Netherlands Spain Canada France

location_facility:
Novartis Investigative Site
MD Anderson Cancer Center - Orlando


title: A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.

summary: For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.

lead_sponsor: Kuros Biosurgery AG

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Switzerland
Spain
France

location_facility: Hospital Universitario de la Princesa (18)

location_facility: Norfolk and Norwich University Hospital (44)

location_facility: Università degli Studi di Roma "Tor Vergata" (10)

location_facility: Hospital Universitario Virgen de la Victoria (51)

location_facility: Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)

location_facility: Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)

location_facility: Szegedi Egyetem AOK Kari Gyogyszertar (27)

location_facility: Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)

location_facility: Petz Alandar County Teaching Hospital (55)

location_facility: Katedra i Klinika Ortopedii - Traumatologii PAM (34)

location_facility: Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)

location_facility: N. Bristol NHS Trust + Univ. of Bristol (52)

location_facility: SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)

location_facility: Fovárosi Önkormányzat Szent János Kórháza és Észak (54)

location_facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)

location_facility: Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)

location_facility: Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)


title: A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

summary: To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

lead_sponsor: Solvay Pharmaceuticals

location_country:
Poland
Romania
Croatia
Russian Federation
France

location_facility:
Site 42
Site 11
Site 24
Site 23
Site 31
Site 44
Site 41
Site 43
Site 33
Site 53
Site 51
Site 22
Site 21
Site 13
Site 52
Site 12
Site 34
Site 32


title: A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures

summary: To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Finland France


title: Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)

acronym: SIRtain

summary: This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

lead_sponsor: Sirtex Medical

location_country:
Spain
United Kingdom
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda


title: Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients

summary:
The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again.

No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.

status: Not yet recruiting

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

lead_sponsor: Takeda

location_country: Germany Italy Spain France

location_facility:
CHU Roeun
Universitätsmedizin Göttingen
Hopital Saint Louis
AZ OSP Citta' Della Salute (Torino)
Universitätsklinikum Würzburg
ICO Hospitalet, Barcelona
Hospital Clinic, Barcelona
Klinikum Ludwigshafen, Hautklinik
Hospital Son Espases
Hopital Saint Andre
Ospedale Maggiore Policlinico


title: Everolimus-Coated Percutaneous Transluminal Coronary Angioplasty Catheter First in Human Clinical Investigation: A Clinical Evaluation in the Treatment of Subjects With In-Stent Restenosis of Previously-treated Coronary Artery Lesions

summary: The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.

lead_sponsor: Chansu Vascular Technologies

location_country: Lithuania Georgia Spain France

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Vilniaus universiteto ligoninė Santaros klinikos

location_facility: Georgian Israeli Research Medical Centre Helsicore


title: A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients With Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy

acronym: BOUNCE

summary: BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.

lead_sponsor: ETOP IBCSG Partners Foundation

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Takeda

location_country:
Italy
Poland
United Kingdom
Spain
France

location_facility: Universita di Verona - Department of Medicine

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Hospital Universitario Dr Balmis Alicante - ISABIAL

location_facility: IRCCS Instituto Tumori Giovanni Paolo II


title: PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

acronym: PROVE

summary:
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation).

The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).

lead_sponsor: University of Leipzig

sponsor_collaborators:
University of Leipzig
National University of Ireland, Galway

location_country: Germany France Netherlands Switzerland Sweden

location_facility: Ap-Hm Hopital La Timone Adultes - Marseille

location_facility: Universitäres Herz- und Gefäßzentrum Hamburg

location_facility: Heart Center Leipzig at Leipzig University

location_facility: Universitätsklinikum Freiburg - Bad Krozingen

location_facility: Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden

location_facility: Centre Cardiologique du Nord Saint-Denis

location_facility: Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG

lead_sponsor_type: academique


title: A Phase II Study of L19IL2/L19TNF in Patients With Skin Cancers Amenable to Intralesional Treatment

acronym: IntriNSiC

summary: Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.

lead_sponsor: Philogen S.p.A.

location_country: Italy Spain France

location_facility: Istituto Nazionale dei Tumori Fondazione IRCCS

location_facility: IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

location_facility: IFO- Istituto Dermatologico San Gallicano

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

location_facility: Azienda Ospedaliero Universitaria Senese Policlinico Le Scotte

location_facility: Fondazione Policlinico Universitario A. Gemelli Università Cattolica del Sacro Cuore


title: An Open Label Study Followed by a Randomised, Double-blind, Placebo-controlled, Parallel Group and an Extension Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC).

summary: This study is an open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC).

lead_sponsor: Galecto Biotech AB

collaborators:
Linical Europe GmbH
Hoffmann-La Roche

sponsor_collaborators:
Galecto Biotech AB
Linical Europe GmbH
Hoffmann-La Roche

location_country: Italy Poland Spain France

location_facility: Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc

location_facility: Hospital Universitario y Politécnico La Fe


title: An Observational, Prospective, European, Multicentre, Mixed Methods Study to Describe the Lived Experience of X-Linked Hypophosphatemia (XLH) for Adolescents at End of Skeletal Growth

summary: An observational, prospective, mixed-methods study involving the integration of quantitative and qualitative data exploring the lived experience of burosumab-treated adolescents with XLH at the end of skeletal growth.

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
United Kingdom
Netherlands
France

location_facility: University Medical Center Groningen - Beatrix Children's Hospital

location_facility: Birmingham Women's and Children's Hospital

location_facility: APHP Paris - Assistance Publique Hopitaux de Paris

location_facility: Centre Hospitalier Universitair de Lille


title: Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access

summary: This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.

lead_sponsor: W.L.Gore & Associates

location_facility: Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Hospital Clínico Universitario San Cecilio

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Unversitaire d'Angers

location_facility: Unità di Chirurgia Vascolare Ospedale San Raffaele

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare


title: A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

summary: This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.

status: Unknown status

lead_sponsor: NEAT ID Foundation

sponsor_collaborators:
NEAT ID Foundation
Gilead Sciences

location_country:
France
United Kingdom
Netherlands
Spain
Israel

location_facility: Hospital Clinico Universitario San Carlos


title: A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults

acronym: LANTIC

summary:
The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.

This study will be conducted in three stages. The full study (including all stages) will have a maximum 448 participants. The protocol is currently approved up to stage 1, step 1 and stage 1/ step 2.

Stage 1 (phase Ib & II)

Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
Step 2 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport

Stage 2 (phase II)

- An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL) or lateral canthal lines (LCL)

Stage 3 (phase II)

- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)

lead_sponsor: Ipsen

location_country: Germany France

location_facility: Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft

location_facility: CRS Clinical Research Services Berlin GMBH


lead_sponsor: aptaTargets S.L.

summary: This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemic stroke patients who are candidates to receive reperfusion therapies.

ReferenceCitation: Hernandez-Jimenez M, Martin-Vilchez S, Ochoa D, Mejia-Abril G, Roman M, Camargo-Mamani P, Luquero-Bueno S, Jilma B, Moro MA, Fernandez G, Pineiro D, Ribo M, Gonzalez VM, Lizasoain I, Abad-Santos F. First-in-human phase I clinical trial of a TLR4-binding DNA aptamer, ApTOLL: Safety and pharmacokinetics in healthy volunteers. Mol Ther Nucleic Acids. 2022 Mar 9;28:124-135. doi: 10.1016/j.omtn.2022.03.005. eCollection 2022 Jun 14.

ReferenceCitation: Duran-Laforet V, Pena-Martinez C, Garcia-Culebras A, Alzamora L, Moro MA, Lizasoain I. Pathophysiological and pharmacological relevance of TLR4 in peripheral immune cells after stroke. Pharmacol Ther. 2021 Dec;228:107933. doi: 10.1016/j.pharmthera.2021.107933. Epub 2021 Jun 24.

sponsor_collaborators:
aptaTargets S.L.
Science and Innovation Spanish Ministry
Anagram

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario de Gerona Dr. Josep Trueta

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Régional Universitaire de Lille

title: A Double-Blind, Placebo-Controlled, Randomized, Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke

ipd_sharing_description: All results obtained in this study will be published.

location_country: Germany Spain France


title: A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression

acronym: GLIOSTAR

summary:
Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed.

L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin. TNF not only induces apoptosis or necrosis in certain target cells, but also exerts inflammation and immunity. L19TNF selectively delivers TNF to the tumor site to spare normal tissues from undesired toxicity. Preclinical experiments with L19TNF have demonstrated tumor growth retardation in various mouse tumor models including models of glioma.

location_country: Germany Italy Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Azienda USL di Bologna IRCCS delle Scienze Neurologiche di Bologna

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Sorbonne University, AP-HP, Paris brain institute

location_facility: Inselspital Universitätsklinik für Medizinische Onkologie Bern

location_facility: Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum

location_facility: Azienda Ospedaliero-Universitaria Senese Policlinico Le Scotte


title: First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PPSGG (PN-1007) in Anti-MAG Neuropathy Patients

summary:
In this study, the new drug called PPSGG (PN-1007) will be tested. Preliminary studies conducted in animals suggest PPSGG (PN-1007) might be a good treatment for reducing levels of anti-MAG antibodies in patients with anti-MAG neuropathy.

This is the first research of PPSGG (PN-1007) in people and its main purpose is to test its safety and acceptability in patients. In this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-MAG neuropathy. PPSGG (PN-1007) will be tested at several different doses.

lead_sponsor: Polyneuron Pharmaceuticals AG

location_country:
United Kingdom
Netherlands
Switzerland
Spain
France

location_facility: Département de Neurologie Pôle Neurosciences Centre de Référence des Neuropathies Amyloïdes Familiales et autres Neuropathies Périphériques Rares Centre Hospitalier Universitaire de Bicêtre

location_facility: Service de Neurologie Centre de Référence Neuropathies Périphériques Rares, CHU Limoges

location_facility: National hospital for neurology and neurosurgery, Queen London

location_facility: Referral centre for neuromuscular diseases and ALS, hôpital La Timone


acronym: BEAN

lead_sponsor: Amgen

summary: The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Hospices Civils de Lyon Hopital Femme Mere Enfant

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
France
Italy
United Kingdom
Switzerland
Spain
Greece
Turkey
Israel


title: A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

summary: This study aims to monitor the safety and effectiveness of the Occlutech AFR device in patients with heart failure for 3 years following AFR device implantation.

lead_sponsor: Occlutech International AB

location_facility:
Knappschaftskrankenhaus Bottrop GmbH
CHU Montpellier
Helios Clinic Erfurt
Clinic Osnabrück
University Clinic Tübingen
CHU Lyon
University Clinic Jena
Elbe Clinic Stade
Hospital Osnabrueck
CHU Besançon
Clinic Coburg
University Clinic
Cardiologicum Hamburg
WKK Heide


title: A European Non-interventional Study to Understand the Criteria Used and the Time Required for the Clinical Diagnosis in Participants With Refractory Epilepsies Associated With Developmental Delay

summary: This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

lead_sponsor: Zogenix, Inc.

collaborators: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_facility: Zentrum für Sozialpädiatrie und Neuropädiatrie (DBZ), Vivantes Klinikum

location_facility: Department of Neurology / Epileptology, University Medicine Greifswald

location_facility: Klinik Für Kinder- und Jugendmedizin, Neuropadiatrie und Epilepsiezentrum

location_facility: Gesellschaft für Epilepsieforschung e. V.

location_facility: Department of Neurology - Foundation John Bost

location_facility: Klinik für Epileptologie, Universitätsklinikum Bonn

location_facility: Klinik für Kinder-und Jugendmedizin II, Universitätsklinikum Schleswig-Holstein

location_facility: Abteilung für Epileptologie, ZfP Südwürttemberg

location_facility: Klinik für Neurologie, Heilig Geist-Krankenhaus GmbH

location_facility: Department of Neurologie University of Magdeburg


title: An International Multicentric Open-label Descriptive Study to Assess the Effects and Evaluate the Tolerance of the Cosmetic Care Product RV3278A in the Follow-up Phase of Facial Acne in Teenagers and Young Adults for 1 Year

summary:
Acne is a chronic inflammatory disease of the pilo-sebaceous unit in the skin. Indeed, your skin is covered with tiny holes called hair follicles, or pores. These pores contain sebaceous glands (also called oil glands) that make sebum, an oil that moistens your hair and skin. Most of the time, the glands make the right amount of sebum and the pores are fine. But sometimes a pore gets clogged up with too much sebum, dead skin cells, and germs called bacteria. This can cause acne.

Pierre Fabre Laboratories have developed a cosmetic care product, a cream which is commercialized since September 2019. This leave-on skin care product is adapted for acne-prone skin.

In this study, we are interested in the effects of this care product in facial acne evolution for 12 months (quality of life, acne severity, number of acne flares). Also, we are interested in the subject's satisfaction regarding the use of this care product. This study will also enable to know if the product is well tolerated in such application circumstances.

This clinical study will be carried out in 54 subjects (female or male), aged between 12 and 35 years, in about 10 centers in different European countries.

The maximal duration of the study for a subject will be 1 year. If you give your consent to take part in this study, you will receive a cosmetic care product, also called study product, that you will apply on your face twice a day (morning and evening) for the whole duration of the study.

What makes this study original is the use of a smartphone application to help you to comply with the study procedures and to help the investigator to follow you.

time_perspective: Other

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_country: Italy Poland France

location_facility: Centre de Santé Sabouraud - Hôpital Saint Louis


title: A Chart Review Study of Patients With Haemophilia A With Inhibitors Treated With rFVIIIFc (Elocta®) for Immune Tolerance Induction

summary: A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
Cerner Enviza

location_country:
Germany
Ireland
Italy
Norway
Kuwait
Switzerland
Saudi Arabia
France

location_facility: Swedish Orphan Biovitrum Research Site (p)

location_facility: Swedish Orphan Biovitrum Research Site (a)


title: ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study

acronym: PERSEPOLIS

summary: The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

lead_sponsor: MicroPort CRM

location_country:
Italy
Portugal
United Kingdom
Spain
France

location_facility: Azienda Ospedaliera Santa Maria degli Angeli

location_facility: Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Clinica Medica - Azienda Ospedaliero Universitaria Careggi

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho

location_facility: Centro Hospitalar de Leiria - Hospital de Santo André


summary: This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

sponsor_collaborators: Kyowa Kirin Pharmaceutical Development Ltd

location_facility: Royal National Orthopaedic Hospital NHS Trust

location_facility: National Hospital for Neurology and Neurosurgery-University College London Hospitals NHS Foundation Trust

location_facility: Nuffield Orthopaedic Centre - Oxford University Hospitals Nhs Trust

location_facility: Azienda ospedaliera universitaria Careggi

title: A Phase 3b Open-label Study of the Anti-FGF23 Antibody, Burosumab (KRN23) in Adult Patients With X-linked Hypophosphatemia (XLH)

location_country:
Ireland
Italy
United Kingdom
France


type: Registry Identifier

title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First Line, Extensive Stage Subjects With Small Cell Lung Cancer

summary:
CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

ReferenceCitation: Kanouni T, Severin C, Cho RW, Yuen NY, Xu J, Shi L, Lai C, Del Rosario JR, Stansfield RK, Lawton LN, Hosfield D, O'Connell S, Kreilein MM, Tavares-Greco P, Nie Z, Kaldor SW, Veal JM, Stafford JA, Chen YK. Discovery of CC-90011: A Potent and Selective Reversible Inhibitor of Lysine Specific Demethylase 1 (LSD1). J Med Chem. 2020 Dec 10;63(23):14522-14529. doi: 10.1021/acs.jmedchem.0c00978. Epub 2020 Oct 9.

license: acs-specific: authorchoice/editors choice usage agreement

license_normalized: publisher-specific

publisher_dissemination: American Chemical Society

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_facility:
Local Institution - 102
Local Institution - 200
Local Institution - 403
Local Institution - 402
Local Institution - 203
Local Institution - 406
Local Institution - 400
Local Institution - 401
Local Institution - 100
Local Institution - 405
Local Institution - 404
Local Institution - 103
Local Institution - 201


title: A Phase II Study Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes Failing Standard of Care Therapy

summary: This is an open-label, single-arm multicenter, phase II study. The primary objective is to assess the efficacy of bemcentinib (BGB324) a highly selective inhibitor of the AXL receptor tyrosine kinase for the treatment of AML and MDS patients failing or being refractory to first line hypomethylating agent (HMA) treatment. Furthermore, safety, disease progression, treatment failure will be assessed. A total of 43 patients will be included in the trial.

lead_sponsor: GWT-TUD GmbH

sponsor_collaborators:
GWT-TUD GmbH
Groupe Francophone des Myelodysplasies
Amsterdam UMC, location VUmc
BerGenBio ASA

location_country: Germany Netherlands France

location_facility: CHU Hôtel Dieu Service d'Hématologie Clinique

location_facility: Hôpital Archet 1 Service d'Hématologie Clinique

location_facility: Technische Universität München, Klinikum rechts der Isar


title: Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

acronym: OPTICO-LM

summary:
Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT.

This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

primary_purpose: Diagnostic

ReferenceCitation: Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.

ReferenceCitation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.

ReferenceCitation: Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18.

ReferenceCitation: de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.

ReferenceCitation: Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_country: Germany Japan Switzerland France

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Department of Cardiovascular Medicine Shinshu University School of Medicine

location_facility: Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie

location_facility: Universitätsklinikum Giessen Justus-Liebig Universität

location_facility: Medical Corporation Ouyuukai Tokorozawa Heart Center


title: Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector

acronym: FRIENDS

summary: The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

location_country: Italy Portugal Spain France

location_facility: Hospital Universitari de Girona Doctor Josepj Trueta

location_facility: Centro Hospitalar de Lisboa Norte - Santa Maria

location_facility: Hospital General Universitario de Alicante


title: Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)

acronym: ILLUMINA

summary: The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.

ReferenceCitation: Steiner S, Honton B, Langhoff R, Chiesa R, Kahlberg A, Thieme M, Zeller T, Garot P, Commeau P, Cremonesi A, Marone EM, Sauguet A, Scheinert D. 2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study. JACC Cardiovasc Interv. 2022 Mar 28;15(6):618-626. doi: 10.1016/j.jcin.2021.12.034. Epub 2022 Feb 23.

lead_sponsor: CID - Carbostent & Implantable Devices

location_country: Germany Italy France

location_facility:
Centre Privé Claude Galien
Universitäts-Herzzentrum Freiburg
Regiomed GefäBzentrum Sonneberg
St. Gertrauden Krankenhaus GmbH
Polyclinique Les Fleurs
Universitätsklinikum Leipzig
Clinique Pasteur
IRCCS Policlinico San Matteo
Maria Cecilia Hospital
San Raffaele Hospital


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 24 Months Study in Patients With Amnestic Mild Cognitive Impairment or Very Mild Alzheimer's Disease to Investigate the Safety, Tolerability and Immune Response of Repeated Subcutaneous Injections of ABvac40

summary:
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide. The amyloid cascade hypothesis of AD proposes that amyloid-β (Aβ) peptide accumulation in the brain, caused by an imbalance between Aβ production and clearance, is the initiating factor of a cascade ultimately leading to dementia.

Aβ peptides are generated from sequential cleavage of the amyloid precursor protein (APP), including Aβ40 and Aβ42. Aβ40 is the predominant variant (90%) among the secreted Aβ forms and although Aβ42 is more hydrophobic and prone to aggregate, and Aβ42 oligomers are regarded to be the most neurotoxic species, Aβ40 can also produce highly toxic diffusible aggregates, which can be prevented in vitro by specific anti-Aβ40 antibodies.

Several studies have proposed that a high concentration of Aβ40 in the brain distinguishes patients with AD from those who have senile plaques but are cognitively normal, pointing to the importance of Aβ40 in the onset of dementia. In keeping with this, previous studies have demonstrated that specific anti-Aβ40 antibodies label NFTs in the entorhinal cortex and the hippocampus of AD brains, and that these do not co-localize with tau NFTs, suggesting the presence of degenerating neuronal populations filled with C-terminal fragments of Aβx-40. In addition, Aβ40 is the main component of amyloid deposition around cerebral arteries causing cerebral amyloid angiopathy (CAA), which has a prevalence of about 80-90% in patients with AD (for more information see Lacosta et al. Alzheimer's Research & Therapy (2018) 10:12 DOI 10.1186/s13195-018-0340-8).

Considering those previous results suggesting that strategies targeting Aβ40 could represent novel disease-modifying therapies, we have developed ABvac40, the first active vaccine targeting the C-terminal end of the Aβ40 peptide.

The purpose of this Phase II study is to confirm in patients with a-MCI or vm-AD the level of safety and tolerability obtained in the ABvac40 Phase I clinical trial in patients with mm-AD. In addition, the study is aimed to better characterize the immune response elicited by ABvac40 and to explore its effects on AD biomarkers.

ReferenceCitation: Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Perez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleon I, San-Jose I, Munuera J, Rodriguez-Gomez O, Abdelnour C, Lafuente A, Buendia M, Boada M, Tarraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Abeta40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8.

lead_sponsor: Araclon Biotech S.L.

location_country: Italy Sweden Spain France

location_facility: BarcelonaBeta Brain Research Center (BBRC)

location_facility: Centre de Recherche Clinique du Gérontopôle

location_facility: Hospital Clínico Universitario Lozano Blesa


acronym: PH2a,12-week, 3 RD of 10 mg/kg IV every 4 weeks, efficacy and safety study in asthma pts with AFAD

lead_sponsor: GlaxoSmithKline

summary: This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.

title: A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)

location_country:
United Kingdom
Netherlands
Russian Federation
France


title: Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

acronym: SALT

summary:
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.

Data will be assessed in two populations.

Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.

Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.

If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.

The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.

Matching criteria comprise the following:

Type of procedure
Age
ASA score
BMI
Duration of procedure (as percentile for this procedure)
Diabetes
Sex

ReferenceCitation: Mellinghoff SC, Bruns C, Al-Monajjed R, Cornely FB, Grosheva M, Hampl JA, Jakob C, Koehler FC, Lechmann M, Maged B, Otto-Lambertz C, Rongisch R, Rutz J, Salmanton-Garcia J, Schlachtenberger G, Stemler J, Vehreschild J, Wulfing S, Cornely OA, Liss BJ. Harmonized procedure coding system for surgical procedures and analysis of surgical site infections (SSI) of five European countries. BMC Med Res Methodol. 2022 Aug 12;22(1):225. doi: 10.1186/s12874-022-01702-w.

ReferenceCitation: Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177. Erratum In: JMIR Res Protoc. 2019 Jan 07;8(1):e10712.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: JMIR Publications

lead_sponsor: University of Cologne

sponsor_collaborators:
University of Cologne
Pfizer

location_country:
Germany
Italy
United Kingdom
Spain
France

location_facility: Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón

location_facility: University of Udine and Azienda Sanitaria Universitaria Integrata

location_facility: Centre Hospitalier Régional et Universitaire de Tours

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Manchester University NHS Foundation Trust (MFT)


lead_sponsor: Alnylam Pharmaceuticals

summary: The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in patients with Primary Hyperoxaluria Type 1.

title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1

location_country:
Germany
France
United Kingdom
Netherlands
Israel


title: A Phase 1/2 Single-arm Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan in Children With Refractory or Recurrent Solid Tumors

summary:
The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding central nervous system [CNS] tumors).

The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).

lead_sponsor: Eisai Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Spain
Greece
France

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: The Leeds Teaching Hospitals Charitable Foundation - Leeds Childrens Hospital (LCH)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Istituto G Gaslini Ospedale Pediatrico IRCCS

location_facility: Aghia Sophia' Children's General Hospital of Athens

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Universitario Vall d'Hebron - PPDS