title: Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes

acronym: RESPOND EDGE

summary: The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

location_country:
Italy
Sweden
Netherlands
Finland
France
Ireland
Denmark
Germany
United Kingdom

location_facility:
Royal Victoria Belfast
Rigshospitalet
University Helsinki
The General Infirmary
Galway University Hospital
Erasmus MC - Thorax Center
Oxford John Radcliffe Hospital
Clinique Pasteur
New Cross Hospital
Az Osp Univ Pisana
University of Lund
Royal Sussex County Hospital
Herzzentrum Universität Leipzig


title: Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

acronym: NACASY

summary: This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Italy
Sweden
Netherlands
Finland
France
Greece
Spain
Denmark
Germany
United Kingdom

location_facility: Paul Papin à Angers et site René Gauducheau

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: EudraCT Number

title: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Serbia
France
Bulgaria
Turkey
Germany
United Kingdom

status_simplified: Unknown


ReferenceType: derived

ReferenceCitation: Mercuri E, Muntoni F, Baranello G, Masson R, Boespflug-Tanguy O, Bruno C, Corti S, Daron A, Deconinck N, Servais L, Straub V, Ouyang H, Chand D, Tauscher-Wisniewski S, Mendonca N, Lavrov A; STR1VE-EU study group. Onasemnogene abeparvovec gene therapy for symptomatic infantile-onset spinal muscular atrophy type 1 (STR1VE-EU): an open-label, single-arm, multicentre, phase 3 trial. Lancet Neurol. 2021 Oct;20(10):832-841. doi: 10.1016/S1474-4422(21)00251-9.

family: Mercuri

full_name: Eugenio Mercuri

given: Eugenio

sequence: first

family: Muntoni

full_name: Francesco Muntoni

given: Francesco

sequence: additional

family: Baranello

full_name: Giovanni Baranello

given: Giovanni

family: Masson

full_name: Riccardo Masson

given: Riccardo

family: Boespflug-Tanguy

full_name: Odile Boespflug-Tanguy

given: Odile

family: Bruno

full_name: Claudio Bruno

given: Claudio

family: Corti

full_name: Stefania Corti

given: Stefania

family: Daron

full_name: Aurore Daron

given: Aurore

family: Deconinck

full_name: Nicolas Deconinck

given: Nicolas

family: Servais

full_name: Laurent Servais

given: Laurent

family: Straub

full_name: Volker Straub

given: Volker

family: Ouyang

full_name: Haojun Ouyang

given: Haojun

family: Chand

full_name: Deepa Chand

given: Deepa

family: Tauscher-Wisniewski

full_name: Sitra Tauscher-Wisniewski

given: Sitra

family: Mendonca

full_name: Nuno Mendonca

given: Nuno

family: Lavrov

full_name: Arseniy Lavrov

given: Arseniy

family: Seferian

full_name: A. Seferian

given: A.

family: De Lucia

full_name: S. De Lucia

given: S.

family: Tachibana

full_name: S. Tachibana

family: Jollet

full_name: A. Jollet

family: Mouffak

full_name: S. Mouffak

family: Pedemonte

full_name: M. Pedemonte

given: M.

family: Brolatti

full_name: N. Brolatti

given: N.

family: Morando

full_name: S. Morando

family: Vanlander

full_name: A. Vanlander

location_facility: The John Walton Muscular Dystrophy Research Centre MRC Centre for Neuromuscular Diseases at Newcastle

location_facility: University Hospital Ghent Neuromuscular reference center

location_facility: Neuropédiatrie - Centre de Référence des Maladies Neuromusculaires

location_facility: Great Ormond Street Hospital for Children

location_facility: Carlo Besta Neurological Research Institute

title: Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

summary: Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.


summary: This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

status: Completed

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.

lead_sponsor: Allergan

location_country:
Italy
France
Israel
Spain
Germany
United Kingdom

status_simplified: Completed


title: An Exploratory, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)

acronym: DECADES

summary: The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel

design_allocation: Non-Randomized

ReferenceCitation: Wykrzykowska JJ, Warnholtz A, de Jaeger P, Curzen N, Oldroyd KG, Collet JP, Ten Berg JM, Rademaker T, Goedhart D, Lissens J, Kint PP, Serruys PW. Effect of clopidogrel discontinuation at 1 year after drug eluting stent placement on soluble CD40L, P-selectin and C-reactive protein levels: DECADES (Discontinuation Effect of Clopidogrel After Drug Eluting Stent): a multicenter, open-label study. J Thromb Thrombolysis. 2009 Nov;28(4):410-7. doi: 10.1007/s11239-009-0354-y.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
United Kingdom
France
Netherlands

intervention_type: Procedure


title: Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

summary: This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

name: Medical Oncology Department; St John of God Midland; Perth Australia

name: Medical Oncology Department; Sir Charles Gairdner Hospital; Perth Australia

family: Hoon

full_name: Siao-Nge Hoon

given: Siao-Nge

name: Medical Oncology Department; Peter MacCallum Cancer Centre; Melbourne Australia

family: Lau

full_name: Peter K H Lau

given: Peter K H

name: Murdoch Community Hospice; St John of God Hospital Murdoch; Perth Australia

name: Palliative Care Department; Royal Perth Hospital; Perth Australia

family: White

full_name: Alison M White

given: Alison M

name: Institute for Health Research; University of Notre Dame Australia; Fremantle Australia

name: School of Population and Global Health; The University of Western Australia; Perth Australia

name: Division of Surgery and Interventional Science; University College London; London UK

family: Bulsara

full_name: Max K Bulsara

given: Max K

name: Medical Oncology Department; University Hospital Geelong; Geelong Australia

family: Banks

full_name: Patricia D Banks

given: Patricia D

name: School of Medicine; University of Western Australia; Perth Australia

name: Medical Oncology Department; Fiona Stanley Hospital; Perth Australia

family: Redfern

full_name: Andrew D Redfern

given: Andrew D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation

acronym: READ-ASV

summary: Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

lead_sponsor: ResMed

location_country: Switzerland France Spain Denmark Germany Portugal

location_facility: Centre d' investigation et de recherche sur le sommeil

location_facility: Sjællands Universitetshospital/Zealand University Hospital Køge

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Klinik für Schlafmedizin Düsseldorf Grand Arc

location_facility: Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

location_facility: Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe

intervention_type: Device


type: Registry Identifier

title: The Effectiveness of Managed Transition in Improving the Health and Social Outcomes for Young People Transitioning From Child to Adult Mental Health Care: the MILESTONE Study

acronym: MILESTONE

summary: This study evaluates the longitudinal health and social outcomes of adolescent mental health service users who are at the transition boundary of their child and adolescent mental health service, and whether the implementation of a model of managed transition at the service boundary benefits them, as compared to usual care.

status: Unknown status

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Santosh P, Singh J, Adams L, Mastroianni M, Heaney N, Lievesley K, Sagar-Ouriaghli I, Allibrio G, Appleton R, Davidović N, de Girolamo G, Dieleman G, Dodig-Ćurković K, Franić T, Gatherer C, Gerritsen S, Gheza E, Madan J, Manenti L, Maras A, Margari F, McNicholas F, Pastore A, Paul M, Purper-Ouakil D, Rinaldi F, Sakar V, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuffrey A, Tuomainen H, Verhulst F, Warwick J, Wilson A, Wolke D, Fiori F, Singh S; MILESTONE Consortium. Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study. BMJ Open. 2020 Jun 23;10(6):e033324. doi: 10.1136/bmjopen-2019-033324.

family: Santosh

full_name: Paramala Santosh

given: Paramala

family: Singh

full_name: Jatinder Singh

given: Jatinder

family: Adams

full_name: Laura Adams

given: Laura

family: Mastroianni

full_name: Mathilde Mastroianni

given: Mathilde

family: Heaney

full_name: Natalie Heaney

given: Natalie

family: Lievesley

full_name: Kate Lievesley

given: Kate

family: Sagar-Ouriaghli

full_name: Ilyas Sagar-Ouriaghli

given: Ilyas

family: Allibrio

full_name: Giovanni Allibrio

given: Giovanni

family: Appleton

full_name: Rebecca Appleton

given: Rebecca

family: Davidović

full_name: Nikolina Davidović

given: Nikolina

family: de Girolamo

full_name: Giovanni de Girolamo

family: Dieleman

full_name: Gwen Dieleman

given: Gwen

family: Dodig-Ćurković

full_name: Katarina Dodig-Ćurković

given: Katarina

family: Franić

full_name: Tomislav Franić

given: Tomislav

family: Gatherer

full_name: Charlotte Gatherer

given: Charlotte

family: Gerritsen

full_name: Suzanne Gerritsen

given: Suzanne

family: Gheza

full_name: Elisa Gheza

given: Elisa

family: Madan

full_name: Jason Madan

given: Jason

family: Manenti

full_name: Lidia Manenti

given: Lidia

family: Maras

full_name: Athanasios Maras

given: Athanasios

family: Margari

full_name: Francesco Margari

given: Francesco

family: McNicholas

full_name: Fiona McNicholas

given: Fiona

family: Pastore

full_name: Adriana Pastore

given: Adriana

repository_institution: University of Warwick - Warwick Research Archive Portal

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

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

ReferenceCitation: Santosh P, Adams L, Fiori F, Davidović N, de Girolamo G, Dieleman GC, Franić T, Heaney N, Lievesley K, Madan J, Maras A, Mastroianni M, McNicholas F, Paul M, Purper-Ouakil D, Sagar-Ouriaghli I, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuomainen H, Verhulst FC, Warwick J, Wolke D, Singh J, Singh SP; MILESTONE Consortium. Protocol for the development and validation procedure of the managing the link and strengthening transition from child to adult mental health care (MILESTONE) suite of measures. BMC Pediatr. 2020 Apr 16;20(1):167. doi: 10.1186/s12887-020-02079-9.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Tuomainen H, Schulze U, Warwick J, Paul M, Dieleman GC, Franić T, Madan J, Maras A, McNicholas F, Purper-Ouakil D, Santosh P, Signorini G, Street C, Tremmery S, Verhulst FC, Wolke D, Singh SP; MILESTONE consortium. Managing the link and strengthening transition from child to adult mental health Care in Europe (MILESTONE): background, rationale and methodology. BMC Psychiatry. 2018 Jun 4;18(1):167. doi: 10.1186/s12888-018-1758-z. Erratum in: BMC Psychiatry. 2018 Sep 14;18(1):295.

repository_institution: University of Melbourne - Minerva Access

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: University College Dublin - Research Repository at University College Dublin

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

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

ReferenceCitation: Singh SP, Tuomainen H, Girolamo G, Maras A, Santosh P, McNicholas F, Schulze U, Purper-Ouakil D, Tremmery S, Franić T, Madan J, Paul M, Verhulst FC, Dieleman GC, Warwick J, Wolke D, Street C, Daffern C, Tah P, Griffin J, Canaway A, Signorini G, Gerritsen S, Adams L, O'Hara L, Aslan S, Russet F, Davidović N, Tuffrey A, Wilson A, Gatherer C, Walker L; MILESTONE Consortium. Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study). BMJ Open. 2017 Oct 16;7(10):e016055. doi: 10.1136/bmjopen-2017-016055.

location_country:
Italy
Netherlands
Croatia
France
Ireland
Belgium
Germany
United Kingdom

location_facility: Warwick Medical School, University of Warwick


title: Phase I Open Label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacokinetics of Intravenously Administered MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

summary: The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Japan
Australia
Spain
Germany

location_facility: MD Anderson Cancer Center/University of Texas MD Anderson CC


title: The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3

summary: The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the development of BR-23 published 1996 the standard therapy of breast cancer has changed. New therapies brought new side effects and different impact on QoL (quality of life) are not sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both from clinical and scientific point of view.

ReferenceType: result

ReferenceCitation: Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68.

ReferenceCitation: Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011

lead_sponsor: Medical University of Graz

location_country: Italy Austria Netherlands Croatia France Poland Spain Germany

location_facility: Jagiellonian University Medical College Krakow

location_facility: Instituto Nazionale Tumori Fondazione Pascale

intervention_type: Other

lead_sponsor_type: academique


lead_sponsor: Evgen Pharma

location_country:
United Kingdom
Belgium
France
Spain

acronym: STEM

location_facility: Grand Hopital de Charleroi, Service D'Oncologie-Hematologie

location_facility: Royal Bournemouth & Christchurch Hospitals NHS

location_facility: University Hospitals Birmingham NHS Foundation

source: euctr

title: STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant

summary:
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.


title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control

acronym: PRECISESADST

summary: Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

ipd_sharing: Undecided

lead_sponsor: Fundación Pública Andaluza Progreso y Salud

location_country: Italy Austria Switzerland Spain France Hungary Belgium Portugal Germany

location_facility: Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

location_facility: Hospital Regional de Málaga Servicio Andaluz de Salud

location_facility: UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)

location_facility: Hospital Universitario Reina Sofía Andaluz de Salud

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)

location_facility: Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

location_facility: Biobanco del Sistema Sanitario Público de Andalucía (SSPA)

location_facility: Hospital Universitario San Cecilio Servicio Andaluz de Salud

location_facility: Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud


title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort

acronym: PRECISESADSI

summary: Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to performe a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research consiteis to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

location_country: Italy Switzerland France Belgium Spain Germany

location_facility: Hospitaux Universitaires de Géneve (UNIGE)

location_facility: Université catholique de Louvain - Cliniques Universitaires Saint-Luc (UCL)


title: Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries

summary: Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

family: Riley

full_name: Robert F. Riley

given: Robert F.

family: Fajadet

full_name: Jean Fajadet

given: Jean

family: Shlofmitz

full_name: Richard A. Shlofmitz

given: Richard A.

family: Saito

full_name: Shigeru Saito

given: Shigeru

family: Ali

full_name: Ziad A. Ali

given: Ziad A.

family: Klein

full_name: Andrew J. Klein

given: Andrew J.

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Hill

full_name: Jonathan M. Hill

given: Jonathan M.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Götberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531.

family: Brinton

full_name: Todd J. Brinton

given: Todd J.

name: NewYork-Presbyterian Hospital/Columbia University Medical Center (Z.A.A.).

name: Cardiovascular Research Foundation, New York (Z.A.A., A.M.).

name: King’s College Hospital, London, UK (J.M.H.).

name: Monash University, Melbourne, Australia (I.T.M.).

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Maehara

full_name: Akiko Maehara

given: Akiko

family: Illindala

full_name: Uday Illindala

given: Uday

name: Yale University School of Medicine, New Haven, CT (A.L.).

name: St. Bartholomew’s Heart Center, London, UK (A.L.).

name: The William Harvey Research Institute, Queen Mary University of London, UK (A.L.).

family: Lansky

full_name: Alexandra Lansky

given: Alexandra

name: Skane University Hospital, Lund, Sweden (M.G.).

family: Götberg

full_name: Matthias Götberg

given: Matthias

name: Erasmus University, Rotterdam, The Netherlands (N.M.V.M.).

family: Van Mieghem

name: St Vincent’s Hospital, Melbourne, Australia (R.W.).

name: Clinique Pasteur, Toulouse, France (J.F.).

name: University Hospital Careggi, Florence, Italy (C.D.M.).

name: Royal Brompton Hospital, London, UK (C.D.M.).

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Sweden
Netherlands
France
Australia
United Kingdom

location_facility:
St. Vincent's Hospital
Thoraxcenter, Erasmus MC
Clinic Pastuer
King's College Hospital
Royal Brompton Hospital
Skane University Hospital- Lund
Monash Heart, Monash Health


title: Transarterial Chemoembolization With Drug-Eluting Beads (Standard Arm) Versus Stereotactic Body Radiation Therapy (Experimental Arm) for Hepatocellular Carcinoma: A Multicenter Randomized Phase II Trial

acronym: TRENDY

summary:
Rationale:

This study will compare head to head in patients with hepatocellular carcinoma (HCC) ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to progression is more favorable after SBRT than after TACE-DEB. The expected time to include the required patients for this trial will be four years.

To the best of the investigators knowledge this study will be the first in the world that will compare both techniques in a randomized trial.

Objective:

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

Study design:

Randomized, prospective, open-label, and phase II study.

Study population:

Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤ 6cm, and ≥ 18 years old.

Intervention:

Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT.

Main study parameters/endpoints:

The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression.

Secondary endpoints will be:

Time to local recurrence
Response rate (complete and partial response)
Overall survival
Toxicity
Quality of life.

lead_sponsor: Erasmus Medical Center

location_country: Belgium France Netherlands

location_facility:
VU MC
Maastro
AMC
LUMC
UH Antwerp
Erasmus MC
UMC Utrecht
UH Lille
UMC Maastricht
UMC St Radboud
UH Leuven


title: The EUROSCA Natural History Study

acronym: EUROSCA-NHS

summary: The key goals of EUROSCA-NHS is to determine and compare the rate of disease progression in SCA1, SCA2, SCA3 and SCA6 including determination of the order and occurrence of non-ataxia symptoms, assessment of activities of daily living (ADL) and quality of life (QoL), and identification of predictors of disease progression and survival.

status: Recruiting

ReferenceCitation: Diallo A, Jacobi H, Cook A, Labrum R, Durr A, Brice A, Charles P, Marelli C, Mariotti C, Nanetti L, Panzeri M, Rakowicz M, Sobanska A, Sulek A, Schmitz-Hübsch T, Schöls L, Hengel H, Melegh B, Filla A, Antenora A, Infante J, Berciano J, van de Warrenburg BP, Timmann D, Boesch S, Pandolfo M, Schulz JB, Bauer P, Giunti P, Kang JS, Klockgether T, Tezenas du Montcel S. Survival in patients with spinocerebellar ataxia types 1, 2, 3, and 6 (EUROSCA): a longitudinal cohort study. Lancet Neurol. 2018 Apr;17(4):327-334. doi: 10.1016/S1474-4422(18)30042-5. Epub 2018 Mar 13.

family: Diallo

full_name: Alhassane Diallo

given: Alhassane

family: Jacobi

full_name: Heike Jacobi

given: Heike

family: Cook

full_name: Arron Cook

given: Arron

family: Labrum

full_name: Robyn Labrum

given: Robyn

family: Durr

full_name: Alexandra Durr

family: Brice

full_name: Alexis Brice

given: Alexis

family: Charles

full_name: Perrine Charles

given: Perrine

family: Marelli

full_name: Cecilia Marelli

given: Cecilia

family: Mariotti

full_name: Caterina Mariotti

given: Caterina

family: Nanetti

full_name: Lorenzo Nanetti

given: Lorenzo

family: Panzeri

full_name: Marta Panzeri

given: Marta

family: Rakowicz

full_name: Maria Rakowicz

given: Maria

family: Sobanska

full_name: Anna Sobanska

given: Anna

family: Sulek

full_name: Anna Sulek

family: Schmitz-Hübsch

full_name: Tanja Schmitz-Hübsch

given: Tanja

family: Schöls

full_name: Ludger Schöls

given: Ludger

family: Hengel

full_name: Holger Hengel

given: Holger

family: Melegh

full_name: Bela Melegh

given: Bela

family: Filla

full_name: Alessandro Filla

given: Alessandro

family: Antenora

full_name: Antonella Antenora

given: Antonella

family: Infante

full_name: Jon Infante

given: Jon

family: Berciano

full_name: José Berciano

given: José

family: van de Warrenburg

full_name: Bart P van de Warrenburg

given: Bart P

family: Timmann

repository_institution: University College London - UCL Discovery

ReferenceCitation: Jacobi H, du Montcel ST, Bauer P, Giunti P, Cook A, Labrum R, Parkinson MH, Durr A, Brice A, Charles P, Marelli C, Mariotti C, Nanetti L, Panzeri M, Rakowicz M, Sulek A, Sobanska A, Schmitz-Hübsch T, Schöls L, Hengel H, Baliko L, Melegh B, Filla A, Antenora A, Infante J, Berciano J, van de Warrenburg BP, Timmann D, Szymanski S, Boesch S, Kang JS, Pandolfo M, Schulz JB, Molho S, Diallo A, Klockgether T. Long-term disease progression in spinocerebellar ataxia types 1, 2, 3, and 6: a longitudinal cohort study. Lancet Neurol. 2015 Nov;14(11):1101-8. doi: 10.1016/S1474-4422(15)00202-1. Epub 2015 Sep 13.

location_country:
Italy
Austria
Netherlands
France
Poland
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour

location_facility: Department of Neurodegeneration and Hertie-Institute for Clinical Brain Research, University of Tübingen

location_facility: Department of Neurology, University of Bonn

location_facility: Université Libre de Bruxelles (ULB), Neurology Service - ULB Hôpital Erasme, ULB Laboratory of Experimental Neurology

location_facility: Department of Neuroscience, Federico II University Naples

location_facility: Department of Neurology, Zala County Hospital

location_facility: Department of Medical Genetics, University of Pecs

location_facility: Department of Neurology, Medical University, Innsbruck

location_facility: Department of Neurology, University Clinic Essen, University of Duisburg-Essen

location_facility: Department of Neurology, University of Frankfurt

location_facility: Department of Neurology, St. Josef Hospital, University Hospital of Bochum

location_facility: University Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria

location_facility: Hôpital de la Pitié-Salpêtrière, Département de Génétique

location_facility: Fondazione-IRCCS Istituto Neurologico Carlo Besta


title: A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors

summary: A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

location_country:
Italy
France
Japan
Singapore
Spain
United States


title: A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study

acronym: EYEGUARD-X

summary: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.

ReferenceCitation: Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gül A. Use of Gevokizumab in Patients with Behçet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.

name: Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey

family: Tugal-Tutkun

full_name: Ilknur Tugal-Tutkun

given: Ilknur

name: Moorfields Eye Hospital and Biomedical Research Center, NHS Foundation Trust, London, UK

family: Pavesio

full_name: Carlos Pavesio

given: Carlos

name: Institut de Recherches Internationales Servier, Suresnes, France

family: De Cordoue

full_name: Agnès De Cordoue

given: Agnès

family: Bernard-Poenaru

full_name: Oana Bernard-Poenaru

given: Oana

name: Department of Internal Medicine, Division of Rheumatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey

family: Gül

full_name: Ahmet Gül

given: Ahmet

journal_name: Ocular Immunology and Inflammation

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Use of Gevokizumab in Patients with Behçet’s Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

location_country:
Italy
Austria
Spain
France
Greece
Tunisia
Australia
Portugal
Turkey
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Moorfields Eye Hospital NHS Foundation Trust

intervention_type: Biological


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 Administered Orally in Patients With Myelofibrosis

summary: This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including changes in spleen volume, JAK2V617F allele burden, and hematologic response.

location_country:
Italy
Netherlands
France
Singapore
Australia
Germany
United Kingdom
Canada


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: Shire

location_country:
Italy
United States
Netherlands
France
Spain
Germany
United Kingdom

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Socio Sanitaria Territoriale - Asst di Monza

location_facility: Hospital Universitario Vall D'hebron - Ppds

title: An Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Mucopolysaccharidosis Type IIIA Disease

summary: This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy of the study drug.


title: Long-term Experience With Abatacept SC in Routine Clinical Practice

acronym: ASCORE

summary: The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

location_country:
Italy
Austria
Switzerland
Netherlands
United Kingdom
France
Greece
Australia
Spain
Germany
Monaco


title: A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

summary: This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.

location_country:
Italy
United States
Netherlands
France
Japan
Australia
Germany


type: Other Grant/Funding Number

title: Giant Intracranial Aneurysm Registry

summary: The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.

ReferenceCitation: Dengler J, Heuschmann PU, Endres M, Meyer B, Rohde V, Rufenacht DA, Vajkoczy P; Giant Intracranial Aneurysm Study Group. The rationale and design of the Giant Intracranial Aneurysm Registry: a retrospective and prospective study. Int J Stroke. 2011 Jun;6(3):266-70. doi: 10.1111/j.1747-4949.2011.00588.x. Epub 2011 Apr 7.

ReferenceCitation: Dengler J, Rüfenacht D, Meyer B, Rohde V, Endres M, Lenga P, Uttinger K, Rücker V, Wostrack M, Kursumovic A, Hong B, Mielke D, Schmidt NO, Burkhardt JK, Bijlenga P, Boccardi E, Cognard C, Heuschmann PU, Vajkoczy P; Giant Intracranial Aneurysm Study Group. Giant intracranial aneurysms: natural history and 1-year case fatality after endovascular or surgical treatment. J Neurosurg. 2019 Dec 6;134(1):49-57. doi: 10.3171/2019.8.JNS183078.

name: 1Department of Neurosurgery, Charité—Berlin;

name: 2Department of Neurosurgery, Helios Clinic, Bad Saarow;

name: 3Brandenburg Medical School Theodor Fontane, Campus Bad Saarow, Germany;

family: Dengler

full_name: Julius Dengler

given: Julius

name: 4Department of Neuroradiology, Clinic Hirslanden, Zurich, Switzerland;

family: Rüfenacht

full_name: Daniel Rüfenacht

given: Daniel

name: 5Department of Neurosurgery, Technical University of Munich;

family: Meyer

full_name: Bernhard Meyer

given: Bernhard

name: 6Department of Neurosurgery, Georg-August-University Goettingen;

family: Rohde

full_name: Veit Rohde

given: Veit

name: 7Department of Neurology, Charité—Berlin;

family: Endres

full_name: Matthias Endres

given: Matthias

family: Lenga

full_name: Pavlina Lenga

given: Pavlina

name: 9Institute of Clinical Epidemiology and Biometry, University of Würzburg;

family: Uttinger

full_name: Konstantin Uttinger

given: Konstantin

family: Rücker

full_name: Viktoria Rücker

given: Viktoria

family: Wostrack

full_name: Maria Wostrack

name: 10Department of Neurosurgery, DONAUISAR Klinik Deggendorf;

family: Kursumovic

full_name: Adisa Kursumovic

given: Adisa

name: 11Department of Neurosurgery, Hannover Medical School, Hannover;

family: Hong

full_name: Bujung Hong

given: Bujung

family: Mielke

full_name: Dorothee Mielke

given: Dorothee

name: 12Department of Neurosurgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany;

family: Schmidt

full_name: Nils Ole Schmidt

given: Nils Ole

name: 13Department of Neurosurgery, University Hospital Zurich;

family: Burkhardt

full_name: Jan-Karl Burkhardt

given: Jan-Karl

name: 14Department of Neurosurgery, University Hospital Geneva, Switzerland;

family: Bijlenga

full_name: Philippe Bijlenga

given: Philippe

name: 15Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy;

family: Boccardi

full_name: Edoardo Boccardi

given: Edoardo

name: 16Department of Neuroradiology, University Hospital Toulouse, France;

family: Cognard

full_name: Christophe Cognard

given: Christophe

name: 17Comprehensive Heart Failure Center Würzburg, University of Würzburg; and

name: 18Clinical Trial Center Würzburg, University Hospital Würzburg, Germany

family: Heuschmann

full_name: Peter U. Heuschmann

given: Peter U.

family: Vajkoczy

full_name: Peter Vajkoczy

given: Peter

journal_name: Journal of Neurosurgery

publisher: Journal of Neurosurgery Publishing Group (JNSPG)

publisher_dissemination: American Association of Neurological Surgeons

publisher_group: American Association of Neurological Surgeons

publisher_normalized: American Association of Neurological Surgeons

ReferenceCitation: Haemmerli J, Lenga P, Hong B, Kursumovic A, Maldaner N, Burkhardt JK, Bijlenga P, Rüfenacht DA, Schmidt NO, Vajkoczy P, Dengler J. Clinical implications and radiographic characteristics of the relation between giant intracranial aneurysms of the posterior circulation and the brainstem. Acta Neurochir (Wien). 2019 Sep;161(9):1747-1753. doi: 10.1007/s00701-019-04016-x. Epub 2019 Jul 29.

family: Haemmerli

full_name: Julien Haemmerli

given: Julien

ReferenceCitation: Lenga P, Hohaus C, Hong B, Kursumovic A, Maldaner N, Burkhardt JK, Bijlenga P, Rüfenacht DA, Schmidt NO, Vajkoczy P, Dengler J. Giant intracranial aneurysms of the posterior circulation and their relation to the brainstem: analysis of risk factors for neurological deficits. J Neurosurg. 2018 Aug 10;131(2):403-409. doi: 10.3171/2018.4.JNS172343.

name: 1Department of Neurosurgery, Charité-Universitaetsmedizin Berlin;

name: 2Department of Neurosurgery, BG Hospital Bergmannstrost, Halle;

name: 3Department of Neurosurgery, Hannover Medical School, Hannover;

name: 4Department of Neurosurgery and Interventional Neuroradiology, DONAUISAR Klinikum Deggendorf, Germany;

name: 5Department of Neurosurgery, University Hospital of Zurich;

name: 6Department of Neurosurgery, University Hospital Geneva;

name: 7Department of Neuroradiology, Clinic Hirslanden, Zurich, Switzerland; and

name: 8Department of Neurosurgery, University Medical Center, Hamburg Eppendorf, Germany

ReferenceCitation: Durner G, Piano M, Lenga P, Mielke D, Hohaus C, Guhl S, Maldaner N, Burkhardt JK, Pedro MT, Lehmberg J, Rufenacht D, Bijlenga P, Etminan N, Krauss JK, Boccardi E, Hänggi D, Vajkoczy P, Dengler J; Giant Intracranial Aneurysm Study Group. Cranial nerve deficits in giant cavernous carotid aneurysms and their relation to aneurysm morphology and location. Acta Neurochir (Wien). 2018 Aug;160(8):1653-1660. doi: 10.1007/s00701-018-3580-2. Epub 2018 Jun 9.

name: on behalf of the Giant Intracranial Aneurysm Study Group

ReferenceCitation: Maldaner N, Guhl S, Mielke D, Musahl C, Schmidt NO, Wostrack M, Rüfenacht DA, Vajkoczy P, Dengler J; Giant Intracranial Aneurysm Study Group. Changes in volume of giant intracranial aneurysms treated by surgical strategies other than direct clipping. Acta Neurochir (Wien). 2015 Jul;157(7):1117-23; discussion 1123. doi: 10.1007/s00701-015-2448-y. Epub 2015 May 23.

name: For the Giant Intracranial Aneurysm Study Group

ReferenceCitation: Dengler J, Maldaner N, Bijlenga P, Burkhardt JK, Graewe A, Guhl S, Hong B, Hohaus C, Kursumovic A, Mielke D, Schebesch KM, Wostrack M, Rufenacht D, Vajkoczy P, Schmidt NO; Giant Intracranial Aneurysm Study Group. Perianeurysmal edema in giant intracranial aneurysms in relation to aneurysm location, size, and partial thrombosis. J Neurosurg. 2015 Aug;123(2):446-52. doi: 10.3171/2014.10.JNS141560. Epub 2015 Apr 17. Erratum in: J Neurosurg. 2015 Aug;123(2):478.

name: 2Service de Neurochirurgie, Faculté de Médecine de Genève and Hôpitaux Universitaire de Genève; and

name: 3Department of Neurosurgery, University Hospital of Zurich, Switzerland

name: 4Department of Neurosurgery, Unfallkrankenhaus Berlin;

name: 5Department of Neurosurgery, University of Greifswald;

name: 6Department of Neurosurgery, Hannover Medical School, Hannover;

name: 7Department of Neurosurgery, BG Hospital Bergmannstrost, Halle;

name: 8Department of Neurosurgery and Interventional Neuroradiology, Klinikum Deggendorf;

name: 9Department of Neurosurgery, Georg-August-University Goettingen;

name: 10Department of Neurosurgery, University of Regensburg;

name: 11Department of Neurosurgery, Technical University of Munich;

name: 12Zentrum fuer Neuroradiologie, Clinic Hirslanden, Zurich;

name: 13Department of Neurosurgery, University Medical Center, Hamburg Eppendorf, Germany;

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Dengler J, Maldaner N, Bijlenga P, Burkhardt JK, Graewe A, Guhl S, Nakamura M, Hohaus C, Kursumovic A, Schmidt NO, Schebesch KM, Wostrack M, Vajkoczy P, Mielke D; Giant Intracranial Aneurysm Study Group. Quantifying unruptured giant intracranial aneurysms by measuring diameter and volume--a comparative analysis of 69 cases. Acta Neurochir (Wien). 2015 Mar;157(3):361-8; discussion 368. doi: 10.1007/s00701-014-2292-5. Epub 2014 Dec 12.

title: Quantifying unruptured giant intracranial aneurysms by measuring diameter and volume—a comparative analysis of 69 cases

location_country:
Italy
Austria
Switzerland
Netherlands
Finland
France
Japan
Russian Federation
Germany

location_facility: Department of Neurosurgery - University of Geneva

location_facility: Department of Neuroradiology - Klinikum Hirslanden

location_facility: Department of Neurosurgery - University of Greifswald

location_facility: Department of Neurology - Charité Berlin

location_facility: Department of Neurosurgery, Jikei University

location_facility: Department of Neurosurgery - University of Regensburg

location_facility: Institut für Klinische Epidemiologie und Biometrie der Universität Wuerzburg

location_facility: Department of Neurosurgery, University Hospital

location_facility: Department of Neurosurgery, Helsinki University Central

location_facility: Department of Neuroradiology, University Hospital

location_facility: Department of Neurosurgery, University of Freiburg

location_facility: Department of Neurosurgery - Technical University of Munich

location_facility: Department of Neurosurgery, Friedrich-Schiller-University

location_facility: Department of Neurosurgery, Medical University Vienna

location_facility: Department of Neurosurgery - University of Goettingen

location_facility: Department of Neurosurgery and Neuroradiology, Klinikum Deggendorf

location_facility: Department of Neuroradiology, University of Leipzig

location_facility: Department of Neurosurgery, Kantonsspital Aarau

location_facility: Department of Neurosurgery, Charité Berlin

location_facility: Department of Neurosurgery - University of Hamburg

location_facility: Department of Neurosurgery, Burdenko Neurosurgical Institute

location_facility: Department of Neuroradiology, Ospedale Niguarda Ca' Granda


title: Phase II Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Metastatic Merkel Cell Carcinoma

summary:
There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated.

This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery.

A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).

lead_sponsor: Philogen S.p.A.

location_country:
Austria
France
Spain
Denmark
Germany
United Kingdom

location_facility:
Charité- Medical University Hospital
Medical University Hospital
Saint-Louis- Hospital
Eberhard-Karls- University Hospital
ICMiD- University Hospital
Universitätsklinik Essen
Herlev- University Hospital
Nottingham Trent- University Hospital


title: Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

summary:
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.

The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.

status: Withdrawn

lead_sponsor: Integra LifeSciences Services

location_country:
Italy
Netherlands
Spain
France
Belgium
Portugal
United Kingdom

location_facility:
Clinique Axium
Hospital Pedro Hispano
Musgrave Park Hospital
I.R.C.C.S. Istituto Ortopedico Galeazzi
Katholieke Universiteit Leuven
Hospital clinico y provincial
AZ Turnout - Clinic Sint-Jozef
Sint Lucas Andreas Ziekenhuis


title: Study 200170: A Rollover Study to Provide Continued Treatment With Eltrombopag

summary: This study will provide continued access to treatment with eltrombopag for subjects who are currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Peru
Hong Kong
Netherlands
France
Poland
Greece
Tunisia
Romania
Ireland
Belgium
China
Korea, Republic of


title: GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

summary: This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.

time_perspective: Cross-Sectional

ReferenceCitation: Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.

name: Department of Sociology, Loyola University of Maryland

name: Department of Medicine, Johns Hopkins University, Baltimore, MD, USA

family: Peyrot

full_name: M. Peyrot

given: M.

name: University of Birmingham and BioMedical Research Unit, Heart of England NHS Foundation Trust, Birmingham, UK

family: Barnett

full_name: A. H. Barnett

given: A. H.

name: Department of Medicine, University of Miami, Miami, FL, USA

family: Meneghini

full_name: L. F. Meneghini

given: L. F.

name: Department of Medicine, Bogenhausen Academic Teaching Hospital, Munich, Germany

family: Schumm‐Draeger

full_name: P.‐M. Schumm‐Draeger

journal_name: Diabetic Medicine

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

location_country:
United States
India
Spain
France
Japan
Russian Federation
China
Turkey
Germany
United Kingdom

intervention_type: Behavioral


title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.

summary: The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

lead_sponsor: Sheba Medical Center

location_country:
Italy
Serbia
France
Greece
Israel
China
Korea, Republic of

location_facility: Gastroenterology department, Soroka medical center

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

location_facility: Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Zvezdara University Clinical Center, Gastroenterology Department

location_facility: Department of Gastroenterology, University Hospital & Medical School of Ionnina

location_facility: 6th affiliated hospital of Sun yat-sen university

location_facility: Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University

location_facility: nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine


title: Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma

acronym: VINILO

summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Italy
Austria
Switzerland
Netherlands
France
Spain
Denmark
Germany
United Kingdom

location_facility: Koordinierungszentrum für Klinische Studien (KKS) der Charité

location_facility: Cancer Research UK Clinical Trials Unit School of Cancer Sciences University of Birmingham


title: PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

ReferenceCitation: Vairy S, Le Teuff G, Bautista F, De Carli E, Bertozzi AI, Pagnier A, Fouyssac F, Nysom K, Aerts I, Leblond P, Millot F, Berger C, Canale S, Paci A, Poinsignon V, Chevance A, Ezzalfani M, Vidaud D, Di Giannatale A, Hladun-Alvaro R, Petit FM, Vassal G, Geoerger B, Le Deley MC, Grill J. Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma. Neurooncol Adv. 2020 Jun 9;2(1):vdaa075. doi: 10.1093/noajnl/vdaa075. eCollection 2020 Jan-Dec.

name: Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France

family: Vairy

full_name: Stephanie Vairy

given: Stephanie

name: Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France

name: Service de Biostatistique et d’Epidémiologie, Gustave Roussy, Villejuif, France

family: Le Teuff

full_name: Gwénaël Le Teuff

given: Gwénaël

family: Bautista

full_name: Francisco Bautista

given: Francisco

name: Département d’Hematologie et d’Oncologie Pediatrique, Centre Hospitalier Universitaire d’Angers, Angers, France

family: De Carli

full_name: Emilie De Carli

given: Emilie

name: Département d’Hematologie et d’Oncologie Pediatrique, Hopital Purpan, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

family: Bertozzi

full_name: Anne-Isabelle Bertozzi

given: Anne-Isabelle

name: Département d’Hematologie et d’Oncologie Pediatrique, Centre Hospitalier Universitaire de Grenoble, La Tronche, France

family: Pagnier

full_name: Anne Pagnier

given: Anne

name: Département d’Hematologie et d’Oncologie Pediatrique, Centre Hospitalier Universitaire de Nancy, Nancy, France

family: Fouyssac

full_name: Fanny Fouyssac

given: Fanny

name: Department of Pediatric Hematology and Oncology, Rigshospitalet, Copenhagen, Denmark

family: Nysom

full_name: Karsten Nysom

given: Karsten

name: SIREDO Center, Institut Curie, Paris, France

family: Aerts

full_name: Isabelle Aerts

given: Isabelle

name: Unité d’oncologie pédiatrique, Centre Oscar Lambret, Lille, France

family: Leblond

full_name: Pierre Leblond

given: Pierre

name: Département d’Hematologie et d’Oncologie Pediatrique, Centre Hospitalier Universitaire de Poitiers, Poitiers, France

family: Millot

full_name: Frederic Millot

given: Frederic

name: Département d’Hematologie et d’Oncologie Pediatrique, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Priest-en-Jarez, France

name: University Research Team EA, SNA-EPIS, Saint-Etienne, France

family: Berger

full_name: Claire Berger

given: Claire

name: Department of Radiology, Gustave Roussy, Villejuif, France

family: Canale

full_name: Sandra Canale

given: Sandra

name: Department of Pharmacology and Pharmacokinetics Unit School of Pharmacy, Université Paris-Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France

family: Paci

full_name: Angelo Paci

given: Angelo

family: Poinsignon

full_name: Vianney Poinsignon

given: Vianney

family: Chevance

full_name: Aurelie Chevance

given: Aurelie

family: Ezzalfani

full_name: Monia Ezzalfani

given: Monia

name: Service de Génétique et Biologie Moléculaires, Hopital Cochin, Hopitaux Universitaires de Paris Centre, Assistance Publique—Hôpitaux de Paris, and EA7331, Faculte de Pharmacie de Paris, Universite Paris Descartes, Paris, France

family: Vidaud

full_name: Dominique Vidaud

given: Dominique

family: Di Giannatale

full_name: Angela Di Giannatale

given: Angela

family: Hladun-Alvaro

full_name: Raquel Hladun-Alvaro

given: Raquel

name: Département de Génétique Moléculaire, Hopital Antoine Beclere, Clamart, France

family: Petit

full_name: Francois M Petit

given: Francois M

family: Vassal

full_name: Gilles Vassal

given: Gilles

family: Geoerger

full_name: Birgit Geoerger

given: Birgit


title: A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

summary: To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

location_country:
Italy
Sweden
France
Japan
Poland
Belgium
Russian Federation
Spain
Turkey
Czech Republic


title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

summary: The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

ReferenceCitation: Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.

family: Thieme

full_name: Marcus Thieme

given: Marcus

family: Von Bilderling

full_name: Peter Von Bilderling

given: Peter

family: Paetzel

full_name: Christian Paetzel

given: Christian

family: Karnabatidis

full_name: Dimitrios Karnabatidis

given: Dimitrios

family: Perez Delgado

full_name: Julio Perez Delgado

given: Julio

family: Lichtenberg

full_name: Michael Lichtenberg

given: Michael

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: C. R. Bard

location_country:
Italy
Austria
Switzerland
France
Poland
Greece
Belgium
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliera della Valtellina e dalla Valchiavenna

location_facility: Szpital Kliniczny Przemienienia Panskiego


title: Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure

summary: This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Austria
France
Australia
Germany
United Kingdom

location_facility:
The Heart and Diabetes Center NRW
Hospitalier Pitié-Salpétrière
Medical University AKH Vienna
Hannover Medical School MHH
Uniklinik Hamburg Eppendorf (UKE)
German Heart Institute Berlin DHZB
St. Vincents Hospital
University of Leipzig Heart Center
Papworth Hospital NHS Foundation
Duesseldorf University Hospital
Freeman Hospital


title: A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

summary: A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

lead_sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

location_country:
United States
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Memorial Sloan Kettering Cancer Center Dept of Onc..


title: A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate

acronym: SERUM

summary: The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

lead_sponsor: Pfizer

location_country:
Hong Kong
France
Israel
Belgium
Australia
Russian Federation
Spain

location_facility: Cliniques Universitaires Saint-Luc / Service de Rhumatologie

location_facility: LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7

location_facility: GBOU VPO Moscow State University of Medicine and Dentistry

location_facility: Scientific Institute of Rheumatology of Russian Academy of Medical Science

location_facility: Hospital Regional Universitario Carlos Haya. Hospital Civil

location_facility: LLC "Alliance Biomedical - Russian Group"


title: A Dose-finding Phase Ib Multicenter Study of Imatinib in Combination With the Oral Phosphatidyl-inositol 3-kinase (PI3K) Inhibitor BYL719 in Patients With Gastrointestinal Stromal Tumor (GIST) Who Failed Prior Therapy With Imatinib and Sunitinib

summary: The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.

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

location_facility: Oregon Health and Science University Dept. of OHSU (3)


title: An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.

summary: This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

time_perspective: Retrospective

ReferenceCitation: van Bömmel F, van Bömmel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Böhm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.

name: Hepatology Section, Department of Gastroenterology and Rheumatology, University Hospital Leipzig, Germany

family: van Bömmel

full_name: Florian van Bömmel

given: Florian

name: Max Planck Institute for Molecular Genetics, Berlin, Germany

full_name: Alena van Bömmel

given: Alena

family: Krauel

full_name: Alexander Krauel

given: Alexander

name: Roche Products, Welwyn Garden City, United Kingdom

family: Wat

full_name: Cynthia Wat

given: Cynthia

family: Pavlovic

full_name: Vedran Pavlovic

given: Vedran

family: Yang

full_name: Lei Yang

given: Lei

family: Deichsel

full_name: Danilo Deichsel

given: Danilo

family: Berg

full_name: Thomas Berg

given: Thomas

name: Max von Pettenkofer-Institute, Ludwig-Maximilians-University, Munich, Germany

family: Böhm

full_name: Stephan Böhm

given: Stephan

journal_name: The Journal of Infectious Diseases

repository_institution: Max Planck Society - MPG.PuRe

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Hong Kong
France
Thailand
Singapore
Australia
Russian Federation
New Zealand
Korea, Republic of
Taiwan


ReferenceCitation: Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Böger CA, Scottà C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Öllinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyó J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7. Erratum in: Lancet. 2020 Jun 27;395(10242):1972.

family: Sawitzki

full_name: Birgit Sawitzki

family: Harden

full_name: Paul N Harden

given: Paul N

family: Reinke

full_name: Petra Reinke

given: Petra

family: Moreau

full_name: Aurélie Moreau

given: Aurélie

family: Hutchinson

full_name: James A Hutchinson

given: James A

family: Game

full_name: David S Game

given: David S

family: Tang

full_name: Qizhi Tang

given: Qizhi

family: Guinan

full_name: Eva C Guinan

given: Eva C

family: Battaglia

full_name: Manuela Battaglia

given: Manuela

family: Burlingham

full_name: William J Burlingham

given: William J

family: Roberts

full_name: Ian S D Roberts

given: Ian S D

family: Streitz

full_name: Mathias Streitz

given: Mathias

family: Josien

full_name: Régis Josien

given: Régis

family: Böger

full_name: Carsten A Böger

given: Carsten A

family: Scottà

full_name: Cristiano Scottà

given: Cristiano

family: Markmann

full_name: James F Markmann

given: James F

family: Hester

full_name: Joanna L Hester

given: Joanna L

family: Juerchott

full_name: Karsten Juerchott

given: Karsten

family: Braudeau

full_name: Cecile Braudeau

given: Cecile

family: James

full_name: Ben James

given: Ben

family: Contreras-Ruiz

full_name: Laura Contreras-Ruiz

given: Laura

family: van der Net

full_name: Jeroen B van der Net

given: Jeroen B

family: Bergler

full_name: Tobias Bergler

given: Tobias

family: Caldara

full_name: Rossana Caldara

given: Rossana

family: Petchey

full_name: William Petchey

given: William

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

location_country:
Italy
United States
France
Germany
United Kingdom

location_facility: Guy's Hospital in affiliation with King's College London

location_facility: Churchill Hospital in affiliation with the University of Oxford

title: Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation

summary: To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.


title: Randomized, Long-Term Administration of pH-Neutral PD Solutions Containing Lactate (BALANCE) or Bicarbonate (BICAVERA) in Children

acronym: BIOKID

summary:
Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved for the European market. Short term administration suggests comparable clearance rates compared with conventional solutions. In vitro studies demonstrate an improved local immune defense system. To compensate for metabolic acidosis, the available solutions either contain lactate or bicarbonate, the impact of either buffer on long term acidosis control and peritoneal membrane integrity, however, is unknown.

The prospective, European multi-center study will provide the first long term administration of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end point will be the effect of either PD-solution on peritoneal transport characteristics (D/P Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants of the peritoneal transporter status and of the continued morphological transformation of the peritoneum will be assessed.

After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution, the patients will be randomized to a 10 month study period using BicaVera and Balance, respectively. Dialysis regime and follow up in the out-patient clinic will be performed according to clinical needs (every 4 weeks); episodes of peritonitis will be treated according to international guidelines. Bicarbonate supplements will be prescribed at a dose of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3, 6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained at any time of abdominal surgery. Adverse events will be screened meticulously. The trial will be carried out in accordance with the German medicines act (AMG) and other local requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and the declaration of Helsinki. At study end, the patients will decide together with the responsible physician which PD-fluid should be used further one.

ReferenceCitation: Nau B, Schmitt CP, Almeida M, Arbeiter K, Ardissino G, Bonzel KE, Edefonti A, Fischbach M, Haluany K, Misselwitz J, Kemper MJ, Rönnholm K, Wygoda S, Schaefer F; European Pediatric Peritoneal Dialysis Study Group. BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991]. BMC Nephrol. 2004 Oct 14;5:14.

ReferenceCitation: Schmitt CP, Nau B, Gemulla G, Bonzel KE, Hölttä T, Testa S, Fischbach M, John U, Kemper MJ, Sander A, Arbeiter K, Schaefer F. Effect of the dialysis fluid buffer on peritoneal membrane function in children. Clin J Am Soc Nephrol. 2013 Jan;8(1):108-15. doi: 10.2215/CJN.00690112. Epub 2012 Nov 2.

family: Schmitt

full_name: Claus Peter Schmitt

given: Claus Peter

family: Nau

full_name: Barbara Nau

given: Barbara

family: Gemulla

full_name: Gita Gemulla

given: Gita

family: Bonzel

full_name: Klaus E. Bonzel

given: Klaus E.

family: Hölttä

full_name: Tuula Hölttä

given: Tuula

family: Testa

full_name: Sara Testa

given: Sara

family: Fischbach

full_name: Michel Fischbach

given: Michel

family: John

full_name: Ulrike John

given: Ulrike

family: Kemper

full_name: Markus J. Kemper

given: Markus J.

family: Sander

full_name: Anja Sander

given: Anja

family: Arbeiter

full_name: Klaus Arbeiter

given: Klaus

family: Schaefer

full_name: Franz Schaefer

given: Franz

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

title: Effect of the Dialysis Fluid Buffer on Peritoneal Membrane Function in Children

lead_sponsor: Heidelberg University

location_country: Italy Austria Finland France Germany

location_facility:
University Children's Hospital
University Children´s Hospital


acronym: PARTITA

summary: The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.

ReferenceCitation: Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65.

ReferenceCitation: Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.

ReferenceCitation: Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2.

ReferenceCitation: Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.

ReferenceCitation: Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.

ReferenceCitation: Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.

ReferenceCitation: Gilliam FR, Hayes DL, Boehmer JP, Day J, Heidenreich PA, Seth M, Jones PW, Stein KM, Saxon LA. Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study. J Cardiovasc Electrophysiol. 2011 Sep;22(9):1023-9. doi: 10.1111/j.1540-8167.2011.02086.x. Epub 2011 May 31.

ReferenceCitation: Carbucicchio C, Santamaria M, Trevisi N, Maccabelli G, Giraldi F, Fassini G, Riva S, Moltrasio M, Cireddu M, Veglia F, Della Bella P. Catheter ablation for the treatment of electrical storm in patients with implantable cardioverter-defibrillators: short- and long-term outcomes in a prospective single-center study. Circulation. 2008 Jan 29;117(4):462-9. doi: 10.1161/CIRCULATIONAHA.106.686534. Epub 2008 Jan 2.

ReferenceCitation: Della Bella P, Baratto F, Tsiachris D, Trevisi N, Vergara P, Bisceglia C, Petracca F, Carbucicchio C, Benussi S, Maisano F, Alfieri O, Pappalardo F, Zangrillo A, Maccabelli G. Management of ventricular tachycardia in the setting of a dedicated unit for the treatment of complex ventricular arrhythmias: long-term outcome after ablation. Circulation. 2013 Apr 2;127(13):1359-68. doi: 10.1161/CIRCULATIONAHA.112.000872. Epub 2013 Feb 25.

ReferenceCitation: Vergara P, Trevisi N, Ricco A, Petracca F, Baratto F, Cireddu M, Bisceglia C, Maccabelli G, Della Bella P. Late potentials abolition as an additional technique for reduction of arrhythmia recurrence in scar related ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2012 Jun;23(6):621-7. doi: 10.1111/j.1540-8167.2011.02246.x. Epub 2012 Apr 4.

ReferenceCitation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

name: Knight Cardiovascular Institute, Oregon Health and Science University, Portland, OR (B.K., E.C.S., B.N.).

family: Kheiri

full_name: Babikir Kheiri

given: Babikir

name: Department of Internal Medicine (M.B., Y.Z., L.R., H.H.K., G.B.), Hurley Medical Center/Michigan State University, Flint.

family: Barbarawi

full_name: Mahmoud Barbarawi

given: Mahmoud

family: Zayed

full_name: Yazan Zayed

given: Yazan

name: Michigan Medicine, University of Michigan, Ann Arbor (M. Hicks).

family: Hicks

full_name: Michael Hicks

given: Michael

name: Division of Cardiology, West Virginia University School of Medicine, Morgantown (M.O.).

family: Osman

full_name: Mohammed Osman

given: Mohammed

family: Rashdan

full_name: Laith Rashdan

given: Laith

family: Kyi

full_name: Htay Htay Kyi

given: Htay Htay

family: Bachuwa

full_name: Ghassan Bachuwa

given: Ghassan

name: Division of Cardiology (M. Hassan), Hurley Medical Center/Michigan State University, Flint.

family: Hassan

full_name: Mustafa Hassan

given: Mustafa

family: Stecker

full_name: Eric C. Stecker

given: Eric C.

family: Nazer

full_name: Babak Nazer

given: Babak

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

journal_name: Circulation: Arrhythmia and Electrophysiology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: IRCCS San Raffaele

location_country: Italy Switzerland France Czechia Belgium Portugal Germany

location_facility: Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria

location_facility: Azienda Ospedaliera Valtellina e Valchiavenna


title: Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations

summary: The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

primary_purpose: Prevention

lead_sponsor: Spirig Pharma Ltd.

location_country:
Austria
Switzerland
Netherlands
United Kingdom
France
Ireland
Turkey
Germany
Czech Republic

location_facility: Hautklinik am Nationalen Zentrum für Tumorerkrankungen

location_facility: Klinikum der Charité Universitätsmedizin

location_facility: Universitätsspital Zürich, Dermatologische Klinik


title: A Phase III Randomized Study of TH (Paclitaxel and Trastuzumab) Versus THL (Paclitaxel, Trastuzumab and Lapatinib) in First Line Treatment of HER2-positive Metastatic Breast Cancer

acronym: TH V THL

summary: The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

lead_sponsor: Cancer Trials Ireland

location_country: Spain Finland France Israel Norway Ireland Portugal Germany

location_facility: Hospital General Universitario de Valencia

location_facility: Interdisziplinäre Onkologische Zentrum München (IOZ München)

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Complejo Hospitalario Xeral Calde / Hospital Lucus Augusti

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario 'Lozano Blesa'