title: ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

acronym: ImpleMentAll

summary:
The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are:

To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services.
To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders.
To disseminate the validated toolkit in various healthcare contexts across Europe.

Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.

primary_purpose: Health Services Research

ReferenceCitation: Doukani A, Cerga Pashoja A, Fanaj N, Qirjako G, Meksi A, Mustafa S, Vis C, Hug J. Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis. JMIR Form Res. 2021 Nov 1;5(11):e29280. doi: 10.2196/29280.

publisher_dissemination: JMIR Publications

ReferenceCitation: Buhrmann L, Schuurmans J, Ruwaard J, Fleuren M, Etzelmuller A, Piera-Jimenez J, Finch T, Rapley T, Potthoff S, Aouizerate B, Batterham PJ, Calear A, Christensen H, Pedersen CD, Ebert DD, Van der Eycken E, Fanaj N, van Genugten C, Hanssen D, Hegerl U, Hug J, Kleiboer A, Mathiasen K, May C, Mustafa S, Oehler C, Cerga-Pashoja A, Pope C, Qirjako G, Rosmalen J, Sacco Y, Samalin L, Skjoth MM, Tarp K, Titzler I, Zanalda E, Zbukvic I, Smit JH, Riper H, Vis C; ImpleMentAll consortium. Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial. Trials. 2020 Oct 28;21(1):893. doi: 10.1186/s13063-020-04686-4.

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

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

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

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

repository_institution: no - no

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;nrl.northumbria.ac.uk;ora.ox.ac.uk;pure.rug.nl;researchonline.lshtm.ac.uk;sdu.dk;ub.uni-erlangen.de-opus

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

ipd_sharing_description: IPD will be available on request following a standardised data accession form on relevant participant data. Note this data does not contain clinical outcomes.

lead_sponsor: VU University of Amsterdam

collaborators: London School of Hygiene and Tropical Medicine

collaborators: Qendres se Shendetit the Mireqenies Komunitare

collaborators: Global alliance of mental illness advocacy networks Europe AISBL

location_country: Germany Italy Albania Denmark Australia Netherlands Spain Kosovo France

location_facility:
Get.On
CMHTIR
DF
UMCG
GGZ InGeest
FDM
ASLTO3
MHCPPriz
Internet Psychiatrien
BDI
ANU
BSA


type: Other Grant/Funding Number

title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17

summary:
Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description.

The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hjermstad MJ, Bergenmar M, Bjordal K, Fisher SE, Hofmeister D, Montel S, Nicolatou-Galitis O, Pinto M, Raber-Durlacher J, Singer S, Tomaszewska IM, Tomaszewski KA, Verdonck-de Leeuw I, Yarom N, Winstanley JB, Herlofson BB; EORTC QoL Group. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer. 2016 Sep;24(9):3915-24. doi: 10.1007/s00520-016-3216-0. Epub 2016 Apr 25.

ReferenceType: result

ReferenceCitation: Hjermstad MJ, Bergenmar M, Fisher SE, Montel S, Nicolatou-Galitis O, Raber-Durlacher J, Singer S, Verdonck-de Leeuw I, Weis J, Yarom N, Herlofson BB. The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients. Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Epub 2012 May 8.

ReferenceType: derived

ReferenceCitation: Johns SA, Brown LF, Beck-Coon K, Talib TL, Monahan PO, Giesler RB, Tong Y, Wilhelm L, Carpenter JS, Von Ah D, Wagner CD, de Groot M, Schmidt K, Monceski D, Danh M, Alyea JM, Miller KD, Kroenke K. Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Support Care Cancer. 2016 Oct;24(10):4085-96. doi: 10.1007/s00520-016-3220-4. Epub 2016 May 17.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

version: submittedVersion

repository_institution: Indiana University - IUScholarWorks

repositories_concat: PubMed Central;scholarworks.iupui.edu

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ipd_sharing: Yes

ipd_sharing_description: Phase III and Phase IV reports approved by the EORTC Quality of Life Group Executive Committee. First publication in Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Second publication accepted for publication in Supp Care Cancer, April 2016

lead_sponsor: Oslo University Hospital

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

location_country:
Germany
Italy
France
Poland
Norway
United Kingdom
Sweden
Netherlands
Greece
Israel

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

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Influence of the Pre-existing Cognitive Status on the Outcome in Patients Treated by Thrombolytic Therapy for Acute Cerebral Ischaemia

acronym: OPHELIE-COG

summary:
At the acute stage of cerebral ischaemia, the only effective drug that increases the proportion of patients who survive without dependency is thrombolytic therapy by intravenous (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice with similar results than in trials, in various places of the world including Europe and Japan.

Stroke and dementia are closely related. About one patient in ten has dementia before a first-ever stroke, and more than one in three has dementia after a recurrent stroke. Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing cognitive impairment without dementia is associated with a higher rate of institutionalisation within 3 years. In many patients cognitive impairment is due to the summation of the effects of vascular and Alzheimer lesions of the brain.

More and more patients nowadays who are eligible for rt-PA are already known as demented at admission. A retrospective study conducted in a cohort of patients with dementia who had an ischaemic stroke and were treated by rtPA suggested that there is no increased risk of cerebral bleeding and death as compared with non demented patients. However, pre-existing cognitive impairment is possibly associated with (i) an increased risk of bleeding in patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of rt-PA on the brain tissue.

Japanese patients differ from European patients by a higher risk of spontaneous intracranial haemorrhage, and a higher proportion of patients with small-vessel diseases.

The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment or dementia. The secondary objectives are to determine whether (i) they have an increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a poor outcome is lower than expected from the placebo group of randomised trials for patients with a similar range of baseline severity, and (iii) the influence of the cognitive state on outcome differs between Japanese and European patients.

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_country: Japan France

location_facility:
Kyushu University
Kyushu Rosai Hospital
Kyushu Medical Center
St. Mary's Hospital
Steel Memorial Yawata Hospital
Kawasaki Medical University
Lille University Hospital
Fukuoka-Higashi Medical center
Fukuoka Redcross Hospital


type: EudraCT Number

title: A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.

acronym: NeoEribulin

summary: This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer.

study_type: Interventional

primary_purpose: Treatment

ReferenceCitation: Prat P, Llombart A, de la Peña L, Di Cosimo S, Oliveira M, Ortega V, Rubio I, Muñoz E, Harbeck N, Cortés J. NeoEribulin: A Phase II, non-randomized, open-label, single-arm, multicenter, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.

lead_sponsor: SOLTI Breast Cancer Research Group

sponsor_collaborators:
SOLTI Breast Cancer Research Group
Eisai Inc.

location_country: Germany Spain Portugal France

location_facility: Brustzentrum im Krankenhaus Köln-Holweide Priv. Doz.

location_facility: Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik

location_facility: Klinikum des Landkreises Deggendorf Frauenklinik Mammazentrum

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE

location_facility: Complejo Hospitalario San Pedro de Alcántara

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Clínico San Carlos

intervention_type: Drug

lead_sponsor_type: industriel


title: European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF

acronym: HISTORIC-AF

summary:
Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining surgical endoscopic and transcatheter techniques in a staged fashion provides superior clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting > 1 year but > 5 years.

The proposed procedure involves the creation of cardiac lesions with epicardially applied radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Bisleri G, Curnis A, Bottio T, Mascioli G, Muneretto C. The need of a hybrid approach for the treatment of atrial fibrillation. Heart Surg Forum. 2005;8(5):E326-30. doi: 10.1532/HSF98.20051125.

ReferenceCitation: Muneretto C, Bisleri G, Rosati F, Krakor R, Giroletti L, Di Bacco L, Repossini A, Moltrasio M, Curnis A, Tondo C, Polvani G. European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):740-745. doi: 10.1093/ejcts/ezx162.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

lead_sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_country:
Germany
Italy
Poland
United Kingdom
France

location_facility:
Ospedale Gavazzeni
Royal Brompton
Hammersmith Hospital
Stadtische Kliniken
Univ.Hosp. Molinette
Heart Center Brandenburg- Immanuel
University Hospital
Louis Pradel Hospital
Univ. Hosp. Spedali Civili
Hamburg Uke

status_simplified: Unknown


title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

acronym: ARTFORCE

summary:
This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

status: Active, not recruiting

design_allocation: Randomized

ReferenceCitation: Heukelom J, Hamming O, Bartelink H, Hoebers F, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: The Netherlands Cancer Institute

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
France
United Kingdom
Netherlands
Spain
Sweden

location_facility:
University Medical Centre Utrecht
Netherlands Cancer Institute
Erasmus Medical Centre
Gustave Roussy Cancer Institute
Karolinska Institute
Maastro Clinic
Universitair Medisch Centrum Groningen
Christie Hospital NHS Trust
University Hospital Vall d'Hebron

status_simplified: Ongoing


title: A Phase IV, Single-blinded, Prospective, Randomized, Controlled, Multi-center Study to Compare the Clinical Outcomes of Genea Embryo Review Instrument Plus (GERI+) Time Lapse System With a Conventional Embryo Culture and Assessment System

acronym: TICON

summary: The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.

study_start_date_type: Actual

status: Terminated

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country: Italy Portugal Norway Denmark Spain Canada France

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

location_facility: Sykehuset Telemark HF Fertilitetsavdeliningen Sor

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Fertility Clinic Skive Regional Hospital

intervention_type: Device


title: Efficacy of Oral Alitretinoin Treatment in Patients With Palmo-plantar Pustulosis (PPP) Inadequately Responding to Standard Topical Treatment

summary: The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.

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: Stiefel, a GSK Company

sponsor_collaborators:
Stiefel, a GSK Company
Basilea Pharmaceutica

location_country:
Germany
United Kingdom
Netherlands
France


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to assess long-term safety and provide continued study treatment access to eligible participants who are judged by the Investigator to benefit from continued treatment with capmatinib monotherapy or in combination with other treatments or with the combination treatment alone in a Novartis sponsored study

location_facility: Massachusetts General Hospital MGH Cancer Center

status: Recruiting

title: An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.

source: euctr

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

design_allocation: Non-Randomized

location_country:
Germany
Italy
Singapore
Denmark
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: Phase III Study Assessing the "Best of" Radiotherapy Compared to the "Best of" Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma

acronym: Best Of

summary:
Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints.

In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance.

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.

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

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Belgium
Spain
France

location_facility: South Tees Hospitals NHS Foundation Trust - The James Cook University Hospital

location_facility: Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

location_facility: UniversitaetsSpital Zurich - Klinik fur Ohren, Hals und Gesichtschirurgie

location_facility: Universitaetsklinikum Tuebingen- Crona Kliniken

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Staedtisches Klinikum Leipzig - Klinikum St Georg

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: Hospital Universitario Central De Asturias

location_facility: Klinikum Rechts der isar Der Technische Universitaet Muenchen

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales

location_facility: Guy's and St Thomas' NHS Foundation trust - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Universitaets Krankenhaus Eppendorf - UKE - University Cancer Center

location_facility: Universitaetklinikum Halle - Martin Luther Universitaet

intervention_type: Procedure


lead_sponsor: Ultragenyx Pharmaceutical Inc

summary: The primary objective of the study was to evaluate the efficacy and safety of UX007 in the treatment of disabling paroxysmal movement disorders associated with Glut1 DS.

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

location_facility: Sheffield Children's NHS Foundation Trust

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Efficacy and Safety of UX007 in the Treatment of Movement Disorders Associated With Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)

location_country:
Germany
Italy
United Kingdom
United States
Spain
France


title: International Registry Study of Neutral Lipid Storage Disease (NLSD) / Triglyceride Deposit Cardiomyovasculopathy (TGCV) and Related Diseases

summary: This study aims to understand the state of onset of NLSD(neutral lipid storage disease) / TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected patients, and natural history of the disease, as well as exploring the prognostic factors and assessing the efficacy of disease-specific treatment.

time_perspective: Other

lead_sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
Austria
United States
China
France

location_facility: National Center of Neurology and Psychiatry


title: A Multi-Center, Open Label, Phase I, Dose Finding and Expansion Study of RO7051790 Administered Orally in Patients With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)

summary: This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
United States
Spain
Canada
France

location_facility: The Ottawa Hospital Cancer Centre; Oncology

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

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


title: Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients With Indolent Non-follicular B-CELL Lymphomas

summary: Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.

ReferenceCitation: Luminari S, Merli M, Rattotti S, Tarantino V, Marcheselli L, Cavallo F, Varettoni M, Bianchi B, Merli F, Tedeschi A, Cabras G, Re F, Visco C, Torresan Delamain M, Cencini E, Spina M, Ferrero S, Ferrari A, Deodato M, Mannina D, Annibali O, Rago A, Orsucci L, Defrancesco I, Frigeni M, Cesaretti M, Arcaini L. Early progression as a predictor of survival in marginal zone lymphomas: an analysis from the FIL-NF10 study. Blood. 2019 Sep 5;134(10):798-801. doi: 10.1182/blood.2019001088. Epub 2019 Jul 10.

oa_colors: green other

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

publisher_dissemination: American Society of Hematology

lead_sponsor: Fondazione Italiana Linfomi - ETS

location_country: Italy Portugal Brazil Austria Ukraine France

location_facility: Oncologia Medica A - Centro di Riferimento Oncologico

location_facility: UO Ematologia con Trapianto Policlinico Consorziale

location_facility: Center of Hematology and Hemotherapy, UNICAMP, University of Campinas

location_facility: Ematologia Ospedale Madonna delle Grazie

location_facility: UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata

location_facility: Divisione di Ematologia, Ospedale San Bortolo

location_facility: UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima

location_facility: SC Oncoematologia con autotrapianto AO S. Maria Terni

location_facility: UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Ematologia IRCCS Policlinico S. Matteo di Pavia

location_facility: Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas

location_facility: Dipartimento di Oncoematologia Ospedale San Raffaele

location_facility: Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia

location_facility: Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara

location_facility: National Cancer Institute of Health Ukraine

location_facility: Unità Operativa Complessa di Ematologia - AO di Cosenza

location_facility: SC Ematologia Universitaria, AO Città della Salute e della Scienza

location_facility: SC. Ematologia. Osp. Riuniti Papardo Piemonte

location_facility: USC Ematologia Ospedali Riuniti di Bergamo

location_facility: SC Ematologia Arcispedale Santa Maria Nuova

location_facility: SC Ematologia, AO Città della Salute e della Scienza

location_facility: Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

location_facility: Clinica Ematologica AO San Gerardo di Monza

location_facility: Ematologia e CTMO Ospedale Maggiore di Parma

intervention_type: Other


title: Influence of Preoperative Hemodialysis or Intraoperative Modified Ultrafiltration on Postoperative Outcome for Patients With Severe Renal Dysfunction Undergoing Open Heart Surgery: Randomized, Controlled, Multicenter Clinical Trial

acronym: SeRenaD-CPB

summary: The purpose of this study is to determine whether preoperative hemodialysis or intraoperative modified ultrafiltration are effective for patients with non-dialysis dependent severe renal dysfunction undergoing open heart surgery.

ReferenceCitation: Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.

ReferenceCitation: Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342.

ReferenceCitation: Levin A, Foley RN. Cardiovascular disease in chronic renal insufficiency. Am J Kidney Dis. 2000 Dec;36(6 Suppl 3):S24-30. doi: 10.1053/ajkd.2000.19928.

ReferenceCitation: Anderson RJ, O'brien M, MaWhinney S, VillaNueva CB, Moritz TE, Sethi GK, Henderson WG, Hammermeister KE, Grover FL, Shroyer AL. Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery. VA Cooperative Study #5. Kidney Int. 1999 Mar;55(3):1057-62. doi: 10.1046/j.1523-1755.1999.0550031057.x.

ReferenceCitation: Cooper WA, O'Brien SM, Thourani VH, Guyton RA, Bridges CR, Szczech LA, Petersen R, Peterson ED. Impact of renal dysfunction on outcomes of coronary artery bypass surgery: results from the Society of Thoracic Surgeons National Adult Cardiac Database. Circulation. 2006 Feb 28;113(8):1063-70. doi: 10.1161/CIRCULATIONAHA.105.580084. Epub 2006 Feb 20.

ReferenceCitation: Zakeri R, Freemantle N, Barnett V, Lipkin GW, Bonser RS, Graham TR, Rooney SJ, Wilson IC, Cramb R, Keogh BE, Pagano D. Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting. Circulation. 2005 Aug 30;112(9 Suppl):I270-5. doi: 10.1161/CIRCULATIONAHA.104.522623.

ReferenceCitation: Weerasinghe A, Hornick P, Smith P, Taylor K, Ratnatunga C. Coronary artery bypass grafting in non-dialysis-dependent mild-to-moderate renal dysfunction. J Thorac Cardiovasc Surg. 2001 Jun;121(6):1083-9. doi: 10.1067/mtc.2001.113022.

ReferenceCitation: Ibanez J, Riera M, Saez de Ibarra JI, Carrillo A, Fernandez R, Herrero J, Fiol M, Bonnin O. Effect of preoperative mild renal dysfunction on mortality and morbidity following valve cardiac surgery. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):748-52. doi: 10.1510/icvts.2007.159392. Epub 2007 Sep 21.

ReferenceCitation: Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Carpentier A, Adams DH. Early and late outcomes of cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):90-5. doi: 10.1510/icvts.2007.164483. Epub 2007 Nov 22.

ReferenceCitation: Devbhandari MP, Duncan AJ, Grayson AD, Fabri BM, Keenan DJ, Bridgewater B, Jones MT, Au J; North West Quality Improvement Programme in Cardiac Interventions. Effect of risk-adjusted, non-dialysis-dependent renal dysfunction on mortality and morbidity following coronary artery bypass surgery: a multi-centre study. Eur J Cardiothorac Surg. 2006 Jun;29(6):964-70. doi: 10.1016/j.ejcts.2006.03.038. Epub 2006 May 3.

ReferenceCitation: Kilo J, Margreiter JE, Ruttmann E, Laufer G, Bonatti JO. Slightly elevated serum creatinine predicts renal failure requiring hemofiltration after cardiac surgery. Heart Surg Forum. 2005;8(1):E34-8. doi: 10.1532/HSF98.20041117.

ReferenceCitation: Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203. doi: 10.7326/0003-4819-128-3-199802010-00005.

ReferenceCitation: Shen I, Giacomuzzi C, Ungerleider RM. Current strategies for optimizing the use of cardiopulmonary bypass in neonates and infants. Ann Thorac Surg. 2003 Feb;75(2):S729-34. doi: 10.1016/s0003-4975(02)04697-0.

ReferenceCitation: Naik SK, Knight A, Elliott MJ. A successful modification of ultrafiltration for cardiopulmonary bypass in children. Perfusion. 1991;6(1):41-50. doi: 10.1177/026765919100600106.

ReferenceCitation: Naik SK, Knight A, Elliott M. A prospective randomized study of a modified technique of ultrafiltration during pediatric open-heart surgery. Circulation. 1991 Nov;84(5 Suppl):III422-31.

ReferenceCitation: Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9. doi: 10.1161/hc37t1.094931.

ReferenceCitation: Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. doi: 10.1016/j.ejcts.2006.09.014. Epub 2006 Oct 13.

ReferenceCitation: Boga M, Islamoglu, Badak I, Cikirikcioglu M, Bakalim T, Yagdi T, Buket S, Hamulu A. The effects of modified hemofiltration on inflammatory mediators and cardiac performance in coronary artery bypass grafting. Perfusion. 2000 Mar;15(2):143-50. doi: 10.1177/026765910001500209.

ReferenceCitation: Capuano F, Bianchini R, Goracci M, Roscitano A, Luciani R, Simon C, Giusti L, Sinatra R. Intraoperative veno-arterial hemofiltration during miniaturized extracorporeal bypass. Ann Thorac Surg. 2007 Jun;83(6):2215-6. doi: 10.1016/j.athoracsur.2006.12.002.

ReferenceCitation: Durmaz I, Yagdi T, Calkavur T, Mahmudov R, Apaydin AZ, Posacioglu H, Atay Y, Engin C. Prophylactic dialysis in patients with renal dysfunction undergoing on-pump coronary artery bypass surgery. Ann Thorac Surg. 2003 Mar;75(3):859-64. doi: 10.1016/s0003-4975(02)04635-0.

ReferenceCitation: Bingol H, Akay HT, Iyem H, Bolcal C, Oz K, Sirin G, Demirkilic U, Tatar H. Prophylactic dialysis in elderly patients undergoing coronary bypass surgery. Ther Apher Dial. 2007 Feb;11(1):30-5. doi: 10.1111/j.1744-9987.2007.00452.x.

ReferenceCitation: Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

lead_sponsor: University Hospital, Geneva

sponsor_collaborators:
University Hospital, Geneva
University of Gaziantep
Ankara University
Pamukkale University
German Heart Institute
Hospices Civils de Lyon
Hospital Clinic of Barcelona

location_country: Germany Switzerland Spain Turkey France

location_facility: Gaziantep University, Department of Cardiovascular Surgery

location_facility: Ankara University, Department of Cardiovascular Surgery

location_facility: University Hospital of Geneva, Service for Cardiovascular Surgery

location_facility: University of Lyon, Hopital Cardiothoracique Louis Pradel

location_facility: Pamukkale University, Department of Cardiovascular Surgery

location_facility: Hospital Clinico, University of Barcelona, Department of Cardiovascular Surgery


intervention_type: Biological

lead_sponsor: CSL Behring

summary: The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

ReferenceCitation: Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, Belohradsky BH, Wahn V, Neufang-Huber J, Zenker O, Grimbacher B. Efficacy and safety of Hizentra((R)) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011 Oct;141(1):90-102. doi: 10.1016/j.clim.2011.06.002. Epub 2011 Jun 12.

ReferenceCitation: Borte M, Pac M, Serban M, Gonzalez-Quevedo T, Grimbacher B, Jolles S, Zenker O, Neufang-Hueber J, Belohradsky B. Efficacy and safety of hizentra(R), a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency. J Clin Immunol. 2011 Oct;31(5):752-61. doi: 10.1007/s10875-011-9557-z. Epub 2011 Jun 15.

title: A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

location_country:
Germany
Italy
Poland
United Kingdom
Romania
Sweden
Switzerland
Spain
France


acronym: RISE

lead_sponsor: Genzyme, a Sanofi Company

summary: This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e., treatment-naïve patients).

location_facility:
Hopital Avicenne/University
St. Johannes-Hospital Duisburg
Royal Bournemouth Hospital
King's College Hospital
UMC St Radboud Centraal
Medizinische Hochschule Hannover
St. James Hospital

title: A Phase II Study of the Efficacy of Rabbit Anti-thymocyte Globulin (rATG) in Patients With Low and Intermediate-1 Risk Myelodysplastic Syndrome


summary: This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention.

ReferenceCitation: Kuemmerle-Deschner JB, Ramos E, Blank N, Roesler J, Felix SD, Jung T, Stricker K, Chakraborty A, Tannenbaum S, Wright AM, Rordorf C. Canakinumab (ACZ885, a fully human IgG1 anti-IL-1beta mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS). Arthritis Res Ther. 2011 Feb 28;13(1):R34. doi: 10.1186/ar3266.

location_facility:
Novartis Investigator Site
Novartis Investigative site
Novartis investigative site

title: An Open-Label, Phase II Dose Titration Study of ACZ885 (Human Anti-IL-1β Monoclonal Antibody) to Assess the Clinical Efficacy, Safety, Pharmacokinetics and Pharmacodynamics in Patients With NALP3 Mutations

location_country:
Germany
India
United Kingdom
Spain
France


title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

summary: Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Poland
United Kingdom
Netherlands
Spain
France


title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.

lead_sponsor: Children's Cancer and Leukaemia Group

location_country:
Ireland
United Kingdom
France

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Sir James Spence Institute of Child Health

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Institute of Child Health at University of Bristol

location_facility: Southampton University Hospital NHS Trust

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

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

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust


title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder

summary:
Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.

ReferenceCitation: Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.

repositories_concat: PubMed Central;sdu.dk

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

publisher_dissemination: Wiley

ReferenceCitation: Buitelaar JK, Trott GE, Hofecker M, Waechter S, Berwaerts J, Dejonkheere J, Schauble B. Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD. Int J Neuropsychopharmacol. 2012 Feb;15(1):1-13. doi: 10.1017/S1461145711001131. Epub 2011 Jul 29.

lead_sponsor: Janssen-Cilag International NV

location_country: Germany Portugal Norway Netherlands Switzerland Spain France


title: A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease

summary: The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Germany Italy Sweden Netherlands Switzerland Spain Turkey France

location_facility:
Ospedale San Martino
Hospital Clínico Universitario
University Faculty of Medicine
Karolinska University Hospital
University Regensburg
Hopital St. Louis
University Hospital


title: A Prospective, Multi-Center, Post-Market Surveillance Study to Assess the Clinical Efficacy and Fusion Rates of the Zimmer TM Ardis Interbody Fusion System

summary: This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability.

ipd_sharing: Undecided

lead_sponsor: Zimmer Biomet

location_country: Germany Sweden Belgium Spain Canada France

location_facility: Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,

location_facility: Sahlgrenska University Hospital Department of Orthopedics, Spine Divison


title: Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.

ReferenceCitation: Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. doi: 10.1016/S1470-2045(13)70272-9. Epub 2013 Jul 4.

evidence: open (via free pdf)

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Elsevier

ReferenceCitation: Weeda VB, Murawski M, McCabe AJ, Maibach R, Brugieres L, Roebuck D, Fabre M, Zimmermann A, Otte JB, Sullivan M, Perilongo G, Childs M, Brock P, Zsiros J, Plaschkes J, Czauderna P, Aronson DC. Fibrolamellar variant of hepatocellular carcinoma does not have a better survival than conventional hepatocellular carcinoma--results and treatment recommendations from the Childhood Liver Tumour Strategy Group (SIOPEL) experience. Eur J Cancer. 2013 Aug;49(12):2698-704. doi: 10.1016/j.ejca.2013.04.012. Epub 2013 May 15.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: University of Leicester

location_country:
Ireland
United Kingdom
Netherlands
France

location_facility: Great Ormond Street Hospital for Children

location_facility: Sir James Spence Institute of Child Health at Royal Victoria Infirmary


title: MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.

ReferenceCitation: McDowell HP, Foot AB, Ellershaw C, Machin D, Giraud C, Bergeron C. Outcomes in paediatric metastatic rhabdomyosarcoma: results of The International Society of Paediatric Oncology (SIOP) study MMT-98. Eur J Cancer. 2010 Jun;46(9):1588-95. doi: 10.1016/j.ejca.2010.02.051. Epub 2010 Mar 24.

lead_sponsor: Societe Internationale d'Oncologie Pediatrique

collaborators:
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique

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


title: An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer

summary:
RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.

ReferenceCitation: Onate-Ocana LF, Alcantara-Pilar A, Vilar-Compte D, Garcia-Hubard G, Rojas-Castillo E, Alvarado-Aguilar S, Carrillo JF, Blazeby JM, Aiello-Crocifoglio V. Validation of the Mexican Spanish version of the EORTC C30 and STO22 questionnaires for the evaluation of health-related quality of life in patients with gastric cancer. Ann Surg Oncol. 2009 Jan;16(1):88-95. doi: 10.1245/s10434-008-0175-9. Epub 2008 Nov 1.

ReferenceCitation: Sadighi S, Montazeri A, Sedighi Z, Mohagheghi MA, Froutan H. Quality of life in patients with gastric cancer: translation and psychometric evaluation of the Iranian version of EORTC QLQ-STO22. BMC Cancer. 2009 Aug 28;9:305. doi: 10.1186/1471-2407-9-305.

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

location_country:
Germany
France
United Kingdom
Spain
Sweden

location_facility:
Universitaetsklinikum Charite
Sahlgrenska University Hospital
Royal Infirmary
Bristol Haematology and Oncology Centre
University of Marburg
Centre Alexis Vautrin
Hospital De Navarra


title: Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation

summary:
Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.

The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.

In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.

In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Insel Gruppe AG, University Hospital Bern

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

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Inselspital, Bern University Hospital, Department of Cardiology


title: Mitral Valve Repair Clinical Trial (MAVERIC Trial)

acronym: MAVERIC

summary: The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).

ReferenceCitation: Erglis A, Narbute I, Poupineau M, Hovasse T, Kamzola G, Zvaigzne L, Erglis M, Erglis K, Greene S, Rogers JH. Treatment of Secondary Mitral Regurgitation in Chronic Heart Failure. J Am Coll Cardiol. 2017 Dec 5;70(22):2834-2835. doi: 10.1016/j.jacc.2017.09.1110. No abstract available.

oa_host_type: closed

ReferenceCitation: Rogers JH, Thomas M, Morice MC, Narbute I, Zabunova M, Hovasse T, Poupineau M, Rudzitis A, Kamzola G, Zvaigzne L, Greene S, Erglis A. Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial). JACC Cardiovasc Interv. 2015 Jul;8(8):1095-1104. doi: 10.1016/j.jcin.2015.04.012. Epub 2015 Jun 24.

lead_sponsor: Mvrx, Inc.

location_country:
Italy
United Kingdom
Australia
Latvia
France

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Brighton and Sussex University Hospitals


title: A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

acronym: PLYCOM

summary: CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

location_country:
Poland
Australia
Korea, Republic of
Spain
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Fundacion Jimenez Diaz; Servicio de Hematologia

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

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii


title: The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers

acronym: EURACAN

summary:
Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care.

The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook).

The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes.

Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU.

ReferenceCitation: Gatta G, Capocaccia R, Botta L, Mallone S, De Angelis R, Ardanaz E, Comber H, Dimitrova N, Leinonen MK, Siesling S, van der Zwan JM, Van Eycken L, Visser O, Zakelj MP, Anderson LA, Bella F, Kaire I, Otter R, Stiller CA, Trama A; RARECAREnet working group. Burden and centralised treatment in Europe of rare tumours: results of RARECAREnet-a population-based study. Lancet Oncol. 2017 Aug;18(8):1022-1039. doi: 10.1016/S1470-2045(17)30445-X. Epub 2017 Jul 4. Erratum In: Lancet Oncol. 2017 Aug;18(8):e433.

ReferenceCitation: Gatta G, Trama A, Capocaccia R; RARECARENet Working Group. Epidemiology of rare cancers and inequalities in oncologic outcomes. Eur J Surg Oncol. 2019 Jan;45(1):3-11. doi: 10.1016/j.ejso.2017.08.018. Epub 2017 Sep 19.

ReferenceCitation: Siesling S, Louwman WJ, Kwast A, van den Hurk C, O'Callaghan M, Rosso S, Zanetti R, Storm H, Comber H, Steliarova-Foucher E, Coebergh JW. Uses of cancer registries for public health and clinical research in Europe: Results of the European Network of Cancer Registries survey among 161 population-based cancer registries during 2010-2012. Eur J Cancer. 2015 Jun;51(9):1039-49. doi: 10.1016/j.ejca.2014.07.016. Epub 2014 Aug 15.

ReferenceCitation: Trama A, Botta L, Foschi R, Visser O, Borras JM, Zagar T, Primic-Zakelj M, Bella F, Dimitrova N, Gatta G, Licitra L. Quality of Care Indicators for Head and Neck Cancers: The Experience of the European Project RARECAREnet. Front Oncol. 2019 Aug 28;9:837. doi: 10.3389/fonc.2019.00837. eCollection 2019.

ReferenceCitation: Orlandi E, Alfieri S, Simon C, Trama A, Licitra L; RARECAREnet Working Group. Treatment challenges in and outside a network setting: Head and neck cancers. Eur J Surg Oncol. 2019 Jan;45(1):40-45. doi: 10.1016/j.ejso.2018.02.007. Epub 2018 Feb 14.

ReferenceCitation: Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/

ipd_sharing_description: The governance (link https://euracan.eu/research/starter/european-registry-governance/)set the data access rules to the federated registry

lead_sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

collaborators: Associazione Italiana Oncologia Cervico Cefalica

location_country: Germany Italy Spain Czechia France

location_facility: Assistance Publique-Hôpitaux de Paris - Hôpital Tenon

location_facility: Centro Nazionale di Adroterapia Oncologica


title: REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

acronym: RESILIENCE

summary: Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.

primary_purpose: Prevention

lead_sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

location_country: Germany Portugal Denmark Netherlands Spain France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital da Luz Learning Health (GLSMED)

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Centro Nacional de Investigaciones Cardiovasculares (CNIC)

location_facility: Hospital Universitario Clínico San Carlos


title: Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery - A Physician-initiated, International, Multicentre, Prospective, Observational Registry of Patients Undergoing Open Thoracic (TAA) and Thoracoabdominal Aortic Aneurysms Repair (TAAA) Using Cryoablation of Intercostal Nerves to Improve Postoperative Pain Control. (Cryo Registry)

summary:
The purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair.

The cryoablation procedure is one of the opportunities for pain control after thoracotomy. So, it is routinely performed in major several centers in aortic surgery around the world as a part of the TAA and TAAA procedure.

The Registry will include approximately 200 patients treated from January 2022 to January 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until January 2027.

status: Suspended

ReferenceCitation: Carlsson CA, Persson K, Pelletieri L. Painful scars after thoracic and abdominal surgery. Acta Chir Scand. 1985;151(4):309-11.

ReferenceCitation: Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7.

ReferenceCitation: Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. doi: 10.1097/00000542-200603000-00027. No abstract available.

ReferenceCitation: Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20.

ReferenceCitation: Johnston KW, Rutherford RB, Tilson MD, Shah DM, Hollier L, Stanley JC. Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg. 1991 Mar;13(3):452-8. doi: 10.1067/mva.1991.26737.

ReferenceCitation: Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. doi: 10.1067/mva.2002.123991. No abstract available.

ReferenceCitation: Achouh PE, Madsen K, Miller CC 3rd, Estrera AL, Azizzadeh A, Dhareshwar J, Porat E, Safi HJ. Gastrointestinal complications after descending thoracic and thoracoabdominal aortic repairs: a 14-year experience. J Vasc Surg. 2006 Sep;44(3):442-6. doi: 10.1016/j.jvs.2006.05.018.

ReferenceCitation: Riambau V, Bockler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005. No abstract available.

ReferenceCitation: Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

ReferenceCitation: Richardson J, Sabanathan S, Shah R. Post-thoracotomy spirometric lung function: the effect of analgesia. A review. J Cardiovasc Surg (Torino). 1999 Jun;40(3):445-56.

lead_sponsor: Germano Melissano

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Austria
Switzerland
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Centro Hospitalar de Entre o Douro e Vouga

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS


lead_sponsor: Shire

summary:
Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5 years. The disease is characterized by developmental delays initially, followed by neurological developmental arrest, then regression. These developmental deficits are typically associated with severe behavioral disturbances. Patients have a significantly reduced lifespan, with few surviving beyond the 2nd or 3rd decade.

The purpose of this study is to evaluate the safety and efficacy of recombinant human heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type III A Disease.

ReferenceCitation: Wijburg FA, Whitley CB, Muenzer J, Gasperini S, Del Toro M, Muschol N, Cleary M, Sevin C, Shapiro E, Bhargava P, Kerr D, Alexanderian D. Intrathecal heparan-N-sulfatase in patients with Sanfilippo syndrome type A: A phase IIb randomized trial. Mol Genet Metab. 2019 Feb;126(2):121-130. doi: 10.1016/j.ymgme.2018.10.006. Epub 2018 Oct 24.

oa_colors: green hybrid

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

location_facility: Hospital Universitario Austral A Unidad de Investigacion

location_facility: U.O.S Malattie Metaboliche Rare Clinical Pediatrica

location_facility: University of Minnesota Department of Pediatrics

title: A Randomized, Controlled, Open-label, Multicenter, Phase IIb Safety and Efficacy Study of rhHNS (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Early Stage Mucopolysaccharidosis Type IIIA Disease

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.

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


title: Development and Internal Validation of a Clinical Nomogram to Diagnose Prostatic Inflammation in Men With Lower Urinary Tract Symptoms

acronym: PIN

summary:
Rationale: Histological inflammation of the prostate is a common finding in the results of the histopathological examinations after a prostate biopsy or a transurethral or open prostatectomy.

Several studies have investigated the role of prostatic inflammation in the development of prostatic enlargement and pathogenesis of Lower Urinary Tract Symptoms (LUTS). Therefore, prostatic inflammation could be a potential treatment target for men with LUTS.

Objective: The aim of the study is the development and the validation of a nomogram based on clinical parameters that could predict the presence of prostatic inflammation.

Study design: Non-interventional, multicentric, cross-sectional, observational prospective study.

Study population: Men, age ≥ 40 yrs, with LUTS who will undergo any prostatic surgery for BPH (Open, laparoscopic, robotic, transurethral resection/enucleation, laser prostatectomy) or TRUS-biopsy according to the standard clinical practice of the participating urologists

Intervention: All included males receive standard care for their symptoms according to the physician's practice. For this study, baseline demographic and clinical characteristics of the patients are recorded and correlated with the histological outcome.

Main study parameters/endpoints: Development and validation of the Prostatic Inflammation Nomogram

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional treatment or intervention related to the study is required.

Therefore no negative outcomes are expected as the standard treatment is unchanged. There is no additional burden for the patients.

ReferenceCitation: Nickel JC, Roehrborn CG, O'Leary MP, Bostwick DG, Somerville MC, Rittmaster RS. The relationship between prostate inflammation and lower urinary tract symptoms: examination of baseline data from the REDUCE trial. Eur Urol. 2008 Dec;54(6):1379-84. doi: 10.1016/j.eururo.2007.11.026. Epub 2007 Nov 20.

ReferenceCitation: Robert G, Descazeaud A, Nicolaiew N, Terry S, Sirab N, Vacherot F, Maille P, Allory Y, de la Taille A. Inflammation in benign prostatic hyperplasia: a 282 patients' immunohistochemical analysis. Prostate. 2009 Dec 1;69(16):1774-80. doi: 10.1002/pros.21027.

ReferenceCitation: Irani J, Levillain P, Goujon JM, Bon D, Dore B, Aubert J. Inflammation in benign prostatic hyperplasia: correlation with prostate specific antigen value. J Urol. 1997 Apr;157(4):1301-3. doi: 10.1016/s0022-5347(01)64957-7.

ReferenceCitation: Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available. Erratum In: Circulation. 2005 Oct 25;112(17):e297. Circulation. 2005 Oct 25;112(17):e298.

ReferenceCitation: Iasonos A, Schrag D, Raj GV, Panageas KS. How to build and interpret a nomogram for cancer prognosis. J Clin Oncol. 2008 Mar 10;26(8):1364-70. doi: 10.1200/JCO.2007.12.9791.

ipd_sharing_description: Not yet decided when and what kind of IPD and supporting information will be available to researchers

lead_sponsor: Institute for Monitoring of Urogenital Diseases

location_country: Italy Cyprus Portugal Spain Greece France

location_facility: Dept of Urology, General Hospital of Larissa

location_facility: Dept of Urology, University Hospital of Larissa

location_facility: Dept of Urology, University Hospital of Florence


title: Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients With Atrial Fibrillation and Associated High Risk Factors for Embolic Events (OAT Pilot Study)

acronym: OAT

summary: The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

primary_purpose: Other

lead_sponsor: Biosense Webster, Inc.

location_country:
United States
Italy
Germany
France

location_facility: Texas Cardiac Arrhythmia Research Foundation


lead_sponsor: Pfizer

summary: The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.

location_facility: Memorial Sloan Kettering Cancer Center Oncology Dept

location_facility: University of California at Los Angeles Dept of Onc

title: A Phase Ib/II, Open-label, Multi-center, Dose Escalation Study of MEK162 in Combination With Panitumumab in Adult Patients With Mutant RAS or Wild-type RAS Metastatic Colorectal Cancer

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.

location_country:
Italy
Netherlands
Belgium
United States
Spain
Canada
France


title: A Phase I, Multi-center, Non-randomized, Open-label, Dose Escalation Design Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1125976 in Subjects With Advanced Solid Tumors

summary:
This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative bioavailability of liquid service formulation and tablets will be determined.

After the MTD is defined breast cancer patients with and without AKT1 mutation will be treated.

The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1125976.

BAY1125976 will be given daily as single oral application. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.

lead_sponsor: Bayer

location_country:
United States
Switzerland
Germany
France


acronym: PENELOPE-B

lead_sponsor: German Breast Group

summary: The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

ReferenceCitation: Mittendorf EA, Jeruss JS, Tucker SL, Kolli A, Newman LA, Gonzalez-Angulo AM, Buchholz TA, Sahin AA, Cormier JN, Buzdar AU, Hortobagyi GN, Hunt KK. Validation of a novel staging system for disease-specific survival in patients with breast cancer treated with neoadjuvant chemotherapy. J Clin Oncol. 2011 May 20;29(15):1956-62. doi: 10.1200/JCO.2010.31.8469. Epub 2011 Apr 11.

ReferenceCitation: Musgrove EA, Caldon CE, Barraclough J, Stone A, Sutherland RL. Cyclin D as a therapeutic target in cancer. Nat Rev Cancer. 2011 Jul 7;11(8):558-72. doi: 10.1038/nrc3090.

ReferenceCitation: ENCODE Project Consortium. An integrated encyclopedia of DNA elements in the human genome. Nature. 2012 Sep 6;489(7414):57-74. doi: 10.1038/nature11247.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Symmans WF, Peintinger F, Hatzis C, Rajan R, Kuerer H, Valero V, Assad L, Poniecka A, Hennessy B, Green M, Buzdar AU, Singletary SE, Hortobagyi GN, Pusztai L. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol. 2007 Oct 1;25(28):4414-22. doi: 10.1200/JCO.2007.10.6823. Epub 2007 Sep 4.

ReferenceCitation: Mauri D, Pavlidis N, Ioannidis JP. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis. J Natl Cancer Inst. 2005 Feb 2;97(3):188-94. doi: 10.1093/jnci/dji021.

ReferenceCitation: von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.

ReferenceCitation: Loibl S, Marme F, Martin M, Untch M, Bonnefoi H, Kim SB, Bear H, McCarthy N, Mele Olive M, Gelmon K, Garcia-Saenz J, Kelly CM, Reimer T, Toi M, Rugo HS, Denkert C, Gnant M, Makris A, Koehler M, Huang-Bartelett C, Lechuga Frean MJ, Colleoni M, Werutsky G, Seiler S, Burchardi N, Nekljudova V, von Minckwitz G. Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer-The Penelope-B Trial. J Clin Oncol. 2021 May 10;39(14):1518-1530. doi: 10.1200/JCO.20.03639. Epub 2021 Apr 1.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators:
German Breast Group
Pfizer
AGO Study Group
NSABP Foundation Inc
Breast International Group

location_facility: Contact: Austrian Breast & Colorectal Cancer Study Group

location_facility: Contact: Australia and New Zealand Breast Cancer Trials Group

location_facility: Contact: Japan Breast Cancer Research Group

title: Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy "PENELOPEB"

location_country:
Germany
Ireland
United Kingdom
Australia
Japan
Austria
United States
Korea, Republic of
Spain
Canada
France


title: Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial

acronym: SAFE-SSPE

summary: The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

ReferenceCitation: Baumgartner C, Klok FA, Carrier M, Limacher A, Moor J, Righini M, Beer JH, Peluso M, Rakovic D, Huisman MV, Aujesky D. Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE). BMJ Open. 2020 Nov 19;10(11):e040151. doi: 10.1136/bmjopen-2020-040151.

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

repository_institution: Leiden University - Leiden Repository

publisher_dissemination: British Medical Journal

ipd_sharing_description: After publication of the study results, a de-identified patient-level data set relating to the primary publication along with the latest version of the study protocol, the informed consent form, the statistical analysis plan, the code used for the analyses, and the Data Management and Quality Plan describing all data management aspects of the study will be made publicly available for replication of the study results and secondary data analyses in the Bern Open Repository and Information System (BORIS) Research Data, an online non-commercial data repository that meets Swiss National Science Foundation requirements for FAIR Data Principles (www.force11.org/group/fairgroup/fairprinciples)

lead_sponsor: Drahomir Aujesky

sponsor_collaborators:
Drahomir Aujesky
University of Bern
Schweizerischer Nationalfonds
Leiden University Medical Center
The Ottawa Hospital
Bayer

location_country: Canada Netherlands Switzerland France

location_facility: Centre Hospitalier Regional Et Universitaire De Brest


title: MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

acronym: MOGAT

summary:
Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life.

The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis.

Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression;

In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.

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

location_country:
Germany
Italy
United Kingdom
Denmark
Spain
Greece
France

location_facility: Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Athens University - Attikon University General Hospital

location_facility: Muehlenkreiskliniken Johannes Wesling Klinikum Minden

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro


title: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

summary: This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Ireland
Italy
France
United States
Spain
Serbia
Israel

location_facility: START Madrid, Hospital Universitario Fundacion Jimenez Diaz

location_facility: Rabin Medical Center, Davidoff Cancer Center

location_facility: Fundación Instituto Valenciano de Oncológia

location_facility: Mater Misericordiae University Hospital, Institute for Cancer Research

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

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: University Hospital Waterford, Department of Medical Oncology

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Beaumont Hospital, Cancer Clinical Trials & Research Unit

intervention_type: Diagnostic Test


summary: This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

ReferenceCitation: Callanan DG, Loewenstein A, Patel SS, Massin P, Corcostegui B, Li XY, Jiao J, Hashad Y, Whitcup SM. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017 Mar;255(3):463-473. doi: 10.1007/s00417-016-3472-1. Epub 2016 Sep 8.

ReferenceCitation: Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

ReferenceCitation: Chakravarthy H, Devanathan V. Molecular Mechanisms Mediating Diabetic Retinal Neurodegeneration: Potential Research Avenues and Therapeutic Targets. J Mol Neurosci. 2018 Nov;66(3):445-461. doi: 10.1007/s12031-018-1188-x. Epub 2018 Oct 6.

lead_sponsor: Allergan

location_country:
Germany
Italy
Portugal
Israel
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
South Africa
France


title: A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis

acronym: FEELING

summary: This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.

ReferenceCitation: Dai Y, Zhou Y, Zhang X, Xue M, Sun P, Leng J, Chapron C. Factors associated with deep infiltrating endometriosis versus ovarian endometrioma in China: a subgroup analysis from the FEELING study. BMC Womens Health. 2018 Dec 22;18(1):205. doi: 10.1186/s12905-018-0697-7.

ReferenceCitation: Chapron C, Lang JH, Leng JH, Zhou Y, Zhang X, Xue M, Popov A, Romanov V, Maisonobe P, Cabri P. Factors and Regional Differences Associated with Endometriosis: A Multi-Country, Case-Control Study. Adv Ther. 2016 Aug;33(8):1385-407. doi: 10.1007/s12325-016-0366-x. Epub 2016 Jun 24.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Ipsen

location_country:
China
Russian Federation
France

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Research Institute of Maternity and Childhood named after V.N. Gorodkov

location_facility: Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology

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


title: An Open-Label Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SBC-102 in Adult Participants With Liver Dysfunction Due to Lysosomal Acid Lipase Deficiency

summary: This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL Deficiency and was designed to examine 3 doses of sebelipase alfa. The targeted number for this study was 9 evaluable participants.

ReferenceCitation: Balwani M, Breen C, Enns GM, Deegan PB, Honzik T, Jones S, Kane JP, Malinova V, Sharma R, Stock EO, Valayannopoulos V, Wraith JE, Burg J, Eckert S, Schneider E, Quinn AG. Clinical effect and safety profile of recombinant human lysosomal acid lipase in patients with cholesteryl ester storage disease. Hepatology. 2013 Sep;58(3):950-7. doi: 10.1002/hep.26289. Epub 2013 Mar 28.

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
United States
Czechia
United Kingdom
France


title: HEPANOVA: A Phase II Trial of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC)

summary: The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

ReferenceCitation: Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

repository_institution: Université de Lausanne - SERVAL

publisher_dissemination: American Medical Association

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum In: JAMA. 2018 May 1;319(17):1824.

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: NovoCure GmbH

location_country: Germany Italy Poland Spain Czechia France

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: University Hospital Fakultni Nemocnice Olomouc, Oncology Clinic

location_facility: Vall d'Hebron Institute of Oncology (VHIO)

location_facility: University Medical Center - University of Freiburg

location_facility: HM Hospitales - Centro Integral Oncológico Clara Campal