title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

acronym: SPRAY

summary: The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

ReferenceCitation: Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.

lead_sponsor: Jazz Pharmaceuticals

sponsor_collaborators:
Jazz Pharmaceuticals
Quintiles, Inc.

location_country:
Finland
France
Germany
Italy
India
Poland
United Kingdom
Romania
Mexico
Belgium
United States
Spain
South Africa
Chile
Canada
Czech Republic

location_facility: CHU Charleroi (Hôpital civil de Charleroi)

location_facility: FN a LF UP Olomouc - Ambulance pro lécbu bolesti

location_facility: District Hospital Dr. Alexandru Simionescu

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: The Center for Clinical Research - Washington County Hospital

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla

location_facility: Spitalul Clinic Judetean Sibiu Oncologie

location_facility: Deenanath Mangeshkar Hospital and Research Center

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Bhagwaan Mahaveer Cancer Hospital and Research Centre

location_facility: UZ Leuven - Algologisch Centrum Anesthesiologie

location_facility: Dir. S.C.D.U. Psicologia Clinica ed Oncologica

location_facility: Basingstoke & North Hampshire NHS Foundation Trust

location_facility: Pacific Coast Hematology/Oncology Medical Group, Inc.

location_facility: Spitalul Judetean de Urgenta "Constantin Opris"

location_facility: Center of Hope for Cancer and Blood Disorders

location_facility: AR klinika FN Plzen -Ambulance pro lécbu bolesti

location_facility: Capital Comprehensive Cancer Care Clinic

location_facility: Trialtech Research - Embassy Drive Medical Centre

location_facility: FN Hradec Králové - Klinika onkologie a radioterapie

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

location_facility: Indo-American Cancer Institute and Research Center

location_facility: ARO, Krajská zdravotni, K.Z. a.s, Nemocnice

location_facility: Instituto Radio-oncológico Santiago (INRAD)

location_facility: International Observatory on End of Life Care

location_facility: S.C. IanuliMed S.R.L. Oncologie Medicala


type: EudraCT Number

title: A Prospective, Randomized, Double-dummy, Double-blind, Multicenter Trial Comparing the Safety and Efficacy of Intravenous Moxifloxacin 400 mg IV QD 24 Hours to That of Ertapenem 1.0 g IV QD 24 Hours for 5 to 14 Days for the Treatment of Subjects With Complicated Intra-abdominal Infections (PROMISE Study)

summary: A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: De Waele JJ, Tellado JM, Alder J, Reimnitz P, Jensen M, Hampel B, Arvis P. Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. Int J Antimicrob Agents. 2013 Jan;41(1):57-64. doi: 10.1016/j.ijantimicag.2012.08.013. Epub 2012 Nov 13.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Bayer

location_country:
Germany
Lithuania
Israel
Argentina
Romania
Belgium
Latvia
Spain
Greece
South Africa
Bulgaria
Estonia
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder

summary: The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

ReferenceType: derived

ReferenceCitation: Berwaerts J, Melkote R, Nuamah I, Lim P. A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. J Affect Disord. 2012 May;138(3):247-58. doi: 10.1016/j.jad.2012.01.047. Epub 2012 Feb 27.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Germany
Poland
India
Romania
Costa Rica
United States
China
Malaysia
Panama
South Africa
Turkey
Bulgaria
Ukraine
Serbia
Russian Federation
France


title: An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

acronym: AURIGA

summary:
AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).

The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries.

Additionally, utilization and treatment regimens in routine clinical practice will be described.

Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

location_country:
Germany
Italy
Russian Federation
Kuwait
Lebanon
United Arab Emirates
China
Saudi Arabia
Taiwan
Egypt
France


title: Post-Market Clinical Follow-up Study With the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups

acronym: P-MAX

summary:
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.

CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.

ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Straub Medical AG

location_country: Germany Ireland Italy Austria France

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock

location_facility: Klinikum Arnsberg, Klinik für Angiologie

status_simplified: Ongoing


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

acronym: READ-ASV

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

lead_sponsor: ResMed

collaborators: CRI-The Clinical Research Institute GmbH

location_country: Germany Portugal Denmark Switzerland Spain France

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

location_facility: Sjællands Universitetshospital/Zealand University Hospital Køge

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Klinik für Pneumologie, Schlaf- und Beatmungsmedizin

location_facility: Klinik für Schlafmedizin Düsseldorf Grand Arc

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

intervention_type: Device


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive

summary: The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.

evidence: open (via free article)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.

lead_sponsor: AstraZeneca

location_country:
United States
Poland
Germany
France


type: Registry Identifier

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

acronym: MILESTONE

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

status: Unknown status

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Gerritsen SE, Maras A, van Bodegom LS, Overbeek MM, Verhulst FC, Wolke D, Appleton R, Bertani A, Cataldo MG, Conti P, Da Fonseca D, Davidovic N, Dodig-Curkovic K, Ferrari C, Fiori F, Franic T, Gatherer C, De Girolamo G, Heaney N, Hendrickx G, Kolozsvari A, Levi FM, Lievesley K, Madan J, Martinelli O, Mastroianni M, Maurice V, McNicholas F, O'Hara L, Paul M, Purper-Ouakil D, de Roeck V, Russet F, Saam MC, Sagar-Ouriaghli I, Santosh PJ, Sartor A, Schandrin A, Schulze UME, Signorini G, Singh SP, Singh J, Street C, Tah P, Tanase E, Tremmery S, Tuffrey A, Tuomainen H, van Amelsvoort TAMJ, Wilson A, Walker L, Dieleman GC; Milestone consortium. Cohort profile: demographic and clinical characteristics of the MILESTONE longitudinal cohort of young people approaching the upper age limit of their child mental health care service in Europe. BMJ Open. 2021 Dec 16;11(12):e053373. doi: 10.1136/bmjopen-2021-053373.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

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

repository_normalized: HAL

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Warwick - Warwick Research Archive Portal

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

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

repository_institution: PubMed Central - Europe PMC

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

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

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

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

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

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

repository_institution: CERN European Organization for Nuclear Research - Zenodo

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

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

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

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;Zenodo;pure.eur.nl;repub.eur.nl;researchrepository.ucd.ie;ricerca.uniba.it;wrap.warwick.ac.uk;www.lenus.ie

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

collaborators: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_country:
Germany
Ireland
Italy
United Kingdom
Netherlands
Belgium
Croatia
France

location_facility: Warwick Medical School, University of Warwick


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

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

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Australia
Japan
United States
Spain
France

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


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

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

ReferenceCitation: Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

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

lead_sponsor: Medical University of Graz

location_country: Germany Italy Poland Netherlands Austria Spain Croatia France

location_facility: Jagiellonian University Medical College Krakow

location_facility: Instituto Nazionale Tumori Fondazione Pascale

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


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

acronym: PRECISESADST

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

lead_sponsor: Fundación Pública Andaluza Progreso y Salud

collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

collaborators: August Pi Sunyer Biomedical Research Institute

collaborators: The Cyprus Foundation for Muscular Dystrophy Research

collaborators: Institut de Recherches Internationales Servier

collaborators: Institut d'Investigació Biomèdica de Bellvitge

location_country: Germany Italy Portugal Hungary Switzerland Austria Belgium Spain France

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

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

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

location_facility: Hospital Universitario San Cecilio Servicio Andaluz de Salud

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

location_facility: Hospital Regional de Málaga Servicio Andaluz de Salud

location_facility: Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

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

location_facility: Hospital Universitario Reina Sofía Andaluz de Salud


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

acronym: PRECISESADSI

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

sponsor_collaborators: Fundación Pública Andaluza Progreso y Salud

sponsor_collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

sponsor_collaborators: August Pi Sunyer Biomedical Research Institute

sponsor_collaborators: The Cyprus Foundation for Muscular Dystrophy Research

sponsor_collaborators: Institut de Recherches Internationales Servier

sponsor_collaborators: Institut d'Investigació Biomèdica de Bellvitge

location_country: Germany Italy Switzerland Belgium Spain France

location_facility: Hospitaux Universitaires de Géneve (UNIGE)

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


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

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

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

ReferenceCitation: Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.

evidence: open (via free pdf)

lead_sponsor: Shockwave Medical, Inc.

location_country:
France
United Kingdom
Australia
Netherlands
Sweden

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


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

acronym: TRENDY

summary:
Rationale:

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

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

Objective:

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

Study design:

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

Study population:

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

Intervention:

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

Main study parameters/endpoints:

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

Secondary endpoints will be:

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

status: Terminated

lead_sponsor: Erasmus Medical Center

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

location_country: Netherlands Belgium France

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


title: The EUROSCA Natural History Study

acronym: EUROSCA-NHS

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

status: Recruiting

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

oa_host_type: repository

version: submittedVersion

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

repositories:
HAL
UCL Discovery

repositories_concat: HAL;UCL Discovery

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

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: green

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

oa_host_type: closed

lead_sponsor: Ataxia Study Group

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

location_facility: Department of Neurology, University of Frankfurt

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

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

location_facility: Department of Neurology, Zala County Hospital

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

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

location_facility: Department of Neurology, Medical University, Innsbruck

location_facility: Fondazione-IRCCS Istituto Neurologico Carlo Besta

location_facility: Department of Neurology, University of Bonn

location_facility: Department of Neuroscience, Federico II University Naples

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

location_facility: Department of Medical Genetics, University of Pecs

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

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


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

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

ReferenceCitation: Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652.

publisher_dissemination: American Association for Cancer Research

location_country:
Italy
Singapore
Japan
United States
Spain
France


title: A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain

acronym: COPE

summary: The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

ReferenceCitation: Sjolund KF, Yang R, Lee KH, Resnick M. Randomized study of pregabalin in patients with cancer-induced bone pain. Pain Ther. 2013 Jun;2(1):37-48. doi: 10.1007/s40122-013-0009-8. Epub 2013 Feb 26.

repositories_concat: PubMed Central

publisher_dissemination: Springer

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Finland
Poland
Thailand
Czechia
Canada
France
Hungary
United States
Peru
Philippines
Egypt
Italy
Venezuela
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


title: A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM

summary: The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

ReferenceType: background

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: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

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.

lead_sponsor: NovoCure Ltd.

location_country:
Germany
Israel
Switzerland
Austria
United States
Czech Republic
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hospital of Neurology Lyon - University Claude Bernard Lyon 1

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: NJ Neuroscience Institute - JFK Medical Center

location_facility: University Hospital of Schleswig-Holstein


title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

summary: The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma Europe B.V.

location_country:
Germany
Italy
Poland
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Belgium
Spain
Greece
Czech Republic
Russian Federation
France

location_facility:
3 Sites
7 Sites
2 Sites


title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

ReferenceCitation: Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.

lead_sponsor: Novartis

location_country:
Finland
Germany
Italy
Poland
Portugal
United Kingdom
Denmark
Switzerland
Spain
Canada
France


type: Other Grant/Funding Number

title: Giant Intracranial Aneurysm Registry

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

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

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

publisher_dissemination: American Association of Neurological Surgeons

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

publisher_dissemination: Springer-Nature

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

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

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

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

oa_colors: green other

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

lead_sponsor: Dr. med. Julius Dengler

sponsor_collaborators:
Dr. med. Julius Dengler
Charite University, Berlin, Germany

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

location_facility: Department of Neuroradiology, University Hospital

location_facility: Department of Neurosurgery, Jikei University

location_facility: Institut für Klinische Epidemiologie und Biometrie der Universität Wuerzburg

location_facility: Department of Neurosurgery, University of Freiburg

location_facility: Department of Neurosurgery, Friedrich-Schiller-University

location_facility: Department of Neurosurgery - University of Hamburg

location_facility: Department of Neuroradiology, Ospedale Niguarda Ca' Granda

location_facility: Department of Neurosurgery - University of Geneva

location_facility: Department of Neurosurgery and Neuroradiology, Klinikum Deggendorf

location_facility: Department of Neurosurgery, Medical University Vienna

location_facility: Department of Neurology - Charité Berlin

location_facility: Department of Neuroradiology - Klinikum Hirslanden

location_facility: Department of Neuroradiology, University of Leipzig

location_facility: Department of Neurosurgery, Kantonsspital Aarau

location_facility: Department of Neurosurgery, Helsinki University Central

location_facility: Department of Neurosurgery, Burdenko Neurosurgical Institute

location_facility: Department of Neurosurgery - University of Goettingen

location_facility: Department of Neurosurgery, University Hospital of Zurich

location_facility: Department of Neurosurgery, Charité Berlin

location_facility: Department of Neurosurgery - Technical University of Munich

location_facility: Department of Neurosurgery - University of Greifswald

location_facility: Department of Neurosurgery - University of Regensburg


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

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

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

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

lead_sponsor: Philogen S.p.A.

sponsor_collaborators:
Philogen S.p.A.
Immatics Biotechnologies GmbH

location_country:
Germany
United Kingdom
Denmark
Austria
Spain
France

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


title: Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

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

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

status: Withdrawn

lead_sponsor: Integra LifeSciences Services

location_country:
Italy
Portugal
United Kingdom
Netherlands
Belgium
Spain
France

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


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

summary: The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.

ipd_sharing: Yes

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

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

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


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

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

time_perspective: Cross-Sectional

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

lead_sponsor: Novo Nordisk A/S

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

intervention_type: Behavioral


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.

summary: The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

lead_sponsor: Bayer

location_country:
Germany
United Kingdom
Sweden
Netherlands
Belgium
United States
France


title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection

summary: Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

primary_purpose: Prevention

ReferenceCitation: Passlick B et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the European Multidisciplinary Conference in Thoracic Oncology (EMCTO), Lugano, Switzerland. 1-3 May 2009; 64 (suppl. 1):S45 (102PD).

ReferenceCitation: Vansteenkiste J et al. Activity of MAGE-A3 cancer immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study. Abstract presented at the 12th Conference on Lung Cancer (WCLC), Seoul, Korea. 2-6 September 2007.

ReferenceCitation: Vansteenkiste J et al. Adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study evaluating the MAGE-A3 cancer immunotherapeutic. Abstract presented at The 14th European Cancer Conference (ECCO) (formerly ECCO14/ESTRO 26), Barcelona, Spain. 23-27 September 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled Phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, Non-Small Cell Lung Cancer (NSCLC). Abstract presented at the 43rd Annual Meeting American Society of Clinical Oncology (ASCO), Chicago, IL. 1-5 June 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, non-small-cell lung cancer (NSCLC). Abstract presented at the 42nd Annual Meeting American Society of Clinical Oncology (ASCO), Atlanta, GA. 2-6 June 2006.

ReferenceCitation: Vansteenkiste J et al. Phase II randomized study of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): 44 month follow-up, humoral and cellular immune response data. European Society for Medical Oncology (IASLC-ESMO) Abstract presented at the 1st European Lung Cancer Conference (ELCC), Geneva, Switzerland. 23-26 April 2008; 3 (4 suppl.1):S55-56.

ReferenceCitation: Zielinski M et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the 17th European Conference on General Thoracic Surgery (ECGTS), Krakow, Poland. 31 May-3 June 2009.

ReferenceCitation: Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

publisher_dissemination: Wiley

ReferenceCitation: Vansteenkiste J, Zielinski M, Linder A, Dahabreh J, Gonzalez EE, Malinowski W, Lopez-Brea M, Vanakesa T, Jassem J, Kalofonos H, Perdeus J, Bonnet R, Basko J, Janilionis R, Passlick B, Treasure T, Gillet M, Lehmann FF, Brichard VG. Adjuvant MAGE-A3 immunotherapy in resected non-small-cell lung cancer: phase II randomized study results. J Clin Oncol. 2013 Jul 1;31(19):2396-403. doi: 10.1200/JCO.2012.43.7103. Epub 2013 May 28.

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

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Italy
Lithuania
Poland
Norway
United Kingdom
Netherlands
Belgium
Latvia
Spain
Greece
Estonia
France

intervention_type: Biological


title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease

summary: The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

lead_sponsor: Mallinckrodt

sponsor_collaborators:
Mallinckrodt
PRA Health Sciences

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Canada
France

location_facility: Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute

location_facility: Centre Hopitalier Universitaire Sart Tilman Liege

location_facility: Centre Hospitalier Universitaire Hospital Bordeaux

location_facility: Weill Medical College of Cornell University

location_facility: Universita di Siena Policlinico Le Scotte

location_facility: Stammzelltransplantationzentrum der Universitat Wurzbrug

location_facility: Klinikum der Universitat Erlangen-Nurnberg

location_facility: University of Michigan Comprehensive Cancer Center


title: MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)

acronym: MVP

summary: The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.

ReferenceCitation: Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
Italy
Israel
Norway
Denmark
United Kingdom
Switzerland
Austria
United States
Spain
Canada
France


title: A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

acronym: HORIZON I

summary: The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
Spain
Canada
Czech Republic
France

location_facility:
Ressearch Site
Research Site


title: A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

summary: Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

ReferenceCitation: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.

lead_sponsor: Valerio Therapeutics

location_country:
Germany
France
United States
Thailand
Israel

location_facility: Songklanagarind Hospital, Prince of Songkla University


title: An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects With Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability

summary: IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

ReferenceCitation: Serruys PW, Garcia-Garcia HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Botker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.

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.

location_country: Germany Poland Norway Denmark Netherlands Austria Belgium Switzerland Spain Czechia France


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

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

ReferenceCitation: Pantaleo MA, Heinrich MC, Italiano A, Valverde C, Schoffski P, Grignani G, Reyners AKL, Bauer S, Reichardt P, Stark D, Berhanu G, Brandt U, Stefanelli T, Gelderblom H. A multicenter, dose-finding, phase 1b study of imatinib in combination with alpelisib as third-line treatment in patients with advanced gastrointestinal stromal tumor. BMC Cancer. 2022 May 6;22(1):511. doi: 10.1186/s12885-022-09610-4.

license: cc-by

license_normalized: cc-by

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;eprints.whiterose.ac.uk;pure.rug.nl;scholarlypublications.universiteitleiden.nl

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

lead_sponsor: Novartis Pharmaceuticals

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

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


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

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

time_perspective: Retrospective

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

repository_institution: Max Planck Society - MPG.PuRe

publisher_dissemination: Oxford University Press

lead_sponsor: Hoffmann-La Roche

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


summary: The objectives of this program are: to further characterize the natural progression of MPS VI disease; to generate and disseminate information on the care and management of MPS VI patients to clinical and medical professionals; to provide a resource to physicians and patients by providing information for optimizing patient care based on aggregate data; to characterize the clinical response to long-term Naglazyme® (galsulfase) treatment; to further characterize the long-term safety of Naglazyme® treatment.

ReferenceCitation: Solanki GA, Sun PP, Martin KW, Hendriksz CJ, Lampe C, Guffon N, Hung A, Sisic Z, Shediac R, Harmatz PR; CSP Study Group. Cervical cord compression in mucopolysaccharidosis VI (MPS VI): Findings from the MPS VI Clinical Surveillance Program (CSP). Mol Genet Metab. 2016 Aug;118(4):310-8. doi: 10.1016/j.ymgme.2016.06.001. Epub 2016 Jun 3.

oa_colors: green hybrid

repository_institution: University of Pretoria - UpSpace Institutional Repository

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Ireland
Italy
Lithuania
Portugal
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
France

location_facility: Sioux Valey Children's Speciality Clinics

location_facility: Rotterdam University Hospital - Sophia's Children's Hospital

location_facility: Great Ormond Street Hospital For Children, NHS Foundation Trust

location_facility: St Mary's Hospital, Willink Biochemical Genetics Unit

location_facility: Birmingham Children's Hospital, Steelhouse

location_facility: University of Minnesota - Fairview University Medical Center

location_facility: Johns Hopkins Univeristy School of Medicine

location_facility: Vilnius University Hospital, Santariskiu Klinikos

location_facility: Children's Hospital and Research Center Oakland

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS

location_facility: Children's Hospital of the King's Daughters

location_facility: Institute of Pathology and Genetics, Metabolic Unit

location_facility: Università Milano Bicocca, Resp. Centro "Fondazione Mariani"

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: Hospital de Sao Joao, Unidae de Doencas Metabolicas

location_facility: Department of Woman's and Child's Health

location_facility: Universitatsklinikum Freiburg, Klinik II


title: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence

summary: Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.

lead_sponsor: Ethicon, Inc.

location_country:
Germany
United Kingdom
Singapore
United States
Korea, Republic of
Canada
France

location_facility: Sunnybrook & Women's College Health Sciences Center

location_facility: University of Ulsan College of Medicine and Asan Medical Center

location_facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery


title: Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An Imaging Study in Patients With Unstable Atherosclerotic Lesions

summary: PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients with single or double vessel coronary artery disease. Approximately 700 patients with ACS will be enrolled into the study at sites in the United States and European Union.

ReferenceCitation: Stone Gregg W, Lansky A.; Carlier S. et. al. A prospective, natural history study of multimodality invasive imaging to characterize vulnerable plaque: First report of the baseline findings from the PROSPECT trial. Journal of the American College of Cardiology 49(9, Suppl. B): p 19B MAR 6 2007.

ReferenceCitation: Ostuka Masato; Bruining N.; Van Pelt, N.; et.al. Three-dimensional quantification of coronary plaque burden by 64-slice computed tomography: A PROS-PECT-MSCT substudy. Journal of the American College of Cardiology 49(9, Suppl. A): p 114A MAR 6 2007

ReferenceCitation: Tanaka K; Carlier SG; Mintz GS; et.al. High risk fibroatheroma lesions are remote from the minimal lumen area site: A virtual histology IVUS analysis from the PROSPECT study AMERICAN JOURNAL OF CARDIOLOGY, 2006, V 98, N8A, P 94M-94M.

ReferenceCitation: Seike F, Mintz GS, Matsumura M, Ali ZA, Liu M, Jeremias A, Ben-Yehuda O, De Bruyne B, Serruys PW, Yasuda K, Stone GW, Maehara A. Impact of Intravascular Ultrasound-Derived Lesion-Specific Virtual Fractional Flow Reserve Predicts 3-Year Outcomes of Untreated Nonculprit Lesions: The PROSPECT Study. Circ Cardiovasc Interv. 2022 Nov;15(11):851-860. doi: 10.1161/CIRCINTERVENTIONS.121.011198. Epub 2022 Nov 15.

ReferenceCitation: Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Vogel B, Giustino G, Serruys PW, Mintz GS, Stone GW. Relationship between insulin resistance, coronary plaque, and clinical outcomes in patients with acute coronary syndromes: an analysis from the PROSPECT study. Cardiovasc Diabetol. 2021 Jan 7;20(1):10. doi: 10.1186/s12933-020-01207-0.

ReferenceCitation: Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Giustino G, Kirtane AJ, Serruys PW, Mintz GS, Stone GW. Impact of Pre-Diabetes on Coronary Plaque Composition and Clinical Outcome in Patients With Acute Coronary Syndromes: An Analysis From the PROSPECT Study. JACC Cardiovasc Imaging. 2019 Apr;12(4):733-741. doi: 10.1016/j.jcmg.2017.06.023. Epub 2017 Oct 18.

ReferenceCitation: Zheng B, Mintz GS, McPherson JA, De Bruyne B, Farhat NZ, Marso SP, Serruys PW, Stone GW, Maehara A. Predictors of Plaque Rupture Within Nonculprit Fibroatheromas in Patients With Acute Coronary Syndromes: The PROSPECT Study. JACC Cardiovasc Imaging. 2015 Oct;8(10):1180-1187. doi: 10.1016/j.jcmg.2015.06.014.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Goto K, Mintz GS, Litherland C, Lansky AJ, Weisz G, McPherson JA, De Bruyne B, Serruys PW, Stone GW, Maehara A. Lumen Measurements From Quantitative Coronary Angiography and IVUS: A PROSPECT Substudy. JACC Cardiovasc Imaging. 2016 Aug;9(8):1011-3. doi: 10.1016/j.jcmg.2015.07.006. Epub 2015 Sep 9. No abstract available.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Xie Y, Mintz GS, Yang J, Doi H, Iniguez A, Dangas GD, Serruys PW, McPherson JA, Wennerblom B, Xu K, Weisz G, Stone GW, Maehara A. Clinical outcome of nonculprit plaque ruptures in patients with acute coronary syndrome in the PROSPECT study. JACC Cardiovasc Imaging. 2014 Apr;7(4):397-405. doi: 10.1016/j.jcmg.2013.10.010. Epub 2014 Mar 13.

ReferenceCitation: Inaba S, Mintz GS, Farhat NZ, Fajadet J, Dudek D, Marzocchi A, Templin B, Weisz G, Xu K, de Bruyne B, Serruys PW, Stone GW, Maehara A. Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT. JACC Cardiovasc Imaging. 2014 Jan;7(1):70-8. doi: 10.1016/j.jcmg.2013.10.007.

ReferenceCitation: Dohi T, Mintz GS, McPherson JA, de Bruyne B, Farhat NZ, Lansky AJ, Mehran R, Weisz G, Xu K, Stone GW, Maehara A. Non-fibroatheroma lesion phenotype and long-term clinical outcomes: a substudy analysis from the PROSPECT study. JACC Cardiovasc Imaging. 2013 Aug;6(8):908-16. doi: 10.1016/j.jcmg.2013.04.008. Epub 2013 Jul 10.

ReferenceCitation: Golinvaux N, Maehara A, Mintz GS, Lansky AJ, McPherson J, Farhat N, Marso S, de Bruyne B, Serruys PW, Templin B, Cheong WF, Aaskar R, Fahy M, Mehran R, Leon M, Stone GW. An intravascular ultrasound appraisal of atherosclerotic plaque distribution in diseased coronary arteries. Am Heart J. 2012 Apr;163(4):624-31. doi: 10.1016/j.ahj.2011.07.031.

ReferenceCitation: Sanidas EA, Mintz GS, Maehara A, Cristea E, Wennerblom B, Iniguez A, Fajadet J, Fahy M, Dressler O, Weisz G, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys P, Stone GW. Adverse cardiovascular events arising from atherosclerotic lesions with and without angiographic disease progression. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S95-S105. doi: 10.1016/j.jcmg.2011.08.024.

ReferenceCitation: Brener SJ, Mintz GS, Cristea E, Weisz G, Maehara A, McPherson JA, Marso SP, Farhat N, Botker HE, Dressler O, Xu K, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Characteristics and clinical significance of angiographically mild lesions in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S86-94. doi: 10.1016/j.jcmg.2011.12.007.

ReferenceCitation: McPherson JA, Maehara A, Weisz G, Mintz GS, Cristea E, Mehran R, Foster M, Verheye S, Rabbani L, Xu K, Fahy M, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Residual plaque burden in patients with acute coronary syndromes after successful percutaneous coronary intervention. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S76-85. doi: 10.1016/j.jcmg.2012.01.005.

ReferenceCitation: Lansky AJ, Ng VG, Maehara A, Weisz G, Lerman A, Mintz GS, De Bruyne B, Farhat N, Niess G, Jankovic I, Lazar D, Xu K, Fahy M, Serruys PW, Stone GW. Gender and the extent of coronary atherosclerosis, plaque composition, and clinical outcomes in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S62-72. doi: 10.1016/j.jcmg.2012.02.003.

ReferenceCitation: Baber U, Stone GW, Weisz G, Moreno P, Dangas G, Maehara A, Mintz GS, Cristea E, Fahy M, Xu K, Lansky AJ, Wennerblom B, Mathey DG, Templin B, Zhang Z, Serruys PW, Mehran R. Coronary plaque composition, morphology, and outcomes in patients with and without chronic kidney disease presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S53-61. doi: 10.1016/j.jcmg.2011.12.008.

ReferenceCitation: Marso SP, Mercado N, Maehara A, Weisz G, Mintz GS, McPherson J, Schiele F, Dudek D, Fahy M, Xu K, Lansky A, Templin B, Zhang Z, de Bruyne B, Serruys PW, Stone GW. Plaque composition and clinical outcomes in acute coronary syndrome patients with metabolic syndrome or diabetes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S42-52. doi: 10.1016/j.jcmg.2012.01.008.

ReferenceCitation: Papadopoulou SL, Neefjes LA, Garcia-Garcia HM, Flu WJ, Rossi A, Dharampal AS, Kitslaar PH, Mollet NR, Veldhof S, Nieman K, Stone GW, Serruys PW, Krestin GP, de Feyter PJ. Natural history of coronary atherosclerosis by multislice computed tomography. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S28-37. doi: 10.1016/j.jcmg.2012.01.009.

ReferenceCitation: Brugaletta S, Garcia-Garcia HM, Serruys PW, Maehara A, Farooq V, Mintz GS, de Bruyne B, Marso SP, Verheye S, Dudek D, Hamm CW, Farhat N, Schiele F, McPherson J, Lerman A, Moreno PR, Wennerblom B, Fahy M, Templin B, Morel MA, van Es GA, Stone GW. Relationship between palpography and virtual histology in patients with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S19-27. doi: 10.1016/j.jcmg.2011.02.026.

ReferenceCitation: Wykrzykowska JJ, Mintz GS, Garcia-Garcia HM, Maehara A, Fahy M, Xu K, Inguez A, Fajadet J, Lansky A, Templin B, Zhang Z, de Bruyne B, Weisz G, Serruys PW, Stone GW. Longitudinal distribution of plaque burden and necrotic core-rich plaques in nonculprit lesions of patients presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S10-8. doi: 10.1016/j.jcmg.2012.01.006.

ReferenceCitation: Maehara A, Cristea E, Mintz GS, Lansky AJ, Dressler O, Biro S, Templin B, Virmani R, de Bruyne B, Serruys PW, Stone GW. Definitions and methodology for the grayscale and radiofrequency intravascular ultrasound and coronary angiographic analyses. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S1-9. doi: 10.1016/j.jcmg.2011.11.019.

ReferenceCitation: Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358. Erratum In: N Engl J Med. 2011 Nov 24;365(21):2040.

ReferenceCitation: Oviedo C, Maehara A, Mintz GS, Araki H, Choi SY, Tsujita K, Kubo T, Doi H, Templin B, Lansky AJ, Dangas G, Leon MB, Mehran R, Tahk SJ, Stone GW, Ochiai M, Moses JW. Intravascular ultrasound classification of plaque distribution in left main coronary artery bifurcations: where is the plaque really located? Circ Cardiovasc Interv. 2010 Apr;3(2):105-12. doi: 10.1161/CIRCINTERVENTIONS.109.906016. Epub 2010 Mar 2.

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

location_facility: Universitäres Herz- und Gefäßzentrum Hamburg

location_facility: St. Vincent's Hospital and Health Care Center

location_facility: St. Joseph's Hospital and Medical Center


title: A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer

summary: 30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

ReferenceCitation: Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.

location_country:
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Netherlands
Belgium
Korea, Republic of
China
Spain
Thailand
Greece
Taiwan
France


title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

summary:
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

ReferenceCitation: Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009 Jul 7;120(1):21-7. doi: 10.1161/CIRCULATIONAHA.108.834275. Epub 2009 Jun 22.

location_country:
Germany
Italy
India
United Kingdom
Argentina
Denmark
Singapore
Brazil
Sweden
United States
Spain
Malaysia
South Africa
France


title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.

summary: The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Italy
Poland
New Zealand
Hungary
Australia
Sweden
Netherlands
Belgium
United States
Spain
France

intervention_type: Genetic


title: Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events

acronym: CONDOR

summary: To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

ReferenceCitation: Kellner HL, Li C, Essex MN. Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial. Open Rheumatol J. 2013 Nov 13;7:96-100. doi: 10.2174/1874312901307010096. eCollection 2013.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Bentham Science Publishers Ltd.

ReferenceCitation: Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. doi: 10.1016/S0140-6736(10)60673-3. Epub 2010 Jun 16. Erratum In: Lancet. 2011 Jul 16;378(9787):228.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Germany
Brazil
Costa Rica
Croatia
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Hong Kong
Latvia
Ukraine
India
Belgium
China
Peru
Estonia
Guatemala
Ecuador
Singapore
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Panama
South Africa
Taiwan
Russian Federation
Sweden


title: A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

summary: The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

ReferenceCitation: Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Germany
Argentina
Australia
Turkey
Chile
Canada
France
Portugal
Hungary
United States
Italy
Cyprus
Norway
Singapore
United Kingdom
Austria
Spain
Greece
South Africa
Taiwan
Sweden


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia.

acronym: RADIANCE 1

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia

ReferenceCitation: Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.

ReferenceCitation: Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.

ReferenceCitation: Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.

ReferenceCitation: Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum In: Circulation. 2009 Feb 10;119(5):e197.

ReferenceCitation: Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94. doi: 10.1185/030079907x182121.

ReferenceCitation: Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH, Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots ML; RADIANCE 1 Investigators. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med. 2007 Apr 19;356(16):1620-30. doi: 10.1056/NEJMoa071359. Epub 2007 Mar 26.

lead_sponsor: Pfizer

location_country:
Finland
Italy
Netherlands
United States
South Africa
Canada
Czech Republic
France


title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

summary: This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

location_country:
Germany
United Kingdom
Australia
Russian Federation
France


title: A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

summary: Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.

ReferenceCitation: Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Italy
France
Netherlands
United States
Taiwan
Israel

location_facility: Chi-Mei Medical Center Dept of Pediatrics

location_facility: Shands Hospital at the University of Florida


title: A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

summary: The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

ReferenceCitation: Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23. Erratum In: Ann Rheum Dis. 2011 Aug;70(8):1519.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Australia
Mexico
Belgium
United States
Spain
Puerto Rico
France


title: Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

summary: The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

primary_purpose: Educational/Counseling/Training

ReferenceCitation: Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, Roth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43. doi: 10.1056/NEJMoa061648.

ReferenceCitation: Hill A, Rother RP, Wang X, Morris SM Jr, Quinn-Senger K, Kelly R, Richards SJ, Bessler M, Bell L, Hillmen P, Gladwin MT. Effect of eculizumab on haemolysis-associated nitric oxide depletion, dyspnoea, and measures of pulmonary hypertension in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2010 May;149(3):414-25. doi: 10.1111/j.1365-2141.2010.08096.x. Epub 2010 Mar 8.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Canada
France

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: St. James Hospital, Haematology Department

location_facility: Ospedale San Martino, Dept. of Hematology

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Universitatsklinik Basel, Division of Hematology

location_facility: Saarland University Medical School, Internal Medicine 1

location_facility: Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale

location_facility: Duke University Health System, Division of Cell Therapy, Heme Malignancies Program

location_facility: City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant

location_facility: Cleveland Clinic, Dept. of Clinical Research

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: Belfast City Hospital, Dept. of Haematology C Floor

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: The Royal Perth Hosptial, Department of Haematology/Level 2

location_facility: St. George's Hospital, Department of Haematology

location_facility: National Heart, Blood, and Lung Institute, National Institutes of Health

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology

location_facility: Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle

location_facility: Royal Cornwall Hospital, Haematology Dept.

location_facility: Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: Lund University Hospital, Department of Internal Medicine, Section of Hematology

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology

location_facility: Queen Elizabeth Hospital, Dept. of Haematology

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin


title: An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

summary: The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Finland
Former Serbia and Montenegro
Germany
United Kingdom
Romania
Netherlands
Belgium
United States
Canada
Russian Federation
France

location_facility: University CF Hospital No.2, Urology Clinic

location_facility: Tampere University Hospital, Dept. of Urology

location_facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department

location_facility: Helsinki University Hospital, Maria Hospital, Dept Urology

location_facility: Clinical Center Novi Sad, Clinic of Urology Hajduk

location_facility: Central Hospital, North Karelian, Dept. of Urology

location_facility: South Orange County Medical Research Center

location_facility: Oulu University Hospital, Department of Surgery Division of Urology

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: Mount Vernon Cancer Centre, Marie Curie Research Wing

location_facility: Clinical Center of Serbia Institute of Urology and Nephrology

location_facility: University of Missouri, Urology, Deptof Surgery

location_facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department

location_facility: Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie

location_facility: Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary

location_facility: The Male/Female Health Centres and Research

location_facility: Level 7, Urology Research Unit, Derriford Hospital

location_facility: Klinik fuer Urologie, Vivantes Klinikum Am Urban

location_facility: Pavlov State Medical University, Urology Department


title: Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

location_country:
United States
Canada
France


summary:
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.

Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)

ReferenceCitation: Geoerger B, Kieran MW, Grupp S, Perek D, Clancy J, Krygowski M, Ananthakrishnan R, Boni JP, Berkenblit A, Spunt SL. Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma. Eur J Cancer. 2012 Jan;48(2):253-62. doi: 10.1016/j.ejca.2011.09.021. Epub 2011 Oct 25.

title: A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors

source: euctr

location_country:
Germany
Poland
Mexico
United States
Canada
Russian Federation
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

summary: This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

location_country:
United States
Russian Federation
France


title: An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes

summary: This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

location_country:
Germany
Italy
Australia
Belgium
United States
Canada
France


title: AURA Study: A Retrospective Non-interventional Study (NIS) to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration (wAMD)

acronym: AURA

summary: Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented and followed up. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

ReferenceCitation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Hykin P, Staurenghi G, Wittrup-Jensen K, Altemark A, Nilsson J, Kim K, Sivaprasad S. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016 Dec;100(12):1623-1628. doi: 10.1136/bjophthalmol-2015-308166. Epub 2016 Mar 30.

ReferenceCitation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.

repository_institution: Radboud University - Radboud Repository

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

lead_sponsor: Bayer

location_country:
Germany
Ireland
Italy
United Kingdom
Venezuela
Australia
Japan
Netherlands
Canada
France