title: A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)

summary: The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

lead_sponsor: Brainsway

location_country:
Germany
France
United States
Canada
Israel

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität

location_facility: Duke Medical Center Department of Psychiatry & Behavioral Sciences

location_facility: Center for Addiction and Mental Health (CAMH)

location_facility: Columbia University / New York State Psychiatric Institute

location_facility: Advanced Mental Health Care Inc. - Royal Palm Beach

location_facility: Advanced Mental Health Care Inc. - Juno Beach


study_start_date_type: Actual

intervention_type: Drug

acronym: Study of the Effects of Oral AT1001 in Patients with Fabry Disease

lead_sponsor: Amicus Therapeutics

summary: The primary objective of this study was to compare the effect of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).

ReferenceType: derived

ReferenceCitation: Bichet DG, Aerts JM, Auray-Blais C, Maruyama H, Mehta AB, Skuban N, Krusinska E, Schiffmann R. Assessment of plasma lyso-Gb3 for clinical monitoring of treatment response in migalastat-treated patients with Fabry disease. Genet Med. 2021 Jan;23(1):192-201. doi: 10.1038/s41436-020-00968-z. Epub 2020 Sep 30. Erratum In: Genet Med. 2020 Nov 20;:

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Germain DP, Nicholls K, Giugliani R, Bichet DG, Hughes DA, Barisoni LM, Colvin RB, Jennette JC, Skuban N, Castelli JP, Benjamin E, Barth JA, Viereck C. Efficacy of the pharmacologic chaperone migalastat in a subset of male patients with the classic phenotype of Fabry disease and migalastat-amenable variants: data from the phase 3 randomized, multicenter, double-blind clinical trial and extension study. Genet Med. 2019 Sep;21(9):1987-1997. doi: 10.1038/s41436-019-0451-z. Epub 2019 Feb 6.

licence_repositories: cc-by-nc-nd cc-by-nc-sa

repository_institution: PubMed Central - Europe PMC

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Universidade Federal do Rio Grande do Sul - Lume

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access;www.lume.ufrgs.br

ReferenceCitation: Schiffmann R, Bichet DG, Jovanovic A, Hughes DA, Giugliani R, Feldt-Rasmussen U, Shankar SP, Barisoni L, Colvin RB, Jennette JC, Holdbrook F, Mulberg A, Castelli JP, Skuban N, Barth JA, Nicholls K. Migalastat improves diarrhea in patients with Fabry disease: clinical-biomarker correlations from the phase 3 FACETS trial. Orphanet J Rare Dis. 2018 Apr 27;13(1):68. doi: 10.1186/s13023-018-0813-7.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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

repository_normalized: Pure (Denmark)

repository_institution: California Digital Library - eScholarship

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

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery;University of Melbourne - Minerva Access;dash.harvard.edu;escholarship.org;r781wj56v;www.lume.ufrgs.br

ReferenceCitation: Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.

ReferenceCitation: Germain DP, Hughes DA, Nicholls K, Bichet DG, Giugliani R, Wilcox WR, Feliciani C, Shankar SP, Ezgu F, Amartino H, Bratkovic D, Feldt-Rasmussen U, Nedd K, Sharaf El Din U, Lourenco CM, Banikazemi M, Charrow J, Dasouki M, Finegold D, Giraldo P, Goker-Alpan O, Longo N, Scott CR, Torra R, Tuffaha A, Jovanovic A, Waldek S, Packman S, Ludington E, Viereck C, Kirk J, Yu J, Benjamin ER, Johnson F, Lockhart DJ, Skuban N, Castelli J, Barth J, Barlow C, Schiffmann R. Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat. N Engl J Med. 2016 Aug 11;375(6):545-55. doi: 10.1056/NEJMoa1510198.

title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamics of AT1001 in Patients With Fabry Disease and AT1001-Responsive GLA Mutations

location_country:
Italy
Poland
United Kingdom
Argentina
Denmark
Australia
Brazil
United States
Spain
Turkey
Canada
Egypt
France


intervention_type: Biological

lead_sponsor: Pfizer

summary: This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.

status: Completed

title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine

primary_purpose: Prevention

source: euctr

enrollment_type: Actual

design_allocation: Non-Randomized

study_completion_date_type: Actual

location_country:
Italy
United Kingdom
Lebanon
United States
Saudi Arabia
Egypt
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


acronym: ENVISION

lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.

ReferenceCitation: Davies JC, Wainwright CE, Canny GJ, Chilvers MA, Howenstine MS, Munck A, Mainz JG, Rodriguez S, Li H, Yen K, Ordonez CL, Ahrens R; VX08-770-103 (ENVISION) Study Group. Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation. Am J Respir Crit Care Med. 2013 Jun 1;187(11):1219-25. doi: 10.1164/rccm.201301-0153OC.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: American Thoracic Society

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis Foundation

location_facility: University of Virginia Pediatric Respiratory Medicine

location_facility: Mukoviszidose-Zentrum am Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Kinder- und Jugendmedizin

location_facility: East Tennessee Children's Hospital Pediatric Pulmonary and Respiratory Care

location_facility: University of Nebraska Medical Center Pediatric Pulmonary/ CF

location_facility: Kinder- und Jugendklinik Universitätsklinikum Erlangen

location_facility: University of Utah Pediatric Pulmonology

location_facility: Helen DeVos Children's Hospital Spectrum Health Hospitals

location_facility: Hôpital Robert Debré - Service de gastro-entérologiemucoviscidose et nutrition

location_facility: University of Iowa Department of Pediatrics

location_facility: Dept of Gene Therapy, Imperial College London

title: A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation

primary_purpose: Treatment

design_allocation: Randomized

location_country:
Germany
Ireland
United Kingdom
Australia
United States
Canada
France


title: A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

acronym: PARSC

summary:
The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate.

Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice.

Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative.

The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide.

The statistical analysis will be performed by Agendia and an independent research institute or hospital.

Study Design Extension Study:

This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made.

This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power).

Reporting of the Results:

Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results.

Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Agendia

location_country:
Germany
United Kingdom
Denmark
Japan
Sweden
Netherlands
Austria
Switzerland
United States
China
Spain
France

location_facility: Albert Einstein College of Medicine, Montefiore Medical Center

location_facility: Sutter Roseville Medical Center /Research

location_facility: Immunology Akademiska sjukhuset/ University Hospital

location_facility: South Orange County Surgical Medical Group

location_facility: University of Hong Kong/ Queen Mary Hospital

location_facility: IDIBELL Institut Catala d'Oncologia (ICO)

status_simplified: Unknown


title: A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)

acronym: IMPRES

summary: A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.

oa_colors: green other

evidence: open (via free pdf)

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.

publisher_dissemination: Wiley

ReferenceCitation: Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

ReferenceCitation: Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.

oa_host_type: publisher

repositories_concat: closed

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Japan
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Canada
France

location_facility:
Novartis Investigative Site
University Hospital Basel
Novartis investigative site


title: A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer

acronym: THYME

summary: The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

lead_sponsor: AstraZeneca

location_country:
France
Italy
Bulgaria
Hungary
United Kingdom
Brazil
Sweden
Switzerland
Belgium
Spain
Panama
Peru
Canada
Czech Republic


title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke

summary:
The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient and doctor about whether surgery or stenting is the more appropriate choice.

The study is looking at immediate risks (within one month)and at long term benefits

ReferenceType: background

ReferenceCitation: Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. doi: 10.1016/S0140-6736(04)16146-1. Erratum In: Lancet. 2004 Jul 31;364(9432):416.

lead_sponsor: University of Oxford

collaborators: NHS Health Technology Assessment Programme

location_country:
Germany
Ireland
Poland
Japan
Brazil
Kazakhstan
Croatia
Czechia
Canada
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Switzerland
United States
Belgium
China
Estonia
Egypt
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Hospital Clinic 1 Provinical de Barcelona

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano

location_facility: Nuovo Ospedale Civile Sant' Agostino Estense

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: V.A. Almazov National Medical Research Centre

location_facility: Novosibirsk Research Institute of Circulation Pathology

location_facility: Policlinico Universitario Campus Bio-medico di Roma

location_facility: Klinikum rechts der Isar derTechnischen Universität Muenchen

location_facility: University of Warsaw/ Institute of Psychiatry

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Dept. of Vascular Surgery, Attikon University Hospital

location_facility: Fondazione Policlinico U. Agostino Gemeli IRCCS

location_facility: HCFM Ribeirao Preto da Universidade de Sao Paulo

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Saint Petersburg Scientific Research Institute for Emergency Care

location_facility: University of Dresden 'Carl-Gustav-Carus'

intervention_type: Procedure

lead_sponsor_type: academique


type: Other Identifier

title: Betaferon Treatment and Exercise Data Gathering IN Early MS

acronym: BEGIN

summary: The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

lead_sponsor: Bayer

location_country:
Germany
Taiwan
Australia
Kuwait
Thailand
Kazakhstan
Canada
France
Czech Republic
Slovenia
Colombia
Portugal
Denmark
Switzerland
Bahrain
Indonesia
Lebanon
Belgium
Oman
Egypt
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
United Arab Emirates
Korea, Republic of
Spain
Greece
Jordan
Israel


lead_sponsor: Allergan

summary: The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

ReferenceCitation: Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.

title: A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Czechia
Canada
France
Portugal
Slovakia
United States
Ukraine
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Spain
South Africa
Taiwan
Russian Federation


title: A Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS Patients

summary:
The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).

The drug works by inhibiting the protein that prevents nerve growth.

This will be the first time the drug will be given to man. The trial is expected to involve approximately 76 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses or repeat dose escalation in patients with ALS.

ReferenceCitation: Meininger V, Pradat PF, Corse A, Al-Sarraj S, Rix Brooks B, Caress JB, Cudkowicz M, Kolb SJ, Lange D, Leigh PN, Meyer T, Milleri S, Morrison KE, Orrell RW, Peters G, Rothstein JD, Shefner J, Lavrov A, Williams N, Overend P, Price J, Bates S, Bullman J, Krull D, Berges A, Abila B, Meno-Tetang G, Wurthner J. Safety, pharmacokinetic, and functional effects of the nogo-a monoclonal antibody in amyotrophic lateral sclerosis: a randomized, first-in-human clinical trial. PLoS One. 2014 May 19;9(5):e97803. doi: 10.1371/journal.pone.0097803. eCollection 2014.

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

lead_sponsor: GlaxoSmithKline

location_country:
United States
Italy
United Kingdom
France


title: PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.

acronym: PEACE

summary: The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.

status: Terminated

lead_sponsor: Ferring Pharmaceuticals

location_country:
Germany
United Kingdom
Denmark
Sweden
Belgium
United States
France

location_facility: Center for Digestive and Liver Disease, Inc

location_facility: Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln


title: Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

acronym: PROCEEDII

summary: The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

ReferenceCitation: Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.

oa_host_type: closed

lead_sponsor: TransMedics

collaborators: Azienda Ospedaliera S. Maria della Misericordia

collaborators: Royal Brompton & Harefield NHS Foundation Trust

intervention_type: Device


title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

acronym: CVS

summary: This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.

ReferenceType: result

ReferenceCitation: Lemp MA, Bron AJ, Baudouin C, Benitez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol. 2011 May;151(5):792-798.e1. doi: 10.1016/j.ajo.2010.10.032. Epub 2011 Feb 18.

ReferenceCitation: Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.

ReferenceCitation: Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.

ipd_sharing: Yes

ipd_sharing_description: Data was published in AJO May 2011 and IOVS Dec.2010.

lead_sponsor: TearLab Corporation

sponsor_collaborators:
TearLab Corporation
Alcon Research

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI

acronym: CRISP-AMI

summary: Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

ReferenceCitation: Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.

ReferenceCitation: Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.

lead_sponsor: Datascope Corp.

collaborators:
Duke University
Flinders Medical Centre

sponsor_collaborators:
Datascope Corp.
Duke University
Flinders Medical Centre

location_country:
Germany
Ireland
Italy
India
United Kingdom
Australia
Netherlands
Belgium
United States
France

location_facility: Klinik fur Innere Medizin und Kardiologie

location_facility: Saint John's Medical College and Hospital

location_facility: Baroda Heart Institute and Research Centre

location_facility: University of Rochester Medical Center-Strong Memorial Hospital

location_facility: Essentia Institute of Rural Health (St Mary's)

location_facility: Azienda Ospedaliero Universitaria Cargeei

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: University of Texas Health Science Center at Houston


title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

acronym: XAMOS

summary: The main goal is to provide additional information to the risk-benefit assessment of the drug.

ReferenceCitation: Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.

ReferenceCitation: Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country: Macedonia, The Former Yugoslav Republic of


type: EudraCT Number

title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

summary: To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

ipd_sharing: No

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

location_country:
Germany
Italy
Hungary
United Kingdom
Japan
United States
Korea, Republic of
Taiwan
Czechia
Russian Federation
France

location_facility: Providence Regional Medical Center Everett - Providence Regional Cancer Partnership

location_facility: Charité - Universitaetsmedizin Berlin, Charité Campus Mitte

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: FSBSI "N.N. Blokhin Russian Cancer Research Center"

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Wisconsin - Hospital and Clinics

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: Nottingham City Hospital / Oncology Department


type: Registry Identifier

title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial

acronym: CHALLENGE

summary:
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.

PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

status: Recruiting

primary_purpose: Other

ReferenceCitation: Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85. doi: 10.3747/co.v15i6.378.

ReferenceCitation: Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801. doi: 10.1123/jpah.7.6.794.

ReferenceCitation: Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial. Cancer Epidemiol Biomarkers Prev. 2016 Jun;25(6):969-77. doi: 10.1158/1055-9965.EPI-15-1267. Epub 2016 Apr 8.

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Canadian Cancer Trials Group

sponsor_collaborators:
Canadian Cancer Trials Group
Survivorship Research Group
Queen's University, Belfast

location_country:
United Kingdom
Australia
United States
Korea, Republic of
Canada
France

location_facility: Macarthur Cancer Therapy Centre - Campbelltown Hospital

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Exercise Medicine Center for Diabetes and Cancer

location_facility: Stronach Regional Health Centre at Southlake

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: North Coast Cancer Institute - Port Macquarie

location_facility: North Coast Cancer Institute Coffs Harbour

intervention_type: Other

status_simplified: Ongoing


title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

summary: This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.

lead_sponsor: Amgen

location_country:
Hong Kong
Mexico
United States
Malaysia
France


title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

acronym: GIDEON

summary: In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

ReferenceCitation: Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781.

evidence: open (via page says license)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Impact Journals, LLC

ReferenceCitation: Ye SL, Yang J, Bie P, Zhang S, Chen X, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Lv Z. Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study. BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9.

publisher_dissemination: Springer-Nature

ReferenceCitation: Kudo M, Lencioni R, Marrero JA, Venook AP, Bronowicki JP, Chen XP, Dagher L, Furuse J, Geschwind JF, Ladron de Guevara L, Papandreou C, Sanyal AJ, Takayama T, Yoon SK, Nakajima K, Lehr R, Heldner S, Ye SL. Regional differences in sorafenib-treated patients with hepatocellular carcinoma: GIDEON observational study. Liver Int. 2016 Aug;36(8):1196-205. doi: 10.1111/liv.13096. Epub 2016 Apr 1.

ReferenceCitation: Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41. doi: 10.1111/j.1742-1241.2010.02414.x.

location_country:
Finland
Japan
Thailand
Kazakhstan
Vietnam
Croatia
Pakistan
Canada
France
Czech Republic
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Qatar
United States
Ukraine
Indonesia
India
Romania
China
Malaysia
Libyan Arab Jamahiriya
Syrian Arab Republic
Philippines
Italy
Norway
Singapore
Venezuela
Sweden
Mexico
United Arab Emirates
Korea, Republic of
Spain
Uruguay
Greece
Russian Federation
Israel


summary: The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

location_country:
Germany
Italy
Poland
Colombia
Romania
Mexico
Belgium
United States
Peru
Bulgaria
France


title: An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Austria
United States
Spain
Canada
France


title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

summary: The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

location_country:
Italy
United Kingdom
Singapore
Australia
Sweden
Netherlands
Switzerland
United States
Greece
Canada
France


title: An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine

summary: This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

ReferenceCitation: Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30.

ReferenceCitation: Schlesinger N, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, So A. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther. 2011 Mar 25;13(2):R53. doi: 10.1186/ar3297.

ReferenceCitation: So A, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, Schlesinger N. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600.

lead_sponsor: Novartis

location_country:
Germany
Poland
United Kingdom
Argentina
Switzerland
Belgium
United States
Turkey
Canada
Russian Federation
France

location_facility: Northern California Institute for Bone Health

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: Center for Clinical Trials of San Gabriel

location_facility: Regional Clinical Research Rheumatology Assoc.

location_facility: San Diego Arthritis & Osteoporosis Medical Clinic


summary: This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.

ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Whittemore VH, Chen D, Sahmoud T, Shah G, Lincy J, Lebwohl D, Budde K. Everolimus for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis (EXIST-2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2013 Mar 9;381(9869):817-24. doi: 10.1016/S0140-6736(12)61767-X.

ReferenceCitation: Bissler JJ, Nonomura N, Budde K, Zonnenberg BA, Fischereder M, Voi M, Louveau AL, Herbst F, Bebin EM, Curatolo P, Zonta A, Belousova E. Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis. PLoS One. 2018 Sep 7;13(9):e0201005. doi: 10.1371/journal.pone.0201005. eCollection 2018.

ReferenceCitation: Bissler JJ, Budde K, Sauter M, Franz DN, Zonnenberg BA, Frost MD, Belousova E, Berkowitz N, Ridolfi A, Christopher Kingswood J. Effect of everolimus on renal function in patients with tuberous sclerosis complex: evidence from EXIST-1 and EXIST-2. Nephrol Dial Transplant. 2019 Jun 1;34(6):1000-1008. doi: 10.1093/ndt/gfy132.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Sparagana S, Franz DN, Krueger DA, Bissler JJ, Berkowitz N, Burock K, Kingswood JC. Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex. PLoS One. 2017 Oct 12;12(10):e0186235. doi: 10.1371/journal.pone.0186235. eCollection 2017.

ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Berkowitz N, Miao S, Segal S, Peyrard S, Budde K. Everolimus for renal angiomyolipoma in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis: extension of a randomized controlled trial. Nephrol Dial Transplant. 2016 Jan;31(1):111-9. doi: 10.1093/ndt/gfv249. Epub 2015 Jul 8.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Massachusetts General Hospital Massachussetts General Hospita

title: A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Netherlands
United States
Spain
Canada
Russian Federation
France


title: Betaferon Prospective Study on Adherence, Coping and Nursing Support

acronym: BEACON

summary:
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

ReferenceCitation: Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.

location_country:
Germany
Taiwan
New Zealand
Argentina
Kuwait
Bosnia and Herzegovina
Pakistan
Canada
France
Czech Republic
Slovenia
Colombia
Portugal
Slovakia
Bahrain
Lebanon
Belgium
China
Syrian Arab Republic
Libyan Arab Jamahiriya
Estonia
Egypt
Italy
Norway
Singapore
United Kingdom
Iran, Islamic Republic of
Sweden
Netherlands
Mexico
Venezuela
United Arab Emirates
Korea, Republic of
Saudi Arabia
Jordan
Israel


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

lead_sponsor: Sanofi

location_country:
France
Bulgaria
Slovakia
Israel
Australia
Netherlands
Belgium
United States
South Africa
Canada
Ukraine
Russian Federation
Czech Republic

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

acronym: CARGOII

summary: The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.

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

repository_normalized: dnet

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

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.

repositories:
PubMed Central
boris.unibe.ch
dnet

repositories_concat: PubMed Central;boris.unibe.ch;dnet

ReferenceCitation: Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A, Ross HJ, Parameshwar J, Zakliczynski M, Fiocchi R, Stypmann J, Hoefer D, Lehmkuhl H, Deng MC, Leprince P, Berry G, Marboe CC, Stewart S, Tazelaar HD, Baron HM, Coleman IC, Vanhaecke J. Concordance among pathologists in the second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation. 2012 Dec 15;94(11):1172-7. doi: 10.1097/TP.0b013e31826e19e2.

lead_sponsor: XDx

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

location_facility: UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)

location_facility: Medical University of Vienna (Medizinische Universität Wien)

location_facility: Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie

location_facility: Inselspital - Universitätsspital Bern Postfach 33


title: Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

acronym: SAPPHIRE

summary: In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).

lead_sponsor: Isarna Therapeutics GmbH

location_country:
Germany
Poland
India
Hungary
Argentina
United Kingdom
Brazil
Austria
Mexico
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France

location_facility: Wojskowy Szpital Kliniczny, Klinika Neurochirurgii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej

location_facility: State Institution Russian Oncology Research Center N.N. Blokhin

location_facility: Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: Manipal Hospital & Manipal Institute for Neurological Disorders

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii

location_facility: Edinburgh Centre for Neuro-Oncology, Western General Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie

location_facility: Chelyabinsk City Hospital #3; Department of Neurosurgery

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Amrita Institute of Medical Sciences Research Center

location_facility: Universitätsklinikum Leipzig, Neurochirurgische Klinik

location_facility: Russian Scientific Research Neurosurgical Institute A.L. Polenov

location_facility: Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: NJ Neuroscience Institute; JFK Medical Center

location_facility: Universitätsklinik Heidelberg Neurologische Klinik

location_facility: Otto-von-Guericke-Universität, Klinik für Neurochirurgie

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Samara Region Clinical Hospital M.I. Kalinin

location_facility: Military Medical Academy, Neurosurgery Dept

location_facility: Universitätsklinik Innsbruck, Abteilung für Neurologie

location_facility: Klinik und Poliklinik für Neurochirurgie

location_facility: Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

location_facility: Medizinische Hochschule Hannover Neurochirurgische Klinik


title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

summary: A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Denmark
Belgium
United States
France

location_facility:
Mayo Clinic
Indiana University Medical Center
University of Pittsburgh
Columbia University Medical Center
Erasme Hospital - Belgium
Fox Chase Cancer Center
Evangelisches Krankenhaus Dusseldorf
California Pacific Medical Center
Hopital Edouard Herriot
Policlinico Agostino Gemelli
Medical University of South Carolina
Cleveland Clinic Foundation
Bispebjerg Hospital, Denmark
University of Colorado Hospital
Beth Israel Deaconess Medical Center


acronym: REPLACE

lead_sponsor: Shire

summary: Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.

ReferenceCitation: Ayodele O, Mu F, Berman R, Swallow E, Rejnmark L, Gosmanova EO, Kaul S. Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Aug;39(8):3845-3856. doi: 10.1007/s12325-022-02198-y. Epub 2022 Jun 11.

ReferenceCitation: Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3557-65. doi: 10.1210/clinem/dgaa490.

publisher_dissemination: The Endocrine Society

ReferenceCitation: Vokes TJ, Mannstadt M, Levine MA, Clarke BL, Lakatos P, Chen K, Piccolo R, Krasner A, Shoback DM, Bilezikian JP. Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-731. doi: 10.1210/jc.2017-01471.

ReferenceCitation: Mannstadt M, Clarke BL, Vokes T, Brandi ML, Ranganath L, Fraser WD, Lakatos P, Bajnok L, Garceau R, Mosekilde L, Lagast H, Shoback D, Bilezikian JP. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83. doi: 10.1016/S2213-8587(13)70106-2. Epub 2013 Oct 7. Erratum In: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3. Dosage error in article text.

location_facility: University of California-San Francisco VA Medical Center

location_facility: University of Cincinnati Bone Health and Osteoporosis Center

location_facility: Capital District Health Authority, QEII Health Sciences Centre

location_facility: Chetre Hospitalier Universitaire de Liege

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

location_country:
Italy
Hungary
United Kingdom
Denmark
Belgium
United States
Canada
France


title: A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

location_country:
France
Germany
Poland
Hungary
Israel
Denmark
Australia
Norway
Netherlands
Sweden
Belgium
United States
Spain
Canada
Russian Federation
Czech Republic

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia

summary: This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.

location_country:
United States
France


lead_sponsor: Novartis Pharmaceuticals

summary: This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

location_country:
Finland
Germany
Italy
Colombia
Poland
New Zealand
Hungary
Argentina
Hong Kong
Australia
Norway
Sweden
Switzerland
Belgium
United States
Thailand
Canada
France


lead_sponsor: Human Genome Sciences Inc., a GSK Company

summary: This is a long-term continuation study to provide continuing treatment to subjects with SLE.

ReferenceCitation: Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.

ReferenceCitation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

ReferenceCitation: Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412.

publisher_dissemination: British Medical Journal

title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

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

location_country:
Germany
Poland
Argentina
Brazil
Chile
Czechia
Canada
France
Colombia
Slovakia
Hong Kong
India
Romania
Belgium
Peru
Puerto Rico
Philippines
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia

summary:
This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs.

Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

ReferenceCitation: Ramirez J, Dartois N, Gandjini H, Yan JL, Korth-Bradley J, McGovern PC. Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia. Antimicrob Agents Chemother. 2013 Apr;57(4):1756-62. doi: 10.1128/AAC.01232-12. Epub 2013 Jan 28.

publisher_dissemination: American Society for Microbiology

lead_sponsor: Pfizer

location_country:
Colombia
Hungary
Argentina
Australia
Brazil
United States
Korea, Republic of
Latvia
Croatia
Chile
Taiwan
Canada
Russian Federation
France


title: Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease

summary: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Denmark
Australia
Switzerland
Austria
Belgium
United States
Spain
South Africa
Canada
Puerto Rico
France


title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

ReferenceCitation: Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.

ReferenceCitation: Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.

location_country:
France
Germany
Italy
Hungary
Argentina
United Kingdom
Brazil
Mexico
United States
China
Korea, Republic of
Taiwan
Canada
Czech Republic


title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

summary: The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

ReferenceCitation: Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.

ReferenceCitation: Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodriguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houe V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

collaborators: Cancer International Research Group (CIRG)

location_country:
Germany
Poland
Argentina
Brazil
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
United States
Egypt
United Kingdom
Sweden
Austria
Uruguay
Spain
Greece
South Africa
Israel

location_facility:
Sanofi-Aventis Administrative Office
sanofi-aventis Administrative office
Sanofi-aventis adminsitrative office
Sanofi-aventis administrative office


title: Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate

summary: This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

ReferenceCitation: Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.

publisher_dissemination: The Journal of Rheumatology

location_country:
Italy
Poland
New Zealand
Australia
Belgium
United States
Spain
Russian Federation
France


title: An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

summary: Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
United Kingdom
Denmark
Australia
France

location_facility: Nephrology Department, Princess Alexandra Hospital

location_facility: The Royal Melbourne Hospital, Department of Nephrology

location_facility: Renal Research Unit, Launceston General Hospital

location_facility: Melbourne Renal Research Group, Epworth Medical Centre

location_facility: Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin

location_facility: Birmingham Hospital, Queen Elizabeth Medical Centre

location_facility: Renal Department, The Royal London Hospital

location_facility: Renal Dialysis Unit, Manchester Royal Infirmary

location_facility: Medicinsk Afdeling, nefrologisk, Roskilde Sygehus

location_facility: Department of Renal Medicine, Hope Hospital

location_facility: Universitätsklinikum Aachen, Medizinsche Klinik II

location_facility: Renal Unit, The Queen Elizabeth Hospital


title: A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease

summary: The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study. Alzheimers Res Ther. 2016 Nov 15;8(1):47. doi: 10.1186/s13195-016-0214-x.

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Feb 21;10:391-401. doi: 10.2147/NDT.S57909. eCollection 2014. Erratum In: Neuropsychiatr Dis Treat. 2014;10:1997.

publisher_dissemination: Informa

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Lithuania
Slovenia
Slovakia
Romania
Latvia
Greece
Ukraine
Estonia
Czech Republic
Russian Federation
France


title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

summary: This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

lead_sponsor: Bausch Health Americas, Inc.

sponsor_collaborators:
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Mexico
Belgium
United States
Canada
France

location_facility:
Salix Investigational Site
Pfizer Investigational Site


acronym: eXplore

summary: This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.

sponsor_collaborators:
Novartis Pharmaceuticals
Genentech, Inc.

title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

location_country:
Germany
United Kingdom
Sweden
Netherlands
United States
Canada
France


title: Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

acronym: MORE

summary: To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

ReferenceCitation: Melamed ML, Blackwell T, Neugarten J, Arnsten JH, Ensrud KE, Ishani A, Cummings SR, Silbiger SR. Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis. Kidney Int. 2011 Jan;79(2):241-9. doi: 10.1038/ki.2010.378. Epub 2010 Oct 6.

lead_sponsor: Eli Lilly and Company

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Canada
France
Czech Republic
Slovenia
Slovakia
Hungary
Denmark
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Israel

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


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic

summary: The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.

lead_sponsor: Rigel Pharmaceuticals

location_country:
Germany
Italy
Colombia
Belgium
United States
Peru
France

location_facility: Reumatologia Azienda Ospedaliera Universitaria

location_facility: Clinical Research Center of Reading, LLP

location_facility: Memorial Medical Group Clinical Research Inst

location_facility: North Shore Long Island Jewich Health System

location_facility: Rheumazentrum am Universitatsklinikum Leipzig

location_facility: Arthritis & Rheumatic Disease Specialties

location_facility: The Osteoporosis & Clinical Trials Center

location_facility: Azienda Ospedaliera Santa Maria della Miseri


title: Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

summary: To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

location_country:
Germany
Slovenia
Portugal
Slovakia
Denmark
Brazil
Sweden
Mexico
Belgium
United States
Spain
Peru
Canada
Russian Federation
France


title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

summary: To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

ReferenceCitation: Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

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

location_country:
Germany
Poland
Australia
Brazil
Czechia
France
Hungary
Hong Kong
Denmark
United States
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Israel


title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma

summary: The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .

ReferenceCitation: Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.

lead_sponsor: European Lung Cancer Working Party

location_country: Belgium France

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

location_facility: Department of Pneumology Hôpital Saint-Joseph

location_facility: Department of Pneumology CHR St joseph - Warquignies

location_facility: Department of Pneumology Hôpital Ixelles-Molière


title: Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

acronym: EPO-PASS

summary: Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

ReferenceCitation: Horl WH, Locatelli F, Haag-Weber M, Ode M, Roth K; Epo-PASS study group. Prospective multicenter study of HX575 (biosimilar epoetin-alpha) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. Clin Nephrol. 2012 Jul;78(1):24-32. doi: 10.5414/cn107440.

ipd_sharing: Undecided

lead_sponsor: Sandoz

sponsor_collaborators:
Sandoz
Hexal AG

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie

location_facility: Ministry of Interior-Central Clinical Base

location_facility: Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Praxis für Innere Medizin und Nephrologie

location_facility: Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto

location_facility: Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum

location_facility: Universitätsklinik für Innere Medizin III

location_facility: Szpital Powiatowy im. Lekarza Z. Koprowskiego

location_facility: Oblasna klinichna likarnia imeni I.I.Mechnikova

location_facility: Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr

location_facility: Nieren- und Diabeteszentrum Viersen-Nettetal

location_facility: Ospedaliero Universitaria Policlinico S. Orsola Malpighi

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.

location_facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.

location_facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: GUZ "Yaroslavl regional clinical hospital"

location_facility: Szpital Specjalistyczny Sw. W. Adalberta

location_facility: Multiprofile Hospital for Active Treatment Pazardzhik

location_facility: Azienda Ospedaliera CTO - Maria Adelaide

location_facility: Fachpraxis für Nieren und Hochdruckerkrankungen

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVITUM

location_facility: Azienda Ospedaliera ospedale S. Salvatore

location_facility: Kuratorium ür Dialyse und Nierentransplantation e.V.

location_facility: Multiprofile Hospital for Active Treatment Dr. Kiro Popov

location_facility: Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen

location_facility: Azienda Ospedaliera Ospedale San Carlo Borromeo

location_facility: Alwall Praxis für Nieren- und Hochdruckkrankheiten

location_facility: Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo

location_facility: Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu

location_facility: U.O.C. Nefrologia e Dialisi, C.G. Mazzoni

location_facility: PHO Clinical Hospital Dr. Trifun Panovski

location_facility: FGUZ Clinical hospital No. 83 of FMBA of Russia

location_facility: Multiprofile Hospital for Active Treatment Rousse

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu

location_facility: Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu

location_facility: Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu

location_facility: Azienda Ospdealiero "Istituti Ospitalieri"

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Azienda Ospedaliera Carlo Poma di Mantova

location_facility: Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego


title: A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

summary: The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

lead_sponsor: Contura

collaborators: Regulatory and Clinical Research Institute (RCRI)

location_country:
United States
Canada
France

location_facility: Midwest Institute for Research & Education

location_facility: Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology

location_facility: Medical University of South Carolina - Department of Urology

location_facility: UT Southwestern Medical Center at Dallas - Department of Urology

location_facility: Virgina Mason Medical Center - Section of Urology and Renal Transplantation

location_facility: Stanford UniveritySchool of Medicine - Departmert of OB/GYN

location_facility: University of Vermont - The Continence Center

location_facility: South California Permanente Medical Group

location_facility: University of Miami and Jackson Memorial Hospital

location_facility: Tower Urology - Institute for Continence - Cedars-Sinai Medical Office


acronym: STEP

lead_sponsor: Bayer

summary:
The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib.

An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

sponsor_collaborators:
Bayer
ICON Clinical Research

title: Sorafenib Long Term Extension Program

ipd_sharing_description:
Availability of this study's data will later 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.

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Canada
France
Colombia
Hong Kong
United States
Ukraine
Belgium
China
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Bulgaria


title: A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

summary: This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Merck KGaA, Darmstadt, Germany

location_country:
France
Germany
United Kingdom
Australia
Switzerland
Lebanon
Belgium
United States
Spain
Canada
Czech Republic


title: A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

acronym: S-1 Pancreas

summary:
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Taiho Pharmaceutical Co., Ltd.

location_country:
Guatemala
Hungary
Israel
Denmark
Romania
Brazil
Costa Rica
Austria
Sweden
Tunisia
United States
Greece
Panama
South Africa
Peru
Canada
France


acronym: AVERT

summary: The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

ReferenceCitation: Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.

ReferenceCitation: Davila-Roman VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72. doi: 10.1016/j.jacc.2003.12.060.

ReferenceCitation: Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92. doi: 10.1016/s0003-4975(01)03442-7.

ReferenceCitation: Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.

ReferenceCitation: Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. doi: 10.1016/j.ejcts.2005.09.014. Epub 2005 Nov 7.

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
University of Pittsburgh

location_country:
Germany
Italy
Netherlands
Switzerland
United States
Spain
Canada
France

location_facility:
Texas Heart Institute
Massachusetts General Hospital
Hopital Regional-Service de Cardiologie
Mayo Clinic
Sisters of Providence Health System
LDS Hospital
University of British Columbia
Brigham and Womens Hospital
Hôpital G. Et R. Laënnec
Inselspital
Hospital 12 de Octubre
St. Antonius Ziekenhuis
Deutches Herzzentrum Berlin
Florida Heart Group
Fond Ne Centro S. Raffaele
University of Alberta Hospital


summary: The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.

title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Chile
France
Colombia
Portugal
Hungary
Switzerland
United States
Romania
Belgium
China
Malaysia
Puerto Rico
Philippines
Italy
United Kingdom
Mexico
Spain
Taiwan


summary: The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).

title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

acronym: VANILLA

summary:
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

ReferenceCitation: Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Germany
Poland
Argentina
Chile
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Switzerland
United States
India
Romania
Belgium
Puerto Rico
Italy
Cyprus
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation


acronym: TAMARIS

summary:
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
The safety of riferminogene pecaplasmid in the study population.

ReferenceCitation: Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21.

ReferenceCitation: Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28.

title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Czech Republic
Belarus
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Estonia
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Sweden