title: Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil

acronym: ORANGE

summary:
The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value < 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia.

Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value.

We hypothesize that:

Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event.
NPi=0 is strongly predictive of mortality (GOS 1).
Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP >20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4).

Methods This international multicentre prospective observational study aims to recruit >400 patients admitted to intensive care units.

Duration of the study 18 months, including 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

ReferenceCitation: Sharshar T, Citerio G, Andrews PJ, Chieregato A, Latronico N, Menon DK, Puybasset L, Sandroni C, Stevens RD. Neurological examination of critically ill patients: a pragmatic approach. Report of an ESICM expert panel. Intensive Care Med. 2014 Apr;40(4):484-95. doi: 10.1007/s00134-014-3214-y. Epub 2014 Feb 13.

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

family: Citerio

full_name: Giuseppe Citerio

given: Giuseppe

family: Andrews

full_name: Peter J. D. Andrews

given: Peter J. D.

family: Chieregato

full_name: Arturo Chieregato

given: Arturo

family: Latronico

full_name: Nicola Latronico

given: Nicola

family: Menon

full_name: David K. Menon

given: David K.

family: Puybasset

full_name: Louis Puybasset

given: Louis

family: Sandroni

full_name: Claudio Sandroni

given: Claudio

family: Stevens

full_name: Robert D. Stevens

given: Robert D.

journal_name: Intensive Care Medicine

ReferenceCitation: Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.

family: Chen

full_name: JeffW Chen

given: JeffW

family: Gombart

full_name: ZoeJ Gombart

given: ZoeJ

family: Rogers

full_name: Shana Rogers

given: Shana

family: Gardiner

full_name: StuartK Gardiner

given: StuartK

family: Cecil

full_name: Sandy Cecil

given: Sandy

family: Bullock

full_name: RossM Bullock

given: RossM

journal_name: Surgical Neurology International

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

title: Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the neurological pupil index

ReferenceCitation: Chen JW, Vakil-Gilani K, Williamson KL, Cecil S. Infrared pupillometry, the Neurological Pupil index and unilateral pupillary dilation after traumatic brain injury: implications for treatment paradigms. Springerplus. 2014 Sep 23;3:548. doi: 10.1186/2193-1801-3-548. eCollection 2014.

ReferenceCitation: Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314. Review.

title: Portable Infrared Pupillometry

ReferenceCitation: Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

title: Portable infrared pupillometry in critical care

ReferenceCitation: Volpi PC, Robba C, Rota M, Vargiolu A, Citerio G. Trajectories of early secondary insults correlate to outcomes of traumatic brain injury: results from a large, single centre, observational study. BMC Emerg Med. 2018 Dec 5;18(1):52. doi: 10.1186/s12873-018-0197-y.

repository_institution: Università degli Studi di Milano - Institutional Research Information System

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

ReferenceCitation: Han J, King NK, Neilson SJ, Gandhi MP, Ng I. External validation of the CRASH and IMPACT prognostic models in severe traumatic brain injury. J Neurotrauma. 2014 Jul 1;31(13):1146-52. doi: 10.1089/neu.2013.3003. Epub 2014 May 12.

name: Department of Neurosurgery, National Neuroscience Institute, Singapore.

name: Manchester Medical School, University of Manchester, Manchester, United Kingdom.

name: Centre of Quantitative Medicine, Duke-National University of Singapore Graduate Medical School, Singapore.

name: Department of Biostatistics, Singapore Clinical Research Institute, Singapore.

title: External Validation of the CRASH and IMPACT Prognostic Models in Severe Traumatic Brain Injury

ReferenceCitation: Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.

ReferenceCitation: Couret D, Simeone P, Freppel S, Velly L. The effect of ambient-light conditions on quantitative pupillometry: a history of rubber cup. Neurocrit Care. 2019 Apr;30(2):492-493. doi: 10.1007/s12028-018-0664-z.

ReferenceCitation: Olson DM, Stutzman S, Saju C, Wilson M, Zhao W, Aiyagari V. Interrater Reliability of Pupillary Assessments. Neurocrit Care. 2016 Apr;24(2):251-7. doi: 10.1007/s12028-015-0182-1.

title: Interrater Reliability of Pupillary Assessments

ReferenceCitation: Hall CA, Chilcott RP. Eyeing up the Future of the Pupillary Light Reflex in Neurodiagnostics. Diagnostics (Basel). 2018 Mar 13;8(1). pii: E19. doi: 10.3390/diagnostics8010019. Review.

repository_institution: University of Hertfordshire - University of Hertfordshire Research Archive

ReferenceCitation: Larson MD, Sessler DI. Pupillometry to guide postoperative analgesia. Anesthesiology. 2012 May;116(5):980-2. doi: 10.1097/ALN.0b013e318251d21b.

name: Department of Anesthesia, University of California, San Francisco, San Francisco, California.

name: Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio. ds@or.org

title: Pupillometry to Guide Postoperative Analgesia

ReferenceCitation: Morelli P, Oddo M, Ben-Hamouda N. Role of automated pupillometry in critically ill patients. Minerva Anestesiol. 2019 Sep;85(9):995-1002. doi: 10.23736/S0375-9393.19.13437-2. Epub 2019 Mar 29. Review.

ReferenceCitation: Shoyombo I, Aiyagari V, Stutzman SE, Atem F, Hill M, Figueroa SA, Miller C, Howard A, Olson DM. Understanding the Relationship Between the Neurologic Pupil Index and Constriction Velocity Values. Sci Rep. 2018 May 3;8(1):6992. doi: 10.1038/s41598-018-25477-7.

ReferenceCitation: Jahns FP, Miroz JP, Messerer M, Daniel RT, Taccone FS, Eckert P, Oddo M. Quantitative pupillometry for the monitoring of intracranial hypertension in patients with severe traumatic brain injury. Crit Care. 2019 May 2;23(1):155. doi: 10.1186/s13054-019-2436-3.

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: Aoun SG, Stutzman SE, Vo PN, El Ahmadieh TY, Osman M, Neeley O, Plitt A, Caruso JP, Aiyagari V, Atem F, Welch BG, White JA, Batjer HH, Olson DM. Detection of delayed cerebral ischemia using objective pupillometry in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Jan 11;132(1):27-32. doi: 10.3171/2018.9.JNS181928.

name: 3Division of Neurocritical Care, University of Texas Southwestern Medical Center, Dallas, Texas

publisher: Journal of Neurosurgery Publishing Group (JNSPG)

publisher_dissemination: American Association of Neurological Surgeons

publisher_group: American Association of Neurological Surgeons

publisher_normalized: American Association of Neurological Surgeons

ReferenceCitation: Osman M, Stutzman SE, Atem F, Olson D, Hicks AD, Ortega-Perez S, Aoun SG, Salem A, Aiyagari V. Correlation of Objective Pupillometry to Midline Shift in Acute Stroke Patients. J Stroke Cerebrovasc Dis. 2019 Jul;28(7):1902-1910. doi: 10.1016/j.jstrokecerebrovasdis.2019.03.055. Epub 2019 Apr 25.

journal_name: Journal of Stroke and Cerebrovascular Diseases

ReferenceCitation: Ong C, Hutch M, Barra M, Kim A, Zafar S, Smirnakis S. Effects of Osmotic Therapy on Pupil Reactivity: Quantification Using Pupillometry in Critically Ill Neurologic Patients. Neurocrit Care. 2019 Apr;30(2):307-315. doi: 10.1007/s12028-018-0620-y.

ReferenceCitation: Phillips SS, Mueller CM, Nogueira RG, Khalifa YM. A Systematic Review Assessing the Current State of Automated Pupillometry in the NeuroICU. Neurocrit Care. 2019 Aug;31(1):142-161. doi: 10.1007/s12028-018-0645-2.

ReferenceCitation: Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.

ReferenceCitation: Zuercher P, Groen JL, Aries MJ, Steyerberg EW, Maas AI, Ercole A, Menon DK. Reliability and Validity of the Therapy Intensity Level Scale: Analysis of Clinimetric Properties of a Novel Approach to Assess Management of Intracranial Pressure in Traumatic Brain Injury. J Neurotrauma. 2016 Oct 1;33(19):1768-1774. Epub 2016 Feb 11.

ReferenceCitation: Wilson L, von Steinbuechel N, Menon DK, Maas AIR. Outcome assessment after traumatic brain injury - Authors' reply. Lancet Neurol. 2018 Apr;17(4):299-300. doi: 10.1016/S1474-4422(18)30045-0. Epub 2018 Mar 13.

title: Outcome assessment after traumatic brain injury – Authors' reply

ReferenceCitation: Oddo M, Taccone F, Galimberti S, Rebora P, Citerio G; Orange Study Group. Outcome Prognostication of Acute Brain Injury using the Neurological Pupil Index (ORANGE) study: protocol for a prospective, observational, multicentre, international cohort study. BMJ Open. 2021 May 11;11(5):e046948. doi: 10.1136/bmjopen-2020-046948.

ipd_sharing_description: Access to data The University of Milano-Bicocca has the property of all the data collected. The data resides at the University Milano-Bicocca as study Sponsor; all procedures will comply with the European Union (EU) regulation on data protection 2016/679 on the protection of natural persons regarding personal data processing and movement. Local site data will be co-owned by each participating centre, and they will be given access to local data for any scientific purpose upon request. By entering data into the ORANGE study database, each centre agrees that the chief can use these data for scientific purposes. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators.

location_country:
Italy
United States
Switzerland
France
Norway
Belgium
Spain
Germany

location_facility: Erasme Hospital, Université Libre de Bruxelles

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital and University of Lausanne

location_facility: Department Anesthesia and Critical Care, University Hospital

location_facility: Hospital Clinic Universitari de València, University of Valencia

location_facility: Department of Neurology, University of California


title: A 54 Week, Randomized, Double-blind, Parallel-group, Multicenter Study Evaluating the Long-term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension

summary: This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10:CD012569. doi: 10.1002/14651858.CD012569.pub2.

name: Department of Pharmacology; School of Pharmacy, Fudan University; Shanghai China

family: Wang

full_name: Gan Mi Wang

given: Gan Mi

sequence: additional

family: Li

full_name: Liang Jin Li

given: Liang Jin

family: Tang

full_name: Wen Lu Tang

given: Wen Lu

name: Department of Anesthesiology, Pharmacology and Therapeutics; University of British Columbia; Vancouver Canada

family: Wright

full_name: James M Wright

given: James M

bso_classification: Chemistry

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Novartis

location_country:
United States
India
France
Argentina
Spain
Germany
Colombia

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension

summary: Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.

design_allocation: Non-Randomized

ReferenceCitation: Oudiz RJ, Brundage BH, Galiè N, Ghofrani HA, Simonneau G, Botros FT, Chan M, Beardsworth A, Barst RJ; PHIRST Study Group. Tadalafil for the treatment of pulmonary arterial hypertension: a double-blind 52-week uncontrolled extension study. J Am Coll Cardiol. 2012 Aug 21;60(8):768-74. doi: 10.1016/j.jacc.2012.05.004. Epub 2012 Jul 18.

family: Oudiz

full_name: Ronald J. Oudiz

given: Ronald J.

sequence: first

family: Brundage

full_name: Bruce H. Brundage

given: Bruce H.

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Ghofrani

full_name: Hossein Ardeschir Ghofrani

given: Hossein Ardeschir

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

family: Botros

full_name: Fady T. Botros

given: Fady T.

family: Chan

full_name: Melanie Chan

given: Melanie

family: Beardsworth

full_name: Anthony Beardsworth

given: Anthony

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

bso_classification: Medical research

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Tadalafil for the Treatment of Pulmonary Arterial Hypertension

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Germany
France
Japan
Ireland
Belgium
Spain
Canada
United Kingdom

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

intervention_type: Drug


title: Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease

acronym: PEPCADIII

summary: The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.

ReferenceType: background

ReferenceCitation: Scheller B, Speck U, Böhm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41.

ReferenceCitation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13.

ReferenceCitation: Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8.

ReferenceCitation: Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9.

ReferenceCitation: Speck U, Scheller B, Abramjuk C, Bernhardt U. Drug delivery by angiographic contrast media: inhibition of restenosis. Acad Radiol. 2005 May;12 Suppl 1:S14-7.

ReferenceCitation: Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6.

ReferenceCitation: Scheller B, Speck U, Schmitt A, Böhm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20.

ReferenceCitation: Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Böhm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7.

ReferenceCitation: Scheller B, Speck U, Schmitt A, Clauss W, Sovak M, Böhm M, Stoll HP. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Invest Radiol. 2002 Jan;37(1):29-34.

lead_sponsor: University Hospital, Saarland

location_country:
Sweden
United Kingdom
Netherlands
France
Belgium
Spain
Germany
Czech Republic

location_facility: Cardiovascular Center OLV Hospital Aalst

location_facility: Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Kardiologie, Campus Virchow-Klinikum, Charite

intervention_type: Device

lead_sponsor_type: academique


summary: The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients

ReferenceCitation: Cuervo J, Castejón N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.

family: Cuervo

full_name: Jesús Cuervo

given: Jesús

family: Castejón

full_name: Nacho Castejón

given: Nacho

family: Khalaf

full_name: Kristin M Khalaf

given: Kristin M

family: Waweru

full_name: Catherine Waweru

given: Catherine

family: Globe

full_name: Denise Globe

given: Denise

family: Patrick

full_name: Donald L Patrick

given: Donald L

currency_apc_doaj: GBP

journal_name: Health and Quality of Life Outcomes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Sussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10.

family: Sussman

full_name: David Sussman

given: David

family: Patel

full_name: Vaishali Patel

given: Vaishali

family: Del Popolo

full_name: Giulio Del Popolo

given: Giulio

family: Lam

full_name: Wayne Lam

given: Wayne

family: Pommerville

full_name: Peter Pommerville

given: Peter

journal_name: Neurourology and Urodynamics

ReferenceCitation: Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13.

family: Cruz

full_name: Francisco Cruz

given: Francisco

family: Herschorn

title: Efficacy and Safety of OnabotulinumtoxinA in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity: A Randomised, Double-Blind, Placebo-Controlled Trial

location_country:
Italy
Brazil
South Africa
Netherlands
Spain
France
Singapore
Portugal
United States
United Kingdom
Canada
Taiwan


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of HMR1766 Assessing the Efficacy and Safety of 3 Doses of HMR1766 Versus Placebo With Cilostazol as a Calibrator, Administered for 26 Weeks in Patients With Peripheral Arterial Disease (PAD) Fontaine Stage II

acronym: ACCELA

summary: The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.

lead_sponsor: Sanofi

location_country:
Austria
South Africa
France
Poland
Russian Federation
United States
Canada


title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

ReferenceCitation: Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.

family: BRANCO

full_name: JAIME C. BRANCO

given: JAIME C.

family: ZACHRISSON

full_name: OLOF ZACHRISSON

given: OLOF

family: PERROT

full_name: SERGE PERROT

given: SERGE

family: MAINGUY

full_name: YVES MAINGUY

given: YVES

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia

lead_sponsor: Pierre Fabre Medicament

location_country:
Italy
Sweden
United Kingdom
Spain
Finland
France
Poland
Norway
Romania
Portugal
Denmark
Germany
Czech Republic

location_facility: FREDERIKSBERG HOSPITAL - Clinic of Rheumatology

location_facility: KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care

location_facility: KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology


title: 24-month Randomized, Double-masked, Controlled, Multicenter, Phase II Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to AMD.

summary: This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

status: Terminated

ReferenceCitation: Ritter M, Simader C, Bolz M, Deák GG, Mayr-Sponer U, Sayegh R, Kundi M, Schmidt-Erfurth UM. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol. 2014 Dec;98(12):1629-35. doi: 10.1136/bjophthalmol-2014-305186. Epub 2014 Jul 30.

family: Ritter

full_name: Markus Ritter

given: Markus

family: Simader

full_name: Christian Simader

given: Christian

family: Bolz

full_name: Matthias Bolz

given: Matthias

family: Deák

full_name: Gábor G Deák

given: Gábor G

family: Mayr-Sponer

full_name: Ulrike Mayr-Sponer

given: Ulrike

family: Sayegh

full_name: Ramzi Sayegh

given: Ramzi

family: Kundi

full_name: Michael Kundi

given: Michael

family: Schmidt-Erfurth

full_name: Ursula M Schmidt-Erfurth

given: Ursula M

journal_name: British Journal of Ophthalmology

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, Pilz S, Weisberger A; MONT BLANC Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012 May;119(5):992-1000. doi: 10.1016/j.ophtha.2012.02.002. Epub 2012 Mar 17.

family: Larsen

full_name: Michael Larsen

full_name: Ursula Schmidt-Erfurth

given: Ursula

family: Lanzetta

full_name: Paolo Lanzetta

given: Paolo

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

family: Tokaji

full_name: Erika Tokaji

given: Erika

family: Pilz

full_name: Stefan Pilz

given: Stefan

family: Weisberger

full_name: Annemarie Weisberger

given: Annemarie

journal_name: Ophthalmology

title: Verteporfin plus Ranibizumab for Choroidal Neovascularization in Age-related Macular Degeneration

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

status_simplified: Unknown


title: A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d

acronym: ALBERIO

summary:
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

location_country:
India
Morocco
Finland
France
Malaysia
Greece
Tunisia
Belgium
Turkey
Estonia
Germany
Korea, Republic of
Taiwan


title: An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder

summary: The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

location_country: Italy Sweden Finland France Belgium Turkey Canada


title: An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

summary: The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

location_country:
Sweden
Mexico
Croatia
France
Russian Federation
Turkey
United States
Czech Republic


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)

summary:
The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.

The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.

ReferenceType: result

ReferenceCitation: Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. Erratum in: Lancet. 2005 Jul 30-Aug 5;366(9483):370.

ReferenceCitation: Van Gaal LF, Scheen AJ, Rissanen AM, Rössner S, Hanotin C, Ziegler O; RIO-Europe Study Group. Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study. Eur Heart J. 2008 Jul;29(14):1761-71. doi: 10.1093/eurheartj/ehn076. Epub 2008 Apr 15.

family: Van Gaal

full_name: Luc F. Van Gaal

given: Luc F.

family: Scheen

full_name: André J. Scheen

given: André J.

family: Rissanen

full_name: Aila M. Rissanen

given: Aila M.

family: Rössner

full_name: Stephan Rössner

given: Stephan

family: Hanotin

full_name: Corinne Hanotin

given: Corinne

family: Ziegler

full_name: Olivier Ziegler

given: Olivier

journal_name: European Heart Journal

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: University of Liège - Open Repository and Bibliography

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study †

location_country:
United States
Sweden
Netherlands
Finland
France
Belgium
Germany


title: A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform

summary: This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country:
Italy
North Macedonia
Croatia
France
Slovakia
Belgium
Turkey
Slovenia

location_facility: Università degli Studi di Padova - Ematologia ed Immunologia Clinica

location_facility: U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

location_facility: Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

location_facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

location_facility: Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia

location_facility: Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

location_facility: U.O. di Ematologia - Casa Sollievo della Sofferenza

location_facility: Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

location_facility: ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

location_facility: Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

location_facility: Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

location_facility: UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1

location_facility: Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

location_facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

location_facility: Divisione di Ematologia Ospedale A. Perrino

location_facility: Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit

location_facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"

location_facility: Divisione di Ematologia - Ospedale S.Eugenio

location_facility: Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

location_facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

location_facility: UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

location_facility: Roma Divisione Ematologia - Università Campus Bio-Medico

location_facility: Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

location_facility: IRCCS_AOU San Martino-IST.Clinica Ematologica

location_facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

location_facility: Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

status_simplified: Ongoing


intervention_type: Biological

lead_sponsor: Faron Pharmaceuticals Ltd

location_country:
Netherlands
Finland
France
Spain
United States
United Kingdom

acronym: MATINS

location_facility: START Madrid - CIOCC Hospital HM Sanchinarro

location_facility: Erasmus University Medical Center Rotterdam

location_facility: The University of Texas Health Science Center at San Antonio

ipd_sharing: No

type: EudraCT Number

source: euctr

title: A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours

summary:
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.

The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.


title: A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea.

This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.

status: Active, not recruiting

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
United States
France
Poland
Hungary
Spain
Germany

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház


lead_sponsor: Wave Life Sciences Ltd.

location_country:
Italy
United States
Netherlands
France
Belgium
Canada
United Kingdom

location_facility: U.O.C di Neurologia e Malattie Neuromuscolari Centro Clinico Nemo Sud

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: London Health Sciences Centre - Hospital

location_facility: Radbound University Nijmegen Medical Care

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

title: A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients With Duchenne Muscular Dystrophy

summary: This is a Phase 1, double-blind, placebo-controlled, single ascending dose cohort study to evaluate the safety, tolerability, and plasma concentrations of WVE-210201 in ambulatory and non-ambulatory male pediatric patients with DMD amenable to exon 51 skipping intervention.


ReferenceCitation: Piha-Paul SA, Azaro A, Arkenau HT, Oh DY, Galsky MD, Pal SK, Hamada K, He Y, Yamamiya I, Benhadji KA, Hollebecque A. A first-in-human phase I study of TAS0728, an oral covalent binding inhibitor of HER2, in patients with advanced solid tumors with HER2 or HER3 aberrations. Invest New Drugs. 2021 Oct;39(5):1324-1334. doi: 10.1007/s10637-021-01104-7. Epub 2021 Mar 27.

family: Piha-Paul

full_name: Sarina A. Piha-Paul

given: Sarina A.

family: Azaro

full_name: Analía Azaro

given: Analía

family: Arkenau

full_name: Hendrik Tobias Arkenau

given: Hendrik Tobias

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Galsky

full_name: Matthew D. Galsky

given: Matthew D.

family: Pal

full_name: Sumanta Kumar Pal

given: Sumanta Kumar

family: Hamada

full_name: Kensuke Hamada

given: Kensuke

family: He

full_name: Yaohua He

given: Yaohua

family: Yamamiya

full_name: Ikuo Yamamiya

given: Ikuo

family: Benhadji

full_name: Karim A Benhadji

given: Karim A

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

journal_name: Investigational New Drugs

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Irie H, Ito K, Fujioka Y, Oguchi K, Fujioka A, Hashimoto A, Ohsawa H, Tanaka K, Funabashi K, Araki H, Kawai Y, Shimamura T, Wadhwa R, Ohkubo S, Matsuo K. TAS0728, A Covalent-binding, HER2-selective Kinase Inhibitor Shows Potent Antitumor Activity in Preclinical Models. Mol Cancer Ther. 2019 Apr;18(4):733-742. doi: 10.1158/1535-7163.MCT-18-1085. Epub 2019 Feb 20.

family: Irie

full_name: Hiroki Irie

given: Hiroki

family: Ito

full_name: Kimihiro Ito

given: Kimihiro

family: Fujioka

full_name: Yayoi Fujioka

given: Yayoi

family: Oguchi

full_name: Kei Oguchi

given: Kei

full_name: Akio Fujioka

given: Akio

family: Hashimoto

full_name: Akihiro Hashimoto

given: Akihiro

family: Ohsawa

full_name: Hirokazu Ohsawa

publisher: American Association for Cancer Research (AACR)

location_country:
United States
United Kingdom
France
Spain

location_facility: City of Hope Comprehensive Cancer Center

title: A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities

summary: This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.


title: Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

summary:
The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation.

The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

lead_sponsor: 4Tech Cardio Ltd.

location_country:
Netherlands
France
Belgium
Australia
Denmark
Germany
United Kingdom

location_facility: Brighton & Sussex University Hospitals - Sussex County Hospital


title: An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder

acronym: AQUARIUS

summary: The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.

location_country:
Austria
South Africa
Sweden
France
Russian Federation
Argentina
Estonia


title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter

acronym: CORYFEE

summary: Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

ReferenceCitation: Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15.

family: KHITRI

full_name: AVINASH R. KHITRI

given: AVINASH R.

family: ALIOT

full_name: ETIENNE M. ALIOT

given: ETIENNE M.

family: CAPUCCI

full_name: ALESSANDRO CAPUCCI

given: ALESSANDRO

family: CONNOLLY

full_name: STUART J. CONNOLLY

given: STUART J.

family: CRIJNS

full_name: HARRY CRIJNS

given: HARRY

family: HOHNLOSER

full_name: STEFAN H. HOHNLOSER

given: STEFAN H.

family: KULAKOWSKI

full_name: PIOTR KULAKOWSKI

given: PIOTR

family: ROY

full_name: DENIS ROY

given: DENIS

family: RADZIK

full_name: DAVID RADZIK

given: DAVID

family: KOWEY

full_name: PETER R. KOWEY

given: PETER R.

journal_name: Journal of Cardiovascular Electrophysiology

title: Celivarone for Maintenance of Sinus Rhythm and Conversion of Atrial Fibrillation/Flutter

location_country:
Italy
United States
Netherlands
France
Hungary
Portugal
Germany
Czech Republic
Canada


title: A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease

summary: The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.

location_country:
Austria
South Africa
Sweden
Morocco
Netherlands
Germany
Spain
France
Tunisia
Portugal
Denmark
Canada
United Kingdom


title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment

acronym: CONTROL

summary:
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Brazil
South Africa
Hong Kong
Netherlands
Switzerland
Germany
United Kingdom
France
Greece
Hungary
Spain
United States
Czech Republic


title: 52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy

acronym: GINGER

summary:
Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

ReferenceCitation: Fritsche A, Hahn A, Landgraf W, Häring HU. Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study. Eur Endocrinol. 2013 Mar;9(1):1-3. doi: 10.17925/EE.2013.09.01.1. Epub 2013 Apr 4.

family: Fritsche

full_name: Andreas Fritsche

given: Andreas

family: Hahn

full_name: Almut Hahn

given: Almut

family: Landgraf

full_name: Wolfgang Landgraf

given: Wolfgang

family: Häring

full_name: Hans-Ulrich Häring

given: Hans-Ulrich

name: Fourth Medical Department and Policlinic, University Tübingen

journal_name: European Endocrinology

publisher: Touch Medical Media, Ltd.

publisher_dissemination: Touch Medical Media, Ltd.

publisher_group: Touch Medical Media, Ltd.

publisher_normalized: Touch Medical Media, Ltd.

title: Incidence of Hypoglycaemia in Patients with Type 2 Diabetes – A Subgroup Analysis from the GINGER study

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
United Kingdom
France
Poland
Slovakia
Romania
Belgium
Australia
Portugal
Germany
Czech Republic

location_facility: Sanofi-Aventis Sanofi-aventis


title: Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease

summary: Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.

ReferenceCitation: Boscaro M, Bertherat J, Findling J, Fleseriu M, Atkinson AB, Petersenn S, Schopohl J, Snyder P, Hughes G, Trovato A, Hu K, Maldonado M, Biller BM. Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study. Pituitary. 2014 Aug;17(4):320-6. doi: 10.1007/s11102-013-0503-3.

family: Boscaro

full_name: M. Boscaro

given: M.

family: Bertherat

full_name: J. Bertherat

given: J.

family: Findling

full_name: J. Findling

family: Fleseriu

full_name: M. Fleseriu

family: Atkinson

full_name: A. B. Atkinson

given: A. B.

family: Petersenn

full_name: S. Petersenn

given: S.

family: Schopohl

full_name: J. Schopohl

family: Snyder

full_name: P. Snyder

given: P.

family: Hughes

full_name: G. Hughes

given: G.

family: Trovato

full_name: A. Trovato

given: A.

family: Hu

full_name: K. Hu

given: K.

family: Maldonado

full_name: M. Maldonado

family: Biller

full_name: B. M. K. Biller

given: B. M. K.

journal_name: Pituitary

evidence: open (via page says license)

license: implied-oa

license_normalized: implied-oa

title: Extended treatment of Cushing’s disease with pasireotide: results from a 2-year, Phase II study

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Germany
United Kingdom

location_facility: University of Pennsylvania Medical Center

location_facility: Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.


title: Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

summary: Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

primary_purpose: Other

ReferenceCitation: Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH; AVOID Study Investigators. Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care. 2010 Nov;33(11):2304-9. doi: 10.2337/dc10-0833. Epub 2010 Aug 6.

family: Persson

full_name: F. Persson

given: F.

family: Lewis

full_name: J. B. Lewis

given: J. B.

full_name: E. J. Lewis

given: E. J.

family: Rossing

full_name: P. Rossing

family: Hollenberg

full_name: N. K. Hollenberg

given: N. K.

family: Parving

full_name: H.-H. Parving

journal_name: Diabetes Care

oa_colors: green other

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Impact of Baseline Renal Function on the Efficacy and Safety of Aliskiren Added to Losartan in Patients With Type 2 Diabetes and Nephropathy

ReferenceCitation: Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK; AVOID Study Investigators. Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.

full_name: Hans-Henrik Parving

given: Hans-Henrik

full_name: Frederik Persson

given: Frederik

full_name: Julia B. Lewis

given: Julia B.

full_name: Edmund J. Lewis

given: Edmund J.

full_name: Norman K. Hollenberg

given: Norman K.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy

location_country:
Italy
Netherlands
Germany
France
Greece
Romania
Russian Federation
Spain
Denmark
United States
United Kingdom
Canada

location_facility:
Investigative Site
Novartis Pharmaceuticals


title: A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy

summary: This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.

lead_sponsor: Pfizer

location_country:
France
Belgium
Spain
United Kingdom
Taiwan


ReferenceCitation: Ben-Menachem E, Dominguez J, Szász J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

name: Institute for Clinical Neuroscience and Physiology, Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

family: Ben‐Menachem

full_name: Elinor Ben‐Menachem

given: Elinor

name: Institute for Neurosciences St. Luke’s Medical Center Quezon City Philippines

family: Dominguez

full_name: Jacqueline Dominguez

given: Jacqueline

name: George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureş Emergency Clinical County Hospital Targu Mures (Spitalul Clinic Judeţean de Urgenţă Târgu Mureş), Sectia Clinica Neurologie II Târgu Mureş Romania

family: Szász

full_name: József Szász

given: József

family: Beller

full_name: Cynthia Beller

given: Cynthia

family: Howerton

full_name: Charles Howerton

given: Charles

family: Jensen

full_name: Lori Jensen

given: Lori

family: McClung

full_name: Carrie McClung

given: Carrie

family: Roebling

full_name: Robert Roebling

given: Robert

family: Steiniger‐Brach

full_name: Björn Steiniger‐Brach

given: Björn

currency_apc_doaj: USD

journal_name: Epilepsia Open

title: Long‐term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open‐label trial

lead_sponsor: UCB Biopharma S.P.R.L.

location_country:
Sweden
Switzerland
Mexico
Philippines
Finland
France
Japan
Bulgaria
Poland
Romania
Russian Federation
Germany
Latvia
Korea, Republic of
Ukraine

title: A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment

summary: Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.


title: The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance

summary:
The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and privacy aspects, and governance.

Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound intake and exposure, biomarkers for food, health and/or disease and health and/or disease related measurements to study the relation between nutrition, health and development of disease (on individual level).

In addition, data will be used to develop applications that visualise personal health risks based for example on (validated) recommendations and applications that predict individual health risks.

The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort will be composed of about 250 life sciences employees and students from different, predominantly European, countries. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male and female scientists per participating country.

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description:
An internal review board, consisting of Principal Investigators from all participating countries, will review all data requests.

A data request format is available that should be used for filing such a request. The format requires stating the research questions that should be answered with the requested data, type of data, populations requirements (exclusion criteria), data analysis and public disclosure.

All study participants have the ability to withdraw their data from use for answering specific research questions at any time.

lead_sponsor: TNO

location_country:
Italy
Austria
Switzerland
Netherlands
Finland
France
Czechia
Ireland
Belgium
Spain
Denmark
United Kingdom

location_facility: INRA - L'Institut Nationel de la Recherche Agronomique

location_facility: CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione


title: European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermúdez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: the International Society of Paediatric Oncology European Neuroblastoma Experience. J Clin Oncol. 2009 Mar 1;27(7):1014-9. doi: 10.1200/JCO.2007.14.5839. Epub 2009 Jan 26.

name: From La Fe Children's Hospital and Biostatistics Department, Universidad de Valencia, Valencia, Spain; Sheffield Children's Hospital, Sheffield; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; Hôpital des Enfants, Toulouse and Institute Curie, Paris, France; Centro di Riferimento Regionali di Ematologia ed Oncologia Pediatrica, Catania; G Gaslini Children's Hospital, Genoa, Italy; St Anna's Children's Hospital, Vienna, Austria; and Saint Luc University Hospital, Catholic University of Louvain...

family: Canete

full_name: Adela Canete

given: Adela

family: Gerrard

full_name: Mary Gerrard

given: Mary

family: Rubie

full_name: Hervé Rubie

given: Hervé

family: Castel

full_name: Victoria Castel

given: Victoria

family: Di Cataldo

full_name: Andrea Di Cataldo

given: Andrea

family: Munzer

full_name: Caroline Munzer

given: Caroline

family: Ladenstein

full_name: Ruth Ladenstein

given: Ruth

family: Brichard

full_name: Bénédicte Brichard

given: Bénédicte

family: Bermúdez

full_name: José D. Bermúdez

given: José D.

family: Couturier

full_name: Jerôme Couturier

given: Jerôme

family: de Bernardi

full_name: Bruno de Bernardi

given: Bruno

family: Pearson

full_name: Andrew J. Pearson

given: Andrew J.

family: Michon

full_name: Jean Michon

given: Jean

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Poor Survival for Infants WithMYCN-Amplified Metastatic Neuroblastoma Despite Intensified Treatment: The International Society of Paediatric Oncology European Neuroblastoma Experience

lead_sponsor: European Infant Neuroblastoma Study Group - 1999

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

intervention_type: Procedure


title: European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: De Bernardi B, Gerrard M, Boni L, Rubie H, Cañete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Ruud E, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J, Pearson AD. Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol. 2009 Mar 1;27(7):1034-40. doi: 10.1200/JCO.2008.17.5877. Epub 2009 Jan 26.


title: European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified

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

PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.


title: European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent outcome with reduced treatment in infants with nonmetastatic and unresectable neuroblastoma without MYCN amplification: results of the prospective INES 99.1. J Clin Oncol. 2011 Feb 1;29(4):449-55. doi: 10.1200/JCO.2010.29.5196. Epub 2010 Dec 20.

name: From the Hôpital des Enfants, Toulouse; Institut Curie, Paris; Département de Pédiatrie, Institut Gustave-Roussy, Villejuif; Unité d'Hémato-Oncologie, Hôpital de la Tronche, Grenoble, France; Giannina Gaslini Children′s Hospital, Genova; Istituto Toscano Tumori, Firenze, Italy; Sheffield Children′s Hospital, Sheffield; the Royal Marsden Hospital, Sutton, Surrey; Great Ormond St Hospital; St George's Hospital, London, United Kingdom; La Fe Children′s Hospital, Valencia; Hospital Virgen del Rocio, Sevilla,...

family: De Bernardi

full_name: Bruno De Bernardi

full_name: Jérôme Couturier

given: Jérôme

family: Ambros

full_name: Peter Ambros

given: Peter

full_name: Andrew D.J. Pearson

given: Andrew D.J.

family: Garaventa

full_name: Alberto Garaventa

given: Alberto

family: Brock

full_name: Penelope Brock

given: Penelope

family: Valteau-Couanet

full_name: Dominique Valteau-Couanet

given: Dominique

family: Holmes

full_name: Keith Holmes

given: Keith

family: Mosseri

full_name: Véronique Mosseri

given: Véronique

family: Marquez

full_name: Catalina Marquez

given: Catalina

family: Plantaz

full_name: Dominique Plantaz

family: Boni

full_name: Luca Boni

given: Luca

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Excellent Outcome With Reduced Treatment in Infants With Nonmetastatic and Unresectable Neuroblastoma Without MYCN Amplification: Results of the Prospective INES 99.1


title: Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

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

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.

lead_sponsor: Societe Internationale d'Oncologie Pediatrique

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

location_facility: Southampton University Hospital NHS Trust


title: CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.

ReferenceCitation: Köhne CH, van Cutsem E, Wils J, Bokemeyer C, El-Serafi M, Lutz MP, Lorenz M, Reichardt P, Rückle-Lanz H, Frickhofen N, Fuchs R, Mergenthaler HG, Langenbuch T, Vanhoefer U, Rougier P, Voigtmann R, Müller L, Genicot B, Anak O, Nordlinger B; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005 Aug 1;23(22):4856-65. Epub 2005 Jun 6.

ReferenceCitation: Kohne CH, Van Custem E, Wils JA, et al.: Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: results of EORTC GI Group study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1018, 2003.

ReferenceCitation: Kohne C, van Cutsem E, Wils J, et al.: Weekly high dose infusional 5-FU plus folinic acid (FA) with or without irinotecan (IRI) in metastatic colorectal cancer (MCRC): interim safety results of EORTC study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-532, 2002.

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

location_country:
Italy
Austria
South Africa
Netherlands
France
Belgium
Russian Federation
Egypt
Germany

location_facility: Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover

location_facility: Henriettenstiftung - Chirurgische Klinik

location_facility: Hermann-Holthusen Institute for Radiotherapy

location_facility: Internistisch - Onkologische Gemeinschaftspraxis

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Harz-Klinikum Wernigerode GMBH - Medizinische Klinik

location_facility: St. Johannes Hospital - Medical Klinik II


title: Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

ReferenceCitation: Giaccone G. Gemcitabine plus taxane combinations in non-small cell lung cancer. Semin Oncol. 1999 Feb;26(1 Suppl 4):19-24. Review.

ReferenceCitation: Efficace F, Bottomley A, Smit EF, Lianes P, Legrand C, Debruyne C, Schramel F, Smit HJ, Gaafar R, Biesma B, Manegold C, Coens C, Giaccone G, Van Meerbeeck J; EORTC Lung Cancer Group and Quality of Life Unit. Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol. 2006 Nov;17(11):1698-704. Epub 2006 Sep 12.

ReferenceCitation: Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G; European Organization for Research and Treatment of Cancer Lung Cancer Group. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003 Nov 1;21(21):3909-17.

location_country:
Italy
South Africa
Switzerland
Netherlands
France
Poland
Greece
Belgium
Egypt
Spain
Germany
Czech Republic

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: University Hospital - Rotterdam Dijkzigt


title: A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)

summary:
RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.

PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.

primary_purpose: Supportive Care

ReferenceCitation: Franchi M, Trimbos JB, Zanaboni F, v d Velden J, Reed N, Coens C, Teodorovic I, Vergote I. Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients. Eur J Cancer. 2007 May;43(8):1265-8. Epub 2007 Apr 26.

location_country: Italy Austria Netherlands Spain France Belgium Portugal Germany

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori


title: Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

ReferenceCitation: Reed NS, Mangioni C, Malmström H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2. Erratum in: Eur J Cancer. 2008 Jul;44(11):1612.

family: Reed

full_name: N.S. Reed

family: Mangioni

full_name: C. Mangioni

given: C.

family: Malmström

full_name: H. Malmström

given: H.

family: Scarfone

full_name: G. Scarfone

given: G.

family: Poveda

full_name: A. Poveda

given: A.

family: Pecorelli

full_name: S. Pecorelli

given: S.

family: Tateo

full_name: S. Tateo

family: Franchi

full_name: M. Franchi

given: M.

family: Jobsen

full_name: J.J. Jobsen

family: Coens

full_name: C. Coens

family: Teodorovic

full_name: I. Teodorovic

given: I.

family: Vergote

full_name: I. Vergote

family: Vermorken

full_name: J.B. Vermorken

journal_name: European Journal of Cancer

title: Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: An European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874)

ReferenceCitation: Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Poland
Belgium
Spain
Canada
United Kingdom

location_facility: Hopital Cantonal Universitaire de Geneva

intervention_type: Radiation


title: European Sepsis Care Survey

summary: The objective of this survey is to investigate the current state of sepsis care around Europe. The study is aiming at hospital structure, emergency departments, wards, intensive care units and clinical diagnostic and microbiological service.

status: Enrolling by invitation

ipd_sharing_description: This study uses no patient data.

lead_sponsor: University Medicine Greifswald

location_country:
Italy
Sweden
Netherlands
Spain
Finland
Moldova, Republic of
France
Czechia
Greece
Israel
Poland
Norway
Romania
Belgium
Russian Federation
Portugal
Turkey
Denmark
Germany
United Kingdom

location_facility: National Institute for Antibiotic Resistance & Infection Control, Ministry of Health

location_facility: Department of Anesthesiology and Intensive Care Medicine University Hospital of Ostrava

location_facility: Department of Anaesthesiology and Intensive Therapy Wroclaw Medical University

location_facility: Corporació Sanitària Parc Taulí · critical care center, sabadell hospital, Corporació Sanitaria Universitaria Parc Tauli

location_facility: Perioperative, Intensive Care and Pain Medicine Helsinki University Hospital

location_facility: Department of Emergency Medicine University of Southern Denmark

location_facility: Faculty of Medicine, Department of Clinical Sciences Lund, Division of Infection Medicine, Lund University

location_facility: Hacettepe University, Department of Internal Medicine Sihhiye, Ankara

location_facility: Universidade do Porto Faculdade de Medicina: Porto

location_facility: "Prof CC Iliescu" Emergency Institute for Cardiovascular Diseases, Bucharest

location_facility: Emergency Department Antwerp University Hospital

location_facility: King's College London, Guy's and St Thomas' Foundation Hospital, Department of Critical Care, London

location_facility: State University of Medicine and Pharmaceutics "Nicolae Testemiţanu"

location_facility: 4th Department of Internal Medicine ATTIKON University Hospital

location_facility: Hopital Raymond Poncare Service de Reanimation Medicale

location_facility: Vladimir L. Vanevskii Department of Anaesthesiology and Reanimatology, North-Western State Medical University named after Ilya I. Mechnikov


type: Registry Identifier

title: A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors

summary: This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Netherlands
France
Spain
United States
Canada


title: REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

acronym: REVEAL-CKD

summary: This is a retrospective, multinational, non-interventional, observational study. A series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 CKD in each region. The study will also assess the current state of CKD management in patients with undiagnosed CKD

time_perspective: Retrospective

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
United States
Spain
France
Japan
China
Germany


title: Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: (AVATAR Trial): A Multicentre Randomized Controlled Trial

acronym: AVATAR

summary: Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left ventricular ejection fraction remains controversial. The investigators therefore try to compare clinical outcomes of elective aortic valve replacement to conventional treatment and watchful waiting strategy in a prospective randomized trial.

ReferenceCitation: Carabello BA. Should severe aortic stenosis be operated on before symptom onset? Aortic valve replacement should be operated on before symptom onset. Circulation. 2012 Jul 3;126(1):112-7. doi: 10.1161/CIRCULATIONAHA.111.079350. Review.

ReferenceCitation: Kang DH, Park SJ, Rim JH, Yun SC, Kim DH, Song JM, Choo SJ, Park SW, Song JK, Lee JW, Park PW. Early surgery versus conventional treatment in asymptomatic very severe aortic stenosis. Circulation. 2010 Apr 6;121(13):1502-9. doi: 10.1161/CIRCULATIONAHA.109.909903. Epub 2010 Mar 22.

ReferenceCitation: Malaisrie SC, McCarthy PM, McGee EC, Lee R, Rigolin VH, Davidson CJ, Beohar N, Lapin B, Subacius H, Bonow RO. Contemporary perioperative results of isolated aortic valve replacement for aortic stenosis. Ann Thorac Surg. 2010 Mar;89(3):751-6. doi: 10.1016/j.athoracsur.2009.11.024.

ReferenceCitation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25.

ReferenceCitation: Banovic M, Iung B, Bartunek J, Asanin M, Beleslin B, Biocina B, Casselman F, da Costa M, Deja M, Gasparovic H, Kala P, Labrousse L, Loncar Z, Marinkovic J, Nedeljkovic I, Nedeljkovic M, Nemec P, Nikolic SD, Pencina M, Penicka M, Ristic A, Sharif F, Van Camp G, Vanderheyden M, Wojakowski W, Putnik S. Rationale and design of the Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A randomized multicenter controlled event-driven trial. Am Heart J. 2016 Apr;174:147-53. doi: 10.1016/j.ahj.2016.02.001. Epub 2016 Feb 9.

ReferenceCitation: Banovic M, Iung B, Bartunek J, Penicka M, Vanderheyden M, Casselman F, van Camp G, Nikolic S, Putnik S. The Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A protocol update. Am Heart J. 2018 Jan;195:153-154. doi: 10.1016/j.ahj.2017.10.005. Epub 2017 Oct 14.

ReferenceCitation: Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, Kirkeeide RL, Gould KL, Johnson NP. Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions. J Interv Cardiol. 2020 Jul 22;2020:4603169. doi: 10.1155/2020/4603169. eCollection 2020. Review.

name: Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands

family: Zelis

full_name: Jo M. Zelis

given: Jo M.

family: Tonino

full_name: Pim A. L. Tonino

given: Pim A. L.

name: Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands

family: Pijls

full_name: Nico H. J. Pijls

given: Nico H. J.

name: Department of Cardiology, Cardiovascular Center Aalst OLV Hospital, Aalst, Belgium

name: Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland

family: De Bruyne

full_name: Bernard De Bruyne

given: Bernard

name: Weatherhead PET Center, Division of Cardiology, Department of Medicine, McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, Texas, USA

family: Kirkeeide

full_name: Richard L. Kirkeeide

given: Richard L.

family: Gould

full_name: K. Lance Gould

given: K. Lance

family: Johnson

full_name: Nils P. Johnson

given: Nils P.

journal_name: Journal of Interventional Cardiology

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

lead_sponsor: Clinical Centre of Serbia

location_country: Italy Serbia Croatia Czechia France Lithuania Poland Ireland Belgium

location_facility: University Clinical Center ''Sestre milosrdnice''

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Insitute for Cardiovascular Diseases "Sremska Kamenica"

location_facility: Città della Salute e della Scienza di Torino

location_facility: Vilnius University Hospital Santariskiu klinikos


title: Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

summary:
Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS.

Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.

lead_sponsor: St. Justine's Hospital

location_country:
Hong Kong
France
Japan
Singapore
United States
Canada

location_facility:
Alfred I. duPont Hospital for Children
St Justine's Hospital
Rady Children's Hospital
Miami Children's Hospital
Mayo Clinic
Queen Mary Hospital
The Meijo Hospital
Robert Debré Hospital
National University


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

lead_sponsor: Shire

location_country:
United States
Mexico
France
Australia
Spain
Canada
United Kingdom

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Hospital Infantil Universitario Niño Jesus

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

title: An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction With Elaprase® in Patients With Hunter Syndrome and Cognitive Impairment

summary: This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.


title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a Retinoic Acid Receptor Gamma (RARγ) Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

summary:
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement.

In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.

ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

lead_sponsor: Clementia Pharmaceuticals Inc.

location_country:
France
Argentina
Australia
United States
United Kingdom

location_facility: The Royal National Orthopaedic Hospital, Brockley Hill

location_facility: Queensland University of Technology (QUT) Institute of Health and Biomedical Innovation (IHBI)

location_facility: Hospital Italiano de Buenos Aires, Department of Pediatrics

location_facility: University of Pennsylvania, Center for FOP & Related Bone Disorders

location_facility: Hôpital Necker-Enfants Malades, Department of Genetics

location_facility: University of California San Francisco, Division of Endocrinology and Metabolism


title: Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer

summary: This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

ReferenceCitation: Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Pikiel J, Eniu AE, Li RK, Tiangco B, Lee SJ, Kim S. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021 Aug;188(3):631-640. doi: 10.1007/s10549-021-06240-5. Epub 2021 Jun 20.

family: Stebbing

full_name: Justin Stebbing

given: Justin

family: Baranau

full_name: Yauheni V. Baranau

given: Yauheni V.

family: Baryash

full_name: Valery Baryash

given: Valery

family: Manikhas

full_name: Alexey Manikhas

given: Alexey

family: Moiseyenko

full_name: Vladimir Moiseyenko

given: Vladimir

family: Dzagnidze

full_name: Giorgi Dzagnidze

given: Giorgi

family: Zhavrid

full_name: Edvard Zhavrid

given: Edvard

family: Boliukh

full_name: Dmytro Boliukh

given: Dmytro

family: Pikiel

full_name: Joanna Pikiel

given: Joanna

family: Eniu

full_name: Alexandru E. Eniu

given: Alexandru E.

family: Li

full_name: Rubi K. Li

given: Rubi K.

family: Tiangco

full_name: Beatrice Tiangco

given: Beatrice

family: Lee

full_name: Sang Joon Lee

given: Sang Joon

family: Kim

full_name: Sunghyun Kim

given: Sunghyun

journal_name: Breast Cancer Research and Treatment

repository_institution: Imperial College London - Spiral

ReferenceCitation: Esteva FJ, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskiy D, Pikiel J, Eniu AE, Li RK, Rusyn AV, Tiangco B, Lee SJ, Lee SY, Yu SY, Stebbing J. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemother Pharmacol. 2019 Oct;84(4):839-847. doi: 10.1007/s00280-019-03920-4. Epub 2019 Aug 19.

family: Esteva

full_name: F. J. Esteva

given: F. J.

full_name: Y. V. Baranau

given: Y. V.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskii D, Pikiel J, Eniu A, Komov D, Morar-Bolba G, Li RK, Rusyn A, Lee SJ, Lee SY, Esteva FJ. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017 Jul;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5. Epub 2017 Jun 4. Erratum in: Lancet Oncol. 2017 Aug;18(8):e433. Lancet Oncol. 2017 Sep;18(9):e510.

location_country:
Peru
Greece
Romania
Russian Federation
Taiwan
Ukraine
Ecuador
India
Spain
France
Japan
Poland
Thailand
Argentina
South Africa
Chile
Philippines
Hungary
Portugal
Italy
Brazil
Bosnia and Herzegovina
Serbia
Mexico
Georgia
Belarus
Turkey
Latvia