title: Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials

acronym: TALISMAN S

summary: The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.

time_perspective: Retrospective

lead_sponsor: Sanofi

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
United States
France


title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)

summary:
Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed.

One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chourdakis M, Hecht C, Gerasimidis K, Joosten KF, Karagiozoglou-Lampoudi T, Koetse HA, Ksiazyk J, Lazea C, Shamir R, Szajewska H, Koletzko B, Hulst JM. Malnutrition risk in hospitalized children: use of 3 screening tools in a large European population. Am J Clin Nutr. 2016 May;103(5):1301-10. doi: 10.3945/ajcn.115.110700. Epub 2016 Apr 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Hecht C, Weber M, Grote V, Daskalou E, Dell'Era L, Flynn D, Gerasimidis K, Gottrand F, Hartman C, Hulst J, Joosten K, Karagiozoglou-Lampoudi T, Koetse HA, Kolacek S, Ksiazyk J, Niseteo T, Olszewska K, Pavesi P, Piwowarczyk A, Rousseaux J, Shamir R, Sullivan PB, Szajewska H, Vernon-Roberts A, Koletzko B. Disease associated malnutrition correlates with length of hospital stay in children. Clin Nutr. 2015 Feb;34(1):53-9. doi: 10.1016/j.clnu.2014.01.003. Epub 2014 Jan 11.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Ludwig-Maximilians - University of Munich

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Romania
Netherlands
Greece
Croatia
France

location_facility: Dr. von Hauner Children's Hospital. Munich, Germany

location_facility: The Children's Memorial Health Institute

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Rigshospitalet, Copenhagen University Hospital

location_facility: Sophia Children's Hospital, Erasmus University

location_facility: Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.

lead_sponsor_type: academique

status_simplified: Completed


title: A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)

acronym: SHIELD

summary: A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Taiwan
Israel
Hong Kong
Singapore
Tunisia
United States
Korea, Republic of
Spain
Greece
Turkey
Jordan
Egypt
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis

summary: The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

lead_sponsor: Cook Group Incorporated

location_country:
Czechia
United Kingdom
Germany
France

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Klinik Dr. Hancken im Elbe Klinikum Stade

intervention_type: Device


title: A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients.

summary: This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.

lead_sponsor: Santhera Pharmaceuticals

location_country: Germany Netherlands Austria Belgium France

location_facility: Neurologische Klinik - Klinikum Grosshadern

location_facility: Neurologische Universitätsklinik und Ploklinik - Universitätsklimikum Bonn

location_facility: UKE Hamburg Neuropädiatrie - Zentrum für Frauen, Kinder und Jugendmedizin

location_facility: Hôpital Erasme - Univeristé Libre de Bruxelles

location_facility: Neurologische Universitätsklinik und Poliklinik

location_facility: Hôpital de la Salpétrière - INSERM U679, Neurologie et Thérapeutique expérimentale

location_facility: Klinik II, Neuropädiatrie und Muskelerkrankungen - Universitätsklinik Freiburg


title: A Multi-centre, Multinational, Open-label, Single-dose Acute Hemodynamic Study Followed by Multi-centre, Multinational, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy (Proof-of-concept) of ACT-293987 (NS-304) in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

summary: This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

study_start_date_type: Actual

primary_purpose: Other

ReferenceCitation: Simonneau G, Torbicki A, Hoeper MM, Delcroix M, Karlocai K, Galie N, Degano B, Bonderman D, Kurzyna M, Efficace M, Giorgino R, Lang IM. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension. Eur Respir J. 2012 Oct;40(4):874-80. doi: 10.1183/09031936.00137511. Epub 2012 Feb 23.

lead_sponsor: Actelion

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Austria
Belgium
France

location_facility: Instytut Gruzilcy i Chorob Pluc, Klinika Chorob Wewnetrznych Klatki Piersiowej

location_facility: Department of Respiratory Medicine, Hannover Medical School

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Innere Medizin II, Kardiologie

location_facility: Gasthuisberg University Hospital, Pneumology

location_facility: Hospital Sant'Orsola Malpighi, Cardiology's Department

location_facility: Semmelweis University, Clinic of Pulmonology


title: Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy

summary: This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

ReferenceType: background

ReferenceCitation: A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

ReferenceCitation: Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90. doi: 10.1093/sleep/13.6.479.

ReferenceCitation: Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20. doi: 10.1093/sleep/16.3.216.

ReferenceCitation: A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

ReferenceType: result

ReferenceCitation: Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46. doi: 10.1093/sleep/29.7.939.

ReferenceCitation: Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.

ReferenceCitation: Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Dauvilliers Y, Roth T, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. Sleep Med. 2017 Dec;40:53-57. doi: 10.1016/j.sleep.2017.07.030. Epub 2017 Oct 7.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Jazz Pharmaceuticals

location_country:
United States
Switzerland
Germany
France

location_facility: Cincinnati Clinic & Sleep Management Institute

location_facility: Vermont Medical Sleep Disorders Center, Inc.

location_facility: SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Centre du sommeil -- Hopital Gui de Chauliac

location_facility: CSC Research -- Grove City Sleep Diagnostic Center

location_facility: Community Research Management Associates,Inc.

location_facility: Sleep Disorders Center -- Union Hospital of Cecil County

location_facility: The Center for Sleep and Wake Disorders/Midwest Neurology

location_facility: ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder

location_facility: Lehigh Valley Hospital Sleep Disorders Center

location_facility: Community Research & Sleep Management Institute

location_facility: Neurologische Poliklinik -- Universitats Spital Zurich

location_facility: Chest Medicine Associates DBA -- Sleep Medicine Specialists

location_facility: St. Jude Medical Center -- Sleep Disorders Institute

location_facility: Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil

location_facility: New Jersey Neuroscience Institute at JFK Medical Center


title: Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

summary: This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Russian Federation
India
United Kingdom
Hong Kong
Singapore
Brazil
United States
Philippines
Thailand
Greece
South Africa
Turkey
Taiwan
Canada
Indonesia
France

location_facility: Columbia Presbyterian Medical Center (Cpmc)


type: EudraCT Number

acronym: IRIS

summary: This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.

ReferenceCitation: Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939.

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7.

publisher_dissemination: SAGE Publications

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Norway
Hong Kong
Australia
Netherlands
United States
France


type: Other Identifier

title: REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

summary: The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.

lead_sponsor: Bayer

location_country:
Germany
Poland
Hungary
Singapore
Sweden
Korea, Republic of
China
Saudi Arabia
Spain
Malaysia
Croatia
South Africa
Thailand
Indonesia
France


acronym: CLARINET LT

summary:
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

ReferenceCitation: Avlonitis VS, Planas S, Hayes AM, Parry A. Occlusion of modified Blalock-Taussig shunt after clopidogrel cessation. Ann Thorac Surg. 2012 Feb;93(2):656-8. doi: 10.1016/j.athoracsur.2011.07.071.

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

title: Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

source: euctr

location_country:
Germany
Italy
Poland
India
Portugal
Hungary
United Kingdom
Brazil
Mexico
United States
Spain
Malaysia
Taiwan
Russian Federation
France


summary: The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.

location_country:
Germany
Poland
New Zealand
Israel
Singapore
United Kingdom
Australia
Brazil
Switzerland
United States
China
Korea, Republic of
Thailand
Taiwan
Canada
Puerto Rico
France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis

summary: This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.

ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

repository_institution: Radboud University - Radboud Repository

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

ReferenceCitation: Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008 Aug 21;359(8):810-20. doi: 10.1056/NEJMoa0706290.

lead_sponsor: Abbott

location_country:
Germany
Italy
Slovakia
Belgium
United States
Spain
Czech Republic
France

location_facility:
Site Reference ID/Investigator# 638
Site Ref # / Investigator 45543
Site Reference ID/Investigator# 625
Site Ref # / Investigator 45522
Site Reference ID/Investigator# 621
Site Reference ID/Investigator# 2538
Site Ref # / Investigator 45523
Site Reference ID/Investigator# 518
Site Reference ID/Investigator# 644
Site Reference ID/Investigator# 2235
Site Reference ID/Investigator# 636
Site Reference ID/Investigator# 3425
Site Reference ID/Investigator# 406
Site Reference ID/Investigator# 516
Site Reference ID/Investigator# 641
Site Reference ID/Investigator# 640
Site Reference ID/Investigator# 645
Site Ref # / Investigator 45544
Site Reference ID/Investigator# 622
Site Reference ID/Investigator# 3713
Site Ref # / Investigator 45542
Site Reference ID/Investigator# 45545
Site Reference ID/Investigator# 386
Site Reference ID/Investigator# 642
Site Reference ID/Investigator# 628
Site Reference ID/Investigator# 519
Site Reference ID/Investigator# 627
Site Reference ID/Investigator# 631
Site Ref # / Investigator 45525
Site Ref # / Investigator 45524
Site Reference ID/Investigator# 2501


title: A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

summary: This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

ReferenceCitation: Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.

location_country:
France
Germany
Italy
Poland
Hungary
Norway
Denmark
Australia
United Kingdom
Mexico
Belgium
United States
Spain
South Africa
Canada
Czech Republic


title: Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

location_country:
Germany
Poland
Australia
Brazil
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Mexico
Spain
South Africa


title: 28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.

acronym: LAPTOP

summary: To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

location_country:
Finland
Italy
Germany
United Kingdom
Sweden
Netherlands
Austria
Switzerland
Spain
France

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


title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

ReferenceCitation: Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.

lead_sponsor: Pierre Fabre Medicament

location_country:
Finland
Italy
Germany
Portugal
Norway
Romania
Sweden
Spain
Czech Republic
France

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


title: Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)

acronym: ERATO

summary: The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

ReferenceCitation: Davy JM, Herold M, Hoglund C, Timmermans A, Alings A, Radzik D, Van Kempen L; ERATO Study Investigators. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008 Sep;156(3):527.e1-9. doi: 10.1016/j.ahj.2008.06.010.

location_country:
Italy
Poland
Sweden
Netherlands
Switzerland
Belgium
Spain
Czech Republic
France


acronym: HIP

lead_sponsor: AstraZeneca

summary: The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.

title: An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study

location_country: Germany Italy Poland Belgium Ukraine France


title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients

acronym: PEITHO

summary: Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.

ReferenceCitation: Wan S, Quinlan DJ, Agnelli G, Eikelboom JW. Thrombolysis compared with heparin for the initial treatment of pulmonary embolism: a meta-analysis of the randomized controlled trials. Circulation. 2004 Aug 10;110(6):744-9. doi: 10.1161/01.CIR.0000137826.09715.9C. Epub 2004 Jul 19.

ReferenceCitation: Zuo Z, Yue J, Dong BR, Wu T, Liu GJ, Hao Q. Thrombolytic therapy for pulmonary embolism. Cochrane Database Syst Rev. 2021 Apr 15;4(4):CD004437. doi: 10.1002/14651858.CD004437.pub6.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Konstantinides SV, Vicaut E, Danays T, Becattini C, Bertoletti L, Beyer-Westendorf J, Bouvaist H, Couturaud F, Dellas C, Duerschmied D, Empen K, Ferrari E, Galie N, Jimenez D, Kostrubiec M, Kozak M, Kupatt C, Lang IM, Lankeit M, Meneveau N, Palazzini M, Pruszczyk P, Rugolotto M, Salvi A, Sanchez O, Schellong S, Sobkowicz B, Meyer G. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. J Am Coll Cardiol. 2017 Mar 28;69(12):1536-1544. doi: 10.1016/j.jacc.2016.12.039.

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

evidence: open (via free article)

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

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: German Federal Ministry of Education and Research

location_country: Germany Italy Poland Slovenia Portugal Hungary Israel Austria Belgium Spain Greece France

location_facility: Istituto di Cardiologia, Policlinico S.Orsola-MaBologna


title: CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months

summary: Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

ReferenceCitation: Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

version: submittedVersion

repository_institution: Indiana University - IUScholarWorks

ReferenceCitation: Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_country: Germany France Denmark Greece Sweden

location_facility:
Research Site
Research


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer

acronym: XENON

summary:
Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
To assess the effects of xaliproden on the time to complete recovery from PSN
To evaluate the safety profile of xaliproden

location_country:
Germany
Italy
United Kingdom
United States
Spain
Greece
Canada
France


title: Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (PTLD-1/3)

summary: This phase-II trial will investigate the efficacy, safety and the tolerability of a sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of rituximab will go on with rituximab monotherapy and will not receive chemotherapy.

design_allocation: Non-Randomized

ReferenceCitation: Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Duhrsen U, Reinke P, Verhoef G, Subklewe M, Huttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Charite University, Berlin, Germany

location_country: Germany Italy Poland Australia Sweden Belgium France

location_facility: Zakład Propedeutyki Onkologii, Gdańskiego Uniwersytetu Medycznego

location_facility: Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102

location_facility: Catholic University of Leuven, Department of Hematology

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1

location_facility: Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital

location_facility: Sahlgrens hospital, Department of Hematology

location_facility: Div. Universitaria Ematologia e Terapie Cellulari, University of Torino


title: Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

summary: The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

primary_purpose: Device Feasibility

ReferenceCitation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.

lead_sponsor: William Cook Europe

sponsor_collaborators:
William Cook Europe
Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia

location_country:
Germany
Italy
Australia
Czech Republic
France

location_facility: Clinic of Internal Medicine, University Hospital Rostock


summary: The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

ReferenceCitation: Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.

lead_sponsor: Allergan

location_country:
France
Italy
Portugal
New Zealand
United Kingdom
Australia
United States
Korea, Republic of
Israel


title: Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder

summary:
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.

enrollment_type: Anticipated

ReferenceCitation: Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guerin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.

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

ReferenceCitation: Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.

ReferenceCitation: Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.

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

location_country:
France
Italy
Portugal
United Kingdom
Romania
Netherlands
Austria
Belgium
Greece
Turkey
Israel

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: St. James's University Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Azienda Ospedaliera Maggiore Della Carita

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Dokuz Eylul University School of Medicine

intervention_type: Biological


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

summary: The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

lead_sponsor: Gilead Sciences

location_country:
Germany
United Kingdom
United States
Canada
France

location_facility: Indiana Univ Infectious Disease Research Clinic

location_facility: Rush Presbyterian - Saint Luke's Med Ctr

location_facility: San Francisco Gen Hosp / UCSF AIDS Program

location_facility: Ctr for AIDS Research / Education and Service (CARES)

location_facility: Univ of Utah Med School / Clinical Trials Ctr

location_facility: Centre hospitalier de l'Universite de Montreal (CHUM)

location_facility: Univ of Texas Southwestern Med Ctr of Dallas

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat


title: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study

acronym: NV-SCC

summary:
The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are:

what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule?
are there any specific factors that could influence prognosis?
is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Other

ReferenceCitation: Ferreli F, Pirola F, Di Santo D, De Virgilio A, Spriano G, Mercante G. A critical analysis of the classifications of squamous cell carcinoma of the nasal vestibule. Oral Oncol. 2022 Jun;129:105880. doi: 10.1016/j.oraloncology.2022.105880. Epub 2022 Apr 28. No abstract available.

ReferenceCitation: Lambertoni A, Cherubino M, Battaglia P, De Col A, Giovannardi M, Antognoni P, Valdatta L, Karligkiotis A, Bignami M, Castelnuovo P, Turri-Zanoni M. Squamous Cell Carcinoma of Nasal Vestibule and Pyramid: Outcomes and Reconstructive Strategies. Laryngoscope. 2021 Apr;131(4):E1198-E1208. doi: 10.1002/lary.29107. Epub 2020 Oct 2.

ReferenceCitation: Chabrillac E, Talawdekar A, Garikipati S, Varley I, Sionis S, Beasley N, Jackson R. A single centre's experience of 23 cases of total rhinectomy for the treatment of squamous cell carcinoma involving the nasal vestibule. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):2069-2075. doi: 10.1007/s00405-021-06972-6. Epub 2021 Jul 5.

ipd_sharing: No

lead_sponsor: Istituto Clinico Humanitas

location_country:
Italy
United Kingdom
France

location_facility: Sheffield Teaching Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Toulouse

intervention_type: Procedure

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Anti-viral Efficacy of Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

summary: The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

publisher_dissemination: American Chemical Society

ipd_sharing_description: Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.

lead_sponsor: AB Science

location_country:
South Africa
Russian Federation
France

location_facility: Intensive Care Unit, CHU Gabriel-Montpied

location_facility: Gabrichevsky Institute of Epidemiology and Microbiology


title: A Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

summary:
This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy.

Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase.

A safety run-in will be conducted in 6 subjects treated with belantamab mafodotin for at least 1 cycle.

According to the two-stage statistical design of the study, an interim analysis of efficacy will occur. If after 15 patients have been enrolled at least 3 complete or very good partial responses have been recorded, the accrual will continue until all planned patients have been enrolled

lead_sponsor: European Myeloma Network

sponsor_collaborators:
European Myeloma Network
GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Netherlands
Greece
France

location_facility: Fondazione I.R.C.C.S Policlinico "San Matteo"

location_facility: Centre hospitalier Universitaire de Limoges -


title: A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border

summary: The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.

lead_sponsor: Smith & Nephew Orthopaedics AG

location_country:
Germany
United Kingdom
France

location_facility: University Hospital Erlangen, Department of Dermatology

location_facility: Klinikum Oldenburg, University Clinic for Dermatology and Allergy

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH


title: Clinical and Radiological Outcomes of Medacta Shoulder System

summary: This is a post-marketing surveillance on Medacta Shoulder System

lead_sponsor: Medacta International SA

location_country: Germany Switzerland France

location_facility: Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation

location_facility: Clinique du Sport et de Chirurgie Orthopédique

location_facility: Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,


title: A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System

summary: The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System.

lead_sponsor: Hologic, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France

location_facility: Institut régional du Cancer de Montpellier

location_facility: Centro de Patalogia de la Mama-Fundacion Tejerina


title: Gestion du Sevrage de la Ventilation mécanique du Patient neurolésé en réanimation et Association Avec le Devenir. Etude Observationnelle Multi-centrique Internationale. Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. The International Observational ENIO Study.

acronym: ENIO

summary:
Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients.

Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy.

Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study.

Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients.

Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality.

Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.

ReferenceCitation: Cinotti R, Pelosi P, Schultz MJ, Aikaterini I, Alvarez P, Badenes R, Mc Credie V, Elbuzidi AS, Elhadi M, Godoy DA, Gurjar M, Haenggi M, Kaye C, Mijangos-Mendez JC, Piagnerelli M, Piracchio R, Reza ST, Stevens RD, Yoshitoyo U, Asehnoune K; ENIO Study Group. Extubation strategies in neuro-intensive care unit patients and associations with outcomes: the ENIO multicentre international observational study. Ann Transl Med. 2020 Apr;8(7):503. doi: 10.21037/atm.2020.03.160.

evidence: open (via page says license)

publisher_dissemination: AME Publishing Company

ipd_sharing: Yes

ipd_sharing_description: All proposals for sub-studies on the main ENIO database are encouraged. Secondary studies must be approved by the steering committee. Study results will be presented and disseminated in a timely manner. Authorship will be proposed by the investigators of the sub-studies and approved by the steering committee. National groups may enter requests for data-access to analyse their national datasets. Owing to the full anonymization of data according to European Union laws and regulations, institutional datasets will not be available.

lead_sponsor: Nantes University Hospital

location_country: Italy India Netherlands France

location_facility:
University of Amsterdam
University of Genes
Nantes University Hospital
Varanasi BHU Hospital
Enschede (Medisch Spectrum Twente)
Haaglanden (Medical Center)

intervention_type: Other


title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

acronym: LOCALIZE

summary: The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

ReferenceCitation: Garcia-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23.

repository_institution: Newcastle Univesity - Newcastle University ePrints

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Spain
United Kingdom
France

location_facility:
Clinica Universitaria de Navarra
Universitäres Herzzentrum Hamburg
Stadtisches Klinikum Karlsruhe
Southampton General Hospital
CHU de Bordeaux
Freeman Hospital


title: Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of Spesolimab in Patients With Active Generalized Pustular Psoriasis

summary: This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of spesolimab in adult patients with active Generalized Pustular Psoriasis (GPP).

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

lead_sponsor: Boehringer Ingelheim

location_country:
Japan
Tunisia
Korea, Republic of
Malaysia
Taiwan
France

location_facility: Hedi Chaker Hospital, Department of Dermatology


title: Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.

acronym: COMBOMESA

summary:
The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation.

The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
France
Italy
Korea, Republic of
Greece
Serbia
Israel

location_facility: Zvezdara University Clinical Center, Gastroenterology Department

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

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


title: An Open-label Study to Evaluate the Efficacy and Safety of Revusiran in Patients With Transthyretin-mediated Familial Amyloidotic Polyneuropathy With Disease Progression Post-Orthotopic Liver Transplant

summary: The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation. Dosing has been discontinued; patients are being followed-up for safety.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
France
Portugal
United Kingdom
Spain
Sweden

location_facility:
Clinical Trial Site
Clinical Trial SIte


title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

summary:
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

lead_sponsor: LEO Pharma

location_country:
Portugal
Norway
United Kingdom
Denmark
Sweden
Spain
Canada
France

location_facility: FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: Hôpital de l'Archet, Service de Dermatologie

location_facility: Hospitais da Universidade de Coimbra, Servico de dermatologia

location_facility: Western Infirmary, Dermatology Department

location_facility: Roskilde Hospital, Division of Dermatology

location_facility: Hospital Virgen de la Macarena, Servicio de Dermatología


title: Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation

acronym: MCLelderly

summary:
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:

Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?

status: Unknown status

ReferenceCitation: Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Prochazka V, Di Raimondo F, Ribrag V, Uppenkamp M, Andre M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. doi: 10.1056/NEJMoa1200920.

ReferenceCitation: Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Geisler CH, Trneny M, Stilgenbauer S, Kaiser F, Doorduijn JK, Salles G, Szymczyk M, Tilly H, Kanz L, Schmidt C, Feugier P, Thieblemont C, Zijlstra JM, Ribrag V, Klapper W, Pott C, Unterhalt M, Dreyling MH. Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. J Clin Oncol. 2020 Jan 20;38(3):248-256. doi: 10.1200/JCO.19.01294. Epub 2019 Dec 5.

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

ReferenceCitation: Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.

ReferenceCitation: Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.

lead_sponsor: European Mantle Cell Lymphoma Network

location_country:
Germany
Italy
Poland
Denmark
Netherlands
Czech Republic
France

location_facility: The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology

location_facility: HOVON - Dutch Haemato-Oncology Association (HOVON-Datacenter)

location_facility: General University Hospital, 1St Department of Medicine

location_facility: Ospedale Ferratotto, Divisione Di Ematologia

location_facility: Groupe D´Etudes des Lymphomes De l´Adulte (GELA)


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

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

location_country:
Germany
Italy
France
United Kingdom
Spain
Israel


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

acronym: DECADES

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

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

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Sanofi

location_country:
Germany
United Kingdom
Netherlands
France


title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

summary: To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

ReferenceCitation: Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3.

lead_sponsor: Pfizer

location_country:
Germany
Sweden
Netherlands
Switzerland
United States
Greece
France


title: An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis

summary:
Primary Objective:

The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).

Secondary Objectives:

The secondary objectives of the study are:

To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

lead_sponsor: Sanofi

location_country:
Hungary
Tunisia
Belgium
United States
Spain
Turkey
Morocco
France


title: Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

summary: Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.

lead_sponsor: Hospices Civils de Lyon

location_country: Germany India Portugal Norway Belgium France

location_facility: Institut f. Pathologie und Neuropathologie


title: Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced And/Or Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery And/Or Radiotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

ReferenceCitation: Witteveen PO, van der Velden J, Vergote I, Guerra C, Scarabeli C, Coens C, Demonty G, Reed N. Phase II study on paclitaxel in patients with recurrent, metastatic or locally advanced vulvar cancer not amenable to surgery or radiotherapy: a study of the EORTC-GCG (European Organisation for Research and Treatment of Cancer--Gynaecological Cancer Group). Ann Oncol. 2009 Sep;20(9):1511-1516. doi: 10.1093/annonc/mdp043. Epub 2009 Jun 1.

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

location_country:
Italy
Portugal
United Kingdom
Netherlands
Belgium
France

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Clatterbridge Centre for Oncology NHS Trust


title: International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma

acronym: ALCL 99

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 for treating anaplastic large cell lymphoma.

PURPOSE: This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma.

ReferenceCitation: Attarbaschi A, Mann G, Rosolen A, Williams D, Uyttebroeck A, Marky I, Lamant L, Horibe K, Wrobel G, Beishuizen A, Wossmann W, Reiter A, Mauguen A, Le Deley MC, Brugieres L; European Intergroup for Childhood Non-Hodgkin Lymphoma (EICNHL) ALCL99 Trial. Limited stage I disease is not necessarily indicative of an excellent prognosis in childhood anaplastic large cell lymphoma. Blood. 2011 May 26;117(21):5616-9. doi: 10.1182/blood-2010-12-324012. Epub 2011 Mar 28.

ReferenceCitation: Wrobel G, Mauguen A, Rosolen A, Reiter A, Williams D, Horibe K, Brugieres L, Le Deley MC; European Inter-Group for Childhood, Non-Hodgkin Lymphoma (EICNHL). Safety assessment of intensive induction therapy in childhood anaplastic large cell lymphoma: report of the ALCL99 randomised trial. Pediatr Blood Cancer. 2011 Jul 1;56(7):1071-7. doi: 10.1002/pbc.22940. Epub 2011 Jan 28.

ReferenceCitation: Le Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugieres L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. doi: 10.1200/JCO.2010.28.5999. Epub 2010 Aug 2.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Karolinska University Hospital - Huddinge


title: Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

summary:
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

ReferenceCitation: Wittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4.

ReferenceCitation: Verbakel WF, Hideghety K, Morrissey J, Sauerwein W, Stecher-Rasmussen F. Towards in vivo monitoring of neutron distributions for quality control of BNCT. Phys Med Biol. 2002 Apr 7;47(7):1059-72. doi: 10.1088/0031-9155/47/7/305.

ReferenceCitation: Husing J, Sauerwein W, Hideghety K, Jockel KH. A scheme for a dose-escalation study when the event is lagged. Stat Med. 2001 Nov 30;20(22):3323-34. doi: 10.1002/sim.954.

ReferenceCitation: Rassow J, Stecher-Rasmussen F, Voorbraak W, Moss R, Vroegindeweij C, Hideghety K, Sauerwein W. Comparison of quality assurance for performance and safety characteristics of the facility for Boron Neutron Capture therapy in Petten/NL with medical electron accelerators. Radiother Oncol. 2001 Apr;59(1):99-108. doi: 10.1016/s0167-8140(00)00298-x.

ReferenceCitation: Sauerwein W, Moss R, Rassow J, Stecher-Rasmussen F, Hideghety K, Wolbers JG, Sack H. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group. Strahlenther Onkol. 1999 Jun;175 Suppl 2:108-11. doi: 10.1007/BF03038906.

ReferenceCitation: Gabel D, Philipp KH, Wheeler FJ, Huiskamp R. The compound factor of the 10B(n,alpha)7Li reaction from borocaptate sodium and the relative biological effectiveness of recoil protons for induction of brain damage in boron neutron capture therapy. Radiat Res. 1998 Apr;149(4):378-86.

ReferenceCitation: Pignol JP, Oudart H, Chauvel P, Sauerwein W, Gabel D, Prevot G. Selective delivery of 10B to soft tissue sarcoma using 10B-L-borophenylalanine for boron neutron capture therapy. Br J Radiol. 1998 Mar;71(843):320-3. doi: 10.1259/bjr.71.843.9616243.

ReferenceCitation: Verbakel WF, Sauerwein W, Hideghety K, Stecher-Rasmussen F. Boron concentrations in brain during boron neutron capture therapy: in vivo measurements from the phase I trial EORTC 11961 using a gamma-ray telescope. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):743-56. doi: 10.1016/s0360-3016(02)04392-4.

ReferenceCitation: Hideghety K, Sauerwein W, Haselsberger K, Grochulla F, Fankhauser H, Moss R, Huiskamp R, Gabel D, de Vries M. Postoperative treatment of glioblastoma with BNCT at the petten irradiation facility (EORTC protocol 11,961). Strahlenther Onkol. 1999 Jun;175 Suppl 2:111-4. doi: 10.1007/BF03038907.

ReferenceCitation: Gabel D, Touw D, Stecher-Rasmussen F, et al.: Quality control of Na2B12H11SH, a drug boron neutron capture therapy in EORTC trial 11961. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Hideghety K, Sauerwein W, Wittig A, Gotz C, Paquis P, Grochulla F, Haselsberger K, Wolbers J, Moss R, Huiskamp R, Fankhauser H, de Vries M, Gabel D. Tissue uptake of BSH in patients with glioblastoma in the EORTC 11961 phase I BNCT trial. J Neurooncol. 2003 Mar-Apr;62(1-2):145-56. doi: 10.1007/BF02699941.

ReferenceCitation: Hideghety W, Sauerwein W, DeVries M, et al.: Post-operative treatment of glioblastoma with boron neutron capture therapy at the European High Flux Reactor Petten (EORTC protocol 11961). [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Sauerwein W, Hideghety K, De Vries M, et al.: Boron neutron capture therapy (BNCT) for the treatment of glioblastoma (EORTC protocol 11961). [Abstract] Radiother Oncol 48(suppl 1): s157, 1998.

ReferenceCitation: Sauerwein W, Hideghety K, De Vries M, et al.: Conducting phase I clinical trial in binary treatment modality: methodical questions for the evaluation of boron neutron capture therapy. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Vos MJ, Turowski B, Zanella FE, Paquis P, Siefert A, Hideghety K, Haselsberger K, Grochulla F, Postma TJ, Wittig A, Heimans JJ, Slotman BJ, Vandertop WP, Sauerwein W. Radiologic findings in patients treated with boron neutron capture therapy for glioblastoma multiforme within EORTC trial 11961. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):392-9. doi: 10.1016/j.ijrobp.2004.06.008.

ReferenceCitation: Haselsberger K, Pendl G, Sauerwein W, et al.: BNCT for glioblastoma in Europe: design of the EORTC protocol 11961 and clinical course of the first patient. [Abstract] J Neurooncol 39 (2): A-P155, 147, 1998.

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

location_country: Germany Italy Netherlands Austria Canada France

location_facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: EC Joint Research Centre - Institute for Energy


acronym: PETITE

lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the optimal BRV dose (Exploratory Cohort) for the treatment of subjects enrolled into the Confirmatory Cohorts of this study.

title: A Multicenter, Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Neonates With Repeated Electroencephalographic Seizures

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Ireland
United Kingdom
Belgium
France


title: An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

summary:
The study is researching an experimental drug called linvoseltamab, also called REGN5458.

Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).

This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of the study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone (called "EPd" in this form), one of these standard treatment options. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. Both linvoseltamab and EPd will be referred to as "study drugs" in this form.

The study is looking at several other research questions, including:

How long participants benefit from receiving linvoseltamab compared with EPd
How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
What side effects happen from taking linvoseltamab compared to EPd
How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
If there is any improvement in pain after treatment with linvoseltamab compared to EPd

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Australia
United States
Spain
Korea, Republic of
France

location_facility: Hospital Gral. Universitari D'Alacant Y C.E Babel (Hospital General De Alicante)

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

location_facility: Clinica Universidad de Navarra - Sede Madrid


title: A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors

summary: To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Singapore
Japan
Belgium
United States
Spain
Taiwan
France

location_facility: Massachusetts General Hospital Dept. of Mass General Hospital

location_facility: University Of California Los Angeles Santa Monica Location


title: Phase I/II Multicenter Study to Assess Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

summary: This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

collaborators: Innovative Therapies For Children with Cancer Consortium

location_country:
Germany
Italy
Singapore
Australia
United States
Spain
France

location_facility: St Jude s Childrens Research Hospital Dept of Regulatory


title: Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomized, Controlled, Double-blind, European Multicentre Clinical Trial

acronym: DISCOVERY

summary: Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.

lead_sponsor: Laboratoires URGO

location_country:
Italy
Poland
United Kingdom
Spain
Czechia
France

location_facility:
Pr PETIT
Pr EDMONDS
Pr PIAGGESI
Dr KORZON
Pr JIRKOVSKA
Pr LAZARO


study_start_date_type: Anticipated

acronym: SAkuraSun

lead_sponsor: Hoffmann-La Roche

summary: This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Fondazione Istituto Neurologico Mondino IRCCS

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

location_facility: Great Ormond Street Hospital for Children

location_facility: Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

title: A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

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

location_country:
Italy
Poland
United Kingdom
Argentina
United States
France


title: PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance

acronym: BRINFF

summary: The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

ReferenceCitation: Korhonen L, Perhomaa M, Kyro A, Pokka T, Serlo W, Merikanto J, Sinikumpu JJ. Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up. Biomaterials. 2018 Dec;185:383-392. doi: 10.1016/j.biomaterials.2018.09.011. Epub 2018 Sep 11.

lead_sponsor: Thomas Klestil

sponsor_collaborators:
Thomas Klestil
Bioretec Ltd.

location_country: Germany Portugal Hungary Denmark Switzerland Austria France

location_facility: University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Herlev and Gentofte University Hospital Department of Orthopedic Surgery

location_facility: Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery

location_facility: Lille University Center, Jeanne de Flandre Hospital

location_facility: Pécs University Hospital, Department of Pediatrics


acronym: APPOINT-PNH

summary: The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.

title: A Multicenter, Single-arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy

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

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

location_country:
Germany
Italy
United Kingdom
Singapore
Korea, Republic of
China
Malaysia
France


title: A Multicenter Study to Estimate the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2-low Status - the RetroBC-HER2L Study

summary: This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.

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

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Japan
United States
Korea, Republic of
Canada
France


acronym: ICC APL Study 02

lead_sponsor: Associazione Italiana Ematologia Oncologia Pediatrica

summary: The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

location_facility: Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo

location_facility: Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E.

location_facility: Pediatrics and Adolescent Medicine Aarhus University Hospital

location_facility: IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica

location_facility: Valencia University Medical School University Hospital La Fe

location_facility: Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III

location_facility: AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica

location_facility: Rappaport Children'S Hospital, Rambam Health Care Campus

location_facility: Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (Huderf)

location_facility: Childrens hematology and oncology Uppsala University

location_facility: Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù"

location_facility: Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica

location_facility: AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO

location_facility: Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica

location_facility: A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica

location_facility: ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica

location_facility: Azienda Ospedaliera di Padova - Oncoematologia Pediatrica

location_facility: Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione

location_facility: Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica

location_facility: AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

location_facility: AOU Policlinico Dipartimento di Pediatria

title: Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

location_country: Germany Ireland Italy Portugal Israel Denmark Sweden Netherlands Belgium Spain Czechia France

appel_a_projets: PHRCK

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: ICC-APL-STUDY 02

titre: ICC-APL-STUDY 02-Étude du  traitement des enfants et des adolescents atteints de leucémie aiguë promyélocytaire : Étude  multicentrique associant le trioxyde d'arsenic (ATO) et l'acide rétinoïque tout trans (ATRA) +/- le Gemtuzumab Ozogamicine pour les patients atteints de leucémie aiguë promyélocytaire de novo

discipline_principale: cancer

nom_porteur: DUCASSOU

prenom_porteur: Stéphane


title: An Exploratory Phase 2 a Study to Assess Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of VAS203 in Patients With Moderate and Severe Traumatic Brain Injury

acronym: NOSTRA

summary:
In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males) receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study for all patients will be Day 14; adverse events and concomitant medications will be documented throughout the study.

Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG, laboratory examinations (clinical chemistry, liver function, haematology/coagulation, urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline, pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy Intensity Level (TIL).

ReferenceCitation: Stover JF, Belli A, Boret H, Bulters D, Sahuquillo J, Schmutzhard E, Zavala E, Ungerstedt U, Schinzel R, Tegtmeier F; NOSTRA Investigators. Nitric oxide synthase inhibition with the antipterin VAS203 improves outcome in moderate and severe traumatic brain injury: a placebo-controlled randomized Phase IIa trial (NOSTRA). J Neurotrauma. 2014 Oct 1;31(19):1599-606. doi: 10.1089/neu.2014.3344. Epub 2014 Jul 28.

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: veriNOS operations GmbH

location_country:
United Kingdom
Switzerland
Austria
Spain
France

location_facility: Medical University Innsbruck Department of Neurology

location_facility: Hospital Clinic University of Barcelona Surgical Intensive Care Unit

location_facility: University Hospital Zuerich Surgical Intensive Care

location_facility: Vall d'Hebron University Hospital Department of Neurosurgery

location_facility: Southampton University Hospital Division of Clinical Neurosciences