title: ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)

lead_sponsor: Karolinska University Hospital


title: A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

source: euctr

lead_sponsor: Sarepta Therapeutics, Inc.

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Unknown


title:
A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

 Etude multicentrique, randomisée, en double aveugle, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi du ligelizumab (QGE031) chez des adolescents et adultes atteints d’urticaire chronique inductible (UCI) non contrôlée par un traitement par antihistaminique anti-H1

lead_sponsor: Novartis Pharma AG

status: Prematurely Ended


type: EudraCT Number

title: An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), biomarker effects, and efficacy of BIIB067 administered to participants with ALS and a confirmed SOD1 mutation.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chio A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Washington University School of Medicine - Digital Commons@Becker

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Biogen

sponsor_collaborators:
Biogen
Ionis Pharmaceuticals, Inc.

location_country:
Germany
Italy
New Zealand
United Kingdom
Japan
Belgium
United States
Canada
France

intervention_type: Drug

status_simplified: Ongoing


title: A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis

acronym: GEMINI 2

lead_sponsor: Genzyme Corporation

status: Ongoing


title: An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)

acronym: IMBRELLA B

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

 Étude de phase 3, randomisée, en ouvert et contrôlée, évaluant le cabozantinib (XL184) en association avec l’atézolizumab vs un deuxième traitement hormonal novateur (THN) chez des patients atteints d’un cancer de la prostate métastatique et résistant à la castration

lead_sponsor: Exelixis, Inc.


title:
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

 Étude d’extension, multicentrique, menée en ouvert, visant à évaluer l’innocuité et la tolérabilité à long terme du dapirolizumab pégol chez des participants atteints de lupus érythémateux disséminé

lead_sponsor: UCB Biopharma SRL


title:
A multicenter study to evaluate long-term safety and tolerability of open label  sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 (PANORAMA-HF)

 Etude multicentrique, en ouvert, évaluant la tolérance et la sécurité d’emploi à long terme de LCZ696 (sacubitril/valsartan) chez des patients pédiatriques atteints d’insuffisance cardiaque due à une dysfonction ventriculaire gauche systolique ayant terminé l'étude CLCZ696B2319


title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

acronym: FINCH 4

summary: The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

design_allocation: Randomized

ReferenceCitation: Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

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

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

repositories_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Galapagos NV

sponsor_collaborators:
Galapagos NV
Gilead Sciences

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Thailand
Chile
Czechia
Canada
Serbia
France
Slovakia
Hungary
Hong Kong
United States
Ukraine
India
Romania
Belgium
Malaysia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu Mures

location_facility: State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine

location_facility: Municipal Institution City Hospital #7, Department of Therapy

location_facility: Municipal Clinical Hospital No. 15 named after O.M. Filatov

location_facility: HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR

location_facility: Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej

location_facility: Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy

location_facility: Umass Memorial Medical Center- Memorial Campus

location_facility: Trinity Universal Research Associates, Inc

location_facility: Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology

location_facility: Weill Cornell Physicians At Brooklyn Heights

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy

location_facility: SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Revmatologicka ambulance, Nuselska Poliklinika

location_facility: Chi Mei Hospital, Chi Mei Medical Center

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie

location_facility: Chanre Rheumatology and Immunology Centre and Research

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Warrington and Halton Hospitals Nhs Foundation Trust

location_facility: Stanford University Hospitals and Clinics (Immunology & Rheumatology)

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Yoshida orthopaedic and rheumatology Clinic

location_facility: Keck Medicine of USC- Division of Rheumatology

location_facility: Hospital HM Nuestra Senora de la Esperanza

location_facility: Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology

location_facility: Institute For Treatment And Rehabilitation Niska Banja

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department

location_facility: University of Florida College of Medicine, Jacksonville - Rheumatology Research

location_facility: Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2

location_facility: Arthrocare, Arthritis Care & Research PC

location_facility: Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology

location_facility: Municipal Institution "City Hospital #1", Department of Therapy

location_facility: Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly

location_facility: Chonbuk National University Medical School

location_facility: Nizhny Novgorod City Clinical Hospital #5

location_facility: Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council

location_facility: Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh

location_facility: C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: City Clinical Hospital #1, Department of Rheumatology

location_facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly

location_facility: Daegu Catholic University Medical Center

location_facility: Centre for Rheumatic Disease, Hermes Doctor House

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski

location_facility: University of California San Diego (UCSD) - Perlman Ambulatory Clinic

location_facility: Military Medical Academy, Clinic of Rheumatology

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"

location_facility: Onganizacion Medica de Investigacion S.A (OMI)

location_facility: Rajiv Gandhi Institute of Medical Sciences and Government General Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie

location_facility: Articularis Healthcare Group d/b/a ACME Research

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Clinical Trial Unit, CCHDB, Wellington Hospital

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Shri Nidaan Hospital and Hope Fertility Centre

location_facility: City Clinical Hospital #4 of Department of Healthcare of Moscow City

location_facility: Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans

location_facility: "MHAT Lyulin" EAD, Department of Rheumatology

location_facility: Department of Rheumatology, KG Medical University

location_facility: Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

location_facility: Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Porznaniu

location_facility: Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie

location_facility: State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Centre De Recherche Musculo Squelettique

location_facility: Santokba Durlabhji Memorial Hospital Cum Medical Research Institute

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Centro De Investigación Clínica De Morelia, Sc

location_facility: Medical College Baroda and Sir Sayajirao General Hospital

location_facility: Articularis Healthcare Group d/b/a Low Country Rheumatology

location_facility: Department of Medicine, Queen Mary Hospital

location_facility: Centro Peninsular De Investigacion Clinica S.C.P.

location_facility: Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz

location_facility: Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department

location_facility: Chung-Ang University Hospital Institutional Review Board

location_facility: MHAT "Sveta Petka" AD, Department of Internal Diseases

location_facility: Chennai Meenakshi Multispeciality Hospital Ltd

location_facility: Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

location_facility: M. Vladimirsky Moscow Regional Research Clinical Institute

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly

location_facility: Rajavithi Hospital, Rheumatology and Allergy Unit

location_facility: Carolina Rheumatology & Neurology Assoc., PC

location_facility: Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: Suretech Hospital and Research Centre Pvt Ltd

location_facility: LLC Polyclinic of Private Security Personnel

location_facility: NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach

location_facility: Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Hôpital Lapeyronie, Service d'Immuno-Rhumatologic

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Department of Medicine & Theraputics, The Chinese University of Hong Kong

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: Twoja Przychodnia -Centrum Medyzcne Nowa Sol

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Kyiv City Clinical Hospital #6, Department of Therapy

location_facility: Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital

location_facility: The Oklahoma Center For Arthritis Therapy & Research, Inc.

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine

location_facility: PA Regional Center For Arthritis And Osteoporosis Research

location_facility: Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"

location_facility: Articularis Healthcare Inc., dba Columbia Arthritis Center, PA

location_facility: Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso

location_facility: State Healthcare Institution, Regional Clinical Hospital

location_facility: The Center For Rheumatology And Bone Research

location_facility: Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"

location_facility: FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: University Hospital, Kyoto Prefectural University of Medicine


title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy

acronym: TECOS

lead_sponsor: Merck & Co., Inc.

status: Completed

status_simplified: Completed


title: An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

acronym: GO-MORE

lead_sponsor: Schering-Plough Research Institute, A Division of Schering Corporation


title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

lead_sponsor: Abbott GmbH & Co. KG (Abbott)


title: Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study).

acronym: POET

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG


title: A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

acronym: INVIGORATE

lead_sponsor: Novartis Pharma Services AG


title:
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary Syndrome
 The ATLAS ACS 2 TIMI 51 Trial (The second trial of Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome)
 Amendment INT-1

acronym: The ATLAS ACS 2 TIMI 51 Trial

lead_sponsor: Janssen-Cilag International N.V.


acronym: HATCY

lead_sponsor: Kiadis Pharma

summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.

location_facility: Ludwig-Maximilians-University Hospital of Munich-Grosshadern

location_facility: Hadassah Medical Center & Hadassah Hospital Ein Karem

location_facility: Servicio de Hematología Hospital, Universitari I politècnic La Fe

location_facility: University Hospital Barcelona Vall d' Hebron

location_facility: University Hospital Frankfurt, Goethe University

location_facility: Sourasky Medical Center & Tel Aviv University

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Faculdade de Medicina da Universidade de Lisboa

location_facility: Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

status: Terminated

title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy

primary_purpose: Prevention

study_completion_date_type: Actual

location_country:
Germany
Italy
Portugal
Israel
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Croatia
Canada
France

ipd_sharing: No


acronym: alleviate 1

lead_sponsor: Novo Nordisk A/S

summary: The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.

ReferenceCitation: Klamroth R, Feistritzer C, Friedrich U, Lentz SR, Reichwald K, Zak M, Chowdary P. Pharmacokinetics, immunogenicity, safety, and preliminary efficacy of subcutaneous turoctocog alfa pegol in previously treated patients with severe hemophilia A (alleviate 1). J Thromb Haemost. 2020 Feb;18(2):341-351. doi: 10.1111/jth.14660. Epub 2019 Nov 15.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

title: Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

type: Other Identifier

type: Registry Identifier

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Germany
Japan
Austria
United States
Serbia
France

ipd_sharing: Yes


title: AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT)

acronym: TRANSIT

lead_sponsor: Janssen-Cilag International NV


title: PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial

summary:
One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Kiss T, Wittenstein J, Becker C, Birr K, Cinnella G, Cohen E, El Tahan MR, Falcao LF, Gregoretti C, Granell M, Hachenberg T, Hollmann MW, Jankovic R, Karzai W, Krassler J, Loop T, Licker MJ, Marczin N, Mills GH, Murrell MT, Neskovic V, Nisnevitch-Savarese Z, Pelosi P, Rossaint R, Schultz MJ, Serpa Neto A, Severgnini P, Szegedi L, Vegh T, Voyagis G, Zhong J, Gama de Abreu M, Senturk M; PROTHOR investigators; Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA). Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):213. doi: 10.1186/s13063-019-3208-8. Erratum In: Trials. 2019 May 8;20(1):259.

license: cc-by

license_normalized: cc-by

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

lead_sponsor: Technische Universität Dresden

collaborators: European Society of Anaesthesiology and Intensive Care

location_country:
Germany
Japan
Brazil
Turkey
Croatia
Chile
Czechia
Serbia
France
Slovenia
Hungary
Switzerland
United States
Latvia
Iraq
Romania
China
Egypt
Italy
Cyprus
Albania
United Kingdom
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Greece
Taiwan

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Clinical Center Nis, Clinic for anesthesia and intensive therapy

location_facility: Institutul de Pneumoftiziologie Bucharest

location_facility: Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia

location_facility: Riga East University Hospital, Riga, Latvia

location_facility: University Hospital of Dijon - François Mitterrand

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Hospital Clínic. Universitat de Barcelona

location_facility: University of Debrecen, Department of anesthesiology and Intensive Care

location_facility: University of Health Science, Konya City Hospital, Turkey

location_facility: Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital

location_facility: University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey

location_facility: NIHS Sheffield Clinical Research Facility

location_facility: Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China

location_facility: Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital

location_facility: Fudan University, Shanghai Cancer Center

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico

location_facility: University School of Medicine Campus Bio-Medico of Rome

location_facility: Hospital General Universitario de Valencia

location_facility: Department of Anesthesiology and Intensive Care, Dresden University of Technology

location_facility: Radboud University Medical Centre Nijmegen

location_facility: Celal Bayar University Medical Faculty, Dept of Anesthesiology

location_facility: Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State

intervention_type: Procedure

lead_sponsor_type: academique


title: An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

acronym: RELAY-1 Extend

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

location_country:
Italy
Slovakia
United Kingdom
Romania
Austria
Belgium
Latvia
Spain
Georgia
Czechia
Bulgaria
Estonia
Serbia
France

location_facility:
Research Site 2
Research Site
Research Site 1


summary: The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

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title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

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Italy
Slovakia
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Romania
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Austria
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