title: A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay ACI 7000PDT Implanted Intrastromally for Modified Monovision in Presbyopic Subjects

summary: The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as glasses or contact lenses to see clearly at near.

lead_sponsor: AcuFocus, Inc.

location_country:
New Zealand
Singapore
Australia
Japan
Netherlands
Austria
Spain
Turkey
Philippines
France

location_facility: Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg

location_facility: Beyoğlu Goz Training and Research Hospital


title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) Used in the Differentiation of Focal Pancreatic Masses

summary:
The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and pancreatic cancer in a prospective multicenter design.

The study will include patients with focal pancreatic masses evaluated by CEH-EUS and EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the patients being included based on a suspicion of focal pancreatic masses after transabdominal ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology and minimum 12 months follow-up.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.

ReferenceCitation: Seicean A, Badea R, Stan-Iuga R, Gulei I, Pop T, Pascu O. The added value of real-time harmonics contrast-enhanced endoscopic ultrasonography for the characterisation of pancreatic diseases in routine practice. J Gastrointestin Liver Dis. 2010 Mar;19(1):99-104.

ReferenceCitation: Hocke M, Schulze E, Gottschalk P, Topalidis T, Dietrich CF. Contrast-enhanced endoscopic ultrasound in discrimination between focal pancreatitis and pancreatic cancer. World J Gastroenterol. 2006 Jan 14;12(2):246-50. doi: 10.3748/wjg.v12.i2.246.

ReferenceCitation: Saftoiu A, Iordache SA, Gheonea DI, Popescu C, Malos A, Gorunescu F, Ciurea T, Iordache A, Popescu GL, Manea CT. Combined contrast-enhanced power Doppler and real-time sonoelastography performed during EUS, used in the differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2010 Oct;72(4):739-47. doi: 10.1016/j.gie.2010.02.056. Epub 2010 Aug 2.

ReferenceCitation: Seicean A. Endoscopic ultrasound in chronic pancreatitis: where are we now? World J Gastroenterol. 2010 Sep 14;16(34):4253-63. doi: 10.3748/wjg.v16.i34.4253.

ReferenceCitation: Dietrich CF, Ignee A, Frey H. Contrast-enhanced endoscopic ultrasound with low mechanical index: a new technique. Z Gastroenterol. 2005 Nov;43(11):1219-23. doi: 10.1055/s-2005-858662.

ReferenceCitation: Seicean A, Badea R, Stan-Iuga R, Mocan T, Gulei I, Pascu O. Quantitative contrast-enhanced harmonic endoscopic ultrasonography for the discrimination of solid pancreatic masses. Ultraschall Med. 2010 Dec;31(6):571-6. doi: 10.1055/s-0029-1245833. Epub 2010 Nov 15.

ReferenceType: derived

ReferenceCitation: Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: University of Medicine and Pharmacy Craiova

collaborators:
Copenhagen University Hospital, Denmark
Caritas-Krankenhaus Bad Mergentheim
Institut Paoli-Calmettes
University of Witten/Herdecke
Hospital Meiningen Germany
Odense University Hospital
University of Santiago de Compostela
Università Vita-Salute San Raffaele
SRH Wald-Klinikum Gera GmbH
University of Bergen
Institutul Clinic Fundeni
Glasgow Royal Infirmary
University College, London

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Romania
Spain
France

location_facility: Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital

location_facility: Hepatobiliary Surgery, Glasgow Royal Infirmary

location_facility: Institute of Hepatology, University College London

location_facility: Center of Gastroenterology and Hepatology, Fundeni Clinical Institute

location_facility: Helios Klinikum, University of Witten/Herdecke

location_facility: Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital

location_facility: University Hospital, Santiago de Compostela

location_facility: Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen

location_facility: Department of Internal Medicine II, Hospital Meiningen

location_facility: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University

location_facility: Gastroenterology Department, University of Medicine and Pharmacy

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy

acronym: IMPACT

summary: This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Mologen AG

location_country:
Germany
United Kingdom
Austria
Czech Republic
Russian Federation
France

location_facility: Oncology Clinic, Faculty Hospital Olomouc

location_facility: State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN"

location_facility: Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie

location_facility: Klinik für Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale)

location_facility: Klinik für Innere Medizin I, Abteilung für Klinische Onkologie, Medizinische Universität Wien

location_facility: Klinik für Innere Medizin, Klinik für Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH

location_facility: Medizinische Klinik, Abteilung für Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tübingen, Immuntherapie, Station 65 Med. Klinik Abt. II

location_facility: Service de Cancérologie Digestive, Institut de Cancérologie Gustave Roussy

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD"

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

intervention_type: Drug

lead_sponsor_type: industriel


title: A Multi-center, Open-Label Extension Study of the Safety and Efficacy of Recombinant Human a-Galactosidase A (r-haGAL) Replacement in Patients With Fabry Disease

summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globatriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.

design_allocation: Non-Randomized

ReferenceCitation: Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University of California - eScholarship University of California

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United Kingdom
Netherlands
United States
Puerto Rico
France

location_facility: University of Rochester School of Medicine

location_facility: University of Washington School of Medicine

location_facility: Northwest Oncology & Hematology Associates

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Hematology/Oncology Associates of South Texas


title: Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

summary:
RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.

ReferenceType: result

ReferenceCitation: Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, Delforge M, Thyss A, Selleslag D, Indrak K, Ossenkoppele G, de Witte T. Value of infliximab (Remicade(R)) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group. Haematologica. 2012 Apr;97(4):529-33. doi: 10.3324/haematol.2011.044347. Epub 2011 Nov 18.

ReferenceCitation: Baila L, Suciu S, Muus P, et al.: Assessment of two doses of infliximab in patients with low/intermediate risk IPSS myelodysplastic syndrome (MDS): an EORTC leukemia group (LG) randomized phase II trial (06023). [Abstract] Blood 110 (11): A-1456, 2007.

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

location_country:
Germany
Italy
Netherlands
Belgium
Czech Republic
France

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Institute of Hematology and Blood Transfusion

intervention_type: Biological


type: Other Identifier

title: A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma

summary: To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

study_start_date_type: Actual

lead_sponsor: Pfizer

location_country:
Germany
United Kingdom
Switzerland
Belgium
United States
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet

location_facility: Universitaet Muenchen Klinikum Grosshadern

location_facility: Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern

location_facility: University of Alabama at Birmingham Kirklin Clinic


title: A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy

summary: The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.

location_country:
France
Germany
Italy
India
Australia
Austria
United States
Spain
South Africa
Croatia
Canada
Russian Federation
Czech Republic


title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

summary: The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

location_country:
Germany
Ireland
Italy
Norway
United Kingdom
Australia
Brazil
Sweden
United States
Spain
Greece
Canada
France


title: A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

summary: The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

location_country:
Germany
Italy
Norway
United Kingdom
Australia
Brazil
Netherlands
Mexico
United States
Spain
Canada
France


title: A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat

summary:
Primary Objective:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.

Secondary Objectives:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:

the total pain relief summed over 15 to 360min (TOTPAR15-360)
the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3

To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:

Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)

lead_sponsor: Sanofi

location_country:
Finland
Germany
Russian Federation
Mexico
Spain
Egypt
France


title: A Phase III Double-blind, Randomised, Placebo-controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

acronym: MICONOS

summary: The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.

lead_sponsor: Santhera Pharmaceuticals

location_country:
Germany
United Kingdom
Netherlands
Austria
Belgium
France

location_facility: Klinik II, Neuropädiatrie u.Muskelerkrankungen- Universitätsklinik Freiburg

location_facility: Neurologische Universitätsklinik und Poliklinik- Universitätsklinikum Bonn

location_facility: University of Newcastle upon Tyne -Mitochondrial Research Group

location_facility: Hôpital Erasme - Université Libre de Bruxelles

location_facility: Neurologische Klinik- klinikum Grosshadern

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

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

location_facility: National Hospital for Neurology & Neurosurgery


lead_sponsor: Stallergenes Greer

summary: The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

sponsor_collaborators:
Stallergenes Greer
Quintiles, Inc.
Aptuit

location_facility: Public Institution Kaunas Medical University Hospital

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

location_facility: National University Hospital - Allergy Unit 4222

location_facility: NHC, Hôpitaux Universitaires de Strasbourg

title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

source: euctr

location_country:
Finland
Lithuania
Germany
Poland
Denmark
Sweden
Russian Federation
France

collaborators:
Quintiles, Inc.
Aptuit


title: A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide

summary: The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

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

location_country:
Germany
Australia
Belgium
United States
Spain
Canada
Russian Federation
France


title: A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease

summary: The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

ReferenceCitation: Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37. doi: 10.1016/s1083-8791(98)90007-6.

ReferenceCitation: Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. doi: 10.3109/10428190009148389.

ReferenceCitation: Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11. Erratum In: Blood. 2009 Apr 30;113(18):4478.

lead_sponsor: Mallinckrodt

location_country:
Germany
Italy
Portugal
Slovakia
United Kingdom
Australia
Switzerland
Austria
United States
Spain
Turkey
France

location_facility: Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona

location_facility: Klinika hematologie a transfuziologie FN

location_facility: Rush Presbyterian - St. Lukes Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer

summary:
RATIONALE: Drugs used in chemotherapy work in 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 whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

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

location_country:
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Spain
France

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Leeds Cancer Centre at St. James's University Hospital


title: A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

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

PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

ReferenceCitation: Shustik C, Turner AR, Desjardins P, Fernandez L, Rubin S, Larratt L, Duncan AM, Rizi D, Sadura A, Shepherd L, Li D, Rassenti L, Kipps T. Oral fludarabine in untreated patients with B-cell chronic lymphocytic leukemia. Leukemia. 2010 Jan;24(1):237-9. doi: 10.1038/leu.2009.205. Epub 2009 Oct 8. No abstract available.

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

location_country: Canada France

location_facility: Algoma Reginal Cancer Program at Sault Area Hospital

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Durham Regional Cancer Centre at Lakeridge Health Oshawa

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Northeastern Ontario Regional Cancer Centre, Sudbury

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Margaret and Charles Juravinski Cancer Centre


title: A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension

acronym: ACCELERATE

summary: This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

primary_purpose: Diagnostic

ReferenceCitation: Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: King's College London - Research Portal

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.

lead_sponsor: Novartis

location_country:
Germany
Guatemala
United Kingdom
Venezuela
Costa Rica
Switzerland
Greece
South Africa
Canada
France


title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke

summary: The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.

lead_sponsor: Bayer

location_country:
Finland
Germany
Italy
Hungary
Israel
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France


title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

summary: In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.

location_country:
Germany
United Kingdom
Netherlands
United States
Canada
France


title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy

summary: Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.

primary_purpose: Prevention

location_country:
Poland
Hong Kong
Singapore
Australia
United States
Greece
Russian Federation
France


title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

summary: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
France

location_facility: Wayne State University Karmanos Cancer Center


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

ReferenceCitation: Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. doi: 10.1056/NEJMoa044396.

lead_sponsor: Biogen

sponsor_collaborators:
Biogen
Elan Pharmaceuticals

location_country:
Germany
Italy
Israel
Austria
Belgium
United States
France

location_facility: Greenstein Neurology Associates & MS Institute

location_facility: Universitaetsklinikum Giessen, Oberarzt Neurologie

location_facility: Universita di Genova, Clinica Neurologica

location_facility: University of Miami, Department of Neurology

location_facility: Michigan Institute for Neurological Disorders

location_facility: Alexian Brothers Center for Clinical Research

location_facility: Buffalo General Hospital, Department of Neurology

location_facility: St. Luke's Roosevelt Hospital, MS Research & Treatment Center

location_facility: Baylor Methodist International MS Center

location_facility: St. Francis Hospital, Center for Neurological Disorders

location_facility: New York Hospital - Cornell Medical Center

location_facility: Fachbereich Neurologie und Klinische Neurophysiologie

location_facility: Maimonides Medical Center, Division of Neurology

location_facility: University of Maryland Hospital, Department of Neurology

location_facility: Hadassah Hebrew Uni Hospital, Department of Neurology

location_facility: Georgetown Univesity Hospital, Research Pharmacy

location_facility: Springfield Clinic Neuroscience Institute

location_facility: University of Pittsburgh, Department of Neurology

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of Arkansas For Medical Sciences

location_facility: University of Alabama-Birmingham, Department of Neurology

location_facility: Northwestern University, Department of Neurology

location_facility: Hospital of the University of Pennsylvania

location_facility: Rush-Presbyterian St. Luke's Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Wake Forest University School of Medicine, Department of Neurology


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

ReferenceCitation: Voloshyna N, Havrdova E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15.

ReferenceCitation: Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. doi: 10.1056/NEJMoa044397.

ReferenceCitation: Balcer LJ, Galetta SL, Polman CH, Eggenberger E, Calabresi PA, Zhang A, Scanlon JV, Hyde R. Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS. J Neurol Sci. 2012 Jul 15;318(1-2):119-24. doi: 10.1016/j.jns.2012.03.009. Epub 2012 Apr 21.

location_country:
Germany
United Kingdom
Netherlands
Belgium
United States
Canada
Czech Republic
France

location_facility: University of Miami School of Medicine, Department of Neurology

location_facility: University of Washington MS Research Center

location_facility: UC Davis School of Medicine, Department of Neurology

location_facility: Yale University School of Medicine, Department of Neurology

location_facility: University of Kansas Medical Center, Department of Neurology

location_facility: Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group

location_facility: Hopital de la Timone, Service de Neurologie

location_facility: Michigan Institute for Neurological Disorders

location_facility: Kings College Hospital, Kings Neuroscience Center

location_facility: Sunnybrook and Women's College and Health Science Centre

location_facility: CHRU - Hopital de Pontchaillou, Service de Neurologie

location_facility: MS Research Unit, Center for Clinical Research

location_facility: University of Toronto, MS Clinic, St. Michael's Hospital

location_facility: Faculty Hospital Motol - Neurological Clinic

location_facility: North Staffordshire Royal Infirmary - Neurology Department

location_facility: General Teaching Hospital - Neurological Department

location_facility: Hospital Pardubice - Department of Neurology

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum

location_facility: Lehigh Valley Hospital, Neurosciences Research

location_facility: Faculty Hospital Plzen - Clinic of Neurology

location_facility: Ipswich Hospital NHS Trust - Department of Clinical Neurology

location_facility: St. James University Hospital, Department of Neurology

location_facility: The Radcliffe Infirmary, University Department of Clinical Neurology

location_facility: Oregon Health Sciences University, Department of Neurology


title: A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer

summary: This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

location_country:
Germany
Poland
Australia
Brazil
Turkey
Canada
France
Lithuania
Hungary
Hong Kong
United States
Ukraine
India
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination With Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

status: Unknown status

lead_sponsor: Facet Biotech

sponsor_collaborators:
Facet Biotech
National Cancer Institute (NCI)

location_country:
Germany
United Kingdom
Netherlands
Belgium
United States
Canada
France

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Queen Elizabeth II Health Science Center

location_facility: Beckman Research Institute, City of Hope

location_facility: Albert Einstein Comprehensive Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Jonsson Comprehensive Cancer Center, UCLA

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.

location_facility: University of Pennsylvania Cancer Center

location_facility: Louisiana State University School of Medicine

location_facility: Washington University Barnard Cancer Center

location_facility: University of California Davis Cancer Center

status_simplified: Unknown


title: Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.

ReferenceCitation: Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.

ReferenceCitation: Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008.

ReferenceCitation: Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. doi: 10.1007/s00277-002-0548-2. Epub 2002 Oct 17. No abstract available.

ReferenceCitation: van Oers MH, Tonnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA. BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study. J Clin Oncol. 2010 May 1;28(13):2246-52. doi: 10.1200/JCO.2009.25.0852. Epub 2010 Apr 5.

ReferenceCitation: van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

ReferenceCitation: van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. doi: 10.1182/blood-2006-05-021113. Epub 2006 Jul 27.

ReferenceCitation: Mattiola I, Mantovani A, Locati M. The tetraspan MS4A family in homeostasis, immunity, and disease. Trends Immunol. 2021 Sep;42(9):764-781. doi: 10.1016/j.it.2021.07.002. Epub 2021 Aug 9.

collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland

collaborators: Australasian Leukaemia and Lymphoma Group

location_country:
Slovenia
Italy
Poland
Portugal
New Zealand
Slovakia
Hungary
Norway
Denmark
Australia
Sweden
Netherlands
United Kingdom
Belgium
South Africa
Canada
Egypt
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: Berkshire Cancer Centre at Royal Berkshire Hospital

location_facility: Medisch Centrum Rynmond-Zuid - Lokatie Zuider

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Medisch Centrum Rynmond Zuid - Lokatie: Clara

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

location_facility: McGill Cancer Centre at McGill University

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Maxima Medisch Centrum - locatie Eindhoven

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: University of Auckland School of Medicine

location_facility: Karolinska University Hospital - Huddinge

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

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: Westmead Breast Centre at NSW Breast Cancer Institute

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Haukeland Hospital - University of Bergen

location_facility: St. George Hospital and Community Health Service

location_facility: Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

location_facility: Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

location_facility: Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: Trillium Health Centre - Mississauga Site

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Royal Free and University College Medical School

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Guy's and St. Thomas' Hospitals NHS Foundation Trust


title: Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

enrollment_type: Anticipated

location_country: Italy Portugal Netherlands Belgium Turkey Croatia France

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.

acronym: SATIN

summary:
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).

The secondary objectives are:

to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.

location_country:
Germany
Poland
United Kingdom
Brazil
Tunisia
Belgium
Uruguay
France


title: A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study to Assess Efficacy and Safety of Rimonabant 20 mg Versus Placebo on Weight Loss and Frequency of Binge Episodes in Obese Patients With Food Craving

summary:
The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder.

The secondary objectives are:

to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ),
to evaluate the safety and tolerability of rimonabant over a period of 6 months.

ReferenceCitation: Pataky Z, Gasteyger C, Ziegler O, Rissanen A, Hanotin C, Golay A. Efficacy of rimonabant in obese patients with binge eating disorder. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):20-6. doi: 10.1055/s-0032-1329957. Epub 2012 Nov 12.

location_country:
Finland
Portugal
Sweden
Netherlands
Switzerland
United States
France


title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week Follow-up

acronym: STRATUS-EU

summary:
The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

location_country:
France
United Kingdom
Denmark
Switzerland
Belgium
Spain
Sweden


title: Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation in Young Patients With Fabry Disease: An Epidemiological, International, Multicenter Prognosis Study

summary:
New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. In this case certain fat molecules are not digested and broken down by the body - but remain in the cells. These fat molecules build up to dangerous levels, which start to damage the body, because they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a stroke.

The purpose of this study is to investigate the stroke rehabilitation of Fabry patients during different therapeutic standard approaches for stroke and for Fabry disease (if any). During this study, stroke patients with Fabry disease will be monitored in greater detail to determine whether the differences in treatment are significant for patient recovery and on what they depend.

ReferenceCitation: Rolfs A, Bottcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Lohr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. doi: 10.1016/S0140-6736(05)67635-0. Erratum In: Lancet. 2006 Dec 23;368(9554):2210.

ipd_sharing: Undecided

lead_sponsor: CENTOGENE GmbH Rostock

sponsor_collaborators:
CENTOGENE GmbH Rostock
Shire Human Genetic Therapies, Inc.

location_country: Germany Poland Portugal Austria Croatia Georgia France

location_facility: Charite Campus Benjamin Franklin, Dept. of Neurology

location_facility: Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

location_facility: Department of Neurology, University Tuebingen

location_facility: Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

location_facility: Ludwig-Maximilians-University of Munich, Klinikum München-Großhadern, Dept. of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Leipzig

location_facility: Department of Neurology, Klinikum Chemnitz gGmbH

location_facility: Institute of Psychiatry and Neurology, Dept. of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Hamburg-Eppendorf

location_facility: Heinrich-Heine-University Duesseldorf, Dept. of Neurology

location_facility: Centro Hospitalar de Lisboa Central, Servico de Neurologia

location_facility: University of Ulm, Department of Neurology

location_facility: University of Giessen-Marburg Dept. of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Carl Gustav Carus

location_facility: Department of Neurology, Klinikum Hohe Warte

location_facility: Department of Neurology, Universitaetsklinikum Jena

location_facility: Department of Neurology, University Hospital Sestre Milosrdnice

location_facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

location_facility: Department of Neurology, Allgemeines Krankenhaus Celle

intervention_type: Other


title: A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.

acronym: VEGA

summary:
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A.

The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period.

The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.

status: Terminated

location_country:
Germany
Italy
Hungary
Australia
Mexico
Spain
Chile
Russian Federation
France


title: A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

summary:
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

To establish the safety profile.
To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
To assess the Overall Survival (OS)

ReferenceCitation: Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

location_country:
Germany
Italy
Portugal
Hungary
United Kingdom
Switzerland
Belgium
United States
Spain
Turkey
Russian Federation
France


title: Investigating Bone Density and Bone Loss Without Baseline Information

summary:
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

ReferenceCitation: Decensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.

oa_host_type: repository

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

repositories_concat: PubMed Central;boris.unibe.ch

unpaywall_oa_status: green

publisher_dissemination: Springer

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Italy
New Zealand
Australia
Switzerland
Spain
South Africa
Peru
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Institute of Oncology at Prince of Wales Hospital

intervention_type: Procedure


title: 2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

lead_sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Netherlands
Switzerland
Czechia
France

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Praxis fur Innere Medizin - Schmiedeberg

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Klinikum Barnim GmbH, Werner Forssmann Krankenhaus

location_facility: Praxis fuer Haematologie und Onkologie - Burgwedel

location_facility: Praxis Internistischer Onkologie und Haematologie - Koeln

location_facility: Onkologische Schwerpunktpraxis Dr. Schmidt

location_facility: Praxis fuer Innere Medizin am Krankenhaus Siloah - Pforzheim

location_facility: Onkologische Schwerpunktpraxis Dr. med. Verpoort, PD Dr. med. Zeller and Dr. med. Wierecky

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

location_facility: Onkologische Schwerpunktpraxis - Straubing

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Haematologische Praxis - Moenchengladbach

location_facility: Gemeinschaftspraxis fuer Dres. Aldaoud und Schwarzer

location_facility: Schwerpunktpraxis Haematologie/Onkologie - Hannover

location_facility: St. Marienkrankenhaus - Frankfurt am Main

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Onkologische Gemeinschaftspraxis - Kaiserslautern

location_facility: Helios Kliniken Wuppertal University Hospital

location_facility: Regional Hospital Am Plattenwald Bad Friedrichshall

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Haematologische/Onkologische Schwerpunktpraxis - Rostock

location_facility: Internistische Gemeinschaftspraxis - Jena

location_facility: Klinik fuer Onkologie - Katharinenhospital Stuttgart

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie - Luebeck

location_facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology

location_facility: Evangelisches Krankenhaus - Lutherstadt Wittenberg

location_facility: Internistische Praxis Dres. Hempel und Hochdorfer

location_facility: Krankenhaus Hohe Warte Mediziniche Klinik

location_facility: Gemeinschaftspraxis fuer Onkologie - Nordhorn

location_facility: St. Marien Hospital - Muelheim an der Ruhr

location_facility: St. Johannes Hospital - Medical Klinik II

location_facility: Praxis fuer Haematologie und Internistische Onkologie - Borken

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

location_facility: Onkologische Schwerpunktpraxis und Tagesklinik Dres

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Praxis Internistischer Onkologie und Haematologie - Frechen

location_facility: Haematologische / Onkologische Schwerpunktpraxis

location_facility: Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke

location_facility: Gemeinschaftspraxis fuer Haematologie - Northeim

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Sophien - und Hufeland - Klinikum Weimar gGmbH

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: Krankenhaus Barmherzige Brueder Regensburg

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Praxisklinik fuer Innere Medizin - Nuernberg

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

location_facility: Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Praxis fuer Onkologie am Diakonissenhaus

location_facility: Gastroenterologische und Haematologisch-Onkologische Praxis E. M. Dr. Hoering von Ehr Respondek

location_facility: Praxis fuer Haematologie und Interne Onkologie

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie - Flensburg

location_facility: Gemeinschaftspraxis feur Haemotologie und Onkologie - Weilheim

location_facility: Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

location_facility: Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

location_facility: Medizinische Klinik III - Universitaetsklinikum Erlangen

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Burkhard and Reimann Gemeinschaftspraxis

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Onkologische Schwerpunktpraxis - Villingen

location_facility: Internistische Gemeinschaftspraxis - Halle

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Gemeinschaftspraxis Dres. med. Ellbrueck/Goeller/Kraenzle/Niedermeier/Jocham

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Onkologische Schwerwpunktpraxis Dr. Ladda

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Staedtisches Krankenhaus Muenchen - Harlaching

location_facility: Klinikum Schwaebisch Gmuend Stauferklinik

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

location_facility: Internistisch-Haematologische Gemeinschaftspraxis - Gustrow

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Haematologie und Internistische Onkologie Praxis

location_facility: Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

location_facility: Gemeinschaftspraxis fuer Internistische - Frankenthal

location_facility: Medizinische Klinik am Lukas - Krankenhaus

location_facility: Internistische Gemeinschaftspraxis - Magdeburg

location_facility: Schwerpunktpraxis Internist Onkologie - Marburg

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Krankenhaus St. Elisabeth und St. Barbara

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: University Leipzig Clinic of Internal Medicine

location_facility: Marienhospital at Ruhr University Bochum

location_facility: Praxis Fuer Internistische Haematologie / Onkologie

location_facility: Gemeinschaftspraxis fuer Haematologie und Internist - Schweinfurt

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide


title: Prospective Randomized Study of the Incidence and Outcome of Veno-Occlusive Disease (VOD) With the Prophylactic Use of Defibrotide (DF) in Pediatric Stem Cell Transplantation

acronym: VOD-DF

summary: The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are at high risk of developing hepatic Veno-occlusive Disease (VOD) will have an impact on the incidence and severity of the disease. Patients will be randomly assigned to one of two treatment arms: Those allocated to the Prophylactic Arm will receive the study drug (Defibrotide) from the day of conditioning onwards. Patients allocated to the Control Arm will receive the study drug (Defibrotide) from the day that VOD is diagnosed.

ReferenceCitation: Corbacioglu S, Cesaro S, Faraci M, Valteau-Couanet D, Gruhn B, Rovelli A, Boelens JJ, Hewitt A, Schrum J, Schulz AS, Muller I, Stein J, Wynn R, Greil J, Sykora KW, Matthes-Martin S, Fuhrer M, O'Meara A, Toporski J, Sedlacek P, Schlegel PG, Ehlert K, Fasth A, Winiarski J, Arvidson J, Mauz-Korholz C, Ozsahin H, Schrauder A, Bader P, Massaro J, D'Agostino R, Hoyle M, Iacobelli M, Debatin KM, Peters C, Dini G. Defibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomised controlled trial. Lancet. 2012 Apr 7;379(9823):1301-9. doi: 10.1016/S0140-6736(11)61938-7. Epub 2012 Feb 23.

lead_sponsor: European Society for Blood and Marrow Transplantation

collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

location_country:
Germany
Ireland
France
Italy
United Kingdom
Sweden
Netherlands
Austria
Switzerland
Israel

location_facility:
Our Lady's Hospital for Sick Children
Medical School
Kinderklinik
Universitätsspital Eppendorf
University Children Hospital
Johann-Wolfgang Goethe Universität
University Hospital
Christian-Albrecht -University
Poliklinik Kinderheilkunde
St Anna Kinderspital
Klinik Kinder-Onkologie
Children's Hospital
Hopital Cantonal Universitaire
Universitätsspital
Inst. Gustave Roussy
Schneider Children's MC
Clinica di Oncoematologia Pediatrica
Ospedale S. Gerardo
Great Ormond Street Hospital
Institute G. Gaslini
Kinderpoliklinik Uni
Sahlgrenska University Hospital
Inselspital


title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

summary: This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.

ReferenceCitation: Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. doi: 10.1530/EJE-06-0598.

ReferenceCitation: Krusenstjerna-Hafstrom T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
France
Poland
Hungary
Norway
Spain
South Africa
Israel


title: Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

summary:
Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

The objective is to compare the efficacy and safety of the different treatment regimens

lead_sponsor: LEO Pharma

location_country:
Germany
United Kingdom
Netherlands
Belgium
Spain
Canada
France

location_facility: Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie

location_facility: Hospital Mutua de Terrassa Dermatology Service

location_facility: Clatterbridge Hospital, Department of Dermatology


type: Other Grant/Funding Number

type: Registry Identifier

title: Early Sleep Apnea Treatment in Stroke: A Multicenter, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation

acronym: eSATIS

summary:
Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome.

To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB.

Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23.

ReferenceCitation: Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. No abstract available.

ReferenceCitation: Duss SB, Brill AK, Baillieul S, Horvath T, Zubler F, Flugel D, Kagi G, Benz G, Bernasconi C, Ott SR, Korostovtseva L, Sviryaev Y, Salih F, Endres M, Tamisier R, Gouveris H, Winter Y, Denier N, Wiest R, Arnold M, Schmidt MH, Pepin JL, Bassetti CLA. Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke). Trials. 2021 Jan 22;22(1):83. doi: 10.1186/s13063-020-04977-w.

ReferenceCitation: Brill AK, Rosti R, Hefti JP, Bassetti C, Gugger M, Ott SR. Adaptive servo-ventilation as treatment of persistent central sleep apnea in post-acute ischemic stroke patients. Sleep Med. 2014 Nov;15(11):1309-13. doi: 10.1016/j.sleep.2014.06.013. Epub 2014 Aug 1.

ReferenceCitation: Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep. 2011 Sep 1;34(9):1271-7. doi: 10.5665/SLEEP.1254.

ReferenceCitation: Parra O, Sanchez-Armengol A, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, de la Torre G, Gonzalez Marcos JR, de la Pena M, Carmen Jimenez M, Masa F, Casado I, Luz Alonso M, Macarron JL. Early treatment of obstructive apnoea and stroke outcome: a randomised controlled trial. Eur Respir J. 2011 May;37(5):1128-36. doi: 10.1183/09031936.00034410. Epub 2010 Sep 16.

ReferenceCitation: Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schabitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.

ReferenceCitation: Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.

ReferenceCitation: Barbe F, Duran-Cantolla J, Sanchez-de-la-Torre M, Martinez-Alonso M, Carmona C, Barcelo A, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, Diaz de Atauri J, Teran J, Mayos M, de la Pena M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

ReferenceCitation: Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.

ReferenceCitation: Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbe F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.

lead_sponsor: Insel Gruppe AG, University Hospital Bern

collaborators: TROPOS Stiftung für Humane Verhaltensforschung

location_country:
Germany
Switzerland
Russian Federation
France

location_facility: Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble

location_facility: Department of Neurology, Pulmonary Medicine and Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital

location_facility: Neurology Department, Cantonal Hospital St.Gallen

location_facility: Federal State Budgetary Institution "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, HNO-Universitätsklinik, Klinik und Poliklinik für Neurologie

location_facility: Department and Out-Patient Care of Neurology, Charité Center Neurology, Neurosurgery and Psychiatry CC 15, Department of Neurology with Experimental Neurology, Center for Stroke Research Berlin (CSB)

intervention_type: Device

status_simplified: Ongoing


title: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

summary: The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.

primary_purpose: Supportive Care

lead_sponsor: Bristol-Myers Squibb

location_country: Poland France

location_facility:
Local Institution - 0003
Local Institution - 0002
Local Institution
Local Institution - 0006


title: The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

summary: The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Italy
Brazil
Mexico
Spain
Canada
Puerto Rico
France

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

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


title: A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)

summary:
Primary Objective:

To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).

Secondary Objective:

To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.

ReferenceCitation: van Sornsen de Koste JR, Senan S, Underberg RW, Oei SS, Elshove D, Slotman BJ, Lagerwaard FJ. Use of CD-ROM-based tool for analyzing contouring variations in involved-field radiotherapy for Stage III NSCLC. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):334-9. doi: 10.1016/j.ijrobp.2005.02.016.

lead_sponsor: Sanofi

location_country:
Finland
Italy
United Kingdom
Netherlands
Belgium
Spain
Turkey
France


title: A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

summary: This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

lead_sponsor: Baxter Healthcare Corporation

location_country: Germany Italy Austria France

location_facility: Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

location_facility: S. Luigi - S. Curro, Presidi Ospedalieri Unificati

location_facility: Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis

location_facility: Istituto Nationale per la Ricerca sul Cancro


title: Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

summary: This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

publisher_dissemination: Wiley

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France

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


title: Single Group Phase 2 Study to Investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI

summary: This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Allecra

sponsor_collaborators:
Allecra
Linical Co., Ltd.

location_country: Poland Slovakia Hungary Spain Czechia France

location_facility: Fakultní nemocnice Hradec Králové -Ústav klinické biochemie a diagnostiky

location_facility: Debreceni Egyetem Klinikai Központ Gyermekgyógyászati Klinika

location_facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Leśnym


title: The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes

summary: Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers

status: Recruiting

time_perspective: Retrospective

lead_sponsor: Helios Health Institute GmbH

sponsor_collaborators:
Helios Health Institute GmbH
Abbott

location_country: Germany Netherlands Belgium France

location_facility: Heart Center Leipzig University Hospital

location_facility: Heart Center Dresden University Hospital


title: Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

summary: This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

ReferenceCitation: Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75-83. doi: 10.1097/YIC.0b013e328341bb5f.

ReferenceCitation: Sheehan DV, Meyers AL, Prakash A, Robinson MJ, Swindle RW, Russell JM, Mallinckrodt CH. The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder. Curr Med Res Opin. 2008 Sep;24(9):2457-66. doi: 10.1185/03007990802293643. Epub 2008 Jul 24.

ReferenceCitation: Hartford JT, Endicott J, Kornstein SG, Allgulander C, Wohlreich MM, Russell JM, Perahia DG, Erickson JS. Implications of pain in generalized anxiety disorder: efficacy of duloxetine. Prim Care Companion J Clin Psychiatry. 2008;10(3):197-204. doi: 10.4088/pcc.v10n0304.

ReferenceCitation: Koponen H, Allgulander C, Erickson J, Dunayevich E, Pritchett Y, Detke MJ, Ball SG, Russell JM. Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians. Prim Care Companion J Clin Psychiatry. 2007;9(2):100-7. doi: 10.4088/pcc.v09n0203.

ReferenceCitation: Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Curr Med Res Opin. 2007 Jun;23(6):1245-52. doi: 10.1185/030079907X182202. Epub 2007 Apr 25.

ReferenceCitation: Endicott J, Russell JM, Raskin J, Detke MJ, Erickson J, Ball SG, Marciniak M, Swindle RW. Duloxetine treatment for role functioning improvement in generalized anxiety disorder: three independent studies. J Clin Psychiatry. 2007 Apr;68(4):518-24. doi: 10.4088/jcp.v68n0405. Erratum In: J Clin Psychiatry. 2007 Apr;68(4):518. J Clin Psychiatry. 2007 May;68(5):806.

location_country:
Germany
Finland
Sweden
United States
Spain
South Africa
France

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


title: Daratumumab as a Treatment for Adult Immune Thrombocytopenia (The DART Study)

summary: A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

lead_sponsor: Ostfold Hospital Trust

sponsor_collaborators:
Ostfold Hospital Trust
Haukeland University Hospital
Oslo University Hospital
University Hospital, Akershus
Henri Mondor University Hospital
Odense University Hospital

location_country: Denmark Norway France

location_facility:
Henri Mondor University Hospital
Akershus University Hospital
Odense University Hospital
Oslo University Hospital
Ostfold Hospital Trust
Haukeland University Hospital


title: Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients From 6 Months to Less Than 2 Years Old

summary:
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed.

However administration of Cystadrops® in patients below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.

lead_sponsor: Recordati Rare Diseases

location_country:
Germany
Italy
United Kingdom
Belgium
France

location_facility:
Bambin Gesù Hospital in Palidoro
UZ Leuven
Hôpital Necker-Enfants Malades
Klinik für Pädiatrische Nieren
Great Ormond Street Hospital
Manchester Royal Eye Hospital


title: Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study

acronym: FASTII

summary: The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.

ReferenceCitation: Masdjedi K, Tanaka N, Van Belle E, Porouchani S, Linke A, Woitek FJ, Bartorelli AL, Ali ZA, den Dekker WK, Wilschut J, Diletti R, Zijlstra F, Boersma E, Van Mieghem NM, Spitzer E, Daemen J. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention. 2022 Apr 22;17(18):1498-1505. doi: 10.4244/EIJ-D-21-00471.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

publisher_dissemination: Europa Digital & Publishing

ipd_sharing_description: Individual participant data are needed for the final analysis which will be done by Erasmus MC.

lead_sponsor: Erasmus Medical Center

sponsor_collaborators:
Erasmus Medical Center
Tokyo Medical University
Centro Cardiologico Monzino
Columbia University
University Hospital Carl Gustav Carus
University Hospital, Lille

location_country:
Germany
Italy
Japan
Netherlands
United States
France

location_facility:
Erasmus Medical Center
Herzzentrum Dresden
Columbia University Medical Center
CHU
Tokyo Medical University
Centro Cardiologico Monzino

intervention_type: Diagnostic Test


title: A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy

acronym: DENIM

summary: This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.

lead_sponsor: Amphera BV

sponsor_collaborators:
Amphera BV
TMC Pharma

location_country:
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Characterization of Acute and Long Term Response to Left Ventricle Only Pacing Combined With MultiPoint Pacing and SyncAV

summary:
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.

This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects.

Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs.

In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure.

Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire.

Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.

status: Enrolling by invitation

ipd_sharing_description: No participant data will be shared to other researchers

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
Abbott

location_country:
Italy
Canada
United Kingdom
France

location_facility:
Queen Elizabeth Hospital
CHU Rennes
Montreal Heart Institute
John Radcliffe Hospital
Policlinico Casilino
St. Bartholomew's Hospital


title: A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.

ReferenceCitation: Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3.

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

location_country:
Germany
United Kingdom
Netherlands
Belgium
France

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg


title: A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries

acronym: BIO-OSCAR SOC

summary: Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.

ipd_sharing_description: The individual participant data (IPD) is not yet drafted. No decision is taken to share it yet.

lead_sponsor: Biotronik AG

location_country: Germany Italy Hungary Switzerland Austria Belgium Spain France

location_facility: LKH Univ.-Klinikum Graz, Ambulanz für Angiologie