title: A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma

summary:
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib.

Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

ReferenceCitation: Rini BI, Stenzl A, Zdrojowy R, Kogan M, Shkolnik M, Oudard S, Weikert S, Bracarda S, Crabb SJ, Bedke J, Ludwig J, Maurer D, Mendrzyk R, Wagner C, Mahr A, Fritsche J, Weinschenk T, Walter S, Kirner A, Singh-Jasuja H, Reinhardt C, Eisen T. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Nov;17(11):1599-1611. doi: 10.1016/S1470-2045(16)30408-9. Epub 2016 Oct 3.

lead_sponsor: Immatics Biotechnologies GmbH

location_country:
Poland
United Kingdom
Italy
Russian Federation
Netherlands
Hungary
United States
France
Romania
Norway
Germany

location_facility: IRCC-Istituto di Ricerca e Cura del Cancro

location_facility: Urology and Urological Oncology Department and Clinic

location_facility: Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic

location_facility: Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"

location_facility: Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)

location_facility: Urologische Klinik Dr. Castringius, München-Planegg

location_facility: Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Weinberg Cancer Institute at Franklin Hospital

location_facility: Centro di riferimento Oncologico di Aviano

location_facility: Moscow Hertsen Scientific Research Oncological Institute

location_facility: Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz

location_facility: Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"

location_facility: Pándy Kálmán County Hospital, Oncology and Radiotherapy Center

location_facility: Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center

location_facility: Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

location_facility: Kaiser Permanente Oncology Hematology Clinic

location_facility: Chemotherapy Department Center of Oncology of the Lublin Region

location_facility: UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"

location_facility: Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"

location_facility: University Medical Center St. Radboud Centraal, Department of Urology

location_facility: Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology

location_facility: Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire

location_facility: Oncology Department, Zala County Hospital

location_facility: Medical Oncology Unit, Policlinico Sant'Orsola Malpighi

location_facility: Urology Department, Bajcsy-Zsilinszky Hospital

location_facility: South West Wales Cancer Institute, Singleton Hospital, School of Medicine

location_facility: State Institution "City Clinical Hospital NO20"

location_facility: "Prof. Dr. Ioan Chiricuta" Oncology Institute

location_facility: Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"

location_facility: University Hospital, UOS - Radiumhospital

location_facility: Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"

location_facility: State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"

location_facility: Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia

location_facility: Klinik für Urologie, Universitätsklinikum Tübingen

location_facility: Centre Rene Gauducheau, Service d'oncologie medicale

location_facility: State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

location_facility: Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology

location_facility: State Institution of Healthcare "Leningrad Regional Oncological Dispensary"

location_facility: Wojewódzki Szpital Zespolony, Oncology Department

location_facility: Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Urologii

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)

location_facility: Centre Francois Baclesse, Comite Urologie-Gynecologie

location_facility: North Central Cancer Treatment Group, Illinois Cancer Care

location_facility: Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna

location_facility: Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital

location_facility: Péterfy Utcai Hospital, Urology department

location_facility: Dipartimento di Oncologia, IRCCS Fondazione

location_facility: Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie

location_facility: Hospital Européen Georges Pompidou, Service d'oncologie medicale

location_facility: Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München

location_facility: County Oncology Centre, Hetényi Géza Hospital

location_facility: State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"

location_facility: University of Debrecen, Faculty of Medicine, Urology Clinic

location_facility: Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm

location_facility: Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH

location_facility: Oncology Centre, Markhot Ferenc Training Hospital and Clinic

location_facility: South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care

location_facility: Prof. Franciszek Łukaszczyk Oncology Center

location_facility: Emergency Clinical County Hospital Oradea

location_facility: Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn

location_facility: State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"

location_facility: CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Debrecen, Faculty of Medicine, Institute of Oncology

location_facility: Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica

location_facility: Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic

location_facility: Postgraduate Medical School, University of Surrey

location_facility: Oncology Therapy Clinic, University of Szeged

location_facility: Uzsoki Utcai Hospital, Oncoradiology Center

location_facility: Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig

location_facility: Orenburg Regional Clinical Oncological Dispensary

location_facility: ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital

location_facility: Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover


type: EudraCT Number

type: Other Identifier

title: A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer

acronym: DISRUPT

summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Secondary Objective:

To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Sanofi

location_country:
Croatia
Poland
Serbia
Italy
Russian Federation
Australia
Ukraine
Korea, Republic of
United States
Chile
France
Romania
Germany

location_facility:
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 380002
Investigational Site Number 152002
Investigational Site Number 840001
Investigational Site Number 152004
Investigational Site Number 410002
Investigational Site Number 380001
Investigational Site Number 616001
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 804002
Investigational Site Number 152005
Investigational Site Number 191003
Investigational Site Number 250002
Investigational Site Number 804001
Investigational Site Number 642004
Investigational Site Number 642003
Investigational Site Number 616004
Investigational Site Number 036001
Investigational Site Number 250001
Investigational Site Number 616003
Investigational Site Number 616005
Investigational Site Number 152003
Investigational Site Number 840009
Investigational Site Number 642002
Investigational Site Number 688001
Investigational Site Number 804003
Investigational Site Number 276003
Investigational Site Number 643004
Investigational Site Number 840002
Investigational Site Number 276002
Investigational Site Number 410003
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 642001
Investigational Site Number 688003
Investigational Site Number 191002
Investigational Site Number 250004
Investigational Site Number 276001
Investigational Site Number 191001
Investigational Site Number 250005
Investigational Site Number 036002

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

summary: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

ReferenceType: derived

ReferenceCitation: Gottenberg JE, Dörner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.

ReferenceCitation: Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczyński P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

lead_sponsor: UCB Pharma

location_country:
Poland
Brazil
Romania
Spain
Italy
Russian Federation
United Kingdom
Canada
Ukraine
Hungary
United States
France
India
South Africa
Mexico
Germany


title: A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

lead_sponsor: GlaxoSmithKline

source: euctr

study_start_date_type: Actual

ReferenceCitation: Goemans N, Mercuri E, Belousova E, Komaki H, Dubrovsky A, McDonald CM, Kraus JE, Lourbakos A, Lin Z, Campion G, Wang SX, Campbell C; DEMAND III study group. A randomized placebo-controlled phase 3 trial of an antisense oligonucleotide, drisapersen, in Duchenne muscular dystrophy. Neuromuscul Disord. 2018 Jan;28(1):4-15. doi: 10.1016/j.nmd.2017.10.004. Epub 2017 Dec 6.

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Netherlands
Argentina
Canada
Hungary
Korea, Republic of
France
Chile
Turkey
Norway
Belgium
Japan
Germany
Czechia

summary: The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.


title: A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2

summary: The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country: Spain Austria Hungary France Belgium

location_facility: Centre Hospitalier de Jolimont-Lobbes, Oncology Médicale

location_facility: Universitätsklinik für Innere medizin, Klinishe abteilung für hämatologie und Onkologie

location_facility: Medical Center of the University of Pecs , National Institute Oncology

location_facility: AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinishe Onkologie

location_facility: Krankenanstalt Rudolfstiftung, 1 medizinishe Abteilung

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Landeskrankenhaus Salzburg, Univ. Klinik für innere Medizin III, Universitätsklinikum der PMU

location_facility: Hospital Universitario Marqués de Valdecilla

lead_sponsor_type: academique


title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.

ReferenceCitation: Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.

ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

lead_sponsor: Hoffmann-La Roche

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Tunisia
Israel
Mexico
Slovakia
Brazil
Switzerland
Hungary
Germany
Bulgaria
Latvia
Estonia
Finland
France
Chile
Netherlands

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: University of California at San Francisco

location_facility: Multicare Research Institute; Multicare Neuroscience Center of Washington

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics

location_facility: Royal North Shore Hospital; Department of Neurology

location_facility: Southern California Permanente Medical Group

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Clinica Centenario Peruano Japonesa; Neurology

location_facility: Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

location_facility: Reg. SI of Health Care Smolensk Regional Clinical Hospital

location_facility: Maritime Medicine Centre of Latvia Hospital of Vecmilgravis; Department of Neurology

location_facility: Hopital Universitaire Fattouma Bourguiba

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Northwestern University; Dept. of Neurology

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: P. Stradins Clinical University Hospital; Neurology

location_facility: MRC for Oncology and Neurology Biotherapy

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Asklepiosklinik Barmbek; Abteilung Neurologie

location_facility: Atrium Health Neurosciences Institute - Charlotte

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Emory University; Department of Neurology

location_facility: Uni of Texas Health Science Center At Houston

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Albert Einstein Medical Center; Depatment of Neurosensory sciences

location_facility: The MS Center; Advance Neurology and Pain

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune

location_facility: Michigan Institute for Neurological Disorders

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: The Ohio State University Wexner Medical Center

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"

location_facility: St.-Peterburg State institution of health care City multifield hospital #2

location_facility: Cliniques Universitaires Saint-Luc; Neurology

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie

location_facility: Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology

location_facility: Chaim Sheba Medical Center; Neurology Department

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (pres

location_facility: Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: MMA of Ministry of Defense of Russia named after S.M. Kirov

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte

location_facility: Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

status_simplified: Ongoing


title: An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

summary: The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72 weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8 (week 24 of that study).

status: Terminated

lead_sponsor: Cephalon

location_country:
Poland
Portugal
Spain
United Kingdom
Ukraine
Hungary
France
United States
Belgium
Germany
Czechia

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Box Arthritis and Rheumatology of the Carolinas PLLC

location_facility: Centre for Rheumatology, Immunology and Arthritis Research

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Scott - White Clinic/Texas A and M University

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Institute of Cardiology named after Strazhesko

location_facility: Országos Reumatológiai és Fizioterápiás Intézet

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Akademicki Szpital Kliniczny we Wroclawiu im. Jana Mikulicza

location_facility: Feinstein Institute for Medical Research

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Unica

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Regional Clinical Hospital for Professional Diseases

status_simplified: Unknown


title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

summary: This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.

status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Eisai Inc.

location_country: Canada France Belgium


title: A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

summary: The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

ReferenceType: result

ReferenceCitation: Baselga J, Costa F, Gomez H, Hudis CA, Rapoport B, Roche H, Schwartzberg LS, Petrenciuc O, Shan M, Gradishar WJ. A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. Trials. 2013 Jul 22;14:228. doi: 10.1186/1745-6215-14-228.

ReferenceCitation: Baselga J, Zamagni C, Gómez P, Bermejo B, Nagai SE, Melichar B, Chan A, Mángel L, Bergh J, Costa F, Gómez HL, Gradishar WJ, Hudis CA, Rapoport BL, Roché H, Maeda P, Huang L, Meinhardt G, Zhang J, Schwartzberg LS. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017 Dec;17(8):585-594.e4. doi: 10.1016/j.clbc.2017.05.006. Epub 2017 May 22.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Sweden
Canada
Hungary
China
Germany
Greece
Ireland
France


title: BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

summary: The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

primary_purpose: Prevention

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Italy
Austria
Finland
Czech Republic
Sweden
Hungary
France
South Africa
Belgium
Norway
Netherlands

location_facility: 1160.19.45042 Orthopedic Surgical Clinic

location_facility: 1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal

location_facility: 1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia

location_facility: 1160.19.36004 Bács-Kiskun County Hospital

location_facility: 1160.19.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus

location_facility: 1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad

location_facility: 1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center

location_facility: 1160.19.43002 Orthopädisches Spital Speising

location_facility: 1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

location_facility: 1160.19.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

location_facility: 1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar

location_facility: 1160.19.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.

location_facility: 1160.19.42009 University Hospital Na Bulovce

location_facility: 1160.19.47002 Sykehuset Telemark HF, Avd. Skien

location_facility: 1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping

location_facility: 1160.19.36001 Kálmán Pándy County Hospital

location_facility: 1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum

location_facility: 1160.19.47001 Nordlandssykehuset HF, Bodø

location_facility: 1160.19.39002 Fondazione Centro S. Raffaele

location_facility: 1160.19.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.39004 Ospedale di Circolo di Varese

location_facility: 1160.19.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.39003 U. O. Ortopedia e Traumatologia

location_facility: 1160.19.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.39001 IRCCS Policlinico San Matteo

location_facility: 1160.19.42003 University Hospital Ostrava


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

ReferenceType: background

ReferenceCitation: Cutolo M, Myerson GE, Fleischmann RM, Lioté F, Díaz-González F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

ReferenceCitation: Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

ReferenceCitation: Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

ReferenceCitation: Gladman DD, Kavanaugh A, Gómez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Estonia
United Kingdom
Canada
Hungary
United States
France
South Africa
Belgium
Germany
Bulgaria
Czechia

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: 17 Diagnostic and Consulting Centre Sofia EOOD

location_facility: St.Petersburg State Medical Academy n. a. I.I.Mechnikov

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Associated Internal Medical Specialist, PC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED

location_facility: Unifour Medical Research Associatets LLC

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Tacoma Center for Arthritis Research, PS

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Basingstoke and North Hampshire Hospital


title: A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation

summary: This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.

lead_sponsor: Novo Nordisk A/S

location_country:
United Kingdom
Canada
Switzerland
United States
France
Germany


title: A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary: The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.

ReferenceCitation: Léger JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies IS; PRIMA study investigators. Efficacy and safety of Privigen(®) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013 Jun;18(2):130-40. doi: 10.1111/jns5.12017.

ReferenceCitation: Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Léger JM; PRIMA trial investigators. Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial. J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204.

lead_sponsor: CSL Behring

location_country: Poland Finland France Belgium Germany

intervention_type: Biological


acronym: Full STEP™

title: A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin With or Without Oral Anti-diabetic Drugs: Step-wise Addition Versus Complete Basal-bolus Therapy

ReferenceCitation: Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):30-7. doi: 10.1016/S2213-8587(13)70090-1. Epub 2013 Sep 25. Erratum in: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3.

location_country: Macedonia, The Former Yugoslav Republic of

summary: This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.


title: TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

acronym: TOTAL

summary: This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

ReferenceCitation: Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemelä K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Džavík V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemelä K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Džavík V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

ReferenceCitation: Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stanković G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Džavík V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17.

ReferenceCitation: Moxham R, Džavík V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.

ReferenceCitation: Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Džavík V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

ReferenceCitation: Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemelä K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Džavík V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Džavík V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.

ReferenceCitation: Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14.

lead_sponsor: Population Health Research Institute

location_facility: The First People's Hospital, Jiatong University

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: Yueyang Hospital Shanghai University of TCM

location_facility: Hampshire Hospitals NHS Fuondation Trust

location_facility: The Tenth People's Hospital Tongji University

location_facility: Soonchunhyang University Cheonan Hospital

location_facility: University of New Mexico Health Sciences Center

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Barts and The London Heart and Chest Centre

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Heart Center, Tampere University Hospital

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Fundação Faculdade de Medicina de São José do Rio Preto

location_facility: Lindner Research Center at Christ Hospital

location_facility: Frimley Park Hospital, NHS Foundation Trust

location_facility: Semmelweis University Heart and Vascular Center

intervention_type: Procedure


title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

ReferenceCitation: Newland A, Godeau B, Priego V, Viallard JF, López Fernández MF, Orejudos A, Eisen M. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827. Epub 2015 Nov 5.

ReferenceCitation: Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.

ReferenceCitation: Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.

ReferenceCitation: Kuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
United States
France
Germany
Czechia

summary: The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.


title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

summary: The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

ReferenceCitation: Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Büttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Brazil
Greece
Italy
Mexico
Russian Federation
Argentina
Canada
United States
France
Turkey
Belgium
Germany

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


acronym: HEPCAT

title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourlière M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Bräu N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.

location_country:
Denmark
Italy
Australia
Canada
Sweden
Puerto Rico
United States
France
Mexico
Germany
Egypt

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Transplant Center And Hepatology Clinic, B-154

location_facility: University Of North Carolina At Chapel Hill School Of Med

location_facility: Upper Delaware Valley Infectious Diseases, Pc

summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


acronym: SPARK

title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandström T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

location_country:
Spain
Italy
United Kingdom
United States
Peru
South Africa
Philippines
Poland
Austria
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Slovakia
Canada
Hungary
Germany
Denmark
Greece
Ireland
Estonia
Finland
Czech Republic
France
Colombia
Netherlands

summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.


title: A 24-month, Multi-center, Open-label, Randomized, Controlled Trial to Investigate Efficacy, Safety and Evolution of Cardiovascular Parameters in de Novo Renal Transplant Recipients After Early Calcineurin Inhibitor to Everolimus Conversion

acronym: ELEVATE

summary: The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

location_country:
Spain
Italy
Lithuania
Romania
Belgium
Portugal
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Germany
Greece
Latvia
Estonia
Thailand
France
Netherlands


title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes

summary: The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Australia
Hungary
Puerto Rico
United States
France
Israel
Czechia


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

ReferenceCitation: Lavalle-González FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

ReferenceCitation: Cefalu WT, Stenlöf K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

ReferenceCitation: Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
United Kingdom
Russian Federation
Australia
Mexico
Guatemala
Hungary
Puerto Rico
United States
France
Israel
Belgium


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

lead_sponsor: Seagen Inc.

ReferenceCitation: Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum in: Lancet. 2015 Aug 8;386(9993):532. Lancet. 2015 Aug 8;386(9993):532.

ReferenceCitation: Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

location_country:
Poland
Serbia
Spain
Italy
Russian Federation
United Kingdom
Hungary
United States
France
Romania
Germany
Bulgaria
Czechia

location_facility: Washington University School of Medicine

location_facility: University of Chicago Section of Hematology/Oncology Lymphoma Program

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: Vojnomedicinska akademija, Klinika za hematologiju

location_facility: University of California at San Francisco

location_facility: Guy's Hospital Haematology Department, 4th Floor Southwark Wing

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Federal Medical Biophysical Center n.a. A.I. Burnazyan

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Vseobecni fakultni nemocnice v Prahe-I. interni klinika

location_facility: James Cancer Hospital / Ohio State University

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: CHU Nantes - Hopital Hotel Dieu Service Hematologie

location_facility: Oregon Health and Science University / Center for Hematologic Malignancies

location_facility: Hospital Clinic i Provincial Servicio Hematologia

location_facility: Complejo Hospitalano de Navarra Servicio Hematologia

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Respublikanskaja bol'nica im. V.A. Baranova

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju

location_facility: Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie

location_facility: Klinicki centar Srbije, Klinika za hematologiju

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High

location_facility: Virginia Commonwealth University Medical Center

location_facility: Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Service des Maladies du Sang / Hospital Saint Louis

location_facility: Leningradskaja oblastnaja klinicheskaja bol'nica

location_facility: Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii

location_facility: Sverdlovskaja oblastnaja klinicheskaja bol'nica #1

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


intervention_type: Other

acronym: CADMUS

title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

ReferenceCitation: Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.

ReferenceCitation: Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.

location_country:
Portugal
United Kingdom
Russian Federation
Canada
Ukraine
Sweden
Hungary
France
Belgium
Germany

summary: This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.


title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

summary: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

ReferenceCitation: Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

location_country:
Croatia
Poland
Brazil
Romania
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
Czech Republic
Taiwan
Hungary
Korea, Republic of
France
India
Belgium
Sweden
Slovakia

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


acronym: COMPOSE EARLY

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

location_country:
Poland
Spain
Ireland
Italy
United Kingdom
Finland
Czech Republic
Canada
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Japan
Germany

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


title: A European, Prospective, Non-Interventional Study to Assess Health Related Quality of Life and to Identify Key Transitional Life Events in Patients With Moderate or Severe Haemophilia A Using Helixate NexGen

summary: The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

study_type: Observational

time_perspective: Prospective

location_country: Spain Italy Austria Switzerland France Belgium Germany

location_facility:
CSLB Study Site 91
CSLB Study Site 64
CSLB Study Site 29
CSLB Study Site 1
CSLB Study Site 7
CSLB Study Site 68
CSLB Study Site 23
CSLB Study Site 66
CSLB Study Site 71
CSLB Study Site 52
CSLB Study Site 2
CSLB Study Site 98
CSLB Study Site 21
CSLB Study Site 51
CSLB Study Site 25
CSLB Study Site 27
CSLB Study Site 72
CSLB Study Site 26
CSLB Study Site 6
CSLB Study Site 35
CSLB Study Site 4
CSLB Study Site 22
CSLB Study Site 24
CSLB Study Site 3
CSLB Study Site 73
CSLB Study Site 20
CSLB Study Site 65
CSLB Study Site 95
CSLB Study Site 74
CSLB Study Site 60
CSLB Study Site 36


acronym: CAMPANULA

title: Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

lead_sponsor: Ipsen

location_country:
Poland
Spain
Ireland
Austria
Italy
Latvia
Finland
Netherlands
Russian Federation
Ukraine
Sweden
France
Israel
United Kingdom
Belgium
Germany
Slovakia
Czechia

location_facility: Voronezh Regional Clinical Oncology Dispensary

location_facility: St-Petersburg State Institution of Public Health City Clinical Oncology dispensary

location_facility: Royal Preston Hospital, Sharoe Green Lane, Lancashire

location_facility: Christie Hospital and Holt Radium Institute

location_facility: Akademiska Hospital, Dept of Oncology & Endocrinology

location_facility: University Hospital, Internal Medicine - Oncology

location_facility: Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital

location_facility: Fakultní nemocnice Na Bulovce, Ústav radiační onkologie

location_facility: St-Petersburg State Medical University named after academician Pavlov I.P.

location_facility: Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan

location_facility: Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"

location_facility: Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center

location_facility: Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi

location_facility: Latvian Oncology centre of Riga Eastern Clinical University Hospital

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea

summary: The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.


title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

lead_sponsor: Astellas Pharma Inc

location_country:
United Kingdom
United States
Spain
France

location_facility: Site ES1346 Hospital Universitario de Salamanca

location_facility: Site ES1339 Hospital Universitario Ramon y Cajal

location_facility: Site US55 Loyola University Hospital - Maywood

location_facility: Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel

location_facility: Site GB2624 The Christie NHS Foundation Trust

location_facility: Site US402 University of Texas Health Science Center - San Antonio

location_facility: Site US2149 Gabrail Cancer Center Research

location_facility: Site ES2967 Hosptial Universitario Madrid Sanchinarro

summary: The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.


title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

summary: The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

primary_purpose: Other

location_country:
Spain
Italy
United States
Costa Rica
Peru
South Africa
Portugal
Russian Federation
Argentina
Indonesia
Puerto Rico
Panama
Mexico
Malaysia
Singapore
Brazil
Canada
Guatemala
Hungary
Taiwan
Dominican Republic
Thailand
France
Chile
Colombia

location_facility:
St Josephs Cmprhnsv Rsch Inst
Phoenix Body Positive, Inc
Jemsek Clinic
University Of Nebraska Medical Center
V.A. Medical Center
St Francis Memorial Hospital
Tarrant County Inf Dis Assoc
Cri Of New England
Clinical Research Puerto Rico, Inc.
Rand Schrader Clinic
Sbma Research, Llc
The Schrader Clinic
Infectious Disease Of Indiana, Psc
Local Institution
Univ Of Kansas Sch Of Med


title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

ReferenceCitation: McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.

ReferenceCitation: Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.

ReferenceCitation: Jones PW, Lamarca R, Chuecos F, Singh D, Agustí A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.

ReferenceCitation: Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. Epub 2012 Mar 22.

lead_sponsor: AstraZeneca

location_country:
Poland
Spain
Italy
Russian Federation
Czech Republic
Ukraine
Hungary
France
Peru
South Africa
Germany

location_facility:
Almirall Investigational Sites#4
Almirall Investigational Site#2
Almirall Investigational Sites#24
Almirall Investigational Site#11
Almirall Investigational Sites#10
Almirall Investigational Sites#1
Almirall Investigational Sites#7
Almirall Investigational Sites#12
Almirall Investigational Sites#25
Almirall Investigational Sites#9
Almirall Investigational Sites#8
Almirall Investigational Sites#13
Almirall Investigational Sites#2
Almirall Investigational Sites#11
Almirall Investigational Sites#23
Almirall Investigational Site#16
Almirall Investigational Sites#3
Almirall Investigational Sites#19
Almirall Investigational Site#7
Almirall Investigational Sites#20
Almirall Investigational Site#10
Almirall Investigational Sites#5
Almirall Investigational Sites#18
Almirall Investigational Sites#15
Almirall Investigational Sites#14
Almirall Investigational Sites#16
Almirall Investigational Sites#21
Almirall Investigational Sites#6


title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

ReferenceCitation: Price T, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Guan X, Peeters M. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016 Nov;68:51-59. doi: 10.1016/j.ejca.2016.08.010. Epub 2016 Oct 5.

ReferenceCitation: Price TJ, Peeters M, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Zhang K, Murugappan S, Sidhu R. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14.

ReferenceCitation: Kim TW, Peeters M, Thomas A, Gibbs P, Hool K, Zhang J, Ang AL, Bach BA, Price T. Impact of Emergent Circulating Tumor DNA RAS Mutation in Panitumumab-Treated Chemoresistant Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Nov 15;24(22):5602-5609. doi: 10.1158/1078-0432.CCR-17-3377. Epub 2018 Jun 13.

ReferenceCitation: Peeters M, Price T, Boedigheimer M, Kim TW, Ruff P, Gibbs P, Thomas A, Demonty G, Hool K, Ang A. Evaluation of Emergent Mutations in Circulating Cell-Free DNA and Clinical Outcomes in Patients with Metastatic Colorectal Cancer Treated with Panitumumab in the ASPECCT Study. Clin Cancer Res. 2019 Feb 15;25(4):1216-1225. doi: 10.1158/1078-0432.CCR-18-2072. Epub 2018 Nov 28.

ReferenceCitation: Price T, Ang A, Boedigheimer M, Kim TW, Li J, Cascinu S, Ruff P, Satya Suresh A, Thomas A, Tjulandin S, Peeters M. Frequency of S492R mutations in the epidermal growth factor receptor: analysis of plasma DNA from patients with metastatic colorectal cancer treated with panitumumab or cetuximab monotherapy. Cancer Biol Ther. 2020 Oct 2;21(10):891-898. doi: 10.1080/15384047.2020.1798695. Epub 2020 Oct 7.

ReferenceCitation: Taniguchi H, Yamanaka T, Sakai D, Muro K, Yamazaki K, Nakata S, Kimura H, Ruff P, Kim TW, Peeters M, Price T. Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G. Cancers (Basel). 2020 Jun 28;12(7). pii: E1715. doi: 10.3390/cancers12071715.

ReferenceCitation: Graham CN, Maglinte GA, Schwartzberg LS, Price TJ, Knox HN, Hechmati G, Hjelmgren J, Barber B, Fakih MG. Economic Analysis of Panitumumab Compared With Cetuximab in Patients With Wild-type KRAS Metastatic Colorectal Cancer That Progressed After Standard Chemotherapy. Clin Ther. 2016 Jun;38(6):1376-1391. doi: 10.1016/j.clinthera.2016.03.023. Epub 2016 Apr 13.

location_country:
Serbia
United Kingdom
Italy
Lithuania
United States
Peru
Romania
Philippines
Belgium
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
India
Israel
Malaysia
Singapore
Sweden
Slovakia
Canada
China
Bulgaria
Taiwan
Latvia
Korea, Republic of
France
Netherlands

summary: The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

acronym: DREAM

summary: The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

ReferenceCitation: Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, Ortega H, Chanez P. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. [Lancet]. 2012;380(August 18, 2012):

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Review.

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

ReferenceCitation: Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.

ReferenceCitation: Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.

ReferenceCitation: Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
United Kingdom
Russian Federation
Australia
Argentina
Canada
Ukraine
Korea, Republic of
United States
Chile
France
Romania
Germany


title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

lead_sponsor: Bial - Portela C S.A.

ReferenceCitation: Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Józwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
Romania
Philippines
Czechia
Poland
Portugal
Austria
Russian Federation
Malaysia
Slovakia
Bosnia and Herzegovina
Hungary
Germany
Moldova, Republic of
Taiwan
France

location_facility: Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"

location_facility: Tempus, s.r.o.Child Epileptology Ambulance

location_facility: Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù

location_facility: Taipei Veterans General Hospital - Department of Paediatrics

location_facility: Hospital Raja Perempuan Zainab II - Jabatan Paediatrik

location_facility: Department of Paediatric, Clarendon Wing, Leeds General Infirmary

location_facility: Children Neurology Clinic, University Hospital Motol

location_facility: Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department

location_facility: Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz

location_facility: Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center

location_facility: Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic

location_facility: IMSP Centrul National Stiintifico-Practic Medicina de Urgenta

location_facility: Clinical hospital Osjek Pediatric clinic, neuropediatric department

location_facility: Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie

location_facility: Hospital Sant Joan de Déu, Dep. Neuropediatría

location_facility: Pécsi Tudományegyetem AOK Gyermekklinika

location_facility: Clinical Hospital for children, Paediatric Neurology clinic

location_facility: Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department

location_facility: National Taiwan University Hospital - Department of Paediatrics

location_facility: Hospital pediatrics of Odessa State Medical University Odessa

location_facility: Hospital Clínico San Carlos, Servicio de Neurología Pediátrica

location_facility: Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1

location_facility: A.O.U. di Cagliari Clinica di neurologia infantile

location_facility: Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.

location_facility: Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg

location_facility: Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Manila Doctors Hospital - Child Nueroscience Center

location_facility: Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii

location_facility: Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie

location_facility: Pediatric Scientific-practical Center of cranio-facial surgery and neurology

location_facility: Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti

location_facility: Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria

location_facility: Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

location_facility: Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche

location_facility: Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"

location_facility: Clinical Centre Banja Luka Pediatric Clinic Department of Neurology

location_facility: Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina

location_facility: WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE

location_facility: Child Neurology Clinic of the DNsP Ostrava

location_facility: Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1

location_facility: Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma

location_facility: Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien

location_facility: Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital

location_facility: IMAS Hospital del Mar - Servicio de Pediatria

location_facility: Research Center of Children Health of RAMS

location_facility: AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego

location_facility: Hospital Materno Infantil Virgen de las Nieves

location_facility: University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences

location_facility: Clinic of Neurology and Psychiatry for Children and Youth

location_facility: SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 6 ŚLĄSKIEJ AKADEMII MEDYCZNEJ W KATOWICACH GÓRNOŚLĄSKIE CENTRUM ZDROWIA DZIECKA I MATKI IM. JANA PAWŁA II Klinika Pediatrii i Neurologii Wieku Rozwojowego

location_facility: Hospital Son Dureta, Dep. Neuropediatría

summary: The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.


title: A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury

acronym: EPO-TBI

summary: This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

ReferenceCitation: Skrifvars MB, Bailey M, Moore E, Martensson J, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi YM, McArthur C, Cooper DJ, Bendel S, Bellomo R; Erythropoietin in Traumatic Brain Injury (EPO-TBI) Investigators and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group. A Post Hoc Analysis of Osmotherapy Use in the Erythropoietin in Traumatic Brain Injury Study-Associations With Acute Kidney Injury and Mortality. Crit Care Med. 2021 Apr 1;49(4):e394-e403. doi: 10.1097/CCM.0000000000004853.

ReferenceCitation: Skrifvars MB, Moore E, Mårtensson J, Bailey M, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi Y, McArthur C, Cooper DJ, Bellomo R; EPO-TBI Investigators and the ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury associated acute kidney injury: A randomized controlled trial. Acta Anaesthesiol Scand. 2019 Feb;63(2):200-207. doi: 10.1111/aas.13244. Epub 2018 Aug 21.

ReferenceCitation: Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettilä V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.

ReferenceCitation: Nichol A, French C, Little L, Presneill J, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial. Trials. 2015 Feb 8;16:39. doi: 10.1186/s13063-014-0528-6.

ReferenceCitation: Presneill J, Little L, Nichol A, French C, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury. Trials. 2014 Dec 20;15:501. doi: 10.1186/1745-6215-15-501.

ReferenceCitation: Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. Review.

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

location_country:
Saudi Arabia
Ireland
Australia
New Zealand
Finland
France
Germany

location_facility:
CHU de Rouen
Royal Hobart Hospital
Gold Coast University Hospital
The Townsville Hospital
Canberra Hospital
King Fahad National Guard Hospital
Auckland City Hospital
John Hunter Hospital
Westmead Hospital
Hôpital universitaire Caremeau
Royal Perth Hospital
Christchurch Hospital
The Royal Melbourne Hospital
Johannes Gutenberg-Universtität
Dunedin Hospital
Royal Adelaide Hosptial
Liverpool Hospital
Royal North Shore Hospital
Helsinki University Central Hospital
Royal Prince Alfred Hospital
Hôpital Lariboisière
Hôpital de Bicêtre
Kuopio University Hospital
Beaumont Hospital
Hôpital Michallon
The Alfred Hospital
Wellington Regional Hospital
St Vincent's Hospital Sydney


title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

enrollment_type: Anticipated

ReferenceCitation: Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

lead_sponsor: Novartis

location_country: Spain Italy Australia Finland Canada France Japan Germany

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Quebec Memory & Motor Skills Disorders Clinic