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Clinical trials for Declaration of Helsinki

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    31 result(s) found for: Declaration of Helsinki. Displaying page 1 of 2.
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    EudraCT Number: 2009-016077-14 Sponsor Protocol Number: RALF1 Start Date*: 2010-11-11
    Sponsor Name:Mika Lehto
    Full Title: Role of ALiskiren, a direct renin inhibitor, in preventing atrial Fibrillation in patients with a pacemaker; RALF Eteisvärinäkuorman määritys sydämentahdistimella aliskireenihoidossa
    Medical condition: Patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10067824 Prophylaxis against atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001784-88 Sponsor Protocol Number: WHO-FIN-COVID-19 Start Date*: 2020-04-29
    Sponsor Name:University of Helsinki
    Full Title: WHO SOLIDARITY Finland: The multicenter trial on the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients (COVID-19)
    Medical condition: SARS-COV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10037373 Pulmonary disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000528-17 Sponsor Protocol Number: IAEA-HypoX Start Date*: 2012-06-05
    Sponsor Name:Department of Experimental Clinical Oncology
    Full Title: A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neck
    Medical condition: Squamous Cell Carcinoma of the Head and Neck region
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed) EE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002369-36 Sponsor Protocol Number: GECP19/01 Start Date*: 2020-04-18
    Sponsor Name:Fundación GECP
    Full Title: Clinical Utility of Liquid Biopsy as a tool to assess the evolution of brigatinib treated patients with non-small cell lung cancer with EML4-ALK translocation: an exploratory study
    Medical condition: ALK+ non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004886-42 Sponsor Protocol Number: TRA114389 Start Date*: 2013-04-01
    Sponsor Name:University of Crete
    Full Title: Study of the effect of the thrombopoietin receptor agonist eltrombopag on thrombocytopenia and megakaryopoiesis of patients with lower and intermediate-1 risk myelodysplastic syndromes.
    Medical condition: Patients with lower and intermediate-1 risk myelodysplastic syndromes.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004515-45 Sponsor Protocol Number: GECP18/02 Start Date*: 2019-04-02
    Sponsor Name:Fundación GECP
    Full Title: A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemotherapy alone for the treatment of locally advanced and potentially resectable non-small cell lung cancer (NSCLC) patients
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011790-32 Sponsor Protocol Number: 09.0111p Start Date*: 2010-03-18
    Sponsor Name:Isala Klinieken Department Cardiology
    Full Title: Catheter ablation versus Amiodarone to prevent future shock episodes in patients with a defibrillator and a history of a myocardial infarction.
    Medical condition: The main objective of this study is to compare the occurrence of next ICD shock therapy for VT or VF in patients with hospital presentation for an ICD shock therapy for VT or VF, with a history of ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003958-25 Sponsor Protocol Number: PI18/01097 Start Date*: 2019-10-25
    Sponsor Name:Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
    Full Title: Screening for cancer with PET / CT in patients with unprovoked venous thromboembolic disease with a high risk of developing cancer. Open randomized clinical trial.
    Medical condition: Venous thromboembolic disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-005965-20 Sponsor Protocol Number: ML20938 Start Date*: 2007-03-07
    Sponsor Name:Roche AB
    Full Title: EFFECTS OF THREE TREATMENT STRATEGIES ON ANEMIA AND QUALITY OF LIFE IN PATIENTS WITH SOLID TUMORS OR LYMPHOPROLIFERATIVE MALIGNANCIES: A RANDOMIZED 3-ARM STUDY ON ACTIVE (A) OR CONVENTIONAL (C) TRA...
    Medical condition: Anemia in patients with cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-019126-13 Sponsor Protocol Number: CE-US Start Date*: 2011-03-04
    Sponsor Name:IST. DI RICERCHE FARMACOLOG. M. NEGRI
    Full Title: A PILOT, EXPLORATIVE STUDY TO IDENTIFY CONTRAST-ENHANCED ULTRASOUND (CE-US) PATTERNS THAT CHARACTERIZE ACUTE ALLOGRAFT REJECTION AND OTHER CAUSES OF ACUTE ALLOGRAFT DYSFUNCTION IN RENAL TRANSPLANT ...
    Medical condition: Renal transplant
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10023438 Kidney transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024230-35 Sponsor Protocol Number: EMABRHIP Start Date*: 2012-04-25
    Sponsor Name:Fundacion par la investigación biomédica del Hospital Universitario La Paz
    Full Title: Effectiveness of hipertonic saline serum 3% nebulized in bronchiolitis
    Medical condition: Bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10000688 Acute bronchitis and bronchiolitis LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004552-64 Sponsor Protocol Number: 131016 Start Date*: 2017-07-03
    Sponsor Name:Center for Digestive Diseases, Karolinska University Hospital
    Full Title: MISTRAL - Mistletoe therapy in primary and recurrent inoperable pancreatic cancer - A phase III prospective, randomized, double blinded, multicenter, parallel group, placebo controlled clinical tr...
    Medical condition: Primary or recurrent inoperable pancreatic cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002620-17 Sponsor Protocol Number: 18-513 Start Date*: 2019-01-08
    Sponsor Name:Portola Pharmaceuticals, Inc
    Full Title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
    Medical condition: Oral FXa inhibitor-treated patients with acute intracranial bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) GR (Completed) CZ (Completed) LV (Completed) FI (Prematurely Ended) NO (Prematurely Ended) LT (Prematurely Ended) PL (Completed) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000182-38 Sponsor Protocol Number: ACYCLOVIR LP 01/06 Start Date*: 2007-07-26
    Sponsor Name:MIPHARM
    Full Title: EFFICACY AND SAFETY OF A NEW TOPICAL FORMULATION OF ACYCLOVIR GEL (LP) IN THE TREATMENT OF HERPES SIMPLEX LABIALIS A RANDOMIZED, Single-BLIND, MULTICENTER, CONTROLLED CLINICAL TRIAL ve...
    Medical condition: Subjects with a clinical diagnosis of Herpes Simplex Labialis on the perioral area.
    Disease: Version SOC Term Classification Code Term Level
    6.1 10019948 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-000213-19 Sponsor Protocol Number: 99824 Start Date*: 2005-03-08
    Sponsor Name:Lundbeck SA
    Full Title: Sertindole versus risperidone safety outcome study: A randomised, partially-blinded, parallel-group, active-controlled, post-marketing study
    Medical condition: Schizophrenic patients most recently treated with antipsychotics other than sertindole or risperidone, requiring a new prescription for an antipsychotic, and without any contraindications for eithe...
    Disease: Version SOC Term Classification Code Term Level
    7 10037175 Psyc
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2014-002248-42 Sponsor Protocol Number: JMC-2014-6TG/6MP Start Date*: 2014-10-22
    Sponsor Name:Bonkolab, Rigshospitalet
    Full Title: The TEAM Study (Thiopurine EnhAnced Maintenance therapy) A Phase 1-2 Study of 6-Thioguanine in Combination with Methotrexate and 6-Mercaptopurine During Maintenance Therapy of Childhood, Adolesce...
    Medical condition: Acute Lymphoblastic Leukemia Lymphoblastic Non-Hodgkin’s Lymphoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2018-004654-17 Sponsor Protocol Number: GECP18/03 Start Date*: 2019-04-02
    Sponsor Name:Fundación GECP
    Full Title: A phase II open-label study of Atezolizumab in combination with bevacizumab as first line treatment for locally advanced or metastatic high-intermediate tumour mutation burden (TMB) selected non-sq...
    Medical condition: Non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005517-20 Sponsor Protocol Number: IRST 100 01 Start Date*: 2008-01-10
    Sponsor Name:ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
    Full Title: Receptor radionuclide therapy with [177Lu- DOTA]0,Tyr3-octreotate (177Lu-DOTATATE): a phase II trial.
    Medical condition: cancer patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028980 Neoplasm LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000875-28 Sponsor Protocol Number: Start Date*: 2016-08-19
    Sponsor Name:NHS Blood & Transplant
    Full Title: A multi-centre, randomised, double blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage. E-FIT 1 Study
    Medical condition: Trauma patients whereby the local major haemorrhage protocol has been activated
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004863 10044461 Trauma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004902-67 Sponsor Protocol Number: GECP20/09 Start Date*: 2021-08-30
    Sponsor Name:Fundación GECP
    Full Title: A phase II single arm clinical trial assessing the efficacy and safety of BIntrafusp alfa (M7824) in previously treated advanced malignant pleural MESothelioma (BIMES).
    Medical condition: Advanced malignant pleural mesothelioma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10035605 Pleural mesothelioma malignant advanced LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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