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Clinical trials for Data Monitoring Committee

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   44334   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    187 result(s) found for: Data Monitoring Committee. Displaying page 1 of 10.
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    EudraCT Number: 2006-002962-20 Sponsor Protocol Number: TMD01/2007 Start Date*: 2007-03-15
    Sponsor Name:Hannover Medical School
    Full Title: Elimination of the preleukemic clone in children with Down syndrome and transient myeloproloferative disorder (TMD) to prevent AML - Model of leukemia prevention
    Medical condition: Preleukemic clones have been frequently detected in newborns. The transient myeloproliferative disorder (TMD) represents a preleukemic clone. More than 20% of the patients developed acute megakaryo...
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-003556-39 Sponsor Protocol Number: DARINA Start Date*: 2012-06-05
    Sponsor Name:Martini Hospital Groningen
    Full Title: A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA
    Medical condition: After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for pre...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000160-28 Sponsor Protocol Number: HTA 03/09/01 Start Date*: 2004-11-12
    Sponsor Name:Department of Health
    Full Title: Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial.
    Medical condition: Fever of early childhood
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-000673-24 Sponsor Protocol Number: PHRC_N_2018_BAY Start Date*: 2021-04-15
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: Faecal microbiota transplantation for prevention of graft-versus-host sisease after allogeneic stem cell transplantation for haematological malignancies
    Medical condition: Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies. Faecal microbiota transplantation (FMT) will be assessed to prevent al...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003438-17 Sponsor Protocol Number: 05/Q1606/143 Start Date*: 2005-11-07
    Sponsor Name:Oxford Radcliffe Hospitals NHS Trust
    Full Title: SimSepT: Simvastatin and severe sepsis in the ICU
    Medical condition: Severe sepsis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005792-25 Sponsor Protocol Number: R04341 Start Date*: 2017-12-22
    Sponsor Name:Manchester University NHS Foundation Trust
    Full Title: Feasibility study on the effects of L-citrulline on uteroplacental and cardiovascular function in hypertensive pregnant women
    Medical condition: The medical condition that is to be investigated in this study is essential hypertension in pregnant women. In this study it is defined as diastolic BP of ≥90 mmHg (average of two clinic readings) ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10014129 Eclampsia PT
    20.0 10047065 - Vascular disorders 10020772 Hypertension PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002904-13 Sponsor Protocol Number: 0019 Start Date*: 2006-11-01
    Sponsor Name:Theravance, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infec...
    Medical condition: Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus
    Disease: Version SOC Term Classification Code Term Level
    6.1 10052596 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) ES (Completed) SI (Completed) SK (Completed) LT (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000663-45 Sponsor Protocol Number: PREVENT-iT-2021.07 Start Date*: 2023-02-01
    Sponsor Name:Hamilton Health Sciences Corporation
    Full Title: Prospective Randomized Evaluation of Emerging Novel Treatments for Infection prophylaxis in Total Joint Replacement (PREVENT-iT): A Pilot Study
    Medical condition: Persistent Draining Wound and Periprosthetic Joint Infection prevention in patients undergoing total joint replacement
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-003606-33 Sponsor Protocol Number: PK 2008 03 Start Date*: 2009-01-15
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Pilot study to investigate the feasibility of 13-cis-Retinoic acid pharmacokinetic monitoring in high-risk neuroblastoma
    Medical condition: High risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029260 Neuroblastoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015626-11 Sponsor Protocol Number: 006983 QM Start Date*: 2010-02-22
    Sponsor Name:Queen Mary University London
    Full Title: Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype.
    Medical condition: Preschool wheeze
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-005137-32 Sponsor Protocol Number: 14-097 Start Date*: 2016-10-12
    Sponsor Name:ENCELADUS Pharmaceuticals BV
    Full Title: A Phase I-IIa, Open label, Multi-Center, Dose Escalating Study to Evaluate the Safety of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate (Oncocort) as Monotherapy in Patients with Pr...
    Medical condition: Multiple Myeloma is a plasma cell malignancy that is characterized by accumulation of clonal plasma cells, mainly in the bone marrow, leading to clinical manifestations such as anemia, bone destruc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-002902-31 Sponsor Protocol Number: 0015 Start Date*: 2005-11-09
    Sponsor Name:Theravance, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infec...
    Medical condition: Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) BE (Completed) DE (Completed) MT (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019218-26 Sponsor Protocol Number: ANA-ALS01 Start Date*: 2010-12-06
    Sponsor Name:Charité - University Hospital of Berlin
    Full Title: Offene Verträglichkeitsstudie zur Evaluierung einer subkutanen Injektionslösung von 100 mg Anakinra in Kombination mit Riluzol bei Patienten mit Amyotropher Lateralsklerose (ALS).
    Medical condition: Amyotophic lateral sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011525-13 Sponsor Protocol Number: V001 Start Date*: 2009-08-28
    Sponsor Name:Vernalis (R&D) Limited
    Full Title: Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients attending a Specialist Clinic
    Medical condition: Treatment resistant and Idiopathic Chronic Cough
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066656 Chronic cough LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004826-12 Sponsor Protocol Number: MAP4B-safety Start Date*: 2021-07-27
    Sponsor Name:Association of Dutch Burn Centres
    Full Title: Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients
    Medical condition: Severe Burns
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002751-25 Sponsor Protocol Number: RG112-14 Start Date*: 2014-10-08
    Sponsor Name:The Walton Centre NHS Foundation Trust
    Full Title: Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular ...
    Medical condition: Chronic radicular pain secondary to a prolapsed intervertebral disc herniation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10039674 Sciatica PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-023409-37 Sponsor Protocol Number: AMLSG_15-10 Start Date*: 2011-03-02
    Sponsor Name:University Hospital Ulm
    Full Title: Randomized Phase III Study of Low-Dose Cytarabine and Etoposide with or without All-Trans Retinoic Acid in Older Patients not Eligible for Intensive Chemotherapy with Acute Myeloid Leukemia and NPM...
    Medical condition: Adult patients (>60) with AML and NPM1 mutation ineligible for intensive chemotherapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-003669-14 Sponsor Protocol Number: ISRCTN15088122 Start Date*: 2012-12-03
    Sponsor Name:London School Of Hygiene and Tropical Medicine
    Full Title: Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial.
    Medical condition: Traumatic Brain Injury
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10060690 Traumatic brain injury LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) IT (Completed) IE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2020-004628-40 Sponsor Protocol Number: MRX-801 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc
    Full Title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis ...
    Medical condition: Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004449-40 Sponsor Protocol Number: BAY 59-7939/11898 Start Date*: 2007-02-02
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with...
    Medical condition: Acute Coronary Syndrome
    Disease: Version SOC Term Classification Code Term Level
    8.1 10051592 Acute coronary syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) HU (Completed) BE (Completed) NL (Completed) DK (Completed) CZ (Completed) SE (Completed) SK (Completed) GB (Completed) BG (Completed) FI (Completed) IT (Completed) ES (Completed)
    Trial results: View results
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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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