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Clinical trials for Observational study

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    409 result(s) found for: Observational study. Displaying page 6 of 21.
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    EudraCT Number: 2014-002317-32 Sponsor Protocol Number: SOFOLT-2 Start Date*: 2014-10-29
    Sponsor Name:Azienda Ospedaliera Papa Giovanni XXIII [...]
    1. Azienda Ospedaliera Papa Giovanni XXIII
    2. AISF (Associazione Italiana per lo Studio del Fegato)
    Full Title: An Open-Label Study to Explore the Clinical Efficacy of GS 7977 (Sofosbuvir -Sovaldi®) with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infe...
    Medical condition: HCV active infection at the time of OLT
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004674-42 Sponsor Protocol Number: GS-US-334-1113 Start Date*: 2015-11-20
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003401-26 Sponsor Protocol Number: 400-12-006 Start Date*: 2014-05-16
    Sponsor Name:Ethicon Inc.
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery in Pediatric P...
    Medical condition: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002957-46 Sponsor Protocol Number: 56021927PCR3015 Start Date*: 2020-05-13
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Controlled, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with Hormone-Sensitive Pr...
    Medical condition: High risk recurrent prostate cancer previously treated with radical prostatectomy
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036911 Prostate cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Trial now transitioned) CZ (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) HU (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000452-34 Sponsor Protocol Number: 3004 Start Date*: 2013-11-19
    Sponsor Name:Steno Diabetes Center
    Full Title: Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria
    Medical condition: Patients with type 2 diabetes mellitus and normoalbuminuria
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) IT (Completed) GB (Completed) NL (Completed) ES (Completed) CZ (Completed) GR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002201-25 Sponsor Protocol Number: CHDR2007 Start Date*: 2020-12-14
    Sponsor Name:Centre for Human Drug Research
    Full Title: A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers
    Medical condition: lichen sclerosus, vulvar (pre)malignancies
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-001957-17 Sponsor Protocol Number: DFNS02 Start Date*: 2015-10-21
    Sponsor Name:Umeå University Hospital
    Full Title: THE EFFECT OF DIFLUNISAL ON FAMILIAL TRANSTHYRETIN AMYLOIDOSIS: An open label phase III extension study of the diflunisal trials (IND 68092 and DFNS01), and an open label observational study on p...
    Medical condition: Familial transthyretin amyloidosis complicated by cardiomyopathy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10019893 Hereditary neuropathic amyloidosis, Swedish type LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001505-22 Sponsor Protocol Number: BST-COVID-01 Start Date*: 2020-04-23
    Sponsor Name:Banc de Sang i Teixits
    Full Title: Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safetyof two doses of WJ-MSC ...
    Medical condition: Acute respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000157-41 Sponsor Protocol Number: UoL001343 Start Date*: 2019-06-07
    Sponsor Name:The University of Liverpool
    Full Title: NEO21-RS: A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadj...
    Medical condition: ER-positive, HER2-negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-005722-35 Sponsor Protocol Number: H--6-2014-070 Start Date*: 2015-06-23
    Sponsor Name:Glostrup University Hospital
    Full Title: Measures of inflammation in low back pain (LBP) and anti-TNFα for the treatment of deemed discogenic LBP - an explorative study
    Medical condition: Low back pain with and without legg-pain In the late periode 1990ies it became clear that various cytokines and other inflammatory elements played a large role for low back pain. One of the known ...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10024891 Low back pain LLT
    18.0 100000004859 10024892 Low back pain (without radiation) LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004110-20 Sponsor Protocol Number: 78666 Start Date*: 2022-10-12
    Sponsor Name:Leiden University Medical Center
    Full Title: Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded, placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG)
    Medical condition: Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004852 10085562 AChR myasthenia gravis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002539-13 Sponsor Protocol Number: CARE-ROP Start Date*: 2014-04-01
    Sponsor Name:University Medical Center Freiburg
    Full Title: Multicenter randomized double masked parallel design exploratory study to assess safety and efficacy of two different doses of intravitreal anti-VEGF treatment with ranibizumab (0.12 mg vs. 0.20 mg...
    Medical condition: retinopathy of prematurity
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10038974 Retrolental fibroplasia LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019102-17 Sponsor Protocol Number: Y-55-52120-147 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: A PHASE III, PROSPECTIVE, MULTICENTRE, OPEN LABEL, EXTENSION STUDY ASSESSING THE LONG TERM SAFETY AND EFFICACY OF REPEATED TREATMENT WITH DYSPORT USED IN THE TREATMENT OF LOWER LIMB SPASTICITY IN C...
    Medical condition: Lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    12.1 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003589-42 Sponsor Protocol Number: SP848-AKEx-1209 Start Date*: 2013-01-16
    Sponsor Name:Spirig Pharma AG
    Full Title: Observational (non-interventional), follow-up trial assessing long-term local tolerability and efficacy (recurrence rate) of resiquimod gel in patients treated for actinic keratosis.
    Medical condition: Actinic Keratosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-000341-13 Sponsor Protocol Number: OTV.PRE.01 Start Date*: 2012-08-28
    Sponsor Name:Weber & Weber GmbH & Co. KG
    Full Title: Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Grou...
    Medical condition: recurrent acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10033078 Otitis media PT
    16.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023988-17 Sponsor Protocol Number: 260777 Start Date*: 2014-04-04
    Sponsor Name:BrepCo Biopharma Limited
    Full Title: Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn
    Medical condition: Low Blood Pressure
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10024895 Low blood pressure LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) CZ (Prematurely Ended) BE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-022284-35 Sponsor Protocol Number: R00002 CR 301 (ORF) Start Date*: 2011-03-08
    Sponsor Name:ORFAGEN
    Full Title: CLINICAL EFFICACY AND SAFETY OF TAZAROTENE CREAM 0.05% IN THE INITIAL AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)
    Medical condition: Lamellar Ichthyosis (LI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10023686 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SE (Completed) DE (Completed) FR (Ongoing) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021070-11 Sponsor Protocol Number: 005/05E Start Date*: 2010-11-23
    Sponsor Name:BioVex Inc
    Full Title: An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEX GM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05
    Medical condition: Unresectable Stage IIIb, IIIc and IV Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018370-21 Sponsor Protocol Number: C-II-007 Start Date*: 2010-05-27
    Sponsor Name:CESAR Central European Society for Anticancer Drug Research EWIV
    Full Title: Phase I/II study with Temsirolimus versus no add-on in patients with castration resistant prostate cancer (CRPC) receiving first-line Docetaxel chemotherapy CESAR Study in Prostrate Cancer wi...
    Medical condition: castration resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004753-87 Sponsor Protocol Number: BBI608-901 Start Date*: 2020-03-18
    Sponsor Name:Sumitomo Dainippon Pharma Oncology, Inc.
    Full Title: A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Sumitomo Dainippon Pharma Oncology, Inc. sponsored Napabucasin Protocols
    Medical condition: Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    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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