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Clinical trials for Adverse outcome

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   44336   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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    2,287 result(s) found for: Adverse outcome. Displaying page 1 of 115.
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    EudraCT Number: 2024-000502-15 Sponsor Protocol Number: mRNA-1345-P202 Start Date*: 2024-12-05
    Sponsor Name:ModernaTX, Inc.
    Full Title: A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Year...
    Medical condition: Respiratory Syncytial Virus
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-001974-14 Sponsor Protocol Number: CCD-050000-01 Start Date*: 2023-08-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant a...
    Medical condition: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002768-28 Sponsor Protocol Number: W-5222-301 Start Date*: 2022-01-04
    Sponsor Name:Wockhardt Bio AG
    Full Title: A Phase 3, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection...
    Medical condition: Complicated urinary tract infection or acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10021881 - Infections and infestations 10080628 Complicated urinary tract infection LLT
    20.1 10021881 - Infections and infestations 10001032 Acute pyelonephritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) BG (Completed) PL (Completed) EE (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005888-31 Sponsor Protocol Number: EHVA_P01/ANRS_VRI08 Start Date*: 2022-10-20
    Sponsor Name:Inserm-ANRS
    Full Title: A phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.
    Medical condition: it's a Phase 1-2 preventive , prophilactic HIV vaccine trial. Vaccine target are healthy subjects aged from 18 to 55 years old. Safety and the immunogenicity of DREP-HIV-PT1 vaccine will be evaluat...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10054925 Prophylaxis against HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004588-11 Sponsor Protocol Number: ABR64005 Start Date*: 2019-09-10
    Sponsor Name:University Maastricht
    Full Title: Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease.
    Medical condition: The chronic inflammatory bowel disease Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001117-86 Sponsor Protocol Number: 16/0340 Start Date*: 2017-07-25
    Sponsor Name:University College London
    Full Title: A phase IV, prospective, randomised single-blind UK multicentre non-inferiority trial of low-dose versus standard dose rituximab for prevention of relapses in acquired TTP
    Medical condition: Acquired thrombotic thrombocytopenic purpura
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-003987-37 Sponsor Protocol Number: 2019-001G Start Date*: 2020-02-26
    Sponsor Name:University Medical Centre Ljubljana, Department of gastroenterology
    Full Title: Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens
    Medical condition: Ulcerative colitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001723-13 Sponsor Protocol Number: 405 Start Date*: 2020-04-17
    Sponsor Name:GROUPE HOSPITALIER PARIS SAINT-JOSEPH
    Full Title: A randomized trial of efficacy and safety of an early OUTpatient treatment of COVID-19 in patients with risk factor for poor outcome : a strategy to prevent hospitalization : OUTCOV Study
    Medical condition: COVID-19 patients with risk factor for poor outcome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003666-41 Sponsor Protocol Number: MEC2020-0078 Start Date*: 2020-04-21
    Sponsor Name:Erasmus MC University Medical Center
    Full Title: Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial.
    Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077323 Infantile mixed apnea LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001069-35 Sponsor Protocol Number: IIBSP-EDA-2020-18 Start Date*: 2021-07-06
    Sponsor Name:Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau
    Full Title: Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF): a Randomized Study.
    Medical condition: Cumulative live-birth rate.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004913-11 Sponsor Protocol Number: 111075 Start Date*: 2021-02-18
    Sponsor Name:Radboudumc
    Full Title: genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease’
    Medical condition: Symptomatic or stable pheripheral artery disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003127-38 Sponsor Protocol Number: NL71001.029.19 Start Date*: 2020-04-09
    Sponsor Name:VUmc Neurology Department
    Full Title: Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial.
    Medical condition: Multiple sclerosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002560-73 Sponsor Protocol Number: SWITCH_ON Start Date*: 2022-09-01
    Sponsor Name:Erasmus MC
    Full Title: SWITCH ON: Analysing the immunogenicity of additional booster vaccinations in healthcare workers.
    Medical condition: To study the necessity to boost healthcare workers (which arre representative for the dutch population) with a COVID vaccin by measuring the immunogenicity at 7 days and 28 days..
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002256-25 Sponsor Protocol Number: HYPATIA Start Date*: 2018-03-09
    Sponsor Name:Guy's and St Thomas' NHS Foundation Trust
    Full Title: HYPATIA: A prospective randomised controlled trial of HYdroxychloroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies
    Medical condition: Pregnant women with antiphospholipid antibodies
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10048678 Antiphospholipid antibodies positive PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005721-43 Sponsor Protocol Number: D4280C00002 Start Date*: 2012-05-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly C...
    Medical condition: Complicated Urinary Tract Infections (cUTIs)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) BG (Completed) DE (Completed) CZ (Completed) SK (Completed) PT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-004505-16 Sponsor Protocol Number: CONVINCE Start Date*: 2016-08-08
    Sponsor Name:University College Dublin
    Full Title: CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicine for secondary prevention after stroke
    Medical condition: The prevention of recurrent stroke and coronary events (fatal and non- fatal) after ischaemic stroke and transient ischaemic attack (TIA) not caused by cardiac embolism or other causes unrelated to...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10044376 Transient cerebrovascular events HLT
    20.0 100000004866 10008205 Cerebrovascular embolism and thrombosis HLT
    22.1 10029205 - Nervous system disorders 10023027 Ischaemic stroke NOS LLT
    21.1 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    20.0 10029205 - Nervous system disorders 10007962 Central nervous system vascular disorders NEC HLT
    20.0 10029205 - Nervous system disorders 10007963 Central nervous system vascular disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) DK (Completed) PT (Completed) BE (Completed) LT (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004555-79 Sponsor Protocol Number: 16-115 Start Date*: 2017-08-08
    Sponsor Name:RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
    Full Title: Impact of preoperative midazolam on outcome of elderly patients: a multicenter randomised controlled trial
    Medical condition: Under investigation are elderly patients (≥65 years of age) undergoing each kind of surgery with planned general or combined regional and general anaesthesia. Primary, we will investigate the posto...
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-006162-33 Sponsor Protocol Number: ML 19835 Start Date*: 2006-07-03
    Sponsor Name:ROCHE
    Full Title: Relationships between pharmacokinetic and pharmacodynamic strategies for assessment of the risks for acute rejection and side effects of mofetil mycophenolate
    Medical condition: Kidney transplantation
    Disease: Version SOC Term Classification Code Term Level
    6.1 10023439 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004630-26 Sponsor Protocol Number: EFC6133,HMR3647B/3004 Start Date*: 2015-03-17
    Sponsor Name:Sanofi-aventis
    Full Title: Multinational, Randomized, Double-Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 10 Days Penicillin V 13.3 mg/kg Tid in Childre...
    Medical condition: Tonsillitis Pharyngitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10049140 Pharyngotonsillitis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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