[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Franciscus Gasthuis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":180},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,72,93,125,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100581055","promoting-optimal-treatment-choices-in-neonates-with-suspected-early-onset-sepsis-100581055",false,"NCT06845332","Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis","PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis","PrOTeCt-NEO","Inclusion Criteria:\n\n* Neonates born at 34 weeks of gestation or later\n* 0-3 days old\n\nExclusion Criteria:\n\n* stillborn neonates","ALL","3 Days",{"count":20,"type":21},55000,"ESTIMATED","OBSERVATIONAL","In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral switch therapy. These strategies have been proven to be effective and safe and are already applied in several Dutch hospitals. However, this is not the case for all hospitals, leading to significant variations in clinical practice. To facilitate the translation of evidence into practice, active implementation will take place.\n\nThe primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. The aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the EOS calculator, PCT-guided therapy and iv-to-oral switch therapy) in Dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies.\n\nA combination of qualitative and quantitative research methods will be used to assess outcomes. Quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the Business Intelligence units of participating hospitals and anonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.",[25],"Early-onset Sepsis",[27,28,29,30,31,32],"early-onset sepsis","neonatal sepsis","early-onset sepsis calculator","PCT-guided therapy","iv-to-oral switch therapy","implementation","RECRUITING","2025-09-18",{"date":36,"type":37},"2025-09-19","ACTUAL",{"date":39,"type":37},"2024-01-01",{"date":41,"type":21},"2026-06-01",{"name":43,"class":44},"Franciscus Gasthuis","OTHER",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100522553","high-flow-nasal-oxygen-for-exacerbation-copd-100522553","NCT06084117","High Flow Nasal Oxygen for Exacerbation COPD","High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease","HiCAP","Inclusion Criteria:\n\n* Known chronic obstructive pulmonary disease\n* Acute hypercapnic exacerbation of this condition, defined as: PaCO2\\>45 mmHg or \\>6.0 kPa and pH 7.20-7.35\n* Age \\>40 years\n\nExclusion Criteria:\n\n* Asthma\n* Immediate need for intubation, based on clinical judgement of the attending physician.\n* Impossibility to apply either one of the two interventions\n* Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).\n* Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).\n* Impeding death\n* Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.\n* Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication\n* Tracheostomized patients\n* Participation in other interventional trials\n* Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care \u002F high dependency unit, depending on local infrastructure).\n* Previous explicit (or written) objection to participation in research - bicarbonate \\\u003C20 mmol\u002FL","40 Years",{"count":56,"type":21},40,"INTERVENTIONAL",[59],"NA","In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated",[62],"Acute Exacerbation of COPD","2025-08-20",{"date":65,"type":37},"2025-08-21",{"date":67,"type":37},"2024-05-14",{"date":69,"type":21},"2026-12-01",{"name":43,"class":44},4,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":57,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100477340","triple-therapy-convenience-by-the-use-of-one-or-multiple-inhalers-and-digital-support-in-chronic-obstructive-pulmonary-disease-100477340","NCT05495698","Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease","TRICOLON","Inclusion Criteria:\n\n* Clinical diagnosis of COPD for at least 1 year before the screening visit\n* Aged 40 years and older\n* An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT).\n* Owner of mobile device compatible with e-device app with access to internet (Android or iOS)\n* Willing to provide written informed consent\n* Current or ex-smoker\n\nExclusion Criteria:\n\n* Inability to comply with study procedures or with study treatment\n* Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed\n* Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed\n* Use of e-health application for COPD in the past six months\n* Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)\n* Use of nebulized bronchodilators, for example via pari boy\n* Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive\n* Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order\n* Patients without the capability to complete the questionnaires",{"count":80,"type":21},300,[59],"TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.",[84,85],"Copd","Adherence, Medication",{"date":65,"type":37},{"date":88,"type":37},"2022-12-13",{"date":90,"type":21},"2026-12",{"name":43,"class":44},1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":17,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":57,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":92},"100590517","the-role-of-obesity-in-severe-covid-19-pathophysiology-100590517","NCT06968442","The Role of Obesity in Severe COVID-19 Pathophysiology","SARS-CoV-2 Antibody-mediated Inflammatory Responses by Macrophages in Individuals With and Without Obesity","SAMO","Inclusion criteria:\n\nCohort 1 (obesity cohort)\n\n* ≥18 and ≤65 years of age\n* BMI ≥30 kg\u002Fm²\n* Patient of Franciscus Hospital\n\nCohort 2 (control cohort)\n\n* ≥18 and ≤65 years of age\n* BMI \\\u003C25 kg\u002Fm²\n* Healthcare workers of Franciscus Hospital\n\nExclusion Criteria (for both cohorts):\n\n* Acute infection or current systemic immunological disorders\n* Use of immune-modulatory medication (i.e., corticosteroids and biologicals)\n* Hormonal therapy",true,"18 Years","65 Years",{"count":105,"type":21},60,[59],"The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in millions of deaths worldwide. As of 2024, the SARS-CoV-2 Omicron variant is the predominant strain circulating within the population, generally causing mild upper respiratory tract infections. However, hospitalizations and case fatalities due to COVID-19 continue, and there is a high probability that a new human coronavirus will emerge in the future. Understanding the pathophysiology of severe COVID-19 remains highly relevant, as its mechanisms may be comparable to those of other respiratory viral infections.\n\nSARS-CoV-2 infects human cells primarily by binding to angiotensin-converting enzyme 2 (ACE2) and type 2 transmembrane serine protease (TMPRSS2) receptors, which are both expressed in alveolar epithelial type II cells, through the virus' spike protein. In a later stage, the replication of SARS-CoV-2 and activation of resident immune cells lead to the infiltration and activation of large numbers of innate immune cells. Consequently, this results in an excessive pro-inflammatory immune response, including increased production of IL-6, a hallmark cytokine of severe COVID-19. Eventually, the excessive inflammation results in microthrombus formation and pulmonary edema.\n\nFurther studies have indicated that SARS-CoV-2 spike-specific antibodies, along with alveolar macrophages, play a pivotal role in the pathophysiology of severe COVID-19. Alveolar macrophages, which reside in the lung alveoli, are typically the first immune cells to sense pulmonary pathogens. However, these cells can also bind IgG antibodies through their Fc-receptor, leading to cellular activation. When stimulated with both a viral stimulus and anti-SARS-CoV-2 IgG antibodies from severe COVID-19 patients (a situation similar to that in the lungs of these patients) alveolar macrophages elicit a significant proinflammatory response. This response aligns with the observed post-seral conversion deterioration in COVID-19 patients.\n\nObesity is a significant risk factor for developing severe COVID-19, but the underlying mechanism is not well understood. Previous studies report that macrophages in obese patients are skewed towards a pro-inflammatory phenotype due to altered fatty acid contents, particularly increased saturated fatty acids. Using our in vitro obesity model, which incorporates higher saturated fatty acid contents, the investigators already demonstrated that SARS-CoV-2 antibody-mediated inflammation of alveolar macrophages is increased (unpublished data). Thus, this may explain why obese patients are more likely to develop severe COVID-19.\n\nTo validate these in vitro findings, the investigators aim to confirm these results in monocyte-derived macrophages isolated from individuals with and without obesity. Additionally, the investigators will investigate the underlying mechanisms involved in detail. This study will provide valuable insights into the role of obesity in severe COVID-19 and potentially inform therapeutic strategies for at-risk populations.",[109,110],"COVID-19","Antibody COVID-19",[109,112,113,114,115,116],"Obesity","Antibodies","Macrophages","Immunity","Fc receptors","2025-05-13",{"date":119,"type":37},"2025-05-16",{"date":121,"type":37},"2025-04-22",{"date":123,"type":21},"2026-04-22",{"name":43,"class":44},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":57,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":92},"100503154","phase-3-expertise-asthma-copd-program-with-digital-support-100503154","NCT05831566","Expertise Asthma COPD Program with Digital Support","EXACT@home","Inclusion criteria:\n\n* Confirmed asthma diagnoses (≥12% and \\>200 ml reversibility in FEV1 or positive histamine\u002Fmethacholine provocation test or FeNO ≥50) according to the asthma guidelines\n* Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) as determined at the regional asthma MDTM according to the asthma guidelines\n* Age ≥ 18 years.\n* Previous prescribed asthma biologics have to be ceased ≥ 4 times the half-life of that specific biologic.\n* The patient has be relatively stable. The onset of an asthma exacerbation and\u002For a respiratory infection has to be ≥ 4 weeks ago.\n\nExclusion criteria:\n\n* Primary COPD diagnosis.\n* History of cancer:\n\n  * Current basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the start of the study.\n  * Current other malignancies. Patients are eligible to participate in the study provided that curative therapy was completed at least 5 years prior to the start of the study.\n* Inability to sufficiently understand and read the Dutch language.\n* Being unable to engage in a remote monitoring and coaching program through the use of a smartphone.\n* Being unable to engage in physical activity (e.g. physical disability).\n* Current pregnancy.\n* Current breastfeeding.\n* A liaison with the coordinating or (principal) investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the WMO - article 5).",{"count":133,"type":21},138,[135],"PHASE3","The aim EXACT@Home is to create an evidence-based health program using e.g. questionnaires, a digital health platform and multiple digital devices to further improve the assessment of patients diagnosed with severe asthma. By better charting treatable traits (e.g. poor adherence, physical inactivity, dysfunctional breathing), we expect to improve the indication for the use of biologics. One the devices that will be used is also a medicinal product: a digital inhaler, which monitors adherence and inhaler technique through its connected application and aims to improve adherence and inhaler technique with reminders and notifications. Next to this an activity tracker, hand-held spirometer and FeNO measuring device will be used. The information of the devices will be collected in a Personal Digital Healthcare Environment (PDHE). Patients diagnosed with severe asthma according to the regional asthma Multi-Disciplinary Team Meeting (MDTM) eligible for a treatment with biologics will be included. Half of the patients will immediately receive a biologic. The other half will first undergo the systematic assessment including home monitoring (=EXACT@home) and afterwards a treatment will be chosen based on this evaluation: optimization of treatable traits when present and\u002For biologics. The chosen treatment of both, the intervention and control group, will be evaluated during 11-12 months.",[138],"Asthma",[140,141,142,143,144,145,146],"severe asthma","ehealth","digital home monitoring","difficult to treat asthma","treatable traits","assessment","biologics","2025-03-21",{"date":149,"type":37},"2025-03-25",{"date":151,"type":37},"2023-01-31",{"date":153,"type":21},"2026-04-30",{"name":43,"class":44},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":57,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":179,"locationsCount":92},"100444109","phase-3-protecting-preterm-infants-from-respiratory-tract-infections-and-wheeze-by-using-bacterial-lysates-100444109","NCT05063149","Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.","Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.","PROTEA","Inclusion Criteria:\n\n* Gestational age at delivery between 30+0 and 35+6 weeks\n* Postnatal age at least 6 weeks at randomization \\& postmenstrual age at least 37 weeks\n* Written informed consent by both parents or formal caregivers\n\nExclusion Criteria:\n\n* Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.\n* Lower RTI before randomization\n* Dysmaturity and\u002For weight \\\u003C 2.5 kg at age of randomization.\n* Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and\u002For breastfeeding\n* Parents unable to speak and read Dutch\u002FEnglish language\n* Known allergic hypersensitivity to the active ingredients\u002Fsubstance or to any of the excipients.","6 Weeks","10 Weeks",{"count":166,"type":21},500,[135],"The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.",[170,171,172],"Wheezing","LRTI","Premature","2024-08-20",{"date":175,"type":37},"2024-08-22",{"date":177,"type":37},"2022-01-18",{"date":90,"type":21},{"name":43,"class":44},""]