[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"therapeutic-drug-monitoring\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:therapeutic-drug-monitoring":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100400575","ofloxacin-concentration-toxicity-relationship-in-the-elderly-100400575",false,"NCT04496024","Ofloxacin Concentration-toxicity Relationship in the Elderly","Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection","ROSCO","Inclusion Criteria:\n\n* Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections\n* Indication for oral switch to ofloxacin\n\nExclusion Criteria:\n\n* Patient refusing to participate in the study\n* Patient under guardianship or curators or deprived of public rights\n* Any liver or biliary injury\n* Any contraindications to ofloxacin","ALL","65 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.",[27,28,29,30],"Ofloxacin","Bone and Joint Infection","Therapeutic Drug Monitoring","Adverse Drug Reactions",[32,28,33,30],"ofloxacin","therapeutic drug monitoring","RECRUITING","2025-06-05",{"date":37,"type":38},"2025-06-10","ACTUAL",{"date":40,"type":38},"2020-06-02",{"date":42,"type":21},"2026-08",{"name":44,"class":45},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100520030","phase-4-tdm-based-infliximab-treatment-for-active-perianal-fistulizing-crohns-disease-100520030","NCT06051253","TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease","Efficacy of Infliximab Treatment Based on TDM (Therapeutic Drug Monitoring) in Adult Patients With Active Perianal Fistulizing Crohn's Disease","* Inclusion Criteria:\n\n  1. Age: 19-80 years\n  2. Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.\n  3. Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) and investigational new drugs\n  4. Subjects with at least one draining perianal fistula\n  5. Subjects not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)\n  6. Women with a childbearing potential: Those who agree to follow contraception during study drug administration and for at least 6 months from the last dosing of the study medication\n* Exclusion Criteria:\n\n  1. In cases where written informed consents cannot be provided by the study subjects or the subjects' legally acceptable representative\n  2. Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators\n  3. Subjects with temporary or permanent stoma\n  4. Subjects with short bowel syndrome\n  5. Subjects not eligible due to significant bowel strictures or intra-abdominal abscesses\n  6. Subjects who received bowel surgery within 6 months of baseline or subjects who were admitted due to complications associated with bowel strictures or intra-abdominal abscesses within 3 months of baseline\n  7. Subjects with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula\n  8. Subjects previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12\u002F23, etc.) or investigational new drugs\n  9. Subjects with a history of hypersensitivity to monoclonal antibody\n  10. Subjects requiring corticosteroid therapy. However, if oral corticosteroid dose lower or equivalent to prednisolone 20 mg\u002Fday before baseline is given and tapering of oral corticoseroid from baseline is planned, that subjects can be included in the study. Oral corticoseroid is tapered at a schedule of prednisolone 5 mg\u002F7 days (example: if the subject was on oral prednisolone 20 mg\u002Fday before baseline, oral prednisolone is tapered as follows: 15 mg\u002Fday x 7 days -\\> 10 mg\u002Fday x 7 days -\\> 5 mg\u002Fday x 7 days -\\> stopping of prednisolone)\n  11. Subjects with active tuberculosis. However, if the subject has a history of tuberculosis, which was cured with standard anti-tuberculosis therapy according to the standard anti-tuberculosis treatment guidelines, that subject can be included\n  12. Subjects with latent tuberculosis: Subjects determined to be positive for latent tuberculosis by the pulmonology specialist after history taking, physical examination, chest X-ray, and interferon gamma release assay during the screening period. However, even if positive for latent tuberculosis, if 4 week-treatment for latent tuberculosis is completed and if further treatment for latent tuberculosis is planned to be completed, that subject can be included\n  13. Subjects positive for HBsAg. In cases of HBsAg (-), but with IgG Anti-HBc (+), real time quantitative PCR for HBV DNA is required. If HBV DNA is 10 IU\u002FmL or over, that subject should be excluded\n  14. Subjects positive for anti-HCV antibody\n  15. Subjects with a history of infection with HIV or subject positive for HIV Ag\n  16. Subjects positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay\n  17. Subjects with a heart disease of NYHA Class III\u002FIV\n  18. Subjects with current or previous demyelinating disease\n  19. Subject with a history of malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) within 5 years or with a history of dysplasia of colon or small bowel within 5 years.\n  20. Subjects with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks\n  21. Subjects with a history of organ transplantation\n  22. Pregnant or lactating women\n  23. Non-Korean ethnicity according to a family tree\n  24. Subjects decided to be not eligible for the study by investigators","19 Years","80 Years",{"count":57,"type":21},86,[59],"PHASE4","This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.",[62,63,64,29,65],"Crohn Disease","Infliximab","Perianal Fistula Due to Crohn's Disease","Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score","2024-05-11",{"date":68,"type":38},"2024-05-14",{"date":70,"type":38},"2023-11-01",{"date":72,"type":21},"2027-06-30",{"name":74,"class":45},"Asan Medical Center",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},"100461018","the-association-between-non-vitamin-k-antagonist-oral-anticoagulant-therapy-and-acute-stroke-severity-and-post-stroke-short-term-and-long-term-outcomes-100461018","NCT05283174","The Association Between Non-vitamin K Antagonist Oral Anticoagulant Therapy and Acute Stroke Severity and Post Stroke Short-term and Long-term Outcomes.","Inclusion Criteria:\n\n* Atrial fibrillation\n* Under dabigatran, rivaroxaban, apixaban or edoxaban therapy.\n* Developing ischemic stroke, transient ischemic attack or intracranial hemorrhage during NOAC therapy.\n\nExclusion Criteria:\n\n* Refuse to provide blood sample for non-vitamin K antagonist oral anticoagulant (NOAC) concentration measurement.\n* Refuse to provide informed consent.","20 Years",{"count":83,"type":21},500,"OBSERVATIONAL","Non-vitamin K antagonist oral anticoagulant (NOAC) is the first line therapy to prevent thromboembolism in atrial fibrillation (AF) patients. Previous investigation showed that preceding NOAC therapy was associated with lower severity of ischemic stroke, but with higher in-hospital mortality in intracerebral hemorrhage (ICH), as compared with antithrombotic agent non-users. Measurement of NOAC level upon acute stroke aids the critical decision of acute management. Real-world data regarding the relationship between the NOAC adherence, the appropriateness of NOAC regimen, or NOAC level in acute stroke and the stroke severity or short-term outcome is lacking. Further, optimal selection for long-term stroke prevention among patients with acute stroke during NOAC therapy remains unclear.\n\nSpecific purpose: To analyze the association between NOAC adherence or NOAC level upon acute stroke and stroke severity or stroke outcomes, and analyze the impact of starting or withholding antithrombotic therapy after acute stroke on long-term stroke outcomes.\n\nSpecific Aim (Year 1):\n\nTo investigate the relationship between NOAC adherence or appropriateness of NOAC dose and acute stroke severity or in-hospital mortality based on National Health Insurance Research Database (NHIRD). Another important goal is to prospectively establish a cohort of AF users who developed acute stroke during NOAC therapy in National Taiwan University Hospital (NTUH) (target: around 100 patients annually), measure the NOAC level upon hospital arrival, record stroke severity, 90-days functional outcomes, post-stroke antithrombotic agents and repeat stable NOAC level in patients who restart NOAC treatment.\n\nSpecific Aim (Year 2):\n\nTo investigate the relationship between post-stroke antithrombotic therapy, especially changing or retaining preceding NOAC and long-term stroke outcomes based on NHIRD. We will also keep enrolling the prospective cohort and follow the 1-year stroke outcome.\n\nSpecific Aim (Year 3):\n\nTo complete the process of study enrollment (total: 300 patients) and conduct statistical analysis. The main goal is to finish the Aim 1 and 2 based on NHIRD. In addition, to provide data of emergent NOAC level and stroke severity or short-term outcome, and post-stroke antithrombotic therapy and long-term outcomes based on the prospectively enrolled cohort.",[29],"2022-03-08",{"date":89,"type":38},"2022-03-16",{"date":91,"type":38},"2022-02-25",{"date":93,"type":21},"2027-12-31",{"name":95,"class":45},"National Taiwan University Hospital"]