[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Korea Otsuka Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100567907",false,"NCT06674291","Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)","Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)","Inclusion Criteria:\n\n1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis\n2. Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form\n\nExclusion Criteria:\n\n1. Patients with confirmed quinolone resistance\n2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide\n3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide\n4. Patients with or with a history of optic neuritis or peripheral neuritis\n5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n6. Pregnant or lactating women\n7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment","ALL","19 Years",{"count":18,"type":19},222,"ESTIMATED","2 Years","OBSERVATIONAL","This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.\n\nIt will be conducted as a non-interventional, prospective, single group, multicenter design.\n\nSubjects who are considered to meet the inclusion \u002Fexclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.",[24],"Tuberculosis, Multidrug-Resistant","NOT_YET_RECRUITING","2024-11-03",{"date":28,"type":29},"2024-11-05","ACTUAL",{"date":31,"type":19},"2024-11-30",{"date":33,"type":19},"2028-12-31",{"name":35,"class":36},"Korea Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"id":38,"slug":4,"hasResults":10,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":44,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100318280","NCT03423680","A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression","A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder","APOLLO","Inclusion Criteria:\n\n* Patients aged ≥ 19 and \\\u003C 70 years at the time of informed consent\n* Patients who are able to understand information required for providing a consent\n* Patients who have received a mood stabilizer (lithium or valproic acid)\n* Patients with bipolar I or II disorder accompanied by major depressive episode\n* Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits\n\nExclusion Criteria:\n\n* Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features\n* Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history","70 Years",{"count":46,"type":19},390,"INTERVENTIONAL",[49],"PHASE3","This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.\n\nThis study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.",[52],"Depression, Bipolar","RECRUITING","2024-08-16",{"date":56,"type":29},"2024-08-19",{"date":58,"type":29},"2018-02-22",{"date":60,"type":19},"2025-12",{"name":35,"class":36},1,""]