[{"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:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100567907","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-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":19,"type":20},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.",[25],"Tuberculosis, Multidrug-Resistant","NOT_YET_RECRUITING","2024-11-03",{"date":29,"type":30},"2024-11-05","ACTUAL",{"date":32,"type":20},"2024-11-30",{"date":34,"type":20},"2028-12-31",{"name":36,"class":37},"Korea Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100318280","phase-3-a-study-of-abilify-tabletaripiprazole-as-an-adjunctive-treatment-in-the-bipolar-depression-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":48,"type":20},390,"INTERVENTIONAL",[51],"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.",[54],"Depression, Bipolar","RECRUITING","2024-08-16",{"date":58,"type":30},"2024-08-19",{"date":60,"type":30},"2018-02-22",{"date":62,"type":20},"2025-12",{"name":36,"class":37},1,""]