[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treat-to-target\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treat-to-target":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100608217","6-months-of-bedaquilinebdq-delamaniddlm-linezolidlzd-and-levofloxacinlfx-in-rr-tb-patients-in-hubei-province-100608217",false,"NCT07198685","6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province","6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province","BDLL","Inclusion Criteria:\n\n* Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.\n* Aged between 18 and 65 years old.\n* Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.\n* Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.\n* No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram.\n* During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression\u002Fworsening during the study or are not suitable for participation in this research.\n* Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA \\> 1000 CPs\u002FmL, accompanied by elevated ALT\u002FAST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).\n* Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL\u002Fmin).\n* Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.\n* Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc \\> 450 ms.\n* Pregnant women or women who may be pregnant.\n* Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction.\n* A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis.\n* A history of allergy or a known allergy to any investigational medicinal product or related substances.\n* HIV-positive.","ALL","18 Years","65 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. The main questions it aims to answer are:\n\nIs the efficacy of short regimen non-inferior to standard regimen? Is the short regimen safe enough to replace the standard regimen?\n\nParticipants will:\n\nBe given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.",[28,29],"Treat to Target","Treatment Duration",[15,31],"RR\u002FMDR-TB","NOT_YET_RECRUITING","2025-09-21",{"date":35,"type":36},"2025-09-30","ACTUAL",{"date":35,"type":22},{"date":39,"type":22},"2028-09-30",{"name":41,"class":42},"Wuhan Pulmonary Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100494361","ultrasound-to-guide-treatment-decisions-in-patients-with-rheumatoid-arthritis-according-to-a-t2t-approach-100494361","NCT05717179","Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach","US-RA-T2T","Inclusion Criteria:\n\n1. Classification of RA according to the ACR-EULAR 2010 criteria\n2. Age of the patients: 18 to 84 years\n3. Patients with moderate or high disease activity according to CDAI (\\>10)\n4. Maximum of 2 clinically swollen joints out of a 44-joint count\n5. Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months\n6. No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg\u002Fday prednisone equivalent.\n7. No corticosteroid intraarticular injection within 4 weeks\n8. Stable or absent dose of NSAIDs for at least 1 week\n9. Patients able and willing to give written informed consent and compliant with the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician\n2. Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality\n3. Initial arthritis manifestations before the age of 18 years\n4. Planned surgery within the study period for any of the joints investigated either clinically or by sonography\n5. Current severe medical illness requiring hospitalization\n6. Active infection or active malignancy at screening \\\u003C5 years\n7. Any contraindication to b\u002Fts DMARDs according to the \"Summary of Product Characteristics\"\n8. Pregnancy or lactation","84 Years",{"count":52,"type":22},158,[25],"Population\n\nPatients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints)\n\nStudy design\n\nRandomised multicentre, parallel-arm clinical study\n\nPrimary objective\n\nNon-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR\u002FEULAR index-based remission criteria (CDAI ≤2.8\u002FBoolean remission) at week 24.\n\nIntervention\n\nThis is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or b-tsDMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms:\n\n1. Clinical decision strategy: All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b\u002FtsDMARD to use at week 12 is at the discretion of the investigator.\n2. Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b\u002FtsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.\n\nSample size\n\n158 patients\n\nTime plan\n\n* Total duration of the study: 72 months\n* Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit)\n* Recruitment: 60 months",[56,57,28],"Arthritis, Rheumatoid","Ultrasound","RECRUITING","2025-05-09",{"date":61,"type":36},"2025-05-14",{"date":63,"type":36},"2023-02-22",{"date":65,"type":22},"2029-02",{"name":67,"class":42},"Italian Society for Rheumatology",1]