[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment-duration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment-duration":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100603557","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-extra-articular-distal-tibia-fractures-100603557",false,"NCT07138066","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Distal Tibia Fracture Healing","Inclusion Criteria:\n\n1. Signed informed consent was provided after being fully informed about participation in the study.\n2. Age: 18 to 80 years for both males and females (pre-menopausal).\n3. Body weight between 40 and 120 kg.\n4. Diagnosed with a closed tibial shaft fracture (AO\u002FOTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.\n5. Fracture treated exclusively with plates and\u002For with an intramedullary nail\n6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).\n7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.\n8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.\n9. Enrollment within 48 hours following surgical intervention.\n10. Alcohol consumption (up to 2-3 times per week) within acceptable limits.\n11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 15, 18, 21, 24, and 36 after surgery.\n12. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable.\"\n\nExclusion Criteria:\n\n1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.\n2. Fractures classified as 41-A, 41-B, or 42 -A,B according to AO\u002FOTA.\n3. Chronic alcoholism (defined as \\>14 standard drinks per week for men or \\>7 for women).\n4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.\n5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.\n6. Lower-limb contractures with functional impairment of grade II or higher.\n7. Pregnancy or intention to conceive during the study period.\n8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.\n9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \\\u003C40% or with symptoms such as edema, dyspnea at rest, or orthopnea).\n10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \\\u003C 60 mmHg) or hypercapnia (PaCO₂ \\> 45 mmHg), requiring oxygen support or significantly limiting physical activity.\n11. Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).\n12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.\n13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).\n14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.\n15. Participation in another clinical study within the past 6 months that could affect the results of the current study.\n16. Ongoing or planned use of medications known to affect bone healing.","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular distal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use.\n\nCan a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes.\n\nParticipants will:\n\nUse Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.",[27,28,29],"Fracture Healing","Treatment Duration","Distal Tibia Fracture",[31,27,32,33,34,35,36,37,38,39,40],"distal tibia fracture","Controlled Mechanical Loading","Weight-Bearing","Finite Element Analysis","Digital Rehabilitation","Smart Crutch Tips","Bone Union","Rehabilitation Monitoring","Lower Limb Fractures","Biofeedback Device","RECRUITING","2026-04-11",{"date":44,"type":45},"2026-04-14","ACTUAL",{"date":47,"type":45},"2025-09-29",{"date":49,"type":21},"2027-01-15",{"name":51,"class":52},"Comeback Mobility Inc","INDUSTRY",18,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":53},"100603264","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-extra-articular-proximal-tibia-fractures-100603264","NCT07134257","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Proximal Tibia Fracture Healing","Inclusion Criteria:\n\n1. Signed informed consent was provided after being fully informed about participation in the study.\n2. Age: 18 to 80 years for both males and females (pre-menopausal).\n3. Body weight between 40 and 120 kg.\n4. Diagnosed with a closed tibial shaft fracture (AO\u002FOTA classification: 41-A2, 41-A3) requiring surgical treatment.\n5. Fracture treated with a plate and\u002For with an intramedullary nail\n6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).\n7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.\n8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.\n9. Enrollment within 48 hours following surgical intervention.\n10. Alcohol consumption (up to 2-3 times per week) within acceptable limits.\n11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 4, 8, 12, 15, 18, 24, and 36 after surgery.\n12. Stable fractures of the proximal tibia with partial extension of the fracture line into the articular surface are eligible\n\nExclusion Criteria:\n\n1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.\n2. Fractures classified as 43-B or 43-C according to AO\u002FOTA.\n3. Chronic alcoholism (defined as \\>14 standard drinks per week for men or \\>7 for women).\n4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.\n5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.\n6. Lower-limb contractures with functional impairment of grade II or higher.\n7. Pregnancy or intention to conceive during the study period.\n8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.\n9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \\\u003C40% or with symptoms such as edema, dyspnea at rest, or orthopnea).\n10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \\\u003C 60 mmHg) or hypercapnia (PaCO₂ \\> 45 mmHg), requiring oxygen support or significantly limiting physical activity.\n11. Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).\n12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.\n13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).\n14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.\n15. Participation in another clinical study within the past 6 months that could affect the results of the current study.\n16. Ongoing or planned use of medications known to affect bone healing.",{"count":20,"type":21},[24],"The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular proximal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use.\n\nCan a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes.\n\nParticipants will:\n\nUse Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.",[28,27,65],"Extra-articular Proximal Tibia Fractures",[27,32,33,34,37,35,36,40,39,38,67],"extra-articular proximal tibia fractures",{"date":44,"type":45},{"date":70,"type":21},"2026-06-20",{"date":72,"type":21},"2027-04-01",{"name":51,"class":52},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100608217","6-months-of-bedaquilinebdq-delamaniddlm-linezolidlzd-and-levofloxacinlfx-in-rr-tb-patients-in-hubei-province-100608217","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.","65 Years",{"count":84,"type":21},52,[24],"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.",[88,28],"Treat to Target",[80,90],"RR\u002FMDR-TB","NOT_YET_RECRUITING","2025-09-21",{"date":94,"type":45},"2025-09-30",{"date":94,"type":21},{"date":97,"type":21},"2028-09-30",{"name":99,"class":100},"Wuhan Pulmonary Hospital","OTHER"]