[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eye & ENT Hospital of Fudan University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":634},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,44,75,95,124,147,171,192,215,239,265,299,320,340,359,384,408,431,456,478,507,537,557,581,603],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100642073","surgery-plus-postoperative-radiotherapy-for-t4-sinonasal-adenoid-cystic-carcinoma-a-prospective-observational-study-100642073",false,"NCT07652489","Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma: A Prospective Observational Study","SPORT-SNACC: A Prospective, Multicenter, Observational Cohort Study of Surgery Plus Postoperative Radiotherapy in T4 Sinonasal Adenoid Cystic Carcinoma","SPORT-SNACC","Inclusion Criteria:\n\n1. Age 18 80 years, any gender; ECOG performance status 0 2; life expectancy ≥6 months.\n2. Histologically confirmed primary sinonasal adenoid cystic carcinoma (cribriform, tubular, solid, or mixed type). Other malignancies excluded.\n3. T4 stage (T4a or T4b) according to AJCC 8th edition, based on contrast enhanced MRI\u002FCT.\n4. N0 2 (operable lymph node metastasis allowed).\n5. M0 (no distant metastasis on chest CT and abdominal ultrasound) OR M1 with stable limited lung metastases; (c) stable on two CT scans ≥3 months apart; (d) no respiratory symptoms.\n6. Previously untreated (no radiotherapy, chemotherapy, targeted therapy, immunotherapy, or tumor resection). MDT deems technically resectable (R0\u002FR1 achievable, not diffusely unresectable).\n7. Adequate organ function within 14 days before enrollment: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, Hb ≥90 g\u002FL; ALT\u002FAST ≤2.5×ULN, TBil ≤1.5×ULN, Cr ≤1.5×ULN or CrCl ≥50 mL\u002Fmin; LVEF ≥50%, no uncontrolled arrhythmia.\n8. Willing and able to provide written informed consent for clinical data collection (and optional biospecimen banking). Investigator judges good compliance.\n\nExclusion Criteria:\n\n1. Progressive lung metastases within 6 months (new lesions or \\>20% increase); extrapulmonary metastases (liver, bone, brain); symptomatic lung metastases.\n2. MDT judged unresectable, e.g., bilateral cavernous sinus invasion, brain parenchyma invasion, bilateral internal carotid artery encasement.\n3. Primary tumor outside sinonasal cavity (e.g., major salivary glands, oropharynx); non ACC histology.\n4. Other active malignancy within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, etc.).\n5. Severe comorbidities: NYHA class III\u002FIV heart failure, recent myocardial infarction or unstable angina, uncontrolled hypertension (≥160\u002F100 mmHg); COPD requiring home oxygen or interstitial lung disease; decompensated cirrhosis; active hepatitis B\u002FC without antiviral therapy; nephropathy requiring dialysis; active serious infection; active bleeding or coagulopathy (INR \\>1.5×ULN without anticoagulation, or platelets \\\u003C50×10⁹\u002FL).\n6. Special populations: pregnant or breastfeeding; unwilling to use contraception (if childbearing potential); severe allergy to medications required for surgery\u002Fradiotherapy; severe psychiatric or cognitive disorder impairing cooperation; currently participating in another interventional trial.\n7. Unable to undergo contrast enhanced MRI (metal implants, claustrophobia, gadolinium allergy); investigator judges inability to complete follow up (e.g., living abroad, substance abuse).","ALL","18 Years","80 Years",{"count":22,"type":23},70,"ESTIMATED","OBSERVATIONAL","This observational study follows patients with T4 stage sinonasal adenoid cystic carcinoma (a rare cancer of the nasal cavity\u002Fsinuses) who receive standard treatment: surgery followed by postoperative radiotherapy. The main goal is to measure the 3-year progression-free survival rate (the percentage of patients alive without cancer growth or spread). We will also assess overall survival, recurrence, side effects, and quality of life. This multicenter, prospective study will provide much-needed real-world data to improve patient counseling and guide future research.",[27,28],"Adenoid Cystic Carcinoma","Sinonasal Carcinoma",[30],"Carcinoma, Adenoid Cystic, Sinonasal, Radiotherapy, Adjuvant, Prospective Studies, Observational Study, Progression-Free Survival","RECRUITING","2026-06-12",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":23},"2026-06-01",{"date":39,"type":23},"2031-06-01",{"name":41,"class":42},"Eye & ENT Hospital of Fudan University","OTHER",6,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":73,"locationsCount":74},"100638733","phase-2-neoadjuvant-anlotinib-and-epirubicin-for-t4-sinonasal-adenoid-cystic-carcinoma-100638733","NCT07616141","Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma","Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial","NAET4-SNACC","Inclusion Criteria:\n\n* Age 18 to 75 years, any sex.\n* Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).\n* Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.\n* Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; ALT\u002FAST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin; left ventricular ejection fraction (LVEF) ≥50%.\n* Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).\n\nExclusion Criteria:\n\n* Prior radiotherapy to the head and neck region.\n* Prior anthracycline therapy with cumulative dose ≥300 mg\u002Fm².\n* Known hypersensitivity to any component of anlotinib or epirubicin.\n* Uncontrolled hypertension, severe cardiovascular disease, or active infection.\n* Pregnant or breastfeeding women.\n* Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.","75 Years",{"count":54,"type":23},76,"INTERVENTIONAL",[57],"PHASE2","T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.\n\nThis is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on\u002F1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.",[27],[27,61,62,63,64,65,66,67],"Sinonasal","T4 Stage","Neoadjuvant Therapy","Anlotinib","Epirubicin","Prospective Study","Phase II Clinical Trial","NOT_YET_RECRUITING","2026-05-23",{"date":37,"type":35},{"date":37,"type":23},{"date":39,"type":23},{"name":41,"class":42},5,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":55,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100638184","phase-2-exploratory-clinical-study-of-neoadjuvant-immunotherapy-combined-with-chemotherapy-in-malignant-melanoma-of-nasal-and-paranasal-mucosa-100638184","NCT07614828","Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses.\n* T stage of T3 or T4a.\n* Age ≥18 years.\n* No distant metastasis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery.\n* Locally resectable with curative intent, and able to undergo contrast-enhanced CT or contrast-enhanced MRI examinations.\n* Adequate organ function: Hematology: white blood cells ≥3.0 × 10\\^9\u002FL; absolute neutrophil count ≥1.5 × 10\\^9\u002FL; hemoglobin ≥80 g\u002FL; platelets ≥100 × 10\\^9\u002FL. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN. Coagulation: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Renal function: serum creatinine ≤1.5 × ULN.\n* Patients with recurrence after prior curative surgery are allowed; for recurrent patients, chemotherapy and immune therapy must have been discontinued for more than 6 months.\n\nExclusion Criteria:\n\n* Patients who refuse to sign the informed consent form.\n* Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment.\n* Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment.\n* Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders.\n* Patients with autoimmune diseases.\n* Patients currently using immunosuppressants, or receiving systemic glucocorticoids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), and who continue to use them within 2 weeks prior to first dosing.\n* Prior treatment with PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies; or a history of severe allergic reactions to other monoclonal antibodies.\n* Receipt of a live vaccine within 6 weeks prior to first dosing, or the possibility of receiving a live vaccine during the study.\n* Any condition that may compromise protocol adherence or safety during the study.\n* Uncontrolled active infection.\n* Pregnant or breastfeeding women.\n* Any other condition deemed unsuitable for enrollment.",{"count":7,"type":23},[57],"Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM.",[85],"Mucosal Melanoma of the Head and Neck","2026-05-22",{"date":88,"type":35},"2026-05-29",{"date":90,"type":35},"2023-06-01",{"date":92,"type":23},"2026-06-30",{"name":41,"class":42},1,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":103,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":94},"100636238","spare-1st-surgery-alone-vs-surgery-plus-postoperative-radiotherapy-for-sinonasal-adenoid-cystic-carcinoma-100636238","NCT07563088","SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma","Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study","SPARE-1st","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Histologically confirmed adenoid cystic carcinoma of cribriform or tubular type (solid type excluded) by central pathology review.\n* Completed radical surgical resection with postoperative pathology confirming R0 resection (negative microscopic margins).\n* Tumor stage T1, T2, or T3 according to AJCC 8th edition, with N0 and M0 status.\n* Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region).\n* ECOG performance status 0 or 1.\n* Adequate bone marrow, liver, and kidney function within 14 days before enrollment:\n\n  * Absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN.\n  * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Tumor stage T4, or presence of regional lymph node metastasis (N+), or distant metastasis (M1).\n* Postoperative pathology showing positive margins (R1 or R2).\n* Prior head and neck radiotherapy.\n* Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Uncontrolled serious concomitant disease (e.g., unstable angina, recent myocardial infarction, uncontrolled hypertension).\n* Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.\n* Psychological, social, or geographic factors that may interfere with study compliance.",{"count":104,"type":23},200,"Background:\n\nSinonasal adenoid cystic carcinoma (ACC) is a rare type of cancer that starts in the nasal cavity or sinuses. Although surgery can remove the tumor, doctors often recommend radiation therapy after surgery to reduce the chance of the cancer coming back. However, radiation can cause long-term side effects such as bone damage, dry mouth, or difficulty opening the mouth. For patients whose tumor has been completely removed (called R0 resection) and who have early-stage disease (T1-T3) without spread to lymph nodes or other organs, it is not clear whether routine radiation therapy is always needed.\n\nStudy Objective:\n\nThis study aims to find out whether simply watching and waiting (surgery alone) is not worse than adding radiation therapy (surgery plus radiation) in terms of keeping patients free from cancer for at least 3 years. If surgery alone is shown to be as good as surgery plus radiation, some patients may be able to avoid the side effects of radiation.\n\nStudy Design:\n\nThis is a prospective, multicenter, real-world study. It is not a randomized trial - patients and their doctors will decide together whether to have radiation after surgery. We will follow about 200 patients from many hospitals across China. About half will receive surgery alone, and the other half will receive surgery followed by radiation therapy. All patients will be followed for at least 3 years.\n\nHypothesis:\n\nWe hypothesize that surgery alone is not inferior to surgery plus radiation therapy for 3-year disease-free survival, with a non-inferiority margin of a hazard ratio of 1.35. In other words, even if surgery alone has a slightly higher risk of cancer returning, the difference is small enough that avoiding radiation side effects may still be worthwhile.\n\nMain Outcome:\n\nThe main outcome is the percentage of patients who are alive and free from cancer recurrence (local, regional, or distant) or death from any cause at 3 years after treatment.\n\nPotential Impact:\n\nIf our hypothesis is confirmed, this study could change current practice. Many patients with completely resected, early-stage sinonasal ACC might safely avoid postoperative radiation and its long-term side effects, improving their quality of life without compromising cancer control.",[27,28],[108,109,110,111,112,113,114,115],"Sinonasal Adenoid Cystic Carcinoma","Radiotherapy","Adjuvant","Watchful Waiting","Observational Study","Prospective Studies","Non-Inferiority Trials","Disease-Free Survival","2026-05-08",{"date":118,"type":35},"2026-05-12",{"date":120,"type":23},"2026-05-01",{"date":122,"type":23},"2032-05-01",{"name":41,"class":42},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":55,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":94},"100633145","phase-2-a-study-of-becotatug-vedotin-mrg003-combined-with-epirubicin-as-neoadjuvant-therapy-for-egfr-positive-unresectable-recurrent-sinonasal-adenoid-cystic-carcinoma-100633145","NCT07522879","A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma","Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study","MRG003-SACC","Inclusion Criteria:\n\nAge ≥ 18 years, male or female. Histopathologically confirmed primary sinonasal adenoid cystic carcinoma (SNACC) that is locally recurrent after prior surgery and\u002For radiotherapy.\n\nEGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.\n\nMultidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.\n\nAt least one measurable lesion in the skull base\u002Fsinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.\n\nWilling to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.\n\nExclusion Criteria:\n\nPrior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.\n\nPrior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.\n\nActive uncontrolled infection, or active autoimmune disease requiring systemic therapy.\n\nSymptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.\n\nKnown severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men\u002Fwomen planning to become pregnant within 6 months after the last dose of study treatment.\n\nAny medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.",{"count":133,"type":23},40,[57],"This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.",[27,28],[138,139,140,61,141,65,113],"EGFR protein","Unresectable","Adenoid cystic carcinoma","Becotatug vedotin",{"date":118,"type":35},{"date":120,"type":23},{"date":145,"type":23},"2030-07-01",{"name":41,"class":42},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":55,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":94},"100617583","phase-2-epirubicin-interventional-chemotherapy-for-sinonasal-adenoid-cystic-carcinoma-snacc-a-prospective-study-100617583","NCT07320508","Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study","A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma","EIC-SNACC","Inclusion Criteria:\n\n1. Age between 18 and 70 years.\n2. Histologically confirmed diagnosis of sinonasal adenoid cystic carcinoma (ACC).\n3. Tumor stage T3 or T4 according to the AJCC (American Joint Committee on Cancer) 8th edition staging system. Participants with lymph node metastasis must be amenable to surgical dissection. Those with distant metastasis must have stable disease.\n4. Ability to provide a sufficient volume (≥0.5 cm³) of fresh tumor tissue via biopsy or surgery for research purposes, with participant's informed consent.\n5. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 to 2.\n6. Voluntary participation and provision of written informed consent. Good compliance, able to cooperate with treatment and follow-up.\n\nExclusion Criteria:\n\n1. Prior treatment with Epirubicin or any other anthracycline-based chemotherapy.\n2. Prior radiotherapy to the head and neck region.\n3. Administration of any other chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to study enrollment.\n4. Concurrent participation in another interventional drug clinical trial.\n5. Inadequate liver, kidney, or bone marrow function that does not meet the requirements for the planned treatment regimen.\n6. Contraindications to anthracycline-containing chemotherapy regimens: known allergy to anthracyclines, presence of ≥ Grade 2 peripheral neuropathy, or uncontrolled nausea\u002Fvomiting or chronic gastrointestinal diseases.\n7. Severe uncontrolled acute infection or decompensated major organ dysfunction.\n8. Pregnancy or lactation.","70 Years",{"count":157,"type":23},100,[57],"This study is for patients with locally advanced sinonasal adenoid cystic carcinoma (SNACC), a rare and challenging cancer that tends to invade nerves and the skull base. The research aims to test a new precise treatment strategy. First, all participants will receive three sessions of \"interventional chemotherapy\" (transarterial chemoembolization) with the drug Epirubicin, which delivers high-dose chemotherapy directly to the tumor to shrink it as much as possible. About 4-6 weeks after the third session, doctors will use MRI scans to evaluate how well the tumor responded. Based on this response, patients will follow one of two personalized treatment paths: those whose tumors did not completely disappear will undergo surgery followed by radiotherapy; those whose tumors show complete disappearance on imaging will receive precise radiotherapy alone, potentially avoiding major surgery. This is a prospective, multicenter study. The main goals are to evaluate the safety and effectiveness of this response-adapted strategy and to see if it can improve outcomes for patients with this difficult-to-treat cancer.",[27,28,65],[162,163,164],"transarterial chemoembolization","objective response rate","2-year progression-free surviva",{"date":118,"type":35},{"date":167,"type":35},"2026-01-20",{"date":169,"type":23},"2029-12-12",{"name":41,"class":42},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":178,"targetDuration":4,"studyType":55,"phases":180,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":94},"100635911","fudan-tinnitus-doctor-for-tinnitus-management-100635911","NCT07558837","Fudan Tinnitus Doctor for Tinnitus Management","A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of subjective tinnitus confirmed by a qualified investigator.\n2. Tinnitus duration ≥ 3 month prior to screening.\n3. THI score of ≥ 18\n4. Aged between 18 and 70 years\n5. The ability to use a smartphone: Both groups will receive therapeutic support and disease management primarily through a mobile application or web-based platform. This requires functional ability to operate the provided software and willingness to engage with the digital intervention protocol.\n6. Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments).\n7. Compliance and consent: Participant is assessed by the Investigator as able to understand study procedures, voluntarily agrees to participate, is willing to comply with all trial-related requirements, and provides signed informed consent prior to performance of any protocol-specified procedure.\n\nExclusion Criteria:\n\n1. Acute-phase tinnitus (duration \\\u003C 3 month or tinnitus secondary to acute otologic events).\n2. Pulsatile or objective tinnitus.\n3. Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline.\n4. Psychiatric contraindication: History or current presence of severe psychiatric disorders (e.g., major depressive disorder with recent suicidality, schizophrenia) that, in the opinion of the Investigator, may interfere with study participation or data validity.\n5. Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments.\n6. Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management.\n7. Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints.\n8. Concurrent trial participation: Active participation in another interventional research study that, in the opinion of the Investigator, could affect tinnitus symptoms or interact with study procedures.\n9. Investigator judgment: Any condition (medical, surgical, psychiatric, or social) or factor which, in the Investigator's judgment, renders the subject unsuitable for participation, places the patient at higher risk, or may interfere with compliance or scientific validity of the trial.",{"count":179,"type":23},256,[181],"NA","The goal of this clinical trial is to evaluate whether a conversational artificial intelligence-based digital intervention can improve symptoms in adults with chronic subjective tinnitus.\n\nThe main questions it aims to answer are:\n\nDoes the Fudan Tinnitus Doctor (FTD) system reduce tinnitus severity as measured by the Tinnitus Handicap Inventory (THI).\n\nDoes the FTD system improve sleep quality, anxiety, depression, and overall patient-reported outcomes.\n\nResearchers will compare the FTD system to a non-conversational digital education program to determine whether the AI-based intervention provides greater clinical benefits.\n\nParticipants will:\n\nUse either the FTD conversational AI system or a static digital education program for 30 days.\n\nComplete standardized questionnaires assessing tinnitus severity, sleep, mood, and overall improvement at baseline, Day 14, and Day 30.\n\nEngage with the digital platform for tinnitus self-management.",[184],"Tinnitus","2026-05-04",{"date":187,"type":35},"2026-05-07",{"date":120,"type":23},{"date":190,"type":23},"2027-05-30",{"name":41,"class":42},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":200,"targetDuration":4,"studyType":55,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":94},"100638394","acupuncture-therapy-for-sudden-sensorineural-hearing-loss-100638394","NCT07575334","Acupuncture Therapy for Sudden Sensorineural Hearing Loss","Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial","SSNHL-Acu","Inclusion Criteria:\n\n* Age between 18 and 70 years;\n* Meets the diagnostic criteria for sudden sensorineural hearing loss (SSNHL): sudden, unexplained sensorineural hearing loss occurring within 72 hours, with a hearing threshold decrease of ≥30 dB in at least three consecutive frequencies among 250, 500, 1000, 2000, 4000, and 8000 Hz (reference: previous audiologic examination or same frequencies of the contralateral ear);\n* Unilateral SSNHL with self-perceived symmetrical hearing in both ears prior to the current episode (or supported by previous audiologic examination reports);\n* Time from symptom onset to enrollment and treatment initiation within 14 days;\n* Clear consciousness and logical responses, able to understand the scale items and complete the assessments;\n* Agrees to participate in the trial and signs a written informed consent form.\n\nExclusion Criteria:\n\n* Identifiable definite etiology after complete examination, including acoustic neuroma, cerebrovascular accident, trauma, Hunt syndrome, etc.;\n* History of hearing abnormality (affected ear) or balance dysfunction prior to the current episode (including previous SSNHL, vestibular migraine, Meniere's disease, benign paroxysmal positional vertigo, congenital\u002Fhereditary\u002Fsyphilitic hearing loss, otosclerosis, etc.);\n* Presence of diseases for which systemic corticosteroid therapy is clinically not recommended (e.g., poorly controlled or insulin-dependent diabetes mellitus, history of peptic ulcer, active infection or tuberculosis, history of hepatitis B or C, pancreatitis, severe osteoporosis, osteonecrosis, etc.);\n* Received systemic or local corticosteroid therapy for 10 days or more prior to enrollment;\n* Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;\n* Presence of severe organ dysfunction;\n* Received acupuncture treatment within the past 12 months;\n* Pregnant or breastfeeding women;\n* Other reasons deemed by the investigator as unsuitable for participation in this clinical study (e.g., high anticipated difficulty in completing follow-up, obvious low compliance, etc.).",{"count":179,"type":23},[181],"The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:\n\nDoes acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.\n\nParticipants will:\n\n1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.\n2. Meanwhile, take oral prednisone (1 mg\u002Fkg\u002Fday, maximum 60 mg\u002Fday) for 7 days followed by a 7-day taper.\n3. Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.\n4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.",[204],"Sudden Sensorineural Hearing Loss (SSNHL)",[206,207],"acupuncture","Sudden sensorineural hearing loss (SSNHL)","2026-05-03",{"date":116,"type":35},{"date":211,"type":35},"2026-04-13",{"date":213,"type":23},"2027-12-31",{"name":41,"class":42},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":222,"maxAge":52,"enrollmentInfo":223,"targetDuration":4,"studyType":55,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":238,"locationsCount":94},"100634518","phase-2-trans-round-window-membrane-intracochlear-steroid-100634518","NCT07540728","Trans-round Window Membrane Intracochlear Steroid","Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n* Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL\n\nExclusion Criteria:\n\n* Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.\n\nHistory of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency","12 Years",{"count":224,"type":23},108,[57],"Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss",[228],"Sudden Hearing Loss",[230,231,232],"intracochlear injection","glucocorticoid","round window membrane",{"date":234,"type":35},"2026-04-20",{"date":234,"type":23},{"date":237,"type":23},"2028-05-01",{"name":41,"class":42},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":246,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":55,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100571398","functional-iol-implantation-in-patients-with-epiretinal-membrane-100571398","NCT06719739","Functional IOL Implantation in Patients With Epiretinal Membrane","Clinical Outcomes in Cataract Patients With Macular Epiretinal Membrane After Implantation of Functional Intraocular Lenses","Inclusion Criteria:\n\n* Requirement for cataract extraction\n* Age \\> 40 years\n* Axial length in 21mm to 25mm\n* ERM\n\nExclusion Criteria:\n\n* Residual corneal astigmatism \\> 1.0 D\n* Amblyopia\n* Previous ocular surgery\n* Other ocular pathologies apart from mERM, such as diabetic retinopathy, macular degeneration, glaucoma with field defects\n* Requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study","20 Years","90 Years",{"count":249,"type":23},90,[181],"We have designed this prospective study to evaluate macular involvement and epiretinal membrane (ERM) grading by OCT in eyes with ERM and to compare clinical outcomes after implantation of Enhance IOL with standard monofocal IOL in eyes with ERM grading preoperatively, aiming to find out whether functional IOL is benefit for patients with ERM.",[253,254,255],"Cataract","Intraocular Lens Complication","Epiretinal Membrane","2026-04-02",{"date":258,"type":35},"2026-04-08",{"date":260,"type":35},"2024-09-21",{"date":262,"type":23},"2026-09-21",{"name":41,"class":42},2,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":275,"conditions":276,"keywords":282,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":94},"100622180","cochlear-implant-recipients-comprehensive-longitudinal-evaluation-100622180","NCT07380269","Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation","Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages","CIRCLE","Inclusion Criteria:\n\n* Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.\n* No restrictions on age or gender.\n* Native language is Mandarin Chinese.\n* The subject and\u002For their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.\n* Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.\n* The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.\n\nExclusion Criteria:\n\n* Presence of other severe diseases unsuitable for cochlear implantation surgery.\n* Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.\n* Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.\n* Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.\n* Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.",{"count":274,"type":23},300,"This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.",[277,278,279,280,281],"Hearing Loss","Hearing Loss, Sensorineural","Deafness","Cochlear Implantation","Speech Perception",[283,284,285,286,287,288,289,290],"Cochlear Implant","Pediatric Cochlear Implantation","Adult Cochlear Implantation","Auditory Rehabilitation","Speech Recognition","Quality of Life","Cognitive Function","Observational Cohort","2026-01-27",{"date":293,"type":35},"2026-02-02",{"date":295,"type":35},"2025-08-22",{"date":297,"type":23},"2030-09",{"name":41,"class":42},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":306,"targetDuration":4,"studyType":55,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":94},"100621416","phase-2-induction-chemotherapy-combined-with-tislelizumab-for-locally-advanced-squamous-cell-carcinoma-of-the-external-auditory-canal-100621416","NCT07370337","Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal","Phase II, Single-Arm, Multicenter Clinical Study of Induction Chemotherapy Combined With Tislelizumab as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal","Inclusion Criteria:\n\n1. Age \\> 18 years old and ≤ 80 years old\n2. Pathologically confirmed as squamous cell carcinoma\n3. Suitable for enhanced MRI\u002FCT imaging assessment\n4. Previously untreated squamous cell carcinoma of the external auditory canal staged as cT3-4NxM0 according to the Pittsburgh clinical staging system\n5. Cases that meet the inclusion criteria following joint discussion with otologists\n6. Expected survival time of at least 1 year\n7. ECOG performance status score of 0-1\n8. Peripheral blood routine examination before treatment meets the following criteria: neutrophil count \\> 2,000\u002Fmm³; platelet count \\> 100,000\u002Fmm³\n9. Liver and kidney function tests before treatment meet the following criteria: bilirubin \\\u003C 1.5 mg\u002Fdl; AST or ALT \\\u003C 1.5 × upper limit of normal (ULN); serum creatinine \\\u003C 1.5 mg\u002Fdl; creatinine clearance rate \\> 60 ml\u002Fmin\n10. Signed informed consent form prior to the initiation of the study\n\nExclusion Criteria:\n\n1. Ear tumors whose pathological type is not squamous cell carcinoma\n2. Patients with early-stage (T1-T2) disease or distant metastasis (M1)\n3. Cases not jointly discussed with an otologist\n4. Non-first-time radiotherapy for the head and neck region\n5. Hypersensitivity to platinum-based drugs or taxane drugs\n6. A history of head and neck malignant tumors, or concurrent multiple primary tumors\n7. Positive pregnancy test result in women of childbearing age\n8. Concurrent diseases or conditions that affect the patient's normal enrollment or safety during the study period\n9. Active mental disorders or other psychological conditions that impair the patient's ability to sign the informed consent form and comprehend study-related information\n10. Uncontrolled active infection",{"count":307,"type":23},50,[57],"To evaluate the efficacy and safety of induction chemotherapy combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal; to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, and posterior cranial nerves, etc.).",[311,312],"Squamous Cell Carcinoma of External Auditory Canal","Locally Advanced Tumor","2026-01-17",{"date":291,"type":35},{"date":316,"type":35},"2025-05-12",{"date":318,"type":23},"2029-12-31",{"name":41,"class":42},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":327,"targetDuration":4,"studyType":55,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":94},"100617221","new-pattern-of-retinal-laser-treatment-for-pdr-100617221","NCT07315802","New Pattern of Retinal Laser Treatment for PDR","A Prospective Study on a New Pattern of Retinal Laser Treatment for Proliferative Diabetic Retinopathy (PDR)","Inclusion Criteria:\n\n1. Having given free and informed consent to take part in the study.\n2. Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);\n3. Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.\n\nExclusion Criteria:\n\n1. Previous treatment with PRP;\n2. Previous treatment with anti-VEGF agents or corticosteroids within 3 months;\n\n2\\. Severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible; 3. Unable to tolerate argon-laser retinal treatment.; 4. Vitreous macular traction or traction retinal detachment need to be performed with vitrectomy; 5. Retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and\u002For neovascularization; 6. Other conditions that the researcher found improper to be included into this study.",{"count":274,"type":23},[181],"The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).",[331,332],"Proliferative Diabetic Retinopathy","Photocoagulation Burn to Retina","2026-01-16",{"date":167,"type":35},{"date":336,"type":23},"2026-01-01",{"date":338,"type":23},"2029-01-31",{"name":41,"class":42},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":348,"studyType":24,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":358,"locationsCount":4},"100617876","validation-of-end-to-end-difficult-airway-pathway-planning-algorithm-eap-lc-100617876","NCT07324317","Validation of End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC)","A Prospective Clinical Validation Study of an End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC) in Patients With Laryngeal Cancer: A Spatial Consistency Assessment Based on Awake Flexible Bronchoscopic Intubation Videos","Inclusion Criteria:\n\n* Patients scheduled to undergo laryngeal cancer surgery under general anesthesia, including supraglottic, glottic, and subglottic laryngeal cancers, as well as lesions involving the hypopharynx-larynx junction, who are assessed preoperatively as requiring awake flexible bronchoscopic intubation. Eligible participants must meet all of the following criteria: age ≥ 18 years, with no restriction on sex; a confirmed diagnosis of laryngeal cancer or laryngeal tumor based on previous or preoperative imaging and\u002For pathological findings; a planned laryngeal surgical procedure; a preoperative anesthetic assessment indicating the need for awake flexible bronchoscopic intubation to ensure airway safety; completion of contrast-enhanced laryngeal and\u002For cervical computed tomography (CT) within 2 weeks prior to surgery, with image quality adequate for analysis by the EAP-LC algorithm; clear consciousness, the ability to understand the study procedures, and voluntary provision of written informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded if they meet any of the following conditions: inability to cooperate with awake intubation due to severe anxiety, cognitive impairment, or psychiatric disorders; a history of total laryngectomy or loss of normal laryngeal anatomical structures that precludes oral or nasal flexible bronchoscopic intubation; severe coagulation disorders or an uncontrollable risk of bleeding; or any other condition deemed by the investigators to make participation inappropriate, such as refusal of video recording or special confidentiality requirements.",{"count":22,"type":23},"1 Day","Patients with laryngeal cancer often present with varying degrees of airway narrowing or anatomical distortion, making airway management particularly challenging. Awake flexible bronchoscopic intubation is a widely accepted and important strategy to ensure airway safety in this population. Currently, the selection of the intubation pathway mainly relies on visual assessment of preoperative computed tomography (CT) images and the clinical experience of anesthesiologists, lacking objective and quantifiable tools for airway pathway planning.\n\nOur research group has developed an end-to-end airway pathway planning algorithm for laryngeal cancer patients (EAP-LC), which can automatically generate predicted nasal or oral intubation pathways based on preoperative pharyngeal and upper airway CT images. Preliminary simulation analyses based on retrospective CT data demonstrated that the algorithm is capable of identifying airway narrowing and generating trajectories that are close to clinically feasible intubation paths (preliminary data, under review). However, to date, no study has directly compared the algorithm-predicted pathways with actual intubation trajectories obtained during awake flexible bronchoscopic intubation. Therefore, a prospective clinical validation study is required to evaluate the spatial consistency and clinical feasibility of the EAP-LC algorithm.\n\nWithout altering routine clinical treatment or anesthetic management, this study aims to evaluate the clinical accuracy, safety, and feasibility of the EAP-LC algorithm by comparing the intubation pathways predicted from preoperative CT images with the real-world trajectories recorded during awake flexible bronchoscopic intubation. The results of this study are expected to provide a more precise and objective decision-support tool for airway management in patients with laryngeal cancer.",[351,352],"Laryngeal Cancer","Difficult Airway","2025-12-24",{"date":355,"type":35},"2026-01-07",{"date":336,"type":23},{"date":92,"type":23},{"name":41,"class":42},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":366,"targetDuration":4,"studyType":55,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100612082","phase-2-neoadjuvant-chemotherapy-combined-with-finotonlimab-in-the-treatment-of-locally-advanced-hypopharyngeal-carcinoma-100612082","NCT07248956","Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma","Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n1. Willingness to provide written informed consent;\n2. Age ≥18 and ≤75 years;\n3. Treatment-naïve for malignant disease;\n4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;\n5. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding status;\n2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;\n3. Poorly controlled cardiovascular conditions or other diseases;\n4. Active or documented history of autoimmune diseases requiring systemic treatment;\n5. Synchronous or metachronous malignancies;\n6. Other conditions deemed ineligible for the study by investigators.",{"count":367,"type":23},116,[57],"This is a multi-center, randomized controlled, prospective clinical study.",[371],"Hypopharyngeal Carcinoma",[373,374,375],"PD-1 inhibitor","neoadjuvant therapy","locally advanced","2025-12-22",{"date":378,"type":35},"2025-12-23",{"date":376,"type":35},{"date":381,"type":23},"2029-12-30",{"name":41,"class":42},7,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":391,"targetDuration":4,"studyType":55,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100477225","the-management-of-metastatic-neck-nodes-in-n23-hypopharyngeal-squamous-cell-carcinoma-100477225","NCT05494190","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study","Inclusion Criteria:\n\n1. Able to understand and willing to sign a written informed consent document.\n2. Age ≥ 18 and ≤ 75 years.\n3. Male or female.\n4. Karnofsky physical status (KPS): ≥ 80\n5. Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal. Kidney function: Serum creatinine \\\u003C upper limit of normal value and creatinine clearance rate \\> 60 ml\u002F(min\\*1.73m2) (Cockcroft-Gault formula). Blood test: neutrophil (Neu) ≥ 1.5×109\u002FL, platelet (PLT) ≥ 100×109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.\n7. After clinical and radiographic evaluations, clinically classified as T1\u002F2 N2\u002F3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).\n8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).\n9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).\n10. Radical treatment intent.\n11. Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and\u002For bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.\n12. Good compliance.\n\nExclusion Criteria:\n\n1. Distant metastatic disease\n2. Have a history of other cancers or coinstantaneous second primary tumor\n3. Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.\n4. Patients who have participated in other clinical trials within 1 month before the test.\n5. Patients estimated to have poor tolerance to induction chemotherapy.\n6. The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \\[within the past year\\] or active suicidal ideation or behavior).\n7. Palliative treatment intent.\n8. Pregnant or lactating women.",{"count":392,"type":23},111,[181],"This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.",[371],[397,398,399],"Metastatic Neck Nodes","Induction Chemotherapy","Neck Dissection",{"date":401,"type":35},"2025-12-30",{"date":403,"type":35},"2022-11-01",{"date":405,"type":23},"2027-11",{"name":41,"class":42},3,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":415,"sex":18,"minAge":19,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":55,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100614794","acute-effects-of-nicotinamide-riboside-on-polysomnography-measured-sleep-structure-in-healthy-adults-100614794","NCT07284225","Acute Effects of Nicotinamide Riboside on Polysomnography-Measured Sleep Structure in Healthy Adults","A Randomized Controlled Study on the Acute Effects of a Single Dose of Nicotinamide Riboside on Sleep Structure in Healthy Adults","Inclusion Criteria:\n\n* Healthy males or females aged 18 to 60 years inclusive;\n* Screening using the Pittsburgh Sleep Quality Index (PSQI) scale with a total score between 5 and 10, indicating mild subjective sleep disturbance;\n* Voluntarily participate in this study and sign a written informed consent form;\n* Able to understand the study procedures and willing to comply with all laboratory regulations.\n\nExclusion Criteria:\n\n* History of any serious neurological, cardiovascular, respiratory, hepatic, renal, hematological, or psychiatric disorders;\n* Medically diagnosed sleep disorders (e.g., insomnia, sleep apnea syndrome, restless legs syndrome);\n* Regular use within the past month of any medication or supplement that may affect sleep (e.g., sedatives, antidepressants, antihistamines, melatonin);\n* Known allergy to nicotinamide riboside (NR) or any component of the study product;\n* History of chronic smoking, heavy alcohol consumption (exceeding weekly recommended intake), or substance abuse;\n* Participation in any other interventional clinical studies within one month prior to study initiation, or exposure to circadian rhythm-disrupting factors such as trans-time zone travel or frequent night shifts;\n* Pregnant women, breastfeeding women, or men of reproductive age with plans to conceive within the next month who are not using effective contraception.",true,"60 Years",{"count":418,"type":23},20,[181],"This study aims to evaluate whether a single oral dose of nicotinamide riboside (NR), a precursor of nicotinamide adenine dinucleotide (NAD+), has acute effects on sleep in healthy adults who report mild sleep difficulties. NR is widely used as a nutritional supplement and is known to increase cellular NAD+ levels, which may influence physiological processes linked to sleep-wake regulation.\n\nIn this randomized, double-blind, placebo-controlled study, 20 healthy adults will complete two overnight sleep assessments using polysomnography (PSG), the gold-standard sleep monitoring method. After a baseline night of sleep recording, participants will receive either NR or a placebo before bedtime on the second night. Researchers will compare sleep duration and sleep structure before and after the intervention to determine whether NR has an acute effect on objective sleep quality.\n\nThe study will also evaluate safety and collect participants' subjective sleep impressions. Findings may help clarify whether NR, a widely used nutritional supplement, has measurable short-term effects on human sleep.",[422],"Healthy Volunteers","2025-12-14",{"date":425,"type":35},"2025-12-16",{"date":427,"type":23},"2025-12-20",{"date":429,"type":23},"2026-12-30",{"name":41,"class":42},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":438,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":55,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":94},"100563890","vision-therapy-versus-prism-treatment-in-small-angle-acute-acquired-concomitant-esotropia-100563890","NCT06622044","Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia","Accommodation and Vergence Exercises Versus Prism Treatment for Small-angle Acute Acquired Concomitant Esotropia","Inclusion Criteria:\n\n1. Aged 10-40 years (including 10 years and 40 years);\n2. Best-corrected visual acuity no worse than 20\u002F20 for both eyes;\n3. Deviation angle less than 15 prism diopters (including 15 prism diopters);\n\nExclusion Criteria:\n\n1. Organic eye diseases;\n2. Lesions of the brain;\n3. Receiving esotropia therapy(including surgery and prism treatment)\n4. Devation angle reducing more than 10 prism diopters after refractive correction","10 Years","40 Years",{"count":157,"type":23},[181],"This is a single-center, randomized controlled clinical trial to compare the effectiveness of vision therapy and prism wearing for the treatment of small-angle acute acquired concomitant esotropia.",[444],"Esotropia",[446,447],"Vision Therapy","Acute Acquired Concomitant Esotropia","2025-12-02",{"date":450,"type":35},"2025-12-09",{"date":452,"type":35},"2024-09-07",{"date":454,"type":23},"2026-12-07",{"name":41,"class":42},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":55,"phases":465,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":94},"100611779","early-phase-1-jn002-for-the-treatment-of-dry-eye-disease-100611779","NCT07245017","JN002 for the Treatment of Dry Eye Disease","Randomized, Double-Blind, Placebo-Controlled, Single Center Clinical Trial to Evaluate the Safety and Preliminary Efficacy of JN002 Ophthalmic Solution in Adult Patients With Dry Eye Disease","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Ocular Surface Disease Index (OSDI) score ≥ 13\n3. Schirmer I test result ≤ 10 mm\u002F5 min\n4. Fluorescein tear film break-up time \\\u003C 10 seconds\n5. Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4\n6. Best corrected visual acuity ≥ 0.6\n7. Intraocular pressure ≤ 21 mmHg\n8. Voluntarily agrees to participate in the study\n\nExclusion Criteria:\n\n1. History of refractive surgery or intraocular surgery within the past 6 months\n2. Clinically relevant ocular abnormalities at screening or baseline, including but not restricted to eye trauma, pterygium, allergic keratoconjunctivitis, active ocular infections, or abnormal ocular structures\n3. Uncontrolled ocular or systemic diseases\n4. Other conditions deemed by the investigators likely to interfere with study parameters\n5. Females with plans for pregnancy at enrollment or during the treatment period",{"count":464,"type":23},30,[466],"EARLY_PHASE1","This is a first-in-human, single-center, randomized, double-blind, placebo-controlled clinical trial designed to:·Evaluate the efficacy of JN002 Ophthalmic Solution in treating dry eye disease (DED)·Assess the safety of JN002 Ophthalmic SolutionResearchers will compare three groups-placebo (vehicle), low-dose JN002 (0.05 mg\u002FmL), and high-dose JN002 (0.1 mg\u002FmL)-to evaluate whether JN002 Ophthalmic Solution improves DED outcomes and to assess its safety profile relative to placebo.Participants will:·Complete a baseline assessment (V0) including ocular exams, OSDI questionnaire, and systemic evaluation;·Administer the assigned study medication three times daily (1 drop per eye per administration);·Attend three follow-up visits (V1: 7±2 days, V2: 14±2 days, V3: 28±2 days post-treatment initiation) for ocular assessments, symptom queries, and adherence checks;·Undergo a full repeat of baseline assessments at V3 to evaluate treatment effects and safety profile",[469],"Dry Eye","2025-11-28",{"date":472,"type":35},"2025-12-01",{"date":474,"type":35},"2025-11-24",{"date":476,"type":23},"2026-03",{"name":41,"class":42},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":247,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":487,"conditions":488,"keywords":495,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":94},"100432252","clinical-treatments-in-specialized-diseases-of-laryngeal-carcinoma-lc-and-hypopharyngeal-carcinoma-hpc-100432252","NCT04908696","Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)","Department of Otorhinolaryngology, Eye & ENT Hospital","Inclusion Criteria:\n\n* Laryngeal cancer: glottic type, supraglottic type, and subglottic type; hypopharyngeal cancer: pyriform sinus type, postcri-coid type, and posterior pharyngeal wall type.\n* T1, T2, T3, and T4 stage.\n* Age 18 - 90.\n* Male or female.\n* Good compliance.\n* No other severe related diseases that may impact the treatment (such as other tumors, severe heart, lung and central nervous system diseases, etc.).\n* Negative pregnancy test (for female patients with fertility).\n* Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients do not have fertility. Female patients with postmenopausal status.\n\nExclusion Criteria:\n\n* Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases.\n* Patients with a known history of active tuberculosis (TB).\n* Pregnant women or lactating women.\n* The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \\[within the past year\\] or active suicidal ideation or behavior).",{"count":486,"type":23},1000,"For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery, open partial laryngectomy, radiotherapy, and transoral robotic surgery were performed according to NCCN guidelines (2020).\n\nFor advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, chemoradiotherapy, neoadjuvant therapy + radiotherapy\u002Fchemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy performed according to NCCN guidelines (2020).\n\nThis study plan to analyze the clinical ouctomes of different treatment for the same T stage disease. The overall survival rate, disease specific survival, disease free survival, local control, regional control, and laryngeal function preservation rate were analyzed in this study.",[489,490,491,492,493,494],"Glottic Carcinoma","Supraglottic Carcinoma","Subglottic Carcinoma","Pyriform Sinus Carcinoma","Postcricoid Carcinoma","Posterior Pharyngeal Wall Carcinoma",[496,497,498,499],"Laryngeal carcinoma","Hypopharyngeal carcinoma","Surgery","Laryngeal function preservation treatment","2025-11-26",{"date":502,"type":35},"2025-12-04",{"date":472,"type":23},{"date":505,"type":23},"2027-12-01",{"name":41,"class":42},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":514,"targetDuration":4,"studyType":55,"phases":516,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100608344","phase-4-anti-il-5-therapy-with-simple-polypectomy-versus-extended-endoscopic-sinus-surgery-for-crswnp-100608344","NCT07200336","Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP","Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)\n2. Nasal obstruction symptoms \\>3 months, nasal obstruction score ≥2 (total 3 points) and\u002For hyposmia ≥2 (maximum 3 points)\n3. Evidence of type 2 inflammation: Nasal polyp tissue Eos \\>55\u002FHPF or \\>27% of inflammatory cells; or Peripheral blood Eos ≥6.9% (without asthma) or ≥3.7% (with asthma) Note: Meet any 2 of the above 3 criteria\n4. Failure after 4 weeks of standard medical therapy including: Intranasal corticosteroids \\>4 weeks; Other agents (oral steroids, macrolides, antihistamines, leukotriene receptor antagonists, decongestants, antibiotics) permitted as needed\n\nExclusion Criteria:\n\n1. Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa\n2. Acute upper respiratory infection within 2 weeks\n3. Asthma exacerbation within 1 month\n4. HIV infection\n5. Parasitic infection within 6 months\n6. History of hypersensitivity to investigational drugs (except aspirin intolerance)\n7. Hypersensitivity to monoclonal antibodies or anti-IL-5 agents\n8. Oral steroid therapy within 1 month\n9. Pregnancy planning, current pregnancy, or lactation\n10. Uncontrolled systemic diseases\n11. Have a history of previous sinus surgery for CRSwNP\n12. Significant septal deviation affecting unilateral ventilation (mild deviation allowed)\n13. Investigator judgment of unsuitability for cohort study",{"count":515,"type":23},360,[517],"PHASE4","This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.",[520],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",[522,523,524,525,526,527],"Anti-IL-5","Biologic-Surgical Combination","Extended Sinus Surgery","SNOT-22","Type 2 Inflammation","Recurrence","2025-09-29",{"date":530,"type":35},"2025-10-01",{"date":532,"type":23},"2025-10-08",{"date":534,"type":23},"2031-10-10",{"name":41,"class":42},17,{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":544,"targetDuration":4,"studyType":55,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":94},"100504805","pilot-study-of-autna-i-100504805","NCT05853107","Pilot Study of AuTNA I","Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.","Inclusion Criteria:\n\n1. Age: 18-70 years of age.\n2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions):\n\n   ① typical triadfundus manifestations: \"osteoblastic\" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc.\n\n   ② typical fundus changes with both a and b, with or without c:\n   1. poor night vision before vision loss;\n   2. standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response\n   3. impaired peripheral visual field in perimetry (when the patient's vision permits).\n3. No or suspicious light perception in the eye for AuTNA I implantation.\n4. Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization.\n5. Voluntary to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc.\n2. Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol\u002FL with medication);\n3. Allergic constitution.\n4. Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc.\n5. Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.\n6. Habits of rubbing the eyes.\n7. Compromised liver function (ALT and AST 1.5 times over the normal limits), renal function (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 times over the normal limits).\n8. Pregnancy, lactating or planning to be pregnant within 6 months.\n9. History of epilepsy or serious psychiatric diseases.\n10. Other local or systemic diseases that may affect the vision.\n11. Participation in other clinical trials within 1 month before this study.\n12. Other conditions that the researcher found imporper to be included into this study.",{"count":383,"type":23},[181],"The objective of the study is to evaluate:\n\n1. Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;\n2. Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.",[548],"Retinitis Pigmentosa","2025-09-18",{"date":551,"type":35},"2025-09-19",{"date":553,"type":35},"2023-05-12",{"date":555,"type":23},"2026-02-28",{"name":41,"class":42},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":415,"sex":18,"minAge":563,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":566,"conditions":567,"keywords":569,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":43},"100534358","a-comparative-analysis-of-speech-perception-between-cochlear-implant-patients-and-dfnb9-patients-receiving-gene-therapy-100534358","NCT06237790","A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy","Inclusion Criteria:\n\n* Patients with congenital hearing loss with hearing thresholds ≥65 dB receive either gene therapy (previously received gene therapy and standardized postoperative rehabilitation and follow-up or plan to receive gene therapy), or cochlear implant surgery. Healthy participants with bilateral hearing thresholds within the normal range (≤20 dB), generally matched to the gene therapy group and the cochlear implant group by age and sex.\n* Age ≥ 6 months old, regardless of gender.\n* Mandarin Chinese as the native language.\n* Participants and their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to follow-up at specified time points.\n* Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.\n* The participant's guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.\n\nExclusion Criteria:\n\n* Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as middle\u002Finner ear dysplasia or malformations that affected the therapeutic effect revealed in CT\u002FMRI scans within 3 months, vestibular-cochlear nerve abnormalities, acute\u002Fchronic otitis media, Meniere's disease, etc.\n* Presence of other severe congenital diseases.\n* Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.\n* Individuals with low immunity, a history of immune deficiency or organ transplantation.\n* Individuals with a history of neurological or mental disorders, such as epilepsy or dementia.\n* Patients with contraindications for surgery or anesthesia assessed by a surgeon, anesthetist, or designated personnel, such as cardiovascular or cerebrovascular events in the past 6 months, allergies to the planned medications, etc.\n* Gene therapy group: gene therapy did not restore hearing; Cochlear implant group: presence of hereditary syndromic deafness or other conditions that seriously affect the efficacy evaluation.\n* Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.","6 Months",{"count":565,"type":23},180,"This cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for congenital deafness, thus providing a reference for making a well-rounded postoperative rehabilitation protocol for gene therapy patients.",[277,568,281],"Genetic Disease",[570,571,572,283,281],"Congenital Hearing Loss","DFNB9","Gene Therapy","2025-08-27",{"date":575,"type":35},"2025-09-04",{"date":577,"type":35},"2024-04-06",{"date":579,"type":23},"2026-12-22",{"name":41,"class":42},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":55,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":94},"100603250","phase-2-intracochlear-injection-of-glucocorticoid-100603250","NCT07134075","Intracochlear Injection of Glucocorticoid","Safety and Efficacy of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Total Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\nAge between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment\n\nExclusion Criteria:\n\nBilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency The CT diagnosis is \"abnormality of the round window niche\"","65 Years",{"count":590,"type":23},150,[57],"This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.",[204],[230,231],"2025-08-14",{"date":597,"type":35},"2025-08-21",{"date":599,"type":23},"2025-08-25",{"date":601,"type":23},"2027-08-01",{"name":41,"class":42},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":415,"sex":18,"minAge":610,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":55,"phases":614,"briefSummary":615,"conditions":616,"keywords":619,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":94},"100594828","perceptual-evaluation-and-rehabilitation-system-development-for-congenital-hearing-loss-100594828","NCT07024524","Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss","Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness","Inclusion Criteria:\n\nFor Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.\n\nFor Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.\n\nMandarin Chinese as the native language. Participants and\u002For their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.\n\nCapable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.\n\nParticipants and\u002For their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.\n\nExclusion Criteria:\n\nPresence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.\n\nPresence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.\n\nIndividuals with low immunity, a history of immune deficiency or organ transplantation.\n\nIndividuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.\n\nAny other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.","1 Year","35 Years",{"count":613,"type":23},210,[181],"This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.",[570,572,281,617,618],"Rehabilitation","Reliability and Validity",[620,621,622,623,624,625,617],"Congenital hearing loss","Gene therapy","Multimodal assessment","Auditory speech perception","Music perception","Spatial hearing","2025-07-24",{"date":628,"type":35},"2025-07-28",{"date":630,"type":35},"2025-07-04",{"date":632,"type":23},"2028-05-05",{"name":41,"class":42},""]