Clinical trials

This multicenter, randomized, sham-controlled clinical trial will evaluate the efficacy and safety of acupuncture for patients with subjective idiopathic tinnitus. A total of 226 eligible participants will be randomly assigned to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus loudness, tinnitus severity, sleep quality, anxiety, depression, audiological assessments, and adverse events. Exploratory neuroimaging outcomes include functional magnetic resonance imaging and magnetoencephalography measures.

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation. These included neuropsychological evaluations (MMSE, MoCA, CDR, BADL, IADL, NPI, AES), neuroimaging (MRI, PET, ultrasound), fluid biomarker analyses (CSF and blood levels of Aβ, Tau, neuroinflammatory factors, etc.), and safety monitoring. The primary efficacy endpoint was the change in CDR-SB score at 12 months post-treatment. Secondary endpoints included changes in multiple cognitive scales, neuroimaging metrics, and biomarkers at 18 months. Safety indicators encompassed adverse event recording, vital signs, and laboratory tests.

This bidirectional cohort study (retrospective + prospective) focuses on three key challenges in oral mucosal melanoma (OMM): clinical staging based on depth of invasion (DOI), molecular subtyping, and precision therapy. By integrating DOI-driven T-stage reclassification, genomic profiling, and longitudinal follow-up, we aim to build a population-specific, high-quality evidence resource to support refined staging, CDK4-targeted treatment, and prognostic modeling for Chinese OMM patients.

This is a prospective, multicenter, multi-cohort, Phase II clinical trial enrolling patients with unresectable, recurrent, or metastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland malignancies (excluding adenoid cystic carcinoma) who have not previously received PD-1 inhibitor therapy. The planned sample size is 10 subjects per cohort, for a total of 40 subjects. Investigators may adjust the cohort sample sizes based on actual enrollment. Potentially eligible subjects will be screened within 4 weeks prior to the first dose to assess their eligibility for study entry. Subjects confirmed by the investigator to meet all inclusion criteria and none of the exclusion criteria will receive the investigational medicinal products as per the study design and undergo efficacy and safety assessments. This trial will consist of three periods: Screening/Baseline Period, Treatment Period, and Follow-up Period. The study procedures include: Screening Period: From the signing of the informed consent form up to 28 days prior to the first dose; Treatment Period: Treatment discontinuation is defined as the cessation of treatment for any reason, such as disease progression or intolerance, or premature withdrawal for any reason; Follow-up Period: Following the subject's last dose, safety follow-up will be initiated to monitor the resolution of adverse events. The first safety follow-up visit will occur 30 ± 7 days after the last study dose (calculated based on the later date of 30 days post the last dose of either camrelizumab or famitinib). Subjects are required to return to the study center for this safety follow-up, regardless of whether they have initiated new antineoplastic therapy. The subsequent two safety visits (60 ± 7 days and 90 ± 7 days after the last dose) may be conducted via telephone. After study discontinuation, survival follow-up will be conducted every 3 months to monitor survival status and subsequent antineoplastic treatments. The dosing regimen is as follows: camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle. Study drugs should be administered at approximately the same time each day. If a patient vomits or misses a dose, no replacement dose should be taken on that day, and the next scheduled dose should be taken as usual. Subjects will continue treatment with camrelizumab and famitinib until discontinuation criteria are met. Clinical tumor imaging assessments will be performed every 2 cycles according to RECIST v1.1 (Appendix IV). Additionally, on Day 1 of each treatment cycle, clinically required assessments must be completed, including vital signs, physical examination, complete blood count, urinalysis, fecal occult blood test, hepatic and renal function tests, serum electrolytes, serum proteins, coagulation profile, serum tumor markers, thyroid function, electrocardiogram (ECG), and ECOG performance status score (specific assessments for each visit are detailed in the Schedule of Assessments). Hepatitis virus carriers will also require viral load monitoring every 2 to 4 treatment cycles.

Paclitaxel polymeric micelles 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)

This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of Sacituzumab Tirumotecan and Toripalimab in the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients with trop2 and CPS positive. The participants would receive Sacituzumab Tirumotecan and Toripalimab until termination criteria are met.

This study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent/metastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.

The goal of this observational study is to investigate whether speech-in-noise perception deficits in older adults aged 60 years or older with objectively normal hearing thresholds are due to impaired ability of processing temporal cues in speech signals. The study further aims to examine whether cognitive and cortical mechanisms provide compensatory support for speech perception in challenging listening environments.

This is a multicenter, randomized, controlled, Phase II clinical study designed to evaluate the efficacy and safety of neoadjuvant and adjuvant therapy with vebikotamab combined with Pucotenlimab compared to standard treatment in patients with locally recurrent resectable head and neck squamous cell carcinoma (HNSCC). Investigational Arm: The dosing regimen for the investigational arm is as follows: Pucotenlimab: 200 mg per dose, administered intravenously (IV) every 3 weeks (Q3W). No dose adjustments are permitted; however, dosing delays are allowed up to a maximum of 12 weeks from the date of the previous dose. This is administered for two preoperative cycles. Becotatug Vedotin: 2.3 mg/kg, administered IV Q3W for two preoperative cycles. Following neoadjuvant therapy, patients will undergo surgery at 4 weeks ± 7 days. Postoperatively (at 6 weeks ± 3 weeks), patients will be stratified for adjuvant therapy based on pathological response: Patients who achieve a major pathological response (MPR) and have no high-risk factors will receive 6 cycles of single-agent adjuvant Pucotenlimab (200 mg/dose, Q3W). Patients who do not achieve MPR or who present with high-risk factors will receive standard postoperative adjuvant therapy. Control Arm: Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.

This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors. Tumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued. Treatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.

The purpose of this study is to compare the efficacy and safety of an individualized two-stage calcium supplementation method versus a conventional commercial RCA-CRRT module in RCA-CRRT for patients with citrate metabolism disorders.

Precision in implant placement is a key requirement for safety and to support the long-term success of dental implants. Optimal placement requires implementing a diagnostic standard that includes careful digital planning based on CBCT and intraoral scanning data. Once the case is planned, adherence to the plan during surgery cannot be achieved through freehand surgery; guidance is needed. Guidance has two key components: real-time tracking of osteotomy site preparation (achieved with dynamic navigation technology) and constraining instrumentation to the planned site (achieved through the application of a surgical template that guides the position and direction of bone drilling). Robotic surgery enables both objectives: real-time monitoring and guidance. Previous studies have shown high precision for both static guidance and robotic surgery, but the evidence is limited to a few small-sample-size studies, mostly in single-tooth gap applications. Evidence of the applicability of the technologies to more challenging clinical conditions, such as the more complex distal extension, is lacking. In addition, so far, dental implant robotics studies have focused only on metrics of implant placement precision and have failed to capture a broader context that may be equally important for clinical decision-making and patient preferences. In this respect, it is important to emphasize the recent implant dentistry core outcome set and measurement (ID-COSM) framework that mandates capturing and reporting a full range of outcomes across multiple domains.

To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\>10cm) femoropopliteal chronic total occlusion.

A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.

This multi-center, cross-sectional diagnostic trial evaluates the accuracy of multiple non-invasive screening tools-including self-reported questionnaires, intra-oral photographs, orthopantomographs (OPGs), intraoral scans (IOS), and salivary/microbial biomarkers-for detecting periodontal health and diseases (gingivitis and periodontitis Stages I-IV), using full-mouth clinical periodontal examination as the reference standard. A total of 2,000 participants will be recruited across five international centers. Diagnostic performance (sensitivity, specificity, AUROC) of individual and combined methods will be assessed using logistic regression and machine learning algorithms to establish an optimized multi-modal screening algorithm.

Periodontitis is highly prevalent and develops from plaque-induced gingivitis. Managing gingivitis is key to preventing periodontitis and its complications. Professional mechanical plaque removal (PMPR) with oral hygiene guidance is effective for gingivitis, but large-scale implementation-especially in China-faces challenges such as workforce shortages. Meanwhile, patient compliance with daily oral hygiene remains poor. An optimal oral care regimen featuring an intelligent electric toothbrush (i-Brush) has shown promise in enhancing self-care adherence and efficiency. However, it remains unclear whether PMPR is still necessary when used in conjunction with this optimal oral care regimen. This study aims to verify whether the i-Brush-based regimen is non-inferior to the combination of PMPR and the regimen in improving gingival inflammation in gingivitis and stage I periodontitis.

Periodontitis is a major public health issue in China: it is responsible for loss of masticatory function in 60 million older adults, and 400-500 million adults are on the same disease trajectory. In addition, gingivitis and early-stage periodontitis are highly prevalent in all age groups. The Lancet 2021 burden of disease study provides worrying projections for China's oral health, with a 47.8% increase in advanced-stage periodontitis and a 217% increase in edentulism by the year 2050. The numbers are not manageable by the Chinese health system unless a series of coordinated actions are implemented: i) health education promoting oral hygiene in school and the workplace; ii) effective AI-based self-detection strategies and accurate identification of high-risk subjects; iii) efficient treatment modalities; and iv) reorganization of the health system. We have developed, patented, and validated a self-detection AI-based screening test for the general population through an app. It is based on a few validated questions and the performance of a lateral flow immunoassay to detect activated matrix metalloproteinase 8 (aMMP8). The algorithm enables accurate self-detection of severe periodontitis. The system, however, cannot identify subjects without clinically evident periodontitis (subjects who present with superficial inflammation consistent with gingivitis and incipient periodontitis) who will develop the disease, which, therefore, should be the target of early interventions. This limitation is due to insufficient knowledge of the process that turns superficial inflammation (gingivitis) into periodontitis. This limitation is apparent in the recently published NIH-sponsored American diagnostic trial results to detect periodontitis onset biomarkers (and progression). In their study, Teles et al. (2024) show that almost 24% of gingivitis subjects progress to periodontitis over a 12-month period but failed to identify salivary or serum biomarkers. Similarly, our recently completed study (Li et al. in preparation) did not identify highly accurate biomarkers for disease onset and progression. Importantly, the American and our study have tested putative biomarkers identified based on the current crude knowledge of the disease process. Gaps in fundamental knowledge are now apparent and limit our ability to detect periodontitis early. In addition, the current crude differential diagnosis based on clinical examination with a periodontal probe with millimeter markings cannot accurately differentiate gingivitis from early-stage periodontitis, complicating the ground truth definition (gold standard). In the current study, we propose implementing a multi-omics approach to test the ability to discriminate a mixed population of clinically undifferentiable gingivitis and stage I periodontitis into two or more clusters. In this biomarker discovery phase, we plan to use multiple state-of-the-art methods: i) laser scanning microdissection proteomics of tissue biopsies, ii) conventional salivary proteomics, iii) tissue biopsy transcriptomics, and iv) shotgun microbiome analysis. The methods will be applied in an agnostic approach to test the following hypotheses: 1. It is possible to identify two or more clusters of subjects from a mixed population of gingivitis and stage I periodontitis subjects. 2. The clusters differ based on host-derived biomarkers and/or microbiome factors and the risk of progression to periodontitis. 3. The biomarker pathways and microbial virulence factors among subjects identified according to the different approaches used to explore disease biology are generally consistent. 4. It is possible to identify a limited set of biomarkers that can be used to predict periodontitis onset and thus target early interventions for this high-risk population.

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.

This study aimed to compare the efficacy (live birth rate) of fresh embryo transfer on Day 2 versus Day 3 in POSEIDON Group 4 patients, and to determine the optimal timing of embryo transfer for this population. It is a single-center, parallel-group, open-label prospective randomized controlled trial, and outcome assessors are masked. The main questions it aims to answer are: Is there a significant difference in the live birth rate between Day 2 and Day 3 fresh embryo transfer in patients with POSEIDON Category 4 low prognosis? What are the differences in secondary outcomes (including clinical pregnancy rate, ongoing pregnancy rate, implantation rate, embryo utilization rate, miscarriage rate, incidence of moderate/severe OHSS, and adverse neonatal outcomes) between the two embryo transfer timings, and which timing is safer and more effective for this patient population? A total of 470 patients meeting the POSEIDON Category 4 criteria will be enrolled and randomly assigned to the Day 2 Fresh Embryo Transfer Group and the Day 3 Fresh Embryo Transfer Group in a 1:1 ratio using stratified block randomization. Researchers will compare the two groups to clarify the difference in live birth rate (primary outcome) and other secondary outcomes, so as to determine the optimal embryo transfer timing. Participants will: * Be female patients aged ≥ 35 years with antral follicle count (AFC) \< 5 or anti-Müllerian hormone (AMH) \< 1.2 ng/mL, undergoing the first or second IVF/ICSI cycle, receiving controlled ovarian hyperstimulation (COH) with the GnRH antagonist protocol, and having ≥ 1 oocyte retrieved (excluding those using donor oocytes/sperm, with uterine cavity abnormalities, or complicated with severe underlying diseases). * Be randomly assigned to either the Day 2 Fresh Embryo Transfer Group or the Day 3 Fresh Embryo Transfer Group, and receive embryo transfer according to the corresponding group's protocol * Receive routine luteal support treatment after embryo transfer * Attend follow-up visits at multiple time points (on the day of transfer, 12-15 days after transfer, 28 days after transfer, during pregnancy, and after delivery) to collect relevant clinical and laboratory data for outcome assessment. * Undergo safety evaluation throughout the study; the study will adopt intention-to-treat (ITT) as the main statistical method and per-protocol (PP) as the sensitivity analysis, with subgroup analysis by age, AMH level, and number of oocytes retrieved, following ethical norms and data quality control requirements.

This prospective diagnostic study aims to validate the clinical utility of a "Periodontal Panoramic Map" generated by the PerioAI V2.0 system, an artificial intelligence-based platform that integrates intraoral scans and cone-beam CT data, for preoperative diagnosis and surgical planning in patients with moderate to severe periodontitis (Stage II-IV). Current clinical standards-manual probing and two-dimensional radiography-have inherent limitations in accurately visualizing complex three-dimensional bone defect morphology, leading to potential underestimation of disease severity and suboptimal surgical outcomes. Building upon our team's previously published high-precision PerioAI V1.0 system, this study will enroll 80 patients requiring periodontal surgery. Preoperative intraoral scans and cone-beam CT images will be acquired as part of routine care, and the PerioAI V2.0 system will automatically generate a "Periodontal Panoramic Map" with intelligent outputs including probing depth, clinical attachment loss, bone defect morphology classification, furcation involvement grading, and automated measurements of key parameters such as intra-bony defect depth and width. These automated diagnostic results will be compared against the gold standard of full mouth clinical examination and intra-operative direct measurements and observations obtained during periodontal surgery under strict blinded conditions. The primary outcome measures are the accuracy of bone defect morphology classification and the agreement between automated and intra-operative linear measurements assessed by intraclass correlation coefficients and Bland-Altman analysis. Secondary outcomes include accuracy of probing depth, clinical attachment loss, periodontitis staging and grading, furcation involvement grading and treatment planning. This study will provide critical evidence supporting the paradigm shift in periodontal surgery from experience-dependent assessment to data-driven precision medicine, ultimately offering clinicians an intuitive, quantitative, and three-dimensional visualization tool for optimized surgical decision-making.

The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site. Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \[MR\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.

The goal of this clinical trial is to evaluate the effect of laser assisted hatching (LAH) on pregnancy outcomes, with live birth rate as the primary outcome, in advanced age infertile women aged ≥35 years who are undergoing non-donor IVF/ICSI cycles and planning vitrified-warmed embryo transfer. It also aims to monitor the safety of LAH and assess various secondary pregnancy and neonatal outcomes. The main questions it aims to answer are: Does laser assisted hatching improve the live birth rate in advanced age women undergoing vitrified-warmed embryo transfer? Does laser assisted hatching affect secondary outcomes including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, ectopic pregnancy rate, ongoing pregnancy rate, miscarriage rate, multiple pregnancy rate, preterm birth rate, and rates of obstetric and neonatal complications as well as congenital anomalies? Researchers will compare the Laser Assisted Hatching (LAH) Group to the Control Group (without LAH) to see if LAH can improve pregnancy outcomes in the study population. Participants will: * Be randomly assigned to either the LAH Group or the Control Group at a 1:1 ratio, stratified by age (\<40 years/≥40 years) and embryo stage (cleavage stage/blastocyst) using stratified block randomization. * Undergo the first or second frozen-thawed embryo transfer cycle, with transferred embryos meeting the quality criteria (cleavage-stage embryos: Grade I, Grade II, or CP and above; blastocysts: 4BC/CB and above). * Receive embryo vitrification and warming after routine fertilization and culture; LAH Group will undergo LAH (thinning zona pellucida for cleavage-stage embryos, removing 1/4-1/3 of zona pellucida circumference for blastocysts) in G2 medium after embryo thawing, while Control Group will not receive assisted hatching. * Have endometrial preparation by natural, ovulatory, or hormone replacement cycles as appropriate, and 1-2 viable embryos will be transferred under ultrasound guidance within 3 hours after thawing, followed by routine luteal support after transfer. * Complete follow-up at multiple time points: 12-15 days after embryo transfer (serum β-hCG test), 28 days after embryo transfer (transvaginal ultrasound), 12 weeks of gestation (ultrasound), 28 weeks of gestation (ultrasound), and 1 month after delivery (collection of delivery and neonatal information). * Provide demographic, clinical, and embryological baseline data, as well as various outcome data during the study period. * Undergo regular monitoring of vital signs, laboratory test results, and adverse events, with key prevention and control of specific risks related to LAH such as embryo damage and multiple pregnancy.

This is a single-center, double-blind, randomized controlled study. The patients were divided into control group and experimental group, 80 cases each. From the first day of radiotherapy to the end of radiotherapy, the experimental group was treated with 24 grams of taurine granule (containing 4.8 grams of taurine) before each day's radiotherapy. The control group was treated with the same amount of placebo.