Clinical trials

This is a multicenter, prospective, single-arm, open-label exploratory clinical study evaluating sintilimab combined with neoadjuvant chemotherapy, concurrent chemoradiotherapy, and optional consolidation chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma. Eligible participants will receive one cycle of sintilimab plus XELOX induction therapy, followed by sintilimab plus capecitabine concurrent radiotherapy. Optional consolidation with sintilimab plus XELOX may be administered according to treatment response, toxicity recovery, nutritional status, surgical feasibility, and multidisciplinary team assessment. Patients who are considered suitable for surgery will undergo radical resection and regional lymph node dissection. The primary endpoint is pathological complete response rate.

The goal of this study is to learn if a weight management program can improve the overall health of college students. The main questions it aims to answer are: * Can a weight management program help college students improve their physical health, such as weight, blood pressure, and blood sugar? * Can the program also improve students' daily habits, like eating and exercise, and their emotional well-being? Researchers will compare students who take part in the weight management program with students who do not, to see if the program makes a difference. Participants in the program will: * Take part in regular sessions about healthy eating, physical activity, and weight management. * Receive support and guidance from trained staff. * Complete surveys and health checks before and after the program. This study is for college students who want to manage their weight and improve their health. Taking part may help students build healthier habits and feel better. The study will also help researchers understand how to design better health programs for college students in the future.

To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.

Prostate cancer is a common malignancy in men, with rising incidence worldwide. Current clinical risk assessment tools-including PSA, Gleason score/ISUP grade, pathological stage, margin status, perineural invasion, and postoperative PSA kinetics-cannot fully explain the marked heterogeneity in disease progression, recurrence, and treatment response, highlighting the need for novel microenvironment-based biomarkers. Emerging evidence has identified intratumoral microbiota as a component of the tumor microenvironment in various solid tumors (e.g., breast, lung, ovarian, pancreatic, and melanoma), where microbial signals correlate with immune infiltration, inflammation, drug metabolism, and patient outcomes. However, the composition, spatial distribution, and immune-related roles of intratumoral microbiota in prostate cancer remain poorly characterized. Given that prostatic tissue resides at the urogenital junction and is continuously exposed to urine, prostatic fluid, and local inflammation, it is plausible that microbial components influence local immunity and tumor behavior. Importantly, intratumoral microbiota represent low-biomass samples, highly susceptible to contamination from reagents, environment, and laboratory procedures. Therefore, this study incorporates rigorous quality controls-including negative controls, process blanks, batch records, contaminant identification, spatial localization validation, and cross-platform verification-to ensure data reliability. Using residual tissue specimens, archived pathological slides, and comprehensive clinicopathological data from prostate cancer patients, we will employ 16S rRNA sequencing, metagenomic/metatranscriptomic sequencing, spatial transcriptomics, spatial proteomics, immunofluorescence, immunohistochemistry, and bioinformatic analyses to profile intratumoral microbiota. Our specific objectives are: (1) to compare microbial composition, abundance, and diversity among tumor, adjacent-normal, and benign tissues; (2) to validate spatial localization of candidate microbial signals via in situ hybridization, immunohistochemistry, and spatial omics; (3) to assess differences in immune cell infiltration, macrophage polarization, T-cell exhaustion markers, and inflammatory pathways between microbe-high and microbe-cold regions; (4) to explore associations between microbial features and Gleason score/ISUP grade, stage, perineural invasion, margin status, postoperative PSA changes, biochemical recurrence, and other clinical outcomes; and (5) to establish a standardized workflow for low-biomass intratumoral microbiome research in prostate cancer. This study aims to provide new insights into microenvironmental heterogeneity and to lay a foundation for identifying prognostic biomarkers and potential therapeutic targets.

Prostate cancer is a common malignancy in men, with substantial prognostic heterogeneity that calls for improved risk stratification at the tissue microenvironment level. Perineural invasion (PNI) is a frequent pathological feature in prostate cancer, associated with local aggressiveness and postoperative recurrence; however, its microenvironmental characteristics and prognostic value remain incompletely characterized. This study plans to enroll approximately 120 prostate cancer patients, collecting tissue specimens and clinicopathological data. We will integrate HE/WSI pathological images, Xenium spatial transcriptomics, PhenoCycler-Fusion spatial proteomics, whole-exome sequencing, and single-cell transcriptomics to systematically compare PNI-positive regions, PNI-negative tumor regions, and adjacent-normal regions in terms of cellular composition, spatial proximity relationships, molecular pathway activities, and genomic alterations. The objectives are to screen candidate molecular markers associated with PNI burden, local invasion, and poor postoperative outcomes, and to explore the establishment of a PNI classification and prognostic risk assessment model based on spatial multi-omics features, thereby providing a foundation for individualized risk stratification and further mechanistic studies in prostate cancer.

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

The goal of this interventional study is to develop and preliminarily evaluate a solution-focused model-based intervention program for reducing social isolation in elderly patients with diabetic foot ulcers. It will also learn about the feasibility and safety of the intervention program. The main questions it aims to answer are: Does the solution-focused intervention program effectively reduce social isolation levels in elderly patients with diabetic foot ulcers? What effects does the intervention have on patients' foot self-care behaviors, social participation, social support, depressive symptoms, and glycemic control? Researchers will compare an intervention group (receiving the solution-focused intervention combined with routine nursing care) to a control group (receiving routine nursing care only) to see if the intervention program works to alleviate social isolation in this population. Participants will: Complete a set of validated questionnaires (including assessments of social isolation, foot self-care behaviors, social support, social participation, and depressive symptoms) and undergo fasting blood glucose measurement at four time points: baseline, after 3 intervention sessions, at intervention completion, and 1-month post-intervention Attend 5 weekly sessions (0.5 -1 hours each) of the solution-focused intervention program, which follows five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation (intervention group only) Receive routine nursing care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions (both groups)

The goal of this clinical trial is to evaluate the effectiveness of a shared decision-making (SDM) intervention program based on the Ottawa Decision Support Framework in adult patients with type 2 diabetes (aged ≥18 years, without severe complications). The main questions it aims to answer are: * Does the intervention improve patients' decisional self-efficacy compared to usual care? * Does the intervention enhance patients' actual participation in treatment decision-making? * Does the intervention reduce diabetes-related distress? * Does the intervention improve diabetes self-management behaviors? Researchers will compare the intervention group (receiving the SDM intervention plus usual care) with the control group (receiving usual care only) to see if the intervention leads to significantly better outcomes in decision self-efficacy, decision participation, diabetes distress, and self-management. Participants will: * Receive a Question Prompt List (QPL) handbook and be guided by a nurse to mark their most concerning questions. * Attend face-to-face educational sessions covering disease basics, medication comparisons, lifestyle adjustments, and complication prevention. * Engage in shared decision-making discussions with physicians, nurses, and family members to co-develop a personalized treatment plan. * Complete follow-up assessments at 4 weeks and 6 weeks after discharge via telephone or outpatient visit, including questionnaires on decision participation, self-efficacy, satisfaction, diabetes distress, and self-management behaviors.

Excessive screen use and anxiety symptoms in preschool children have become increasingly prominent public health problems. This randomized controlled trial aims to determine whether, compared with a control group, an ecological momentary parenting intervention delivered via text messages and a WeChat public account can reduce screen use, anxiety symptoms, and social-emotional behavior problems in preschool children. A total of 356 caregiver-child dyads with children aged 3 to 6 years will be randomly assigned to an intervention group with 178 dyads or a control group with 178 dyads. The intervention group will receive an ecological momentary parenting intervention, including text messages and posts on a WeChat public account, focusing on guidance for emotion recognition, anxiety soothing, establishing regular routines, and reasonable screen use management. The control group will receive only general pediatric health science popularization text messages, which do not include content related to child emotion management, anxiety intervention, or screen use management. The primary outcome is children's anxiety symptoms, assessed by the Spence Preschool Anxiety Scale. Secondary outcomes include children's screen use assessed by the ScreenQ scale and social-emotional behavior problems assessed by the Social Competence and Behavior Evaluation Scale-30 (SCBE-30)

To investigate the intervention effect of high-definition transcranial alternating current stimulation (HD-tACS) on patients with Non-suicidal Self-injury (NSSI) and its underlying neural mechanism by magnetic resonance imaging (MRI).

Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.

This study focuses on adolescent boxing athletes as the research subjects, employing the Attention Network Test to systematically investigate the effects of one-year boxing training on the attentional functions of adolescent athletes and their developmental patterns over time. Through a randomized controlled trial design, this study aims to reveal the association between boxing exercise and attention, thereby providing scientific and quantifiable empirical evidence for optimizing specialized training and protective measures for this population. Additionally, the Attention Network Test employed in this study is capable of sensitively capturing subtle changes in attentional networks, and may thus serve as a reference and provide insights for future research investigating the relationship between other combat sports and attention.

Evaluate the safety and efficacy of personalized network-guided transcranial magnetic stimulation for treating behavioral and psychological symptoms in patients with Alzheimer's disease.

The goal of this clinical trial is to evaluate whether an evidence-based anti-inflammatory dietary intervention can reduce inflammation and improve glycemic control in patients with type 2 diabetes mellitus (T2DM). T2DM is a chronic metabolic disease characterized by elevated blood glucose levels and is closely associated with chronic low-grade inflammation. The main questions it aims to answer are: Does an anti-inflammatory dietary intervention reduce levels of hs-CRP, a key marker of chronic inflammation, in patients with T2DM? Does the intervention improve dietary inflammatory index (DII) scores and glycemic outcomes, including fasting blood glucose and 2-hour postprandial blood glucose? Researchers will compare an anti-inflammatory diet intervention group to a standard diabetes dietary control group to determine whether the anti-inflammatory dietary pattern provides additional benefits beyond routine dietary management. Participants will: Be randomly assigned to either the anti-inflammatory diet group or the standard diabetes diet group Receive dietary guidance based on structured anti-inflammatory food recommendations or routine diabetes dietary advice Complete dietary assessments, including 24-hour dietary recalls to calculate dietary inflammatory index (DII) Provide blood samples to measure hs-CRP, fasting blood glucose, and 2-hour postprandial blood glucose at baseline and after 4 weeks Complete questionnaires on dietary adherence and quality of life Participate in a 4-week intervention period with follow-up assessments

The goal of this study is to learn if a classroom-based physical activity program can improve academic self-efficacy in university students. The main question it aims to answer is: Do students who take part in classroom-based physical activities have higher academic self-efficacy scores than students who do not? Researchers will compare students in classrooms that do the physical activity program to students in classrooms that continue their usual class routine (no extra activities). Participants will: If in the activity group: take part in one time per day, five times a week, a total of eight weeks during regular classes. If in the control group: attend classes as normal. Complete a questionnaire about their academic self-efficacy.

NSSI behavior is highly prevalent among adolescents, and its mechanisms are closely associated with attentional bias toward self-injury-related information and impulsivity, both of which may be related to reduced dlPFC activation levels. Introducing taVNS as a priming stimulus to pre-regulate brain state and optimize subsequent tACS treatment response provides a novel approach to addressing inconsistent intervention effects. Simultaneously, this facilitates a shift in the brain from passive stimulus reception to active state regulation, offering important theoretical foundations for developing more precise and efficient cross-modal neuromodulation therapies.This study aims to systematically validate the efficacy of a combined protocol using taVNS as a priming modality followed by tACS over the left dlPFC through a randomized controlled trial (RCT). The investigators hypothesize that: ① Compared to tACS intervention alone, this combined approach will not only demonstrate non-inferiority in overall therapeutic efficacy but, more importantly, significantly reduce inter-individual variability in treatment response to tACS. This would mitigate the issue of high clinical response heterogeneity and enhance the stability and predictability of treatment outcomes. ② Early behavioral biomarkers of intervention response are anticipated: Immediate improvements in attentional bias following a single combined intervention session will significantly predict reductions in the frequency and intensity of Non-Suicidal Self-Injury (NSSI) after a full course (14 sessions) of treatment. This suggests that early positive changes in cognitive function could serve as valid indicators predicting long-term clinical efficacy, offering a critical time window for implementing individualized treatment adjustments. ③ The study will elucidate the effects of the taVNS-primed combined tACS treatment on neuroimaging mechanisms in adolescents with NSSI.

The purpose of this study is to investigate the effectiveness of a dual-target non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain, to guide the stimulation to two specific targets: the left auditory association cortex and the primary motor cortex (M1). Participants will be randomly assigned to one of two groups. One group will receive active dual-target cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days. Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity.

This study is a prospective, single-center, observational study of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Minimal residual disease (MRD) detection is used to investigate the actual efficacy responses of mHSPC patients with different gene mutation characteristics to treatment regimens. Factors influencing efficacy are further analyzed to provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.

The pathological-omics and imaging-omics in this study are combined to construct an artificial intelligence (AI) model that can predict whether high-risk prostate cancer patients may have lymph node metastasis. The model determines whether the patient has lymph node metastasis based on the MRI results and the pathological section image information of the case combined with clinical data before radical resection of the prostate. This study is a multicenter, prospective clinical study to verify the model's ability to predict whether high-risk prostate cancer patients may have lymph node metastasis.

A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.

This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. The main questions it seeks to address are: Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment? Participants will: Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT). Have structural and resting-state functional MRI scans before and after treatment. Be monitored for any treatment-related adverse events.

The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are: Can 100HZ RAVANS improve apathy in people with PD? Did the participants have any side effects or safety issues when undergoing 100HZ RAVANS? Researchers compared 100HZ RAVANS with sham stimulation (low-dose stimulation of the same site and treatment parameters) to see if 100HZ RAVANS could improve non-motor symptoms in patients with PD. Participants will: Receive 100HZ RAVANS or sham stimulation for 2 weeks. Neuropsychological assessment, imaging and biological sample collection were conducted before and after the entire cycle.

To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on cardiometabolic risk in Chinese adolescents with overweight/obesity and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can improve cardiovascular metabolic health. Participants in the intervention group will receive vitamin D3. The control group will receive vitamin D placebo. Researchers will compare the change in cardiometabolic risk from baseline to post-intervention at 12 weeks between the intervention and control groups.

The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.