Clinical trials

49

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.

Participants needed: 108
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Sep 24, 2026Locations: 1
Eligibility criteria

Patients who are willing to receive neoadjuvant therapy. [+13]

History of other malignant diseases in the past 5 years. [+17]

Status: Recruiting

Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Acute kidney injury (AKI) is a common complication after cardiac surgery using cardiopulmonary bypass, leading to longer hospital stays and worse outcomes. Effective preventive therapies are lacking. This randomized controlled trial investigates whether transcutaneous auricular vagus nerve stimulation (taVNS)-a non-invasive ear stimulation technique-can reduce AKI after cardiac surgery. A total of 152 patients undergoing elective cardiac surgery with cardiopulmonary bypass will be randomly assigned to receive either taVNS or sham stimulation. The intervention begins before surgery and continues daily through postoperative day 5. The primary outcome is the incidence of AKI within 7 days after surgery. Secondary outcomes include AKI severity, need for dialysis, kidney function recovery, complications, and inflammatory biomarkers. This study is approved by the institutional ethics committee. All participants will provide written informed consent.

Participants needed: 152
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Sep 10, 2026Locations: 1
Eligibility criteria

Age ≥18 years [+6]

Solitary kidney, history of kidney transplantation, pre-existing renal replaceme... [+8]

Status: Recruiting

Electroacupuncture at ST36 for Reducing Postoperative Inflammation After Cardiac Surgery With Cardiopulmonary Bypass

Cardiac surgery using cardiopulmonary bypass can trigger a marked systemic inflammatory response and may contribute to postoperative organ dysfunction and delayed recovery. Electroacupuncture at the Zusanli acupoint (ST36) may regulate inflammatory responses, but its clinical effects in patients undergoing cardiac surgery remain uncertain. This prospective, randomized, parallel-group study will enroll 140 adults undergoing elective cardiac surgery with cardiopulmonary bypass. After surgery and admission to the intensive care unit, participants will be randomly assigned in a 1:1 ratio to receive either bilateral ST36 electroacupuncture or a control procedure involving the same acupoint localization, skin disinfection, needle insertion, and needle retention without electrical stimulation. Both groups will receive standard postoperative care. The intervention will be administered twice for 30 minutes per session. The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary outcomes include the duration of vasoactive drug use, incidence and severity of systemic inflammatory response syndrome, duration of mechanical ventilation, length of intensive care unit and hospital stay, and perioperative inflammatory markers. The study will evaluate whether ST36 electroacupuncture can reduce postoperative inflammation and organ injury and improve recovery after cardiac surgery.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Sep 8, 2026Locations: 1
Eligibility criteria

Age ≥18 years. [+3]

Membership in a vulnerable population other than older adults or individuals who... [+13]

Status: Not yet recruiting

Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC

Ulcerative colitis (UC) is a chronic, relapsing inflammatory disease of the colon that causes diarrhea, bleeding, and abdominal pain. Mesalazine (5-aminosalicylic acid) is the current standard first-line treatment for mild-to-moderate UC, but many patients do not respond well enough, and some experience side effects. Etrasimod is an oral, selective sphingosine-1-phosphate (S1P) receptor modulator that helps reduce gut inflammation by keeping immune cells from moving into the intestinal wall. This study will test whether etrasimod works better than mesalazine in Chinese adults with active UC. The study plans to enroll about 320 patients from multiple hospitals across China. Eligible participants are adults aged 18 years or older with active UC, defined by a modified Mayo score of 3 to 6 (including specific endoscopic and bleeding criteria). Both newly diagnosed patients (within the past 4 weeks, with no prior UC treatment) and those who had an inadequate response, intolerance, or non-standard use of conventional therapies-but who have never taken biologics or other small-molecule drugs-may join. Patients will be randomly assigned in a 1:1 ratio to receive either etrasimod 2 mg once daily or mesalazine (starting at 4 g/day for 12 weeks, then at least 2 g/day based on response) for 24 weeks. Randomisation will balance important factors like steroid use and baseline endoscopic severity. The primary research objective is whether more patients on etrasimod achieve clinical remission at week 24. Clinical remission means no rectal bleeding, normal or near-normal stool frequency, and an endoscopic score of 1 or less (without easy bleeding). The study will also measure other benefits, such as symptom improvement, endoscopic healing, normalisation of blood and stool inflammation markers, bowel ultrasound response, tissue healing, and quality of life using standard questionnaires. Safety will be carefully tracked by recording all adverse events during treatment and follow-up. This is an open-label study (patients and clinical staff know which drug is given) to reflect real-world practice, but the clinical staff who read the colonoscopy results and tissue samples will not know the treatment assignment. An independent statistician will analyse the results. One interim analysis is planned to check for early evidence of benefit or futility. The study involves 24 weeks of treatment, with visits at baseline, week 6, week 12, and week 24, plus a 4-week safety follow-up. Sample size calculation indicates that 320 participants (160 per group) will provide 90% power to detect a clinically important difference, accounting for a 30% dropout rate. The primary analysis will compare remission rates between groups, adjusting for the stratification factors. All findings will be published to share knowledge with the medical community and help guide future treatment decisions for UC patients in China.

Participants needed: 320
Trial details
Phase: Phase 4Age: 18-100Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Aug 24, 2026
Eligibility criteria

Male or female, aged 18 years or above. [+3]

Subjects with contraindications to etrolimod or mesalazine. [+6]

Status: Recruiting

Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are: Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery. Participants will: Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days. Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.

Participants needed: 190
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Aug 14, 2026Locations: 2
Eligibility criteria

Age ≥ 65 years old. [+4]

Previous history of abdominal gastrointestinal surgery. [+10]

Status: Not yet recruiting

Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.

Participants needed: 236
Trial details
Age: 40-80Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Aug 6, 2026Locations: 4
Eligibility criteria

Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) w... [+5]

Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmona... [+4]

Status: Recruiting

Group-based IMPROVE Therapy for Problematic Internet Use in University Students

Problematic internet use (PIU) is a growing behavioral health concern among university students. This study aims to evaluate the effectiveness and psychological mechanisms of "IMPROVE," a manualized, multimodal group-based psychotherapy. The IMPROVE program integrates cognitive-behavioral strategies with motivational elements, mindfulness training, and socially interactive exercise. In this randomized controlled trial, 600 university students with moderate to severe PIU will be randomized to either the 8-week IMPROVE intervention or an enhanced waitlist control group. The primary outcome is the change in PIU severity, assessed by the Internet Addiction Test (IAT) score, from baseline to the post-intervention endpoint (8 weeks).

Participants needed: 600
Trial details
Age: 18-30Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Aug 5, 2026Locations: 2
Eligibility criteria

be university students aged between 18 and 30 years; [+3]

a self-reported history of substance use (excluding tobacco and alcohol) within... [+3]

Status: Not yet recruiting

PTSD Risk Prediction Model for EICU Survivors

Brief Title: PTSD Risk Prediction Model for EICU Survivors Official Title: Development and Validation of a Risk Prediction Model for Post-Discharge Post-Traumatic Stress Disorder in Emergency Department-Admitted EICU Survivors Study Type: Observational Brief Summary: This study aims to develop and validate a risk prediction model for post-traumatic stress disorder (PTSD) at 1 month after hospital discharge in adult survivors of emergency intensive care unit (EICU) care. PTSD is a common and serious psychological condition that can occur after a life-threatening medical event. Many EICU survivors experience persistent stress responses, sleep problems, avoidance behaviors, and difficulty returning to normal life after leaving the hospital. This prospective observational cohort study will enroll approximately 800 adult patients who are admitted to the EICU through the emergency department at Sir Run Run Shaw Hospital and other participating centers. Participants will be followed up at 1 month after EICU discharge to complete the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a diagnostic interview for PTSD. Clinical data collected during the emergency department stay and EICU course-including vital signs, laboratory tests, treatments, and severity of illness-will be used to build statistical models to predict which patients are most likely to develop PTSD. The study does not involve any experimental treatments or additional procedures beyond routine clinical care. Results from this study may help healthcare providers identify high-risk patients early and provide timely psychological support and follow-up care. Detailed Description: Background: Advances in critical care medicine have enabled an increasing number of emergency critical care patients to survive to ICU or hospital discharge. However, a substantial proportion of survivors experience persistent psychological sequelae, including post-traumatic stress disorder (PTSD), which significantly impairs quality of life. Patients admitted to the EICU via the emergency department are exposed to multiple stressors during the early phase-sudden life-threatening illness, pain, hypoxia, altered consciousness, mechanical ventilation, sedation, and separation from family-which may serve as important risk factors for subsequent PTSD. Objectives: To develop and validate a risk prediction model for predicting 1-month post-discharge PTSD in adult patients admitted to the EICU via the emergency department. Study Design: This is a prospective observational cohort study conducted at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (coordinating center) and multiple other centers. Study Population: Adult patients (≥18 years) admitted to the emergency department and subsequently transferred to the EICU, with an ICU length of stay of at least 24 hours, who survive to EICU discharge and have a Glasgow Coma Scale score ≥12 at discharge or follow-up. Sample Size: Approximately 800 patients (approximately 200 per center if 4 centers participate), calculated based on an estimated 25% PTSD prevalence at 1 month post-discharge, with 6-8 candidate predictors, expected Nagelkerke R² of 0.15, target shrinkage of 0.90, and accounting for 15%-20% attrition. Data Collection: All variables are routine clinical observation and laboratory parameters, categorized into six domains: (1) baseline susceptibility variables (demographics, social support, psychiatric history, trauma history, prior ICU admission, substance use, chronic disease burden); (2) emergency admission phase variables (mode of admission, severity, vital signs, etiology, early labs, emergency treatments); (3) first 24 hours in EICU variables (severity scores, organ support, sedation/analgesia, neurological status, nursing exposures, early complications); (4) cumulative EICU exposure variables (duration of organ support, cumulative sedation/analgesia, mechanical ventilation duration, physical restraints, delirium, infections, major complications); (5) disease process and treatment-related variables (severe infection, respiratory failure, AKI, ARDS, transfusion, emergency surgery, intubation, CPR); and (6) 1-month post-discharge follow-up (CAPS-5 diagnostic PTSD assessment). Primary Outcome Measure: CAPS-5-diagnosed PTSD at 1 month post-EICU discharge. Statistical Analysis: Three types of prediction models will be developed: (1) an early model using variables available within the first 6 hours from emergency department presentation to EICU admission; (2) a discharge-updated model adding ICU exposure, treatment interventions, complications, and pre-discharge information; and (3) a dynamic digital model further adding post-discharge electronic follow-up and digital phenotyping data. Candidate modeling approaches include logistic regression, LASSO/ElasticNet penalized regression, random forest, gradient boosting trees, XGBoost/LightGBM, and support vector machines. Model performance will be evaluated for di

Participants needed: 800
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sir Run Run Shaw HospitalUpdated: Aug 5, 2026Locations: 1Duration: 1 Month
Eligibility criteria

Age ≥ 18 years [+6]

Voluntary withdrawal by the participant [+5]

Status: Not yet recruiting

Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients

Problematic mobile phone use is excessive dependence and use of electronic products and their functions, which affects the daily life of users. Previous studies have shown that mobile phone addiction is related to depression, anxiety severity, and stress, and it is negatively correlated with sleep quality. For hospitalized patients in the mental health department, symptoms such as anxiety, depression, and poor sleep are very common. Cognitive behavioral therapy has been widely applied in online gaming addiction and is also effective in intervening in mobile phone addiction. Therefore, Hospitalized patients in the mental health department will be randomized to either the CBT interventions or an control group. The main outcome measure is the Simplified Smartphone Addiction Scale (SAS-SV), measured before intervention and after the completion of the last brief intervention.

Participants needed: 140
Trial details
Age: 14+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Jul 29, 2026Locations: 1
Eligibility criteria

Age ≥ 14 years old. [+2]

Having serious physical or mental illnesses (such as ongoing psychotic symptoms,... [+3]

Status: Not yet recruiting

Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials

The primary aim of this study is to evaluate the predictive value of the inspiratory regional diaphragmatic synchrony index (RDSI-insp) during PSV-SBT for first-attempt weaning failure. Secondary objectives include: (1) assessing the correlation between RDSI-insp and conventional respiratory mechanics and diaphragmatic ultrasound parameters such as RSBI, MIP/NIF, VC, CPF, P0.1, DE, and DTF; (2) comparing differences in RDSI and DPSI between successful and failed weaning groups during inspiration, end-inspiration, and expiration; (3) exploring the association of anterior diaphragmatic dyssynchrony index, posterior/crural dyssynchrony index, and regional time-to-peak dispersion with weaning outcomes; and (4) evaluating the feasibility, analyzable image rate, and repeatability of diaphragmatic speckle-tracking and RDSI calculation in patients undergoing PSV-SBT.

Participants needed: 110
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sir Run Run Shaw HospitalUpdated: Jul 29, 2026
Eligibility criteria

Age: Age ≥ 18 years. [+4]

Known or highly suspected phrenic nerve injury, or unilateral/bilateral diaphrag... [+6]

Status: Recruiting

Effectiveness of DITM Versus IMT in COPD Patients

The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1/FVC \< 60%). The main questions it aims to answer are: Does DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength. Participants will: DITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback. IMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training. DITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions. Control Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.

Participants needed: 410
Trial details
Age: 40+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Jul 24, 2026Locations: 9
Eligibility criteria

Diagnosed as COPD according to "GOLD2024" [+4]

Unstable angina or severe arrhythmia [+9]

Status: Not yet recruiting

End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study

This study proposes the End-expiratory Diaphragmatic Residual Contraction (EDRC) index to quantify residual diaphragmatic activity at end-expiration during Pressure Support Ventilation (PSV) mode. The study aims to validate the relationship between EDRC and dynamic intrinsic PEEP (PEEPi), triggering load, patient-ventilator asynchrony, and PEEP responsiveness through a brief, standardized PEEP titration trial conducted within a clinically safe range. This will provide a basis for subsequent individualized PEEP setting guided by EDRC.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sir Run Run Shaw HospitalUpdated: Jul 13, 2026
Eligibility criteria

Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure S...

Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, str...

Status: Not yet recruiting

Application of Multimodal Intervention in the Prevention of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery

1. Background Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia, with an incidence as high as 80% in gynecological laparoscopic surgery. Transcutaneous electrical acupoint stimulation (TEAS) has shown potential as a non-invasive, side-effect-free intervention. Combining pharmacological agents (dexamethasone or amisulpride) with TEAS may provide a synergistic preventive effect, aligning with enhanced recovery after surgery (ERAS) principles. 2. Study Objectives To evaluate the preventive effect of TEAS on PONV in patients undergoing gynecological laparoscopic surgery, compared with sham stimulation. To explore the synergistic effect of dexamethasone or amisulpride when combined with TEAS, and to optimize PONV prevention strategies. To assess the impact of multimodal intervention on postoperative recovery quality, length of hospital stay, and patient satisfaction. To evaluate the safety of the combined interventions and record any adverse events. 3. Study Design Design type: 2×2 factorial, randomized, double-blind (participants, outcome assessors, and data analysts blinded to group assignment). Randomization: 1:1:1:1 allocation using an online randomization tool. 3.1 Study Groups Group Intervention A TEAS + Dexamethasone B TEAS + Amisulpride C Sham stimulation + Dexamethasone D Sham stimulation + Amisulpride 3.2 Participants Inclusion criteria: Age 18-65 years; ASA physical status I-II; scheduled for elective gynecological laparoscopic surgery (e.g., ovarian cystectomy, myomectomy) under general anesthesia; willing to provide informed consent. Exclusion criteria: Severe cardiac, hepatic, renal, or pulmonary disease; allergy or skin disease at TEAS application site; Receipt of antiemetics within 24 h before surgery; Implanted cardiac pacemaker, cardioverter-;pregnancy or lactation; vulnerable populations (e.g., critically ill, psychiatric disorders, cognitive impairment, illiteracy); any condition deemed unsuitable by the investigator. 3.3 Interventions A wearable transcutaneous electrical acupoint stimulation (TEAS) wristband will be applied to the P6 (Neiguan) acupoint on the dominant upper extremity. The P6 acupoint is located approximately 3-5 cm proximal to the distal wrist crease, between the tendons of the flexor carpi radialis and palmaris longus. The device integrates the stimulating electrodes within the wristband and does not require external adhesive electrodes. TEAS or sham stimulation will be administered at three time points: 30 minutes before surgery and 24 and 48 hours after surgery, with each session lasting 30 minutes. Dexamethasone 5 mg (off-label for PONV; approved for inflammatory/allergic conditions). Amisulpride 5 mg. 3.4 Outcome Measures Primary outcomes (0-48 h postoperatively): PONV incidence (proportion of patients with nausea, vomiting, or retching). PONV severity (0 = none, 1 = nausea only, 2 = vomiting/retching, 3 = refractory nausea/vomiting). Secondary outcomes: Recovery quality: time to first flatus, first ambulation, hospital stay, bowel function recovery. Patient satisfaction: Visual Analogue Scale (VAS, 0-10) and QoR-15 score (0-150). Rescue antiemetic use. Management needs for severe PONV. Postoperative pain (VAS at rest and on movement) and opioid consumption. Device-related adverse events (skin irritation, burning, allergy). Drug-related adverse events (e.g., hyperglycemia, hypotension, headache, dizziness, QT prolongation). Intraoperative hemodynamics and postoperative complications (e.g., infection, shivering, urinary retention). 3.5 Follow-up Schedule Postoperative day 1 (24 h): PONV assessment, time to first flatus and ambulation. Postoperative day 2 (48 h): PONV incidence/severity, rescue medication. At discharge: Satisfaction, hospital stay (via in-person or telephone follow-up). 4. Sample Size Calculation Assumptions: PONV incidence 50% in control groups, 30% in TEAS groups; two-sided α = 0.05; power = 80%. Each main effect level requires \~93 patients. For a 2×2 factorial design with 1:1:1:1 allocation, this translates to 47 patients per group (total 188). Accounting for a 10% dropout rate, final sample size = 212 patients (53 per group). 5. Data Management and Confidentiality Electronic Data Capture (EDC) system with unique coding (no direct identifiers). Access restricted to authorized research team members. 6. Informed Consent Written informed consent will be obtained from each participant after full explanation of the study purpose, procedures, risks, and benefits. Participants are informed of their right to withdraw at any time. 7. Adverse Event Management Dexamethasone-related AEs (transient hyperglycemia, blood pressure fluctuation, gastrointestinal discomfort, rare allergic reactions). Amisulpride-related AEs (headache, dizziness, constipation/diarrhea, QT prolongation, allergic reactions). TEA-related AEs (local skin discomfort, redness, itching, rare blisters or mild burns).

Participants needed: 212
Trial details
Age: 18-65Biological sex: FemaleType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Age 18-65 years; [+3]

Severe cardiac, hepatic, renal, or pulmonary disease; [+4]

Status: Not yet recruiting

Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies

This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.

Participants needed: 34
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: May 20, 2026
Eligibility criteria

Participants who have signed a written Informed Consent Form (ICF); [+7]

Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcino... [+6]

Status: Not yet recruiting

Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations

This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.

Participants needed: 164
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: May 20, 2026
Eligibility criteria

Age ≥ 18 years old, both genders are eligible. [+6]

Within the 3 months prior to enrollment, the participant has not participated in... [+11]

Status: Not yet recruiting

The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma

(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Local control status is defined as the local failure rate (occurrence of local recurrence or local lymph node metastasis).

Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Apr 7, 2026
Eligibility criteria

1) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically co...

1) Received PD1, PDL1, PDL2, CTLA4 treatment before enrollment, or directly rece...

Status: Not yet recruiting

Decision-making and Optimization of Ventilatory Support for AECOPD Patients

The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are: 1. How are different respiratory support modalities selected for patients with AECOPD in real-world practice? 2. What clinical patterns are associated with escalation, de-escalation, switching, or discontinuation of respiratory support during hospitalization? Researchers will review de-identified hospital records of patients admitted with AECOPD and analyze the dynamic use of respiratory support during hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, non-invasive ventilation, and invasive mechanical ventilation. Participants will not receive any study-assigned intervention. The study will use existing clinical data collected during routine inpatient care and will not change diagnosis, treatment, or follow-up.

Participants needed: 1,000
Trial details
Biological sex: AllType: ObservationalSponsor: Sir Run Run Shaw HospitalUpdated: Apr 2, 2026Locations: 1
Eligibility criteria

Hospitalized patients with a documented diagnosis of acute exacerbation of chron... [+3]

Patients admitted primarily for other acute conditions, including but not limite... [+3]

Status: Recruiting

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is: Can Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation? Participants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result. If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. Regardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.

Participants needed: 846
Trial details
Phase: Phase 4Age: 18-80Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Apr 2, 2026Locations: 5
Eligibility criteria

Age 18-80 years (inclusive); [+2]

Valvular atrial fibrillation or paroxysmal atrial fibrillation [+15]

Status: Recruiting

Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study

Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure. Primary Research Questions To characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure. To assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure. Secondary Research Questions Feasibility and inter-operator reproducibility of diaphragmatic speckle tracking. Assessment of the Diaphragmatic Contraction Synchrony Index. Evaluation of End-Diaphragmatic Residual Contraction (EDRC). Additional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Mar 25, 2026Locations: 2
Eligibility criteria

Age ≥18 years old. [+3]

Severe chest wall deformities or diaphragmatic paralysis. [+3]

Status: Recruiting

Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE

Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem. A new combination drug, Aztreonam-Avibactam (we'll call it ATM-AVI), has been developed to fight these tough bacteria. This new drug was recently approved for use in Europe (April 2024), the United States (February 2025), and China (June 2025). Because it is so new, there is very little information available, especially in China, on how well it works for real patients outside of initial testing. This lack of real-world experience means we don't know enough about: * How effective it is for typical patients in China. * The types of patients and infections it is used for. * How it affects a patient's time in the hospital. This study aims to fill these gaps by looking at how ATM-AVI performs in Chinese hospitals, which will help doctors better treat these dangerous infections and improve patient recovery. What the Study Aims to Find Out Main Goal: To see how well ATM-AVI works for adult patients in China with these specific antibiotic-resistant infections. Other Goals: To gather more details about: * How patients are responding to the treatment at different points (e.g., after 5 days, at the end of treatment, and at a follow-up check). * Whether the bacteria causing the infection are cleared. * How the treatment affects the patient's hospital stay and use of resources. * The number of patients who, unfortunately, pass away during or after treatment. * The characteristics of the patients (like age) and their infections. * How doctors are using this new drug and if it's used alongside other antibiotics. How the Study Will Work This is an observational study that will be conducted in about 30 hospitals across China. We plan to include around 100 adult patients who were hospitalized with these tough infections and received the new drug, ATM-AVI, for at least one full day. The study will run from October 2025 to June 2027. We will look at both past (retrospective) and future (prospective) patients. For past patients, we will review their existing medical records. For future patients, we will ask for their permission (informed consent) before collecting any information. We will collect information from patient records, such as: * Basic patient details and the nature of their infection. * How and when the ATM-AVI drug was used. * Details about their hospital stay. * The results of their lab tests. A doctor will assess and record how each patient is doing at key points: 5 days after starting the drug, at the end of the treatment, and at a follow-up check to see if the infection is cured.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sir Run Run Shaw HospitalUpdated: Mar 23, 2026Locations: 2
Eligibility criteria

1. Age 18 years or older 2. Hospitalized with a diagnosis of confirmed cIAI or H...

1. Confirmed or suspected infection caused by Gram-negative species not expected...

Status: Not yet recruiting

Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins

The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are: Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies? Participants will: Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination. Record their symptoms

Participants needed: 206
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Mar 3, 2026Locations: 21
Eligibility criteria

Not listed

Status: Recruiting

The Hi-tACS on Cognitive Function in Patients With Schizophrenia

This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Mar 2, 2026Locations: 2
Eligibility criteria

Meets the diagnostic criteria for schizophrenia according to DSM-5. [+5]

Psychotic disorders caused by split affective disorder, bipolar disorder, intell... [+7]

Status: Not yet recruiting

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma

This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy. Main Questions This Trial Aims to Answer: 1. Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)? 2. What are the safety and tolerability profiles of the combination therapy? 3. Does the treatment improve disease-free survival at 1 year after treatment? What Participants Will Do: Treatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting. Treatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen. Follow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy. Outcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Feb 6, 2026Locations: 1
Eligibility criteria

Aged 18-70 years (inclusive). [+14]

Cachexia or multiple organ failure. [+17]

Status: Recruiting

Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer

This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor ("lymph-node-sparing" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1/CTLA-4 immune checkpoint inhibitors. Two weeks after completing chemo-immunotherapy, tumor response is assessed. Patients who achieve a clinical complete response may enter a "watch-and-wait" program; others will undergo local excision or total mesorectal excision (TME) as appropriate. The primary endpoint is the rate of complete response (clinical and pathological). Secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life measures. Results from a pilot study suggest that this regimen may substantially improve complete response rates while reducing radiation-related toxicity, potentially allowing more patients to avoid radical surgery and permanent stoma.

Participants needed: 52
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Patients who have a strong willingness to preserve the anus and are willing to r... [+6]

Patients with a previous history of malignant tumors besides rectal cancer. [+11]

Status: Recruiting

Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma

Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma

Participants needed: 33
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sir Run Run Shaw HospitalUpdated: Nov 24, 2025Locations: 1
Eligibility criteria

(1) 18~75 years old (including boundary values). [+11]

(1) The pathological diagnosis is non hepatocellular carcinoma. [+16]