CLINICAL DYNAMICS

Study Name: Feasibility and Effectiveness Clinical Study of SIMEOX Airway Clearance Technology in Stable Chinese Bronchiectasis Patients
Site: Zhongshan Hospital, Fudan University
Sponsor: VVR International, Shanghai
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

Study Name: Flow Cytometer and Monoclonal Antibody Reagent Quality Release and Stability Testing Using Peripheral Blood Sample Collection Project
Site: Kunshan Traditional Chinese Medicine Hospital (Kunshan Branch of Jiangsu Traditional Chinese Medicine Clinical Research Institute)
Sponsor: BD Rapid Diagnostic Products Co, Suzhou
HGRAC Approval Time: January 2024

Study Name: Prospective Multicenter Randomized Controlled Study of Radical Surgery Combined with Intraoperative Hyperthermic Intraperitoneal Chemotherapy for High-Risk Peritoneal Metastasis from Colorectal Cancer
Site: Cancer Hospital, Guangzhou Medical University (Guangzhou Cancer Center)
HGRAC Approval Time: January 2024

Study Name: Research on Novel Treatment Targets for Aortic Aneurysm and Dissection Based on Data Mining
Site: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor: Peking University
HGRAC Approval Time: January 2024

Study Name: Prospective, Multicenter Clinical Trial to Evaluate the Effectiveness and Safety of Drug-Coated Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty (PTA) for Arteriovenous Fistula Stenosis in Hemodialysis Patients
Site: Haidian Hospital, Beijing
Sponsor: Acotec, Beijing 
HGRAC Approval Time: January 2024
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

Study Name: Safety and Clinical Effectiveness Evaluation Trial of the LuX-Valve Plus Artificial Tricuspid Valve System in Treating Patients with Severe and Above Severe Tricuspid Regurgitation
Site: Beijing Anzhen Hospital, Capital Medical University
Sponsor: Jenscare Scientific (Netherlands) B.V.
HGRAC Approval Time: January 2024
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

Study Name: Clinical trial on evaluating the safety and efficacy of rigid gas scleral contact lenses (model: KTSL) for astigmatism, myopia, or hyperopia correction
Site: 5 sites, Eye hospital of Shandong First Medical University; Tian Jin Eye Hospital; Liao Ning Aier Eye Hospital; He Bei General Hospital; Tian Jin Medical University Eye Hospital 
Sponsor: Tianjin Shi Ji Kang Tai Biomedical Engineering Co.,Ltd
Target Disease: Astigmatism, myopia, hyperopia
Study Type: Interventional study
Study Design: Parallel 
Study Objective: The purpose of this study is to evaluate the safety and effectiveness of the rigid gas scleral contact lenses (model: KTSL) researched and produced by Tianjin Shi Ji Kang Tai Biomedical Engineering Co.,Ltd. for astigmatism, myopia or hyperopia correction.
Inclusion Criteria: 1.The age of people between 8 years old (included) and 55 years old (included), regardless of gender. And under the age of 18, people need the written consent from their guardian. They voluntarily participate in the trial and sign an informed consent form. 2.The best corrected visual acuity for frame glasses is ≥ 4.0 (standard logarithmic visual acuity chart); 3.The diopter of one or both eyes is -25.00 to+25.00 D (including -25.00 D and+25.00 D), or presence of corneal astigmatism. According to the situation of the subjects, if one eye of the subjects meets the inclusion and exclusion criteria, it will be included in the study. If both eyes of the subjects meet the inclusion and exclusion criteria, they will be included in the study.
Exclusion Criteria: 
1. The density of endothelial cells is less than 2000/mm2 or there is a significant corneal endothelial cell defect; 2. Dry eye syndrome (those with tear film rupture time test results less than 5 seconds); 3.Abnormal intraocular pressure (intraocular pressure<10mmHg or intraocular pressure>21mmHg, or binocular intraocular pressure difference ≥ 5mmHg); 4. Explicit strabismus; 5. Bacterial, fungal, viral and other active corneal infections; 6. People are using drugs that may cause dry eyes, affect the eyeball, affect vision, or affect corneal curvature (such as intraocular pressure lowering drugs); 7.Decreased corneal perception and active corneal lesions; 8.Routine slit lamp microscopy and ophthalmoscopy examination, including corneal diseases, iridocyclitis, chronic uveitis, cataracts, and vitreoretinal related eye diseases or active and progressive diseases (1. vitreous hemorrhage or severe turbidity; 2. retinal vascular diseases; 3. macular diseases; 4. choroidal hemorrhage and inflammatory diseases); 9. Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle related diseases, visual pathway diseases, glaucoma (uncontrollable increase in intraocular pressure), and severe traumatic vitreous loss caused by a large amount of vitreous body damage, which the researchers have determined to affect visual recovery and need to exclude; 10. Patients with systemic diseases that cause low immunity (such as acute and chronic sinusitis, diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, psychotic patients, etc. within one year, or other diseases that researchers believe cannot wear rigid contact lenses; 11. Have a history of allergies to contact lenses or contact lens care solutions; 12. Pregnancy, lactation, or planned pregnancy in the near future; 13. After comprehensively considering the corneal parameters, morphological characteristics, and refractive examination results of the examination results, the researchers believe that subjects who cannot wear rigid contact lenses are not eligible; 14. Those who have worn hard corneal contact lenses within 30 days or those who have worn soft hydrophilic contact lenses within 10 days; 15. Those who participate in clinical trials of other drugs three months before screening, and those who participate in clinical trials of other medical devices within 30 days; 16. Cyclops patients; 17. Individuals with strong foreign body sensation and poor compliance cannot seek timely and regular medical treatment as required; 18. Other situations where the researcher determines that the patient is not suitable for inclusion.
Group 1: Trial group, Wearing rigid gas scleral contact lenses, sample size of 88
Group 2: Control group, Wearing rigid gas scleral contact lenses, sample size of 88
Primary Indicator: The percentage of subjects whose best corrected visual acuity improved by two or more lines (compared to the best corrected visual acuity of frame glasses) or was greater than or equal to 5.0 (standard logarithmic visual acuity chart) with contact lenses
Secondary Indicator: Best corrected visual acuity with contact lenses; diopter
Randomization Procedure: The block randomization method was used for randomization. The PROC PLAN process step in SAS 9.4 was used to generate a random allocation table for subjects. The random seed and block length were specified by the unblinded statistician.
EC Approval Time: 16 May 2022

Study Name: A computer-aid breast cancer adjuvant diagnostic and prognostic prediction system based on deep learning-based multi-omics analysis
Site: Guangdong Provincial People's Hospital
Target Disease: Breast cancer
Study Type: Diagnostic test
Study Design: Sequential
Study Objective: Aiming at the major clinical problem of the difficulty of accurate diagnosis and treatment of breast cancer, this project aims to comprehensively penetrate intelligence into the diagnostic and treatment process of breast cancer. By using deep learning technology to quantify, analyse and integrate the characteristics of multi-omics data to provide intelligent auxiliary diagnostic and treatment suggestions, so as to achieve individualized and accurate diagnostic and treatment of breast cancer, and ultimately to improve the prognosis of the patients.
Inclusion Criteria: ① Contains complete clinical and pathological information; ② Undergo imaging examination prior to any treatment.
Exclusion Criteria: ① Previous history of breast cancer treatment (including: anti-hormonal therapy, targeted therapy, radiotherapy, etc.);② Incomplete or poor quality MRI image;③ History of puncture within 6 months prior to MRI; ④ Failure to complete a full course of neoadjuvant therapy.
Gold Standard or Reference Standard: Pathological result
Index test: A computer-aid multimodal intergrated evaluation system
Target condition: Patients with complete pathological information and pre-treatment imaging. They were divided into groups according to different studies, such as the benign breast lesion group and the malignant breast lesion group.
Sample size: 30000
Primary Indicator: Area under the curve of the receiver operating characteristic
Secondary Indicator: Sensitivity; Specificity
EC Approval Time: 04 March, 2024

Study Name: The effectiveness of Natural Orifice Uterine Suspension for advanced uterine prolapse: A national multicenter study
Site: 13 sites, West China Hospital, Sichuan University; Meishan City People’s Hospital; The First Affiliated Hospital of Chengdu Medical; Shunde Hospital of Southern Medical University; Anhui Medical University Affiliated Maternity and Child Health Hospital; the Affiliated Hospital of Qingdao University; Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital, Zhejiang University School of medicine; The first peoples' hospital of Neijiang; The Affiliated Hospital of Guizhou Medical University; Qinghai Provincial People's Hospital; The First People’s Hospital of Kunming; Yan'an Hospital Affiliated to Kunming Medical University
Target Disease: Pelvic organ prolapse
Study Type: Observational study
Study Design: Retrospective study, Cohort 
Study Objective: To explore the effectiveness and safety of Natural Orifice Uterine Suspension for advanced uterine prolapse.
Inclusion Criteria: 1. patients with advanced uterine prolapse (POP-Q stage >II) who prefer surgical treatment; 2. age ≥65 years old; 3. patients with an atrophic uterus.
Exclusion Criteria: 1. patients with a history of total or partial hysterectomy; 2. patients with any gynaecological malignancy or pathology (e.g., fibroids, adenomyosis, abnormal uterine bleeding, and cervical dysplasia); 3. patients with total or partial trachelectomy; 4. patients with a history of pelvic radiotherapy; 5. patients with a history of lower abdominal or pelvic operation; 6. coagulopathy; 7. any contraindication to general anesthesia surgeries.
Group: Patients underwent the Natural Orifice Uterine Suspension (the Natural Orifice Uterine Suspension), Sample size: 150
Primary Indicator: objective cure; subjective cure
Secondary Indicator: pelvic organ prolapse quantitation score; Pelvic Floor Impact Questionnaire (PFIQ - 7); Pelvic Floor Distress Inventory (PFDI - 20)
Adverse events: complication
EC Approval Time: 07 November, 2023

Study Name: Development and validation of prognostic models based on machine learning for postoperative survival in patients with cervical cancer
Site: West China Second University Hospital of Sichuan University
Target Disease：Cervical Cancer
Study Type: Prognosis study
Study Design: Retrospective study, Sequential
Study Objective: Models for predicting cervical cancer survival was developed and validated using an artificial intelligence machine learning algorithm combined with perioperative data containing anaesthesia related events.
Inclusion Criteria: 1. Patients who underwent radical surgery for cervical cancer in West China Second Hospital of Sichuan University from January 1, 2014 to January 1, 2020 2.ASA grade I-III; 3. The time from operation to death exceeds 1 month
Exclusion Criteria: Non-radical surgery and re-surgery after recurrence
Group: Case series, Sample size: 2000
Primary Indicator: Death
Secondary Indicator: Recurrence       
Additional Indicator: AUROC; DCA; C-index; Briers score
EC Approval Time: 05 July, 2022