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NCT ID: NCT05808374 Recruiting - Chronic Hepatitis B Clinical Trials

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

Start date: April 30, 2023
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.

NCT ID: NCT05808140 Recruiting - Disc Herniation Clinical Trials

Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

Start date: April 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary. In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots. The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.

NCT ID: NCT05807659 Recruiting - Clinical trials for Myeloid Malignancies

Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies

Start date: March 16, 2023
Phase: Phase 2
Study type: Interventional

The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are: - The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT. - The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT. Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2, cytarabine 1g/m2,d-6~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.

NCT ID: NCT05807347 Recruiting - Clinical trials for Refractory/Relapse Acute Myeloid Leukemia

Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

NCT ID: NCT05807217 Recruiting - Sepsis Clinical Trials

A Pharmacokinetics Study of Meropenem and Piperacillin in Patients With Sepsis

APSOMAPIPWS
Start date: October 26, 2022
Phase:
Study type: Observational

This study was a single-center, open clinical study in Chinese septic patients with or without acute kidney injury. The aims of this study were to obtain the blood concentration and pharmacokinetic parameters of meropenem and piperacillin, exosome information and endogenous biomarker, and to explore the functional changes of OATs under the condition of sepsis and acute kidney injury.

NCT ID: NCT05806736 Recruiting - Parkinson Disease Clinical Trials

Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Non-motor Symptoms of PD

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study is a double-blind comparative study examining the curative effect and mechanism of the transcutaneous auricular vagus nerve stimulation treatment on non-motor symptoms of Parkinson's disease patients. The investigators hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve the non-motor symptoms, such as improving sleep, and improve cortical activity simultaneously in Parkinson's disease patients.

NCT ID: NCT05806580 Recruiting - Clinical trials for Relapsed or Refractory B-cell Lymphoma

Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma

Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.

NCT ID: NCT05806333 Recruiting - Liver Cancer Clinical Trials

[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

NCT ID: NCT05806125 Recruiting - Cervical Cancer Clinical Trials

Clinical Value of the Fertility-preserving Surgery in Cervical Cancer

Start date: January 1, 2023
Phase:
Study type: Observational

Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. Patients in the postoperative group will undergo computed tomography angiography (CTA) after surgery and patients in the preoperative group will undergo CTA before RT. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.

NCT ID: NCT05806099 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL

Start date: June 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)