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NCT ID: NCT05913024 Completed - Healthy Volunteers Clinical Trials

Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.

NCT ID: NCT05912816 Recruiting - Clinical trials for Upper Urinary Tract Urothelial Carcinoma

Combination of RC48 and Tislelizumab for Renal Preservation in High-risk UTUC Patients

Start date: June 10, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, open, single-center clinical study of renal preservation therapy in high-risk upper urinary tract urothelial carcinoma patients . The study was conducted in accordance with the Good Practice for Quality Control of Clinical Trials for Pharmaceutical Products (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (2.0 mg/kg intravenously every 3 weeks) combined with Tislelizumab (200mg intravenously every 3 weeks).

NCT ID: NCT05912738 Recruiting - Clinical trials for Shear Wave Elastography

Muscle Elasticity Assessment of Postherpetic Neuralgia Using Elasticity Ultrasound

Start date: August 14, 2023
Phase:
Study type: Observational [Patient Registry]

Herpes zoster (HZ), also known as shingles, is caused by the varicella-zoster virus (VZV). Approximately 1/4 of the global population is affected by HZ, with statistics showing that about 90% of shingles patients experience acute neuralgia, and about 1/3 develop postherpetic neuralgia (PHN) after shingles. In PHN patients, about 30%-50% of the pain can persist for more than one year, and some cases can last for more than 10 years. PHN is a common complication of HZ characterized by intense pain in the area where the rash has healed, often described as burning, electric shock-like, or stabbing pain, severely affecting patients' sleep, emotions, work, and daily life. Additionally, approximately 43% of PHN patients exhibit symptoms of toxic anxiety or depression, significantly impacting their quality of life and increasing the societal burden. Due to the global aging population, the incidence of HZ and PHN is expected to significantly increase in the next 10 years, making effective prevention and treatment of PHN an urgent health issue. Although various treatments are available for PHN, a small number of patients remain unresponsive to multiple therapies, resulting in treatment-resistant chronic pain. The lack of a clear understanding of the underlying mechanisms contributes to the suboptimal treatment outcomes for PHN. Elastography, a technique that quantifies the mechanical properties of tissues by measuring their natural elasticity, trauma, degeneration, and healing processes, has shown promise as an innovative approach. Shear wave elastography (SWE) has been used to study the biomechanical characteristics of skeletal muscles by measuring the propagation speed of shear waves induced by ultrasound to quantify the shear elastic modulus, which characterizes the stiffness of soft tissues. In this study, the investigators intend to use elastography to observe the elasticity of muscle tissue in the lesions of PHN patients, with the unaffected side serving as a control. Elastography offers non-invasive, convenient, and straightforward advantages, further contributing to providing new directions for treatment and revealing the role of muscle tissue in PHN by offering new evidence. It also offers new treatment options and targets for PHN patients.

NCT ID: NCT05912712 Not yet recruiting - Clinical trials for Ulcerative Colitis Chronic Moderate

Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers

Start date: July 1, 2023
Phase: Phase 1
Study type: Interventional

Ulcerative colitis (UC) is a chronic persistent inflammatory disease. The lesions are mainly confined to the large intestine and continuously affect the rectum and part or all of the colon. Its histological characteristics are diffuse neutrophil infiltration in the lamina propria of the colon mucosa, mucosal erosion, ulcer, cryptitis, and crypt abscess. The most common clinical manifestations are abdominal pain, diarrhea, and bloody mucopurulent stool, accompanied by extraintestinal manifestations such as mouth, skin, joints, and eyes. Severe lesions can be complicated by toxic megacolon, intestinal perforation, lower gastrointestinal hemorrhage, intraepithelial neoplasia, and cancer, so surgical treatment is necessary. Studies have reported that UC patients have a 10-year cumulative recurrence risk of 70%-80%, nearly 50% of patients require UC-related hospitalization, and the 5-year risk of re-hospitalization is ~ 50%. The 5-year and 10-year cumulative risk of patients undergoing colectomy is 10%-15%, which dramatically endangers the health of patients and reduces the quality of life of patients. Currently, the commonly used medical treatment drugs for UC patients include 5-aminosalicylic acid, topical and systemic glucocorticoids, immunomodulators, anti-tumor necrosis factor drugs, and other biological agents. The most commonly used optimization methods are drug escalation therapy and combining drugs with different mechanisms. The real-world data results of an initial population-based cohort study from six Asian countries showed that the endoscopic mucosal healing rate of patients with ulcerative colitis in the first year of diagnosis was 38.2%, and the histological mucosal healing rate was 23.1%. It can be expected that the mucosal healing rate of patients with moderate to severe UC may be lower. Long-term chronic recurrent diseases may lead to poorer quality of life, extended hospital stays, heavier financial burdens, and more physical and mental pain. Therefore, optimizing the treatment plan for patients with moderate to severe UC needs more exploration and research. Autologous Platelet-rich plasma (A-PRP) is A platelet-rich concentrate obtained by centrifugation of whole blood. As a concentrated source of autologous platelets, they contain a large number of Growth factors (GF) and cytokines, such as platelet-derived Growth factor (PDGF), transforming growth factor β(TGF-β), vascular endothelial growth factor (VEGF) and epithelial growth factor (EGF), which regulate cell function. Such as attachment, macrophage migration, proliferation, and differentiation, promote extracellular matrix accumulation and ultimately improve tissue healing and regeneration. At the same time, A-PRP has A lower risk of adverse reactions such as immune rejection and allergy due to its isolation from autologous blood. After PRP is induced by activators such as calcium and thrombin, activated platelets degranulate immediately and secrete multiple high concentrations of growth factors. 70% of the growth factors can be released within 10 minutes of activation, and more than 95% can be released within the first hour. Platelet-rich Gel (PG), which can embed growth factors to improve clinical efficacy, keeps platelets and their release products in the target wound area and promotes healing. Although the safety and efficacy of PRP still need to be fully confirmed by large-scale clinical trials, its sound effect has been verified in many clinical practices and basic scientific research in cell culture and animal models. At present, it mainly includes the treatment of oral and maxillofacial external, musculoskeletal system, plastic skin, and chronic wounds (such as pressure ulcers, venous leg ulcers, diabetic foot ulcers, etc.). They can be mixed into bone grafts, sprayed on soft tissue surfaces as a biofilm, or made into eye drops. The use of PRP in intestinal mucosal ulcers has rarely been reported. There are no prospective randomized studies of its clinical use in patients with ulcerative colitis. Therefore, we planned to conduct a prospective, randomized, double-blind, controlled clinical trial to investigate the efficacy and safety of repeated treatment with autologous platelet-rich plasma gel on an intestinal mucosal ulcer in patients with moderate to severe UC involving the rectum in Xijing Hospital, China IBD Regional Center. To provide a new option for remission induction therapy in patients with moderate to severe ulcerative colitis.

NCT ID: NCT05912686 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

This project investigates the impact of statins on cerebral vascular wall damage after mechanical thrombectomy. The investigators will undertake a multi-center, prospective, parallel-controlled, open-label, superiority randomized controlled study based on past research on intense lipid-lowering intervention trials. Patients undergoing post-thrombectomy will be divided into two groups: the test group and the control group. After surgery, the test group will be given a high dose of atorvastatin (80mg/day), followed by a standard dose (20mg/day). The control group will continue to receive the standard dose of atorvastatin (20mg/day). The investigators will compare the high-resolution vascular wall MRI characteristics (vascular wall enhancement, lumen stenosis rate, and so on) within 3-5 days of the operation, as well as the composite incidence of ischemic stroke, transient ischemic attack, intracranial hemorrhage 1 month postoperatively, and the modified Rankin Score at 90 days.

NCT ID: NCT05912582 Not yet recruiting - Clinical trials for Stage IVA Nasopharyngeal Carcinoma

Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma

Start date: June 25, 2023
Phase:
Study type: Observational

This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in stage IVa nasopharyngeal carcinoma.

NCT ID: NCT05912296 Recruiting - Hyperlipemia Clinical Trials

A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022

Start date: May 17, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously administered RBD7022 in participants with normal or elevated LDL-c cholesterol. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in participants. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information in each cohort.

NCT ID: NCT05912114 Recruiting - Clinical trials for Bowel Cleansing; Good Taste

Effectiveness of Mannitol Versus Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

Start date: June 10, 2023
Phase: N/A
Study type: Interventional

For patients with inadequate bowel preparation, current guidelines recommend either remedial measures or rescheduling the endoscopy, but previous surveys have found that approximately 30% of patients do not follow medical advice to reschedule the examination if it is rescheduled, while those who take remedial measures on the same day are more compliant, so remedial measures may be a better option than rescheduling the examination. As for the remedy regimen, it has been demonstrated that oral PEG is superior to the enema regimen in terms of bowel cleansing, but PEG is very resistant to be taken by most patients due to its poor taste and the larger doses required, resulting in poor bowel preparation and poor compliance. In contrast, oral mannitol has the advantages of small dose and good taste, and patient compliance may be higher.

NCT ID: NCT05912049 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects

Start date: July 26, 2023
Phase: Phase 1
Study type: Interventional

This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

NCT ID: NCT05912010 Recruiting - Pneumonia Clinical Trials

A Study on Pathogenic Surveillance and Nasopharyngeal Carriage of Children and Adolescents Based on Hospitals and Communities in Hainan Province

Start date: April 24, 2023
Phase:
Study type: Observational

This study intends to screen children under the age of 10 for respiratory pathogens, Streptococcus pneumoniae, and serotyping in three representative cities in Hainan province: Haikou, Wanning, and Baisha, in order to provide a foundation for the subsequent promotion of Streptococcus pneumoniae vaccines.