View clinical trials related to Efficacy.
Filter by:The goal of this a clinical trial is to learn about the efficacy，safety and Pharmacokinetics of Hepenofovir Fumarate Tablets（HTS） in patients with CHB. The main questions it aims to answer are： 1. Evaluate the efficacy and safety of multiple doses of continuous administration of HTS in patients with chronic hepatitis B, and compare it with Tenofovir alafenamide Fumarate tablets（TAF）. 2. To evaluate the pharmacokinetic characteristics of HTS in patients with chronic hepatitis B after multiple oral administration. 3. To evaluate the pharmacodynamic changes of HTS in patients with chronic hepatitis B after multiple consecutive administrations, and compare it with TAF. Positive control drug：Tenofovir alafenamide Fumarate tablets（25mg/d） Test drug：Hepenofovir Fumarate Tablets（10mg/d、20mg/d、40mg/qod） Test process：This study was divided into 4 groups, with the specific list shown below. The initial plan was to include 12 subjects in each group, stratified by HBeAg status, with 4 subjects negative for HBeAg and 8 subjects positive for HBeAg. A total of 48 subjects were included in this trial, and they were randomly assigned to multiple doses at a ratio of 1:1:1:1. The dosing period was 24 weeks. However, after enrolling 37 subjects (29 positive for HBeAg and 8 negative for HBeAg), the protocol was adjusted (V4.0): the remaining 11 subjects would be included, all of whom were over 30 years old with ALT < ULN and met all the inclusion criteria but none of the exclusion criteria. The random assignment was: 7 subjects positive for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 2:2:2:1; and 4 subjects negative for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 1:1:1:1.
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter. Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria. This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.
Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes. It is the leading cause of nontraumatic lower-extremity amputations while the conventional treatment is not effective. Therefore, new therapeutic methods are urgently needed. Cell therapy has shown unique advantages and potential in tissue regeneration and wound repair, and is considered as a new effective method to treat diabetic foot. Meanwhile, human cord blood-derived mononuclear cells (HCB-MNCs) with its sufficient sources, strong ability of proliferation and differentiation, and weak immunogenicity, is suitable for the treatment of diabetic foot. It is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of local injection of HCB-MNCs in the treatment of refractory diabetic foot.
Kirsten rat sarcoma (KRAS) mutation is one of the most common genetic mutations associated with tumor development in various human cancers, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Previous studies have shown that KRAS mutations are present in approximately 70% of pancreatic cancer patients, 35% of colorectal cancer patients, 20% of non-small cell lung cancer patients, and 15% of cervical cancer patients. Patients with KRAS mutations generally have a shorter overall survival and increased resistance to treatment compared to wild-type tumors. KRAS mutations have been known for decades, but they have been considered "undruggable" as effective therapies targeting them were lacking. Preclinical studies focusing on colorectal and non-small cell lung cancer cell lines have suggested that colorectal cancer cell lines exhibit a stronger response to EGFR signaling and activation of multiple RTKs (Receptor Tyrosine Kinases) than non-small cell lung cancer cell lines. As a result, they show poorer responses to KRAS G12C inhibitors, leading to the development of initial and acquired resistance to KRAS G12C inhibition. Based on this hypothesis, a phase 1-2 clinical trial, known as the KRYSTAL-1 study, was conducted in patients with metastatic colorectal cancer. The study demonstrated that the objective response rate was 19% with adagrasib monotherapy and 46% with the combination of adagrasib and cetuximab (an EGFR inhibitor), indicating that the addition of an EGFR inhibitor can overcome resistance. Building on this hypothesis, a phase 3 trial is currently underway for KRAS G12C inhibition plus EGFR blockade in metastatic colorectal cancer (ClinicalTrials.gov identifiers: NCT04793958, NCT05198934). In this study, the aim is to investigate the efficacy of sotorasib (KRAS G12C inhibitor) plus panitumumab (EGFR inhibitor) in patients with advanced solid tumors harboring KRAS G12C mutations, who have failed standard treatments.
Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.
The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are: - How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? - How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.
1. To evaluate the efficacy and safety of levosimendan in the treatment of heart failure ; 2. Guide patients to apply levosimendan individually and establish a dose adjustment program.
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit. Subject inclusion criteria: A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria: - patients hospitalized in the intensive care unit, - female or male sex, - age over 18 years, - linezolid is prescribed by the attending physician, in empirical or targeted treatment Exclusion criteria: Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent
A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach