Taiyuan

Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early clinical effects of BNT3212, both alone and combined with pumitamig, in adults with advanced solid tumors who have exhausted other treatment options. This first-in-human, open-label study includes dose escalation and expansion phases to find the best dose and assess how the treatments work across different tumor types. The study is divided into four parts Part A and Part B focus on BNT3212 as a single therapy, with dose escalation followed by dose expansion in specific tumor types. Parts C and D evaluate the combination of BNT3212 with a fixed dose of pumitamig, again starting with dose escalation and then expansion cohorts. Treatments are given by intravenous infusion, and doses are adjusted to find the maximum tolerated dose and recommended dose for further study. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels and immune reactions, and imaging to measure tumor response. Researchers will track side effects, treatment interruptions, and response rates over approximately 31 months. The study also measures progression-free and overall survival. Continuous evaluation of safety and clinical data supports participant well-being throughout the trial.

Researchers are conducting a Phase III study to evaluate the safety, tolerability, dose-limiting toxicity DLT, maximum tolerated dose MTD, and recommended Phase II dose RP2D of WJB001 capsules in patients with advanced solid tumors. The study includes multiple phases dose escalation, dose expansion, and cohort expansion, aiming to understand the drugs initial efficacy, safety, and pharmacokinetic characteristics. During the dose escalation phase, accelerated titration was used for the first two dose groups, followed by a Bayesian optimal interval BOIN combination method for later dose groups. In the dose expansion phase, one to two doses were selected based on previous data to confirm the RP2D and further evaluate efficacy and safety. The cohort expansion phase plans to expand two to three patient groups using the Simon two-stage optimal method. Participants will undergo screening, treatment, and follow-up periods. Researchers will assess dose-limiting toxicities over 21 days and monitor adverse events, serious adverse events, objective response rate, and survival outcomes for up to three years. Pharmacokinetic measurements including peak time, plasma concentration, clearance rate, and half-life will be collected at specific time points during treatment cycles. This extensive monitoring aims to understand WJB001s effects and determine appropriate dosing for future studies.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are evaluating CNSI-Fe, an innovative anti-cancer drug containing Fe2 loaded on carbon nanoparticles, in people with advanced solid tumors. CNSI-Fe works by regulating a cell death process called ferroptosis and aims to improve cancer treatment through intratumoral injections. This Phase IbIIa study follows an initial Phase I trial where different doses showed promising safety and disease control in various advanced solid tumor patients. Participants will receive CNSI-Fe injections directly into 1 to 3 tumor lesions every two weeks for a total of 4 doses, with the possibility of additional doses if the benefits outweigh risks. The study includes a screening period, treatment period, and follow-up phase. Tumor response and safety will be closely monitored, and injections will stop or switch lesions based on tumor shrinkage or disappearance. During the study, participants will undergo safety checks before each dose and tumor evaluations at specified intervals, including before the third dose, after the fourth dose, and every six weeks thereafter. Follow-up includes safety monitoring 28 days after the last dose and regular checks for disease progression until new treatment, death, or study end. Samples will be collected at scheduled visits to assess safety, drug levels, and anti-tumor effects.

Researchers are conducting a multicenter, ambispective cohort study to collect and analyze samples and data from patients with acute ischemic stroke caused by large vessel occlusion AIS-LVO. The study aims to build a comprehensive biobank including thrombi, intracranial blood, peripheral arterial and venous blood, along with clinical, laboratory, imaging, and follow-up information. This will help explore differences in blood samples and develop a detailed multiomics profile related to stroke. Samples such as blood clots and blood from different sites undergo pathological, metabolomic, proteomic, and genomic tests for multidimensional analysis. The study collects data from five stroke centers and includes pathological and histological examination of thrombus samples for some patients. Researchers plan to use these findings to identify stroke causes, therapeutic targets, risk factors, and prognosis by creating prediction models based on the combined multiomics data. Participants provide clinical and biological samples, and their health status is monitored through clinical and imaging evaluations over time. The primary outcome measured is the number of patients experiencing futile recanalization from enrollment to three months follow-up. Secondary outcomes include stroke causes, hemorrhagic transformation within seven days, and infarct expansion at baseline. The study is observational and involves no experimental treatments, focusing on data and sample collection to advance stroke research.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating a modified acupotomy technique guided by ultrasound to treat ankylosing spondylitis AS. This randomized controlled trial aims to assess the safety and effectiveness of this new method in reducing disease activity and improving clinical outcomes for people with AS. The study also seeks to provide evidence-based support to improve diagnosis and treatment standards for this condition. Participants will be randomly assigned to one of two groups. One group receives ultrasound-guided acupotomy targeting specific vertebral ligaments once a week for four sessions over three weeks. The other group receives a sham procedure mimicking the treatment process without actual tissue release to maintain blinding. Both groups undergo baseline assessments before treatment begins. Throughout the study, participants will complete assessments including the Bath Ankylosing Spondylitis Disease Activity Index at the start and after four weeks. Additional measures such as functional ability, disease activity scores, quality of life, pain levels, and medication use will be monitored at several points up to eight weeks. These evaluations help researchers understand treatment effects while ensuring participant safety during and after the intervention period.

The trial focuses on hospitalized children aged 0 to 18 years who require gastric tube placement, aiming to improve practices in pediatric enteral nutrition. Researchers are evaluating evidence-based methods to enhance safety and effectiveness in tube placement by addressing gaps between current practices and the latest guidelines. This quality improvement project seeks to update healthcare professionals knowledge and standardize procedures to improve pediatric care quality. The study involves establishing an enteral nutrition management team that will lead a 3-month quality improvement initiative. During this time, pediatric nurses will receive regular training through lectures, group discussions, demonstrations, and simulations focused on gastric tube placement and maintenance. The project will observe changes in compliance with protocols and nursing knowledge as the new practices are implemented. Participants will be monitored through assessments of protocol adherence and knowledge levels before and after the intervention. Data collected will include compliance rates with gastric tube placement protocols and the personal knowledge of nursing staff. The study aims to ensure safer and more effective tube placement, with evaluations conducted throughout the 3-month implementation period and ongoing support for nurses.

Researchers are investigating the differences in biomarker expression in various sample types between healthy individuals and different subgroups of Combined Allergic Rhinitis and Asthma Syndrome CARAS. The study aims to identify potential biomarkers using a simple, direct, and objective approach, focusing on those identifiable by Chinese medicine symptoms and disease stages to support personalized diagnosis and treatment. This observational study is sponsored by Henan University of Traditional Chinese Medicine and involves adults aged 18 to 80 years. Participants are divided into several groups based on disease status, including acute exacerbation CARAS, chronic persistence CARAS, clinical control CARAS, acute exacerbation bronchial asthma BA, chronic persistence BA, clinical control BA, intermittent allergic rhinitis AR, persistent AR, and healthy individuals. No interventions are performed instead, relevant patient information, blood samples, and exhaled breath condensate are collected. Subjects also complete questionnaire surveys as part of data collection. During the study, participants provide blood and exhaled breath condensate samples and complete questionnaires to assess various biomarkers such as interleukin-2 variants, interferon-gamma, tumor necrosis factor-beta, eosinophil cationic proteins, and immunoglobulin E at baseline. Secondary measures include fractional exhaled nitric oxide, lung function tests like forced expiratory volume in one second and forced vital capacity. The study monitors these markers to better understand CARAS, with participation lasting until May 30, 2025.

Researchers are evaluating the long-term treatment of liver fibrosis in patients with chronic viral hepatitis B. This Phase IIIb extension trial builds on a previous randomized, double-blind, placebo-controlled study that assessed hydronidone capsules. The aim is to assess how effective and safe hydronidone capsules are over an extended period in managing liver fibrosis progression and reducing clinical endpoint events related to liver disease. Participants receive either hydronidone capsules or placebo capsules three times daily, with each dose consisting of three capsules taken half an hour before meals. Both groups also receive entecavir antiviral therapy once daily, or an alternative antiviral if entecavir is unsuitable. The treatment period in this extension trial lasts for five years, continuing the original protocol from the prior Phase III study. Throughout the study, participants undergo regular assessments including clinical laboratory tests every six months, evaluation of liver enzymes ALT and AST, hepatitis B viral load measurement, and transient elastography to monitor liver stiffness. The researchers track the cumulative incidence of clinical endpoint events over five years to evaluate treatment outcomes. The study also allows some flexibility in the frequency of examinations to improve participant compliance while maintaining at least yearly evaluations.