Linfen

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon compared to the standard care of percutaneous coronary intervention (PCI) using drug eluting stents (DES) or balloon angioplasty in patients with new (de novo) coronary lesions in native coronary arteries. This prospective, multicenter, open-label, randomized controlled trial seeks to provide insight into treatment strategies for coronary arterial disease in this patient group. The study also includes pharmacokinetic (PK) and intravascular ultrasound (IVUS) sub-studies to gather additional data. Participants will be randomly assigned to receive either the AGENT Drug-Coated Balloon or standard PCI treatment, which may include any commercially available drug eluting stent or balloon angioplasty, especially for bifurcation side branches. The study focuses on successful lesion pre-dilation before treatment. Interventions are delivered during the PCI procedure, aiming to treat the target lesion effectively while avoiding stent placement when possible. The trial also ensures treatment of any non-target lesions first, if necessary. During the study, participants will undergo evaluations including angiographic imaging to confirm lesion characteristics and success of the procedure. Follow-up assessments will monitor the primary outcome of target lesion failure (TLF) rate at 12 months. Safety monitoring includes evaluating cardiac function, screening for adverse events, and ensuring adherence to follow-up visits. Women of child-bearing potential must use contraception throughout the study and for 12 months afterward. The total duration of participation includes the initial procedure and follow-up evaluations over one year.

Researchers are evaluating the combination of anlotinib hydrochloride capsules and penpulimab injection as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after radical surgery or ablation. This phase 3, randomized, double-blind, placebo-controlled study aims to compare this combination treatment against a placebo to assess its effect on recurrence-free survival (RFS). Participants will receive either anlotinib hydrochloride capsules combined with penpulimab injection or matching placebos. The study focuses on patients who have undergone radical excision or ablation (radio frequency or microwave) within 4 to 12 weeks before randomization and have high risk factors for recurrence. The investigational drugs target multiple pathways: anlotinib hydrochloride as a multitargeted receptor tyrosine kinase inhibitor and penpulimab as an antibody targeting PD-1. Throughout the study, participants will be monitored for recurrence-free survival up to 3 years from baseline. Eligibility assessments ensure participants have no extrahepatic metastasis or vascular invasion and have recovered from surgery or ablation. The study includes careful tracking of disease status and safety, with follow-up visits to evaluate the treatment's impact on preventing cancer recurrence over time.

Researchers are evaluating the effects of remimazolam, a new benzodiazepine, on patients undergoing bladder cancer surgery. Bladder cancer is a common genitourinary cancer, and most cases are nonmuscle invasive. The standard treatment is transurethral resection of bladder tumor (TURBT), but patients remain at risk for cancer recurrence and progression. Benzodiazepines have shown the ability to inhibit cancer cell growth in laboratory studies, but some studies suggest they may increase postoperative delirium. This study aims to explore how remimazolam affects emergency delirium and long-term recurrence-free survival after bladder cancer surgery. Participants receive general anesthesia with either remimazolam or propofol given intravenously. The dose is adjusted to maintain a specific brain activity level (BIS value between 40 and 60). Pain relief is provided with remifentanil and/or sufentanil, and muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation may be added if needed. Both drugs are used during anesthesia induction and maintenance to compare their impact on patient outcomes. During the study, participants are monitored for delirium in the first two hours after surgery while in the post-anesthesia care unit. Researchers will also track recurrence-free survival for up to three years. Evaluations include brain function monitoring, clinical assessments, and follow-up visits. The study is designed to gather safety data and long-term outcomes to understand how the choice of anesthetic may influence recovery and cancer prognosis.

Researchers are comparing two types of total intravenous anesthesia—remimazolam and propofol—in patients who are at moderate to high risk and undergoing major elective noncardiac surgery under general anesthesia. This Phase 4 randomized controlled trial aims to determine if using remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery compared to propofol. The study focuses on patients aged 45 years and older with specific health risks undergoing surgeries expected to last more than 2 hours with postoperative stays longer than 2 days. Participants receive either remimazolam or propofol administered intravenously for both induction and maintenance of general anesthesia during their surgery. The trial is conducted across multiple centers and involves strict criteria to select patients with conditions such as coronary artery disease, stroke history, heart failure, diabetes, or other listed risks. The study excludes patients undergoing certain types of surgeries or with severe organ dysfunction to ensure safety and appropriate comparison. During the study, researchers will monitor patients for 30 days after surgery, focusing on the primary outcome of days alive and out of the hospital. Safety and recovery will be closely tracked, including the need for postoperative ventilatory support and any complications during the hospital stay. The total involvement includes surgery and follow-up assessments to evaluate the effectiveness and safety of the anesthesia methods in this patient population.

This research aims to explore how high caloric oral nutritional supplements affect growth, weight, body proportions, neuropsychological development, and related health aspects such as gut health, immune function, and quality of life in malnourished children aged 1 to 3 years. It also seeks to evaluate the safety of these supplements. The study addresses a lack of multicenter clinical data in China regarding the benefits of oral nutritional supplements for malnourished children. Participants are divided into two groups through random assignment. The experimental group receives nutritional education plus daily high caloric oral nutritional supplements that provide 30% of their energy needs. The control group receives nutritional education and dietary guidance appropriate to the child's age and condition. Nutritional education is delivered every 4 weeks via WeChat or text messages, while dietary guidance is provided during scheduled visits at 0, 1, 2, 3, 6, and 12 months after enrollment. Throughout the study, researchers collect data on dietary intake, physical growth measurements, developmental scores, quality of life, gut health, infection history, and safety lab tests such as blood and urine analysis. The main outcome measured is the BMI-for-age Z-score at 6 months. Safety is closely monitored, and participants are followed for a total of 12 months. Guardians provide informed consent, and privacy protections are in place for participant data.

Fibromyalgia is a chronic condition marked by widespread pain, fatigue, and emotional difficulties. This research evaluates whether combining pregabalin with venlafaxine provides better pain relief compared to pregabalin alone, aiming to improve treatment outcomes without increasing side effects. The study is motivated by the limited effectiveness and common adverse reactions of current pregabalin treatment and the potential benefits of venlafaxine in managing fibromyalgia symptoms through pain pathway modulation. Participants will be divided into two groups: one receiving pregabalin alone and the other receiving pregabalin combined with venlafaxine. Pregabalin treatment starts at 150 mg per day in two doses, increasing to 300 mg after one week, with possible further increases up to 450 mg based on response and tolerance. The combination group starts venlafaxine at 75 mg daily, with potential weekly increases of 75 mg to a maximum of 225 mg, alongside the same pregabalin dosing schedule. During the study, researchers will monitor participants’ pain intensity over four weeks to assess effectiveness. Participants will be evaluated regularly for treatment response and side effects. The main outcome measured is average pain intensity at four weeks. The study includes adults over 18 years diagnosed with moderate to severe fibromyalgia who have not yet received recommended drug treatments. Safety and tolerability will also be tracked throughout the trial.

Researchers are evaluating the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma, a condition with poor prognosis after standard treatments. This phase 1 dose-finding study uses a Bayesian Optimal Interval design to explore treatment options for patients whose disease has returned or worsened despite prior chemotherapy with drugs like doxorubicin, vincristine, cyclophosphamide, ifosfamide, and etoposide. The treatment involves giving irinotecan hydrochloride liposome injections once a week for five doses over six weeks. This approach may improve convenience and effectiveness compared to traditional irinotecan infusion schedules. The study aims to find the maximum tolerated dose of this weekly liposomal formulation. Participants will be closely monitored throughout the study period with assessments including imaging scans to measure tumor response and evaluations of organ function. The main outcome measured is the maximum tolerated dose over six weeks. Researchers will also track safety, treatment tolerability, and disease progression during the study.