Pingdingshan

Researchers are evaluating the long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. This multicenter, open-label Phase Ib/II clinical trial includes a Phase Ib dose-determination phase and a Phase II efficacy and safety phase. The study specifically targets patients with advanced solid tumors, including gastric and gastroesophageal junction cancers, to explore the potential benefits and risks of this combination treatment. The trial compares LM-108 injection combined with penpulimab plus chemotherapy agents oxaliplatin and capecitabine, as well as other combinations including tislelizumab with oxaliplatin and capecitabine. LM-108 is a monoclonal antibody that selectively clears regulatory T cells in tumor sites, while penpulimab and tislelizumab are monoclonal antibodies targeting programmed cell death proteins. Treatment dosing and scheduling are guided by the phase and cohort within the study, with doses adjusted in Phase Ib and further explored in Phase II. Participants will undergo assessments including evaluations of dose-limiting toxicities within 21 days after the first dose and measurement of progression-free survival, estimated at 10 months. Clinical visits involve laboratory tests to monitor organ function, imaging to measure tumor lesions, and safety evaluations. The study requires participants to comply with scheduled visits, treatments, and tests, and includes monitoring for adverse effects and treatment tolerability throughout the trial period.

Primary liver cancer, particularly hepatocellular carcinoma (HCC) at BCLC stage C, is a common and serious cancer where many patients are not eligible for surgery due to advanced disease. Researchers are evaluating the effectiveness and safety of two treatments: drug-eluting bead transarterial chemoembolization (DEB-TACE) alone versus DEB-TACE followed by hepatic artery infusion chemotherapy (HAIC). This study aims to see if combining these treatments provides better outcomes for patients with unresectable advanced liver cancer. The trial compares two groups: one receiving DEB-TACE alone and the other receiving DEB-TACE followed by sequential HAIC using a FOLFOX-based chemotherapy regimen. DEB-TACE uses drug-loaded beads to block tumor blood supply and release chemotherapy slowly, while HAIC delivers chemotherapy directly into the liver artery. This combination is designed to enhance the anti-tumor effect while potentially reducing side effects. Treatment is administered in a multi-center setting with careful monitoring. Participants will be monitored from the first DEB-TACE treatment up to 36 months or until disease progression or death. Assessments include imaging scans to evaluate tumor response according to mRECIST criteria, laboratory tests, and safety evaluations. Researchers will measure progression-free survival, which is the time without tumor growth or death. Participants must cooperate with treatment, complete scheduled visits, and provide informed consent, with an estimated life expectancy of at least 3 months.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.

Researchers are investigating the effectiveness and safety of ursodeoxycholic acid in treating gastric intestinal metaplasia in adults aged 18 to 75 years who do not have Helicobacter pylori infection. The study aims to find out if ursodeoxycholic acid can help reverse this condition compared to a placebo. This is a Phase 4, multicenter, randomized, placebo-controlled trial focusing on patients with specific stages of gastric intestinal metaplasia diagnosed within the last 3 months. Participants will take either ursodeoxycholic acid or a placebo capsule, each 250mg, three times daily for 6 months. They will visit the hospital every 4 weeks for symptom evaluation and to receive their medication supply. The treatment period lasts 6 months with regular monitoring to assess the impact of the drug. Throughout the study, participants will have clinic visits every 4 weeks for checkups and tests to track their symptoms and medication adherence. Researchers will measure the regression and progression rates of gastric intestinal metaplasia based on OLGIM stages from enrollment until the end of treatment at 6 months. Safety and any medical problems experienced during treatment will also be closely monitored.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

This research aims to evaluate and compare treatments for people infected with Helicobacter pylori, a type of bacteria that can cause stomach problems. It is a Phase 4 multicenter prospective study including 200 patients confirmed positive for H. pylori by rapid urease test or 13C urea breath test. The study will follow ethical guidelines and obtain informed consent from all participants before enrollment. Researchers will assess factors such as antibiotic resistance, success rates, adverse reactions, and patient compliance during treatment. Participants will receive either a high-dose dual therapy or a quadruple therapy containing minocycline and other medications. The drugs studied include vonoprazan (a potassium competitive acid blocker), amoxicillin, bismuth potassium citrate (which protects the stomach lining and fights H. pylori), and a combination of minocycline and metronidazole antibiotics. All patients will undergo H. pylori culture and drug sensitivity testing to guide therapy. During the study, researchers will monitor the eradication rate of H. pylori six weeks after therapy completion. They will also observe adverse reactions and patient adherence to treatment. The study includes careful follow-up and assessments to measure treatment outcomes and antibiotic resistance impact. The total participation period and further follow-up details are guided by study protocols to ensure comprehensive evaluation of therapies.

Researchers are conducting a multicenter, prospective, observational real-world study across 200 hospitals in China to examine treatment patterns for chronic hepatitis B (CHB). The study aims to compare patient outcomes under various therapies to provide evidence-based data that can help optimize CHB treatment and follow-up, with the ultimate goal of advancing a functional cure for chronic hepatitis B. The focus includes monitoring the incidence of hepatocellular carcinoma (HCC) associated with hepatitis B. Participants receive treatments including entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF), or Peginterferon α-2b injection. The study follows both patients currently on these therapies and those initiating or re-initiating Peginterferon α-2b therapy. These treatments are assessed in routine clinical practice settings without intervention from the study team. Throughout the study, patients are monitored from week 4 up to week 240 for the development of HBsAg-associated hepatocellular carcinoma (HCC) and overall HCC incidence. Researchers collect data on treatment effectiveness and safety as part of the observational follow-up. Participants provide informed consent and are observed under real-world conditions to evaluate long-term outcomes and risks associated with chronic hepatitis B and its treatments.

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.

Researchers are evaluating the efficacy and safety of Shuxuening injection as an additional treatment to intravenous thrombolysis in patients with acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled phase 3 trial involves patients aged 18 to 100 years who have experienced an ischemic stroke and can be treated within 6 hours of symptom onset. The study aims to improve functional outcomes by reducing brain cell death after stroke using this multi-target neuroprotective agent alongside the standard clot-busting therapy. Participants are randomly assigned in a 1:1 ratio to receive either Shuxuening injection or a placebo. Both groups receive a daily intravenous drip of 20 ml of the study drug or placebo combined with 250 ml of 0.9% sodium chloride injection for 10 to 14 days. The treatment starts as soon as possible after intravenous thrombolysis therapy, and the study compares these two groups to assess differences in recovery and safety. During the trial, researchers will monitor participants for 90 days after randomization. They will assess the primary outcome by measuring the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating good functional recovery. Safety will be evaluated by tracking adverse events over the same 90-day period. Participants will be closely followed with clinical evaluations to understand the effects and tolerability of Shuxuening injection in stroke recovery.