Pingdingshan

Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

Researchers are evaluating the safety, tolerance, and preliminary effectiveness of LM-108 combined with anti-tumor treatments in people with advanced solid tumors. This multicenter, open-label Phase IbII clinical trial focuses on determining the best dose of LM-108 with penpulimab, oxaliplatin, and capecitabine in Phase Ib, and then assessing the combinations effects in Phase II. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive various drug combinations including LM-108 injection, penpulimab, oxaliplatin, capecitabine, and tislelizumab. These drugs are administered mainly via intravenous infusion on Day 1 of each 21-day treatment cycle, with capecitabine taken orally twice daily from Day 1 to Day 14 or with a specific dosing schedule. Different study groups receive different combinations and doses based on the trial phase and cohort. During the study, participants will be monitored for side effects and treatment responses through lab tests, imaging, and clinical evaluations. Key measurements include dose-limiting toxicities within 21 days of the first dose and progression-free survival over about 10 months. Other outcomes assessed are overall response rate, duration of response, disease control rate, overall survival up to 5 years, and safety events up to 90 days after the last dose. Participants will be followed regularly throughout the treatment cycles and monitored for immunogenicity and drug pharmacokinetics.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

Researchers are evaluating ursodeoxycholic acid as a potential treatment for gastric intestinal metaplasia IM in adults who do not have Helicobacter pylori infection. This Phase 4 clinical trial aims to understand if ursodeoxycholic acid can help reverse IM and to assess any medical problems participants may experience while taking the medication. The study compares ursodeoxycholic acid to a placebo to determine its impact on this stomach condition. Participants are randomly assigned to one of two groups. One group takes oral ursodeoxycholic acid capsules at a dose of 250 mg three times daily for six months, while the other group takes matching placebo capsules at the same dose and schedule. Participants visit the clinic every four weeks for checkups, symptom evaluations, and to receive their medication supply. During the study, participants undergo assessments including upper gastrointestinal endoscopy and histopathological examinations to monitor changes in gastric intestinal metaplasia and gastric atrophy stages. Researchers measure the regression and progression rates of these conditions based on OLGIM and OLGA staging from enrollment through the six-month treatment period. Safety and any side effects are also closely monitored throughout the trial.

Researchers are evaluating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for treating pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive ERhuman epidermal growth factor 2 negative HER2- breast cancer who have an ESR1 mutation and have previously been treated with ribociclib or palbociclib. The study aims to compare the effectiveness, safety, and tolerability of these two treatment combinations. Participants are randomly assigned to one of two groups one receives 5 mg daily oral lasofoxifene plus oral abemaciclib 150 mg twice a day the other receives fulvestrant 500 mg via intramuscular injections on Days 1, 15, and 29 and then monthly thereafter, combined with oral abemaciclib 150 mg twice a day. This open-label study assesses these treatments over approximately three years. During the trial, participants will be monitored through regular assessments including tumor measurements, survival tracking, quality of life questionnaires, and evaluation of adverse events. Researchers will measure progression-free survival as the primary outcome and also track response rates, overall survival, treatment duration, and time to chemotherapy. Brain metastases patients meeting specific criteria are allowed, and safety is closely observed throughout the study period which may last up to about three years.

Researchers are evaluating treatment options for patients infected with Helicobacter pylori HP, a common stomach infection. This prospective, multicenter study enrolls 200 patients who test positive for HP through rapid urease tests or 13C urea breath tests. The study aims to assess the success rate of HP eradication, side effects, patient compliance, antibiotic resistance, and how these factors impact treatment outcomes. Participants will receive one of two experimental treatments a high-dose dual therapy consisting of Vonoprazan, a potassium competitive acid blocker, and Amoxicillin, an antibiotic or a minocycline-containing quadruple therapy including Bismuth Potassium Citrate for stomach protection, along with Minocycline and Metronidazole antibiotics. Patients will undergo HP culture and drug sensitivity tests before treatment. The study is non-randomized and does not use blinding. Throughout the study, patients will be monitored for HP eradication six weeks after finishing therapy. Researchers will also track adverse effects and treatment compliance within seven days following therapy completion. Participation involves informed consent and ongoing assessments to evaluate treatment effectiveness and safety. The total participation period extends at least six weeks after therapy to assess outcomes and side effects.

Researchers are conducting a multicenter, prospective observational study across 200 hospitals in China to examine current treatment patterns for chronic hepatitis B CHB. The study aims to compare patient outcomes under different treatment regimens to provide evidence-based data that can improve CHB treatment strategies and follow-up care, ultimately advancing efforts toward a functional cure for chronic hepatitis B. Participants include those receiving or planned to receive treatments such as entecavir ETV, tenofovir disoproxil fumarate TDF, tenofovir alafenamide fumarate TAF, tenofovir amibufenamide TMF, or peginterferon alpha-2b injection. The study observes real-world clinical practice without assigning treatments, capturing data on these therapies over an extended period. During the study, researchers will monitor outcomes including the percentage of patients developing HBsAg-associated hepatocellular carcinoma HCC, incidence of HCC, rates of HBsAg seroclearance and seroconversion, changes in HBsAg levels, HBV DNA levels, liver fibrosis improvement, and liver-related complications. Data collection spans from week 4 up to week 240, with continuous follow-up to assess treatment effects and patient status over time.

Researchers are evaluating and comparing the effects of total intravenous anesthesia using remimazolam versus propofol in patients at moderate to high risk undergoing major elective noncardiac surgery under general anesthesia. This randomized controlled trial aims to determine if remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery. The study is conducted by Nanfang Hospital, Southern Medical University and is classified as a phase 4 trial. Participants receive either remimazolam or propofol as anesthesia. Remimazolam is given intravenously at 6-12 mgkgh for induction and 1.0-2.0 mgkgh for maintenance, adjusted to keep the Bispectral Index between 40 and 60. Propofol is administered intravenously at 1.5-2.5 mgkg for induction and 4-12 mgkgh for maintenance, also titrated to maintain the same Bispectral Index range. These dosing strategies help monitor and control anesthesia depth during surgery. During the study, participants will be closely monitored for outcomes including days alive and out of hospital at 30 days after randomization, all-cause mortality within 30 days, length of hospital stay, unplanned re-hospitalizations, postoperative complications, and quality of recovery on the first day after surgery. The trial involves double-blind randomization and includes follow-up assessments at 30 days to gather comprehensive data on recovery and safety.

Researchers are evaluating the safety and effectiveness of SG301 SC Injection in adults with primary immune thrombocytopenia ITP, a condition characterized by low platelet counts. This Phase II, randomized, double-blind, placebo-controlled study aims to compare low and high doses of SG301 SC Injection against placebo. The study also assesses how the drug behaves in the body and its immune response effects. Participants are randomly assigned to one of three groups low dose SG301 SC Injection, high dose SG301 SC Injection, or placebo, each receiving weekly subcutaneous injections for a total of 8 doses. Background therapies for ITP may be continued at stable doses throughout the study period. The study includes approximately 60 participants, with about 20 in each group. During the trial, participants will undergo safety monitoring for adverse events and evaluation of platelet response up to 24 weeks. Researchers will collect clinical and laboratory data to understand the drugs effects and immune activity. Participants will be assessed regularly to measure treatment outcomes and overall health status throughout the study duration.

Researchers are evaluating Shuxuening injection, a multi-target neuroprotective agent, to see its effects when added to intravenous thrombolysis therapy in patients with acute ischemic stroke. This large, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of Shuxuening injection in improving outcomes after stroke. Intravenous thrombolysis with rt-PA is the current standard treatment, but many patients still experience significant disability, so neuroprotective agents like Shuxuening may help reduce brain cell death. Participants will be randomly assigned to one of two groups one group will receive Shuxuening injection combined with intravenous thrombolysis, and the other will receive a placebo combined with intravenous thrombolysis. Both treatments involve a daily intravenous drip of 20 ml Shuxuening or placebo plus 250 ml of 0.9% sodium chloride for 10 to 14 days. The study plans to enroll 1380 patients within 6 hours of stroke onset from 50 centers across China. During the study, participants will be monitored closely with assessments including the modified Rankin Scale mRS score at 90 days to measure functional recovery, along with safety monitoring for adverse events over 90 days. Other evaluations include neurological function scores, quality of life surveys, and various safety outcomes. The trial will last for at least 90 days after treatment, with data collected on disability, recovery, and any side effects experienced.