Sanming

This trial investigates treatments for children aged 2 to less than 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib, a drug approved for patients 12 years and older, with subcutaneous dupilumab, focusing on safety, adverse events, and changes in disease activity. The study is phase 3, open-label, and efficacy-assessor-blinded, enrolling about 675 participants worldwide who require systemic anti-inflammatory treatment beyond topical therapies. Participants will be randomly assigned to receive upadacitinib daily as oral tablets or oral solution for 160 weeks, or dupilumab by injection according to its approved dosing every 2 or 4 weeks for 52 weeks. Participants are stratified by disease severity, age, and previous treatment response. After completing treatment, follow-up visits occur for 30 days after upadacitinib and at least 12 weeks after dupilumab. The trial may involve more treatment visits than standard care. Throughout the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor disease severity and side effects. Researchers measure the percentage of participants achieving significant improvement in eczema severity by week 16 and track adverse events up to about week 172. This careful monitoring helps evaluate the safety and efficacy of the treatments over the long term.

Researchers are evaluating a community-based integrated care model called RISIMA, designed for patients aged 40 to 70 with diabetes and/or hypertension to manage cardiovascular disease (CVD) risk. This pragmatic cluster randomized trial assesses how multi-level family health teams within a county healthcare consortium deliver CVD risk assessment, treatment, and management tailored to patient risk levels. The study aims to improve care by providing coordinated services based on patients' cardiovascular risk. The RISIMA model involves a family healthcare team including village doctors, general physicians at township health centers, and specialists such as cardiologists, neurologists, or endocrinologists from county hospitals. Patients are categorized into low, middle, or high CVD risk groups using the WHO/ISH score, with care plans adjusted accordingly for health education, follow-up frequency, and treatment. The intervention includes monthly health education sessions, individual counseling at 4 months, self-management evaluations at 8 months, and continuous education messages. Financial incentives support service quality, and a health information system tracks patient risk data, home visits, education attendance, and medical records. Participants will be involved in regular monitoring of their cardiovascular risk over 12 months. Researchers will evaluate outcomes including the 10-year cardiovascular disease risk score. The health information system facilitates data collection and real-time updates for healthcare providers, while specialists guide management for high-risk patients. The study measures service quality and performance to evaluate the integrated care model's impact on patient cardiovascular health.

Cervical precancerous lesions, specifically Cervical Intraepithelial Neoplasia grade 2 (CIN2), pose significant risks to the health and fertility of young women. This research evaluates how the integration of Human Papillomavirus (HPV) DNA affects the progression and prognosis of CIN2 in women aged 45 and below. The study also explores the relationship between HPV integration status, vaginal flora diversity, and cervical cytology findings to improve understanding of disease outcomes. The study follows 300 women diagnosed with CIN2 confirmed by biopsy, recruiting them from multiple hospitals in China. Participants undergo comprehensive testing, including HPV viral integration tests, HPV genotyping, cervical cytology (ThinPrep tests), and vaginal secretion analysis at baseline and at 3, 6, 9, and 12 months. Colposcopy and biopsies are performed at the 6- and 12-month visits to assess lesion progression. No surgical or medication treatments are given unless the disease progresses during the 12-month observation. Participants will attend scheduled visits for sample collection and testing throughout the year-long follow-up. Researchers will perform various laboratory analyses, including HPV integration and genotyping, cervical cytology, and 16SrRNA sequencing of vaginal secretions. These assessments aim to monitor disease progression, understand HPV's role in CIN2 outcomes, and evaluate changes in vaginal flora. The study's comprehensive data collection supports a detailed evaluation of prognostic factors and disease management in young women with CIN2.

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.

Researchers are evaluating the safety and effectiveness of a modified low-dose treatment combining trifluridine/tipiracil and bevacizumab in patients aged over 60 with metastatic colorectal cancer that has not responded to at least two standard chemotherapy regimens. This phase II, single-center, prospective trial focuses on patients with advanced disease who need third-line or beyond therapy options. The study addresses concerns about toxicity by adjusting the dose and schedule of trifluridine/tipiracil to potentially reduce side effects. Participants will receive trifluridine/tipiracil orally at 17.5 mg/m2 twice daily for 10 days followed by 4 days off in each 14-day cycle. Bevacizumab will be given intravenously at 5 mg/kg on day 1 every 14 days. All patients will receive this combination treatment until their disease progresses, side effects become intolerable, or they decide to withdraw consent. During the study, participants will be monitored for progression-free survival over six months as the primary outcome. Researchers will assess safety and treatment tolerability throughout the treatment period. Eligibility includes adequate organ function and performance status, and participants will provide informed consent and agree to follow the study protocol. The study aims to provide information on the balance of treatment effectiveness and side effects in this patient group.

Researchers are evaluating the safety and effectiveness of a combination treatment using zanidatamab, tislelizumab, and chemotherapy before surgery in patients with HER2-positive muscle-invasive bladder cancer (MIBC) at stages cT2-4aN0-1M0. This phase II, open-label, multicenter study aims to assess whether this neoadjuvant therapy can lead to bladder preservation through selective treatment strategies. Participants will receive four cycles of zanidatamab (dosed by weight), tislelizumab, and chemotherapy every three weeks. After this neoadjuvant therapy, their disease status will be reassessed. Those who achieve a clinical complete response (cCR) may continue maintenance therapy with zanidatamab and tislelizumab for additional cycles as part of bladder preservation. Patients without cCR may undergo radiotherapy or partial cystectomy followed by maintenance therapy, or proceed directly to radical cystectomy followed by adjuvant tislelizumab. Throughout the study, participants will be closely monitored with clinical evaluations to measure the clinical complete response rate at the end of neoadjuvant therapy cycles. Safety and disease status assessments will guide subsequent treatment decisions. The study includes detailed follow-up for maintenance therapy and possible surgical interventions, with overall participation spanning multiple treatment phases to observe long-term outcomes.

Primary liver cancer, especially hepatocellular carcinoma (HCC), is a serious health issue in China due to its high rates of occurrence and death, along with poor long-term survival. A rare but deadly complication called spontaneous rupture of HCC (SRHCC) happens more often in Asian populations and leads to high death rates. Surgical removal of the tumor can offer hope for cure in patients with good liver function, but the risk of cancer returning after surgery is high, and no effective additional treatments currently exist to prevent this recurrence. This study evaluates a combination treatment using sintilimab, an immune checkpoint inhibitor, and a bevacizumab biosimilar, an anti-angiogenic agent, as additional therapy after surgery for patients with ruptured HCC. Patients receive sintilimab (200 mg) and the bevacizumab biosimilar (15 mg/kg) intravenously every three weeks. This is a Phase II, single-arm trial focused on patients who have undergone curative liver surgery and are at high risk of cancer returning. The treatment aims to improve outcomes by reducing recurrence risk after surgery. Participants will be closely monitored for up to three years to track disease-free survival and treatment tolerability. Assessments include imaging scans within 4 to 8 weeks after surgery to confirm complete tumor removal, regular laboratory tests, and ongoing evaluation of side effects. Patients must meet specific health and laboratory criteria before starting treatment and will be followed regularly to measure how well the therapy works and to ensure safety throughout the study.