Sanming

This trial evaluates treatments for children aged 2 to under 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib to subcutaneous dupilumab, focusing on changes in disease activity and side effects. The study involves participants who need systemic anti-inflammatory therapy because topical treatments alone are insufficient. The trial is a phase 3, randomized study conducted worldwide with about 675 children. Participants receive either upadacitinib daily as oral tablets or solution for up to 160 weeks, or dupilumab injections every 2 or 4 weeks for 52 weeks, following approved dosing schedules. Some participants are randomized to receive different doses of upadacitinib or dupilumab. Participants are grouped based on disease severity, age, and prior treatment responses. After treatment, there is a follow-up period of at least 30 days for upadacitinib and 12 weeks for dupilumab to monitor safety. During the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers measure outcomes including the percentage of participants achieving significant reductions in eczema severity using specific scales at week 16 and other timepoints, as well as tracking adverse events up to week 172. The study aims to understand treatment safety and effectiveness over a long term.

Researchers are evaluating the RISIMA model, an integrated care approach for patients aged 40 to 70 with hypertension andor type 2 diabetes. This model focuses on cardiovascular disease CVD risk assessment, treatment, and management through a community-based healthcare consortium. The trial aims to assess how well this risk-stratified integrated care model works compared to standard care in improving patient outcomes related to cardiovascular risk. The study compares two groups one receiving usual public health services including quarterly follow-ups and annual physical exams, and the other receiving the RISIMA model. This integrated model includes team-based care by family health teams, a risk-stratified care pathway based on CVD risk scores, enhanced health education sessions, financial incentives for care integration, and a supporting health information system. The intervention is delivered as a package with tailored management plans according to patients cardiovascular risk levels. Participants will be involved for at least 12 months, during which researchers will monitor outcomes such as the 10-year CVD risk score, blood pressure control, cholesterol, fasting blood sugar, and cardiovascular event rates. The study also evaluates cost-effectiveness. Participants will attend regular follow-ups, education sessions, and risk assessments, with data collected via a health information system that supports care coordination and performance evaluation.

Researchers are studying the role of HPV integration in predicting the prognosis of young women aged 45 and below diagnosed with cervical intraepithelial neoplasia grade 2 CIN2, a precancerous cervical condition. The study aims to explore the correlation between HPV integration, vaginal flora changes, and cervical cytology results to better understand disease progression and outcomes. This multi-center cohort study includes 300 participants from hospitals in China, focusing on the natural course of CIN2 without surgical or medication treatment when appropriate. Participants will be followed at enrollment and then at 3, 6, 9, and 12 months. At these visits, HPV viral integration tests, HPV genotyping tests, cervical cytology, and sequencing of vaginal secretions will be performed. Colposcopies and biopsies will be conducted at 6 and 12 months to closely monitor cervical tissue changes. The study observes participants under regular clinical follow-up without intervention unless disease progression occurs. During the study, participants will provide cervical secretions and exfoliated cell samples for testing. Researchers will assess cervical histopathology, HPV integration status, cervical cytology, vaginal flora diversity, and HPV genotyping at multiple time points. Outcomes measured include cervical tissue changes and HPV-related markers to evaluate the diseases natural course. The study lasts 12 months with scheduled clinical visits and laboratory assessments to monitor participants cervical health and HPV status throughout this period.

This research aims to evaluate the effect of preoperative intercostal nerve block ICNB using liposomal bupivacaine compared to conventional bupivacaine hydrochloride on the quality of recovery after video-assisted thoracoscopic surgery VATS for partial pneumonectomy. VATS is a less invasive lung surgery technique, but managing postoperative pain remains a challenge. Liposomal bupivacaine is designed to provide longer-lasting pain relief, potentially improving recovery quality by reducing pain and opioid use after surgery. Participants receive a single-dose ICNB under thoracoscopy before surgery. One group gets 30 mL of 0.25% bupivacaine hydrochloride injected into six intercostal spaces, while the other group receives a 30 mL diluted solution of bupivacaine liposome similarly administered. This study compares these two nerve block methods to assess their impact on recovery. During the study, participants recovery quality is assessed primarily by the Quality of Recovery-15 QoR-15 score at 24 hours post-surgery, with additional measures at 48 hours. Other evaluations include pain scores, opioid consumption, patient satisfaction, and recovery times in the post-anesthesia care unit. The study follows participants until 48 hours after surgery to monitor these outcomes.

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 a modified low-dose regimen of trifluridinetipiracil combined with bevacizumab for patients with metastatic colorectal cancer that no longer responds to standard treatments. This phase II, single-center study aims to assess the effectiveness and safety of this treatment approach, addressing concerns about toxicity from standard doses. Participants will have previously received at least two chemotherapy regimens or been intolerant to them. The treatment involves taking trifluridinetipiracil orally at 17.5 mgm2 twice daily for 10 days, followed by 4 days off, in a 14-day cycle. Bevacizumab is given intravenously at 5 mgkg on day 1 of each cycle, also every 14 days. This combined treatment will continue until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo regular assessments to monitor disease progression and side effects. The main outcome measured is the progression-free survival rate at 6 months. Secondary outcomes include tracking adverse events, objective response rate up to 16 weeks, overall progression-free survival up to 60 months, and overall survival up to 100 months. Participants are monitored throughout treatment and followed for safety and effectiveness until the study ends.

Researchers are investigating a new treatment approach for patients with HER2-positive muscle-invasive bladder cancer MIBC staged cT2-4aN0-1M0. This phase II, multicenter, open-label study evaluates combining zanidatamab and tislelizumab with chemotherapy before surgery, aiming to preserve the bladder selectively. The study focuses on assessing the treatments effectiveness and safety in this specific patient group. Participants receive neoadjuvant therapy consisting of zanidatamab, tislelizumab, and chemotherapy drugs such as cisplatin, gemcitabine, or nab-paclitaxel over four cycles, each lasting 21 days. After these initial treatments, patients are reassessed for clinical complete response cCR. Those achieving cCR continue maintenance therapy with zanidatamab and tislelizumab, while others may undergo radiotherapy or partial cystectomy followed by maintenance therapy or proceed directly to radical cystectomy with adjuvant tislelizumab. Throughout the trial, participants undergo regular evaluations including tumor assessments and safety monitoring. The main outcome is the rate of clinical complete response at the end of neoadjuvant therapy. Secondary outcomes include disease-free survival rates, recurrence-free survival, overall survival, safety, and quality of life measures over up to three years. The study aims to understand how well this treatment strategy can preserve the bladder and improve patient outcomes.

Researchers are conducting a multicenter, prospective observational study to evaluate how well artificial intelligence AI models using pre-treatment dynamic contrast-enhanced MRI DCE-MRI can predict the benefit of neoadjuvant chemotherapy in women with hormone receptor-positive, HER2-negative HRHER2- breast cancer. The study aims to stratify patients into groups with high or low expected benefit from chemotherapy and assess outcomes such as residual cancer burden and long-term survival. Participants receive routine standard neoadjuvant chemotherapy and undergo pre-treatment breast DCE-MRI scans. The AI model analyzes these images to categorize patients into high-benefit or low-benefit subgroups. Data collected include baseline clinical and pathological information, chemotherapy regimens, and post-surgery residual cancer classifications. The study evaluates response rates and survival outcomes up to five years after surgery. During the study, participants provide clinical data and imaging before starting chemotherapy. After treatment and surgery, researchers measure residual cancer burden and objective tumor response. Long-term follow-up tracks disease-free and overall survival for up to 60 months. The main outcome is the rate of minimal residual cancer after chemotherapy, helping to verify the AI models usefulness for individualized treatment selection in this breast cancer population.

Researchers are studying patients with hepatocellular carcinoma HCC who have experienced spontaneous tumor rupture with hemorrhage. This condition has a high risk of death and recurrence after surgery, especially in Asian populations. The study evaluates the use of a combination of two drugs, sintilimab and a bevacizumab biosimilar, as additional treatment after surgical removal of the tumor. This is a Phase II, single-arm study aiming to find out if this treatment is tolerable and may improve outcomes for these high-risk patients. Participants will receive sintilimab 200 mg and bevacizumab biosimilar 15 mgkg intravenously on day 1 every three weeks. Treatment will continue after surgery for up to three years. The study focuses on patients who have undergone complete tumor removal, have good liver function, and no remaining visible cancer. The combination therapy is given as an adjuvant treatment to potentially delay or prevent cancer recurrence. During the study, participants will be monitored regularly for disease-free survival, overall survival, and any side effects using standard criteria. Imaging and laboratory tests will be done to check for liver cancer recurrence or spread within and outside the liver. The study will last up to three years, with ongoing assessments to track the timing and proportion of cancer recurrence or metastasis. Safety and tolerability of the treatment will also be closely observed throughout the study period.

Researchers are evaluating benralizumab in patients aged 12 years and older with severe eosinophilic asthma to better understand its clinical profile and how well it works in a real-world setting in China. The study aims to observe early treatment responses, treatment outcomes, and changes in asthma control. It also looks at reasons why doctors may stop or switch benralizumab therapy. Participants receive benralizumab as prescribed by their clinician without any additional intervention from the study, as this is a non-interventional observational trial. The study collects data over time, focusing on asthma control and lung function. There is only one group of patients receiving benralizumab, and treatment decisions are made by healthcare providers as usual. Participants will be followed and monitored with asthma control questionnaires at weeks 1, 2, 4, 8, 16, 24, 40, and 56. Lung function changes will also be evaluated at weeks 8, 16, and 56. The primary outcome is asthma control at week 8. Data collection will continue until the study ends in January 2028, providing insights into treatment effects and patient experiences in routine care.