Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

To conduct a preliminary screening of the primary health issues among preschool children in extremely high-altitude areas of Xizang autonomous region, providing a basis for future large-scale epidemiological investigations.

Hepatocellular carcinoma (HCC) is a prevalent malignant tumor that poses a significant threat to public health. Advances in medical science and increased screening awareness have improved early-stage diagnosis rates, allowing more patients to undergo radical treatment at initial diagnosis. Concurrently, ongoing developments in treatment modalities have expanded the options available for both patients and clinicians. The challenge now lies in making informed decisions to achieve individualized precision medicine, which merits thorough exploration. This article aims to review the latest research on personalized treatment strategies for early-stage HCC, providing a reasonable reference and valuable insights for clinicians.

The liver is the most common anatomical site for hematogenous metastases of colorectal cancer. Hepatic resection is the preferred treatment for colorectal cancer liver metastasis (CRLM). However, a disappointingly small proportion of patients are deemed suitable for surgical resection upon initial consultation. Failure to adequately address these metastatic tumors results in a dire 5-year survival rate of less than 5%. In recent times, thermal ablation, a minimally invasive procedure aimed at controlling local tumor progression, has undergone rigorous validation and garnered recognition for its effectiveness and safety in managing CRLM. This article endeavors to review the advancements in research concerning thermal ablation in the treatment of CRLM, exploring its efficacy, safety profile, and the promising avenues for its clinical application.

Previous research emphasized negative stress and mood disorders impacting cancer patients' quality of life.Growing evidence indicates these psychological factors directly influence cancer prognosis,with molecular mechanisms being explored and validated in animal models.Acting as cancer risk factors,psychological stress and mood disorders modulate the tumor immune microenvironment via the hypothalamic-pituitary-adrenal axis or sympathetic nervous system,suppressing anti-tumor immunity.Conversely,the tumor acts as a stressor,inducing mood disorders that further impair patient outcomes and quality of life,creating a vicious cycle.Investigating the mechanisms of this bidirectional stress-tumor interplay and identifying therapeutic targets to disrupt it are crucial for improving cancer patient prognosis and well-being.

Previous research emphasized negative stress and mood disorders impacting cancer patients' quality of life.Growing evidence indicates these psychological factors directly influence cancer prognosis,with molecular mechanisms being explored and validated in animal models.Acting as cancer risk factors,psychological stress and mood disorders modulate the tumor immune microenvironment via the hypothalamic-pituitary-adrenal axis or sympathetic nervous system,suppressing anti-tumor immunity.Conversely,the tumor acts as a stressor,inducing mood disorders that further impair patient outcomes and quality of life,creating a vicious cycle.Investigating the mechanisms of this bidirectional stress-tumor interplay and identifying therapeutic targets to disrupt it are crucial for improving cancer patient prognosis and well-being.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Hepatocellular carcinoma (HCC) is a prevalent malignant tumor that poses a significant threat to public health. Advances in medical science and increased screening awareness have improved early-stage diagnosis rates, allowing more patients to undergo radical treatment at initial diagnosis. Concurrently, ongoing developments in treatment modalities have expanded the options available for both patients and clinicians. The challenge now lies in making informed decisions to achieve individualized precision medicine, which merits thorough exploration. This article aims to review the latest research on personalized treatment strategies for early-stage HCC, providing a reasonable reference and valuable insights for clinicians.

The liver is the most common anatomical site for hematogenous metastases of colorectal cancer. Hepatic resection is the preferred treatment for colorectal cancer liver metastasis (CRLM). However, a disappointingly small proportion of patients are deemed suitable for surgical resection upon initial consultation. Failure to adequately address these metastatic tumors results in a dire 5-year survival rate of less than 5%. In recent times, thermal ablation, a minimally invasive procedure aimed at controlling local tumor progression, has undergone rigorous validation and garnered recognition for its effectiveness and safety in managing CRLM. This article endeavors to review the advancements in research concerning thermal ablation in the treatment of CRLM, exploring its efficacy, safety profile, and the promising avenues for its clinical application.

Hepato-pancreato-biliary diseases (HPBD) are often complicated. The diagnosis and treatment of HPBD involve many disciplines. The malignant degree of hepatobiliary pancreatic system is high, and the prognosis of patients is poor. The multidisciplinary team (MDT) brings specialists from different disciplines together to make a comprehensive and individualized treatment for patients. MDT is emerging in HPBD in recent years. MDT helps improve the accuracy of diagnosis and prognosis. However, there are still some controversies and obstacles in the application of MDT for patients with HPBD. We reviewed the development, current status and experience of MDT in the field of HPBD, analyze the current controversy and obstacles, and providing reference for its future application.