By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
Objective To systematically evaluate the risk factors and population attributable risk of children leukemia in China, so as to provide references for policy-making. Methods The case-control studies about risk factors of children leukemia in China were searched in PubMed, CNKI, CBM, VIP and WanFang Data from inception to December 2011. According to the inclusion and exclusion criteria, two reviewers independently screened articles, extracted data, and evaluated the quality of the included studies. Then Meta-analysis was performed using STATA 11 and Excel 2003. The pooled odds ratio (OR) and 95% confidence interval (95%CI) of each risk factor were calculated, and the population attributable risk percent (PARP) based on the exposure rate of the risk factors was computed, and published bias was estimated according to the fail-safe number. Results A total of 15 case-control studies were included. The first 5 risk factors related to children leukemia were: dwelling environmental pollution (OR=2.782, 95%CI 2.268 to 3.413), house decoration (OR=2.525, 95%CI 1.736 to 3.673), maternal exposure to chemical hazards (OR=2.428, 95%CI 1.976 to 2.985), family history of tumor (OR=2.212, 95%CI 1.677 to 2.919), and child exposure to electromagnetic field around dwelling (OR=2.144, 95%CI 1.761 to 2.610). Factors with higher PARP were influenza history (37.56%), house decoration history (32.95%), X-ray exposure history (20.47%), and chemical hazards exposure history (17.37%). The fail-safe number showed the results were generally reliable. Conclusion In order to prevent and control children leukemia, positive and effective measures should be taken in the following aspects: strengthening child care, avoiding unnecessary X-ray exposure, and providing good living environment.
Objective To compare the social support condition of Three Gorges migrants, that is, latter resettled migrants (in Chongqing) versus outside moving migrants (in Shandong). Methods Migrants were selected in both Chongqing Municipality and Shandong Province by a cluster random sampling method, and the survey was performed by completing the questionnaire of general status and the social support rating scale (SSRS). Results A total of 319 among 330 questionnaires distributed to Chongqing migrants were effective, accounting for 98.3%, and 320 among 340 questionnaires distributed to Shangdong migrants were effective, accounting for 94.1%. The results of the survey on social support showed that, a) The total score of social support of Chongqing migrants was significantly lower than that of Shandong migrants (Plt;0.01); b) The total score of Chongqing migrants in different genders was significantly lower than that of Shandong migrants in the same gender, respectively (Plt;0.05); c) All the scores of Chongqing migrants were significantly lower than those of Shandong migrants at the same age level except the objective score of the migrants at the age below 50 (Plt;0.05); and d) All the scores of Chongqing migrants were significantly lower than those of Shandong migrants at the same education levels except the objective score of the migrants at the education level above junior high school (Plt;0.05). Conclusion Compared to the latter resettled migrants in Chongqing, outside moving migrants in Shandong obtain more social support and fully take advantage of that.
Objective To explore the effectiveness of partial translocation of flexor carpi radialis tendon in the treatment of traumatic dislocation of the first carpometacarpal joint. Methods The clinical data of 6 patients with traumatic dislocation of the first carpometacarpal joint who met the selection criteria between March 2020 and June 2024 were retrospectively analyzed. There were 3 males and 3 females with an average age of 33.5 years (range, 16-42 years). All the 6 cases were treated with plaster immobilization for 4-6 weeks, and the time from injury to operation was 6-12 weeks, with an average of 8.8 weeks. All patients underwent reconstruction of the metacarpophalangeal anterior oblique ligament and dorsal posterior oblique ligament of the first carpometacarpal joint with partial translocation of flexor carpi radialis tendon. The pain relief was evaluated by visual analogue scale (VAS) score before and after operation, and the pinch force, palmar abduction and radial abduction angles of the affected side and the healthy side were recorded before and after operation, and the ratio of the above indexes between the affected side and the healthy side was calculated to evaluate the effectiveness. ResultsAll the incisions healed by first intention after operation, and there was no complication related to operation such as neurovascular injury. All patients were followed up 6-19 months (mean, 12.7 months). The range of motion of the thumb on the affected side was the same as that on the healthy side, the first carpometacarpal joint was stable without recurrent dislocation and pain. At last follow-up, the VAS score, the pinch force of the affected side, the abduction angle of the palmar side of the affected thumb, the abduction angle of the radial side of the affected thumb, and the pinch force ratio, the palmar abduction angle ratio of the thumb, and the radial abduction angle ratio of the thumb of the affected side to the healthy side significantly improved when compared with those before operation (P<0.05). ConclusionPartial translocation of the flexor carpi radialis tendon to reconstruct the metacarpophalangeal and dorsal radial ligaments for the treatment of traumatic dislocation of the first carpometacarpal joint is a reliable surgical method.
The National Health and Nutrition Examination Survey (NHANES) in the United States is a research program designed to assess the health and nutritional status of adults and children in the country. Due to its adoption of a complex sampling design, it is imperative to correctly apply the weights provided by NHANES to ensure the accuracy and external validity of research results. This article first introduces the relevant concepts of the NHANES database and its weights, followed by a practical demonstration of weight selection, calculation, and implementation in the R programming language. It further discusses the significance of using weights in NHANES data and systematically showcases how to perform weighted analysis based on R, providing a valuable reference for relevant researchers.
ObjectiveTo detect the level of serum melanoma-inbibiting activity (MIA) in patients with uveal melanomas, and investigate the value of MIA in diagnosing and inspecting uveal melanomas.MethodsEnzyme-linked immunosorbent assay (ELISA) was used to detect the concentrations of MIA in peripheral serum of 27 patients with uveal melanoma, 6 with melanocyte tumor, 7 with other ocular tumors and 16 healthy individuals, respectively.ResultsThe concentration of MIA in patients with uveal melanoma was significantly higher than that in the healthy ones (16 individuals) and the patients with adenoma of non pigmented ciliary epithelium (4 patients), retinoblastoma (2 patients), and retinal angioma 91 patient). The concnetration of MIA in patients with uveal melanoma without scleral infiltration or remote metastasis was obviously lower than that in the patients with scleral infiltration or remote metastasis, but didn′t differ much from which in the patients with melanocyte tumor. In the patients with uveal melanoma without infiltration or remote metastasis, there was no significant difference of MIA level between patients with spindle cell and mixed and epithelioid cell.ConclusionThe level of serum MIA may be an effective index in diagnosing uveal melanoma, which can monitor the metastasis of uveal melanoma.(Chin J Ocul Fundus Dis, 2005,21:153-155)
ObjectiveTo investigate the short-term effectiveness of MAKO robot assisted complex total hip arthroplasty (THA). Methods The clinical data of 15 patients (17 hips) underwent MAKO robot assisted complex THA between May 2020 and June 2021 were analyzed retrospectively. There were 5 males and 10 females with the age ranged from 19 to 70 years (median, 49 years), included 9 cases (9 hips) of developmental dysplasia of the hip (Crowe type Ⅱ in 5 hips, type Ⅲ in 1 hip, and type Ⅳ in 3 hips), 1 case (2 hips) of rheumatoid arthritis, 2 cases (3 hips) of ankylosing spondylitis, 3 cases (3 hips) of secondary arthritis with a history of acetabular fracture and internal fixation. The acetabular cup abduction angle and anteversion angle were measured at 3 months after operation, and compared with those measured by MAKO robot system before and immediately after operation. The femoral offset and leg length discrepancy (LLD) were measured at 3 months after operation, which were compared with those before operation. Harris hip score (HHS) and visual analogue scale (VAS) score were used to evaluate hip function before operation and at 3 months after operation. Results All 15 patients (17 hips) completed the operation successfully. The operation time was 75-175 minutes, with an average of 116.3 minutes; the intraoperative blood loss was 100-800 mL, with an average of 381.3 mL. Two patients were not included in the statistics because of intraoperative and postoperative complications, the remaining 13 patients (15 hips) had no serious complication such as vascular and nerve injuries, and 3 patients had intermuscular vein thrombosis. The 13 patients (15 hips) were followed up 3-15 months, with an average of 8 months. At last follow-up, the position of prosthesis did not change and there was no signs of loosening. There was no significant difference in acetabular abduction angle at immediate and 3 months after operation when compared with preoperative one (P>0.05), and the acetabular anteversion angle was significantly lower than that before operation (P<0.05). There was no significant difference in acetabular abduction angle and anteversion angle between at immediate and 3 months after operation (P>0.05). The LLD, offset, HHS score, and VAS score were significantly improved at 3 months after operation when compared with preoperative ones (P<0.05). Conclusion MAKO robot assisted complex THA can achieve good short-term effectiveness, improve the hip range of motion, reduce the length difference between bilateral lower limbs, and improve the quality of patients’ life.
ObjectiveTo investigate the effect of curcumin on the expression regulation of endogenousβ-glucoronidase (β-GD) induced by lipopolysaccharide (LPS).Methods① Human normal intrahepatic biliary epithelial cell line (HiBEpiC) cells in the logarithmic growth phase were divided into blank control group (0 h group) and 7 different stimulation time groups. The cell density was adjusted to 1×104/mL, and the cells were stimulated with 100 mg/mL LPS for 1, 3, 6, 18, and 24 hours respectively, including another two groups where the cells were cultured with LPS-free medium for 18 and 24 hours after LPS stimulation for 24 h. ② HiBEpiC cells in the logarithmic growth phase were divided into blank control group, LPS+low, medium, and high concentration curcumin group. The cell density was adjusted to 1×104/mL. In the blank control group, cells were not stimulated with any reagent; in the LPS group, cells were stimulated with 100 mg/mL LPS, in the other three groups, the cells were stimulated with 100 mg/mL LPS and simultaneously 20, 40, and 80 μmol/L curcumin, respectively, for 24 hours. The expressions of c-myc and endogenous β-GD were detected by Western blot method.Results① The expressions of endogenous β-GD and c-myc in HiBEpiC cells gradually increased with the prolongation of treatment time by LPS, and the expression levels of β-GD and c-myc at each time point group were significantly different from those in the 0 h group (P<0.05). ② There were significant difference between any two groups of the blank control group, LPS group, LPS+low concentration of curcumin group, LPS+medium concentration of curcumin group, and LPS+high concentration of curcumin group (P<0.05).ConclusionCurcumin is able to inhibit the increased expression of endogenous β-GD induced by LPS, possibly via inhibiting expression of c-myc.
ObjectiveTo evaluate the predictive value of critical illness scores for hospital mortality of severe respiratory diseases in respiratory intensive care unit (ICU).MethodsThe clinical data of the patients who needed intensive care and primary diagnosed with respiratory diseases from June, 2001 to Octomber, 2012 were extracted from MIMIC-Ⅲ database. The Acute Physiology Score (APS) Ⅲ, Simplified Acute Physiology Score (SAPS) Ⅱ, Oxford Acute Severity of Illness Score (OASIS), Logistic Organ Dysfunction System (LODS), Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) were calculated according to the requirements of each scoring system. ICU mortality was set up as primary outcome and receiver operating characteristic (ROC) analysis was performed to evaluate the predictive performances by comparing the areas under ROC curve (AUC). According to whether they received invasive mechanical ventilation during ICU, the patients were divided into two groups (group A: without invasive mechanical ventilation group; group B: with invasive mechanical ventilation group). The AUCs of six scoring systems were calculated for groups A and B, and the ROC curves were compared independently.ResultsA total of 2988 patients were recruited, male accounted for 49.4%, median age was 67 (55, 79), and ICU mortality was 13.2%. The AUCs of SAPSⅡ, LODS, APSⅢ, OASIS, SOFA and SIRS were 0.73 (0.70, 0.75), 0.71 (0.68, 0.73), 0.69 (0.67, 0.72), 0.69 (0.67, 0.72), 0.67 (0.64, 0.70) and 0.58 (0.56, 0.62). Subgroup analysis showed that in group A, the AUCs of OASIS, SAPSⅡ, LODS, APSⅢ, SOFA and SIRS were 0.81 (0.76, 0.85), 0.80 (0.75, 0.85), 0.77 (0.72, 0.83), 0.75 (0.70, 0.80), 0.73 (0.68, 0.78) and 0.63 (0.56, 0.69) in the prediction of ICU mortality; in group B, the AUCs of SAPSⅡ, APSⅢ, LODS, SOFA, OASIS and SIRS were 0.68 (0.64, 0.71), 0.67 (0.63, 0.70), 0.65 (0.62, 0.69), 0.62 (0.59, 0.66), 0.62 (0.58, 0.65) and 0.57 (0.54, 0.61) in the prediction of ICU mortality. The results of independent ROC curve showed that the AUC differences between groups A and B were statistically significant in terms of OASIS, SAPSⅡ, LODS, APSⅢ and SOFA, but there were no significant differences in SIRS.ConclusionsThe predictive values of six critical illness scores for ICU mortality in respiratory intensive care are low. Lack of ability to predict ICU mortality of patients with invasive mechanical ventilation should hold primary responsibility.