To conduct a statistical analysis of clinical trial visit time windows and propose targeted recommendations based on risk management from the perspective of the institutional office, so as to provide references for clinical research practice.

Data of drug clinical trial projects undertaken by a single institution from 2018 to 2024 were collected. Visit time windows were statistically analyzed and compared across the screening phase, visit phase, and follow-up phase. A risk classification standard for time windows was established by integrating management practice, regulatory requirements, and relevant literature. Corresponding recommendations were put forward for sponsors, researchers, participants, and the institutional office based on this classification.

A total of 137 projects were included, with the number of visits ranging from 1 to unlimited. Visit modalities included on-site visits and remote visits (telephone visits). The most prevalent time windows in each phase were 28 days (45.99%) for the screening phase, 3 days (62.26%) for the visit phase, and 7 days (68.93%) for the follow-up phase. The risk classification results were as follows: extremely high-risk time windows (1 to 30 minutes in the visit phase), high-risk time windows (42 to 183 days: before screening in the screening phase, 1 to 24 hours in the visit phase, and 1 to 3 days in the follow-up phase), medium-risk time windows (1 to 7 days: before screening in the screening phase, 1 to 3 days in the visit phase, and 5 to 10 days in the follow-up phase), and low-risk time windows (14 to 35 days: before screening in the screening phase, 4 to 14 days in the visit phase, and 14 to 30 days in the follow-up phase). Compared phase Ⅱ with phase Ⅲ or phase Ⅳ, statistically significant differences were all observed in the distribution of visit windows during the visit phase (all P<0.05). Based on this classification, the institutional office recommends that all parties adopt strategies of scientific design, risk-based response, and closed-loop management, and deeply understand and actively cooperate with each other for different risk levels of time windows.

Significant differences exist in visit time windows across different phases of clinical trials. Risk classification and targeted responses from all parties can effectively ensure the quality of clinical trial data and the rights and interests of participants.

To investigate the association between CAPN10 rs3792269 and SLC47A2 rs12943590 gene polymorphisms and the efficacy of metformin in type 2 diabetes mellitus (T2DM) patients receiving metformin monotherapy in Xinjiang, providing references for individualized drug therapy in local patients.

A total of 450 T2DM patients who had been regularly taking metformin monotherapy for ≥3 months from July 2024 to July 2025 in a tertiary hospital in Xinjiang were selected. Clinical data were collected and target locus genotypes were detected. Using glycated hemoglobin (HbA1c%) as the efficacy indicator, patients were divided into wild-type homozygous and mutant genotype groups. Propensity score matching (PSM) was employed to analyze the association between gene polymorphisms and efficacy, followed by post hoc power analysis.

The PSM analysis revealed that the CAPN10 rs3792269 A>G variant was an independent protective factor for good glycemic control (PSM-adjusted OR=0.478, 95%CI 0.266-0.862, P<0.05). In contrast, the SLC47A2 rs12943590 polymorphism showed no significant association with treatment efficacy. For the CAPN10 rs3792269 locus, the absolute difference in glycemic control rates between the two groups was 17.3%, with OR=2.10 and statistical power of approximately 90%. For the SLC47A2 rs12943590 locus, the absolute difference was 2.5%, with OR=0.91 and statistical power of only 7%.

This study clarifies that the CAPN10 rs3792269 A>G variant is significantly associated with improved efficacy of metformin in the Xinjiang population of China, while the SLC47A2 rs12943590 locus shows no association in this sample. The influence of genetic factors on metformin efficacy exhibits population heterogeneity. The sample size in this study provids sufficient power for detecting moderate to large effects, which may serve as a reference for individualized medication and blood glucose management in local patients.

To explore changes in serum diamine oxidase (DAO) levels and their clinical significance in patients with gastrointestinal toxicity induced by fluorouracil antineoplastic drugs.

Patients with gastrointestinal tumors receiving fluorouracil-based antineoplastic therapy were divided into treatment group and control group according to whether gastrointestinal toxicity occurred during chemotherapy. The treatment group was further subdivided into ≤grade Ⅱ group and grade Ⅲ group based on the severity of gastrointestinal toxicity. General clinical data were collected, and serum DAO levels before chemotherapy and 7 days after chemotherapy were compared between treatment and control groups, as well as among patients with different grades of gastrointestinal toxicity. Logistic regression model was used to analyze the relationship between DAO levels and gastrointestinal toxicity, and receiver operating characteristic (ROC) curve analysis was performed to evaluate the predictive value of serum DAO levels 7 days after chemotherapy for the occurrence of gastrointestinal toxicity.

A total of 50 patients were ultimately included as study subjects, with 26 in treatment group and 24 in control group. The serum DAO levels 7 days after chemotherapy were (14.71±3.44) and (10.89±3.67) U·L^-1 in treatment and control groups, respectively. The serum DAO level in treatment group was significantly higher than that in control group 7 days after chemotherapy (P<0.05). The serum DAO levels 7 days after chemotherapy in ≤grade Ⅱ subgroup and grade Ⅲ subgroup were (13.38±3.06) and (16.37±3.25) U·L^-1, respectively. The serum DAO level in the ≤grade Ⅱ subgroup was significantly lower than that in the grade Ⅲ subgroup (P<0.05). Multivariate logistic regression analysis indicated that the serum DAO level 7 days after chemotherapy was an influencing factor for the occurrence of gastrointestinal toxicity in patients (P<0.001). ROC curve analysis showed that the optimal threshold for serum DAO in predicting gastrointestinal toxicity after chemotherapy was 11.92 U·L^-1, with an area under the curve (AUC) of 0.79 (P<0.05). The sensitivity and specificity were 77.78% and 86.96%, respectively.

Chemotherapy with fluorouracil-based antineoplastic drugs can lead to elevated serum DAO levels in patients with gastrointestinal tumors. The serum DAO level is associated with the severity of gastrointestinal toxicity and the grade of adverse drug reactions, and may serve as a predictive indicator for the occurrence of gastrointestinal toxicity following chemotherapy.

To observe the clinical efficacy and safety of trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules in advanced colorectal cancer patients after progression in second-line treatment.

Advanced colorectal cancer patients who had progression after second-line treatment were divided into the control group and the treatment group according to the treatment methods. The control group received tislelizumab injection 200 mg combined with fruquintinib capsules 5 mg, and the treatment group received 25 mg·m² trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules. A 21-day period was considered as one cycle, and both groups were treated continuously for 3 cycles. Clinical efficacy, tumor marker levels, angiogenesis factor levels, safety evaluation and survival were compared between the two groups.

This study enrolled 86 patients in total. The control group consisted of 45 patients, while the treatment group had 41 patients. After treatment, the disease control rates of the control group and the treatment group were 48.89% (22 cases/45 cases) and 73.17% (30 cases/41 cases), respectively; the levels of carbohydrate antigen 125 were (51.97±6.49) and (48.17±4.55) U·mL^-1, respectively; the levels of cytokeratin 19 fragment antigen 21-1 were (24.41±4.54) and (21.53±3.56) μg·L^-1, respectively; the levels of carcinoembryonic antigen were (30.84±6.42) and (27.76±4.44) ng·mL^-1, respectively; the levels of vascular endothelial growth factor (VEGF) were (97.82±16.74) and (90.29±16.74) pg·mL^-1, respectively; the levels of angiopoietin (Ang)-1 were (11 829.14±1 367.27) and (12 612.20±1 889.47) pg·mL^-1, respectively; the levels of Ang-2 were (486.90±113.66) and (430.59±76.93) pg·mL^-1, respectively; the levels of interleukin (IL)-8 were (10.54±2.39) and (9.05±1.85) pg·mL^-1, respectively; and the median progression free survival periods were 11 and 16 months, respectively. The above indicators of the treatment group were statistically significant different compared with the control group (all P<0.05). The main adverse drug reactions in the treatment group and the control group were nausea and vomiting, leukopenia, anemia, thrombocytopenia, hematochezia, elevated alanine aminotransferase, hand-foot syndrome, hypothyroidism, oral mucositis, hypertension and proteinuria. There was no statistically significant difference in the incidence of adverse drug reactions between the treatment group and the control group (P>0.05).

Trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules can significantly improve the clinical efficacy in patients with advanced colorectal cancer who progressed after second-line treatment, prolong progression-free survival, reduce angiogenesis factor levels, and have a certain degree of safety.

To observe the clinical efficacy and safety of anlotinib hydrochloride capsules combined with standard chemotherapy (cisplatin for injection+paclitaxel injection) in the treatment of patients with recurrent and metastatic cervical cancer.

The patients with recurrent and metastatic cervical cancer were divided into treatment group and control group according to the treatment methods. In control group, paclitaxel injection (175 mg·m^-2, infused within 3 hours) and cisplatin for injection (infusion time≥1 h) were intravenously infused. In treatment group, based on the treatment in control group, anlotinib hydrochloride capsules (12 mg qd) were orally administered. Both groups were continuously treated for 4 courses. The clinical efficacy, tumor marker levels, tumor angiogenesis-related indicators, quality of life, short-term prognosis of the two groups were compared, and the safety was evaluated.

The patients (n=125) were divided into control group (n=64) and treatment group (n=61). After treatment, the disease control rate (DCR) was 67.19% (43 cases/64 cases) in control group and 83.61% (51 cases /61 cases) in treatment group; the objective response rate (ORR) were 23.44% (15 cases /64 cases) and 40.98% (25 cases /61 cases), respectively; the median progression-free survival (PFS) were 6.40 and 11.31 months, respectively; and the median overall survival (OS) were 10.22 and 16.13 months, respectively. All the aforementioned indicators in treatment group were statistically significantly different from those in control group (all P<0.05). After treatment, the squamous cell carcinoma antigen levels in control group and treatment group were (2.80±0.53) and (2.56±0.47) ng·mL^-1, respectively; the carcinoembryonic antigen levels were (3.09±0.62) and (2.85±0.45) μg·L^-1, respectively; the carbohydrate antigen 19-9 levels were (21.08±3.04) and (19.59±2.72) U·mL^-1, respectively; the cytokeratin 19 fragment antigen 21-1 levels were (26.09±3.44) and (24.63±3.01) μg·L^-1, respectively; the vascular endothelial growth factor receptor levels were (461.93±97.86) and (415.74±101.87) pg·mL^-1, respectively; the platelet-derived growth factor receptor levels were (69.68±12.15) and (64.87±11.39) pg·mL^-1, respectively; the physiological condition scores were (18.66±4.04) and (21.49±4.15) points, respectively; the social/family situation scores were (17.16±4.03) and (19.57 ± 4.15) points, respectively; the functional status scores were (14.64±2.99) and (16.36±3.81) points, respectively; and the emotional state scores were (16.89±3.32) and (18.46±5.19) points, respectively. All the above-mentioned indicators in treatment group had statistically significant differences from those in control group (all P<0.05). No statistical significant difference in adverse drug reactions was observed between the two groups (P>0.05).

Anlotinib combined with the standard chemotherapy regimen has a remarkable efficacy in treating patients with recurrent and metastatic cervical cancer. It can reduce the levels of tumor markers in patients, inhibit tumor angiogenesis, improve their quality of life and short-term prognosis, and is highly safe.

To observe the clinical efficacy and safety of quilu tablets combined with lithium carbonate tablets and modified electroconvulsive therapy (MECT) in the treatment of bipolar disorder.

Patients with bipolar disorder were divided into control group and treatment group, both receiving routine treatment. The control group received MECT in addition to conventional treatment, with 3 sessions per week, administered every other day, totaling 12 treatments. During the treatment period, the patient was prescribed sustained-release lithium carbonate tablets with an initial dose of 0.25 g·d^-1, administered in 1-2 divided doses. Serum lithium levels were monitored weekly, maintained within the therapeutic range of 0.8-1.2 mmol·L^-1, and the medication was continued for a total of 6 weeks. The treatment group took quetiapine fumarate tablets orally after meals based on control group. The total doses for the first 4 days were 50, 100, 20 and 300 mg, respectively, taken in 2 doses. After the 4th day, the dose gradually increased to 300-450 mg·d^-1, and the dose was adjusted according to the patient’s clinical response and tolerance. The intake was controlled at 150-750 mg·d^-1, and the medication was shared for 6 weeks. Clinical efficacy, serological testing, depression and mania severity, cognitive ability, social function and occurrence of adverse drug reactions were compared between the two groups.

A total of 136 cases were screened in this study. Among them, 22 did not meet the inclusion and exclusion criteria, leaving 114 eligible for the study. They were divided into treatment group and control group, each comprising 57 cases. Six cases in control group were excluded due to personal reasons and loss to follow-up, while two cases in treatment group were excluded due to adverse drug reactions and loss to follow-up. Ultimately, 51 and 55 cases were included in control and treatment groups, respectively. After 6 weeks of treatment, the overall response rates were 72.55% (37 cases/51 cases) and 89.09% (49 cases /55 cases) in control and treatment groups; thyroid-stimulating hormone (TSH) levels were (2.72±0.42) and (2.90±0.44) μIU·mL^-1, respectively; prolactin (PR) levels were (13.58±2.40) and (15.27±2.56) ng·mL^-1, respectively; Hamilton depression scale -17 (HAMD-17) scores were (9.53±1.79) and (8.76±1.67) score, respectively; Bech - Rafaelsen mania rating scale (BRMS) scores were (7.04±1.39) and (6.47±1.35) score, respectively; Hopkins verbal learning test-revised (HVLT-R) scores were (26.94±4.85) and (29.76±3.81) score, respectively; continuous performance test (CPT) scores were (0.79±0.12) and (0.84±0.10) score, respectively; and social dysfunction screening scale (SDSS) scores were (6.92±1.18) and (6.38±0.99) score, respectively. All these indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). During treatment, the main adverse drug reactions in treatment group were drowsiness, dry mouth, dizziness and orthostatic hypotension; while those in control group were nausea, drowsiness, dry mouth and constipation. The overall incidence of adverse drug reactions were 11.76% (6 cases/51 cases) and 7.27% (4 cases /55 cases) in control and treatment groups, respectively, with no statistically significant difference (P>0.05).

Quetiapine tablets combined with lithium carbonate tablets and MECT are more effective than using only lithium carbonate tablets and MECT in treating bipolar disorder, and the safety is good.