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Key Points: Question: Does the addition of linear ablation combined with ethanol infusion via the vein of Marshall (EIVOM) to pulmonary vein isolation (PVI) improve rhythm outcomes for patients with persistent atrial fibrillation (AF)? Findings: In this randomized clinical trial that included 498 patients with persistent AF undergoing first-time ablation, linear ablation combined with EIVOM significantly improves freedom from atrial arrhythmia recurrence without antiarrhythmic drugs (70.7% vs 61.5%; hazard ratio, 0.73). Meaning: Linear ablation combined with EIVOM provides additional benefit in rhythm outcomes for the ablation of persistent AF. Importance: Success rates of pulmonary vein isolation (PVI) are modest for persistent atrial fibrillation (AF). Additional linear ablation beyond PVI has not been proved superior to PVI alone in randomized trials. Ethanol infusion of the vein of Marshall (EIVOM) facilitates ablation at the mitral isthmus and may lead to improved effectiveness of a linear ablation strategy. Objective: To determine whether linear ablation with radiofrequency energy combined with EIVOM added to PVI improves sinus rhythm maintenance compared with PVI alone in patients with persistent AF. Design, Setting, and Participants: The PROMPT-AF trial is an investigator-initiated, multicenter, open-label, randomized trial involving 12 tertiary hospitals in China. A total of 498 patients aged 18 to 80 years, with AF persisting for more than 3 months, undergoing first-time AF ablation, were enrolled and randomized from August 27, 2021, to July 16, 2023. Interventions: Patients were randomized to undergo PVI alone or PVI plus EIVOM and linear ablation (intervention). The latter group first underwent EIVOM, followed by PVI and linear ablation of the left atrial roof, mitral isthmus, and cavotricuspid isthmus. Main Outcomes and Measures: The primary end point was freedom from any documented atrial arrhythmias lasting more than 30 seconds, without the use of antiarrhythmic drugs within 12 months. Secondary outcomes included freedom from atrial arrhythmia recurrence, AF, atrial arrhythmia recurrence after multiple procedures, and documented atrial tachycardia or atrial flutter with or without antiarrhythmic drugs; AF burden; and improvement in quality of life. Patients were monitored with wearable single-lead electrocardiographic (ECG) patches, worn for 24 hours a week, supplemented by symptom-triggered ECGs and Holter monitoring. Results: Among 498 randomized patients, 495 (99.4%) were included in the primary analysis (mean age, 61.1 years [SD, 9.7] years, 361 male [72.9%]). After 12 months, 174 of 246 patients (70.7%) assigned to undergo PVI plus EIVOM and linear ablation and 153 of 249 patients (61.5%) assigned to undergo PVI alone remained free from atrial arrhythmias without taking antiarrhythmic drugs (hazard ratio, 0.73; 95% CI, 0.54-0.99, P =.045). The intervention effect was consistent across all prespecified subgroups. The comparison of secondary outcomes did not demonstrate significant results. Conclusion: Among patients with persistent AF, linear ablation combined with EIVOM in addition to PVI significantly improved freedom from atrial arrhythmias within 12 months compared with PVI alone. Trial Registration: ClinicalTrials.gov Identifier: NCT04497376 This clinical trial evaluates whether linear ablation combined with ethanol infusion of the vein of Marshall and pulmonary vein isolation (PVI) is more effective than PVI alone in patients with persistent atrial fibrillation. [ABSTRACT FROM AUTHOR]

Key Points: Question: In pregnant individuals with hepatitis B virus (HBV) and high viremia, is initiation of tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations of infants noninferior to initiation of TDF at week 28 combined with HBV vaccinations and HBV immune globulin (HBIG) in preventing mother-to-child transmission? Findings: Initiating maternal TDF therapy at week 16 combined with HBV vaccinations for infants was noninferior to initiating maternal TDF therapy at week 28 combined with HBIG and HBV vaccinations for infants in preventing mother-to-child transmission of HBV (0.76% [1/131] vs 0% [0/142]). Meaning: TDF therapy at gestational week 16 combined with HBV vaccinations of infants avoided the need for HBIG and was noninferior to standard care for preventing HBV transmission from pregnant women to infants. Importance: Standard care for preventing mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly viremic mothers consists of maternal antiviral prophylaxis beginning at gestational week 28 combined with an HBV vaccine series and HBV immune globulin (HBIG) at birth. However, HBIG is unavailable in some resource-limited areas. Objective: To determine whether initiating tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations for infants is noninferior to the standard care of TDF at gestational week 28 combined with HBV vaccinations and HBIG for infants in preventing MTCT in mothers with HBV and high levels of viremia. Design, Setting, and Participants: An unblinded, 2-group, randomized, noninferiority clinical trial was conducted in 7 tertiary care hospitals in China. A total of 280 pregnant individuals (who all identified as women) with HBV DNA levels greater than 200 000 IU/mL were enrolled between June 4, 2018, and February 8, 2021. The final follow-up occurred on March 1, 2022. Interventions: Pregnant individuals were randomly assigned to receive either TDF starting at gestational week 16 with HBV vaccinations for the infant or TDF starting at gestational week 28 with HBV vaccinations and HBIG administered to the infant. Main Outcomes and Measures: The primary outcome was the MTCT rate, defined as detectable HBV DNA greater than 20 IU/mL or hepatitis B surface antigen positivity in infants at age 28 weeks. Noninferiority was established if the MTCT rate in the experimental group did not increase by more than an absolute difference of 3% compared with the standard care group, as measured by the upper limit of the 2-sided 90% CI. Results: Among 280 pregnant individuals who enrolled in the trial (mean age, 28 years; mean gestational age at enrollment, 16 weeks), 265 (95%) completed the study. Among all live-born infants, using the last observation carried forward, the MTCT rate was 0.76% (1/131) in the experimental group and 0% (0/142) in the standard care group. In the per-protocol analysis, the MTCT rate was 0% (0/124) in the experimental group and 0% (0/141) in the standard care group. The between-group difference was 0.76% (upper limit of the 2-sided 90% CI, 1.74%) in all live-born infants and 0% (upper limit of the 2-sided 90% CI, 1.43%) in the per-protocol analysis. Both comparisons met the criterion for noninferiority. Rates of congenital defects and malformations were 2.3% (3/131) in the experimental group and 6.3% (9/142) in the standard care group (difference, 4% [2-sided 95% CI, −8.8% to 0.7%]). Conclusions and Relevance: Among pregnant women with HBV and high levels of viremia, TDF beginning at gestational week 16 combined with HBV vaccination for infants was noninferior to the standard care of TDF beginning at gestational week 28 combined with HBIG and HBV vaccination for infants. These results support beginning TDF at gestational week 16 combined with infant HBV vaccine to prevent MTCT of HBV in geographic areas where HBIG is not available. Trial Registration: ClinicalTrials.gov Identifier: NCT03476083 This noninferiority randomized clinical trial investigates whether administering tenofovir to pregnant individuals with hepatitis B virus beginning at gestational week 16 is noninferior to administering tenofovir beginning at gestational week 28 in preventing mother-to-child transmission. [ABSTRACT FROM AUTHOR]

Digital therapeutics (DTx) are software-driven solutions for prevention, treatment, and management of medical conditions. Despite a pro-DTx momentum in China, global DTx trial assessments overlooked the country. We identified 756 DTx trials in China and analyzed their characteristics and quality parameters. Over 70% were funded by governments, hospitals, and universities, with tertiary hospitals in eastern China leading most trials. 44.8% used automated DTx, with 39.2% DTx-guided. Most trials focused on management (52.5%) and treatment (38.1%), with few on prevention (9.4%). Mental, behavioral, or neurodevelopmental disorders represented the leading condition category of focus. Recent declines in median sample size, median duration, and mean number of sites were noted. Only 18% of trials were at low overall risk of bias. While recognizing the rapid development of DTx trials in China, we call for better trial design and methodological rigor, prioritization of preventive and primary care, wider condition category scope, and higher inclusivity. [ABSTRACT FROM AUTHOR]

Background: This study aimed to analyze the changing trend of diabetes drugs clinical trials in China during 2013-2023, and provided a reference for the research and development of diabetes drugs. Methods: Diabetes drug clinical trial data were obtained from the registration and information disclosure platform of the National Medical Products Administration (NMPA) between January 1, 2013, and December 31, 2023. Trends of clinical trials on diabetes drugs were systematically analyzed in terms of characteristics, trial design, time trends, drug type, and indications. Results: From 2013 to 2023, a total of 1,256 diabetes drugs clinical trials have been registered on the NMPA platform, of which 1056 were chemical drugs and 184 were biological products. The indications are mainly type 2 diabetes mellitus (n=1237, 98.49%). Among them, 838 clinical trials have been completed, 379 were proceeding, and 39 have been terminated or suspended. There were 42 international multi-center clinical trials, and the remaining 1034 clinical trials were domestic. Bioequivalence trials were 691, accounting for 55.02%, followed by 340 phase I clinical trials and 169 phase III clinical trials. The leading units were mostly distributed in eastern China. The proportion of clinical trial sponsorship from domestic pharmaceutical companies is higher than that from overseas companies. Conclusions: China has made significant advancements in diabetes drug research and development over the past decade. However, problems such as serious drug homogeneity, and insufficient innovation have become increasingly prominent. The government, clinical trial institutions, and pharmaceutical companies must collaborate to promote the high-quality development of drug clinical trials. [ABSTRACT FROM AUTHOR]

Obicetrapib is a selective cholesteryl ester transfer protein (CETP) inhibitor. Previous research has demonstrated similar pharmacokinetic (PK) responses to single doses of obicetrapib between Japanese and White males, but the PK responses have not been established in Chinese individuals. The purpose of this randomized, parallel, open‐label trial was to characterize the PK and pharmacodynamic (PD; CETP activity and plasma lipids) responses and safety of single doses (5, 10, or 25 mg; N = 36) and multiple doses (10 mg for 14 days; N = 12) of obicetrapib in healthy Chinese individuals. The maximum concentration and area under the drug concentration‐time curve of obicetrapib from 0 h to infinity increased with dose after all single doses of obicetrapib. After 7 consecutive days of dosing, low‐density lipoprotein cholesterol and high‐density lipoprotein cholesterol reached their minimum and maximum changes of 42% reduction and 108% increase, respectively. Primary PK and PD parameters after single‐ and multiple‐dose administration of obicetrapib were similar to those in healthy white participants in previous studies. One participant in the 5 mg dose group experienced a treatment‐emergent adverse event of decreased white blood cell and neutrophil counts, which resolved without intervention. In conclusion, these findings support the inclusion of Chinese individuals in the ongoing phase 3 clinical development program of obicetrapib. [ABSTRACT FROM AUTHOR]

Investigator-Initiated Trials (IITs) have seen substantial growth in China, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical practices. Despite their potential, IITs in China face challenges, including regulatory ambiguities, funding limitations, quality control issues, and inconsistencies in ethical review processes. This paper examines the current IIT landscape, identifies major obstacles, and proposes solutions, including regulatory reforms, funding increases, ethical review standardization, and international collaboration, to enhance IITs' effectiveness and impact on Chinese clinical research. [ABSTRACT FROM AUTHOR]

Enlonstobart (Enshuxing®), a recombinant, fully humanised immunoglobulin G4 monoclonal antibody targeted against programmed cell death protein 1 (PD-1), is being developed by the CSPC Pharmaceutical Group for the treatment of advanced cervical cancer and other solid tumours. Enlonstobart received its first approval (a conditional marketing authorisation) in June 2024, in China, for use in patients with recurrent or metastatic programmed cell death ligand 1 (PD-L1)-positive cervical cancer who have failed previous platinum-containing chemotherapy. Phase III clinical evaluation of enlonstobart for use as first-line treatment (in combination with chemotherapy ± bevacizumab) in patients with recurrent or metastatic PD-L1-positive cervical cancer is also underway in China. Additionally, phase II clinical development of enlonstobart (as a part of combination therapy) for use against a range of other solid tumour types is continuing. This article summarises the milestones in the development of enlonstobart leading to this first approval for recurrent or metastatic cervical cancer. [ABSTRACT FROM AUTHOR]

Scientific and effective training is important to enhance the theoretical knowledge and practical skills of clinical nurses in coronavirus disease 2019 (COVID‐19) prevention and control (IPC), so as to improve the IPC capacity. The study aimed to design and implement a COVID‐19 IPC training program for clinical nurses based on the ADDIE model, and to evaluate its clinical application effects. This was a pretest–posttest study in which 389 clinical nurses were recruited through convenience sampling. The IPC training program for clinical nurses was developed based on the five stages of ADDIE model. Data were analyzed using pared‐sample t test, McNemar's test, and Wilcoxon test. After training, nurses' theoretical scores and operational scores except for hand hygiene were improved significantly (p < 0.001). Compared to pre‐training assessment, their job performances were also significantly improved (p < 0.001). And they had higher satisfaction with the program post‐training. Under the situation of COVID‐19, training based on the ADDIE model can effectively improve the IPC ability of clinical nurses. Besides, it provides new ideas, methods, and approaches for future clinical IPC training. [ABSTRACT FROM AUTHOR]

BACKGROUND: Maca extract may regulate oxidative stress and muscle damage after exhaustive endurance exercise (EEE); however, its impact on these physiological activities remains obscure. OBJECTIVE: To examine the effects of Maca extract supplementation on oxidative stress, muscle damage and aerobic capacity after EEE. METHODS: Twenty healthy men were assigned to Maca or placebo groups and received two doses per day for 12 weeks. Pre- and post-EEE tests assessed levels of oxidative stress and muscle damage. The EEE test also recorded metrics such as time to exhaustion, peak oxygen consumption, and maximal and average heart rates. RESULTS: Post-exercise, there was no significant difference in oxidative stress markers between the Maca and placebo groups. However, the Maca group exhibited lower stress levels at both Post-4 and Post-24 in comparison to Post-0, while the placebo group only displayed a decrease at Post-4. Notably, Maca extract supplementation immediately increased catalase activity at Post-0. Though muscle damage markers did not significantly differ, the slope of CK elevation in the Maca group appeared lower than the Placebo group, suggesting Maca's potential in preventing muscle damage. However, no differences were noted on aerobic capacity markers. CONCLUSIONS: Maca extract may have some beneficial effects on reducing oxidative stress and possibly muscle damage after EEE. [ABSTRACT FROM AUTHOR]

Early reading skills are a prerequisite for children to acquire subsequent reading skills. Many online programs have been reported to be effective in improving students' reading skills. However, there is limited evidence demonstrating the effectiveness of online early reading programs for students with intellectual disability (ID). Using a single-case multiple-probe across-participant design, the study examined whether a family member–assisted online early reading program could improve the early Chinese reading skills of students with ID. All three participants demonstrated significant treatment effects on early reading skills in response to the program. These acquired effects were generalized across settings and maintained in follow-up conditions for all participants. As such, this study extends the limited literature on the effectiveness of online programs to develop early reading skills in students with ID. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy and safety of selective posterior rhizotomy (SPR) for the treatment of pure hereditary spastic paraplegia (PHSP) - associated lower limb spasticity. Methods Nine patients with PHSP were admitted to Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from January 2021 to February 2023. The Ashworth Scale (AS) score of hip adductors, quadriceps femoris, triceps surae and hamstring, femoral angle, popliteal fossa angle and dorsiflexion angle of foot, and Gross Motor Function Classification System (GMFCS) score before and after surgery were analyzed. Postoperative complications were recorded. Results All 9 patients completed SPR. No serious complication was observed. The AS score before and after surgery were significantly different of hip adductors (F = 43.568, P = 0.000), quadriceps femoris (F = 43.000, P = 0.000), triceps surae (F = 59.200, P = 0.000) and hamstring (F = 116.138, P = 0.000). The AS score of hip adductors (P = 0.000, 0.000), quadriceps femoris (P = 0.000, 0.000), triceps surae (P = 0.000, 0.000) and hamstring (P = 0.000, 0.000) 1 d and 12 months after surgery were significantly decreased comparing with those before surgery. The femoral angle (t = - 17.812, P = 0.000) and popliteal angle (t = - 12.791, P = 0.000) 5 d after the surgery were significantly increased comparing with those before surgery, while the dorsiflexion angle of foot 5 d after surgery was significantly decreased comparing with that before surgery (t = 14.050, P = 0.000). The GMFCS score before and 12 months after surgery were no significantly different (t = 1.000, P = 0.347). Conclusions SPR has good efficacy and safety for the treatment of PHSP-associated lower limb spasticity. [ABSTRACT FROM AUTHOR]

Purpose: With the rapid development of Phase I clinical trials for anticancer drugs in China, addressing ethical concerns is imperative. In order to safeguard the rights, interests, and well-being of research participants, this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs. Methods: This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were submitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023. Based on Chinese and international research regulations and guidelines, these documents, as well as initial and follow-up review resolutions, have been classified and analyzed. Results: Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vulnerability of participants enrolled with advanced cancer status, it is important to review investigator qualifications, preliminary findings, research methods, inclusion and exclusion criteria in the protocol, as well as the validity and readability of informed consent. Additionally, attention should be given to follow-up reviews, particularly regarding safety reports and protocol deviations. Conclusion: To effectively protect the rights, interests and safety of research participants. Relevant stakeholders, including sponsors, researchers, and regulatory bodies, should diligently evaluate potential risks and provision contingency plan to minimize the latent risk. [ABSTRACT FROM AUTHOR]

Key Points: Question: Is the long-term efficacy of adjuvant 3-cycle carboplatin, etoposide, and vincristine (CEV) regimen considered noninferior to the standard 6-cycle CEV regimen in patients with pathologically high-risk retinoblastoma? Findings: In this noninferiority randomized clinical trial of 187 patients with a median follow-up of 79.0 months, 5-year disease-free survival for patients receiving 3-cycle and 6-cycle CEV was 90.4% and 89.2%, respectively. The difference met the noninferiority margin criterion of 12%. Meaning: A 3-cycle CEV regimen demonstrated noninferiority compared with a 6-cycle approach and was and proved to be an efficacious adjuvant chemotherapy regimen for individuals diagnosed with pathologically high-risk retinoblastoma. Importance: Adjuvant therapy is an important and effective treatment for retinoblastoma. However, there is a lack of head-to-head clinical trials comparing 3 vs 6 cycles of CEV chemotherapy (carboplatin, etoposide, and vincristine) for enucleated unilateral retinoblastoma with high-risk pathological features. Objective: To assess whether 3 cycles of CEV chemotherapy is noninferior to 6 cycles for enucleated unilateral retinoblastoma with high-risk pathological features. Design, Setting, and Participants: This double-center, randomized, open-label, noninferiority trial was conducted at 2 premier eye centers in China and included 187 patients who had undergone enucleation for unilateral retinoblastoma with high-risk pathological features (massive choroidal infiltration, retrolaminar optic nerve invasion, or scleral infiltration) between August 2013 and March 2024. The final date of follow-up was March 21, 2024. Interventions: Patients were randomly assigned to receive either 3 (n = 94) or 6 (n = 93) cycles of CEV chemotherapy regimen after enucleation. Main Outcomes and Measures: The primary end point was disease-free survival, with a noninferiority margin of 12%. Secondary end points encompassed overall survival, safety, economic burden, and the quality of life of children. Results: All 187 patients (median [IQR] age, 25.0 [20.0-37.0] months; 83 [44.4%] female) completed the trial. Median (IQR) follow-up was 79.0 (65.5-102.5) months. Five-year disease-free survival was 90.4% for the 3-cycle group vs 89.2% for the 6-cycle group (difference, 1.2% [95% CI, −7.5% to 9.8%]), which met the noninferiority criterion (P =.003 for noninferiority). The 6-cycle group experienced a higher frequency of adverse events, greater reduction in quality of life scores, and increased costs compared with the 3-cycle group. Conclusions and Relevance: Among patients with unilateral pathologic high-risk retinoblastoma, 3 cycles of CEV chemotherapy resulted in 5-year disease-free survival that was noninferior to 6 cycles of CEV chemotherapy. Trial Registration: ClinicalTrials.gov Identifier: NCT01906814 This randomized clinical trial examines whether 3 cycles of carboplatin, etoposide, and vincristine chemotherapy is noninferior to 6 cycles for enucleated unilateral retinoblastoma with high-risk pathological features. [ABSTRACT FROM AUTHOR]

Background: Capsaicin is the main component of chili peppers and is believed to have antidiabetic effects. However, the association between spicy food consumption and the incidence of diabetes remains unclear. Methods: A cohort of 20,490 Han residents aged 30–79 without diabetes at baseline were followed from enrollment to June 2, 2023. The consumption of spicy food was obtained through face-to-face surveys conducted during the baseline survey from October 2018 to February 2019. The definition of type 2 diabetes onset was based on the ICD-10 code of E11 in the diabetes case reporting system and death system; Additionally, self-reported diagnosis of diabetes by a physician in active follow-ups, or a fasting blood glucose level of ≥ 7 mmol/L or a glycated hemoglobin percentage of ≥ 6.5% found on-site during the resurvey. Both Cox proportional hazard regression and competing risk regression were used to calculate hazard ratios (HRs) and confidence intervals (CIs). Results: During the follow-up period (53.5 ± 3.0 months), 182 individuals (1.1%) were newly diagnosed with T2D with an incidence rate of 246.2 per 100,000 person-years. Cox regression analyses revealed that spicy food consumers had a 34% reduced risk of developing type 2 diabetes (HR: 0.66, 95% CI: 0.48, 0.91) compared to non-consumers. The HRs (95% CIs) for participants consuming spicy food 3–5 days/week, 6–7 days/week, and with weak pungency were 0.45 (95% CI: 0.25, 0.81), 0.69 (0.49, 0.98), and 0.64 (0.46, 0.90), respectively. However, little significant protective effect was observed among those who consumed spicy food for 1–2 days/week, with moderate pungency, or with strong pungency (all P > 0.05). Conclusions: Consuming spicy food may lower the risk of developing type 2 diabetes, particularly at a frequency of 3–5 days/week, and with weak pungency. Further multicenter prospective studies or interventional studies are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Key Points: Question: Is tenecteplase noninferior to alteplase for patients with acute ischemic stroke (AIS) eligible for intravenous thrombolysis within 4.5 hours after stroke onset? Findings: In this noninferiority randomized clinical trial including 1489 participants, a total of 72.7% of patients receiving tenecteplase and 70.3% receiving alteplase achieved modified Rankin Scale scores of 0 or 1 (excellent functional outcome), resulting in a risk ratio of 1.03 (95% CI, 0.97-1.09), which met the predefined noninferiority margin of 0.937. Meaning: Findings from this study support tenecteplase as a suitable alternative to alteplase for patients with AIS eligible for thrombolysis. Importance: Tenecteplase is a bioengineered variant of alteplase with greater fibrin specificity and a longer half-life, allowing single-bolus administration. Evidence on the treatment effect of tenecteplase 0.25 mg/kg in Chinese patients with acute ischemic stroke (AIS) is limited. Objective: To establish the noninferiority of tenecteplase to alteplase in patients with AIS within 4.5 hours of symptom onset. Design, Setting, and Participants: The ORIGINAL study was a multicenter, active-controlled, parallel-group, randomized, open-label, blinded end point, noninferiority trial conducted between July 14, 2021, and July 14, 2023. Participants were recruited from 55 neurology clinics and stroke centers in China and were eligible if they had AIS with a National Institutes of Health Stroke Scale score of 1 to 25 with measurable neurologic deficit and were symptomatic for at least 30 minutes without significant improvement. Interventions: Patients were randomized (1:1) within 4.5 hours of symptom onset to receive intravenous tenecteplase (0.25 mg/kg) or intravenous alteplase (0.9 mg/kg). Main Outcomes and Measures: The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0 or 1 (no symptoms or no significant disability) at day 90, tested for noninferiority (risk ratio [RR] margin, 0.937). Safety end points included symptomatic intracerebral hemorrhage (per European Cooperative Acute Stroke Study III definition) and 90-day all-cause mortality. Results: Among the 1489 patients randomized, 1465 patients were included in the full analysis set (732 in the tenecteplase group; 733 in the alteplase group) and 446 (30.4%) were female. The primary outcome occurred in 72.7% (532/732) of patients receiving tenecteplase and 70.3% (515/733) receiving alteplase (RR, 1.03 [95% CI, 0.97-1.09]; noninferiority threshold met). Symptomatic intracerebral hemorrhage occurred in 9 patients (1.2%) in each group (RR, 1.01 [95% CI, 0.37-2.70]). The 90-day mortality rate was 4.6% (34/732) in the tenecteplase group and 5.8% (43/736) in the alteplase group (RR, 0.80 [95% CI, 0.51-1.23]). Conclusions and Relevance: In patients with AIS eligible for intravenous thrombolysis within 4.5 hours after stroke onset, tenecteplase was noninferior to alteplase with respect to excellent functional outcome (mRS score of 0 or 1) at 90 days and had a similar safety profile. Findings from this study support tenecteplase as a suitable alternative to alteplase in this setting. Trial Registration: ClinicalTrials.gov Identifier: NCT04915729 This noninferiority randomized clinical trial investigates whether tenecteplase is noninferior to alteplase for the treatment of Chinese patients with acute ischemic stroke eligible for intravenous thrombolysis within 4.5 hours after symptom onset. [ABSTRACT FROM AUTHOR]

This prospective interventional study investigated the impact of individualized nutritional interventions on immune function and infection rates in burn patients. This study enrolled 120 burn patients between December 2022 and January 2024. The nutritional interventions focused on protein supplementation, micronutrient replenishment, and inclusion of anti-inflammatory nutrients, specifically omega-3 fatty acids and vitamin C. The nutrients were administered through oral, enteral, and parenteral routes based on dietary preferences and the medical condition of individuals. Protein was prioritized because of its role in leukocyte production; zinc and vitamin C were supplemented to optimize immune function; and omega-3 fatty acids were included to mitigate inflammation and enhance wound healing. The study assessed outcomes through changes in leukocyte and lymphocyte counts, cytokine levels, infection rates, wound healing rates, and the length of hospital stays. Results indicated significant improvements in immune markers and reduced infection rates post-intervention (P < 0.05). Leukocyte count increased significantly, cytokine levels decreased, and the infection rate reduced from 30% to 14.2% (P < 0.05). These outcomes highlighted the efficacy of targeted nutritional interventions in supporting immune health and reducing infections in burn patients. The findings advocated for integrating comprehensive nutritional strategies in managing burn injuries to improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Objective: Tegoprazan represents a newly developed potassium-competitive acid blocker utilized for the treatment of acid-related disorders. The present study aimed to explore the therapeutic effectiveness of tegoprazan in Chinese individuals with duodenal ulcers (DU). Methods: In the current multicenter, randomized, double-blind, double-dummy, parallel-group, non-inferiority, phase III clinical trial, individuals with DU underwent randomization 1:1 to be administered tegoprazan 50 mg or lansoprazole 30 mg once daily. The primary efficacy endpoint was the 6-week cumulative endoscopic ulcer healing rate. Secondary endpoints included 4-week endoscopic ulcer healing rate and relief of DU-related gastrointestinal symptoms at weeks 2, 4, and 6. Safety analysis encompassed adverse events (AEs) and laboratory indexes. Results: The 6-week cumulative endoscopic ulcer healing rates were 96.9% (188/194) and 99.0% (189/191) in the tegoprazan and lansoprazole groups, respectively, indicating a difference of −2.0% (95% confidence interval (CI) = −4.9 to 0.8) in the full analysis set (FAS). The corresponding healing rates were 98.4% (185/188) and 99.5% (183/184) in the per-protocol set, respectively, indicating a difference of −1.1% (95% CI = −3.1 to 1.0). The 4-week healing rates in the tegoprazan and lansoprazole groups were 89.2% (173/194) and 88.5% (169/191) in the FAS, respectively, with a difference of 0.7% (95% CI = −5.6 to 7.0). Treatment-related AEs, all mild-to-moderate, were reported in 38.2% (78/204) and 48.2% (94/195) of participants in the tegoprazan and lansoprazole groups, respectively. Conclusions: Tegoprazan 50 mg once daily is effective and non-inferior to lansoprazole 30 mg once daily in Chinese patients with DU, showing a promising safety and tolerability profile. ClinicalTrials.gov registration number: NCT05010954. [ABSTRACT FROM AUTHOR]

Objective To investigate the efficacy and safety of modified SWIM technique for mechanical thrombectomy in patients with acute ischemic stroke. Methods Total 114 patients with acute ischemic stroke who underwent mechanical thrombectomy in The Third the People's Hospital of Bengbu from January 2021 to January 2024 were included. Modified SWIM technique (modified thrombectomy group, n = 57) and conventional SWIM technique (conventional thrombectomy group, n = 57) were given respectively. Vascular recanalization rate of the first thrombectomy, overall vascular recanalization rate, the number of thrombectomy, puncture-to-reperfusion time, near-term neurological deficits [National Institutes of Health Stroke Scale (NIHSS) at 14 d postoperatively] and long-term neurological prognosis [modified Rankin Scale (mRS) at 90 d postoperatively] were recorded, as well as symptomatic intracranial hemorrhage (sICH) rate and mortality. Results The vascular recanalization rate of the first thrombectomy in modified thrombectomy group was higher than that in conventional thrombectomy group (χ² = 5.054, P = 0.025), the number of thrombectomy was less than (Z = 2.014, P = 0.044), and puncture-to-reperfusion time was shorter than (Z = 2.630, P = 0.009) conventional thrombectomy group. There was a statistically significant difference in NIHSS score between modified thrombectomy group and conventional thrombectomy group before and after surgery (F = 5.185, P = 0.025), and there was also a statistically significant difference in NIHSS score between the 2 groups at admission and 14 d after surgery (F = 133.705, P = 0.000). There was not an interaction between treatment factors and measurement times (F = 3.148, P = 0.079). The NIHSS score 14 d after surgery in modified thrombectomy group was lower than that in conventional thrombectomy group (t = 2.969, P = 0.004). The NIHSS score of modified thrombectomy group (t = 10.286, P = 0.000) and conventional thrombectomy group (t = 6.428, P = 0.000) were lower at 14 d after surgery than those at admission. There was a statistically significant difference in mRS score between modified thrombectomy group and conventional thrombectomy group before and after surgery (F = 7.581, P = 0.007), and there was also a statistically significant difference in mRS score between the 2 groups at admission and 90 d after surgery (F = 277.328, P = 0.000). There was an interaction between treatment factors and measurement times (F = 10.471, P = 0.002), and the effect of modified SWIM technique was better. Modified thrombectomy group had a better prognosis (mRS score ≤ 2) at 90 d after surgery than conventional thrombectomy group (χ² = 4.267, P = 0.039). There were no significant differences in the incidence of postoperative sICH rate (χ² = 0.077, P = 0.782) and the mortality (χ² = 0.101, P = 0.751) between 2 groups. Conclusions The application of modified SWIM technique in mechanical thrombectomy has better efficacy and safety than conventional SWIM technique, and is worthy of clinical promotion. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: To assess the effects of the nurse–manager dualistic intervention (NMDI) program on work engagement and job crafting of ICU burnout nurses. Background: Work engagement is crucial for nurses' job performance and quality of clinical care. Personal and work resources are important antecedents of work engagement. However, few intervention studies focused on improving nurses' personal and work resources to promote work engagement and job crafting of burnout nurses. Methods: This was a quasi‐experimental study. One hundred and two ICU nurses from two tertiary hospitals in Shandong Province were recruited. Forty‐two ICU nurses from one hospital were set as the intervention group and underwent NMDI. Sixty ICU nurses from the other hospital constituted the control group, which received routine occupational health guidance from the hospital. Demographic characteristics, burnout, work engagement, and job crafting were collected at baseline (T0), postintervention (T1), and 3‐month postintervention (T2). Results: Compared to baseline, both work engagement and job crafting scores increased in the intervention group at postintervention (T1). At postintervention (T1), work engagement and job crafting were significantly higher in the intervention group than in the control group (βworkengagement = 3.894, p = 0.016 and βjobcrafting = 6.104, p = 0.010), but the difference between the two groups was not significant at the 3‐month follow‐up (βworkengagement = 3.618, p = 0.066 and βjobcrafting = 3.554, p = 0.15). Conclusion: The NMDI program can significantly improve ICU burnout nurses' work engagement and job crafting. Nevertheless, the sustainability of these effects over time has been found to be limited, indicating that future research needs to explore and implement strategies to bolster the long‐term efficacy of this intervention. Implications for Nursing Management: Nurse managers are suggested to integrate the NMDI program into routine nursing management. Managers ought to prioritize appreciative and constructive dialog between themselves and nurses in order to support nurses in inquiring personal and work resources and encourage nurses to develop work plans to utilize resources. This will help to increase nurses' engagement and job crafting. Trial Registration: ClinicalTrials.gov identifier: ChiCTR2100047974 [ABSTRACT FROM AUTHOR]

With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews. [ABSTRACT FROM AUTHOR]

Background: Many parturients have poor self-care ability, strong dependence on others, and lack mother-infant related nursing skills and health care knowledge. Due to their lack of pregnancy experience, many primiparas lack the relevant skills and knowledge, which can affect maternal and infant health and maternal quality of life. Purpose: The study aimed to investigate the effects of the PRECEDE-PROCEDE model on self-care ability and quality of life among primipara during puerperium. Methods: This quasi-clinical study selected eligible primaparas from those who gave birth at a Grade A hospital in Hengyang, China between April and July 2019. Eighty puerperium primiparas were divided into a control group receiving standard care and an intervention group following the PRECEDE-PROCEDE model. Comparison of self-care ability and quality of life scores was conducted between the two groups pre-intervention, at 3 weeks, and at 6 weeks postpartum. Statistical analysis using SPSS 18.0 included mean and standard deviation for measurement data, and frequency and constituent ratio for counting data. Tests such as t-test, Chi-squared test, rank-sum test, and repeated measure analysis of variance were applied. Findings: The control group's self-care ability scores were (150.8 ± 9.9), (150.9 ± 9.3), and (152.0 ± 10.2) before intervention, at 3 weeks postpartum, and at 6 weeks postpartum, respectively. For the intervention group, the corresponding scores were (151.1 ± 15.1), (157.8 ± 8.5), and (162.4 ± 7.2). Quality of life scores for the control group were (54.7 ± 8.6), (54.8 ± 7.7), and (55.1 ± 7.7) before intervention, at 3 weeks postpartum, and at 6 weeks postpartum, respectively. At the same time points, while the intervention group saw increases from (55.6 ± 7.6) to (59.2 ± 5.9) and (61.0 ± 5.3). There were statistically significant differences in the time effect and inter-group effect of the total score of self-care ability during puerperium, total score of quality of life, and the score of each dimension between the two groups (P < 0.05), and we also found an interaction effect between grouping and time factors (P < 0.05). After intervention, the incidence of common puerperium health problems except neonatal constipation and diarrhea in the intervention group was lower than that in the control group (P < 0.05). Conclusion: PRECEDE-PROCEDE model may improve self-care ability, reduce the occurrence of common health problems, and improve the quality of life of primiparas during puerperium. [ABSTRACT FROM AUTHOR]

Background: This study aims to investigate the short-term effects and safety of adjunct Suxiao Jiuxin Pills (SJPs) on conventional therapy in chronic coronary syndrome (CCS) patients who are intolerant to the adverse effects of long-acting nitrates. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 174 CCS participants from eight clinical study centers in China were included in the modified intention-to-treat analyses. Participants with CCS and intolerance to the adverse effects of long-acting nitrates were recruited and randomized to either the SJPs or the placebo group for a duration of 4 weeks. Results: Compared to the placebo group, the SJPs group showed a significant improvement in the efficacy rate after 4 weeks (OR = 2.43, 95% CI = 1.32 to 4.47, P = 0.004). Besides, individuals without a history of alcohol consumption showed a greater improvement in the SAQ summary score compared to those with a history of alcohol consumption. Conclusion: Adjunctive SJPs enhance the effectiveness of short-term conventional anti-angina treatment for patients with CCS who experience intolerance to long-acting nitrates, without significant adverse effects during application. Trial registration: Chinese Clinical Trials Registry Platform, ChiCTR2100050066. Registered 16 August 2021, https://www.chictr.org.cn/showproj.html?proj=131470. [ABSTRACT FROM AUTHOR]

This study aimed to develop and validate a community-based ostomy care training program for nursing staff, with the goal of enhancing their ostomy nursing competencies and improving patient satisfaction. Between March 2021 and October 2021, 20 registered nurses and 50 patients with enterostomy surgery who took part in the promotion of a new nursing technique in five community health service centers in the Wuxing District, Huzhou City, were enrolled in this study (forming the intervention group). In addition, 15 registered nurses and 40 patients with enterostomy surgery from four community health service centers with similar economic and health conditions in the same area were randomly selected as the control group. All community health service centers were independent institutions. The indexes before and after the promotion of the technique were compared, and the effectiveness of the training was evaluated by observing the improvement in nursing skills and changes in patient quality of life after the training. The "quality-of-life scale" was used to analyze the quality of life of patients who had undergone colostomy surgery. The new approach to ostomy care delivered in a community setting was found to improve staff knowledge and skill in ostomy care (p < 0.001), improve the quality-of-life scores of patients and reduce patient travel time and medical expenses. The promotion of ostomy nursing techniques in community health service centers has several benefits. It improves the ostomy nursing skill levels of community medical staff. This reduces the occurrence of ostomy complications. Additionally, it establishes an effective connection between tertiary hospitals and community health service centers. This connection is conducive to better nursing care for patients who have undergone ostomy surgery. The hospital – community – family nursing model can improve self-management abilities and reduce the incidence of complications of enterostomies. [ABSTRACT FROM AUTHOR]

Background: Adequate nutritional knowledge and healthy dietary behaviours are essential for promoting rational nutrition for children. However, lack of nutritional knowledge and unhealthy dietary behaviours are common among Chinese children. Therefore, we developed a school‐based nutrition education (NE) program to assess its impacts on nutritional knowledge and dietary behaviours in pupils. Methods: In this trial, one school was assigned as an intervention group (n = 199) and the other two schools were designated as a control group (n = 140). Children in the intervention group received the NE program in addition to their regular health curriculum, whereas the control group continued with their usual health curriculum without any NE program materials. Results: Concerning nutritional knowledge, the mean difference (follow‐up minus baseline) of average knowledge scores in the intervention group was significantly higher than that in the control group (1.99 ± 3.22 vs. 0.66 ± 3.60, p = 0.001). However, subgroup analysis revealed that this difference disappeared among boys and students with malnutrition status. Regarding dietary behaviours, the NE program significantly increased the proportion of children exhibiting high frequencies of meat and nuts consumption in the intervention group, along with diverse food choice at breakfast. Additionally, it markedly reduced the proportion of children exhibiting high frequencies of sugar‐sweetened beverages and fast food consumption. Structural equation modelling analyses indicated a significant direct effect of NE intervention on nutritional knowledge and an indirect effect on dietary behaviours. Conclusions: The NE program effectively enhanced nutritional knowledge scores and further improved dietary behaviours among Chinese primary school students. Future NE programs should pay more attention to boys and children with malnutrition. Highlights: The nutrition education (NE) program is a school‐based initiative that aims to provide NE and assess its impacts on nutritional knowledge and dietary behaviours in pupils.The NE program significantly enhanced students' nutritional knowledge, particularly among female students and those with normal weight.A marked increase in the proportion of children consuming meat and nuts was observed, whereas there was a decrease in the proportion of consuming sugar‐sweetened beverages and fast food.Structural equation modelling analyses indicated that the NE intervention had a significant direct effect on nutritional knowledge and an indirect effect on dietary behaviours. [ABSTRACT FROM AUTHOR]

Mild cognitive impairment (MCI) marks a critical phase in the progression to dementia. In our study, social workers utilized the Multicomponent Nonpharmacological Intervention Approach (MCNIA) to aid MCI participants (N = 52) and their caregivers, dividing into intervention and control groups. The intervention group underwent an additional regimen of non-pharmacological therapies besides pharmacological treatment. Our findings highlighted that: 1) MCNIA significantly enhanced cognitive and daily living abilities in the intervention group; 2) Caregivers experienced reduced burdens and improved social support; 3) Correlation analyses involving biomarkers indicated that MCNIA was particularly effective in alleviating depression in those with slightly more severe cognitive impairment. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill (QSYQ) in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods: This multicentre prospective cohort study was conducted at 40 centers in China. Patients with ACS after PCI entered either the QSYQ or Western medicine (WM) groups naturally based on whether they had received QSYQ before enrollment. QSYQ group received QSYQ (0.52 g, 3 times a day for 12 months) in addition to WM. The primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization. The secondary endpoint included rehospitalization due to ACS, heart failure, stroke, and other thrombotic events. Quality of life was assessed by the Seattle Angina Questionnaire (SAQ). Results: A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018. Overall, 487 patients received QSYQ and WM. During a median follow-up of 566 days (inter quartile range, IQR, 517–602), the primary endpoint occurred in 46 (9.45%) and 65 (14.48%) patients in QSYQ and WM groups respectively [adjusted hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.41–0.90; P=0.013]. The secondary endpoint occurred in 61 (12.53%) and 74 (16.48%) patients in QSYQ and WM groups, respectively (adjusted HR 0.76, 95% CI 0.53–1.09; P=0.136). In sensitivity analysis, the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint (HR 0.67, 95% CI 0.46–0.98; P=0.039). Moreover, QSYQ improved the disease perception domain of the SAQ (P<0.05). Conclusion: In patients with ACS after PCI, QSYQ combined with WM reduced the incidence of the primary endpoint. These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization through intermittent administration of QSYQ (Registration No. ChiCTR-OOC-14005552) [ABSTRACT FROM AUTHOR]

Objective To explore the application effect of rehabilitation education based on motivation behavior transformation in the rehabilitation of elderly patients with thoracolumbar compression fractures. Methods A total of 54 elderly patients with thoracolumbar compression fractures who received routine education at the 909th Hospital from January to December 2022 were included in the control group, and 54 patients of the same type who received rehabilitation education under motivation behavior transformation during the same period were included in the observation group. The psychological state, rehabilitation compliance, rehabilitation situation, quality of life and satisfaction rate of the two groups were compared. Results After one month of intervention, the psychological state scores of the observation group were lower than those of the control group (both P < 0. 05), and the compliance scores of exercise time, exercise location, exercise movements, and exercise enthusiasm were higher in the observation group than in the control group (all P < 0. 05). The rehabilitation score of the observation group was higher than that of the control group after one month of intervention (P < 0. 05). After one month of intervention, the quality of life scores of the observation group were higher than those of the control group in all aspects (all P < 0. 05). The satisfaction rate of the observation group was also higher than that of the control group (P < 0. 05). Conclusion Rehabilitation education based on motivation behavior transformation for elderly patients with thoracolumbar compression fractures is helpful to change their negative mentality and compliance, accelerate the speed of rehabilitation, and improve the quality of life and satisfaction rate of patients. [ABSTRACT FROM AUTHOR]

Objective To explore the application effect of pressure and stress theory combined with ABC emotional nursing in patients with hyperthyroidism. Methods A total of 106 patients with hyperthyroidism who received treatment at the Nantong Third People's Hospital from January 2020 to January 2023 were selected as the research subjects. They were divided into two groups using a lottery method. 53 patients in the control group received conventional intervention methods, and 53 patients in the observation group received pressure and stress theory combined with ABC emotional nursing on the basis of the control group's methods. The score of Positive and Negative Emotion Scale, the score of Athens Insomnia Scale, the level of health knowledge mastery, and the overall satisfaction with clinical nursing were compared between the two groups. Results After 4 and 8 weeks of intervention, the scores of positive emotion and negative emotion in the Positive and Negative Emotion Scale and the scores of the Athens Insomnia Scale in the observation group were better than those in the control group at the same time (all P < 0. 05), and the scores of both groups were better than those at admission (all P < 0. 05). The excellent rate of mastering health knowledge and the overall satisfaction rate of clinical nursing were compared between the two groups, and the results showed that the observation group had higher rates (both P < 0. 05). Conclusion Combining pressure and stress theory with ABC emotional nursing for patients with hyperthyroidism can effectively alleviate their negative emotions, improve their sleep quality, enhance their mastery of health knowledge and nursing satisfaction. [ABSTRACT FROM AUTHOR]

Background: Rimegepant, a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, is indicated for acute and preventive migraine treatment in the United States and other countries. However, there is a lack of prospective real-world evidence for the use of rimegepant in Chinese migraine patients. Methods: This was a single-arm, prospective, real-world study. While taking rimegepant to treat migraine attacks as needed, eligible participants were asked to record their pain intensity, functional ability, and accompanying symptoms for a single attack at predose and 0.5, 1, 2, 24, and 48 h postdose via a digital platform. Adverse events (AEs) during the rimegepant treatment period were recorded and analysed. The percentages of participants who experienced moderate to severe pain at predose and 0.5, 1, 2, 24, and 48 h postdose were assessed. Additionally, the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose were analysed. In addition, the total cohort (full population, FP) was stratified into a prior nonresponder (PNR) group to observe the effectiveness and safety of rimegepant for relatively refractory migraine and a rimegepant and eptinezumab (RE) group to observe the effectiveness and safety of the combination of these drugs. Results: By November 24th, 2023, 133 participants (FP, n = 133; PNR group, n = 40; RE group, n = 28) were enrolled, and 99 participants (FP, n = 99; PNR group, n = 30; RE group, n = 23) were included in the analysis. Rimegepant was effective in treating migraine in the FP and both subgroups, with a significant decreasing trend in the percentages of participants experiencing moderate to severe pain postdose (p < 0.05) and a marked increase in the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose compared with predose. AEs were reported by 6% of participants in the FP, and all AEs were mild. Conclusions: In the real world, rimegepant is effective in the acute treatment of migraine patients in China. The low incidence rate of AEs highlighted the favourable tolerability profile of rimegepant. Trial registration: Clinicaltrials.gov NCT05709106. Retrospectively registered on 2023-02-01. [ABSTRACT FROM AUTHOR]

Purpose: This study assesses the cost-effectiveness of rimegepant for the ondemand acute treatment of migraine in the Chinese population, focusing on headache relief within a 2 h timeframe. Utilizing data from Phase III clinical trials on rimegepant involving Asian populations, this analysis aims to provide essential insights for healthcare decision-making in the context of migraine management in China. Patients and methods: Employing a decision tree model, this research evaluates the cost-effectiveness of rimegepant over a concise 2 h period, exclusively considering its direct market price of 219.00 CNY per dose for on-demand, single-use treatment upon approval in China. This model is based on pain relief outcomes from a clinical trial, categorizing health outcomes by the achievement of pain freedom and alleviation from the most bothersome symptom within two hours post-administration. Results: The study unveils that rimegepant adds 0.0018 quality-adjusted life days (QALD) with an incremental cost-effectiveness ratio (ICER) of 122,166.07 CNY/QALD. Against a daily cost-effectiveness threshold derived from the 2023 per capita GDP of China (734.45 CNY/day), rimegepant falls short of proving its cost-effectiveness. A significant price reduction to approximately 1.32 CNY per dose is required for rimegepant to be considered cost-effective within this framework. Furthermore, a series of sensitivity analyses were conducted to validate the robustness of these results. Conclusion: While rimegepant shows clinical efficacy in providing rapid relief from migraine symptoms, its current pricing exceeds the threshold for costeffectiveness in the Chinese healthcare setting. This study underscores the need for price adjustments to enhance the accessibility and economic viability of new migraine treatments. [ABSTRACT FROM AUTHOR]

Purpose: This study examined the feasibility, acceptability, and preliminary effectiveness of Parenting for Lifelong Health for Parents and Adolescents program in reducing the risk of child maltreatment in Chinese families with adolescents. Methods: A pre-post single-arm pilot trial was conducted in July and August, 2023, and involved 16 parents and 13 teenagers with a mixed-methods design to collect both quantitative and qualitative data. Results: Parents reported enhanced positive parenting and reduced child behavioral problems. Adolescents reported decreased general child maltreatment and emotional maltreatment, along with perceived improvements in positive parenting and parent-child communication. Thematic analyses suggested of tangible benefits for participants, as well as for their family dynamics. Discussion: The program demonstrated promising feasibility, and it was significantly associated with reduced adolescent maltreatment. Further rigorous randomized controlled trials are needed. [ABSTRACT FROM AUTHOR]

Purpose: The Program for the Education and Enrichment of Relational Skills (PEERS®) is a group-based social skills training program for adolescents on the autism spectrum. Although the program has been shown to be effective in improving social skills in autistic adolescents, evidence of its effectiveness from the Mandarin-speaking Chinese population is sparse. The present study used a non-randomized, pre- and post-intervention research design to investigate the feasibility and cultural validity of the program, as well as examine the moderators of intervention outcomes. Methods: Thirty-three autistic adolescents with intelligence quotient above 70 (Mage = 13.57, SDage = 1.43; Male: Female 25:8) and their parents received 14 concurrent 90-minute sessions. Adolescents' autistic traits, challenging behaviors, emotional functioning, socio-cognitive process, social environment factors (school support), and caregivers' well-being were evaluated. Results: The findings suggest that with minor adjustments, the Mandarin version of PEERS® was generally acceptable and feasible for autistic adolescents and their parents. PEERS® may improve the social skills knowledge, reciprocal communication abilities, and emotional well-being of autistic adolescents. Also, participants with a higher level of school support, and parents with lower perceived subjective well-being at baseline may gain more benefits from PEERS®. The cultural adaptation and acceptability of the Mandarin Version of PEERS® were discussed. Conclusion: This feasibility study (Chinese Clinical Trial Registry: ChiCTR2200061417, 2022-06-23, retrospectively registered) provides a basis for further randomized control trials of the Mandarin version of PEERS®. [ABSTRACT FROM AUTHOR]

Rationale: This study presents the first comprehensive analysis and mapping of scientific research on point‐of‐care testing (POCT) in infectious diseases, filling a gap in understanding the evolving landscape of this field. The identification of research themes and global contributions offers valuable insights. Aims and Objectives: This manuscript aims to analyse and map scientific research on POCT in the context of infectious diseases. Methods: The study employed a comprehensive search strategy using terms related to POCT and infectious diseases. The search was conducted on the Scopus database, refining results based on inclusion and exclusion criteria. The dataset of 1719 research articles was then subjected to descriptive analysis and mapping using VOSviewer. Results: The research findings indicate an exponential growth in POCT‐related publications, with 46.8% published post the COVID‐19 pandemic. Plos One journal led in publication frequency, and Biosensors and Bioelectronics received the highest citations per article. North America and Western Europe dominated contributions, with notable participation from China, South Africa, and India. The research landscape revealed the following research themes: detection technologies, human immunodeficiency virus (HIV)/sexually transmitted infection (STI) diagnosis, antibiotic optimisation, and schistosomiasis. Clinical trials focused on antibiotic prescribing, HIV, STIs, and specific infections. The findings suggest a shifting landscape towards POCT, emphasising the need for future planning and investment in healthcare systems. The research identifies areas for future exploration, such as the impact of POCT on antibiotic prescribing and its role in combating infectious diseases in low‐ and middle‐income countries. Conclusion: Implementation of POCT has the potential to revolutionise infectious disease management, improve patient outcomes, and reduce the global burden of diseases. Better public awareness, healthcare team management, and planning for POCT at entry points are crucial for societal benefit. Results demonstrated the evolving role of POCT in infectious disease management and prevention. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Key Points: Question: Among patients with non–small cell lung cancer with the epidermal growth factor receptor (EGFR) variant who experienced resistance to EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment, does the addition of ivonescimab (a bispecific antibody targeting programmed cell death 1 protein and vascular endothelial growth factor) to chemotherapy improve progression-free survival compared with chemotherapy alone? Findings: In this phase 3 trial that enrolled 322 patients whose disease progressed while receiving EGFR-TKI treatment, ivonescimab plus chemotherapy significantly improved progression-free survival compared with placebo plus chemotherapy. Median progression-free survival was 7.06 months with ivonescimab vs 4.80 months with placebo. Meaning: Ivonescimab plus chemotherapy significantly improved progression-free survival with tolerable safety profile in patients with non–small cell lung cancer who previously underwent EGFR-TKI treatment and may offer a new treatment option for patients with TKI resistance. Importance: For patients with non–small cell lung cancer whose disease progressed while receiving EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, particularly third-generation TKIs, optimal treatment options remain limited. Objective: To compare the efficacy of ivonescimab plus chemotherapy with chemotherapy alone for patients with relapsed advanced or metastatic non–small cell lung cancer with the epidermal growth factor receptor (EGFR) variant. Design, Setting, and Participants: Double-blind, placebo-controlled, randomized, phase 3 trial at 55 sites in China enrolled participants from January 2022 to November 2022; a total of 322 eligible patients were enrolled. Interventions: Participants received ivonescimab (n = 161) or placebo (n = 161) plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by maintenance therapy of ivonescimab plus pemetrexed or placebo plus pemetrexed. Main Outcomes and Measures: The primary end point was progression-free survival in the intention-to-treat population assessed by an independent radiographic review committee (IRRC) per Response Evaluation Criteria in Solid Tumors version 1.1. The results of the first planned interim analysis are reported. Results: Among 322 enrolled patients in the ivonescimab and placebo groups, the median age was 59.6 vs 59.4 years and 52.2% vs 50.9% of patients were female. As of March 10, 2023, median follow-up time was 7.89 months. Median progression-free survival was 7.1 (95% CI, 5.9-8.7) months in the ivonescimab group vs 4.8 (95% CI, 4.2-5.6) months for placebo (difference, 2.3 months; hazard ratio [HR], 0.46 [95% CI, 0.34-0.62]; P <.001). The prespecified subgroup analysis showed progression-free survival benefit favoring patients receiving ivonescimab over placebo across almost all subgroups, including patients whose disease progressed while receiving third-generation EGFR-TKI therapy (HR, 0.48 [95% CI 0.35-0.66]) and those with brain metastases (HR, 0.40 [95% CI, 0.22-0.73]). The objective response rate was 50.6% (95% CI, 42.6%-58.6%) with ivonescimab and 35.4% (95% CI, 28.0%-43.3%) with placebo (difference, 15.6% [95% CI, 5.3%-26.0%]; P =.006). The median overall survival data were not mature; at data cutoff, 69 patients (21.4%) had died. Grade 3 or higher treatment-emergent adverse events occurred in 99 patients (61.5%) in the ivonescimab group vs 79 patients (49.1%) in the placebo group, the most common of which were chemotherapy-related. Grade 3 or higher immune-related adverse events occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group. Grade 3 or higher vascular endothelial growth factor–related adverse events occurred in 5 patients (3.1%) in the ivonescimab group vs 4 (2.5%) in the placebo group. Conclusions: Ivonescimab plus chemotherapy significantly improved progression-free survival with tolerable safety profile in TKI-treated non–small cell lung cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT05184712 This randomized clinical trial examines the efficacy of ivonescimab plus chemotherapy vs chemotherapy alone for patients with advanced or metastatic non–small cell lung cancer with the epidermal growth factor receptor (EGFR) variant. [ABSTRACT FROM AUTHOR]

Background: Non-invasive neuroregulation techniques have been demonstrated to improve certain motor symptoms in Parkinson's disease (PD). However, the currently employed regulatory techniques primarily concentrate on stimulating single target points, neglecting the functional regulation of networks and circuits. The supplementary motor area (SMA) has a significant value in motor control, and its functionality is often impaired in patients with PD. The matching SMA-primary motor cortex (M1) paired transcranial magnetic stimulation (TMS) treatment protocol, which benefits patients by modulating the sequential and functional connections between the SMA and M1, was elucidated in this study. Methods: This was a single-center, double-blind, randomized controlled clinical trial. We recruited 78 subjects and allocated them in a 1:1 ratio by stratified randomization into the paired stimulation (n = 39) and conventional stimulation groups (n = 39). Each patient underwent 3 weeks of matching SMA-M1 paired TMS or sham-paired stimulation. The subjects were evaluated before treatment initiation, 3 weeks into the intervention, and 3 months after the cessation of therapy. The primary outcome measure in this study was the Unified Parkinson's Disease Rating Scale III, and the secondary outcome measures included non-motor functional assessment, quality of life (Parkinson's Disease Questionnaire-39), and objective assessments (electromyography and functional near-infrared spectroscopy). Discussion: Clinical protocols aimed at single targets using non-invasive neuroregulation techniques often improve only one function. Emphasizing the circuit and network regulation in PD is important for enhancing the effectiveness of TMS rehabilitation. Pairing the regulation of cortical circuits may be a potential treatment method for PD. As a crucial node in motor control, the SMA has direct fiber connections with basal ganglia circuits and complex fiber connections with M1, which are responsible for motor execution. SMA regulation may indirectly regulate the function of basal ganglia circuits. Therefore, the developed cortical pairing stimulation pattern can reshape the control of information flow from the SMA to M1. The novel neuroregulation model designed for this study is based on the circuit mechanisms of PD and previous research results, with a scientific foundation and the potential to be a means of neuroregulation for PD. [ABSTRACT FROM AUTHOR]

Background: Data literacy (DL) is vital for teachers, as it enables them to build on data and improve teaching and learning. Therefore, developing DL among pre‐service teachers is critical. Objectives: The purpose of this study is threefold: to evaluate whether a feedback visualisation of peer assessment‐based teaching approach (FVPA‐based teaching approach) can (1) promote pre‐service teachers' DL; (2) enhance their learning motivation; and (3) improve their cognitive load. Methods: The research was conducted based on a pre‐test‐post‐test control group quasi‐experimental design. With 20 participants in the experimental group and 21 in the control group, a total of 41 pre‐service teachers were included in the study. The pre‐service teachers in the experimental group adopted the FVPA‐based teaching approach, and those in the control group adopted the traditional peer assessment‐based learning approach. Results and Conclusions: The experimental group participants outperformed the control group participants in DL, learning motivation, and cognitive load. FVPA was conducive to helping pre‐service teachers critically interpret data, understand their teaching and learning issues, and improve self‐reflection. The findings indicate a reciprocal relationship between learning motivation and DL; improving the learning motivation of pre‐service teachers could promote their DL. Implications: This study contributes to current knowledge by providing empirical evidence on the benefits of an FVPA‐based teaching approach in improving pre‐service teachers' DL, motivation, and cognitive load. The study findings, limitations, and prospects for future research are discussed. Lay Description: What is already known about this topic?: Teacher data literacy has emerged as a crucial competency for the forthcoming generation of educators, gaining attention from education institutions globally.Peer assessment, a well‐established practice in pre‐service teacher education, has proven effective in enhancing the learning experience for disadvantaged students by fostering motivation and improving academic performance.Despite the acknowledged benefits of feedback visualisation in facilitating self‐reflection, motivation, and academic performance, creating meaningful visualisations remains a challenge for educators and learners. What this paper adds?: This study introduces feedback visualisation in peer assessment to enhance comprehension of feedback information among pre‐service teachers.Feedback visualisation augments the benefits derived from peer assessment, refining data literacy, improving learning motivation, and alleviating cognitive load among pre‐service educators.The analysis of data directly relevant to pre‐service teachers and the provision of timely feedback can motivate critical analysis and utilisation of data, facilitating the identification of pedagogical and learning challenges.The study explores intricate interactions among learning motivation, data literacy, and cognitive load within the context of peer assessment visual feedback. The implications of study findings for practitioners: We encourage teacher educators to implement peer assessment instruction grounded in visual feedback for a comprehensive understanding of learning outcomes, identification of pedagogical challenges, determination of causes, and evidence‐informed instructional decision‐making.Teacher educator should diversify strategies to augment the motivation of pre‐service teachers, cultivating their proactive engagement in data analysis, interpretation, and application to enhance overall data literacy.We recommend that teacher educators provide rich visual feedback or present complex data in a visually accessible format for pre‐service teachers who need additional assistance to mitigate cognitive load and facilitate successful learning outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To examine the effect of walking interventions on sleep quality of persons with dementia (PWD) and their caregivers (dyads), and how different companions affect results. Method: Forty-five dyads were divided into three groups: a control group and two experimental groups (one with a care attendant, one with a family caregiver). The two experimental groups engaged in 120 minutes of walking per week for 24 weeks. Results: A significant improvement in sleep quality was observed among PWD in the family caregiver group (Wald χ2 = 4.55, p = 0.033), whereas there was no improvement in the care attendant group. A slight improvement in sleep quality of family caregivers was also found. Conclusion: Findings suggest the importance of creating individualized walking activity plans for dyads, incorporating trust and rapport-building strategies to improve sleep quality. [Journal of Gerontological Nursing, 50(8), 46–56.] [ABSTRACT FROM AUTHOR]

Purpose: This phase I trial is to determine the recommended dose of the TAS-102, irinotecan plus bevacizumab regimen and assess its safety and efficacy in patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin treatment. Methods: A 3 + 3 designed dose escalation was performed. Patients were administered TAS-102 (30–35 mg/m2 twice daily on days 1–5) and irinotecan (150–165 mg/m2 on day 1) combined with a fixed dose of bevacizumab (5 mg/kg on day 1) every two weeks. The primary endpoint was the determination of the recommended phase II dose. Results: Eighteen patients were enrolled: 6 at the Level 1 (TAS-102 30 mg/m2 twice daily, irinotecan 150 mg/m2 plus bevacizumab 5 mg/kg), six at the Level 2 (TAS-102 35 mg/m2 twice daily, irinotecan 150 mg/m2 plus bevacizumab 5 mg/kg), and six at the Level 3 (TAS-102 30 mg/m2 twice daily, irinotecan 165 mg/m2 plus bevacizumab 5 mg/kg). Five dose-limiting toxicities occurred: one observed at Level 1 (thrombocytopenia), two at Level 2 (neutropenia and diarrhea), and two at Level 3 (fatigue and neutropenia). The RP2D was established as TAS-102 30 mg/m2 twice daily and irinotecan 150 mg/m2 plus bevacizumab 5 mg/kg. The most frequent grade 3/4 treatment-related adverse events were neutropenia (33.3%), diarrhea (16.7%), and thrombocytopenia (11.1%). No treatment-related death occurred. Two patients (11.1%) experienced partial responses and 14 (77.8%) had stable disease. Conclusion: The regimen of TAS-102, irinotecan, and bevacizumab is tolerable with antitumor activity for metastatic colorectal cancer patients refractory to first-line fluoropyrimidines and oxaliplatin treatment. [ABSTRACT FROM AUTHOR]

Introduction Fruquintinib is approved in China for patients with metastatic colorectal cancer (CRC) who progressed after 2 lines of chemotherapy. This postmarketing study was conducted to evaluate the safety of fruquintinib in the Chinese population, including previously treated patients with advanced CRC and other solid tumors. Methods Patients in the first cycle of fruquintinib or expected to start fruquintinib within a week were enrolled. Fruquintinib was administrated according to the label or per physicians' discretion. Patient characteristics and safety information were collected at baseline, 1 month, and 6 months after consent (or 30 days after the last dose). Results Overall, 3005 patients enrolled between April 24, 2019 and September 27, 2022. All enrolled patients received at least one dose of fruquintinib. Most patients had metastases at baseline. The median age was 60 years. More than half (64.0%) of the patients started fruquintinib at 5 mg, and the median treatment exposure was 2.7 months. Nearly one-third (32.5%) of patients with CRC received fruquintinib with concomitant antineoplastic agents. Treatment-emergent adverse events (TEAEs) leading to dose modification were reported in 626 (20.8%) patients, and 469 (15.6%) patients experienced TEAEs leading to treatment discontinuation. The most common grade ≥ 3 TEAEs were hypertension (6.6%), palmar-plantar erythrodysesthesia syndrome (2.2%), and platelet count decreased (1.0%). Combination therapy did not lead to excessive toxicities. Conclusions The safety profile of fruquintinib in the real world was generally consistent with that in clinical studies, and the incidence of TEAEs was numerically lower than known VEGF/VEGFR inhibitor-related AEs. Fruquintinib exhibited manageable safety and tolerability in Chinese patients in the real-world setting. [ABSTRACT FROM AUTHOR]

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We conducted a phase I, randomized, double-blind, placebo-controlled trial including healthy adults in Sui County, Henan Province, China. Ninety-six adults were randomly assigned to one of three groups (high-dose, medium-dose, and low-dose) at a 3:1 ratio to receive one vaccine dose or placebo. Adverse events up to 28 days after each dose and serious adverse events up to 6 months after all doses were reported. Geometric mean titers and seroconversion rates were measured for anti-rotavirus neutralizing antibodies using microneutralization tests. The rates of total adverse events in the placebo group, low-dose group, medium-dose group, and high-dose group were 29.17 % (12.62 %–51.09 %), 12.50 % (2.66 %–32.36 %), 50.00 % (29.12 %–70.88 %), and 41.67 % (22.11 %–63.36 %), respectively, with no significant difference in the experimental groups compared with the placebo group. The results of the neutralizing antibody assay showed that in the adult group, the neutralizing antibody geometric mean titer at 28 days after full immunization in the low-dose group was 583.01 (95 % confidence interval [CI]: 447.12–760.20), that in the medium-dose group was 899.34 (95 % CI: 601.73–1344.14), and that in the high-dose group was 1055.24 (95 % CI: 876.28–1270.75). The GMT of serum-specific IgG at 28 days after full immunization in the low-dose group was 3444.26 (95 % CI: 2292.35–5175.02), that in the medium-dose group was 6888.55 (95 % CI: 4426.67–10719.6), and that in the high-dose group was 7511.99 (95 % CI: 3988.27–14149.0). The GMT of serum-specific IgA at 28 days after full immunization in the low-dose group was 2332.14 (95 % CI: 1538.82–3534.45), that in the medium-dose group was 4800.98 (95 % CI: 2986.64–7717.50), and that in the high-dose group was 3204.30 (95 % CI: 2175.66–4719.27). In terms of safety, adverse events were mainly Grades 1 and 2, indicating that the safety of the vaccine is within the acceptable range in the healthy adult population. Considering the GMT and positive transfer rate of neutralizing antibodies for the main immunogenicity endpoints in the experimental groups, it was initially observed that the high-dose group had higher levels of neutralizing antibodies than the medium- and low-dose groups in adults aged 18–49 years. This novel inactivated rotavirus vaccine was generally well-tolerated in adults, and the vaccine was immunogenic in adults (ClinicalTrials.gov number, NCT04626856). [ABSTRACT FROM AUTHOR]