bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety, tolerability and pharmacokinetics of WXFL10203614 in healthy Chinese subjects: A randomized, double-blind, placebo-controlled phase Ⅰ study
Authors: Huang Kai , Ding Ying , Que Linling , Chu Nannan , Shi Yunfei , Qian Zhenzhong , Qin Wei , Chen Yuanxin , Gu Xianghong , Wang Jiakun , Zhang Zhiwei , Xu Jianguo , He Qing 
Published: November 2022

Objective: This study was conducted to investigate the safety, tolerability and pharmacokinetics (PK) of WXFL10203614 after single and multiple oral doses in healthy Chinese subjects.Methods: A single-center, randomized, double-blind, placebo-controlled phase Ⅰ study was performed on healthy Chinese subjects. In the single-dose study, Subjects were randomized into 7 dose levels of WXFL10203614 (1 mg group, n = 2; 2, 5, 10, 17, 25 and 33 mg groups with placebo, 8 subjects per group, 2 of them given placebo). In the multiple-dose study, subjects received 5 or 10 mg WXFL10203614 once daily (QD), 5 mg twice daily (BID) or placebo for 7 consecutive days. Safety, tolerability and PK of WXFL10203614 were all assessed.Results: A total of 592 subjects were screened, 50 subjects were enrolled in the single-dose study and 30 in the multiple-dose study. All adverse events (AEs) were mild or moderate and resolved spontaneously. No Serious Adverse Events (SAEs) or deaths were reported during the study. WXFL10203614 was absorbed rapidly after dosing with Tmax of 0.48–0.98 h, Cmax, AUC0-t and AUC0-∞ were all increased in a dose-related manner over the range of 1–33 mg. Renal excretion was the major route of elimination of WXFL10203614. Steady-state PK parameters (Cmax,ss, AUC0-t,ss and AUC0-∞,ss) were elevated after once-daily administration of 5–10 mg WXFL10203614 and non- and weak drug accumulations were observed, whereas moderate drug accumulation occurred in the 5 mg BID group.Conclusion: WXFL10203614 exhibited good safety, tolerability and favorable PK profiles in healthy Chinese subjects, supporting further clinical development in patients with rheumatoid arthritis.Clinical Trials Registration Number:http://www.chinadrugtrials.org.cn/index.html, #CTR20190069 and CTR20200143.
The efficacy and safety of mecobalamin combined with Chinese medicine injections in the treatment of diabetic peripheral neuropathy: A systematic review and Bayesian network meta-analysis of randomized controlled trials
Authors: Ma Yuqi , Chen Ji , Huang Xinggui , Liu Yuan 
Published: November 2022

Background: In recent years, people pay more and more attention to diabetic peripheral neuropathy (DPN). As a neurotrophic agent, mecobalamin is able to repaire nerves, which has already become a consensus among experts. However, it has been found that mecobalamin has poor effect to increase nerve conduction velocity, which is an important indicator. Clinical data have shown that Chinese medicine injection, combined with mecobalamin injection, can significantly improve nerve conduction velocity of the limbs. Nevertheless, several kinds of Chinese medicine injections have been used to treat DPN. The effect of these Chinese medicine injections for DPN are various. Therefore, it is necessary to evaluate the effectiveness of Chinese medicine injections combined with mecobalamin in the treatment of DPN.Methods: All relevant articles published before 12 March 2022 were searched in eight electronic databases. Randomized controlled trials (RCTs) on Chinese medicine injections plus Mecobalamin for DPN were identified according to inclusion criteria, and were assessed using the revised Cochrane risk of bias tool (ROB2.0). R software and stata15 was used to create the ranking probabilities and network meta-analysis.Results: A total of 80 RCTs involving 6,980 patients were included. The results showed that mecobalamin plus Dengzhanxixin injection (ME + DZXX) ranked first in overall response rate [RR = 1.64, 95% CI (1.26, 2.21)] and median motor nerve conduction velocity [MD = 9.46, 95% CI (5.67, 13.28)]. Then, mecobalamin plus Kudiezi Injection (ME + KDZ) had the best effect in median sensory nerve conduction velocity [MD = 10.41, 95% CI (−13.31, −7.52)], and mecobalamin plus Honghua injection (ME + HH) ranked highest in common peroneal motor nerve conduction velocity [MD = 6.8, 95% CI (4.13, 9.49)] and common peroneal sensory nerve conduction velocity [MD = −6.25, 95% CI (−8.85, −3.65)].Conclusion: This study determined the efficacy of different Chinese medicine injections combined with mecobalamin. DZXX may be the best adjunctive Chinese medicine injection for DPN patients. However, due to potential risk of bias and limited RCTs, our results need to be treated with reservations.
Meaning in life among Chinese undergraduate students in the post-epidemic period: A qualitative interview study
Authors: Ge Ying , Lu Cun Yang , Shuai Mei Qiong , Wenger Jay L. , Peng Chun Hua , Wang Hong 
Published: November 2022

BackgroundCOVID-19 epidemic has lasted for nearly 3 years, and revolutionized social life. In the study, in-depth interviews were conducted with Chinese undergraduate students to explore their understanding and experience of meaning in life. Meaning of life is interpreted from four aspects: life goals, life value, life enthusiasm, and life freedom. These four aspects are independent yet interrelated. Based on the free grasp of life, individuals explore and pursue the true meaning of life goals, acquire life value in evaluating the completion of life goals, and subsequently experience enthusiasm for life. Life enthusiasm and the perception of life value can help individuals to further understand and possess their meaning of life.Materials and methodsThe present study adopts the qualitative method to understand the experience of meaning in life among Chinese undergraduate students. Semi-structured interviews were conducted, and six people participated the study. The Grounded Theory was adopted to analyze the qualitative data.Results(1) Chinese undergraduates had clear life goals and obtained a certain sense of achievement and satisfaction when striving for these goals. (2) The life value of Chinese undergraduates was mainly to their families, but there was also a willingness to make due contributions to the country and society. (3) Chinese undergraduates’ feelings about life were polarized, but they all expressed the view of “living in the moment and cherishing the present.” (4) Chinese undergraduate students see life freedom as freedom of choice and generally believed that COVID-19 did not restrict their lives very much. (5) Chinese undergraduate students gained a deeper understanding of meaning in life after this major public health emergency.
Self-care behaviors in older adults suffering from knee osteoarthritis: Application of theory of planned behavior
Authors: Jormand Hanieh , Mohammadi Nasim , Khani Jeihooni Ali , Afzali Harsini Pooyan 
Published: November 2022

BackgroundOsteoarthritis is one of the main reasons causing disablement. Educational intervention for self-care behaviors of patients suffering from knee osteoarthritis is important because its effect on quality of patient life decreases the economic burden of disorder on society and family. This study aimed to investigate the effect of educational intervention based on the theory of planned behavior (TPB) on promoting self-care behaviors in elderly patients suffering from knee osteoarthritis.MethodsThis quasi-experimental study was performed on 200 elderlies suffering from knee osteoarthritis in the rheumatology clinics of Shiraz, Iran, in 2019. The subjects were divided into two groups (100 experimental and 100 control). Before and after 4 months, both experimental and control groups filled a questionnaire. After administering a pre-test to both groups, only the experimental group was trained based on the TPB constructs on self-care behaviors in elderly people suffering from knee osteoarthritis in eight sessions by presenting educational films and images, power points, and group discussions for solving problems.ResultsThe mean age of the experimental group was 67.25 ± 3.64, and the mean age of the control group was 66.12 ± 3.50. The average scores of attitudes, subjective norms, perceived behavioral control, intention, and behavior before the educational intervention did not have significant differences in experimental and control groups, however, 4 months after the educational intervention, the pairedt-test indicated significant enhancement in every construct in the experimental group, but no significant changes in the control group.ConclusionAccording to the results, the educational intervention increased the self-care behaviors of patients suffering from knee osteoarthritis based on the theory of planned behavior. Therefore, the results of this study can be used in theory-based intervention strategies for self-care behaviors of patients suffering from knee osteoarthritis.
A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital
Authors: Villanueva-Bueno Cristina , Collado-Borrell Roberto , Escudero-Vilaplana Vicente , Revuelta-Herrero José Luis , Marzal-Alfaro María Belén , González-Haba Eva , Arranz-Arija José Ángel , Osorio Santiago , Herranz-Alonso Ana , Sanjurjo-Saez María 
Published: November 2022

ObjectiveThis study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents.Material and methodsWe performed an observational, prospective study of cancer outpatients treated with oral antineoplastic agents (OAA), monitored by the eOncosalud app between August 2017 and October 2021. Safety variables were collected from eOncosalud: the number of AE; severity of the AE according to CTCAE, version 4.03; timelapse from app installation to first recorded AE; automatic recommendations issued; and the patient's acceptance of the recommendations made. To assess the impact of the recommendations generated by the algorithm, we calculated the positive predictive value (PPV) as the number of recommendations accepted out of the total number of recommendations generated. Safety-related patient messages were also analyzed (AE, drug–drug interactions, drug administration).ResultThe app was downloaded and used by 186 patients (58.0% women), with a mean age of 59.0 years. A total of 1,368 AE were recorded, the most frequent being fatigue (19.37%), diarrhea (18.20%), and skin changes (9.21%). Regarding the recommendations issued by the app algorithm, 102 patients received 344 information brochures, 39 patients received 51 recommendations for supportive care to control AE, 60 patients received 240 recommendations to visit their primary care doctor, 14 patients received 16 recommendations to contact their specialist pharmacist or oncologist-hematologist, and 34 patients received 73 recommendations to go to the emergency room. The suggestion to go to the emergency room and contact the specialist pharmacist or oncologist-hematologist had a PPV of 0.51 and 0.35, respectively. Half of the patients (50.4%) used the messaging module. A total of 1,668 messages were sent. Of these, 47.8% were related to treatment safety: AE, 22.7%; drug-drug interactions, 20.6%; drug administration, 3.6%; and missing a dose, 1.0%.ConclusionsThe eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm have optimized available healthcare resources. The app facilitated early detection of AE, thus enabling patients themselves to improve the safety of their treatment.
Impact of primary site on survival in patients with nasopharyngeal carcinoma from 2004 to 2015
Authors: Shen Tianyi , Cai Wenting , Li Tingting , Yu Donghui , Ren Chengda , Yu Jing 
Published: November 2022

BackgroundNasopharynx carcinoma (NPC) is the most common malignant tumor of the nasopharynx. Many studies have shown some factors related with the prognosis of NPC patients. Our study aims to evaluate the differences of prognosis between initial and second primary NPC.Material and methodsThe Surveillance, Epidemiology, and End Results (SEER) program was used to perform the population-based analysis in NPC patients who were newly diagnosed between 2004 and 2015. Kaplan-Meier and Cox regressions were used to evaluate the effects of primary site on the overall survival (OS), as well as the cancer-specific survival (CSS).ResultsOur study included 5,012 NPC patients: 4,474 initial primary NPC patients and 5,38 s primary NPC patients. Significant differences were observed in sex, age at diagnosis, race, median household income, histological type, American Joint Committee on Cancer (AJCC) stage, N-stage, radiation treatment and chemotherapy between patients with initial and second NPC (P &lt; 0.05). Moreover, the patients with second NPC had longer survival months. In addition, radiation and chemotherapy were recommended both in first and second primary NPC patients.ConclusionWorse prognosis was observed in patients with second primary NPC compared with those with primary NPC in all subgroups of AJCC stage and age at diagnosis.
Transvaginal natural orifice endoscopic surgery for myomectomy: Can it be a conventional surgery?
Authors: Hou Qiannan , Li Xin , Huang Lu , Xiong Ying , Feng Dan , Zhang Qiang , Zeng Xiaoyan , Yang Yang , Liu Tianjiao , Li Yalan , Lin Yonghong , He Li 
Published: November 2022

IntroductionAs a new minimally invasive surgery, transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has been proved to be suitable for the treatment of a variety of gynecological benign diseases. However, compared with other minimally invasive surgeries that have been widely used, such as conventional multiport laparoscopy and transumbilical laparoendoscopic single-site surgery (LESS), their advantages and disadvantages and how to choose are still unknown. The purpose of our study is to compare the advantages and disadvantages of the three minimally invasive surgeries in myomectomy and to provide theoretical basis for the wider development of vNOTES surgery.Material and methodsThis retrospective study included 282 patients at our hospital who underwent laparoscopic myomectomy from May 2021 to March 2022. Based on the surgical approach, patients were classified into multiport, transumbilical LESS, and vNOTES groups. The patients’ demographic characteristics and follow-up data were collected during the perioperative period and at 1 month postoperatively.ResultsAmong the three procedures, vNOTES had the shortest anal exhaust time but also the highest postoperative infection rate. Multiple linear regression analysis showed that the operative time increased by 3.5 min for each 1 cm increase in myoma, and intraoperative bleeding increased by approximately 12 ml. The average duration of single pores increased by 25 min compared to that of multiports, and the operative duration increased by 10.48 min for each degree of adhesion.ConclusionsFor gynecologists who have mastered vNOTES, this procedure has the same efficacy and safety as the two existing minimally invasive surgeries in myomectomy, but it shows obvious advantages in postoperative recovery.
Efficacy of ultrasound guided dry needling as an adjunct to conventional physical therapy for patients with jumper’s knee: A randomized controlled trial
Authors: Sharif Faiza , Ahmad Ashfaq , Gilani Syed Amir , Bacha Raham , Hanif Asif , Arif Muhammad Asim 
Published: November 2022

BackgroundJumper’s knee is a degenerative condition among athletes, and it has been treated with conventional physical therapy (CPT). Ultrasound guided dry needling (USG-DN) is a relatively new technique to explore clinical outcomes in patients with tendinopathy.MethodsThis parallel group, single-blinded randomized controlled trial was carried out involving 94 athletes with clinically diagnosed jumper’s knee, divided into an intervention group (USG-DN + CPT, n = 47) and a control group (CPT, n = 47). Participants received a 4-week programme; the intervention group received ultrasound guided patellar tendon dry needling (DN) in conjunction with CPT. The control group received only CPT. The visual analog scale (VAS), Victorian institute of sports assessment-Patellar tendinopathy (VISA-P) questionnaire, Lysholm scale, Knee injury and osteoarthritis outcome score (KOOS) and ultrasonographic features of patellar tendinopathy were evaluated at baseline,1 week, 2 weeks, and 4 weeks. The data were analyzed through SPSS-26.ResultsThe study found statistically significant differences (P &lt; 0.05) regarding VAS, Lysholm, VISA-P, and KOOS scales at baseline, 1st, 2nd, and 4th week post-intervention. Within-group differences also showed statistically significant results after the intervention. There were significant results observed in ultrasonographic outcomes between both groups at 1 month post-intervention (all P &lt; 0.05).ConclusionThe results of the current study suggest, ultrasound guided DN of patellar tendon in combination with CPT reduced pain, improved function, and showed a tendency to decrease tendon thickness in patients with patellar tendinopathy.Clinical Trial Registration Number(IRCT20210409050913N1). Dated: 17.04.2021. https://www.irct.ir/user/trial/55607/view.
Does the continuation of low-dose acetylsalicylic acid during the perioperative period of thyroidectomy increase the risk of cervical haematoma? A 1-year experience of two Italian centers
Authors: Canu Gian Luigi , Medas Fabio , Cappellacci Federico , Giordano Alessio Biagio Filippo , Casti Francesco , Grifoni Lucrezia , Feroci Francesco , Calò Pietro Giorgio 
Published: November 2022

BackgroundA growing number of patients taking antiplatelet drugs, mainly low-dose acetylsalicylic acid (ASA) (75–150 mg/day), for primary or secondary prevention of thrombotic events, are encountered in every field of surgery. While the bleeding risk due to the continuation of these medications during the perioperative period has been adequately investigated in several surgical specialties, in thyroid surgery it still needs to be clarified. The main aim of this study was to assess the occurrence of cervical haematoma in patients receiving low-dose acetylsalicylic acid, specifically ASA 100 mg/day, during the perioperative period of thyroidectomy.MethodsPatients undergoing thyroidectomy in two high-volume thyroid surgery centers in Italy, between January 2021 and December 2021, were retrospectively analysed. Enrolled patients were divided into two groups: those not taking ASA were included in Group A, while those receiving this drug in Group B. Univariate analysis was performed to compare these two groups. Moreover, multivariate analysis was employed to evaluate the use of low-dose ASA as independent risk factor for cervical haematoma.ResultsA total of 412 patients underwent thyroidectomy during the study period. Among them, 29 (7.04%) were taking ASA. Based on the inclusion criteria, 351 patients were enrolled: 322 were included in Group A and 29 in Group B. In Group A, there were 4 (1.24%) cervical haematomas not requiring surgical revision of haemostasis and 4 (1.24%) cervical haematomas requiring surgical revision of haemostasis. In Group B, there was 1 (3.45%) cervical haematoma requiring surgical revision of haemostasis. At univariate analysis, no statistically significant difference was found between the two groups in terms of occurrence of cervical haematoma, nor of the other early complications of thyroidectomy. At multivariate analysis, the use of low-dose ASA did not prove to be an independent risk factor for cervical haematoma.ConclusionsBased on our findings, we believe that in patients receiving this drug, either for primary or secondary prevention of thrombotic events, its discontinuation during the perioperative period of thyroidectomy is not necessary.
Outcomes after superficial temporal artery–middle cerebral artery anastomosis combined with multiple burr hole surgery and dural inversion synangiosis for moyamoya disease in adults
Authors: Xu Dongxiao , Zheng Bingjie , Wu Qiaowei , Yao Jinbiao , Ilyasova Tatiana , Beilerli Aferin , Shi Huaizhang 
Published: November 2022

ObjectiveSeveral forms of cerebral revascularization have been carried out to treat moyamoya disease, however, the existing methods are accompanied by a variety of complications. In this study, the authors aimed to evaluate the clinical and angiographic outcomes of a new surgical procedure: superficial temporal artery–middle cerebral artery (STA-MCA) anastomosis combined with multiple burr hole (MBH) surgery and dural inversion synangiosis for the treatment of moyamoya disease in adults.MethodsPatients treated for moyamoya disease from August 2019 to July 2021 were retrospectively reviewed. Clinical data, including perioperative complications and follow-up outcomes, were noted. Preoperative and postoperative angiograms were compared, and the diameters of the frontal branch of the superficial temporal artery (F-STA), the deep temporal artery (DTA), the distal superficial temporal artery (STA) before the bifurcation and the middle meningeal artery (MMA) were measured on preoperative and postoperative angiograms. Meanwhile, a Matsushima score was assigned from postoperative angiograms.ResultsThis study included 66 patients (67 hemispheres). During the follow-up period, a median of 18 (IQR, 13–21) months, no stroke or death occurred in any of the patients. The clinical outcomes were excellent in 27 patients (40.9%), good in 34 patients (51.6%), fair in 4 patients (6.0%), and poor in 1 patient (1.5%); the overall rate of favorable clinical outcomes (excellent and good) was 92.5%. The modified Rankin Scale (mRS) score was significantly improved at follow-up (P &lt; 0.001). There were 41 hemispheres imaged by cerebral angiography after the operation, at a median postoperative interval of 9 (IQR, 8–12) months; among them, 34 (82.9%) hemispheres had Matsushima scores of grade A and grade B. The average postoperative diameters in the STA, DTA and MMA were increased significantly in 41 hemispheres at follow-up (P &lt; 0.001). Sixteen (24.2%) patients suffered from perioperative complications, including focal hyperperfusion syndrome (HS) in 8 (12.2%) patients, cerebral infarction in 3 (4.5%) patients (including one case accompanied by wound infection), cerebral hemorrhage in 2 (3.0%) patients, seizures in 2 (3.0%) patients, and subdural effusion in 1 (1.5%) patient.ConclusionsThe procedure of STA-MCA anastomosis combined with MBH surgery and dural inversion synangiosis may be a safe and effective treatment for adult patients with moyamoya disease.