bluuebunny/crossref_metadata_2025_split huggingface dataset:
Application of a New Hemostatic Clip to Prevent Delayed Bleeding After Endoscopic Sphincterotomy
Authors: Dong Jinpei , Feng Qiushi , Teng Guigen , Niu Haixia , Bian Dapeng 
Published: August 2023

Background and Aim:
Delayed bleeding after endoscopic sphincterotomy (ES) is a serious adverse event of endoscopic retrograde cholangiopancreatography. The aim of this study is to evaluate the effect of prevent delayed bleeding of hemostatic clip (Sureclip) after ES.

Methods:
Consecutive patients diagnosed with common bile duct stones with a high risk of delayed bleeding who received ES from January 1, 2013, to July 31, 2022, were analyzed retrospectively. A 1:1 propensity score–matching analysis and logistic regression analysis were used. The patients were allocated into the hemostatic clip and control groups. The rate of delayed bleeding, hyperamylasemia, pancreatitis, and hemostatic clip closing the bile duct or pancreatic duct by mistake were compared between the 2 groups.

Results:
Overall, 161 and 232 patients were allocated to the control and hemostatic clip groups, respectively, propensity score matching created 120 matched pairs. The rate of delayed bleeding was significantly lower in the hemostatic clip group than in the control group (1.67% vs. 7.5%, P=0.031). After adjusting for confounding factors, logistic regression showed hemostatic clip was associated with decreased odds of delayed bleeding (0.134, 95% CI: 0.025-0.719). No case of hemostatic clip closing the bile duct or pancreatic duct by mistake occurred in the hemostatic clip group. No significant differences were observed in postoperative hyperamylasemia and pancreatitis between the 2 groups.

Conclusions:
This study indicated that the prophylactic application of a hemostatic clip is associated with a significantly reduced rate of delayed bleeding after ES in high-risk patients. This approach did not increase the risk of adverse event.
Application Value of the Automated Machine Learning Model Based on Modified Computed Tomography Severity Index Combined With Serological Indicators in the Early Prediction of Severe Acute Pancreatitis
Authors: Zhang Rufa , Yin Minyue , Jiang Anqi , Zhang Shihou , Liu Luojie , Xu Xiaodan 
Published: August 2023

Background and Aims:
Machine learning (ML) algorithms are widely applied in building models of medicine due to their powerful studying and generalizing ability. To assess the value of the Modified Computed Tomography Severity Index (MCTSI) combined with serological indicators for early prediction of severe acute pancreatitis (SAP) by automated ML (AutoML).

Patients and Methods:
The clinical data, of the patients with acute pancreatitis (AP) hospitalized in Hospital 1 and hospital 2 from January 2017 to December 2021, were retrospectively analyzed. Serological indicators within 24 hours of admission were collected. MCTSI score was completed by noncontrast computed tomography within 24 hours of admission. Data from the hospital 1 were adopted for training, and data from the hospital 2 were adopted for external validation. The diagnosis of AP and SAP was based on the 2012 revised Atlanta classification of AP. Models were built using traditional logistic regression and AutoML analysis with 4 types of algorithms. The performance of models was evaluated by the receiver operating characteristic curve, the calibration curve, and the decision curve analysis based on logistic regression and decision curve analysis, feature importance, SHapley Additive exPlanation Plot, and Local Interpretable Model Agnostic Explanation based on AutoML.

Results:
A total of 499 patients were used to develop the models in the training data set. An independent data set of 201 patients was used to test the models. The model developed by the Deep Neural Net (DL) outperformed other models with an area under the receiver operating characteristic curve (areas under the curve) of 0.907 in the test set. Furthermore, among these AutoML models, the DL and gradient boosting machine models achieved the highest sensitivity values, both exceeding 0.800.

Conclusion:
The AutoML model based on the MCTSI score combined with serological indicators has good predictive value for SAP in the early stage.
Drug-eluting beads versus conventional transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma: A meta-analysis
Authors: Wang Zi-Yu , Xie Chun-Feng , Feng Kun-Liang , Xiong Cheng-Ming , Huang Jun-Hai , Chen Qing-Lian , Zhong Chong , Zhou Zhai-Wen 
Published: August 2023

Background:
Transarterial chemoembolization (TACE) consists of conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE). The benefits of the 2 treatments remain controversial. We conduct this meta-analysis to assess the efficacy and safety of the 2 methods for the patients with unresectable hepatocellular carcinoma.

Methods:
In order to get a sound conclusion, we did thorough search all relevant studies with clear and stringent keyword criteria on the main databases. Objective tumor response rate, overall survival (OS) rate and adverse events were calculated and analyzed by RevMan 5.3 software. The random-effects or fixed-effects model was applied to pool the estimates according to Cochran Q test and I
2 statistics.

Results:
Twenty-four studies involving 2987 patients were eligible. DEB-TACE significantly improved objective tumor response rate (OR) (risk ratio [RR] = 1.27, 95% confidence interval [CI] [1.08, 1.48]; P = .003). While as for 1-year, 2-year, 3-year, 5-year OS rates, there were no evidences to indicate that DEB-TACE was significantly better than cTACE (RR = 1.05, 95% CI [0.99, 1.11]; P = .08), (RR = 1.02, 95% CI [0.93, 1.11]; P = .68), (RR = 0.92, 95% CI [0.77, 1.10]; P = .37), (RR = 0.92, 95% CI [0.47, 1.80]; P = .81), respectively. Adverse events rate (AE) was also similar in both groups (RR = 1.11, 95% CI [0.99,1.26]; P = .08).

Conclusion:
This meta-analysis demonstrates that DEB-TACE is not superior than cTACE regarding to OS and AE. However, DEB-TACE still be considered to provide a better objective tumor response rate for patients with unresectable hepatocellular carcinoma.
Clinical efficacy of low-dose aspirin combined with calcium in preventing preeclampsia: A systematic review and meta-analysis
Authors: Chen Wen-Yue , Sun Su-Fang 
Published: August 2023

Objective:
This systematic review and meta-analysis aimed to evaluate the clinical effectiveness of low-dose aspirin combined with calcium supplements for the prevention of preeclampsia.

Methods:
China National Knowledge Infrastructure, VIP, Wanfang, PubMed, EMBASE, and Cochrane Library databases were searched from inception until December 2022. Randomized controlled trials investigating the preventive use of aspirin in combination with calcium supplementation for preeclampsia in high-risk pregnant women were included. The quality of the literature was evaluated, and a meta-analysis was conducted using RevMan 5.3 software to analyze the clinical efficacy of low-dose aspirin combined with calcium supplementation in preventing preeclampsia.

Results:
Seven randomized controlled trials were included in this meta-analysis, and compared with the control group, the experimental group had lower incidence rates of preeclampsia with gestational hypertension (odds ratios [OR]: 0.17, 95% confidence interval [CI]: 0.11–0.28), preeclampsia (OR: 0.20, 95% CI: 0.10–0.37), gestational hypertension (OR: 0.15, 95% CI: 0.07–0.31), preterm birth (OR: 0.26, 95% CI: 0.16–0.44), postpartum hemorrhage (OR: 0.15, 95% CI: 0.08–0.27), and fetal growth restriction (OR: 0.16, 95% CI: 0.08–0.33).

Conclusion:
Compared with aspirin alone, low-dose aspirin combined with calcium supplementation was more effective in preventing preeclampsia, reduced the risk of preterm birth and postpartum hemorrhage, and promoted fetal growth. This intervention has clinical value and should be considered for high-risk pregnant women.
Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study
Authors: Richarz Ute , Han John , Bai Ya-Mei , Yu-Hai Chen Eric , Chung Young Chul , Jhanwar Venu Gopal , Kim Sung-Wan , Sulaiman Ahmad Hatim , Knight Karl , Gopal Srihari 
Published: August 2023

Background:
Evaluate efficacy and safety of paliperidone palmitate 6-monthly (PP6M) for patients with schizophrenia in the Asian subgroup of a global, multicenter, noninferiority phase-3 study (NCT03345342).

Methods:
Patients received paliperidone palmitate 1-monthly (PP1M, 100/150 mg eq.) or paliperidone palmitate 3-monthly (PP3M, 350/525 mg eq.) during the maintenance phase and entered a 12-month double-blind (DB) phase, wherein they were randomized (2:1) to PP6M (700/1000 mg. eq.) or PP3M (350/525 mg eq.). Subgroup analysis was performed for 90 (12.7%) patients from Asia region (India, Taiwan, Malaysia, Hong Kong, and Korea). Primary endpoint was time-to-relapse during DB phase (Kaplan–Meier estimates). Secondary endpoints were changes from baseline in Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale, Personal and Social Performance (PSP) scale score.

Results:
In Asian subgroup, 91.9% (82/90) of patients completed DB phase (PP6M: 54/62 [87%]; PP3M: 28/28 [100%]). Median time-to-relapse was “not-estimable” due to low relapse rates in both groups. Estimated difference (95% confidence interval [CI]) between relapse-free patients in PP6M and PP3M groups of Asian subgroup was −0.1% [−8.5%, 8.4%] (global study population: −2.9% [−6.8%, 1.1%]). Mean change from baseline in secondary efficacy parameters was comparable between both groups, similar to the global study population. The incidence of extrapyramidal symptoms was higher in the Asian subgroup than in the global study population.

Conclusion:
Consistent with the global study population, PP6M was noninferior to PP3M in preventing relapse in patients with schizophrenia from the Asia region. Findings suggest the possibility of switching from PP1M/PP3M to twice-yearly PP6M without loss of efficacy and with no unexpected safety concerns.
The effects of paroxetine therapy on depressive symptom and motor function in the treatment of depression with Parkinson’s disease: A meta-analysis
Authors: Jiang Li-Lin , Wu Yu-Lin , Mo Ye , Gou Ling , Chen Mei-Ling , Wang Yan , Zang Qing-Min , Jiang De-Qi 
Published: August 2023

Background:
Paroxetine therapy has been used for treatment of patients with depression and Parkinson’s disease (dPD) in many clinical studies, but, the effects of paroxetine in dPD patients are not completely understood. The aim of this study was to systematically evaluate the effects of paroxetine therapy on depressive symptom and motor function in the treatment of dPD, in order to confer a reference for clinical practice.

Methods:
Randomized controlled trials (RCTs) of paroxetine for dPD published up to October, 2022 were retrieved. Standardised mean difference (SMD), odds ratio (OR), and 95% confidence interval (CI) were calculated and heterogeneity was measured with the I
2 test. The outcomes of interest were as follows: the efficacy, Hamilton depression rating scale score, unified Parkinson’s disease rating scale score, Hamilton anxiety rating scale score or adverse events.

Results:
Thirty-four RCTs with 2819 participants were included. Compared with control group, the pooled effects of paroxetine therapy on depression were (22 trials; OR 3.62, 95% CI 2.63 to 4.98, P < .00001) for antidepressant response (25 trials; SMD -2.14, 95% CI -2.73 to -1.56, P < .00001) for Hamilton depression rating scale score, the pooled effects of paroxetine therapy on motor function were (10 trials; OR 4.63, 95% CI 3.15 to 6.79, P < .00001) for anti-PD efficacy (18 trials; SMD -2.02, 95% CI -2.48 to -1.55, P < .00001) for total unified Parkinson’s disease rating scale score. The Hamilton anxiety rating scale score showed significant decrease in the paroxetine treatment group compared to control group (10 trials; SMD -1.93, 95% CI -2.65 to -1.22, P < .00001). In addition, paroxetine therapy reduced the number of any adverse events obviously in dPD patients (twenty trials; OR 0.42, 95% CI 0.31 to 0.57, P < .00001).

Conclusions:
Paroxetine therapy has clinical benefits for improvement of depressive symptom and motor function in dPD patients, moreover, it is of high drug safety. Further well-designed, multi-center RCTs needed to identify these findings.
Homologous platelet gel on radiation-induced dermatitis in a patient receiving head and neck radiotherapy plus cetuximab: A case report
Authors: Guberti Monica , Schiroli Davide , Marraccini Chiara , Mazza Genny , Iotti Cinzia , Baricchi Roberto , Iotti Barbara , Merolle Lucia 
Published: August 2023

Introduction:
Acute radiodermatitis is a significant complication of cancer radiotherapy, and platelet-based therapies are emerging as potential new treatments.

Main symptoms and important clinical findings:
In this report, we present the case of a patient with head and neck cancer undergoing radiotherapy combined with the monoclonal antibody cetuximab. After 4 weeks of this treatment, the patient developed cutaneous radiation dermatitis. Despite receiving standard treatment with corticosteroids and emollient cream, the lesion did not improve.

Main diagnosis:
cutaneous radiation dermatitis on head and neck cancer patient.

Therapeutic interventions:
Topical application of platelet gel was initiated on the wound. From the second week of radiotherapy to the 4th week, homologous platelet-rich plasma was applied on the dermatitis using a bandage, 4 times a day.

Outcomes:
The topical treatment with homologous platelet gel resulted in complete healing of the radiodermatitis, including restoration of the epidermis, reepithelialization, and reduction in associated pain.

Conclusion:
homologous platelet gel might be an alternative to standard treatment of radiation dermatitis.
Efficacy of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy: A prospective, randomized, pilot trial
Authors: Wang Cheng-Long , Zhao Zi-Ye , Wu Jia-Yi , Yan Fei-Hu , Yuan Jie , Xing Jun-Jie , Wang Hao , Yu En-Da 
Published: August 2023

Background:
Although colonoscopic retroflexion has been proved effective in reducing missed adenomas, there is still a lack of comprehensive and in-depth research focused on the ascending colon. We aimed to conduct a randomized controlled trial and tandem colonoscopy to investigate whether cecal retroflexion observed during colonoscopy can reduce missed adenomas in the ascending colon.

Methods:
Men and women required to be between 45 and 80 years of age were screened for enrollment in the trial. Patients were randomly assigned according to a 1:1 ratio to either the trial group or control group. Patients in the trial group underwent 2 forward examination and a cecal retroflexion observed in the ascending colon, while patients in the control group underwent only 2 forward examinations in the ascending colon. The primary outcome was adenoma miss rate. The secondary outcomes contained adenoma detection rate, polyp miss rate, polyp detection rate, insertion time and withdrawal time. Differences between groups in the primary outcome and in the other categorical indicators were tested using chi-squared test and Fisher exact test. For the comparison of continuous outcomes, the Student t test was applied.

Results:
A total of 60 subjects were eligible for the study between April to June 2020, of which 55 were randomized and eligible for analysis (26 to the control group and 29 to the trial group). The characteristics of patients were no significant differences statistically between the trial group and the control group. Similarly, the characteristics of the colonoscopy procedures included cecal insertion distance, the length of cecum and ascending colon, insertion time, withdrawal time, quality of bowel preparation, numerical rating scale for pain, polyps detected, and adenomas detected, and there were no significant differences statistically between the 2 groups (P = .864, P = .754, P = .700, P = .974, P = .585, P = .835, P = .373, P = .489). The characteristics of the polyps were also no significant differences statistically between the 2 groups.

Conclusion:
This pilot trial failed to show benefit of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy; however, further conclusions require a prospective study with a higher level of evidence. (NCT03355443).
Meta-analysis of the efficacy and safety of Xihuang Pills/capsules in adjuvant treatment of uterine cervical neoplasms
Authors: Xu Huirong , Tian Guangyu , Wu Chunli , Sun Xiaowen , Li Kejian 
Published: August 2023

Background:
Xihuang Pills/Capsules have a longstanding history of utilization in traditional Chinese medicine (TCM) for treating cancer. Nevertheless, a comprehensive investigation is required regarding the specific impacts and safety of Xihuang Pills/Capsules in individuals with uterine cervical neoplasms. Thus, conducting a meta-analysis is essential to evaluate the clinical effectiveness of combining Xihuang Pills/Capsules with Western medicine in patients with cervical neoplasms.

Methods:
The research involved searching 5 English and 4 Chinese databases for randomized controlled trials (RCTs) investigating the use of Xihuang Pills/Capsules in conjunction with Western medicine for treating uterine cervical neoplasms. Subsequently, statistical analysis was carried out using Review Manager software (version 5.3).

Results:
This research encompassed 10 RCTs involving 937 patients. The findings revealed that the combination of Xihuang Pills/Capsules with Western medicine treatment led to improvements in various aspects of the patients’ condition. Specifically, there was an enhancement in the short-term efficacy rate (risk ratio [RR] = 1.14, 95% confidence interval [CI]: 1.06–1.22, P = .0003), Karnofsky performance score (KPS) (mean difference [MD] = 5.90, 95% CI: 0.54–11.26, P = .03), survival rates, CD3+, CD3 + CD4+, CD3 + CD8+, CD3–CD56 + cells, and immunoglobulin M in patients with uterine cervical neoplasms. Moreover, the combination treatment resulted in a reduction of adverse reactions, including gastrointestinal reactions (RR = 0.52, 95% CI: 0.42–0.64, P < .00001), radiation proctitis (RR = 0.47, 95% CI: 0.33–0.68, P < .0001), myelosuppression (RR = 0.41, 95% CI: 0.26–0.64, P < .0001), as well as carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCC-Ag) levels. Additionally, the treatment exhibited an inhibitory effect on white blood cells (WBCs) and platelets (PLTs).

Conclusion:
The amalgamation of Xihuang Pills/Capsules with conventional anti-tumor therapy proves to be both effective and safe in the treatment of cervical neoplasms. However, further validation through high-quality RCTs is necessary to substantiate these findings.
The effect of gender on the clinical outcome of PD-1/PD-L1 inhibitor in advanced lung cancer patients
Authors: Wu Bing , Sun Congcong , Sun Xiaoqin , Li Xue 
Published: August 2023

Background:
Programmed death protein-1/ligand-1 (PD-1/L1) inhibitors have widely used in the treatment of lung cancer. Some literatures indicated that different gender might not have equal immune response, but no agreement have reached on the issue. Hence, we performed a systematic review and meta-analysis that examine the effect of gender on the clinical outcome of PD-1/PD-L1 inhibitor in advanced lung cancer patients.

Methods:
Related database and conferences were searched. Studies that reported the relationship between gender and the overall survival (OS) or progression-free survival (PFS) of PD-1/L1 inhibitor were included. Meta-analysis was conducted to obtain pooled hazard ratios (HRs) with 95% CI.

Results:
We included 34 studies with 11,883 lung cancer patients. Meta-analysis showed that PD-1/PD-L1 inhibitors significantly prolonged the OS (males: HR 0.71, 95%CI 0.66–0.77; females: HR 0.72, 95%CI 0.63–0.82) and PFS (males: HR 0.60, 95%CI 0.55–0.66; females: HR 0.72, 95%CI 0.62–0.84) versus chemotherapy. The clinical benefit (OS HR: 0.99; PFS HR: 0.83) was not statistically significant between males and females. In patients treated with cemiplimab, male patients had a better OS (0.53, 95%CI 0.42–0.66) and PFS (OS 1.51, 95%CI 0.80–2.82) compared with female patients, but the small number of female patients precludes us from drawing any firm conclusions in female subpopulations.

Conclusion:
The clinical benefit of PD-1/PD-L1 inhibitors was not statistically significant between males and females during the treatment of lung cancer. In the future, researchers who are designing new immunotherapy studies should ensure a larger inclusion of women in trials, to avoid erroneously extending to women results that are obtained mainly in male patients.
Safety and efficacy of 5-aminolevulinic acid phosphate/iron in mild-to-moderate coronavirus disease 2019: A randomized exploratory phase II trial
Authors: Tanaka Takeshi , Tashiro Masato , Ota Kenji , Fujita Ayumi , Sawai Toyomitsu , Kadota Junichi , Fukuda Yuichi , Sumiyoshi Makoto , Ide Shotaro , Tachikawa Natsuo , Fujii Hiroshi , Hibino Makoto , Shiomi Hisanori , Izumida Mai , Matsui Kohsuke , Yamauchi Momoko , Takahashi Kensuke , Yamanashi Hirotomo , Sugimoto Takashi , Akabame Shogo , Umeda Masataka , Shimizu Masumi , Hosogaya Naoki , Kosai Kosuke , Takeda Kazuaki , Iwanaga Naoki , Ashizawa Nobuyuki , Hirayama Tatsuro , Takazono Takahiro , Yamamoto Kazuko , Imamura Yoshifumi , Miyazaki Taiga , Kobayashi Yusuke , Ariyoshi Koya , Mukae Hiroshi , Yanagihara Katsunori , Kita Kiyoshi , Izumikawa Koichi 
Published: August 2023

Background:
5-aminolevulinic acid (5-ALA), a natural amino acid that is marketed alongside sodium ferrous citrate (SFC) as a functional food, blocks severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) proliferation in vitro and exerts anti-inflammatory effects. In this phase II open-label, prospective, parallel-group, randomized trial, we aimed to evaluate the safety and efficacy of 5-ALA in patients with mild-to-moderate coronavirus disease 2019.

Methods:
This trial was conducted in patients receiving 5-ALA/SFC (250/145 mg) orally thrice daily for 7 days, followed by 5-ALA/SFC (150/87 mg) orally thrice daily for 7 days. The primary endpoints were changes in SARS-CoV-2 viral load, clinical symptom scores, and 5-ALA/SFC safety (adverse events [AE] and changes in laboratory values and vital signs).

Results:
A total of 50 patients were enrolled from 8 institutions in Japan. The change in SARS-CoV-2 viral load from baseline was not significantly different between the 5-ALA/SFC (n = 24) and control (n = 26) groups. The duration to improvement was shorter in the 5-ALA/SFC group than in the control group, although the difference was not significant. The 5-ALA/SFC group exhibited faster improvement rates in “taste abnormality,” “cough,” “lethargy,” and “no appetite” than the control group. Eight AEs were observed in the 5-ALA/SFC group, with 22.7% of patients experiencing gastrointestinal symptoms (decreased appetite, constipation, and vomiting). AEs occurred with 750/435 mg/day in 25.0% of patients in the first phase and with 450/261 mg/day of 5-ALA/SFC in 6.3% of patients in the second phase.

Conclusion:
5-ALA/SFC improved some symptoms but did not influence the SARS-CoV-2 viral load or clinical symptom scores over 14 days. The safety of 5-ALA/SFC in this study was acceptable. Further evaluation using a larger sample size or modified method is warranted.