bluuebunny/crossref_metadata_2025_split huggingface dataset:
First-line atezolizumab/durvalumab plus platinum–etoposide combined with radiotherapy in extensive-stage small-cell lung cancer
Authors: Li Lijuan , Yang Dan , Min Yanmei , Liao Anyan , Zhao Jing , Jiang Leilei , Dong Xin , Deng Wei , Yu Huiming , Yu Rong , Zhao Jun , Shi Anhui 
Published: April 2023

Abstract
Background
Immunotherapy has made significant advances in the treatment of extensive-stage small-cell lung cancer (ES-SCLC), but data in combination with radiotherapy are scarce. This study aims to assess the safety and efficacy of chemoimmunotherapy combined with thoracic radiotherapy in patients with ES-SCLC.

Methods
This single-center retrospective study analyzed patients with ES-SCLC who received standard platinum–etoposide chemotherapy combined with atezolizumab or durvalumab immunotherapy as induction treatment, followed by consolidative thoracic radiotherapy (CTRT) before disease progression in the first-line setting. Adverse events during radiotherapy with or without maintenance immunotherapy and survival outcomes were assessed.

Results
Between December 2019 and November 2021, 36 patients with ES-SCLC were identified to have received such treatment modality at one hospital. The number of metastatic sites at diagnosis was 1–4. The biological effective dose of CTRT ranged from 52 to 113 Gy. Only two patients (6%) developed grade 3 toxic effect of thrombocytopenia, but none experienced grade 4 or 5 toxicity. Four patients developed immune-related pneumonitis during the induction treatment period but successfully completed later CTRT. The rate of radiation-related pneumonitis was 8% with grades 1–2 and well tolerated. The median progression-free survival (PFS) was 12.8 months, but the median overall survival (OS) was not determined. The estimated 1-year OS was 80.2% and 1-year PFS was 53.4%.

Conclusions
Immunotherapy combined with CTRT for ES-SCLC is safe and has ample survival benefit.
Efficacy and safety of transurethral resection of bladder tumour combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer: a protocol for a randomized controlled trial
Authors: Yang Xiangwei , Zhang Shiqiang , Cui Yajiao , Li Yamei , Song Xinyue , Pang Jun 
Published: April 2023

Abstract
Background
Bladder cancer is the tenth most common cancer worldwide. For patients with T1 high-grade or T2 bladder cancer, radical cystectomy is recommended. However, radical cystectomy is associated with various complications and has a detrimental impact on the quality of life. Bladder-sparing therapy has been widely explored in patients with muscle-invasive bladder cancer, and whether a combination of transurethral resection of bladder tumour (TURBT) with chemotherapy and immunotherapy shows definite superiority over TURBT plus chemotherapy is still a matter of debate. The aim of this study is to investigate the efficacy and safety of TURBT combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer who are unwilling or unsuitable to undergo radical cystectomy.

Methods
An open-label, multi-institutional, two-armed randomized controlled study will be performed with 86 patients with T1 high-grade or T2 bladder cancer meeting the eligibility criteria. Participants in the experimental group (n = 43) will receive TURBT combined with chemotherapy (GC: gemcitabine 1000 mg/m2 on the 1st day and the 8th day, cisplatin 70 mg/m2 on the 2nd day, repeated every 21 days) and immunotherapy (toripalimab 240 mg on the 5th day, repeated every 21 days), and those in the control group (n = 43) will receive TURBT plus chemotherapy (GC). The primary outcome is pathological response, and the secondary outcomes include progression-free survival, overall survival, toxicities, and quality of life.

Discussion
To the best of our knowledge, this is the first study to evaluate the efficacy and safety of TURBT combined with GC regimen and toripalimab in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer. The expected benefit is that the combination of TURBT with chemotherapy and immunotherapy would be more effective than TURBT plus chemotherapy without compromising the quality of life and increasing the toxicity.

Trial registration
ChiCTR2200060546, chictr.org.cn, registered on June 14, 2022.
Bacillary layer detachment with malignant choroidal tumors: a case series
Authors: Fouad Yousef Ahmed , Salman Abdelrahman Gaber , Ashour Doaa Maamoun , Elkady Mohamed Sabry , Abdel-khalek Noha , Nowara Mohamed , Ebeid Weam Mohamed 
Published: April 2023

Abstract
Purpose
To study the incidence and characteristics of bacillary layer detachment (BALAD) occurring with the two most common choroidal malignancies, choroidal metastasis and choroidal melanoma.

Methods
A retrospective multicentric record analysis. Eyes with a diagnosis of choroidal melanoma or choroidal metastasis that had good-quality fundus photography and spectral domain optical coherence tomography (OCT) scans of the macular and tumor regions allowing for delineation of the retinal layers were included for analysis. Qualitative image evaluation was done by two independent graders for the presence, location, and OCT features of BALAD, as well as any associated intraretinal or subretinal fluid. Demographic and clinical data were also retrieved.

Results
Of the 11 eyes with choroidal metastasis and 7 eyes with choroidal melanoma that were included in the final analysis, 6 (54.5%) and 1 (14.3%) had BALAD, respectively. The BALAD co-localized with the subretinal fluid in all cases and with the intraretinal fluid in 1/3 cases (33.3%), was foveal in location in 3 eyes (42.9%), was overlying the tumor in 6 eyes (85.7%), and varied in number and size. Reflectivity within the BALAD was consistently higher than the vitreous and adjacent subretinal fluid, and discernable suspended hyperreflective particles were noted in 5 eyes (71.4%).

Conclusion
BALAD is relatively common with choroidal metastasis. The OCT features described supplement our recognition of this new entity.
The association between fasting plasma glucose variability and incident eGFR decline: evidence from two cohort studies
Authors: Deravi Niloofar , Sharifi Yasaman , Koohi Fatemeh , Zadeh Seyed Saeed Tamehri , Masrouri Soroush , Azizi Fereidoun , Hadaegh Farzad 
Published: April 2023

Abstract
Background
Glycemic variability (GV) is developing as a marker of glycemic control, which can be utilized as a promising predictor of complications. To determine whether long-term GV is associated with incident eGFR decline in two cohorts of Tehran Lipid and Glucose Study (TLGS) and Multi-Ethnic Study of Atherosclerosis (MESA) during a median follow-up of 12.2 years.

Methods
Study participants included 4422 Iranian adults (including 528 patients with T2D) aged ≥ 20 years from TLGS and 4290 American adults (including 521 patients with T2D) aged ≥ 45 years from MESA. The Multivariate Cox proportional hazard models were used to assess the risk of incident eGFR decline for each of the fasting plasma glucose (FPG) variability measures including standard deviation (SD), coefficient of variation (CV), average real variability (ARV), and variability independent of the mean (VIM) both as continuous and categorical variables. The time of start for eGFR decline and FPG variability assessment was the same, but the event cases were excluded during the exposure period.

Results
In TLGS participants without T2D, for each unit change in FPG variability measures, the hazards (HRs) and 95% confidence intervals (CI) for eGFR decline ≥ 40% of SD, CV, and VIM were 1.07(1.01–1.13), 1.06(1.01–1.11), and 1.07(1.01–1.13), respectively. Moreover, the third tertile of FPG-SD and FPG-VIM parameters was significantly associated with a 60 and 69% higher risk for eGFR decline ≥ 40%, respectively. In MESA participants with T2D, each unit change in FPG variability measures was significantly associated with a higher risk for eGFR decline ≥ 40%.Regarding eGFR decline ≥ 30% as the outcome, in the TLGS, regardless of diabetes status, no association was shown between FPG variability measures and risk of eGFR decline in any of the models; however, in the MESA the results were in line with those of GFR decline ≥ 40%.Using pooled data from the two cohorts we found that generally FPG variability were associated with higher risk of eGFR decline ≥ 40% only among non-T2D individuals.

Conclusions
Higher FPG variability was associated with an increased risk of eGFR decline in the diabetic American population; however, this unfavorable impact was found only among the non-diabetic Iranian population.
Heterogeneous uptake of 18F-FDG and 18F-PSMA-1007 PET/CT in lung cancer and lymph node metastasis
Authors: Hu Yuan , Wang Peng , Dai Wenli 
Published: April 2023

Abstract
Background
PSMA PET/CT has shown excellent results in imaging of prostate cancer. However, some nonprostatic malignancies can also demonstrate 18 F-PSMA uptake, including primary lung cancer. 18 F-FDG PET/CT is widely employed in initial staging, response to therapy and follow-up assessment for lung cancer. Here we present an interesting case report on the different patterns of PSMA and FDG uptake between primary lung cancer and metastatic intrathoracic lymph node metastases in a patient with concurrent metastatic prostate cancer.

Case presentation
A 70-year-old male underwent 18 F-FDG PET/CT and 18 F-PSMA-1007 PET/CT imaging due to suspicion primary lung cancer and prostate cancer. The patient eventually was diagnosed with non-small cell lung cancer (NSCLC) with mediastinal lymph node metastases and prostate cancer with left iliac lymph node and multiple bone metastases. Interestingly, our imaging revealed different patterns of tumor uptake detected on 18 F-FDG and 18 F-PSMA-1007 PET/CT in primary lung cancer and lymph node metastases. The primary lung lesion showed intense FDG uptake, and mild uptake with 18 F-PSMA-1007. Whereas the mediastinal lymph node metastases showed both intense FDG and PSMA uptake. The prostate lesion, left iliac lymph node, and multiple bone lesions showed significant PSMA uptake and negative FDG uptake.

Conclusion
In this case, there was a homogeneity of 18 F-FDG intense uptake between LC and metastatic lymph nodes, but a heterogeneity in 18 F-PSMA-1007 uptake. It illustrated that these molecular probes reflect the diversity of tumor microenvironments, which may help us understand the differences of the tumor response to treatment.
Uretero-neocystostomy: a retrospective comparison of open, laparoscopic and robotic techniques
Authors: Ramesmayer Christian , Pallauf Maximilian , Gruber Ricarda , Kunit Thomas , Oswald David , Lusuardi Lukas , Mitterberger Michael 
Published: April 2023

Abstract
Background
Uretero-neocystostomy (UNC) is the gold-standard for distal-ureter repair. Whether the surgery should be conducted minimally invasive (laparoscopic (LAP), robotic RAL)) or open remains unanswered by the literature.

Methods
Retrospective analysis of surgical outcome of patients treated with UNC for distal ureteral stenosis (January 2012 - October 2021). Patient demographics, estimated blood loss (EBL), surgical technique, operative time, complications and length of hospital stay (LOS) were recorded. During the follow-up period, patient underwent renal ultrasound and kidney function tests. Success was defined as relieve of symptoms or no findings of obstruction needing urine drainage.

Results
60 patients were included (9 RAL, 25 LAP, 26 open). The different cohorts were similar of age, gender, American Society of Anesthesiologists (ASA) score, body-mass index and history of prior treatment of the ureter. No intraoperative complications were detected in all groups. There was no conversion to open surgery in the RAL group, whereas one was found in the LAP arm. Six patients had a recurrent stricture, but with no significant difference between the cohorts. EBL was not different between the groups. LOS was significantly lower in the RAL + LAP group compared to open (7 vs. 13 days, p = 0.005) despite significantly longer operating times (186 vs. 125.5 min, p = 0.005).

Conclusion
Minimal invasive UNC, especially RAL, is a feasible and safe surgical method and provides similar results in terms of success rates in comparison to open approach. A shorter LOS could be detected. Further prospective studies need to be done.
Assessing the implementation and effectiveness of early integrated palliative care in long-term care facilities in France: an interventional mixed-methods study protocol
Authors: Bagaragaza Emmanuel , Colombet Isabelle , Perineau Mireille , Aegerter Philippe , Guirimand Frédéric 
Published: April 2023

AbstractBackgroundMajority of residents in long-term care facilities (LTCF) have limited and delayed access to palliative care even though many suffer from incurable chronic illnesses that will likely require the provision of palliative care. We present the study protocol of “PADI-Palli”, an intervention aims to advance early integrated palliative care into standard care delivered in LTCF. This study will assess the effectiveness of early integrated palliative care on palliative care accessibility for older persons in LTCF, and identify the key factors for the successful implementation of early integrated palliative care and its sustainability in the LTCF context.MethodsThis multicentre interventional study utilises a pragmatic research design with a convergent parallel mixed-methods approach. The qualitative study will use a case study design and the quantitative study will use a stepped wedge cluster randomised trial. In total, 21 participating LTCF from three French regions will be randomly allocated to one of seven clusters. The clusters will cross over from the usual care to the active intervention condition over the course of the study. The primary outcome relates to the accurate identification of palliative care needs and early access to palliative care for LTCF residents. Secondary outcomes are quality of care, quality of life for residents and their families, and quality of life at work for professionals. Measurements will be performed before and after the intervention. Implementation and evaluation of PADI-Palli intervention is grounded in the Consolidated Framework for Implementation Research.DiscussionExisting evidence demonstrates that early integrated palliative care in cancer care leads to a significant improvement in patient outcomes and processes of care. Little is known, however, about early integrated palliative care in the context of LTCF for older persons. This study has the potential to fill this gap in the literature by providing evidence on the effectiveness of early integrated palliative care for older persons in LTCF. Moreover, this study will provide a better understanding of the relevant contextual elements that facilitate or hinder early integrated palliative care implementation and transferability. If proven effective, this intervention can be scaled to other care settings in which older persons require palliative care.Trial registrationClinicalTrials.gov ID: NCT04708002; National registration: ID-RCB number: 2020-A01832-37.
Association between endometriosis and sexual satisfaction among a sample of lebanese women
Authors: Kfoury Maya , Barakat Habib , Hallit Souheil , Saliba Sahar 
Published: April 2023

Abstract
Background
Endometriosis is a complex disease that affects approximately 10% of women of childbearing age. It is characterized by the presence of endometrial-like tissue outside the uterus and often results in symptoms such as pelvic pain and infertility. This condition may disturb mental health and decrease both the mental and physical health related quality of life of women. The aim of this study was to assess the emotional state and the intimate relational aspect of life in Lebanese women living with endometriosis.

Methods
This is a case-control study that included 317 women (65 participants with endometriosis and 252 controls (1:3 ratio)). Participants completed an online survey that included questions related to endometriosis, Sexual Satisfaction Scale for Women, Couple Satisfaction Index, Perceived Partner Responsiveness Scale and the Depression, Anxiety and Stress Scale.

Results
A significantly higher mean sexual satisfaction score was found in women without endometriosis compared to those with endometriosis (90.83 vs. 83.42; p = 0.006). No significant difference was found in terms of couple satisfaction, depression, anxiety, stress, and perceived partner responsiveness between the two groups. Higher couple satisfaction (Beta = 1.30) and perceived partner responsiveness (Beta = 0.16) were significantly associated with higher sexual satisfaction, whereas higher depression (Beta=-1.70) and having endometriosis compared to not (Beta=-6.51) were significantly associated with lower sexual satisfaction.

Conclusion
This study validated the link between endometriosis and sexual satisfaction and invalidated the association between endometriosis and emotional state, as well as couple satisfaction and perceived partner responsiveness. Greater sexual satisfaction was, however, linked to greater perceived partner responsiveness and greater couple satisfaction, as well as decreased signs of depression, anxiety, and stress. More research is warranted to better understand how Lebanese women are coping with the disease and how clinicians may help them further.
Phytochemical profile, comparative evaluation of Satureja montana alcoholic extract for antioxidants, anti-inflammatory and molecular docking studies
Authors: Abdelshafeek Khaled Abdelhady , Osman Abeer Fouad , Mouneir Samar Mohamed , Elhenawy Ahmed Abdelmonem , Abdallah Walid Elsayed 
Published: April 2023

Abstract
Background
The most common species in the Satureja genus is Satureja montana (family Lamiaceae). The present work aims to use the molecular docking study to predict the isolated constituents against an immune system immunomodulator and tested alcoholic extract as an in-vitro immunomodulatory agent.

Methods
All isolated compound's structures were determined using various chromatographic and spectroscopic techniques. Anti-inflammatory and antioxidant profiles were studied for an alcoholic extract of the plant; the molecular docking study was performed for the isolated compounds (1–4).

Results
In this work, four recognized compounds were extracted from the ethyl acetate fraction of S. montana (Sm) methanolic extract and identified as two triterpenes ursolic acid (1) and oleanolic acid (2), one phenolic acid as ellagic acid (3), and one flavonoidal compound as isoscutellarein (4).
The total alcoholic extract exhibited good in vitro anti-inflammatory, antioxidant, and apoptotic activity. Its IC50 was 10.12 compared to 15.1 μg/ml of standard celecoxib. It also showed potent antioxidant activity with IC50 10.4, 11.3, 14.6, and 22.3 IU/ml for SOD, MDA, catalase, and TAC, respectively. According to the drug similarity and ADMET tests, their ligands may have favorable pharmacokinetic characteristics with minimal carcinogenic influence. The molecular docking study was performed for the isolated compounds (1–4).

Conclusions
The alcoholic extract of the plant showed promising anti-inflammatory, antioxidant, and antiapoptotic properties. The theoretical studies for the isolated compounds showed promising binding affinity against all the examined enzymes.
A deep neural network framework to derive interpretable decision rules for accurate traumatic brain injury identification of infants
Authors: Zou Baiming , Mi Xinlei , Stone Elizabeth , Zou Fei 
Published: April 2023

Abstract
Objective
We aimed to develop a robust framework to model the complex association between clinical features and traumatic brain injury (TBI) risk in children under age two, and identify significant features to derive clinical decision rules for triage decisions.

Methods
In this retrospective study, four frequently used machine learning models, i.e., support vector machine (SVM), random forest (RF), deep neural network (DNN), and XGBoost (XGB), were compared to identify significant clinical features from 24 input features associated with the TBI risk in children under age two under the permutation feature importance test (PermFIT) framework by using the publicly available data set from the Pediatric Emergency Care Applied Research Network (PECARN) study. The prediction accuracy was determined by comparing the predicted TBI status with the computed tomography (CT) scan results since CT scan is the gold standard for diagnosing TBI.

Results
At a significance level of $$p = 0.05$$

p
=
0.05

, DNN, RF, XGB, and SVM identified 9, 1, 2, and 4 significant features, respectively. In a comparison of accuracy (Accuracy), the area under the curve (AUC), and the precision-recall area under the curve (PR-AUC), the permutation feature importance test for DNN model was the most powerful framework for identifying significant features and outperformed other methods, i.e., RF, XGB, and SVM, with Accuracy, AUC, and PR-AUC as 0.915, 0.794, and 0.974, respectively.

Conclusion
These results indicate that the PermFIT-DNN framework robustly identifies significant clinical features associated with TBI status and improves prediction performance. The findings could be used to inform the development of clinical decision tools designed to inform triage decisions.
Development of an integrated and comprehensive clinical trial process management system
Authors: Shen Liang , Zhai You , Pan AXiang , Zhao Qingwei , Zhou Min , Liu Jian 
Published: April 2023

Abstract
Background
The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection.

Methods
The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information.

Results
The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine.

Conclusion
The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.