bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interpapillary muscle distance independently predicts recurrent mitral regurgitation
Authors: Gambardella Ivancarmine , Spadaccio Cristiano , Singh Sanjeet S. A. , Shingu Yasushige , Kunihara Takashi , Wakasa Satoru , Nappi Francesco 
Published: March 2024

Abstract
Objective
Ischaemic secondary mitral regurgitation (ISMR) after surgery is due to the displacement of papillary muscles resulting from progressive enlargement of the left ventricle end-diastolic diameter (LVEDD). Our aim was to prove that if the interpapillary muscle distance (IPMD) is surgically stabilized, an increase in LVEDD will not lead to a recurrence of ischaemic mitral regurgitation (MR).

Methods
Ninety-six patients with ISMR, who underwent surgical revascularisation and annuloplasty, were randomly assigned in a 1:1 ratio to undergo papillary muscle approximation (PMA). At the 5-year follow-up, we assessed the correlation between PMA and echocardiographic improvements, the effect size of PMA on echocardiographic improvements, and a prediction model for recurrent MR using inferential tree analysis.

Results
There was a significant correlation between PMA and enhancements in both the α and β angles (Spearman’s rho > 0.7, p < 0.01). The α angle represents the angle between the annular plane and either the A2 annular-coaptation line or the P2 annular-coaptation line. The β angle indicates the angle between the annular plane and either the A2 annular-leaflet tip line or the P2 annular-leaflet tip line. PMA led to substantial improvements in LVEDD, tenting area, α and β angles, with a large effect size (Hedge’s g ≥ 8, 95% CI ORs ≠ 1). The most reliable predictor of recurrent MR grade was the interpapillary distance, as only patients with an interpapillary distance greater than 40 mm developed ≥ 3 + grade MR. For patients with an IPMD of 40 mm or less, the best predictor of recurrent MR grade was LVEDD. Among the patients, only those with LVEDD greater than 62 mm showed moderate (2+) MR, while only those with LVEDD less than or equal to 62 mm had absent to mild (1+) MR.

Conclusion
Prediction of recurrent ischaemic MR is not independent of progressive LVEDD increase. PMA-based surgical procedure stabilises IPMD.
Choosing and evaluating randomisation methods in clinical trials: a qualitative study
Authors: Bruce Cydney L. , Iflaifel Mais , Montgomery Alan , Ogollah Reuben , Sprange Kirsty , Partlett Christopher 
Published: March 2024

Abstract
Background
There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is still a lot of variety in practice not explained. This study used qualitative methods to explore more deeply the motivations behind researchers’ choice of randomisation, and which features of the method they use to evaluate the performance of these methods.

Methods
Data was collected from online focus groups with various stakeholders involved in the randomisation process. Focus groups were recorded and then transcribed verbatim. A thematic analysis was used to analyse the transcripts.

Results
Twenty-five participants from twenty clinical trials units across the UK were recruited to take part in one of four focus groups. Four main themes were identified: how randomisation methods are selected; researchers’ opinions of the different methods; which features of the method are desirable and ways to measure method features.
Most researchers agree that the randomisation method should be selected based on key trial characteristics; however, for many, a unit standard is in place.
Opinions of methods were varied with some participants favouring stratified blocks and others favouring minimisation. This was generally due to researchers’ perception of the effect these methods had on balance and predictability.
Generally, predictability was considered more important than balance as adjustments cannot be made for it; however, most researchers felt that the importance of these two methods was dependent on the design of the study.
Balance is usually evaluated by tabulating variables by treatment arm and looking for perceived imbalances, predictability was generally considered much harder to measure, partly due to differing definitions.

Conclusion
There is a wide variety in practice on how randomisation methods are selected and researcher’s opinions on methods. The difference in practice observed when looking at randomisation method selection can be explained by a difference in unit practice, and also by a difference in researchers prioritisation of balance and predictability. The findings of this study show a need for more guidance on randomisation method selection.
The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation
Authors: Matlock David N. , Ratcliffe Sarah J. , Courtney Sherry E. , Kirpalani Haresh , Firestone Kimberly , Stein Howard , Dysart Kevin , Warren Karen , Goldstein Mitchell R. , Lund Kelli C. , Natarajan Aruna , Demissie Ejigayehu , Foglia Elizabeth E. 
Published: March 2024

Abstract
Background
Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7–276/7 weeks’ gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation.

Methods
This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24–276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks’ postmenstrual age, discharge, death, or transfer.

Discussion
The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites.

Trial registration
www.ClinicalTrials.gov, trial identifier NCT05446272, registered July 6, 2022.
A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study
Authors: Wiedermann Christian J. , Marino Pasqualina , Mahlknecht Angelika , Barbieri Verena , Piccoliori Giuliano , Engl Adolf , Gidding-Slok Annerika H. M. 
Published: March 2024

Abstract
Background
Chronic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes, and heart failure, often coexist and contribute to a significant burden on individuals and health systems. The Assessment of Burden of Chronic Conditions (ABCC) tool, already in routine clinical use in the Netherlands, aims to comprehensively assess and visualize disease burden, stimulate self-management, and encourage shared decision-making. This study aims to validate the German and Italian versions of the ABCC tool and evaluate its effectiveness and cost-effectiveness in the South Tyrolean Primary Care setting.

Methods
This is a cluster-randomized study involving approximately 400 patients with COPD, asthma, type 2 diabetes, and heart failure who received care from the South Tyrolean General Practices. Initially, the ABCC tool will be translated into German and Italian and validated. Subsequently, half of the participants will use the validated ABCC tool for patient-reported outcome measurement assessments, while the other half will receive usual care. The primary outcome measure is the change in the patients’ perception of the quality of care after 18 months. The secondary outcomes included changes in quality of life, self-management behavior, and healthcare utilization. The missing data will be managed using multiple imputations. Additionally, a cost-effectiveness analysis that considers the direct medical costs reimbursed by the National Health Service will be conducted.

Discussion
This study provides insights into the application, validation, and efficacy of the ABCC tool in the South Tyrolean healthcare context. The tool’s potential to enhance person-centered care, improve the quality of life, and possibly reduce healthcare costs could greatly contribute to sustainable healthcare. The challenges of implementation, such as software integration and the use of an EU data platform, will provide lessons for future international patient care data management.

Trial registration
ISRCTN registry, ISRCTN13531607. Registered on August 23, 2023.
Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study)
Authors: Zhang Ping-ping , Wang You-xin , Shen Fang-jing , Xing Yun-fei , Gu Jia-ying , Li Xue-ying , Jin Han , Jin Shi-feng , Xu Miao , Wang Hai-jun , Wang Hui , Li Li 
Published: March 2024

Abstract
Background
The increasing prevalence of childhood obesity has become an urgent public health problem, evidence showed that intervention for childhood obesity bring enormous health benefits. However, an effective individualized intervention strategy remains to be developed, and the accompanying remission of related complications, such as nonalcoholic fatty liver disease (NAFLD), needs to be assessed. This study aimed to develop an m-Health-assisted lifestyle intervention program targeting overweight/obese children and assess its effectiveness on indicators of adiposity and NAFLD.

Methods
This is a cluster-randomized controlled trial that conducted in children with overweight/obesity in Ningbo city, Zhejiang Province, China. Students in Grade 3 (8–10 years old) were recruited from six primary schools, with three be randomized to intervention group and three to usual practice group. The intervention program will last for one academic year and consists of health education, dietary guidance, and physical activity reinforcement. This program is characterized by encouraging four stakeholders, including School, Clinic, famIly, and studENT (SCIENT), to participate in controlling childhood obesity, assisted by m-Health technology. Assessments will be conducted at baseline and 3 months, 9 months, 24 months, and 36 months after baseline. The primary outcome will be the differences between the two groups in students’ body mass index and fatty liver index at the end of the intervention (9 months after baseline). During the implementation process, quality control methods will be adopted.

Discussion
The program will test the effectiveness of the m-Health-assisted lifestyle intervention on children with obesity and NAFLD. The results of this study will provide evidence for establishing effective lifestyle intervention strategy aimed at childhood obesity and NAFLD and may help develop guidelines for the treatment of obesity and NAFLD in Chinese children.

Trial registration
Clinicaltrials.gov NCT05482191. Registered on July 2022.
On the existence, uniqueness, stability, and numerical aspects for a novel mathematical model of HIV/AIDS transmission by a fractal fractional order derivative
Authors: Wu Yanru , Nosrati Sahlan Monireh , Afshari Hojjat , Atapour Maryam , Mohammadzadeh Ardashir 
Published: March 2024

AbstractIn this study, we explore a mathematical model of the transmission of HIV/AIDS. The model incorporates a fractal fractional order derivative with a power-law type kernel. We prove the existence and uniqueness of a solution for the model and establish the stability conditions by employing Banach’s contraction principle and a generalized α-ψ-Geraghty type contraction. We perform stability analysis based on the Ulam–Hyers concept. To calculate the approximate solution, we utilize Gegenbauer polynomials via the spectral collocation method. The presented model includes two fractal and fractional order derivatives. The influence of the fractional and fractal derivatives on the outbreak of HIV is investigated by utilizing real data from the Cape Verde Islands in 1987–2014.
Dual-energy computed tomography in a multiparametric regression model for diagnosing lymph node metastases in pancreatic ductal adenocarcinoma
Authors: Li Sheng , Jiang Dongping , Jiang Linling , Yan Shumei , Liu Lizhi , Ruan Guangying , Zhou Xuhui , Zhuo Shuiqing 
Published: March 2024

Abstract
Objective
To investigate the diagnostic value of dual-energy computed tomography (DECT) quantitative parameters in the identification of regional lymph node metastasis in pancreatic ductal adenocarcinoma (PDAC).

Methods
This retrospective diagnostic study assessed 145 patients with pathologically confirmed pancreatic ductal adenocarcinoma from August 2016–October 2020. Quantitative parameters for targeted lymph nodes were measured using DECT, and all parameters were compared between benign and metastatic lymph nodes to determine their diagnostic value. A logistic regression model was constructed; the receiver operator characteristics curve was plotted; the area under the curve (AUC) was calculated to evaluate the diagnostic efficacy of each energy DECT parameter; and the DeLong test was used to compare AUC differences. Model evaluation was used for correlation analysis of each DECT parameter.

Results
Statistical differences in benign and metastatic lymph nodes were found for several parameters. Venous phase iodine density had the highest diagnostic efficacy as a single parameter, with AUC 0.949 [95% confidence interval (CI):0.915–0.972, threshold: 3.95], sensitivity 79.80%, specificity 96.00%, and accuracy 87.44%. Regression models with multiple parameters had the highest diagnostic efficacy, with AUC 0.992 (95% CI: 0.967–0.999), sensitivity 95.96%, specificity 96%, and accuracy 94.97%, which was higher than that for a single DECT parameter, and the difference was statistically significant.

Conclusion
Among all DECT parameters for regional lymph node metastasis in PDAC, venous phase iodine density has the highest diagnostic efficacy as a single parameter, which is convenient for use in clinical settings, whereas a multiparametric regression model has higher diagnostic value compared with the single-parameter model.
Tumor suppression effect of ultrasound-sensitive nanoparticles with focused ultrasound in a pancreas cancer xenograft model
Authors: Kim Soojin , Lee Jae Young , Park Eun-Joo , Ahn Yun Deok , Cheon Yuri , Sim Wonchul , Lee Hak Jong 
Published: March 2024

Abstract
Background
We investigated the tumor suppression effect of an ultrasound-sensitive doxorubicin-loaded liposome-based nanoparticle, IMP301, to enhance the synergistic effect with focused ultrasound (FUS) in an animal model of pancreatic cancer.

Methods
Thirty nude mice with xenografts of PANC-1 human pancreatic cancer cells were randomly and prospectively allocated to 6 different groups (5 per group) each for Study-1 (dose–response test) and Study-2 (synergistic effect test). Study-1 consisted of control, gemcitabine, Doxil with FUS, and three different doses of IMP301 (2, 4, 6 mg/kg) with FUS groups. Study-2 consisted of control, FUS only, gemcitabine, Doxil with FUS, and IMP301 (4 mg/kg) with or without FUS groups. Differences in tumor volume and growth rate were evaluated by one-way ANOVA and Student–Newman–Keuls test.

Results
In Study-1, 4 mg/kg or greater IMP301 with FUS groups showed lower tumor growth rates of 14 ± 4 mm3/day (mean ± standard deviation) or less, compared to the control, gemcitabine, and Doxil with FUS groups with rates exceeding 28 ± 5 (p < 0.050). The addition of FUS in Study-2 decreased the tumor growth rate in the IMP301-treated groups from 36 ± 17 to 9 ± 6, which was lower than the control, FUS only, gemcitabine, and Doxil with FUS groups (p < 0.050).

Conclusions
IMP301 combined with FUS exhibited higher tumor growth suppression compared to the use of a conventional drug alone or the combination with FUS. The present study showed the potential of IMP301 to enhance the synergistic effect with FUS for the treatment of pancreatic cancer.

Relevance statement
This article aims to evaluate the synergistic effect of FUS and ultrasound-responsive liposomal drug in tumor growth suppression by using xenograft mouse model of pancreatic ductal adenocarcinoma. FUS-induced ultrasound-sensitive drug release may be a potential noninvasive repeatable treatment option for patients with locally advanced or unresectable pancreatic cancer.

Key points
• Modification of conventional drugs combined with FUS would maximize tumor suppression.
• IMP301 with FUS had higher tumor suppression effect compared to conventional chemotherapy.
• This image-guided drug delivery would enhance therapeutic effects of systemic chemotherapy.

Graphical Abstract
Germline variants in the Von Hippel-Lindau tumor suppressor gene in Cuban patients
Authors: Esperón Álvarez Antonio Alejandro , Noa Hechavarría Inés Virginia , López Reyes Ixchel , Collazo Mesa Teresa 
Published: March 2024

Abstract
Background
Von Hippel-Lindau (VHL) syndrome is an autosomal dominantly inherited disorder that predisposes to multiple neoplasms. Patients may develop hemangioblastomas of the central nervous system and retina, multiple cysts in the pancreas and kidneys, renal carcinoma, and pheochromocytomas, among other lesions. This disease is caused by germline genetic variants in the VHL gene. The regulation of the alpha subunit of hypoxia-inducible factor-1 is the key tumor suppressor function of the VHL protein. To date, more than seven hundred variants have been reported in VHL gene. This study aimed to investigate the molecular etiology of VHL syndrome in Cuban patients.

Results
DNA samples from twenty-two individuals were analyzed by Sanger sequencing or enzymatic restriction. The analysis identified four novel pathogenic variants for the Cuban population: c.463 + 2T > C, C162W, R167W, and S183X, in addition to D121G and R161X, previously described in another work. The diagnosis was confirmed in seven patients with clinical manifestations and family history. Two at-risk family members without clinical signs were positive for presymptomatic diagnosis.

Conclusions
The spectrum of germinal point mutations of VHL gene in Cuban patients was updated. The presence of genetic variants was ruled out in eight asymptomatic relatives, which is a psychological relief for these individuals. The results allow for offering other at-risk relatives the presymptomatic diagnosis and the possibility of receiving genetic counseling.
Role of multi-parametric magnetic resonance imaging in preoperative staging of cervical carcinoma in females
Authors: Sadec Hoda Mohamed Helmy Ahmed , Awadallah Shrouk Mohamed , Ibrahim Ahmed Mohamed , Abdel-Aziz Amany Mohamed Rashad , Sheha Aliaa Sayed 
Published: March 2024

Abstract
Background
In cervical cancer, accurate diagnosis of parametrial invasion (PMI) helps in determining the next step in management, either surgical resection or neoadjuvant therapy. Cervical cancer staging is still determined according to the clinical findings. But it is widely recognized that there are differences between clinical evaluation and the actual disease extent, particularly for PMI. In this prospective study, we investigate the relationship between clinical staging and magnetic resonance imaging (MRI) staging with post-management findings among patients with cervical cancer who underwent pre-treatment MRI, using fused T2-weighted image/diffusion-weighted imaging (T2/DWI).

Results
Based on examination under anesthesia (EUA), 80% of patients showed PMI, while fused T2/DWI was positive for PMI in 77.5% of patients. In all analyzed cases (40 females), MRI had sensitivity, specificity, and accuracy of 91%, 75%, and 87.5% compared to EUA. In the operated patients (24 females), MRI likewise had sensitivity, specificity, and accuracy of 81.3%, 87.5%, and 83%, respectively. In comparison with the postoperative results, the EUA showed higher sensitivity and accuracy than MRI (92.9% vs. 81.3%) and (83.3% vs. 79.2%), respectively, in the detection of PMI in operated cases. However, MRI was more specific in the PMI detection in cases with cervical cancer than EUA (75% vs. 70%).

Conclusion
MRI (with the aid of fused T2/DWI) improves the diagnostic performance for the PMI assessment in cases with cervical carcinoma. Therefore, MRI is helpful in choosing surgical candidates.
Determinants of compliance with routine antenatal medications among pregnant women in Lagos, Nigeria
Authors: Oshinyemi Temitope Ebunoluwa , Oluwatosin O Abimbola , Edet Olaide B , Aluko Joel O , Adeyemo Moridiyat O A 
Published: March 2024

Background/Aims Routine antenatal medications are essential drugs used during pregnancy to improve maternal and fetal outcomes and prevent complications. These include iron, folic acid and sulfadoxine–pyrimethamine. This study evaluated pregnant women's knowledge of and compliance with these medications in selected antenatal care centres in Lagos, Nigeria. Methods A descriptive cross-sectional study was conducted among 356 pregnant women. Multistage random sampling was used to select the study population and structured questionnaires were administered. Data were analysed using descriptive statistics and hypotheses were tested using a Chi-squared test. Results The majority (63.7%) of participants had adequate knowledge of routine antenatal medications. There was high compliance with folic acid (64.0%), iron (71.5%) and sulfadoxine-pyrimethamine (56.5%), with overall 64.9% showing high compliance with routine antenatal medications. Conclusions Participants demonstrated high knowledge of and compliance with routine antenatal medications, which is vital to improving maternal health and preventing complications.