bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of early vitamin D supplementation on the incidence of preeclampsia in primigravid women: a randomised clinical trial in Eastern Democratic Republic of the Congo
Authors: Kabuyanga Richard Kabuseba , Tugirimana Pierrot Lundimu , Sifa Balungwe , Balezi Mwanga , Dikete Michel Ekanga , Mitangala Prudence Ndeba , Elongi Jean Pierre Moyene , Kinenkinda Xavier Kalume , Kakoma Jean-Baptiste Sakatolo Zambeze 
Published: February 2024

Abstract
Background
Previous studies have reported the association between maternal vitamin D deficiency and preeclampsia. However, the efficacy of vitamin D supplementation in reducing the occurrence of preeclampsia remains unclear. The objective of this study was to evaluate the effect of cholecalciferol supplementation on the incidence of preeclampsia in primigravid women and its related maternal and foetal outcomes.

Methods
A single-blinded clinical trial was conducted in fourteen antenatal care health facilities in the North (Goma, Mwesso, Nyiragongo) and South Kivu (Bukavu-Panzi) provinces of the Democratic Republic of Congo from March 1, 2020, to June 30, 2021. A total of 1300 primigravid women not exceeding 16 weeks of gestation were randomised with a 1:1 ratio to either the supplemented (A) or control (B) group. Each pregnant woman (A) presenting for antenatal care received a single monthly dose of cholecalciferol (60,000 IU) orally for 6 months. The control group received no vitamin D supplementation or placebo. Serum 25(OH)D was measured at recruitment and at 34 weeks of gestation. Outcomes were assessed monthly until delivery.

Results
The median maternal age was 21 years (14–40), while the median gestational age was 15 weeks (5.4–29.0). A significant reduction in the risk of preeclampsia [RR = 0.36 (0.19–0.69); p = 0.001] and preterm delivery [RR = 0.5 (0.32–0.78); p = 0.002] was observed in the intervention group. An RR of 0.43 [(0.27–0.67); p < 0.001] was found for low birth weight. The RR for caesarean section was 0.63 [(0.52–0.75); p < 0.001]. The APGAR score at the 5th minute (p = 0.021) and the size of the newborn were significantly higher in the supplemented group (p = 0.005).

Conclusion
A single monthly dose (60,000 IU) of vitamin D supplementation, started in earlypregnancy, significantly reduced the incidence of preeclampsia and its maternal and foetal complications.

Trial registration
ISRCTN Register with ISRCTN46539495 on 17 November 2020.
Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients – a randomized controlled trial. (OxaNeuro)
Authors: Gehr Nina Lykkegaard , Karlsson Páll , Timm Signe , Christensen Signe , Hvid Christian Andreas , Peric Jana , Hansen Torben Frøstrup , Lauritzen Lotte , Finnerup Nanna Brix , Ventzel Lise 
Published: February 2024

Abstract
Background
Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors’ quality of life and causes premature cessation of potentially lifesaving treatment. No preventive treatments and no effective treatment for chronic OIPN exist despite many attempts. One of several suggested mechanisms includes neuroinflammation as a contributing factor to OIPN. Fish oil containing long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFAs) are precursors to specialized proresolving mediators that mediate the resolution of inflammation. Our primary hypothesis is that a high supplementation of n-3 LCPUFAs will lower the prevalence and severity of OIPN.

Methods
The OxaNeuro project is an investigator-initiated, multicenter, double-blinded, randomized, placebo-controlled clinical study. We will include 120 patients eligible to receive adjuvant oxaliplatin after colorectal cancer surgery. Patients will receive fish oil capsules containing n-3 LCPUFAs or corn oil daily for 8 months.
The primary endpoint is the prevalence of OIPN at 8 months defined as relevant symptoms, including one of the following: abnormal nerve conduction screening, abnormal vibration threshold test, abnormal skin biopsy, or abnormal pinprick test. Additional endpoints include the intensity and severity of OIPN-related neuropathic pain, patient-reported OIPN symptoms, quality of life, mental health symptoms, body composition, and cognitive evaluation. Furthermore, we will evaluate inflammatory biomarkers in blood samples and skin biopsies, including the potential OIPN biomarker neurofilament light protein (NfL) which will be measured before each cycle of chemotherapy.

Discussion
If readily available fish oil supplementation alleviates OIPN prevalence and severity, it will significantly improve the lives of both cancer survivors and palliative cancer patients receiving oxaliplatin; it will improve their quality of life, optimize chemotherapeutic treatment plans by lowering the need for dose reduction or premature cessation, and potentially increase survival.

Trial registration
ClinicalTrial.gov identifier: NCT05404230
Protocol version: 1.2, April 25th. 2023
The efficacy and safety of vincristine, irinotecan and anlotinib in Epithelioid Sarcoma
Authors: Xie Lu , Sun Xin , Xu Jie , Liang Xin , Liu Kuisheng , Sun Kunkun , Yang Rongli , Tang Xiaodong , Guo Wei 
Published: February 2024

Abstract
Background
Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.

Methods
We retrospectively reviewed data from patients with metastatic or unresectable epithelioid sarcoma at the Peking University People’s Hospital treated with irinotecan (50 mg/m2/d d1-5 Q3W) in combination with Anlotinib (12 mg Qd, 2 weeks on and 1 week off) from July 2015 to November 2021.

Results
A total of 54 courses were administered. With a median follow up of 21.2 months (95% CI, 12.2, 68.1), the 5-year overall survival rate was 83.3%. Five of eight (62.5%) patients presented with unresectable localized lesions, including local tumor thrombosis and lymphatic metastasis. The other patients had unresectable pulmonary metastases. Six of eight (75%) patients had progressed following two lines of systemic therapy. The objective response rate reached 37.5% (three of eight patients) while stabilized disease was observed in 62.5% (five of eight) of patients. No patient had progressed at initial evaluation. At the last follow up, two patients were still using the combination and three patients had ceased the therapy due to toxicities such as diarrhea, nausea, and emesis. One patient changed to tazemetostat for maintenance and one patient stopped treatment due to coronavirus disease 2019 (COVID-19). Another patient stopped therapy as residual lesions had been radiated.

Conclusions
The combination of irinotecan and Anlotinib as a salvage regimen may be considered another effective treatment option for refractory epithelioid sarcoma.

Trial registration
This study was approved in the Medical Ethics Committee of Peking University People’s Hospital on October 28, 2022 (No.: 2022PHD015-002). The study was registered in Clinicaltrials.gov with identifier no. NCT05656222.
Focused ultrasound versus the loop electrosurgical excision procedure to treat women with cervical high-grade squamous intraepithelial lesions under 40: a retrospective study
Authors: Xiao Linlin , Dong Xu , Sun Jiangchuan , Zhang Xuerui , Feng Qing , Chang Shufang 
Published: February 2024

Abstract
Background
This study aimed to compare the efficacy of focused ultrasound (FUS) and the loop electrosurgical excision procedure (LEEP) for the treatment of cervical high-grade squamous intraepithelial lesions (HSILs) among women of reproductive age.

Methods
Case records of patients aged < 40 years who were treated for cervical HSILs using either FUS or LEEP from September 1, 2020 to May 31, 2022 were retrospectively reviewed. Patients were followed up for cure, recurrence, human papillomavirus (HPV) clearance, and complications within 1 year of treatment. Odds ratios and 95% confidence intervals were determined using univariate and multivariate logistic regression models to analyze the association between disease evidence or HPV clearance and treatment modalities or other covariates.

Results
Of the 1,054 women who underwent FUS or LEEP, 225 met our selection criteria. Among the selected women, 101 and 124 received FUS and LEEP, respectively. There was no significant difference between the FUS and LEEP groups in the cure rate during the 3–6 months of follow-up (89.11% vs. 94.35%, P = 0.085) and recurrence rate during the 6–12 months follow-up (2.22% vs. 1.71%, P = 0.790). Both groups exhibited enhanced cumulative HPV clearance rates; however, the rates were not significantly different between the FUS and LEEP groups (74.23% vs. 82.79%, P = 0.122 during the 3–6 months follow-up; 84.95% vs. 89.17%, P = 0.359 during the 6–12 months follow-up). Furthermore, the incidence of complications caused by the FUS and LEEP techniques was comparable (5.0% vs. 5.6%, P = 0.818).

Conclusions
We found that FUS and LEEP have similar efficacy, safety, and reliability in treating women (aged < 40 years) with HSILs.
Brain tissue heterotopic in the adrenal gland in a child: a scarce case report
Authors: Zhanghuang Chenghao , Wu Chengchuang , Chen Junling , Ji Fengming , Yao Zhigang , Li Li , Yang Zhen , Tang Haoyu , Zhang Kun , Hang Yu , Xie Yucheng , Yan Bing 
Published: February 2024

AbstractHeterotopic brain tissue is rare and has not been reported. Our center made the first report. 4 years and 2 months old Girl presented with a cystic mass in the right adrenal gland 2 weeks after right upper abdominal pain. The operation was successful, and the diagnosis was confirmed by postoperative pathology. 6 months after the procedure, the incision healed well without recurrence. This case report has a detailed diagnosis and treatment process and satisfactory examination results. It can provide a reference for diagnosing and treating clinical HBT and reduce the risk of misdiagnosis and mistreatment.
Territorial gaps on quality of causes of death statistics over the last forty years in Spain
Authors: Cirera Lluís , Bañón Rafael-María , Maeso Sergio , Molina Puri , Ballesta Mónica , Chirlaque María-Dolores , Salmerón Diego ,   Mortality Working Group of the Spanish Association of Epidemiology
Published: February 2024

Abstract
Background
The quality of the statistics on causes of death (CoD) does not present consolidated indicators in literature further than the coding group of ill-defined conditions of the International Classification of Diseases. Our objective was to assess the territorial quality of CoD by reliability of the official mortality statistics in Spain over the years 1980–2019.

Methods
A descriptive epidemiological design of four decades (1980-, 1990-, 2000-, and 2010–2019) by region (18) and sex was implemented. The CoD cases, age-adjusted rates and ratios (to all-cause) were assigned by reliability to unspecific and ill-defined quality categories. The regional mortality rates were contrasted to the Spanish median by decade and sex by the Comparative Mortality Ratio (CMR) in a Bayesian perspective. Statistical significance was considered when the CMR did not contain the value 1 in the 95% credible intervals.

Results
Unspecific, ill-defined, and all-cause rates by region and sex decreased over 1980–2019, although they scored higher in men than in women. The ratio of ill-defined CoD decreased in both sexes over these decades, but was still prominent in 4 regions. CMR of ill-defined CoD in both sexes exceeded the Spanish median in 3 regions in all decades. In the last decade, women’s CMR significantly exceeded in 5 regions for ill-defined and in 6 regions for unspecific CoD, while men’s CMR exceeded in 4 and 2 of the 18 regions, respectively on quality categories.

Conclusions
The quality of mortality statistics of causes of death has increased over the 40 years in Spain in both sexes. Quality gaps still remain mostly in Southern regions. Authorities involved might consider to take action and upgrading regional and national death statistics, and developing a systematic medical post-grade training on death certification.
Sexual and Reproductive Health Service Seeking Scale (SRHSSS): development, validity, and reliability
Authors: Özdal Dilem , Demiralp Meral 
Published: February 2024

Abstract
Background
Young adults are a diverse group with diverse cares, choices and preferences in accessing and using Sexual and Reproductive Health (SRH) services, they should be at the center of the development of new managed models and solutions for the delivery of SRH services. The purpose of the study is to develop a valid and reliable measurement tool that can be used to determine the knowledge and attitudes of young adults about SRH and the barriers for accessing services, and to evaluate the attitudes and needs of young adults to receive SRH services.

Methods
In this study, the questions of the scale were developed through literature review, focus group interview with 8 people and expert evaluation were made, and a pre-test application was also carried out. Exploratory factor analysis and reliability testing were performed with a sample of 458 young adults. The re-test reliability was performed with 220 participants who were reached one month after the first measurement. Principal component analysis was used to establish the construct validity. The reliability of the scale was assessed using the Cronbach's alpha value.

Results
A 23-item scale has been developed to identify and evaluate young adults' thoughts, attitudes, and perceived barriers for accessing services regarding SRH. In the exploratory factor analysis conducted to examine the construct validity of SRHSSS, a four-factor structure was obtained that explained 89.45% of the total variance. The factor loadings of the scale items were found to vary between 0.78–0.97. At the same time, the Cronbach's alpha value of the scale is 0.90, indicates a good internal consistency.

Conclusions
SRHSSS is a scale with sufficient validity and reliability to determine young adults' SRH Service Seeking.
Advancing sustainable implementation of an evidence-based mental health intervention in Sierra Leone’s schools: protocol for a hybrid type 3 implementation-effectiveness trial
Authors: Desrosiers Alethea , Carrol Bidemi , Ritsema Haley , Higgins Walker , Momoh Fatoma , Betancourt Theresa S. 
Published: February 2024

Abstract
Background
Mental health disorders among youth contribute substantially to the global burden of disease, which is exacerbated in low- and middle-income countries (LMICs) due to large mental health treatment gaps. In Sierra Leone, a West African country with a long history of complex adversity, the mental health treatment gap is estimated at 98%. Implementing innovative mental health interventions that can be sustained at scale is a priority. The Youth Readiness Intervention (YRI) is an evidence-based mental health intervention for youth that can be delivered feasibly by lay health workers/nonspecialists. Using mobile-based technologies to assist implementation could improve the reach and sustainability of the YRI in Sierra Leone. This study aims to train teachers to deliver the YRI in Sierra Leone’s secondary schools and test the feasibility, acceptability, cost, and fidelity to the YRI of a mobile-based supervision model compared with standard, in-person supervision.

Methods
We will conduct a hybrid type 3 implementation-effectiveness cluster randomized trial to assess the feasibility, acceptability, costs and fidelity to the YRI implemented by teachers receiving mobile-based supervision vs. standard supervision. Enrolled schools (N = 50) will be randomized to YRI + mobile supervision (N = 20), YRI + standard supervision (N = 20) or waitlist control (N = 10). We will recruit and enroll four teachers per intervention-condition school (N = 160) and 1200 youth. We will collect data on implementation outcomes among teachers, principals and youth via a mixed methods approach at baseline and post-intervention. We will also collect quantitative data on youth mental health and functioning as secondary outcomes at baseline and post-intervention, as well as cost-effectiveness data at 12-month follow-up.

Discussion
Study findings have the potential to expand the reach of mental health services among youth in low-resource settings via a teacher workforce. The use of mobile tools, if successful, could support further scale out and sustainment of the YRI to other regions of Sierra Leone and West Africa more broadly, which could help address the mental health treatment gap.

Trial registration
Clinical Trial Network: NCT05737667.
Neoadjuvant stereotactic ablative body radiotherapy combined with surgical treatment for renal cell carcinoma and inferior vena cava tumor thrombus: a prospective pilot study
Authors: Chen Jiyuan , Liu Zhuo , Peng Ran , Liu Yunchong , Zhang Hongxian , Wang Guoliang , Tian Xiaojun , Pei Xinlong , Wang Junjie , Zhang Shudong , Wang Hao , Ma Lulin 
Published: February 2024

Abstract
Background
Surgical treatment for renal cell carcinoma (RCC) and inferior vena cava (IVC) tumor thrombus (TT) is difficult, and the postoperative complication rate is high. This study aimed to explore the safety and oncologic outcomes of neoadjuvant stereotactic ablative body radiotherapy (SABR) combined with surgical treatment for RCC and IVC-TT.

Methods
Patients with RCC and IVC-TTs were enrolled in this study. All patients received neoadjuvant SABR focused on the IVC at a dose of 30 Gy in 5 fractions, followed by 2 ~ 4 weeks of rest. Then, radical nephrectomy and IVC tumor thrombectomy were performed for each patient. Adverse effects, perioperative outcomes, and long-term prognoses were recorded.

Results
From June 2018 to January 2019, 8 patients were enrolled—4 with Mayo grade II TT and 4 with Mayo grade III TT. Four (50%) patients had complicated IVC wall invasion according to CT/MRI. All patients received neoadjuvant SABR as planned. Short-term local control was observed in all 8 patients. Only Grade 1–2 adverse events were reported. In total, 3 (37.5%) laparoscopic surgeries and 5 (62.5%) open surgeries were performed. The median operation time was 359 (IQR: 279–446) min, with a median intraoperative bleeding volume of 750 (IQR: 275–2175) ml. The median postoperative hospital stay was 7 (5–10) days. With a 26-month (range: 5–41) follow-up period, the estimated mean overall survival was 30.67 ± 5.38 months.

Conclusions
This is the first preoperative radiotherapy study in Asia that focused on patients with TT. This study revealed the considerable safety of neoadjuvant SABR for RCC with IVC-TT.

Trial registration
This study was registered in the Chinese Clinical Trials Registry on 2018-03-08 (ChiCTR1800015118). For more information, please see the direct link (https://www.chictr.org.cn/showproj.html?proj=25747).
Converting between the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC) urinary subscales: modeling and external validation
Authors: Windisch Paul , Becker Ivo , Tang Hongjian , Schröder Christina , Buchali André , Aebersold Daniel M. , Zwahlen Daniel R. , Förster Robert , Shelan Mohamed 
Published: February 2024

Abstract
Background
Prostate-related quality of life can be assessed with a variety of different questionnaires. The 50-item Expanded Prostate Cancer Index Composite (EPIC) and the International Prostate Symptom Score (IPSS) are two widely used options. The goal of this study was, therefore, to develop and validate a model that is able to convert between the EPIC and the IPSS to enable comparisons across different studies.

Methods
Three hundred forty-seven consecutive patients who had previously received radiotherapy and surgery for prostate cancer at two institutions in Switzerland and Germany were contacted via mail and instructed to complete both questionnaires. The Swiss cohort was used to train and internally validate different machine learning models using fourfold cross-validation. The German cohort was used for external validation.

Results
Converting between the EPIC Urinary Irritative/Obstructive subscale and the IPSS using linear regressions resulted in mean absolute errors (MAEs) of 3.88 and 6.12, which is below the respective previously published minimal important differences (MIDs) of 5.2 and 10 points. Converting between the EPIC Urinary Summary and the IPSS was less accurate with MAEs of 5.13 and 10.45, similar to the MIDs. More complex model architectures did not result in improved performance in this study. The study was limited to the German versions of the respective questionnaires.

Conclusions
Linear regressions can be used to convert between the IPSS and the EPIC Urinary subscales. While the equations obtained in this study can be used to compare results across clinical trials, they should not be used to inform clinical decision-making in individual patients.

Trial registration
This study was retrospectively registered on clinicaltrials.gov on January 14th, 2022, under the registration number NCT05192876.
Comparison of stress distribution around all-on-four implants of different angulations and zygoma implants: a 7-model finite element analysis
Authors: Tezerişener Hüseyin Alican , Özalp Öznur , Altay Mehmet Ali , Sindel Alper 
Published: February 2024

Abstract
Background
In recent years, zygomatic implants and the all-on-four treatment concept have been increasingly preferred for rehabilitation of atrophic maxillae. However, debate continues regarding the optimal configuration and angulation of the implants. The aim of this study was to analyze the biomechanical stress in implants and peri-implant bone in an edentulous maxilla with zygomatic implants and the all-on-four concept, using multiple implant configurations.

Methods
A total of 7 models consisting different combinations of 4-tilted dental implants and zygomatic implants were included in the study. In each model, a total of 200 N perpendicular to the posterior teeth and 50 N with 45° to the lateral tooth were applied. A finite element analysis was performed for determination of stress distribution on implants and peri-implant bone for each model.

Results
Higher stress values were observed in both cortical and trabecular bone around the 45°-tilted posterior implants in all-on-four models when compared to zygomatic implants. In cortical bone, the highest stress was established in an all-on-four model including 45°-tilted posterior implant with 4,346 megapascal (MPa), while the lowest stress was determined in the model including anterior dental implant combined with zygomatic implants with 0.817 MPa. In trabecular bone, the highest stress was determined in an all-on-four model including 30°-tilted posterior implant with 0.872 MPa while the lowest stress was observed in quad-zygoma model with 0.119 MPa. Regarding von Mises values, the highest stress among anterior implants was observed in an all-on-four model including 17° buccally tilted anterior implant with 38.141 MPa, while the lowest was in the including anterior dental implant combined with zygomatic implants with 20,446 MPa. Among posterior implants, the highest von Mises value was observed in the all-on-four model including 30°-tilted posterior implant with 97.002 MPa and the lowest stress was in quad zygoma model with 35.802 MPa.

Conclusions
Within the limits of the present study, the use of zygoma implants may provide benefit in decreasing biomechanical stress around both dental and zygoma implants. Regarding the all-on-four concept, a 17° buccal angulation of anterior implants may not cause a significant stress increase while tilting the posterior implant from 30° to 45° may cause an increase in the stress around these implants.