bluuebunny/crossref_metadata_2025_split huggingface dataset:
Factors associated with the level of physical activity in a multi-ethnic pregnant population – a cross-sectional study at the time of diagnosis with gestational diabetes
Authors: Garnweidner-Holme L , Henriksen L , Bjerkan K , Lium J , Lukasse M 
Published: January 2022

Abstract
Background
Regular physical activity during pregnancy can prevent several adverse health outcomes during this period of a woman’s life. Previous studies have shown that many women do not meet national recommendations for physical activity. This study aims to examine factors associated with sufficient leisure-time physical activity (LTPA) in a multicultural sample of pregnant women recently diagnosed with gestational diabetes mellitus (GDM).

Methods
We performed a cross-sectional study among 238 pregnant women. The women were recruited at diabetes outpatient clinics in the Oslo region of Norway from October 2015 to April 2017. The participants reported their activity levels using the Pregnancy Physical Activity Questionnaire (PPAQ). Pearson’s chi-square tests were used to assess differences in socio-demographic, health and pregnancy-related characteristics in relation to sufficient and insufficient LTPA, and logistic regression modelling was employed to predict the likelihood of insufficient LTPA.

Results
Less than half of the women in the sample (44.5%) had sufficient LTPA according to the minimum of ≥600 Met minutes per week. The majority of women were motivated to be physically active during pregnancy (84.9%). A low joint family income and being over 38 years of age increased the odds of not having sufficient LTPA. Women with sufficient LTPA had significantly higher scores of perceived health (p = 0.007).

Conclusions
The study indicates that pregnant women need to be better informed about the positive effects of physical activity on individually perceived health. To address the low levels of LTPA among pregnant women, communication strategies must be tailored towards women with low socio-economic backgrounds.
Trial registration:https://clinicaltrials.gov/ct2/show/NCT02588729
Obstetric and neonatal outcomes of gestational diabetes mellitus in twin pregnancies according to changes in its diagnostic criteria from National Diabetes Data Group criteria to Carpenter and Coustan criteria: a retrospective cohort study
Authors: Kim Yejin , Hong Sir-yeon , Kim Seo-yeon , Kim Yoo-min , Sung Ji-Hee , Choi Suk-Joo , Oh Soo-young , Roh Cheong-Rae 
Published: January 2022

AbstractBackgroundTo compare obstetric and neonatal outcomes in twin pregnancies with or without gestational diabetes mellitus (GDM) before and after changes in GDM diagnostic criteria.MethodsThis was a retrospective cohort study of 1,764 twin pregnancies including 130 women with GDM (GDM group) and 1,634 women without GDM (non-GDM group). Patients with pregestational diabetes, unknown GDM status, and fetal death at < 24 gestational weeks were excluded. Obstetric and neonatal outcomes were compared between the two groups by two periods: period 1 (1995–2005) and period 2 (2005–2018) when National Diabetes Data Group criteria and Carpenter and Coustan criteria were used for diagnosis of GDM, respectively.ResultsThe incidence of GDM in twin pregnancies increased from 4.0% in period 1 to 9.3% in period 2. Composite obstetric complications rate was significantly higher in the GDM group than that in the non-GDM group during period 1 (72.0% vs. 45.5%,P = 0.009). However, it became comparable during period 2 (60.0% vs. 57.4%,P = 0.601). Interaction between GDM and period indicated a significant differential effect of GDM by period on the rate of composite obstetric complications. The rate of composite neonatal complications was similar between the two groups during both periods. The interaction between GDM and period was not significant.ConclusionAfter changes of GDM diagnostic criteria, the incidence of GDM increased more than twice, and the rate of composite obstetric complications decreased, but the rate of composite neonatal complications did not change significantly.
Microbiome composition indicate dysbiosis and lower richness in tumor breast tissues compared to healthy adjacent paired tissue, within the same women
Authors: Esposito Maria Valeria , Fosso Bruno , Nunziato Marcella , Casaburi Giorgio , D’Argenio Valeria , Calabrese Alessandra , D’Aiuto Massimiliano , Botti Gerardo , Pesole Graziano , Salvatore Francesco 
Published: January 2022

AbstractBackgroundBreast cancer (BC) is the most common malignancy in women, in whom it reaches 20% of the total neoplasia incidence. Most BCs are considered sporadic and a number of factors, including familiarity, age, hormonal cycles and diet, have been reported to be BC risk factors. Also the gut microbiota plays a role in breast cancer development. In fact, its imbalance has been associated to various human diseases including cancer although a consequential cause-effect phenomenon has never been proven.MethodsThe aim of this work was to characterize the breast tissue microbiome in 34 women affected by BC using an NGS-based method, and analyzing the tumoral and the adjacent non-tumoral tissue of each patient.ResultsThe healthy and tumor tissues differed in bacterial composition and richness: the number of Amplicon Sequence Variants (ASVs) was higher in healthy tissues than in tumor tissues (p = 0.001). Moreover, our analyses, able to investigate from phylum down to species taxa for each sample, revealed major differences in the two richest phyla, namely, Proteobacteria and Actinobacteria. Notably, the levels of Actinobacteria and Proteobacteria were, respectively, higher and lower in healthy with respect to tumor tissues.ConclusionsOur study provides information about the breast tissue microbial composition, as compared with very closely adjacent healthy tissue (paired samples within the same woman); the differences found are such to have possible diagnostic and therapeutic implications; further studies are necessary to clarify if the differences found in the breast tissue microbiome are simply an association or a concausative pathogenetic effect in BC. A comparison of different results on similar studies seems not to assess a universal microbiome signature, but single ones depending on the environmental cohorts’ locations.
Landscape of homologous recombination deficiencies in solid tumours: analyses of two independent genomic datasets
Authors: Lai Zhongwu , Brosnan Matthew , Sokol Ethan S. , Xie Mingchao , Dry Jonathan R. , Harrington Elizabeth A. , Barrett J. Carl , Hodgson Darren 
Published: January 2022

Abstract
Background
DNA repair deficiencies are characteristic of cancer and homologous recombination deficiency (HRD) is the most common. HRD sensitizes tumour cells to PARP inhibitors so it is important to understand the landscape of HRD across different solid tumour types.

Methods
Germline and somatic BRCA mutations in breast and ovarian cancers were evaluated using sequencing data from The Cancer Genome Atlas (TCGA) database. Secondly, a larger independent genomic dataset was analysed to validate the TCGA results and determine the frequency of germline and somatic mutations across 15 different candidate homologous recombination repair (HRR) genes, and their relationship with the genetic events of bi-allelic loss, loss of heterozygosity (LOH) and tumour mutation burden (TMB).

Results
Approximately one-third of breast and ovarian cancer BRCA mutations were somatic. These showed a similar degree of bi-allelic loss and clinical outcomes to germline mutations, identifying potentially 50% more patients that may benefit from precision treatments. HRR mutations were present in sizable proportions in all tumour types analysed and were associated with high TMB and LOH scores. We also identified numerous BRCA reversion mutations across all tumour types.

Conclusions
Our results will facilitate future research into the efficacy of precision oncology treatments, including PARP and immune checkpoint inhibitors.
Metastatic gastroesophageal cancer in older patients – is this patient cohort represented in clinical trials?
Authors: Hennessy Maeve A. , Hamid Munzir , Keegan Niamh M. , Corrigan Lynda , Goggin Caitriona , Oo Nay Myo , Carrigan Marie , Mockler David , O’Donovan Anita , Horgan Anne M. 
Published: January 2022

Abstract
Background
Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer.

Methods
A search strategy was developed encompassing Embase, PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies from 1st January 1995 to 18th November 2020 were identified. These were screened for eligibility using reference management software (Covidence; Veritas Health Innovation Ltd). Data including age inclusion/exclusion criteria and median age of participants were recorded. The percentage of patients ≥ 65 enrolled was collected where available. The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model.

Results
Three hundred sixty-three phase III studies were identified and screened, with 66 trials remaining for final analysis. The majority of trials were Asian (48%; n = 32) and predominantly evaluated gastric malignancies, (86%; n = 56).
The median age of participants was 62 (range 18–94). Thirty-two percent (n = 21) of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 (range 65–80). All studies prior to 2003 used an upper age exclusion (n = 12); whereas only 9 that started in 2003 or later did (17%). Among later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). Fifty-two percent (n = 34) of studies specified the proportion of their study population who were ≥ 65 years. Older patients represented only 36% of the trial populations in these studies (range 7–60%).

Conclusions
Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.
Optimal surgical treatment for paratesticular leiomyosarcoma: retrospective analysis of 217 reported cases
Authors: Kamitani Rei , Matsumoto Kazuhiro , Takeda Toshikazu , Mizuno Ryuichi , Oya Mototsugu 
Published: January 2022

Abstract
Background
Paratesticular leiomyosarcoma (LMS) is a rare tumor. Conventionally, tumor resection by high inguinal orchiectomy is performed as the preferred treatment approach for paratesticular sarcoma. On the other hand, testis-sparing surgery has recently attracted attention as a less-invasive treatment option for paratesticular sarcoma. However, the prognostic predictors and optimal treatment strategy for paratesticular LMS remain unclear because of its rarity. In this study, we systematically reviewed previously reported cases of paratesticular LMS to evaluate the prognostic factors and establish the optimal treatment strategy.

Methods
A systematic search of Medline, Web of Science, Embase, and Google was performed to find articles describing localized paratesticular LMS published between 1971 and 2020 in English. The final cohort included 217 patients in 167 articles. The starting point of this study was the time of definitive surgical treatment, and the end point was the time of local recurrence (LR), distant metastasis (DM), and disease-specific mortality.

Results
Patients with cutaneous LMS had a slightly better LR-free survival, DM-free survival, and disease-specific survival than those with subcutaneous LMS (p = 0.745, p = 0.033, and p = 0.126, respectively). Patients with higher grade tumors had a significantly higher risk of DM and disease-specific mortality (Grade 3 vs Grade 1 p < 0.001, and Grade 3 vs Grade 1 p < 0.001, respectively). In addition, those with a microscopic positive margin had a significantly higher risk of LR and DM than those with a negative margin (p < 0.001, and p = 0.018, respectively). Patients who underwent simple tumorectomy had a slightly higher risk of LR than those who underwent high inguinal orchiectomy (p = 0.067). Subgroup analysis of cutaneous LMS demonstrated that the difference in LR between simple tumorectomy and high inguinal orchiectomy was limited (p = 0.212). On the other hand, subgroup analysis of subcutaneous LMS revealed a significant difference in LR (p = 0.039).

Conclusions
Our study demonstrated that subcutaneous LMS and high-grade tumors are prognostic factors for paratesticular LMS. For subcutaneous LMS, tumorectomy with high inguinal orchiectomy should be the optimal treatment strategy to achieve a negative surgical margin.
Assessing frequency and clinical outcomes of BRCA mutated ovarian cancer in Saudi women
Authors: Agha Naela , Alshamsan Bader , Al-Farsi Sharifa , Ateya Heba Aly , Almugbel Fahad A. , Alotaibi Hazem Abdullah , Omar Ayman , Mohamed Amgad Shahin , Alharthy Hanan , Elhassan Tusneem , Salem Hany , Alhusaini Hamed 
Published: January 2022

Abstract
Purpose
BRCA gene mutations (BRCAm) have an impact on patients’ characteristics and clinical outcomes of ovarian cancer (OC). The frequency and patterns of BRCAm vary among countries and ethnicities. There are limited data from Saudi Arabia (SA); thus, this study aims to determine the frequency, pattern, and impact on patient characteristics and outcomes of BRCAm OC compared to wild-type BRCA (BRCAw) in Saudi women.

Methods
This retrospective study evaluated women diagnosed with non-mucinous OC, fallopian tube, or peritoneal carcinoma who had BRCA status tested in an accredited lab between January 2016 and December 2017. The associations between various parameters and BRCAm were estimated using logistic regression. Statistical analysis performed with SPSS (Version 27).

Result
Sixty-one women with a median age of 52 at diagnosis were analyzed. Germline BRCA mutations were found in 41% of cases (25/61). The most common deleterious germline BRCA1 mutation was c.1140dupG (39%). Most women (72%) had no family history of cancers and 82% had advanced stage. Regardless of BRCA mutations, an optimal overall response rate (ORR) to first-line treatment has been achieved although most cases relapsed (84%) and the majority were platinum-sensitive relapse (85%). Higher ORR to subsequent lines and better survival were obtained in women with BRCA-mutation.

Conclusion
The prevalence of BRCAm of OC was higher in Saudi women compared to regional and most of the international figures. The better clinical outcomes of BRCAm women agreed with the reported evidence. Further studies on BRCA mutations of OC and genetic counseling are highly recommended.

Trial registration
Trial approved by the Institutional Review Board of King Faisal Specialist Hospital and Research Center (RAC # 2171137) and conducted at King Faisal Specialist Hospital and Research Center, PO Box 3354, Riyadh 11,211, Saudi Arabia.
High score of LDH plus dNLR predicts poor survival in patients with HER2-positive advanced breast cancer treated with trastuzumab emtansine
Authors: Li Liru , Ai Lin , Jia Lin , Zhang Lei , Lei Boya , Zhang Qingyuan 
Published: January 2022

Abstract
Objective
To investigate the prognostic value of derived neutrophil to lymphocyte ratio (dNLR) and lactate dehydrogenase (LDH) in patients with advanced HER2 positive breast cancer treated with trastuzumab emtansine.

Methods
Fifty one patients with advanced HER2 positive breast cancer who received T-DM1 treatment in Harbin Medical University Cancer Hospital were selected. The clinical data and blood test indexes were collected, and the ROC curve determined the optimal cut-off value. Kaplan-Meier survival curve and Cox regression model was used to analyze the effect of different levels of dNLR,LDH,LNI (dNLR combined with LDH index) before and after T-DM1 treatment on the survival of patients.

Results
The median PFS and OS of the patients with advanced HER2 positive breast cancer who received T-DM1 treatment were 6.9 months and 22.2 months, respectively. The optimal cut-off value of LDH and dNLR before T-DM1 treatment was 244 U / L (P = 0.003) and 1.985 (P = 0.013), respectively. Higher LDH and dNLR were significantly correlated with shorter median PFS and OS (P < 0.05). The median PFS of patients with LNI (0), LNI (1) and LNI (2) were 8.1 months, 5.5 months and 2.3 months, respectively, P = 0.007. Univariate and multivariate analysis showed that LDH > 244 U / L, dNLR > 1.985, LNI > 0, ECOG ≥1 and HER-2 (IHC2 +, FISH+) before the T-DM1 treatment were the poor prognostic factors. LDH uptrend after the T-DM1 treatment also predicted poor prognosis.

Conclusion
Serum LDH > 244 U / L and dNLR > 1.985 before the T-DM1 treatment were prognostic risk factors for patients with advanced HER2 positive breast cancer receiving T-DM1 treatment. The higher LNI score was significantly associated with shorter PFS and OS. LDH uptrend after T-DM1 treatment was also related to the poor prognosis.
A phase IA dose-escalation study of PHI-101, a new checkpoint kinase 2 inhibitor, for platinum-resistant recurrent ovarian cancer
Authors: Park Soo Jin , Chang Suk-Joon , Suh Dong Hoon , Kong Tae Wook , Song Heekyoung , Kim Tae Hun , Kim Jae-Weon , Kim Hee Seung , Lee Sung-Jong 
Published: January 2022

AbstractBackgroundPHI-101 is an orally available, selective checkpoint kinase 2 (Chk2) inhibitor. PHI-101 has shown anti-tumour activity in ovarian cancer cell lines and impaired DNA repair pathways in preclinical experiments. Furthermore, the in vivo study suggests the synergistic effect of PHI-101 through combination with PARP inhibitors for ovarian cancer treatment. The primary objective of this study is to evaluate the safety and tolerability of PHI-101 in platinum-resistant recurrent ovarian cancer.MethodsChk2 inhibitor for Recurrent EpitheliAl periToneal, fallopIan, or oVarian cancEr (CREATIVE) trial is a prospective, multi-centre, phase IA dose-escalation study. Six cohorts of dose levels are planned, and six to 36 patients are expected to be enrolled in this trial.Major inclusion criteria include ≥ 19 years with histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal cancer. Also, patients who showed disease progression during platinum-based chemotherapy or disease progression within 24 weeks from completion of platinum-based chemotherapy will be included, and prior chemotherapy lines of more than five will be excluded. The primary endpoint of this study is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of PHI-101.DiscussionPHI-101 is the first orally available Chk2 inhibitor, expected to show effectiveness in treating recurrent ovarian cancer. Through this CREATIVE trial, DLT and MTD of this new targeted therapy can be confirmed to find the recommended dose for the phase II clinical trial. This study may contribute to developing a new combination regimen for the treatment of ovarian cancer.Trial registrationClinicalTrials.govIdentifier:NCT04678102.
Prognostic nomogram for patients with unresectable pancreatic cancer treated with gemcitabine plus nab–paclitaxel or FOLFIRINOX: A post–hoc analysis of a multicenter retrospective study in Japan (NAPOLEON study)
Authors: Shibuki Taro , Mizuta Toshihiko , Shimokawa Mototsugu , Koga Futa , Ueda Yujiro , Nakazawa Junichi , Komori Azusa , Otsu Satoshi , Arima Shiho , Fukahori Masaru , Makiyama Akitaka , Taguchi Hiroki , Honda Takuya , Mitsugi Kenji , Nio Kenta , Ide Yasushi , Ureshino Norio , Shirakawa Tsuyoshi , Otsuka Taiga 
Published: January 2022

Abstract
Background
No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab–paclitaxel (GnP) or FOLFIRINOX.

Methods
This analysis was conducted using clinical data of Japanese patients with unresectable pancreatic cancer undergoing GnP or FOLFIRINOX treatment obtained from a multicenter study (NAPOLEON study). A Cox proportional hazards model was used to identify the independent prognostic factors. A nomogram to predict 6–, 12–, and 18–month survival probabilities was generated, validated by using the concordance index (C–index), and calibrated by the bootstrapping method. And then, we attempted risk stratification for survival by classifying the patients according to the sum of the scores on the nomogram (total nomogram points).

Results
A total of 318 patients were enrolled. A prognostic nomogram was generated using data on the Eastern Cooperative Oncology Group performance status, liver metastasis, serum LDH, serum CRP, and serum CA19–9. The C–indexes of the nomogram were 0.77, 0.72 and 0.70 for 6–, 12–, and 18–month survival, respectively. The calibration plot showed optimal agreement at all points. Risk stratification based on tertiles of the total nomogram points yielded clear separations of the survival curves. The median survival times in the low–, moderate–, and high–risk groups were 15.8, 12.8 and 7.8 months (P<0.05), respectively.

Conclusions
Our nomogram might be a convenient and inexpensive tool to accurately predict survival in Japanese patients with unresectable pancreatic cancer undergoing treatment with GnP or FOLFIRINOX, and will help clinicians in selecting appropriate therapeutic strategies for individualized management.
Application of protection motivation theory (PMT) on skin cancer preventive behaviors amongst primary school students in rural areas of Fasa city-Iran
Authors: Khani Jeihooni Ali , Bashti Somayeh , Erfanian Bahareh , Ostovarfar Jeyran , Afzali Hasirini Pooyan 
Published: January 2022

Abstract
Background
Considering that exposure to sunlight in childhood and adolescence has an important role in skin cancer, so it seems that training protective behaviors in this period is more effective.

Objectives
To survey the application of protection motivation theory (PMT) on skin cancer preventive behaviors among students in rural areas of Fasa city, Iran.

Methods
This study was done in two stages: Phase I of this study, the descriptive-analytic and cross-sectional study was conducted in 2018 to investigate the predictive value of the protection motivation theory on skin cancer preventive behaviors. In the second stage, a quasi-experimental interventional study was conducted on 400 primary school students in 2019. The educational intervention was performed in the experimental group for 8 sessions. Data were collected using a demographic information questionnaire and protection motivation theory before and six months after the intervention.

Results
The constructs of protection motivation theory predicted 58.6% of skin cancer preventive behaviors. The results indicated that there was no significant difference between the two groups in terms of knowledge, perceived sensitivity, perceived severity, reward, fear, protection motivation, response efficacy, self-efficacy, response costs, and the skin cancer preventive behaviors in before the intervention (p > 0.05). However, six months after the intervention, the experimental group showed a significant increase in each of the mentioned constructs and skin cancer protective behaviors (p < 0.05).

Conclusion
This study showed the effectiveness of the intervention based on the PMT constructs in adoption of skin cancer preventive behaviors in 6 months’ post intervention in primary school students.