bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis
Authors: Bailey Christine K. , Caltabiano Stephen , Cobitz Alexander R. , Huang Chun , Mahar Kelly M. , Patel Vickas V. 
Published: October 2019

Abstract

Background
Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor currently being investigated as a treatment for anemia of chronic kidney disease (CKD) in both dialysis and nondialysis patients. In clinical studies to date, daprodustat has been administered orally as a once-daily regimen. This randomized, double-blind, placebo-controlled study characterized the initial dose-hemoglobin response as well as the efficacy and safety of three times weekly (TIW) daprodustat in hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule.

Methods
103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5 g/dL and previously receiving a stable dose of rhEPO or its analogs were randomized 1:1:1:1:1 to receive daprodustat 10, 15, 25, or 30 mg or placebo TIW over 29 days.

Results
Mean baseline hemoglobin was 10.6 g/dL for the placebo group and each daprodustat cohort. Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29. Using a Bayesian approach, the estimated dose conversion ratio between once-daily and TIW daprodustat was ~ 2.0 across the evaluated dose range using an Emax model. Daprodustat was generally well tolerated, with an adverse event (AE) profile consistent with the hemodialysis population.

Conclusions
These data help inform the appropriate dose conversion ratio to be applied to daily doses to obtain equivalent daprodustat TIW doses and suggest TIW treatment with daprodustat can treat anemia of CKD safely, supporting future long-term studies for this indication using a TIW dosing regimen.

Trial registration
ClinicalTrials.gov Identifier: NCT02689206; date registered: 02/11/2016.
Clinical outcomes and prognostic factors to predict treatment response in high risk neuroblastoma patients receiving topotecan and cyclophosphamide containing induction regimen: a prospective multicenter study
Authors: Rujkijyanont Piya , Photia Apichat , Traivaree Chanchai , Monsereenusorn Chalinee , Anurathapan Usanarat , Seksarn Panya , Sosothikul Darintr , Techavichit Piti , Sanpakit Kleebsabai , Phuakpet Kamon , Wiangnon Surapon , Chotsampancharoen Thirachit , Chainansamit Su-on , Kanjanapongkul Somjai , Meekaewkunchorn Arunotai , Hongeng Suradej 
Published: October 2019

Abstract

Background
Neuroblastoma is the most common extra-cranial solid tumor among children. Despite intensive treatment, patients with advanced disease mostly experience dismal outcomes. Here, we proposed the use of topotecan and cyclophosphamide containing induction regimen as an upfront therapy to high risk neuroblastoma patients.

Methods
Patients with high risk neuroblastoma undergoing ThaiPOG high risk neuroblastoma protocol from 2016 to 2017 were studied. All patients received 6 cycles of induction regimen consisting of 2 cycles topotecan (1.2 mg/m2/day) and cyclophosphamide (400 mg/m2/day) for 5 days followed by cisplatin (50 mg/m2/day) for 4 days combined with etoposide (200 mg/m2/day) for 3 days on the third and fifth cycles and cyclophosphamide (2100 mg/m2/day) for 2 days combined with doxorubicin (25 mg/m2/day) and vincristine (0.67 mg/m2/day) for 3 days on the fourth and sixth cycles. Treatment response after the 5th cycle before surgery and treatment-related toxicities after each topotecan containing induction cycle were evaluated. Relevant prognostic factors were analyzed to measure the treatment response among those patients.

Results
In all, 107 high risk neuroblastoma patients were enrolled in the study. After the 5th cycle of induction regimen, the patients achieved complete response (N = 2), very good partial response (N = 40), partial response (N = 46) and mixed response (N = 19). None of the patients experienced stable disease or disease progression. The most significant prognostic factor was type of healthcare system. The most common adverse effect was febrile neutropenia followed by mucositis, diarrhea and elevated renal function.

Conclusion
The topotecan and cyclophosphamide containing induction regimen effectively provides favorable treatment response. The regimen is well tolerated with minimal toxicity among patients with high risk neuroblastoma in Thailand.
Ionizing radiation increases the endothelial permeability and the transendothelial migration of tumor cells through ADAM10-activation and subsequent degradation of VE-cadherin
Authors: Kouam Pascaline Nguemgo , Rezniczek Günther A. , Adamietz Irenäus A. , Bühler Helmut 
Published: October 2019

AbstractBackgroundWe analyzed the changes in permeability of endothelial cell layers after photon irradiation, with a focus on the metalloproteases ADAM10 and ADAM17, and on VE-cadherin, components crucial for the integrity of endothelial intercellular junctions, and their roles in the transmigration of cancer cells through endothelial cell monolayers.MethodsPrimary HUVEC were irradiated with 2 or 4 Gy photons at a dose rate of 5 Gy/min. The permeability of an irradiated endothelial monolayer for macromolecules and tumor cells was analyzed in the presence or absence of the ADAM10/17 inhibitors GI254023X and GW280264X. Expression of ADAM10, ADAM17 and VE-Cadherin in endothelial cells was quantified by immunoblotting and qRT. VE-Cadherin was additionally analyzed by immunofluorescence microscopy and ELISA.ResultsIonizing radiation increased the permeability of endothelial monolayers and the transendothelial migration of tumor cells. This was effectively blocked by a selective inhibition (GI254023X) of ADAM10. Irradiation increased both, the expression and activity of ADAM10, which led to increased degradation of VE-cadherin, but also led to higher rates of VE-cadherin internalization. Increased degradation of VE-cadherin was also observed when endothelial monolayers were exposed to tumor-cell conditioned medium, similar to when exposed to recombinant VEGF.ConclusionsOur results suggest a mechanism of irradiation-induced increased permeability and transendothelial migration of tumor cells based on the activation of ADAM10 and the subsequent change of endothelial permeability through the degradation and internalization of VE-cadherin.
Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources
Authors: Daien Vincent , Eldem Bora M. , Talks James S. , Korobelnik Jean-Francois , Mitchell Paul , Finger Robert P. , Sakamoto Taiji , Wong Tien Yin , Evuarherhe Obaro , Carter Gemma , Carrasco Joao 
Published: October 2019

Abstract

Background
Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes.

Methods
A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a ‘good–moderate–poor’ rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest.

Results
A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies.

Conclusions
The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology.
The influence of the maternal peer group (partner, friends, mothers’ group, family) on mothers’ attitudes to obesity-related behaviours of their children
Authors: Cameron Adrian J. , Charlton Emma , Walsh Adam , Hesketh Kylie , Campbell Karen 
Published: October 2019

Abstract

Background
Relationships with others can have an impact on the attitudes of new mums to the obesity-related behaviours of their children. The aim of this study was to understand the degree to which other new mums (from their mothers’ group), friends, partners, and other family members have an influence on maternal attitudes to child feeding, physical activity and television viewing behaviours in order to more accurately target obesity prevention interventions.

Methods
In a retrospective cohort study design using data from the InFANT randomized controlled trial, first-time mothers (n = 307) from Melbourne, Australia were asked in 2012–13 how much of an influence their partner, friends, mothers’ group and family were on their attitudes to their pre-school aged child’s feeding, physical activity and television viewing behaviours. The level of influence was examined using chi-square tests, t-tests, and analysis of variance, stratified by maternal education, age and body weight. We also examined associations between the influence of others on maternal attitudes and actual behaviours including breastfeeding duration, age at introduction of solid food and time their child spent outside.

Results
Mothers rated partners as having the strongest influence on their attitudes toward all obesity-related behaviours. The percentage reporting partners as a major influence were 28.7% (95% CI 23.8,34.0), 33.1% (28.0, 38.6) and 24.2% (19.6, 29.3) for child feeding, physical activity and television viewing, respectively. More highly educated mothers rated social connections as more influential than less educated mothers. The influence of partners on attitudes toward child feeding was associated with longer breastfeeding duration.

Conclusions
Mothers rated partners as a powerful influence on their attitudes toward the obesity-related behaviours of their pre-school children, suggesting that partners could be an important target of obesity-prevention initiatives. Since less educated mothers reported peers and family as a much weaker influence on their attitudes to obesity-related behaviours than more educated mothers, equity should be taken into consideration when contemplating obesity-prevention interventions that target mothers’ groups.
Statistical analysis of socioeconomic and demographic correlates of perinatal mortality in Tigray region, Ethiopia: a cross sectional study
Authors: Woldeamanuel Berhanu Teshome , Gelebo Kumachew Kusse 
Published: October 2019

Abstract

Background
Though Ethiopia achieved the fourth Millennium Development Goal, commit to reducing under five child mortalities by the year 2015, but perinatal mortality has remained a major public health problem in Ethiopia, and the Tigray region is experiencing a high perinatal mortality rate. This study aimed to assess the risk factors attributed to perinatal death in the Tigray region.

Methods
A retrospective cross-sectional study was used. The information collected from 2738 children born five years preceding the survey was considered. Variables such as maternal social and demographic characteristics, child demographic characteristics, health and environmental factors were considered as risk factors of perinatal death. The study used descriptive statistics, and logistic regression model to identify significant correlates of perinatal mortality.

Results
The data showed that from total children included in the study, 4.1% are early neonatal deaths, and 2.1% are stillbirth. Overall the prevalence of experiencing perinatal mortality was 6.2% the Tigray region. The logistic analysis revealed, factors small birth interval (less than 15 months) (AOR = 7.902; 95% CI: (4.526–13.795)) and 16–26 months (AOR =2.088; 95% CI: (1.292–3.375)), poor wealth index (AOR = 1.948; 95% CI: (1.011–3.754)), having no toilet facility (AOR =1.649; 95% CI: (1.093–2.488)), child sex (being male) (AOR =1.74; 95% CI: (1.234–2.454)), giving birth at older maternal age (45–49 years) (AOR = 0.293; 95% CI: (0.128–0.668)), rural residence and using the unprotected well water were significantly associated with a higher risk of perinatal death.

Conclusions
The study identified sex of a child, previous birth intervals, availability of toilet facilities, wealth index, birth type, mother’s age, parity, place of residence, mother’s occupation and source of drinking water were the factors significantly associated with perinatal mortality. The prevalence of perinatal mortality shows that Tigray region was experiencing a high perinatal mortality rate than the national.
Simulation as tool for evaluating and improving technical skills in laparoscopic gynecological surgery
Authors: Mannella Paolo , Malacarne Elisa , Giannini Andrea , Russo Eleonora , Caretto Marta , Papini Francesca , Montt Guevara Maria Magdalena , Pancetti Federica , Simoncini Tommaso 
Published: October 2019

Abstract

Background
Simulation in laparoscopic surgery is nowadays recognized as a valid instrument for learning and training surgeons in different procedures. However, its role as evaluation test and self-assessment tool to verify basic surgical skills is still under discussion.

Methods
Thirty-three residents in obstetrics and gynecology at University of Pisa, Italy were recruited, and they received a simulation program consisting of 5 tasks. They had to perform basic laparoscopic surgery maneuvers as creating pneumoperitoneum, positioning trocars under vision, demonstrating the appropriate use of dominant and non-dominant hand and making single stitch and knot. They were evaluated with a modified OSATs scale.

Results
Senior trainees had better score than junior trainees (p value< 0,005) and after different sessions of simulation scores of both groups significantly improved (p < 0,001), especially for the junior group. All the trainees reported self-assessments that matched with the evaluation of external observers demonstrating the importance of simulation also as auto-evaluation test.

Conclusions
In this study, we demonstrated the role of simulation as powerful tool to evaluate and to self-assess surgical technical skills and to improve own capacities, with the use of a modified OSATs scale adapted to specific exercises.
PREVALENCE OF FATIGUE AND IMPACT ON QUALITY OF LIFE IN CASTRATION-RESISTANT PROSTATE CANCER PATIENTS: the VITAL study
Authors: Rodríguez Antolín A. , Martínez-Piñeiro L. , Jiménez Romero M. E. , García Ramos J. B. , López Bellido D. , Muñoz del Toro J. , García García-Porrero A. , Gómez Veiga F. 
Published: October 2019

Abstract

Background
Fatigue is one of the most prevalent symptoms among cancer patients. Specifically, in metastatic castration-resistant prostate cancer (mCRPC) patients, fatigue is the most common adverse event associated with current treatments. The purpose of this study is to describe the prevalence of fatigue and its impact on quality of life (QoL) in patients with CRPC in routine clinical practice.

Methods
This was a cross-sectional, multicentre study. Male chemo-naïve adults with high-risk non-metastatic (M0) CRPC and metastatic (M1) CRPC (mCRPC) were eligible. Fatigue was measured using the Brief Fatigue Inventory (BFI) and QoL was assessed using the Functional Assessment of Cancer Therapy questionnaire for patients with prostate cancer (FACT-P) and the FACT-General (FACT-G) questionnaire. Data were analysed using Mann-Whitney or Kruskal-Wallis tests (non-parametric distribution), a T-test or an ANOVA (parametric distribution) and the Fisher or chi-squared tests (categorical variables).

Results
A total of 235 eligible patients were included in the study (74 [31.5%] with M0; and 161 [68.5%] with M1). Fatigue was present in 74%, with 38.5% of patients reporting moderate-to-severe fatigue. Mean FACT-G and FACT-P overall scores were 77.6 ± 16.3 and 108.7 ± 21.4, respectively, with no differences between the CRPC M0 and CRPC M1 subgroups. Fatigue intensity was associated with decreased FACT-G/P scores, with no differences between groups. Among 151 mCRPC patients with available treatment data, those treated with abiraterone-prednisone ≥3 months showed a significant reduction in fatigue intensity (p = 0.043) and interference (p = 0.04) compared to those on traditional hormone therapy (HT). Patients on abiraterone-prednisone ≥3 months showed significantly better FACT-G/P scores than patients on HT (p = 0.046 and 0.018, respectively).

Conclusion
Our data show a high prevalence and intensity of fatigue and its impact on QoL in chemo-naïve CRPC patients. There is an association between greater fatigue and less QoL, irrespective of the presence or absence of metastasis. Chemo-naïve mCRPC patients receiving more than 3 months of abiraterone acetate plus prednisone showed an improvement of fatigue and QoL when compared to those on traditional HT.

Trial registration
Not applicable since it is not an interventional study.
Association of adiposity with thyroid nodules: a cross-sectional study of a healthy population in Beijing, China
Authors: Yang Hui-xia , Zhong Yu , Lv Wei-hua , Zhang Feng , Yu Hong 
Published: October 2019

Abstract

Background
The relationship between thyroid nodules (TNs) and adiposity is controversial. This paper describes a cross-sectional investigation performed to determine the existence of any such relationship. To assess adiposity, body mass index (BMI) and visceral fat area (VFA) were utilized.

Methods
Between January 1, 2017 and March 3, 2019. Three thousand five hundred thirty four healthy people were examined using thyroid ultrasonography, visceral fat and anthropometric measurements, laboratory tests and questionnaire interview. Binary logistic regression analyses were used.

Results
Of the 3534 healthy subjects, 58.69% (2074/3534) of the subjects had TNs. A total of 55.91% (1976/3534) had BMI ≥ 25 kg/m2 and 39.67% (1402/3534) had VFA ≥ 100 cm2. After adjustment to address confounders, BMI-based overweight and obesity levels only correlated with higher risk TNs when used as a continuous variable (OR = 1.031, 95% CI: 1.008–1.055, P = 0.008), while VFA was both a continuous variable (OR = 1.003, 95% CI: 1.000–1.005, P = 0.034) and a categorical variable (OR = 1.198, 95% CI: 1.014–1.417, P = 0.034) associated with significantly elevated risk of TNs. Analyzing the subgroups, BMI ≥ 25 kg/m2 (OR = 1.500, 95% CI: 1.110–2.026, P = 0.008) was significantly correlated with TN risk in individuals with TG ≥ 1.7 mmol/L. VFA ≥ 100 cm2 correlated with the TN risk irrespective of age (< 50 years: OR = 1.374, 95% CI: 1.109–1.703, P = 0.004; ≥ 50 years: OR = 1.367, 95% CI: 1.063–1.759, P = 0.015) and in the following subgroups: women (OR = 4.575, 95% CI: 2.558–8.181, P = 0.000), FBG ≥ 6.1 mmol/L (OR = 1.522, 95% CI: 1.048–2.209, P = 0.027), and TG ≥ 1.7 mmol/L (OR = 1.414, 95% CI: 1.088–1.838, P = 0.010).

Conclusions
Adiposity correlates with TNs. To assess TN risk in Chinese individuals, VFA is better than BMI.
Patients’ and parents’ perception of care on a paediatric interprofessional training ward
Authors: Straub Christine , Bode Sebastian F. N. 
Published: October 2019

Abstract

Background
Interprofessional training wards (ITWs) have been established in different fields of adult medicine to promote interprofessional learning and interprofessional collaboration of health care profession students. High patient satisfaction rates have been reported for ITWs. No data of parents’ and especially patients’ evaluation of care on a paediatric ITW have been reported so far. This study aims to evaluate parents’ and patients’ perceptions of medical and nursing care on a paediatric ITW.

Methods
In 2017 we established and started an interprofessional training ward in the setting of a general paediatric ward (IPAPAED). Medical students and nurse trainees care for 4–6 patients under supervision of registered nurses and certified physicians. All parents and all patients older than 8 years were invited to evaluate different aspect of their care on the IPAPAED.

Results
Since November 2017 until February 2019 parents (n = 109) rated the overall care of their children on the IPAPAED ward with m = 1.21 (SD ± .43) (1 = “excellent”, 4 = “poor”). Patients (n = 56) rated their overall care with m = 1.29 (SD ± 0.5). Other aspects of care and interprofessional collaboration were rated equally well. Analysis of the (limited) free-text commentaries revealed that perceived quality of care, friendliness and communication were especially valued by patients and parents.

Discussion & conclusion
On a paediatric ITW, in the view of parents and patients in our sample, a high level of care is delivered and satisfaction rates are excellent. An ITW seems, from a patient and parent point of view, feasible, even in paediatrics.