bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and efficacy of direct-acting antivirals for chronic hepatitis C in patients with chronic kidney disease
Authors: Iliescu Elena Laura , Mercan-Stanciu Adriana , Toma Letitia 
Published: January 2020

Abstract
Background
This is a real-world evidence study that aims to analyze the efficacy, tolerability and safety profile of paritaprevir/ombitasvir/ritonavir and dasabuvir, in patients with renal impairment.

Methods
We conducted an observational prospective study, on 232 patients with chronic kidney disease, undergoing treatment with paritaprevir/ombitasvir/ritonavir and dasabuvir, for chronic hepatitis C infection - genotype 1b. Renal and liver function were assessed at the beginning of therapy, monthly during treatment and three months after therapy completion.

Results
All patients achieved sustained virologic response. Common side effects were nausea, fatigue and headache. Close monitoring of tacrolimus blood levels and dose reduction was required in kidney transplant recipients.

Conclusions
HCV therapy in the setting of renal dysfunction has always been a challenging topic. Direct-acting antivirals have shown promising effects, demonstrating good tolerance and efficacy in patients with HCV infection and renal impairment. Sustained virologic response within our study population was 100%.
The prediction of acute ischemic stroke patients’ long-term functional outcomes treated with bridging therapy
Authors: Chang Yu-Jun , Liu Chi-Kuang , Wu Wen-Pei , Wang Shih-Chun , Chen Wei-Liang , Lin Chih-Ming 
Published: January 2020

Abstract
Background
Intravenous thrombolysis therapy (IVT) bridged with intra-arterial thrombectomy (IAT) has recently been recommended as favorable treatment option to ensure that the thrombolytic effect is delivered to the affected region for acute ischemic stroke patients. However, there remains a lack of studies reporting outcome prediction in this group of patients. In this study, we aimed to identify indicators from baseline data that could be used for early prediction of long-term functional outcomes.

Methods
This retrospective single center cohort study included acute ischemic stroke (AIS) patients (n = 92) who received IVT and IAT. Functional outcomes were assessed by the National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index. We investigated the relationship between functional outcomes at one-year post-procedure and potential predictors such as occlusion site, modified thrombolysis in cerebral infarction (mTICI) score following the IVT/IAT procedure, and degree of stenosis measured by carotid duplex.

Results
67.4% of the studied patients had satisfactory outcomes with mTICI grades of 2b or 3. From baseline to one-year post-procedure, the NIHSS score improved in 88.0%, the mRS score improved in 69.6%, and the Barthel index improved with 59.8%. Patients with internal carotid artery (ICA) or vertebral artery (VA) stenosis detected by carotid duplex had significantly poorer functional outcomes, measured by the mRS score and Barthel index. In patients with a satisfactory mTICI grade, improvement in the mRS score was only observed in 60.0% of patients with ICA stenosis, compared to 93.8% without ICA stenosis. The VA stenosis was the most significant factor associated with the improvement of mRS (OR = 0.08; 95% CI: 0.01–0.63; P = 0.017) and Barthel Index (OR = 0.06; 95% CI: 0.01–0.47; P = 0.008) in multiple regression analysis.

Conclusions
ICA or VA stenosis detected by carotid duplex could serve as predictors of significantly poorer functional outcomes in stroke patients treated with bridging therapy; they might be useful clinical markers, particularly as stenosis could be detected by a non-invasive and portable method.
GC-PROM: validation of a patient-reported outcomes measure for Chinese patients with gastric cancer
Authors: Hu Xiaojuan , Zhao Fen , Yu Hongmei , Luo Yanhong , Liu Jinchun , Zhang Yanbo 
Published: January 2020

Abstract
Background
There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer.

Method
Following the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method.

Results
The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains.

Conclusions
The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.
Cleidocranial dysplasia with growth hormone deficiency: a case report
Authors: Takaki Nozomi , Mori Jun , Matsuo Satoshi , Osamura Toshio , Michigami Toshimi 
Published: January 2020

Abstract
Background
Cleidocranial dysplasia (CCD) is a rare skeletal disorder with autosomal dominant inheritance that is characterized by hypoplastic clavicles, delayed closure of the cranial sutures, dental abnormalities, and short stature, among other features. The responsible gene for CCD is RUNX2 located on the short arm of chromosome 6p21. In general, there are intrafamilial variations in height among CCD patients. Few studies have reported data on recombinant human growth hormone (rhGH) treatment for patients with CCD; thus, it remains to be elucidated whether rhGH treatment can improve short stature. Here, we report a case of a 6-year-old girl with CCD who has growth hormone deficiency (GHD) and a novel mutation of RUNX2.

Case presentation
At 5 years of age, this patient was diagnosed with GHD and rhGH treatment was initiated. Thereafter, she was diagnosed with CCD due to the presence of hypoplastic clavicles and an open fontanelle, which was also observed in her mother and brother. She responded well to rhGH treatment; her height improved from − 3.2 SD to − 2.4 SD after 13 months.

Conclusion
A detailed patient history and physical examination are necessary for the early diagnosis of CCD. Similarly, to ascertain the effect of rhGH treatment, careful evaluation of the patient’s final height post-therapy is needed.
Computer-assisted preoperative planning improves the learning curve of PFNA-II in the treatment of intertrochanteric femoral fractures
Authors: Wang Dongdong , Zhang Kun , Qiang Minfei , Jia Xiaoyang , Chen Yanxi 
Published: January 2020

Abstract
Background
Intertrochanteric femoral fractures are prevalent among the elderly, and usually demands surgical treatments. Proximal femoral nail antirotation Asian version (PFNA-II) is widely used for intertrochanteric fracture treatment. The computer-assisted preoperative planning (CAPP) system has the potential to reduce the difficulty of PFNA-II in the treatment of intertrochanteric fractures. The aim of the study was to investigate and compare the learning curves of PFNA-II treatment with CAPP and conventional preoperational planning methods for intertrochanteric femoral fractures.

Methods
A total of 125 patients with intertrochanteric fracture who were treated with PFNA-II between March 2012 and June 2015 were retrospectively analyzed. Patients who underwent surgery with CAPP procedure by a junior surgeon were regarded as group A (n = 53); patients who underwent the conventional surgery by another junior surgeon were regarded as group B (n = 72). Each group was divided into three subgroups (case 1–20, case 21–40, case 41–53 or case 41–72).

Results
The average operation time of group A was 45.00(42.00, 50.00) minutes, and in group B was 55.00 (50.00, 60.00) minutes (P < 0.01). Average radiation frequency and blood loss were 13.02 ± 2.32, 160.00 (140.00, 170.00) ml and 20.92 ± 3.27, 250.00 (195.00, 279.50) ml, respectively, with significant differences (P < 0.01). The learning curve of the surgical procedure in group A was steeper than that in group B. There were no significant differences in patient reported outcomes, hospital stay and complication rate between the two groups. Significant differences were observed between group A and B in Harris score at last follow-up in the AO/OTA type 31-A2 intertrochanteric fracture (P < 0.05).

Conclusion
Compared with conventional preoperative planning methods, CAPP system significantly reduced operation time, radiation frequency and blood loss, thus reshaped the learning curve of PFNA-II treatment with lower learning difficulty.

Trial registration
researchregistry4770. Registered 25 March 2019.
An extremely rare case of lesser omental hernia in an elderly female patient following total colectomy
Authors: Liu Zhicheng , He Liang , Jiao Yan , Xu Zhonghang , Suo Jian 
Published: January 2020

Abstract
Background
An intro-abdominal hernia through the lesser omentum is a rare but severe condition that can cause intestinal obstruction and other life-threating complications. Until now, only a handful of cases have been reported worldwide. The diagnosis of lesser omental hernia remains challenging for emergency surgeons because of the unspecific symptoms. Therefore, there is a need for a better understanding of the characteristics of this condition.

Case presentation
In this report, we described the case of a 73-year-old female patient who was diagnosed with a lesser omental hernia caused by previous total colectomy. The patient underwent emergency surgery, and the intraoperative findings revealed a 200-cm segment of the small intestine was herniated through a defected lesser omentum (approximately 3 × 4 cm) from the lesser retrogastric curvature of the stomach. Besides, we summarize the specific abdominal computed tomography (CT) findings of lesser omental hernia by reviewing the literature.

Conclusion
The lesser omental hernia is extremely rare but can cause serious complications. The cause of lesser omental hernia can be congenital or acquired. Careful examination of the small omentum before the closure of the abdomen is expected to reduce the occurrence of these abdominal surgery-associated complications. The specific features of abdominal CT in cases of lesser omental hernia, which are summarized in this article, can help other clinicians to obtain accurate diagnoses of lesser omentum hernia in the future.
A meta-ethnography to understand the experience of living with urinary incontinence: ‘is it just part and parcel of life?’
Authors: Toye Francine , Barker Karen L. 
Published: January 2020

Abstract
Background
Urinary incontinence (UI) is highly prevalent and affects the lives of many men and women. We aimed to conduct a qualitative evidence synthesis (QES) to explore the experience of living with UI and to develop a conceptual model that can help us to understand this experience, and the potential barriers to appropriate healthcare.

Methods
We used the methods of meta-ethnography developed by Noblit and Hare and recently refined for larger studies. Meta-ethnography involves identifying concepts from the studies and abstracting these concepts into a line of argument. We searched for studies that explored the experience of adults with UI. We used the GRADE-CERQual framework to assess confidence in review findings.

Results
We screened 2307 titles, 429 abstracts, 107 full texts and included 41 studies (36 unique samples) in the synthesis. We organised the concepts into 26 conceptual categories, which we further abstracted into 6 themes: (1) Am I ill or is this normal? (2) It effects who I am and how I feel; (3) I feel stigmatised, ashamed and guilty; (4) talking can be difficult but it can help; (5) keeping incontinence under control; (6) have I got to the point that I need help? Our model conceptualises living with UI as navigating antagonists: Is UI normal or am I ill? Do I need help or am I managing? Do I keep UI to myself (and manage alone) or do I tell other people (and get the support that I need)? Do I use control strategies that focus on concealing (avoid risky situations, wear pads) versus, I use strategies that focus on improving the bodily function to improve continence. Our model highlights the experience of stigma, shame and guilt which exert a pull towards concealment.

Conclusions
The culture of secrecy and profound sense of shame is barrier to seeking help. An environment which reduces the shame and stigma of UI may help people to switch the focus to strategies that will improve continence, rather than conceal incontinence.
Peers as OSCE assessors for junior medical students – a review of routine use: a mixed methods study
Authors: Schwill Simon , Fahrbach-Veeser Johanna , Moeltner Andreas , Eicher Christiane , Kurczyk Sonia , Pfisterer David , Szecsenyi Joachim , Loukanova Svetla 
Published: January 2020

Abstract
Background
Peer-assisted learning is well established in medical education; however, peer tutors rarely act as assessors for the OSCE. In the compulsory, near-peer teaching programme covering basic medical skills at the University of Heidelberg, peer tutors serve as assessors on a formative OSCE. This study aimed to investigate the feasibility and acceptance of peer assessors and to survey the perceived advantages and disadvantages of their use.

Methods
In 2016 and 2017 all OSCE peer assessors (third to sixth-year medical students) and all of the peer-assessed students in 2017 (second-year-medical students) were invited to participate in a survey. Both groups were asked to complete a tablet-based questionnaire immediately after the OSCE. Peer assessors were asked to rate eight statements and the peer-assessed students to rate seven statements on a five-point Likert scale. Both were asked to comment on the advantages and disadvantages of peer-assessors.

Results
Overall, 74 of 76 peer assessors and 307 of 308 peer-assessed students participated in the study. 94% (67/74) of peer assessors and 90% (276/307) of the peer-assessed group thought that it is important to have peer tutors as assessors. Of the peer assessors, 92% (68/74) felt confident in giving structured feedback during the OSCE and 66% (49/74) felt they had improved their teaching skills. Of the peer-assessed students, 99% (306/307) were satisfied with their peers as OSCE assessors and 96% (292/307) considered the peer feedback during the OSCE as helpful. The participants mentioned structural benefits, such as lower costs, and suggested the quality of the OSCE was higher due to the use of peer assessors. The use of peer assessors was found to be beneficial for the learners in the form of high-quality feedback and an overall reduction in stress. Furthermore, the use of peer assessors was found to be beneficial for the peer assessors (improved teaching and clinical skills).

Conclusion
From a learner’s perspective, the use of peer assessors for a formative OSCE that is part of a near-peer teaching program aimed at junior medical students is favourable for all. A broad implementation of peer assessment in the formative OSCE should be encouraged to investigate effects on quality and stress-reduction.
The complex microbiome from native semen to embryo culture environment in human in vitro fertilization procedure
Authors: Štšepetova Jelena , Baranova Juliana , Simm Jaak , Parm Ülle , Rööp Tiiu , Sokmann Sandra , Korrovits Paul , Jaagura Madis , Rosenstein Karin , Salumets Andres , Mändar Reet 
Published: January 2020

Abstract
Background
Only a few microbial studies have conducted in IVF (in vitro fertilization), showing the high-variety bacterial contamination of IVF culture media to cause damage to or even loss of cultured oocytes and embryos. We aimed to determine the prevalence and counts of bacteria in IVF samples, and to associate them with clinical outcome.

Methods
The studied samples from 50 infertile couples included: raw (n = 48), processed (n = 49) and incubated (n = 50) sperm samples, and IVF culture media (n = 50). The full microbiome was analyzed by 454 pyrosequencing and quantitative analysis by real-time quantitative PCR. Descriptive statistics, t-, Mann-Whitney tests and Spearman’s correlation were used for comparison of studied groups.

Results
The study involved normozoospermic men. Normal vaginal microbiota was present in 72.0% of female partners, while intermediate microbiota and bacterial vaginosis were diagnosed in 12.0 and 16.0%, respectively. The decreasing bacterial loads were found in raw (35.5%), processed (12.0%) and sperm samples used for oocyte insemination (4.0%), and in 8.0% of IVF culture media. The most abundant genera of bacteria in native semen and IVF culture media were Lactobacillus, while in other samples Alphaproteobacteria prevailed. Staphylococcus sp. was found only in semen from patients with inflammation. Phylum Bacteroidetes was in negative correlation with sperm motility and Alphaproteobacteria with high-quality IVF embryos.

Conclusion
Our study demonstrates that IVF does not occur in a sterile environment. The prevalent bacteria include classes Bacilli in raw semen and IVF culture media, Clostridia in processed and Bacteroidia in sperm samples used for insemination. The presence of Staphylococcus sp. and Alphaproteobacteria associated with clinical outcomes, like sperm and embryo quality.
Knowledge of obstetric danger signs and associated factors: a study among mothers in Shashamane town, Oromia region, Ethiopia
Authors: Wassihun Biresaw , Negese Berhanu , Bedada Hunduman , Bekele Solomon , Bante Agegnehu , Yeheyis Tomas , Abebe Agere , uli Duro , Mohammed Merima , Gashawbez Salasebish , Hussen Emebet 
Published: January 2020

Abstract
Background
Child birth which is a special moment for parents, families and communities is also a time of intense vulnerability. In many developing countries including Ethiopia, maternal morbidity and mortality still pose a substantial burden. Raising awareness of women about the danger signs of pregnancy and childbirth is the first essential step in appropriate and timely obstetric care.

Objective
To assess the knowledge of obstetric danger signs among mothers and associated factors in Shashamane town, oromia region, Ethiopia.

Methods
A community based cross sectional study design was employed. All kebeles were included in study; the number of households was determined using proportionate-to-population size then systematic random sampling technique to select 422 women who gave birth in Shashamane town between April and May 2018. A structured questionnaire was used to collect data. Data was checked and entered into Epi data version 3.1 then exported to Statistical Package for Social Science version 23 for analysis. Univariate, bivariate and multivariable analysis with 95% CI was carried out. Women who spontaneously mentioned at least two danger signs of pregnancy from eight items were considered to have good knowledge of the obstetric danger signs.

Result
A total of 422 mothers were involved in the study. The mean age of the respondent was 25 with a standard deviation of 4.3 year. 59.5% of the respondents were found to have poor knowledge of obstetric danger signs. Majority of respondents mentioned vaginal bleeding (64.7%) as a danger sign of pregnancy. According to the result of the multivariable analysis, antenatal care was significantly associated with the knowledge of obstetric danger sign. Respondents who attended antenatal care were 1.26 times more likely to have good knowledge of obstetric danger signs than those who had no antenatal care [AOR = 1.26, 95%CI (1.08–1.85)]. Respondents who gave birth at health center were 3.57 time more likely to have good knowledge of obstetric danger signs than those who gave birth at home [AOR = 3.57, 95%CI (1.23–10.39)].

Conclusion
According to this study, the knowledge of obstetric danger signs was poor. Some of the factors associated with this knowledge were antenatal care attendance and place of delivery; therefore, it is recommended that mothers should have at least four antenatal visits; this may create good relationship with the providers and enhance their knowledge. In addition to this providing compassionate and respectful maternity care in health facility is also crucial steps to attract more women to health facilities, and to reduce home deliveries.
First-in-human phase I study of BPI-9016M, a dual MET/Axl inhibitor, in patients with non-small cell lung cancer
Authors: Hu Xingsheng , Zheng Xin , Yang Sheng , Wang Lin , Hao Xuezhi , Cui Xinge , Ding Lieming , Mao Li , Hu Pei , Shi Yuankai 
Published: January 2020

Abstract
Background
BPI-9016M is a novel small-molecule inhibitor that simultaneously targets both c-Met and AXL tyrosine kinases. This phase I study aimed to determine the maximum tolerated dose (MTD), safety, pharmacokinetics, and antitumor activity of BPI-9016M in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Methods
Over the dose range of 100 mg to 800 mg, eligible patients were administered with a single dose of 9016M tablet and received 7 days of pharmacokinetics evaluation, followed by continuous dose administration (QD dosing, 28 days). Standard “3 + 3” dose escalations were performed.

Results
Twenty NSCLC patients were treated. All patients experienced at least one adverse event (AE), of which treatment-related adverse events (TRAEs) were reported in 17 (85.0%) patients. The most common TRAEs were alanine transaminase (ALT) elevation (60%), bilirubin increased (40%), dysgeusia (40%), constipation (30%), hypertension (25%), and palmar-plantar erythrodysesthesia syndrome (15%). The TRAEs of grade 3 or higher during treatment were hypertension (15%), pulmonary embolism (5%), and laryngeal pain (5%). No dose-limiting toxicity (DLT) was observed, and the MTD was not reached. The median time to Cmax ranged from 2.0 to 3.5 h, and the plasma concentration of BPI-9016M declined rapidly after Tmax fitting a single-compartment model. The mean AUC0–72 h of M1 and M2-2, main metabolites of BPI-9016M, were 4.8–6.6 folds and 4.1–9.8 folds higher than that of BPI-9016M, respectively. Exposure to BPI-9016M, M1, and M2-2 reached moderate saturation at 600 mg. Among 19 evaluable patients, 1 had a partial response and 10 patients had stable disease.

Conclusion
BPI-9016M showed favorable safety and pharmacokinetic profiles, and no DLT was observed at doses up to 800 mg once daily. The promising antitumor activity in Chinese NSCLC patients supports further development of this tyrosine kinase inhibitor.

Trial registration
Clinical Trial ID: NCT02478866, registered May 21, 2015.