bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial
Authors: Oldgren Jonas , Steg Philippe Gabriel , Hohnloser Stefan H , Lip Gregory Y H , Kimura Takeshi , Nordaby Matias , Brueckmann Martina , Kleine Eva , ten Berg Jurrien M , Bhatt Deepak L , Cannon Christopher P 
Published: January 2019

Abstract

Aims
After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.

Methods and results
In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35–0.63) for 110 mg and 0.67 (0.50–0.90) for 150 mg]; elective PCI [0.57 (0.43–0.76) for 110 mg and 0.76 (0.56–1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28–0.76) for 110 mg and 0.59 (0.34–1.04) for 150 mg]; or clopidogrel [0.51 (0.41–0.64) for 110 mg and 0.73 (0.58–0.91) for 150 mg], all interaction P-values &gt;0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values &gt;0.10.

Conclusion
The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.
Unintended HIV-1 Transmission to a Sex Partner in a Study of a Therapeutic Vaccine Candidate
Authors: Lelièvre Jean-Daniel , Hocqueloux Laurent 
Published: January 2019

Abstract
We report a case of sexual transmission of human immunodeficiency virus (HIV) that occurred during treatment discontinuation in a therapeutic vaccine trial, following oral sex. Transmission occurred even though the index participant was an HIV/AIDS activist, particularly well informed about the risks and modalities of transmission. This case report highlights the risk of secondary transmission of HIV during cessation of treatment in HIV cure–related trials.
Simple Detection of Hepatitis B Virus in Using Loop-Mediated Isothermal Amplification Method
Authors: Chen Hua-Wei , Belinskaya Tatyana , Zhang Zhiwen , Ching Wei-Mei 
Published: January 2019

AbstractIntroductionUS Military and civilian personnel regularly deploy to regions that are endemic for the Hepatitis B virus (HBV), including the Western Pacific, Africa, Eastern Mediterranean, Southeast Asia, and Europe. When patients have life-threatening injuries that require any blood component that is not immediately available, they are typically transfused with locally collected fresh whole blood from a walking blood bank. Currently, there is no simple and easy method for sensitively screening fresh blood in deployed theaters of conflict.Materials and methodsIn order to fill the gap, we have developed a loop-mediated isothermal amplification (LAMP) assay to detect the presence of HBV in blood products. The primers were designed to target the gene of the pre-Surface/Surface antigen region of HBV. The amplification reaction mixture was incubated at 60°C for 60 min. The amplicon can be detected by a handheld fluorescence tube scanner or an immune-chromatography test strip.ResultsWe were able to detect down to 10 copies of viral DNA by LAMP reaction for HBV DNA extracted from HBV-positive plasma. We also identified the optimal heat treatment condition (125°C for 10 min) for plasma specimens without requiring DNA extraction for the LAMP assay. The sensitivity of the assay was evaluated with polymerase chain reaction (PCR) confirmed HBV-positive samples. Using LAMP, we detected HBV in 107 out of 127 (84%) samples.ConclusionThis LAMP assay has the potential to be used in resource-limited settings to improve the safety of locally collected blood in endemic regions.
Ecological principle meets cancer treatment: treating children with acute myeloid leukemia with low-dose chemotherapy
Authors: Hu Yixin , Chen Aili , Zheng Xinchang , Lu Jun , He Hailong , Yang Jin , Zhang Ya , Sui Pinpin , Yang Jingyi , He Fuhong , Wang Yi , Xiao Peifang , Liu Xin , Zhou Yinmei , Pei Deqing , Cheng Cheng , Ribeiro Raul C , Hu Shaoyan , Wang Qian-fei 
Published: January 2019

Abstract
Standard chemotherapy regimens for remission induction of pediatric acute myeloid leukemia (AML) are associated with significant morbidity and mortality. We performed a cohort study to determine the impact of reducing the intensity of remission induction chemotherapy on the outcomes of selected children with AML treated with a low-dose induction regimen plus granulocyte colony stimulating factor (G-CSF) (low-dose chemotherapy (LDC)/G-CSF). Complete response (CR) after two induction courses was attained in 87.0% (40/46) of patients receiving LDC/G-CSF. Post-remission therapy was offered to all patients, and included standard consolidation and/or stem cell transplantation. During the study period, an additional 94 consecutive children with AML treated with standard chemotherapy (SDC) for induction (80/94 (85.1%) of the patients attained CR after induction II, P = 0.953) and post-remission. In this non-randomized study, there were no significant differences in 4-year event-free (67.4 vs. 70.7%; P = 0.99) and overall (70.3 vs. 74.6%, P = 0.69) survival in the LDC/G-CSF and SDC cohorts, respectively. After the first course of induction, recovery of white blood cell (WBC) and platelet counts were significantly faster in patients receiving LDC/G-CSF than in those receiving SDC (11.5 vs. 18.5 d for WBCs (P &lt; 0.001); 15.5 vs. 22.0 d for platelets (P &lt; 0.001)). To examine the quality of molecular response, targeted deep sequencing was performed. Of 137 mutations detected at diagnosis in 20 children who attained hematological CR after two courses of LDC/G-CSF (n = 9) or SDC (n = 11), all of the mutations were below the reference value (variant allelic frequency &lt;2.5%) after two courses, irrespective of the treatment group. In conclusion, children with AML receiving LDC/G-CSF appear to have similar outcomes and mutation clearance levels, but significantly lower toxicity than those receiving SDC. Thus, LDC/G-CSF should be further evaluated as an effective alternative to remission induction in pediatric AML.
Choice of Empirical Antibiotic Therapy and Adverse Outcomes in Older Adults With Suspected Urinary Tract Infection: Cohort Study
Authors: Ahmed Haroon , Farewell Daniel , Francis Nick A , Paranjothy Shantini , Butler Christopher C 
Published: January 2019

Abstract

Background
Nitrofurantoin is widely recommended for empirical treatment of urinary tract infection (UTI), but primary care clinicians may prescribe alternative antibiotics to improve prognosis in older, sicker patients. We assessed whether prescribing alternative antibiotics was associated with reduced risk of adverse outcomes in older patients.

Methods
This retrospective cohort study included patients aged ≥65 years empirically treated for a UTI with nitrofurantoin, cefalexin, ciprofloxacin, or co-amoxiclav. We matched patients on their propensity to receive a nitrofurantoin prescription and used mixed-effects logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for reconsultation and represcription (proxy for treatment failure), hospitalization for UTI, sepsis, or acute kidney injury, and death.

Results
We identified 42 298 patients aged ≥65 years prescribed empirical nitrofurantoin, cefalexin, ciprofloxacin, or co-amoxiclav for a UTI. Compared with nitrofurantoin, patients prescribed cefalexin, ciprofloxacin, or co-amoxiclav had lower odds of reconsultation and represcription (OR for cefalexin = 0.85, 95% CI = 0.75–0.98; OR for ciprofloxacin = 0.48, 95% CI = 0.38–0.61, OR for co-amoxiclav = 0.77, 95% CI = 0.64–0.93). Patients prescribed cefalexin or ciprofloxacin had greater odds of hospitalization for sepsis (OR for cefalexin = 1.89, 95% CI = 1.03–3.47; OR for ciprofloxacin = 3.21, 95% CI = 1.59–6.50), and patients prescribed cefalexin had greater odds of death (OR = 1.44, 95% CI = 1.12–1.85).

Conclusions
Compared with nitrofurantoin, prescribing of alternative antibiotics for UTI in older people may be associated with lower rates of treatment failure but was not associated with reduced risk of UTI-related hospitalization or death.
Variables Associated With the Use of Prophylactic Amitriptyline Treatment in Patients With Tension-type Headache
Authors: Palacios-Ceña Maria , Wang Kelun , Castaldo Matteo , Ordás-Bandera Carlos , Torelli Paola , Arendt-Nielsen Lars , Fernández-de-las-Peñas César 
Published: January 2019

Objective:
The objective of this study was to investigate differences in clinical, psychological, and psychophysical outcomes according to use of prophylactic medication (amitriptyline) in tension-type headache (TTH).

Methods:
In total, 173 individuals with TTH participated. Headache features and symptomatic medication intake were collected with a 4-weeks headache diary at baseline and at 6-months. Burden of headache (Headache Disability Inventory-HDI), sleep quality (Pittsburgh Sleep Quality Index-PSQI), anxiety/depression (Hospital Anxiety and Depression Scale-HADS), and trait/state anxiety levels (State-Trait Anxiety Inventory-STAI) were also assessed at baseline. Pressure pain thresholds (PPT) were assessed over the temporalis, C5-C6 joint, second metacarpal, and tibialis anterior at baseline. Differences between participants taking or not taking prophylactic medication based on self-perceived effectiveness of the medication on headache characteristics were assessed.

Results:
In total, 49 (28%) reported taking prophylactic medication for the headaches (amitriptyline: 100%). From these, 11 (23%) reported no effect, 25 (51%) reported moderate effect, and 13 (26%) reported positive effect with medication. Patients taking prophylactic medication had longer headache history, higher frequency of headaches (61% CTTH), higher headache burden, worse quality of sleep, and higher depression than those not taking medication. Prophylactic medication was less effective in patients with generalized pressure pain hyperalgesia. No other significant differences were found.

Conclusions:
Prophylactic medication is used by TTH patients with higher headache frequency, higher headache burden, worse sleep quality, and higher depression. Lower effectiveness of prophylactic amitriptyline was associated with widespread pain hyperalgesia.
Oral Riboflavin to Assess Ureteral Patency During Cystoscopy
Authors: Stitely Michael L. , Harlow Keryn , MacKenzie Elliot 
Published: January 2019

OBJECTIVE:
To evaluate whether oral riboflavin is more effective than placebo as a marker of ureteric patency at cystoscopy.

METHODS:
Patients scheduled for gynecologic surgery where cystoscopy was a planned component of the procedure were randomized to receive riboflavin 400 mg or placebo orally the night before surgery. During cystoscopy, the operating surgeon visualized ureteric jets and video recorded the cystoscopy portion of the procedure. The primary outcome was to determine whether orally administered riboflavin produced stronger yellow color of urine seen on cystoscopy than placebo on a 3-point scale. Secondary outcomes were to assess whether riboflavin administration improved ease of identifying ureteric jets (5-point scale) and whether a greater proportion of patients had both ureteric jets visualized with riboflavin compared with placebo. A sample size of 33 per group was planned.

RESULTS:
From June 28, 2017, to February 19, 2018, 72 women were screened and 66 were randomized, with 33 patients in each study group. The groups were similar in age, weight, body mass index, and ethnicity. The patients in the riboflavin group had significant increase of yellow-colored urine as rated by the operating surgeon, with a median of 2 compared with 1 on a 3-point scale (P<.001). The ureteral jets were more easily visualized in the riboflavin group as rated by the operating surgeon, with a median of 5 compared with 4 on a 5-point scale (P<.013). Bilateral ureteral patency was confirmed in 30 of 33 women (91%) in the riboflavin group and in 28 of 33 women (85%) in the placebo group (P=.71).

CONCLUSIONS:
The administration of riboflavin before gynecologic surgery improves the ease of visualizing the ureteric jets by inducing yellow coloration of the urine.

CLINICAL TRIALS REGISTRATION:
Australian New Zealand Clinical Trials Registry, 12616001367437.
Side Effects and Health Benefits of Depot Medroxyprogesterone Acetate
Authors: Dianat Shokoufeh , Fox Edith , Ahrens Katherine A. , Upadhyay Ushma D. , Zlidar Vera M. , Gallo Maria F. , Stidd Reva L. , Moskosky Susan , Dehlendorf Christine 
Published: January 2019

OBJECTIVE:
Counseling about potential side effects and health benefits of contraceptive methods could facilitate continued method use and method satisfaction, yet no evidence-based compilation of side effects and benefits exists to aid such counseling. Among contraceptive methods in the United States, depot medroxyprogesterone acetate (DMPA) injectables have the highest discontinuation rates, and most discontinuation is attributable to side effects. This review examines the side effects and health benefits of DMPA to inform counseling.

DATA SOURCES:
We searched PubMed, POPLINE, EMBASE, Web of Science, Campbell Collaboration Library of Systematic Reviews, the Cochrane Database of Systematic Reviews, the Cochrane Center Register of Controlled Trials, and ClinicalTrials.gov.

METHODS OF STUDY SELECTION:
We included English-language studies published from 1985 to 2016 that enrolled healthy, nonbreastfeeding females aged 13–49 years at risk of unintended pregnancy, compared intramuscular or subcutaneous progestin-only injectables to a contemporaneous comparison group, and addressed at least one key question: 1) What side effects are associated with progestin-only injectable contraceptive use? 2) What health benefits are associated with progestin-only injectable contraceptive use? Study quality was assessed using criteria from the U.S. Preventive Services Task Force.

TABULATION, INTEGRATION, AND RESULTS:
Twenty-four studies met inclusion criteria. None were randomized controlled trials. There were 13 prospective cohort, five retrospective cohort, four case–control, and two cross-sectional studies. Studies of moderate or high risk of bias suggest an association between DMPA use and weight gain, increased body fat mass, irregular bleeding, and amenorrhea. Inconsistent evidence exists for an association between DMPA use and mood or libido changes. Limited evidence exists for an association between DMPA use and decreased risk of cancers and tubal infertility.

CONCLUSION:
Higher-quality research is needed to clarify DMPA's side effects and benefits. In absence of such evidence, patient-centered counseling should incorporate the available evidence while acknowledging its limitations and recognizing the value of women's lived experiences.
Application of next-generation sequencing for the diagnosis of fetuses with congenital heart defects
Authors: Qiao Fengchang , Hu Ping , Xu Zhengfeng 
Published: January 2019

Purpose of review
Congenital heart defects (CHDs) are the most common type of birth defects, and are thought to result from genetic–environmental interactions. Currently, karyotype and chromosomal microarray analyses are the primary methods used to detect chromosomal abnormalities and copy number variations in fetuses with CHD. Recently, with the introduction of next-generation sequencing (NGS) in prenatal diagnosis, gene mutations have been identified in cases of CHD. The purpose of this review is to summarize current studies about the genetic cause of fetal CHD, paying particular attention to the application of NGS for fetuses with CHD.

Recent findings
In addition to chromosomal abnormalities, gene mutations are an important genetic cause of fetal CHD. Furthermore, incidences of pathogenic mutations in fetuses with CHD are associated with the presence of other structural anomalies, but are irrelevant to the categories of CHD.

Summary
Gene mutations are important causes of fetal CHD and NGS should be applied to all fetuses with normal karyotype and copy number variations, regardless of whether the CHD is isolated or syndromic.
Acupuncture for pain caused by prostate cancer
Authors: Wang Jisheng , Lei Yi , Bao Binghao , Yu Xudong , Dai Hengheng , Chen Fei , Li Haisong , Wang Bin 
Published: January 2019

Abstract

Background:
Prostate cancer is a male malignant tumor disease with high prevalence in recent years. Patients with advanced prostate cancer are more likely to have bone metastasis and strong bone pain, and even lead to pathological fracture, which has a serious impact on the quality of life of patients. Acupuncture has good clinical efficacy in treating pain caused by prostate cancer. This review hopes to adopt meta-analysis to evaluate the efficacy and safety of acupuncture in the treatment of pain caused by prostate cancer and provides evidence for its application in clinical practice.

Methods and analysis:
We will search for PubMed, Cochrane Library, AMED, EMbase, WorldSciNet, Nature, Science online and China Journal Full-text Database (CNKI), China Biomedical Literature CD-ROM Database (CBM), and related randomized controlled trials included in the China Resources Database. The time is limited from the construction of the library to November 2018. We will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the Revman 5.3 and Stata 13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of epididymitis.

Ethics and dissemination:
This systematic review will evaluate the efficacy and safety of acupuncture for pain caused by prostate cancer. Owing to the fact that all of the data used in this systematic review and meta-analysis have been published, this review does not require ethical approval. Furthermore, all data will be anonymously analyzed during the review process trial.

Trial registration number:
PROSPERO CRD42018111550
A cut-off value of shear wave speed to distinguish nonalcoholic steatohepatitis candidates
Authors: Suda Takeshi , Kanefuji Tsutomu , Abe Atsushi , Nagayama Itsuo , Hoshi Takahiro , Morita Shinichi , Yagi Kazuyoshi , Hatakeyama Shigeaki , Hayatsu Masafumi , Hasegawa Noboru , Terai Shuji 
Published: January 2019

Abstract
To distinguish and characterize nonalcoholic steatohepatitis (NASH) candidates from among medical checkup visitor diagnosed with nonalcoholic fatty liver diseases (mcNAFLDs).
A cut-off value has not been established to differentiate NASH at the earliest stage in NAFLD.
Shear wave speed (SWS) was measured in the livers of 480 mcNAFLDs. NASH candidates were screened out by adopting a statistically defined cut-off value of SWS and were characterized in terms of food preference.
SWS ranged between 1.11 and 2.18 m/s and fit a Gaussian distribution (r2 = 0.98) with an average and SD of 1.324 and 0.0847 m/s, respectively, in 320/160 males/females 64.4 (interquartile range 57.3–69.4) years old. The average plus SD (1.41 m/s) screened out 82 (17.1%) NASH candidates, who were significantly older (66.8 vs. 64.1 years old, P = 0.001) and had higher fibrosis 4 index values (1.58 vs. 1.33, P < 0.0001) than the remaining mcNAFLDs. The number of patients with a BMI greater than 25 kg/m2 was 118 (29.6%) mcNAFLDs and 34 (41.5%) NASH candidates, with a significantly higher frequency in NASH candidates (P = 0.05). Obese patients preferentially ate fatty acids in general, while NASH candidates preferred to consume several long-chain unsaturated fatty acids irrespective of their BMI.
These results suggest that NASH candidates who have a longer disease duration and pathological progression can be distinguished from mcNAFLDs by a statistically defined cut-off value of SWS. The defined value indicates that there are different food habitats associated with obesity and NAFLD progression.
Subjective rating scale for discourse: Evidence from the efficacy of subjective rating scale in amnestic mild cognitive impairments
Authors: Kim JungWan , Shim Jihye , Yoon Ji Hye 
Published: January 2019

Abstract
In clinical settings, the language ability of patients with neurologic communication disorders have been measured by quantitative parameters such as the total number of words in dialogue and picture description tasks. However, this quantitative analysis requires a long period of time in order to analyze the quantitative parameters, and results can differ according to discourse tasks. The purposes of this study are to explore whether SR-D may predict the quantitative measures of discourse tasks. Forty patients with amnestic MCI and 40 normal elderly participated in the study. We gathered responses to 10 items regarding SR-D and analyzed the quantitative measures of narrative discourse through 3 discourse tasks (i.e, picture description, dialogue, procedural discourse). We found significant differences in MLTW, CIU, and SR-D scores between the 2 groups. In particular, 4 items were significantly correlated with the performance of MLTW and CIU. Sensitivity and specificity of these 4 items were 100% and 75%, respectively. In terms of economic opportunity costs, objective measures cannot be evaluated to be practical, since it is used in research rather than clinical diagnosis in general. Therefore, evaluation of discourse using a few items proven in its sensitivity and specificity could allow a wide use of such measure in not only research but also in clinical diagnosis. These findings suggest that subjective measures of narrative discourse may be valid with objective language tests to predict individual discourse performance.
Resolution of left ventricular thrombus by edoxaban after failed treatment with warfarin overdose
Authors: Kao Pei-Heng , Chou Ping-Yin , Hsu Po-Chao , Huang Tien-Chi 
Published: January 2019

Abstract

Rationale:
Although novel oral-anticoagulants are widely used in patients with atrial fibrillation (AF) for stroke prevention, there was only limited evidence for their use in left ventricular (LV) thrombus.

Patient concerns:
A 41-year-old man who presented with acute onset of right-hand clumsiness and aphasia even under high international normalized ratio (INR: 7.64) from warfarin use. He was previously treated with warfarin for the LV thrombus and non-valvular AF. Brain magnetic resonance imaging (MRI) showed multiple acute infarction in the cortex of the bilateral frontal lobes, left parietal lobe, and bilateral central semiovale, which highly suggested embolic stroke.

Diagnosis:
The repeated transthoracic echocardiogram still revealed LV thrombus (1.27 × 0.90 cm), which failed to respond to warfarin therapy.

Interventions:
Due to acute infarctions occurred under supratherapeutic range of INR, we switched warfarin to edoxaban (dose: 60 mg/day) after INR decreased to less than 2.

Outcomes:
The thrombus disappeared after receiving edoxaban for 23 days, and no more recurrent stroke was noted for more than 6 months.

Lessons:
This is the first case demonstrates that while facing ineffective treatment of warfarin for LV thrombus, edoxaban could be safely and effectively used under this situation.