bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety of Shujinjianyao pill in clinical real world
Authors: Cui Xin , Liang Long , Wang Lianxin , Wang Zhifei , Li Yuanyuan , Gao Yang , Zhang Cheng , Sun Menghua , Wang Shiheng , Liu Jiani , Zhang Yue , wang Zhibo , Wei Xu , Xie Yanming 
Published: August 2019

Abstract

Background:
Low back pain is a common health problem worldwide, which also is a leading cause of long-term disability and has an important effect on the global economy and society. Usually, conservative therapies are used to treat low back pain. As a kind of Chinese patent medicine, Shujinjianyao pill (SJJYP) has a great curative effect on low back pain. However, its safety has not been studied yet. Therefore, we carried out this clinical trial to observe the safety of SJJYP in the real world.

Methods:
First, participants need to meet the medication standards according to inclusion and exclusion criteria. Then, participants are conducted safety examination before taking SJJYP. After qualified screening, participants can be enrolled into the group. Second, all enrolled participants will receive SJJJYP for a period of 4 weeks. During the observation period, participants need to return to the hospital for a subsequent visit after 2 weeks of medication, and come to the hospital for safety check after 4 weeks of medication. Third, telephone follow-up is used to investigate any participants’ physical discomfort after 6 to 8 weeks (2–4 weeks after medication withdrawal). After all these steps are completed, clinical observation is finished. If any adverse events occur during this process, we will record them in time. When serious adverse events occur, we will use nested case–control study to explore the causes and mechanisms.

Discussion:
This study will obtain the safety results of SJJYP in clinical real world, which will offer a scientific basis for clinicians in the treatment of low back pain, and also provide a methodological basis for the safety study of other medicines.

Trial registration:
ClinicalTrial.gov registration number is NCT03598153. This study was approved by the ethics committee of Wangjing hospital, China Academy of Chinese Medical Sciences (WJEC-KT-2018-012-P002).
Efficacy of flap repair for anal fistula: study protocol for a systematic review of randomized controlled trial
Authors: Zhang Hao , Xu Tao , Zhang Xiao-dong 
Published: August 2019

Abstract

Background:
Clinical trials have reported that flap repair (FR) can treat anal fistula (AF) effectively. However, no study systematically investigated its efficacy and safety for patients with AF. This study will systematically assess its efficacy and safety of AF.

Methods:
We will retrieve MEDLINE, EMBASE, Cochrane Library, Elsevier, Springer, Web of Science, Scopus, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, and Wanfang Data from their inceptions to May 1, 2019 without any language limitations. The primary outcome is fistula cure rate. The secondary outcomes consist of fistula recurrence rate, fecal continence, quality of life, and complications. RevMan 5.3 software will be used for methodological quality assessment, data synthesis, subgroup analysis and sensitivity analysis.

Results:
The results of this study will summarize a high-quality synthesis of current evidence for the treatment of FR for patients with AF.

Conclusion:
The findings of this proposed study will provide evidence for judging whether FR is an effective and safety intervention for AF or not.
PROSPERO registration number: PROSPERO CRD42019135507.
Artificial neural networks-based classification of emotions using wristband heart rate monitor data
Authors: Chen Yi-Chun , Hsiao Chun-Chieh , Zheng Wen-Dian , Lee Ren-Guey , Lin Robert 
Published: August 2019

Abstract
Heart rate variability (HRV) is an objective measure of emotional regulation. This study aimed to estimate the accuracy with which an artificial neural network (ANN) algorithm could classify emotions using HRV data that were obtained using wristband heart rate monitors.
Four emotions were evoked during gameplay: pleasure, happiness, fear, and anger. Seven normalized HRV features (i.e., 3 time-domain features, 3 frequency-domain features, and heart rate), which yielded 29,727 segments during gameplay, were collected and analyzed first by statistics and then classified by the trained ANN model.
General linear model adjusted for individual differences in HRV showed that all HRV features significantly differed across emotions, despite disparities in their magnitudes and associations. When compared to neutral status (i.e., no emotion evoked), the mean of R-R interval was significantly higher for pleasure and fear but lower for happiness and anger. In addition, pleasure evidenced the HRV features that suggested a superior parasympathetic to sympathetic activation. Happiness was associated with a prominent sympathetic activation. These statistical findings suggest that HRV features significantly differ across emotions evoked by gameplay. When further utilizing ANN-based emotion classification, the accuracy rates for prediction were above 75.0% across the 4 emotions with accuracy rates for classification of paired emotions ranging from 82.0% to 93.4%.
For classifying emotion in an individual person, the trained ANN model utilizing HRV features yielded a high accuracy rate in our study. ANN is a time-efficient and accurate means to classify emotions using HRV data obtained from wristband heart rate monitors. Thus, this integrated platform can help monitor and quantify human emotions and physiological biometrics.
Intrahepatic arterial localizer guided transjugular intrahepatic portosystemic shunt placement
Authors: Haochen Wang , Yinghua Zou , Jian Wang 
Published: August 2019

Abstract
Transjugular intra-hepatic portosystemic shunts (TIPS) had been considered a standard procedure in patients suffering from portal hypertension. The most challenging step in TIPS placement is blind puncture of the portal vein. We had established a localization method by introducing an Intra-Hepatic Arterial based puncture directing Localizer (IHAL) with the assistance of the enhanced computed tomography (CT) reconstruction. This study aimed to evaluate the feasibility, efficacy, and technical success of this method.
From June 2018 to August 2018, 10 consecutive patients suffering from refractory ascites or esophageal gastric bleeding by liver cirrhosis were included in this retrospective study to evaluate feasibility, efficacy, and technical success of enhanced CT assisted IHAL-guided puncture of the portal vein. As a control, 10 patients receiving TIPS placement before Jun 2018 with cone beam CT (CBCT)-guided puncture were included to compare the reduction of portal-systemic pressure gradient (PSPG), portal entry time (PET), the number of puncture, dose area product (DAP) and contrast medium consumption.
Technical success was 100% in the study group (IHAL-guided group) and in 90.0% of the control group (CBCT-guided group). Appropriate IHAL point could be achieved in all patients under the enhanced CT reconstruction assistance. The median number of punctures and DAP in IHAL group were significantly less than those in CBCT group. The reduction of PSPG, PET, and contrast medium consumption in IHAL group showed no significant differences than those in CBCT group.
Enhanced CT reconstruction assisted IHAL-guided portal vein puncture is technically feasible and a reliable tool for TIPS placement resulting in a significant reduction of the number of punctures and DAP.
Successful blind lung isolation with the use of a novel double-lumen endobronchial tube in a patient undergoing lung transplantation with massive pulmonary secretion
Authors: Seo Yijun , Kim Namo , Paik Hyo Chae , Park Dahee , Oh Young Jun 
Published: August 2019

Abstract

Rationale:
Precise lung isolation technique with visual confirmation is essential for thoracic surgeries to create a safe and clear surgical field. However, in certain situations, such as when patients have massive pulmonary secretion or when the fiberoptic bronchoscopy (FOB) is not applicable, lung isolation has been performed blindly.

Patient concern:
A 52-year-old woman, whose airway was unable to visualize with FOB due to massive pulmonary secretion, was presented for bilateral sequential lung transplantation. Extracorporeal membranous oxygenation, tracheostomy, and mechanical ventilation were applied to the patient for 39 days preoperatively as a bridge for lung transplantation.

Diagnosis:
Patient was diagnosed with an idiopathic pulmonary fibrosis and obesity.

Intervention:
Initially, height-based blind positioning with a conventional double-lumen endobronchial tube (DLT) failed to ventilate the patient properly, and the confirmation of DLT positioning with FOB was impossible due to massive pulmonary secretion. Therefore, a novel DLT (ANKOR DLT) that has one more cuff, located at a point between the distal opening of the tracheal lumen and the starting point of bronchial cuff, than conventional DLT was used for the lung isolation in the patient.

Outcomes:
After the completion of lung graft, FOB finding showed that the ANKOR DLT was optimally positioned at the tracheobronchial tree of the patient, and its depth was 2.5 cm shallower than that of the conventional tube.

Lessons:
ANKOR DLT would be a feasible choice to achieve successful blind lung isolation when the use of FOB is impossible to achieve the optimal lung isolation.
Acupuncture treatment for optic atrophy
Authors: Zhou Ping-ping , Sun Peng , Liu Hong-wei , Meng Yan 
Published: August 2019

Abstract

Background:
Optic atrophy (OPA) is a very tricky disorder. Presently, no effective management is available for this condition. Previous studies have reported that acupuncture may be effective for the treatment of OPA. However, its effectiveness is still inconclusive. Thus, this study will aim to assess the effectiveness and safety of acupuncture for OPA.

Methods:
A comprehensive literature search for relevant studies will be performed from the databases of PUMBED, EMBASE, CINAHI, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Cochrane Library, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, and other literature sources from inception up to the present. No language limitations will be applied to all literature searches. We will consider all randomized controlled trials (RCTs) and case-controlled trials (CCTs) for assessing the effectiveness and safety of acupuncture for OPA. The primary outcomes include the rates of vision improvement and visual field improvement. The secondary outcomes consist of the increased visual field average sensitivity, pattern visual evoked potential (PVEP) amplitude, and shortened PVEP latency, as well as any expected and unexpected adverse reactions. Risk of bias assessment will be performed by Cochrane risk of bias for RCTs and Newcastle-Ottawa Scale for CCTs.

Results:
In this study, we will outline details of the aims and methods on the effectiveness and safety of acupuncture for the treatment of OPA.

Conclusion:
The results of this study will summarize the most current evidence of acupuncture for the treatment of patients with OPA.

Dissemination and ethics:
The results of this study are expected to be published on peer-reviewed journals. This is a literature-based study; therefore, no ethical approval is necessary.

Systematic review registration:
PROSPERO CRD42019135785
A novel mutation causes Hermansky-Pudlak syndrome type 4 with pulmonary fibrosis in 2 siblings from China
Authors: Wu Wenjuan , Lin Keqin , Yang Yanni , Dong ZhaoXing , Zhang Tao , Lei Wen , Yang Weimin , Yang Zhaoqing 
Published: August 2019

Abstract
Hermansky-Pudlak syndrome (HPS) is a rare autosomal recessive multisystem disorder characterized by oculocutaneous albinism (OCA) and bleeding diathesis, although it displays both genetic and phenotypic heterogeneity. Several genetic subtypes of HPS have been identified in human; however, the characterizations of HPS type 4 (HPS-4) genotype and phenotype remain unclear. This study was aimed to identify gene mutation responsible for HPS-4 with pulmonary fibrosis (PF).
Two Chinese siblings in their 50 s afflicted with OCA and progressive dyspnea were recruited and underwent clinical and genetic examinations. In both patients, chest high-resolution computerized tomography showed severe interstitial PF in bilateral lung fields, and the pulmonary function test indicated restrictive lung disease. A novel homozygous frameshift mutation (NM_022081: c.630dupC; p.A211fs) in the HPS4 gene was identified by whole-exome sequencing analysis followed by Sanger DNA sequencing, and it segregated with the phenotypes. The c.630dupC mutation was not found in unaffected healthy controls. The patients were considered as HPS-4 with interstitial PF and eventually died of respiratory failure.
This is the first report on the genotype and clinical phenotype of HPS-4 in China. Our results demonstrate the association between a novel frameshift mutation in HPS4 and severe PF with poor prognosis in HPS is presented.
Closed rupture of extensor tendon resulting from untreated Kienböck disease
Authors: Tomori Yuji , Nanno Mitsuhiko , Takai Shinro 
Published: August 2019

Abstract

Rationale:
Spontaneous closed extensor tendon rupture is a rare complication of Kienböck disease with only 23 cases reported in the English literature.

Patient concerns:
We present a case of painless attritional rupture of the extensor tendons of the right fourth finger in a 69-year-old woman with Kienböck disease and review reported cases of Kienböck disease with subcutaneous closed tendon rupture.

Diagnoses:
Physical examination had shown mild painless swelling of the dorsum of the right hand. Plain radiographs showed a dorsally displaced fragment of collapsed lunate bone fracture (Lichtman grade IIIb). Although surgery was recommended, the patient did not desire surgery because she had no pain and no interference with the activities of daily living. Six months later, however, the patient returned to our hospital with complaints of loss of spontaneous extension of the fourth finger. CT and MRI showed aseptic necrosis and large dorsally displaced fragments of the lunate under the extensor tendons of the fingers, suggesting a subcutaneous fourth extensor tendon rupture.

Interventions:
Surgery was performed to achieve functional recovery of the ring extensor and to prevent further subcutaneous tendon rupture. The extensor digitorum communis (EDC) of the ring finger was found to be ruptured and the EDCs to the third and fifth fingers were frayed due to attrition from the protrusion of the dorsal fragmented lunate bone. Inspection of the floor of the compartment revealed that the dorsally displaced fragment of the lunate bone had perforated the wrist capsule and protruded into the fourth compartment. The dorsal and volar fragments of the lunate bone were excised completely and scaphocapitate arthrodesis followed by the reconstruction of the fourth extensor tendon was performed.

Outcomes:
A year after the surgery, radiography showed complete union of the scaphocapitate arthrodesis. The joint motion reached 45% of normal without any pain and there was full active extension of the fourth finger.

Lessons:
Because dorsally displacement of collapsed lunate bone fragments is a risk factor for attritional closed rupture of tendons, radiography, and MRI are essential to diagnose and to treat any closed tendon rupture.
Post percutaneous coronary interventional outcomes on proximal vs non-proximal lesions of the left and right coronary arteries
Authors: Tang Bing , Yang Hua 
Published: August 2019

Abstract

Background:
The prognosis of patients with coronary artery disease is mainly related to the extent of myocardium at risk. Proximal coronary arteries, especially the proximal left anterior descending coronary artery (LAD), supply a large part of the myocardium. In this analysis, we aimed to systematically compare the post percutaneous coronary interventional (PCI) outcomes observed with proximal vs non-proximal lesions of the left and right coronary arteries.

Methods:
MEDLARS Online, Excerpta Medica database, www.ClinicalTrials.gov, and the Cochrane databases were searched for relevant studies comparing the post PCI outcomes reported on proximal vs non-proximal lesions of the coronary arteries. RevMan software version 5.3 was used to analyze the data to generate respective results. Odds ratios (OR) and 95% confidence intervals (CI) were derived to represent the results appropriately.

Results:
Six studies with a total number of 11,109 participants who were enrolled between 1990 and 2015 were included in this analysis. The current results showed major adverse cardiac events (MACEs) (OR: 1.28, 95% CI: 1.14–1.45; P = .0001) and mortality (OR: 1.70, 95% CI: 1.43–2.03; P = .00001) to be significantly higher with proximal compared to non-proximal coronary lesions irrespective of the follow-up time periods. However, re-infarction (OR: 1.05, 95% CI: 0.80–1.38; P = .71), repeated revascularization (OR: 1.08, 95% CI: 0.92–1.27; P = .35) and stent thrombosis (OR: 0.59, 95% CI: 0.27–1.31; P = .20) were not significantly different.
When patients specifically with LAD lesions were compared with associated non-proximal lesions, mortality was still significantly higher with proximal lesions (OR: 2.26, 95% CI: 1.52–3.36; P = .0001). However, when patients with right proximal coronary artery lesions were compared with the corresponding non-proximal lesions, no significant difference was observed in mortality.

Conclusion:
In-hospital and long-term MACEs and mortality were significantly higher in patients with proximal compared to non-proximal coronary lesions following PCI. In addition, mortality was significantly higher in patients with proximal LAD lesions whereas no significant difference was observed in patients with right proximal coronary artery lesions. Larger trials should further confirm these hypotheses.
Adverse drug events associated with ibrutinib for the treatment of elderly patients with chronic lymphocytic leukemia
Authors: Zhou Yanhua , Lu Hongtao , Yang Meifeng , Xu Chenhong 
Published: August 2019

Abstract

Background:
Chronic lymphocytic leukemia (CLL) is a rare hematological malignancy classified in the non-Hodgkin's lymphoma category. Ibrutinib, a first-in-class Bruton tyrosine kinase inhibitor has been approved for use in the treatment of CLL. This drug has shown beneficial effects including a higher overall response rate, sustained remissions, and a tolerable toxicity level. In this meta-analysis, we aimed to compare the adverse drug events which were associated with the use of ibrutinib for the treatment of patients with CLL.

Methods:
A careful search was carried out through the Cochrane Central, EMBASE, MEDLINE (PubMed), and through www.ClinicalTrials.com. The following criteria for inclusion were considered: Both randomized trials and observational cohorts; Studies comparing the adverse drug events observed with the use of ibrutinib versus a control group for the treatment of CLL. The RevMan software (version 5.3) was used to carry out this analysis and the analyzed data were represented by risk ratios (RR) and 95% confidence intervals (CI).

Results:
A total number of 2456 participants with CLL were included in this analysis. One thousand one hundred thirteen participants were treated with ibrutinib whereas the remaining 1343 participants were assigned to the control (non-ibrutinib) group. Results of this current analysis showed Ibrutinib not to be associated with significantly higher risk of anemia (RR: 0.90, 95% CI: 0.67–1.21; P = .49), thrombocytopenia (RR: 0.61, 95% CI: 0.32–1.14; P = .12), neutropenia (RR: 0.50, 95% CI: 0.25–1.00; P = .05), and febrile neutropenia (RR: 0.89, 95% CI: 0.32–2.49; P = .83) in these patients with CLL. The risk for respiratory tract infection was also similarly manifested (RR: 1.01, 95% CI: 0.78–1.30; P = .96). However, ibrutinib was associated with a high risk of abdominal manifestations in comparison to the control group (RR: 1.62, 95% CI: 1.32–2.00; P = .00001). The risk for diarrhea was also significantly higher in the Ibrutinib group (RR: 2.14, 95% CI: 1.44–3.17; P = .0002).

Conclusions:
During the treatment of CLL, ibrutinib was not associated with significantly higher risks of anemia, thrombocytopenia, or neutropenia compared to the control group. However, abdominal manifestations were significantly higher with ibrutinib. Advanced phase trials should further confirm this hypothesis.
Concentration of Physician Services Across Insurers and Effects on Quality
Authors: Welch W. Pete , Sen Aditi P. , Bindman Andrew B. 
Published: August 2019

Background:
A growing proportion of Medicare beneficiaries is covered by private insurers through Medicare Advantage, yet little is known about how these plans are structured in terms of relationships with physicians and implications for quality of care.

Objective:
The objective of this study was to assess whether greater physician concentration of services across insurers was associated with higher quality in Medicare Advantage (MA), overall and particularly among MA insurers serving a high proportion of vulnerable enrollees.

Research Design:
A retrospective cohort design with regression analysis.

Data Sources:
The primary dataset was 2014 MA encounter records submitted by insurers to the Centers for Medicare and Medicaid Services, covering 600,329 physicians across 119 insurers. These data were merged with Centers for Medicare and Medicaid Services data on MA contract quality rating as well as physician characteristics in the Medicare Data on Provider Practice and Specialty file.

Measures:
Two measures were generated to capture the concentration of physician services across insurers: the percentage of a physician’s Medicare services which was through MA (MA penetration); and the percentage of a physician’s MA services with a specific insurer (insurer share of MA services).

Results:
Greater MA penetration and insurer share of MA services were each associated with higher MA plan quality. The relationship between insurer share and quality was stronger in contracts with a relatively high percentage of disabled enrollees.

Conclusion:
Greater physician concentration of services across MA insurers was associated with a higher quality of care overall and especially among vulnerable enrollees.
Optimizing value in head and neck cancer free flap surgery
Authors: Cash Harrison , Abouyared Marianne , Houlton Jeffrey J. 
Published: August 2019

Purpose of review
Value has become an increasingly important topic in healthcare delivery as our systems attempt to deliver increased value to patients at lower costs. This review highlights research performed regarding value for head and neck cancer reconstruction in three evolving areas: care pathway development, virtual surgical planning (VSP), and free flap versus locoregional flap reconstruction.

Recent findings
Improvements in quality-driven patient care in head and neck free tissue transfer are possible in a number of areas. Care pathways and appropriate management of patients prone to comorbidities decrease hospital length of stay and readmission rates. Further, high-cost hospital stays partially driven by ICU admissions may be reduced by step-down units. Intraoperatively, VSP may reduce operative time in difficult cases and careful selection of free versus locoregional flap reconstruction may decrease cost, operative time, and complications after surgery.

Summary
Head and neck reconstruction is a costly endeavor both for the patient and the healthcare system. Careful consideration of practices which may improve outcomes for patients while maximizing efficiency is necessary in our changing healthcare landscape, and providers should identify areas for improvement in their own practices. Further study within the field of head and neck oncology that are specific and data-driven are necessary.