bluuebunny/crossref_metadata_2025 huggingface dataset:
Randomized Controlled Study to Compare Uncovered Stent Versus Covered Stent as Percutaneous Endoprosthesis for Malignant Biliary Obstruction (JIVROSG-0207)
Authors: Onishi Yasuyuki , Yoshioka Tetsuya , Arai Yasuaki , Inaba Yoshitaka , Saito Hiroya , Aramaki Takeshi , Anai Hiroshi , Sone Miyuki
Published: August 2020

Objectives:

The objective of this study was to compare the clinical effectiveness of uncovered stent and covered stent as percutaneous endoprosthesis for malignant biliary obstruction of the extrahepatic bile duct.

Materials and Methods:

After completion of percutaneous internal and external tube placement for unresectable malignant biliary obstruction, 60 patients were registered and randomly assigned in a 1:1 ratio to an uncovered or covered stent group. Metallic stent placement was performed within 1 week after registration, and an external biliary drainage tube was removed >3 days after stent placement. The primary endpoint was the obstructive jaundice-free survival rate at 24 weeks after registration, and the secondary endpoints were the success rate of percutaneous tube removal and adverse events.

Results:

The obstructive jaundice-free survival rate at 24 weeks after registration was 13/29 (44.8%, 95% confidence interval [CI]: 28.4%-62.5%) and 15/30 (50.0%, 95% CI: 33.2%-66.8%) in the uncovered and covered stent groups, respectively. The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively. There were no procedure-related deaths. Twenty-eight adverse events were observed in 21 patients (7 in the uncovered stent group and 14 in the covered stent group).

Conclusions:

There was no significant difference in the obstructive jaundice-free survival rate at 24 weeks between the 2 groups. Considering the technical difficulty and invasiveness of covered stent placement, the placement of covered stents may not be needed in patients with a short prognosis of <24 weeks.
The use and reporting of neonatal pain scales: a systematic review of randomized trials
Authors: Olsson Emma , Ahl Hanna , Bengtsson Kevin , Vejayaram Dhashini N. , Norman Elisabeth , Bruschettini Matteo , Eriksson Mats
Published: August 2020

The burden of pain in newborn infants has been investigated in numerous studies, but little is known about the appropriateness of the use of pain scales according to the specific type of pain or infant condition. This systematic review aimed to evaluate the reporting of neonatal pain scales in randomized trials. A systematic search up to March 2019 was performed in Embase, PubMed, PsycINFO, CINAHL, Cochrane Library, Scopus, and Luxid. Randomized and quasirandomized trials reporting neonatal pain scales were included. Screening of the studies for inclusion, data extraction, and quality assessment was performed independently by 2 researchers. Of 3718 trials found, 352 with 29,137 infants and 22 published pain scales were included. Most studies (92%) concerned procedural pain, where the most frequently used pain scales were the Premature Infant Pain Profile or Premature Infant Pain Profile—Revised (48%), followed by the Neonatal Infant Pain Scale (23%). Although the Neonatal Infant Pain Scale is validated only for acute pain, it was also the second most used scale for ongoing and postoperative pain (21%). Only in a third of the trials, blinding for those performing the pain assessment was described. In 55 studies (16%), pain scales that were used lacked validation for the specific neonatal population or type of pain. Six validated pain scales were used in 90% of all trials, although not always in the correct population or type of pain. Depending on the type of pain and population of infants included in a study, appropriate scales should be selected. The inappropriate use raises serious concerns about research ethics and use of resources.
Effects of dapagliflozin on blood pressure variability in patients with prediabetes and prehypertension without pharmacological treatment: a randomized trial
Authors: Díaz-Cruz Cristal , González-Ortiz Manuel , Rosales-Rivera Lizet Y. , Patiño-Laguna Anayeli de J. , Ramírez-Rodríguez Zaire G. , Díaz-Cruz Karina , Martínez-Abundis Esperanza
Published: August 2020

Aim

The aim of the study was to evaluate the effect of dapagliflozin on blood pressure variability (BPV) in patients with prediabetes and prehypertension without pharmacological treatment.

Methods

A double-blind, randomized, placebo-controlled clinical study was performed in 30 patients (30–60 years) diagnosed with prediabetes and prehypertension. Study subjects were divided into two groups: a 10-mg dose of dapagliflozin was administered daily before breakfast for 12 weeks in 15 patients or placebo in the remaining 15 patients. At the beginning and end of the study, clinical and metabolic evaluations were performed, and the 24-h BPV was calculated.

Results

Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and it significantly increased the percentage of the dipper circadian BP pattern (16.7 vs. 30.8%, P = 0.047). After the administration of dapagliflozin, some of the patients did not meet the diagnostic criteria for prediabetes (26.9%) or prehypertension (26.9%).

Conclusions

The administration of 10 mg dapagliflozin once daily for 90 days in patients with prediabetes and prehypertension decreased BPV by reducing 24-h and nighttime SBP, and increasing the dipper circadian BP pattern.
Comparison of plaque distribution and wire-free functional assessment in patients with stable angina and non-ST elevation myocardial infarction: an optical coherence tomography and quantitative flow ratio study
Authors: Dan Kazuhiro , Garcia-Garcia Hector M. , Yacob Omar , Kuku Kayode O. , Kolm Paul , Shah Nikunj , Bennett Martin R. , Curzen Nick , Waksman Ron , Mahmoudi Michael
Published: August 2020

Background

Data comparing plaque characteristics and wire-free physiological assessment in the target vessel in patients with stable angina versus acute coronary syndrome are sparse. Therefore, we investigated the difference in plaque distribution between stable angina and non-ST-elevation myocardial infarction (NSTEMI) and explored the relationship between target vessel vulnerability by optical coherence tomography (OCT) and wire-free functional assessment with quantitative flow ratio (QFR).

Methods

Patients with stable angina (n = 25) and NSTEMI (n = 24) were in the final prospective study cohort from the DECODE study (ClinicalTrials.gov, NCT02335086). All 5480 OCT frames in the region of interest were analyzed to study plaque morphology in the target vessel. QFR was analyzed from baseline coronary angiography before percutaneous coronary intervention. Vulnerable vessel score (VVS) was calculated from each plaque, and vessel QFR was then compared.

Results

Out of all frames, thin-cap fibroatheroma was common with NSTEMI compared to stable angina (10.9 versus 6.3%, P < 0.01), while fibrous plaque was more commonly seen with stable angina compared to NSTEMI (19.7 versus 14.4%, P < 0.01). Calcified plaque was similar in both clinical settings (approximately 6%). Regression analysis showed that segments with normal vessel walls were located significantly farther from the other plaque types. Longitudinal distances for plaque-type in NSTEMI were numerically greater than those for stable angina; however, the mean difference was less than 10 mm. The VVS had a significant inverse linear correlation with QFR (r = −0.34, P = 0.009).

Conclusions

The plaque distribution by OCT between stable angina and NSTEMI was similar. Target vessel vulnerability was greater in patients with lower QFR value.
Development and evaluation of a computerized clinical outcome assessment tool for head and neck cancer patients
Authors: Lin Ching-Rong , Fan Kang-Hsing , Lin Chien-Yu , Hung Tsung-Min , Huang Bing-Shen , Chen Eric Yen-Chao , Kang Chung-Jan , Huang Shiang-Fu , Chang Joseph Tung-Chieh , Chang Chih-Hung
Published: August 2020

Paper-based clinical outcome data collection methods have practical limitations when used in clinical settings, as the data are often not summarized in time to facilitate patient–physician communications and therefore cannot be used in clinical decision making. This study aimed to develop a computerized clinical outcome assessment tool (COAT) and evaluate its acceptability, feasibility, and potential clinical applications during clinical encounters for patients with head and neck cancer (HNC).

The traditional Chinese (TChi) character version of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) questionnaire was first transcribed and implemented into a touch-screen computerized administration and reporting system (COAT-HNC for short). Each HNC patient was invited to complete the COAT-HNC during their scheduled clinic visits as part of their clinical care. Upon completion, a structured summary report was generated, and subsequently used for treatment evaluation and planning.

A cohort of 385 HNC patients were enrolled. Each scale of the computerized TChi FACT-H&N questionnaire demonstrated acceptable internal consistency, with Cronbach coefficient alpha ranging from 0.74 to 0.90. The touch-screen-based and audio-capable COAT-HNC was reported to be easy to use. Patients and physicians were able to utilize the summary report during their clinical encounters to discuss treatment progress and to plan care.

It is practically feasible to design, develop, and implement the COAT-HNC system in routine HNC care. The COAT-HNC has the potential to become a valuable tool for data collection and management of clinical outcomes, and appears useful for HNC patients. However, larger studies to demonstrate its clinical usefulness are still needed.
Ultrasound diagnosis and clinicopathological traits of female genital system malignant lymphomas
Authors: He Min , Hu Sha , Luo Hong
Published: August 2020

This study investigated the clinicopathological traits and ultrasound features (including 2-dimensional and color Doppler ultrasound) of female genital system malignant lymphomas and explored the diagnostic performance of ultrasonography in this disease.

Cases of female pelvic lymphoma diagnosed and treated at our hospital between July 2009 and July 2019 were included in this study. Pathological data and ultrasonic manifestations were assessed retrospectively to summarize the clinical traits and ultrasonic features of female genital system lymphoma (FGSL). Based on the results, recommendations for ultrasonography-based diagnosis of this disease are proposed.

During the 10-year study period, 20 female patients were diagnosed with malignant lymphomas in the pelvic cavity based on postoperative pathology tests. The age of the patients ranged from 11 to 83 years, and no patients demonstrated specific clinical traits; however, examination of tumor biomarkers revealed that certain patients had elevated levels of CA125. Twenty-eight lesions were identified in the 20 patients, including 24 involving the reproductive system. The primary ultrasonic manifestations were hypoechoic or extremely hypoechoic solid lesions that were relatively large in size, had a relatively regular shape, and had clear boundaries. Certain patients had concurrent ascites, and although some lesions lacked blood supply, most lesions had medium to abundant blood flow, which was largely characterized by low resistance. Almost none of the lesions were definitively diagnosed preoperatively.

Diagnosing malignant lymphomas in the female genital tract remains a considerable clinical challenge. Although certain clinical traits and ultrasonic features are associated with this disease and color Doppler ultrasonography might provide vital information indicating the presence of lymphoma, the final diagnosis depends on the clinical and pathological test results of the patients.
Efficacy of music-based cognitive behavior therapy on the management of test-taking behavior of children in basic science using a randomized trial group: Implication for community development
Authors: Agboeze Matthias U. , Ugwuanyi Christian S. , Okeke Chinedu I.O. , Ugwu Gloria C. , Obikwelu Chizoba L. , Obiozor Elizabeth E. , Oyigbo Dorida N. , Mbam David
Published: August 2020

Background:

This study sought the efficacy of cognitive-behavioral therapy-based music group (CBT-Music) intervention program on primary school children's test-taking behavior in Southeast Nigeria.

Methods:

A pretest, posttest randomized controlled trial experimental design was adopted for the study using a sample of 53 primary three (3) children. A test-taking behavior questionnaire was used for data collection. The instrument was face validated by test development experts. Construct validation of the instrument was done by subjecting the instrument to factor analysis after trial testing. Data were analyzed using independent samples t-test and paired samples t-test.

Results:

The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children. Furthermore, the test-taking scores of children in the music-based CBT group were significantly lower than those in the control group at the follow-up measure. This implies that the test-taking behavior of the children can be better managed using the CBT-music intervention program to enable the children to grow better academically and contribute to the community they belong to.

Conclusion:

Music-based CBT demonstrated significant efficacy in the management of children's test-taking behavior. Thus, primary school teachers should be enlightened on how to make use of CBT-Music in the management of test-taking behavior among children.
Obstructive sleep apnea hypopnea syndrome
Authors: Wanyan Pingping , Wang Jianqin , Wang Wenge , Kong Yuke , Liang Yaojun , Liu Wei , Yu Qin
Published: August 2020

Background:

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outcomes sets (COSs) for OSAHS's clinical trials.

Methods:

The development of COSs of OSAHS will include 5 stages:

Results:

The results of our study will be published in a peer-reviewed journal.

Discussion:

The development of the COSs of OSAHS will improve the design and operation of OSAHS clinical trials to conform to international standards and ensure the credibility of the outcomes. In addition, this study will involve different stakeholder groups to help ensure that the developed COSs will be suitable and well accepted.

Trial registration number:

1544.
Gene polymorphisms (rs324957, rs324981) in NPSR1 are associated with increased risk of primary insomnia
Authors: Xie Yuping , Zhao Yuan , Zhou Liya , Zhao Lijun , Wang Jinfeng , Ma Wei , Su Xiaoyan , Hui Peilin , Guo Bin , Liu Yu , Fan Jie , Zhang Shangli , Yang Jun , Chen Wenjuan , Wang Jing
Published: August 2020

Neuropeptide S and neuropeptide S receptor (NPSR1) are associated with sleep regulation. Herein, the possible contribution of 6 polymorphisms in NPSR1 on the chromosome to primary insomnia (PI) and objective sleep phenotypes was investigated.

The study included 157 patients with PI and 133 age- and sex-matched controls. All subjects were investigated by polysomnography for 3 consecutive nights. The genotyping of 6 polymorphisms was carried out by polymerase chain reaction-restriction fragment length polymorphism method.

A significant difference was detected for rs324957 and rs324981 between PI and controls. The PI patients had a higher frequency of AA than controls in rs324957 (P = .02) and rs324981 (P = .04). However, for other single nucleotide polymorphisms (rs323922, rs324377, rs324396, and rs324987), no significant differences were observed between PI patients and controls. There were 2 different allelic combinations that were associated with PI susceptibility (CATGTC, GCCAAT) and its risk factor. A significant difference in sleep latency was observed among 3 genotype carriers of NPSR1 gene polymorphism rs324957 in PI group (P = .04), with carriers of the A/A genotype having the longest sleep latency (mean ± SD: 114.80 ± 58.27), followed by the A/G genotype (112.77 ± 46.54) and the G/G genotype (92.12 ± 42.72).

This study provided the evidence that the NPSR1 gene polymorphisms (rs324957, rs324981) might be susceptibility loci for PI. Further studies are needed to explore the role of NPSR1 gene polymorphisms in molecular mechanisms of PI in a larger sample size.
Full-term pregnancy in a rudimentary horn with a live fetus
Authors: Zhang Yu , Pang Yingxin , Zhang Xue , Zhao Zhe , Liu Peishu
Published: August 2020

Introduction:

Rudimentary horns and unicornuate uteri, 2 types of Mullerian duct abnormalities, often lack obvious symptoms. Ultrasonography (US) and magnetic resonance imaging (MRI) are alternative examinations but have low accuracy. Full-term rudimentary horn pregnancies are rather rare but life-threatening.

Patient concerns:

A 30-year-old Chinese woman complained of lower abdominal pain one year after a full-term unicornate uterus pregnancy and a rudimentary horn pregnancy successively.

Diagnosis:

Uterine dysplasia (right rudimentary uterine horn and left unicornate uterus), hematometra and right fallopian tube effusion were diagnosed.

Interventions:

We performed laparoscopic hysterectomy (rudimentary horn), right salpingectomy, pelvic adhesion release and hysteroscopy.

Outcomes:

The patient has not complained of specific discomfort during the one-year follow-up so far.

Conclusion:

The reported case was a rare full-term rudimentary horn pregnancy. The degree of development of the rudimentary horn, such as the endometrial function, muscle layer thickness, and uterine shape and size, is closely related to pregnancy outcome. The rudimentary horn with a functional endometrium must be disposed of once it is definitely diagnosed. Pregnancy in the rudimentary horn with a weak muscular layer should be treated as soon as possible. Detailed and scientific prenatal examination is important.
Kimura's disease and ankylosing spondylitis
Authors: Chen Anping , Cui Beibei , Li Yanhong , Zhang Qiuping , Yuan Mingqi , Liu Yi
Published: August 2020

Rationale:

Ankylosing spondylitis (AS) and Kimura's disease (KD) which is quite rare are both chronic inflammatory diseases. Recently we encountered a patient who suffered from KD and AS, and some of his family members also suffer from AS. We, therefore, investigated this unique case and conducted the family-based whole exome sequencing to explore the possible genetic alterations.

Patient concerns:

Here, we reported a case of a 44-year-old Chinese man with multiple painless masses all over his body and a back pain for 32 years. His uncle and sister were diagnosed with AS.

Diagnosis:

The diagnosis of KD was based on the patient's clinical features and the biopsy of the neck masses. The diagnosis of AS was based on the patient's clinical features, HLA-B27(+) and the radiologic changes of sacroiliac joints. The genetic test showed that ARPC1B gene which was associated with recurrent infections, auto-inflammatory changes and elevated IgE levels was mutated in this patient.

Interventions:

Neck masses were removed by surgery. Systemic glucocorticoid, nonsteroidal anti-inflammatory agents, combined with cyclosporine were orally administered, and Etanercept was injected subcutaneously.

Outcomes:

The masses disappeared rapidly after surgery combined with systemic glucocorticoid, but relapsed shortly after the therapy was discontinued. Low dose glucocorticoid, cyclosporine and Etanercept could keep both KD and AS remained long-term remission.

Lessons:

Our experience suggests that low dose glucocorticoid, cyclosporine and Etanercept could be beneficial for the patient with KD and AS. The mutation of ARPC1B gene in this case, which is associated with immunologic disturbance, may increase the susceptibility of KD.
Association of patterns of multimorbidity with length of stay
Authors: Aubert Carole E. , Schnipper Jeffrey L. , Fankhauser Niklaus , Marques-Vidal Pedro , Stirnemann Jérôme , Auerbach Andrew D. , Zimlichman Eyal , Kripalani Sunil , Vasilevskis Eduard E. , Robinson Edmondo , Metlay Joshua , Fletcher Grant S. , Limacher Andreas , Donzé Jacques
Published: August 2020

The aim of this study was to identify the combinations of chronic comorbidities associated with length of stay (LOS) among multimorbid medical inpatients.

Multinational retrospective cohort of 126,828 medical inpatients with multimorbidity, defined as ≥2 chronic diseases (data collection: 2010–2011). We categorized the chronic diseases into comorbidities using the Clinical Classification Software. We described the 20 combinations of comorbidities with the strongest association with prolonged LOS, defined as longer than or equal to country-specific LOS, and reported the difference in median LOS for those combinations. We also assessed the association between the number of diseases or body systems involved and prolonged LOS.

The strongest association with prolonged LOS (odds ratio [OR] 7.25, 95% confidence interval [CI] 6.64–7.91, P < 0.001) and the highest difference in median LOS (13 days, 95% CI 12.8–13.2, P < 0.001) were found for the combination of diseases of white blood cells and hematological malignancy. Other comorbidities found in the 20 top combinations had ORs between 2.37 and 3.65 (all with P < 0.001) and a difference in median LOS of 2 to 5 days (all with P < 0.001), and included mostly neurological disorders and chronic ulcer of skin. Prolonged LOS was associated with the number of chronic diseases and particularly with the number of body systems involved (≥7 body systems: OR 21.50, 95% CI 19.94–23.18, P < 0.001).

LOS was strongly associated with specific combinations of comorbidities and particularly with the number of body systems involved. Describing patterns of multimorbidity associated with LOS may help hospitals anticipate resource utilization and judiciously allocate services to shorten LOS.
The efficacy and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty
Authors: Gao Dehong , Liu Xin , Zhang Fan , Ding Mingyan
Published: August 2020

Background:

Concerns exist regarding the analgesia effect and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the dexamethasone administration, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the different dose of dexamethasone on postoperative pain and complications in patients undergoing unicompartmental knee arthroplasty.

Methods:

This randomized, prospective, controlled study was carried out between January 2018 and August 2019. It was approved by the institutional review board in our hospital (HBRM2020013). A total of 80 patients were randomly assigned to each group: the study group (n = 40) and the control group (n = 40). All surgical procedures were performed by a similar orthopedic surgeon. In the study group, patients received intravenously 20 mg dexamethasone (4 mL, Tianjin Kingyork group Co., Ltd., China) just after the anesthesia, and repeated at 24 hours after the surgery. Patients in the control group received intravenously 10 mg dexamethasone solution (2 mL) just after the anesthesia, and repeated at 24 hours after the surgery. CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.

Conclusion:

We hypothesized that patients receiving multiple doses of dexamethasone was associated with better outcomes compared with patients receiving single dose of dexamethasone.

Trial registration:

This study protocol was registered in Research Registry (researchregistry5770).
Clinical efficacy and safety of spironolactone in patients with resistant hypertension
Authors: Chen Cong , Zhu Xue-Ying , Li Dong , Lin Qian , Zhou Kun
Published: August 2020

Background:

We conducted a meta-analysis to summarize all available evidence from randomized controlled trial studies regarding the clinical efficacy and safety of spironolactone in patients with resistant hypertension (RH) and provided a quantitative assessment.

Methods:

A systematic search of PubMed, Web of Science, Cochrane Library, Embase, and China National Knowledge Infrastructure (CNKI) databases through December 8, 2019, was performed. Randomized controlled trials randomized controlled trials meeting inclusion criteria were included to assess the effect of the addition of spironolactone on office blood pressure (BP), 24-hour ambulatory BP or adverse events in RH patients.

Results:

Twelve trials, which enrolled a total of 1655 patients, were included in this meta-analysis. In comparison with placebo, spironolactone significantly reduced office BP (office SBP, weighted mean difference [WMD] = −20.14, 95% CI = −31.17 to −9.12, P < .001; office DBP WMD = −5.73, 95% CI = −8.13 to −3.33, P < .001) and 24-hour ambulatory BP (ASBP, WMD = −10.31, 95% CI = −12.86 to −7.76, P < .001; ADBP, WMD = −3.94, 95% CI = −5.50 to −2.37, P < .001). Compared with alternative drugs, spironolactone treatment in RH patients significantly decreased 24-hour ambulatory BP (ASBP, WMD = −6.98, 95% CI = −12.66 to −1.30, P < .05; ADBP, WMD = −3.03, 95% CI = −5.21 to −0.85, P < .001).

Conclusion:

This meta-analysis fully evaluated the antihypertensive effect of spironolactone compared with placebo, alternative drugs, renal nerve denervation and no treatment. Spironolactone can result in a substantial BP reduction in patients with RH at 3 months.
Yangxin Decoction combined acupuncture on blood lipid metabolism in Qi Deficiency and Blood Stasis type of Chest Bi-Syndrome
Authors: Yu Xiao-hong , Yu Xi-wen , Zhang Qi , Wang Yu-ping , Yu Guo-qiang
Published: August 2020

Background:

In recent years, clinical studies about Yangxin Decoction combined acupuncture (YXDA) for the treatment of Qi Deficiency and Blood Stasis type of Chest Bi-Syndrome (CBS-QDBS) has been increased, but the results are different. The aim of this study is to investigate the effect of YXDA on blood lipid metabolism (BLMB) in patients with CBS-QDBS.

Methods:

We will collect any randomized controlled trials that assess the effect of YXDA on BLMB in CBS-QDBS from PUBMED, EMBASE, Cochrane Library, PsycINFO, CINAHL, Allied and Complementary Medicine Database, and China National Knowledge Infrastructure. All of these databases will be searched from their initial time to the present. All language limitation will be imposed. Literature selection, information collection, and risk of bias assessment will be performed independently by two authors, respectively. All data analysis will be undertaken using RevMan 5.3 Software.

Results:

This study will summarize the systematic nature of the literature search and its methods for assessing study quality and analyzing all relevant outcome data. Considering the inconsistent results, this study will improve the existing evidence on the effect of YXDA on BLMB in CBS-QDBS.

Conclusion:

The findings of this study will present the latest evidence of YXDA on BLMB in patients with CBS-QDBS.

Study registration: INPLASY202070047.
The efficacy and safety of intravenous tranexamic acid in anterior cruciate ligament reconstruction
Authors: Xu Hongyao , Xia Pengcheng , Zou Xiangjie , Huang He
Published: August 2020

Background:

The safety and efficacy of intravenous tranexamic acid (TXA) in the anterior cruciate ligament (ACL) reconstruction remains controversial. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the TXA administration, and investigate its clinical applicability. The purpose of this work is to assess the safety and efficacy of the intravenous TXA in decreasing perioperative blood loss in the patients undergoing ACL reconstruction.

Methods:

This randomized, controlled, prospective research was carried out between January 2017 and January 2018. All the patients and their family members signed the informed consent forms, and this current work was authorized via the ethics committee of Nanjing first hospital (registration No.: NJU1003586). A total of 100 patients were divided randomly into 2 group: the control group (n = 50) and study group (n = 50). The study group receives intravenous TXA administration [1 g] before skin incision. The control group receives equivalent normal saline. Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded. The measures of secondary outcomes refer to the clinical data involving the range of motion and postoperative pain score. The pain score was quantified by utilizing the 10-cm scale of visual analog. The pain strength was in the range of 0–10, where 0 is totally no pain and 10 represents the most severe pain.

Results:

This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention.

Conclusion:

Our results can bring a new perspective on the use of TXA after arthroscopically assisted ACL surgery.

Trial registration:

This study protocol was registered in Research Registry (researchregistry5798).
Chryseobacterium arthrosphaerae ventriculitis
Authors: Im Jae Hyoung , Kim Donghwi , Kim Jin Ju , Kim Eun Young , Park Young Kyoung , Kwon Hea Yoon , Chung Moon-Hyun , Baek Ji Hyeon , Lee Jin-Soo
Published: August 2020

Introduction:

Chryseobacterium arthrosphaerae is a gram-negative bacteria, known for its intrinsic multidrug resistance, which can lead to treatment difficulties.

Patient concerns:

A 56-year-old male had an indwelling external ventricular drainage catheter for 6 months and had been frequently treated with antibiotics for nosocomial infections. He showed cerebrospinal fluid pleocytosis and an abrupt fever during hospitalization.

Diagnosis:

He was diagnosed as a ventriculitis caused by Chryseobacterium arthrosphaerae (C arthrosphaerae).

Intervention:

Initially, we used ciprofloxacin as the backbone in combination with minocycline (and rifampin). However, fever and pleocytosis persisted, and improvement was slow. We then switched the minocycline and rifampin regiment to trimethoprim/sulfamethoxazole. Following this switch of antibiotics, the patient's pleocytosis rapidly improved, allowing the replacement of his external ventricular drainage catheters. C arthrospharae was no longer growing in cerebrospinal fluid and he was recovered from ventriculitis.

Outcomes:

The patient remains alive without any incidence of C arthrosphaerae recurrence.

Conclusion:

We propose trimethoprim/sulfamethoxazole alone or in combination with ciprofloxacin to be good candidates for the treatment of ventriculitis by C arthrosphaerae.
Rapidly progressive cognitive impairment: an unusual presentation of cerebral venous thrombosis caused by JAK2 V617F-positive primary myelofibrosis
Authors: Jin Chongyao , Pu Jiali , Zhou Zhijian , Chen Xia , Wu Jimin , Zhang Baorong
Published: August 2020

Rationale:

Cerebral venous thrombosis (CVT) is a rare cerebrovascular condition, which mainly manifests as headaches, seizures, and focal neurological deficits. JAK2 mutation in myeloproliferative diseases increases the risk of CVT.

Patient concerns:

This 40-year-old woman suffered from rapidly progressive cognitive impairment and limb weakness. Her symptoms worsened while being treated with mannitol with the diagnose of cerebral hemorrhage.

Diagnosis:

The patient was diagnosed with CVT and multiple intracranial hemorrhage caused by JAK2 V617F mutation-positive primary myelofibrosis by neuroimage and whole-exome sequencing.

Intervention:

She received low-molecular-weight heparin sodium 3800 IU twice a day followed by oral anticoagulant therapy.

Outcomes:

The patient showed full recovery from limb weakness and in the follow-up period she noticed no change in her memory.

Lessons:

Clinicians should be aware of the possibility of the JAK2 V617F mutation in CVT patients without known causes or risk factors
Efficacy of nasal high flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in chronic obstructive pulmonary disease patients
Authors: Ayuse Terumi , Hisamatsu Noriko , Yamaguchi Taiki , Takahashi Yosuke , Tamada Yasushi , Kurata Shinji , Mishima Gaku , Pinkham Max , Tatkov Stanislav , Takahata Hideaki , Ayuse Takao
Published: August 2020

Background:

There are some clinical reports on dysphagia in patients with chronic obstructive pulmonary disease (COPD); however, its pathophysiology remains largely unknown.

Changes in respiratory function occur in patients with COPD causing a decrease in tidal volume and an increase in respiratory rate (tachypnea). In addition, it leads to lack of coordination between respiration and swallowing.

A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure. The NHF therapy involves inhalation of high flow of humidified air, which reduces respiratory effort in patients with COPD. Furthermore, NHF therapy facilitates swallowing of saliva even during respiratory management. A recent clinical study reported that high-flow nasal cannula oxygen therapy for 6 weeks improved the health-related quality of life and reduced hypercapnia in patients with stable COPD. Taken together, NHF therapy is gaining attention in the clinical management of patients with COPD.

Therefore, in this study, we aim to examine the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during daytime nap in patients with COPD.

Methods/Design:

This open-label, investigator-initiated, single center study will evaluate the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during the daytime nap in COPD patients with forced expiratory volume in 1 second (FEV1%) of <70% during treatment at the Nagasaki University Hospital Respiratory Rehabilitation Center. Evaluations will be performed during the 90 to 180 minute “daytime nap” in the measurement room of the hospital. The primary endpoint will be the rate of appearance of the expiratory phase after swallowing of saliva and the frequency of swallowing during the measurement period.

Discussion:

The purpose of this study is to obtain evidence regarding the utility of NHF as a potential therapeutic device for COPD patients to prevent aspiration of saliva during the sleep stage of daytime nap. The utility will be assessed by comparing the decrease in incidence rates of the expiratory phase after swallowing of saliva in the NHF device group and the control group, wherein this device was not used.
Manual therapy for idiopathic scoliosis
Authors: Huang Qian , Zhang Lei , Li Zhiwei , Kong Lingjun
Published: August 2020

Introduction:

More patients with idiopathic scoliosis (IS) preferred to choose manual therapy as a complementary conservative treatment, but the effects of manual therapy for IS remains controversial. The previous reviews could not draw reliable conclusion due to few eligible studies to perform a meta-analysis. In the last decade, however, several new studies were published that assessed the effects of manual therapy in the management of IS, especially in China. Therefore, the present systematic review and meta-analysis will be performed to examine whether manual therapy is effective for IS primarily in improving patient-centerd symptoms and secondarily in radiographic outcomes.

Methods and analysis:

A computerized literature search will be performed in the following electronic databases from their inceptions to June 2020 to identify randomized controlled trials of manual therapy in the management of IS: PubMed, EMBASE, MEDLINE, Cochrane Central Register of Controlled Clinical Trials, China Knowledge Resource Integrated Database, Wanfang Data Information, and Weipu Database for Chinese Technical Periodicals. The quality of included studies will be assessed independently by 2 reviewers using the Physiotherapy Evidence Database scale. The meta-analysis will be performed with the Review Manager Version 5.3 software to assess the effects on patient-centred outcomes and radiographic outcomes of manual therapy for IS. The heterogeneity will be assessed using I
2 statistic and Cochran Q statistic. The subgroup analysis will be conducted based on different control interventions and subpopulations. Quality of evidence will be assessed using the Grades of Recommendation, Assessment, Development and Evaluation.

Ethics and dissemination:

No ethical statement will be required for the performance of this review and meta-analysis. The results of this review will be published in an international peer-reviewed journal.

INPLASY registration number: INPLASY202070058
Efficacy and safety of scalp acupuncture in improving neurological dysfunction after ischemic stroke
Authors: Sun Lei , Fan Yihua , Fan Wei , Sun Jing , Ai Xia , Qiao Haifa
Published: August 2020

Background:

Scalp acupuncture is remarkable in improving neurological dysfunction of ischemic stroke patients. This study aims to systematically evaluate the efficacy and safety of scalp acupuncture in improving neurological dysfunction of ischemic stroke patients.

Methods:

Randomized controlled trials of scalp acupuncture against ischemic stroke patients will be searched in PubMed, Web of Science, Embase, Cochrane Library, the Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biological and Medical database, China National Knowledge Infrastructure, and Wanfang database from inception to July, 2020. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3.

Results:

This study will summarize the present evidence by exploring the efficacy and safety of scalp acupuncture in improving neurological dysfunction in ischemic stroke patients.

Conclusions:

The findings of the study will help to determine potential benefits of scalp acupuncture against ischemic stroke at different stage.

OSF Registration number:

DOI 10.17605/OSF.IO/T26P8.
Next-generation sequencing identifies a novel heterozygous I229T mutation on LMNA associated with familial cardiac conduction disease
Authors: Gao Yuan , Han Zhonglin , Wu Xiang , Lan Rongfang , Zhang Xinlin , Shen Wenzhi , Liu Yu , Liu Xuehua , Lan Xi , Xu Biao , Xu Wei
Published: August 2020

LMNA gene encodes Lamin A and C (Lamin A/C), which are intermediate filament protein implicating in DNA replication and transcription. Mutations in LMNA are validated to cause cardiac conduction disease (CCD) and cardiomyopathy.

In a Chinese family, we identified 5 members harboring the identical heterozygous LMNA (c.686T>C, I229T) disease-causing mutation, which was not found in the 535 healthy controls. In silico analysis, we revealed structural alteration in Lamin A/C I229T mutant. Furthermore, molecular docking identified human polycomb repressive complex 2 and Lamin A/C interact with higher affinity in the presence of I229T, thus may downregulate Nav1.5 channel expression.

Our findings expanded the spectrum of mutations associated with CCD and were valuable in the genetic diagnosis and clinical screening for CCD. Molecular docking analysis provided useful information of increased binding affinity between mutant Lamin A/C and polycomb repressive complex 2. However, the concrete mechanism of LMNA mutation (I229T) remains undetermined in our study, future genetics and molecular studies are still needed.
Comparison between atlas and convolutional neural network based automatic segmentation of multiple organs at risk in non-small cell lung cancer
Authors: Zhang Tao , Yang Yin , Wang Jingbo , Men Kuo , Wang Xin , Deng Lei , Bi Nan
Published: August 2020

Delineation of organs at risk (OARs) is important but time consuming for radiotherapy planning. Automatic segmentation of OARs based on convolutional neural network (CNN) has been established for lung cancer patients at our institution. The aim of this study is to compare automatic segmentation based on CNN (AS-CNN) with automatic segmentation based on atlas (AS-Atlas) in terms of the efficiency and accuracy of OARs contouring.

The OARs, including the lungs, esophagus, heart, liver, and spinal cord, of 19 non-small cell lung cancer patients were delineated using three methods: AS-CNN, AS-Atlas in the Pinnacle3-software, and manual delineation (MD) by a senior radiation oncologist. MD was used as the ground-truth reference, and the segmentation efficiency was evaluated by the time spent per patient. The accuracy was evaluated using the Mean surface distance (MSD) and Dice similarity coefficient (DSC). The paired t-test or Wilcoxon signed-rank test was used to compare these indexes between the 2 automatic segmentation models.

In the 19 testing cases, both AS-CNN and AS-Atlas saved substantial time compared with MD. AS-CNN was more efficient than AS-Atlas (1.6 min vs 2.4 min, P < .001). In terms of the accuracy, AS-CNN performed well in the esophagus, with a DSC of 73.2%. AS-CNN was better than AS-Atlas in segmenting the left lung (DSC: 94.8% vs 93.2%, P = .01; MSD: 1.10 cm vs 1.73 cm, P < .001) and heart (DSC: 89.3% vs 85.8%, P = .05; MSD: 1.65 cm vs 3.66 cm, P < .001). Furthermore, AS-CNN exhibited superior performance in segmenting the liver (DSC: 93.7% vs 93.6%, P = .81; MSD: 2.03 cm VS 2.11 cm, P = .66). The results obtained from AS-CNN and AS-Atlas were similar in segmenting the right lung. However, the performance of AS-CNN in the spinal cord was inferior to that of AS-Atlas (DSC: 82.1% vs 86.8%, P = .01; MSD: 0.87 cm vs 0.66 cm, P = .01).

Our study demonstrated that AS-CNN significantly reduced the contouring time and outperformed AS-Atlas in most cases. AS-CNN can potentially be used for OARs segmentation in patients with pathological N2 (pN2) non-small cell lung cancer.
Epidemiological and clinical features of 201 COVID-19 patients in Changsha city, Hunan, China
Authors: Zhou Jian , Sun Jingjing , Cao Ziqin , Wang Wanchun , Huang Kang , Zheng Fang , Xie Yuanlin , Jiang Dixuan , Zhou Zhiguo
Published: August 2020

In December 2019, a cluster of coronavirus Disease 2019 (COVID-19) occurred in Wuhan, Hubei Province, China. The present study was conducted to report the clinical characteristics of 201 COVID-19 patients in Changsha, China, a city outside of Wuhan. All of the patients with confirmed COVID-19 were admitted to the First Hospital of Changsha City, the designated hospital for COVID-19 assigned by the Changsha City Government. The clinical and epidemiological characteristics, data of laboratory, radiological picture, treatment, and outcomes records of 201 COVID-19 patients were collected using electronic medical records. This study population consisted of 201 hospitalized patients with laboratory-confirmed COVID-19 in Changsha by April 28, 2020. The median age of the patients was 45 years (IQR 34–59). About half (50.7%) of the patients were male, and most of the infected patients were staff (96 [47.8%]). Concerning the epidemiologic history, the number of patients linked to Wuhan was 92 (45.8%). The most common symptoms were fever (125 [62.2%]), dry cough (118 [58.7%]), fatigue (65 [32.3%]), and pharyngalgia (31 [15.4%]). One hundred and forty-four (71.6%) enrolled patients showed bilateral pneumonia. Fifty-four (26.9%) patients showed unilateral involvement, and three (1.5%) patients showed no abnormal signs or symptoms. The laboratory findings differed significantly between the Intensive Care Unit (ICU) and non-ICU groups. Compared with non-ICU patients, ICU patients had depressed white blood cell (WBC), neutrocytes, lymphocytes, and prolonged prothrombin time (PT). Moreover, higher plasma levels of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin (PCT), alanine aminotransferase (ALA), aspartate aminotransferase (AST), creatine kinase (CK), creatine kinase-MB (CK-MB), creatinine (CREA), and lactate dehydrogenase (LDH) were detected in the ICU group. In this single-center study of 201 COVID-19 patients in Changsha, China, 22.4% of patients were admitted to ICU. Based on our findings, we propose that the risk of cellular immune deficiency, hepatic injury, and kidney injury should be monitored. Previous reports focused on the clinical features of patients from Wuhan, China. With the global epidemic of COVID-19, we should pay more attention to the clinical and epidemiological characteristics of patients outside of Wuhan.
Adipose tissue derived stromal vascular fraction as an adjuvant therapy in stroke rehabilitation
Authors: Lee Hoon-Bum , Park Si-Woon , Kim Il-Kwon , Kim Jae-Hyung , Kim Doo Young , Hwang Ki-Chul
Published: August 2020

Introduction:

Stroke often causes residual hemiparesis, and upper extremity motor impairment is usually more disabling than lower extremity in those who are suffering from post-stroke hemiparesis. Cell therapy is one of the promising therapies to reduce post-stroke disability.

Patient concerns:

Three male participants were included in the study to investigate the feasibility and tolerability of autologous adipose tissue derived stromal vascular fraction.

Diagnosis:

All participants had hemiparesis after 1st-ever stroke longer than 6 months previously.

Interventions:

Under general anesthesia, liposuction of abdominal subcutaneous fat was performed. Stromal vascular fraction freshly isolated from the adipose tissue extract was injected into the muscles of paretic upper extremity. All participants received inpatient stroke rehabilitation consisted of physical and occupational therapy more than 3 hours a day for 2 months or more.

Outcomes:

The whole procedure did not produce any significant adverse event in all participants. Adipose tissue extracts yielded sufficient stromal cells. One participant showed clinically important change in upper extremity Fugl–Meyer assessment after the injection and it lasted up to 6 months. Functional magnetic resonance imaging showed concomitant increase in ipsilesional cortical activity. The other 2 participants did not show remarkable changes.

Lessons:

Intramuscular injection of autologous adipose tissue derived stromal vascular fraction seems to be a safe and tolerable procedure in subjects with chronic stroke, and its utility in rehabilitation needs further investigation.