bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia
Authors: Xu Shiqin , Mao Mao , Zhang Susu , Qian Ruifeng , Shen Xiaofeng , Shen Jinchun , Wang Xian 
Published: December 2019

Abstract

Background:
Studies have shown the efficacy of norepinephrine in the treatment of maternal hypotension during cesarean section by comparing it to treatment with phenylephrine. However, few studies have compared the efficacy of norepinephrine to ephedrine.

Methods:
Ninety-seven women undergoing elective cesarean section were administered norepinephrine at 4 μg/minute (group N; n = 48) or ephedrine at 4 mg/minute (group E; n = 49) immediately postspinal anesthesia, with an on-off titration to maintain systolic blood pressure (SBP) at 80% to 120% of baseline. A rescue bolus of 8 μg norepinephrine was given whenever SBP reached the predefined lower limit. Our primary outcome was the incidence of tachycardia. Secondary outcomes included the incidence of bradycardia, hypertension, hypotension, severe hypotension, hypotensive episodes, number of rescue top-ups, hemodynamic performance error including median performance error (MDPE), and median absolute performance error (MDAPE). Neonatal Apgar scores and umbilical arterial (UA) blood gas data were also collected.

Results:
Women in group N experienced fewer cases of tachycardia (4.2% vs 30.6%, P = .002, odds ratio: 0.11 [95% confidence interval, CI: 0.02–0.47]), a lower standardized heart rate (HR) (70.3 ± 11 vs 75 ± 11, P = .04, difference: 4.7 ± 2.2 [95% CI: 0.24–9.1]), and a lower MDPE for HR (1.3 ± 9.6 vs 8.4 ± 13.5 bpm, P = .003, difference: 3.1 ± 1.8 [95% CI: −0.6–6.7]). In addition, the lowest or the highest HR was lower in group N compared to group E (both P < .05). Meanwhile, the standardized SBP in group N was lower than that in group E (P = .04). For neonates, the UA blood gas showed a higher base excess (BE) and a lower lactate level in group N compared to E (both P < .001). Other hemodynamic variables, maternal, and neonatal outcomes were similar.

Conclusion:
Infusion of 4 μg/minute norepinephrine presented fewer cases of tachycardia, less fluctuation and a lower HR compared to baseline values, as well as a less stressed fetal status compared to ephedrine infusion at 4 mg/minute. In addition, norepinephrine infusion presented a lower standardized SBP compared to ephedrine.
Acupuncture therapy for patients with hemifacial spasm
Authors: Yang Han , Zhou Jun , Zhong Dongling , Yin Zihan , Xu Guixing , Chen Jiao , Li Juan , Liang Fanrong 
Published: December 2019

Abstract

Background:
Hemifacial spasm (HFS) brings a lot of trouble to patients’ daily life, having a severe influence on the psychological and physical wellbeing of patients. Relevant researches suggested that acupuncture therapy has potential benefits for HFS. However, there is no consistent conclusion. The purpose of our study is to assess whether acupuncture therapy is effective and safe for HFS.

Methods:
To collect relevant randomized controlled trials (RCTs), the following electronic databases will be searched: Web of Science, the Cochrane Library, EMBASE, MEDLINE, ISI Web of Knowledge, PsycINFO, Allied and Alternative Medieine, Chinese National Knowledge Infrastructure, Wanfang data, and Chinese Scientific Journals Database. We will take the cure rate and the total effective rate as the primary outcomes, and change in intensity after treatment, change in frequency after treatment, the recurrence rate, and adverse events as secondary outcomes. Endnote software 9.1 will be used for study selection, Review Manager software 5.3, and STATA 13.0 software will be used for analysis and synthesis.

Results:
Current relevant studies will be synthesized to assess whether acupuncture therapy is effective and safe for HFS.

Conclusion:
Our research will provide evidence of acupuncture therapy for HFS.

Registration:
International Prospective Register of Systematic Reviews (PROSPERO) CRD42019142473.
Atypical musculoskeletal manifestations on flexor hallucis longus tendon of gout causing tarsal tunnel syndrome in diabetic patients
Authors: Kim Yoon Seok , Lee Min Ki , Yi Young 
Published: December 2019

Abstract

Rationale:
Deposition of tophus is a common feature in chronic gout; however, signs and symptoms are not always well-pronounced in cases of uncommon sites. We report a rare case with a tophaceous tendonitis on the flexor hallucis longus (FHL) tendon with tarsal tunnel syndrome (TTS). This is the first surgical case of TTS by gouty tophi in FHL.

Patient Concerns:
A 55-year-old woman presented with a 6-month history of mild discomfort at the right foot, which gradually worsened in the past 3 weeks. The patient visited our outpatient clinic due to persistent and aggravating foot pain and swelling around the tarsal tunnel.

Diagnosis:
The patient was diagnosed with hyperuricemia and diabetes mellitus with chronic kidney disease, and did not receive regular antigout treatments. Paresthesia was found along the distribution of medial and plantar nerve and tinel test was positive on tarsal tunnel. Biochemical examination showed she had raised serum uric acid (10.6 mg/dL) and decreased estimated glomerular filtration rate (69 mL/min/1.73 m2). Conventional radiography examination showed negative pathology except soft tissue swelling. Magnetic resonance imaging revealed a fusiform mass within the FHL tendon and fluid collection around tarsal tunnel.

Interventions:
Surgical exploration was performed to remove the mass. Inflammation fluid exploded out from FHL tendon sheath, which was later proven to have infiltration of monosodium urate crystal. Superficial dissection revealed a white chalky mass and posterior tibial nerve was significantly compressed by the tophus mass.

Outcomes:
The mass was removed and the symptoms were relieved at immediate postoperative period.

Lessons:
A tophaceous tendonitis on FHL tendon can cause TTS and surgical decompression of the gout lesion can reduce the symptoms.
A systematic review of the effectiveness and safety of Chinese herbal medicine formula Gualou Xiebai Banxia (GLXBBX) decoction for the treatment of stable angina pectoris
Authors: Chen Mingtai , Men Ling , Wu Haibin , Zhong Guofu , Ou Lijun , Li Tao , Guo Yingyi , Lin Haidan , Zhang Jian , Wang Dongcai , Zhang Zhong 
Published: December 2019

Abstract

Background:
A growing number of studies suggest that Gualou Xiebai Banxia (GLXBBX) decoction, a well-known Chinese herbal formula, has beneficial effects on eliminating angina pectoris symptoms and improving condition of stable angina pectoris (SAP) patients. However, whether this treatment is effective and safe for SAP or not, evidence supporting the effectiveness and safety of this treatment is still incomplete. Besides, there is lack of systematic review to assess the detailed situation (including risk of bias and methodology) of current related clinical studies. This study aimed to evaluate the effectiveness and safety of GLXBBX in treating SAP.

Methods:
The major databases (MEDLINE, Embase, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP) Database, Chinese Biomedical Database (CBM), Chinese Biomedical Literature Service System (SinoMed), and Wanfang Database) were searched from inception to March 2019. Randomized controlled trials (RCTs) of GLXBBX alone or combined with conventional drugs against conventional drugs for SAP were identified. Two assessors reviewed each trial independently. The methodological quality of the eligible studies was evaluated according to the Cochrane Collaboration's tool for assessing risk of bias. Both the data extraction and the literature quality screening evaluation were conducted independently by 2 researchers.

Result:
Totally 17 clinical RCTs were included in this study, involving 1676 patients. Due to the high probability of bias of the included studies, it was inappropriate to undertake a meta-analysis. Thus, we only conducted a systematic review and mainly discussed the methodology and limitation of the included studies.

Conclusion:
Although the current evidence prompted that GLXBBX might benefit SAP patients in improvement of angina pectoris, ECG, and blood lipid on a certain extent, this systematic review revealed no definite conclusion about the application of GLXBBX for SAP due to the poor methodological quality, high risk of bias, and inadequate reporting on clinical data. More rigorous, multicenter, sufficient-sample, and double-blind randomized clinical trials are warranted.
The efficacy and safety of omadacycline in treatment of acute bacterial infection
Authors: Lan Shao-Huan , Chang Shen-Peng , Lai Chih-Cheng , Lu Li-Chin , Chao Chien-Ming 
Published: December 2019

Abstract

Background:
This study aims to assess the clinical efficacy and safety of omadacycline for the treatment of acute bacterial infections in adult patients through meta-analysis.

Methods:
PubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated omadacycline and other comparators for treating acute bacterial infections in adult patients were included. The primary outcome was the clinical response rate at the posttreatment evaluation, whereas the secondary outcomes were risk of an adverse event (AE) and mortality.

Results:
Four RCTs were included. Overall, omadacycline had a clinical response rate noninferior to comparators in the treatment of acute bacterial infection in the modified intent-to-treat population (odds ratio [OR], 1.31; 95% confidence interval [CI], 1.04–1.65; I
2 = 0%) and in the clinically evaluable population (OR, 1.53; 95% CI, 1.11–2.11; I
2 = 0%). Furthermore, no significant differences were found between omadacycline and comparators for the risk of treatment-emergent AEs (OR, 1.13; 95% CI, 0.60–2.14; I
2 = 93%), treatment-related AEs (OR, 0.70; 95% CI, 0.46–1.04; I
2 = 56%), serious AEs (OR, 1.01; 95% CI, 0.64–1.58; I
2 = 0%), and discontinuation of study drug due to an AE (OR, 0.78; 95% CI, 0.47–1.29; I
2 = 0%). However, in the clinical trial, NCT02877927, in which omadacycline was used in only oral form, the reported incidence of nausea and vomiting were 30.2% (111/368) and 16.9% (62/368), respectively. Finally, the mortality rate was similar between omadacycline and comparator in the treatment of acute bacterial infection (OR, 1.32; 95% CI, 0.47–3.67; I
2 = 0%).

Conclusion:
The clinical efficacy of omadacycline is not inferior to that of comparators in the treatment of acute bacterial infections in adult patients, and this antibiotic is also well tolerated.
Relationship between urate within tophus and bone erosion according to the anatomic location of urate deposition in gout
Authors: Shi Dan , Chen Jie-Yu , Wu Hua-Xiang , Zhou Qi-Jing , Chen Hai-Yan , Lu Yuan-Fei , Yu Ri-Sheng 
Published: December 2019

Abstract
The aim of this study was to measure the urate volume within tophus and bone erosion volume using dual-energy computed tomography in patients with tophaceous gout. Furthermore, our study aims to quantitatively analyze the relationship between monosodium urate (MSU) crystal deposition and bone erosion according to the anatomic location of urate deposition.
Seventy-seven subjects with chronic gout were positively identified for the presence of urate deposition. Only 27 subjects identified for the presence of urate in contact with bone erosion were included in this study. The urate volumes and associated erosion volumes were measured. The relationships between urate within tophus and bone erosion were separately analyzed according to the anatomic location of urate deposition.
Twenty-seven subjects were all male (100%) with a median (interquartile range, IQR) age of 52 (45–61) years. From all the subjects, 103 tophi depositions were identified in contact with bone erosion, including 58/103 tophi that contained an intraosseous component and 45/103 nonintraosseous tophi. Tophi containing intraosseous components were larger than nonintraosseous tophi (urate volume: median [IQR] 45.64 [4.79–250.89] mm3 vs 19.32 [6.97–46.71] mm3, P = .035) and caused greater bone erosion (erosion volume: 249.03 [147.08–845.33] mm3 vs 69.07 [32.88–111.24] mm3, P < .001). Almost all erosion volumes were larger than urate volumes in nonperiarticular tophi, in contrast to most erosion volumes, which were less than urate volumes in the tophi that contained a periarticular component (odds ratio, 95% confidence interval: 74.00, 14.70–372.60; P < .001). Urate volume and erosion volume demonstrated positive correlations in intraosseous tophi, intraosseous-intra-articular-periarticular tophi, and intraosseous-intra-articular tophi (rs = 0.761, rs = 0.695, rs = 0.629, respectively, P < .05).
MSU crystal deposition shows a promoting effect on the development of bone erosions in varying degrees, associated with the location of MSU crystals deposited in the joints. The intraosseous tophi contribute the most to bone erosions, followed by intra-articular tophi, and periarticular tophi.
The management of Salter-Harris type II fracture with associated posterior sternoclavicular joint displacement using a locking compression plate
Authors: Vitali Matteo , Drossinos Andreas , Pironti Pierluigi , Pesce Elisa , Salini Vincenzo 
Published: December 2019

Abstract

Rationale:
Posterior sternoclavicular joint dislocations (PSCJDs) are particularly rare injuries, accounting for 3% to 5% of sternoclavicular joint dislocations. With very few cases reported in the literature, these injuries are often misdiagnosed and imaging is not always clear, thus making physicians often unaware of them. The present case report aims to investigate a rare case involving a clavicular Salter-Harris II fracture with associated posterior displacement of the diaphysis, a term coined a “pseudodislocation.”

Patient concerns:
We present a case of a 14-year-old adolescent who sustained a traumatic injury to the shoulder while falling during a soccer match. His main concern was about recovery time and the return to daily life activities.

Diagnoses:
Multiple imaging studies imaging (X-rays, computed tomography, magnetic resonance imaging) revealed a Salter-Harris II fracture of the right clavicle with posterior displacement of the diaphysis.

Interventions:
The patient underwent primary surgery to reduce the fracture, using an articular locking compression plate, and secondary surgery to remove the hardware.

Outcomes:
Following the removal of the hardware at 60 days after the initial surgery and a number of cycles of physiotherapy the patient reported a pain-free range of motion with slight limitation at extremes. Full return to recreational and everyday life activities were achieved at 3 months from the initial surgery.

Lessons:
The PSCJDs are challenging injuries, as they are surrounded by delicate structures inside the mediastinum. Attention must be taken while diagnosing and treating these injuries as the risk of complications and iatrogenic injuries is high. To the author's knowledge, this case is one of the first of its kind described in the literature where we have a Salter-Harrys type II fracture associated with a posterior pseudodislocation of the lateral clavicle. Given the positive results of the case, we recommend the above-mentioned treatment protocol in PSCJD with associated Salter-Harris II fractures in adolescent patients.
Reactivation of latent tuberculosis infection induced by cabazitaxel in a patient with prostate cancer
Authors: Hashimoto Mamoru , Minami Takafumi , Hamaguchi Mamoru , Fujimoto Saizo , Takahashi Tomoki , Kikuchi Takashi , Adomi Shogo , Banno Eri , Ohzeki Takayuki , Shimizu Nobutaka , Mori Yasunori , Nozawa Masahiro , Nose Kazuhiro , Yoshimura Kazuhiro , Uemura Hirotsugu 
Published: December 2019

Abstract

Rationale:
Latent tuberculosis infection (LTBI) describes the dormant state of tuberculosis (TB), in which persistent immune-related interaction between TB and T-cells maintain its state. Cabazitaxel (CBZ) is reported to improve overall survival in patients with castration-resistant prostate cancer (CRPC) after progression observed in regimens including docetaxel. CBZ is known for severe myelosuppression; however there is no recommendation for the treatment of LTBI before CBZ treatment. To the authors’ knowledge, this is the first report to describe reactivation of LTBI induced by CBZ.

Patient concerns:
A 75-year-old Japanese male with a medical history of TB since 16 years of age had been treated for prostate cancer (PC) (initial prostate-specific antigen 532 ng/ml; cT4N1M1b; Gleason score4+4) with androgen deprivation therapy, abiraterone, and docetaxel. Calcified nodules and radiological findings of LTBI were present in the upper right lobe since the diagnosis of PC. After progression was observed during these treatments, CBZ was administered combined with pegfilgrastim, long-acting granulocyte colony-stimulating factor (G-CSF). Seven days after the third course of CBZ, he was admitted to the authors’ hospital to treat febrile neutropenia (FN). High fever persisted even after myelosuppression had recovered. Computed tomography (CT) revealed distribution of small nodules in the bilateral lungs, for which miliary TB was included in the differential diagnosis. T-Spot, interferon-gamma-release assay, and bronchoscopy yielded no significant findings; however, sputum and urine culture confirmed the diagnosis of TB.

Diagnosis:
CT, sputum and urine culture confirmed the diagnosis of miliary TB.

Interventions:
The patient was treated with anti-bacterial therapy (cefepime) on hospital admission, which was not effective. After the diagnosis of miliary TB was confirmed, anti-TB drugs, including isoniazid, rifampicin, pyrazinamide and ethambutol, were administered.

Outcomes:
Despite anti-TB therapy, high fever persisted and radiological findings worsened. Fifty days after the third course of CBZ, the patient died of respiratory dysfunction caused by progression of miliary TB.

Lessons:
Management of LTBI is needed in cases of radiographic findings of LTBI and medical history of TB before CBZ treatment, despite the rarity of LTBI reactivation in patients with PC.
A nomogram for prediction of posthepatectomy liver failure in patients with hepatocellular carcinoma
Authors: Shen Yi-Nan , Tang Tian-Yu , Yao Wei-Yun , Guo Cheng-Xiang , Yi-Zong  , Song Wei , Liang Ting-Bo , Bai Xue-Li 
Published: December 2019

Abstract
To generate a nomogram to predict posthepatectomy liver failure (PHLF), we attempted to elucidate salient risk factors in patients with hepatocellular carcinoma (HCC).
We performed a retrospective review of 665 patients with HCC who received hepatectomy in 2 academic institutions in China. Independent risk factors for PHLF were identified from putative demographic, intrinsic, biochemical, surgery-related, and volumetric data. A predictive nomogram was formulated based on relevant risk factors, and we compared this with existing models.
We identified clinical signs of portal hypertension (P = .023), serum total bilirubin (P = .001), serum creatinine (P = .039), and intraoperative hemorrhage (P = .015) as being important risk factors in predicting PHLF. The nomogram had a C-index of 0.906 for the externally validated data. The nomogram displayed better predictive value than 2 of the other most cited models (C-indices of 0.641 and 0.616, respectively) in the current cohort. Additionally, we were able to patients into low- (<10%), intermediate- (10–30%), and high-risk (≥30%) groups based on the nomogram. This allows us to facilitate person-specific management.
Here, we constructed a simple nomogram for prediction of PHLF in patients with HCC weighted by independent risk factors. Further prospective studies are required to confirm the predictive ability of our nomogram.
The low-density lipoprotein cholesterol lowering is an ineffective surrogate marker of statin responsiveness to predict cardiovascular outcomes
Authors: Hyun Myung Han , Jang Jae Won , Choi Byoung Geol , Na Jin Oh , Choi Cheol Ung , Kim Jin Won , Kim Eung Ju , Rha Seung-Woon , Park Chang Gyu , Lee Eunmi , Seo Hong Seog 
Published: December 2019

Abstract
Statins therapy decrease both low-density lipoprotein cholesterol (LDL-C) levels and the risk of atherosclerotic cardiovascular disease (ASCVD) with considerable individual variability. Whether the amount of LDL-C lowering is a surrogate maker of statin responsiveness to ASCVD prevention has not been fully investigated. Among 2352 eligible patients with statin prescriptions in a cardiovascular center between January 2005 and February 2014, one-third of patients (33%) on statin therapy failed to achieve effective reductions in LDL-C (LDL-C level reduction of less than 15%). By using, propensity-score matched population (480 pairs, n = 960), the 5-year cumulative incidences of total major adverse cardiac events (MACE) were evaluated. The 5-year total MACE did not differ between normal cholesterol responders and non-responders (15.4% vs 16.1%, respectively; P = .860). In the subgroup analysis, male sex, older age, percutaneous coronary intervention, and heart failure were positive predictors, and dyslipidemia at the beginning of statin therapy was the only negative predictor of MACE in the 5-year follow-up (all P value < .05). However, cholesterol responsiveness after statin therapy did not influence the incidence of MACE (P = .860). The amount of LDL-C lowering did not predict beneficial effect on clinical outcomes of ASCVD after statin therapy. This result supports that given statin therapy, total ASCVD risk reduction should be tailored, which may not dependent to adherence to degree of LDL-C lowering or LDL-C goal based treatment.
Brief Report: Prediction of Serum HIV-1 Neutralization Titers After Passive Administration of VRC01
Authors: Huang Yunda , Zhang Yuanyuan , Bailer Robert , Grunenberg Nicole , Carpp Lindsay N. , Seaton Kelly , Mayer Kenneth H. , Ledgerwood Julie , Corey Lawrence , Mascola John , Montefiori David , Gilbert Peter B. 
Published: December 2019

Background:
VRC01 is a human IgG1 broadly neutralizing antibody (bnAb) that binds to the HIV-1 envelope glycoprotein. It is being evaluated in two ongoing Phase 2b trials, the first efficacy assessment of a passively-administered bnAb for HIV-1 prevention. HVTN 104 was a phase 1 trial of VRC01.

Setting:
We measured serum concentrations and serum neutralization of VRC01 in 1079 longitudinal samples collected after passive administration of VRC01 in 84 HVTN 104 participants. As assays for measuring VRC01 serum neutralization titers are resource-intensive, we investigated approaches to predicting such titers.

Methods:
Serum concentration was measured using an anti-idiotypic ELISA assay. Serum neutralization ID50 titers and in vitro neutralization potency IC50 of the VRC01 clinical lot were measured against Env-pseudoviruses. Three approaches were used to predict serum neutralization ID50 titers based on (1) observed serum concentration divided by IC50, (2) pharmacokinetics model-predicted serum concentration divided by IC50, and (3) joint modeling of the longitudinal serum concentrations and ID50 titers.

Results:
All 3 approaches yielded satisfactory prediction of neutralization titers against viruses of varied sensitivities; the median fold differences (FDs) of observed-over-predicted ID50 titers were between 0.95 and 1.37. Approach 3 generally performed the best with fold differences between 0.95 and 0.99 and <82% mean squared prediction error relative to approach 1. Similar results were obtained for ID80 titers.

Conclusion:
VRC01 serum neutralization could be accurately predicted, especially when using pharmacokinetics models. The proposed prediction approaches could potentially save significant resources for the characterization of serum neutralization of VRC01, including for other bnAbs and bnAb combinations.