bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase 1 clinical study of cell therapy with effective-mononuclear cells (E-MNC) for radiogenic xerostomia (first-in-human study) (FIH study on E-MNC therapy for radiogenic xerostomia)
Authors: Sumita Yoshinori , Iwamoto Naoki , Seki Makoto , Yoshida Takako , Honma Ryo , Iwatake Mayumi , Ohba Seigo , Takashi I. , Hotokezaka Yuka , Harada Hiroshi , Kuroshima Shinichiro , Nagai Kazuhiro , Asahara Takayuki , Atsushi Kawakam I , Asahina Izumi 
Published: June 2020

Abstract

Background:
Treatment for most patients with head and neck cancers includes ionizing radiation with or without chemotherapy. This treatment causes irreversible damage to salivary glands in the irradiation field accompanied by a loss of fluid-secreting acinar cells and a considerable decrease of saliva secretion. There is currently no adequate conventional treatment for this condition. In recent years, we developed an effective culture method to enhance the anti-inflammatory and vasculogenic phenotypes of peripheral blood mononuclear cells (PBMNCs), and such effectively conditioned PBMNC (E-MNC) therapy has shown promising improvements to the function of radiation-injured salivary glands in preclinical studies. However, the safety and effect of E-NMC therapy have yet assessed in human. The objective of this ongoing first-in-man study is to assess the safety, tolerability, and in part the efficacy of E-MNC therapy for treating radiation-induced xerostomia.

Methods/design:
This phase 1 first-in-man study is an open-label, single-center, two-step dose escalation study. A total of 6 patients, who had no recurrence of head and neck cancer over 5 years following radiation therapy and suffered from radiation-induced xerostomia, will receive a transplantation of E-NMCs derived from autologous PBMNCs to a submandibular gland. The duration of the intervention will be 1 year. To analyze the recovery of salivary secretion, a gum test will be performed. To analyze the recovery of atrophic salivary glands, computed tomography (CT), and magnetic resonance imaging (MRI) of salivary glands will be conducted. The primary endpoint is the safety of the protocol. The secondary endpoints are the changes from baseline in whole saliva secretion and salivary gland atrophy.

Discussion:
This will be the first clinical study of regenerative therapy using E-MNCs for patients with severe radiation-induced xerostomia. The results of this study are expected to contribute to developing the low-invasive cell-based therapy for radiation-induced xerostomia.

Trial registration:
This study was registered with the Japan Registry of Clinical Trials (http://jrct.niph.go.jp) as jRCTb070190057.
Multimode tumor ablation therapy induced different diffusion and microvasculature related parameters change on functional magnetic resonance imaging compared to radiofrequency ablation in liver tumor
Authors: Zhang Guangyuan , Li Wentao , Wang Guangzhi , He Xinhong , Xu Lichao , Wang Shengping , Peng Weijun 
Published: June 2020

Abstract
To explore different posttreatment changes between multimode tumor ablation therapy (MTAT) and radiofrequency ablation (RFA) using intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) and diffusion kurtosis imaging (DKI) in patients with hepatic malignancies.
Eighty - seven patients with one hundred and twenty eight hepatic lesions receiving MTAT or RFA underwent IVIM-DWI and DKI before and after treatment. The mean value of apparent diffusion coefficient (ADC), IVIM-DWI parameters, including true diffusion coefficient (D), pseudo-diffusion coefficient (DP), perfusion fraction (f), and DKI parameters including diffusion coefficient (DK), apparent diffusional kurtosis (K) were retrospectively compared prior to and following treatment as well as between treatment groups. The degree of parameters change after ablation was compared between 2 treatment modalities.
The mean value of ADC, D, and DK increased while f, and K decreased significantly in MTAT group. In RFA group, just ADC and K showed significantly change following treatment. The ADC and D value were higher in MTAT group than in RFA group 1 month after treatment. While f was lower in MTAT group after treatment compared with RFA group. The ADC, D and DK increased (21.89 ± 24.95% versus 8.76 ± 19.72%, P = .04 for ADC, 33.78 ± 54.01% versus 7.91 ± 25.16%, P = .03 for D, 25.91 ± 36.28% versus 1.75 ± 46.42%, P = .01 for DK) while f declined (-32.62 ± 41.48% versus 6.51 ± 44.16%, P < .001) more in MTAT group.
The MTAT induced different posttreatment changes on water molecule diffusion and microvasculature related functional MR parameters compared to RFA in patients with liver tumors.
Improvement of image quality on low-dose dynamic myocardial perfusion computed tomography with a novel 4-dimensional similarity filter
Authors: Tsuneta Satonori , Oyama-Manabe Noriko , Kameda Hiroyuki , Harada Taisuke , Kato Fumi , Smit Ewoud J. , Prokop Mathias , Kudo Kohsuke 
Published: June 2020

Abstract
The aim of this study was to evaluate the effect of a novel 4-dimensional similarity filter (4DSF) on quantitative and qualitative parameters of low-dose dynamic myocardial computed tomography perfusion (CTP) images.
In this retrospective study, medical records of 32 patients with suspected or known coronary artery disease who underwent dynamic myocardial CTP at 80 kV were included. The 4DSF reduces noise by averaging voxels that have similar dynamic behavior after adaptive iterative dose reduction 3D (AIDR3D) and deformable image registration were applied. Qualitative (artefact, contour sharpness, and myocardial homogeneity [1 = poor; 2 = intermediate; 3 = good]) and quantitative measurement (standard deviation [SD] and signal-to-noise ratio [SNR]) were compared between the 4DSF and AIDR3D. Contrast-to-noise ratio (CNR) between ischemic and normal remote myocardium was also assessed using myocardial perfusion magnetic resonance imaging as the reference standard in seven patients.
The 4DSF was successfully applied to all the images. Improvement in subjective image quality yielded by 4DSF was higher than that yielded by AIDR3D (homogeneity, 1.0 [3 vs 2]; artefact, 1.5 [3 vs 1.5]; P < .001) in all patients. The 4DSF significantly decreased the SD by 59% (AIDR3D vs 4DSF: 33.5 ± 0.4 vs 13.8 ± 0.4, P < .001), increased the SNR by 134% (AIDR3D vs 4DSF: 4.4 ± 0.2 vs 10.3 ± 0.2, P < .001), and increased the CNR by 131% (AIDR3D vs 4DSF: 1.6 ± 0.2 vs 3.7 ± 0.2, P < .001).
The 4DSF improved the qualitative and quantitative parameters of low-dose dynamic myocardial CTP images.
Primary pulmonary extranodal natural killer/T-cell lymphoma (ENKTL), nasal type
Authors: Hu Qun , Xu Liyu , Zhang Xiaoming , Wang Jie , Zhou Zizi 
Published: June 2020

Abstract

Introduction:
Extranodal natural killer/T-cell lymphoma (ENKTL) – nasal type is an aggressive form of malignant non-Hodgkin lymphoma with a very poor prognosis. Especially primary pulmonary ENKTL is a relatively rare form of non-Hodgkin lymphoma. Until now, the prevalence of primary pulmonary ENKTL is unknown. Since 2001, only 18 cases of primary pulmonary ENKTL have been published, in addition to the 2 cases reported here.

Patient concerns:
We describe 2 cases of primary pulmonary ENKTL. Both patients were male non-smokers, aged 61 and 49 years. Their main clinical symptoms included cold-like symptoms and intermittent fever (39.3°C and 38.8°C) for some days (40 days and 3 weeks). Both patients had no relevant personal or family medical history.

Diagnosis:
The patients were initially misdiagnosed with community-acquired pneumonia. Primary pulmonary ENKTL was confirmed by immunohistochemical staining of computed tomography-guided transthoracic needle biopsy specimens. Both cases were positive for CD56, CD3, and in situ hybridization for Epstein-Barr virus-encoded small RNA, but negative for CD20.

Interventions:
Initially, both patients were treated inadequately with intravenous moxifloxacin administration (unknown dosage and 400 mg q.d) in their local hospitals. Once diagnosed with primary pulmonary ENKTL in our hospital, they received 3 cycles of chemotherapy with combined regimens of dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE), and in the second patient, bone marrow transplantation was performed following the third chemotherapy cycle.

Outcomes:
Clinical follow-up after the chemotherapy showed that the condition of the first patient progressively deteriorated. He died 2 months following the initial diagnosis. However, the presence of the hemophagocytic lymphohistocytosis gradually improved in the second patient during chemotherapy. Ultimately, the second patient died of acute transplant rejection 6 months after the initial diagnosis.

Conclusion:
The diagnosis of ENKTL should be considered when patients present with fever and expansile consolidation of the lung not responding to antibiotics. The diagnosis depends on histopathology and immunophenotyping. Percutaneous transthoracic needle biopsy is a safe and effective biopsy method. Chemotherapy may improve the prognosis, but this should be confirmed by prospective multicenter studies.
Atypical primary pulmonary amyloidosis
Authors: Peng Xiong , Wang Xiaolei , Luo Daya , Zuo Wei , Yao Huiming , Zhang Wei 
Published: June 2020

Abstract

Rationale:
Pulmonary amyloidosis is a rare respiratory disease characterized by amyloid deposition in the lungs. The clinical manifestations of pulmonary amyloidosis are variable and without specific symptoms.

Patient concerns:
We report a rare case of tracheobronchial amyloidosis to improve our understanding of the disease.

Diagnoses:
The diagnosis of tracheobronchial amyloidosis was finally established by transbronchoscopic lung biopsy and histological examination.

Interventions:
The patient significantly improved with methylprednisolone sodium succinate for injection (40 mg/day) for 5 days and low-dose oral prednisone for 10 days.

Outcomes:
After treatment, discomfort, such as cough, stridor, dyspnea, and chest tightness, disappeared, and he was discharged. The patient was in good clinical condition after 8 months of follow-up.

Conclusion:
This case clearly shows that it is difficult to distinguish tracheobronchial amyloidosis from other diseases with manifestations of cough, dyspnea and chest tightness because of their similar symptoms and imaging findings. Thus, the role of transbronchoscopic lung biopsy and histological examination in the diagnosis of tracheobronchial amyloidosis is very important.
Efficacy comparison of different acupuncture methods for herpes zoster
Authors: Xu Huachong , Shi Yucong , Liu Pei , Deng Li 
Published: June 2020

AbstractBackground:Acupuncture methods (include moxibustion) are used frequently in the treatment of herpes zoster. However, the choice is usually made only based on personal experience among different acupuncture methods. This study aims to compare the efficacy of different acupuncture methods for herpes zoster.Methods:All randomized controlled trials of acupuncture methods for herpes zoster will be searched in 7 databases including Cochrane Library, Embase, PubMed, Web of Science, Wan-fang database, China National Knowledge Infrastructure database, and VIP Chinese Science and Technique Journals database database. After screening process, effectiveness rate will be extracted from all the included randomized controlled trials as primary outcomes. The Bayesian network meta-analysis will be conducted by generate mixed treatment comparisons 0.14.3, Stata13.0, and Review Man 5.3.Results:The results of this study will be submitted to a peer-reviewed journal for publication.Conclusions:Our review will compare the efficacy of different acupuncture treatments for herpes zoster and find a better selection guideline for clinicians and patients.PROSPERO registration number:CRD42020175189.
The role of an antibiotic envelope in the prevention of major cardiac implantable electronic device infections
Authors: Asbeutah Abdul Aziz A. , Salem Majed H. , Asbeutah Saad A. , Abu-Assi Mona A. 
Published: June 2020

Abstract

Background:
Over the past decade, rates of cardiac implantable electronic device (CIED) related infections have increased and been associated with increased morbidity, mortality and financial burden on healthcare systems.

Methods:
To examine the effect of an antibacterial envelope in reducing major CIED related infections, we performed a systematic review and meta-analysis by searching PubMed/MEDLINE, CENTRAL, Google scholar and Clinicaltrials.gov for studies that examined the effect of an antibiotic envelope in reducing major related CIED infections, comprising of device-related endocarditis, systemic infection requiring systemic antibiotics and or device extraction, compared to control up till February 15th, 2020. A random-effects meta-analysis was conducted by calculating risk ratios (RR) and respective 95% confidence intervals (CI).

Results:
We include 6 studies that comprise of 11,897 patients, of which 5844 received an antibiotic envelope and 6053 did not. Compared with control, utilization of an antibiotic envelope at the time of procedure was associated with a significant 74% relative risk reduction in major CIED related infections among patients at high risk for infection (RR: 0.26 [95% CI, 0.08–0.85]; P = .03), while no significant reduction was observed among patients enrolled from studies with any risk for infection (RR: 0.53 [95% CI, 0.06–4.52]; P = .56). Additionally, no reduction in mortality among patients that received an envelope compared to control was observed (RR: 1.15 [95% CI, 0.53–2.50]; P = .72).

Conclusion:
The utilization of an antibiotic envelope at the time of device implantation or upgrade reduces major CIED infections, especially if used in patients perceived to be at higher risk for infection.
Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra
Authors: Xu Xia , Wang Yajie , Yang Chen , Song Xinyu , Chen Zhilong , Yang Lingge , Li Yaxin 
Published: June 2020

Abstract

Background:
Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises.

Methods:
For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention.

Results:
The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences.

Conclusions:
This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR.

Trial registration:
This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.
Poor bladder compliance due to malacoplakia with xanthogranulomatous cystitis
Authors: Xiao Ning , Tang RongYu , Ge Bo , Zhao HuaSheng , Wang JianFeng 
Published: June 2020

Abstract

Rationale:
Either malacoplakia or xanthogranulomatous cystitis (XC) is a rare chronic infection disease of urinary bladder, which often mimics bladder masses undifferentiated from malignance and results in severe lower urinary tract symptoms. The malacoplakia combined with XC is even rarer in the literature.

Patient concerns:
A 64-year-old female, who presented with nocturia, frequency of micturition, severe urgency with occasional urinary incontinence, and recurrent hematuria for >2 years, was diagnosed with azotemia and anemia. In addition, two 1.0 × 1.0 cm masses of bladder were detected by computer tomography.

Diagnoses:
Malacoplakia combined with xanthogranulomas cystitis was diagnosed histologically. Video urodynamic test showed poor bladder compliance (9 mL/comH2O), markedly decreased maximum bladder capacity (120 mL), and right vesicoureteral reflux at a low intravesical pressure level (25 cmH2O).

Interventions:
Transurethral resection of bladder masses was carried out after treatment of urinary infection by intravenous piperacillin-tazobactam. Oral Ciprofloxacin and Tolterodine were postoperatively used to prevent recurrent lower urinary tract infections and alleviate detrusor overactivity.

Outcomes:
The treatment did not alleviate azotemia, frequency, urgency with incontinence, and bilateral hydroureteronephrosis, but the patient refused to undergo bladder augmentation on account of her poor economic status.

Lessons:
Malacoplakia or/and xanthogranulomas cystitis may lead to poor bladder compliance and video urodynamic study should be considered in patients with refractory chronic lower urinary tract symptoms.
Primary hepatic neuroendocrine carcinoma coexisting with distal cholangiocarcinoma
Authors: Xin Qi , Lv Rong , Lou Cheng , Ma Zhe , Liu Gui-Qiu , Zhang Qin , Yu Hai-Bo , Zhang Chuan-Shan 
Published: June 2020

Abstract

Introduction:
Although primary hepatic neuroendocrine carcinomas, whose prognostic mechanisms remain unclear, are rare, coexistence of neuroendocrine carcinomas and other tumors is rarer. In this report, we describe a unique case of coexistence between primary hepatic neuroendocrine carcinoma and a distal cholangiocarcinoma in the pancreas.

Patient concerns:
A 64-year-old woman with a history of diabetes, but none of hepatitis, was admitted to hospital because of intermittent epigastric distension and pain discomfort for more than 1 month aggravated 1 day. A contrast-enhanced computed tomography (CT) scan of the upper abdomen and abdominal magnetic resonance imaging (MRI) revealed a thickening of the bile duct wall in the middle and lower segment of common bile duct and the corresponding lumen is narrow and low-density tumors with ring enhancement (1.83 cm × 1.9 cm) in lobi hepatis dexte.

Diagnosis:
Primary neuroendocrine carcinoma of the liver was diagnosed to be coexisting with a distal cholangiocarcinoma, which had invaded the pancreas. Immunohistochemical examination revealed that the neoplastic cells strongly expressed chromogranin A, synaptophysin, and CD56 proteins. The tumor cells did not express HepPar-1, glypican-3, S-100, CK7, and CK19 in the liver tumor. A distal bile duct in pancreatic tissues shows the characteristics of typical bile duct carcinoma, as an invasion of carcinoma is also seen in the pancreatic tissues. Gastrointestinal endoscopy, chest and abdominal CT, abdominal MRI, and positron emission tomography (PET)-CT were used to exclude metastatic neuroendocrine tumors of the liver.

Interventions:
Resection of the pancreas-duodenum, the right anterior lobe of the liver, and regional lymph nodes was performed in patients.

Outcomes:
The patient had survived for 5 months after the operation.

Conclusion:
A unique case of a coexistence of primary hepatic neuroendocrine carcinoma and a distal cholangiocarcinoma, which had invaded the pancreas. No treatment guidelines are established for the treatment of the unique case.
Deep surgical site infection after posterior instrumented fusion for rheumatoid upper cervical subluxation treated with antibiotic-loaded bone cement
Authors: Ogihara Satoshi , Murase Shuhei , Oguchi Fumihiko , Saita Kazuo 
Published: June 2020

Abstract

Introduction:
Patients with rheumatoid arthritis (RA) tend to be immunosuppressed due to RA itself and the therapeutic drugs administered. The management of surgical site infection (SSI) following upper cervical spinal instrumented fusion in RA patients is challenging; however, literature on the treatment for such conditions is scarce. We report 3 consecutive patients with RA, who developed deep SSI following upper cervical posterior fusion and were treated using antibiotic-loaded bone cement (ALBC).

Patient Concerns:
All 3 patients reported in the current study experienced compression myelopathy with upper cervical spinal deformity and received prednisolone and methotrexate for controlling RA preoperatively. The patient in Case 1 underwent C1–2 posterior fusion and developed deep SSI due to methicillin-sensitive Staphylococcus aureus at 3 months postoperatively; the patient in Case 2 underwent occipito-C2 posterior fusion and developed deep SSI due to methicillin-sensitive Staphylococcus aureus at 2 weeks postoperatively; and the patient in Case 3 underwent occipito-C2 posterior instrumented fusion and laminoplasty at C3–7, and developed deep SSI due to methicillin-resistant coagulase negative staphylococci at 3 weeks postoperatively.

Diagnosis:
All patients developed deep staphylococcal SSI in the postoperative period.

Interventions:
All 3 patients were treated using ALBC placed on and around the instrumentation to cover them and occupy the dead space after radical open debridement.

Outcomes:
The deep infection was resolved uneventfully after the single surgical intervention retaining spinal instrumentation. Good clinical outcomes of the initial surgery were maintained until the final follow-up without recurrence of SSI in all 3 cases.

Conclusion:
ALBC embedding spinal instrumentation procedure can be a viable treatment for curing SSI in complex cases, such as patients with RA who undergo high cervical fusion surgeries without implant removal.
Apoptosis in cerebrospinal fluid as outcome predictors in severe traumatic brain injury
Authors: Jiang Wenqing , Jin Peng , Wei Wenfeng , Jiang Wei 
Published: June 2020

Abstract
Traumatic brain injury (TBI), due to its high mortality and morbidity, is an important research topic. Apoptosis plays a pathogenic role in a series of neurological disorders, from neurodegenerative diseases to acute neurological lesions.
In this study, we analyzed the association between apoptosis and the Glasgow Outcome Scale (GOS), to examine the potential of apoptosis as a biomarker for a TBI outcome. Patients with severe TBI were recruited at the Department of Neurosurgery, Wujin Hospital Affiliated with Jiangsu University, between January 2018 and December 2019. As a control group, healthy subjects were recruited. The concentrations of caspase-3, cytochrome c, sFas, and caspase-9 in the cerebrospinal fluid (CSF) were analyzed by enzyme-linked immunosorbent assay (ELISA). The association between the GOS and the clinical variables age, sex, initial Glasgow Coma Scale (GCS) score, intracranial pressure (ICP), cerebral perfusion pressure (CPP), initial computed tomography (CT) findings, and apoptotic factors was determined using logistic regression. The area under the receiver operator characteristic (ROC) curve (AUC), and thus the sensitivity and specificity of each risk factor, were obtained.
The levels of caspase-3, cytochrome c, sFas, and caspase-9 in the TBI group were significantly higher than those in the control group (P < .05). The logistic regression results showed that ICP and caspase-3 were significant predictors of outcome at 6 months post-TBI (P < .05). The AUC was 0.925 and 0.888 for ICP and caspase-3, respectively. However, the AUC for their combined prediction was 0.978, with a specificity and sensitivity of 96.0% and 95.2%, respectively, showing that the combined prediction was more reliable than that of the 2 separate factors.
We demonstrated that caspase-3, cytochrome C, sFas, and caspase-9 were significantly increased in the CSF of patients following severe TBI. Furthermore, we found that ICP and caspase-3 were more reliable for outcome prediction in combination, rather than separately.