bluuebunny/crossref_metadata_2025_split huggingface dataset:
Surgical site infection leading to gangrene and amputation after ambulatory surgical care of an ingrown toenail: a case report
Authors: Noula Aimé Gilbert Mbonda , Tochie Joel Noutakdie , Tchuenkam Landry W. , Abang Desmond Aji , Essomba René 
Published: December 2019

AbstractBackgroundCurrently, the management of ingrown toenail (onychocryptosis) ranges from conservative medical management to surgical treatment. Surgical management is typically performed as an outpatient procedure due to it numerous advantages such as the simplicity of the technique and the low incidence of postoperative complications. The most common postoperative complications are recurrences and surgical site infections, whereas gangrene complicating a surgical site infection has been scarcely reported. We are reporting a rare complication following ambulatory surgery untimely requiring amputation.Case presentationA twelve-year-old boy was referred to our orthopedic surgical department for a surgical site infection complicating an initial surgical management of a left ingrown big toenail leading to a dry gangrene of the affected toe. The gangrene toe was amputated under peripheral nerve block and the patient was discharged home the same day on antibiotics, analgesics and with sessions of rehabilitation and psychological support planned. The postoperative course was uneventful at 6 months of follow-up.ConclusionThe authors report this case to draw clinicians’ attention, especially wound care specialists, orthopedists and podiatrists to this rare but potentially debilitating disease.
Intra-patient potassium variability after hypothermic cardiac arrest: a multicentre, prospective study
Authors: Pasquier M. , Blancher M. , Buse S. , Boussat B. , Debaty G. , Kirsch M. , de Riedmatten M. , Schoettker P. , Annecke T. , Bouzat P. 
Published: December 2019

Abstract
Background
To date, the decision to set up therapeutic extra-corporeal life support (ECLS) in hypothermia-related cardiac arrest is based on the potassium value only. However, no information is available about how the analysis should be performed. Our goal was to compare intra-individual variation in serum potassium values depending on the sampling site and analytical technique in hypothermia-related cardiac arrests.

Methods
Adult patients with suspected hypothermia-related refractory cardiac arrest, admitted to three hospitals with ECLS facilities were included. Blood samples were obtained from the femoral vein, a peripheral vein and the femoral artery. Serum potassium was analysed using blood gas (BGA) and clinical laboratory analysis (CL).

Results
Of the 15 consecutive patients included, 12 met the principal criteria, and 5 (33%) survived. The difference in average potassium values between sites or analytical method used was ≤1 mmol/L. The agreement between potassium values according to the three different sampling sites was poor. The ranges of the differences in potassium using BGA measurement were − 1.6 to + 1.7 mmol/L; − 1.18 to + 2.7 mmol/L and − 0.87 to + 2 mmol/L when comparing respectively central venous and peripheral venous, central venous and arterial, and peripheral venous and arterial potassium.

Conclusions
We found important and clinically relevant variability in potassium values between sampling sites. Clinical decisions should not rely on one biological indicator. However, according to our results, the site of lowest potassium, and therefore the preferred site for a single potassium sampling is central venous blood. The use of multivariable prediction tools may help to mitigate the risks inherent in the limits of potassium measurement.

Trial registration
ClinicalTrials.gov Identifier: NCT03096561.
High expression of miR-222-3p in children with Mycoplasma pneumoniae pneumonia
Authors: Chu Chu , Lei Xiaoli , Li Yuqin , Luo Yali , Ding Ying , Zhou Weifang , Ji Wei 
Published: December 2019

Abstract
Objectives
Mycoplasma pneumoniae is a leading cause of community-acquired pneumonia in children. However, its mechanism of pathogenesis is not fully understood, and microRNAs might play a role. This study aimed to explore the microRNA-222-3p (miR-222-3p) expression and its possible role in children with M.pneumoniae pneumonia (MPP).

Methods
Thirty-six children with MPP and twenty-seven age-matched controls from Children’s Hospital of Soochow University were enrolled in this study. MiR-222-3p and cluster of differentiation 4 (CD4) mRNA were detected using real-time PCR in children’s peripheral blood plasma samples. THP-1 cells and mice were stimulated with M.pneumoniae lipid-associated membrane proteins(LAMPs).

Results
Children with MPP had significantly higher levels of miR-222-3p and lower levels of CD4 in peripheral blood plasma (P <  0.05). Additionally, Sixteen children with MPP complicated with pleural effusion had higher miR-222-3p levels than those without pleural effusion. MiR-222-3p or CD4 in THP-1 cells increased or decreased, respectively, in a dose dependent manner after LAMP stimulation. In LAMP-stimulated mice massive inflammatory cells infiltrates surrounded the bronchioles, and miR-222-3p increased in the bronchoalveolar lavage fluid. In conclusion, miR-222-3p was highly expressed in children with MPP, especially those with pleural effusion.

Conclusion
Small sample studies showed that M.pneumoniae or its LAMPs could increase miR-222-3p and decrease CD4 in macrophages,both in vitro and vivo.Thus, miR-222-3p might be an MPP biomarker for the diagnosis and prognosis.
The effect of dexmedetomidine and clonidine on the inflammatory response in critical illness: a systematic review of animal and human studies
Authors: Flanders Charles A. , Rocke Alistair S. , Edwardson Stuart A. , Baillie J. Kenneth , Walsh Timothy S. 
Published: December 2019

AbstractBackgroundThe α2 agonists, dexmedetomidine and clonidine, are used as sedative drugs during critical illness. These drugs may have anti-inflammatory effects, which might be relevant to critical illness, but a systematic review of published literature has not been published. We reviewed animal and human studies relevant to critical illness to summarise the evidence for an anti-inflammatory effect from α2 agonists.MethodsWe searched PubMed, the Cochrane library, and Medline. Animal and human studies published in English were included. Broad search terms were used: dexmedetomidine or clonidine, sepsis, and inflammation. Reference lists were screened for additional publications. Titles and abstracts were screened independently by two reviewers and full-text articles obtained for potentially eligible studies. Data extraction used a bespoke template given study diversity, and quality assessment was qualitative.ResultsStudy diversity meant meta-analysis was not feasible so descriptive synthesis was undertaken. We identified 30 animal studies (caecal ligation/puncture (9), lipopolysaccharide (14), acute lung injury (5), and ischaemia-reperfusion syndrome (5)), and 9 human studies. Most animal (26 dexmedetomidine, 4 clonidine) and all human studies used dexmedetomidine. In animal studies, α2 agonists reduced serum and/or tissue TNFα (20 studies), IL-6 (17 studies), IL-1β (7 studies), NFκB (6 studies), TLR4 (6 studies), and a range of other mediators. Timing and doses varied widely, but in many cases were not directly relevant to human sedation use. In human studies, dexmedetomidine reduced CRP (4 studies), TNFα (5 studies), IL-6 (6 studies), IL-1β (3 studies), and altered several other mediators. Most studies were small and low quality. No studies related effects to clinical outcomes.ConclusionEvidence supports potential anti-inflammatory effects from α2 agonists, but the relevance to clinically important outcomes is uncertain. Further work should explore whether dose relationships with inflammation and clinical outcomes are present which might be separate from sedation-mediated effects.
The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes
Authors: Lim Sahnah , Wyatt Laura C. , Mammen Shinu , Zanowiak Jennifer M. , Mohaimin Sadia , Goldfeld Keith S. , Shelley Donna , Gold Heather T. , Islam Nadia S. 
Published: December 2019

Abstract
Background
Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes.

Methods/design
The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss.

Discussion
This study will be the first to test the efficacy of an integrated EHR–CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study’s implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways.

Trial registration
This study protocol has been approved and is made available on ClinicalTrials.gov by NCT 03188094 as of 15 June 2017.
ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial
Authors: Booth J. , Aucott L. , Cotton S. , Goodman C. , Hagen S. , Harari D. , Lawrence M. , Lowndes A. , Macaulay L. , MacLennan G. , Mason H. , McClurg D. , Norrie J. , Norton C. , O’Dolan C. , Skelton D. A. , Surr C. , Treweek S. 
Published: December 2019

Abstract
Background
Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents’ dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences.

Methods
This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers.

Discussion
TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication.

Trial registration
ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017.
ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.
Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial
Authors: Wang Jingjing , Wang Ying , He Yan , Guan Hui , He Ling , Mu Xiaoli , Peng Xingchen 
Published: December 2019

Abstract
Background
It has been reported that radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide (TMZ) to treat these patients, although large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in high-risk patients with low-grade gliomas (LGGs).

Methods/design
This is a two-group, randomized controlled trial (RCT) enrolling patients who have LGGs (WHO grade 2) and are aged 40 years or older without regard to the extent of resection or are aged younger than 40 years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive RT alone or RT plus TMZ chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is PFS, and it will be analyzed by the intention-to-treat approach. Secondary outcomes include OS, adverse events, and cognitive function.

Discussion
The objective of our research is to assess the effect of radiotherapy coupled with TMZ in high-risk patients with LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined, and a corresponding subgroup analysis will be conducted. Our data can provide evidence for postoperative adjuvant therapy in patients with high-risk LGGs in China.

Trial registration
Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13 March 2018.
Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial
Authors: Every-Palmer Susanna , Flewett Tom , Dean Shaystah , Hansby Oliver , Colman Atalie , Weatherall Mark , Bell Elliot 
Published: December 2019

Abstract
Background
Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD). Forensic mental health services provide assessment and treatment of people with mental illness and a history of criminal offending, or those who are at risk of offending. Forensic mental health services include high, medium, and low-security inpatient settings as well as prison in-reach and community outpatient services. There is a high prevalence of PTSD in forensic settings and posttraumatic experiences can arise in people who violently offend in the context of serious mental illness (SMI). Successful treatment of PTSD may reduce the risk of relapse and improve clinical outcomes for this population. This study aims to assess the efficacy, risk of harm, and acceptability of EMDR within forensic and rehabilitation mental health services, as compared to treatment as usual (routine care).

Methods
This is a single-blind, randomized controlled trial comparing EMDR therapy to the waiting list (routine care). Adult forensic mental health service users (n = 46) with SMI and meeting the criteria for PTSD will be included in the study. Participants will be randomized after baseline assessment to either treatment as usual plus waiting list for EMDR or to treatment as usual plus EMDR. The EMDR condition comprises nine sessions, around 60 min in length delivered weekly, the first of which is a case conceptualization session. The primary outcomes are clinician and participant-rated symptoms of PTSD, and adverse events. Secondary outcomes include psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties. A trained assessor blinded to the treatment condition will assess outcomes at baseline, 10 weeks, and 6 months. Additionally, grounded theory qualitative methods will be used to explore participant experience of EMDR for a subset of participants.

Discussion
This study will contribute to the currently limited evidence base for EMDR for PTSD in forensic settings. It is the first randomized clinical trial to assess the efficacy, risk of harm, and acceptability of EMDR for PTSD in people with SMI in either forensic, mental health inpatient, or custodial settings.

Trial registration
Australia and New Zealand Clinical Trials Network, ACTRN12618000683235. Registered prospectively on 24 April 2018.
Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study
Authors: Chen Yuqin , He Wenjun , Ouyang Haiping , Liu Chunli , Hong Cheng , Wang Tao , Yang Kai , Lu Wenju , Wang Jian 
Published: December 2019

Abstract
Background
Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH.

Methods/design
A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded.

Discussion
We aimed to determine the efficacy and safety of TMP for the treatment of PH.

Trial registration
Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.
Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial
Authors: Zhang Hailong , Li Jiansheng , Yu Xueqing , Li Suyun , Wang Haifeng , Ruan Huanrong , Si Yimei , Xie Yang , Wang Minghang 
Published: December 2019

Abstract
Background
The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD.

Methods/design
This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up.

Discussion
This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD.

Trial registration
ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.