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Πέμπτη 12 Νοεμβρίου 2020

The Need for Ocular Protection for Health Care Workers During SARS-CoV-2 Outbreak and a Hypothesis for a Potential Personal Protective Equipment

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SARS-CoV-2 is a coronavirus with high infectivity and has caused dramatic pressure on health systems all over the world. Appropriate personal protection for medical staffs is critical. For ocular protection, there is ongoing hot debate and concern for potential ocular transmission of SARS-CoV-2. Ocular manifestations and positive detection of viral RNA in ocular samples were only reported in very small number of patients infected with SARS-CoV-2. However, health care workers need to face patients more closely and have higher risk of aerosol contamination. Thus, appropriate ocular protection for medical workers is still recommended by organizations such as WHO and American Academy of Ophthalmology. Although eye goggles provide excellent protection and are mandatory fo r medical practitioners with high risk of exposure, they are not ideal for common clinical practice, because they can disturb vision due to extensive formation of water droplets and frequently cause moderate to severe discomfort after longtime wearing, which have been reported to interfere with working status. For the majority of medical workers who don't deal with high risk patients, they are not advised to wear goggles in daily practice. However, they also face the risk of infection due to the presence of asymptomatic carriers. Especially in situations with high risk of ocular exposure, such as close physical examination, eye surgery, dental clinics and surgery, ocular protection may be needed. Griffithsin has been shown to directly bind to spike proteins and has anti-viral activity against a broad spectrum of viruses, including coronavirus. Griffithsin is found to inhibit the entry of SARS-CoV at relatively low concentration and is stable and non-toxic. SARS-CoV-2 and SARS-CoV sh are the same entry receptors and their spike proteins are similar in conformation. We hypothesize that contact lenses containing nanoparticles loaded with griffithsin may provide sufficient ocular protection for medical staffs without high risk of exposure during the outbreak period of SARS-CoV-2. If proven effective, griffithsin-loaded contact lens can be considered as a supplementary ocular protective equipment for medical workers who can tolerate well. The daily disposable contact lens should be applied as needed and refrain from extended wearing in order to reduce potential side effects.

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Protocol for a case-control study of vitamin D status, adult multidrug-resistant tuberculosis disease and tuberculosis infection

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Introduction

Vitamin D status may be an important determinant of multidrug-resistant tuberculosis (MDR-TB) infection, progression to disease and treatment outcomes. Novel and potentially cost-effective therapies such as vitamin D supplementation are needed to stem the tide of TB and MDR-TB globally, particularly in India, a country that accounts for the largest fraction of the world's TB incidence and MDR-TB incidence, and where vitamin D deficiency is endemic. While vitamin D has shown some promise in the treatment of MDR-TB, its role in the context of MDR-TB infection and progression to disease is largely unknown.

Methods and analysis

Through a case–control study in Mumbai, India, we aim to examine associations between vitamin D status and active MDR-TB and to investigate vitamin D status and TB infection among controls. Cases are adult outpatient pulmonary patients with MDR-TB recruited from two public TB clinics. Controls are recruited from the cases' household contacts and from non-respiratory departments of the facilities where cases were recruited. Cases and controls are assessed for serum 25-hydroxyvitamin D concentration, nutrient intake, diet quality, anthropometry and other relevant clinical and sociodemographic parameters. Controls undergo additional clinical assessments to rule out active TB and laboratory assessments to determine presence of TB infection. Statistical analysis investigates associations between vitamin D status and active MDR-TB and between vitamin D status and TB infection among controls, accounting for potential confounding effects of diet, anthropometry and other covariates.

Ethics and dissemination

This study has been approved by Harvard T.H. Chan School of Public Health Institutional Review Board; Foundation for Medical Research Institutional Research Ethics Committee and Health Ministry's Screening Committee of the Indian Council for Medical Research. Permission was granted by the Municipal Corporation of Greater Mumbai, India, a collaborating partner on this research. Outcomes will be disseminated through publication and scientific presentation.

Trial registration number

NCT04342598.

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Fibrosis-4 index as a predictor for mortality

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Objective

The reliable risk factors for mortality of COVID-19 has not evaluated in well-characterised cohort. This study aimed to identify risk factors for in-hospital mortality within 56 days in patients with severe infection of COVID-19.

Design

Retrospective multicentre cohort study.

Setting

Five tertiary hospitals of Daegu, South Korea.

Participants

1005 participants over 19 years old confirmed COVID-19 using real-time PCR from nasopharyngeal and oropharyngeal swabs.

Methods

The clinical and laboratory features of patients with COVID-19 receiving respiratory support were analysed to ascertain the risk factors for mortality using the Cox proportional hazards regression model. The relationship between overall survival and risk factors was analysed using the Kaplan-Meier method.

Outcome

In-hospital mortality for any reason within 56 days.

Results

Of the 1005 patients, 289 (28.8%) received respiratory support, and of these, 70 patients (24.2%) died. In multivariate analysis, high fibrosis-4 index (FIB-4; HR 2.784), low lymphocyte count (HR 0.480), diabetes (HR 1.917) and systemic inflammatory response syndrome (HR 1.714) were found to be independent risk factors for mortality in patients with COVID-19 receiving respiratory support (all p<0.05). Regardless of respiratory support, survival in the high FIB-4 group was significantly lower than in the low FIB-4 group (28.8 days vs 44.0 days, respectively, p<0.001). A number of risk factors were also significantly related to survival in patients with COVID-19 regardless of respiratory support (0–4 risk factors, 50.2 days; 49.7 days; 44.4 days; 32.0 days; 25.0 days, respectively, p<0.001).

Conclusion

FIB-4 index is a useful predictive marker for mortality in patients with COVID-19 regardless of its severity.

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Prevalence and predictors of poor sexual well-being over 5 years following treatment for colorectal cancer: results from the ColoREctal Wellbeing (CREW) prospective longitudinal study

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Objectives

To describe prevalence and predictors of poor sexual well-being for men and women over 5 years following treatment for colorectal cancer.

Design

Prospective longitudinal study, from presurgery to 5 years postsurgery, with eight assessment points. Logistic regression models predicted sexual well-being from presurgery to 24 months and 24 months to 60 months; time-adjusted then fully adjusted models were constructed at each stage.

Setting

Twenty-nine hospitals in the UK.

Participants

Patients with Dukes' stage A–C, treated with curative intent, aged ≥18 years and able to complete questionnaires were eligible.

Outcome measures

The dependent variable was the Quality of Life in Adult Cancer Survivors sexual function score. Independent variables included sociodemographic, clinical and psychosocial characteristics.

Results

Seven hundred and ninety participants provided a sexual well-being score for at least one time point. Thirty-seven per cent of men and 14% of women reported poor sexual well-being at 5 years. Baseline predictors for men at 24 months included having a stoma (OR 1.5, 95% CI 1.02 to 2.20) and high levels of depression (OR 2.69/2.01, 95% CI 1.68 to 4.32/1.12 to 3.61); men with high self-efficacy (OR confident 0.33/0.48, 95% CI 0.18 to 0.61/0.24 to 1.00; very confident 0.25/0.42, 95% CI 0.13 to 0.49/0.19 to 0.94) and social support (OR 0.52/0.56, 95% CI 0.33 to 0.81/0.35 to 0.91) were less likely to report poor sexual well-being. Predictors at 60 months included having a stoma (OR 2.30/2.67, 95% CI 1.22 to 4.34/1.11 to 6.40) and high levels of depression (OR 5.61/2.58, 95% CI 2.58 to 12.21/0.81 to 8.25); men with high self-efficacy (very confident 0.14, 95% CI 0.047 to 0.44), full social support (OR 0.26; 95% CI 0.13 to 0.53) and higher quality of life (OR 0.97, 95% CI 0.95 to 0.98) we re less likely to report poor sexual well-being. It was not possible to construct models for women due to low numbers reporting poor sexual well-being.

Conclusions

Several psychosocial variables were identified as predictors of poor sexual well-being among men. Interventions targeting low self-efficacy may be helpful. More research is needed to understand women's sexual well-being.

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Comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use

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Introduction

Intranasal (IN) naloxone is widely used to treat opioid overdoses. The advantage of nasal administration compared with injection lies in its suitability for administration by lay people as it is needless. Approved formulations of nasal naloxone with bioavailability of approximately 50% have only undergone trials in healthy volunteers, while off-label nasal sprays with low bioavailability have been studied in patients. Randomised clinical trials are needed to investigate efficacy and safety of approved IN naloxone in patients suffering overdose. This study investigates whether the administration of 1.4 mg naloxone in 0.1 mL per dose is non-inferior to 0.8 mg intramuscular injection in patients treated for opioid overdose.

Methods and analysis

Sponsor is the Norwegian University of Science and Technology. The study has been developed in collaboration with user representatives. The primary endpoint is the restoration of spontaneous respiration≥10 breaths/min based on a sample of 200 opioid overdose cases. Double-dummy design ensures blinding, which will be maintained until the database is locked.

Ethics and dissemination

The study was approved by the Norwegian Medicines Agency and Regional Ethics Committees (REC: 2016/2000). It adheres to the Good Clinical Practice guidelines as set out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Informed consent will be sought through a differentiated model. This allows for deferred consent after inclusion for patients who have regained the ability to consent. Patients who are unable to consent prior to discharge by emergency services are given written information and can withdraw at a later date in line with user recommendations. Metadata will be published in the Norwegian University of Science and Technology Open repository. Deidentified individual participant data will be made available to recipients conditional of data processor agreement being entered.

Trial registration numbers

EudraCT Registry (2016-004072-22) and Clinicaltrials.gov Registry (NCT03518021).

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Translating the Symptom Screening in Paediatrics Tool (SSPedi) into North American Spanish and Among Spanish-speaking children receiving cancer treatments: evaluating understandability and cultural relevance in a multiple-phase descriptive study

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Objectives

Symptom screening is important to achieving symptom control. Symptom Screening in Paediatrics Tool (SSPedi) is validated for English-speaking children. Objectives were to translate SSPedi into Spanish, and to evaluate the understandability and cultural relevance of the translated version among Spanish-speaking children with cancer and paediatric haematopoietic stem cell transplant recipients.

Methods

We conducted a multiphase, descriptive study to translate SSPedi into Spanish. The first step was to determine whether one Spanish version would be appropriate for both North America and Argentina. Once this decision was made, forward and backward translations were performed. The translated version was evaluated by Spanish-speaking children 8–18 years of age receiving cancer treatments.

Primary and secondary outcome measures

Primary outcome was child self-reported difficulty with understanding of the entire instrument and each symptom using a 5-point Likert scale. Secondary outcomes were incorrect understanding of SSPedi items identified by cognitive interviews with the children using a 4-point Likert scale and cultural relevance, which was assessed qualitatively.

Results

This report focuses on North American Spanish as a separate version will be required for Argentinian Spanish SSPedi based on different common vocabulary and grammatical structure. There were 20 children from Toronto and San Antonio included in cognitive interviews. The most common types of Spanish spoken were Mexican (13, 65%), Central American (2, 10%) and South American (2, 10%). No child reported that it was hard or very hard to complete Spanish SSPedi. Changes to the instrument itself were not required based on understanding or cultural relevance.

Conclusions

We translated and finalised Spanish SSPedi appropriate for use in North America. Future research will translate and evaluate SSPedi for use in Argentina and other Spanish-speaking countries.

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Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment: a proof-of-concept study--The PRO-ART study protocol

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Introduction

Asthma is associated with prolonged time to pregnancy and a higher need for fertility treatment. However, the mechanism underlying this association remains incompletely understood. Previous research points to asthma-driven systemic inflammation also affecting the reproductive organs and thereby fertility. The aim of this study was to determine if treatment with omalizumab prior to fertility treatment will increase pregnancy rate among women with asthma by decreasing the systemic asthma-related inflammation and, by that, to provide insight into the underlying mechanisms.

Methods and analysis

This is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark. The patients are randomised 1:1 to either omalizumab or placebo. The primary endpoint is the difference in pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy. The secondary endpoints are change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death between groups.

Ethics and dissemination

The methods used in this study are of low risk, but if successful, our findings will have a large impact on a large group of patients as infertility and asthma are the most common chronic diseases among the young population. The study has been approved by the Ethics Committee–Danish national research ethics committee (H-18016605) and the Danish Medicines Agency (EudraCT no: 2018-001137-41) and the Danish Data Protection Agency (journal number: VD-2018486 and I-Suite number 6745). The test results will be published regardless of whether they are positive, negative or inconclusive. Publication in international peer-reviewed scientific journals is planned.

Trial registration number

NCT03727971.

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Thromboelastography-guided blood transfusion during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: study protocol for a prospective randomised controlled trial

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Introduction

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is a well-established treatment for peritoneal cancer (PC). However, this kind of combination therapy is associated with a high incidence of complications. Moreover, relative studies have indicated that traditional laboratory testing is insufficient to demonstrate the overall haemostatic physiology of CRS/HIPEC. Thromboelastography (TEG), administered by monitoring dynamic changes in haemostasis, has been shown to contribute to reducing transfusion requirements and improving survival. However, there is no evidence to verify whether TEG can be applied to guide transfusion strategies during CRS/HIPEC. Therefore, we aim to investigate whether TEG-guided blood product transfusion (TEG-BT) therapy is superior to traditional blood product transfusion (T-BT) therapy for guiding perioperative blood transfusion treatment and improving the prognosis of patients undergoing CRS/HIPEC.

Methods and analysis

The TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18–64 years and undergoing CRS/HIPEC. Participants will be randomly allocated to receive TEG-BT or T-BT. The primary outcome will be the evaluation of perioperative blood transfusion, which refers to the total amount of blood transfusion given from the time patients enter the operating room up to 72 hours postoperatively. The secondary outcomes will include the transfusion volume during surgery, total amount of intraoperative infusion, amount of blood lost during the operation, total blood transfusion between 0 and 72 hours after surgery, lowest haemoglobin level within 72 hours after surgery, intensive care unit duration, overall length of stay, total cost of hospitalisation and adverse events. Data will be analysed according to the intention-to-treat principle.

Ethics and dissemination

The study protocol has been approved by the Scientific Research Ethics Committee of Beijing Shijitan Hospital Affiliated with Capital Medical University (Approval Number: sjtkyll-lx-2020-3). The results will be published in peer-reviewed journals.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2000028835).

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Life-threatening corrosive injury with hepato-renal-pulmonary failure in boric acid poisoning

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CASE

A young female presented with burning sensation, ulceration of mouth and oral cavity following the intake of uncooked rice after a quarrel with her parents. Further enquiry revealed that they used boric acid powder as insecticide to preserve the rice. Clinically, she had extensive ulceration with congestion involving the buccal mucosa of lips, oral cavity and tongue (figure 1). Upper gastrointestinal endoscopy also revealed extensive corrosive injury with ulceration, mucosal hyperaemia and slough formatio n involving oropharynx, oesophagus and stomach, for which nasojejunal tube was placed for nutritional supplementation. She also developed acute hepatitis (aspartate aminotransferase 117 U/L, alanine aminotransferase 215 U/L, bilirubin 5.9 mg/dL) with acute renal failure (blood urea 155 mg/dL, serum creatinine 7.6 mg/dL), for which she received supportive care and haemodialysis. After 2 weeks, she developed progressive shortness of breath with ARDS (figures 2 and 3) requiring mechanical ventilation, and subsequently she succumbed...

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Antithrombotic therapy and the risk of new-onset dementia in elderly patients with atrial fibrillation

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Background

Atrial fibrillation (AF) is associated with an increased risk of dementia. Little is known about the relationship of antithrombotic therapy and the risk of dementia in patients with AF without clinical stroke.

Method

This was an observational study based on a hospital AF registry. Patients aged 65–85 years at the time of AF diagnosis were identified via the computerised database of the clinical management system. Patients with prior stroke or known cognitive dysfunction were excluded. Th e primary outcome was newly diagnosed dementia during the follow-up period.

Results

3284 patients (mean age 76.4±5.3 years, 51.6% male) were included for analysis. The mean CHA2DS2-VASc score was 3.94±1.44. 18.5% patients were prescribed warfarin, 39.8% were prescribed aspirin and 41.7% were prescribed no antithrombotic therapy. After a mean follow-up of 3.6 years, 71 patients (2.2%) developed dementia, giving rise to an incidence of 0.61%/year. The incidence of dementia were 1.04%/year, 0.69%/year and 0.14%/year for patients on no therapy, aspirin and warfarin, respectively. Both univariate and multivariate analyses showed that age ≥75 years, female gender and high CHA2DS2-VASc score were associated with significantly higher risk of dementia; warfarin use was associated with significantly lower risk of dementia (HR: 0.14%, 95% CI 0.05 to 0.36, p<0.001). Patients on warfarin with time in therapeutic range (TTR) � ��65% had a non-significant trend towards a lower risk of dementia compared with those with TTR <65%.

Conclusion

In elderly AF patients, warfarin therapy was associated with a significantly lower risk of new-onset dementia compared those with no therapy or aspirin.

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The starry sky of tuberculoma

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A 17-year-old female on anti-tubercular therapy for pulmonary tuberculosis presented with headache and recurrent episodes of vomiting for 3 months. She had multiple episodes of generalized tonic-clonic seizures with progressive deterioration of sensorium for 1 week prior to hospitalization. Neurological examination revealed meningeal irritation signs and papilloedema in both eyes. The cerebrospinal fluid analysis demonstrated lymphocytic pleocytosis with low glucose and highly elevated protein levels. Contras t-enhanced MRI of the brain showed numerous small, enhancing, discrete and coalescent lesions scattered in the brainstem, basal ganglia and bilateral cerebral and cerebellar hemispheres as well as upper cervical cord (Panel C, D; arrow). Most of the lesions were isointense in T1 weighted imaging (T1WI) (Panel A; arrow) and hypointense in T2 weighted imaging (T2WI) located at the grey–white matter junction (Panel B; arrow) with heterogeneous contrast enhancement and non-enhancing centres, suggestive of a starry sky appearance (Panel C, D) (figure...

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