Πέμπτη 12 Νοεμβρίου 2020

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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Cystinuria

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The patient was an 8-year-old boy with flank pain and past medical history of more than 10 episodes of renal stone since the age of 18 months. Urine analysis revealed positive blood (20–25/HPF) and hexagonal crystals in the sediment (figure 1). The crystals had a negative birefringence with polarised microscopy. The cyanide nitroprusside test was positive (figure 2). The patient was under the treatment of potassium citrate, high fluid intake, low sodium, and low protein diet since the age of 18 mo nths with the diagnosis of cystinuria. D-penicillamine (tiopronin which is a better choice is not available in Iran pharmaceutical market) was also started for the patient at the age of 2 years after the first recurrence of the renal stone.

Cystinuria is a rare hereditary cause of renal stones. It is an autosomal recessive disease due to mutation in SLC3A1 (type A) and SLC7A9 (type B) which...

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Haemolytic crisis of hereditary spherocytosis

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A 23-year-old man presented to the emergency department with a 2-day history of fever, nausea, conjunctival pallor and new yellowing of the skin. His medical history was unremarkable. Physical examination demonstrated mild jaundice of the sclera and skin and a palpable spleen. Laboratory testing showed a haemoglobin of 6.6 g/L (reference range 13.7–16.8 g/L), total bilirubin of 7.03 mg/dL (0.4–1.5 mg/dL), direct bilirubin of 0.67 mg/dL (0–0.4 mg/dL) and a reticulocyte fraction of 2.8% (0 .67–1.92%). Ultrasonography (US) and enhanced CT revealed splenomegaly and non-obstructing gallstones (figure 1). A peripheral blood smear test showed spherocytosis. (figure 2). He disclosed that his family history was notable for splenectomy in his father due to hereditary spherocytosis. A diagnosis of haemolytic crisis of hereditary spherocytosis was made based on these clinical findings. The patient received 2 units of packed red blood cells soon after the admission. Hereditary spherocytosis is the most...

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Effects of the Mediterranean diet adherence on body composition, blood parameters and quality of life in adults

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Background

It has been reported that Mediterranean diet (MD) may improve quality of life and may reduce the risk of chronic diseases such as metabolic syndrome, type 2 diabetes, cardiovascular diseases (CVD), some neurodegenerative diseases and cancer. Therefore, this study aimed to determine adults' adherence to the MD and evaluate the effect of the adherence to the MD on anthropometric measurements, specific biochemical parameters and quality of life.

Methods

A total of 142 volunteer adults were includ ed. Food frequency questionnaire, MD adherence with 14-item scale, quality of life, anthropometric measurements via bioelectrical impedance analysis and certain blood parameters were evaluated.

Results

Out of 14 points, the mean MD adherence score of the participants was 6.89. The mean fat mass was significantly higher in those with low MD adherence (p=0.024). The results of other anthropometric measurements (except height) were higher in those with low MD adherence, though results were non-significant. The participants with high adherence to the MD had lower levels of fasting blood glucose (FBG) (p=0.041), insulin (p=0.019) and triglyceride (TG) (p=0.012) compared with those with lower adherence. No significant relationship was found between the MD and quality of life and other blood parameters.

Conclusion

According to our study, MD adherence was associated with decreased fat mass, FBG, insulin and TG levels which suggests that the MD may be useful in the treatment of som e chronic diseases such as obesity, diabetes, metabolic syndrome and CVD. However, more clinical trials may be performed to determine the relationship between MD and chronic diseases.

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Improving postoperative mobilisation rates in patients undergoing elective major hepatopancreatobiliary surgery

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Background

Early mobilisation reduces postoperative complications such as pneumonia, deep vein thrombosis and hospital length of stay. Many authors have reported poor compliance with early mobilisation within Enhanced Recovery After Surgery initiatives.

Objectives

The primary objective was to increase postoperative day (POD) 2 mobilisation rate from 23% to 75% in patients undergoing elective major hepatopancreatobiliary (HPB) surgery within 6 months.

Methods

We report a multidisciplinary team cl inical practice improvement project (CPIP) to improve postoperative mobilisation of patients undergoing elective major HPB surgery. We identified the common barriers to mobilisation and analysed using the fishbone or cause-and-effect diagram and Pareto chart. A series of Plan–Do–Study–Act cycles followed this. We tracked the rate of early mobilisation and mean distance walked. In the post hoc analysis, we examined the potential cost savings based on reduced hospital length of stay.

Results

Mobilisation rate on POD 2 following elective major HPB surgery improved from 23% to 78.9%, and this sustained at 6 months after the CPIP. Wound pain was the most common reason for failure to ambulate on POD 2. Hospital length of stay reduced from a median of 8 days to 6 days with an estimated cost saving of S$2228 per hospital stay.

Conclusion

Multidisciplinary quality improvement intervention effort resulted in an improved POD 2 mobilisation rate for patients who underw ent elective major HPB surgery. This observed outcome was sustained at 6 months after completion of the CPIP with potential cost savings.

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'The photographic negative of pulmonary oedema in COVID-19 pneumonia

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A 53-year-old man presented to the emergency room (ER) with fever, dry cough and shortness of breath for 6 days. Clinically he had tachycardia (114 beats per minute), tachypnoea (30 per minute) and was maintaining oxygen saturation of 88% on room air. He had acute respiratory distress syndrome (ARDS) (PaO2/FiO2 of 0.28), and there was no leucopaenia or lymphopaenia. Chest X-ray revealed peripheral consolidations with base towards pleura and sparing of peri-hilar region consistent with a r everse batwing appearance (figure 1). The patient's nasopharyngeal swab was tested for SARS Cov-2 RT-PCR, and it was positive. He was diagnosed to have COVID-19 pneumonia and started on oxygen supplementation and supportive care. The patient gradually improved and was discharged. In resource-constrained settings, a chest radiograph is the only investigation available for most patients. The findings have been used to support the diagnosis, determine the severity, guide the treatment and...

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Iatrogenic extracranial internal carotid artery aneurysm

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A previously healthy 25-year-old female was presented to the otorhinolaryngology outpatient clinic, complaining of painless progressive pulsatile swelling over the left side of the neck for 1 month. The patient gave a history of fine-needle aspiration cytology (FNAC) of left cervical lymph node a month ago at a peripheral hospital for reactive cervical lymphadenopathy. She noted the onset of swelling 2–3 days after the FNAC which progressively increased to the current size. Examination showed a fir m, non-tender, pulsatile swelling of size 10 x 8 cm over the left side of the neck (figure 1A), with visible pulsations and bruit on auscultation. Laryngoscopy showed a left lateral pharyngeal wall bulge without any airway compromise. MRI of the neck revealed a well-defined heterointense lesion noted arising from the left proximal internal carotid artery (ICA) displacing external carotid artery anteriorly and a peripheral T2 hyperintense thrombus with central flow voids likely an...

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