Σφακιανάκης Αλέξανδρος
ΩτοΡινοΛαρυγγολόγος
Αναπαύσεως 5 Άγιος Νικόλαος
Κρήτη 72100
00302841026182
00306932607174
alsfakia@gmail.com

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Παρασκευή 1 Φεβρουαρίου 2019

Impact of Lower Extremity Dysmorphia on Lymphedema Patients’ Quality of Life

No abstract available

http://bit.ly/2HOo4Ff

Expanding the use of the perforator free flap in breast reconstructive and aesthetic surgery

No abstract available

http://bit.ly/2sZbR6m

In Defense of Evidence-Based Medicine in Plastic Surgery

No abstract available

http://bit.ly/2HNmBiF

Breast implant weight vs volume: Reappraising breast implant compatibility with tissue characteristics

No abstract available

http://bit.ly/2sZ72dp

Browning of Human Subcutaneous Adipose Tissue after Its Transplantation in Nude Mice

No abstract available

http://bit.ly/2HJibct

Refining Post-Orthognathic Surgery Facial Contour with Computer-Designed: Computer-Manufactured Alloplastic Implants

No abstract available

http://bit.ly/2sZKJ78

Reply to the letter: “Reply to: Enhancement of Progenitor Cells by Two-Step Centrifugation of Emulsified Lipoaspirates”

No abstract available

http://bit.ly/2HW4jvk

Reply to: ‘Enhancement of Progenitor Cells by Two-Step Centrifugation of Emulsified Lipoaspirates.’

No abstract available

http://bit.ly/2sZKGZ0

Re: Use of hyaluronic acid fillers for acquired contour deformities

No abstract available

http://bit.ly/2HKzA4E

RESPONSE: A simple way to reduce surgical-site infections in body contouring surgery

No abstract available

http://bit.ly/2t2UEca

A simple way to reduce surgical-site infections in body contouring surgery

No abstract available

http://bit.ly/2HW4jeO

“Response to: Refining Post-Orthognathic Surgery Facial Contour with Computer-Designed/Computer-Manufactured Alloplastic Implants.”

No abstract available

http://bit.ly/2t5B3rL

Reply: Impact of Lower Extremity Dysmorphia on Lymphedema Patients’ Quality of Life

No abstract available

http://bit.ly/2HJhWhz

Estrogen Signaling in Endometrial Cancer: a Key Oncogenic Pathway with Several Open Questions

Abstract

Endometrial cancer is the most common gynecological cancer in the developed world, and it is one of the few cancer types that is becoming more prevalent and leading to more deaths in the USA each year. The majority of endometrial tumors are considered to be hormonally driven, where estrogen signaling through estrogen receptor α (ER) acts as an oncogenic signal. The major risk factors and some treatment options for endometrial cancer patients emphasize a key role for estrogen signaling in the disease. Despite the strong connections between estrogen signaling and endometrial cancer, important molecular aspects of ER function remain poorly understood; however, progress is being made in our understanding of estrogen signaling in endometrial cancer. Here, we discuss the evidence for the importance of estrogen signaling in endometrial cancer, details of the endometrial cancer-specific actions of ER, and open questions surrounding estrogen signaling in endometrial cancer.



http://bit.ly/2HP4fh4

Primary Prevention of Food Allergy

Abstract

Purpose of Review

The goal of this review is to present an updated summary of the various approaches to prevent childhood food allergies and report recent advances in potential prevention trials for food allergy.

Recent Findings

Several approaches related to maternal dietary supplementation as well as infant GI-based supplementation have been tried and are the subject of ongoing clinical investigation.

Summary

The prevalence of food allergy appears to be increasing but several, varied approaches to prevention are being actively pursued such that an effective strategy may not be too far in the future.



http://bit.ly/2Ts4Jv0

Optimization of the Surgical Field in Endoscopic Sinus Surgery: an Evidence-Based Approach

Abstract

Purpose of Review

The advent of endoscopic sinus surgery (ESS) has enabled the development of minimally invasive surgical procedures in Rhinology. However, proficiency with ESS techniques can still be hampered by poorly controlled bleeding limiting visibility of the surgical field (VSF). This can lead to increased operating time and, more importantly, increased risk of major and minor complications. To optimize the VSF and mitigate the risk of complications, many strategies have been explored.

Recent Findings

This is a narrative review of the relative risks and benefits of pre- and intra-operative interventions aimed at optimizing intraoperative conditions during ESS. The value of these interventions is determined based on their impact on intraoperative blood loss, time of surgery, and the VSF, and weighed against their adverse event profile.

Summary

This review provides a comprehensive overview of the evidence relating to the safety and efficacy of interventions used to improve intraoperative conditions during ESS.



http://bit.ly/2BipHFx

The impact of chlorophyllin on deoxynivalenol transport across jejunum mucosa explants obtained from adult pigs

Abstract

Regardless of the efforts put into preventing or reducing fungal growth, extensive mycotoxin contamination has been reported in animal feeds. In the case of pigs, one of the mycotoxins of major concern is deoxynivalenol (DON). The use of adsorbents as feed additives represents one of the strategies to control mycotoxins' contamination in feedstuff. Therefore, the aim of the study was to verify the ability of chlorophyllin (CHL) to reduce the absorption rate of DON in swine mucosa explants. Intestine was obtained from routinely slaughtered adult pigs. The mucosa explants were studied by means of Ussing chamber technique. The effect of DON (10 and 30 μg/ml) on mucosa viability and permeability and CHL (100 μg/ml) impact on DON (30 μg/ml) absorption was verified. The results revealed that mucosa explants isolated from adult animals remained unaffected for 90 min in the presence of DON in the lower concentration (10 μg/ml). Mycotoxin in the higher dose (30 μg/ml) increased mucosa permeability (decreased transepithelial electrical resistance value) and enhanced paracellular transport of lucifer yellow and mannitol but did not affect lactate dehydrogenase leakage. The introduction of CHL neither diminished the absorption rate of DON across swine mucosa explants nor prevented the toxic effects of DON on intestine. In conclusion, the results confirm the negative effect of DON on pig jejunum mucosa. However, the toxic effect of DON was observed only when it was used in relatively high doses. A promising adsorbent agent, CHL, failed to reduce the intensity of DON transport across intestine under in vitro conditions.



http://bit.ly/2GermiN

Iodine supplementation in women of reproductive age: a survey of clinical practice among Italian gynecologists and midwives



http://bit.ly/2WAMFRq

Asthma and Allergy Mobile Apps in 2018

Abstract

Purpose of Review

This paper offers a comprehensive review of interactive mobile allergy and asthma smartphone applications available within the USA in 2018, with an emphasis on interactive asthma apps.

Recent Findings

Primary care and specialty clinicians interested in introducing digital health apps into their practices will soon have more choices, for Apple® and major electronic medical record software companies are investing heavily in the mobile medical marketplace, guaranteeing personal health information and access to care will always be immediately available in one's digital hand.

Summary

Interactive mobile asthma applications are valuable assets for patients and caregivers alike, for they offer immediate communications between patients and those responsible for providing for their needs.



http://bit.ly/2GmD8r8

Role of Metformin in the Treatment of Patients with Thyroid Nodules and Insulin Resistance: A Systematic Review and Meta-Analysis

Thyroid, Ahead of Print.


http://bit.ly/2TrJEAJ

Impact of type of tooth on outcome of non-surgical root canal treatment

Abstract

Objectives

We assessed the impact of type of tooth on the outcome of root canal treatment (RCT) according to factors potentially weakening the prognosis such as preoperative apical periodontitis (AP) and treatment modality (primary or secondary RCT).

Materials and methods

We scrutinized patient documents including pre- and postoperative radiographs of 640 permanent teeth receiving non-surgical RCT at Helsinki University Clinic in 2008–2011. Of teeth, 44% were molars, 32% premolars, and 24% anterior teeth. Patients' mean age was 51.5 years; 51% were male. AP was present in 60.5% of teeth preoperatively. We used the periapical index (PAI) to assess the radiographs and defined radiographically "healthy" and "healing" cases as successful. Statistical evaluation included chi-squared tests, Fisher's exact tests, t tests, and logistic regression modeling.

Results

The overall success rate (SR) was 84.1%; 88.3% for primary and 75.5% for secondary RCT (p < 0.001). The SRs for anterior teeth, premolars and molars were 85.6%, 88.8%, and 79.7%, respectively. Teeth with and without AP had SRs of 77.3% and 94.5%, respectively (p < 0.001). The RCTs were more likely to succeed in anterior teeth and premolars than in molars (OR 1.7; 95% CI 1.1–2.7) and in females than in males (OR 1.9; 95% CI 1.2–3.1).

Conclusions

Apart from existing AP and retreatment scenario, also, the type of tooth and gender had a significant influence on the outcome of RCT in this study.

Clinical relevance

The prognosis of RCT varies by type of tooth; special attention should be given to RCT of molar teeth.



http://bit.ly/2G7iFHy

High incidence of MTHFR, CBS, and MTRR polymorphisms in vitiligo patients. Preliminary report in a retrospective study

OBJECTIVE: Vitiligo is a multifactorial polygenic disorder with a complex pathogenesis. It is related to both genetic and no genetic factors. The role of genetics is currently studied with several analytical approaches, such as genetic linkage, candidate gene association studies, genome-wide association studies (GWAS), deep DNA re-sequencing and gene expression studies. To date, there are no genetic traits directly related to vitiligo pathogenesis.

PATIENTS AND METHODS: 43 cases of vitiligo patients and 30 healthy donors recruited as control, were screened by assaying the biochemical molecules involved in the self-cells cytotoxicity (haptoglobin and homocysteine) and candidate genes involved in the regulatory process of the re-methylation cycles and transsulfuration. Candidate genes and their polymorphisms screened are methylene-tetrahydrofolate-reductase (MTHFR) C677T and A1298C; cystathionine-beta-synthase enzyme (CBS) I278T and Ins68bp; and methionine-synthase-reductase (MTRR) A66G.

RESULTS: A peculiar genetic profile in vitiligo patients are defined: 11.6% of vitiligo patients shown polymorphic variant MTHFR 677TT vs. 3.3% of healthy donor MTHFR 677CC profile (p=0.0017); 14.0% of vitiligo patients shown CBS polymorphic variant 278TT vs. 3.3% of healthy donor 278II profile (p=0.0012); and 11.6% of vitiligo patients shown MTRR 66GG vs. 3.3% of healthy donor MTRR 677AA profile (p>0.0001).

CONCLUSIONS: This is the first study reporting the correlation between the polymorphic status of MTHFR C677T, CBS I278T, and MTRR A66G and vitiligo. The genetic screening of these polymorphisms could be useful for early detection of the inheritance risk factor in a subject carrying relatives with vitiligo. Although these data could suggest a kind of dysregulation, genetically based, of thiols production mechanisms. Based on these results, we have not been able to get hypothesis about the putative pathogenesis of vitiligo, and the precise cause remains unclear.

L'articolo High incidence of MTHFR, CBS, and MTRR polymorphisms in vitiligo patients. Preliminary report in a retrospective study sembra essere il primo su European Review.



http://bit.ly/2UtlxSo

High incidence of MTHFR, CBS, and MTRR polymorphisms in vitiligo patients. Preliminary report in a retrospective study

OBJECTIVE: Vitiligo is a multifactorial polygenic disorder with a complex pathogenesis. It is related to both genetic and no genetic factors. The role of genetics is currently studied with several analytical approaches, such as genetic linkage, candidate gene association studies, genome-wide association studies (GWAS), deep DNA re-sequencing and gene expression studies. To date, there are no genetic traits directly related to vitiligo pathogenesis.

PATIENTS AND METHODS: 43 cases of vitiligo patients and 30 healthy donors recruited as control, were screened by assaying the biochemical molecules involved in the self-cells cytotoxicity (haptoglobin and homocysteine) and candidate genes involved in the regulatory process of the re-methylation cycles and transsulfuration. Candidate genes and their polymorphisms screened are methylene-tetrahydrofolate-reductase (MTHFR) C677T and A1298C; cystathionine-beta-synthase enzyme (CBS) I278T and Ins68bp; and methionine-synthase-reductase (MTRR) A66G.

RESULTS: A peculiar genetic profile in vitiligo patients are defined: 11.6% of vitiligo patients shown polymorphic variant MTHFR 677TT vs. 3.3% of healthy donor MTHFR 677CC profile (p=0.0017); 14.0% of vitiligo patients shown CBS polymorphic variant 278TT vs. 3.3% of healthy donor 278II profile (p=0.0012); and 11.6% of vitiligo patients shown MTRR 66GG vs. 3.3% of healthy donor MTRR 677AA profile (p>0.0001).

CONCLUSIONS: This is the first study reporting the correlation between the polymorphic status of MTHFR C677T, CBS I278T, and MTRR A66G and vitiligo. The genetic screening of these polymorphisms could be useful for early detection of the inheritance risk factor in a subject carrying relatives with vitiligo. Although these data could suggest a kind of dysregulation, genetically based, of thiols production mechanisms. Based on these results, we have not been able to get hypothesis about the putative pathogenesis of vitiligo, and the precise cause remains unclear.

L'articolo High incidence of MTHFR, CBS, and MTRR polymorphisms in vitiligo patients. Preliminary report in a retrospective study sembra essere il primo su European Review.



http://bit.ly/2UtlxSo

A pilot prospective study of 577-nm yellow subthreshold micropulse laser treatment with two different power settings for acute central serous chorioretinopathy

Abstract

To compare the efficacy of 50% threshold power with 25% threshold power of 577-nm subthreshold micropulse laser (SMPL) for acute central serous chorioretinopathy (CSC). Prospective, interventional, non-randomized, comparative case series. A total of 54 patients (54 eyes) with acute CSC were enrolled. Twenty-four eyes received 25% threshold power and 30 eyes received 50% threshold power of 577-nm SMPL. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and complete absorption of subretinal fluid (SRF) were evaluated at 1 month and 3 months. The complete absorption rate of SRF in the 50% power group was significantly greater than that in the 25% power group at 1 month (70.0% vs 25.0%, p < 0.001) and at 3 months (83.3% vs 54.2%, p < 0.001). Mean BCVA improved from 0.34 ± 0.20 LogMAR to 0.02 ± 0.13 LogMAR in the 50% power group and from 0.27 ± 0.15 LogMAR to 0.14 ± 0.21 LogMAR in the 25% power group with a significant difference between the two groups after 3 months (p = 0.027). In the 50% power group, the CMT decreased from 491.6 ± 154.8 μm at baseline to 231.3 ± 92.3 μm at 1 month and 228.2 ± 88.1 μm at 3 months, and in the 25% power group, the CMT decreased from 444.9 ± 164.1 to 306.8 ± 102.6 μm at 1 month and 254.5 ± 101.7 μm at 3 months. There was statistical difference of CMT at 1 month (p = 0.009) but no significant difference at 3 months between the two groups (p = 0.232). SMPL with 50% threshold power may be more effective than 25% threshold power for acute CSC.



http://bit.ly/2MMDBEy

The photocytotoxicity effect of cationic sulfonated corrole towards lung cancer cells: in vitro and in vivo study

Abstract

Corrole is a kind of new and promising photosensitizer (PS) in cancer photodynamic therapy (PDT). However, the protein molecular mechanism of PDT activity for corrole under light irradiation is still not clear. In this paper, water-soluble cationic sulfonated corrole (1) and its metal complexes (1-Fe, 1-Mn, and 1-Cu) were prepared, and the photodynamic anti-cancer activity against various tumor cells was investigated by MTT assay. The potential molecular mechanism of PDT activity was elucidated by fluorescence microscope, flow cytometry, molecular docking, and western blotting analysis. Besides, the potential PDT anti-tumor effect of 1 in vivo was assessed in human tumor xenografts in mice. Quantitative analysis revealed that 1's phototoxicity triggered a significant generation of reactive oxygen species, causing disruption of mitochondrial membrane potential. The results of western blotting (WB) assay shown in 1's phototoxicity could induce cell apoptosis via ROS-mediated mitochondrial caspase apoptosis pathway, in which SIRT1 protein degradation played a key role. PTD activity in vivo shown in 1 could significantly reduce the growth of A549 xenografted tumor, without obvious loss of mice body weight. We clearly found that cationic sulfonated corrole is a potential candidate of PS in vitro and in vivo. The phototoxicity of 1 could induce A549 cell apoptosis by inducing ROS production increase, further to activate the mitochondrial apoptosis pathway. We concluded that SIRT1 protein is a more appropriate target in this progress.



http://bit.ly/2DQ04NW

Neoadjuvant Management of Early Breast Cancer: A Clinical and Investigational Position Statement

AbstractBackground.Neoadjuvant treatment is increasingly one of the preferred therapeutic options for early breast cancer and may have some unique outcomes, such as identifying predictive and prognostic factors of response or increasing the knowledge of individual tumor biology.Design.A panel of experts from different specialties reviewed published clinical studies on the neoadjuvant management of breast cancer. Recommendations were made that emphasized the clinical multidisciplinary management and the investigational leverage in early breast cancer.Results.Neoadjuvant therapy has equivalent efficacy to adjuvant therapy, and it has some additional benefits that include increasing breast conservation, assessing tumor response, establishing prognosis based on the pathological response, and providing a "second opportunity" for nonresponding patients. Achieving pathological complete remission because of neoadjuvant therapy has been correlated with long‐term clinical benefit, particularly in HER2‐positive and triple‐negative breast cancer. In addition, the neoadjuvant setting is a powerful model for the development of new drugs and the identification of prognostic markers. Finally, neoadjuvant therapy has proven to be cost‐effective by reducing nondrug costs, avoiding radical surgery, and reducing hospital stays when compared with other treatment approaches.Conclusion.Neoadjuvant therapy has clinical benefits in early breast cancer and provides in vivo information of individual breast cancer biology while allowing the investigation of new treatment approaches. Access to neoadjuvant therapy should be an option available to all patients with breast cancer through multidisciplinary tumor management.Implications for Practice.Neoadjuvant treatment should be strongly considered as a therapeutic option for localized breast cancer and is a powerful tool for understanding breast cancer biology and investigating new treatment approaches.

http://bit.ly/2S8SvLi

A Pilot Study of Vinorelbine Safety and Pharmacokinetics in Patients with Varying Degrees of Liver Dysfunction

AbstractBackground.Vinorelbine has demonstrated anticancer activity and is primarily metabolized in the liver. This single‐institution, phase I pilot study describes the safety and pharmacokinetics of vinorelbine in patients with varying degrees of hepatic impairment.Materials and Methods.Patients with treatment‐refractory solid tumors were enrolled into treatment arms based on vinorelbine dose (weekly infusions of 7.5–30 mg/m2) and liver function (normal liver function, mild, moderate, or severe liver dysfunction). Vinorelbine pharmacokinetics were evaluated to describe its relationship with liver function. Indocyanine green (ICG) clearance was assessed for correlation with pharmacokinetics.Results.Forty‐seven patients were enrolled, and a total of 108 grade 3–4 treatment‐related adverse events (AEs) occurred. Of these, grade 3–4 myelosuppression was the most common (34.3%). Thirty‐three (30.6%), 22 (20.4%), and 9 (8.3%) grade 3–4 AEs were observed in the vinorelbine 20 mg/m2/severe, 15 mg/m2/moderate, and 7.5 mg/m2/severe liver dysfunction groups, respectively, with the majority being nonhematologic toxicities. ICG clearance decreased as liver function worsened. Vinorelbine pharmacokinetics were not correlated with ICG elimination or the degree of liver dysfunction.Conclusion.For patients with severe liver dysfunction (bilirubin >3.0 mg/dL), vinorelbine doses ≥7.5 mg/m2 are poorly tolerated. The high incidence of grade 3–4 AEs with 15 mg/m2 vinorelbine in moderate liver dysfunction (bilirubin 1.5–3.0 mg/dL) raises concerns for its safety in this population. Vinorelbine pharmacokinetics are not affected by liver dysfunction; however, levels of the active metabolite 4‐O‐deacetylvinorelbine were not measured and may be higher in patients with liver dysfunction if its elimination is impacted by liver impairment to a greater degree than the parent drug.Implications for Practice.Vinorelbine remains widely prescribed in advanced malignancies and is under development in immunotherapy combinations. Given vinorelbine is primarily hepatically metabolized, understanding its safety and pharmacokinetics in liver dysfunction remains paramount. In this phase I pilot study, weekly vinorelbine at doses ≥7.5 mg/m2 is poorly tolerated in those with severe liver dysfunction. Furthermore, a high incidence of grade 3–4 toxicities was observed with vinorelbine at 15 mg/m2 in those with moderate liver dysfunction. Vinorelbine pharmacokinetics do not appear affected by degree of liver dysfunction. Further evaluation of levels of the free drug and active metabolites in relationship to liver function are warranted.

http://bit.ly/2UzOQmi

A Cost‐Effectiveness Analysis of Nivolumab and Ipilimumab Versus Sunitinib in First‐Line Intermediate‐ to Poor‐Risk Advanced Renal Cell Carcinoma

AbstractBackground.The treatment paradigm of advanced renal cell carcinoma (RCC) has changed rapidly in recent years. In first‐line treatment of intermediate‐ to poor‐risk patients, the CheckMate 214 study demonstrated a significant survival advantage for nivolumab and ipilimumab versus sunitinib. The high cost of combined immune‐modulating agents warrants an understanding of the combination's value by considering both efficacy and cost. The objective of this study was to estimate the cost‐effectiveness of nivolumab and ipilimumab compared with sunitinib for first‐line treatment of intermediate‐ to poor‐risk advanced RCC from the U.S. payer perspective.Materials and Methods.A Markov model was developed to compare the costs and effectiveness of nivolumab and ipilimumab with those of sunitinib in the first‐line treatment of intermediate‐ to poor‐risk advanced RCC. Health outcomes were measured in life‐years and quality‐adjusted life‐years (QALYs). Drug costs were based on Medicare reimbursement rates in 2017. We extrapolated survival beyond the trial closure using Weibull distribution. Model robustness was addressed in univariable and probabilistic sensitivity analyses.Results.The total mean cost per‐patient of nivolumab and ipilimumab versus sunitinib was $292,308 and $169,287, respectfully. Nivolumab and ipilimumab generated a gain of 0.978 QALYs over sunitinib. The incremental cost‐effectiveness ratio (ICER) for nivolumab and ipilimumab was $125,739/QALY versus sunitinib.Conclusion.Our analysis established that the base case ICER in the model for nivolumab and ipilimumab versus sunitinib is below what some would consider the upper limit of the theoretical willingness‐to‐pay threshold in the U.S. ($150,000/QALY) and is thus estimated to be cost‐effective.Implications for Practice.This article assessed the cost‐effectiveness of nivolumab and ipilimumab versus sunitinib for treatment of patients with intermediate‐ to poor‐risk metastatic kidney cancer, from the U.S. payer perspective. It would cost $125,739 to gain 1 quality‐adjusted life‐year with nivolumab and ipilimumab versus sunitinib in these patients.

http://bit.ly/2S8Sjvy

Changes in the Use of Comprehensive Geriatric Assessment in Clinical Trials for Older Patients with Cancer over Time

AbstractBackground.The objective of this study was to describe the implementation of comprehensive geriatric assessment (CGA) in clinical trials dedicated to older patients before and after the creation of the International Society of Geriatric Oncology in the early 2000s.Subjects, Materials, and Methods.All phase I, II, and III trials dedicated to the treatment of cancer among older patients published between 2001 and 2004 and between 2011 and 2014 were reviewed. We considered that a CGA was performed when the authors indicated an intention to do so in the Methods section of the article. We collected each geriatric domain assessed using a validated tool even in the absence of a clear CGA, including nutritional, functional, cognitive, and psychological status, comorbidity, comedication, overmedication, social status and support, and geriatric syndromes.Results.A total of 260 clinical trials dedicated to older patients were identified over the two time periods: 27 phase I, 193 phase II, and 40 phase III trials. CGA was used in 9% and 8% of phase II and III trials, respectively; it was never used in phase I trials. Performance status was reported in 67%, 79%, and 75% of phase I, II, and III trials, respectively. Functional assessment was reported in 4%, 11%, and 13% of phase I, II, and III trials, respectively. Between the two time periods, use of CGA increased from 1% to 11% (p = .0051) and assessment of functional status increased from 3% to 14% (p = .0094).Conclusion.The use of CGA in trials dedicated to older patients increased significantly but remained insufficient.Implications for Practice.This article identifies the areas in which research efforts should be focused in order to offer physicians well‐addressed clinical trials with results that can be extrapolated to daily practice.

http://bit.ly/2UzOJqS

Analyse und Management von postoperativen Schmerzen nach Sialendoskopie

10-1055-a-0834-6147-1.jpg

Laryngo-Rhino-Otol
DOI: 10.1055/a-0834-6147

Hintergrund Die Sialendoskopie ist ein minimal-invasives Verfahren zur Diagnostik und Therapie von Erkrankungen des Speicheldrüsengangsystems. Sie kann in ITN und in LA durchgeführt werden. Vor diesem Hintergrund ist die postoperative Schmerzsituation interessant, über deren Ausmaß aktuell jedoch wenig bekannt ist. Daher wurden in dieser Studie die postoperativen Schmerzen nach Sialendoskopie in LA und ihr Schmerzmanagement in einer quantitativen Untersuchung erfasst und analysiert. Material und Methoden Es wurden 103 Patienten in die retrospektive Studie eingeschlossen, bei denen im Zeitraum von 2013 bis 2015 eine Sialendoskopie der Glandula parotis oder der Glandula submanibularis in Lokalanästhesie durchgeführt wurde. Analysiert wurden die postoperativen Schmerzen in Ruhe und bei Belastung am Operationstag, sowie am ersten und zweiten postoperativen Tag. Die Schmerzen wurden anhand einer numerischen Rating Skala (NRS 0–10) erfasst, welche im Rahmen des QUIPS-Projektes (Qualitätsverbesserung in der postoperativen Schmerztherapie) verwendet wird. Ergebnisse Am Operationstag betrug der Schmerz in Ruhe 0,9 ± 1,9 und bei Belastung 0,7 ± 1,4. Am ersten postoperativen Tag wurden Schmerzen von 1,2 ± 1,8 in Ruhe und 0,9 ± 1,9 bei Belastung festgestellt. Am zweiten postoperativen Tag zeigte sich eine Reduktion der Schmerzen auf 0,75 ± 1,6 in Ruhe und 0,73 ± 1,5 bei Belastung. Insgesamt wurden Metamizol (Novalgin®) und Ibuprofen als häufigste postoperative Analgetika eingesetzt. Am Operationstag erhielten 37,9 % der Patienten Schmerzmittel, am ersten postoperativen Tag 26,2 % der Patienten und am zweiten postoperativen Tag 12,6 % der Patienten. Schlussfolgerung Sialendoskopien der Glandula submandibularis und parotis sind mit moderaten postoperativen Schmerzen verbunden, welche sich gut mit Nicht-Opioiden behandeln lassen.
[...]

© Georg Thieme Verlag KG Stuttgart · New York

Article in Thieme eJournals:
Table of contents  |  Abstract  |  Full text



http://bit.ly/2TsWA9s

EU Panel Recommends Humira Biosimilars Idacio, Kromeya

The EMA's Committee for Medicinal Products for Human Use has recommended marketing authorization for two biosimilars that are highly similar to Humira (adalimumab, AbbVie).
International Approvals

https://wb.md/2D1lYMy

Does information and communication technologies improve environmental quality in the era of globalization? An empirical analysis

Abstract

This study intends to examine the impact of ICTs (i.e., internet usage and mobile cellular subscriptions), globalization, electricity consumption, financial development, and economic growth on environmental quality by using 1994–2014 panel data of BRICS economies. This study employed a second-generation panel unit root test accounting for the presence of cross-sectional dependence and indicated that carbon dioxide emissions, electricity consumption, financial development, internet usage, mobile usage, globalization, and economic growth have integration of order one. The results from Westerlund panel co-integration test confirms that the variables are co-integrated and revealed that ICT-finance-globalization-electricity-GDP-CO2 nexus has long-run equilibrium relationship. The results from dynamic seemingly unrelated regression (DSUR) indicate that internet usage and mobile cellular subscriptions (ICTs) have significant, adverse impact on carbon dioxide emissions. To put it simply, ICT positively contributes towards environmental quality. Similarly, economic growth also has an adverse effect on carbon dioxide emissions. On the other hand, electricity consumption, globalization, and financial development have a significant positive effect on carbon emissions. In addition, Granger causality test results show the presence of a bidirectional causal relationship between internet usage and environmental quality, financial development and electricity consumption, ICT and financial development, mobile cellular subscription and globalization, economic growth and environmental quality, and internet usage and economic growth. A unidirectional causal link is detected running from mobile cellular subscriptions towards environmental quality, ICT towards electricity consumption, financial development towards environmental quality, globalization towards environmental quality, and globalization towards economic growth. Moreover, time series analysis has also been done in this study to analyze the findings for each of BRICS countries which are directed towards important policy implications. For instance, ICT policy can play an integral part in improving environmental quality policy.



http://bit.ly/2S4g9Iv

Experimental investigation of diesel engine performance fuelled with the blends of Jatropha curcas , ethanol, and diesel

Abstract

Nonrenewable fossil fuels show increased demand and with fossil fuels at a rapid depleting stage, there seems to be an increase in requirement for alternative fuels too. Biofuels and blended fossil fuels are one of a kind. Nonedible jatropha (Jatropha curcas) oil-based methyl ester was produced and mixed with ethanol and blended with conventional diesel in various compositions. Jatropha biodiesel is used because of its great blending capacity with diesel. Sodium hydroxide is used as a catalyst which allows miscibility between ethanol and diesel. In present epoch, the paucity of fossil fuels and its adverse impact have driven researchers to focus on alternative fuels. Biodiesel is one of the most favorable and promising alternatives in the application of automobiles, boilers, gas turbines, etc. This study targets at finding the engine performance and emission characteristics under various load conditions on Kirloskar single-cylinder VCR research engine by blending both jatropha biodiesel and ethanol with base diesel at various compositions. Both jatropha biodiesel and ethanol have high calorific value which is a most important factor for engine power production. The performance analysis showed that the biodiesel blend of 98% diesel with 1.5% jatropha biodiesel and 0.5% (D98J1.5E0.5) of ethanol had a significant improvement in the engine performance than the conventional diesel.



http://bit.ly/2UBglMu

REPLY to ‘Comment on “Anti-aging effects of ingenol mebutate for patients with actinic keratosis” and phenol-croton oil peelings’



http://bit.ly/2G52kDy

Follicular mucinosis in patients with hematologic malignancies other than mycosis fungoides: A clinicopathologic study

Follicular mucinosis in association with systemic hematologic disorders other than mycosis fungoides is poorly characterized. Clinicopathological features of follicular mucinosis in the setting of hematopoietic stem cell transplantation and diverse systemic hematologic malignancies differ from mycosis fungoides-associated cases and follicular mucinosis is not necessarily a precursor to cutaneous T-cell lymphoma.

http://bit.ly/2D0QYMN

About “Anti-aging effects of ingenol mebutate for patients with actinic keratosis” and phenol-croton oil peelings



http://bit.ly/2G67BKK

Book Review: Biodynamic Excisional Skin Tension Lines for Cutaneous Surgery



http://bit.ly/2D2bVH9

Secukinumab for moderate to severe palmoplantar pustular psoriasis: Results of the 2PRECISE study

Palmoplantar pustular psoriasis is chronic, disabling and resistant to treatment. The 2PRECISE randomized controlled trial shows potential benefits of secukinumab in the treatment of palmoplantar pustular psoriasis over 52 weeks with improved quality of life, and no unexpected adverse events.

http://bit.ly/2RxhSB9

Inhibition of Histone Methyltransferase G9a Attenuates Noise-Induced Cochlear Synaptopathy and Hearing Loss

ABSTRACT

Posttranslational modification of histones alters their interaction with DNA and nuclear proteins, influencing gene expression and cell fate. In this study, we investigated the effect of G9a (KMT1C, EHMT2), a major histone lysine methyltransferase encoded by the human EHMT2 gene and responsible for histone H3 lysine 9 dimethylation (H3K9me2) on noise-induced permanent hearing loss (NIHL) in adult CBA/J mice. The conditions of noise exposure used in this study led to losses of cochlear synapses and outer hair cells (OHCs) and permanent auditory threshold shifts. Inhibition of G9a with its specific inhibitor BIX 01294 or with siRNA significantly attenuated these pathological features. Treatment with BIX 01294 also prevented the noise-induced decrease of KCNQ4 immunolabeling in OHCs. Additionally, G9a was increased in cochlear cells, including both outer and inner sensory hair cells, some spiral ganglion neurons (SGNs), and marginal cells, 1 h after the completion of the noise exposure. Also subsequent to noise exposure, immunoreactivity for H3K9me2 appeared in some nuclei of OHCs following a high-to-low frequency gradient with more labeled OHCs in the 45-kHz than the 32-kHz region, as well as in the marginal cells and in some SGNs of the basal turn. These findings suggest that epigenetic modifications of H3K9me2 are involved in NIHL and that pharmacological targeting of G9a may offer a strategy for protection against cochlear synaptopathy and NIHL.



http://bit.ly/2WAxcRi

Synthesis and characterization of magnetic Fe 3 O 4 @CaSiO 3 composites and evaluation of their adsorption characteristics for heavy metal ions

Abstract

A two-component material (Fe3O4@CaSiO3) with an Fe3O4 magnetite core and layered porous CaSiO3 shell from calcium nitrate and sodium silicate was synthesized by precipitation. The structure, morphology, magnetic properties, and composition of the Fe3O4@CaSiO3 composite were characterized in detail, and its adsorption performance, adsorption kinetics, and recyclability for Cu2+, Ni2+, and Cr3+ adsorption were studied. The Fe3O4@CaSiO3 composite has a 2D core–layer architecture with a cotton-like morphology, specific surface area of 41.56 m2/g, pore size of 16 nm, and pore volume of 0.25 cm3/g. The measured magnetization saturation values of the magnetic composite were 57.1 emu/g. Data of the adsorption of Cu2+, Ni2+, and Cr3+ by Fe3O4@CaSiO3 fitted the Redlich–Peterson and pseudo-second-order models well, and all adsorption processes reached equilibrium within 150 min. The maximum adsorption capacities of Fe3O4@CaSiO3 toward Cu2+, Ni2+, and Cr3+ were 427.10, 391.59, and 371.39 mg/g at an initial concentration of 225 mg/L and a temperature of 293 K according to the fitted curve with the Redlich–Peterson model, respectively. All adsorption were spontaneous endothermic processes featuring an entropy increase, including physisorption, chemisorption, and ion exchange; among these process, chemisorption was the primary mechanism. Fe3O4@CaSiO3 exhibited excellent adsorption, regeneration, and magnetic separation performance, thereby demonstrating its potential applicability to removing heavy metal ions.



http://bit.ly/2MJDUzO

Preparation of various thiol-functionalized carbon-based materials for enhanced removal of mercury from aqueous solution

Abstract

In this work, biochar (BC), activated carbon (AC), and graphene oxide (GO) were thiol-functionalized using 3-mercaptopropyltrimethoxysilane (3-MPTS) (named as BCS, ACS, and GOS, respectively). BCS, ACS, and GOS were synthesized mainly via the interaction between hydrolyzed 3-MPTS and surface oxygen-containing functional groups (e.g., –OH, O–C=O, and C=O) and π-π interaction. The materials before and after modification were characterized and tested for mercury removal, including sorption kinetics and isotherms, the effects of adsorbent dosage, initial pH, and ionic strength. Pseudo-second-order sorption kinetic model (R2 = 0.992~1.000) and Langmuir sorption isotherm model (R2 = 0.964~0.998) fitted well with the sorption data of mercury. GOS had the most –SH groups with the largest adsorption capacity for Hg2+ and CH3Hg+ (449.6 and 127.5 mg/g), followed by ACS (235.7 and 86.7 mg/g) and BCS (175.6 and 30.3 mg/g), which were much larger than GO (96.7 and 4.9 mg/g), AC (81.1 and 24.6 mg/g), and BC (95.6 and 9.4 mg/g). GOS and ACS showed stable mercury adsorption properties at a wide pH range (2~9) and ionic strength (0.01~0.1 mol/L). Mercury maybe removed by ligand exchange, surface complexation, and electrostatic attraction.



http://bit.ly/2DOZBf6

The application of forward osmosis for simulated surface water treatment by using trisodium citrate as draw solute

Abstract

In this study, trisodium citrate was used as draw solute in forward osmosis (FO) due to its biodegradability and easy reuse after FO dilution. The effect of operating conditions on FO performance was investigated. The study focused on the long-term flux performance and membrane fouling when surface water was used as feed solution. A water flux of 9.8 LMH was observed using 0.5 M trisodium citrate as draw solution in PRO mode. In the long-term FO process, trisodium citrate showed a slight decrease in total flux loss (13.06%) after 20 h of operation. The membrane fouling was significantly reduced after a two-step physical cleaning. A considerable flux recovery (> 95%) of the fouled membrane was finally obtained. Therefore, this study proves the superiority of trisodium citrate as draw solution and paves a new way in applying FO directly for surface water reclamation.



http://bit.ly/2MJDSba

Inhibition of Histone Methyltransferase G9a Attenuates Noise-Induced Cochlear Synaptopathy and Hearing Loss

ABSTRACT

Posttranslational modification of histones alters their interaction with DNA and nuclear proteins, influencing gene expression and cell fate. In this study, we investigated the effect of G9a (KMT1C, EHMT2), a major histone lysine methyltransferase encoded by the human EHMT2 gene and responsible for histone H3 lysine 9 dimethylation (H3K9me2) on noise-induced permanent hearing loss (NIHL) in adult CBA/J mice. The conditions of noise exposure used in this study led to losses of cochlear synapses and outer hair cells (OHCs) and permanent auditory threshold shifts. Inhibition of G9a with its specific inhibitor BIX 01294 or with siRNA significantly attenuated these pathological features. Treatment with BIX 01294 also prevented the noise-induced decrease of KCNQ4 immunolabeling in OHCs. Additionally, G9a was increased in cochlear cells, including both outer and inner sensory hair cells, some spiral ganglion neurons (SGNs), and marginal cells, 1 h after the completion of the noise exposure. Also subsequent to noise exposure, immunoreactivity for H3K9me2 appeared in some nuclei of OHCs following a high-to-low frequency gradient with more labeled OHCs in the 45-kHz than the 32-kHz region, as well as in the marginal cells and in some SGNs of the basal turn. These findings suggest that epigenetic modifications of H3K9me2 are involved in NIHL and that pharmacological targeting of G9a may offer a strategy for protection against cochlear synaptopathy and NIHL.



http://bit.ly/2WAxcRi

In vivo comparison of the proangiogenic properties of chlordecone and three of its dechlorinated derivatives formed by in situ chemical reduction

Abstract

In situ chemical reduction (ISCR) has been identified as a possible way for the remediation of soils contaminated by chlordecone (CLD). Evidences provided by the literature indicate an association between the development of prostate cancer and CLD exposure (Multigner et al. 2010). In a previous in vitro study, we demonstrated that the two main dechlorinated CLD derivatives formed by ISCR, CLD-1Cl, and CLD-3Cl have lower cytotoxicity and proangiogenic properties than CLD itself (Legeay et al. 2017). By contrast, nothing is known on the in vivo proangiogenic effect of these dechlorinated derivatives. Based on in vitro data, the aims of this study were therefore to evaluate the in vivo influence of CLD and three of its dechlorinated metabolites in the control of neovascularization in a mice model of prostate cancer. The proangiogenic effect of CLD and three of its dechlorinated derivatives, CLD-1Cl, CLD-3Cl, and CLD-4Cl, was evaluated on a murine model of human prostate tumor (PC-3) treated, at two exposure levels: 33 μg/kg and 1.7 μg/kg respectively reflecting acute and chronic toxic exposure in human. The results of serum measurements show that, for the same ingested dose, the three metabolite concentrations were significantly lower than that of CLD. Dechlorination of CLD lead therefore to molecules that are biologically absorbed or metabolized, or both, faster than the parent molecule. Prostate tumor growth was lower in the groups treated by the three metabolites compared to the one treated by CLD. The vascularization measured on the tumor sections was inversely proportional to the rate of dechlorination, the treatment with CLD-4Cl showing no difference with control animals treated with only the vehicle oil used for all substances tested. We can therefore conclude that the proangiogenic effect of CLD is significantly decreased following the ISCR-resulting dechlorination. Further investigations are needed to elucidate the molecular mechanisms by which dechlorination of CLD reduces proangiogenic effects in prostate tumor.



http://bit.ly/2S1RdkZ

Biocompatibility and biodistribution of surface-modified yttrium oxide nanoparticles for potential theranostic applications

Abstract

The surface of ultrafine yttrium oxide nanoparticles (NPs) with mean size of 7–8 nm was modified with a functional polymer layer to improve their dispersion and impart fluorescent properties for imaging purposes. Surface functionalization was achieved by silanization of yttrium oxide NPs with 3-trimethoxysilylpropyl methacrylate followed by grafting of a co-polymer made of acrylic acid (AA) and ethylene glycol methacrylate phosphate (EGMP). The polymer shell decreases the surface energy of NPs, enhances their polarity, and, as a result, improves their colloidal stability. The synthesized NPs are capable of scavenging free radicals and for this reason have therapeutic potential that warrants further investigations. Furthermore, these stabilized core–shell NPs showed a very low cytotoxicity, confirming that the polymer shell sensibly improves the biocompatibility of bare yttrium oxide NPs, which are otherwise toxic on their own. Poly-EGMP yttrium NPs proved to be safe up to 0.1 mg/g body weight in 1 month old Sprague–Dawley rats, showing also the ability to cross the blood–brain barrier short time after tail injection. The surface modification of yttrium NPs here described allows these NPs to be potentially used in theranostics to reduce neurodegenerative damage due to the heat stress.



http://bit.ly/2UwAYJx

Implications and Future Perspectives of AGEs in PCOS Pathophysiology

Publication date: Available online 1 February 2019

Source: Trends in Endocrinology & Metabolism

Author(s): Zaher Merhi, Eleni A. Kandaraki, Evanthia Diamanti-Kandarakis

Human, animal, and in vitro studies provide evidence that advanced glycation end-products (AGEs) may contribute to the pathogenesis of polycystic ovary syndrome (PCOS) and its metabolic and reproductive consequences. AGEs are able to induce, via activation of key intracellular signaling pathways, the generation of oxidative stress and proinflammatory cytokines, thus contributing to the adverse health impact of PCOS. This review presents the implications of AGEs in several disease pathophysiologies, including PCOS, as well as the cellular and systemic effects of AGEs on insulin resistance (IR), hyperandrogenemia, endoplasmic reticulum (ER) stress, hypoxia, and ovarian function. The gaps in our knowledge will serve as launching pad for future developments ranging from dietary and lifestyle changes to pharmaceutical interventions aiming at potential applications in women with PCOS.



http://bit.ly/2S0uHJk

Spatial Technologies in Obesity Research: Current Applications and Future Promise

Publication date: Available online 1 February 2019

Source: Trends in Endocrinology & Metabolism

Author(s): Peng Jia, Hong Xue, Li Yin, Alfred Stein, Minqi Wang, Youfa Wang

Geographic Information Systems (GIS), Global Positioning Systems (GPS), and remote sensing (RS) are revolutionizing obesity-related research. The primary applications of GIS have included visualizing obesity outcomes and risk factors, constructing obesogenic environmental indicators, and detecting geographical patterns of obesity prevalence and obesogenic environmental features. GPS was mainly used to delineate individual activity space and combined with other devices to measure obesogenic behaviors. RS has been understated for its role as important sources of data about natural and built environments. These spatial technologies, collectively called the 3S technologies, will be useful in measuring more facets of obesogenic environments and individual environmental exposure at finer levels and studying obesity etiology and interventions.



http://bit.ly/2D4zUp2

Anticatabolic Effects of Ketone Bodies in Skeletal Muscle

Publication date: Available online 31 January 2019

Source: Trends in Endocrinology & Metabolism

Author(s): Andrew P. Koutnik, Dominic P. D'Agostino, Brendan Egan

The ketone bodies acetoacetate (AcAc) and β-hydroxybutyrate (βHB) are the subject of renewed interest given recently established pleiotropic effects regulating inflammation, oxidative stress, and gene expression. Anticatabolic effects of β-hydroxybutyrate have recently been demonstrated in human skeletal muscle under inflammatory insult, thereby expanding upon the wide-ranging therapeutic applications of nutritional ketosis.



http://bit.ly/2S1EQW8

Environmental risk appraisement of disinfection by-products (DBPs) in plant model system: Allium cepa

Abstract

The organic toxicants formed in chlorinated water cause potential harm to human beings, and it is extensively concentrated all over the world. Various disinfection by-products (DBPs) occur in chlorinated water are genotoxic and carcinogenic. The toxicity is major concern for chlorinated DBPs which has been present more in potable water. The purpose of the work was to evaluate genotoxic properties of DBPs in Allium cepa as a plant model system. The chromosomal aberration and DNA laddering assays were performed to examine the genotoxic effect of trichloroacetic acid (TCAA), trichloromethane (TCM), and tribromomethane (TBM) in a plant system with distinct concentrations, using ethyl methanesulfonate (EMS) as positive control and tap water as negative control. In Allium cepa root growth inhibition test, the inhibition was concentration dependent, and EC50 values for trichloroacetic acid (TCAA), trichloromethane (TCM), and tribromomethane (TBM) were 100 mg/L, 160 mg/L, and 120 mg/L respectively. In the chromosome aberration assay, root tip cells were investigated after 120 h exposure. The bridge formation, sticky chromosomes, vagrant chromosomes, fragmented chromosome, c-anaphase, and multipolarity chromosomal aberrations were seen in anaphase–telophase cells. It was noticed that with enhanced concentrations of DBPs, the total chromosomal aberrations were more frequent. The DNA damage was analyzed in roots of Allium cepa exposed with DBPs (TCAA, TCM, TBM) by DNA laddering. The biochemical assays such as lipid peroxidation, H2O2 content, ascorbate peroxidase, guaiacol peroxidase, and catalase were concentration dependent. The DNA interaction studies were performed to examine binding mode of TCAA, TCM, and TBM with DNAs. The DNA interaction was evaluated by spectrophotometric and spectrofluorometric studies which revealed that TCAA, TCM, and TBM might interact with Calf thymus DNA (CT- DNA) by non-traditional intercalation manner.



http://bit.ly/2Rt1fql

Extremity nevus count is an independent risk factor for basal cell carcinoma and melanoma, but not squamous cell carcinoma

Publication date: Available online 31 January 2019

Source: Journal of the American Academy of Dermatology

Author(s): Erin X. Wei, Xin Li, Hongmei Nan

Background

The presence of nevi portends an increased risk for melanoma.

Objective

We sought to examine the association between extremity nevus count and the risk of melanoma and keratinocyte cancers.

Methods

We evaluated prospective cohorts of 176,317 women (the Nurses' Health Study, 1986-2012 and the Nurses' Health Study 2, 1989-2013) and 32,383 men (Health Professionals Follow-up Study, 1986-2012). Information on nevus count (none, 1-5, 6-14, ≥15) on the extremity was collected at baseline.

Results

There were 1704 incident cases of melanoma, 2296 incident cases of squamous cell carcinoma, and 30,457 incident cases of basal cell carcinoma, with a total of 4,655,043 person-years for melanoma and 4,267,708 person-years for keratinocyte cancers. The presence of an extremity nevus was associated with an increased risk of melanoma in all anatomic areas and increased risk of basal cell carcinoma (BCC). Individuals with ≥15 nevi had the highest risk of melanoma and BCC compared to those without any extremity nevi (melanoma hazard ratio 2.79 [95% confidence interval 2.04-3.83]; BCC HR 1.40 [95% confidence interval 1.32-1.49]). No significant association was observed for squamous cell carcinoma.

Limitations

Limitations of our study included self-reported nevus count and detection bias.

Conclusions

Extremity nevus count is a helpful clinical marker in risk-stratifying individuals for BCC and melanoma on all body sites.



http://bit.ly/2WyAXqm

A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

Condition:   Head and Neck Cancer
Intervention:   Biological: PepCan
Sponsor:   University of Arkansas
Not yet recruiting

http://bit.ly/2t1D0pc

A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC

Condition:   Esophageal Squamous Cell Carcinoma
Interventions:   Drug: SHR-1210;   Drug: Placebo
Sponsors:   The First Affiliated Hospital of Zhengzhou University;   Jiangsu HengRui Medicine Co., Ltd.
Not yet recruiting

http://bit.ly/2sYUCC3

A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

Condition:   Scoliosis; Adolescence
Interventions:   Device: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing;   Device: spinal orthosis
Sponsor:   Changhua Christian Hospital
Recruiting

http://bit.ly/2t1qndL

Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma

Condition:   Esophageal Squamous Cell Carcinoma
Intervention:   Drug: recombinant anti-EGFR monoclonal antibody
Sponsors:   Sinocelltech Ltd.;   Tianjin Medical University Cancer Institute and Hospital
Recruiting

http://bit.ly/2HJLHi5

The endoscopic endonasal approach for pediatric craniopharyngiomas

Publication date: Available online 1 February 2019

Source: Operative Techniques in Otolaryngology-Head and Neck Surgery

Author(s): Ian J. Koszewski, Hermes G. Garcia, William Parkes, Chandala Chitguppi, Mindy R. Rabinowitz, Gurston G. Nyquist, James J. Evans, Marc R. Rosen

Craniopharyngiomas are rare but challenging tumors of the ventral skull base affecting primarily pediatric patients. In select cases, the endoscopic endonasal approach represents an appropriate surgical option when tumor resection is favored. However, nuances of the pediatric nasal corridor must be carefully considered to optimize both tumor resection and skull base reconstruction. Here we review pertinent developmental details, options for creation of an optimal endonasal corridor, principles of tumor resection, and techniques for reconstruction. Considerations for intraoperative and postoperative patient care are also reviewed.



http://bit.ly/2HXuq5t

Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia

Conditions:   Thyroid Cancer;   Thyroid Nodule;   Thyroid Adenoma
Interventions:   Procedure: Flexible fiberoptic laryngoscopy;   Procedure: Direct laryngoscopy
Sponsor:   Istanbul University
Not yet recruiting

http://bit.ly/2HJkhZV

Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT

Condition:   Peritonsillar Abscess
Interventions:   Diagnostic Test: Intraoral ultrasound;   Procedure: The landmark technique
Sponsors:   Tobias Todsen;   Odense University Hospital
Recruiting

http://bit.ly/2HJkjkv

Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

Condition:   Advanced Solid Tumors Cancer
Interventions:   Drug: ABBV-151;   Drug: ABBV-181
Sponsor:   AbbVie
Not yet recruiting

http://bit.ly/2t0RhCI

Tavokinogene Telseplasmid With Electroporation, Pembrolizumab, and Epacadostat in Treating Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck

Conditions:   Metastatic Head and Neck Squamous Cell Carcinoma;   Recurrent Head and Neck Squamous Cell Carcinoma;   Unresectable Head and Neck Squamous Cell Carcinoma
Interventions:   Device: Electroporation;   Drug: Epacadostat;   Drug: Pembrolizumab
Sponsors:   University of California, San Francisco;   National Cancer Institute (NCI)
Not yet recruiting

http://bit.ly/2HM4Y2q

Intra-parotid Facial Nerve Imaging in Parotidectomy

Conditions:   Parotid Tumors;   Facial Nerve Paresis
Intervention:   Diagnostic Test: 3D-DESS MRI (3 dimensional double echo steady state MRI)
Sponsor:   Samsung Medical Center
Recruiting

http://bit.ly/2t44Oct

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

Condition:   Oropharyngeal Cancer
Interventions:   Radiation: Radiation;   Drug: Cisplatin
Sponsor:   Canadian Cancer Trials Group
Not yet recruiting

http://bit.ly/2HHDjzP

Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

Condition:   Vestibular Neuritis
Interventions:   Other: Vestibular rehabilitation;   Drug: Corticosteroid
Sponsor:   Aalborg Universitetshospital
Recruiting

http://bit.ly/2HKNjby

Efficacy of Navigation for Disparities and Untimely Radiation ThErapy: The ENDURE Study

Condition:   Cancer of Head and Neck
Intervention:   Other: Patient Navigation
Sponsor:   Medical University of South Carolina
Not yet recruiting

http://bit.ly/2t8LFGJ

Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer

Conditions:   Esophageal Cancer;   Biliary Tract Cancer;   GastroEsophageal Cancer;   Hepatobiliary Neoplasm
Interventions:   Drug: DKN-01;   Drug: Atezolizumab;   Drug: Paclitaxel
Sponsors:   European Organisation for Research and Treatment of Cancer - EORTC;   Hoffmann-La Roche;   Leap Therapeutics, Inc.
Not yet recruiting

http://bit.ly/2HLy7uO

Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck

Condition:   Head and Neck Neoplasms
Interventions:   Drug: Atezolizumab;   Drug: Bevacizumab
Sponsor:   Centre Leon Berard
Not yet recruiting

http://bit.ly/2t0yxU0

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma

Condition:   Head and Neck Cancer
Interventions:   Drug: ABBV-181;   Drug: ABBV-368;   Drug: ABBV-927
Sponsor:   AbbVie
Not yet recruiting

http://bit.ly/2HLQIGX

Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

Conditions:   Gastric Carcinoma;   Liver and Intrahepatic Bile Duct Carcinoma;   Unresectable Esophageal Carcinoma;   Unresectable Pancreatic Carcinoma
Intervention:   Dietary Supplement: Zinc
Sponsor:   Emory University
Not yet recruiting

http://bit.ly/2t8LFqd

Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma

Condition:   Head and Neck Squamous Cell Carcinoma
Intervention:   Diagnostic Test: USPIO-enhanced MRI
Sponsor:   Radboud University
Not yet recruiting

http://bit.ly/2t2wjDv

The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients

Condition:   Esophageal Cancer
Intervention:   Device: High flow nasal cannula, HFNC
Sponsor:   National Taiwan University Hospital
Not yet recruiting

http://bit.ly/2HLxQrM

Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Condition:   Locally Advanced Malignant Neoplasm
Interventions:   Drug: Induction chemotherapy;   Combination Product: Chemoradiotherapy
Sponsor:   Barretos Cancer Hospital
Recruiting

http://bit.ly/2HLxKAq

Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia

Conditions:   Thyroid Cancer;   Thyroid Nodule;   Thyroid Adenoma
Interventions:   Procedure: Flexible fiberoptic laryngoscopy;   Procedure: Direct laryngoscopy
Sponsor:   Istanbul University
Not yet recruiting

http://bit.ly/2HJkhZV

A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

Condition:   Scoliosis; Adolescence
Interventions:   Device: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing;   Device: spinal orthosis
Sponsor:   Changhua Christian Hospital
Recruiting

http://bit.ly/2t1qndL

Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT

Condition:   Peritonsillar Abscess
Interventions:   Diagnostic Test: Intraoral ultrasound;   Procedure: The landmark technique
Sponsors:   Tobias Todsen;   Odense University Hospital
Recruiting

http://bit.ly/2HJkjkv

Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

Condition:   Advanced Solid Tumors Cancer
Interventions:   Drug: ABBV-151;   Drug: ABBV-181
Sponsor:   AbbVie
Not yet recruiting

http://bit.ly/2t0RhCI

Tavokinogene Telseplasmid With Electroporation, Pembrolizumab, and Epacadostat in Treating Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck

Conditions:   Metastatic Head and Neck Squamous Cell Carcinoma;   Recurrent Head and Neck Squamous Cell Carcinoma;   Unresectable Head and Neck Squamous Cell Carcinoma
Interventions:   Device: Electroporation;   Drug: Epacadostat;   Drug: Pembrolizumab
Sponsors:   University of California, San Francisco;   National Cancer Institute (NCI)
Not yet recruiting

http://bit.ly/2HM4Y2q

Intra-parotid Facial Nerve Imaging in Parotidectomy

Conditions:   Parotid Tumors;   Facial Nerve Paresis
Intervention:   Diagnostic Test: 3D-DESS MRI (3 dimensional double echo steady state MRI)
Sponsor:   Samsung Medical Center
Recruiting

http://bit.ly/2t44Oct

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

Condition:   Oropharyngeal Cancer
Interventions:   Radiation: Radiation;   Drug: Cisplatin
Sponsor:   Canadian Cancer Trials Group
Not yet recruiting

http://bit.ly/2HHDjzP

A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

Condition:   Head and Neck Cancer
Intervention:   Biological: PepCan
Sponsor:   University of Arkansas
Not yet recruiting

http://bit.ly/2t1D0pc

Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

Condition:   Vestibular Neuritis
Interventions:   Other: Vestibular rehabilitation;   Drug: Corticosteroid
Sponsor:   Aalborg Universitetshospital
Recruiting

http://bit.ly/2HKNjby

Efficacy of Navigation for Disparities and Untimely Radiation ThErapy: The ENDURE Study

Condition:   Cancer of Head and Neck
Intervention:   Other: Patient Navigation
Sponsor:   Medical University of South Carolina
Not yet recruiting

http://bit.ly/2t8LFGJ

Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer

Conditions:   Esophageal Cancer;   Biliary Tract Cancer;   GastroEsophageal Cancer;   Hepatobiliary Neoplasm
Interventions:   Drug: DKN-01;   Drug: Atezolizumab;   Drug: Paclitaxel
Sponsors:   European Organisation for Research and Treatment of Cancer - EORTC;   Hoffmann-La Roche;   Leap Therapeutics, Inc.
Not yet recruiting

http://bit.ly/2HLy7uO

Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck

Condition:   Head and Neck Neoplasms
Interventions:   Drug: Atezolizumab;   Drug: Bevacizumab
Sponsor:   Centre Leon Berard
Not yet recruiting

http://bit.ly/2t0yxU0

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma

Condition:   Head and Neck Cancer
Interventions:   Drug: ABBV-181;   Drug: ABBV-368;   Drug: ABBV-927
Sponsor:   AbbVie
Not yet recruiting

http://bit.ly/2HLQIGX

Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

Conditions:   Gastric Carcinoma;   Liver and Intrahepatic Bile Duct Carcinoma;   Unresectable Esophageal Carcinoma;   Unresectable Pancreatic Carcinoma
Intervention:   Dietary Supplement: Zinc
Sponsor:   Emory University
Not yet recruiting

http://bit.ly/2t8LFqd

Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma

Condition:   Esophageal Squamous Cell Carcinoma
Intervention:   Drug: recombinant anti-EGFR monoclonal antibody
Sponsors:   Sinocelltech Ltd.;   Tianjin Medical University Cancer Institute and Hospital
Recruiting

http://bit.ly/2HJLHi5

Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma

Condition:   Head and Neck Squamous Cell Carcinoma
Intervention:   Diagnostic Test: USPIO-enhanced MRI
Sponsor:   Radboud University
Not yet recruiting

http://bit.ly/2t2wjDv

The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients

Condition:   Esophageal Cancer
Intervention:   Device: High flow nasal cannula, HFNC
Sponsor:   National Taiwan University Hospital
Not yet recruiting

http://bit.ly/2HLxQrM

A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC

Condition:   Esophageal Squamous Cell Carcinoma
Interventions:   Drug: SHR-1210;   Drug: Placebo
Sponsors:   The First Affiliated Hospital of Zhengzhou University;   Jiangsu HengRui Medicine Co., Ltd.
Not yet recruiting

http://bit.ly/2sYUCC3

Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Condition:   Locally Advanced Malignant Neoplasm
Interventions:   Drug: Induction chemotherapy;   Combination Product: Chemoradiotherapy
Sponsor:   Barretos Cancer Hospital
Recruiting

http://bit.ly/2HLxKAq

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

Condition:   Lymph Node Metastases
Intervention:   Procedure: lymph node dissection
Sponsor:   Zhejiang University
Not yet recruiting

http://bit.ly/2sZNk1d

😴😴😴Sleep Medicine🕵🕵️‍♀️


16:51
  Characterizing Pediatric Inpatient Sleep Duration and Disruptions
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Amarachi I. Erondu, Nicola M. Orlov, Leah B. Peirce, Samantha L. Anderson, Michael Chamberlain, Kelsey Hopkins, Christopher Lyttle, David Gozal, Vineet M. Arora

Abstract
Objective
To contextualize inpatient sleep duration and disruptions in a general pediatric hospital ward by comparing in-hospital and at-home sleep durations to recommended guidelines and objectively measure nighttime room entries.

Methods
Caregivers of patients 4 weeks - 18 years of age reported patient sleep duration and disruptions in anonymous surveys. Average at-home and in-hospital sleep durations were compared to National Sleep Foundation recommendations. Objective nighttime traffic was evaluated as the average number of room entries between 11:00pm and 7:00am using GOJO hand-hygiene room entry data.

Results
Among 246 patients, patients slept less in the hospital than at home with newborn and infant cohorts experiencing 7- and 4-hour sleep deficits respectively (Newborn: 787 ± 318 min at home vs. 354 ± 211 min in hospital, p<0.001; Infants: 530 ± 115 min at home vs. 412 ± 152 min in hospital, p<0.01). Newborn children also experienced >2 hour sleep deficits at home when compared to NSF recommendations (Newborns: 787 ± 318 min at home vs. 930 min recommended, p< 0.05). Objective nighttime traffic measures revealed that hospitalized children experienced 10 room entries/night (10 ± 5.9 entries). Nighttime traffic was significantly correlated with caregiver-reported nighttime awakenings (Spearman Rank Correlation Coefficient: 0.58, p=.04).

Conclusion
Hospitalization is a missed opportunity to improve sleep both in the hospital and at home.

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16:51
  Insomnia Treatment Response as a Function of Objectively Measured Sleep Duration
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Amélie Rochefort, Denise C. Jarrin, Lynda Bélanger, Hans Ivers, Charles M. Morin

Abstract
Objectives
To examine the potential moderating effect of objectively measured sleep duration at baseline on the response to cognitive behavioral therapy for insomnia (CBT-I), administered singly or combined with medication (CBT-I+Med).

Methods
Based on the average PSG-derived sleep duration across two baseline nights and the type of treatment received, 159 adults with insomnia (50.3 ± 10.1 years; 61.0% women) were classified into one of four groups: participants with short sleep duration (i.e., ≤ 6h) treated with CBT-I (n = 26) or CBT-I+Med (n = 25), and participants with normal sleep duration (i.e., > 6h) treated with CBT-I (n = 54) or CBT-I+Med (n = 54). Primary outcome measures were sleep/wake parameters derived from a sleep diary and insomnia severity and secondary outcomes were beliefs about sleep, fatigue, depression and anxiety.

Results
Patients with both short and normal sleep durations at baseline improved significantly on most sleep continuity parameters with CBT-I administered singly or combined with medication. Irrespective of treatment received, participants with short sleep duration also showed significantly greater improvements in subjective sleep (i.e., reduced wake after sleep onset, increased sleep efficiency) relative to those with normal sleep duration. Conversely, participants with normal sleep duration showed greater improvements on some measures of daytime functioning and sleep satisfaction.

Conclusions
There was no moderating effect of baseline sleep duration on treatment response to cognitive behavioral therapy. Despite some marginal differential treatment response on selected daytime functioning outcomes, the benefits from CBT-I were not significantly different as a function of short or normal sleep duration at baseline. Further prospective investigation of insomnia phenotypes taking into account other variables than sleep duration is warranted in order to develop more targeted insomnia therapies.

Trial registration
www.clinicaltrials.gov (#NCT 00042146)

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Thu Jan 31, 2019 12:40
  Association of change in physical activity and sleep complaints: Results from a 6-year longitudinal study with Swedish health care workers
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Markus Gerber, Mats Börjesson, Ingibjörg H. Jonsdottir, Magnus Lindwall

Abstract
Objective
To increase our understanding of patterns of change in physical activity and sleep complaints and to test whether intra-individual changes in physical activity are correlated with intra-individual changes in sleep complaints across four measurement time-points over six years, adopting both a between-person and within-person perspective.

Methods
Data from a longitudinal cohort study were used in this research. At baseline, 3187 participants took part in the study (86% women, Mage=46.9 years). The response rate was 84% (n=3136) after two years, 60% (n=2232) after four years, and 40% (n=1498) after six years. Physical activity was assessed with the [51] widely used 4-level physical activity scale (SGPALS), and sleep complaints, with three items from the Karolinska Sleep Questionnaire (KSQ). Patterns and correlations of change between physical activity and sleep complaints were examined with latent growth curve modeling.

Results
Changes in physical activity were associated with changes in sleep complaints across the six years. More specifically, significant associations occurred between baseline levels, correlated (between-person) change, and coupled (within-person change). These associations indicate that higher physical activity levels are not only cross-sectionally linked with fewer sleep complaints, but that increases in physical activity over time (either in comparison to others or to oneself) are paralleled by decreases in sleep complaints.

Conclusions
Given that changes in physical activity and sleep are correlated, our findings indicate that it is both worthwhile to initiate more physically active lifestyles in physically inactive individuals and to ensure that those who are already physically active maintain their physical activity levels over longer periods.

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  Continuous positive airway pressure alters brain microstructure and perfusion patterns in patients with obstructive sleep apnea
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Hillel S. Maresky, Isaac Shpirer, Miriam M. Klar, Max Levitt, Efrat Sasson, Sigal Tal

Abstract
Objectives
To assess the effects of continuous positive airway pressure (CPAP) treatment on brain structure and function in patients with obstructive sleep apnea (OSA).

Methods
A prospective study of seven OSA patients recruited from the sleep center at our institution was carried out. Patients were treated with 6 weeks of CPAP treatment. Pre-treatment and post-treatment magnetic resonance imaging (MRI) perfusion scans were obtained and compared to assess for treatment-induced changes. Microstructural changes were quantified using functional anistrophy (FA) and mean diffusivity (MD), and brain perfusion was quantified using cerebral blood flow (CBF) and cerebral blood volume (CBV).

Results
Of the seven patients included the in study, six (85.7%) were male, and the mean age of the study population was 51 years (standard deviation = 13.14). Increased FA and decreased MD were found in the hippocampus, temporal lobes, fusiform gyrus, and occipital lobes. Decreased FA and increased MD were found in frontal regions for all patients (p<0.05). Increased CBF and CBV were also observed following treatment (p<0.05).

Conclusion
In addition to symptom resolution, CPAP treatment may allow for healing of OSA-induced brain damage as seen by restoration of brain structure and perfusion.

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Thu Jan 31, 2019 12:40
  Postpartum fatigue, daytime sleepiness, and psychomotor vigilance are modifiable through a brief residential early parenting program
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Nathan Wilson, Karen Wynter, Clare Anderson, Shantha.M.W. Rajaratnam, Jane Fisher, Bei Bei

Abstract
Objective
/Background: In the months after childbirth, women are vulnerable to sleep disturbances and sleep-related deficits in functioning, such as fatigue, daytime sleepiness, and attentional lapses. Currently there is limited evidence that these deficits are modifiable. Using both self-report and objective measures, this study examined changes in sleep-related daytime functioning among women attending a residential early parenting program for assistance with unsettled infant behavior and mild to moderate postpartum distress.

Methods
Participants were 78 women (age M=34.16, SD=4.16 years) attending a 5-day program with their infants (age M=8.67, SD=4.82 months). Sleep was assessed via self-report. Sleep-related daytime functioning was operationalized as fatigue, sleepiness, and sustained attention, and measured using validated questionnaires (all women) and the 10-min visual Psychomotor Vigilance Test (PVT; subgroup of 47 women). All measures were administered on both admission (baseline) and discharge.

Results
On admission, participants reported elevated sleep disturbance (94%), fatigue (91%), as well as trait (54%) and state (67%) sleepiness. From admission to discharge, there were medium effect size reductions in fatigue and sleepiness, and large effect size improvements in sleep quality related domains such as increased sleep efficiency and reduced nighttime awakenings (all p<.001); changes in total sleep time were nonsignificant (p=.22). PVT reciprocal mean reaction times were also significantly faster (p=.001; medium effect size).

Conclusions
This study demonstrated that among women attending a brief residential early parenting program, fatigue, daytime sleepiness, and objectively measured psychomotor vigilance can be improved. Implications for further research and potential treatments are discussed.

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Thu Jan 31, 2019 12:40
  Poor sleep quality and lipid profile in a rural cohort (The Baependi Heart Study)
via Sleep Medicine
Publication date: Available online 30 January 2019

Source: Sleep Medicine

Author(s): Glaucylara Reis Geovanini, Geraldo Lorenzi-Filho, Lilian K. de Paula, Camila Maciel Oliveira, Rafael de Oliveira Alvim, Felipe Beijamini, André Brooking Negrão, Malcolm von Schantz, Kristen L. Knutson, José Eduardo Krieger, Alexandre Costa Pereira

Abstract
Aim
To test the association between cardiometabolic risk factors and subjective sleep quality assessed by the Pittsburgh sleep quality index (PSQI), independent of obstructive sleep apnea (OSA) and sleep duration.

Methods
A total of 573 participants from the Baependi Heart Study, a rural cohort from Brazil, completed sleep questionnaires and underwent polygraphy for OSA evaluation. Multivariable linear regression analysis tested the association between cardiovascular risk factors (outcome variables) and sleep quality measured by PSQI, adjusting for OSA and other potential confounders (age, sex, race, salary/wage, education, marital status, alcohol intake, obesity, smoking, hypertension, and sleep duration).

Results
The sample mean age was 43±16 years, 66% were female, and mean body mass index (BMI) was 26±5 kg/m2. Only 20% were classified as obese (BMI ≥30). Fifty per cent of participants reported poor sleep quality as defined by a PSQI score ≥5. A high PSQI score was significantly associated with higher very-low-density lipoprotein (VLDL) cholesterol levels (beta=0.392, p=0.012) and higher triglyceride levels (beta=0.017, p=0.006), even after adjustments, including the apnea–hypopnea index. Further adjustments accounting for marital status, alcohol intake, and medication use did not change these findings. No significant association was observed between PSQI scores and glucose or blood pressure. According to PSQI components, sleep disturbances (beta=1.976, p=0.027), sleep medication use (beta=1.121, p=0.019), and daytime dysfunction (beta=1.290, p=0.024) were significantly associated with higher VLDL serum levels. Only the daytime dysfunction domain of the PSQI components was significantly associated with higher triglyceride levels (beta=0.066, p=0.004).

Conclusion
Poorer lipid profile was independently associated with poor sleep quality, assessed by the PSQI questionnaire, regardless of a normal sleep duration and accounting for OSA and socio-economic status.

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Thu Jan 31, 2019 12:40
  The journal on a new trajectory
via Sleep Medicine
Publication date: January 2019

Source: Sleep Medicine, Volume 53

Author(s): Sudhansu Chokroverty

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🤓🧘 Dangerous non-food products🧛‍♂️🤦🤦‍♀️

Serious risk 

1 of 3 photos

Alert number: A12/0189/19       
Category:  Hobby/sports equipment
 
Product:  Self-balancing scooter (hoverboard)
 
Brand: GOCLEVER
 
Name: City Board SUV - Hoverboard
 
Type / number of model:  CBLSSBEU Black with LG battery
 
Batch number / Barcode:  5906736072463
 
Risk type:  Burns, Fire
 
The hoverboard's charging circuit has no cut-off switch. The battery can consequently overcharge and overheat which could lead to a fire.
In addition, the plastic housing of the hoverboard can easily catch fire.

The product does not comply with the requirements of the Machinery Directive and the relevant European Standards EN 60335-1 and EN 62133-2.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

1 of 2 photos

Alert number: A12/0190/19       
Category:  Hobby/sports equipment
 
Product:  Self-balancing scooter/Hoverboard
 
Brand: Denver
 
Name: Balance scooter
 
Type / number of model:  Scooter: DBO-6501 WHITE MK2 Power charger: JY-420150
 
Batch number / Barcode:  5706751035494
 
Risk type:  Burns, Fire
 
The charging circuit of the product has no cut-off switch.
The battery can consequently overcharge and overheat which may lead to a fire. Furthermore, the plastic housing of the hoverboard can easily catch fire. 

The product does not comply with the requirements of the Machinery Directive and the relevant European Standard EN 60335-1.
 

Measures ordered by public authorities (to: Other): Warning consumers of the risks, Withdrawal of the product from the market

 

1 of 1 photo

Alert number: A12/0172/19       
Category:  Chemical products
 
Product:  Tattoo ink
 
Brand: Eternal Ink
 
Name: ROSA - HOT PINK
 
Type / number of model:  Unknown
 
Batch number / Barcode:  Batch number 02/09/16
 
Risk type:  Chemical
 
The product contains the aromatic amine o-anisidine (measured value: 26 mg/kg).
This aromatic amine can cause cancer, cell mutations and affect reproduction. 

The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, recommends that aromatic amines with carcinogenic mutagenic, reprotoxic or sensitising properties should neither be present in tattoos and permanent make-up products nor released from azo-colourants.
 

Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures

 

1 of 2 photos

Alert number: A12/0174/19       
Category:  Chemical products
 
Product:  Tattoo ink
 
Brand: Eternal Ink
 
Name: CARAMEL
 
Type / number of model:  Unknown
 
Batch number / Barcode:  batch R-136, expiry date 06/2020
 
Risk type:  Chemical
 
The product contains the aromatic amines o-anisidine (measured value 74 mg/kg) and o-toluidine (measured value 67 mg/kg).
Aromatic amines can cause cancer, cell mutations and affect reproduction. 

The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, recommends that aromatic amines with carcinogenic, mutagenic, reprotoxic or sensitising properties should neither be present in tattoos and permanent make-up products nor released from azo-colourants.
 

Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures

 

1 of 1 photo

Alert number: A12/0179/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Butane gas lighters - coke bottle
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
THE PRODUCT IS COUNTERFEIT
 
Risk type:  Burns, Fire
 
The lighter is appealing to children due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

1 of 1 photo

Alert number: A12/0180/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Refillable butane gas lighter in the form of a lip
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Fire
 
The lighter is appealing to children. due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

1 of 1 photo

Alert number: A12/0181/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Accessories - butane gas lighter-fire-extinguisher
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Fire
 
The lighter is appealing to children due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

Alert number: A12/0158/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Cadillac
 
Name: Escalade
 
Type / number of model:  Type-approval number: e13*2007/46*1479*00 Type: K2XX
 
Batch number / Barcode:  The vehicles concerned were manufactured in 2015.
 
Risk type:  Injuries
 
The software is faulty which may lead to sporadic failure of the electric power steering.
The driver might consequently lose control of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0159/19       
Category:  Motor vehicles
 
Product:  Motorcycle
 
Brand: Yamaha
 
Name: Tricity, MWS125, MWS125A, MWS150A
 
Type / number of model:  Type-approval number: e13*168/2013*00049 Type: SEC 2
 
Batch number / Barcode:  The vehicles concerned were produced between 2017 and 2018.
 
Risk type:  Injuries
 
Poor material resistance of the hoses in the area of the cooling water expansion tank can lead to the loss of cooling water.
The cooling liquid could leak onto the road and the rider could consequently lose control of the motorcycle. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0160/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: VW
 
Name: Touareg
 
Type / number of model:  Type-approval number: e1*2007/46*1827*; Type: CR
 
Batch number / Barcode:  The vehicles in question were produced between 8/8/2018 and 5/10/2018.
 
Risk type:  Injuries
 
A seat-belt latch may not have been sufficiently secured to the rear, right-hand seat.
In the event of an accident, the rear seat-belt latch may therefore break, increasing the risk of injuries to passengers.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0161/19       
Category:  Motor vehicles
 
Product:  Passenger Car
 
Brand: Bentley
 
Name: Mulsanne
 
Type / number of model:  Type approval numbers: e11*KS07/46*0116*00, e11*KS07/46*0116*01, e11*KS07/46*0116*02, e11*KS07/46*0116*03, e11*KS07/46*0116*04, e11*KS07/46*0116*05
 
Batch number / Barcode:  The affected vehicles were manufactured between 08/03/2012 and 21/07/2018
 
Risk type:  Injuries
 
The body mounting panels of the rear seatbelt buckle anchorages have been made using an incorrect grade of material.
In the event of an impact accident, if the rear centre seat is occupied at the same time as an outer rear seat, the rear seatbelt buckle may become detached from the bodywork, leading to injuries.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0162/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: A-class
 
Type / number of model:  Type-approval number: e1*2007/46*1829*03; Type: F2A
 
Batch number / Barcode:  The vehicles in question were manufactured between 13/11/2017 and 22/08/2018.
 
Risk type:  Injuries
 
No perforation has been made in the outer covering of the instrument panel to enable the deployment of the passenger airbag.
In the event of an accident involving deployment of the airbag at low temperatures, sharp edges could be created on the instrument panel in the airbag's deployment area, damaging the airbag. Moreover, parts of the instrument panel may become detached, increasing the risk of injury to the occupants. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0163/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: C-class, GLC
 
Type / number of model:  EC type approvals: e1*2001/116*0480*23-30, e1*2007/46*1884*00, e1*2001/116*0431*48-50, e1*2001/116*0457*35-41, e1*2001/116*0463*20, e1*2001/116*0464*22 Types: 204, -X, -X AMG, -K, -K AMG, -AMG
 
Batch number / Barcode:  The vehicles in question were manufactured between 1 August 2017 and 11 October 2018.
 
Risk type:  Injuries
 
In vehicles with automatic child-seat detection, the status shown in the centre console of the passenger airbags may not be correctly indicated.
In this case, the vehicle users would not be correctly informed of the actual activation status of the passenger airbag and may not react appropriately to a potentially false passenger classification, thereby increasing the risk of injury for passengers in the event of an accident. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0164/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: C-class, E-class, CLS
 
Type / number of model:  EC type-approvals: e1*2001/116*0431, e1*2001/116*0457, e1*2001/116*0501, e1*2007/46*1560, e1*2007/46*1818, e1*2001/116*0464, e1*2001/116*0463, e1*2007/46*1666*08 , Types: 204, 204 K, 212, R1ES, R1ECLS, 204 AMG, 204 K AMG, R1EC
 
Batch number / Barcode:  The vehicles in question were produced between 14 February 2014 and 16 December 2018.
 
Risk type:  Injuries
 
There may be cracks in a securing nut in the steering gear of rear-wheel-drive vehicles.
The nut could consequently break if the steering system is subject to a very high lateral force, which could result in rotating parts in the steering gear affecting the casing and thereby blocking the steering system.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0170/19       
Category:  Motor vehicles
 
Product:  Tyres
 
Brand: Continental
 
Name: Winter Contact TS860
 
Type / number of model:  ECE type approvals: R30: E4 0289778; R117: E4 027400 S2WR2
 
Batch number / Barcode:  This concerns one week of the manufacturing year 2018 identified by the following code: DOT 6GAED29W4118.
 
Risk type:  Injuries
 
Loosening of the tread could occur.
This could have an adverse effect on the handling and stability of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0171/19       
Category:  Motor vehicles
 
Product:  Tyres
 
Brand: Uniroyal
 
Name: MS Plus 77
 
Type / number of model:  ECE type approvals: R30: E4 0268280; R117: E4 025045 S2WR2
 
Batch number / Barcode:  This concerns one week of the manufacturing year 2018 identified by the following code: DOT 6GXWDDBR4118.
 
Risk type:  Injuries
 
Loosening of the tread could occur.
This could have an adverse effect on the handling and stability of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0175/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Jeep
 
Name: Cherokee, Compass
 
Type / number of model:  EC type-approvals: e4*2007/46*0783*11, e11*2007/46*4037*02; Types: KL, MX
 
Batch number / Barcode:  The vehicles concerned were produced between 17 March 2018 and 21 June 2018.
 
Risk type:  Injuries
 
Incorrect coating of the brake pistons can result in the formation of gas in the hydraulic system.
This may adversely affect the functioning of the brakes on the rear-axle wheels.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0176/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Alfa Romeo
 
Name: Stelvio
 
Type / number of model:  EC type-approval: e3*2007/46*0435*02; Type: 949; sales description: Stelvio
 
Batch number / Barcode:  The vehicles concerned were produced between 18 January 2017 and 18 September 2018.
 
Risk type:  Fire
 
A non-compliant generator cable may be damaged as a result of contact with the exhaust gas recirculation line.
This could cause a short-circuit and in the worst case fire in the engine compartment.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0178/19       
Category:  Motor vehicles
 
Product:  Vehicle component
 
Brand: JOST
 
Name: KLK HE 1200-22; KLK HE 1300-22
 
Type / number of model:  Unknown
 
Batch number / Barcode:  Period of manufacture: December 2016 to 16.11.2018.
 
Risk type:  Injuries
 
Owing to a defect in the continuous steel casting process, the ball-bearing turntables may break.
Consequently, the connection to the lower turntable of a trailer may be lost, which could lead to an accident.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

Company recall page:  https://www.jost-klk.com/en/

 

Alert number: A12/0183/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Opel
 
Name: Zafira
 
Type / number of model:  Type-approval numbers: e1*2001/116*0325*00-11, e1*2007/46*0497*00-05 Type: A-H/monocab
 
Batch number / Barcode:  The vehicles concerned were manufactured between 2 November 2004 and 24 October 2014.
 
Risk type:  Fire
 
There is a defective regulator on the blower motor.
This can cause a fire in the cable set.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0185/19       
Category:  Motor vehicles
 
Product:  Passenger Car
 
Brand: Land Rover
 
Name: Range Rover, Sport, Velar, Discovery
 
Type / number of model:  Range Rover E11*2007/46*0649 Range Rover Sport E11*2007/46*0909 Range Rover Velar E11*2007/46*3954 Discovery E11*2007/46*3784
 
Batch number / Barcode:  Specific vehicles built between 10/10/2018 and 19/12/2018
 
Risk type:  Injuries
 
The crankshaft pulley retaining bolt may fracture.
As a consequence, the crankshaft nose could break leading to engine power loss and the potential for engine failure. Furthermore, the loose pulley could damage under bonnet components or puncture the bonnet and become a hazard to pedestrians or other road users.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0188/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Porsche
 
Name: 991 Carrera, Cayenne, Macan, Panamera
 
Type / number of model:  Type-approval numbers: se13*2007/46*1187 e13*2007/46*1085* e13*2007/46*1106* e13*2007/46*1107* e13*2007/46*1108* e13*2007/46*1164* e13*2007/46*0970* e13*2007/46*1143* e13*2007/46*1160* , e13*2007/46*1161*; types: 991, 92A, 95B, 970;
 
Batch number / Barcode:  The vehicles concerned were produced in 2014 and 2015
 
Risk type:  Injuries
 
It is possible that the vehicles do not meet the series standards applicable at the time of delivery as regards certain safety systems and assemblies (e.g. seating, front axle control arm bolts, brake components).
As a consequence, the cars might be unsafe.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0192/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Jaguar
 
Name: F-Pace, F-Type, XJ
 
Type / number of model:  F-PACE E11*2007/46*3324 F-TYPE E11*2001/116*0272 XJ E11*2007/46*0089
 
Batch number / Barcode:  Specific vehicles built between 12/10/2018 and 11/12/2018
 
Risk type:  Injuries
 
The crankshaft pulley retaining bolt may fracture.
As a consequence, the crankshaft nose could break leading to engine power loss and the potential for engine failure. Furthermore, the loose pulley could damage under bonnet components or puncture the bonnet and become a hazard to pedestrians or other road users.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0193/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Land Rover
 
Name: Range Rover, Range Rover Sport
 
Type / number of model:  Type Approval Number : Range Rover E11*2007/46*0649 Range Rover Sport E11*2007/46*0909
 
Batch number / Barcode:  Specific vehicles built between 10/11/2017 and 18/12/2018 and fitted with the 4.4L SDV8 diesel engines
 
Risk type:  Injuries
 
Due to a faulty software, the directional indicators may fail to operate when the steering column mounted control stalks are used and the driver does not receive visual or audible warnings if this occurs.
As a consequence, there is an increased risk of a crash.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0194/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Bentley
 
Name: Continental GT
 
Type / number of model:  Type approval numbers: e13*2007/46*0634*01 e13*2007/46*0634*02
 
Batch number / Barcode:  Specific vehicles built between 22/01/2018 and 17/12/2018
 
Risk type:  Injuries
 
Due to a software fault a temporary loss of power assistance could occur, requiring the driver to apply additional steering force.
This could lead to an accident.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

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Alert number: A12/0157/19       
Category:  Other
 
Product:  Smart watch for children
 
Brand: ENOX
 
Name: Safe-KID-One
 
Type / number of model:  Unknown
 
Batch number / Barcode:  4260088660947
 
Risk type:  Other
 
The mobile application accompanying the watch has unencrypted communications with its backend server and the server enables unauthenticated access to data. As a consequence, the data such as location history, phone numbers, serial number can easily be retrieved and changed.
A malicious user can send commands to any watch making it call another number of his choosing, can communicate with the child wearing the device or locate the child through GPS. 

The product does not comply with the Radio Equipment Directive.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users

 

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Alert number: A12/0152/19       
Category:  Toys
 
Product:  Toy scooter
 
Brand: illumination
 
Name: Despicable Me DM3
 
Type / number of model:  808580
 
Batch number / Barcode: Unknown
 
Risk type:  Injuries
 
The scooter is not sufficiently stable.
Children can fall to the ground and hurt themselves. 

The product does not comply with the requirements of the Toy Safety Directive and with the relevant European Standard EN 71-1.
 

Measures taken by economic operators: Destruction of the product (By: Importer)
Measures ordered by public authorities (to: Importer): Import rejected at border

 

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Alert number: A12/0168/19       
Category:  Toys
 
Product:  Children's fancy-dress costume
 
Brand: Unknown
 
Name: ABYED - Anime Animal Costume Cosplay
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Choking
 
The slider of the zip can be easily detached.
A child could put it in the mouth and choke on it. 

The product does not comply with the requirements of the Toy Safety Directive and the relevant European Standard EN 71-1.
 

Measures taken by economic operators: This product listing was removed by AMAZON, Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0182/19       
Category:  Toys
 
Product:  Pull-along toy
 
Brand: ECOTOYS
 
Name: Drewniany piesek na sznurku
 
Type / number of model:  Item N0. 2205
 
Batch number / Barcode:  4 894063 031592 Seria 07/2016
 
Risk type:  Strangulation
 
The cord attached to the toy is too long.
The cord could wrap itself around the child's neck without the child being able to remove it, causing strangulation.

The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1.
 

Measures ordered by public authorities (to: Importer): Making the marketing of the product subject to prior conditions

 

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Alert number: A12/0184/19       
Category:  Toys
 
Product:  Educational toy
 
Brand: Makeblock
 
Name: mBot
 
Type / number of model:  FRA mBot V1.1-Blue (bluethooth version)
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Chemical
 
Due to a short-circuit, the batteries can overheat and the plastic of the battery compartment can melt. Moreover, the battery compartment of the remote-control can easily be opened without use of any tools, giving access to the button cell batteries.
A child may sustain burns from the overheating parts or put the batteries in the mouth and swallow them, which can cause damage to the child's gastrointestinal tract. 

The product does not comply with the requirements of the Toy Safety Directive and the relevant European standards EN 62115 and EN 71-1.
 

Measures ordered by public authorities (to: Importer): Import rejected at border

 

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Alert number: A12/0191/19       
Category:  Toys
 
Product:  Squeezable toy
 
Brand: Unknown
 
Name: Children's toy
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Chemical
 
The plastic material of the product contains di-(2-ethylhexyl) phthalate (DEHP) (measured value: 12% by weight) and diisobutyl phthalate (DIBP) (26% by weight).
These phthalates may harm the health of children causing possible damage to the reproductive system.

The product does not comply with the REACH Regulation.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0195/19       
Category:  Toys
 
Product:  Soft toy
 
Brand: Unknown
 
Name: Soft toy turtle, 18 cm
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Chemical, Choking
 
The eyes and the suction cup can easily be detached and the paint on the eyes contains lead (measured value: 63 mg/kg)
The fibrous stuffing material of the toy is easily accessible due to the weakness of certain seams.

A small child may put the small parts, the suction cup or the stuffing material in the mouth and choke. Exposure to lead is harmful for human health and can cause developmental neurotoxicity.

The product does not comply with the requirements of the Toy Safety Directive and with the relevant European standards EN 71-1 and EN 71-3.
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0196/19       
Category:  Toys
 
Product:  Electric toy
 
Brand: Unknown
 
Name: Funny microphone
 
Type / number of model:  NO. 729
 
Batch number / Barcode: Unknown
 
Risk type:  Environment
 
Four solders in the toy contain lead (measured value up to 44.8% by weight) and two of the four solders contain cadmium (measured value up to 0.66% by weight) in concentrations above limit values.

Lead and cadmium pose a risk to the environment.
The product does not comply with the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). 
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Importer)

 

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Alert number: A12/0200/19       
Category:  Toys
 
Product:  Science kit
 
Brand: Alga
 
Name: Electro Alarm
 
Type / number of model:  21928505
 
Batch number / Barcode:  4893669285057
 
Risk type:  Environment
 
Solder in one place in the toy contains lead in concentration above limit value (measured value up to 11.7% by weight).
Lead poses a risk to the environment. 

The product does not comply with the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive).
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Manufacturer)

 

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Alert number: A12/0165/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's dress
 
Brand: Lamond
 
Name: Lány ruha
 
Type / number of model:  999-0521-3
 
Batch number / Barcode: Unknown
 
Risk type:  Choking, Injuries
 
The small decorative rhinestones can easily be detached from the dress. 

A small child may put them in the mouth and choke.
The sharp safety pin of the decorative flower is easily accessible.

A small child may put the small parts in the mouth and choke, while the safety pin can cause eye or skin injuries.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market

 

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Alert number: A12/0166/19       
Category:  Clothing, textiles and fashion items
 
Product:  Babies' clothing set
 
Brand: Petite Ponpon Baby
 
Name: Unknown
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Choking
 
The small decorative elements of the product may be easily detached.
A small child may put them in the mouth and choke.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market

 

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Alert number: A12/0169/19       
Category:  Clothing, textiles and fashion items
 
Product:  Ladies' sandals
 
Brand: ElleNor
 
Name: Damen Pantolette
 
Type / number of model:  Unknown
 
Batch number / Barcode:  4039653754509
 
Risk type:  Chemical
 
The amount of chromium (VI) in the leather of the insoles is too high (measured value 12.4 mg/kg).
Chromium (VI) is sensitising and may trigger allergic reactions.

The product does not comply with the REACH Regulation.
 

Measures taken by economic operators: Recall of the product from end users (By: Importer)

 

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Alert number: A12/0186/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's sweatshirt
 
Brand: RITCHIE JEANS CO
 
Name: Deška jopa
 
Type / number of model:  RT7394X, Reference: WIPACK J
 
Batch number / Barcode:  3660283413408
 
Risk type:  Strangulation
 
There are drawstrings with free ends in the hood.
The drawstrings may become trapped during various activities of the child, leading to strangulation.

The product does not comply with the relevant European standard EN 14682.
 

Measures taken by economic operators: Making the marketing of the product subject to prior conditions (By: Distributor)

 

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Alert number: A12/0187/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's sweatshirt
 
Brand: LONGBOARD
 
Name: Deška jopa
 
Type / number of model:  JUST MUVE, Reference 46974000
 
Batch number / Barcode:  3253538179817
 
Risk type:  Strangulation
 
There are drawstrings with free ends in the hood.
The drawstrings may become trapped during various activities of the child, leading to strangulation.

The product does not comply with the relevant European standard EN 14682.
 

Measures taken by economic operators: Making the marketing of the product subject to prior conditions (By: Distributor)

 

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Alert number: A12/0173/19       
Category:  Cosmetics
 
Product:  Hair dye
 
Brand: Color Mate
 
Name: Hair Color
 
Type / number of model:  Light Brown 9.7
 
Batch number / Barcode:  8 906016 050843 Batch Number: 07
 
Risk type:  Chemical
 
The product contains barium (measured value: 13.6 % by weight) as peroxide.

Barium peroxide is corrosive and irritant. Barium can be absorbed from the dye and have toxic effects on kidney and heart.
The product contains too much p-aminophenol (measured value: 13.6% by weight, final calculated concentration: 3.8%) and insufficient coupling agent.

Uncoupled p-aminopohenol is a strong skin sensitiser and may trigger allergic skin reactions.

The product does not comply with the Cosmetic Products Regulation.
 

Measures ordered by public authorities (to: Retailer): Destruction of the product

 

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Alert number: A12/0153/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Samsung (Counterfeit)
 
Name: Samsung EP-TA20EWE (Counterfeit)
 
Type / number of model:  EP-TA20EWE
 
Batch number / Barcode: Unknown
THE PRODUCT IS COUNTERFEIT
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0154/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: EP-TA20EWE
 
Type / number of model:  EP-TA20EWE
 
Batch number / Barcode:  86696806738
 
Risk type:  Electric shock
 
The electrical insulation and the clearance /creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0155/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: Unknown
 
Type / number of model:  keke-f5
 
Batch number / Barcode: Unknown
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

1 of 2 photos

Alert number: A12/0156/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: Unknown
 
Type / number of model:  EP-TA20JWE
 
Batch number / Barcode:  S/N R37G15Z7JP1RT3
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 
Weekly overview report on professional products
Serious risk 

Alert number: A12/0167/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mitsubishi Fuso
 
Name: eCanter
 
Type / number of model:  Type-approval number: E4*2007/46*0785*; Type: FE4P10TF1N2
 
Batch number / Barcode:  The vehicles concerned were produced between September 2017 and December 2017.
 
Risk type:  Burns, Fire, Injuries
 
Owing to a defective power distribution unit (PDU), short circuits in the vehicle electronics may occur. Increased resistance or a power interruption may occur and/or, where currents are high, a thermal event may ensue.
This could lead to the vehicle breaking down or catching fire.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0177/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mercedes-Benz
 
Name: Econic
 
Type / number of model:  Type-approval number: e1*2007/46*1221* Type: NGE-L64
 
Batch number / Barcode:  The vehicles in question were manufactured between 1 October 2013 and 26 July 2018.
 
Risk type:  Injuries
 
Pneumatic brake lines on the parking brake may, under certain conditions, be damaged by chafing on the drive shafts when the vehicle is lowered to the lowest position.
As a result, it could, over time, cause the wheels to jam when applying the brakes.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0197/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mercedes-Benz
 
Name: Unimog
 
Type / number of model:  Type-approval numbers: e1*2007/46*1214, *1215, *1216 Types: UGE-452, UGE-232, UGE-453
 
Batch number / Barcode:  The vehicles affected were produced between August 2013 and January 2018.
 
Risk type:  Injuries
 
There is a possible damage to the electrical wiring harness.
This may affect the functioning of the rear lighting unit (including trailer), the electrical supply to the cab, the motor control module (MCM) and the anti-lock braking system (ABS) of the rear axle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0198/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Scania
 
Name: 4-, G-, P-, R-series and possibly others
 
Type / number of model:  EC type-approvals: e4*2007/46*0030, *0031, *0032, *0038, *0039, *0040, *0045, *0046, *0605 and possibly other types: N320, N321, N322, N330, N331, N332, N340, N341, N351.
 
Batch number / Barcode:  The vehicles affected were produced between 2007 and June 2017.
 
Risk type:  Injuries
 
Defective alignment of the steering geometry, or inadequate alignment of the steering stops, may result in chafing of the wheels on the steering column.
As a result, the steering column might break, leading to a loss of steering control.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0199/19       
Category:  Motor vehicles
 
Product:  Bus
 
Brand: EvoBus
 
Name: Sprinter Transfer, Sprinter Mobility
 
Type / number of model:  EC type-approvals: e13*2007/46*1295, e13*2007/46*1294 Types: KA-UM/UL/UXL-M2, KA-UM/UL/UXL-M3
 
Batch number / Barcode:  The vehicles concerned were manufactured between June 2010 and July 2018.
 
Risk type:  Injuries
 
The inbuilt microphone for tour guide announcements is located in the passenger airbag's inflation zone.
If the airbag were activated, it could be damaged.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

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