| 1. |
- Jain, Shubham, et al.
(författare)
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Understanding of how the properties of medical grade lactide based copolymer scaffolds influence adipose tissue regeneration : Sterilization and a systematic in vitro assessment
- 2021
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Ingår i: Materials science & engineering. C, biomimetic materials, sensors and systems. - : Elsevier BV. - 0928-4931 .- 1873-0191. ; 124
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Tidskriftsartikel (refereegranskat)abstract
- Aliphatic polyesters are the synthetic polymers most commonly used in the development of resorbable medical implants / devices. Various three-dimensional (3D) scaffolds have been fabricated from these polymers and used in adipose tissue engineering. However, their systematic evaluation altogether lacks, which makes it difficult to select a suitable degradable polymer to design 3D resorbable implants and / or devices able to effectively mimic the properties of adipose tissue. Additionally, the impact of sterilization methods on the medical devices, if any, must be taken into account. We evaluate and compare five different medical-grade resorbable polyesters with l-lactide content ranging from 50 to 100 mol% and exhibiting different physiochemical properties depending on the comonomer (d-lactide, ε-caprolactone, glycolide, and trimethylene carbonate). The salt-leaching technique was used to prepare 3D microporous scaffolds. A comprehensive assessment of the physical, chemical, and mechanical properties of the scaffolds was carried out in PBS at 37 ° C. The cell-material interactions and the ability of the scaffolds to promote adipogenesis of human adipose tissue-derived stem cells were assessed in vitro. The diverse physical and mechanical properties of the scaffolds, due to the different composition of the copolymers, influenced human adipose tissue-derived stem cells proliferation and differentiation. Scaffolds made from polymers which were above their glass transition temperature and with low degree of crystallinity showed better proliferation and adipogenic differentiation of stem cells. The effect of sterilization techniques (electron beam and ethylene oxide) on the polymer properties was also evaluated. Results showed that scaffolds sterilized with the ethylene oxide method better retained their physical and chemical properties. Overall, the presented research provides (i) a detailed understanding to select a degradable polymer that has relevant properties to augment adipose tissue regeneration and can be further used to fabricate medical devices / implants; (ii) directions to prefer a sterilization method that does not change polymer properties. the presented research provides (i) a detailed understanding to select a degradable polymer that has relevant properties to augment adipose tissue regeneration and can be further used to fabricate medical devices / implants; (ii) directions to prefer a sterilization method that does not change polymer properties. the presented research provides (i) a detailed understanding to select a degradable polymer that has relevant properties to augment adipose tissue regeneration and can be further used to fabricate medical devices / implants; (ii) directions to prefer a sterilization method that does not change polymer properties.
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| 2. |
- Persson, Christina, 1959, et al.
(författare)
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Scandcleft Project Trial 3: Comparison of Speech Outcomes in Relation to Sequence in 2-Stage Palatal Repair Procedures in 5-Year-Olds With Unilateral Cleft Lip and Palate.
- 2020
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Ingår i: The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association. - : SAGE Publications. - 1545-1569. ; 57:3, s. 352-363
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Tidskriftsartikel (refereegranskat)abstract
- To compare speech outcome following different sequencing of hard and soft palate closure between arms and centers within trial 3 and compare results to peers without cleft palate.A prospective randomized clinical trial.Two Norwegian and 2 British centers.One hundred thirty-six 5-year-olds with unilateral cleft lip and palate were randomized to either lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months (arm A) or lip and hard palate closure at 3 to 4 months and soft palate closure at 12 months (arm D).A composite measure of velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate). Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs).Across the trial, 47% had VPC, with no statistically significant difference between arms within or across centers. Thirty-eight percent achieved a PCC score of >90%, with no difference between arms or centers. In one center, significantly more children in arm A produced ≥3 active CSCs (P < .05). Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D).Less than half of the 5-year-olds achieved VPC and around one-third achieved age-appropriate PCC scores. Cleft speech characteristics were more common in arm A, but outcomes varied within and across centers. Thus, outcome of the same surgical method can vary substantially across centers.
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| 3. |
- Rautio, Jorma, et al.
(författare)
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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results
- 2017
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - : TAYLOR & FRANCIS LTD. - 2000-656X .- 2000-6764. ; 51:1, s. 14-20
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Tidskriftsartikel (refereegranskat)abstract
- Background: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate, and randomised trials have only rarely been performed. The Scandcleft Project consists of three trials commenced in 1997 involving ten centres in Denmark, Finland, Norway, Sweden, and the UK. Three groups of centres tested a newly-defined common technique for palatal repair (Arm A) against their local protocols (Arms B, C, D). Arm A was familiar to most of the surgeons in Trial 1, but not to the surgeons in the other Trials. Aim: To evaluate surgical events and complications of the 448 (293 boys, 155 girls) patients with complete unilateral cleft lip and palate (UCLP) enrolled in the three trials. Method: The three trials were carried out in parallel in adherence with a fully developed, ethically approved protocol. Operative time, bleeding, complications, and major dehiscence during and after both primary surgeries were recorded by the surgeon. Rates of fistula and surgery for velopharyngeal incompetence (VPI) were assessed until the youngest patient of the study had reached the age of 9 years. Pearson Chi-square statistical analysis was used to compare the outcomes. Results: No significant differences in bleeding, infection, anaesthetic complications or length of hospital stay between the different arms were found for Trial 1. However, in Trials 2 and 3 there were more airway problems in Arm A than with the traditional local protocols (Arms C or D). In Trial 3 fistula and VPI surgery rates were also higher in Arm A. Conclusions: The results do not provide statistical evidence that any technique is better than others, but indicate that surgery was more problematic for surgeons who were still gaining experience with an unfamiliar surgical protocol.
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| 4. |
- Semb, Gunvor, et al.
(författare)
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A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
- 2017
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - : Taylor & Francis. - 2000-656X .- 2000-6764. ; 51:1, s. 2-13
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project.METHOD: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes.RESULTS: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years.CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series.TRIAL REGISTRATION: ISRCTN29932826.
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| 5. |
- Valen, Anja, et al.
(författare)
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Driver-related risk factors of fatal road traffic crashes associated with alcohol or drug impairment
- 2019
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Ingår i: Accident Analysis and Prevention. - : Elsevier. - 0001-4575 .- 1879-2057. ; 131, s. 191-199
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Tidskriftsartikel (refereegranskat)abstract
- Fatal road traffic crashes are often related to speeding, non-use of a seatbelt, and alcohol/drug-impaired driving. The aim of this study was to examine associations between driving under the influence of drugs and/or alcohol and driver-related risk factors that have been reported as significantly contributing causes of fatal road traffic crashes. The data were extracted from Norwegian road traffic crash registries and forensic toxicology databases. Drug/alcohol investigated car and van drivers and motorcycle riders fatally injured in road traffic crashes in Norway during 2005–2015 were included in this study (n = 772). Drug and alcohol concentrations corresponding to 0.5 g/kg alcohol in blood were used as the lower limits for categorising drivers/riders as impaired; 0.2 g/kg was the upper limit for being categorised as sober. Associations between driver-related risk factors and impairment from specific substance groups were calculated using multivariable logistic regression, adjusted for other substance groups, age, and sex, and were reported when the confidence intervals did not contain the value 1 or lower. Substances found in concentrations above the impairment limits were mainly alcohol (20%), medicinal drugs (10%: benzodiazepines, opioids, z-hypnotics), stimulants (5%: amphetamines, methylphenidate, and cocaine), and cannabis (4%: THC). The drug/alcohol-impaired drivers had compared to the sober drivers more often been speeding (68% versus 32%), not used a seatbelt (69% versus 30%), and been driving without a valid driver license (26% versus 1%). Logistic regression analysis showed that impairment from alcohol or stimulants (mainly amphetamines) was associated with all three risk factors, medicinal drugs with all except speeding, and impairment from cannabis (THC) with not having a valid driver license. Among motorcycle riders, drug/alcohol impairment was associated with not having a valid driver license and non-use of a helmet. At least one of the risk factors speeding, non-use of a seatbelt/helmet, and driving without a valid license were present among the vast majority of the drug/alcohol-impaired fatally injured drivers and riders, and also among more than half of the fatally injured sober drivers.
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| 6. |
- Valen, Anja, et al.
(författare)
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Fatally injured drivers in Norway 2005–2015 : Trends in substance use and crash characteristics
- 2019
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Ingår i: Traffic Injury Prevention. - : Taylor and Francis Inc.. - 1538-9588 .- 1538-957X. ; 20:5, s. 460-466
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Norway introduced a “Vision Zero” strategy in 2001, using multiple approaches, aiming toward a future in which no one will be killed or seriously injured in road traffic crashes (RTCs). Official statistics show that the number of fatally injured road users has declined substantially from 341 deaths in 2000 to 117 in 2015. In-depth crash investigations of all fatal RTCs started in Norway in 2005. The aim of this study was to investigate whether fatal crash characteristics, vehicle safety features, and prevalence of drugs and/or alcohol among fatally injured drivers and riders has changed during 2005–2015, accompanying the reduction in road fatalities.Methods: Data on all car/van drivers and motorcycle/moped riders fatally injured in RTCs during 2005–2015 were extracted from Norwegian road traffic crash registries and combined with forensic toxicology data.Results: The proportion of cars and motorcycles with antilock braking systems and cars with electronic stability control, increased significantly during the study period. The prevalence of nonuse of seat belts/helmets and speeding declined among both fatally injured drivers and riders. In addition, the prevalence of alcohol declined, though no significant change in the total prevalence of other substances was noted.Conclusion: The observed changes toward more safety installations in cars and motorcycles and lower prevalence of driver-related risk factors like alcohol use, speeding, and nonuse of seat belts/helmets among fatally injured drivers/riders may have contributed to the decrease in road traffic deaths.
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