| 1. |
- Isacsson, G., et al.
(författare)
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Bibloc and Monobloc Oral appliances in the Treatment of Obstructive Sleep apnoea : a Multicenter, Randomized, Blinded, Parallel-Group Trial
- 2017
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Ingår i: Sleep Medicine. - : Elsevier. - 1389-9457 .- 1878-5506. ; 40:Suppl 1, s. E142-E143
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: The clinical benefit of bibloc over monobloc appliances has not been established in randomized trials treating obstructive sleep apnoea (OSA). We hypothesized that the two types of appliances are equally effective in treating moderate to severe OSA. Materials and methods: We performed a blinded, multicenter, randomized, controlled, prospective, parallel-group trial including patients aged 18 years or older who had moderate-to-severe OSA. Patients were randomly assigned to receive either a bibloc or a monobloc appliance with the intention to protrude the mandible 75% of the individual maximal protrusion capacity. At baseline a one-night respiratory polygraphy was done without any respiratory support. The polygraphy was iterated with the appliance in place at a 6-week follow-up. The primary outcome was the absolute change in the apnoea-hypopnea-index (AHI) from baseline to the 6-week follow-up, analysed in the per-protocol population. All patients who received an appliance were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02148510, and approved by Uppsala Regional Ethical Review Board, Sweden (#2014/021). Results: We recruited patients from three dental specialist clinics in Sweden; enrolment of 302 patients was done between March 2014 and April 2016; 146 randomized to bibloc and 156 to monobloc appliance. Twenty-three patients in the bibloc group and 17 in the monobloc group were withdrawn due to reasons like appliance could not be fitted, lack of compliance, adverse events or non-valid follow-up polygraphy i.e. a per-protocol group of 123 bibloc and 139 monobloc treated patients. The mean change of AHI from baseline to 6 weeks of treatment was -13.8 (95% CI -16.1 to -11.5; p < 0.001) in the bibloc group and -12.5 (95% CI -14.8 to -10.3; p < 0.001) in the monobloc group. The mean difference was not significant between the groups (-1.3 (95% CI -4.5 to 1.9). The most common adverse event in the orofacial region was upper airway infection followed by complains from various parts of the mouth, jaws and teeth. Conclusions: Bibloc and monobloc appliance treatment was equal in their effects in treating OSA as measured by at home polygraphic respiratory measures and the appliances were associated with a similar degree of adverse events. Acknowledgements: Funding from Uppsala-Örebro Regional Research Council and Vastmanland County Council, Sweden.
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| 2. |
- Ahmed, N, et al.
(författare)
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The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke
- 2016
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Ingår i: European stroke journal. - : SAGE Publications. - 2396-9881 .- 2396-9873. ; 1:3, s. 213-221
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Tidskriftsartikel (refereegranskat)abstract
- The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3–4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. Patients and methods Inclusion of at least 1000 patients treated within 3–4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3–4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0–2, favourable outcome (mRS 0–1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. Results 4157 patients from 81 centres in 12 EU countries were entered prospectively ( N = 1118 in the 3–4.5 h, N = 3039 in the 0–3 h time window) and 3454 retrospective patients in the 0–3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3–4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3–4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). Discussion Main weakness is the observational design of the study. Conclusion This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.
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| 3. |
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| 4. |
- Lendaro, Eva, 1989, et al.
(författare)
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Phantom motor execution as a treatment for phantom limb pain: Protocol of an international, double-blind, randomised controlled clinical trial
- 2018
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Ingår i: BMJ Open. - : BMJ. - 2044-6055 .- 2044-6055. ; 8:7
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Methods and analysis Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: Frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.
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| 5. |
- Oskarsson, Marie E., et al.
(författare)
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The BRICHOS domain of Bri2 inhibits islet amyloid polypeptide (IAPP) fibril formation and toxicity in human beta cells
- 2018
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Ingår i: Proceedings of the National Academy of Sciences of the United States of America. - : Proceedings of the National Academy of Sciences. - 0027-8424 .- 1091-6490. ; 115:12, s. E2752-E2761
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Tidskriftsartikel (refereegranskat)abstract
- Aggregation of islet amyloid polypeptide (IAPP) into amyloid fibrils in islets of Langerhans is associated with type 2 diabetes, and formation of toxic IAPP species is believed to contribute to the loss of insulin-producing beta cells. The BRICHOS domain of integral membrane protein 2B (Bri2), a transmembrane protein expressed in several peripheral tissues and in the brain, has recently been shown to prevent fibril formation and toxicity of Aβ42, an amyloid-forming peptide in Alzheimer disease. In this study, we demonstrate expression of Bri2 in human islets and in the human beta-cell line EndoC-βH1. Bri2 colocalizes with IAPP intracellularly and is present in amyloid deposits in patients with type 2 diabetes. The BRICHOS domain of Bri2 effectively inhibits fibril formation in vitro and instead redirects IAPP into formation of amorphous aggregates. Reduction of endogenous Bri2 in EndoC-βH1 cells with siRNA increases sensitivity to metabolic stress leading to cell death while a concomitant overexpression of Bri2 BRICHOS is protective. Also, coexpression of IAPP and Bri2 BRICHOS in lateral ventral neurons of Drosophila melanogaster results in an increased cell survival. IAPP is considered to be the most amyloidogenic peptide known, and described findings identify Bri2, or in particular its BRICHOS domain, as an important potential endogenous inhibitor of IAPP aggregation and toxicity, with the potential to be a possible target for the treatment of type 2 diabetes.
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| 6. |
- Pfeifer, H., et al.
(författare)
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Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph plus ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1
- 2019
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Ingår i: Leukemia. - : NATURE PUBLISHING GROUP. - 0887-6924 .- 1476-5551. ; 33:8, s. 1910-1922
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Tidskriftsartikel (refereegranskat)abstract
- Minimal residual disease (MRD) is a powerful prognostic factor in acute lymphoblastic leukemia (ALL) and is used for patient stratification and treatment decisions, but its precise role in Philadelphia chromosome positive ALL is less clear. This uncertainty results largely from methodological differences relating to the use of real-time quantitative PCR (qRT-PCR) to measure BCR-ABL1 transcript levels for MRD analysis. We here describe the first results by the EURO-MRD consortium on standardization of qRT-PCR for the e1a2 BCR-ABL1 transcript in Ph + ALL, designed to overcome the lack of standardisation of laboratory procedures and data interpretation. Standardised use of EAC primer/probe sets and of centrally prepared plasmid standards had the greatest impact on reducing interlaboratory variability. In QC1 the proportion of analyses with BCR-ABL1/ABL1 ratios within half a log difference were 40/67 (60%) and 52/67 (78%) at 10(-3) and 36/67 (53%) and 53/67 (79%) at 10(-4)BCR-ABL1/ABL1. Standardized RNA extraction, cDNA synthesis and cycler platforms did not improve results further, whereas stringent application of technical criteria for assay quality and uniform criteria for data interpretation and reporting were essential. We provide detailed laboratory recommendations for the standardized MRD analysis in routine diagnostic settings and in multicenter clinical trials for Ph + ALL.
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| 7. |
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| 8. |
- Rudner, Mary, et al.
(författare)
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Training literacy skills through sign language
- 2015
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Ingår i: Deafness and Education International. - : Maney Publishing. - 1464-3154 .- 1557-069X. ; 17:1, s. 8-18
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Tidskriftsartikel (refereegranskat)abstract
- The literacy skills of deaf children generally lag behind those of their hearing peers. The mechanisms of reading in deaf individuals are only just beginning to be unraveled but it seems that native language skills play an important role. In the present study 12 deaf pupils (six in grade 1-2 and six in grade 4-6) at a Swedish state primary school for deaf and hard of hearing children were trained on the connection between Swedish Sign Language and written Swedish using a pilot sign language version of the literacy training software program Omega-is. Literacy skills improved substantially across the 20 days of the study. These literacy gains may have rested upon the specific softwarebased intervention, upon regular classroom activities, or upon a combination of these factors. Omega-is-d, and similar software utilizing sign language as a component, targets an important mechanism supporting reading development in deaf children and could play an important role in bilingual education refinements.
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| 9. |
- Tartaglia, L., et al.
(författare)
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Interacting supernovae and supernova impostors. SN 2007sv : the major eruption of a massive star in UGC 5979
- 2015
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Ingår i: Monthly notices of the Royal Astronomical Society. - : Oxford University Press (OUP). - 0035-8711 .- 1365-2966. ; 447:1, s. 117-131
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Tidskriftsartikel (refereegranskat)abstract
- We report the results of the photometric and spectroscopic monitoring campaign of the transient SN 2007sv. The observables are similar to those of Type IIn supernovae, a well-known class of objects whose ejecta interact with pre-existing circumstellar material (CSM). The spectra show a blue continuum at early phases and prominent Balmer lines in emission; however, the absolute magnitude at the discovery of SN 2007sv (M-R=-14.25 +/- 0.38) indicate it to be most likely a supernova impostor. This classification is also supported by the lack of evidence in the spectra of very high velocity material as expected in supernova ejecta. In addition, we find no unequivocal evidence of broad lines of alpha- and/or Fe-peak elements. The comparison with the absolute light curves of other interacting objects (including Type IIn supernovae) highlights the overall similarity with the prototypical impostor SN 1997bs. This supports our claim that SN 2007sv was not a genuine supernova, and was instead a supernova impostor, most likely similar to the major eruption of a luminous blue variable.
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| 10. |
- Tegelberg, Åke, et al.
(författare)
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Respiratory outcome after one-year treatment of obstructive sleep apnea with bibloc versus monobloc oral appliances : a multicenter, randomized equivalence trial
- 2019
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Ingår i: Sleep Medicine. - : Elsevier. - 1389-9457 .- 1878-5506. ; 64:Suppl. 1, s. S378-S378
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: The benefit of bibloc over monobloc appliances in one-year obstructive sleep apnea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances are equally effective.Methods: In this multicenter, randomized equivalence trial patients with OSA were assigned to either bibloc or monobloc appliance treatment. At baseline a one-night home respiratory polygraphy was done without respiratory support, and at one-year follow-up examination iterated with the appliance in place. The outcome was the change in the apnea-hypopnea-index (AHI) and the equivalence limits were set at ±5.Results: Out of 302 patients 146 were randomly assigned to bibloc and 156 to monobloc. In 88 and 104 patients, respectively, were analysed per-protocol with a significant reduction of AHI with a mean change -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc and not significantly equivalent. The proportion of responders defined as AHI < 10 at the follow-up was 68% and 65% for bibloc and monobloc, respectively. Treatment related adverse events were generally mild and transient and occurred similar in frequencies between groups.Conclusions: Bibloc and monobloc appliance treatment gave a significant positive effect in treating OSA. The treatment modalities were not statistically equivalent, with a numerically greater reduction with bibloc, and, were associated with a similar degree of adverse events.
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