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- Benatar, Michael, et al.
(författare)
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Safety and efficacy of arimoclomol in patients with early amyotrophic lateral sclerosis (ORARIALS-01) : a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial
- 2024
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Ingår i: Lancet Neurology. - : Elsevier. - 1474-4422 .- 1474-4465. ; 23:7, s. 687-699
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Tidskriftsartikel (refereegranskat)abstract
- Background: Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder leading to muscle weakness and respiratory failure. Arimoclomol, a heat-shock protein-70 (HSP70) co-inducer, is neuroprotective in animal models of amyotrophic lateral sclerosis, with multiple mechanisms of action, including clearance of protein aggregates, a pathological hallmark of sporadic and familial amyotrophic lateral sclerosis. We aimed to evaluate the safety and efficacy of arimoclomol in patients with amyotrophic lateral sclerosis.Methods: ORARIALS-01 was a multinational, randomised, double-blind, placebo-controlled, parallel-group trial done at 29 centres in 12 countries in Europe and North America. Patients were eligible if they were aged 18 years or older and met El Escorial criteria for clinically possible, probable, probable laboratory-supported, definite, or familial amyotrophic lateral sclerosis; had an ALS Functional Rating Scale-Revised score of 35 or more; and had slow vital capacity at 70% or more of the value predicted on the basis of the participant's age, height, and sex. Patients were randomly assigned (2:1) in blocks of 6, stratified by use of a stable dose of riluzole or no riluzole use, to receive oral arimoclomol citrate 1200 mg/day (400 mg three times per day) or placebo. The Randomisation sequence was computer generated centrally. Investigators, study personnel, and study participants were masked to treatment allocation. The primary outcome was the Combined Assessment of Function and Survival (CAFS) rank score over 76 weeks of treatment. The primary outcome and safety were analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03491462, and is completed.Findings: Between July 31, 2018, and July 17, 2019, 287 patients were screened, 245 of whom were enrolled in the trial and randomly assigned. The modified intention-to-treat population comprised 239 patients (160 in the arimoclomol group and 79 in the placebo group): 151 (63%) were male and 88 (37%) were female; mean age was 57·6 years (SD 10·9). CAFS score over 76 weeks did not differ between groups (mean 0·51 [SD 0·29] in the arimoclomol group vs 0·49 [0·28] in the placebo group; p=0·62). Cliff's delta comparing the two groups was 0·039 (95% CI –0·116 to 0·194). Proportions of participants who died were similar between the treatment groups: 29 (18%) of 160 patients in the arimoclomol group and 18 (23%) of 79 patients in the placebo group. Most deaths were due to disease progression. The most common adverse events were gastrointestinal. Adverse events were more often deemed treatment-related in the arimoclomol group (104 [65%]) than in the placebo group (41 [52%]) and more often led to treatment discontinuation in the arimoclomol group (26 [16%]) than in the placebo group (four [5%]).Interpretation: Arimoclomol did not improve efficacy outcomes compared with placebo. Although available biomarker data are insufficient to preclude future strategies that target the HSP response, safety data suggest that a higher dose of arimoclomol would not have been tolerated.Funding: Orphazyme.
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- Olson, L, et al.
(författare)
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Neonatal resuscitation monitoring: A low-cost video recording setup for quality improvement in the delivery room at the resuscitation table
- 2022
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Ingår i: Frontiers in pediatrics. - : Frontiers Media SA. - 2296-2360. ; 10, s. 952489-
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Tidskriftsartikel (refereegranskat)abstract
- The quality of neonatal resuscitation after delivery needs to be improved to reach the Sustainable Development Goals 3.2 (reducing neonatal deaths to <12/1,000 live newborns) by the year 2030. Studies have emphasized the importance of correctly performing the basic steps of resuscitation including stimulation, heart rate assessment, ventilation, and thermal control. Recordings with video cameras have previously been shown to be one way to identify performance practices during neonatal resuscitation.MethodsA description of a low-cost delivery room set up for video recording of neonatal resuscitation. The technical setup includes rechargeable high-definition cameras with two-way audio, NeoBeat heart rate monitors, and the NeoTapAS data collection tools for iPad with direct data export of data for statistical analysis. The setup was field tested at Mulago National Referral Hospital, Kampala, Uganda, and Phu San Hanoi Hospital, Hanoi, Vietnam.ResultsThe setup provided highly detailed resuscitation video footage including data on procedures and team performance, heart rate monitoring, and clinical assessment of the neonate. The data were analyzed with the free-of-charge NeoTapAS for iPad, which allowed fast and accurate registration of all resuscitative events. All events were automatically registered and exported to R statistical software for further analysis.ConclusionsVideo analysis of neonatal resuscitation is an emerging quality assurance tool with the potential to improve neonatal resuscitation outcomes. Our methodology and technical setup are well adapted for low- and lower-middle-income countries settings where improving neonatal resuscitation outcomes is crucial. This delivery room video recording setup also included two-way audio communication that potentially could be implemented in day-to-day practice or used with remote teleconsultants.
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- Andersson, C., et al.
(författare)
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Fully electric ship propulsion reduces airborne noise but not underwater noise
- 2024
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Ingår i: Ocean Engineering. - Göteborg : Elsevier. - 0029-8018 .- 1873-5258. ; 302
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Tidskriftsartikel (refereegranskat)abstract
- Electrification of ships offers zero-emission travel and is spreading rapidly, but the relation between electric ship propulsion and noise pollution is not generally understood. Here, three different types of diesel-electric hybrid ferries have been measured in two operating modes: running in hybrid mode with the diesel engine powering an electric generator; and running in fully electric battery powered mode. Measurements were performed to simultaneously quantify airborne and underwater radiated noise. Findings are that on-board diesel engines for electricity generation do not contribute a large extent of the underwater radiated noise, whilst a major source of airborne low-frequency radiation.
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- Borg, Erik A., 1961-, et al.
(författare)
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Corporate governance networks between international financial market actors within investment banking
- 2017
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Ingår i: Proceedings of the 59<sup>th</sup> Annual Meeting of the Academy of International Business. - East Lansing, USA : Academy of International Business. ; , s. 19-
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Konferensbidrag (refereegranskat)abstract
- This article presents a study of networks in the financial services market. We invoke network theory to study the role of connection between market actors within investment banking. We look at the relationship between corporate governance and the networks and performance of financial market actors. A comprehensive set of secondary data is analyzed with a multiple correspondence analysis methodology. The data is compared with evidences of rankings of the financial service divisions of investment banks. We have found that the forming of formal networks ties between market actors can be associated with the rating of financial banking service. Actors with more network connections are rated higher in customer ratings than those with fewer network ties. The forming of formal ties in boards and committees has a positive impact on the performance ratings of providers of financial services. Our data consists of three clusters. The first entails international banks with high turnover and superior customer reviews. The second cluster consists of small unranked banks with considerably lower turnover, and the third cluster is represented by the midsized banks.
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- Finsel, Julia, et al.
(författare)
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Determining impairment in the Swedish, Polish and German ECAS : the importance of adjusting for age and education
- 2023
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Ingår i: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. - : Taylor & Francis. - 2167-8421 .- 2167-9223. ; 24:5-6, s. 475-484
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Age and years of education are strong predictors of cognitive performance in several versions of the Edinburgh Cognitive and Behavioral ALS Screen (ECAS) and cutoffs for the Swedish and Polish versions are not established yet. Here we evaluated the performance of healthy subjects on the national versions of the Swedish and Polish ECAS and compared cognitive performance on three European translations of the ECAS.Methods: The ECAS performances of healthy subjects from Sweden (n = 111), Poland (n = 124) and Germany (n = 86) were compared. Based on the test results on the national versions of ECAS, age- and education-adjusted cutoffs were compared for the German, Swedish and Polish versions, respectively.Results: Age and years of education correlated with performance in the ECAS. Swedish subjects under the age of 60 years and Swedish subjects with low education level scored significantly higher in memory than the respective German and Polish subgroups. German and Polish subjects over 60 years of age performed significantly better in language than the respective Swedish subgroup. The Polish cohort in total had lower executive scores compared to the Swedish cohort, and lower than the German subjects in the higher education subgroup.Conclusions: The results highlight the importance of establishing age- and education-adjusted ECAS cutoffs not only in general, but also for seemingly similar populations of different origins. The results should be taken into account when comparing cognition data across patient populations including in drug trials where an ECAS test result is being used as an inclusion criterium or outcome measure.
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