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- Chowdhury, F., et al.
(författare)
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A phase I/II study to evaluate safety, tolerability and immunogenicity of Hillchol®, an inactivated single Hikojima strain based oral cholera vaccine, in a sequentially age descending population in Bangladesh
- 2021
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X. ; 39:32, s. 4450-4457
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Tidskriftsartikel (refereegranskat)abstract
- Background: The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified OCVs (Dukoral, Shanchol, Euvichol) contain multiple heat and formalin-killed V. cholerae strains of Inaba and Ogawa serotypes. MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. in technical collaboration with University of Gothenburg, Sweden has developed a new single strain OCV, Hillchol. This vaccine consists of formaldehyde-inactivated whole cell El Tor V. cholerae O1 bacteria engineered into the Hikojima serotype for stable expression of both the Ogawa (AB) and Inaba (AC) LPS antigens on the bacterial surface. We evaluated the safety and immunogenicity of this novel and potentially much less expensive OCV in comparison with Shanchol. Methods: We conducted a randomized, non-inferiority, age-descending clinical trial of OCV (Hillchol vs. Shanchol) in the Mirpur area of Dhaka city from July 2016 to May 2017. This study was carried out in three different age cohorts (1–<5, 5–17 and ≥18 years old). Two doses of vaccine were given at 14 days intervals to 560 healthy participants. Findings: No serious adverse events were reported. There were no significant differences in the rates of adverse events between the test vaccine (Hillchol) and the comparator (Shanchol) group. Serum vibriocidal antibody responses in all age groups combined were comparable for all the O1 Ogawa (59% vs. 67%; 90% CI of difference: −14.55, −0.84) and Inaba (70% vs. 71%; 90% CI of difference: −7.24, 5.77) serotypes, showing that the Hillchol vaccine was non-inferior to Shanchol. This new vaccine was also non-inferior to Shanchol in the different age strata. Conclusion: The safety and immunogenicity profile of the new OCV Hillchol is comparable to Shanchol in persons residing in a cholera-endemic setting. ClinicalTrials.gov number: NCT02823899. © 2021
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| 2. |
- Nordqvist, D., et al.
(författare)
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Incorporating Amylopectin in Poly(lactic Acid) by Melt Blending Using Poly(ethylene-co-vinyl Alcohol) as a Thermoplastic Carrier. (I) Morphological Characterization
- 2010
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Ingår i: Journal of Applied Polymer Science. - : Wiley. - 0021-8995 .- 1097-4628. ; 115:3, s. 1315-1324
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Tidskriftsartikel (refereegranskat)abstract
- In this study, the possibility of using a biodegradable grade of thermoplastic poly(ethylene-co-vinyl alcohol) with high (71 mol %) vinyl alcohol (EVOH-29), as a carrier to incorporate the renewable and biodegradable component amylopectin (AP) into poly(lactic acid) (PLA) through melt blending, was investigated. The effect of using a plasticizer/compatibilizer (glycerol) in the blend systems was also investigated. In a first step, the EVOH/AP blends were produced and thereafter, in a second step, these were mixed with PLA. In this first study, the blend morphology was investigated using optical microscopy, scanning electron microscopy and Raman imaging spectroscopy and the thermal properties were measured by differential scanning calorimetry. Despite the fact that EVOH and AP are both highly polar, their blends were immiscible. Still, the blends exhibited an excellent phase dispersion on a micron level, which was enhanced further by the addition of glycerol. A good phase dispersion was finally observed by incorporation of the latter blends in the PLA matrix, suggesting that the proposed blending route can be successfully applied for these systems. Finally, the Differential scanning calorimetry (DSC) data showed that the melting point of EVOH dropped in the EVOH/AP blends, but the properties of the PLA phase was still relatively unaffected as a result of blending with the above components.
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| 3. |
- Clevers, Egbert, et al.
(författare)
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Food-symptom diaries can generate personalized lifestyle advice for managing gastrointestinal symptoms: A pilot study
- 2020
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Ingår i: Neurogastroenterology and Motility. - : Wiley. - 1350-1925 .- 1365-2982. ; 32:8
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Tidskriftsartikel (refereegranskat)abstract
- Background Gastrointestinal (GI) symptoms have a heterogeneous pathophysiology. Yet, clinical management uses group-level strategies. There is a need for studies exploring personalized management options in patients with GI symptoms. From diaries of GI symptoms, food intake, and psychological distress, we extracted and validated personalized lifestyle advice. Secondly, we investigated group-level GI symptom triggers using meta-analysis. Methods We collected 209 diaries of GI symptoms, food intake, and psychological distress, coming from 3 cohorts of patients with GI symptoms (n = 20, 26, and 163, median lengths 24, 17, and 38 days). Diaries were split into training and test data, analyzed, and the triggers emerging from the training data were tested in the test data. In addition, we did a random effects meta-analysis on the full data to establish the most common GI symptom triggers. Key Results Analysis of the training data allowed us to predict symptom triggers in the test data (r = 0.27, P < .001), especially in the subset of patients with a strong global association between lifestyle factors and symptoms (r = 0.45, P < .001). Low exposure to these triggers in the test data was associated with symptom reduction (P = .043). Meta-analysis showed that caloric intake in the late evening or night predicted an increase in GI symptoms, especially bloating. Several food-symptom associations were found, whereas psychological distress did not clearly lead to more severe GI symptoms. Conclusions & Inferences Diaries of GI symptoms, food intake, and psychological distress can lead to meaningful personalized lifestyle advice in subsets of patients.
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| 5. |
- Fletcher, Denise, et al.
(författare)
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Qualitative research practices and family business scholarship : A review and future research agenda
- 2016
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Ingår i: The Journal of Family Business Strategy. - : Elsevier. - 1877-8585 .- 1877-8593. ; 7:1, s. 8-25
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Tidskriftsartikel (refereegranskat)abstract
- In spite of various calls for a wider application of qualitative research in the family business field, it is our contention that the full potential of qualitative inquiry is not being fully realized. Part of the reason for this relates to the tendency to promote methods choice and diversity rather than addressing the foundational questions and processes which underlie qualitative research choices. These tendencies obscure attention to the reasons why researchers choose qualitative methods and the kinds of foundational issues about family businesses that are brought to light through qualitative research. To address this, we undertake an analysis of the most-cited articles using qualitative methods from an annotated bibliography of family business studies. From this, we identify the strengths and weaknesses of extant qualitative studies in family business research and argue for the need to re-orientate calls in family business research towards the foundational questions (rather than methods) that underline qualitative inquiry.
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| 9. |
- Sanchez-Garcia, M. D., et al.
(författare)
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Incorporating Amylopectin in Poly(lactic acid) by Melt Blending Using Poly(ethylene-co-vinyl alcohol) as a Thermoplastic Carrier. II. Physical Properties
- 2011
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Ingår i: Journal of Applied Polymer Science. - : Wiley. - 0021-8995 .- 1097-4628. ; 119:6, s. 3708-3716
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Tidskriftsartikel (refereegranskat)abstract
- This study adds to a previous morphological work (paper I) with further characterization of the developed poly(lactic acid) (PLA) blends containing amylopectin, which made use of an ethylene-vinyl alcohol copolymer (EVOH) as a melt-compoundable carrier for the polysaccharide in the biopolyester. The effect of using glycerol as compatibilizer was also characterized. Water and oxygen transport parameters, mechanical properties, and comparative biodegradability tests were evaluated for the blends. From the results, the barrier properties to oxygen were only seen to improve at 0% RH and mostly for the PLA-EVOH blends, which furthermore showed a positive deviation from the rule of mixtures. At high relative humidity, the blends showed somewhat poorer barrier performance due to the comparatively higher improvement in barrier of the neat PLA at 80% RH. Interestingly, room temperature biodegradability testing suggested that low additions of the blending elements seemed to facilitate the biodegradability of the biopolyester. Despite the fact that properties were not so dramatically improved, incorporating renewable resources within PLA seems as a potentially viable route to reduce PLA supply dependency, retain good optical properties and to overcome some drawbacks associated to the use of this biopolyester. (C) 2010 Wiley Periodicals, Inc. J Appl Polym Sci 119: 3708-3716, 2011
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