| 1. |
- Cavadino, Alana, et al.
(författare)
-
Signal Detection in EUROmediCAT : Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
- 2021
-
Ingår i: Drug Safety. - : ADIS INT LTD. - 0114-5916 .- 1179-1942. ; 44:7, s. 765-785
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications. Aims This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals. Methods Signals of medication-congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation. Results EUROmediCAT analysis identified 49 signals of medication-congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly. Conclusion EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.
|
|
| 2. |
- Jung, Christian, et al.
(författare)
-
A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention
- 2019
-
Ingår i: Journal of critical care. - : W B SAUNDERS CO-ELSEVIER INC. - 0883-9441 .- 1557-8615. ; 52, s. 141-148
-
Tidskriftsartikel (refereegranskat)abstract
- Background: We aimed to evaluate differences in outcome between patients admitted to intensive care unit (ICU) after elective versus acute surgery in a multinational cohort of very old patients (80 years; VIP). Predictors of mortality, with special emphasis on frailty, were assessed.Methods: In total, 5063 VIPs were induded in this analysis, 922 were admitted after elective surgery or intervention, 4141 acutely, with 402 after acute surgery. Differences were calculated using Mann-Whitney-U test and Wilcoxon test. Univariate and multivariable logistic regression were used to assess associations with mortality.Results: Compared patients admitted after acute surgery, patients admitted after elective surgery suffered less often from frailty as defined as CFS (28% vs 46%; p < 0.001), evidenced lower SOFA scores (4 +/- 5 vs 7 +/- 7; p < 0.001). Presence of frailty (CFS >4) was associated with significantly increased mortality both in elective surgery patients (7% vs 12%; p = 0.01), in acute surgery (7% vs 12%; p = 0.02).Conclusions: VIPs admitted to ICU after elective surgery evidenced favorable outcome over patients after acute surgery even after correction for relevant confounders. Frailty might be used to guide clinicians in risk stratification in both patients admitted after elective and acute surgery.
|
|
| 3. |
- Abulaiti, Yiming, et al.
(författare)
-
Measurement of the double-differential high-mass Drell-Yan cross section in pp collisions at root s=8 TeV with the ATLAS detector
- 2016
-
Ingår i: Journal of High Energy Physics (JHEP). - : Springer. - 1126-6708 .- 1029-8479. ; :8
-
Tidskriftsartikel (refereegranskat)abstract
- This paper presents a measurement of the double-differential cross section for the Drell-Yan Z/gamma* -> l(+)l(-) and photon-induced gamma gamma -> l(+)l(-) processes where l is an electron or muon. The measurement is performed for invariant masses of the lepton pairs, m(ll), between 116 GeV and 1500 GeV using a sample of 20.3 fb(-1) of pp collisions data at centre-of-mass energy of root s = 8TeV collected by the ATLAS detector at the LHC in 2012. The data are presented double differentially in invariant mass and absolute dilepton rapidity as well as in invariant mass and absolute pseudorapidity separation of the lepton pair. The single-differential cross section as a function of m(ll) is also reported. The electron and muon channel measurements are combined and a total experimental precision of better than 1% is achieved at low m(ll). A comparison to next-to-next-to-leading order perturbative QCD predictions using several recent parton distribution functions and including next-to-leading order electroweak effects indicates the potential of the data to constrain parton distribution functions. In particular, a large impact of the data on the photon PDF is demonstrated.
|
|
| 4. |
- Alexander, Karen P., et al.
(författare)
-
Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial
- 2016
-
Ingår i: Circulation. - 0009-7322 .- 1524-4539. ; 133:1, s. 39-47
-
Tidskriftsartikel (refereegranskat)abstract
- Background Angina often persists or returns in populations following percutaneous coronary intervention (PCI). We hypothesized that ranolazine would be effective in reducing angina and improving quality of life (QOL) in incomplete revascularization (ICR) post-PCI patients. Methods and Results In RIVER-PCI, 2604 patients with a history of chronic angina who had ICR post-PCI were randomized 1:1 to oral ranolazine versus placebo; QOL analyses included 2389 randomized subjects. Angina and QOL questionnaires were collected at baseline and months 1, 6, and 12. Ranolazine patients were more likely than placebo to discontinue study drug by month 6 (20.4% versus 14.1%, P<0.001) and 12 (27.2% versus 21.3%, P<0.001). Following qualifying index PCI, the primary QOL outcome (Seattle Angina Questionnaire [SAQ] angina frequency score) improved markedly, but similarly, in the ranolazine and placebo groups, respectively, from baseline (67.324.5 versus 69.724.0, P=0.01) to month 1 (86.6 +/- 18.1 versus 85.8 +/- 18.5, P=0.27) and month 12 (88.4 +/- 17.8 versus 88.5 +/- 17.8, P=0.94). SAQ angina frequency repeated measures did not differ in adjusted analysis between groups post baseline (mean difference 1.0; 95% CI -0.2, 2.2; P=0.11). Improvement in SAQ angina frequency was observed with ranolazine at month 6 among diabetics (mean difference 3.3; 95% CI 0.6, 6.1; P=0.02) and those with more angina (baseline SAQ angina frequency 60; mean difference 3.4; 95% CI 0.6, 6.2; P=0.02), but was not maintained at month 12. Conclusions Despite ICR following PCI, there was no incremental benefit in angina or QOL measures by adding ranolazine in this angiographically-identified population. These measures markedly improved within 1 month of PCI and persisted up to 1 year in both treatment arms. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01442038.
|
|
| 5. |
- Erlandsson, Kerstin, et al.
(författare)
-
Qualitative interviews with adolescents about "Friends-with-Benefits" relationships
- 2013
-
Ingår i: Public Health Nursing. - : Wiley-Blackwell. - 0737-1209 .- 1525-1446. ; 30:1, s. 47-57
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To describe the thoughts, reflections, and experiences of friends-with-benefits relationships among a group of Swedish adolescents. Design and Sample: A qualitative study with an explorative and descriptive design. Eight adolescents, aged 16-18, were interviewed. Measures: Individual in-depth interviews were undertaken. Data were analyzed using latent content analysis. Results: The informants involved themselves in Friends-with-benefits (FWB) relationships to find physical and psychological intimacy without any expectations or demands. FWB relationships were perceived to have more advantages when the partner was a close friend with whom an informant felt comfortable. There was ambivalence about the legitimacy of romantic feelings in an FWB relationship, although it was quite common. Sexual concurrency was common and often accepted. Sexual risk-taking behavior involving the use of alcohol and a lack of contraception was considered common in FWB relationships. Informants requested more education and support as regards their sexual behavior. Conclusions: FWB relationships were often initiated to find physical and psychological intimacy with no expectations or demands. Advantages such as sexual concurrency and no demands were central. A deeper understanding of how adolescents think and reason about sexuality and relationships can make a difference when working to improve young people's sexual and reproductive health.
|
|
| 6. |
- Ohman, E. A., et al.
(författare)
-
Effects of dietary and exercise treatments on HDL subclasses in lactating women with overweight and obesity: a secondary analysis of a randomised controlled trial
- 2022
-
Ingår i: British Journal of Nutrition. - : Cambridge University Press (CUP). - 0007-1145 .- 1475-2662. ; 128:11, s. 2105-2114
-
Tidskriftsartikel (refereegranskat)abstract
- Childbearing decreases HDL-cholesterol, potentially contributing to the increased risk of CVD in parous women. Large HDL particles (HDL-P) are associated with lower risk of CVD. In this secondary analysis of a randomised controlled trial, we investigated the effects of 12-week dietary and exercise treatments on HDL-P subclass concentration, size and apoA1 in lactating women with overweight/obesity. At 10-14 weeks postpartum, 68 women with pre-pregnant BMI 25-35 kg/m(2) were randomised to four groups using 2 x 2 factorial design: (1) dietary treatment for weight loss; (2) exercise treatment; (3) both treatments and (4) no treatment. Lipoprotein subclass profiling by NMR spectroscopy was performed in serum at randomisation and after 3 and 12 months, and the results analysed with two-way ANCOVA. Lipid concentrations decline naturally postpartum. At 3 months (5-6 months postpartum), both diet (P = 0 center dot 003) and exercise (P = 0 center dot 008) reduced small HDL-P concentration. Concurrently, exercise limited the decline in very large HDL-P (P = 0 center dot 002) and the effect was still significant at 12 months (15 months postpartum) (P = 0 center dot 041). At 12 months, diet limited the decline in very large HDL-P (P = 0 center dot 005), large HDL-P (P = 0 center dot 001) and apoA1 (P = 0 center dot 002) as well as HDL size (P = 0 center dot 002). The dietary treatment for weight loss and the exercise treatment both showed effects on HDL-P subclasses in lactating women with overweight and obesity possibly associated with lower CVD risk. The dietary treatment had more effects than the exercise treatment at 12 months, likely associated with a 10 % weight loss.
|
|
| 7. |
- Ohman, Micael Bjorn, et al.
(författare)
-
Dimensional stability in four different wooden facade claddings
- 2016
-
Ingår i: WCTE 2016. - 9783903024359 ; , s. 2810-2818
-
Konferensbidrag (refereegranskat)abstract
- The hypothesis is that a good cladding system in wood should be characterized by a homogeneous dimensional behaviour with minimal variation between individual panel boards to minimize maintenance, i.e. repainting or, in the worst case, replacement of whole panels. Four different types of cladding panels were tested: a regular spruce panel, a quality-sorted P-marked spruce panel, a regular panel of pine heartwood and a spruce glulam panel, 50 panels of each type. The objective was to study the dimensional changes under changing moisture conditions in order to find the cladding material with the smallest possible dimensional and distortion movements. The shape stability of the panels was measured and expressed in terms of bow, spring, twist and cupping. The spruce glulam panels showed the best shape stability, proven significantly different in comparison to the other two spruce panel systems. Panels of pine heartwood showed a tendency greater dimensional stability than the spruce panels, but not enough to be considered statistically significantly different in this study.
|
|
| 8. |
- Weisz, Giora, et al.
(författare)
-
Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI) : a multicentre, randomised, double-blind, placebo-controlled trial
- 2016
-
Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 387:10014, s. 136-145
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention.METHODS: We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038.FINDINGS: Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575-758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82-1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04).INTERPRETATION: Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population.FUNDING: Gilead Sciences, Menarini.
|
|
| 9. |
- Aad, G., et al.
(författare)
-
- 2015
-
Tidskriftsartikel (refereegranskat)
|
|
