33 research outputs found
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.
No full textBackground: Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.
Methods: 273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.
Results: 268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.
Conclusions: AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237)
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.
No full textBACKGROUND: Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.
METHODS: 273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.
RESULTS: 268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p\u3c 0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.
CONCLUSIONS: AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237)
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: A comparative efficacy trial.
No full textBACKGROUND: Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa. METHODS: 273 patients (≥6years); randomized to three 28-day courses (AZLI 75mg [three-times/day] or TNS 300mg [twice/day]); 28 off-days separated each course. RESULTS: 268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV(1) was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period. CONCLUSIONS: AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237).JOURNAL ARTICLESCOPUS: ar.jinfo:eu-repo/semantics/publishe
Do UK based weight management programmes cause weight loss maintenance in adults? A systematic review
No full textThe aim of this dissertation was to examine whether UK based weight management programmes promote weight loss maintenance (follow up of 12 months to assess effectiveness of intervention in weight loss) in adults through the process of a systematic review. The World Health Organisation (WHO) has described obesity as a "global epidemic". Weight management comprises two phases; weight loss and weight loss maintenance. The latter phase is the true goal for obesity and the most difficult element of weight management to achieve. However much less is know about this as compared with the weight loss phase. There is little purpose in committing time and money to reducing obesity if the weight is regained. This is counter-productive and weight loss maintenance is essential to combat the obesity epidemic. Searches were made for relevant information from a variety of scientific online databases and journals,. Seven articles met the inclusion criteria and were analysed in the review. All studies incorporated a multi-component (diet, exercise, behaviur modification) intervention approach. All control and internvetion groups reported weight loss at 12 months when compared with baseline. All groups recieved an intervention. One study reported a significant difference (P<0.05) between groups. Four studies reported on at least one component (diet, physical activity, behaviour modification) however there was not enough information to conclude whether they complied with national guidelines (NICE CG43 and SIGN 115). High attrition rates and loss to follow up are problematic for each study except one. Analysis on an intention to treat basis was common however this is problematic and there are alternative methods which may be more suitable for dealing with missing data
Computerised memory specificity training (c-MeST) for the treatment of major depression: a study protocol for a randomised controlled trial
No full textINTRODUCTION: Major depression is a prevalent and debilitating disorder, but many sufferers do not receive support or respond to current treatments. The development of easily accessible and low-intensity treatments that have clear cognitive mechanisms of change is indicated. Memory specificity training (MeST) is an intervention for depression that targets deficits in recalling detailed memories of past experiences through repeated practice of autobiographical memory retrieval. This randomised controlled trial will assess the efficacy of an online, computerised version of MeST (c-MeST). METHODS AND ANALYSIS: Adults aged 18 and over with a current major depressive episode (MDE) will be recruited and randomised to have access to the seven session, online c-MeST programme for 2 weeks, or to a wait-list control group. The primary outcomes will be diagnostic status of MDE and self-reported depressive symptoms at postintervention. One-month and three-month follow-ups will be collected. Increases in autobiographical memory specificity will be assessed as a mediator of change, as well as other variables thought to contribute to reduced memory specificity, such as rumination and cognitive avoidance. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Deakin University Human Research Ethics Committee to conduct the study (ID: 2017_168). The findings will be disseminated through scholarly publications and workshops and will inform future trials, such as with an active comparator or as an adjunct treatment. TRIAL REGISTRATION NUMBER: ACTRN12618000257268; Pre-results.sponsorship: The lead author received support for this research from Deakin University, as part of a Deakin Health Postdoctoral Research Fellowship. (Deakin University, as part of a Deakin Health Postdoctoral Research Fellowship)status: Publishe
The effectiveness of interventions to treat severe acute malnutrition in young children: a systematic review
No full textSevere acute malnutrition (SAM) arises as a consequence of a sudden period of food shortage and is associated with loss of a person’s body fat and wasting of their skeletal muscle. Many of those affected are already undernourished and are often susceptible to disease. Infants and young children are the most vulnerable as they require extra nutrition for growth and development, have comparatively limited energy reserves and depend on others. Undernutrition can have drastic and wide-ranging consequences for the child’s development and survival in the short and long term. Despite efforts made to treat SAM through different interventions and programmes, it continues to cause unacceptably high levels of mortality and morbidity. Uncertainty remains as to the most effective methods to treat severe acute malnutrition in young children.ObjectivesTo evaluate the effectiveness of interventions to treat infants and children aged < 5 years who have SAM.Data sourcesEight databases (MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, CAB Abstracts Ovid, Bioline, Centre for Reviews and Dissemination, EconLit EBSCO and The Cochrane Library) were searched to 2010. Bibliographies of included articles and grey literature sources were also searched. The project expert advisory group was asked to identify additional published and unpublished references.Review methodsPrior to the systematic review, a Delphi process involving international experts prioritised the research questions. Searches were conducted and two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to the full texts of retrieved papers by one reviewer and checked independently by a second. Included studies were mapped to the research questions. Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer. Differences in opinion were resolved through discussion at each stage. Studies were synthesised through a narrative review with tabulation of the results.ResultsA total of 8954 records were screened, 224 full-text articles were retrieved, and 74 articles (describing 68 studies) met the inclusion criteria and were mapped. No evidence focused on treatment of children with SAM who were human immunodeficiency virus sero-positive, and no good-quality or adequately reported studies assessed treatments for SAM among infants < 6 months old. One randomised controlled trial investigated fluid resuscitation solutions for shock, with none adequately treating shock. Children with acute diarrhoea benefited from the use of hypo-osmolar oral rehydration solution (H-ORS) compared with the standard World Health Organization-oral rehydration solution (WHO-ORS). WHO-ORS was not significantly different from rehydration solution for malnutrition (ReSoMal), but the safety of ReSoMal was uncertain. A rice-based ORS was more beneficial than glucose-based ORSs, and provision of zinc plus a WHO-ORS had a favourable impact on diarrhoea and need for ORS. Comparisons of different diets in children with persistent diarrhoea produced conflicting findings. For treating infection, comparison of amoxicillin with ceftriaxone during inpatient therapy, and routine provision of antibiotics for 7 days versus no antibiotics during outpatient therapy of uncomplicated SAM, found that neither had a significant effect on recovery at the end of follow-up. No evidence mapped to the next three questions on factors that affect sustainability of programmes, long-term survival and readmission rates, the clinical effectiveness of management strategies for treating children with comorbidities such as tuberculosis and Helicobacter pylori infection and the factors that limit the full implementation of treatment programmes. Comparison of treatment for SAM in different settings showed that children receiving inpatient care appear to do as well as those in ambulatory or home settings on anthropometric measures and response time to treatment. Longer-term follow-up showed limited differences between the different settings. The majority of evidence on methods for correcting micronutrient deficiencies considered zinc supplements; however, trials were heterogeneous and a firm conclusion about zinc was not reached. There was limited evidence on either supplementary potassium or nicotinic acid (each produced some benefits), and nucleotides (not associated with benefits). Evidence was identified for four of the five remaining questions, but not assessed because of resource limitation.LimitationsThe systematic review focused on key questions prioritised through a Delphi study and, as a consequence, did not encompass all elements in the management of SAM. In focusing on evidence from controlled studies with the most rigorous designs that were published in the English language, the systematic review may have excluded other forms of evidence. The systematic review identified several limitations in the evidence base for assessing the effectiveness of interventions for treating young children with severe acute malnutrition, including a lack of studies assessing the different interventions; limited details of study methods used; short follow-up post intervention or discharge; and heterogeneity in participants, interventions, settings, and outcome measures affecting generalisability.ConclusionsFor many of the most highly ranked questions evidence was lacking or inconclusive. More research is needed on a range of topic areas concerning the treatment of infants and children with SAM. Further research is required on most aspects of the management of SAM in children < 5 years, including intravenous resuscitation regimens for shock, management of subgroups (e.g. infants < 6 months old, infants and children with SAM who are human immunodeficiency virus sero-positive) and on the use of antibiotics.FundingThe National Institute for Health Research Technology Assessment programme.<br/
A series-parallel load-resonant converter for a controlled-current arc-welding power supply
No full textA power supply incorporating a series-parallel load-resonant converter, capable of very
efficient operation over a wide range of output power is presented. The series-parallel
load-resonant converter is shown to have three pairs of resonant frequencies.
Operation of the circuit at each of these resonant frequencies maintains zero current
switching and high frequency operation. Design mathematics is developed which
allow series-parallel load-resonant converters to be designed with specific resonant
frequencies and circuit resistances. A new method of power control for series-parallel
load-resonant converters is presented; the power delivered to the circuit and hence the
load is shown to var substantially depending on which resonant frequency the circuit
is excited at. Two series-parallel load-resonant converters are designed simulated,
constructed and tested. There is good agreement between the simulation and
experimental results. One of the circuits produces an output current of 200 A while
the second demonstrates the new power control technique pulsing between 55 A and
145 A while running at frequencies of 63 kHz and 100 kHz. The new power supply
is particularly suited to arc-welding. It contains an active rectifier and draws near
unity power factor
A pragmatic randomised controlled trial of preferred intensity exercise in depressed adult women in the United Kingdom: Secondary analysis of individual variability of depression
No full textBackground: This study is a secondary analysis of the trial by Callaghan et al. (2011), which reported higher antidepressant effects for preferred intensity (n = 19) vs. prescribed intensity (n = 19) exercise of three sessions/week over four weeks in depressed women. In particular, the present study sought to examine whether greater clinically significant individual change/recovery was observed in the preferred compared to the prescribed exercise group. Methods: The reliable change index and the Ccutoff score criteria described by Jacobson and Truax (1991) were employed to determine clinical significance. These criteria examined if individual change in depression scores from pre- to post-intervention in the preferred intensity group were statistically significant beyond the standard error of difference derived from the active comparator prescribed group, and subsequently within a normal population range. Patients fulfilling the first or both criteria were classified as improved or recovered, respectively. Results: Post-intervention depression scores of six patients in the preferred intensity exercise group (32%) demonstrated statistically reliable improvement (p < 0.05) and recovery. Half of this subgroup started as moderately depressed. No patient demonstrated a reliable deterioration in depression. Due to a small sample size, it was impossible to determine whether patients on psychiatric medication or medication-free patients were equally benefited from preferred intensity exercise. Thirteen patients in the preferred intensity group (68%) displayed non-statistically significant change in post-intervention depression scores (p > 0.05), although eight of them showed a non-significant improvement in post-intervention depression scores and three could not technically show an improvement in depression due to floor effects (baseline depression within normal range). Conclusions: Preferred intensity exercise of three sessions/week over four weeks led almost a third of the patients to record scores consistent with recovery from depression. Health professionals may consider that short-term preferred intensity exercise provides clinically significant antidepressant effects comparing favourably to exercise on prescription. © 2019 The Author(s)
Real-world effectiveness of vortioxetine in outpatients with major depressive disorder: functioning and dose effects
No full textBackground: Functional recovery is an important treatment goal in major depressive disorder (MDD). This study assessed the real-world effectiveness of vortioxetine in patients with MDD, with particular focus on functioning; dose–response was also assessed. Methods: This was a non-interventional, prospective, multicenter study conducted in Greece. Adult outpatients with MDD (n = 336) initiating vortioxetine (5–20 mg/day flexible dosing) as treatment for a current major depressive episode were followed for 3 months. Analyses were stratified according to vortioxetine dosage at 3 months: 5–10 mg/day versus 15–20 mg/day. Functioning was assessed using the Sheehan Disability Scale (SDS). Results: Mean ± standard error SDS total score decreased (improved) from 18.7 ± 0.3 at baseline to 12.9 ± 0.3 after 1 month of vortioxetine treatment and 7.8 ± 0.4 after 3 months (p < 0.001 vs. baseline for all comparisons). Functional recovery (SDS score ≤ 6) was achieved in 14.6% of patients after 1 month of treatment and 48.4% of patients after 3 months. Improvement from baseline in SDS total and domain scores at 3 months was more pronounced in patients receiving vortioxetine 15–20 mg/day than in those receiving vortioxetine 5–10 mg/day. The mean ± standard error change in SDS total score from baseline was 9.2 ± 0.8 in the 5–10 mg/day group and 12.1 ± 0.4 in the 15–20 mg/day group (p < 0.001). Limitations of this study include its non-interventional study design and lack of a control group or active comparator. Conclusions: Statistically significant and clinically relevant improvements in functioning were seen in patients with MDD treated with vortioxetine in a real-world setting. Higher doses of vortioxetine were associated with significantly greater improvements in functioning. © 2022, The Author(s)
State of the Art on the European Court of Justice and Enacting Citizenship. CEPS Special Report, April 27 2009
No full textThis report provides a state of the art of the main interdisciplinary academic discussions, EU acts and European Court of Justice (ECJ) case law surrounding issues related to citizenship, migration and integration. The report was finalised in mid-2008 and has provided the basis upon which the work conducted by the Justice and Home Affairs Section at CEPS in the framework of the ENACT research project funded by DG Research of the European Commission has been developed. In particular, the general objectives of CEPS’ contribution to this project are: first, to assess the impact of Community governance on the enactment of European citizenship and the exclusivity of the nation-state competence over nationality matters; and to examine the ways in which the ECJ and the adoption of the Council Directive 2004/38/EC on the rights of citizens of the Union and their family members to move and reside freely have influenced its enactment; second, to analyse the impacts of the enlargement processes, and of accompanying measures such as the transitional arrangements inserted in the Acts of Accession and other restrictions to the fundamental right of freedom of movement, on the status and practices of European citizenship; and third, to assess the tensions inherent to nationality and/or residence-based enactment of citizenship versus European citizenship of TCNs; to address the effects and dilemmas posed by the Council Directive 2003/109/EC of November 2003 on the status of third country nationals who are long-term residents
