13 research outputs found
Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design.
No full textBACKGROUND: The drug development process can be streamlined by combining the traditionally separate stages of dose-finding (Phase IIb) and confirmation of efficacy and safety (Phase III) using an adaptive seamless design. This approach was used in a clinical study of indacaterol, a novel once-daily (od) inhaled long-acting beta(2)-adrenoreceptor agonist bronchodilator for the treatment of COPD (chronic obstructive pulmonary disease). METHODS: The study comprised a dose-finding stage with dose selection after 14 days of treatment, and a second stage evaluating efficacy and safety during 26 weeks of treatment. The dose-finding stage included seven randomized treatment arms: double-blind indacaterol 75 microg, 150 microg, 300 microg or 600 microg od, the beta(2)-adrenoceptor agonist formoterol 12 microg twice-daily or placebo, or the anticholinergic tiotropium 18 microg od open-label. An independent data monitoring committee selected two indacaterol doses based on unblinded results of an interim analysis performed by an independent statistician. The sponsor, investigators and patients remained blinded to the results. The indacaterol doses were selected using pre-set efficacy criteria for trough (24-h post-dose) and early (1-4 h post-dose) bronchodilator effect after 14 days, and all safety data. To qualify for selection, the doses had to exceed a threshold for clinical relevance or be superior to either tiotropium or formoterol, whichever was the highest value. Selected doses were continued into the second, 26-week stage. The two other indacaterol doses not selected, and formoterol, were discontinued following dose selection. RESULTS: 801 patients with moderate-to-severe COPD were evaluated. Indacaterol 150 microg was the lowest effective dose, exceeding criteria for trough FEV(1) (reference value 140 mL vs placebo) and FEV(1) AUC(1-4 h) (reference value 220 mL vs placebo). No safety signal was observed with any dose of indacaterol. Thus, indacaterol 150 and 300 microg were selected to continue into the second, 26-week stage. CONCLUSION: The adaptive seamless design is a novel and efficient way to combine dose selection with efficacy evaluation and safety confirmation in a single trial
Additional file 1: of Trend of HIV/AIDS for the last 26 years and predicting achievement of the 90–90-90 HIV prevention targets by 2020 in Ethiopia: a time series analysis
No full textTrend of HIV/AIDS for the last 26 Years and Predicting Achievement of the 90-90-90 HIV Prevention Targets by 2020 in Ethiopia: A Time Series Analysis. (XLSX 18 kb
FIGURES 19–28 in Mejdalania, a new genus and three new species of Neocoelidiinae from Brazil (Insecta: Hemiptera: Cicadellidae)
No full textFIGURES 19–28. Mejdalania unciformis gen. et sp. nov., holotype male: 19, head, frontal view; 20, forewing; 21, pygofer and anal tube, lateral view; 22, pygofer and anal tube, caudal view; 23, valve and subgenital plates, lateral view; 24, valve and subgenital plates, ventral view; 25, connective and style, dorsal view; 26, style, lateral view; 27, aedeagus, lateral view; 28, aedeagus, caudal view. Scale bars: 19 = 1.0 mm, 20 = 2.0 mm, 21–28 = 0.5 mm.Published as part of Gonçalves, Clayton C., 2021, Mejdalania, a new genus and three new species of Neocoelidiinae from Brazil (Insecta: Hemiptera: Cicadellidae), pp. 109-118 in Zootaxa 5039 (1) on page 115, DOI: 10.11646/zootaxa.5039.1.4, http://zenodo.org/record/550628
Additional file 1: of Gender disparity in epidemiological trend of HIV/AIDS infection and treatment in Ethiopia
No full textGender disparity in Epidemiological Trend of HIV/AIDS infection and treatment in Ethiopia. (XLSX 15Â kb
The DYD-RCT protocol: an on-line randomised controlled trial of an interactive computer-based intervention compared with a standard information website to reduce alcohol consumption among hazardous drinkers
No full textBackground: Excessive alcohol consumption is a significant public health problem throughout the world. Although there are a range of effective interventions to help heavy drinkers reduce their alcohol consumption, these have little proven population-level impact. Researchers internationally are looking at the potential of Internet interventions in this area.Methods/Design: In a two-arm randomised controlled trial, an on-line psychologically enhanced interactive computer-based intervention is compared with a flat, text-based information web-site. Recruitment, consent, randomisation and data collection are all on-line. The primary outcome is total past-week alcohol consumption; secondary outcomes include hazardous or harmful drinking, dependence, harm caused by alcohol, and mental health. A health economic analysis is included.Discussion: This trial will provide information on the effectiveness and cost-effectiveness of an on-line intervention to help heavy drinkers drink less.Trial registration: International Standard Randomised Controlled Trial Number Register ISRCTN31070347
The applicability of the basic preventive measures of the pandemic COVID-19 among residents in Guraghe Zone, 2020 (n = 634).
No full textThe applicability of the basic preventive measures of the pandemic COVID-19 among residents in Guraghe Zone, 2020 (n = 634).</p
Bivariable analysis of factors associated with the applicability of the basic preventive measures of the pandemic COVID-19 among residents in Guraghe Zone, 2020 (n = 634).
No full textBivariable analysis of factors associated with the applicability of the basic preventive measures of the pandemic COVID-19 among residents in Guraghe Zone, 2020 (n = 634).</p
The level of attitude towards the prevention of COVID-19 among residents in Guraghe Zone, 2020 (n = 634).
No full textThe level of attitude towards the prevention of COVID-19 among residents in Guraghe Zone, 2020 (n = 634).</p
Knowledge status of the respondents on COVID-19 among residents in Guraghe Zone, 2020 (n = 634).
No full textKnowledge status of the respondents on COVID-19 among residents in Guraghe Zone, 2020 (n = 634).</p
