Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Interpretation Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke

Łączenie zdjęć satelitarnych i danych bezzałogowego statku powietrznego w celu monitorowania eksploatacji kopalni odkrywkowej

Discovering the variation of an open-pit mine in vertical, horizontal, and temporal dimensions as well to characterize the stages and the trends of the exploitation are indispensable tasks which provide information supporting decision making and planning for sustainable development of the mining industry. Remote sensing technique with the advantages of multi-spatial, multi-spectral, multi-temporal resolution is a promising solution to meet the information requirement. This study proposes an approach of coupling the high-resolution satellite images and Unmanned Aerial Vehicle (UAV) data to observe the variation of Tan An open rocky mine during its lifetime. Five satellite images with the resolution of 0.5 m acquired in 2006, 2012, 2014, 2016, 2018, and two ortho-images with 0.034 m resolution constructed from UAV photos captured in 2019, 2020 are used to make land cover maps. The analysis of land cover changes discovers 3 stages of open-pit mine exploitation consisting of unprompted exploitation, exploiting outbreak and stable exploitation corresponding to the changes in the mine. Besides, two Digital Surface Models (DSM) constructed by UAV photos are compared to calculate the elevation and volume changes. The assessment of the correlation between elevation change and land cover change indicates that the mineral exploitation is in the vertical range from 645 m to 660 m, and the exploitation trend is following the horizontal expansion rather than the deep excavation. Additionally, this experiment results in 79,422 m3 of mineral taken from the mine, and 34,022 m3 of soil used for the restoration within a year from June 2019 to June 2020.Monitorowanie zmienności kopalni odkrywkowej w wymiarze pionowym, poziomym i czasowym oraz scharakteryzowanie etapów i trendów eksploatacji są niezbędnymi zadaniami niezbędnymi do dostarczenia informacji wspomagających podejmowanie decyzji i planowanie zrównoważonego rozwoju górnictwa. Technika teledetekcji z zaletami wieloprzestrzennej, wielospektralnej, wieloczasowej rozdzielczości jest obiecującym rozwiązaniem spełniającym powyższe wymaganie. Niniejsze badanie proponuje podejście po-legające na połączeniu obrazów satelitarnych o wysokiej rozdzielczości i danych z bezzałogowego statku powietrznego (BSP) w celu obserwacji zmian w otwartej kopalni skalnej Tan An w czasie jej życia. Pięć zdjęć satelitarnych o rozdzielczości 0,5 m, pozyskanych w latach 2006, 2012, 2014, 2016, 2018 oraz dwa ortofotomapy o rozdzielczości 0,034 m wykonane ze zdjęć BST wykonanych w 2019, 2020 r. Są wykorzystywane do tworzenia map pokrycia terenu. Analiza zmian pokrycia terenu ujawnia 3 etapy eksploatacji kopalni odkrywkowej, na które składają się: eksploatacja niezamówiona, ognisko eksploatacyjne oraz etapy stabilnej eksploatacji odpowiadające zmianie pokrycia terenu w kopalni. Ponadto porównuje się dwa modele numeryczne powierzchni (MNP) zbudowane na podstawie zdjęć BSP, aby obliczyć wysokość i zmiany objętości kopalni. Ocena korelacji między zmianą wysokości a zmianą pokrycia terenu wskazuje, że eksploatacja kopaliny mieści się w przedziale od 645 m do 660 m npm, a trend eksploatacji raczej według ekspansji poziomej niż metodą wydobywczą. Dodatkowo, w wyniku tego doświadczenia uzyskano 79 422 m3 gruntów pobranego z kopalni oraz 34022 m3 gruntów użytej do rekultywacji w ciągu roku od czerwca 2019 do czerwca 2020

The Study Of Land Cover Change Using Change Vector Approach Integrated With Unsupervised Classification Method: A Case In Duy Tien (Vietnam)

Investigating information on land cover changes is an indispensable task in studies related to the variation of the environment. Land cover changes can be monitored using multi-temporal satellite images at different scales. The commonly used method is the post-classification change detection which can figure out the replacement of a land cover by the others. However, the magnitude and dimension of the changes are not been always exploited. This study employs the mixture of categorical and radiometric change methods to investigate the relations between land cover classes and the change magnitude, the change direction of land covers. Applying the Change Vector Analysis (CVA) method and unsupervised classification for two Landsat images acquired at the same day of years in 2000 and in 2017 in Duy Tien district, the experimental results show that a low magnitude of change occurs in the largest area of direction I and direction IV regarding the increase of Normalized Difference Vegetation Index (NDVI), but the opposite trend of (Bare soil Index) BI in the rice field. Alternately, the high magnitude of change is seen in the build-up class which occupies the smallest area with 1700 ha. The characterized changes produced by the CVA method provide a picture of change dynamics of land cover over the period of 2000-2017 in the study area

Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration

Background and Purpose: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. Methods: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. Results: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76–1.14]; P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%]; P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%]; P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%]; P =0.05), or seizures (11 [1.71%] versus 8 [1.25%]; P =0.64) at 12 months. Conclusions: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. REGISTRATION: URL: http://www.anzctr.org.au/ ; Unique identifier: ACTRN12611000774921