A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer's Disease

Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24 h delivery rate) and 10-cm2 (18-mg loading dose; 9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward) at week 24, delayed deterioration was seen with the 10-cm2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005) and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067). Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042) and on the Disability Assessment for Dementia (DAD; p = 0.024) and Mental Function Impairment (MENFIS; p = 0.016) subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD

Spontaneous regression of mediastinal seminoma

A 27-year-old man was transferred to our hospital with the complaint of facial edema and diagnosis of giant anterior mediastinal tumor. But soon after admission, the size of the tumor decreased remarkably, although he had no particular treatment. As the tumor was not completely regressed, surgical resection was performed subsequently, and examination of the specimen showed small foci of seminoma within the area of dense fibrous scar tissue, originated from the thymus. While regression of germ cell tumors are well recognized in cases of nonseminomatous germ cell tumors, this phenomenon of primary mediastinal seminoma was not reported previously

Temporary Division of the Superior Vena Cava For Extended Left Atriotomy ; Left-sided Atrioventricular Valve Repair in Corrected Transposition of the Great Arteries

The extended left atriotomy which combines the standard approach with the superior approach by concomitant temporary division of the superior vena cava (SVC) is a safe and useful method in the case of a small atrium. The approach used here is a modification of that which was reported by Selle and Kyger. This technique made it possible to sufficiently expose the laterally situated small left atrium in the case of corrected transposition of the great arteries (cTGA) which requires repair of the left-sided atrioventricular valve (tricuspid valve). In recent mitral surgery, median sternotomy is used with cannulation of the ascending aorta and both venae cavae to establish cardiopulmonary bypass. Although there are some approaches for left atriotomy, the standard procedure is to use vertical left atriotomy immediately posterior and parallel to interatrial sulcus. And in the case of combined mitral with tricuspid valve surgery, a right atriotomy with incision of interatrial septum has been employed to allow excellent exposure of the left atrium and mitral and tricuspid valve including subvalvular supporting structures. Surgical exposure of the mitral valve is often difficult by the conventional approach, especially in the patient with a small left atrium and a deep chest. In the case of cTGA too, sufficient exposure of the left atrium can not be obtained under median sternotomy on accout of anatomical abnormality. We performed prosthetic valve implantaion to the left-sided atrioventricular valve which is tricuspid valve in structure in the case of cTGA by means of new approach with the incision of the lateral to superior wall of the left atrium combined with division of the SVC temporarily. This technique was introduced by Selle 1) in a recent article

Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy

BACKGROUND: This was a Japanese subpopulation analysis of MONARCH 2, a double-blind, randomized, placebo-controlled, phase 3 study of abemaciclib plus fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC). METHODS: Eligible women had progressed on (neo)adjuvant endocrine therapy (ET),  ≤ 12 months from end of adjuvant ET, or on first-line ET for ABC, and had not received chemotherapy for ABC. Patients were randomized 2:1 to receive abemaciclib or placebo plus fulvestrant. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), pharmacokinetics (PK), health-related quality of life (HRQoL), and safety. RESULTS: In Japan, 95 patients were randomized (abemaciclib, n = 64; placebo, n = 31). At final PFS analysis (February 14, 2017), median PFS was 21.2 and 14.3 months, respectively, in the abemaciclib and placebo groups (hazard ratio: 0.672; 95% confidence interval: 0.380-1.189). Abemaciclib had a higher objective response rate (37.5%) than placebo (12.9%). PK and safety profiles for Japanese patients were consistent with those of the overall population, without clinically meaningful differences across most HRQoL dimensions evaluated. The most frequent adverse events in the abemaciclib versus placebo groups were diarrhea (95.2 versus 25.8%), neutropenia (79.4 versus 0%), and leukopenia (66.7 versus 0%). At a second data cutoff (June 20, 2019), median OS was not reached with abemaciclib and 47.3 months with placebo (hazard ratio: 0.755; 95% confidence interval: 0.390-1.463). CONCLUSIONS: Results of the Japanese subpopulation were consistent with the improved clinical outcomes and manageable safety profile observed in the overall population. CLINICAL TRIAL REGISTRATION: NCT02107703; U.S. National Library of Medicine: https://clinicaltrials.gov/ct2/show/NCT02107703

Designing digital memorials: commemorating the Black Saturday Bushfires

© 2015 Dr. Joji Cyrus MoriDigital memorials are novel technologies used for commemorative purposes. There is a growing interest in their design amongst HCI researchers. Existing studies focus on commemorating deceased loved ones, where personal and familial remembrance is emphasised. However, there are fewer examples where digital memorials play a wider social and cultural role. Commemorating a war, terrorist attack, natural disaster or death of somebody of special significance such as a leader or even celebrity, are examples where commemoration extends beyond the personal and familial, and into broader social contexts. In these instances, it is likely that large numbers of people may wish to participate, from those with deeply personal reasons, to others with only a passing interest. This thesis examines the design of digital memorials for use in contexts where these diverse audiences come together in commemoration. This thesis presents three studies, in which commemoration following the Black Saturday bushfires was used as the setting for the research. The fires occurred in 2009 in Victoria, Australia. Asides the devastation caused to the natural environment, there were 173 fatalities and massive destruction caused to homes and other infrastructure. The first study was an exploratory study examining how people commemorated Black Saturday within the first two years after the fires. The findings extend current understandings of commemoration using technology by showing similarities between how people engage with physical and web-based memorials. The second study involved participants in fire-affected communities who were asked to generate design ideas for digital memorials to commemorate Black Saturday. The study contributed a novel craft-based approach to designing technology in the commemorative context. For the third study, a digital memorial was developed that included a website and internet-connected tablet computer app to commemorate the fourth anniversary of the fires. This technology was designed for both those within the fire-affected communities and those outside. The findings report on an evaluation of the experiences of those who engaged with the digital memorial. Selected findings from the three thesis studies are expressed as a set of five design considerations intended for future designers and researchers interested in digital memorials. These are: privacy, control and context collapse; considerations for symbolism and metaphoric representations; utilising physical locations; having sensitivity towards temporal patterns; and, designing for pace and asynchronicity

Biomass and distribution of filamentous cyanobacteria, Trichodesmium spp., in spring in the East China Sea

Trichodesmium biovolume and its distributional pattern were investigated in spring in the East China Sea. It showed surface-biased distribution at all stations where it was detected. The maximum biovolume in each water column was 0-4.4 × 107 μm3 L-1, and it was sometimes larger than that of coccoid cyanobacteria (8.9 × 10 6-2.0 × 107 μm3 L-1). Horizontal distribution of Trichodesmium around the boundary between continental shelf water and Kuroshio water showed different patterns between a large-sized fasciculated form and other forms; the former was more abundant on the Kuroshio side and the latter, small-sized fasciculated form or separate filamentous form, more abundant on the continental shelf side, while the abundance of all types varied temporally. Considering that the large fasciculated form may develop from the separate filamentous form or the small fasciculated form, and it may be more efficient for N2-fixation under an aerobic conditions, this contrastive horizontal distribution might reflect an adaptive enlargement process in Trichodesmium colonies accompanied with passive transport from continental shelf water to more oligotrophic Kuroshio waters