FULFIL Trial: Once-Daily Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease

RATIONALE: Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited. OBJECTIVES: We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy. METHODS: FULFIL was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA(®) inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler(®)). A patient subgroup remained on blinded treatment for up to 52 weeks. Co-primary endpoints were change from baseline in trough forced expiratory volume in 1 second (FEV1) and in St George's Respiratory Questionnaire (SGRQ) Total score, at Week 24. MEASUREMENTS AND MAIN RESULTS: In the intent-to-treat population (N = 1,810) at Week 24 for triple therapy (n = 911) and ICS/LABA therapy (n = 899): mean change from baseline in FEV1 was 142 mL (95% confidence interval [CI], 126,158) and -29 mL (95% CI, -46,-13), respectively; mean change from baseline SGRQ was -6.6 units (95% CI, -7.4,-5.7) and -4.3 units (95% CI, -5.2,-3.4), respectively. For both endpoints, the between-group differences were statistically significant (P < 0.001). There was a statistically significant reduction in moderate/severe exacerbation rate with triple versus ICS/LABA therapy (35% reduction, 95% CI, 14,51; P = 0.002). The safety profile of triple therapy reflected the known profiles of the components. CONCLUSIONS: These results support the benefits of single inhaler triple therapy compared with ICS/LABA therapy, in patients with advanced COPD. Clinical trial registration available at www.clinicaltrials.gov, ID NCT02345161

Ontogeny of the digestive tract in stinging catfish, Heteropneustes fossilis (Bloch) larvae

Heteropneustes fossilis (Bloch) is an important candidate species for diversification of freshwater aquaculture in India. However, high mortality rate during larval rearing is the most serious bottleneck in commercial production of this species. A proper understanding of the ontogenic development of digestive system provides the basis to understand the nutritional physiology of larvae and develop appropriate feeding strategies. In the present study, the ontogenical development of the digestive tract in H. fossilis larvae was studied from hatching until 30 day post-hatching (dph) at 29 °C. At hatching (2.8 ± 0.2 mm standard length, SL), the digestive tract was undifferentiated and attached dorsally to the yolk sac. At 1 dph (2.9 ± 0.2 mm SL), the mouth opened and oral valves were visible. At 2 dph (3.0 ± 0.3 mm SL), goblet cells were observed in the buccoparyngaeal cavity. At this age, exogenous feeding started and the intestine was differentiated into the anterior and posterior regions, and the rudimentary liver and pancreas were also seen. Small supranuclear vacuoles were observed in the enterocytes of the posterior intestine at 2 dph. Zymogen granules were observed in acinar cells of pancreas by 3 dph, and islets of Langerhans were visible at 4 dph (3.5 ± 0.1 mm SL). At the same age, most of the yolk sac reserves were consumed, whereas they were completely exhausted by 5 dph (3.9 ± 0.5 mm SL). Between 4 and 6 dph, the liver elongated in size and started to accumulate lipids in the hepatocytes. Gastric glands were detected at 4 dph, and the pyloric sphincter was completely differentiated at 9 dph (6.1 ± 0.4 mm SL) as an epithelial fold that separated stomach from the anterior intestine. By 13 dph (8.6 ± 0.2 mm SL), profuse gastric glands were visible inside longitudinal mucosal folds of the stomach. The formation of gastric glands and their development were noticed as the last events in the development of the digestive tract in H. fossilis. This indicated the end of the larval period and the commencement of the juvenile stage. Considering these observations, it is suggested that H. fossilis larvae have a morphologically complete digestive tract by 13 dph. The findings of the study on the development of the digestive system in H. fossilis may help in synchronising the larval stage of development and feeding strategies and would be helpful in improving larval rearing techniques for catfish species.info:eu-repo/semantics/acceptedVersio

Current Status of Knowledge on Hilsa

Species of the family Clupeidae are highly preferred food fishes in the world. The Indian shad, hilsa, belonging to the family Clupeidae, contribute to commercial catches in a number of countries bordering the Bay of Bengal, Indian Ocean, Persian Gulf and Arabian Sea. The species normally inhabit rivers, estuaries and coastal waters. The highest catch comes from the deltaic region of the Gangetic system in the coastal Bay o f Bengal. The fish is anadromous; grows and matures in the sea and migrates to freshwater fo r spawning. Hilsa fisheries provides direct and indirect livelihood to millions o f fishers along the coastal and riverine stretches in its range of distribution. They are highly delicious, priced and has important sociocultural importance, especially in West Bengal and the north eastern States of India. On account of its commercial importance and migratory habit, hilsa received research attraction since 1907 and there is a wealth of disseminated literature on various aspects o f hilsa by researchers o f different countries, including India

Small individual loans and mental health: a randomized controlled trial among South African adults

<p>Abstract</p> <p>Background</p> <p>In the developing world, access to small, individual loans has been variously hailed as a poverty-alleviation tool – in the context of "microcredit" – but has also been criticized as "usury" and harmful to vulnerable borrowers. Prior studies have assessed effects of access to credit on traditional economic outcomes for poor borrowers, but effects on mental health have been largely ignored.</p> <p>Methods</p> <p>Applicants who had previously been rejected (n = 257) for a loan (200% annual percentage rate – APR) from a lender in South Africa were randomly assigned to a "second-look" that encouraged loan officers to approve their applications. This randomized encouragement resulted in 53% of applicants receiving a loan they otherwise would not have received. All subjects were assessed 6–12 months later with questions about demographics, socio-economic status, and two indicators of mental health: the Center for Epidemiologic Studies – Depression Scale (CES-D) and Cohen's Perceived Stress scale. Intent-to-treat analyses were calculated using multinomial probit regressions.</p> <p>Results</p> <p>Randomization into receiving a "second look" for access to credit increased perceived stress in the combined sample of women and men; the findings were stronger among men. Credit access was associated with reduced depressive symptoms in men, but not women.</p> <p>Conclusion</p> <p>Our findings suggest that a mechanism used to reduce the economic stress of extremely poor individuals can have mixed effects on their experiences of psychological stress and depressive symptomatology. Our data support the notion that mental health should be included as a measure of success (or failure) when examining potential tools for poverty alleviation. Further longitudinal research is needed in South Africa and other settings to understand how borrowing at high interest rates affects gender roles and daily life activities. CCT: ISRCTN 10734925</p

Reproductive life disorders in Italian celiac women. A case-control study

BACKGROUND: The aim of this study is to explore the association between celiac disease and menstrual cycle, gestation and puerperal disorders. METHODS: The association between celiac disease and menstrual cycle, gestation and puerperal disorders in a sample of 62 childbearing age women (15-49 age) was assessed within an age and town of residence matched case-control study conducted in 2008. Main outcome measures were the presence of one or more disorders in menstrual cycle and the presence of one or more complication during pregnancy. RESULTS: 62 celiac women (median age: 31.5, range: 17-49) and 186 healthy control (median age: 32.5, range: 15-49) were interviewed. A higher percentage of menstrual cycle disorders has been observed in celiac women. 19.4% frequency of amenorrhea was reported among celiac women versus 2.2% among healthy controls (OR = 33, 95% CI = 7.17-151.8;, p = 0.000). An association has been observed between celiac disease and oligomenorrhea, hypomenorrhea, dysmenorrhea and metrorrhagia (p < 0.05). The likelihood of having at least one complication during pregnancy has been estimated to be at least four times higher in celiac women than in healthy women (OR = 4.1, 95% CI = 2-8.6, p = 0.000). A significant correlation has emerged for celiac disease and threatened abortion, gestational hypertension, placenta abruption, severe anaemia, uterine hyperkinesia, intrauterine growth restriction (p < 0.001). A shorter gestation has on average been observed in celiac women together with a lower birth weight of celiac women babies (p < 0.001). CONCLUSIONS: The occurrence of a significant correlation between celiac disease and reproductive disorders could suggest to consider celiac disease diagnostic procedures (serological screening) in women affected by these disorders

Identification and Characterization of Microsporidia from Fecal Samples of HIV-Positive Patients from Lagos, Nigeria

BACKGROUND: Microsporidia are obligate intracellular parasites that infect a broad range of vertebrates and invertebrates. They have been increasingly recognized as human pathogens in AIDS patients, mainly associated with a life-threatening chronic diarrhea and systemic disease. However, to date the global epidemiology of human microsporidiosis is poorly understood, and recent data suggest that the incidence of these pathogens is much higher than previously reported and may represent a neglected etiological agent of more common diseases indeed in immunocompetent individuals. To contribute to the knowledge of microsporidia molecular epidemiology in HIV-positive patients in Nigeria, the authors tested stool samples proceeding from patients with and without diarrhea. METHODOLOGY/PRINCIPAL FINDINGS: Stool samples from 193 HIV-positive patients with and without diarrhea (67 and 126 respectively) from Lagos (Nigeria) were investigated for the presence of microsporidia and Cryptosporidium using Weber's Chromotrope-based stain, Kinyoun stain, IFAT and PCR. The Weber stain showed 45 fecal samples (23.3%) with characteristic microsporidia spores, and a significant association of microsporidia with diarrhea was observed (O.R. = 18.2; CI: 95%). A similar result was obtained using Kinyoun stain, showing 44 (31,8%) positive samples with structures morphologically compatible with Cryptosporidium sp, 14 (31.8%) of them with infection mixed with microsporidia. The characterization of microsporidia species by IFAT and PCR allowed identification of Enterocytozoon bieneusi, Encephalitozoon intestinalis and E. cuniculi in 5, 2 and 1 samples respectively. The partial sequencing of the ITS region of the rRNA genes showed that the three isolates of E.bieneusi studied are included in Group I, one of which bears the genotype B. CONCLUSIONS/SIGNIFICANCE: To our knowledge, this is the first report of microsporidia characterization in fecal samples from HIV-positive patients from Lagos, Nigeria. These results focus attention on the need to include microsporidial diagnosis in the management of HIV/AIDS infection in Nigeria, at the very least when other more common pathogens have not been detected