Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallelgroup, open-label, randomised controlled phase 3 trial

Background: Iron deficiency anaemia is of major concern in low-income settings, especially for women of childbearing age. Oral iron substitution efficacy is limited by poor compliance and iron depletion severity. We aimed to assess the efficacy and safety of intravenous ferric carboxymaltose versus oral iron substitution following childbirth in women with iron deficiency anaemia in Tanzania. Methods: This parallel-group, open-label, randomised controlled phase 3 trial was done at Bagamoyo District Hospital and Mwananyamala Hospital, Tanzania. Eligible participants were close to delivery and had iron deficiency anaemia defined as a haemoglobin concentration of less than 110 g/L and a ferritin concentration of less than 50 μg/L measured within 14 days before childbirth. Participants were randomly assigned 1:1 to receive intravenous ferric carboxymaltose or oral iron, stratified by haemoglobin concentration and site. Intravenous ferric carboxymaltose was administered at a dose determined by the haemoglobin concentration and bodyweight (bodyweight 35 kg to <70 kg and haemoglobin ≥100 g/L: 1000 mg in one dose; bodyweight 35 kg to <70 kg and haemoglobin <100 g/L, or bodyweight ≥70 kg and haemoglobin ≥100 g/L: 1500 mg in two doses at least 7 days apart; bodyweight ≥70 kg and haemoglobin 115 g/L) at 6 weeks. Follow-up visits were at 6 weeks, and 3, 6, and 12 months. Analyses were done in the modified intention-totreat population of participants who had a 6-week haemoglobin concentration result, using logistic and linear regression models for binary and continuous outcomes, adjusted for baseline haemoglobin concentration and site. This trial is registered with ClinicalTrials.gov, NCT02541708. Findings: Between Oct 8, 2015, and March 14, 2017, 533 individuals were screened and 230 were enrolled and randomly assigned to a study group (114 to intravenous iron, 116 to oral iron). At 6 weeks, 94 (82%) participants in the intravenous iron group and 92 (79%) in the oral iron group were assessed for the primary outcome. 75 (80%) participants in the intravenous iron group and 47 (51%) in the oral iron group had normalised haemoglobin (odds ratio 4·65, 95% CI 2·33-9·27). There were two mild to moderate infusion-related adverse events; and five serious adverse events (three in the intravenous iron group, two in the oral iron group), unrelated to the study medication. Interpretation: Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better haemoglobin response than oral iron. To our knowledge, this is the first study to provide evidence of the benefits and safety of intravenous iron substitution in a low-income setting

International cohort study for pediatric Behçet’s Disease: update 2011

PubMe

From Acting What’s next to Speeding Trap: Co-Evolutionary Dynamics of an Emerging Technology-Leader

JEL Classifications: O33, O53, L63[[abstract]]How does technological innovation emerge and evolve? We approach such an inquiry by synthesizing the perspectives of dynamic capabilities and co-evolutionary dynamics to portray organizational routines and multi-phase strategic renewals of an emerging technology-leader. To untangle the emergence of technological innovation, we conducted a longitudinal case study on the first and the largest dedicated semiconductor foundry, TSMC, located in the emerging economy of Taiwan. The firm-case of TSMC illustrates two unique co-evolutionary paths, that is, transforming from industry-latecomer to technology-leader and from process innovation to product innovation. We found multi-motor co-evolutionary dynamics between TSMC and the semiconductor industry, where its co-evolutionary mechanism of managed selection in its creating phase of mature process-innovation (1987-1998) has migrated to hierarchical renewal in its extending phase of advanced process-innovation (1999-2001), and then to holistic renewal in its modifying phase of product-innovation (2002-2007). During such paths, our research discovered a unique type of organizational routines, acting what’s next because TSMC has proactively searched for potential problems sooner than its competitors. However, such routines, although driving technological innovation, also lead to a unique type of success-trap, that is, speeding trap. When an emerging technology-leader fundamentally changes the industrial structures to over-specs, the growth driven by technology speeding may trap such a leader in a loop of over-exploration.[[sponsorship]]The authors are grateful to the research grant from the National Science Council (NSC) in Taiwan. The earlier manuscript of this paper was presented at the 2009 Annual Meeting of Academy of International Business (AIB) in San Diego, USA.[[notice]]補正完畢[[journaltype]]國外[[ispeerreviewed]]Y[[booktype]]紙本[[booktype]]電子版[[countrycodes]]CA

On the robustness of noise-blind low-rank recovery from rank-one measurements.

We prove new results about the robustness of well-known convex noise-blind optimization formulations for the reconstruction of low-rank matrices from an underdetermined system of random linear measurements. Specifically, our results address random Hermitian rank-one measurements as used in a version of the phase retrieval problem; that is, each measurement can be represented as the inner product of the unknown matrix and the outer product of a given realization of the standard complex Gaussian random vector. We obtain our results by establishing that with high probability the measurement operator consisting of independent realizations of such a random rank-one matrix exhibits the so-called Schatten-1 quotient property, which corresponds to a lower bound for the inradius of their image of the nuclear norm (Schatten-1) unit ball. We complement our analysis by numerical experiments comparing the solutions of noise-blind and noise-aware formulations. These experiments confirm that noise-blind optimization methods exhibit comparable robustness to noise-aware formulations

In vitro biomechanical comparison of headless compression versus cortex screws for fixation of simulated midbody proximal sesamoid bone fractures in horses

A midbody fracture of a proximal sesamoid bone (PSB) is a severe injury, especially in racehorses. Screw fixation may be the only option for horses to return to athletic activity. In a cadaveric biomechanical study, fixation of simulated transverse midbody PSB fractures with a 4.5 mm headless compression screw (HCS) was compared to the fixation using a 4.5 mm cortex screw (CS) inserted in lag fashion. The front limbs of 8 horses were prepared with a standardized midbody transverse osteotomy in each medial PSB. The left or the right limb of each pair was randomly assigned to the CS or HCS group. Fracture reduction and fixation was controlled by radiography. Markers were fixed proximal and distal to the osteotomy to document gap opening by an image correlation measurement. Cyclic compressive loading was applied with a hydraulic cylinder in an axial manner leading to tensile cyclic loading in the PSBs. After mechanical testing all limbs were radiographed to document the mode of failure. The mean cycles to total failure were 27,803 for the HCS group and 36,624 for the CS group, respectively. A mean of 14,444 cycles (HCS group) versus 27,464 cycles (CS group) was recorded at a fracture gap opening of 10 %. The mean value of initial stiffness was 300 N/mm (HCS group) versus 590 N/mm (CS group). On post-testing radiographs, failure by screw breakage was detected in 3/8 limbs of the HCS group and in 2/8 limbs of the CS group. Screw pullout and bone failure was noted in 5 limbs in each group. In one limb of the CS group, the medial suspensory branch was disrupted and the fracture fixation was intact. None of the differences between HCS and CS constructs reached statistical significance. However, the lower absolute numbers of cycles sustained before failure, at 10 % gap opening and lower initial stiffness of HCS constructs as well as limitations of the study warrant further investigation before clinical use of the HCS for this indication can be recommended