37 research outputs found

    Study protocol for preventing early-onset pneumonia in young children through maternal immunisation: a multi-centre randomised controlled trial (PneuMatters)

    Get PDF
    Background: Preventing and/or reducing acute lower respiratory infections (ALRIs) in young children will lead to substantial short and long-term clinical benefits. While immunisation with pneumococcal conjugate vaccines (PCV) reduces paediatric ALRIs, its efficacy for reducing infant ALRIs following maternal immunisation has not been studied. Compared to other PCVs, the 10-valent pneumococcal-Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) is unique as it includes target antigens from two common lower airway pathogens, pneumococcal capsular polysaccharides and protein D, which is a conserved H. influenzae outer membrane lipoprotein. Aims: The primary aim of this randomised controlled trial (RCT) is to determine whether vaccinating pregnant women with PHiD-CV (compared to controls) reduces ALRIs in their infants' first year of life. Our secondary aims are to evaluate the impact of maternal PHiD-CV vaccination on different ALRI definitions and, in a subgroup, the infants' nasopharyngeal carriage of pneumococci and H. influenzae, and their immune responses to pneumococcal vaccine type serotypes and protein D. Methods: We are undertaking a parallel, multicentre, superiority RCT (1:1 allocation) at four sites across two countries (Australia, Malaysia). Healthy pregnant Australian First Nation or Malaysian women aged 17-40 years with singleton pregnancies between 27+6 and 34+6 weeks gestation are randomly assigned to receive either a single dose of PHiD-CV or usual care. Treatment allocation is concealed. Study outcome assessors are blinded to treatment arms. Our primary outcome is the rate of medically attended ALRIs by 12-months of age. Blood and nasopharyngeal swabs are collected from infants at birth, and at ages 6- and 12-months (in a subset). Our planned sample size (n = 292) provides 88% power (includes 10% anticipated loss to follow-up). Discussion: Results from this RCT potentially leads to prevention of early and recurrent ALRIs and thus preservation of lung health during the infant's vulnerable period when lung growth is maximum. The multicentre nature of our study increases the generalisability of its future findings and is complemented by assessing the microbiological and immunological outcomes in a subset of infants. Clinical Trial Registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374381, identifier: ACTRN12618000150246.Anne B. Chang, Maree Toombs, Mark D. Chatfield, Remai Mitchell, Siew M. Fong, Michael J. Binks ... at al

    Two phases of sulphide saturation in RĂ©union magmas: Evidence from cumulates

    No full text
    The behaviour of chalcophile elements in magmas is controlled both by degassing and by partitioning into a sulphide melt. While sulphide melts are rarely observed in erupted volcanic products, their high densities ensure that they should be concentrated in the plutonic roots of active volcanoes. The eruptions of the Bellecombe ash member on RĂ©union included plentiful sulphide-bearing ultramafic cumulate nodules and sulphides were also observed in oxide bearing gabbro nodules. However, RĂ©union melt inclusions also show that S is affected by degassing. We have combined analyses of cumulates, sulphides and melt inclusions with an investigation of published data to determine the roles of sulphide saturation and magmatic degassing at RĂ©union. It is possible to identify two sulphide saturation events during magmatic evolution. The first relates to S becoming saturated during fractional crystallisation and formation of sulphide melts prior to partitioning into a gas phase. The second is more obvious in the more differentiated magmas of Piton des Neiges and is prompted by the crystallisation of titanomagnetite which reduces the sulphur concentration at sulphide melt saturation. Sulphide melts saturation and segregation is likely to be a common feature at many volcanoes and should be taken into account when using trace metal concentrations to track gas transfer processes or when using the petrologic method to estimate loss of volatile or chalcophile elements such as S and Cu to the atmosphere. At RĂ©union loss of sulphur by degassing could be over estimated by 20–90% when sulphide saturation is not taken into account. The effect of sulphide melt formation and immiscibility on gas compositions in volcanic systems has important implications for both ore exploration and atmospheric monitoring

    Systematic review of oncological outcomes following surgical management of localised renal cancer.

    Get PDF
    Item does not contain fulltextCONTEXT: Renal cell carcinoma (RCC) accounts for 2-3% of adult malignancies. There remain uncertainties over the oncological outcomes for the surgical management of localised RCC. OBJECTIVE: Systematically review relevant literature comparing oncological outcomes of surgical management of localised RCC (T1-2N0M0). EVIDENCE ACQUISITION: Relevant databases including Medline, Embase, and the Cochrane Library were searched up to October 2010, and an updated scoping search was performed up to January 2012. Randomised controlled trials (RCTs) or quasi-RCTs, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The main outcomes were overall survival, cancer-specific survival, recurrence, and metastases. The Cochrane risk of bias tool was used to assess RCTs, and an extended version was used to assess nonrandomised studies (NRSs). The quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). EVIDENCE SYNTHESIS: A total of 4580 abstracts and 389 full-text articles were assessed. Thirty-four studies met the inclusion criteria (6 RCTs and 28 NRSs). Meta-analyses were planned but were deemed inappropriate due to data heterogeneity. There were high risks of bias and low-quality evidence across the evidence base. Open radical nephrectomy and open partial nephrectomy showed similar cancer-specific and overall survival, but when both open and laparoscopic approaches are considered together, the evidence showed improved survival for partial nephrectomy for tumours </=4cm. The overall evidence suggests either equivalent or better survival with partial nephrectomy. Laparoscopic radical nephrectomy offered equivalent survival to open radical nephrectomy, and all laparoscopic approaches achieved equivalent survival. Open and laparoscopic partial nephrectomy achieved equivalent survival. The issue of ipsilateral adrenalectomy or complete lymph node dissection with radical nephrectomy or partial nephrectomy remains unresolved. CONCLUSIONS: The evidence base suggests localised RCCs are best managed by nephron-sparing surgery where technically feasible. However, the current evidence base has significant limitations due to studies of low methodological quality marked by high risks of bias.1 mei 201

    Diagnostic and prognostic factors in patients with prostate cancer : a systematic review protocol

    Get PDF
    Funding PIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement No. 777492. IMI2 receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).Peer reviewedPublisher PD
    corecore