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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Vijaya M, Musini; Kendra Ak, Lawrence; Patricia M, Fortin; Ken, Bassett; +1 Authors

    Background Hypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II. Objectives To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension. To determine the change in BP variability, pulse pressure, and heart rate and to evaluate adverse events (mortality, non-fatal serious adverse events, total adverse events, withdrawal due to adverse effects and specific adverse events such as dry cough, diarrhoea and angioedema). Search methods The Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to February 2017: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. There was no restriction by language or publication status. We also searched the European Medicines Agency (EMA) for clinical study reports, the Novartis Clinical Study Results Database, bibliographic citations from retrieved references, and contacted authors of relevant papers regarding further published and unpublished work. Selection criteria We included randomized, double-blinded, placebo-controlled studies evaluating BP lowering efficacy of fixed-dose monotherapy with renin inhibitor compared with placebo for a minimum duration of three to 12 weeks in adult patients with primary hypertension. Data collection and analysis This systematic review is a comprehensive update which includes four additional studies and extensive detail from nine clinical study reports (CSRs) of previously included studies obtained from EMA. The remaining three CSRs are not available. Two review authors independently assessed study eligibility and extracted data. In all cases where there was a difference between the CSR and the published report, data from the CSR was used. Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence intervals (CIs) and continuous outcomes as mean difference (MD) with 95% CIs. Main results 12 studies (mean duration of eight weeks) in 7439 mostly Caucasian patients (mean age 54 years) with mild-to-moderate uncomplicated hypertension were eligible for inclusion in the review. Aliskiren was the only renin inhibitor evaluated. All included studies were assessed to have high likelihood of attrition, reporting and funding bias. Aliskiren has a dose-related systolic/diastolic blood pressure (SBP/DBP) lowering effect as compared with placebo MD with 95% CI: aliskiren 75 mg (MD -2.97, 95% CI -4.76 to -1.18)/(MD -2.05, 95% CI -3.13 to -0.96) mm Hg (moderate-quality evidence), aliskiren 150 mg (MD -5.95, 95% CI -6.85 to -5.06)/ (MD -3.16, 95% CI -3.74 to -2.58) mm Hg (moderate-quality evidence), aliskiren 300 mg (MD -7.88, 95% CI -8.94 to -6.82)/ (MD -4.49, 95% CI -5.17 to -3.82) mm Hg (moderate-quality evidence), aliskiren 600 mg (MD -11.35, 95% CI -14.43 to -8.27)/ (MD -5.86, 95% CI -7.73 to -3.99) mm Hg (low-quality evidence). There was a dose-dependent decrease in blood pressure for aliskiren 75 mg, 150 mg and 300 mg. The blood pressure lowering effect of aliskiren 600 mg was not different from 300 mg (MD -0.61, 95% CI -2.78 to 1.56)/(MD -0.68, 95% CI -2.03 to 0.67). Aliskiren had no effect on blood pressure variability. Due to very limited information available regarding change in heart rate and pulse pressure, it was not possible to meta-analyze these outcomes. Mortality and non-fatal serious adverse events were not increased. This review found that in studies of eight week duration aliskiren may not increase withdrawal due to adverse events (low-quality evidence). Diarrhoea was increased in a dose-dependent manner (RR 7.00, 95% CI 2.48 to 19.72) with aliskiren 600 mg (low-quality evidence). The most frequent adverse events reported were headache, nasopharyngitis, diarrhoea, dizziness and fatigue. Authors' conclusions Compared to placebo, aliskiren lowered BP and this effect is dose-dependent. This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). There is no difference in mortality, nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy. Diarrhoea was considerably increased with aliskiren 600 mg.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Cochrane Database of...arrow_drop_down
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    Europe PubMed Central
    Other literature type . 2017
    Data sources: PubMed Central
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      Europe PubMed Central
      Other literature type . 2017
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Alexander Aarvold; Ryan Lohre; Harpreet Chhina; Kishore Mulpuri; +1 Authors

    Aims Though the pathogenesis of Legg-Calve-Perthes disease (LCPD) is unknown, repetitive microtrauma resulting in deformity has been postulated. The purpose of this study is to trial a novel upright MRI scanner, to determine whether any deformation occurs in femoral heads affected by LCPD with weightbearing. Methods Children affected by LCPD were recruited for analysis. Children received both standing weightbearing and supine scans in the MROpen upright MRI scanner, for coronal T1 GFE sequences, both hips in field of view. Parameters of femoral head height, width, and lateral extrusion of affected and unaffected hips were assessed by two independent raters, repeated at a one month interval. Inter- and intraclass correlation coefficients were determined. Standing and supine measurements were compared for each femoral head. Results Following rigorous protocol development in healthy age-matched volunteers, successful scanning was performed in 11 LCPD-affected hips in nine children, with seven unaffected hips therefore available for comparison. Five hips were in early stage (1 and 2) and six were in late stage (3 and 4). The mean age was 5.3 years. All hips in early-stage LCPD demonstrated dynamic deformity on weightbearing. Femoral head height decreased (mean 1.2 mm, 12.4% decrease), width increased (mean 2.5 mm, 7.2% increase), and lateral extrusion increased (median 2.5 mm, 23% increase) on standing weightbearing MRI compared to supine scans. Negligible deformation was observed in contra-lateral unaffected hips, with less deformation observed in late-stage hips. Inter- and intraclass reliability for all measured parameters was good to excellent. Conclusion This pilot study has described an effective novel research investigation for children with LCPD. Femoral heads in early-stage LCPD demonstrated dynamic deformity on weightbearing not previously seen, while unaffected hips did not. Expansion of this protocol will allow further translational study into the effects of loading hips with LCPD. Cite this article: Bone Joint Open 2020;1-7:364–369.

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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Almoudaris, A; Mamidanna, R; Bottle, A; Aylin, P; +3 Authors

    IMPORTANCE: Gastroesophageal cancer resections are associated with significant reintervention and perioperative mortality rates. OBJECTIVE: To compare outcomes following operative and nonoperative reinterventions between high- and low-mortality gastroesophageal cancer surgical units in England. DESIGN: All elective esophageal and gastric resections for cancer between 2000 and 2010 in English public hospitals were identified from a national administrative database. Units were divided into low- and high-mortality units (LMUs and HMUs, respectively) using a threshold of 5% or less for 30-day adjusted mortality. The groups were compared for reoperations and nonoperative reinterventions following complications. SETTING: Both LMUs and HMUs. PARTICIPANTS: Patients who underwent esophageal and gastric resections for cancer. EXPOSURE: Elective esophageal and gastric resections for cancer, with reoperations and nonoperative reinterventions following complications. MAIN OUTCOMES AND MEASURES: Failure to rescue is defined as the death of a patient following a complication; failure to rescue-surgical is defined as the death of a patient following reoperation for a surgical complication. RESULTS: There were 14 955 esophagectomies and 10 671 gastrectomies performed in 141 units. For gastroesophageal resections combined, adjusted mortality rates were 3.0% and 8.3% (P < .001) for LMUs and HMUs, respectively. Complications rates preceding reoperation were similar (5.4% for LMUs vs. 4.9% for HMUs; P = .11). The failure to rescue-surgical rates were lower in LMUs than in HMUs (15.3% vs. 24.1%; P < .001). The LMUs performed more nonoperative reinterventions than the HMUs did (6.7% vs. 4.7%; P < .001), with more patients surviving in LMUs than in HMUs (failure to rescue rate, 7.0% vs. 12.5%; P < .001). Overall, LMUs reintervened more than HMUs did (12.2% vs 9.6%; P < .001), and LMUs had lower failure to rescue rates following reintervention than HMUs did (9.0% vs. 18.3%; P = .001). All P values stated refer to 2-sided values. CONCLUSIONS AND RELEVANCE: Overall, LMUs were more likely to reintervene and rescue patients following gastroesophageal cancer resections in England. Patients were more likely to survive following both reoperations and nonsurgical interventions in LMUs.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ JAMA Surgery; Oxford...arrow_drop_down
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    JAMA Surgery
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      JAMA Surgery
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  • Authors: Winau, L.; Baydes, R.H.; Braner, A.; Drott, U.; +12 Authors

    BackgroundCardiovascular (CV) involvement in patients with systemic lupus erythematosus (SLE) is presumably subclinical for the major part of its evolution. We evaluated the associations between high-sensitive troponin T (hs-TropT), a sensitive marker of myocardial injury, and CV involvement using cardiac magnetic resonance (CMR).Methods and resultsThis is a two-centre (London and Frankfurt) CMR imaging study at 3.0 Tesla of consecutive 92 patients with SLE free of cardiac symptoms, undergoing screening for cardiac involvement. Venous samples were drawn and analysed post-hoc for cardiac biomarkers, including hs-TropT, high-sensitive C reactive protein and N-terminal pro brain natriuretic peptide. Compared with age-matched/gender-matched non-SLE controls (n=78), patients had significantly raised cardiac biomarker levels, native T1 and T2, aortic and ventricular stiffness, and reduced global longitudinal strain (p<0.01). In SLE, hs-TropT was significantly and independently associated with native T2, followed by the models including native T1 and aortic stiffness (Χ2 0.462, p<0.01). There were no relationships between hs-TropT and age, gender, CV risk factors, duration of systemic disease, cardiac structure or function, or late gadolinium enhancement.ConclusionsPatients with SLE have a high prevalence of subclinical myocardial injury as demonstrated by raised high-sensitive troponin levels. CMR with T2 mapping reveals myocardial oedema as the strongest predictor of hs-TropT release, underscoring the inflammatory interstitial remodelling as the main mechanism of injury. Patients without active myocardial inflammation demonstrate diffuse interstitial remodelling and increased vascular stiffness. These findings substantiate the role of CMR in screening of subclinical cardiac involvement.Trial registration numerNCT02407197; Results.

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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Peige Song; Manli Wang; Xinlei Chang; Jiawen Wang; +2 Authors

    ABSTRACTAimTo assess the prevalence of impaired renal function and its associated factors in Chinese children.MethodsChildren aged 7–18 years in China Health and Nutrition Survey (CHNS) 2009 were included as participants, and their anthropometric measurements, blood pressure (BP) and biochemical parameters were taken for analysis. The estimated glomerular filtration rate (eGFR) was calculated by using the Schwartz ‘original’ formula.ResultsThe prevalence of estimated glomerular filtration rate (eGFR) < 90 mL/min per 1.73 m2 and <75 mL/min per 1.73 m2 was 10.09% (95% CI: 8.03–12.11) and 1.01% (95% CI: 0.38–1.77), respectively. The prevalence of impaired renal function (eGFR <60 mL/min per 1.73 m2) was 0.25%. Age was detected as a negative associated factor whereas hyperuricemia and elevated total cholesterol (TC) were positively associated factors for subjects with eGFR <90 mL/min per 1.73 m2. In the group of eGFR <75 mL/min per 1.73 m2, only elevated TC was related to the increased odds of decreased eGFR.ConclusionOur findings underscore the need for large‐scale programs to detect and treat the early‐stage impaired renal function in the paediatric population in China.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Europe PubMed Centra...arrow_drop_down
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    Europe PubMed Central
    Other literature type . 2019
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    Nephrology
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    image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
    Nephrology
    Article . 2019
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      Europe PubMed Central
      Other literature type . 2019
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      Nephrology
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      image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
      Nephrology
      Article . 2019
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    Authors: Naida L. Graham; Carol Leonard; David F. Tang-Wai; Sandra Black; +5 Authors

    <b><i>Background/Aims:</i></b> Frank agrammatism, defined as the omission and/or substitution of grammatical morphemes with associated grammatical errors, is variably reported in patients with nonfluent variant primary progressive aphasia (nfPPA). This study addressed whether frank agrammatism is typical in agrammatic nfPPA patients when this feature is not required for diagnosis. <b><i>Method:</i></b> We assessed grammatical production in 9 patients who satisfied current diagnostic criteria. Although the focus was agrammatism, motor speech skills were also evaluated to determine whether dysfluency arose primarily from apraxia of speech (AOS), instead of, or in addition to, agrammatism. Volumetric MRI analyses provided impartial imaging-supported diagnosis. <b><i>Results:</i></b> The majority of cases exhibited neither frank agrammatism nor AOS. <b><i>Conclusion:</i></b> There are nfPPA patients with imaging-supported diagnosis and preserved motor speech skills who do not exhibit frank agrammatism, and this may persist beyond the earliest stages of the illness. Because absence of frank agrammatism is a subsidiary diagnostic feature in the logopenic variant of PPA, this result has implications for differentiation of the nonfluent and logopenic variants, and indicates that PPA patients with nonfluent speech in the absence of frank agrammatism or AOS do not necessarily have the logopenic variant.

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    Europe PubMed Central
    Article . 2016
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    Dementia and Geriatric Cognitive Disorders Extra
    Article . 2016
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    Dementia and Geriatric Cognitive Disorders Extra
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    Article . 2016
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      Dementia and Geriatric Cognitive Disorders Extra
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      Dementia and Geriatric Cognitive Disorders Extra
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    In principle, accurate guideline recommendations should lead to optimal management based on a secure diagnosis. However, current IPF diagnostic guidelines do not meet the needs of a major sub-group (possibly the majority) of patients with idiopathic pulmonary fibrosis (IPF). A great many IPF patients have HRCT appearances of “possible UIP”. A surgical biopsy is very often impracticable due to age, disease severity, co-morbidities or patient refusal. A guideline-based diagnosis cannot be made in these patients, although the diagnosis is often obvious. Inflexible diagnostic criteria, although essential for treatment trials, must necessarily be structured around an inflexible diagnostic algorithm. With this approach, non-standardised information (i.e. not available in all patients) must be omitted, including observed disease behaviour prior to and on treatment, findings on bronchoalveolar lavage, likelihoods in relation to age and a wealth of ancillary clinical information. However, when a diagnosis cannot be made using guideline criteria, a probable or highly probable “working diagnosis” of IPF can and should be made in most IPF patients by means of clinical reasoning, integrating all available non-standardised information.

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    BMC Medicine
    Article . 2016
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    Europe PubMed Central
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    Europe PubMed Central
    Article . 2016
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    BMC Medicine
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    BMC Medicine
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    https://pubmed.ncbi.nlm.nih.go...
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    Authors: Harrison, Mark J; Dusheiko, Mark; Sutton, Matt; Gravelle, Hugh; +2 Authors

    OBJECTIVE: To estimate the impact of a national primary care pay for performance scheme, the Quality and Outcomes Framework in England, on emergency hospital admissions for ambulatory care sensitive conditions (ACSCs). DESIGN: Controlled longitudinal study. SETTING: English National Health Service between 1998/99 and 2010/11. PARTICIPANTS: Populations registered with each of 6975 family practices in England. MAIN OUTCOME MEASURES: Year specific differences between trend adjusted emergency hospital admission rates for incentivised ACSCs before and after the introduction of the Quality and Outcomes Framework scheme and two comparators: non-incentivised ACSCs and non-ACSCs. RESULTS: Incentivised ACSC admissions showed a relative reduction of 2.7% (95% confidence interval 1.6% to 3.8%) in the first year of the Quality and Outcomes Framework compared with ACSCs that were not incentivised. This increased to a relative reduction of 8.0% (6.9% to 9.1%) in 2010/11. Compared with conditions that are not regarded as being influenced by the quality of ambulatory care (non-ACSCs), incentivised ACSCs also showed a relative reduction in rates of emergency admissions of 2.8% (2.0% to 3.6%) in the first year increasing to 10.9% (10.1% to 11.7%) by 2010/11. CONCLUSIONS: The introduction of a major national pay for performance scheme for primary care in England was associated with a decrease in emergency admissions for incentivised conditions compared with conditions that were not incentivised. Contemporaneous health service changes seem unlikely to have caused the sharp change in the trajectory of incentivised ACSC admissions immediately after the introduction of the Quality and Outcomes Framework. The decrease seems larger than would be expected from the changes in the process measures that were incentivised, suggesting that the pay for performance scheme may have had impacts on quality of care beyond the directly incentivised activities.

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    BMJ
    Article . 2014
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    BMJ
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    Apollo
    Other literature type . 2014
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    Apollo
    Article . 2018
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    BMJ
    Article . 2014
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    Article . 2014
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      Apollo
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      BMJ
      Article . 2014
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    Authors: Lamiya Mohiyiddeen; William G. Newman; Christian Cerra; Gregory P. Horne; +4 Authors

    The objective of this study was to assess the role of the variant p.Asn680Ser in the FSH receptor gene (FSHR) in determining oocyte maturity. It also assessed the relationship between this FSHR variant with metaphase-II oocyte output rate (MOR) and the fertilization rate. This was a prospective observational study based at a tertiary referral centre for reproductive medicine. Women (n=212) undergoing their first cycle of ovarian stimulation for IVF with intracytoplasmic sperm injection (ICSI) were included in the study. Baseline pelvic ultrasound and blood tests were taken on day 2 or 3 of the cycle for assessment of baseline hormones and for DNA extraction. Genotypes for FSHR p.Asn680Ser was determined using TaqMan allelic discrimination assay. The outcome measures were the total dose of exogenous gonadotrophins used, antral follicle count (AFC), number of mature (metaphase-II) oocytes retrieved, MOR and fertilization rate. No statistically significant differences were found between the number of mature oocytes retrieved, MOR or fertilization rates among the patients with different p.Asn680Ser FSHR genotypes. No significant difference was noted in the clinical pregnancy rates per transfer. There is no evidence that the p.Asn680Ser FSHR genotype predicts oocyte maturity.

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    Reproductive BioMedicine Online
    Article . 2013
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      Reproductive BioMedicine Online
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  • Authors: Sean M, O'Cathail; Roekshana, Shaboodien; Sarah, Mahmoud; Karen, Carty; +6 Authors

    ObjectiveDexamethasone premedication is required with paclitaxel to prevent infusion-related hypersensitivity reactions (HSRs). Both oral dexamethasone (PO-D; 20 mg 12 and 6 hours before paclitaxel) and intravenous dexamethasone (IV-D; 20 mg 30 minutes before paclitaxel) regimens are used. The optimal premedication regimen and management of patients after HSR are unclear.MethodsData on HSRs in women receiving paclitaxel, 175 mg/m2, every 3 weeks at Imperial College Healthcare Trust from May 2011 to February 2012 were obtained from the pharmacy database. During this period, dexamethasone premedication for paclitaxel was administered orally (PO-D; 20 mg 12 and 6 hours before paclitaxel) from May to August 2011, then changed to intravenous dexamethasone (IV-D; 20 mg 30 minutes before paclitaxel) for 3 months, and then reverted to PO-D from November 2011. There were 93 and 55 patients who received PO-D and IV-D before paclitaxel, respectively. Hypersensitivity reaction rates were pooled with those from published studies for analysis. Gynecologic oncology centers in the UK and Canada were surveyed regarding premedication and post-HSR management. A Markov Monte-Carlo simulation model compared costs and benefits of different strategies.ResultsHypersensitivity reaction rates with PO-D and IV-D were 5.4% (5/93) versus 14.5% (8/55) (P= 0.07) in Imperial College Healthcare Trust patients, and 6.8% (20/290) versus 14.1% (30/212) (P= 0.009) on pooled analysis with data from 2 additional studies (502 patients), respectively. However, IV-D is the most common premedication regimen used in the UK and Canada (48.5% and 34.2% of centers). Post-HSR paclitaxel on a desensitization protocol is a cost-effective alternative to discontinuing paclitaxel altogether.ConclusionOral dexamethasone seems to be superior to IV-D in preventing HSRs. Post-HSR patients should be considered for desensitization.

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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Vijaya M, Musini; Kendra Ak, Lawrence; Patricia M, Fortin; Ken, Bassett; +1 Authors

    Background Hypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II. Objectives To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension. To determine the change in BP variability, pulse pressure, and heart rate and to evaluate adverse events (mortality, non-fatal serious adverse events, total adverse events, withdrawal due to adverse effects and specific adverse events such as dry cough, diarrhoea and angioedema). Search methods The Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to February 2017: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. There was no restriction by language or publication status. We also searched the European Medicines Agency (EMA) for clinical study reports, the Novartis Clinical Study Results Database, bibliographic citations from retrieved references, and contacted authors of relevant papers regarding further published and unpublished work. Selection criteria We included randomized, double-blinded, placebo-controlled studies evaluating BP lowering efficacy of fixed-dose monotherapy with renin inhibitor compared with placebo for a minimum duration of three to 12 weeks in adult patients with primary hypertension. Data collection and analysis This systematic review is a comprehensive update which includes four additional studies and extensive detail from nine clinical study reports (CSRs) of previously included studies obtained from EMA. The remaining three CSRs are not available. Two review authors independently assessed study eligibility and extracted data. In all cases where there was a difference between the CSR and the published report, data from the CSR was used. Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence intervals (CIs) and continuous outcomes as mean difference (MD) with 95% CIs. Main results 12 studies (mean duration of eight weeks) in 7439 mostly Caucasian patients (mean age 54 years) with mild-to-moderate uncomplicated hypertension were eligible for inclusion in the review. Aliskiren was the only renin inhibitor evaluated. All included studies were assessed to have high likelihood of attrition, reporting and funding bias. Aliskiren has a dose-related systolic/diastolic blood pressure (SBP/DBP) lowering effect as compared with placebo MD with 95% CI: aliskiren 75 mg (MD -2.97, 95% CI -4.76 to -1.18)/(MD -2.05, 95% CI -3.13 to -0.96) mm Hg (moderate-quality evidence), aliskiren 150 mg (MD -5.95, 95% CI -6.85 to -5.06)/ (MD -3.16, 95% CI -3.74 to -2.58) mm Hg (moderate-quality evidence), aliskiren 300 mg (MD -7.88, 95% CI -8.94 to -6.82)/ (MD -4.49, 95% CI -5.17 to -3.82) mm Hg (moderate-quality evidence), aliskiren 600 mg (MD -11.35, 95% CI -14.43 to -8.27)/ (MD -5.86, 95% CI -7.73 to -3.99) mm Hg (low-quality evidence). There was a dose-dependent decrease in blood pressure for aliskiren 75 mg, 150 mg and 300 mg. The blood pressure lowering effect of aliskiren 600 mg was not different from 300 mg (MD -0.61, 95% CI -2.78 to 1.56)/(MD -0.68, 95% CI -2.03 to 0.67). Aliskiren had no effect on blood pressure variability. Due to very limited information available regarding change in heart rate and pulse pressure, it was not possible to meta-analyze these outcomes. Mortality and non-fatal serious adverse events were not increased. This review found that in studies of eight week duration aliskiren may not increase withdrawal due to adverse events (low-quality evidence). Diarrhoea was increased in a dose-dependent manner (RR 7.00, 95% CI 2.48 to 19.72) with aliskiren 600 mg (low-quality evidence). The most frequent adverse events reported were headache, nasopharyngitis, diarrhoea, dizziness and fatigue. Authors' conclusions Compared to placebo, aliskiren lowered BP and this effect is dose-dependent. This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). There is no difference in mortality, nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy. Diarrhoea was considerably increased with aliskiren 600 mg.

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    Europe PubMed Central
    Other literature type . 2017
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Alexander Aarvold; Ryan Lohre; Harpreet Chhina; Kishore Mulpuri; +1 Authors

    Aims Though the pathogenesis of Legg-Calve-Perthes disease (LCPD) is unknown, repetitive microtrauma resulting in deformity has been postulated. The purpose of this study is to trial a novel upright MRI scanner, to determine whether any deformation occurs in femoral heads affected by LCPD with weightbearing. Methods Children affected by LCPD were recruited for analysis. Children received both standing weightbearing and supine scans in the MROpen upright MRI scanner, for coronal T1 GFE sequences, both hips in field of view. Parameters of femoral head height, width, and lateral extrusion of affected and unaffected hips were assessed by two independent raters, repeated at a one month interval. Inter- and intraclass correlation coefficients were determined. Standing and supine measurements were compared for each femoral head. Results Following rigorous protocol development in healthy age-matched volunteers, successful scanning was performed in 11 LCPD-affected hips in nine children, with seven unaffected hips therefore available for comparison. Five hips were in early stage (1 and 2) and six were in late stage (3 and 4). The mean age was 5.3 years. All hips in early-stage LCPD demonstrated dynamic deformity on weightbearing. Femoral head height decreased (mean 1.2 mm, 12.4% decrease), width increased (mean 2.5 mm, 7.2% increase), and lateral extrusion increased (median 2.5 mm, 23% increase) on standing weightbearing MRI compared to supine scans. Negligible deformation was observed in contra-lateral unaffected hips, with less deformation observed in late-stage hips. Inter- and intraclass reliability for all measured parameters was good to excellent. Conclusion This pilot study has described an effective novel research investigation for children with LCPD. Femoral heads in early-stage LCPD demonstrated dynamic deformity on weightbearing not previously seen, while unaffected hips did not. Expansion of this protocol will allow further translational study into the effects of loading hips with LCPD. Cite this article: Bone Joint Open 2020;1-7:364–369.

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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Almoudaris, A; Mamidanna, R; Bottle, A; Aylin, P; +3 Authors

    IMPORTANCE: Gastroesophageal cancer resections are associated with significant reintervention and perioperative mortality rates. OBJECTIVE: To compare outcomes following operative and nonoperative reinterventions between high- and low-mortality gastroesophageal cancer surgical units in England. DESIGN: All elective esophageal and gastric resections for cancer between 2000 and 2010 in English public hospitals were identified from a national administrative database. Units were divided into low- and high-mortality units (LMUs and HMUs, respectively) using a threshold of 5% or less for 30-day adjusted mortality. The groups were compared for reoperations and nonoperative reinterventions following complications. SETTING: Both LMUs and HMUs. PARTICIPANTS: Patients who underwent esophageal and gastric resections for cancer. EXPOSURE: Elective esophageal and gastric resections for cancer, with reoperations and nonoperative reinterventions following complications. MAIN OUTCOMES AND MEASURES: Failure to rescue is defined as the death of a patient following a complication; failure to rescue-surgical is defined as the death of a patient following reoperation for a surgical complication. RESULTS: There were 14 955 esophagectomies and 10 671 gastrectomies performed in 141 units. For gastroesophageal resections combined, adjusted mortality rates were 3.0% and 8.3% (P < .001) for LMUs and HMUs, respectively. Complications rates preceding reoperation were similar (5.4% for LMUs vs. 4.9% for HMUs; P = .11). The failure to rescue-surgical rates were lower in LMUs than in HMUs (15.3% vs. 24.1%; P < .001). The LMUs performed more nonoperative reinterventions than the HMUs did (6.7% vs. 4.7%; P < .001), with more patients surviving in LMUs than in HMUs (failure to rescue rate, 7.0% vs. 12.5%; P < .001). Overall, LMUs reintervened more than HMUs did (12.2% vs 9.6%; P < .001), and LMUs had lower failure to rescue rates following reintervention than HMUs did (9.0% vs. 18.3%; P = .001). All P values stated refer to 2-sided values. CONCLUSIONS AND RELEVANCE: Overall, LMUs were more likely to reintervene and rescue patients following gastroesophageal cancer resections in England. Patients were more likely to survive following both reoperations and nonsurgical interventions in LMUs.

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  • Authors: Winau, L.; Baydes, R.H.; Braner, A.; Drott, U.; +12 Authors

    BackgroundCardiovascular (CV) involvement in patients with systemic lupus erythematosus (SLE) is presumably subclinical for the major part of its evolution. We evaluated the associations between high-sensitive troponin T (hs-TropT), a sensitive marker of myocardial injury, and CV involvement using cardiac magnetic resonance (CMR).Methods and resultsThis is a two-centre (London and Frankfurt) CMR imaging study at 3.0 Tesla of consecutive 92 patients with SLE free of cardiac symptoms, undergoing screening for cardiac involvement. Venous samples were drawn and analysed post-hoc for cardiac biomarkers, including hs-TropT, high-sensitive C reactive protein and N-terminal pro brain natriuretic peptide. Compared with age-matched/gender-matched non-SLE controls (n=78), patients had significantly raised cardiac biomarker levels, native T1 and T2, aortic and ventricular stiffness, and reduced global longitudinal strain (p<0.01). In SLE, hs-TropT was significantly and independently associated with native T2, followed by the models including native T1 and aortic stiffness (Χ2 0.462, p<0.01). There were no relationships between hs-TropT and age, gender, CV risk factors, duration of systemic disease, cardiac structure or function, or late gadolinium enhancement.ConclusionsPatients with SLE have a high prevalence of subclinical myocardial injury as demonstrated by raised high-sensitive troponin levels. CMR with T2 mapping reveals myocardial oedema as the strongest predictor of hs-TropT release, underscoring the inflammatory interstitial remodelling as the main mechanism of injury. Patients without active myocardial inflammation demonstrate diffuse interstitial remodelling and increased vascular stiffness. These findings substantiate the role of CMR in screening of subclinical cardiac involvement.Trial registration numerNCT02407197; Results.

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    Authors: Peige Song; Manli Wang; Xinlei Chang; Jiawen Wang; +2 Authors

    ABSTRACTAimTo assess the prevalence of impaired renal function and its associated factors in Chinese children.MethodsChildren aged 7–18 years in China Health and Nutrition Survey (CHNS) 2009 were included as participants, and their anthropometric measurements, blood pressure (BP) and biochemical parameters were taken for analysis. The estimated glomerular filtration rate (eGFR) was calculated by using the Schwartz ‘original’ formula.ResultsThe prevalence of estimated glomerular filtration rate (eGFR) < 90 mL/min per 1.73 m2 and <75 mL/min per 1.73 m2 was 10.09% (95% CI: 8.03–12.11) and 1.01% (95% CI: 0.38–1.77), respectively. The prevalence of impaired renal function (eGFR <60 mL/min per 1.73 m2) was 0.25%. Age was detected as a negative associated factor whereas hyperuricemia and elevated total cholesterol (TC) were positively associated factors for subjects with eGFR <90 mL/min per 1.73 m2. In the group of eGFR <75 mL/min per 1.73 m2, only elevated TC was related to the increased odds of decreased eGFR.ConclusionOur findings underscore the need for large‐scale programs to detect and treat the early‐stage impaired renal function in the paediatric population in China.

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    Nephrology
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    Nephrology
    Article . 2019
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    Authors: Naida L. Graham; Carol Leonard; David F. Tang-Wai; Sandra Black; +5 Authors

    <b><i>Background/Aims:</i></b> Frank agrammatism, defined as the omission and/or substitution of grammatical morphemes with associated grammatical errors, is variably reported in patients with nonfluent variant primary progressive aphasia (nfPPA). This study addressed whether frank agrammatism is typical in agrammatic nfPPA patients when this feature is not required for diagnosis. <b><i>Method:</i></b> We assessed grammatical production in 9 patients who satisfied current diagnostic criteria. Although the focus was agrammatism, motor speech skills were also evaluated to determine whether dysfluency arose primarily from apraxia of speech (AOS), instead of, or in addition to, agrammatism. Volumetric MRI analyses provided impartial imaging-supported diagnosis. <b><i>Results:</i></b> The majority of cases exhibited neither frank agrammatism nor AOS. <b><i>Conclusion:</i></b> There are nfPPA patients with imaging-supported diagnosis and preserved motor speech skills who do not exhibit frank agrammatism, and this may persist beyond the earliest stages of the illness. Because absence of frank agrammatism is a subsidiary diagnostic feature in the logopenic variant of PPA, this result has implications for differentiation of the nonfluent and logopenic variants, and indicates that PPA patients with nonfluent speech in the absence of frank agrammatism or AOS do not necessarily have the logopenic variant.

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    Europe PubMed Central
    Article . 2016
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    Dementia and Geriatric Cognitive Disorders Extra
    Article . 2016
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    Dementia and Geriatric Cognitive Disorders Extra
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    DOAJ
    Article . 2016
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      Dementia and Geriatric Cognitive Disorders Extra
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      Dementia and Geriatric Cognitive Disorders Extra
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    In principle, accurate guideline recommendations should lead to optimal management based on a secure diagnosis. However, current IPF diagnostic guidelines do not meet the needs of a major sub-group (possibly the majority) of patients with idiopathic pulmonary fibrosis (IPF). A great many IPF patients have HRCT appearances of “possible UIP”. A surgical biopsy is very often impracticable due to age, disease severity, co-morbidities or patient refusal. A guideline-based diagnosis cannot be made in these patients, although the diagnosis is often obvious. Inflexible diagnostic criteria, although essential for treatment trials, must necessarily be structured around an inflexible diagnostic algorithm. With this approach, non-standardised information (i.e. not available in all patients) must be omitted, including observed disease behaviour prior to and on treatment, findings on bronchoalveolar lavage, likelihoods in relation to age and a wealth of ancillary clinical information. However, when a diagnosis cannot be made using guideline criteria, a probable or highly probable “working diagnosis” of IPF can and should be made in most IPF patients by means of clinical reasoning, integrating all available non-standardised information.

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    BMC Medicine
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    Europe PubMed Central
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    BMC Medicine
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    Authors: Harrison, Mark J; Dusheiko, Mark; Sutton, Matt; Gravelle, Hugh; +2 Authors

    OBJECTIVE: To estimate the impact of a national primary care pay for performance scheme, the Quality and Outcomes Framework in England, on emergency hospital admissions for ambulatory care sensitive conditions (ACSCs). DESIGN: Controlled longitudinal study. SETTING: English National Health Service between 1998/99 and 2010/11. PARTICIPANTS: Populations registered with each of 6975 family practices in England. MAIN OUTCOME MEASURES: Year specific differences between trend adjusted emergency hospital admission rates for incentivised ACSCs before and after the introduction of the Quality and Outcomes Framework scheme and two comparators: non-incentivised ACSCs and non-ACSCs. RESULTS: Incentivised ACSC admissions showed a relative reduction of 2.7% (95% confidence interval 1.6% to 3.8%) in the first year of the Quality and Outcomes Framework compared with ACSCs that were not incentivised. This increased to a relative reduction of 8.0% (6.9% to 9.1%) in 2010/11. Compared with conditions that are not regarded as being influenced by the quality of ambulatory care (non-ACSCs), incentivised ACSCs also showed a relative reduction in rates of emergency admissions of 2.8% (2.0% to 3.6%) in the first year increasing to 10.9% (10.1% to 11.7%) by 2010/11. CONCLUSIONS: The introduction of a major national pay for performance scheme for primary care in England was associated with a decrease in emergency admissions for incentivised conditions compared with conditions that were not incentivised. Contemporaneous health service changes seem unlikely to have caused the sharp change in the trajectory of incentivised ACSC admissions immediately after the introduction of the Quality and Outcomes Framework. The decrease seems larger than would be expected from the changes in the process measures that were incentivised, suggesting that the pay for performance scheme may have had impacts on quality of care beyond the directly incentivised activities.

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    Article . 2014
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    Apollo
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    BMJ
    Article . 2014
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    Article . 2014
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      BMJ
      Article . 2014
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    Authors: Lamiya Mohiyiddeen; William G. Newman; Christian Cerra; Gregory P. Horne; +4 Authors

    The objective of this study was to assess the role of the variant p.Asn680Ser in the FSH receptor gene (FSHR) in determining oocyte maturity. It also assessed the relationship between this FSHR variant with metaphase-II oocyte output rate (MOR) and the fertilization rate. This was a prospective observational study based at a tertiary referral centre for reproductive medicine. Women (n=212) undergoing their first cycle of ovarian stimulation for IVF with intracytoplasmic sperm injection (ICSI) were included in the study. Baseline pelvic ultrasound and blood tests were taken on day 2 or 3 of the cycle for assessment of baseline hormones and for DNA extraction. Genotypes for FSHR p.Asn680Ser was determined using TaqMan allelic discrimination assay. The outcome measures were the total dose of exogenous gonadotrophins used, antral follicle count (AFC), number of mature (metaphase-II) oocytes retrieved, MOR and fertilization rate. No statistically significant differences were found between the number of mature oocytes retrieved, MOR or fertilization rates among the patients with different p.Asn680Ser FSHR genotypes. No significant difference was noted in the clinical pregnancy rates per transfer. There is no evidence that the p.Asn680Ser FSHR genotype predicts oocyte maturity.

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    Reproductive BioMedicine Online
    Article . 2013
    License: Elsevier TDM
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Reproductive BioMedi...arrow_drop_down
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
      Reproductive BioMedicine Online
      Article . 2013
      License: Elsevier TDM
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  • Authors: Sean M, O'Cathail; Roekshana, Shaboodien; Sarah, Mahmoud; Karen, Carty; +6 Authors

    ObjectiveDexamethasone premedication is required with paclitaxel to prevent infusion-related hypersensitivity reactions (HSRs). Both oral dexamethasone (PO-D; 20 mg 12 and 6 hours before paclitaxel) and intravenous dexamethasone (IV-D; 20 mg 30 minutes before paclitaxel) regimens are used. The optimal premedication regimen and management of patients after HSR are unclear.MethodsData on HSRs in women receiving paclitaxel, 175 mg/m2, every 3 weeks at Imperial College Healthcare Trust from May 2011 to February 2012 were obtained from the pharmacy database. During this period, dexamethasone premedication for paclitaxel was administered orally (PO-D; 20 mg 12 and 6 hours before paclitaxel) from May to August 2011, then changed to intravenous dexamethasone (IV-D; 20 mg 30 minutes before paclitaxel) for 3 months, and then reverted to PO-D from November 2011. There were 93 and 55 patients who received PO-D and IV-D before paclitaxel, respectively. Hypersensitivity reaction rates were pooled with those from published studies for analysis. Gynecologic oncology centers in the UK and Canada were surveyed regarding premedication and post-HSR management. A Markov Monte-Carlo simulation model compared costs and benefits of different strategies.ResultsHypersensitivity reaction rates with PO-D and IV-D were 5.4% (5/93) versus 14.5% (8/55) (P= 0.07) in Imperial College Healthcare Trust patients, and 6.8% (20/290) versus 14.1% (30/212) (P= 0.009) on pooled analysis with data from 2 additional studies (502 patients), respectively. However, IV-D is the most common premedication regimen used in the UK and Canada (48.5% and 34.2% of centers). Post-HSR paclitaxel on a desensitization protocol is a cost-effective alternative to discontinuing paclitaxel altogether.ConclusionOral dexamethasone seems to be superior to IV-D in preventing HSRs. Post-HSR patients should be considered for desensitization.

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