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Blinded Manner (blinded + manner)
Selected AbstractsA blinded, crossover study of the efficacy of the ketogenic dietEPILEPSIA, Issue 2 2009John M. Freeman Summary Despite over 80 years of use, the ketogenic diet (KD) has never been tested in a blinded manner. Twenty children with intractable Lennox-Gastaut syndrome (LGS) were fasted 36 h and then randomized to receive the classic KD in conjunction with a solution containing either 60 g/day of glucose or saccharin. Parents and physicians were blinded to both the solution composition and level of ketosis. A crossover to the KD with the alternate solution occurred following the sixth day and a repeat fast. A 24-h electroencephalography (EEG) was obtained at baseline and after each arm. After administration of the solution, there was moderate evidence of a reduction in parent-reported seizures between the glucose and saccharin arms, with a median difference of 1.5 seizures per day (p = 0.07). There was no reduction in the number of EEG-identified events, with a median reduction of 7 events per day (p = 0.33). Ketosis was not completely eliminated in the glucose-added arm. [source] Correction for heart rate variability during 3D whole heart MR coronary angiographyJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 5 2008Stijntje D. Roes MD Abstract Purpose To evaluate the effect of a real-time adaptive trigger delay on image quality to correct for heart rate variability in 3D whole-heart coronary MR angiography (MRA). Materials and Methods Twelve healthy adults underwent 3D whole-heart coronary MRA with and without the use of an adaptive trigger delay. The moment of minimal coronary artery motion was visually determined on a high temporal resolution MRI. Throughout the scan performed without adaptive trigger delay, trigger delay was kept constant, whereas during the scan performed with adaptive trigger delay, trigger delay was continuously updated after each RR-interval using physiological modeling. Signal-to-noise, contrast-to-noise, vessel length, vessel sharpness, and subjective image quality were compared in a blinded manner. Results Vessel sharpness improved significantly for the middle segment of the right coronary artery (RCA) with the use of the adaptive trigger delay (52.3 ± 7.1% versus 48.9 ± 7.9%, P = 0.026). Subjective image quality was significantly better in the middle segments of the RCA and left anterior descending artery (LAD) when the scan was performed with adaptive trigger delay compared to constant trigger delay. Conclusion Our results demonstrate that the use of an adaptive trigger delay to correct for heart rate variability improves image quality mainly in the middle segments of the RCA and LAD. J. Magn. Reson. Imaging 2008;27:1046,1053. © 2008 Wiley-Liss, Inc. [source] Direct immunofluoresence in vasculitic neuropathy: Specificity of vascular immune depositsMUSCLE AND NERVE, Issue 1 2010Michael P. Collins MD Abstract In suspected vasculitic neuropathy, vasculitis is demonstrated in only 30% of superficial peroneal nerve (SPN)/peroneus brevis muscle (PBM) specimens. Pathologic predictors of vasculitis are thus needed for non-diagnostic cases. Immune deposits in epineurial vessels have an established sensitivity but unknown specificity. In this study we assessed specificity using direct immunofluorescence (DIF) in SPN/PBM biopsies for suspected vasculitic neuropathy. Biopsies from 13 patients with vasculitis, 13 without vasculitis, and 6 with diabetic radiculoplexus neuropathy (DRPN) were stained for immunoglobulin G (IgG), IgM, and complement 3 (C3), and analyzed in a blinded manner. Vascular immunoglobulin or C3 deposits occurred in 12 of 13 nerve or muscle biopsies (11 of 13 nerves, 5 of 13 muscles) in vasculitis vs. 1 of 13 (1 of 13 nerves, 0 of 13 muscles) in controls (P = 0.00003). Specificity was 92%. For DRPN, vascular immune deposits occurred in 5 of 6 nerves or muscles (4 of 6 nerves, 1 of 5 muscles), similar to vasculitis but significantly different from controls. Epineurial/perimysial vascular deposits of immunoglobulin/C3 by DIF are a specific marker of vasculitic neuropathy. Muscle Nerve 000:000,000, 2009 [source] Reversal of rocuronium-induced neuromuscular blockade by pyridostigmine in patients with Duchenne muscular dystrophyPEDIATRIC ANESTHESIA, Issue 3 2008TINO MUENSTER MD Summary Background:, The aim of this study was to investigate the effect and safety of pyridostigmine for the reversal of a neuromuscular block (NMB) in patients with Duchenne muscular dystrophy (DMD). In patients with DMD recovery from a rocuronium-induced NMB is markedly delayed. Methods:, Fourteen DMD patients (aged between 11 and 19 years) scheduled for elective scoliosis repair were studied. Following tracheal intubation without muscle relaxant, all patients received a single dose of rocuronium 0.6 mg·kg,1. NMB was monitored by acceleromyography at the adductor pollicis muscle. When the first twitch height (T1) of the train-of-four (TOF) had recovered to 25% seven patients received either pyridostigmine 0.1 mg·kg,1 (the anticholinergic drug with a long duration of action) or saline in a blinded manner. The times to attain TOF ratio of 0.9 were recorded. For comparison the Mann,Whitney U -test was used. Results:, Recovery to TOF ratio of 0.9 was significantly (P < 0.05) accelerated by pyridostigmine [84 (median), 57,141(range)] compared with controls (148, 84,243 min). The recovery time (time between T1 of 25% and TOF of 90%) was also significantly (P < 0.01) shortened by pyridostigmine (15, 8,49 vs 76, 43,144 min, respectively). Time to recovery of T1 to 90% was not different between the groups (108, 63,134 vs 169. 61,208 min, respectively). Conclusions:, Pyridostigmine 0.1 mg·kg,1 effectively reversed a rocuronium-induced NMB in DMD patients. [source] An exploration of Glo-3A antibody levels in children at increased risk for type 1 diabetes mellitusPEDIATRIC DIABETES, Issue 8 2009M Simpson Aims: To determine whether Glo-3A, (formerly referred to as homologue of Glb1 or Glb1) antibodies are associated with islet autoimmunity (IA) in children at increased risk for type 1 diabetes (T1D) and to investigate their relation with environmental correlates of T1D. Methods: We selected a sample from the Diabetes Autoimmunity Study in the Young (DAISY), a prospective study of children at increased risk for T1D. Cases were positive for insulin, glutamic acid decarboxylase (GAD), or insulinoma-associated antigen-2 (IA-2) autoantibodies on two consecutive visits and either diagnosed with diabetes mellitus or still autoantibody positive when selected. Controls were from the same increased risk group, of similar age as the cases but negative for autoantibodies. Sera from 91 IA cases and 82 controls were analyzed in a blinded manner for immunoglobulin G (IgG) antibodies to Glo-3A by ELISA. Results: Adjusting for family history of T1D and human leukocyte antigen (HLA)-DR4 positivity, Glo-3A antibodies were not associated with IA case status (OR: 1.01, 95% CI: 0.99,1.03). Adjusting for age, family history of T1D, and HLA-DR4 positivity, Glo-3A antibody levels were inversely associated with breast-feeding duration (beta = ,0.08, p = 0.001) and directly associated with current intake of foods containing gluten (beta = 0.24, p = 0.007) in IA cases but not in controls. Zonulin, a biomarker of gut permeability, was directly associated with Glo-3A antibody levels in cases (beta = 0.73, p = 0.003) but not in controls. Conclusion: Differing correlates of Glo-3A antibodies in IA cases and controls suggest an underlying difference in mucosal immune response. [source] The Influence of Knowledge of Mammography Findings on the Accuracy of Breast Ultrasound in Symptomatic WomenTHE BREAST JOURNAL, Issue 3 2005FAFPHM, FASBP, Nehmat Houssami MBBS Abstract: Breast ultrasound is generally interpreted with knowledge of the mammographic examination. This study examined the influence of knowledge of mammography findings on the accuracy of ultrasound in women with breast symptoms. Subjects were sampled from all women 25,55 years of age consecutively attending a breast clinic. This included all 240 women shown to have breast cancer and 240 age-matched women shown not to have cancer. Ultrasound films were prospectively reviewed and reported by two radiologists independent of each other and in a blinded manner. A two-phase design was used. In the first phase, the radiologists provided an opinion on the ultrasound films. In the second phase, the ultrasound films were reread with consideration of the corresponding mammographic examination. The accuracy of reading the ultrasound with and without knowledge of the findings on mammography was compared using sensitivity and specificity, and receiver operating characteristics (ROC) curves. Reporting the ultrasound with knowledge of mammography (compared to without mammography) improved sensitivity and reduced specificity for both radiologists. For one reader, sensitivity increased from 77.5% to 86.7% (p = 0.0002) and specificity decreased from 89.7% to 85.4% (p = 0.04). For the other reader, sensitivity increased from 81.3% to 87.5% (p = 0.0023) and specificity decreased from 87.1% to 85.0% (p = 0.27). ROC curves for both radiologists showed that reporting ultrasound with knowledge of mammography resulted in small (about 3%), but significant improvement in the area under the ROC curve. Our study indicates that knowledge of the findings of mammography improves the interpretation of breast ultrasound in symptomatic women., [source] Cardiovascular disease in patients with inflammatory rheumatic disease is associated with up-regulation of markers of inflammation in cardiac microvessels and cardiomyocytesARTHRITIS & RHEUMATISM, Issue 3 2010Cecilia Grundtman Objective Various inflammatory rheumatic diseases (IRDs) are associated with increased mortality due to cardiovascular disease. The aim of this study was to investigate heart biopsy specimens obtained from patients undergoing coronary artery bypass grafting and compare markers of inflammation and endothelial cell activation in the cardiac and skeletal muscle of patients with and those without IRD. Methods Paired biopsy specimens of cardiac and skeletal muscle were obtained from 22 consecutive patients with IRD and 8 patients without IRD, all of whom were undergoing coronary artery bypass grafting. The biopsy specimens were evaluated in a blinded manner by conventional microscopy and digital image analysis for cell markers (CD3, CD4, CD8, CD68, CD163, and CD31), HLA (HLA,ABC, HLA,DR, and HLA,DQ), adhesion molecules (intercellular adhesion molecule 1 and vascular cell adhesion molecule 1), and proinflammatory cytokines (interleukin-1,, interleukin-1,, and tumor necrosis factor). Results Patients with IRD had significantly higher expression of adhesion molecules, proinflammatory cytokines, and all classes of HLA on cardiomyocytes and endothelial cells but no increase on mononuclear cells in the myocardium compared with patients without IRD. Furthermore, cardiac muscle from patients with IRD displayed significantly higher local expression of inflammation and activation of cardiac microvessels compared with skeletal muscle from the same patients. Conclusion Patients with cardiovascular disease had increased expression of adhesion molecules, HLA, and proinflammatory cytokines in heart tissue, indicating local inflammation involving microvessels and cardiomyocytes that could play a role in the pathogenesis of cardiovascular disease. The more pronounced changes in patients with IRD compared with patients without IRD might contribute to the increased risk of cardiovascular disease and premature death in patients with IRD. [source] Evaluation of the diagnostic utility of spinal magnetic resonance imaging in axial spondylarthritisARTHRITIS & RHEUMATISM, Issue 5 2009A. N. Bennett Objective Magnetic resonance imaging (MRI) is increasingly used for the diagnosis of axial spondylarthritis (SpA), but it is unknown whether characteristic lesions are actually specific for SpA. This study was undertaken to compare MRI patterns of disease in active SpA, degenerative arthritis (DA), and malignancy. Methods Fat-suppressed MRI of the axial skeleton was performed on 174 patients with back pain and 11 control subjects. Lesions detected by MRI, including Romanus lesions (RLs) and end-plate, diffuse vertebral body, posterior element, and spinous process bone marrow edema (BME) lesions, were scored in a blinded manner. An imaging diagnosis was given based on MRI findings alone, and this was compared with the gold-standard treating physician's diagnosis. Results The physician diagnosis was SpA in 64 subjects, DA in 45 subjects, malignancy in 45 subjects, other diagnoses in 20 subjects, and normal in 11 subjects. There was 72% agreement between the imaging diagnosis and physician diagnosis. End-plate edema, degenerative discs, and RLs were frequently observed in patients with any of the 3 major diagnoses. Single RLs were of low diagnostic utility for SpA, but ,3 RLs (likelihood ratio [LR] 12.4) and severe RLs (LR infinite) in younger subjects were highly diagnostic of SpA. Posterior element BME lesions of mild or moderate grade were also highly diagnostic of SpA (LR 14.5). The most common diagnostic confusion was between SpA and DA, since both had RLs present and the presence/absence of degenerative discs did not change the diagnostic assessment. Conclusion This study confirms the high diagnostic utility of MRI in axial SpA, with severe or multiple RLs evident on MRI being characteristic in younger patients and mild/moderate posterior element lesions being specific for SpA. However, MRI lesions previously considered to be characteristic of SpA could also be found frequently in patients with DA and patients with malignancy, and therefore such lesions should be interpreted with caution, particularly in older patients. [source] The early disease stage in axial spondylarthritis: Results from the german spondyloarthritis inception cohort,ARTHRITIS & RHEUMATISM, Issue 3 2009Martin Rudwaleit Objective Ankylosing spondylitis (AS) is diagnosed late, because radiographs of the sacroiliac joints often do not show definite sacroiliitis at the time of disease onset. The aim of this study was to investigate whether patients without definite radiographically defined sacroiliitis, referred to as nonradiographic axial spondylarthritis (SpA), are different from patients with AS with regard to clinical manifestations and disease activity measures. Moreover, we sought to identify determinants of the development of radiographic sacroiliitis. Methods In a cross-sectional analysis of 462 patients, we compared 226 patients with nonradiographic axial SpA (symptom duration ,5 years) and 236 patients with AS (symptom duration ,10 years) who are participants in the German Spondyloarthritis Inception Cohort. Radiographs of the sacroiliac joints and the spine were assessed by 2 readers in a blinded manner. Logistic regression analysis was applied to identify parameters associated with structural damage. Results The 2 groups did not differ in the frequency of HLA,B27 positivity, inflammatory back pain, arthritis, enthesitis, and uveitis and had similar levels of disease activity, using measures such as the Bath Ankylosing Spondylitis Disease Activity Index. In both groups, HLA,B27 positivity determined the age at disease onset. Male sex (adjusted odds ratio [OR] 2.38, 95% confidence interval [95% CI] 1.19,4.73 [P = 0.014]) and an elevated C-reactive protein (CRP) level (adjusted OR 1.85, 95% CI 0.96,3.56 [P = 0.066]) were associated with radiographic sacroiliitis. In patients with AS, male sex and an elevated CRP level were also associated with the presence of syndesmophytes. Conclusion Clinical manifestations and disease activity measures are highly comparable between patients with early nonradiographic axial SpA and those with early AS, suggesting that these 2 entities are part of the same disease. Male sex and an elevated CRP level are associated with structural damage on radiographs, whereas HLA,B27 positivity determines the age at disease onset. [source] The influence of patient characteristics, disease variables, and HLA alleles on the development of radiographically evident sacroiliitis in juvenile idiopathic arthritisARTHRITIS & RHEUMATISM, Issue 4 2002Berit Flatø Objective To assess the frequency of sacroiliitis and the radiographic and clinical outcome in juvenile idiopathic arthritis (JIA) and determine patient characteristics, early disease variables, and genetic markers that predict development of sacroiliitis. Methods We performed a retrospective cohort study of 314 (79%) of the 400 JIA patients first admitted to the hospital between 1980 and 1985. The participants were examined after a median disease duration of 14.9 years (range 11.7,25.1). Radiographs of the sacroiliac joints, hips, ankles, and tarsi were obtained and studied in a blinded manner by 2 radiologists. The presence of HLA,DRB1 and DPB1 alleles was determined by genotyping and that of HLA,B27 by serologic testing. Variables relating to the onset and course of the disease were obtained by chart reviews. Results Twenty (6%) of the JIA patients developed radiographic sacroiliitis according to the New York criteria. In 9 patients (45%), sacroiliitis had not been demonstrated before the followup examination. At followup, spinal flexion (lateral and anterior) was reduced in 70,75% of patients with sacroiliitis and in 30,35% of those without sacroiliitis. Compared with the JIA patients without sacroiliitis, those with sacroiliitis more frequently had inflammatory back pain, enthesitis, radiographic changes in the hips and calcanei, erosions of any peripheral joint, and uveitis. Predictors of sacroiliitis were HLA,B27, absence of DPB1*02, hip joint involvement within the first 6 months, and disease onset after age 8 years. The following factors were more common among patients in whom sacroiliitis developed than in other JIA patients: DRB1*04, male sex, family history of ankylosing spondylitis, psoriasis, inflammatory back pain, and enthesitis within the first 6 months. Conclusion In the current study, radiographically evident sacroiliitis had developed in 6% of JIA patients after a median disease duration of 14.9 years. HLA,B27, absence of DPB1*02, late onset of disease, and early hip involvement were predictors of sacroiliitis. [source] Effect of millimeter waves on natural killer cell activationBIOELECTROMAGNETICS, Issue 1 2005V.R. Makar Abstract Millimeter wave therapy (MMWT) is being widely used for the treatment of many diseases in Russia and other East European countries. MMWT has been reported to reduce the toxic effects of chemotherapy on the immune system. The present study was undertaken to investigate whether millimeter waves (MMWs) can modulate the effect of cyclophosphamide (CPA), an anticancer drug, on natural killer (NK) cell activity. NK cells play an important role in the antitumor response. MMWs were produced with a Russian-made YAV-1 generator. The device produced modulated 42.2,±,0.2 GHz radiation through a 10,×,20 mm rectangular output horn. Mice, restrained in plastic tubes, were irradiated on the nasal area. Peak SAR at the skin surface and peak incident power density were measured as 622,±,100 W/kg and 31,±,5 mW/cm2, respectively. The maximum temperature elevation, measured at the end of 30 min, was 1 °C. The animals, restrained in plastic tubes, were irradiated on the nasal area. CPA injection (100 mg/kg) was given intraperitoneally on the second day of 3-days exposure to MMWs. All the irradiation procedures were performed in a blinded manner. NK cell activation and cytotoxicity were measured after 2, 5, and 7 days following CPA injection. Flow cytometry of NK cells showed that CPA treatment caused a marked enhancement in NK cell activation. The level of CD69 expression, which represents a functional triggering molecule on activated NK cells, was increased in the CPA group at all the time points tested as compared to untreated mice. However, the most enhancement in CD69 expression was observed on day 7. A significant increase in TNF-, level was also observed on day 7 following CPA administration. On the other hand, CPA caused a suppression of the cytolytic activity of NK cells. MMW irradiation of the CPA treated groups resulted in further enhancement of CD69 expression on NK cells, as well as in production of TNF-,. Furthermore, MMW irradiation restored CPA induced suppression of the cytolytic activity of NK cells. Our results show that MMW irradiation at 42.2 GHz can up-regulate NK cell functions. Bioelectromagnetics 26:10,19, 2005. © 2004 Wiley-Liss, Inc. [source] Reproducibility of coronary lumen, plaque, and vessel wall reconstruction and of endothelial shear stress measurements in vivo in humansCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2003Ahmet U. Coskun PhD Abstract The purpose of this study was to assess the reproducibility of an in vivo methodology to reconstruct the lumen, plaque, and external elastic membrane (EEM) of coronary arteries and estimate endothelial shear stress (ESS). Ten coronary arteries without significant stenoses (five native and five stented arteries) were investigated. The 3D lumen and EEM boundaries of each coronary artery were determined by fusing end-diastolic intravascular ultrasound images with biplane coronary angiograms. Coronary flow was measured. Computational fluid dynamics was used to calculate local ESS. Complete data acquisition was then repeated. Analysis was performed on each data set in a blinded manner. The intertest correlation coefficients for all arteries for the two measurements of lumen radius, EEM radius, plaque thickness, and ESS were r = 0.96, 0.96, 0.94, 0.91, respectively (all P values < 0.0001). The 3D anatomy and ESS of human coronary arteries can be reproducibly estimated in vivo. This methodology provides a tool to examine the effect of ESS on atherogenesis, remodeling, and restenosis; the contribution of arterial remodeling and plaque growth to changes in the lumen; and the impact of new therapies. Catheter Cardiovasc Interv 2003;60:67,78. © 2003 Wiley,Liss, Inc. [source] | ||||||||||