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Relevant Differences (relevant + difference)
Selected AbstractsThe Unified Parkinson's Disease Rating Scale (UPDRS): Status and recommendationsMOVEMENT DISORDERS, Issue 7 2003Article first published online: 18 MAR 200 Abstract The Movement Disorder Society Task Force for Rating Scales for Parkinson's Disease prepared a critique of the Unified Parkinson's Disease Rating Scale (UPDRS). Strengths of the UPDRS include its wide utilization, its application across the clinical spectrum of PD, its nearly comprehensive coverage of motor symptoms, and its clinimetric properties, including reliability and validity. Weaknesses include several ambiguities in the written text, inadequate instructions for raters, some metric flaws, and the absence of screening questions on several important non-motor aspects of PD. The Task Force recommends that the MDS sponsor the development of a new version of the UPDRS and encourage efforts to establish its clinimetric properties, especially addressing the need to define a Minimal Clinically Relevant Difference and a Minimal Clinically Relevant Incremental Difference, as well as testing its correlation with the current UPDRS. If developed, the new scale should be culturally unbiased and be tested in different racial, gender, and age-groups. Future goals should include the definition of UPDRS scores with confidence intervals that correlate with clinically pertinent designations, "minimal," "mild," "moderate," and "severe" PD. Whereas the presence of non-motor components of PD can be identified with screening questions, a new version of the UPDRS should include an official appendix that includes other, more detailed, and optionally used scales to determine severity of these impairments. © 2003 Movement Disorder Society [source] Changes of the hepatic proteome in murine models for toxically induced fibrogenesis and sclerosing cholangitisPROTEINS: STRUCTURE, FUNCTION AND BIOINFORMATICS, Issue 24 2006Corinna Henkel Abstract We investigated the changes in the hepatic proteome in murine models for toxic-induced fibrogenesis and sclerosing cholangitis. A comprehensive comparison of protein changes observed is made and the mechanistical basis of the expression changes is discussed. Hepatic fibrosis was induced by repetitive intraperitoneal CCl4 treatment of BALB/c mice or developed spontaneously in BALB/c-ATP-binding cassette, subfamily B, member 4 (Abcb4) knock out mice. Fibrosis was verified by a morphometric score and assessment of hydroxyproline content of liver tissue, respectively. The innovative difference in-gel electrophoresis (DIGE) technique was used to analyse protein expression levels of the mouse proteome. Results were confirmed by Western blotting and real-time RT-PCR. In CCl4 -induced fibrosis 20 out of 40 and in BALB/c- Abcb4,/, mice 8 out of 28 differentially expressed proteins were identified utilizing DIGE. Only two proteins, selenium-binding protein (Sbp2) and carbonic anhydrase 3, have been unidirectionally expressed (i.e. down-regulated) in both models. Relevant differences in the pathogenesis of toxically induced liver fibrosis and sclerosing cholangitis exist. The only novel protein with regard to liver fibrosis depicting a unidirectional expression pattern in both animal models was Sbp2. An explicit protein function could not be clarified yet. [source] A comparison of severely injured trauma patients admitted to level 1 trauma centres in Queensland and GermanyANZ JOURNAL OF SURGERY, Issue 3 2010Johanna M. M. Nijboer Abstract Background:, The allocation of a trauma network in Queensland is still in the developmental phase. In a search for indicators to improve trauma care both locally as state-wide, a study was carried out comparing trauma patients in Queensland to trauma patients in Germany, a country with 82.4 million inhabitants and a well-established trauma system. Methods:, Trauma patients ,15 years of age, with an Injury Severity Score (ISS) , 16 admitted to the Princess Alexandra Hospital (PAH) and to the 59 German hospitals participating in the Trauma Registry of the German Society for Trauma Surgery (DGU-G) during the year 2005 were retrospectively identified and analysed. Results:, Both cohorts are comparable when it comes to demographics and injury mechanism, but differ significantly in other important aspects. Striking is the low number of primary admitted patients in the PAH cohort: 58% versus 83% in the DGU-G cohort. PAH patients were less physiologically deranged and less severely injured: ISS 25.2 ± 9.9 versus 29.9 ± 13.1 (P < 0.001). Subsequently, they less often needed surgery (61% versus 79%), ICU admission (49% versus 92%) and had a lower mortality: 9.8% versus 17.9% of the DGU-G cohort. Conclusions:, Relevant differences were the low number of primary admissions, the lesser severity of injuries, and the low mortality of the patients treated at the PAH. These differences are likely to be interrelated and Queensland's size and suboptimal organization of trauma care may have played an important role. [source] HARMONIZING REGULATIONS FOR BIOMEDICAL RESEARCH: A CRITICAL ANALYSIS OF THE US AND VENEZUELAN SYSTEMSDEVELOPING WORLD BIOETHICS, Issue 3 2008DANNIE DI TILLIO-GONZALEZ ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze , as an example , the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. [source] EXPLORING DISPARITIES BETWEEN GLOBAL HIV/AIDS FUNDING AND RECENT TSUNAMI RELIEF EFFORTS: AN ETHICAL ANALYSISDEVELOPING WORLD BIOETHICS, Issue 1 2007TIMOTHY CHRISTIE ABSTRACT Objective:, To contrast relief efforts for the 26 December 2004 tsunami with current global HIV/AIDS relief efforts and analyse possible reasons for the disparity. Methods:, Literature review and ethical analysis. Results:, Just over 273,000 people died in the tsunami, resulting in relief efforts of more than US$10 bn, which is sufficient to achieve the United Nation's long-term recovery plan for South East Asia. In contrast, 14 times more people died from HIV/AIDS in 2004, with UNAIDS predicting a US$8 bn funding gap for HIV/AIDS in developing nations between now and 2007. This disparity raises two important ethical questions. First, what is it that motivates a more empathic response to the victims of the tsunami than to those affected by HIV/AIDS? Second, is there a morally relevant difference between the two tragedies that justifies the difference in the international response? The principle of justice requires that two cases similarly situated be treated similarly. For the difference in the international response to the tsunami and HIV/AIDS to be justified, the tragedies have to be shown to be dissimilar in some relevant respect. Are the tragedies of the tsunami disaster and the HIV/AIDS pandemic sufficiently different, in relevant respects, to justify the difference in scope of the response by the international community? Conclusion:, We detected no morally relevant distinction between the tsunami and the HIV/AIDS pandemic that justifies the disparity. Therefore, we must conclude that the international response to HIV/AIDS violates the fundamental principles of justice and fairness. [source] A comparison between two-dimensional and three-dimensional cephalometry on frontal radiographs and on cone beam computed tomography scans of human skullsEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 3 2009Olivier J. C. Van Vlijmen The aim of this study was to evaluate whether measurements performed on conventional frontal radiographs are comparable to measurements performed on three-dimensional (3D) models of human skulls derived from cone beam computed tomography (CBCT) scans and if the latter can be used in longitudinal studies. Cone beam computed tomography scans and conventional frontal cephalometric radiographs were made of 40 dry human skulls. From the CBCT scan a 3D model was constructed. Standard cephalometric software was used to identify landmarks and to calculate ratios and angles. The same operator identified 10 landmarks on both types of cephalometric radiographs, and on all images, five times with a time interval of 1 wk. Intra-observer reliability was acceptable for all measurements. There was a statistically significant and clinically relevant difference between measurements performed on conventional frontal radiographs and on 3D CBCT-derived models of the same skull. There was a clinically relevant difference between angular measurements performed on conventional frontal cephalometric radiographs, compared with measurements performed on 3D models constructed from CBCT scans. We therefore recommend that 3D models should not be used for longitudinal research in cases where there are only two-dimensional (2D) records from the past. [source] Defining a minimal clinically relevant difference for the unified Parkinson's rating scale: An important but still unmet needMOVEMENT DISORDERS, Issue 8 2006Olivier Rascol MD [source] Ambiguous Figures and the Content of ExperienceNOUS, Issue 1 2006Fiona Macpherson Representationalism is the position that the phenomenal character of an experience is either identical with, or supervenes on, the content of that experience. Many representationalists hold that the relevant content of experience is nonconceptual. I propose a counter-example to this form of representationalism that arises from the phenomenon of Gestalt switching, which occurs when viewing ambiguous figures. First, I argue that one does not need to appeal to the conceptual content of experience or to judgements to account for Gestalt switching. I then argue that experiences of certain ambiguous figures are problematic because they have different phenomenal characters but that no difference in the nonconceptual content of these experiences can be identified. I consider three solutions to this problem that have been proposed by both philosophers and psychologists and conclude that none can account for all the ambiguous figures that pose the problem. I conclude that the onus is on representationalists to specify the relevant difference in content or to abandon their position. [source] Impact of Perioperative Systemic Steroids on Surgical Outcomes in Patients With Chronic Rhinosinusitis With Polyposis: Evaluation With the Novel Perioperative Sinus Endoscopy (POSE) Scoring System,THE LARYNGOSCOPE, Issue S115 2007Erin D. Wright MDCM Abstract Objectives/Hypothesis: The objective of this randomized, double-blind, placebo-controlled study was to assess the effect of perioperative systemic steroids on subjective and objective surgical outcomes for patients undergoing endoscopic sinus surgery (ESS) for chronic rhinosinusitis with polyposis (CRSwP). The secondary objective was to begin validation of the newly developed Perioperative Sinus Endoscopy (POSE) scoring system. Methods: Patients who had failed maximal medical therapy and were scheduled to undergo ESS were eligible for the study. Participants were randomized to receive either 30 mg of prednisone or placebo for 5 days preoperatively and 9 days postoperatively. Operative and baseline clinical data were collected using the Lund-McKay staging system including its Sinus Symptom Questionnaire as well as additional data regarding mucosal health, the technical difficulty of surgery, and endoscopic data using the Lund-Kennedy Endoscopic Score (LKES) and POSE scale. Data were also collected at 2 weeks, 1 month, 3 months, and 6 months postoperatively. A sample size of 24 was calculated to detect a clinically relevant difference between groups of 40%. Routine statistical comparisons were performed as were repeated measures analysis of variance with Bonferroni adjustment because of the multiple comparisons performed. To address the secondary objective, data were also collected at all postoperative time points using the POSE instrument, which was designed with the intention of enhancing face validity and responsiveness to change. Comparisons were performed between the POSE and LKES, including assessment of sensitivity to change, correlation between the two scales, and correlation with symptom scores. Results: Twenty-six patients participated in the study. Operative data demonstrated a significantly higher percentage of severely inflamed sinonasal mucosa in patients not pretreated with systemic steroids, which was associated with technically more difficult surgery in the estimation of the operating surgeon. In terms of postoperative symptoms, there was no difference between treatment groups, with both placebo and prednisone significantly improved over baseline up to 4 weeks postoperatively. Endoscopic assessment of patients postoperatively demonstrated a treatment effect (P < .05), with clinically healthier cavities seen in patients treated with prednisone up to 6 months postoperatively as compared with baseline (P < .001), although the strongest effect was seen at the 2-week time point. In comparing the two endoscopic scales, the POSE and LKES correlated highly (R > 0.70; P < .001) both in terms of absolute score and change in score. There is some evidence that the POSE score may be more sensitive to change than the LKES, and the POSE scores did correlate more strongly with symptom scores than the LKES, although both endoscopic scores correlated only weakly with symptom scores. Conclusions: The data presented in this study support the practice of administering preoperative systemic steroids to patients undergoing ESS for CRSwP. Furthermore, in the practice of surgeons who provide intensive postoperative care post-ESS, including debridement and medical therapy based on the endoscopic findings, there is evidence to support administering systemic steroids in the postoperative period. The POSE scoring system compares favorably with the LKES and may confer advantages in terms of face/content validity and responsiveness to change and is worthy of further validation. [source] ALTERNATE NUCLEAR TRANSFER IS NO ALTERNATIVE FOR EMBRYONIC STEM CELL RESEARCHBIOETHICS, Issue 2 2008JOHN A. FENNEL ABSTRACT Recent developments allow for the creation of human stem cells without the creation of human embryos, a process called alternate nuclear transfer (,ANT'). Pursuing this method of stem cell research makes sense for pro-lifers if arguments for the sanctity of the human embryo do not apply to ANT. However, the technology that makes ANT possible undermines the erstwhile technical barrier between human embryos and somatic cell DNA. These advances bring home the force of hypothetical arguments about the potential of the DNA in somatic cells, showing that there is not a morally relevant difference between the potential of an embryo and the potential of the DNA in a somatic cell. Therefore, the supposed distinction between entities that are potential human life and entities that are human life does not give any support to arguments for the sanctity of the human embryo because those arguments extend value to too many entities. [source] Establishing Efficacy of a New Experimental Treatment in the ,Gold Standard' DesignBIOMETRICAL JOURNAL, Issue 6 2005Dieter Hauschke Abstract Provided that there are no ethical concerns, the comparison of an active drug with placebo in a randomized two-arm clinical trial provides the most convincing way to demonstrate the efficacy of a new experimental treatment. However, in a placebo-controlled clinical trial it is not sufficient to demonstrate merely a statistically significant treatment difference. Regulatory authorities strongly recommend to assess additionally whether the observed treatment difference is also of clinical relevance. The inherent issue is the necessity of the a priori definition of what constitutes a clinically relevant difference in efficacy. This problem can be solved in a three-arm study by including an active control group. We address the necessary conditions in the gold standard design which allow the claim of efficacy for the new treatment with particular focus on assay sensitivity. (© 2005 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first-line therapy in advanced nonsmall cell lung cancerCANCER, Issue 4 2007Se Hoon Park MD Abstract BACKGROUND. There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall-cell lung cancer (NSCLC). METHODS. Consenting patients with advanced NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m2 on Day 1, plus 3-weekly (75 mg/m2 on Day 1) or weekly (35 mg/m2 on Days 1, 8, and 15 of a 4-week cycle) docetaxel, for up to 6 cycles. RESULTS. Of 86 patients accrued, 41 patients were treated with 3-weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3-weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3-weekly and 39% with the weekly arm (P = .74). The median progression-free survival was 4.3 months in the 3-weekly arm and 3.9 months in the weekly arm (P = .08) and the median survival was 10.3 and 10.0 months, respectively (P = .76). Quality of life data showed no relevant difference between the arms. CONCLUSIONS. The weekly schedule of docetaxel plus cisplatin combination as first-line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3-weekly regimen. Cancer 2007. © 2007 American Cancer Society. [source] TNF-, and intPLA2 genes' polymorphism in anorexia nervosaACTA NEUROPSYCHIATRICA, Issue 6 2004Agnieszka Slopien Objective:, The aim of this study was the assessment of ,308G/A tumor necrosis factor (TNF)- , gene polymorphism and intPLA2 gene polymorphism in patients with anorexia nervosa (AN) and healthy controls. Subjects:, We studied 91 non-related patients with AN and 144 healthy women (blood donors and students). The mean age of women from study group was 18.22 years (SD ± 3.13 years) and from control group was 31.71 years (SD ± 8.22). Methods:, ,Gene polymorphisms were studied with the use of polymerase chain reaction-restriction fragment length polymorphism method. TNF-, gene polymorphism consists of G/A substitution in ,308 promoter region. IntPLA2 gene polymorphism is related to intron 1, in which restrictive region is found and recognized by BanI enzyme. Results:, We did not obtain statistically significant differences in the frequency of genotypes and alleles of ,308G/A TNF-, polymorphism between the study and control groups (genotypes: P = 0.106, alleles: P = 0.076). We did analogous analysis in the restrictive and bulimic subgroups. We did not observe statistically relevant differences in the frequency of genotypes (P = 0.700) and alleles (P = 0.305). We did not obtain statistically relevant difference in the frequency of genotypes and alleles of intPLA2 gene between the study group and controls (genotypes: P = 0.300, alleles: P = 0.331). We did analogous analysis in both subgroups of AN. We did not observe statistically relevant differences in the frequency of genotypes (P = 0.344) and alleles (P = 0.230). Conclusions:, There was no statistically relevant trend for the association between TNF-, polymorphism and AN. We did not find association between studied polymorphism of intPLA2 gene and risk of AN. [source] Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups,DIABETES OBESITY & METABOLISM, Issue 5 2006M. Hompesch Aim:, To evaluate the time-action profiles and the dose,response relationship of the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH) in type 2 diabetic patients belonging to different ethnic groups. Methods:, Forty-eight type 2 diabetic patients belonging to different ethnic groups (three groups of 16 African Americans (AA), 16 Hispanics/Latinos (HL) and 16 Caucasians) participated in this double-blind crossover trial. Each patient took part in six 16-h isoglycaemic glucose clamps (clamp target 7.2 mmol/l) and was randomly allocated to three doses (0.3, 0.6 and 1.2 (I)U/kg) of IDet and NPH, respectively. Results:, IDet and NPH showed comparable pharmacodynamic effects [the area under the glucose infusion rate curve (AUCGIR 0-16 h) (mg/kg)] in the investigated dose range: IDet, 0.3 U/kg, 207 AA, 535 HL, 285 Caucasians; 0.6 U/kg, 1203 AA, 824 HL and 1126 Caucasians; 1.2 U/kg, 1502 AA, 1977 HL and 2269 Caucasians; NPH, 0.3 IU/kg, 733 AA, 1148 HL and 1148 Caucasians; 0.6 IU/kg, 1395 AA, 1976 HL and 1077 Caucasians; 1.2 IU/kg, 2452 AA, 3296 HL and 2455 Caucasians. Both IDet and NPH showed a linear dose,response relationship in all three groups (p = 0.31), without any significant differences in slope (p = 0.71) or intercept (p = 0.51). Comparable results were obtained for pharmacokinetics. Conclusions:, These results confirm a linear dose,response relationship of IDet, without any relevant differences between ethnic groups. This suggests that similar dosing recommendation can be used for IDet in type 2 diabetic patients belonging to different ethnic group. [source] Ginkgo biloba and donepezil: a comparison in the treatment of Alzheimer's dementia in a randomized placebo-controlled double-blind studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 9 2006M. Mazza The Ginkgo biloba special extract EGb 761 seems to produce neuroprotective effects in neurodegenerative diseases of multifactorial origin. There is still debate about the efficacy of Ginkgo biloba special extract EGb 761 compared with second-generation cholinesterase inhibitors in the treatment of mild to moderate Alzheimer's dementia. Our aim is to assess the efficacy of the Ginkgo biloba special extract E.S. in patients with dementia of the Alzheimer type in slowing down the disease's degenerative progression and the patients' cognitive impairment compared with donepezil and placebo. The trial was designed as a 24-week randomized, placebo-controlled, double-blind study. Patients aged 50,80 years, suffering from mild to moderate dementia, were allocated into one of the three treatments: Ginkgo biloba (160 mg daily dose), donepezil (5 mg daily dose), or placebo group. The degree of severity of dementia was assessed by the Syndrom Kurz test and the Mini-Mental State Examination. Clinical Global Impression score was recorded to assess the change in the patients' conditions and the therapeutic efficacy of tested medications. Our results confirm the clinical efficacy of Ginkgo biloba E.S. (Flavogin) in the dementia of the Alzheimer type, comparable with donepezil clinical efficacy. There are few published trials that have directly compared a cholinesterase inhibitor with Ginkgo for dementia. This study directly compares a cholinesterase inhibitor with Ginkgo biloba for dementia of the Alzheimer type and could be a valid contribution in this debate. Our study suggests that there is no evidence of relevant differences in the efficacy of EGb 761 and donepezil in the treatment of mild to moderate Alzheimer's dementia, so the use of both substances can be justified. In addition, this study contributes to establish the efficacy and tolerability of the Ginkgo biloba special extract E.S. in the dementia of the Alzheimer type with special respect to moderately severe stages. [source] Differences in personality characteristics between body-modified and non-modified individuals: associations with individual personality traits and their possible evolutionary implicationsEUROPEAN JOURNAL OF PERSONALITY, Issue 7 2007Silke Wohlrab Abstract After a long history of negative stigmatisation, the practices of tattooing and body piercing have become fashionable in the last decade. Today, 10% of the population in modern western societies have some form of body modification. The aim of this study was to quantify the demographic and personality traits of tattooed and pierced individuals and to compare them with a control group of individuals without body modifications. These comparisons are based on questionnaires completed by 359 individuals that investigate the details of body modification, and which incorporate five personality scales. We describe several sex differences in ornament style and location. We found no relevant differences between modified and non-modified individuals in relation to demographic variables. This indicates that some of the traditional attitudes towards tattoos and piercings appear to be outdated. However, we found striking differences in personality traits which suggest that body-modified individuals are greater sensation seekers and follow a more unrestricted mating strategy than their non-modified contemporaries. We discuss these differences in light of a potential signalling function of tattoos and piercings in the mating context. Copyright © 2007 John Wiley & Sons, Ltd. [source] RESURRECTING THE ROLE OF TRANSCRIPTION FACTOR CHANGE IN DEVELOPMENTAL EVOLUTIONEVOLUTION, Issue 9 2008Vincent J. Lynch A long-standing question in evolutionary and developmental biology concerns the relative contribution of cis- regulatory and protein changes to developmental evolution. Central to this argument is which mutations generate evolutionarily relevant phenotypic variation? A review of the growing body of evolutionary and developmental literature supports the notion that many developmentally relevant differences occur in the cis -regulatory regions of protein-coding genes, generally to the exclusion of changes in the protein-coding region of genes. However, accumulating experimental evidence demonstrates that many of the arguments against a role for proteins in the evolution of gene regulation, and the developmental evolution in general, are no longer supported and there is an increasing number of cases in which transcription factor protein changes have been demonstrated in evolution. Here, we review the evidence that cis- regulatory evolution is an important driver of phenotypic evolution and provide examples of protein-mediated developmental evolution. Finally, we present an argument that the evolution of proteins may play a more substantial, but thus far underestimated, role in developmental evolution. [source] Tolerance to challenges miming gastrointestinal transit by spores and vegetative cells of Bacillus clausiiJOURNAL OF APPLIED MICROBIOLOGY, Issue 6 2006G. Cenci Abstract Aims:, To study Bacillus clausii from a pharmaceutical product (Enterogermina O/C, N/R, SIN, T) and reference strains (B. clausii and Bacillus subtilis) for eco-physiological aspects regarding the gut environment. Methods and Results:, Spores and vegetative cells were challenged in vitro miming the injury of gastrointestinal transit: pH variations, exposure to conjugated and free bile salts, microaerophilic and anaerobic growth. No relevant differences were found studying the growth at pH 8 and 10, whereas at pH 7 the yields obtained for O/C and SIN were higher than those obtained for N/R and T strains. The spores were able to germinate and grow in the presence of conjugated bile salts (up to 1%, w/v) or free bile salts (0·2%) and also exhibited tolerance for the combined acid-bile challenge. As evidenced by lag-time, growth rate and cell yield the tolerance of Enterogermina isolates for conjugated salts was comparable with that of B. clausii type strain (DSM 8716T), and resulted higher than that observed for B. subtilis (ATCC 6051T). All the considered B. clausii strains demonstrated microaerophilic growth, but only some grew anaerobically in a nitrate medium. Conclusions:, The ability of B. clausii spores to germinate after an acid challenge and grow as vegetative cells both in the presence of bile and under limited oxygen availability is consistent with the beneficial health effects evidenced for spore-forming probiotics in recent clinical studies. Significance and Impact of the Study:, The experimental evidence from this study emphasizes some functional properties of B. clausii strains regarding their use as probiotics. [source] Expression of phospholipase C beta family isoenzymes in C2C12 myoblasts during terminal differentiation,JOURNAL OF CELLULAR PHYSIOLOGY, Issue 2 2004Irene Faenza In the present work, we have analyzed the expression and subcellular localization of all the members of inositide-specific phospholipase C (PLC,) family in muscle differentiation, given that nuclear PLC,1 has been shown to be related to the differentiative process. Cell cultures of C2C12 myoblasts were induced to differentiate towards the phenotype of myotubes, which are also indicated as differentiated C2C12 cells. By means of immunochemical and immunocytochemical analysis, the expression and subcellular localization of PLC,1, ,2, ,3, ,4 have been assessed. As further characterization, we investigated the localization of PLC, isoenzymes in C2C12 cells by fusing their cDNA to enhanced green fluorescent protein (GFP). In myoblast culture, PLC,4 was the most expressed isoform in the cytoplasm, whereas PLC,1 and ,3 exhibited a lesser expression in this cell compartment. In nuclei of differentiated myotube culture, PLC,1 isoform was expressed at the highest extent. A marked decrease of PLC,4 expression in the cytoplasm of differentiated C2C12 cells was detected as compared to myoblasts. No relevant differences were evidenced as regards the expression of PLC,3 at both cytoplasmatic and nuclear level, whilst PLC,2 expression was almost undetactable. Therefore, we propose that the different subcellular expression of these PLC isoforms, namely the increase of nuclear PLC,1 and the decrease of cytoplasmatic PLC,4, during the establishment of myotube differentiation, is related to a spatial-temporal signaling event, involved in myogenic differentiation. Once again the subcellular localization appears to be a key step for the diverse signaling activity of PLC,s. © 2004 Wiley-Liss, Inc. [source] Regenerative periodontal surgery in interproximal intrabony defects with biodegradable barriersJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 3 2000Christof E. Dörfer Abstract Aim: The comparison of the effects of guided-tissue regeneration (GTR) using 2 different biodegradable barriers (polylactide acetyltributyl citrate; polydioxanon) in 3- and 2-wall intrabony defects. Method: The polydioxanon barrier is an experimental membrane for GTR therapy that consists of an continuous occlusive barrier that has a layer of slings on the side that is meant to face the mucoperiosteal flap. 15 patients provided 15 pairs of similar contralateral periodontal defects: 12 predominantly 2-wall and 18 predominantly 3-wall intrabony defects. Each defect was randomly assigned to treatment with either polylactide acetyltributyl citrate (control [c]) or polydioxanon (test [t]) devices. At baseline and 6 months after surgery, clinical measurements (PlI, GI, PPD, PAL-V) were performed. Results: Barrier exposure was commonly observed in both groups (control/test): 5/4 after 7 days, 9/11 after 14 days and 11/12 after 28 days postsurgically. 4 weeks after surgery, 77% of all barriers were exposed to some extent. However, both treatments revealed a significant GI reduction (p<0.05), PPD reduction [,4.63±1.85 mm (t), ,4.17±1.89 mm (c); p<0.001] and PAL-V gain [3.97±1.17 mm (t), 3.40 mm±1.40 (c); p<0.001] 6 months after surgery. Regarding GI and PPD reduction as well as PAL-V gain, there were neither statistically significant nor clinically relevant differences between test and control: similar clinical results were found 6 months after surgical treatment using both biodegradable barriers. Conclusions: Based on the results of the present study, the use of both biodegradable barriers in GTR therapy may be recommended. [source] Community-acquired febrile urinary tract infection in diabetics could deserve a different management: a case,control studyJOURNAL OF INTERNAL MEDICINE, Issue 3 2003J. P. Horcajada Abstract., Horcajada JP, Moreno I, Velasco M, Martínez JA, Moreno-Martínez A, Barranco M, Vila J, Mensa J (Hospital Clínic Universitari-IDIBAPS, Barcelona, Spain) Community-acquired febrile urinary tract infection in diabetics could deserve a different management: a case,control study. J Intern Med 2003; 254: 280,286. Objective., To investigate if there are relevant differences in clinical, microbiological and outcome characteristics of community-acquired febrile urinary tract infection (UTI) between diabetic and nondiabetic patients. Design., A prospectively matched case,control study. Setting., An 800-bed tertiary care university-affiliated hospital. Subjects., A total of 108 patients (54 diabetic and 54 nondiabetic patients matched by age and gender) admitted between January 1996 and September 1999 with febrile UTI. Methods., Clinical, analytical, microbiological and outcome variables were analysed by means of McNemar test (categorical) or Wilcoxon matched pairs signed rank test (continuous). Results., Mean age (SD) in both groups was 67.9 (14.4) years. In comparison with controls, diabetic patients were more likely to have fever without localizing symptoms (27% vs. 9%, P , 0.0001), diminished consciousness level at admission (25% vs. 10%, P = 0.03), aetiological microorganism different from Escherichia coli (17% vs. 0, P = 0.0004), and quinolone-resistant bacteria (17% vs. 3.7%, P = 0.07). Duration of fever after the onset of treatment was 1.75 (1) days in diabetics and 1.5 (1.1) days in nondiabetics (P = 0.17). However, diabetic patients had a longer hospitalization [5.2 (3.3) days] than nondiabetics [3.9 (2.6) days, P = 0.006]. Conclusions., In diabetic patients, febrile UTIs have clinical and microbiological peculiarities that may have diagnostic and therapeutic implications. [source] Local staging of rectal carcinoma and assessment of the circumferential resection margin with high-resolution MRI using an integrated parallel acquisition techniqueJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 1 2005Katja Oberholzer MD Abstract Purpose To assess the diagnostic accuracy of integrated parallel acquisition technique (iPAT) in local staging of rectal carcinoma in comparison to conventional high-resolution MRI. Materials and Methods A total of 28 patients with a neoplasm of the rectum and 15 control patients underwent MRI of the pelvis. High-resolution images were acquired conventionally and with iPAT using a modified sensitivity encoding (mSENSE). Image quality, signal-to-noise and contrast-to-noise ratios (SNR, CNR), tumor extent, nodal status, and delineation of the circumferential resection margin (CRM) were compared. In 19 patients with a carcinoma, MR findings were correlated with the histopathological diagnosis. Tumor distance to the CRM was matched with resection specimen in 12 cases. Results The comparison of both MR techniques revealed no clinically relevant differences in tumor staging and delineation of the CRM, though SNR and CNR were significantly lower in mSENSE images. Tumor stage was concordant in 17 of 19 cases compared to histopathology. In four of nine patients with T3 and T4 carcinomas, the histopathological resection margin was ,2 mm, in five cases MRI predicted a margin of ,2 mm. Conclusion The application of iPAT in local staging of rectal carcinoma is time-saving and does not degrade diagnostic accuracy. Tumor stage, nodal status, and the CRM can be assessed equally compared to conventional acquisition techniques. J. Magn. Reson. Imaging 2005;22:101,108. © 2005 Wiley-Liss, Inc. [source] Biological Markers of Alcohol Consumption in Nondrinkers, Drinkers, and Alcohol-Dependent Brazilian PatientsALCOHOLISM, Issue 7 2002N. B. Figlie Background The purpose of this study was to compare the sensitivity and specificity of some new and traditional biological markers and indicators of health among Brazilian nondrinkers, drinkers, and alcohol-dependent patients. Material and Methods We evaluated 130 nondrinkers, 167 drinkers, and 183 alcohol-dependent drinkers from Brazil who participated in the WHO/ISBRA Study on State and Trait Markers of Alcohol Use and Dependence. A standardized WHO/ISBRA Interview Schedule provided background information on the subjects' characteristics including reported health problems and alcohol consumption. Blood samples were analyzed for aspartate aminotransferase (AST), carbohydrate deficient transferrin (CDT), ,-glutamyltransferase (GGT), blood alcohol levels (BAL), and platelet adenylate cyclase activity (basal levels [AC] and levels after stimulation with Gpp(NH)p, cesium fluoride, and forskolin). Results The alcohol-dependent drinkers presented higher levels of AST, GGT, AC, CDT, and BAL than the nondrinkers and drinkers, whose levels were similar. Sex differences in the sensitivity of CDT and AC were found. The alcohol-dependent women presented a lower prevalence of abnormal values of CDT and Gpp(NH)p-stimulated AC than the alcohol-dependent men, despite the fact that they presented similar alcohol consumption levels. The alcohol-dependent drinkers presented a higher prevalence of clinical disorders than the nondrinkers and drinkers. The drinkers and alcohol-dependent patients presented significantly higher rates of gastritis than the nondrinkers. Conclusions Sex differences in the sensitivity of CDT and AC suggest that these markers are not as sensitive at detecting excessive alcohol use in women as they are in men. If data from this Brazilian sample are compared with those reported for international samples, relevant differences are detected, which suggests that genetic and cultural differences should be considered in the selection of biological markers of heavy alcohol consumption. [source] Duloxetine compared with placebo for treating women with symptoms of overactive bladderBJU INTERNATIONAL, Issue 2 2007William D. Steers OBJECTIVE To evaluate duloxetine (a serotonin-noradrenaline reuptake inhibitor) in women with symptoms of overactive bladder (OAB), as it has been shown to increase the bladder capacity in an animal model. PATIENTS AND METHODS In all, 306 women (aged 21,84 years) were recruited and randomly assigned to placebo (153) or duloxetine (80-mg/day for 4 weeks increased to 120-mg/day for 8 weeks; 153). Symptoms of OAB were defined as bothersome urinary urgency and/or urge urinary incontinence (UI) for ,3 months. Participants were also required to have a mean daytime voiding interval (VI) of ,2 h and urodynamic observations of either detrusor overactivity (DOA) or urgency which limited bladder capacity to <400 mL, both with no stress UI (SUI). The primary efficacy analysis compared the treatment effects on mean change from baseline to endpoint in the mean number of voiding episodes (VE)/24 h. The secondary efficacy analyses compared the treatment effects on the number of UI episodes (IE)/24 h, in the Incontinence Quality of Life questionnaire (I-QOL) score, and on the mean daytime VI. Safety was assessed with vital signs, adverse event reporting, routine laboratory testing, electrocardiogram, and the measurement of postvoid residual urine volumes (PVR). RESULTS Patients randomized to duloxetine had significant improvements over those randomized to placebo for decreases in VE and IE, for increases in the daytime VI, and for improvements in I-QOL scores at both doses of duloxetine. Urodynamic studies showed no significant increases in maximum cystometric capacity or in the volume threshold for DOA. The most common treatment-emergent adverse events with duloxetine (nausea, 31%; dry mouth, 16%; dizziness, 14%; constipation, 14%; insomnia, 13%; and fatigue, 11%) were the same as those reported by women with SUI and were significantly more common with duloxetine than placebo. Laboratory assessments, vital signs and electrocardiograms were stable relative to baseline, with no relevant differences detected between groups. There was a significant difference in the change in PVR with duloxetine (<5 mL mean increase) but no patient reported hesitancy or retention. CONCLUSION In this trial, duloxetine was better than placebo for treating women with ,wet' and ,dry' symptoms of OAB associated with DOA or a bladder capacity of <400 mL. [source] TNF-, and intPLA2 genes' polymorphism in anorexia nervosaACTA NEUROPSYCHIATRICA, Issue 6 2004Agnieszka Slopien Objective:, The aim of this study was the assessment of ,308G/A tumor necrosis factor (TNF)- , gene polymorphism and intPLA2 gene polymorphism in patients with anorexia nervosa (AN) and healthy controls. Subjects:, We studied 91 non-related patients with AN and 144 healthy women (blood donors and students). The mean age of women from study group was 18.22 years (SD ± 3.13 years) and from control group was 31.71 years (SD ± 8.22). Methods:, ,Gene polymorphisms were studied with the use of polymerase chain reaction-restriction fragment length polymorphism method. TNF-, gene polymorphism consists of G/A substitution in ,308 promoter region. IntPLA2 gene polymorphism is related to intron 1, in which restrictive region is found and recognized by BanI enzyme. Results:, We did not obtain statistically significant differences in the frequency of genotypes and alleles of ,308G/A TNF-, polymorphism between the study and control groups (genotypes: P = 0.106, alleles: P = 0.076). We did analogous analysis in the restrictive and bulimic subgroups. We did not observe statistically relevant differences in the frequency of genotypes (P = 0.700) and alleles (P = 0.305). We did not obtain statistically relevant difference in the frequency of genotypes and alleles of intPLA2 gene between the study group and controls (genotypes: P = 0.300, alleles: P = 0.331). We did analogous analysis in both subgroups of AN. We did not observe statistically relevant differences in the frequency of genotypes (P = 0.344) and alleles (P = 0.230). Conclusions:, There was no statistically relevant trend for the association between TNF-, polymorphism and AN. We did not find association between studied polymorphism of intPLA2 gene and risk of AN. [source] Reaction time during semi-automated kinetic perimetry (SKP) in patients with advanced visual field lossACTA OPHTHALMOLOGICA, Issue 1 2010Katarzyna Nowomiejska Abstract. Purpose:, This study aimed to evaluate reaction time (RT) in patients with advanced visual field (VF) loss using semi-automated kinetic perimetry (SKP). Methods:, Seventy-eight patients with advanced VF loss caused by glaucoma (31) or retinitis pigmentosa (19), homonymous VF loss caused by post-chiasmal lesions (18) and unilateral anterior ischaemic optic neuropathy (AION) (10) were examined with SKP (Octopus 101 perimeter). One eye in each patient was enrolled. Additionally, VFs in the 10 healthy fellow eyes of the patients with AION were compared with those in the 10 affected eyes. Reaction time was assessed during the SKP session by presenting kinetic stimuli (III4e) with constant angular velocities of 3 °/second moving linearly along so-called ,RT vectors' at four different locations inside the III4e isoptre. Each stimulus presentation was repeated four times in randomized order. Results:, The geometric mean RT was 794 ms (95% reference interval [RI] 391,1615 ms) in patients with glaucoma, 702 ms (95% RI 306,1608 ms) in patients with retinitis pigmentosa and 675 ms (95% RI 312,1460 ms) in patients with hemianopia. Increases in RT for every 1 ° of eccentricity were 1%, 0.9% and 0.4%, respectively. The geometric mean RT in the 10 patients with unilateral optic neuropathy was 644 ms in affected eyes and 435 ms in unaffected eyes, reflecting an increase of 51% (95% confidence interval 42,62%). Conclusions:, We found substantial inter-subject variability in RT in patients with advanced VF loss. It is possible to correct the position of the isoptres by assessing individual RT. There were no relevant differences in RT between the disease groups. Reaction time increases with eccentricity. In monocular disease (AION), RT is prolonged, compared with in healthy fellow eyes. However, in clinical routine the RT-related displacement of isoptres is negligible in the vast majority of cases. [source] Efficacy and tolerability of EPs 7630 in patients (aged 6,18 years old) with acute bronchitisACTA PAEDIATRICA, Issue 4 2010A randomized, double-blind, placebo-controlled clinical dose-finding study Abstract Aim:, For EPs-7630, a herbal drug preparation from Pelargonium sidoides roots, therapeutic effects in respiratory tract infections outside the strict indication for antibiotics have already been demonstrated in adults. Now, a dose-finding study for EPs-7630 was performed in children and adolescents. Methods:, A total of 400 patients (aged 6,18 years) were randomized to receive either 30 mg, 60 mg or 90 mg EPs-7630 or placebo daily. Primary outcome criterion was the change in the Bronchitis Severity Score (BSS) from day 0 to day 7. Results:, After 7 days of treatment, the change in the BSS total score was significantly better in the 60 mg and 90 mg groups compared with placebo that of the without relevant differences between these two dosages. Especially ,coughing', ,sputum' and ,rales at auscultation' improved under EPs-7630. Onset of effect was faster, time of bed rest shorter and treatment outcome and satisfaction with treatment were rated better. Tolerability was comparable with placebo in all treatment groups. Conclusion:, EPs-7630 is effective in acute bronchitis outside the strict indication for antibiotics in 6,18 years old patients, with a dose of 60 mg or 90 mg daily offering the best benefit/risk ratio. EPs-7630 significantly reduces the severity of symptoms, leads to a more favourable course of the disease and a faster recovery from acute bronchitis compared with the placebo, and is well tolerated. [source] |