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Standard Protocol (standard + protocol)
Selected AbstractsVariation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical TrialACADEMIC EMERGENCY MEDICINE, Issue 6 2001Thomas O. Stair MD Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source] A Standard Protocol for Liana Censuses,BIOTROPICA, Issue 2 2006Jeffrey J. Gerwing ABSTRACT A recent increase in published studies of lianas has been paralleled by a proliferation of protocols for censusing lianas. This article seeks to increase uniformity in liana inventories by providing specific recommendations for the determination of which taxa to include, the location of diameter measurement points on individual stems, the setting of minimum stem diameter cutoffs, the treatment of multiple-stemmed and rooted clonal groups, and the measurement of noncylindrical stems. Use of more uniform liana censusing protocols may facilitate comparison of independently collected data sets and further our understanding of global patterns in liana abundance, diversity, biomass, and dynamics. RESUMEN El reciente incremento de publicaciones sobre bejucos ha estado acompañado por una proliferación de protocolos para censarlos. Este artículo busca incrementar la uniformidad de los inventarios de lianas dando recomendaciones específicas sobre los taxa que deben incluirse, la ubicación de los puntos de medición del diámetro en tallos individuales, el establecimiento de diámetros mínimos de medición, la forma de tratar a grupos de tallos múltiples y clones arraigados, y la medición de tallos no cilíndricos. El uso de protocolos de medición más uniformes facilitará la comparación de bases de datos colectadas de forma independiente y incrementará nuestro entendimiento de patrones globales de abundancia, diversidad, biomasa y dinámica de lianas. [source] Comparison of flat film to total package water vapour transmission rates for several commercial food wrapsPACKAGING TECHNOLOGY AND SCIENCE, Issue 1 2002Matthew D. Steven Abstract The barrier properties of a package are the sum of material and seal permeations. Although addressed for hermetically sealed and modified atmosphere packages, little consideration of total package permeation has been given to commercial food wraps. Standard protocols were used to compare the water vapour transmission rates (WVTRs) of materials and packages for seven commercial food wraps: aluminum foil; poly(vinylidene chloride) (PVdC) film; three poly(ethylene) (PE) films; an adhesive-modified PE film; and plasticized poly(vinyl chloride) (PVC) film. Water ingress for a complete package was compared to calculated material permeation based on film WVTRs. Film-to-glass adhesion strength was also measured. Model systems (desiccant) were compared to foods at ambient and refrigeration temperatures. Aluminum foil had the lowest material WVTR (0.10 g/h/m2), closely followed by PVdC (0.13 g/h/m2). These WVTRs were approximately five-fold lower than the PEs (,0.65 g/h/m2), which were nearly 10-fold lower than PVC (4.9 g/h/m2). The adhesive-modified PE film had the lowest difference between material and package transmission rates (0.7 E-03 g/h), approximately half that of the PVdC film (1.1 E-03 g/h), which was significantly lower than the remaining films (2.3 E-03 ,3.9 E-03 g/h). The adhesive PE film had the strongest film,glass adhesion. Ambient food product test results were similar to model system (desiccant) results, but refrigerated trials showed significantly different relative package transmission rates. This was attributed to the reduced adhesion of most wraps at refrigeration temperatures. Copyright © 2002 John Wiley & Sons, Ltd. [source] Worster-Drought syndrome: poorly recognized despite severe and persistent difficulties with feeding and speechDEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 1 2010MARIA CLARK Aim, Worster-Drought syndrome (WDS), or congenital suprabulbar paresis, is a permanent movement disorder of the bulbar muscles causing persistent difficulties with swallowing, feeding, speech, and saliva control owing to a non-progressive disturbance in early brain development. As such, it falls within the cerebral palsies. The aim of this study was to describe the physical and neuropsychological profiles of children with WDS. Method, Forty-two children with WDS (26 males, 16 females; mean age 7y 10mo, SD 3y 1mo; range 2y 6mo to 16y 5mo) were studied prospectively using a standard protocol. Results, All of the children had severe bulbar dysfunction; 36 out of 42 had feeding difficulties and 23 of 38 had unintelligible speech, which was poorly compensated for by augmentative communication. There were accompanying disturbances in cognition (mean non-verbal IQ 59), behaviour (12/40 attention-deficit,hyperactivity disorder [ADHD]), social communication (8/42 autism), and epilepsy (12/39). The severity of bulbar dysfunction and impact of additional impairments made it difficult to use formal assessments. Interpretation, WDS causes severe and persistent bulbar dysfunction that is often accompanied by additional impairments, as in other cerebral palsies. Speech prognosis is particularly poor. Early diagnosis with appreciation of the underlying neurology would encourage critical evaluation of interventions and long-term planning to improve outcome. [source] Evaluation of a Pediatric-sedation Service for Common Diagnostic ProceduresACADEMIC EMERGENCY MEDICINE, Issue 6 2006Wendalyn K. King MD Abstract Background: Pediatric patients often require sedation for diagnostic procedures such as magnetic resonance imaging and computed tomography scanning. In October 2002, a dedicated sedation service was started at a tertiary care pediatric facility as a joint venture between pediatric emergency medicine and pediatric critical care medicine. Before this service, sedation was provided by the department of radiology by using a standard protocol, with high-risk patients and failed sedations referred for general anesthesia. Objectives: To describe the initial experience with a dedicated pediatric-sedation service. Methods: This was a retrospective analysis of quality-assurance data collected on all sedations in the radiology department for 23-month periods before and after sedation-service implementation. Study variables were number and reasons for canceled or incomplete procedures, rates of referral for general anesthesia, rates of hypoxia, prolonged sedation, need for assisted ventilation, apnea, emesis, and paradoxical reaction to medication. Results are reported in odds ratios (OR) with 95% confidence intervals (95% CI). Results: Data from 5,444 sedations were analyzed; 2,148 before and 3,296 after sedation-service activation. Incomplete studies secondary to inadequate sedation decreased, from 2.7% before the service was created to 0.8% in the post,sedation-service period (OR, 0.29; 95% CI = 0.18 to 0.47). There also were decreases in cancellations caused by patient illness (3.8% vs. 0.6%; OR, 0.16; 95% CI = 0.10 to 0.27) and rates of hypoxia (8.8% vs. 4.6%; OR, 0.50; 95% CI = 0.40 to 0.63). There were no significant differences between the groups in rates of apnea, need for assisted ventilation, emesis, or prolonged sedation. The implementation of the sedation service also was associated with a decrease in both the number of patients referred to general anesthesia without a trial of sedation (from 2.1% to 0.1%; OR, 0.33; 95% CI = 0.06 to 1.46) and the total number of general anesthesia cases in the radiology department (from 7.5% to 4.4% of all patients requiring either sedation or anesthesia; OR, 0.56; 95% CI = 0.45 to 0.71). Conclusions: The implementation of a dedicated pediatric-sedation service resulted in fewer incomplete studies related to inadequate sedation, in fewer canceled studies secondary to patient illness, in fewer referrals for general anesthesia, and in fewer recorded instances of sedation-associated hypoxia. These findings have important implications in terms of patient safety and resource utilization. [source] Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical TrialACADEMIC EMERGENCY MEDICINE, Issue 6 2001Thomas O. Stair MD Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source] Interleukin 6 alleviates hepatic steatosis and ischemia/reperfusion injury in mice with fatty liver diseaseHEPATOLOGY, Issue 4 2004Feng Hong Fatty liver, formerly associated predominantly with excessive alcohol intake, is now also recognized as a complication of obesity and an important precursor state to more severe forms of liver pathology including ischemia/reperfusion injury. No standard protocol for treating fatty liver exists at this time. We therefore examined the effects of 10 days of interleukin 6 (IL-6) injection in 3 murine models of fatty liver: leptin deficient ob/ob mice, ethanol-fed mice, and mice fed a high-fat diet. In all 3 models, IL-6 injection decreased steatosis and normalized serum aminotransferase. The beneficial effects of IL-6 treatment in vivo resulted in part from an increase in mitochondrial , oxidation of fatty acid and an increase in hepatic export of triglyceride and cholesterol. However, administration of IL-6 to isolated cultured steatotic hepatocytes failed to decrease lipid contents, suggesting that the beneficial effects of IL-6 in vivo do not result from its effects on hepatocytes alone. IL-6 treatment increased hepatic peroxisome proliferator-activated receptor (PPAR) , and decreased liver and serum tumor necrosis factor (TNF) ,. Finally, 10 days of treatment with IL-6 prevented the susceptibility of fatty livers to warm ischemia/reperfusion injury. In conclusion, long-term IL-6 administration ameliorates fatty livers and protects against warm ischemia/reperfusion fatty liver injury, suggesting the therapeutic potential of IL-6 in treating human fatty liver disease. Supplementary material for this article can be found on the Hepatology website (http://interscience.wiley.com/jpages/0270-9139/suppmat/index.html). (HEPATOLOGY 2004;40:933,941.) [source] Preoperative staging and evaluation of resectability in pancreatic ductal adenocarcinomaHPB, Issue 1 2004R Andersson Background Cancer of the pancreas is a common disease, but the large majority of patients have tumours that are irresectable at the time of diagnosis. Moreover, patients whose tumours are clearly beyond surgical cure are best treated non-operatively, if possible, by relief of biliary obstruction and percutaneous biopsy to confirm the diagnosis and then consideration of oncological treatment, notably chemotherapy. These facts underline the importance of a standard protocol for the preoperative determination of operability (is it worth operating?) and resectability (is there a chance that the tumour can be removed?). Recent years have seen the advent of many new techniques, both radiological and endoscopic, for the diagnosis and staging of pancreatic cancer. It would be impracticable in time and cost to submit every patient to every test. This review will evaluate the available techniques and offer a possible algorithm for use in routine clinical practice. Discussion In deciding whether to operate with a view to resecting a pancreatic cancer, the surgeon must take into account factors related to the patient, the tumour and the institution and team entrusted with the patient's care. Patient-related factors include age, general health, pain and the presence or absence of malnutrition and an acute phase inflammatory response. Tumour-related factors include tumour size and evidence of spread, whether to adjacent organs (notably major blood vessels) or further afield. Hospital-related factors chiefly concern the volume of pancreatic cancer treated and thus the experience of the whole team. Determination of resectability is heavily dependent upon detailed imaging. Nowadays conventional ultrasonography can be supplemented by endoscopic, laparoscopic and intra-operative techniques. Computed tomography (CT) remains the single most useful staging modality, but MRI continues to improve. PET scanning may demonstrate unsuspected metastases and likewise laparoscopy. Diagnostic cholangiography can be performed more easily by MR techniques than by endoscopy, but ERCP is still valuable for preoperative biliary decompression in appropriate patients. The role of angiography has declined. Percutaneous biopsy and peritoneal cytology are not usually required in patients with an apparently resectable tumour. The prognostic value of tumour marker levels and bone marrow biopsy is yet to be established. Preoperative chemotherapy or chemoradiation may have a role in down-staging an irresectable tumour sufficiently to render it resectable. Selective use of diagnostic laparoscopy staging is potentially helpful in determination of resectability. Laparotomy remains the definitive method for determining the resectability of pancreatic cancer, with or without portal vein resection, and should be undertaken in suitable patients without clear-cut evidence of irresectability. [source] Evaluation of eosin-5-maleimide flow cytometric test in diagnosis of hereditary spherocytosisINTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY, Issue 1p2 2010R. KAR Summary A flow cytometry-based test using eosin-5-maleimide (EMA) dye was used for diagnosis of hereditary spherocytosis (HS). The mean fluorescence intensiy (MFI) of EMA tagged erythrocytes is lower in HS than that in other hemolytic and nonhemolytic anemias. We enrolled 114 subjects comprising 20 confirmed HS, 20 suspected HS/hemolytic anemia (HA), 20 normal controls, 20 other hemolytic anemias [13 autoimmune hemolytic anemia, three congenital dyserythropoietic anemia (CDA), one pyruvate kinase deficiency, two microangiopathic hemolytic anemia], 18 microcytic anemia and 16 macrocytic anemia cases. All samples were subjected to flow cytometry as per standard protocol. The mean MFI of normal control subjects was 11 861.5 (SD 883.5) and of confirmed HS was 7949.3 (SD 1304.1). Using this test, of 20 patients suspected to be HS/HA but with no confirmatory diagnosis, eight patients were diagnosed as HS. Using logistic regression analysis, the optimum cut-off MFI value between HS and normal controls was 10126. The area under the ROC curve was 0.99. The statistical significance of MFI values was obtained by t -test or Wilcoxon rank sum test as applicable. Compared with normal controls, the MFI values in HS were lower and in megaloblastic anemia were higher which was statistically highly significant (P < 0.01), and the MFI values in CDA were lower which was statistically significant (P < 0.05). False-positive values were obtained in three cases of AIHA and two cases of CDA. The sensitivity and specificity was 96.4% and 94.2% respectively. The EMA-based flow cytometry test is a highly sensitive and specific method for the diagnosis of HS. [source] Influence of temperature and time before centrifugation of specimens for routine coagulation testingINTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY, Issue 4 2009G. L. SALVAGNO Summary The accurate standardization of the preanalytical phase is of pivotal importance for achieving reliable results of coagulation tests. Because information on the suitable storage conditions for coagulation testing is controversial, we aimed at investigating the sample stability with regard to the temperature and time before centrifugation. The activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen and D-dimer were assayed in specimens collected from 26 consecutive patients on antivitamin K therapy on the ACL TOP analyzer. Three primary 3.6-ml siliconized evacuated tubes containing 0.109 mol/l buffered trisodium citrate were sequentially collected from each patient. These three tubes were mixed, pooled and divided into seven identical aliquots. The first aliquot was immediately centrifuged according to the standard protocol [1500 g for 15 min at room temperature (RT)] and analyzed. The other aliquots were left for 3, 6 and 24 h, respectively, at RT or 4 °C, and then centrifuged and analyzed. Test results were compared with those obtained on the reference specimen. Statistically significant prolongations were observed for aPTT in all the samples. Such differences exceeded the analytical quality specifications for desirable bias in the samples stored for 24 h. A significant reduction, yet comprised within the desirable bias, was observed for PT and fibrinogen in uncentrifuged specimens stored at RT for 3 and 6 h. No significant biases could be recorded in D-dimer. In conclusion, a 6-h storage of uncentrifuged specimens at either RT or 4 °C may still be suitable to achieve results of routine coagulation testing comprised within the analytical quality specifications for desirable bias. [source] Our experience with third renal transplantation: Results, surgical techniques and complicationsINTERNATIONAL JOURNAL OF UROLOGY, Issue 12 2007Mohammad Hossein Nourbala Background: Despite the popularity of kidney transplantation in the current era, second and third kidney transplantation are not yet widely accepted and practiced. Each center has its own regulations and experiences and there is no accepted protocol for third kidney transplantation. We report here our 15 years of experience with third kidney transplantation. Methods: This is a report of all the third kidney transplantations performed in Baqiyatallah Hospital, Tehran, Iran, between 1991 and 2006. Demographic data, surgical techniques, complications and outcomes are reported. Results: Of the nine third kidney transplant patients, six were male. The median age was 43 years (32,52). All of the patients received kidney from living donors. All operations were performed by a midline incision and the grafts were placed at the midline, in the intraperitoneal space. For arterial anastomosis, we used internal iliac, right common iliac and both the right external iliac and inferior mesenteric artery in 4, 4 and 1 case(s), respectively. For venous anastomosis, we used vena cava, common iliac and external iliac veins in 3, 5 and 1 case(s), respectively. During the follow up period (38 months), 6 grafts (66.6%) were functioning. None of the graft rejections were due to surgical complications. Wound dehiscence occurred in two patients. No other surgical complications including infection, lymphocele or hemorrhage were observed. Conclusion: Third kidney transplantation is a field that has not been fully explored. The rate of complications seems to be not much higher than the first transplantation. Defining a standard protocol seems necessary. [source] Prospective Study of Cardiac Sarcoid Mimicking Arrhythmogenic Right Ventricular DysplasiaJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2009SMIT C. VASAIWALA M.D. Introduction: Case studies indicate that cardiac sarcoid may mimic the clinical presentation of arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C); however, the incidence and clinical predictors to diagnose cardiac sarcoid in patients who meet International Task Force criteria for ARVD/C are unknown. Methods and Results: Patients referred for evaluation of left bundle branch block (LBBB)-type ventricular arrhythmia and suspected ARVD/C were prospectively evaluated by a standardized protocol including right ventricle (RV) cineangiography-guided myocardial biopsy. Sixteen patients had definite ARVD/C and four had probable ARVD/C. Three patients were found to have noncaseating granulomas on biopsy consistent with sarcoid. Age, systemic symptoms, findings on chest X-ray or magnetic resonance imaging (MRI), type of ventricular arrhythmia, RV function, ECG abnormalities, and the presence or duration of late potentials did not discriminate between sarcoid and ARVD/C. Left ventricular dysfunction (ejection fraction <50%) was present in 3/3 patients with cardiac sarcoid, but only 2/17 remaining patients with definite or probable ARVD/C (P = 0.01). Conclusions: In this prospective study of consecutive patients with suspected ARVD/C evaluated by a standard protocol including biopsy, the incidence of cardiac sarcoid was surprisingly high (15%). Clinical features, with the exception of left ventricular dysfunction and histological findings, did not discriminate between the two entities. [source] Efficacy of Listerine® Antiseptic in reducing viral contamination of salivaJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 4 2005Timothy F. Meiller Abstract Aim: The anti-viral efficacy of oral antimicrobial rinses has not been adequately studied in terms of potential clinical significance. As a follow-up to an in vitro study on the effect of oral antiseptics on Herpes simplex virus, Type 1, this study was undertaken to evaluate the in vivo effect of an essential oil containing oral antiseptic on the reduction of viral titer in saliva during active viral infection. Method: Patients were recruited and evaluated in a single visit protocol at the onset of a perioral outbreak, consistent historically and clinically with recurrent Herpes labialis. Direct immunofluorescence of cytological smears of the lesions/oral fluids was used to confirm Herpes simplex virus types I or II. Patients were randomly assigned to one of two treatment groups: (1) active ingredient and (2) sterile water control. The viral lesion was evaluated as to clinical stage according to standard protocol. Salivary fluid samples were taken: (1) at baseline; (2) immediately following a 30 s rinse; (3) 30 min. after the 30 s rinse; and (4) on the repeat trial, also at 60 min. after the 30 s rinse. All samples were evaluated for viral titer and results compared. Results: In Trial 1, the sample population consisted of 19 males and 21 females with an average age of 29.2 and in Trial 2, 21 males, 19 females with an average age of 28. In both Trials 1 and 2, recoverable infectious virions were reduced to zero after a 30 s experimental rinse; whereas, the control rinse resulted in a non-significant (p>0.05) reduction. The experimental group also demonstrated a continued significant (p<0.05) reduction 30 min. post rinse when compared with baseline while the control group returned to baseline levels. In Trial 2, the 60 min. post rinse follow-up demonstrated a 1,2 log residual reduction from baseline in the experimental group; however, this was not significant. Conclusions: There is clinical efficacy in utilizing an oral rinse with the antimicrobial agent Listerine® Antiseptic in reducing the presence of viral contamination in oral fluids for at least 30 min. after oral rinse. The risk of viral cross contamination generated from these oral fluids in person to person contact or during dental treatment may be reduced. [source] Genetic polymorphism of CYP2C8 in three Malaysian ethnics: CYP2C8*2 and CYP2C8*3 are found in Malaysian IndiansJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 5 2005Y. D. Muthiah PhD candidate Summary Background:,CYP2C8 is genetically polymorphic. Four variants, CYP2C8*2, CYP2C8*3, CYP2C8*4 and CYP2C8*5, which contain mutations in the coding regions have been reported to exhibit different enzyme activity as compared with CYP2C8*1. Objective:, To determine the allele frequency of three codon-changing variants (CYP2C8*2, CYP2C8*3 and CYP2C8*4) in the Malaysian population. Method:, Healthy unrelated volunteers from three major races in Malaysia were recruited. The study was approved by the local Research Ethics Committee. DNA was extracted using a standard protocol. A two-step multiplex PCR method was developed to detect three alleles of CYP2C8. PCR results were confirmed by subsequent direct DNA sequencing. Result:, Only the Indians showed CYP2C8 polymorphism with allele frequency of 98% for CYP2C8*1, 0·8% for CYP2C8*2 and 1·2% for CYP2C8*3. CYP2C8*4 was not detected in any of the ethnic groups. Conclusion:, To the best of our knowledge, the current study described, for the first time polymorphisms of CYP2C8 in Malaysian Indians. [source] Force-field parameters for the simulation of tetrahedral intermediates of serine hydrolasesJOURNAL OF COMPUTATIONAL CHEMISTRY, Issue 1 2009Nikolaj Otte Abstract CHARMM force-field parameters are reported for the tetrahedral intermediate of serine hydrolases. The fitting follows the standard protocol proposed for CHARMM22. The reference data include ab initio (RHF/6-31G*) interaction energies of complexes between water and the model compound 1,1-dimethoxyethoxide, torsional profiles of related model compounds from correlated ab initio (MP2/6-311+G*//B3LYP/6-31+G*) calculations, as well as molecular geometries and vibrational frequencies from density functional theory (B3LYP/6-31+G*). The optimized parameters reproduce the target data well. Their utility is demonstrated by a QM/MM study of the tetrahedral intermediate in Bacillus subtilis lipase A, and by classical molecular modeling of enantioselectivity in Pseudomonas aeruginosa lipase and its mutants. © 2008 Wiley Periodicals, Inc. J Comput Chem, 2009 [source] Argon plasma coagulation as first-line treatment for chronic radiation proctopathyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 10 2004SHAJI SEBASTIAN Abstract Background and Aim:, Chronic radiation proctopathy is a troublesome complication of radiotherapy to the pelvis, for which current treatment modalities are unsatisfactory. The present prospective study was designed to determine the usefulness and safety of argon plasma coagulation in the management of chronic radiation proctopathy. Methods:, Twenty-five consecutive patients (M:F 24:1, mean age: 69 years) with radiation proctopathy were prospectively included. All patients received argon plasma coagulation by a standard protocol. Response to treatment was assessed by symptom response, bleeding severity score, hematological parameters and transfusion requirements over a median 14-month follow up. Results:, Patients received a median of one treatment session with argon plasma coagulation. There was significant improvement in rectal bleeding in all patients, with complete cessation of bleeding in 21 (81%) of the patients. The median bleeding severity score fell from 3 to 0 (P < 0.0005). The mean hemoglobin level rose from 10.05 ± 2.21 g/dL before treatment to 12.44 ± 1.09 g/dL at 6 months following treatment (P < 0.002). There was also improvement in other symptoms such as urgency and diarrhea. Over the period of follow up, there was no recurrence of anemia and no complications were noted. Conclusion:, These results suggest that argon plasma coagulation is a safe and effective modality in the treatment of chronic radiation proctopathy. © 2004 Blackwell Publishing Asia Pty Ltd [source] A 15 - minute [13C]-urea breath test for the diagnosis of Helicobacter pylori infection in patients with non-ulcer dyspepsiaJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 3 2000Nan-Jing Peng Abstract Background: Non-ulcer dyspepsia (NUD) accounts for the majority of dyspeptic patients and studies on the epidemiology of Helicobacter pylori infection in NUD depend on a non-invasive and rapid diagnostic test. This study was performed to determine the sensitivity and specificity of a 15-min simplified protocol of the [13C]-urea breath test ([13C]-UBT) for the diagnosis of H. pylori infection in patients with NUD. Methods: One hundred and thirty-six patients with a clinical and endoscopic diagnosis of NUD were included. The [13C]-UBT was modified from the European standard protocol. The baseline breath sample was collected 5 min after the patient took a test meal and the 13CO2 was collected 15 min after the patient drank 100 mg [13C]-urea. The gold standard used for comparison was either a positive culture or positive histology + positive rapid urease test sampled on upper gastrointestinal endoscopy. Results: The prevalence of H. pylori infection in NUD by the gold standard was 59.6%, whereas that calculated by the [13C]-UBT was 60.3%. The sensitivity and specificity of [13C]-UBT was 93.8 and 89.1% compared with the gold standard. The shortened collection time and simplification of the procedure may have led to a decline in specificity. Conclusion: The 15-min [13C]-UBT is a rapid but less specific protocol for detecting the presence of H. pylori infection in patients with NUD. © 2000 Blackwell Science Asia Pty Ltd [source] The efficacy of orally dosed ketamine and ketamine/medetomidine compared with intramuscular ketamine in rhesus macaques (Macaca mulatta) and the effects of dosing route on haematological stress markersJOURNAL OF MEDICAL PRIMATOLOGY, Issue 3 2008Andrew N Winterborn Abstract Background, This study compared the efficacy of two orally-dosed (PO) anaesthetic regimens for chemical immobilization in rhesus macaques (Macaca mulatta), versus the standard protocol of intramuscular (TM) ketamine. In addition, the effects of dosing route on haematological stress markers were evaluated. Methods, Testing was conducted on 18 chronically housed animals. Animals were trained to accept oral dosing and then randomly assigned to one of three drug regimens: (1) ketamine IM, (2) ketamine PO, (3) Ketamine/medetomidine PO. Sedation levels for each regimen were evaluated. Results, Oral dosing alone was not sufficient to achieve a plane of sedation that allowed for safe handling. Serum cortisol and glucose levels were unchanged across groups, although differences were observed in the leukogram profiles. Conclusion, The oral dosages used in this study fell short in providing adequate sedation for safe handling for routine veterinary procedures. Leukogram profiles indicated that orally dosed animals experienced a higher level of stress. [source] Microarray Analysis of Ethanol-Treated Cortical Neurons Reveals Disruption of Genes Related to the Ubiquitin-Proteasome Pathway and Protein SynthesisALCOHOLISM, Issue 12 2004Ramana Gutala Background: Chronic ethanol abuse results in deleterious behavioral responses such as tolerance, dependence, reinforcement, sensitization, and craving. The objective of this research was to identify transcripts that are differentially regulated in ethanol-treated cortical neurons compared with controls by using a pathway-focused complementary DNA microarray. Methods: Cortical neurons were isolated from postconception day 14 C57BL/6 mouse fetuses and cultured according to a standard protocol. The cortical neuronal cells were treated with 100 mM ethanol for five consecutive days with a change of media every day. A homeostatic pathway-focused microarray consisting of 638 sequence-verified genes was used to measure transcripts differentially regulated in four ethanol-treated cortical neuron samples and four control samples. Quantitative real-time reverse transcriptase-polymerase chain reaction analysis was used to verify the mRNA expression levels of genes of interest detected from the microarray experiments. Results: We identified 56 down-regulated and 10 up-regulated genes in ethanol-treated cortical neurons relative to untreated controls at a 5% false-discovery rate. The expression of many genes involved in ubiquitin-proteasome and protein synthesis was decreased by ethanol, including ubiquitin B, ubiquitin-like 3, ubiquitin-conjugating enzyme E3A, 20S proteasome ,- and ,-subunits, and members of the ribosomal proteins. Furthermore, the mRNA expression of heat shock proteins, myristoylated alanine-rich protein kinase C substrate, phosphatase and tensin homolog deleted on chromosome 10, and FK506 binding protein rapamycin-associated protein (FKBP) (mTOR) was also decreased in ethanol-treated cortical neurons. Quantitative real-time reverse transcriptase-polymerase chain reaction analysis of genes involved in the ubiquitin-proteasome cascade revealed a down-regulation of these genes, thereby corroborating our microarray results. Conclusions: Our results indicate that chronic ethanol treatment of cortical neurons resulted in decreased mRNA expression of genes involving the ubiquitin-proteasome pathway and ribosomal proteins together with mTOR expression leading to disruption of protein degradation mechanism and impairment of protein synthesis machinery. [source] Improved performance characteristics of the von Willebrand factor ristocetin cofactor activity assay using a novel automated assay protocolJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 10 2010A. HILLARP Summary.,Background, objectives and methods:,An accurate, sensitive and precise assay for reliable determination of the ristocetin cofactor activity of von Willebrand factor (VWF:RCo) in plasma and von Willebrand Factor (VWF)-containing concentrates has been evaluated. The assay is based on a commercially available automated protocol with modifications including a combination of adding additional ristocetin and the use of two calibration curves for the high and low measuring ranges. Results:,Addition of extra ristocetin resulted in improved measurement of VWF recoveries from various VWF-containing concentrates that were underestimated using the standard automated protocol. The modifications resulted in improved assay performance over an extended measuring range (2.00,0.03 IU mL,1). Accuracy was tested using VWF deficiency plasma spiked with the 1st international standard (IS) for VWF concentrate. Seven dilutions, ranging from 1.80 to 0.05 IU mL,1, were analyzed and resulted in measured concentrations between 80% and 100% of the assigned potency of the standard. Linearity was determined from the regression plot of the same concentrate dilutions and resulted in a correlation coefficient of 0.998. The repeatability, expressed as coefficient of variation, was 2% in the normal range (0.90 IU mL,1) and 8% at the level of 0.05 IU mL,1. The corresponding reproducibility results were 2% and 15% at the normal and low measuring ranges, respectively. Conclusions:,Analysis of patients with von Willebrand disease (VWD) indicates that the modified automated BCS® protocol has a superior discrimination power compared with the standard protocol. This is especially true in samples with low VWF, as in patients with type 3 VWD. [source] Comparison of the quality of some Croatian and German wheat varieties according to the German standard protocolMOLECULAR NUTRITION & FOOD RESEARCH (FORMERLY NAHRUNG/FOOD), Issue 2 2003Ljiljana Unbehend Abstract Ten Croatian and five German wheat varieties were tested. They were carried out using the German standard testing protocol. The results demonstrated that the quality of the Croatian wheat varieties could be ranged in A,C quality groups according to the German testing protocol. Croatian wheat varieties were comparable in many parameters (protein content, hardness, water absorption, dough handling properties and volume yield) with chosen German wheat varieties. Some differences were found in falling number, sedimentation value, flour yield, and ash value number. [source] Hepatitis B vaccination in haemodialysis patients: A randomized clinical trialNEPHROLOGY, Issue 3 2009MARILENE BOCK SUMMARY Aim: A short vaccination protocol against hepatitis B was compared to the standard approach in patients under haemodialysis who were primarily non-responsive to the vaccine. Methods: This randomized, controlled open trial included 51 chronic haemodialysis subjects previously vaccinated against hepatitis B and with anti-HBs levels of less than 10 IU/mol/L. Twenty-six patients received 20 µg i.m. once a week for 8 weeks (short protocol) and 25 subjects three doses of 40 µg i.m. at months 0, 1 and 6 (standard protocol). Clinical and laboratory data were compared between responders and non-responders. A logistic regression model included selected parameters to assess risk factors for non-seroconversion. Results: Seroconversion rates to vaccine at 2 months were 80% and 78% in the short and standard protocol groups, respectively (P = 0.99). Median of anti-HBs levels were similar up to 6 months of follow up, but patients in the standard protocol showed a trend to higher anti-HBs in month 3 and a more steady decline in antibody titres. Non-responders were older, had longer duration of dialysis and a higher prevalence of a prior renal transplant and hepatitis C. In multivariate analysis, only advanced age and hepatitis C remained independently associated with non-responsiveness to vaccination. Conclusion: In haemodialysis patients, a short vaccination protocol against hepatitis B did not provide any benefit compared to the standard approach with respect to peak anti-HBs titres or a higher rate of seroprotection at the end of follow up. Other strategies to increase seroconversion rates should be explored, especially in the elderly and in patients with hepatitis C. [source] Impact of modified acidic soft drinks on enamel erosionORAL DISEASES, Issue 1 2005T Attin Objective:, To evaluate the enamel erosive potential of modified acidic soft drinks under controlled conditions in an artificial mouth. Materials and methods:, From each of 144 bovine incisors one enamel sample was prepared. Labial surfaces of the samples were ground flat, polished and covered with adhesive tape, leaving an exposed area. The samples were distributed among four (A,D) groups for treatment with A: Coca-Cola, B: Sprite; C: Sprite light, D: orange juice. Either 1.0 mmol l,1 calcium (Ca) or a combination (comb.) of 0.5 mmol l,1 calcium plus 0.5 mmol l,1 phosphate plus 0.031 mmol l,1 fluoride was added to the beverages. Samples of each group were subdivided into three subgroups (-original; -Ca and -comb.) for treatment with original and modified drinks. De- and remineralization cycles were based on a standard protocol described earlier. Surface loss of the specimens was determined using profilometry after test procedure. Results:, In all subgroups, loss of enamel was observed. The enamel loss recorded for the samples rinsed with original Sprite and original orange juice was significantly higher compared with all other solutions (P = 0.001). Lowest enamel loss was recorded for the original Coca-Cola group (P = 0.001). With the exception of Coca-Cola, demineralization with the modified beverages led to significantly lower losses compared with the respective original solutions. Conclusion:, Modification of the test soft drinks with low concentrations of calcium or a combination of calcium, phosphate and fluoride may exert a significant protective potential with respect to dental erosion. [source] Langerhans cell histiocytosis with digestive tract involvement,PEDIATRIC BLOOD & CANCER, Issue 4 2010Satya P. Yadav DCH Abstract Gastrointestinal tract (GIT) involvement in Langerhans cell histiocytosis (LCH) is not commonly described. We present two children presenting with GIT involvement with LCH, one successfully treated on standard protocol and other being treated on a protocol for relapsed disease. A review of literature showed almost 95% children were less than 2 years of age and 62% were females. Vomiting, abdominal pain, constipation, intractable diarrhea, malabsorption, bloody stools, protein-losing enteropathy, and even intestinal perforation are some of the reported symptoms. More than 50% patients died within 18 months from diagnosis. Pediatr Blood Cancer. 2010;55:748,753. © 2010 Wiley-Liss, Inc. [source] Loss of antibody titers and effectiveness of revaccination in post-chemotherapy pediatric sarcoma patients,PEDIATRIC BLOOD & CANCER, Issue 5 2007Jennifer Yu BA Abstract Background Little is known about the effects of chemotherapy on patient antibody titers to vaccine-preventable infectious diseases; thus, there is no standard protocol for revaccinating post-chemotherapy patients. Procedures To assess losses of detectable antibody titers due to chemotherapy, we retrospectively examined antibody titers for tetanus, varicella, measles, mumps, rubella, hepatitis B, and polio in 109 pediatric sarcoma patients. We also evaluated revaccination data to determine current practices and efficacy of revaccination. We limited our sample to osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma patients to control for the chemotherapy regimen patients received. Results Patients had pre-treatment detectable antibody titer that fell within the range of healthy children's antibody titers. However, 71% of patients had post-chemotherapy negative titers for at least one infectious disease. Patients most commonly had negative titers for hepatitis B (64%). Few patients had negative titers for measles (14%), mumps (9%), rubella (4%), polio 1 (0%), polio 2 (2.9%), polio 3 (4.8%), tetanus (5%), or varicella (11%). Revaccinations most frequently administered were hepatitis B and polio. Conclusions Our findings suggest that post-chemotherapy patients may need to be revaccinated against certain vaccine-preventable diseases including hepatitis B, tetanus, varicella, polio, measles, mumps, and rubella. Larger studies need to be performed to establish guidelines for revaccinating post-chemotherapy pediatric patients. Pediatr Blood Cancer 2007;49:656,660. © 2007 Wiley-Liss, Inc. [source] Cultural consonance, a 5HT2A receptor polymorphism, and depressive symptoms: A longitudinal study of gene × culture interaction in urban BrazilAMERICAN JOURNAL OF HUMAN BIOLOGY, Issue 1 2009William W. Dressler In this study in urban Brazil we examine, as a predictor of depressive symptoms, the interaction between a single nucleotide polymorphism in the 2A receptor in the serotonin system (,1438G/A) and cultural consonance in family life, a measure of the degree to which an individual perceives her family as corresponding to a widely shared cultural model of the prototypical family. A community sample of 144 adults was followed over a 2-year-period. Cultural consonance in family life was assessed by linking individuals' perceptions of their own families with a shared cultural model of the family derived from cultural consensus analysis. The ,1438G/A polymorphism in the 2A serotonin receptor was genotyped using a standard protocol for DNA extracted from leukocytes. Covariates included age, sex, socioeconomic status, and stressful life events. Cultural consonance in family life was prospectively associated with depressive symptoms. In addition, the interaction between genotype and cultural consonance in family life was significant. For individuals with the A/A variant of the ,1438G/A polymorphism of the 2A receptor gene, the effect of cultural consonance in family life on depressive symptoms over a 2-year-period was larger (, = ,0.533, P < 0.01) than those effects for individuals with either the G/A (, = ,0.280, P < 0.10) or G/G (, = ,0.272, P < 0.05) variants. These results are consistent with a process in which genotype moderates the effects of culturally meaningful social experience on depressive symptoms. Am. J. Hum. Biol., 2009. © 2008 Wiley-Liss, Inc. [source] The effect of measurement protocol on active cervical motion in healthy subjectsPHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 3 2002Professor Zeevi Dvir Abstract Background and Purpose Although the assessment of cervical motion is routinely performed in clinical practice, no standard protocol for this procedure has ever been established formally. The specific aim of the present study was to select from four different measurement protocols the one which was most stable in terms of reproducibility and was appropriate for clinical and/or medicolegal applications. Method A repeated measurement, test,retest of cervical motion study design using an ultrasound-based system for three-dimensional (3D) motion analysis; cervical range of motion was measured along the six primary directions: flexion; extension; right and left rotation; and right and left lateral flexion, in 20 healthy subjects who were tested twice over a period of lasting from one to four weeks. ,Protocol A' (reciprocal,intermittent testing) consisted of moving the head along a given primary direction, return to the neutral position, a pause and then motion to the opposite primary direction and return to neutral position. These movements were repeated three times. ,Protocol B' (reciprocal,continuous testing) was identical to Protocol A, but without the pause between the primary directions. ,Protocol C' consisted of three repetitions of the same primary direction with a break between two consecutive primary directions. Three sets of six randomly ordered primary directions constituted ,Protocol D'. Results Protocol D was associated with a significantly smaller range of motion and with the least intra-test reproducibility, as indicated by the coefficient of variation. The differences between the other protocols were largely negligible. Conclusion In routine clinical practice, either of protocols A, B or C may be applied. Copyright © 2002 Whurr Publishers Ltd. [source] Concurrent validity of the NK hand dexterity testPHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 2 2001Joy C MacDermid BSc, PT PhD Co-Director Abstract Background and Purpose The present study evaluated the concurrent validity of the NK hand dexterity test (NKHDT) by use of three separate analyses: (1) the correlation between the NKHDT and a criterion comparator (Jebson's Hand Function Test (JHFT)); (2) the correlation between both dexterity tests and a patient-rated function questionnaire; and (3) the ability of subscales to differentiate between subjects with and without upper extremity pathology. Method The study population included 40 individuals with a variety of musculoskeletal problems affecting the upper extremity and 10 individuals without any history of upper extremity problems. Both dexterity tests were administered on a single occasion according to a standard protocol. Subjects also completed a rating scale which evaluated self-care, household work, work and recreation on an 0,10-point scale. Results The validity of the NKHDT was supported in all three analyses because: (1) the correlation between the NKHDT and JHFT subtests was moderate to strong (Pearson's r=0.47,0.87) and stronger when the objects were more similar in size; (2) both scales correlated to a similar extent with patient-rated function (Pearson's r=,0.34,0.67); and (3) all subscales were statistically different between subjects with and without upper extremity pathology (p<0.01). Conclusions The present study supports the use of the NKHDT as a measure of hand dexterity. Copyright © 2001 Whurr Publishers Ltd. [source] Long-term field studies: positive impacts and unintended consequencesAMERICAN JOURNAL OF PRIMATOLOGY, Issue 9 2010Karen B. Strier Abstract Long-term field studies of wild primates can have far-reaching impacts that transcend their contributions to science. These impacts can benefit not only the study animals, study areas, and local human communities, but they can also have unintended, potentially negative consequences. Examples of some of the positive impacts from the Northern Muriqui Project of Caratinga, in Minas Gerais, Brazil, include contributions to conservation efforts on behalf of this critically endangered species, capacity building through the training of Brazilian students, and employment opportunities for local people through our collaboration with a locally administered NGO that is facilitating ecotourism, education, and reforestation programs. Some concerns about unintended consequences of the research include the effects of our trails and trail traffic on surrounding vegetation and other aspects of the environmental "footprints" that both long-term researchers and short-term visitors may leave. In addition, although precautions against potential health risks from routine exposure to human observers are now standard protocol, little is known about the other ways in which our long-term research presence can affect the primates' experiences or alter their perceptions of their social and ecological environments. Risk analysis, which weighs both the positive and negative impacts can provide useful perspectives for addressing the ethical considerations that can arise during long-term field studies. Am. J. Primatol. 72:772,778, 2010. © 2010 Wiley-Liss, Inc. [source] Nasal Provocation Testing as an International Standard for Evaluation of Allergic and Nonallergic RhinitisTHE LARYNGOSCOPE, Issue 3 2005Jan Gosepath MD Abstract Standardized nasal provocation testing (NPT) has been shown to be a safe and very useful tool in the diagnosis of allergic and nonallergic rhinitis. However, in the United States, its use has been mostly limited to scientific investigations, and it has not yet been widely accepted as a standard diagnostic procedure in clinical practice. NPT aims to identify and quantify the clinical relevance of inhalant allergens or occupational irritants. During NPT, nasal respiratory mucosa is exposed to an airborne substance suspected to cause symptoms in the respective individual. Clinical reactions are monitored in a controlled and standardized fashion. Nasal secretions, symptoms such as itching, sneezing and, most importantly, nasal obstruction are assessed as well as ocular, bronchial, cutaneous, and systemic reactions. To achieve objective data on changes in nasal airflow and patency after the challenge, anterior rhinomanometry and acoustic rhinometry have been included in the standard protocol of NPT. By monitoring changes of nasal airflow on one hand and of nasal geometry on the other hand, these methods display nasal function in a graphic way just as speech and pure tone audiometry do for auditory function. Also, by their objective nature, these methods offer a clear and internationally comparable standard. This review outlines a protocol for NPT and discusses practical applications and clinical indications. The use of rhinomanometry and acoustic rhinometry as objective diagnostic tools is emphasized. For the diagnosis of allergic and occupational rhinitis, standardized NPT should be regarded as an international diagnostic standard. [source] | ||||||||||||||||||||||||||||||||||