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Detailed Protocol (detailed + protocol)
Selected Abstracts,Sulfo-click' for ligation as well as for site-specific conjugation with peptides, fluorophores, and metal chelatorsJOURNAL OF PEPTIDE SCIENCE, Issue 1 2010Dirk T. S. Rijkers Abstract The ,sulfo-click' reaction, which is a chemoselective amidation reaction involving the reaction of an aminoethane sulfonyl azide with a thio acid, encompasses a new approach for ligation and conjugation. Detailed protocols are provided for decorating biologically active peptides or dendrimers with biophysical tags, fluorescent probes, metal chelators, and small peptides by using this reaction as a novel, metal-free ,sulfo-click' approach. Copyright © 2009 European Peptide Society and John Wiley & Sons, Ltd. [source] EAACI/GA2LEN guideline: aspirin provocation tests for diagnosis of aspirin hypersensitivityALLERGY, Issue 10 2007E. Ni, ankowska-Mogilnicka Abstract:, Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most common causes of adverse drug reactions. Majority of them are of the hypersensitivity type. The two frequent clinical presentations of aspirin hypersensitivity are: aspirin-induced bronchial asthma/rhinosinusitis (AIA/R) and aspirin-induced urticaria/angioedema (AIU). The decisive diagnosis is based on provocation tests with aspirin, as the in vitro test does not hold diagnostic value as yet. Detailed protocols of oral, bronchial and nasal aspirin provocation tests are presented. Indications, contraindications for the tests, the rules of drug withdrawal and equipment are reviewed. Patient supervision and interpretations of the tests are proposed. [source] Statistical issues in first-in-man studiesJOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES A (STATISTICS IN SOCIETY), Issue 3 2007Professor Stephen Senn Preface., In March 2006 a first-in-man trial took place using healthy volunteers involving the use of monoclonal antibodies. Within hours the subjects had suffered such adverse effects that they were admitted to intensive care at Northwick Park Hospital. In April 2006 the Secretary of State for Health announced the appointment of Professor (now Sir) Gordon Duff, who chairs the UK's Commission on Human Medicines, to chair a scientific expert group on phase 1 clinical trials. The group reported on December 7th, 2006 (Expert Scientific Group on Clinical Trials, 2006a). Clinical trials have a well-established regulatory basis both in the UK and worldwide. Trials have to be approved by the regulatory authority and are subject to a detailed protocol concerning, among other things, the study design and statistical analyses that will form the basis of the evaluation. In fact, a cornerstone of the regulatory framework is the statistical theory and methods that underpin clinical trials. As a result, the Royal Statistical Society established an expert group of its own to look in detail at the statistical issues that might be relevant to first-in-man studies. The group mainly comprised senior Fellows of the Society who had expert knowledge of the theory and application of statistics in clinical trials. However, the group also included an expert immunologist and clinicians to ensure that the interface between statistics and clinical disciplines was not overlooked. In addition, expert representation was sought from Statisticians in the Pharmaceutical Industry (PSI), an organization with which the Royal Statistical Society has very close links. The output from the Society's expert group is contained in this report. It makes a number of recommendations directed towards the statistical aspects of clinical trials. As such it complements the report by Professor Duff's group and will, I trust, contribute to a safer framework for first-in-man trials in the future. Tim Holt (President, Royal Statistical Society) [source] Adverse Event Protocol for Interventional Pain Medicine: The Importance of an Organized ResponsePAIN MEDICINE, Issue S1 2008B. Todd Sitzman MD ABSTRACT Although a significant number of interventional pain therapies are performed in office and fluoroscopy suite settings, the incidence of adverse events associated with these procedures is unknown. To minimize patient morbidity and physician liability, the preparation for and response to such events should follow a standardized protocol. This article provides a detailed protocol for responding to adverse events associated with interventional pain procedures performed in private office or fluoroscopy suite settings. The purposes of this protocol are to ensure quality patient care during and after an adverse event, to promote a better understanding of staff responsibilities at those times, to decrease the likelihood that an adverse event will become life-threatening, to suggest an appropriate format for the documentation of such events, and to reduce the likelihood of the recurrence of adverse events from a similar cause. Adherence to this protocol may also mitigate professional liability. [source] Evaluation of 2407 fetuses in a Turkish populationPRENATAL DIAGNOSIS, Issue 9 2007Gülay Ceylaner Abstract Objectives Congenital anomalies and intrauterine fetal death (IUFD) are frequent problems in pregnancies. Detection of the etiology is important for genetic counseling, and presenting the geographic distribution of the causes of disorders is necessary for a national policy on precautions. Here, we report the findings of terminated fetuses due to IUFD and congenital anomalies in Turkish population. Methods Physical examinations of fetuses and genetic evaluations of families were done. X-ray studies and autopsy were done in the event of necessity. Findings of these studies were combined with prenatal ultrasound results. All cases were classified according to ICD-10. Results The number of fetuses examined was 2407. Out of these, 1268 fetuses had congenital anomalies. Neurologic anomalies and musculoskeletal system malformations were the most frequent disorders. Specific diagnoses were possible in 64% of all multiple malformation syndromes. Abnormal findings were detected in 18.8% of IUFD fetuses. Nine percent had congenital anomalies and 5.2% had cord complications. The percentage of twins and triplets was 7.5% and 13% of them had anomalies. Conclusion Postmortem evaluation is useful to detect findings necessary for genetic counseling. Our protocol is effective especially in fetuses with congenital anomalies but it can detect only some of the fetal reasons in IUFD cases. A more detailed protocol is needed to investigate IUFD cases. Copyright © 2007 John Wiley & Sons, Ltd. [source] The impact of targeted training, a dedicated protocol and on-site training material in reducing observer variability of prostate and transition zone dimensions measured by transrectal ultrasonography, in multicentre multinational clinical trials of men with symptomatic benign prostatic enlargementBJU INTERNATIONAL, Issue 1 2007Philip S. Murphy OBJECTIVE To assess the variability of a standardized protocol of transrectal ultrasonography (TRUS), with targeted training, and compare it to the variability in other multicentre clinical trials, as TRUS-estimated total prostate volume (TPV) and transition zone volume (TZV) are considered important efficacy endpoints in assessing new drug therapies for benign prostatic enlargement (BPE), but standardizing TRUS remains a challenge in such studies. PATIENTS AND METHODS In all, 174 patients with BPE in the placebo arm of a 30-centre clinical trial were analysed at baseline, 13 and 26 weeks with TRUS, to extract TPV and TZV values. All TRUS operators received training in the standardized methods, which was supplemented at the outset by a compact disc-based video. RESULTS The mean (sd) changes from baseline in TPV at 13 and 26 weeks were ,,2.9 (8.9) and ,1.9 (8.5) mL, respectively; the respective mean changes from baseline in TZV were ,1.2 (6.4) and +,0.7 (7.8) mL. For TPV, 80% of the measurements had differences of +,5.2 to ,13.4 mL at 13 weeks, and +,8.0 to ,,10.9 mL at 26 weeks. For TZV, 80% of the differences were +,5.8 to ,,7.4 at 13 weeks, and +,9.3 to ,6.5 mL at 26 weeks. CONCLUSION The performance of TRUS compared favourably with similar published multicentre studies, which we suggest relates in part to the careful implementation of the protocol. We showed that diligent implementation of a detailed protocol, supplemented by targeted training of investigators and provision of on-site training material, promoted consistent acquisition and successful derivation of key clinical trial endpoints. Quantifying the variability of such endpoints will enable us to track deployment quality for future clinical trials, and will ensure that trials are sufficiently powered to define small changes in prostate size. [source] | ||||||||||