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  • 1
    Electronic Resource
    Electronic Resource
    How to Obtain and Analyze Electrocardiograms in Clinical Trials (1999)
    Oxford, UK : Blackwell Publishing Ltd
    Annals of noninvasive electrocardiology 4 (1999), S. 0 
    Details
    ISSN: 1542-474X
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Prolongation of the QTc interval on the ECG associated with reports of sudden death produced by noncardiac drugs has focused the attention of regulatory authorities on ECG findings from clinical drug development programs. During clinical testing, the nonrigorous, site-specific, and largely uncontrolled methods for performing and analyzing ECGs that is currently practiced should now be reconsidered. Current methods may miss important cardiac electrophysiological effects of new drugs as well as produce false-positive ECG findings that are artifactual and the result of the methods used. The use of a core ECG laboratory that has cardiovascular expertise, state-of-the-art information management technologies, and ECG reading systems that are scientifically validated, quality assured, and precise can cost effectively manage a development program's entire ECG safety program. A.N.E. 1999;4(4):425–433
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1542-474X.1999.tb00233.x
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  • 2
    Electronic Resource
    Electronic Resource
    Electrocardiographic Identification of Drug-Induced QT Prolongation: Assessment by Different Recording and Measurement Methods (2004)
    350 Main Street , Malden , MA 02148 , USA , and 9600 Garsington Road , Oxford OX4 2DQ , UK . : Blackwell Science Inc
    Annals of noninvasive electrocardiology 9 (2004), S. 0 
    Details
    ISSN: 1542-474X
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background: Careful assessment of QT interval prolongation is required before novel drugs are approved by regulatory authorities. The choice of the most appropriate method of electrocardiogram (ECG) acquisition and QT/RR interval measurement in clinical trials requires better understanding of the differences among currently available approaches. This study compared standard and Holter-derived 12-lead ECGs for utility in detecting sotalol-induced QT/QTc and RR changes. Manual methods (digitizing pad and digital on-screen calipers) were compared for precision of QT and RR interval measurement. Methods and Results: Sixteen hundred pairs of serial 12-lead digital ECGs were recorded simultaneously by standard resting ECG device and by continuous 12-lead digital Holter over 3 days in 39 healthy male and female volunteers. No therapy was given on the 1st day followed by 160 mg and 320 mg of sotalol on the 2nd and 3rd day, respectively. Holter-derived and standard ECGs produced nearly identical sotalol-induced QT/QTc and RR changes from baseline, as did the manual digipad and on-screen caliper measurements. The variability of on-screen QT measurement in this study was greater than that of digipad. Conclusions: Digital 12-lead Holter and standard 12-lead ECG recorders, as well as the manual digitizing pad and digital on-screen calipers, are of equal utility for the assessment of drug-induced change from baseline in QT and RR interval, although the variability of the on-screen method in this study was greater than of the digipad.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1542-474X.2004.91546.x
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    New Insights into the Drug Treatment of Ventricular Arrhythmias (1984)
    Oxford, UK : Blackwell Publishing Ltd
    International journal of dermatology 23 (1984), S. 0 
    Details
    ISSN: 1365-4632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-4362.1984.tb04213.x
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  • 4
    Electronic Resource
    Electronic Resource
    SV40 Virus-induced Tumour Specific Transplantation Antigen in Cultured Mouse Cells (1970)
    [s.l.] : Nature Publishing Group
    Nature 227 (1970), S. 141-145 
    Details
    ISSN: 1476-4687
    Source: Nature Archives 1869 - 2009
    Topics: Biology , Chemistry and Pharmacology , Medicine , Natural Sciences in General , Physics
    Notes: [Auszug] The new transplantation antigen in SV40 transformed cells is found in highest concentration in immunogenic membrane-rich subcellular fractions, and has been ...
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1038/227141a0
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  • 5
    Electronic Resource
    Electronic Resource
    THE ATHLETE'S HEART SYNDROME: A NEW PERSPECTIVE (1977)
    Oxford, UK : Blackwell Publishing Ltd
    Annals of the New York Academy of Sciences 301 (1977), S. 0 
    Details
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1749-6632.1977.tb38259.x
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  • 6
    Electronic Resource
    Electronic Resource
    Computer Recognition of Cardiac Arrhythmias and Statistical Approaches to Arrhythmia Analysis (1984)
    Oxford, UK : Blackwell Publishing Ltd
    Annals of the New York Academy of Sciences 432 (1984), S. 0 
    Details
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1749-6632.1984.tb14514.x
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  • 7
    Electronic Resource
    Electronic Resource
    Determination of antiarrhythmic drug efficacy in the treatment of ventricular arrhythmias (1990)
    Springer
    Cardiovascular drugs and therapy 4 (1990), S. 669-673 
    Details
    ISSN: 1573-7241
    Keywords: Holter monitoring ; ventricular arrhythmias ; antiarrhythmic drugs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The presence of ventricular arrhythmias mark an individual with underlying structural heart disease as a candidate at high risk for sudden cardiac death. It is still unknown whether suppression of those ventricular arrhythmias by all drugs will in fact prevent sudden cardiac death. Therefore, the efficacy of an antiarrhythmic drug at present must be defined as only its pharmacologic activity that relates to its ability to reduce the frequency of ventricular arrhythmias rather than to a potential beneficial effect on patient outcome. Ventricular arrhythmias can be differentiated using a prognostic classification into those that are benign, potentially lethal, or lethal. Benign and potentially lethal ventricular arrhythmias undergo a high degree of spontaneous variability, and therefore the degree of frequency suppression needed to differentiate drug suppression from spontaneous variability must be carefully considered. It therefore is important to establish the mean ventricular premature complex frequency per hour over at least 24 hours at baseline using quantitative continuous ambulatory electrocardiographic (Holter) monitoring. To eliminate spontaneous variability, a repeat Holter monitoring session after the initiated therapy has reached steady state should show at least a 75% reduction in the mean VPC/hr frequency and at least a 90% suppression in the number of beats in the form of nonsustained ventricular tachycardia (NSVT). Exercise testing is a complementary technique and is best suited for patients with NSVT developing during exercise testing from either a “catecholamine” or an “ischemic” mechanism. Efficacy at present should be defined as abolition of that arrhythmia in light of the high spontaneous variability of such dysrhythmias on exercise testing. Programmed electrical stimulation is probably the most effective means of defining therapeutic efficacy in patients with lethal ventricular arrhythmias where the most conservative definition of efficacy is abolition of the inducible ventricular tachycardia on therapy compared to baseline. Definitions for proarrhythmia due to antiarrhythmic drug therapy (the opposite of efficacy) have been established. Until we know that suppression of ventricular arrhythmias can in fact prevent sudden cardiac death, the definition of drug efficacy must be relegated to statistical pharmacologic approaches.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01856553
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  • 8
    Electronic Resource
    Electronic Resource
    Sensitivity to atypical mycobacterial antigens in patients with Crohn's disease (1970)
    Springer
    Digestive diseases and sciences 15 (1970), S. 653-657 
    Details
    ISSN: 1573-2568
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Twenty-two patients with Crohn's disease were investigated for the presence of delayed cutaneous reactions and precipitating antibodies to atypical mycobacterial antigens of Runyon's Groups I, II and III as well as standard PPD. The results obtained, when compared to the control groups, do not show an increased incidence of sensitivity to such antigens in patients with Crohn's disease. However, their potential relevance to the pathogenesis of this disorder remains to be determined.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02236026
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  • 9
    Electronic Resource
    Electronic Resource
    Cellular and humoral sensitivity to gluten fractions in patients with treated nontropical sprue (1972)
    Springer
    Digestive diseases and sciences 17 (1972), S. 205-212 
    Details
    ISSN: 1573-2568
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The presence of circulating antibodies and lymphocyte response to gliadin and fraction III were measured in three groups of 12 patients each. Group I consisted of patients with nontropical sprue maintained on a gluten-free diet; Group II contained patients with other gastrointestinal diseases manifesting malabsorption and Group III was composed of normal controls. Rabbits immunized to both antigens provided positive controls for each method of antibody determination. Results agree with those previously reported in that negligible antibody titers were present to either antigen in normals, patients with other forms of malabsorption or patients with nontropical sprue maintained, for some time, on a gluten-free diet. Lymphocyte stimulation failed to occur with either gluten fraction although the hyporesponsiveness to phytohemagglutinin, previously reported by others, was not observed. Further studies are needed in patients with nontropical sprue following controlled antigenic challenge. Antibody levels in jejunal fluid should also be studied. Until such studies are carried out, evaluation of immunologic factors in the pathogenesis of nontropical sprue will be incomplete.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02232292
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