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  • 1
    ISSN: 1432-1173
    Keywords: Schlüsselwörter Good clinical practice ; „Null-Arm” ; Arzt-Patienten-Zusammenarbeit ; Key words Good clinical practice ; ”No treatment group” ; Doctor-patient-interaction
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary Guidelines of good clinical practice regulate controlled clinical studies. Goal of the study, type of treatment and possible side effects have to be explained. The physician faces problems, if the study includes a ”no treatment group”. Referring to the literature and based on our own experience with tumor patients, several criteria are proposed to optimize the recruitment of patients. Important points are:  Explanations should be given by an experienced doctor. He must be informed about the study and therapeutic alternative treatments. • The atmosphere for the talk must be quiet. The participation of a person whom the patient trusts is desirable. • The necessity of the study must be explained. Randomization in different study groups should be discussed without any preference. • Prognosis should be explained without any detailed statistical data. • Form of treatment, possible side effects and control examinations have to be discussed. The family physician’s cooperation should be stressed. • Personal autonomy in the patient’s decision to participate in the study must be emphasized. Enough time for reflection must be granted before the final decision. It must be assured that the patient receives the same medical attention even after rejecting the study. These recommendations might help to avoid major mistakes which are harmful for the doctor-patient-relationship and further tumor therapy. A good initial discussion forms the basis for effective cooperation during tumor treatment. It may counteract the personal fear and negative reports in media of being ”a guinea pig”. The patient will appreciate the efforts of the doctor to provide optimal therapy. Furthermore, he will realize that such studies are necessary to improve future therapies.
    Notes: Zusammenfassung Bei der Durchführung von klinischen Studien nach den Richtlinien der Good Clinical Practice (GCP) muß der Patient umfassend über Studienziel, Art der Behandlung und mögliche Nebenwirkungen aufgeklärt werden. Der aufklärende Arzt stößt auf Schwierigkeiten, wenn es sich dabei um randomisierte Studien mit einem sog. „Null-Arm” handelt (keine Therapie, Placebo, nur Operation ohne zusätzliche medikamentöse Therapie). Die Autoren haben aufgrund der Literatur und ihrer eigenen Erfahrungen mit Tumorpatienten Kriterien erarbeitet, die dieses Aufklärungsgespräch effektiver gestalten sollen. Wesentliche Punkte sind: • Die Aufklärung sollte durch einen erfahrenen Arzt, der nicht nur über die Studie, sondern auch über therapeutische Alternativen informiert ist, erfolgen. • Eine ruhige Gesprächsatmosphäre unter Hinzuziehung einer Vertrauensperson des Patienten ist wünschenswert. • Die Notwendigkeit der Studie muß eingehend erläutert werden. Bei mehreren Studienarmen sollte der aufklärende Arzt keine Präferenz erkennen lassen. • Die Prognose ist zu erläutern, ohne jedoch primär exakte statistische Zahlen zu nennen. • Verabreichung der Studienmedikation, mögliche Nebenwirkungen und begleitende Kontrolluntersuchungen sind detailliert zu erklären. Die Kooperation mit dem Hausarzt bei der Durchführung der Studie ist zu besprechen. • Dem Patienten ist die Entscheidungsautonomie zu verdeutlichen. Für die Entscheidung muß ausreichend Bedenkzeit eingeräumt werden. Dem Patienten sollte klar sein, daß er jederzeit seine Entscheidung rückgängig machen kann, und trotzdem die gleiche aufmerksame ärztliche Fürsorge erhalten bleibt. Durch Beachtung dieser Grundsätze können gravierende Fehler vermieden werden, die das Arzt-Patienten-Verhältnis in der Tumortherapie beeinträchtigen. Ein gutes Aufklärungsgespräch als Grundlage für die weitere Zusammenarbeit von Arzt und Patient kann auch dem möglichen Empfinden und Pressemitteilungen entgegenwirken, daß„der Patient ein Versuchsobjekt” sei. Das Bemühen des Arztes um die optimale Therapie wird transparent und der Patient wird verstehen, daß die Studienplanung in seinem Sinne und im Sinne der zukünftigen Therapieverbesserung angeboten wird.
    Type of Medium: Electronic Resource
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  • 2
    Electronic Resource
    Electronic Resource
    Springer
    Der Hautarzt 49 (1998), S. 556-559 
    ISSN: 1432-1173
    Keywords: Schlüsselwörter Tumoren ; Schwenklappenplastik ; Kosmetische Chirurgie ; Key words Tumors ; Rotating flaps ; Cosmetic surgery
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary The closure of large circular defects on the scalp is technically difficult and cosmetically often not satisfying, if a free transplant is necessary. Following the technique of Tillmann described first in 1908, several flaps shaped like a windmill can be combined. We report on 14 patients (ages 41–88 years) where large defects resulting from the excision of various tumors (5 melanomas, 5 basal cell carcinomas, 1 keratoacanthoma, 1 trichilemmal cyst, 1 squamous cell carcinoma, 1 skin metastasis) were successfully closed by this method. The diameter of the defect ranged between 4 and 8 cm (mean 5,7 cm). Size and number of the rotating flaps (3 or 4) was varied according to the size of the defect and the mobility of the surrounding tissue. The procedure was performed with local anesthesia in all cases. Wound healing occurred without complications except in 3 cases. 2 patients (63 years, 70 years) developed small necrotic areas on the tips of the flaps. In a 74 year old man with a very large defect of 8 cm diameter, one flap of four underwent total necrosis. The cosmetic result was rated ”very good” in 71,4% and ”good” in 14,3%. The preservation of the terminal hair turned out to be of special advantage. The ”windmill procedure” is an important addition to the surgical approaches for closure of large defects on the scalp, particularly in young patients.
    Notes: Zusammenfassung Der Verschluß von großen zirkulären Defekten auf dem behaarten Kopf ist technisch schwierig und kosmetisch oft unbefriedigend, wenn ein freies Transplantat verwendet werden muß. Bei der von Tillmann 1908 erstmals beschriebenen Technik werden mehrere Schwenklappen in Form eines Windmühlenmusters kombiniert. Wir berichten über 14 Patienten (Alter 41–88 Jahre), bei denen große Defekte nach Exzision verschiedener Tumoren mit dieser Methode erfolgreich verschlossen werden konnten (5 Melanome, 5 Basaliome, 1 Keratoakanthom, 1 Tricholemmalzyste, 1 Spinaliom, 1 Hautmetastase). Der Defektdurchmesser variierte zwischen 4 und 8 cm (Mittelwert 5,7 cm). Größe und Anzahl der Schwenklappen (3 oder 4) wurden jeweils der Größe des Hautdefektes bzw. der Mobilisationsreserve der Defektumgebung angepaßt. Der Eingriff konnte in allen Fällen in Lokalanästhesie durchgeführt werden. Die Wundheilung war komplikationslos bis auf 3 Fälle: Zwei Patienten (63 Jahre, 70 Jahre) entwickelten umschriebene Lappenspitzennekrosen. Bei einem 74jährigen mit sehr großem Defekt von 8 cm ∅ zeigte ein Lappen von vieren eine vollständige Nekrose. Das kosmetische Ergebnis wurde in 71,4% als „sehr gut” und in 14,3% als „gut” eingestuft. Die Erhaltung des Terminalhaares erwies sich als besonderer Vorteil. Die „Windmühlenplastik” ist eine wichtige Ergänzung der Operationstechniken zum Verschluß großer Defekte auf dem Kapillitium, insbesondere bei jüngeren Patienten.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    Contact dermatitis 2 (1976), S. 0 
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: A procedure has been designed (the chamber-scarification test), which possesses greatly increased sensitivity for assessing the irritancy of topically applied materials. A forearm test site is criss-cross scarified by drawing a 30-gauge needle over the skin with just enough pressure to cleave the epidermis without drawing blood. The test agent is applied in an aluminum chamber once daily for 3 days.The advantages of the method over conventional patch testing are: enhanced capacity to measure mild irritants, reduced time (3 days versus 10 to 21 days), less effort, less cost, less discombort for the volunteers and greater reproducibility.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Based on the information of the interdisciplinary task force on allergy diagnostics in the metal branch, in 2001, the German Contact Dermatitis Research Group (DKG) compiled two metalworking fluid (MWF) test series with currently and previously used components, respectively. After 2 years of patch testing, we present results obtained with these series, based on data of the Information Network of Departments of Dermatology (IVDK). 251 metalworkers who were patch tested because of suspected MWF dermatitis in 2002 and 2003 were included in this retrospective data analysis. Of these, 206 were tested with the current MWF series and 155 with the historical MWF series. Among the current MWF allergens, monoethanolamine ranked 1st with 11.6% positive reactions. Diethanolamine (3.0%), triethanolamine (1.1%), and diglycolamine (1.9%) elicited positive reactions far less frequently. Allergic reactions to p-aminoazobenzene were frequently observed (6.0%), but the relevance of these reactions is still obscure. Positive reactions to biocides ranged from 4.5% for Bioban® CS 1135 to 0.5% for iodopropynyl butylcarbamate and 2-phenoxyethanol. Concomitant reactions to formaldehyde, which caused positive reactions in 3.3%, and formaldehyde releasers occurred to varying extents without conclusive pattern. No positive reactions were seen to dibutyl phthalate, di-2-ethylhexyl phthalate, tricresyl phosphate, isopropyl myristate or benzotriazole. With the historical MWF test series, positive reactions to methyldibromo glutaronitrile (MDBGN) were observed most frequently. However, sensitization via allergen sources other than MWF seems likely, as MDBGN, during the study period, has been one of the most frequent preservative allergens in cosmetics and body care products. Other historical MWF allergens comprised morpholinyl mercaptobenzothiazole (3.3%), benzisothiazolinone (BIT; 2.0%) and Bioban® P 1487(1.3%). BIT is currently used in MWF again, so it was shifted to the current MWF test series. As decreasing reaction frequencies to former MWF allergens that are no longer used can be expected, the historical series should be re-evaluated after some years. The test series with current MWF allergens has to be kept up-to-date based on information from industry and to be kept concise by eliminating test substances which never cause positive reactions.
    Type of Medium: Electronic Resource
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  • 5
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: To support the decision as to whether erythematous patch test reactions to allergens are irritant or allergic, sodium lauryl sulfate (SLS, 0·5% in water) has been added to the standard patch tests since July 1996 in the Dortmund Department of Dermatology. Data on 1600 patients patch tested up until June 2001, as well as standardized data on ambient temperature and humidity obtained by the German Meteorological Service, were included in a logistic regression analysis taking age, sex and atopy as potential confounders into account. The pattern of association was heterogeneous: while doubtful reactions to nickel sulfate were significantly associated with dry/cold weather conditions, but not with SLS reactivity, the opposite was observed for lanolin alcohol, benzocaine and Myroxylon pereirae resin (balsam of Peru). Doubtful reactions to other allergens, namely formaldehyde, fragrance mix or p-phenylenediamine, were associated with both factors. For several other allergens of the standard series, no distinct, significant pattern could be discerned. In conclusion, meteorological conditions and SLS reactivity independently contribute information on individual irritability at the time of patch testing, and both should be considered.
    Type of Medium: Electronic Resource
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  • 6
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Thiuram mix is tested in the standard series at a test concentration of 1% pet. The single thiurams (DPTD, TMTD, TMTM, TETD), however, are usually tested at 0.25% pet. in Germany. In other countries, the individual components of thiuram mix are tested at 1% pet. The German Contact Dermatitis Research Group (DKG) compared both patch test concentrations in 530 patients in order to find out if (i) a significant number of positive patch tests are missed by testing at the lower concentration, (ii) problems with irritant test reactions occur by increasing the test concentration to 1%, and (iii) the sensitivity of the thiuram mix rises when the breakdown test is done with the higher concentration. Slightly more positive reactions were seen with the higher concentration, but this increase did not reach statistical significance. The reaction index, as a measure for the relation of positive to irritant and/or questionable reactions, remained unchanged for the individual thiurams. The sensitivity of the mix also did not change when the breakdown test was performed with 1% pet. instead of 0.25% pet. Thus, we conclude that both concentrations are of equal diagnostic value in patch testing.
    Type of Medium: Electronic Resource
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  • 7
    Electronic Resource
    Electronic Resource
    Oxford, UK : Munksgaard International Publishers
    Contact dermatitis 46 (2002), S. 0 
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Lyral® 5% pet. was tested in 3245 consecutive patch test patients in 20 departments of dermatology in order (i) to check the diagnostic quality of this patch test preparation, (ii) to examine concomitant reactions to Lyral and fragrance mix (FM), and (iii) to assess the frequency of contact allergy to Lyral in an unselected patch test population of German dermatological clinics. 62 patients reacted to Lyral, i.e. 1.9%. One third of the positive reactions were + + and + + + . The reaction index was 0.27. Thus, the test preparation can be regarded a good diagnostic tool. Lyral and fragrance mix (FM) were tested in parallel in 3185 patients. Of these, 300 (9.4%) reacted to FM, and 59 (1.9%) to Lyral. In 40 patients, positive reactions to both occurred, which is 13.3% of those reacting to FM, and 67.8% of those reacting to Lyral. So the concordance of positive test reactions to Lyral and FM was only slight. Based on these results, the German Contact Dermatitis Research Group (DKG) decided to add Lyral 5% pet. to the standard series.
    Type of Medium: Electronic Resource
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  • 8
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    Contact dermatitis 39 (1998), S. 0 
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
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  • 9
    Electronic Resource
    Electronic Resource
    Copenhagen : Munksgaard International Publishers
    Experimental dermatology 9 (2000), S. 0 
    ISSN: 1600-0625
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Abstract: The effect of natural and recombinant interferons (nIFN, rIFN) on cell growth, apoptosis and the production of vascular endothelial growth factor (VEGF) was investigated in the human melanoma cell line IGR 1. We determined cell proliferation, cell vitality, DNA synthesis, apoptosis, intracellular oxygen radicals (ROS) and VEGF-mRNA as well as VEGF-protein levels. rIFN-γ significantly inhibited growth by decreasing DNA synthesis and increasing apoptosis. Less pronounced was the growth inhibitory effect of nIFN-β because an increased rate of apoptosis was outweighed by enhanced DNA synthesis. nIFN-α only had minor effects on cell growth parameters. Under long-term incubation (144 h) nIFN-β decreased, but rIFN-γ increased production of the angiogen VEGF. Our data underscore the multiple effects of IFNs on melanoma cells and may contribute to the understanding of ambivalent results of melanoma therapy by IFNs. Particularly, the increased VEGF production under long-term treatment with serum IFN levels between 100 and 1200 IU/ml should be kept in mind.
    Type of Medium: Electronic Resource
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  • 10
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    Contact dermatitis 16 (1987), S. 0 
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
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