[Medical research ethics committees in the Federal Republic of Germany: establishment and integration into medical research].

In Germany, the only research ethics committees (RECs) that are entitled to assess all fields of biomedical research are those set up according to state law by faculties of medicine, medical associations or state authorities. In a multidisciplinary review, research projects are evaluated against the criteria of "scientific quality," "conformity with law" and "ethical and medical acceptability."Since 2004, the "favourable opinion" of an REC and the approval by the competent federal drug authority, jointly constitute a legal condition to conduct drug trials.

[Responsibility and function of Research Ethics Committees].

In Germany, only Research Ethics Committees (REC) set up according to States law at Faculties of Medicine, Medical Associations or States authorities are entitled to assess all areas of biomedical research. In a multidisciplinary review, research projects are evaluated using the criteria "scientific quality", "accordance with law" and "ethical acceptability". Since 2004, the "favorable opinion" of a REC is together with the approval by the competent Federal Authority a legal requirement for drug trials.

[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].

Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community.

Good medical research--the view of the CDBI/Council of Europe.

Medical research aims to achieve a better scientific understanding of health and disease. It is firstly undertaken for the improvement of medical care in general, not excluding a potential direct benefit for participants undergoing such research. There is a traditional conflict between the fundamental rights and the dignity of those participating individuals and the interests of science, researchers and even the society.

[Animal experiment studies on the functional evaluation of hydronephrosis with non-catheter unilateral determination of 131I-hippuran clearance].

In 64 dogs the influence of a sudden unilateral ureteral obstruction on renal blood flow (RBF), on renal extraction of PAH and 131I-hippurate and on kidney function as determined by clearance methods was studied. By measuring the venous blood flow, using the method of Bretschneider, a decrease of the RBF was observed generally although in some cases the RBF remained constant or even increased. The arterial blood flow, controlled by electromagnetic means, showed a tendency to increase but in some cases remained constant or decreased.

[Endoprosthetic treatment of a solitary femoral metastasis in follicular carcinoma of the thyroid (author's transl)].

A radical surgical resection of a metastasis in the upper part of the femur is paradigmatically discussed. The implantation of a so-called tumour endoprothesis yields a functionally sufficient long-time substitute without local relapsing of tumour during time of observation. Further short-term investigation for tumour spreading is necessary.

[Investigations on 131I-hippurate-clearance in obstructive-uropathy; extraction of para-aminohippuric acid and 131I-hippurate in the acutely obstructed canine kidney (author's transl)].

The results of more recent clinical and experimental investigations have thrown doubt on the usefulness of determining the individual 131I-hippurate clearance for evaluation of the function of acutely obstructed kidneys. There is a significant difference (5% level) between the kidney performance determined with external measurement on the one hand and with PAH and 125I-hippurate clearance in the steady state on the other. With the steady state method, the restriction of function to be expected in consequence of urinary obstruction is demonstrated, whereas with simultaneous measurement with catheterless 131I-hippurate clearance, an increase in function is detected.

[The effect of urinary obstruction on the results of catheterless divided 131I hippuran clearance studies (author's transl)].

During catheterless renal 131I Hippuran clearance studies, the function of each kidney can be calculated from the area integral, which is derived from the total body curve and to segments of phase II of each nephrographic curve measured for 120 seconds after the injection. For this it is assumed that the course of this phase depends entirely on the function of the renal parenchyma and is not affected by other factors such as urinary obstruction. During investigations of obstructed kidneys, considerable discrepancies were found repeatedly between clearances calculated by this method and the operative findings of a paper thin renal parenchyma of the kidney in question.

[Treatment of chronic arterial occlusive disease. Clinical study with a new galenic preparation of Pentoxifyllin (Trental 400) (author's transl)].

26 patients suffering from arterial occlusive disease in the legs, stages IIa to IV according to Fontaine classification, and 7 patients with serious vascular disorders in the arm, were treated with daily 3- to 4 X 1 tablet Trental 400 (400 mg Pentoxifylline per tablet) over extended periods. In order to establish the therapeutic efficacy of the drug, influence on microcirculation (133Xenon-muscle clearance), poststenotic blood pressure (Doppler ultrasonic technique), oscillography, walking distance and alteration of clinical stage (following Fontaine classification) were studied. The medication resulted in a significant increase in muscular capillary flow whereby more affected legs showed better response than those initially less impaired.

[Studies on renal clearance measurements by nuclear medicine methods (author's transl)].

Two mathematical models are employed to describe and interpret the time-activity course in the human body outside the reno-vesical compartment of a tracer that has been injected intravenously by the single-shot method and is excreted via the kidneys. From the results a method is derived which permits a practical determination of total clearance. The individual clearance of each kidney is calculated using a simplified method of background (EPA) correction.

[The aid of bone scans in diagnosis of fibrous dysplasia (author's transl)].

Fibrous dysplasia of the bone does not only occur in childhood as commonly believed, but may also be diagnosed during adult life as a stepwise progressing disease. Bone scans are useful to differentiate active from non-active disease. Suspicious accumulations of the radio-pharmaceutical which may be detected by total body scanning, should be confirmed by roentgen examination as a more specific method.

Renal function after ligation of the left renal vein.

In animal experiments the ligation of the left renal vein after nephrectomy on the right side and the ligation of the suprarenal inferior vena cava is explored by four different methods. Degree and length of postoperative renal dysfunction depend on the preliminary ligation or the narrowing of the suprarenal inferior vena cava. The period of adaptation is correlated to the development of a collateral circulation of the left renal vein.

[Therapy simulator for radiotherapy planning].

The ideas prevailing so far with regard to therapy simulators are represented and the type of the simulator used is described; after that, the range of problems a simulator is applied to, is being analysed more detailedly. The use of the simulator is necessary within two phases of irradiation planning: Firstly, to trace that cross-sectional view of the body which is best adapted to dosage planning along with a preliminary adjustment informing upon the beam directions and the field sizes needed. Secondly, to accomplish the final fixation of the needed beam directions and field sizes inclusively the marking of cutaneous fields, a definitive schedule of doses having been laid down before.

[Results of radiotherapy of bronchial carcinoma (author's transl)].

In a joint retrospective study by 17 radiotherapy clinics in German-speaking countries the results of treatment of bronchial carcinoma after radiotherapy were analysed in 7503 cases. The age peak was between the 60th and 70th year. Squamous-cell carcinoma was the most frequent histological type, followed by anaplastic carcinoma, with adenocarcinoma being rare.

[Radiological diagnosis of echinococcus disease in man (author's transl)].

The position of radiological diagnostics in the context of the diagnosis of echinococcosis was discussed on the basis of 11 examined cases of Echinococcus cysticus (9) and Echinococcus alveolaris (2). General thoracic x-rays as well as radiological examination of the gastrointestinal track and the kidneys were used to establish the extent of echinococcosis and to determine the involvement of neighboring organs. Diagnosis of the liver is generally of major interest diagnostically.

[Transferrin variants: significance and identification in paternity cases (author's transl)].

Transferrin phenotypes were determined in 3380 sera of unrelated persons of the western region of Germany with 97.60 percent for TfC and 2.40 percent for Tf variants.