Abstract:
BACKGROUND:The aim of most of the trials of the Competence Network Malignant Lymphoma is to optimize the standard treatment of lymphoma using only registered drugs in the case of medicinal therapies (quality assurance protocols). In contrast to regulatory trials, special regulations for quality assurance protocols are not given by the legislature. However, there is agreement that also for this type of studies the declaration of Helsinki and the Guidelines of the International Conference on Harmonisation (ICH) are relevant. The ICH Guidelines must be formulated to take into account the specific situation of quality assurance protocols and to ensure at the same time efficiency and transparency of these studies. This is the aim of the quality management of the study groups in the Competence Network Malignant Lymphoma. METHOD:The quality assurance measures already established in the study groups are being expanded to a comprehensive quality management concept in agreement with the ICH Guidelines and allowing for the situation of quality assurance protocols. To this end, a working group for quality management (AG-QM) has been set up to define and establish general quality standards for all aspects of planning, executing and evaluating quality assurance protocols in study centers. RESULTS:The AG-QM has developed a system of Standard Operating Procedures (SOPs) reflecting all working procedures of the study centers. Furthermore, evaluation parameters for the quality of trial execution have been identified and the harmonisation of documentation parameters has been initiated. Term definitions are collected and their harmonisation coordinated. CONCLUSIONS:Development of quality standards is the first step of quality management. To ensure the realisation of these standards in practice, the AG-QM will establish quality assurance measures including continuous reevaluation of quality criteria and actualization of quality standards if necessary.
journal_name
Klin Padiatrjournal_title
Klinische Padiatrieauthors
Pfistner B,Mehl C,Klöss M,Löffler M,Herrmann-Frank A,Diehl Vdoi
10.1055/s-2003-45493keywords:
subject
Has Abstractpub_date
2003-11-01 00:00:00pages
341-4issue
6eissn
0300-8630issn
1439-3824journal_volume
215pub_type
杂志文章abstract:OBJECTIVE:To identify obstetric and neonatal risk factors associated with the development of germinal matrix-intraventricular hemorrhage (GM-IVH) in high-risk preterm neonates. METHODS AND PATIENTS:Data from 279 preterm infants (246 mothers) with a gestational age≤28+0 weeks admitted to our NICU between January 2004 a...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0042-111689
更新日期:2016-09-01 00:00:00
abstract:UNLABELLED:We present updated results of stem cell transplantation with highly purified stem cells from haploidentical parental donors and infection with human adenovirus (HAdV) post stem cell transplantation (SCT). Survival post SCT is primarily determined by relapse, infections and far less by GvHD or other transplan...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2005-872530
更新日期:2005-11-01 00:00:00
abstract::Growing teratoma is still an often unsolved problem especially in male with mixed malignant GCTs of the testis or the mediastinum. This specific situation with progressive tumor growth and simultaneous normalization of tumor markers during or after treatment of malignant GCTs with teratomatous elements is judged as a ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0029-1220738
更新日期:2009-05-01 00:00:00
abstract::We studied the influence of preload augmentation on Doppler-derived left ventricular diastolic function parameters in infants with a birth weight <1500 g. In 44 neonates with a closed duct and 29 neonates with an open ductus arteriosus a complete echocardiographic study including Doppler investigations of the mitral i...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2004-817684
更新日期:2004-01-01 00:00:00
abstract::This report describes the case of a 10 days old newborn of a diabetic mother with gestosis, who developed erythema and swelling of the right cheek. A diagnosis of acute suppurative parotitis due to S. aureus was made. Following this case report the most important facts of epidemiology, pathogenesis, clinical manifesta...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2004-822675
更新日期:2005-03-01 00:00:00
abstract::The case of a newborn with duplications of rectum, presenting as a tumor of the labia majora, and duplication of bladder and urethra is reported. In addition malformations from the VACTERL-association (sacral malformation, anal atresia with vestibulum fistula, renal dysplasia, only eleven pairs of ribs with hypoplasia...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1026776
更新日期:1987-03-01 00:00:00
abstract:BACKGROUND:For Thrombasthenia Glanzmann (GT) patients presenting with a severe clinical phenotype due to complete lack of thrombocyte function or increased titres of anti-platelet antibodies hematopoietic stem cell transplantation (SCT) is the only curative therapy. CASE REPORT:We report the case of a 13-month-old boy...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0031-1273726
更新日期:2011-05-01 00:00:00
abstract:BACKGROUND:Transumbilical laparoscopic-assisted appendectomy (TULAA) is fast and cost-effective since no endoloops, staplers or wound protection devices are used. We analyzed the effects of TULAA as first approach for perforated (PA) and non-perforated (NPA) appendicitis in children. PATIENTS:We performed a retrospect...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0044-101622
更新日期:2018-07-01 00:00:00
abstract::Neurofibromatosis type 1 is the most common of the phakomatoses and the clinical follow-up is an interdisciplinary challenge. The data of 27 patients with NF1 were systematically reviewed and compared to data from the literature. All of our patients had clinical signs of NF1. Besides the classic criteria café-au-lait ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2007-973086
更新日期:2007-11-01 00:00:00
abstract:BACKGROUND:After a first afebrile seizure, EEG in addition to cMRI is recommended for pediatric patients. Once indications requiring immediate treatment are excluded, it is of interest to determine if the results provide a prognostic tool for seizure relapses. METHODS:Patients aged between 1 month and 18 years who had...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0034-1394421
更新日期:2015-03-01 00:00:00
abstract::Standards for supine length/height velocity from birth to 16 years (percentiles, mean and standard deviation) are presented, based on the longitudinal growth studies from Bonn and Dortmund. During the first two years of life growth velocity is twice to three times higher as in the following years. Many things point to...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1033752
更新日期:1988-11-01 00:00:00
abstract::Waardenburg syndrome Type I is described on the basis of an observation of a family. The characteristic signs including lateral displacement of medial canthi ("telecanthus"), wide bridge of the nose, white forelock and severe cochlear deafness are found in one female patient only; however, her eyes are not of differen...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1033785
更新日期:1982-03-01 00:00:00
abstract:BACKGROUND:Burning pain of red and warm hands and/or feet are the classical symptoms of erythromelalgia. CASE REPORT:We describe the symptoms of acute idiopathic erythromelalgia and arterial hypertension in a five-year-old boy. Five days after a gastroenteritis the patient developed burning hands and feet in combinati...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1043837
更新日期:1999-11-01 00:00:00
abstract:UNLABELLED:In the prophylaxis of stress ulcers with antacids in young infants there are no recommendations of dosages that consider the physiologic maturation of gastric acid secretion. During the first six month of life the amount of gastric acid secretion in relation to body weight and body surface area increases exp...
journal_title:Klinische Padiatrie
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1055/s-2008-1043985
更新日期:1996-01-01 00:00:00
abstract::Analysis of the cellular DNA content was carried out in 162 children with ALL and 34 children with AML admitted to the university children's hospital Münster between 1979 and 1984. DNA aneuploidies were identified at a similar frequency in ALL (40%) and AML (44%). However, the degree of DNA aneuploidies (DNA-index) wa...
journal_title:Klinische Padiatrie
pub_type: 临床试验,杂志文章
doi:10.1055/s-2008-1033972
更新日期:1985-05-01 00:00:00
abstract:BACKGROUND:Autism spectrum disorders (ASDs) are a group of developmental disabilities in childhood and adolescence. Beside genetic predisposition also environmental influences may contribute to the ASD pathogenesis. Family members of children and adolescents with ASD often ask for specific diets to alleviate ASD-associ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章,评审
doi:10.1055/s-0041-110207
更新日期:2016-03-01 00:00:00
abstract::We report about two patients with compression of the spinal cord caused by lymphosarcomas. In the first patient the tumour was localized in the lumbal region and destroyed two vertebrae. In the second patient the lymphosarcoma also infiltrated the meninx, the cord, and some internal organs. Both children died. ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:
更新日期:1979-03-01 00:00:00
abstract::Comparison of cytogenetic chimaerism was performed in two children after bone marrow transplantation (bmt) with resp. without T-cell depletion for ANLL. It showed a marked delay of full bone marrow function in the patient with a T-depleted graft. Host type bone marrow cells persisted over many months, whereas they dis...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1026783
更新日期:1987-05-01 00:00:00
abstract::During angiogenesis new blood vessels sprout from an existing vascular bed. This is a prerequisite for tumor growth beyond a certain size and for metastasis formation. Tumors produce a number of cytokines. The development of in vivo bio-assays for angiogenesis and in vitro analysis of endothelial cells permits charact...
journal_title:Klinische Padiatrie
pub_type: 杂志文章,评审
doi:10.1055/s-2008-1043960
更新日期:1997-07-01 00:00:00
abstract::In the period from 1965 to 1979 biopsies from the oropharynx of 11 children with non-Hodgkin's lymphoma were collected at the Lymph Node Registry in Kiel. Palatine tonsil tissue was examined in all cases and, in addition, specimens from the retrolingual region of one child and the epipharynx of two patients. All biops...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1034073
更新日期:1983-05-01 00:00:00
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journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2004-816279
更新日期:2005-01-01 00:00:00
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journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1026726
更新日期:1989-07-01 00:00:00
abstract::Prolactin levels were measured immediately after the seizure in some, and 15 to 20 minutes later in all of 67 children aged between 6 months and 17 years. Values were determined after grand mal, complex partial and petit mal seizures and psychogen seizures. A more than 2 to 3 fold prolactin increase over the baseline ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2007-1025341
更新日期:1992-05-01 00:00:00
abstract::Polycythemia vera - the most frequent form of a primary erythrocytosis in adult patients - represents an extremely rare disease in pediatric and juvenile patients as do congenital primary and secondary erythrocytoses. Frequently, in patients with these diseases clinical problems do not occur before adulthood. Systemat...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2004-822628
更新日期:2004-05-01 00:00:00
abstract::The therapy of complicated Kaposiform hemangioendothelioma (KHE) is still difficult. We present the first case of laryngomalacia with simultaneous mammalian target of Rapamycin (mTOR)-positive KHE of the neck and thoracic inlet and concurrent Kasabach-Meritt Phenomenon (KMP) in an 11-month-old boy suffering life-threa...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-0034-1372587
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND:We wanted improve the nutritional status of patients with cystic fibrosis with enteral feeding via a percutaneous endoscopic gastrostomy (PEG). PATIENTS AND METHODS:In a period of 8 years 11 patients underwent a percutaneous endoscopic gastrostomy (PEG), 4 males and 7 females, in the median 14,9 years of ag...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2001-18460
更新日期:2001-11-01 00:00:00
abstract::Reliability and accuracy of the measured ventilatory and lung mechanical parameters of different diagnostic systems (SensorMedics 2600, Med-Science RDS 4500) and respiratory monitoring systems (BI-CORE CP-100, monitor of Babylog 8000) were investigated using a mechanical lung model. The accuracy of pressure and volume...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1046597
更新日期:1994-05-01 00:00:00
abstract:BACKGROUND:Up to now, reliable data has not been available on the actual costs of treating oncological patients. However, such data material is urgently required in view of the institution of the health service reform with the concomitant introduction of the G-DRG remuneration system. PATIENTS:The medical services and...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2003-39379
更新日期:2003-05-01 00:00:00
abstract::The investigation of Immunoglobulins-and Total protein concentrations in saliva of healthy children shows an agreement with literature, a maturation in individual development of the saliva-producing organs in the mouth. ...
journal_title:Klinische Padiatrie
pub_type: 杂志文章
doi:10.1055/s-2008-1035623
更新日期:1980-09-01 00:00:00