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Background: The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization., Methods: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization., Results: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12)., Conclusion: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS., Gov Identifier: NCT02183454., (Copyright © 2019 Elsevier B.V. All rights reserved.)

The article introduces an ambient intelligence system for blind people which besides providing assistance in home environment also helps with various situations and roles in which blind people may find themselves involved. RUDO, the designed system, comprises several modules that mainly support or ensure recognition of approaching people, alerting to other household members' movement in the flat, work on a computer, supervision of (sighted) children, cooperation of a sighted and a blind person (e.g., when studying), control of heating and zonal regulation by a blind person. It has a unified user interface that gives the blind person access to individual functions. The interface for blind people offers assistance with work on a computer, including writing in Braille on a regular keyboard and specialized work in informatics and electronics (e.g., programming). RUDO can complement the standard aids used by blind people at home, it increases their independence and creates conditions that allow them to become fully involved. RUDO also supports blind people sharing a home with sighted people, which contributes to their feeling of security and greater inclusion in society. RUDO has been implemented in a household for two years, which allows an evaluation of its use in practice., Competing Interests: The authors declare no conflict of interest.

Objective: The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied., Methods: Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated., Results: A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001)., Conclusions: PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575)., Trial Registration Number: NCT02629575., Competing Interests: Competing interests: FK received lecturing fees, and MWW and MB served full time employment at the Department of Medical Scientific Affairs, B. Braun Melsungen AG.

Background: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease., Methods: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed., Findings: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (p non-inferiority <0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; p superiority <0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010)., Interpretation: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment., Funding: Isala Heart Centre and Medtronic., Competing Interests: Declaration of interests EKe reports institutional research grants from Abbott Vascular Laboratories and Medtronic and proctor or lecture fees from Abbott Vascular. RSH reports lecture fees from Abbott Vascular, Amgen, Novartis, Edwards Lifesciences, and Meril. DvG reports lecture fees from Cardiovasculair Onderwijs Instituut. GA reports lecture fees from Medtronic, Abbott, and Meril Life, patents planned for Tdaflo, and being a data and safety monitoring board member for Vivasure. IJA-S reports proctor, lecture, and consultant fees from Medtronic, Boston Scientific, Meril Life, and Products&Features. MA reports institutional research grants from Edwards, Abbott, Medtronic, and LSI, and proctor, lecture, and consultant fees from Edwards Lifesciences, Abbott, Medtronic, Boston, Zoll, and BBraun. GB reports a consulting grant from Medtronic. LC reports consulting fees from Medtronic, Abbott, JenaValve, Edwards Lifesciences, BostonScientific, PiCardia, MicroPort, VenusMedtech, 4C Medical, Smartcanula, MicroInterventions, and Neovasc, support for attending meetings or travel (or both) from Medtronic, Abbott, JenaValve, Edwards Lifesciences, and BostonScientific, and being a data and safety monitoring board member for Medtronic, Abbott, and JenaValve. LvG reports proctor fees from Edwards Lifesciences and support for attending meetings or travel (or both) from Edwards Lifesciences, Corcym, and Atricure. WW reports lecture fees from Medtronic and is a data safety monitoring board member for Medtronic. VV reports consulting fees from Medtronic. JS reports lecture fees from Abiomed. EL reports institutional research grants from Abbott. LN-F reports consulting fees from Abbot, Edwards Lifesciences, and Boston, and proctor, lecture, and consultant fees from Abbott, Edwards Lifesciences, Medtronic, and Boston. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: The aim of this study was to determine the long-term symptom control after laparoscopic fundoplication for gastroesophageal reflux disease (GERD), and possible prognostic factors., Methods: A cohort of 271 patients, operated on at a university hospital from 1996 through 2002, was eligible for evaluation after a median interval of 102 months (range = 12-158). The time between surgery and recurrence of reflux symptoms (i.e., time to treatment failure) served as the end point for statistical analysis. Putative risk factors for symptom recurrence were analyzed by univariate analysis and by using Cox's multiple-hazards regression., Results: According to Kaplan-Meier estimates, the rate of reflux symptom recurrence was 15 % after 108 months, 11 % in cases without intestinal metaplasia, but 43 % in patients with long-segment (≥ 3 cm) Barrett's esophagus (BE; p < 0.0001). Reflux symptoms recurred in 22 % of cases with a hiatal hernia (HH) ≥ 3 cm before operation, but only in 7 % with smaller or absent HH (p = 0.005). Multivariate analysis revealed a relative risk of 6.6 (CI = 3.0-13.0) for long-segment BE and 3.0 (CI = 1.7-10.1) for HH ≥ 3 cm. A strong statistical interaction was found between HH ≥ 3 cm and long-segment BE: the small group (n = 18) of cases exhibiting both risk factors had an exaggerated recurrence rate of 72 % at 108 months., Conclusions: Laparoscopic fundoplication for symptomatic GERD provided a long-lasting abolition of reflux symptoms in 231 of 271 (85 %) patients. HH ≥ 3 cm and long-segment BE were shown as independent prognostic factors favoring recurrence.

Background: Immunomagnetic EpCAM based methods are used to enrich circulating tumor cells (CTCs) in metastatic breast cancer (mBC) patients. EpCAM negative CTCs may be missed. We addressed the question of the reliability of an EpCAM dependent assay to enrich CTCs., Methods: To elucidate this issue, our study has been designed to assess two different CTC enrichment technologies (i) in EpCAM positive (+) and EpCAM negative cell lines and (ii) in mBC patients in dependency on their respective EpCAM expression. These two technologies encompass one anti-EpCAM immunomagnetic enrichment technology, MACS HEA MicroBeads(®) (MACS), and one EpCAM independent density centrifugation method, OncoQuick(®) plus (OQ+). Furthermore, the coherence between EpCAM expression in the primary tumor tissue of mBC patients and the CTC detection rates in the corresponding patients is analyzed., Results: (i) MACS recovered significantly more EpCAM (+) than EpCAM (-) tumor cells (p < 0.001) in spiked blood samples. With OQ+ no significantly different recovery rates between EpCAM (+) and EpCAM (-) tumor cells (p = 0.796) were detected. (ii) In mBC patients MACS yielded a significantly higher (p = 0.024) detection rate of EpCAM (+) CTCs. No statistically significant difference (p = 0.070) was found concerning the EpCAM status-based detection rate of CTCs by OQ+. (iii) CTC detection rates are independent of the primary tumors' EpCAM expression., Conclusions: EpCAM (-) CTCs can not be detected by immunomagnetic EpCAM dependent enrichment methods. EpCAM independent enrichment technologies seem to be superior to detect the entire CTC population. Evaluation of CTCs as prognostic marker should compromise EpCAM (+) and (-) subpopulations.

An adjuvant chemotherapeutic standard has not been identified in triple negative breast cancer (TNBC) yet. One hundred and forty-one adjuvant treated TNBC patients had a median follow-up of 71 months. Larger tumor size (p = .005) and positive lymph-node status (p = .033) were associated with a significant shorter overall survival. Sixty-one percent of patients received anthracycline-containing chemotherapy, 28.4% a non-anthracycline-containing regimen, and 10.6% an anthracycline/taxane-containing regimen. Overall survival, disease-free survival, local recurrence-free survival and distant disease-free survival did not differ between the chemotherapeutic groups. Non-anthracycline-containing regimen appeared to be an effective treatment in TNBC.

Comprehensive in vitro and in vivo studies comparing EpCAM-based methods with other cytometric CTC enrichment technologies in metastatic colorectal cancer (mCRC) patients are lacking. We compare four manual cytometric methods to detect CTCs in vitro and in mCRC patients. The EpCAM-based technology, MACS HEA MicroBeads((R)), showed a significant better tumor cell recovery rate compared to other cytometric methods (p-value<0.0001). CTCs of 38 mCRC patients were enriched with MACS HEA MicroBeads(R). Progression-free survival did significantly differ between mCRC patients without detectable and with >or= 1 CTCs (p=0.007). CTC enrichment with EpCAM coupled antibodies is superior to other cytometric methods and is a feasible method for CTC detection in mCRC patients.

Background: The aim of this retrospective study was to analyse the MGMT (0(6)-methylguanine-DNA methyltransferase) promoter methylation status in long-term surviving (≥ 3 years) patients with glioblastoma multiforme (GBM)., Methods: The methylation status of the MGMT promoter was determined by bisulfite modification of the DNA and subsequent methylation-specific polymerase-chain-reaction (MSP). DNA was extracted from routinely formalin-fixed and paraffin-embedded tumour tissue samples., Results: MSP yielded interpretable results in only 14 of 33 (42%) long-term surviving patients with GBM. A methylated band was seen in 3 of 14, methylated as well as unmethylated bands in 8 of 14 and an only unmethylated band in 3 of 14 patients, thus, yielding MGMT promoter methylation in 11 of 14 patients. The two groups of patients with methylated and unmethylated MGMT promoter status were too small to draw any firm statistical conclusions., Conclusions: Long-term surviving patients with GBM have very frequently intratumoural MGMT promoter methylation. This phenomenon discriminates long-term survivors from a non-selected group of patients with GBM. The standardization of the MSP for the determination of the MGMT promoter methylation status seems to be necessary in order to make this methodology a more reliable one.

Background: Cell cycle progression is regulated by cyclin dependent kinases (cdk) and cdk inhibitors. Recent immunohistological studies suggested that dysregulation of cyclin A, cyclin D, cyclin E, p16(ink4), p21(waf1/cip1), and p27(kip1) are of prognostic value in patients with breast cancer. Our study represents the first comprehensive immunohistochemical cell cycle marker analysis for cdc25A, cyclin A, cyclin D, cyclin E, p16(ink4), p21(waf1/cip1), p27(kip1), and pRb in tumor tissue and adjacent benign breast tissue from 69 primarily untreated breast cancer patients., Methods: Immunhistochemistry using primary monoclonal antibodies to detect cdc 25A, cyclin A, cyclin D, cyclin E, p16(ink4), p21(waf1/cip1), p27(kip1), and pRb has been performed., Results: Sixty-nine patients with untreated, invasive breast cancer (n = 69) were divided into a low/ intermediate and a high risk group according to the St. Gallen 2005 consensus conference. High risk patients (n = 22) had a significantly (p = 0.003) shorter mean and median survival (282.85 weeks; 383.0 weeks, respectively) than low/intermediate risk patients (375.41 weeks; not reached yet, respectively). A subgroup of high risk breast cancer patients characterized in addition by overexpression of cdc25A, cyclin A, cyclin E, p16(ink4a), and p27(kip1) experienced a shortened mean survival of 222.03, 235.71, 257.25, 239.18, and 261.94 weeks, respectively. Regarding benign breast tissue adjacent to breast cancer tissue, 59.4% of the patients investigated overexpressed cdc25A, 23.2% overexpressed pRb, and 63.2% exerted dysregulation of p27(kip1) while they proved to be negative for immunohistochemical staining regarding all other markers tested., Conclusion: The immunohistological analyses of cdc25A, cyclin A, cyclin E, p16(ink4a), and p27(kip1) have the potential for further refining the risk assessment in patients with untreated breast cancer who belong to the high risk category defined according to the St. Gallen 2005 consensus conference. These cell cycle markers define a subgroup of high risk patients with even higher risk of metastazation and shortened survival. For confirmation a prospective study using standardized laboratory procedures in a larger population is needed.

Objective: The objective of this study is to establish clinical evidence that the p53 genotype can serve as a predictive marker for response to cisplatin-based induction therapy., Methods: Patients with advanced non-small cell lung cancer who had received neoadjuvant chemotherapy in the context of a prospective phase II trial were analyzed for the p53 genotype of their tumors. Response to induction therapy was then correlated to the p53 genotype as assessed by complete direct DNA sequencing. Patients had received 3 cycles of cisplatin and etoposide, and 1 cycle of simultaneous radiochemotherapy. All 3 treatment components mediate their cytotoxic effect through induction of apoptosis, which is suggested to require an intact p53 gene. In addition, the results from a previously published hypothesis-finding study are updated to demonstrate the consistency of clinical results and summarize currently available clinical evidence., Results: In the phase II trial, 35 patients underwent resection after induction chemotherapy, allowing a pathohistologic response assessment. The presence of a mutant p53 genotype was highly indicative of resistance to induction chemotherapy (P < .002). The sensitivity of a mutant p53 genotype to identify nonresponders was 94% (71.3-99.9 confidence interval). A normal p53 gene was significantly associated with radical resection (P < .004) and survival advantage (P = .02)., Conclusion: This is the second clinical evaluation demonstrating a significant relation between p53 genotype and response to induction therapy in non-small cell lung cancer. We conclude that the p53 genotype should be evaluated as a predictive marker for response to induction therapy in prospective randomized protocols.

The efficacy and tolerability of docetaxel 100 mg/m(2) every 3 weeks as second-line chemotherapy in patients with metastatic breast cancer was investigated. In addition, the efficacy of a 3-day prophylaxis against cumulative dose-related fluid retention was examined with methylprednisolone 32 mg twice daily for 3 days starting 12 and 3 h before the docetaxel infusion together with oral cetirizine 10 mg 12 and 3 h before start of docetaxel for prevention of acute hypersensitivity reactions. According to the intent to treat-analysis 35% (95%CI: 25; 46) of the 94 patients entered responded to therapy. Their median survival was 12 months (range 0-20 months). The respective response rate for the 87 patients eligible for response evaluation was 37% (95%CI: 27; 48). Their median duration of response was 8 months (range 3-12 months), their median time to progression was 4 months (range 1-12 months). The corresponding response rate in the eligible patient cohort with anthracycline-resistant disease was 28% (95%CI: 15; 45) and increased to 44% (95%CI: 30; 59) in the cohort with non-anthracycline-resistant disease. Patients with visceral metastases responded in 36% and patients with > or = 3 organs involved in 33%. In a retrospective analysis, the 3-day premedication of corticosteroids and antihistamines proved to be as effective as the established but more toxic 5-day regimen in delaying and preventing the occurrence of docetaxel derived toxicities especially the cumulative fluid retention. In conclusion, docetaxel represents one of the most active agents for second-line treatment of metastatic breast cancer, especially for anthracycline-resistant patients. Due to comparable effectiveness of the 5-day regimen which is widely used by others and the 3-day premedication tested in this trial the latter proved to be more favourable and was therefore recommended for future therapies.

We report the case of a 56 year old male with hereditary haemochromatosis complicated by hepatic cirrhosis, insulin treated diabetes mellitus, hypogonadism and secondary hypothyroidism, the latter which was corrected by iron depletion. This is only the second such case to be reported.

In this contribution we discuss some fundamental aspects of biostatistics in the context of research in clinical oncology. Starting with a general presentation of basic principles of confirmatory statistics we deal with specific questions which typically arise in practical situations. This covers the importance of prespecification of statistical analyses before looking at the data as well as the judgment of multiple p-values and the interpretation of subgroup analyses. Subsequently we propose essential principles and techniques for the design and analysis of controlled clinical trials, which are relevant to achieve valid results with regard to cause-effect relationships from clinical observations. We specifically point out that an exact definition of the whole research design together with the methods of analysis and evaluation as well as planning of interim analyses and possible termination strategies have to be defined clearly in advance. General hints with regard to reporting standards conclude this chapter. In the final chapter we discuss general ideas behind meta-studies and demonstrate by means of a small example some basic analytical techniques for the summarization of single study results., (Copyright 2008 S. Karger AG, Basel.)

Arterial chemoembolization with subsequent systemic chemotherapy was assessed prospectively. Of 94 consecutive patients with HCC, 31 patients were considered to have inoperable disease and were selected for chemoembolization. Twenty-two of the 31 patients underwent chemoembolization. In eight patients, technical problems with catheterization prevented the application of therapy, and one patient rejected further treatment. Regimen: Three monthly cycles of chemoembolization with cisplatin 20 mg/m(2) mixed with lipiodol delivered intraarterially with Gelfoam or collagen on day 1, followed by intravenous chemotherapy with cisplatin 60 mg/m(2) on day 2; interferon alpha-2c 30 microg (10 M IU) subcutaneously on days 2, 5, 9, and 12. Three percent of the patients (1/31) (CI 95% 0.08; 16.7) experienced a partial clinical response, in 53% alpha-fetoprotein levels decreased by more than 50%. On univariate analysis, performance status, Child score, Okuda stage, albumin levels, and lactate dehydrogenase were found to have an effect on survival. Postchemoembolization syndrome occurred in 68% of the patients, nausea/vomiting grades 3/4 (according to the World Health Organization WHO) in six patients, anemia grade 3 in three patients, leukopenia grade 3 in one patient and thrombocytopenia grade 3 in one patient. This treatment regimen is a very selective procedure. Because of the low response rate it is not recommended for routine clinical use.

Background: The objective of this Phase II study was to assess the clinical activity and toxicity of docetaxel (D) and cisplatin (P) in patients with locally advanced unresectable, metastatic, or recurrent squamous cell carcinoma of the head and neck (SCCHN)., Patients: Of 34 patients, 30 were eligible for treatment with D 80 mg/m(2) on Day 1 and P 70 mg/m(2) on Day 2. Therapy was repeated every 3 weeks. At the start of chemotherapy, the tumors had the following extensions: locoregional, n = 15; distant metastatic, n = 2; and relapse, n = 13., Results: Overall, the rate of objective responses in the population of all eligible patients based on an intention-to-treat analysis was 53%, with a 95% confidence interval (CI; 34.33-71.66%). Two patients had complete disease remission (pathologic), 4 patients had complete disease remission (clinical), 10 patients had partial disease remission, 3 patients had no change in disease status, and 7 patients had disease progression. The duration of objective response was median 5+ months (range 3-8+ months). Eleven patients (37%) had Grade 4 granulocytopenia and three patients (10%) had Grade 3 granulocytopenia (grades were based on the classification of the National Cancer Institute of Canada-Common Toxicity Criteria). Six patients died of septicemia., Conclusions: Overall, the combination of D and P represents a highly active chemotherapeutic regimen for the treatment of patients with SCCHN. However, because of the high toxicity of this regimen, prophylactic administration of antibiotics and hematopoietic growth factors is essential as is a three-day corticosteroid premedication regimen. Above all, this combination of drugs is not recommended for treatment of patients with a World Health Organization performance status of >1., (Copyright 2002 American Cancer Society.)

Histologic examination of an excisionally biopsied botryoid odontogenic cyst (BOC) documented that it was composed of at least 2 separate cysts, the location of which suggested that both originated within the alveolar bone rather than from within the periodontal ligament. These observations provide evidence for a multicentric origin of this example of BOC, and are consistent with a previous suggestion that lateral periodontal cysts of non-inflammatory origin arise from remnants of the dental lamina.

Calcium carbonate is added to fermentation media in biosynthesis of tetracyclines for providing definite pH values and binding tetracycline into insoluble complexes. Seven different samples were studied with respect to their physical properties, such as the microscopic size of the particles, their form, capacity for agglomeration, specific volume, rate of the particle precipitation and chemical properties, such as purity, buffer capacity, effect on the medium pH before and after sterilization. The above properties were studied in comparison with activity chlortetracycline biosynthesis. Microfine calcium carbonate proved to be the best from the point of view of productivity of Str. aureofaciens. With its use the activity of the culture fluid increased by 20 per cent as compared to the other samples. The titration curve of the sample had the lowest bend.

The authors in their work present some of the most common causes in breakage of osteosynthetic material. They emphasise the quality of the material is mainly satisfactory but the material should be from the same factory. Exhaustion of the material and corrosion are two of the common causes of the osteosynthetic material breakage. However uncorrect application and errors during the operation are the most common causes of breakage. The mechanical differences of the intramedullar nail and plate as two of the most used materials and their influences are explained. The most common errors which appear during the performance of opperation are explained to.

In a multicentre, retrospective observational study on carcinomas of the oral cavity, including the lips and oropharynx, data material of 1021 patients has been analysed. The specific goals of this study were: Review of existing proposals for classification. Analysis of prognostically relevant factors of the tumour disease. Construction of a prognostic index for the determination of individual and collective prognoses. The following results were achieved: ad 1: All existing TNM-Classifications of oral cavity carcinomas so far fail to meet the requirements of the necessary criteria. ad 2: The multivariate analyses of prognostically relevant factors were performed with and without taking therapeutic factors into account. The results show unequivocally that reliable prognoses are only possible if various treatment modalities are considered. ad 3: This led to the construction of the treatment-dependent prognostic index TPI, which will be eligible for use in clinical-therapeutic cancer research and in clinical practice.

Serum C-reactive protein (CRP) and alpha 1-acid glycoprotein (AAG) levels were studied in 188 patients undergoing heart operations with cardiopulmonary bypass. Mediastinitis or osteomyelitis of the sternum or both developed in 10 patients on postoperative day 4 to 13 (median, day 9). The mean CRP levels on day 2 were lower in patients with later deep sternal wound infection (9.1 +/- 1.5 mg/dl [mean +/- standard error]) compared with patients without major infections (14.0 +/- 0.8 mg/dl; p = 0.103 [univariate logistic regression]). AAG levels on day 2 reacted in a similar manner, yielding 78.2 +/- 5.5 mg/dl and 100.9 +/- 2.7 mg/dl, respectively (p = 0.0004). No correlation was found between CRP or AAG and duration of cardiopulmonary bypass, number of blood transfusions, or total protein levels on day 2. The white blood cell count (WBC) on day 2 was 13.1 +/- 1.7 X 10(3)/microliter for patients with infection and 9.7 +/- 0.3 for those without infection. Multivariate logistic regression analysis revealed that AAG, WBC, and CRP on day 2 were significant risk factors sufficiently predicting the probability of a deep sternal infection. After adjustment for these three variables, other variables (age, sex, total protein on day 2, diabetes mellitus, type of operation, duration of cardiopulmonary bypass, length of operation, repeat thoracotomy for bleeding, number of blood transfusions on the day of operation, intraaortic balloon pumping, reoperation, emergency operation, and surgeon's professional status) were not of additional significance. The goodness of fit of the statistical model was confirmed by a high correspondence between predicted and observed cases of deep sternal infection.(ABSTRACT TRUNCATED AT 250 WORDS)

In 30 anatomical specimens of the forearm the dynamic fracture of radius has been performed with a special hammer. In these specimens the pure kinetic energy of the fracture of the radius and the absorption of the impact energy in the palmar soft tissues has been determined.

The "Treatment Dependent Prognostic Index" (TPI), which has been published by the authors in 1982 as a result of a retrospective observational study of the DOSAK (German-Austrian-Swiss Association for Head and Neck Tumors), is submitted to a critical review. For this purpose a sample of 1485 patients representing the "Prospective DOSAK-Study on Squamous Cell Carcinomas of the Lips, the Oral Cavity and the Oropharynx" were classified according to TPI. 13 TPI groups exhibited greater than or equal to 20 patients and were suitable for calculation of observed survival and comparison to their TPI prognoses. In 10 of 13 TPI groups observed and predicted survival are almost identical. 3 TPI groups show a considerable lack of correspondence between observation and prognosis. In general, the analyses revealed a high prognostic validity of TPI in its substantial parts. A further improvement of TPI by taking several tumor sites into consideration seems possible and will be a subject of future investigations.

In a multicentric, retrospective observational study on carcinomas of the oral cavity including the lips and the oropharynx a data material of 1021 patients has been analyzed. The specific goals of this study were: Review of existing proposals for classification; Analysis of prognostically relevant factors of the tumor disease; Construction of a prognostic index for the determination of individual and collective prognoses. The following results were gained: None of the TNM-classifications of oral cavity carcinomas does the necessary criteria justice not even approximately. The multivariate analyses of prognostically relevant factors were performed with and without taking therapeutical factors into account. The results unequivocally show that reliable prognoses are only possible under consideration of various treatment modalities. This led to the construction of the treatment-dependent prognostic index TPI, which will be eligible for the use within the clinical-therapeutical cancer research and within the clinical practice.

The capillary assay for quantitative characterization of bacterial motility and chemotaxis is analyzed in terms of a mathematical model for cell population migration, in order to determine values for the cell random motility coefficient, mu and the cell chemotaxis coefficient, chi. The analysis involves both analytical perturbation methods and numerical finite-difference techniques. Transient cell density profiles within the capillary tube are determined as they depend upon micro and chi, providing a means for estimating micro and chi from the common protocol measurements of cell accumulation in the tube at specified observation times. The effects of extraneous factors such as assay geometry, stimulus diffusivity, bacterial density, and observation time are thus separated from the intrinsic cell-stimulus interaction and response. This allows independent population measurements of cell chemosensory movement properties to be extrapolated to situations involving growth and competition of populations, for purposes of better understanding microbial population dynamics in systems of biotechnological and microbial ecological importance.

Risk factors for severe bacterial infections, that is, deep sternal wound infection, pneumonia, septicemia, and prosthetic valve endocarditis, were evaluated in 246 consecutive patients undergoing valve replacement (N = 84) or aortocoronary bypass operation (N = 162). Multiple logistic regression analysis was applied to determine the ability of putative risk factors to predict infection. The risk factors considered were age, sex, diabetes mellitus, duration of cardiopulmonary bypass (CPB), duration of operation, amount of blood restored on the day of operation, repeat thoracotomy for bleeding, intraaortic balloon pumping, reoperation, emergency operation, and the professional status of the surgeon. Severe infections occurred in similar frequency after valve replacement (8/84; 9.5%) and aortocoronary bypass (11/162; 6.8%). For patients who had a bypass procedure, repeat thoracotomy was the only factor significantly associated with infection (p = 0.0004). However, the classification analysis revealed that this variable alone is too unspecific for a reliable prediction. Univariate analysis indicated that restoration of more than 2,500 ml of blood (p = 0.0001), reoperation (p = 0.0821), duration of operation (p = 0.0061), duration of CPB (p = 0.0318), and intraaortic balloon pumping (p = 0.0281) were associated with infection following valve replacement. A model with three variables emerged from the multiple logistic regression: after correction for blood restoration, reoperation, and duration of CPB, no other variable was of additional predictive value. For patients who underwent valve replacement, the model performed well in predicting complications. The classification analysis revealed a high correspondence between observed and predicted instances of infection: it correctly predicted 75% of the patients with infection and 96% of those without infection.(ABSTRACT TRUNCATED AT 250 WORDS)

The specific problems of biostatistical evaluation of adjuvant therapy are discussed. These problems arise from the fact that the effect of adjuvant therapy is usually rather small; in particular, for many kinds of cancer it is smaller than the variability in prognosis among patients due to different prognostic factors. Knowledge about prognostic factors for a particular type of cancer is therefore an essential precondition for the correct planning of controlled clinical trials. The importance of prognostic factor studies is stressed and it is shown how results of such studies can be utilized for the design of efficient trials for adjuvant therapy assay. The results of the retrospective DOSAK study on carcinomas of the oral cavity are reported. Based on a sample of 1021 patients in this study, numerous prognostic factors were analysed by both univariate and multivariate statistical techniques. On the basis of these analyses, a prognostic index was developed which should be a valuable aid for the design of clinical trials.

In a retrospective study, on a sample of 1021 patients with carcinoma of the lips, oral cavity and oropharynx, the clinically available factors at the time of the patient's first admission are analysed with reference to their prognostic relevance. Prognostically relevant factors are determined by both univariate and multivariate analyses. Of the 18 factors analysed, the following seven finally proved to be prognostically relevant: tumour size, degree of infiltration, degree of histological differentiation and site by organ of the primary tumour, the combination of evidence + clinical appearance + degree of fixation of the regional lymph nodes, age of the patient, and evidence of distant metastases. On the basis of these results it will be possible to create a prognostic index. This prognostic index should be eligible for use in clinical practice, as opposed to usual classification models.