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To determine the effect of the polymerization mode of simplified bonding systems and the corresponding core buildup resin composite on the bond strength to dentin.Composite core buildups were bonded to flat prepared dentin surfaces of 320 human molars using a two-step etch-and-rinse (Excite, ER) and a two-step self-etching (AdheSE, SE) bonding system. Bonding systems were used both with and without their respective self-curing activators (Excite DSC, ER+SC; AdheSE DC, SE+SC). Six curing protocols for the dual-curing composite (MultiCore Flow) were examined: self-curing for 5 min (a); irradiation with light from each aspect for 10 s (b), 20 s (c), and 40 s (d); and irradiation with light from the occlusal aspect only for 60 s (e) and 120 s (f). Shear bond strengths were measured immediately after curing. Additional measurements were performed after water storage of the specimens for 24 h at 37°C. These specimens had been cured according the curing protocols given in the manufacturer's instructions (groups a and d). Failure modes were analyzed using scanning electron microscopy.Immediate bond strengths were significantly different among the bonding systems (p0.001): SEERER+SCSE+SC. Immediate bond strengths of ER and SE were significantly lower when the composite was self-cured (p0.05). The use of SC activators reduced the bond strength and promoted adhesive failures to dentin. A severe incompatibility problem was observed between the composite and SE+SC.Dentin bonding of dual-curing composite core buildups in combination with simplified bonding systems is still unsatisfactory, even when SC activators are employed. For adequate bonding to dentin, polymerization of the dual-curing composite should always be light initiated.

Background: The purpose of this study was to examine the efficacy of sodium 2-mercaptoethanesulfonate (MESNA), a reactive oxygen scavenger, in at-risk patients given radiographic contrast agents. Contrast-induced nephropathy (CIN) is a common complication of radiographic procedures ; reactive oxygen species (ROS) could play a key role. Methods: We conducted a randomized, double-blinded, placebo-controlled trial in 100 patients with stable serum creatinine levels ≥ 150 μmol/l. They received an infusion of either 1,600 mg of MESNA (n = 51) or placebo (n = 49) plus 0.9% saline prior to and after contrast administration. CIN was defined as a ≥ 25% increase in serum creatinine after 48 h compared to baseline. Results: CIN occurred in 7 patients in the placebo group and none in the MESNA group (p = 0.005). The adjusted odds ratio for CIN was 0.17 (95% confidence interval 0.03 - 0.80, p = 0.026) in the MESNA group compared to the placebo group. Cystatin C concentrations decreased slightly in the MESNA group but increased in the control group (p < 0.05). Conclusion: MESNA plus volume expansion before and during contrast exposure was effective in this single-center study for preventing CIN compared to volume expansion alone.

Purpose of this study was to determine the accuracy of prediction of non-sentinel lymph node (NSLN) involvement in sentinel node (SLN)-positive breast cancer patients based on protein concentrations measured in lysates from initially taken breast biopsies. Data on protein expression, previously generated by multiplexed bead-based immunoassays, were analysed by multivariate logistic regression to define parameter sets of value to predict NSLN involvement. Receiver-operator characteristics (ROCs) were calculated as indicators of diagnostic significance. Analyses of data from all patients (n = 99) resulted in parameter sets that allowed direct prediction of the NSLN status with a ROC area under the curve (AUC) of 0.83. The clinically most relevant prediction of NSLN status in SLN-positive patients (n = 37) based on only seven parameters (including TIMP-2 as the most relevant single value) was possible with high accuracy indicated by an AUC of 0.89. Parallel assessment of protein concentrations in breast biopsies is a highly promising approach to predict nodal involvement and even the NSLN status in SLN-negative breast cancer patients. Such diagnostic information could substantially reduce the number of completion axillary lymph node dissections in clinical practice.

Summary OBJECTIVES: To compare the long-term effects of com-prehensive outpatient versus inpatient rehabilitation withrespect to morbidity and mortality, as well as to changes inphysical performance and physical activity.DESIGN: A total of 163 consecutive patients were en-rolled for comprehensive cardiac rehabilitation (CCR) fol-lowing a recent coronary event, to outpatient or inpatientCCR according to treatment preference because random-isation was accepted by only 4 patients. CCR was six hoursper day for 4 weeks and consisted of exercise training,education, psychological support, and nutritional and oc-cupational advice. Examinations were before, after and 12months after CCR. Primary outcome measures were event-free survival with or without interventions, EFS-I or EFS,respectively, 12 months after rehabilitationRESULTS: Main patient characteristics were distrib-uted equally in the cohorts. Results were adjusted by logist-ic regression for age, BMI, LV-function, exercise capacityand physical activity before the event. Adjusted EFS, EFS-I , overall survival and other morbidity outcome measuresdid not differ significantly. During CCR, physical activ-ity was higher in outpatients, but this difference was notmaintained in the follow up. Average physical activity wasincreased 12 month after CR with no difference betweengroups.CONCLUSION: Although influenced by patient pref-erence, participation in either inpatient or outpatient CCRled to comparable results in terms of all-cause or cardiacoverall survival, event-free survival and other secondaryoutcome measures like cardiac morbidity, physical per-formance and increased physical activity.

Bevor statistische Auswertungen mit einem Datensatz durchgefuhrt werden konnen, muss dieser oft zuerst aufbereitet werden. Dazu gehort das Andern von Variablennamen und Variablenwerten (Abschn. 4.1), die Korrektur von Variablenformaten (Abschn. 4.2), das Hinzufugen (Abschn. 4.3) oder Loschen von Variablen (Abschn. 4.5) oder Beobachtungen (Abschn. 4.6), die Einteilung von Datenwerten in Klassen (Abschn. 4.4) sowie das Zusammenfugen von Dateien (Abschn. 4.7) und die Sortierung der Daten nach bestimmten Variablen (Abschn. 4.8). Des Weiteren ist dargestellt, wie Teilmengen eines Datensatzes (Abschn. 4.9) ausgewahlt werden konnen und wie die Datenubertragung von R nach Excel (Abschn. 4.10) moglich ist. Die Bearbeitung des Datensatzes erfolgt in Excel oder mit Hilfe des R-Commander.

Die folgenden Abschn. 2.1 und 2.2 zeigen, wie die RExcel-Oberflache geoffnet und wieder beendet wird.

In den folgenden Kapiteln 6–12 werden Auswertungsmoglichkeiten, die mit RExcel ausgefuhrt werden konnen, beschrieben. Es werden allerdings nicht alle in RExcel realisierte Moglichkeiten dargestellt, sondern wir orientieren uns am Stoffplan der Vorlesung „Medizinische Biometrie“, einer Pflichtveranstaltung fur Studenten der Humanmedizin. Ausfuhrliche statistische Hintergrunde mochten wir im Rahmen dieses Buches nicht darstellen. Dazu verweisen wir auf die entsprechenden Literaturangaben im (Anhang A.7), besonders empfehlen wir hierfur das Buch von Christel Weiss: Basiswissen Medizinische Statistik.

In Abschn. 3.1 wird aufgezeigt, wie eine einheitliche Dezimalschreibweise erreicht wird. Das ist wichtig damit R mit Excel-Dateien problemlos arbeiten kann. Es gibt mehrere Moglichkeiten Daten in Excel einzulesen, z. B. kann man Daten direkt in das Excel-Tabellenblatt eintragen, das wird in Abschn. 3.2 beschrieben. In Abschn. 3.3 wird gezeigt, wie eine vorhandene Excel-Datei geoffnet wird. Damit die R-Funktionen aufgerufen werden konnen, muss eine Datenubertragung von Excel nach R erfolgen, dies zeigt das Abschn. 3.4.

OBJECTIVE: Mild hypothermia after perinatal hypoxic-ischemic encephalopathy (HIE) reduces neurologic sequelae without significant adverse effects, but studies are needed to determine the most-efficacious methods. METHODS: In the neo.nEURO.network trial, term neonates with clinical and electrophysiological evidence of HIE were assigned randomly to either a control group, with a rectal temperature of 37°C (range: 36.5–37.5°C), or a hypothermia group, cooled and maintained at a rectal temperature of 33.5°C (range: 33–34°C) with a cooling blanket for 72 hours, followed by slow rewarming. All infants received morphine (0.1 mg/kg) every 4 hours or an equivalent dose of fentanyl. Neurodevelopmental outcomes were assessed at the age of 18 to 21 months. The primary outcome was death or severe disability. RESULTS: A total of 129 newborn infants were enrolled, and 111 infants were evaluated at 18 to 21 months (53 in the hypothermia group and 58 in the normothermia group). The rates of death or severe disability were 51% in the hypothermia group and 83% in the normothermia group (P = .001; odds ratio: 0.21 [95% confidence interval [CI]: 0.09–0.54]; number needed to treat: 4 [95% CI: 3–9]). Hypothermia also had a statistically significant protective effect in the group with severe HIE (n = 77; P = .005; odds ratio: 0.17 [95% CI: 0.05–0.57]). Rates of adverse events during the intervention were similar in the 2 groups except for fewer clinical seizures in the hypothermia group. CONCLUSION: Systemic hypothermia in the neo.nEURO.network trial showed a strong neuroprotective effect and was effective in the severe HIE group.

This study investigated the antibacterial effect of a resin composite matrix with or without incorporated triclosan (0.3 wt%) on Streptococcus mutans, Actinomyces viscosus and Lactobacillus casei. In the quantitative assay, bacterial suspensions were filled into 20-μl cavities within temporary restorative resins. After 0, 4, 8, 12, 24 and 48 h of incubation, the suspensions were removed from the restoratives and the numbers of viable bacteria were determined. Bacterial suspensions incubated without restoratives served as the controls. Ten replicates were carried out for each experiment. The resin composite containing triclosan demonstrated variable degrees of antibacterial activity against the microorganisms, revealing a significant inhibitory effect on S. mutans within 12 h compared to the control. The viable counts of A. viscosus significantly decreased after 24 h. A significant reduction of L. casei was observed after 48 h. The unloaded resin composite did not reveal a marked antibacterial effect. The resin composite loaded with triclosan might be beneficial in preventing cavity contamination and minimizing the risk of pulpal irritation in the short-term.

General practitioners (GPs) play an important role in influenza vaccination. However, reliable data on the influenza immunisation coverage rate in primary care patients are quite rare. Due to a lack of personal and time resources general practitioners cannot afford to collect such data by themselves. Hence fifth-year students have been involved in the scientific data collection during their practical placement in 118 GP practices. Using logistic regression analysis of a representative sample (n = 541) plausible factors associated with the influenza immunisation coverage rate have been identified. These factors were found to be both patient- and practice-specific. This practice-oriented study was conducted to improve the available data base on the influenza immunisation coverage rate among elderly patients in primary care settings.

Nonalcoholic fatty liver disease (NAFLD) is known to have a gender-dimorphic prevalence in obese children. Less information is available on predictive factors for NAFLD in obese youths.The aim of the study was to examine the prevalence pattern and to identify clinical and laboratory markers associated with the risk for NAFLD.This was a cross-sectional study.The study setting was a rehabilitation clinic.A total of 532 obese subjects (291 girls) aged 8-19 yr participated in the study.Steatosis hepatis and visceral fat mass were determined by ultrasound. Laboratory tests included serum lipids, adiponectin, high-sensitivity C-reactive protein, sex steroids, and an oral glucose tolerance test.Prevalence of hepatic steatosis was significantly higher in boys (41.1%) than in girls (17.2%) and was highest in postpubertal boys (51.2%) and lowest in postpubertal girls (12.2%). Severity of steatosis was associated with increased visceral fat mass, insulin resistance, lower adiponectin levels, and higher blood pressure. Three factors were extracted from the panel of investigated parameters by principal component analysis. Logistic regression analysis revealed significant associations of simple steatosis with the "insulin resistance and visceral fat" factor and the "body fat distribution and inflammation" factor in both genders and additionally with the "steroid hormones" factor in girls. Risk for steatosis hepatis with concomitantly elevated ALT was associated only with "insulin resistance and visceral fat" in girls and with all three factors in boys.Our results suggest significant associations of NAFLD with markers of visceral obesity and insulin resistance in both genders and gender-specific associations with parameters of body fat distribution and sex steroids.

This study investigated the effects of fiber posts, silanization, and luting agents on the interfacial strength to root dentin and composite cores. Root canals of 120 crownless human teeth were instrumented. Three different posts (opaque and translucent), with and without silane treatment, were bonded using etch-and-rinse, self-etch, and self-adhesive luting agents. The restored roots were built up with dual-curing composite. After storage in water for 24 h at 37 degrees C, 2-mm-thick slices were cut from each sample: one from the composite core and one from the restored root. Interfacial push-out bond strengths of the posts were determined in a universal testing machine. Failure modes were analyzed using scanning electron microscopy. The post type and the luting agent had significant effects on both the post-to-dentin and post-to-core strengths. Silanization did not significantly influence post-to-dentin strengths, but enhanced post-to-core strengths. With etch-and-rinse luting agents, debonding occurred predominantly between the post and the cement, while the self-etch and self-adhesive luting agents showed more failures on root dentin. No failures occurred between the composite core and the cement. The combination of translucent posts and etch-and-rinse dual-curing luting agents can positively influence the retention of fiber posts in root canals. Silanization seems to be less relevant for intra-root canal bonding, but may have beneficial effects on post-to-core strengths.

Musculoskeletal complaints are very common in primary care settings. Lipid-lowering drugs are one of several causes of musculoskeletal symptoms. However, data showing an association of lipid-lowering drug therapy and increased odds of musculoskeletal complaints in primary care patients are lacking.To investigate the association between statin use and the reporting of muscular complaints by patients and simultaneously control for several known factors of musculoskeletal complaints.In a cross-sectional study with 1031 consecutive patients (50 years of age) in 26 offices of GPs, two investigators collected the data from the office files and by interviewing the patients. A logistic regression model was used to identify variables affecting the odds of muscular symptoms.The prevalence of lipid-lowering drug prescription was 23% (n = 239) and that of muscular complaints was 40% (n = 411). In all, 44% (n = 106) of the patients with lipid-lowering drug prescription had muscular complaints compared to 39% (n = 305) of the patients without lipid-lowering drug therapy. Statin prescription and 10 variables remained in the final model. Statin prescription is associated with a 1.5-fold odds of musculoskeletal complaints compared to non-prescription {odds ratio [OR] = 1.5 [95% confidence interval (CI), 1.1-2.0], P = 0.02}.Having a statin prescription appears to be an independent factor associated with musculoskeletal symptoms in primary care settings. Statin use may be more often associated with musculoskeletal complaints than previously assumed.

CT scans of 474 patients with suspected chronic obstructive pulmonary disease (COPD) were retrospectively evaluated by automated software. There was a correlation between the total lung capacity (TLC) and the total lung volume (TLV) (r=.675, P.001), between the TLC and the total emphysema volume (r=.571, P.001), as well as between the TLC and the emphysema index (r=.532, P.001), respectively. The correlation between the TLC and the TLV was dependent on the COPD severity according to the Global Initiative for Chronic Obstructive Lung Disease classification (chi(2)=6.3079, P=.043). The TLC allows a prediction of clinical illness severity.

Apolipoprotein[a] polymorphism has been investigated by sodium dodecyl sulfate polyacrylamide (5.37%) gel electrophoresis and immunoblotting using a standardized sample load in four ethnic groups: German, Ghanaian, Chinese, and San (Kalahari Bushmen). A total of 10 different apparent molecular weight (Mr) polymorphs, designated 1 to 10 with increasing Mr, were detected in greater than 99% of all individuals tested (German, 99%; Ghanaian, 99%; Chinese, 100%; San 100%). A null allele is therefore at most an infrequent variant in all populations. Polymorphs 6-10 were common to all four populations, while polymorphs 1-5 appeared to be relatively rare variants not universally detected in each group in the present study. The Chinese had the highest proportion of double-band phenotypes and the observed frequencies were not significantly different from those expected according to simple Mendelian inheritance, whereas the observed apo[a] phenotype distributions of the other three groups did not concur with those expected for Hardy Weinberg equilibrium. The German and Ghanaian groups displayed similar distributions of apo[a] phenotypes while the Chinese and San had significantly higher frequencies of polymorphs 9 and 10. Mean plasma Lp[a] concentrations in Ghanaians (36.2 +/- 31.5 mg/dl) were almost 2-fold greater than in Germans (18.7 +/- 23.1 mg/dl) and ca 1.65-fold greater than in either Chinese (22.9 +/- 18.3 mg/dl) or San (21.1 +/- 19.3 mg/dl). A strong inverse correlation was observed between apo[a] Mr and plasma Lp[a] concentration in Germans but this was much less pronounced in Ghanaians. While the mean plasma Lp[a] levels associated with polymorphs 1-6 were similar in both Germans (43.4 +/- 30.0 mg/dl) and Ghanaians (49.2 +/- 37.6 mg/dl), those Ghanaians with any combination of the polymorphs 9 and 10 had an almost 3-fold greater mean plasma Lp[a] level (20.6 +/- 11.3 mg/dl) than their German counterparts (7.8 +/- 5.7 mg/dl). It is therefore apparent that: 1) differences in apo[a] allele frequencies are not primarily responsible for differences in Lp[a] levels between populations; and 2) the greatest ethnic variation is observed in plasma Lp[a] concentrations associated with the high molecular weight apo[a] polymorphs.

Background Attempts to reduce high utilisation of psychiatric inpatient care by targeting the critical time of hospital discharge have been rare. Methods This paper presents design and methods of the study "Effectiveness and Cost-Effectiveness of Needs-Oriented Discharge Planning and Monitoring for High Utilisers of Psychiatric Services" (NODPAM), a multicentre RCT conducted in five psychiatric hospitals in Germany. Inclusion criteria are receipt of inpatient psychiatric care, adult age, diagnosis of schizophrenia or affective disorder, defined high utilisation of psychiatric care during two years prior to the current admission, and given informed consent. Consecutive recruitment started in April 2006. Since then, during a period of 18 months, comprehensive outcome data of 490 participants is being collected at baseline and during three follow-up measurement points. The manualised intervention applies principles of needs-led care and focuses on the inpatient-outpatient transition. A trained intervention worker provides two intervention sessions: (a) Discharge planning: Just before discharge with the patient and responsible clinician at the inpatient service; (b) Monitoring: Three months after discharge with the patient and outpatient clinician. A written treatment plan is signed by all participants after each session. Primary endpoints are whether participants in the intervention group will show fewer hospital days and readmissions to hospital. Secondary endpoints are better compliance with aftercare, better clinical outcome and quality of life, as well as cost-effectiveness and cost-utility. Discussion If a needs-oriented discharge planning and monitoring proves to be successful in this RCT, a tool will be at hand to improve patient outcome and reduce costs via harmonising fragmented mental health service provision. Trial Registration ISRCTN59603527

This study involved 92 patients with clinically diagnosed pneumonia. Differences in the frequency of typical pattern were calculated for patients with mild pneumonia and for patients with severe pneumonia (confusion, respiratory rate, blood pressure, 65 years of age and older). The frequency of singular morphologic changes did not differ significantly between the two groups. Empyema and pleural effusion, as well as an atelectasis in combination with patchy infiltrates and a positive bronchogram/multisegmental infiltrates, seem to have an influence on severity of pneumonia.

This study was conducted to evaluate whether instillation of NaCl 0.9% solution into the biopsy track reduces the incidence of pneumothoraces after CT-guided lung biopsy. A total of 140 consecutive patients with pulmonary lesions were included in this prospective study. All patients were alternatingly assigned to one of two groups: group A in whom the puncture access was sealed by instillation of NaCl 0.9% solution during extraction of the guide needle (n = 70) or group B for whom no sealing was performed (n = 70). CT-guided biopsy was performed with a 18-G coaxial system. Localization of lesion (pleural, peripheral, central), lesion size, needle-pleural angle, rate of pneumothorax and alveolar hemorrhage were evaluated. In group A, the incidence of pneumothorax was lower compared to group B (8%, 6/70 patients vs. 34%, 24/70 patients; P < 0.001). All pneumothoraces occurred directly post punctionem after extraction of the guide needle. One patient in group A and eight patients in group B developed large pneumothoraces requiring chest tube placement (P = 0.01). The frequency of pneumothorax was independent of other variables. After CT-guided biopsy, instillation of NaCl 0.9% solution into the puncture access during extraction of the needle significantly reduces the incidence of pneumothorax.

The aim of this study was to compare a conventional oncological inpatient rehabilitation programme with an inpatient step-by-step rehabilitation programme with regard to quality of life in breast cancer patients.Women with the diagnosis of breast cancer were randomly assigned to either the step-by-step programme (group A: 3-week rehabilitation plus 4 and 8 months later a 1-week sojourn each time) or the conventional rehabilitation programme (group B: 4- week stay and no further interventions afterwards). Quality of life was assessed with the QLQ-C30 of the EORTC at t0 (beginning of the study), t1 (end of 3- or 4-week stay) and t2 (12 months after t0, end of study).Between t0 and t1, a tendency (0.1p = 0.05) could be shown in group B towards better improvement in global quality of life and emotional function. In the subgroup of patients that had impaired functions of quality of life at t0, superiority in group B reached significance (p0.05) for emotional and cognitive function at t1. Between t1 and t2, cognitive function improved further in group A, but diminished in group B. For the subgroup of patients with impaired cognitive function at t0, this difference between both groups became significant (p = 0.0098).Although not generally superior to conventional inpatient rehabilitation programmes, the analysed step-by- step rehabilitation provided marked benefits for patients with cognitive impairments.

Discomfort during insulin injection and self-monitoring of blood glucose (SMBG) is a potential obstacle in diabetes therapy, but its prevalence and extent in relation to clinical variables is uncertain.We prospectively assessed treatment-associated discomfort and pain in an unselected cohort of patients (60 boys and 52 girls; mean age 14.6+/-3.0 years, mean A1C 8.0+/-1.4%) with type 1 diabetes and multiple daily self-injections of insulin, using visual analogue/verbal rating scales (range, 0-10) and a six-item questionnaire.Pain during insulin injection was absent to very low in 91.9% of patients, and its intensity was independent of age, gender, diabetes duration, current A1C, injection volume, or type of insulin. Injection was more unpleasant than SMBG in 64.2% of patients (mean difference of pain score, 1.0+/-1.7, p0.0001). Injection into the upper arm was less painful than into the thigh and abdomen. Surprisingly, painlessness of injection and SMBG was not judged an important treatment goal by 22.0 and 32.9% of patients, respectively. Logistic difficulties (41.2% of responses) and time requirements (23.8%), but not pain (10.1%), were considered most relevant problems.In young patients with access to optimized diabetes care, pain during insulin injection and SMBG is infrequent or mild, and not widely perceived as problematic, thus encouraging the use of multiple daily injection treatment.

352 Background: Pancreatic ductal adenocarcinoma still remains a major cause of cancer related deaths in the western world. The current study was conducted to confirm the activity and feasibility of docetaxel/ oxaliplatin combination in second line treatment of advanced pancreatic ductal adenocarcinoma. Methods: Prospective single arm, non-randomized, multi-center, Simon’s two stage phase II trial using docetaxel (75 mg/m2, 60 min, d 1) and oxaliplatin (80 mg/m2, 120 min, d 2) in 21-day cycles. Duration of the trial was scheduled up two 8 cycles. Primary endpoint was tumor response according to RECIST 1.0. Secondary endpoints were progression free survival, overall survival, safety/toxicity, quality of life and clinical benefit. Results: Data represents the intention to treat analysis of 44 patients included between 2008 and 2012. The majority of patients received a gemcitabine based first-line chemotherapy (95.5%). The primary endpoint of tumor response was achieved in 15.9% (7 partial remissions, no complete remission), with a disease control rate of 48% after the first two treatment cycles. Median progression free survival was 7 weeks (CI 6-15.9 weeks) and overall survival 40 weeks (CI 20.4-56.4 weeks). No unexpected adverse events occured. The recorded AEs were mainly hematologic (neutropenia grade 3/4 63.6%, febrile neutropenia 4.6%), gastrointestinal (29.6% grade 3/4 AEs) and infectious (18.2% grade 3/4 AEs). Conclusions: In this single-arm second line trial for the treatment of advanced PDAC, the combination of docetaxel and oxaliplatin shows promising results comparable with other second line protocols such as OFF (oxaliplatin, 5-FU, leucovorin) or liposomal irinotecan (MM-398) plus 5-FU/leucovorin (NAPOLI 1-trial). Some patients seem to benefit particularly as indicated by long periods of treatment in this setting. Even after 8 cycles of treatment with DocOx, partial response was observed in 2 patients and stable disease in another 6 patients corresponding to a disease control rate of 18%. The toxicity profile was quite tolerable and comparable to other second line studies. Clinical trial information: NCT00690300.

e18556 Background: Patients (pts) with small cell lung cancer (SCLC) often suffer from relevant comorbidity. In addition, they frequently present with a compromised performance status (PS). Outside...

TPS497 Background: Resectable pancreatic cancer still has an unfavourable prognosis. Neoadjuvant or perioperative therapies might improve the prognosis of these patients. Recently, two phase III trials demonstrated for the first time, a substantial improvement in overall response, PFS and OS in patients with metastatic pancreatic cancer compared to standard gemcitabine (FOLFIRINOX and nab-paclitaxel/gemcitabine). The combination of nab-paclitaxel/gemcitabine has a more favourable toxicity profile compared to the FOLFIRINOX protocol and appears applicable in a perioperative setting. Methods: NEONAX is a study for patients (to be enrolled: n=166) with resectable ductal adenocarcinoma of the pancreas ≤ T3 in two arms: Arm A (perioperative arm): 2 cycles nab-paclitaxel (125 mg/m2)/gemcitabine (1000 mg/m2, d1, 8 and 15 of an 28 day-cycle) - tumor surgery - 4 cycles nab-paclitaxel/gemcitabine, Arm B (adjuvant only arm): tumor surgery - 6 cycles nab-paclitaxel/gemcitabine. NEONAX is an interventional, prospective, randomized, controlled, open label, two sided phase II study with an unconnected analysis of the results in both experimental arms against a fixed survival probability (38% at 18 month with adjuvant gemcitabine). The randomization (1:1) is eminent to achieve two comparable patient groups. Primary objective is DFS at 18 months after randomization. Key secondary objectives are 3-year OS and DFS, progression during neoadjuvant therapy and QoL. In the perioperative group tumor tissue will be collected prior to and post-surgery and subjected to microdissection and exome sequencing of tumor tissue. Tumor regression will be assessed both in the perioperative and the adjuvant group, respectively. In addition, circulating tumor-DNA will be analyzed in patients with the best and the worst responses to the neoadjuvant treatment. Start of trial will be in IV/2014 in 20 high-volume centers for pancreatic surgery in Germany. Clinical trial information: NCT02047513. Clinical trial information: NCT02047513.

TPS786 Background: Prevention of colorectal cancer is a major health care issue. After polypectomy there is an increased risk of polyp recurrence and various means of chemoprevention have been tried to prevent this. NSAIDs have been shown to be effective but confer side effects such as gastrointestinal bleeding. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and some clinical trials. However, their value in preventing colorectal polyps has not been demonstrated in a large, randomized trial. The beneficial safety profile of decaffeinated green tea extract and accumulating evidence of its cancer preventive potential justify and require, in our view, a validation of this compound for the nutriprevention of colorectal adenoma. Good accessibility and low costs might render this neutraceutical a top candidate for wider use as nutritional supplement in colon cancer prevention. Methods: Randomized, double blinded, placebo-controlled, multicenter trial. After a one month run-in period with verum, 918 patients (age: 50-80 years) who have undergone polypectomy within the last 6 months will be randomized to receive either decaffeinated green tea extract (containing 150 mg epigallocatechin gallate (EGCG) two times daily) or placebo over a period of three years. Primary outcome: Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous, serrated lesions) at the 3 year follow-up colonoscopy. Secondary outcomes: Occurrences, number, localization, size and histological subtypes of adenomas, frequency of colorectal carcinoma. In addition, genetic and biochemical biomarkers in blood samples and genetic alterations (Ras, B-raf, microRNAs) in tissue samples of adenomas will be analyzed (biobanking subprojects). Additionally, nutrikinetics and nutrigenetics of EGCG and other catechins will be assessed in healthy volunteers. Patient recruitment has started in November 2011. At September 2014, 785 patients were recruited and 651 patients were randomized. We expect the last patient out in Spring 2018. (Trial identifier NCT01360320) Clinical trial information: NCT01360320.

Background: The medical faculty of Ulm University has launched the postgraduate master online study programme Advanced Oncology (AO) in 2010. We describe the challenges in developing an e-learning module using the example of a medical biometry course, focusing the implementation of the course material and our single-loop learning experience after the first students have finished and evaluated the lecture. Methods: Programme participants are qualified medical doctors and researchers in biomedical areas related to the field of oncology. The study programme provides the majority of lectures online via didactic videos accompanied by one-week attendance seminars. Supplementary learning materials include review articles, supportive reading material, multiple choice questions, and exercises for each unit. Lecture evaluations based on specific questions concerning learning environment and information learned, each measured on a five-point Likert scale. Results: Lecture videos were implemented following the classical triad of the didactic process, using oncological examples from practice to teach. The online tutorial support offered to students was hardly used, thus we enhanced faculty presence during the face-to-face seminars. Lecture evaluations improved after revising the learning material on the basis of the first AO student cohort's comments. Discussion: Developing and implementing an online study programme is challenging with respect of maximizing the information students learn due to limited opportunities for personal contact between lecturers and students. A more direct interaction of lecturers and students in a blended learning setting outperforms a mere web-based contact in terms of learning advantage and students' satisfaction, especially for complex methodological content.

Background: Localized scleroderma is characterized by circumscribed fibrotic plaques and may progress to widespread skin involvement and fibrosis. Interferon gamma (IFN-γ) has been shown to be a potent inhibitor of collagen synthesis and of the migration and proliferation of dermal fibroblasts. Objective: Our purpose was to determine whether IFN-γ is effective in the treatment of localized scleroderma. Methods: A double-blind, randomized, placebo-controlled, multicenter study was conducted. Twenty-four patients with progressive lesions received 100 μg of IFN-γ or placebo subcutaneously on 5 consecutive days for 2 weeks followed by 100 μg of IFN-γ or placebo once weekly for 4 weeks. Thereafter patients were observed for 18 weeks. To determine whether improvement could be related to an altered level of collagen messenger RNA (mRNA), biopsy specimens were taken from uninvolved and involved skin before and after therapy. Results: The patients treated with IFN-γ or placebo showed no significant difference in size or fibrosis of lesions or collagen type I mRNA synthesis. However, a reduction in the number of new lesions was observed in the IFN-γ-treated group. The biopsy specimens obtained from involved skin showed a moderate increase of type I collagen and a significant decrease in the small proteoglycan decorin mRNA levels. Conclusion: The results indicate that IFN-γ is ineffective in the treatment of localized scleroderma, but may inhibit the development of new lesions.

The acceptance of quality management is strongly influenced by the additional work-load necessary to obtain data. "Quality management questionnaire? Do we really need it? In rehabilitation, we must deliver a long and detailed discharge report anyway...". This frequent comment from the physician side has prompted us to investigate whether compilation of quality-management questionnaires really provides new information, or if a prediction model (for example similar to that predicting early retirement based on routine data in a discharge report) could be used to replace the physician judgement. If the prediction accuracy of the model is sufficiently high, the compilation of quality-management questionnaires might become obsolete, sparing the paperwork load of the physician. A central issue in the quality-management system of the LVA Baden-Wuerttemberg (a regional pension insurance institute) is the mutual agreement on a certain rehabilitation goal by patient and physician at the beginning of therapy. At the end of the rehabilitation program, the achievement of the goal is discussed with the patient in a discharge interview. In addition, patient and physician fill out a structured questionnaire with specification on three rehabilitation dimensions (WHO standard ICF: Body function and structure, activity, and participation). However, the results of multivariate modelling of 10 routinely observed parameters on more than 12,000 observations in patients with musculoskeletal diseases demonstrate that the agreement between the prediction model and the physician judgement of rehabilitation success is far away from optimal values. Thus, in this case the physician judgement can not be replaced by a forecast model solely based on routine data. Accordingly, the evaluation of rehabilitation success within the framework of a quality-management system based on currently valid standards must directly rely on the physician judgement.

OBJECTIVE We sought to assess the frequency, symptoms, and management of hemorrhagic complications in patients undergoing tension-free vaginal tape (TVT) procedure. METHODS Over a 5-year period the clinical course of all 336 consecutive patients undergoing TVT procedure in our hospital was recorded, including diagnostic approaches and management strategies for both increased intraoperative blood loss and clinically relevant hematoma. RESULTS In 87 patients (26%), TVT procedure was combined with other gynecologic surgeries, and 249 patients (74%) underwent TVT alone. In 7 cases (2.1%), increased intraoperative blood loss (250-400 mL) was managed by electro-coagulation, manual compression, tamponade, and/or insertion of a drain. The postoperative course in these patients was uncomplicated. In 14 women (4.1%) who did not show increased bleeding during the operation, retropubic hematoma developed, the volume of which exceeded 300 mL in 4 cases (1.2%). These required surgical intervention. In the first case we performed open laparotomy, whereas in the following cases the hematoma could be successfully drained by endoscopy. Postoperative development of a hematoma did not lead to recurrence of stress incontinence. CONCLUSION Bleeding complications during or after TVT procedure are rare events. Increased intraoperative bleeding can usually be managed with electro-coagulation, compression, and drainage. LEVEL OF EVIDENCE II-3.

Global brain atrophy was determined in 70 patients suffering from Huntington's disease (HD) and 70 healthy controls, using brain parenchymal fractions calculated from 3D MRI data in a standardized procedure. In HD patients, brain parenchymal fractions were significantly reduced compared to controls in all age groups; the physiological decline with age was less pronounced in HD. However, brain parenchymal fraction values did not allow the prediction of clinical impairment (as assessed by clinical scores). Global brain parenchyma reduction seems to be an early or even constitutional feature of HD, but clinical symptoms appear to reflect regiona! rather than global atrophy. Overall, MRI-based brain volume quantification correlated with clinical scores clarifies the functional impact of morphological brain alterations.

The effectiveness of a computer-assisted balance training was compared with a home based exercise program in healthy elderly subjects. Twenty-four physically active community dwelling elderly (median age 71 years) participated in the study. Balance was assessed by a summary performance score, measuring postural stability while standing, reaching, stepping and walking. Subjects of the computer-assisted balance training group could considerably improve their performance on the training device (p = 0.0078) as well as in the summary balance score (p = 0.0176). No improvement of balance was documented in the home-based exercise group. A superiority of the computer-assisted balance training exercise protocol over the home-based exercise group could not be documented (p = 0.3934). The study indicates that a computer-assisted balance training, focussing on one motor skill, can improve balance. It is suggested that a home-based exercise program is ineffective to improve balance in elderly persons, if there is no direct supervision.

Power has been demonstrated to be an early and potent marker of frailty. The measurements currently available are tied to locality. Usually, measurements include single joint movements or movements of only the legs and the resistance is not adjusted for body weight. In this study, a portable method to measure power in the sit-to-stand transfer was developed and tested. Mean power was calculated from the vertical ground reaction force of body weight, the difference between height in a sitting and in an upright position and the time taken to stand up. The results of this power measurement were compared with an isokinetic force measurement, the "Nottingham power rig", and measurement of physical performance in a five-repetition chair rise (five-chair rise). A convenience sample of 33 healthy elderly subjects [mean (SD) age: 67.8 (6.7) years; 17 men, 16 women] was included. Measurement of power during the sit-to-stand transfer showed good correlation to isokinetic force measurement (r=0.68) and to the "Nottingham power rig" (r=0.6). Correlation to five-chair rise was poor (r=−0.08). In conclusion, the study shows that the method presented is able to measure power during performance of a daily task. The poor correlation between the introduced measurement and the five-chair rise suggests that it might be able to detect decline in muscle function earlier by the introduced measurement than by measurement of the functional status. As it is inexpensive and portable, its use in clinical practice and research contexts, including home-bound individuals, is feasible.

Hyperuricemia is part of the "metabolic syndrome". The aim of this study was to investigate the regulation and role of serum uric acid in the cardiovascular risk factor profile of obese children and adolescents. Serum levels of uric acid and selected risk factors and hormones were determined in 269 children aged 10.0-15.9 years with a BMI >90th percentile (mean 24.0 kg/m2, SD 5.43). Stepwise regression adjusted for age and sex revealed that testosterone (p < 0.0001), BMI (p < 0.0001), systolic blood pressure (p < 0.0017), triglycerides (p < 0.0345) and cholesterol/HDL ratio (p < 0.0393) were positively correlated with serum uric acid and accounted for 42.1% of the variance. Additional regression models with the same set of variables indicated that uric acid contributed significantly to levels of cholesterol/HDL, total cholesterol, BMI and systolic blood pressure, respectively. These results suggest a not yet described impact of androgens in the regulation of serum uric acid in obese children and adolescents. Furthermore, they show that uric acid is a reliable indicator for the "pre-metabolic syndrome" in obese youths.

For advanced progressive primary IgA nephropathy (IgAN) no established therapy exists. We conducted a prospective, uncontrolled trial to evaluate the effect of intravenous cyclophosphamide pulse (CyP) therapy on the course of advanced progressive IgAN. Twenty-one patients (mean age 52 ± 10 years; male/female 20/1) with biopsy-proven IgAN without crescentic extracapillary proliferation and a serum creatinine of more than 2.0 mg/dl and/or an increase more than 25% in the previous 3 months were included. Patients were treated with CyP (750 mg/m2 body surface area) every 4 weeks for 6 months and low dose oral prednisolone. The loss of renal function per year was significantly reduced from 16% before therapy to 4% after therapy (p < 0.001). A further increase >25% of serum creatinine after therapy was observed in 8 patients after 0.7 years (range 0.3–3.0 years), and 3 of these patients developed end-stage renal disease. Proteinuria decreased significantly during CyP therapy. A low nadir of white blood cell and platelet count was associated with a better renal outcome (p = 0.025). In conclusion, CyP therapy and low dose oral prednisolone is effective in preserving renal function in a subgroup of patients with advanced progressive IgAN.