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The German government initiated the Network University Medicine (NUM) in early 2020 to improve national research activities on the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic. To this end, 36 German Academic Medical Centers started to collaborate on 13 projects, with the largest being the National Pandemic Cohort Network (NAPKON). The NAPKON's goal is creating the most comprehensive Coronavirus Disease 2019 (COVID-19) cohort in Germany. Within NAPKON, adult and pediatric patients are observed in three complementary cohort platforms (Cross-Sectoral, High-Resolution and Population-Based) from the initial infection until up to three years of follow-up. Study procedures comprise comprehensive clinical and imaging diagnostics, quality-of-life assessment, patient-reported outcomes and biosampling. The three cohort platforms build on four infrastructure core units (Interaction, Biosampling, Epidemiology, and Integration) and collaborations with NUM projects. Key components of the data capture, regulatory, and data privacy are based on the German Centre for Cardiovascular Research. By April 01, 2022, 34 university and 40 non-university hospitals have enrolled 5298 patients with local data quality reviews performed on 4727 (89%). 47% were female, the median age was 52 (IQR 36–62-) and 50 pediatric cases were included. 44% of patients were hospitalized, 15% admitted to an intensive care unit, and 12% of patients deceased while enrolled. 8845 visits with biosampling in 4349 patients were conducted by April 03, 2022. In this overview article, we summarize NAPKON's design, relevant milestones including first study population characteristics, and outline the potential of NAPKON for German and international research activities. Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04768998.https://clinicaltrials.gov/ct2/show/NCT04747366.https://clinicaltrials.gov/ct2/show/NCT04679584 [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range -1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI -0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease. [ABSTRACT FROM AUTHOR]

Endurance training may lead to different hormonal alterations e. g., exercised induced hypothalamic ovarian/testicular dysfunction. The aim of this study was to reveal new connections between physical exercise, leptin and hormonal responses. 36 male participants of the Berlin-Marathon had their blood samples taken 2 days before the marathon. Hormones of the hypothalamic-pituitary axis and leptin were correlated with the training status and the achieved marathon time. Leptin correlated with the achieved marathon time after being adjusted for age and BMI (r = 0.607, p < 0.001) and was lowest in the best trained runners. Additionally, when the group was divided into quartiles of their achieved marathon time, significantly increased cortisol, fT4, cortisol/DHEAS ratio and decreased IGF-1 levels were observed in the slowest group. In the better trained group, a decrease of testosterone/ DHT ratio and an increase of testosterone/cortisol ratio were observed. Our study supports the thesis of a linear relationship between physical fitness and leptin variations in the physiological range. We found an increased anabolic hormonal response in well trained marathon runners and hormonal reactions of increased stress in less trained runners. As the stress-induced neuroendocrine adaptations in our study group are associated with more higher leptin values, the pathophysiological role of decreased leptin values seems to be limited to overtrained athletes. [ABSTRACT FROM AUTHOR]

Background: Regular exercise is beneficial for cardiovascular health but a recent meta-analysis indicated a relationship between extensive endurance sport and a higher risk of atrial fibrillation, an independent risk factor for stroke. However, data on the frequency of cardiac arrhythmias or (clinically silent) brain lesions during and after marathon running are missing. Methods/ Design: In the prospective observational "Berlin Beat of Running" study experienced endurance athletes underwent clinical examination (CE), 3 Tesla brain magnetic resonance imaging (MRI), carotid ultrasound imaging (CUI) and serial blood sampling (BS) within 2-3 days prior (CE, MRI, CUI, BS), directly after (CE, BS) and within 2 days after (CE, MRI, BS) the 38th BMW BERLIN-MARATHON 2011. All participants wore a portable electrocardiogram (ECG)-recorder throughout the 4 to 5 days baseline study period. Participants with pathological MRI findings after the marathon, troponin elevations or detected cardiac arrhythmias will be asked to undergo cardiac MRI to rule out structural abnormalities. A follow-up is scheduled after one year. Results: Here we report the baseline data of the enrolled 110 athletes aged 36-61 years. Their mean age was 48.8 ± 6.0 years, 24.5% were female, 8.2% had hypertension and 2.7% had hyperlipidaemia. Participants have attended a mean of 7.5 ± 6.6 marathon races within the last 5 years and a mean of 16 ± 36 marathon races in total. Their weekly running distance prior to the 38th BMW BERLIN-MARATHON was 65 ± 17 km. Finally, 108 (98.2%) Berlin Beat-Study participants successfully completed the 38th BMW BERLIN-MARATHON 2011. Discussion: Findings from the "Berlin Beats of Running" study will help to balance the benefits and risks of extensive endurance sport. ECG-recording during the marathon might contribute to identify athletes at risk for cardiovascular events. MRI results will give new insights into the link between physical stress and brain damage. Trial registration: clinicaltrials.gov NCT01428778 [ABSTRACT FROM AUTHOR]

Objective: The study aimed to assess cancer patients' use of psychological care and its correlates in a large sample of cancer patients in Comprehensive Cancer Centers (CCCs) in Germany., Methods: In a multicenter study in Germany, cancer patients with various diagnoses were evaluated for self-reported use of psychological support. We measured psychological distress, depression and anxiety, quality of life, and social support with standardized questionnaires and analyzed its association with the utilization of psychological care using multivariable logistic regression. This paper focuses on a cross-sectional analysis of the data assessed during inpatient care., Results: Three thousand fifty-four (50%) of hospitalized patients were asked for participation, and n = 1632 (53.6%) participated. We were able to analyze n = 1,398 (45.9%) patients. Three hundred ninety-seven (28.4%) of the sample utilized psychological support. Users of psychological care were significantly younger than nonusers (odds ratio [OR]: 0.967, P < 0.001) and were more often female (OR: 1.878, P < 0.001), whereas educational level was not associated with the use of psychological care. In the multivariable analysis, effects on the use of psychological care were observed for Hospital Anxiety and Depression Scale (HADS) anxiety (OR: 1.106, P = 0.001) and both subscales of the 12-item Short Form Health Survey (SF-12) quality of life measure (mental, OR: 0.97, P = 0.002; physical, OR: 0.97, P = 0.002)., Conclusion: Psychological distress and anxiety are higher, and quality of life is lower in users of psychological care in comparison with nonusers during inpatient cancer treatment. Although psychooncological services should be provided to all patients who need them, special efforts should be made to reach populations that report low utilization., (© 2018 John Wiley & Sons, Ltd.)

Purpose: The recently introduced Cancer Communication Assessment Tool (CCAT-PF) measures congruence in patient-caregiver communication and was initially validated in lung cancer patients. Contributing to a greater proportion of the variance in the conflict scores, primary caregivers were hypothesized to experience greater stress. For a detailed understanding of conflicting communication patterns of cancer-affected families, our study aimed for psychometric validation of the CCAT-PF in a sample covering heterogeneous tumor entities., Methods: Subsequent to a cross-sectional survey of 189 pairs of cancer patients (31 % gastrointestinal, 34 % lung, and 35 % urological) and their caregivers' exploratory factor analysis with principal component condensation and varimax rotation was conducted (response rate, 74.2 %). Reliability and construct validity were assessed calculating Cronbach's α and Pearson correlation coefficients for CCAT-P and CCAT-F scales and related constructs, respectively., Results: Cancer-related communication according to the CCAT-PF can be subdivided into four factors including the scales Disclosure, Limitation of treatment, Family involvement in treatment decisions, and Continuing treatment. Reliability ranged from α = .51-.68. The Disclosure scale, describing poor cancer-related communication of the patient, was correlated with patient's distress (QSC-R10: r = .30, p < .0001), unmet needs in several areas (SCNS-SF-34: r = .25-.32, p < .001), and negatively with social/family well-being (FACT: r = -0.31, p < .0001). Higher scores on the scale were significantly associated with considerable decrements in emotional well-being especially for caregivers perceiving patients' disclosure as problematic., Conclusions: The Disclosure scale originating from the CCAT-PF emerged as a short, valid, and reliable stand-alone instrument for identifying conflicting communication in patient-caregiver-dyads at risk.

Background and Objective: Considering the prolonged life-expectancies and the resulting demands that are placed on cancer patients and their relatives, the importance of specific counseling and support services including psycho-oncology, social services, nutritional, and exercise counseling has profoundly increased. The main focus of the current study was to evaluate the multidisciplinary health care needs of emotionally distressed cancer patients whoe were treated in a Comprehensive Cancer Center. METHODS AND STUDYGROUP: 831 out-patients were evaluated with regard to their psychological distress level and their multidisciplinary health care needs for specialist services of psycho-oncology, social services, nutritional, and exercise counseling using a tablet-PC assisted screening questionnaire. Separate analyses were completed for patients with and without psychological distress., Results: One third of the screened patients showed clinically relevant psychological distress. Health care needs for all specialist services were significantly greater among these patients compared to patients without psychological distress (all p-values < 0.005). The higher needs were foremost presented by the number of needed specialist services (p < 0.001): two thirds of the psychologically distressed patients demonstrated, besides the need for a psycho-oncological service, a need for two or three further specialist services, whereas among patients without psychological distress more than 70% showed a need for at most one specialist service., Conclusion: Multidisciplinary health care needs of psychologically distressed cancer patients should be systematically addressed in a Comprehensive Cancer Center, and patients should be offered a coordinated and integrated health care program., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Discrepancies within cancer-affected couples can disrupt security within the dyadic relationship during cancer treatment. This study investigated the patients' and caregivers' distress and associations between the caregivers' perception of the patients' degree of open communication and their distress., Participants and Methods: In a cross-sectional survey, 189 pairs of cancer patients (31% gastrointestinal, 34% lung, 35% urological cancers) and their partners were assessed for distress (QSC-R10), depression and anxiety (PHQ-2/GAD-2). The caregivers also reported their perception of the patients' degree of disclosure regarding cancer-relevant topics (CCAT-F Disclosure subscale), caregiver strain (CSI), and unmet needs (SCNS-P&C). Prevalences of clinically significant distress were calculated. Associations were calculated between the caregivers' and the patients' ratings and between the caregivers' distress and their perception of the patients' degree of disclosure., Results: 33% of the caregivers and 25% of the patients exhibited significant anxiety, with a tendency towards a higher frequency in the caregivers (p = 0.10). The prevalence of depression was lower but equally high in caregivers and patients. The caregivers' perceived non-disclosure by the patients was primarily associated with their anxiety (r = 0.31), disease-specific distress (r = 0.32), and psychological/emotional needs (r = 0.35)., Conclusion: The identification of caregivers reporting problems in communicating with patients should be pursued in clinical practice as this might indicate that caregivers are particularly burdened., (© 2014 S. Karger GmbH, Freiburg.)

Aim: To evaluate quality of life (QoL) after curative liver resection and identify variables associated with decreased QoL., Methods: From October 2001 to July 2004, 323 patients underwent liver resection. At 3-36 mo after discharge, 188 patients were disease free. QoL was assessed using the Short Form (SF)-12 Health Survey with mental and physical component scales (SF-12 MCS and PCS), supplemented with generic questions concerning pain and liver-specific items., Results: Sixty-eight percent (128/188) returned the questionnaire, which was completed in 75% (96/128) of cases. Median SF-12 PCS and MCS were 46.7 (interquartile range: 34.2-53.9) and 54.1 (42.8-58.2). Fifty percent were pain free with a median symptom score of 1.75 (1.38-2.13). PCS was higher after major hepatectomy [57% (55/96)] compared to minor resection (P = 0.0049), which represented an improved QoL. QoL was not affected by sex but by age compared to the general German population. MCS was higher after liver surgery for metastatic disease [55.9 (47.5-58.8)] compared to primary carcinoma [49.6 (36.5-55.1)] and benign disease [49.2 (37.7-56.3)] (P = 0.0317). There was no correlation between length of postoperative period and QoL. Pain, deficiencies in everyday life and a high symptom score significantly decreased MCS and PCS., Conclusion: Most patients were only marginally affected even after major liver resection; however, minor complications were associated with decreased SF-12 MCS and PCS and need careful attention.