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  • 1
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    Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study
    Elsevier BV ; 2024
    In:  The Lancet Oncology ( 2024-7)
    Details
    In: The Lancet Oncology, Elsevier BV, ( 2024-7)
    Type of Medium: Online Resource
    ISSN: 1470-2045
    URL: Article
    DOI: 10.1016/S1470-2045(24)00326-7
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 2049730-1
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  • 2
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    Prognostic PSMA-PET PROMISE nomograms for patients with prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2024
    In:  Journal of Clinical Oncology Vol. 42, No. 16_suppl ( 2024-06-01), p. 5016-5016
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 42, No. 16_suppl ( 2024-06-01), p. 5016-5016
    Abstract: 5016 Background: Prostate Specific Membrane Antigen Positron-Emission-Tomography (PSMA-PET) was introduced for prostate cancer staging in 2012. PSMA-PET reported by standardized PROMISE criteria delivers accurate staging with potential prognostic value. Here we assess the prognostic value of PSMA-PET including tumor volume in a large prostate cancer dataset with overall survival follow-up and compare it head-to-head to clinical risk scores. Methods: Prostate cancer patients, who underwent PSMA-PET between October 2014 and December 2019 at the Essen University Hospital, were analyzed retrospectively. We collected PSMA-PET stage using the molecular imaging TNM system (miTNM), tumor volume, SUVmean and overall survival follow-up. The dataset was split into development and validation cohorts (2:1). We created a visual and quantitative nomogram based on Cox regression models with LASSO penalty using the development cohort. Performance of nomograms in the validation cohort were measured using C-index and calibration plots. Head-to-head comparison to clinical risk scores for each staging group was examined using ROC-curves and C-index. Results: The cohort includes 1612 prostate cancer patients across all disease stages with 567 (35.2%) recorded deaths. PSMA-PET based predictors included into the quantitative PSMA-PET nomogram were locoregional lymph node metastases (miN2), distant metastases (miM1a, miM1b pattern, miM1c), tumor volume and tumor SUVmean (Table). The visual nomogram includes distant metastases and total tumor lesion count. Overall C-indices were 0.81 or 0.78 for the quantitative or visual nomogram, respectively. The quantitative PSMA-PET nomogram was superior to STARCAP at initial staging (AUC: 0.72 vs. 0.53; p=0.02), to EAU risk score at BCR (AUC: 0.69 vs. 0.52; p 〈 0.001), and to NCCN groups at any timepoint (AUC: 0.81 vs. 0.73; p 〈 0.001). The visual PSMA-PET nomogram was superior to EAU risk score (AUC: 0.64 vs. 0.52; p 〈 0.001) and NCCN groups (AUC: 0.79 vs. 0.73 p 〈 0.001). Conclusions: Our prognostic PSMA-PET nomograms based on PROMISE criteria were accurate in early and late stages of prostate cancer. Prediction of overall survival was superior when compared to clinical risk tools. Multi-center validation in the PROMISE registry is ongoing. Development cohort (n=1110 patients) univariate regression findings for PROMISE variables included in the quantitative PSMA-PET nomogram for prediction of overall survival.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2024.42.16_suppl.5016
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2024
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 3
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    Weight cycling and the risk of type 2 diabetes in the EPIC-Germany cohort
    Springer Science and Business Media LLC ; 2015
    In:  Diabetologia Vol. 58, No. 12 ( 2015-12), p. 2718-2725
    Details
    In: Diabetologia, Springer Science and Business Media LLC, Vol. 58, No. 12 ( 2015-12), p. 2718-2725
    Type of Medium: Online Resource
    ISSN: 0012-186X , 1432-0428
    URL: Article
    DOI: 10.1007/s00125-015-3755-9
    RVK:
    XA 40615
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2015
    detail.hit.zdb_id: 1458993-X
    detail.hit.zdb_id: 1694-9
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  • 4
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    Prediagnostic Plasma Bile Acid Levels and Colon Cancer Risk: A Prospective Study
    Oxford University Press (OUP) ; 2020
    In:  JNCI: Journal of the National Cancer Institute Vol. 112, No. 5 ( 2020-05-01), p. 516-524
    Details
    In: JNCI: Journal of the National Cancer Institute, Oxford University Press (OUP), Vol. 112, No. 5 ( 2020-05-01), p. 516-524
    Abstract: Bile acids have been proposed to promote colon carcinogenesis. However, there are limited prospective data on circulating bile acid levels and colon cancer risk in humans. Methods Associations between prediagnostic plasma levels of 17 primary, secondary, and tertiary bile acid metabolites (conjugated and unconjugated) and colon cancer risk were evaluated in a nested case-control study within the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. Bile acid levels were quantified by tandem mass spectrometry in samples from 569 incident colon cancer cases and 569 matched controls. Multivariable logistic regression analyses were used to estimate odds ratios (ORs) for colon cancer risk across quartiles of bile acid concentrations. Results Positive associations were observed between colon cancer risk and plasma levels of seven conjugated bile acid metabolites: the primary bile acids glycocholic acid (ORquartile 4 vs quartile 1= 2.22, 95% confidence interval [CI] = 1.52 to 3.26), taurocholic acid (OR = 1.78, 95% CI = 1.23 to 2.58), glycochenodeoxycholic acid (OR = 1.68, 95% CI = 1.13 to 2.48), taurochenodeoxycholic acid (OR = 1.62, 95% CI = 1.11 to 2.36), and glycohyocholic acid (OR = 1.65, 95% CI = 1.13 to 2.40), and the secondary bile acids glycodeoxycholic acid (OR = 1.68, 95% CI = 1.12 to 2.54) and taurodeoxycholic acid (OR = 1.54, 95% CI = 1.02 to 2.31). By contrast, unconjugated bile acids and tertiary bile acids were not associated with risk. Conclusions This prospective study showed that prediagnostic levels of certain conjugated primary and secondary bile acids were positively associated with risk of colon cancer. Our findings support experimental data to suggest that a high bile acid load is colon cancer promotive.
    Type of Medium: Online Resource
    ISSN: 0027-8874 , 1460-2105
    URL: Article
    DOI: 10.1093/jnci/djz166
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2992-0
    detail.hit.zdb_id: 1465951-7
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  • 5
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    Distinct Reproductive Risk Profiles for Intrinsic-Like Breast Cancer Subtypes: Pooled Analysis of Population-Based Studies
    Oxford University Press (OUP) ; 2022
    In:  JNCI: Journal of the National Cancer Institute Vol. 114, No. 12 ( 2022-12-08), p. 1706-1719
    Details
    In: JNCI: Journal of the National Cancer Institute, Oxford University Press (OUP), Vol. 114, No. 12 ( 2022-12-08), p. 1706-1719
    Abstract: Reproductive factors have been shown to be differentially associated with risk of estrogen receptor (ER)-positive and ER-negative breast cancer. However, their associations with intrinsic-like subtypes are less clear. Methods Analyses included up to 23 353 cases and 71 072 controls pooled from 31 population-based case-control or cohort studies in the Breast Cancer Association Consortium across 16 countries on 4 continents. Polytomous logistic regression was used to estimate the association between reproductive factors and risk of breast cancer by intrinsic-like subtypes (luminal A-like, luminal B-like, luminal B-HER2–like, HER2-enriched–like, and triple-negative breast cancer) and by invasiveness. All statistical tests were 2-sided. Results Compared with nulliparous women, parous women had a lower risk of luminal A-like, luminal B-like, luminal B-HER2–like, and HER2-enriched–like disease. This association was apparent only after approximately 10 years since last birth and became stronger with increasing time (odds ratio [OR] = 0.59, 95% confidence interval [CI] = 0.49 to 0.71; and OR = 0.36, 95% CI = 0.28 to 0.46 for multiparous women with luminal A-like tumors 20 to less than 25 years after last birth and 45 to less than 50 years after last birth, respectively). In contrast, parous women had a higher risk of triple-negative breast cancer right after their last birth (for multiparous women: OR = 3.12, 95% CI = 2.02 to 4.83) that was attenuated with time but persisted for decades (OR = 1.03, 95% CI = 0.79 to 1.34, for multiparous women 25 to less than 30 years after last birth). Older age at first birth (Pheterogeneity & lt; .001 for triple-negative compared with luminal A-like breast cancer) and breastfeeding (Pheterogeneity & lt; .001 for triple-negative compared with luminal A-like breast cancer) were associated with lower risk of triple-negative breast cancer but not with other disease subtypes. Younger age at menarche was associated with higher risk of all subtypes; older age at menopause was associated with higher risk of luminal A-like but not triple-negative breast cancer. Associations for in situ tumors were similar to luminal A-like. Conclusions This large and comprehensive study demonstrates a distinct reproductive risk factor profile for triple-negative breast cancer compared with other subtypes, with implications for the understanding of disease etiology and risk prediction.
    Type of Medium: Online Resource
    ISSN: 0027-8874 , 1460-2105
    URL: Article
    DOI: 10.1093/jnci/djac117
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2992-0
    detail.hit.zdb_id: 1465951-7
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  • 6
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    Effect of High-Dose Creatine Therapy on Symptoms of Exercise Intolerance in McArdle Disease : Double-blind, Placebo-Controlled Crossover Study
    American Medical Association (AMA) ; 2002
    In:  Archives of Neurology Vol. 59, No. 1 ( 2002-01-01), p. 97-
    Details
    In: Archives of Neurology, American Medical Association (AMA), Vol. 59, No. 1 ( 2002-01-01), p. 97-
    Type of Medium: Online Resource
    ISSN: 0003-9942
    URL: Article
    DOI: 10.1001/archneur.59.1.97
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2002
    detail.hit.zdb_id: 80049-1
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  • 7
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    Development and validation of a lifestyle-based model for colorectal cancer risk prediction: the LiFeCRC score
    Springer Science and Business Media LLC ; 2021
    In:  BMC Medicine Vol. 19, No. 1 ( 2021-12)
    Details
    In: BMC Medicine, Springer Science and Business Media LLC, Vol. 19, No. 1 ( 2021-12)
    Abstract: Nutrition and lifestyle have been long established as risk factors for colorectal cancer (CRC). Modifiable lifestyle behaviours bear potential to minimize long-term CRC risk; however, translation of lifestyle information into individualized CRC risk assessment has not been implemented. Lifestyle-based risk models may aid the identification of high-risk individuals, guide referral to screening and motivate behaviour change. We therefore developed and validated a lifestyle-based CRC risk prediction algorithm in an asymptomatic European population. Methods The model was based on data from 255,482 participants in the European Prospective Investigation into Cancer and Nutrition (EPIC) study aged 19 to 70 years who were free of cancer at study baseline (1992–2000) and were followed up to 31 September 2010. The model was validated in a sample comprising 74,403 participants selected among five EPIC centres. Over a median follow-up time of 15 years, there were 3645 and 981 colorectal cancer cases in the derivation and validation samples, respectively. Variable selection algorithms in Cox proportional hazard regression and random survival forest (RSF) were used to identify the best predictors among plausible predictor variables. Measures of discrimination and calibration were calculated in derivation and validation samples. To facilitate model communication, a nomogram and a web-based application were developed. Results The final selection model included age, waist circumference, height, smoking, alcohol consumption, physical activity, vegetables, dairy products, processed meat, and sugar and confectionary. The risk score demonstrated good discrimination overall and in sex-specific models. Harrell’s C-index was 0.710 in the derivation cohort and 0.714 in the validation cohort. The model was well calibrated and showed strong agreement between predicted and observed risk. Random survival forest analysis suggested high model robustness. Beyond age, lifestyle data led to improved model performance overall (continuous net reclassification improvement = 0.307 (95% CI 0.264–0.352)), and especially for young individuals below 45 years (continuous net reclassification improvement = 0.364 (95% CI 0.084–0.575)). Conclusions LiFeCRC score based on age and lifestyle data accurately identifies individuals at risk for incident colorectal cancer in European populations and could contribute to improved prevention through motivating lifestyle change at an individual level.
    Type of Medium: Online Resource
    ISSN: 1741-7015
    URL: Article
    DOI: 10.1186/s12916-020-01826-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2131669-7
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  • 8
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    Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 10 ( 2023-12), p. 1169-1177
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 10 ( 2023-12), p. 1169-1177
    Abstract: The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications. Aims: In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA. Methods: PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or late ( 〉  7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. Results: Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.10–2.21) for early dabigatran use versus VKA use and an adjusted HR of 0.09 (95% CI: 0.00–13.11) for late dabigatran use versus VKA use. No differences were found between early initiation of dabigatran versus VKA use regarding ischemic endpoints. Conclusions: The early application of dabigatran appears to be safer than VKA administered at any time point with regards to the risk of hemorrhagic complications and in particular for intracranial hemorrhage. This result, however, must be interpreted with caution in view of the low precision of the estimate.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231184366
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2303728-3
    detail.hit.zdb_id: 2211666-7
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  • 9
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    Rationale, Design and Methods of the Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) Study
    SAGE Publications ; 2021
    In:  European Stroke Journal Vol. 6, No. 4 ( 2021-12), p. 438-444
    Details
    In: European Stroke Journal, SAGE Publications, Vol. 6, No. 4 ( 2021-12), p. 438-444
    Abstract: The optimal timing of anticoagulation following acute ischaemic stroke or TIA in patients with atrial fibrillation (AF) is a frequent challenge. Early initiation of anticoagulation can reduce the risk for recurrent ischaemic events, but may lead to an increased risk for intracerebral haemorrhage. Aim The Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study was initiated to investigate outcome events under antithrombotic therapy after ischaemic stroke or TIA in patients with AF. The main objective is to compare the three-month rates of major haemorrhagic events between early (≤ 7 days) versus late ( 〉 7 days) administration of dabigatran or treatment with vitamin-K antagonists started at any time. Occurrences of ischaemic and major haemorrhagic events will be evaluated to determine the optimal time point for initiation or resumption of anticoagulation. Design and Methods PRODAST is a prospective, multicenter, observational, non-interventional post-authorization safety study. 10,000 patients with recent (≤ 1 week from index event) ischaemic stroke or TIA and non-valvular AF were recruited at 86 German sites starting in July 2015. The observational plan includes a baseline visit, documentation of data during hospitalization and a telephone-based, central follow-up at three months after the index event. The primary endpoint is the major bleeding rate within three months. Secondary endpoints include rates of recurrent ischaemic or haemorrhagic stroke, TIA, systemic embolism, myocardial infarction and death. Summary PRODAST will provide important real-world data on safety and efficacy of antithrombotic therapy after acute stroke and TIA in patients with AF.
    Type of Medium: Online Resource
    ISSN: 2396-9873 , 2396-9881
    URL: Article
    DOI: 10.1177/23969873211060219
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2851287-X
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  • 10
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    Leadership program with skills training for general practitioners was highly accepted without improving job satisfaction: the cluster randomized IMPROVEjob study
    Springer Science and Business Media LLC ; 2022
    In:  Scientific Reports Vol. 12, No. 1 ( 2022-10-25)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 12, No. 1 ( 2022-10-25)
    Abstract: Leadership has become an increasingly important issue in medicine as leadership skills, job satisfaction and patient outcomes correlate positively. Various leadership training and physician psychological well-being programmes have been developed internationally, yet no standard is established in primary care. The IMPROVE job leadership program was developed to improve job satisfaction among German general practitioners and practice personnel. Its acceptance and effectiveness were evaluated. The IMPROVE job intervention is a participatory, interdisciplinary and multimodal leadership intervention that targets leadership, workflows and communication in general practices using three elements: (1) two leadership workshops with skills training; (2) a toolbox with printed and online material, and (3) a 9-month implementation phase supported by facilitators. A cluster-randomised trial with a waiting-list control evaluated the effectiveness on the primary outcome job satisfaction assessed by the Copenhagen Psychosocial Questionnaire (range 0–100). A mixed-methods approach with questionnaires and participant interviews evaluated the acceptance of the intervention and factors influencing the implementation of intervention content. Statistical analyses respected the clustered data structure. The COVID-19 pandemic necessitated intervention adjustments: online instead of on-site workshops, online material instead of facilitator practice visits. Overall, 52 of 60 practices completed the study, with altogether 70 practice leaders, 16 employed physicians, and 182 practice assistants. According to an intention-to-treat analysis, job satisfaction decreased between baseline and follow-up (not significantly) in the total study population and in both study arms, while the subgroup of practice leaders showed a non-significant increase. A mixed multilevel regression model showed no effect of the intervention on job satisfaction ( b  = − 0.36, p   〉  0.86), which was influenced significantly by a greater sense of community ( b  = 0.14, p   〈  0.05). The acceptance of the IMPROVE job workshops was high, especially among practice leaders compared to assistants (1 = best to 5 = worst): skills training 1.78 vs. 2.46, discussions within the practice team 1.87 vs. 2.28, group discussions 1.96 vs. 2.21. The process evaluation revealed that the COVID-19 pandemic complicated change processes and delayed the implementation of intervention content in practice routines. The workshops within the participatory IMPROVE job intervention were rated very positively but the multimodal intervention did not improve job satisfaction 9 months into the pandemic. Qualitative data showed an impairment of implementation processes by the unforeseeable COVID pandemic. Trial registration Registration number: DRKS00012677 on 16/10/2019.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-022-22357-z
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2615211-3
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