Clinical Laboratory Data: Data Management and Reporting from Large Scale, Long-Term, Multicenter Trials

1985 ◽  
Vol 3 (4) ◽  
pp. 445-445
Author(s):  
Joseph McDevitt ◽  
James McCafferty ◽  
Peter Zarevics
1986 ◽  
Vol 84 ◽  
Author(s):  
Rodney C. Ewing ◽  
Michael J. Jercinovic

AbstractOne of the unique and scientifically most difficult aspects of nuclear waste isolation is the extrapolation ofshot-term laboratory data (hours to years) to the long time periods (103-105 years) required by regulatory agencies for performance assessment. The direct verification of these extrapolations is not possible, but methods must be developed to demonstrate compliance with government regulations and to satisfy the lay public that there is a demonstrable and reasonable basis for accepting the long-term extrapolations. Natural analogues of both the repository environment (e.g. radionuclide migration at Oklo) and nuclear waste form behavior (e.g. alteration of basaltic glasses and radiation damage in minerals) have been used to demonstrate the long-term behavior of large scale geologic systems and, on a smaller scale, waste form durability. This paper reviews the use of natural analogues to predict the long-term behavior of nuclear waste form glasses. Particular emphasis is placed on the inherent limitations of any conclusions that are based on “proof” by analogy. An example -- corrosion of borosilicate glass -- is discussed in detail with specific attention to the proper and successful use of natural analogues (basaltic glass) in understanding the long-term corrosion behavior of borosilicate glass.


2021 ◽  
Vol 12 ◽  
Author(s):  
Rayus Kuplicki ◽  
James Touthang ◽  
Obada Al Zoubi ◽  
Ahmad Mayeli ◽  
Masaya Misaki ◽  
...  

Neuroscience studies require considerable bioinformatic support and expertise. Numerous high-dimensional and multimodal datasets must be preprocessed and integrated to create robust and reproducible analysis pipelines. We describe a common data elements and scalable data management infrastructure that allows multiple analytics workflows to facilitate preprocessing, analysis and sharing of large-scale multi-level data. The process uses the Brain Imaging Data Structure (BIDS) format and supports MRI, fMRI, EEG, clinical, and laboratory data. The infrastructure provides support for other datasets such as Fitbit and flexibility for developers to customize the integration of new types of data. Exemplar results from 200+ participants and 11 different pipelines demonstrate the utility of the infrastructure.


2021 ◽  
Author(s):  
Raid Al-Omari ◽  
◽  
Mohammed Fattah ◽  
Mudhafar Hameedi ◽  
◽  
...  

The long-term settlements in organic clay can create a kind of an engineering challenge that appear in most facilities design and construction in areas with deep deposits of soft clay. Peat ground is widely distributed throughout the southern part of Iraq. Peat contains a large amount of organic matter and has a very high natural water content. Three soil samples were collected from depths of 1.5 m, 2.5 m, and 3.5 m, below the soil surface in Halfaya oilfield, which lies east of Missan governorate southern Iraq. A series of tests were conducted in a large-scale model using a plate footing and considering three different percent of organic content. The percent of secondary settlement found is dependent on the stress level applied. A large fraction of the total settlement may be due to secondary compression. The assumption of a constant coefficient of secondary compression, Cα, may not be valid for a long-term settlement of peats. Laboratory data indicate that Cα generally increases with time. Thus, settlement predictions using constant Cα may underestimate field settlement.


2011 ◽  
Vol 57 (11) ◽  
pp. 1616-1617 ◽  
Author(s):  
Hedwig CM Stepman ◽  
Dietmar Stöckl ◽  
Veronique Stove ◽  
Tom Fiers ◽  
Pedro Couck ◽  
...  

2021 ◽  
Vol 10 (21) ◽  
pp. 5160
Author(s):  
Egesta Lopci

Immunotherapy with checkpoint inhibitors has prompted a major change not only in cancer treatment but also in medical imaging. In parallel with the implementation of new drugs modulating the immune system, new response criteria have been developed, aiming to overcome clinical drawbacks related to the new, unusual, patterns of response characterizing both solid tumors and lymphoma during the course of immunotherapy. The acknowledgement of pseudo-progression, hyper-progression, immune-dissociated response and so forth, has become mandatory for all imagers dealing with this clinical scenario. A long list of acronyms, i.e., irRC, iRECIST, irRECIST, imRECIST, PECRIT, PERCIMT, imPERCIST, iPERCIST, depicts the enormous effort made by radiology and nuclear medicine physicians in the last decade to optimize imaging parameters for better prediction of clinical benefit in immunotherapy regimens. Quite frequently, a combination of clinical-laboratory data with imaging findings has been tested, proving the ability to stratify patients into various risk groups. The next steps necessarily require a large scale validation of the most robust criteria, as well as the clinical implementation of immune-targeting tracers for immuno-PET or the exploitation of radiomics and artificial intelligence as complementary tools during the course of immunotherapy administration. For the present review article, a summary of PET/CT role for immunotherapy monitoring will be provided. By scrolling into various cancer types and applied response criteria, the reader will obtain necessary information for better understanding the potentials and limitations of the modality in the clinical setting.


2021 ◽  
pp. 144-145
Author(s):  
Mariam Mgeladze ◽  
George Kamkamidze

Goal: The main objective of our study was to evaluate the effect of long-term treatment in patients with high liver fibrosis who have achieved a sustainable viral response (SVR) after receiving direct antiviral medication (DAA). Assess sociodemographic characteristics and clinical /laboratory data role in changing the level of liver fibrosis. The Methods: study cohort included patients from the Hepatitis C Elimination Program treated with direct antiviral drugs (DAA), with high-grade elastography-determined liver fibrosis (> = F3), and patients with a FIB4 score above 3.25 and sustainable viral response is achieved within 12-24 weeks after completion of treatment. The study group was selected retrospectively from Clinic Neolab's medical database and records. A total of 150 patients were studied. Data were processed in the statistical program SPSS24. The Wilcoxon Signed Ranks test was used from the statistical tests.Results: The study was conducted in 2020. These data were determined both before and after treatment. After treatment on the metavir scale, liver damage levels improved in 51.7% of patients.Statistical analysis showed that the change in fibrosis level after treatment was statistically significant (P <0.001). The study normalized data from laboratory studies such as Alt (85,3%) and Ast (80 5%).


2020 ◽  
Author(s):  
Michael Finkel ◽  
Albrecht Baur ◽  
Tobias K.D. Weber ◽  
Karsten Osenbrück ◽  
Hermann Rügner ◽  
...  

&lt;p&gt;The consistent management of research data is crucial for the success of long-term and large-scale collaborative research. Research data management is the basis for efficiency, continuity, and quality of the research, as well as for maximum impact and outreach, including the long-term publication of data and their accessibility. Both funding agencies and publishers increasingly require this long term and open access to research data. Joint environmental studies typically take place in a fragmented research landscape of diverse disciplines; researchers involved typically show a variety of attitudes towards and previous experiences with common data policies, and the extensive variety of data types in interdisciplinary research poses particular challenges for collaborative data management.We present organizational measures, data and metadata management concepts, and technical solutions to form a flexible research data management framework that allows for efficiently sharing the full range of data and metadata among all researchers of the project, and smooth publishing of selected data and data streams to publicly accessible sites. The concept is built upon data type-specific and hierarchical metadata using a common taxonomy agreed upon by all researchers of the project. The framework&amp;#8217;s concept has been developed along the needs and demands of the scientists involved, and aims to minimize their effort in data management, which we illustrate from the researchers&amp;#8217; perspective describing their typical workflow from the generation and preparation of data and metadata to the long-term preservation of data including their metadata.&lt;/p&gt;


Lupus ◽  
2019 ◽  
Vol 28 (11) ◽  
pp. 1294-1301 ◽  
Author(s):  
J Won ◽  
J S Lee ◽  
J S Oh ◽  
Y-G Kim ◽  
C-K Lee ◽  
...  

Objectives Favourable long-term prognosis in proliferative lupus nephritis (LN) is associated with the achievement of complete renal response (CR), which is defined as a urine protein/creatinine ratio (UPCR) of < 0.5. However, it is unclear whether a more stringent cut-off for proteinuria (normal value of proteinuria; UPCR < 0.15) is better than CR. We aimed to evaluate the effect of stringent CR, defined as a UPCR of <0.15, on long-term renal outcomes in proliferative LN. Methods We included 87 patients with class III or IV LN who achieved CR at one year after induction therapy. Clinical and laboratory data were compared between the stringent and non-stringent CR groups. Logistic regression analysis was performed to identify factors associated with achievement of stringent CR. Cox analysis was performed to analyse the risk factors for renal flare and development of chronic kidney disease (CKD). Results The stringent and non-stringent CR groups included 58 and 29 patients, respectively. The two groups showed no significant baseline differences in terms of the clinical, laboratory and pathological classification. The sustained CR rates during five years were 91.3% and 50.0% ( p = 0.014) in the stringent and non-stringent CR groups, respectively. In Cox analyses, the achievement of stringent CR was associated with a lower risk of five-year renal flare rate (hazard ratio (HR) = 0.161, 95% confidence interval (CI) 0.063–0.411, p < 0.01) and development of CKD (HR = 0.189, 95% CI 0.047–0.752, p = 0.018). Mycophenolate mofetil induction therapy was associated with achievement of stringent CR at a borderline level of significance (HR = 7.268, 95% CI 0.894–59.089, p = 0.064). Conclusion Achievement of stringent CR predicted lower risk of renal flare and development of CKD in proliferative LN. These findings suggest that stringent CR is a valuable treatment target in proliferative LN.


2021 ◽  
Vol 34 (2) ◽  
pp. 129-137
Author(s):  
Seniha Basaran ◽  
Oguz Evlice ◽  
Aysun Benli ◽  
Serap Simsek-Yavuz ◽  
Atahan Çağatay ◽  
...  

Objective: Skull base osteomyelitis (SBO) is a rare, life-threatening infection and frequently followed and treated by otolaryngologists previously. In this study, we analyzed the diagnosis, treatment and long-term outcomes of SBO from the perspective of infectious diseases and clinical microbiology (IDCM). Methods: Hospitalized patients with SBO between 2012-2019 were evaluated retrospectively. Epidemiological, clinical, laboratory data of the patients were recorded. The patients who recovered with and without sequelae were compared. Results: The mean age of 16 SBO cases was 66 years, 75% of them were male and 87.5% had diabetes mellitus (DM). Cranial nerve and vascular/dural involvement were present in 75% and 56.3% of them, respectively. The most common isolated microorganism were P. aeruginosa, staphylococci and Candida spp. 81.2%, 43.7%, and 56% of the patients received anti-pseudomonal antibiotics, additional glycopeptide and additional antifungal drugs, respectively. The sequelae rate was 46.7% in a 24-month follow-up. Hypertension (p=0.041), duration of complaints (p=0.003), bilateral involvement of skull base (p=0.001), vascular thrombosis/inflammation or dural involvement (p=0.007), previous surgical intervention (p=0.041) and elevated ESR at the end of treatment (p=0.014) were defined as risk factors for permanent sequelae. There was no in-hospital mortality.  Conclusions: SBO mainly affects older male patients with DM and causes significant sequelae in half of them. In the cases unresponsive to anti-pseudomonal agents, the addition of antifungal therapy empirically may provide a clinical response. Permanent sequelae are more common in cases with delayed diagnosis/treatment, bilateral, vascular or dural involvement, and elevated ESR at the end of treatment.  ESR can be used to determine the treatment response and duration. The follow-up and treatment of SBO cases by IDCM with the support of experienced surgeons may contribute to the positive clinical results.


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