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Journal articles on the topic 'Diagnostic trials'

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1

Makhlouf, Hala, Mark A. Watson, Heather A. Lankes, et al. "Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials." American Journal of Clinical Pathology 153, no. 2 (2019): 149–55. http://dx.doi.org/10.1093/ajcp/aqz141.

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Abstract Objectives The National Cancer Institute (NCI) National Clinical Trials Network performs phase II and III clinical trials, which increasingly rely on the submission of diagnostic formalin-fixed, paraffin-embedded tissue blocks for biomarker assessment. Simultaneously, advances in precision oncology require that clinical centers maintain diagnostic specimens for ancillary, standard-of-care diagnostics. This has caused tissue blocks to become a limited resource for advancing the NCI clinical trial enterprise and the practice of modern molecular pathology. Methods The NCI convened a 1-da
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2

Suzuki, M., S. Katoh, R. Miyahara, K. Ariyoshi, and K. Morimoto. "Accuracy of composite diagnostic standards for pneumococcal pneumonia in vaccine trials." Epidemiology and Infection 146, no. 6 (2018): 712–15. http://dx.doi.org/10.1017/s0950268818000651.

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AbstractBecause of a lack of gold standard diagnostics, a combination of multiple diagnostic tests, or composite diagnostic standard, has been used to measure pneumococcal pneumonia (PP) in pneumococcal vaccine trials. We estimated the accuracy of composite diagnostic standards for PP used in previous randomised controlled trials by simple formulas. A systematic literature review identified five eligible trials and all trials had used different combinations of diagnostic tests for PP. The estimated values of sensitivity and minimum specificity of composite diagnostic standards varied substanti
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3

Hahn, Andreas, Ulrike Loderstädt, Hagen Frickmann, and Norbert G. Schwarz. "Sparing the control arm using well-characterized diagnostic approaches – the Gart and Buck prevalence estimator for efficacy estimation in single-arm trials." Journal of Laboratory Medicine 43, no. 5 (2019): 279–81. http://dx.doi.org/10.1515/labmed-2019-0091.

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Abstract Efficacy estimation of medical interventions in clinical trials requires diagnostics to assess the study endpoint. The imperfect nature of diagnostics often leads to biased efficacy estimations, usually underestimation, that could result in failure of clinical trials. Adjustment methods can be used if sensitivity and specificity are known, but they are not regularly applied. Double-arm clinical trials are the standard for demonstrating the superiority of a medical intervention. However, sometimes single-arm trials are the only option: for example, if a parallel group trial design with
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4

Brooke, M. H. "Diagnostic criteria in clinical trials." Neurology 47, Issue 4, Supplement 2 (1996): 67S—70S. http://dx.doi.org/10.1212/wnl.47.4_suppl_2.67s.

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5

Majstorović, Nikola, Goran Nešić, Vladimir Grbić, et al. "RELIABILITY OF A SIMPLE NOVEL FIELD TEST FOR THE MEASUREMENT OF PLANTAR FLEXOR MUSCLE STRENGTH." Revista Brasileira de Medicina do Esporte 27, no. 1 (2021): 98–102. http://dx.doi.org/10.1590/1517-8692202127012019_0002.

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ABSTRACT Introduction When a person is in a standing position, the plantar flexor muscles are involved in most static and dynamic body movements. Objectives The aim of this study was to investigate the trial to trial and factorial reliability of measuring the contractile characteristics of PF muscles using a simple novel field test. Methods The sample consisted of 452 healthy subjects, 120 male and 332 female. The research was conducted by means of the trial to trial testing method, using isometric dynamometry performed in field conditions. ANOVA was used to estimate the differences among the
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6

Morant, Steven V., Frank H. Dodd, and Roger P. Natzke. "Consequences of diagnostic errors in mastitis therapy trials." Journal of Dairy Research 55, no. 3 (1988): 315–29. http://dx.doi.org/10.1017/s0022029900028570.

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SummaryThe effect of errors that occur in the diagnosis of intramammary infectious mastitis on the precision of experiments measuring the efficacy of mastitis therapy has been investigated. Diagnostic errors within the range found by experienced workers can create large biases in the apparent cure rate of therapy particularly at cure rates of less than 0·5. Using confirmed methods of diagnosis rather than single samples and reducing the probabilities of false positive and false negative diagnoses to 0·01 and 0·05 respectively, the biases in the apparent cure rates are reduced to acceptable lev
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Mockus, Susan M., Sara E. Patterson, Cara Statz, Carol J. Bult, and Gregory J. Tsongalis. "Clinical Trials in Precision Oncology." Clinical Chemistry 62, no. 3 (2016): 442–48. http://dx.doi.org/10.1373/clinchem.2015.247437.

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Abstract BACKGROUND Availability of genomic information used in the management of cancer treatment has outpaced both regulatory and reimbursement efforts. Many types of clinical trials are underway to validate the utility of emerging genome-based biomarkers for diagnostic, prognostic, and predictive applications. Clinical trials are a key source of evidence required for US Food and Drug Administration approval of therapies and companion diagnostics and for establishing the acceptance criteria for reimbursement. CONTENT Determining the eligibility of patients for molecular-based clinical trials
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8

Lee, You Kyoung, and Sang Moo Lee. "Clinical Trials and Accuracy of Diagnostic Tests." Journal of Genetic Medicine 8, no. 1 (2011): 28–34. http://dx.doi.org/10.5734/jgm.2011.8.1.28.

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9

Dong, Ting, Liansheng Larry Tang, and William F. Rosenberger. "Optimal sampling ratios in comparative diagnostic trials." Journal of the Royal Statistical Society: Series C (Applied Statistics) 63, no. 3 (2013): 499–514. http://dx.doi.org/10.1111/rssc.12043.

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10

Tang, L. L., and A. Liu. "Sample size recalculation in sequential diagnostic trials." Biostatistics 11, no. 1 (2009): 151–63. http://dx.doi.org/10.1093/biostatistics/kxp044.

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11

Konietschke, Frank, Randolph R. Aguayo, and Wieland Staab. "Simultaneous inference for factorial multireader diagnostic trials." Statistics in Medicine 37, no. 1 (2017): 28–47. http://dx.doi.org/10.1002/sim.7507.

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12

Bouchard, Rémi W. "Diagnostic Criteria of Dementia." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 34, S1 (2007): S11—SS18. http://dx.doi.org/10.1017/s0317167100005497.

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In the past two decades there has been a tremendous effort among clinicians and searchers to improve the diagnostic criteria of the dementias on the basis of the differential neurological and neuropsychological profiles. This was an obligatory requirement for clinical trials and the development of treatments. Over the years it became rapidly evident that the cohorts of patients in studies had some degree of heterogeneity, making it difficult to interpret the results of some studies, particularly in the vascular dementias and the mild cognitive impairment (MCI) group. For example, many sub-type
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13

Tønning, Morten Lindbjerg, Lars Vedel Kessing, Jakob Eivind Bardram, and Maria Faurholt-Jepsen. "Methodological Challenges in Randomized Controlled Trials on Smartphone-Based Treatment in Psychiatry: Systematic Review." Journal of Medical Internet Research 21, no. 10 (2019): e15362. http://dx.doi.org/10.2196/15362.

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Background Smartphone-based technology is developing at high speed, and many apps offer potential new ways of monitoring and treating a range of psychiatric disorders and symptoms. However, the effects of most available apps have not been scientifically investigated. Within medicine, randomized controlled trials (RCTs) are the standard method for providing the evidence of effects. However, their rigidity and long time frame may contrast with the field of information technology research. Therefore, a systematic review of methodological challenges in designing and conducting RCTs within mobile h
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14

Rodgers, Anthony, and Stephen MacMahon. "Systematic Underestimation of Treatment Effects as a Result of Diagnostic Test Inaccuracy: Implications for the Interpretation and Design of Thromboprophylaxis Trials." Thrombosis and Haemostasis 73, no. 02 (1995): 167–71. http://dx.doi.org/10.1055/s-0038-1653746.

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SummaryMany clinical trials that have assessed strategies for the prevention of deep vein thrombosis have employed diagnostic tests that are less accurate than venography. The correct interpretation of these trials has been the subject of considerable debate. This paper attempts to quantify the likely effects of the use of inaccurate diagnostic tests (in particular fibrinogen scanning) on the validity and precision of estimates of treatment effects. It is shown that, if there is no difference in the rate of misclassification of deep vein thrombosis between study and control groups, then treatm
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15

Lauer, Michael S. "Believability of clinical trials: A diagnostic testing perspective." Journal of Thoracic and Cardiovascular Surgery 132, no. 2 (2006): 249–51. http://dx.doi.org/10.1016/j.jtcvs.2006.03.044.

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16

Nease, Robert F. "Utility assessment and clinical trials of diagnostic interventions." Academic Radiology 6 (January 1999): S103—S108. http://dx.doi.org/10.1016/s1076-6332(99)80102-0.

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17

Kinsey, C. Matthew, and David E. Ost. "Randomization in Diagnostic and Therapeutic Interventional Pulmonary Trials." Journal of Bronchology & Interventional Pulmonology 23, no. 4 (2016): 272–78. http://dx.doi.org/10.1097/lbr.0000000000000342.

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18

Prosser, N. L., J. M. K. Horwood, J. Baker, et al. "Clinical trials of a dual-sensor diagnostic pacemaker." Journal of Biomedical Engineering 13, no. 1 (1991): 19–26. http://dx.doi.org/10.1016/0141-5425(91)90039-a.

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19

Ellis, Peter M., Phyllis N. Butow, Martin H. N. Tattersall, Stewart M. Dunn, and Nehmat Houssami. "Randomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate." Journal of Clinical Oncology 19, no. 15 (2001): 3554–61. http://dx.doi.org/10.1200/jco.2001.19.15.3554.

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PURPOSE: To explore the association at different time points in the trajectory of breast cancer care, between anxiety, knowledge, and attitudes, on women’s willingness to participate in randomized clinical trials. MATERIALS AND METHODS: A cross-sectional survey was undertaken among women attending a breast clinic for screening mammography or diagnostic assessment plus women with newly diagnosed breast cancer to assess attitudes toward and willingness to participate in randomized clinical trials of breast cancer treatment. RESULTS: Five hundred forty-five women completed questionnaires assessin
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20

Fazzio, Luis E., Guillermo A. Mattioli, Sebastian J. Picco, Diana E. Rosa, Leonardo Minatel, and Eduardo J. Gimeno. "Diagnostic value of copper parameters to predict growth of suckling calves grazing native range in Argentina." Pesquisa Veterinária Brasileira 30, no. 10 (2010): 827–32. http://dx.doi.org/10.1590/s0100-736x2010001000004.

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A study was conducted to evaluate the predictive diagnostic value of different copper (Cu) parameters as indicators of average daily gain (ADG) in growing calves. The effects in calves of cow Cu supplementation in the last one-third gestation period were also evaluated. Five supplementation trials, with a total of 300 calves, were carried out. Two groups of 30 calves were randomly assigned to each trial, one group was parenterally supplemented (SG) and the other was not supplemented (NSG). Trials began when calves were three-month-old and ended at weaning time. At each sampling calves were wei
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21

Hasman, A., J. W. Arends, and L. M. de Bruijn. "Automatic Coding of Diagnostic Reports." Methods of Information in Medicine 37, no. 03 (1998): 260–65. http://dx.doi.org/10.1055/s-0038-1634526.

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AbstractA method is presented for assigning classification codes to pathology reports by searching similar reports from an archive collection. The key for searching is textual similarity, which estimates the true, semantic similarity. This method does not require explicit modeling, and can be applied to any language or any application domain that uses natural language reporting. A number of simulation experiments was run to assess the accuracy of the method and to indicate the role of size of the archive and the transfer of document collections across laboratories. In at least 63% of the simul
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22

Berry, Colin, David Corcoran, and Kenneth Mangion. "Cardiovascular health technology assessment: recommendations to improve the quality of evidence." Open Heart 6, no. 1 (2019): e000930. http://dx.doi.org/10.1136/openhrt-2018-000930.

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The aim of this article is to review the role of Health Technology Assessment (HTA) organisations in appraising and recommending innovative cardiovascular technologies. We consider how bias impairs the quality of evidence from clinical trials involving cardiovascular healthcare technologies. Finally, we provide recommendations to HTA organisations to take account of bias when making guideline recommendations.Clinical research studies of medical devices, diagnostics and interventions in cardiovascular healthcare are susceptible to impairment through bias. While HTA organisations, such as the Na
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23

Khurana, Surender, James Needham, Bonnie Mathieson, et al. "Human Immunodeficiency Virus (HIV) Vaccine Trials: a Novel Assay for Differential Diagnosis of HIV Infections in the Face of Vaccine-Generated Antibodies." Journal of Virology 80, no. 5 (2006): 2092–99. http://dx.doi.org/10.1128/jvi.80.5.2092-2099.2006.

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ABSTRACT All current human immunodeficiency virus (HIV) vaccine candidates contain multiple viral components and elicit antibodies that react positively in licensed HIV diagnostic tests, which contain similar viral products. Thus, vaccine trial participants could be falsely diagnosed as infected with HIV. Additionally, uninfected, seropositive vaccinees may encounter long-term social and economic harms. Moreover, this also interferes with early detection of true HIV infections during preventive HIV vaccine trials. An HIV-seropositive test result among uninfected vaccine trial participants is a
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24

Marantz, Paul R. "Diagnostic Heterogeneity in Clinical Trials for Congestive Heart Failure." Annals of Internal Medicine 109, no. 1 (1988): 55. http://dx.doi.org/10.7326/0003-4819-109-1-55.

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25

Kaufmann, Stefan H. E., January Weiner, and Jeroen Maertzdorf. "Accelerating tuberculosis vaccine trials with diagnostic and prognostic biomarkers." Expert Review of Vaccines 16, no. 8 (2017): 845–53. http://dx.doi.org/10.1080/14760584.2017.1341316.

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26

Lu, Bo, and Constantine Gatsonis. "Efficiency of study designs in diagnostic randomized clinical trials." Statistics in Medicine 32, no. 9 (2012): 1451–66. http://dx.doi.org/10.1002/sim.5655.

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27

Van Tinteren, H., O. S. Hoekstra, and M. Boers. "Do we need randomised trials to evaluate diagnostic procedures?" European Journal of Nuclear Medicine and Molecular Imaging 31, no. 1 (2003): 129–31. http://dx.doi.org/10.1007/s00259-003-1384-x.

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28

Valk, Peter E. "Do we need randomised trials to evaluate diagnostic procedures?" European Journal of Nuclear Medicine and Molecular Imaging 31, no. 1 (2004): 132–35. http://dx.doi.org/10.1007/s00259-003-1385-9.

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29

Pugh, Stephanie L., and Pedro A. Torres-Saavedra. "Fundamental Statistical Concepts in Clinical Trials and Diagnostic Testing." Journal of Nuclear Medicine 62, no. 6 (2021): 757–64. http://dx.doi.org/10.2967/jnumed.120.245654.

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30

Petersen, Lars J., Martin N. Johansen, Jesper Strandberg, Louise Stenholt, and Helle D. Zacho. "Reporting and handling of equivocal imaging findings in diagnostic studies of bone metastasis in prostate cancer." Acta Radiologica 61, no. 8 (2019): 1096–104. http://dx.doi.org/10.1177/0284185119890087.

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Background Equivocal scanning results occur. It remains unclear how these results are presented and their management influence diagnostic characteristics. Purpose To investigate the reporting and handling of equivocal imaging findings in diagnostic studies of bone metastases, and to assess the impact on diagnostic performance of the methods used to analyze equivocal findings. The conceptual issue was reified based on two actual observations. Material and Methods A recent meta-analysis of bone metastases in prostate cancer was conducted and data were obtained from a large clinical trial with a
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31

Ahmad, Sarah R., and Heather E. Moss. "Update on the Diagnosis and Treatment of Idiopathic Intracranial Hypertension." Seminars in Neurology 39, no. 06 (2019): 682–91. http://dx.doi.org/10.1055/s-0039-1698744.

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AbstractAdvances in ophthalmic diagnostics and results of interventional clinical trials are shifting diagnosis and management of idiopathic intracranial hypertension (IIH) to be more technology- and evidence-based. In this article, the evidence supporting current diagnostic criteria, evaluation, and medical and surgical management of IIH are reviewed.
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Stawski, Robert, Emilia Stec-Martyna, Adam Chmielecki, Dariusz Nowak, and Ewelina Perdas. "Current Trends in Cell-Free DNA Applications. Scoping Review of Clinical Trials." Biology 10, no. 9 (2021): 906. http://dx.doi.org/10.3390/biology10090906.

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We aimed to summarize the current knowledge about the trends in cfDNA application based on the analysis of clinical trials registered until April 2021. International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov were searched with the keywords: “cf-DNA”; “Circulating DNA”; “Deoxyribonucleic Acid”; and “Cell-Free Deoxyribonucleic Acid”. Of 605 clinical trials, we excluded 237 trials, and 368 remaining ones were subject to further analysis. The subject, number of participants, and study design were analyzed. Our scoping review revealed three main trends: oncology (n = 255), no
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Bautista, F., A. Cañete, G. L. Ramírez-Villar, et al. "ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain." Clinical and Translational Oncology 21, no. 12 (2019): 1763–70. http://dx.doi.org/10.1007/s12094-019-02221-9.

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Abstract Introduction Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufficient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of financial support and limited research infrastructure in o
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34

Burke, Jack D. "Field Trials of the 1987 Draft of Chapter V (F) of ICD-10." British Journal of Psychiatry 152, S1 (1988): 33–37. http://dx.doi.org/10.1192/s0007125000295597.

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IntroductionThis paper will review the major objectives and study design of the Field Trials of the draft chapter on Mental Behavioural and Developmental Disorders in the tenth revision of the International Classification of Diseases (ICD-10), now in preparation. The text used in this Field Trial is the Clinical Descriptions and Diagnostic Guidelines, which is more elaborate than the Short Glossary for this chapter that will be published in the main volume of ICD-10. The text for the former will be published together with the Diagnostic Criteria for Research and other parts of the WHO family o
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35

Roberts, Christine, and Joel Maslow. "Assay Challenges for Emerging Infectious Diseases: The Zika Experience." Vaccines 6, no. 4 (2018): 70. http://dx.doi.org/10.3390/vaccines6040070.

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From the perspective of vaccine development, it is imperative to accurately diagnose target infections in order to exclude subjects with prior exposure from evaluations of vaccine effectiveness, to track incident infection during the course of a clinical trial and to differentiate immune reactions due to natural infections from responses that are vaccine related. When vaccine development is accelerated to a rapid pace in response to emerging infectious disease threats, the challenges to develop such diagnostic tools is even greater. This was observed through the recent expansion of Zika virus
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Shafique, Sadaf, Farheen Aslam, Raheel Khan, and Asma Shaukat. "Interpretation of Diagnostic Tests for COVID-19 (SARS-COV-2)." BioMedica 36, no. 2S (2020): 93–96. http://dx.doi.org/10.51441/biomedica//biomedica/5-392.

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<p>The knowledge regarding diagnostic testing for SARS COV-2 is still at hit-and-trial phases, all over the world. Evolving day by day through ongoing research and extensive trials, use for SARS-COV-2 infectionsReverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and IgM/ IgG serology by Enzyme Linked Immunosorbent Assay (ELISA) or Electro-Chemiluminescent Immunoassay remain the main stay of diagnosis. However, the time course for the PCR positivity and seroconversion seem to vary in children and adults both, which also includes a huge population of asymptomatic individuals who are p
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37

Lilford, Richard J. "Evaluating New Treatments and Diagnostic Technologies in Obstetrics: Practical Problems, Ethics, and Solutions." International Journal of Technology Assessment in Health Care 5, no. 3 (1989): 459–72. http://dx.doi.org/10.1017/s0266462300007510.

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This article develops arguments for the use of decision theory, rather than intuition, to determine the size of trials. It is wrong to expect doctors to ignore personal preferences in favor of clinical experiments unless the trial is capable of showing differences in treatment effect that would influence clinical practice substantially. It follows from our analysis that if delta (the treatment effect that the trial is designed to detect) is sufficient to alter clinical practice, then the alpha and beta errors of a trial should be equal. This applies even if a new treatment is to be compared wi
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Sahm, Felix, and Maria Martinez-Lage. "Practical Implications of the Updated WHO Classification of Brain Tumors." Seminars in Neurology 38, no. 01 (2018): 011–18. http://dx.doi.org/10.1055/s-0038-1641162.

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AbstractThe updated 2016 WHO classification of Central Nervous System tumors introduced a novel concept of neuropathology diagnostics. Molecular parameters are now included into the definition of several entities. This evolution from a previously purely histology-based classification to an integrated approach of histology and genetic characteristics has implications in daily diagnostic and clinical practice. Both the spectrum of diagnostic workup demanded from the neuropathologist and the range of relevant markers to be considered by clinicians and clinical investigators have increased. This a
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Volz, H., R. Stieglitz, K. Menges, and H. Möller. "Somatoform Disorders - Diagnostic Concept, Controlled Clinical Trials, and Methodological Issues." Pharmacopsychiatry 27, no. 06 (1994): 231–37. http://dx.doi.org/10.1055/s-2007-1014310.

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40

Rejniak, K. A., M. C. Lloyd, D. R. Reed, and M. M. Bui. "Diagnostic assessment of osteosarcoma chemoresistance based on Virtual Clinical Trials." Medical Hypotheses 85, no. 3 (2015): 348–54. http://dx.doi.org/10.1016/j.mehy.2015.06.015.

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Hooper, R., K. Díaz-Ordaz, A. Takeda, and K. Khan. "Comparing diagnostic tests: trials in people with discordant test results." Statistics in Medicine 32, no. 14 (2012): 2443–56. http://dx.doi.org/10.1002/sim.5676.

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Mori, Joji, Yutaka Kano, Masahiro Yoshizaki, and Satoru Fukinbara. "Latent class models for medical diagnostic tests in multicenter trials." Statistics in Medicine 32, no. 29 (2013): 5091–105. http://dx.doi.org/10.1002/sim.5962.

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43

Ng, P. C. "Clinical Trials for Evaluating Diagnostic Markers of Infection in Neonates." Neonatology 87, no. 2 (2005): 111–12. http://dx.doi.org/10.1159/000081980.

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44

Arehart-Treichel, Joan. "DSM-5Field Trials Test Proposals for Changes to Diagnostic Criteria." Psychiatric News 45, no. 18 (2010): 1–8. http://dx.doi.org/10.1176/pn.45.18.psychnews_45_18_002.

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Lalumera, Elisabetta, and Stefano Fanti. "Randomized Controlled Trials for Diagnostic Imaging: Conceptual and Pratical Problems." Topoi 38, no. 2 (2017): 395–400. http://dx.doi.org/10.1007/s11245-017-9535-z.

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46

Bradley, Linda A., James E. Haddow, and Glenn E. Palomaki. "Population Screening for Haemochromatosis: A Unifying Analysis of Published Intervention Trials." Journal of Medical Screening 3, no. 4 (1996): 178–84. http://dx.doi.org/10.1177/096914139600300404.

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Objectives— To examine the efficacy of population screening for haemochromatosis by analysing the screening performance of seven intervention trials, and to compare this with the expected performance derived from family studies. Setting— Seven population intervention trials carried out between 1983 and 1995 in Australia, Scandinavia, Iceland, and the United States. Methods— Seven of 23 English language trials identified were suitable for the meta-analysis. Transferrin saturation and serum ferritin measurements derived from family studies were used to predict detection and false positive rates
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Menon, Manoj P., Nixon Niyonzima, Julie Gralow, and Jackson Orem. "Breast Cancer Clinical Trials: The Landscape at the Uganda Cancer Institute and Lessons Learned." JCO Global Oncology, no. 7 (January 2021): 127–32. http://dx.doi.org/10.1200/go.20.00185.

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The Uganda Cancer Institute, the sole national comprehensive cancer center in Uganda, has a long and rich history of clinical investigation and locally relevant cancer research. Given the increasing burden of breast cancer in Uganda and elsewhere in sub-Saharan Africa (SSA) and driven by the limited availability of immunohistochemistry (IHC), we launched a clinical trial aimed at evaluating locally available diagnostics to detect the presence of hormone receptors (estrogen receptor and progesterone receptor) and human epidermal growth factor receptor 2. Preliminary data from 32 women in the di
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48

Kaal, K. Julia, Magda Aguiar, Mark Harrison, Patrick J. McDonald, and Judy Illes. "The Clinical Research Landscape of Pediatric Drug-Resistant Epilepsy." Journal of Child Neurology 35, no. 11 (2020): 763–66. http://dx.doi.org/10.1177/0883073820931255.

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Objective: To characterize the clinical research landscape of pediatric drug-resistant epilepsy (DRE) with a focus on neurotechnology. Method: We searched the ClinicalTrials.gov registry using the terms “epilepsy” and “drug resistant” for studies including participants age 0-17 years. Returns were grouped by intervention (eg, neurotechnological, drug). Key trial features such as age range, trial status and outcomes were compared across interventions. Results: We identified 101 registered trials with pediatric DRE patients. Thirty-two (32%) investigate neurotechnological interventions, devices,
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Lippi, Giuseppe, Alexander von Meyer, Janne Cadamuro, Ana-Maria Simundic, and _. _. "PREDICT: a checklist for preventing preanalytical diagnostic errors in clinical trials." Clinical Chemistry and Laboratory Medicine (CCLM) 58, no. 4 (2020): 518–26. http://dx.doi.org/10.1515/cclm-2019-1089.

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AbstractAlthough the importance of guaranteeing a high level of preanalytical quality in routine diagnostic testing has already been largely acknowledged over the past decades, minor emphasis is currently being placed on the fact that accurate performance and standardization of many preanalytical activities are also necessary prerogatives of clinical trials. Reliable evidence exists that clear indications on how to manage the different preanalytical steps are currently lacking in many clinical trials protocols, nor have detailed authoritative documents been published or endorsed on this matter
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Haas, Lenneke E. M., and Marcus J. Schultz. "Selective Decontamination of the Digestive Tract Reduces Pneumonia and Mortality." Critical Care Research and Practice 2010 (2010): 1–11. http://dx.doi.org/10.1155/2010/501031.

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Abstract:
Selective decontamination of the digestive tract (SDD) has been subject of numerous randomized controlled trials in critically ill patients. Almost all clinical trials showed SDD to prevent pneumonia. Nevertheless, SDD has remained a controversial strategy. One reason for why clinicians remained reluctant to implement SDD into daily practice could be that mortality was reduced in only 2 trials. Another reason could be the heterogeneity of trials of SDD. Indeed, many different prophylactic antimicrobial regimes were tested, and dissimilar diagnostic criteria for pneumonia were applied amongst t
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