scholarly journals Clinical Trial Subject Unique Identifier

2020 ◽  
Author(s):  
Keyword(s):  
Clinical Trial ◽  
Unique Identifier ◽  
Trial Subject

scholarly journals Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis

Circulation ◽  
2019 ◽  
Vol 140 (18) ◽  
pp. 1451-1459 ◽  
Author(s):  
John W. Eikelboom ◽  
Stuart J. Connolly ◽  
Jacqueline Bosch ◽  
Olga Shestakovska ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gastrointestinal Bleeding ◽  
Cancer Diagnosis ◽  
Minor Bleeding ◽  
Antithrombotic Drugs ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Risk Of Bleeding ◽  
Genitourinary Cancer

Background: Patients treated with antithrombotic drugs are at risk of bleeding. Bleeding may be the first manifestation of underlying cancer. Methods: We examined new cancers diagnosed in relation to gastrointestinal or genitourinary bleeding among patients enrolled in the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) and determined the hazard of new cancer diagnosis after bleeding at these sites. Results: Of 27 395 patients enrolled (mean age, 68 years; women, 21%), 2678 (9.8%) experienced any (major or minor) bleeding, 713 (2.6%) experienced major bleeding, and 1084 (4.0%) were diagnosed with cancer during a mean follow-up of 23 months. Among 2678 who experienced bleeding, 257 (9.9%) were subsequently diagnosed with cancer. Gastrointestinal bleeding was associated with a 20-fold higher hazard of new gastrointestinal cancer diagnosis (7.4% versus 0.5%; hazard ratio [HR], 20.6 [95% CI, 15.2–27.8]) and 1.7-fold higher hazard of new nongastrointestinal cancer diagnosis (3.8% versus 3.1%; HR, 1.70 [95% CI, 1.20–2.40]). Genitourinary bleeding was associated with a 32-fold higher hazard of new genitourinary cancer diagnosis (15.8% versus 0.8%; HR, 32.5 [95% CI, 24.7–42.9]), and urinary bleeding was associated with a 98-fold higher hazard of new urinary cancer diagnosis (14.2% versus 0.2%; HR, 98.5; 95% CI, 68.0–142.7). Nongastrointestinal, nongenitourinary bleeding was associated with a 3-fold higher hazard of nongastrointestinal, nongenitourinary cancers (4.4% versus 1.9%; HR, 3.02 [95% CI, 2.32–3.91]). Conclusions: In patients with atherosclerosis treated with antithrombotic drugs, any gastrointestinal or genitourinary bleeding was associated with higher rates of new cancer diagnosis. Any gastrointestinal or genitourinary bleeding should prompt investigation for cancers at these sites. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.

scholarly journals Building a specialized lexicon for breast cancer clinical trial subject eligibility analysis

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822198939
Author(s):  
Euisung Jung ◽  
Hemant Jain ◽  
Atish P Sinha ◽  
Carmelo Gaudioso
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Text Mining ◽  
Language Processing ◽  
Snomed Ct ◽  
Lexical Resources ◽  
Named Entities ◽  
Domain Experts ◽  
Trial Subject

A natural language processing (NLP) application requires sophisticated lexical resources to support its processing goals. Different solutions, such as dictionary lookup and MetaMap, have been proposed in the healthcare informatics literature to identify disease terms with more than one word (multi-gram disease named entities). Although a lot of work has been done in the identification of protein- and gene-named entities in the biomedical field, not much research has been done on the recognition and resolution of terminologies in the clinical trial subject eligibility analysis. In this study, we develop a specialized lexicon for improving NLP and text mining analysis in the breast cancer domain, and evaluate it by comparing it with the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). We use a hybrid methodology, which combines the knowledge of domain experts, terms from multiple online dictionaries, and the mining of text from sample clinical trials. Use of our methodology introduces 4243 unique lexicon items, which increase bigram entity match by 38.6% and trigram entity match by 41%. Our lexicon, which adds a significant number of new terms, is very useful for matching patients to clinical trials automatically based on eligibility matching. Beyond clinical trial matching, the specialized lexicon developed in this study could serve as a foundation for future healthcare text mining applications.

scholarly journals Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm

2020 ◽  
pp. 174749301989785 ◽  
Author(s):  
Xiaoying Chen ◽  
Jingwei Li ◽  
Craig S Anderson ◽  
Richard I Lindley ◽  
Maree L Hackett ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Logistic Regression ◽  
Outcome Measurement ◽  
Demographic Data ◽  
Weighted Kappa ◽  
Alternative Measure ◽  
Modified Rankin Scale ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Quality Of Life Scale

Background and aims The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. Methods Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. Results SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. Conclusions This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. Clinical Trial registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616.

scholarly journals Novel Supreme TM DES with Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation after DES implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial

Circulation ◽  
2021 ◽  
Author(s):  
Alexandra J. Lansky ◽  
Dean J. Kereiakes ◽  
Andreas Baumbach ◽  
Stephan Windecker ◽  
Yasin Hussain ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Absolute Risk ◽  
Target Lesion ◽  
Base Layer ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Durable Polymer ◽  
Coronary Syndromes

Background: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug eluting stents (DES). The novel Supreme TM DES (Supreme) is designed to synchronize early drug delivery within 4-6 weeks of implantation, leaving behind a pro-healing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long term clinical outcomes is not known. Methods: In an international 2:1 randomized single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-DES) in patients with acute and chronic coronary syndromes. The primary endpoint was target lesion failure (TLF) - a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (TLR). The trial was designed to demonstrate non-inferiority (margin of 3.58%) of the Supreme DES at 12 months compared to DP-DES (clinicaltrials.gov-NCT03168776). Results: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-DES (N=543). At 12 months, TLF occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-DES group (Absolute Risk Difference 0.32%, 95%CI [-1.87%, 2.5%]; p non-inferiority =0.002]. There were no significant differences in rates of device success, clinically driven TLR or stent thrombosis at 12 months, and the safety composite of CV Death and TV MI was 3.5% vs 4.6%; HR [95.0% CI] 0.76 [0.46, 1.25] with Supreme DES compared to DP-DES, though rates of combined clinical and non-clinical driven TLR at 12 months were higher with Supreme DES. Conclusions: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be non-inferior to the standard DP-DES. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03168776

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