Biomarkers Sample Clauses

Biomarkers. The following Biomarkers will be validated as part of the Services: Provide sequence of the Biomarker.
Sample 1Sample 2
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Biomarkers. Blood biomarkers including C-reactive protein, adiponectin, and fibrinogen will be evaluated at baseline (Visit 2) and end of treatment (Visit 17 or study withdrawal). All post-screening biomarker results will be blinded to investigators and sponsor. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
Biomarkers. Biomarkers in SLE are often used for diagnosis but do not always correlate with changes in disease activity. The following biomarkers will be evaluated to determine if a change in level correlates with a change in disease activity: anti-dsDNA Ab, anti–U1-70K snRNP Ab, ANA, anti-Sm Ab, and C3, C4, CRP, IgG, IgM, IgA and IgE.
Sample 1
Biomarkers. Currently, there is a critical need for biomarkers of prostate cancer that can distinguish between locally indolent and metastatically aggressive disease191. The only FDA approved biomarker, prostate specific antigen (PSA), has historically been used for screening and detection of prostate cancer, but not for prognosis nor detection of CRPC. A major issue with PSA is that it detects prostate cells, not prostate cancer cells, and thus can result in over diagnosis and over treatment. While results of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial showed no reduction in prostate cancer specific mortality when comparing systematic annual PSA screening to opportunistic screening192, the European Randomized Study of Screening for Prostate Cancer (ERPSC) found a small reduction in mortality (1 death per 1000 men screened) in a PSA-screening naïve population193. However, several potential flaws in the ERPSC study194 and the associated xxxxx of over diagnosis and over treatment led the US Preventive Services Task Force (USPSTF) to recommend against PSA screening195, 196. Given the recent controversy in its screening effectiveness, PSA is now recommended primarily for the determination of prostate cancer progression and recurrence. However, there are potential replacements for PSA for detection screening under development, including PCA3 and the ETS fusion gene TMPRSS2-ERG197, 198, 199, 200, 201, 202, 203. TMPRSS2-ERG has been shown to be a predictive indicator of prostate cancer development in patients who present with high-grade prostatic intraepithelial neoplasia200. FISH analyses of CRPC and metastatic prostate cancers found that TMPRSS2-ERG was detected more often in metastatic cancer, and that TMPRSS2-ERG positivity was strongly correlated to both AR and ERG expression201. TMPRSS2-ERG expression has also been seen in otherwise histologically benign radical prostatectomy as well as in cystoprostatectomy specimens. TMPRSS2-ERG and PCA3 can also be detected in patient urine post-digital rectal exam204. However, there are still conflicting data regarding the prognostic value of PCA3 or TMPRSS2-ERG. A 2011 study by Xxxxxx et al. found that the TMPRSS2-ERG fusion gene could be accurately assayed in circulating prostate tumor cells present in the blood of CRPC patients, but did not show that the presence of the fusion was a significant factor in abiraterone acetate treatment response198. Another prospective study of 322 patients illustrated...
Sample 1
Biomarkers. For diabetic subjects, we expect a significant reduction of HGT respect to baseline after XXXXXX trial. A similar significant reduction trend we will expect for dyslipidemic participants (defined as LDL > 130 mg/dL or 3.37 mmol/L, Total Cholesterol > 200 mg/dL or 5.18 mmol/L).
Sample 1

Related to Biomarkers

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • Screening 3.13.1 Refuse containers located outside the building shall be fully screened from adjacent properties and from streets by means of opaque fencing or masonry walls with suitable landscaping.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Collaboration We believe joint effort toward common goals achieves trust and produces greater impact for L.A. County’s youngest children and their families.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

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