Study designs Sample Clauses

Study designs. A double-blind, stratified and randomised evaluation of AZD5363 when combined with weekly paclitaxel vs. weekly paclitaxel plus placebo. Approximately 100 female patients, with ER+ve advanced or metastatic breast cancer will be enrolled in this phase, of which approximately 50 must have a tumour detectable as carrying a PIK3CA mutation. The dose and schedule of AZD5363 will be selected as an outcome from the safety run-in, Part A. All enrolled patients will be stratified to either the PIK3CA mutation ‘detected’ or ‘not detected’ group by the outcome of two tests (tissue and blood (ctDNA)). If a patient is detected as having the PIK3CA mutation in both or either of the two tests, they will be assigned to the mutation detected strata. If the mutation is not detected in both of the two tests, (or should one test be not detected and the other is either unknown or not completed for any reason) the patient will be assigned to the not detected strata. This will be referred to as the protocol definition of PIK3CA mutational status. Patients within each stratum will be randomised to 28-day cycles comprising either of: • Paclitaxel 90 mg/m2 IV once weekly plus AZD5363 capsules taken orally, twice daily. • Paclitaxel 90 mg/m2 IV once weekly plus AZD5363-matching placebo capsules taken orally, twice daily. The overall study plan for PART B is shown in Figure 1.
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Study designs. After evaluators choose a framework, they are ready to select an appropriate study design. There are three kinds of designs: the simple before-after evaluation, the controlled before-after evaluation, and the randomized controlled trial. Simple before-after evaluation The simple before-after design is the most commonly used non-experimental design for information system evaluation. In this design, the evaluation team will compare the current system performance with its previous performance. Of course, an appropriate amount of time should be left to allow the new system to be fully functional. Moreover, measuring indicators repeatedly at different time points may also help to show the reliability of those effects (Shojania KG et al. 2005).

Related to Study designs

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Research Design The data generated by excavations at the prehistoric site(s) will be used to examine at least three topics: (1) chronology; (2) technology; and (3) subsistence practices. Insights into changing patterns of community organization may also be granted, as may insights into changes in social organization. The data recovered will then be compared to data from other regional sites.

  • ROADWAY DESIGN MISCELLANEOUS (ROADWAY) The Engineer shall provide the following services:

  • Program Design The County Human Resources Department will operate a Catastrophic Leave Bank which is designed to assist any County employee who has exhausted all paid accruals due to a serious or catastrophic illness, injury, or condition of the employee or family member. The program establishes and maintains a Countywide bank wherein any employee who wishes to contribute may authorize that a portion of his/her accrued vacation, compensatory time, holiday compensatory time or floating holiday be deducted from those account(s) and credited to the Catastrophic Leave Bank. Employees may donate hours either to a specific eligible employee or to the bank. Upon approval, credits from the Catastrophic Leave Bank may be transferred to a requesting employee's sick leave account so that employee may remain in paid status for a longer period of time, thus partially ameliorating the financial impact of the illness, injury, or condition. Catastrophic illness or injury is defined as a critical medical condition, a long-term major physical impairment or disability which manifests itself during employment.

  • Preliminary Design § 4.3.1 Upon the Owner’s issuance of a written consent to proceed under Section 4.2.3, the Design-Builder shall prepare and submit a Preliminary Design to the Owner. The Preliminary Design shall include a report identifying any deviations from the Owner’s Criteria, and shall include the following:

  • Schematic Design See Section 2, Part 1, Article 2.1.4, Paragraph 2.1.4.2.

  • 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.

  • Curriculum Vitae (a) The Chief Librarian shall maintain a curriculum vita for each Librarian. It is the Librarian’s responsibility to ensure that the curriculum vita on file is kept current. Members shall prepare their curriculum vita with the advice and assistance of their Chief Librarian. Members may revise their curriculum vita at any time.

  • Study Area The study area focused on the Bulk Power System in South-Eastern New York between Albany and New York City, and voltages underlying systems at 115 kV and above in the lower Xxxxxx Valley (Zones G, H & I). In the PSS™E power flow base case provided by NYISO, facilities rated at 115 kV and above in PSS™E designated areas 6 through 11 are monitored in the study. These areas are: • Capital District • Xxxxxx • Millwood • Xxxxxxxxx • Con Ed • Long Island

  • Curriculum Work Service on a District curriculum committee shall be required for grade level or department chairpersons. All other teachers working on such committee(s) shall be designated (in writing) by the Curriculum Director and shall be paid, at the hourly rate contained in Schedule B, for all documented hours of committee service (up to such limits as may be imposed by the District) occurring when school is not in session (e.g. during the summer), during duty-free lunch periods or preparation periods, and before/after the teacher’s regularly scheduled work day. Curriculum committee work shall occur at such times as are determined or approved by the Curriculum Director.

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