PROTOCOL SYNOPSIS Sample Clauses

PROTOCOL SYNOPSIS. Title: An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003 Protocol Number: BA058-05-005 Test Drug: Alendronate Study Objectives: Please note that the name of BA058 Injection 80 µg has been changed to Abaloparatide-SC, therefore the name has been changed throughout the document. The primary objective of this study is to collect clinical information regarding six months of treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with Abaloparatide-SC or Placebo in Study BA058-05-003. Safety data will be obtained via clinical, laboratory and radiologic assessments. Following the initial six months of treatment in the study, subjects will then enter the long-term observational phase of the study during which subjects will continue to receive alendronate treatment for an additional 18 months (for a total of 24 months). The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of treatment with Abaloparatide-SC/Placebo. The analysis performed at six months of this Extension Study will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Vertebral fractures based on radiologic assessments will also be analyzed at Month 24. Additional analyses for other endpoints will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.
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PROTOCOL SYNOPSIS. Study Title The PISCES Study: A Multicenter Phase 2, Open-Label Trial of Intratumoral pIL-12 plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment Protocol No. OMS-I103 [*****] [*****] Study Phase 2 Therapeutic Indication Intratumoral injection of plasmid interleukin-12 followed by electroporation (ImmunoPulse® IL-12), in combination with an anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab, is indicated for the treatment of unresectable or metastatic melanoma. Study Objectives ● To assess efficacy of best overall response rate (BXXX) by independent central review based on RECIST v1.1 over 24 weeks (end of Core study) of intratumoral pIL-12-EP in combination with pembrolizumab (IV) (collectively ‘the combined treatment’) in patients with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with other approved checkpoint inhibitor. ● To assess safety and tolerability of the combined treatment in patients with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with other approved checkpoint inhibitor). ● To assess duration of response (DOR), objective response rate (OXX), immune BXXX (iBORR), progression free survival (PFS), immune PFS (iPFS), and overall survival (OS) of combination therapy; ● [*****] Investigational Product Route and Dosage Form Plasmid interleukin-12 (pIL-12) will be injected intratumorally (on Days 1, 5 and 8 every 6 weeks) [*****] Pembrolizumab will be administered at a dose of 200 mg [*****]
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PROTOCOL SYNOPSIS. Study Design Text revised: “…Randomization will be stratified by age (12-14 vs 15-1716 years old) and gender ”
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PROTOCOL SYNOPSIS. Study Population: Key Exclusion Criteria Text added: “…History of bipolar disorder or psychosis, greater than one lifetime episode of major depressive disorder, depression of moderate or greater severity...”
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PROTOCOL SYNOPSIS. Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
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PROTOCOL SYNOPSIS. Title: An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003 Protocol Number: BA058-05-005 Test Drug: BA058 Injection
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PROTOCOL SYNOPSIS 
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Related to PROTOCOL SYNOPSIS

  • Protocol The attached Protocol shall be an integral part of this Agreement.

  • Synopsis The proposed amendment adds a special rate for bulk cargo discharged to barges. The agreement continues to run through April 14, 2006. By Order of the Federal Maritime Commission. Dated: January 18, 2002. Xxxxxx X. XxxXxxxxx, Secretary. [FR Doc. 02–1801 Filed 1–23–02; 8:45 am] BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as Non-Vessel Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. app. 1718 and 46 CFR 515). Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573. Non-Vessel Operating Common Carrier Ocean Transportation Intermediary Applicants US Rich Long, Inc., 00000 Xxxxxxx Xxxx, #H, El Monte, CA 91733, Officers: Xxxxxx Xxx, President, (Qualifying Individual), Xxxxxx You, Xxxx, CA 91754, Officers: Xxx Xx, Secretary, (Qualifying Individual), Xx, Xxxx Xxx, President Non-Vessel Operating Common Carrier and Ocean Freight Forwarder Transportation Intermediary Applicants KCC Logistics Inc., 0000 X. Xxxxxxx Road, Suite #204, Elk Grove Village, IL 60007, Officer: Xxxxx X. Xxx, President, (Qualifying Individual) Associated Consolidators Express, 1273 Industrial Pkwy, Xxxx 000, Xxxxxxx, XX 00000, Officer: Xxxxx Xxxxxxxxx, Operations Manager, (Qualifying Individual) American Links Logistics International, Inc., 0000 Xxxxxxxx Xxxxx, Xxx Xxxxx, XX 00000, Officers: Xxxxx Xxxxxxx, Import Manager, (Qualifying Individual), Xxxxxxxx X. Xxxxxx, President 7 Seas Shipping, Inc. dba X X Freight Forwarding, Inc., 0000 Xxxxxxx Xxxxxx, Xxxxx 000, Xx Xxxxx, XX 00000, Officer: Xxxxx Xxx, President, (Qualifying Individual) Moog International, Inc., 0000 Xxxxx Road, Pittsburgh, PA 15234–2397, Officers: Xxxxx X. Xxxx, Vice President, (Qualifying Individual), Xxxxxx X. Xxxx, President United Shipping Services, Inc., 2321 Highbury Xxxxxx, #00, Xxx Xxxxxxx, XX 00000, Officers: Xxxxxx Xxx, President, (Qualifying Individual), Xxxx-Xxxx Xxx, Secretary Ocean Freight Forwarder—Ocean Transportation Intermediary Applicant Xxxxx International Inc., 0000 X. 00xx Xxxxxx, Xxxxxxxxx, XX 00000, Officer: Xxxx X. Xxxxx, President, (Qualifying Individual) Dated: January 18, 2002. Xxxxxx X. XxxXxxxxx, Secretary. [FR Doc. 02–1802 Filed 1–23–02; 8:45 am] BILLING CODE 6730–01–P banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at xxx.xxxxx.xxx/xxx/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 15, 2002.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Technology Research Analyst Job# 1810 General Characteristics Maintains a strong understanding of the enterprise’s IT systems and architectures. Assists in the analysis of the requirements for the enterprise and applying emerging technologies to support long-term business objectives. Responsible for researching, collecting, and disseminating information on emerging technologies and key learnings throughout the enterprise. Researches and recommends changes to foundation architecture. Supports research projects to identify and evaluate emerging technologies. Interfaces with users and staff to evaluate possible implementation of the new technology in the enterprise, consistent with the goal of improving existing systems and technologies and in meeting the needs of the business. Analyzes and researches process of deployment and assists in this process.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • 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.

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