Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).
Population The Population shall be defined as all Paid Claims during the 12-month period covered by the Claims Review.
Target Population TREATMENT FOR ADULT (TRA) Target Population
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.
Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)
Screening After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.
Long Term Cost Evaluation Criterion # 4 READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not i ncrease your catalog prices (as defined herein) more than X% annually over the previous year for years two and thr ee and potentially year four, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIP S, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentati on, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from th e “Attachments” section, complete according to the instructions on the form, then uploading the completed form, wit h any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they ma y apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@t xxx-xxx.xxx
Long Term Cost Evaluation Criterion 4. READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not increase your catalog prices (as defined herein) more than X% annually over the previous year for the life of the contract, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIPS, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentation, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from the “Attachments” section, complete according to the instructions on the form, then uploading the completed form, with any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they may apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@xxxx-xxx.xxx If the vendor is awarded a contract with TIPS under this solicitation, the vendor agrees to make any Choice of Law clauses in any contract or agreement entered into between the awarded vendor and with a TIPS member entity to read as follows: "Choice of law shall be the laws of the state where the customer resides" or words to that effect.
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.
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.
