Prior and Concomitant Medications Sample Clauses

Prior and Concomitant Medications. Prior IBS medications and ongoing (concomitant) medications will be recorded beginning at the signing of the ICF and continuing until the Safety Follow-up call.
Sample 1
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Prior and Concomitant Medications. Medications will be recorded at each study visit during the study and will be coded using World Health Organization-Drug dictionary (WHO-DD) September 2016, or later. Medications will be presented according to whether they are being taken prior to and/or during the study (concomitant). Prior medications are defined as those taken prior to the first dose of study drug. Concomitant medications are defined as those with a start date on or after the first dose of study drug, or those with a start date before the first dose of study drug that are ongoing or with a stop date on or after the first dose of study drug. If medication dates are incomplete and it is not clear whether the medication was concomitant, it will be assumed to be concomitant. Details of prior and concomitant medications will be listed by subject, start date, and verbatim term.
Sample 1
Prior and Concomitant Medications. Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 and 4.2. Prior and concomitant medications and therapies will be coded using the latest version of the World Health Organization Drug Dictionary.
Sample 1
Prior and Concomitant Medications. The dosing regimen for oral corticosteroids for treatment of DMD including, but not limited to, prednisolone and prednisone, should be kept the same throughout the study. The following therapies may be used before enrollment and throughout the study; however, the dosage should be constant throughout the treatment period, unless clinically indicated: • Oral ACE inhibitors, including but not limited to perindopril and lisinopril • Oral β-blockers, including but not limited to carvedilol and atenolol • Angiotensin-receptor blockers, including but not limited to losartan, irbesartan, valsartan, and candesartan • Oral laxatives, including but not limited to lactulose, Senokot, and Movicol • Vitamin D and calcium supplements • Alendronate (Fosamax) or other bisphosphonates used to treat osteoporosis/osteopenia by inhibiting osteoclasts • Over-the-counter herbal preparations, including herbal supplements, vitamins, minerals, and homeopathic preparations, provided the patient had been on stable doses for 24 weeks before enrollment in this study Other concomitant medications (e.g., vitamins or other non-RNA antisense medications) may also be taken if, in the opinion of the Investigator, they do not interfere with study assessments and outcomes. The Investigator should contact the Medical Monitor if he/she is unsure of the impact of a concomitant medication on study assessments and outcomes. Every attempt should be made to keep the dosage constant throughout the study period (i.e., through Week 96); although modifications to accommodate changes in weight are permitted. Introduction of new physiotherapy interventions during the course of the study must be avoided unless the best interests of the patient are at risk. Should a contracture develop during the course of the study, and it is considered in the best interest of the patient to treat the contracture, then any of the following interventions may be used to reduce the contracture, but they must be clearly documented: • Contracture control devices • Night splints • Stretching exercises (passive, active, self) • Serial casting The following therapies are not permitted during the conduct of this study: • Systemic or oral steroids for non-DMD conditions • Investigational agents for the treatment of DMD • Any medication with the potential to affect muscle mass, strength, and/or function, such as, but not limited to, growth hormone and PDE-5 inhibitors • Immunosuppressants (other than oral or systemic corticosteroids, ...
Sample 1

Related to Prior and Concomitant Medications

  • Prescription Medications Medications whose sale and use are legally restricted to the order of a physician.

  • PRESCRIPTION MEDICATION BENEFITS, LIMITATIONS AND EXCLUSIONS The following items are limited or excluded from your Prescription Medication coverage:

  • Medications Psychotropic medications and medications associated with treating a diagnosed mental health condition.

  • Durable Medical Equipment (DME), Medical Supplies, Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) This plan covers durable medical equipment and supplies, prosthetic devices and enteral formula or food as described in this section. Durable Medical Equipment (DME) DME is equipment which: • can withstand repeated use; • is primarily and customarily used to serve a medical purpose; • is not useful to a person in the absence of an illness or injury; and • is for use in the home. DME includes supplies necessary for the effective use of the equipment. This plan covers the following DME: • wheelchairs, hospital beds, and other DME items used only for medical treatment; and • replacement of purchased equipment which is needed due to a change in your medical condition or if the device is not functional, no longer under warranty, or cannot be repaired. DME may be classified as a rental item or a purchased item. In most cases, this plan only pays for a rental DME up to our allowance for a purchased DME. Repairs and supplies for rental DME are included in the rental allowance. Preauthorization may be required for certain DME and replacement or repairs of DME. Medical Supplies Medical supplies are consumable supplies that are disposable and not intended for re- use. Medical supplies require an order by a physician and must be essential for the care or treatment of an illness, injury, or congenital defect. Covered medical supplies include: • essential accessories such as hoses, tubes and mouthpieces for use with medically necessary DME (these accessories are included as part of the rental allowance for rented DME); • catheters, colostomy and ileostomy supplies, irrigation trays and surgical dressings; and • respiratory therapy equipment. Diabetic Equipment and Supplies This plan covers diabetic equipment and supplies for the treatment of diabetes in accordance with R.I. General Law §27-20-30. Covered diabetic equipment and supplies include: • therapeutic or molded shoes and inserts for custom-molded shoes for the prevention of amputation; • blood glucose monitors including those with special features for the legally blind, external insulin infusion pumps and accessories, insulin infusion devices and injection aids; and • lancets and test strips for glucose monitors including those with special features for the legally blind, and infusion sets for external insulin pumps. The amount you pay differs based on whether the equipment and supplies are bought from a durable medical equipment provider or from a pharmacy. See the Summary of Pharmacy Benefits and the Summary of Medical Benefits for details. Coverage for some diabetic equipment and supplies may only be available from either a DME provider or from a pharmacy. Visit our website to determine if this is applicable or call our Customer Service Department. Prosthetic Devices Prosthetic devices replace or substitute all or part of an internal body part, including contiguous tissue, or replace all or part of the function of a permanently inoperative or malfunctioning body part and alleviate functional loss or impairment due to an illness, injury or congenital defect. Prosthetic devices do not include dental prosthetics. This plan covers the following prosthetic devices as required under R.I. General Law § 27-20-52: • prosthetic appliances such as artificial limbs, breasts, larynxes and eyes; • replacement or adjustment of prosthetic appliances if there is a change in your medical condition or if the device is not functional, no longer under warranty and cannot be repaired; • devices, accessories, batteries and supplies necessary for prosthetic devices; • orthopedic braces except corrective shoes and orthotic devices used in connection with footwear; and • breast prosthesis following a mastectomy, in accordance with the Women’s Health and Cancer Rights Act of 1998 and R.I. General Law 27-20-29. The prosthetic device must be ordered or provided by a physician, or by a provider under the direction of a physician. When you are prescribed a prosthetic device as an inpatient and it is billed by a provider other than the hospital where you are an inpatient, the outpatient benefit limit will apply. Enteral Formulas or Food (Enteral Nutrition) Enteral formula or food is nutrition that is absorbed through the intestinal tract, whether delivered through a feeding tube or taken orally. Enteral nutrition is covered when it is the sole source of nutrition and prescribed by the physician for home use. In accordance with R.I. General Law §27-20-56, this plan covers enteral formula taken orally for the treatment of: • malabsorption caused by Crohn’s Disease; • ulcerative colitis; • gastroesophageal reflux; • chronic intestinal pseudo obstruction; and • inherited diseases of amino acids and organic acids. Food products modified to be low protein are covered for the treatment of inherited diseases of amino acids and organic acids. Preauthorization may be required. The amount that you pay may differ depending on whether the nutrition is delivered through a feeding tube or taken orally. When enteral formula is delivered through a feeding tube, associated supplies are also covered. Hair Prosthesis (Wigs) This plan covers hair prosthetics (wigs) worn for hair loss suffered as a result of cancer treatment in accordance with R.I. General Law § 27-20-54 and subject to the benefit limit and copayment listed in the Summary of Medical Benefits. This plan will reimburse the lesser of the provider’s charge or the benefit limit shown in the Summary of Medical Benefits. If the provider’s charge is more than the benefit limit, you are responsible for paying any difference. Early Intervention Services (EIS) This plan covers Early Intervention Services in accordance with R.I. General Law §27- 20-50. Early Intervention Services are educational, developmental, health, and social services provided to children from birth to thirty-six (36) months. The child must be certified by the Rhode Island Department of Human Services (DHS) to enroll in an approved Early Intervention Services program. Services must be provided by a licensed Early Intervention provider and rendered to a Rhode Island resident. Members not living in Rhode Island may seek services from the state in which they reside; however, those services are not covered under this plan. Early Intervention Services as defined by DHS include but are not limited to the following: • speech and language therapy; • physical and occupational therapy; • evaluation; • case management; • nutrition; • service plan development and review; • nursing services; and • assistive technology services and devices.

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