Concomitant Therapy Sample Clauses

A Concomitant Therapy clause defines the rules and restrictions regarding the use of additional medications or treatments by participants during a clinical trial. It typically outlines which therapies are permitted, prohibited, or require prior approval while the study drug is being administered. For example, participants may be allowed to continue certain standard treatments but must avoid others that could interfere with the study results. The core function of this clause is to ensure the integrity of the trial data by minimizing confounding factors and maintaining participant safety.
Concomitant Therapy. Concomitant medications are any prescription or over-the-counter preparations used by subjects during participation in the trial. Use of concomitant medications will be recorded on the Concomitant Medications case report form (CRF) beginning at the Screening Visit until the Week 16/Early Termination visit. The dose and dosing regimen of all prescription and non-prescription therapies and medications, including herbs, vitamins, or other nutritional supplements administered will be documented. Standardized home therapy program including Achilles tendon and plantar fascia stretching exercises and night splints will also be recorded throughout the study.
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Concomitant Therapy. Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or herbal supplements) or other specific categories of interest) that the participant is receiving from 14 days prior to study enrollment (Day -7) until the end of study visit must be recorded along with: • Reason for use • Dates of administration including start and end dates • Dosage information including dose and frequency The Medical Monitor should be contacted if there are any questions regarding concomitant and/or prior therapy.
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Concomitant Therapy. This study is a comparison of standard care plus levosimendan to standard care plus placebo for the treatment of subjects in the immediate perioperative period. All patients should receive standard evidenced based therapies as recommended in local clinical practice guidelines. The patient’s regular per oral concomitant treatments (diuretics, digitalis, ACE inhibitors, nitrates, beta-blockers, and other medications e.g. antibiotics and analgesics) can be administered according to the investigator’s clinical judgment, All subjects may receive additional standard of care medications including inotropes, pressors, vasopressin, antiarrhythmics, diuretics, nitrates, and nitric oxide as needed. Due to the potentially hypotensive effects of the study drug, the concomitant use of vasodilatory active drugs should be used with caution as per the following guidance.
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Concomitant Therapy. Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for at least 90 days prior to Screening. Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study. From study start, sites should enroll patients into both categories in parallel until informed otherwise. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Other prescription or over the counter medication not specifically excluded by entry criteria may be continued during the study, provided that the patient has been on this medication for at least 30 days at a stable dose prior to the date of randomization, and usage is expected to remain stable throughout the study. In addition, certain other medications will also be prohibited and may require washout, or exclusion of the patient if washout is not appropriate. Chronic use of NSAIDs daily is not allowed, therefore those on daily NSAIDs necessary for treatment of other medical conditions (e.g., arthritis), should not be enrolled. NSAIDs may be used as needed for abortive migraine treatment only if they are part of the patient’s typical migraine/headache abortive treatment regimen. Other use of NSAIDs is allowed as needed for other acute pain syndromes, but daily use is not allowed. Use of ibuprofen for such PRN use of NSAIDs is preferred over longer acting NSAIDs, e.g., naproxen and celecoxib. Concomitant medications or other treatments must be recorded in the patient’s medical record and case report form along with the dose and dates of treatment.
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Concomitant Therapy. Concomitant medications will be summarized for the safety population.
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Concomitant Therapy. Throughout the study, investigators may prescribe any concomitant medications or treatments deemed necessary to provide adequate supportive care except for those listed in Section 6.9. Any medication including over the counter or prescription medicines, vitamins and/or herbal supplements that the participant is receiving at the time of enrollment / randomization or receives during the study through to week 24 must be recorded in the eCRF along with reason for use, dates of administration (including start and end dates) and dosage information (e.g. dose).
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Concomitant Therapy. Patients enrolled in this trial may receive any conventional stroke treatment at the discretion of their attending physicians. Patients may not be enrolled in another therapeutic clinical trial until after exit from FAST-MAG after the 90 day visit. Patients may not be treated with other experimental stroke therapies. Treatment with tissue plasminogen activator within 3 hours of symptom onset, after exclusion of intracranial hemorrhage, is encouraged in patients who meet thrombolytic treatment criteria outlined in national consensus guidelines. Since in vitro compatibility has not been tested, a separate IV line should be employed if tissue plasminogen activator and the FAST- MAG trial solution are being infused simultaneously. Prespecified secondary analyses will examine the effect of study treatment in ischemic stroke patients treated with and treated without thrombolytic therapy. Evidence for the safety of concomitant magnesium sulfate and fibrinolytic therapy comes from the absence of adverse interaction among more than 41,000 MI patients receiving both magnesium sulfate and fibrinolytic agents in large cardiac trials, as reviewed above. [1,2] Additionally, the US manufacturer of TPA has on file no reports of adverse interactions between magnesium sulfate and tissue plasminogen activator in preclinical or clinical datasets (personal communication, ▇▇▇▇▇▇▇ ▇▇▇▇▇, M.D, Genentech, 9/02) and the FDA Medwatch program has not logged any reports of adverse magnesium-TPA interactions (FDA FOIA inquiry, 9/02).
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Concomitant Therapy. 6.3.1 Cyclosporin A 6.3.2 Intrathecal Methotrexate and Glucocorticoids 6.3.3 Other possible concomitant therapies 6.3.4 Not allowed concomitant therapies
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Concomitant Therapy. The use of any concomitant medication, prescription or over-the-counter, is to be recorded on the subject’s electronic case report form (eCRF) at each visit, along with the reason the medication is taken, the dates of administration, and the dose.
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Related to Concomitant Therapy

  • Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed • loss of speech or communication function; or • impairment as a result of an acute illness or injury, or an acute exacerbation of a chronic disease. Speech therapy services must relate to: • performing basic functional communication; or • assessing or treating swallowing dysfunction. See Autism Services when speech therapy services are rendered as part of the treatment of autism spectrum disorder. The amount you pay and any benefit limit will be the same whether the services are provided for habilitative or rehabilitative purposes.

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  • Disease Management If you have a chronic condition such as asthma, coronary heart disease, diabetes, congestive heart failure, and/or chronic obstructive pulmonary disease, we’re here to help. Our tools and information can help you manage your condition and improve your health. You may also be eligible to receive help through our care coordination program. This voluntary program is available at no additional cost you. To learn more about disease management, please call (▇▇▇) ▇▇▇-▇▇▇▇ or ▇-▇▇▇-▇▇▇-▇▇▇▇. Our entire contract with you consists of this agreement and our contract with your employer. Your ID card will identify you as a member when you receive the healthcare services covered under this agreement. By presenting your ID card to receive covered healthcare services, you are agreeing to abide by the rules and obligations of this agreement. Your eligibility for benefits is determined under the provisions of this agreement. Your right to appeal and take action is described in Appeals in Section 5. This agreement describes the benefits, exclusions, conditions and limitations provided under your plan. It shall be construed under and shall be governed by the applicable laws and regulations of the State of Rhode Island and federal law as amended from time to time. It replaces any agreement previously issued to you. If this agreement changes, an amendment or new agreement will be provided.

  • Therapies Acupuncture and acupuncturist services, including x-ray and laboratory services. • Biofeedback, biofeedback training, and biofeedback by any other modality for any condition. • Recreational therapy services and programs, including wilderness programs. • Services provided in any covered program that are recreational therapy services, including wilderness programs, educational services, complimentary services, non- medical self-care, self-help programs, or non-clinical services. Examples include, but are not limited to, Tai Chi, yoga, personal training, meditation. • Computer/internet/social media based services and/or programs. • Recreational therapy. • Aqua therapy unless provided by a physical therapist. • Maintenance therapy services unless it is a habilitative service that helps a person keep, learn or improve skills and functioning for daily living. • Aromatherapy. • Hippotherapy. • Massage therapy rendered by a massage therapist. • Therapies, procedures, and services for the purpose of relieving stress. • Physical, occupational, speech, or respiratory therapy provided in your home, unless through a home care program. • Pelvic floor electrical and magnetic stimulation, and pelvic floor exercises. • Educational classes and services for speech impairments that are self-correcting. • Speech therapy services related to food aversion or texture disorders. • Exercise therapy. • Naturopathic, homeopathic, and Christian Science services, regardless of who orders or provides the services. • Eye exercises and visual training services. • Lenses and/or frames and contact lenses for members aged nineteen (19) and older. • Vision hardware purchased from a non-network provider. • Non-collection vision hardware. • Lenses and/or frames and contact lenses unless specifically listed as a covered healthcare service.