--- a +++ b/clusters/9knumclustersv2/clust_1140.txt @@ -0,0 +1,63 @@ +Patients must have a thyroid-stimulating hormone (TSH) with reflex free T/free T (if TSH is out of normal range) and electrocardiogram (EKG) obtained within days prior to sub-study registration +Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T) serum tests demonstrating values within the normal range, within days prior to registration; Note: TSH, with reflex T is allowable if per institutional standard; otherwise, both TSH and free-T must be obtained +Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T is normal and patient is clinically euthyroid, patient is eligible +Re-registration: TSH WNL; supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T is normal and patient is clinically euthyroid, patient is eligible +Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T is normal and patient is clinically euthyroid, patient is eligible +Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however if the Free T is normal and patient is clinically euthyroid, patient is eligible +A serum thyroid-stimulating hormone (TSH) must be obtained within days prior to step registration to obtain a baseline value +Thyroid-stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy) +Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism): antinuclear antibody, thyroid-stimulating hormone (TSH), free thyroxine (FT), rheumatoid factor +Thyroid stimulating hormone (TSH) OR free thyroxine (T) within the normal limits +Thyroid stimulating hormone (TSH) =< x ULN. +Thyroid-stimulating hormone (TSH) WNL\r\n* Supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T is normal and patient is clinically euthyroid, patient is eligible +Adequate thyroid function within days prior to registration defined as serum thyroid-stimulating hormone (TSH) within the normal range +Normal serum TSH within months preceding surgery +Patients may have had a recent previous hospital admission (within days) or be admitted preoperatively but not for the following conditions\r\n* Unstable angina\r\n* Congestive heart failure\r\n* Severe hypothyroidism thyroid-stimulating hormone (TSH) >\r\n** Endocrine consult and intervention may allow participation at the discretion of the principal investigator (PI) for a TSH > +Triiodothyronine measurement (T), thyroxine (T) or thyroid-stimulating hormone (TSH) =< . x IULN +Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits +Participants with DTC must be receiving thyroxine suppression therapy and levels of thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than or equal to . milliunits per liter (mU/L)). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH less than . mU/L). +Thyroid-stimulating hormone (TSH) and free thyroxine (T) within normal limits (patients may be on thyroid hormone replacement) +A serum thyroid-stimulating hormone (TSH), free T, and AM (morning) cortisol must be obtained within days prior to randomization to obtain a baseline value and be within normal limits for the local laboratory +Thyroid stimulating hormone (TSH) within normal limits +Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits +Normal thyroid function testing (thyroid stimulating hormone [TSH]) within days prior to registration +Thyroid-stimulating hormone (TSH) up to times ULN if thyroxine (T) is normal +Thyroid-stimulating hormone (TSH) within institutional/laboratory normal limits +Thyroid stimulating hormone (TSH) within institutional normal range patients with thyroid disease are eligible if euthyroid on suppressive or replacement therapy +Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however free T and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible +Thyroid stimulating hormone (TSH) within normal limits +Normal (=< upper limit of normal) levels of thyroid stimulating hormone (TSH), free T, adrenocorticotropic hormone (ACTH), morning AM cortisol, amylase and lipase are required for entry to cohorts , and (AM cortisol testing may be taken up to pm per Moffit Cancer Center guidelines) +Patients should have normal baseline thyroid-stimulating hormone (TSH); patients with elevated TSH level (between .- mU/L in the absence of symptoms of hypothyroidism) must have a normal free thyroxine (T); TSH that is mU/L or higher is exclusionary\r\n* A history of hypothyroidism and/or hyperthyroidism is allowed, as long as the patient has stable well-controlled thyroid function for a minimum of months +Thyroid stimulating hormone (TSH) within institutional limits (ie: normal); if TSH is greater or less than institutional limits patients may participate if their T is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed +Adequate thyroid function within days prior to registration defined as serum thyroid-stimulating hormone (TSH) in normal range +Thyroid-stimulating hormone (TSH) (.-.) and free thyroxine (.-.) within Mayo normal range +Uncompensated hypothyroidism (defined as thyroid-stimulating hormone [TSH] greater than x upper limit of normal not treated with replacement hormone) +Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits +Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of hypothyroidism and/or hyperthyroidism is allowed +Thyroid stimulating hormone (TSH) within institutional limits (i.e.: normal); if TSH is greater or less than institutional limits patients may participate if their T is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed (labs should be performed within days of treatment initiation) +Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline +Thyroid stimulating hormone (TSH) within normal limits (WNL); medications for thyroid dysfunction are allowed as long as TSH is normal at registration; in patients with abnormal TSH, if the free thyroxine (free T) and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible +Any ongoing toxicity from prior anti-cancer therapy that is > grade and/or that is progressing in severity; hypothyroidism treated with medication is not excluded if thyroid-stimulating hormone (TSH) is within normal limits +The patient has normal thyroid function tests (thyroid-stimulating hormone [TSH], free T) as defined by the testing laboratory, a test abnormality that is asymptomatic and does not warrant medical intervention, or a pre-existing thyroid disorder that is controlled on medical treatment +Thyroid-stimulating hormone (TSH) >= LLN and free T within normal limits; patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism; the thyroid supplement dose must be a stable dose for at least one month prior to study enrollment +Performed within days of treatment initiation: Thyroid stimulating hormone (TSH) within institutional limits (ie: normal); if TSH is greater or less than institutional limits patients may participate if their thyroxine (T) is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed +Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than mIU/mL while receiving appropriate thyroid hormone therapy +Adequate thyroid-stimulating hormone (TSH) suppression (< . mIU/L) +Normal thyroid function (thyroid stimulating hormone [TSH] and free thyroxine [T]) (clinically euthyroid patients are acceptable) +Thyroid stimulating hormone (TSH) within normal limits (WNL) (patients may be on thyroid hormone replacement) +Thyroid-stimulating hormone (TSH) within normal limits (WNL) \r\n* Supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T is normal and patient is clinically euthyroid, patient is eligible +Patients must have normal baseline thyroid function tests (thyroid stimulating hormone [TSH], triiodothyronine [T], thyroxine [T]); a history of hypothyroidism and/or hyperthyroidism is allowed, as long as the patient has stable well-controlled thyroid function for a minimum of months +Abnormal thyroid-stimulating hormone (TSH) +Thyroid stimulating hormone (TSH) < mIU/L +History of uncontrolled hypothyroidism as evidenced by thyroid test (thyroid-stimulating hormone [TSH]) within the last month, hypercalcemia or hyperglycemia (within the last days) +Thyroid-stimulating hormone (TSH) within normal institutional limits +Thyroid stimulating hormone (TSH) =< . times ULN, within days prior to enrollment +Thyroid stimulating hormone (TSH) . - . ulU/mL +Hyperthyroidism (thyroid-stimulating hormone [TSH] < . mIU/L and free T > . ng/dL) +Thyroid-stimulating hormone (TSH) ? micro international units/mL +Thyroid-stimulating hormone (TSH) < micro international units/mL +Prior bovine thyroid stimulating hormone (TSH) use +Thyroid-stimulating hormone (TSH) < micro International units/mL +Thyroid-stimulating hormone (TSH) =< micro international units/mL +Thyroid-stimulating hormone (TSH) < micro international units/mL +Participants must be receiving thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be ?. mcIU/ML). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH <. mcIU/ML) and this dose may be changed concurrently upon starting study drug treatment.