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Free Thyroxine Index

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81. Lenvima - lenvatinib

zero to infinity BCRP breast cancer resistance protein BID bis in die, twice a day BMI body mass index BP blood pressure BOR best overall response CAF circulating angiogenic factor CBR clinical benefit rate CHF congestive heart failure CI confidence interval CL/F apparent total clearance following extravascular administration CHMP Committee for medicinal products for Human Use Cmax maximum observed concentration CNS central nervous system CPMP Committee for Proprietary Medicinal Products CR (...) cancer OOL optional open label ORR objective response rate OS overall survival PD pharmacodynamic(s) PD progressive disease PFS progression-free survival P-gp P-glycoprotein PK pharmacokinetic(s) PPE palmar-plantar erythrodysaesthesia PR partial response QD quaque die, once a day RAF Rapidly Accelerated Fibrosarcoma RECIST Response Evaluation Criteria in Solid Tumors EMA/250082/2015 Page 7/169 RPLS reversible posterior leukoencephalopathy syndrome RPSFT rank-preserving structural failure time RR

2015 European Medicines Agency - EPARs

82. Farydak - panobinostat

modified European Group for Blood and Marrow Transplantation MM Multiple myeloma MR minimal response MRR minimal response rate MTD maximum tolerable dose NCI National Cancer Institute nCR Near complete response NMR Nuclear magnetic resonance ORR overall response rate OS overall survival PAN panobinostat PAR Proven Acceptable Range PBO placebo PCTFE Polychlorotrifluoroethylene PD progressive disease PE Polyethylene PEP Protein electrophoresis PFS progression-free survival Ph. Eur. European Pharmacopoeia (...) PR partial response Assessment report EMA/CHMP/496296/2015 Page 5/124 PRO patient-reported outcome PVC Polyvinyl chloride PVDC Polyvinylidene chloride QbD Quality by design QoL quality of life QP Qualified person RH Relative humidity RR response rate sCR stringent complete response SCT stem cell transplantation SD stable disease sFLC serum free light chain SmPC Summary of product characteristics TGA Thermogravimetric analysis TIW three times per week TP1 Treatment phase 1 TP2 Treatment phase 2

2015 European Medicines Agency - EPARs

83. Addyi - Flibanserin

. placebo in sexual desire measured by another instrument – the Female Sexual Function Index desire domain (FSFI-desire). The Applicant stated that the results from the secondary FSFI-desire endpoint should be adequate to support approval. Most of the AC members did not agree with the Applicant’s proposal to alter the methodology of analysis post-hoc. The AC voted 10 to 1 that the Applicant had not provided sufficient evidence of efficacy. Safety concerns raised by the AC included central nervous system

2015 FDA - Drug Approval Package

84. Corluxin - mifepristone

cells SAE Serious Adverse Event SBP Systolic Blood Pressure SD Standard Deviation SOC System Organ Class T4 Free Thyroxine TEAE Treatment-emergent adverse event TQT Thorough QT Interval study TSH Thyroid-stimulating Hormone UFC Urinary Free Cortisol WBC White Blood Cells Corluxin Withdrawal assessment report EMA/235012/2015 Page 6/42 1. Recommendation Based on the review of the data on quality, safety and efficacy, the CHMP considers that the application for Corluxin, in the treatment of signs (...) chemistry, and urinalysis) and electrocardiograms (ECGs). Thyroid status was evaluated by thyroid stimulating hormone (TSH) and free thyroxine (T4). ACTH, serum cortisol, nocturnal salivary cortisol, and 24- hour urinary free cortisol (UFC) were measured throughout the study. Subjects with pituitary- based disease had magnetic resonance imaging (MRI) to monitor for the development of pituitary enlargement. Women with an intact uterus underwent transvaginal ultrasound and endometrial biopsies (biopsies

2015 European Medicines Agency - EPARs

85. Guidance on the clinical management of depressive and bipolar disorders, specifically focusing on diagnosis and treatment strategies

most of the day nearly every day or hospitalisation Marked impairment (Mania only) Yes BD II Hypomania +Depression 2 Weeks Marked Impairment Hypomania b 4 consecutive days, present most of the day nearly every day. No marked impairment In depression but not in hypomania Cyclothymia d Subthreshold c hypomania + subthreshold c depression 2 years with no more than two months symptom- free Clinically significant impairment 2 years with no more than two months symptom-free Clinically significant (...) impairment No MDD e Depression 2 Weeks Marked Impairment N/A N/A Yes PDD d Depression 2 Weeks Clinically significant impairment N/A N/A No DMDD f* Chronic irritability and temper outbursts >12 mths with no more than 3 mths symptom- free =3 Temper outbursts per week. Present in =2 settings N/A N/A No PMDD g * Depression Final week before menses to a few days after. Causes distress or interference with functioning N/A N/A No Note: For full criteria for manic, hypomanic and depressive episodes, refer to DSM

2015 Royal Australian and New Zealand College of Psychiatrists

86. Guideline on the management of premature ovarian insufficiency

:// (Archived by WebCite at Aydin ZD. Determinants of age at natural menopause in the Isparta Menopause and Health Study: premenopausal body mass index gain rate and episodic weight loss. Menopause 2010;17: 494-505. Baron JA. Smoking and estrogen-related disease. Am J Epidemiol 1984;119: 9-22. Bromberger JT, Matthews KA, Kuller LH, Wing RR, Meilahn EN, Plantinga P. Prospective study of the determinants of age at menopause. Am J Epidemiol (...) , Butterworth S, Kok H, Richards M, Hardy R, Wadsworth ME, Leon DA. Childhood cognitive ability and age at menopause: evidence from two cohort studies. Menopause 2005;12: 475-482. Luborsky JL, Meyer P, Sowers MF, Gold EB, Santoro N. Premature menopause in a multi-ethnic population study of the menopause transition. Hum Reprod 2003;18: 199-206. Morris DH, Jones ME, Schoemaker MJ, McFadden E, Ashworth A, Swerdlow AJ. Body mass index, exercise, and other lifestyle factors in relation to age at natural

2015 European Society of Human Reproduction and Embryology

88. Risk Factors for the Relapse of Graves' Disease Treated With Antithyroid Drugs: a Systematic Review and Meta-Analysis. (Abstract)

(weighted raw mean difference [RMD], -3.51; 95% CI, -5.74 to -1.29), larger thyroid volume (RMD, 4.38; 95% CI, 1.68 to 7.08), bigger goiter size (1.94% risk; 95% CI, 0.43 to 3.46), higher free triiodothyronine level (RMD, 5.09; 95% CI, 4.42 to 5.77), and higher free thyroxine level (RMD, 4.21; 95% CI, 0.54 to 7.89) were associated with the higher relapse rate of GD. The block-replace ATD regimen (a fixed high dose of an ATD with levothyroxine supplementation to maintain euthyroidism) (risk ratio, 0.64 (...) ; 95% CI, 0.52 to 0.78) exhibits a lower relapse rate than the titration regimen (an ATD used alone and dose adjusted according to thyroid function tests).This analysis revealed that certain risk factors were associated with GD relapses such as younger age, larger goiter size or thyroid volume, and the higher free triiodothyronine or free thyroxine level in the diagnosing phase of GD. For patients with these clinical characteristics, early definitive treatment with radioactive iodine or surgery

2020 Clinical therapeutics

89. A cross-sectional study: Associations between sarcopenia and clinical characteristics of patients with type 2 diabetes. (Full text)

, of which, 38 (28.8%) were diagnosed with sarcopenia. 94 (71.2%) were with no sarcopenia. Logistic regression analysis showed that age (OR: 1.182, 95%CI: 1.038-1.346), trunk fat mass (TFM) (OR: 1.499, 95%CI: 1.146-1.960) and free thyroxine (FT4) (OR: 1.342, 95%CI: 1.102-1.635) were independent risk factors for sarcopenia. BMI (body mass index) (OR: 0.365, 95%CI: 0.236-0.661), exercise (OR: 0.016, 95%CI: 0.001-0.169), female (OR: 0.000, 95%CI: 0.00-0.012), metformin (OR: 0.159, 95%CI: 0.026-0.967

2020 Medicine PubMed abstract

90. Thyroid function before and after Roux-en-Y gastric bypass: an observational study. (Abstract)

(class II and III) and to observe the behavior of thyroid hormones (TSH, hormone triiodothyronine, thyroxine, free thyroxine) with significant weight loss after RYGB.Hospital Nossa Senhora das Graças, Curitiba, Paraná, Brazil.We retrospectively reviewed the medical records of 215 obese patients who underwent RYGB between 2005 and 2012 with a follow-up of at least 2 years. The study was observational and descriptive. The selected times for clinical and laboratory evaluations were preoperative, 3, 6 (...) Thyroid function before and after Roux-en-Y gastric bypass: an observational study. Population studies have shown a positive association between thyroid-stimulating hormone (TSH) and body mass index. Recent studies have shown a significant increase in the prevalence of subclinical hypothyroidism (SCH) in obesity. Weight reduction after Roux-en-Y gastric bypass (RYGB) seems to significantly decrease TSH levels.The purpose of this study was to evaluate the prevalence of SCH in obese patients

2020 Surgery for Obesity and Related Diseases

91. Genetics of Endocrine and Neuroendocrine Neoplasias (PDQ®): Health Professional Version

–56 y; P < .05) in family members diagnosed by predictive genetic testing.[ ] Nonetheless, the lag time between the diagnosis of MEN1 in an and the diagnosis of MEN1 in family members can be significant, leading to increased morbidity and mortality.[ ] This was demonstrated in a Dutch MEN1 Study Group analysis, which showed that 10% to 38% of non-index cases already had an MEN1-related manifestation at diagnosis; 4% of these individuals died of an MEN1-related cause that developed during or before (...) (18F-FDG PET-CT) identified those NETs with an increased malignant potential; the FDG avidity correlated with a Ki-67 index.[ ] Tumor size does seem to influence patient survival, with patients with smaller tumors having increased survival after resection.[ ] While more-extensive surgical approaches (e.g., pancreatoduodenectomy) have been associated with higher cure rates and improved overall survival,[ - ] they also have higher rates of postoperative complications and long-term morbidity

2018 PDQ - NCI's Comprehensive Cancer Database

93. Thyroid Cancer Treatment (PDQ®): Health Professional Version

, and Radiotherapy. Philadelphia, Pa: Lippincott-Raven, 1997, pp 127-175. American Cancer Society: Cancer Facts and Figures 2019. Atlanta, Ga: American Cancer Society, 2019. . Last accessed December 12, 2019. Tennvall J, Biörklund A, Möller T, et al.: Is the EORTC prognostic index of thyroid cancer valid in differentiated thyroid carcinoma? Retrospective multivariate analysis of differentiated thyroid carcinoma with long follow-up. Cancer 57 (7): 1405-14, 1986. [ ] Khoo ML, Asa SL, Witterick IJ, et al.: Thyroid (...) . [ ] Lennard CM, Patel A, Wilson J, et al.: Intensity of vascular endothelial growth factor expression is associated with increased risk of recurrence and decreased disease-free survival in papillary thyroid cancer. Surgery 129 (5): 552-8, 2001. [ ] van Herle AJ, van Herle KA: Thyroglobulin in benign and malignant thyroid disease. In: Falk SA: Thyroid Disease: Endocrinology, Surgery, Nuclear Medicine, and Radiotherapy. Philadelphia, Pa: Lippincott-Raven, 1997, pp 601-618. Ruiz-Garcia J, Ruiz de Almodóvar

2018 PDQ - NCI's Comprehensive Cancer Database

94. Polycystic ovary syndrome

is unknown. It is likely to be multifactorial, with both genetic and environmental factors playing a part. Complications include: Metabolic disorders, such as impaired glucose tolerance and type 2 diabetes. Cardiovascular disease. Infertility. Pregnancy complications, such as pre-eclampsia and gestational diabetes. Endometrial cancer. Psychological disorders, such as anxiety and depression. Obstructive sleep apnoea. To help diagnose PCOS: Free androgen index should be calculated to assess the amount (...) with PCOS and provides a surrogate measurement of the degree of hyperinsulinaemia. Calculate free androgen index (100 multiplied by the total testosterone value divided by the SHBG value) to assess the amount of physiologically active testosterone present — this is normal or elevated in women with PCOS (the normal range is usually less than 5, but this depends on local laboratories). Measure the following to rule out other causes of oligomenorrhoea and amenorrhoea (such as premature ovarian failure

2018 NICE Clinical Knowledge Summaries

95. Hypothyroidism

deficiency or an abnormality within the gland itself. [ ; ]. It is categorised into: Overt hypothyroidism (OH) TSH levels are above the normal reference range (usually above 10 mU/L) and free thyroxine (FT4) is below the normal reference range [ ]. OH may or may not be symptomatic [ ; ]. OH in pregnancy is defined as TSH above 10 mU/L regardless of the level of T4 [ ; ]. Subclinical hypothyroidism (SCH) TSH levels are above the normal reference range but T3 and T4 are within the normal reference range (...) on . Signs of other autoimmune disease such as vitiligo. Signs of . Arrange investigations including: Blood tests for thyroid stimulating hormone (TSH) and free thyroxine (FT4): Diagnose overt hypothyroidism (OH) if TSH is greater than 10 mU/L and FT4 is below the reference range. Suspect subclinical hypothyroidism (SCH) if TSH is above the reference range and FT4 is within the reference range. In non-pregnant people repeat TSH and T4 (ideally at the same time of day) 3–6 months after the initial result

2018 NICE Clinical Knowledge Summaries

96. Clinical Practice Guidelines on Obesity

• Fasting plasma glucose • Alanine transaminase / aspartate transaminase • ECG (if > 50 years)3 Assessment for secondary causes: • Thyroid function tests: Thyroid stimulating hormone / free thyroxine • Cushing’s syndrome: Screen only if clinically suspected • Hypogonadism: Screen only if clinically suspected BMI: body mass index; ECG: electrocardiography; HDL: high-density lipoprotein; LDL: low-density lipoprotein GPP C Patient motivation – an important prerequisite in weight loss management – should (...) be defined as a condition of abnormal or excessive accumulation of body fat to the extent that health may be adversely affected 1 and is associated with various major chronic diseases including cardiovascular disease, Type 2 diabetes mellitus and cancer. These are discussed in greater detail in Chapter 3. 2.2 Overweight and obesity in Singaporean adults The prevalence of overweight (body mass index [BMI] = 25 kg/m 2 ) among all Singapore adults in 2013 was 34.3% with 40.2% of males and 28.6% of females

2016 Ministry of Health, Singapore

97. Management of carpal tunnel syndrome evidence-based clinical practice guideline

Abduction Weakness or Abductor Pollicis Brevis Manual Muscle Testing ? 2-point discrimination ? Semmes-Weinstein Monofilament Test ? CTS-Relief Maneuver (CTS-RM) ? Pin Prick Sensory Deficit; thumb or index or middle finger ? ULNT Criterion C ? Tethered median nerve stress test ? Vibration perception – tuning fork ? Scratch collapse test ? Luthy sign ? Pinwheel Strength of Recommendation: Moderate Evidence Description: Evidence from two or more “Moderate” strength studies with consistent findings (...) (CTS) a. Peri-menopausal b. Wrist Ratio/Index c. Rheumatoid Arthritis d. Psychosocial factors e. Distal upper extremity tendinopathies f. Gardening g. ACGIH Hand Activity Level at or above threshold h. Assembly line work i. Computer work j. Vibration k. Tendonitis l. Workplace forceful grip/exertion Strength of Recommendation: Moderate Evidence Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending

2016 American Academy of Orthopaedic Surgeons

98. Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement From the American Heart Association (Full text)

, there is evidence that cardiotoxicity can be seen at much lower doses than previously thought. The early detection of cardiotoxic- ity related to anthracyclines has improved significantly over the years, and this is the likely explanation for identification of cardiotoxicity at lower doses. In highly susceptible patients, even 1 dose could be enough. The probability of developing impaired myocardial function based on a combined index of signs, symptoms, and decline in LVEF is estimated to be ˜5%, 16%, and 26 (...) factors that influence LVEF in patients receiving anthracycline-containing regimens include fluid overload, sepsis, ischemic heart disease, and use of other chemotherapy drugs. Prevention of anthracycline- induced myocardial damage by use of free radical scav- engers and antioxidants could reduce cardiotoxicity in some patients. Other therapeutic agents known to result in cardio- myopathy include trastuzumab 119–121 and certain anti– vascular endothelial growth factor inhibitors, 122–124

2016 American Heart Association PubMed abstract

99. AACE/ACE/AME Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules

; FNA-PTH = parathyroid hormone measurement in fine-needle aspiration washout; FNA-Tg = thyroglobulin measure- ment in fine-needle aspiration washout; FN/SFN = pure follicular patterned lesion, suggesting a follicular neo- plasm; FTC = follicular thyroid cancer; FT 3 = free triio- dothyronine; FT 4 = free thyroxine; GEC = gene expres- sion classifier; IMAX = maximum intensity of peak; LTA = laser thermal ablation; LT 4 = levothyroxine; MEN2 = multiple endocrine neoplasia type 2; MeSH = Medical (...) of serum TSH is the best initial laboratory test of thyroid function and should be followed by measurement of free thyroxine (FT 4 ) and free triiodothyronine (FT 3 ) when the TSH value is decreased, and measurement of thyroid peroxidase anti- bodies (TPOAbs) and FT 4 when the TSH value is above the reference range. A single, nonstimulated serum calci- tonin measurement should be performed only when med- ullary thyroid carcinoma (MTC) is suspected due to FNA results or history. Thyroid nodules

2016 American Association of Clinical Endocrinologists

100. Hormonal Replacement in Hypopituitarism in Adults (Full text)

addresses special circumstances that may affect the treatment of patients with hypopituitarism, including pregnancy care, post-surgical care following pituitary or other operations, treatment in combination with anti-epilepsy medication, and care following pituitary apoplexy—a serious condition that occurs when there is bleeding into the gland or blood flow to it is blocked. Recommendations from the guideline include: Measurements of both free thyroxine and thyroid-stimulating hormone are needed (...) to evaluate central hypothyroidism, a condition where the thyroid gland does not produce enough hormones because it isn’t stimulated by the pituitary gland. People who have central hypothyroidism should be treated with levothyroxine in doses sufficient to raise levels of the thyroid hormone free thyroxine to the upper half of the reference range. Growth hormone stimulation testing should be used to diagnose patients with suspected growth hormone deficiency. People who have proven cases of growth hormone

2016 The Endocrine Society PubMed abstract

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