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associated with first trimester maternal exposure to fluoxetine. Issued in June 2011. September 2010 — minor update. Text amended to include recommendations from the National Institute for Health and Care Excellence (NICE) public health guidance 27 about preparing for pregnancy for women with a body mass index (BMI) of 30 kg/m 2 or more. Issued September 2010. January 2009 — minor update to clarify the advice for folic acid supplementation in women with sickle-cell anaemia and thalassaemia. Issued (...) information about how to assess and manage individual components is provided by following the hyperlinks. Assess the following in a woman who is planning to become pregnant: Plans for timing of pregnancy. Previous obstetric history. Dietary habits and body mass index. Use of folic acid and dose taken in relation to her risk of neural tube defect . Cervical smear status. Smoking status. Amount of alcohol consumed. Use of illicit drugs and risk of hepatitis B. Immunity to rubella and chickenpox. Concerns
Risks 86 Benefit-risk balance 88 4. Recommendations 89 Outcome 89 Page 3/90 Conditions or restrictions regarding supply and use 89 Conditions and requirements of the Marketing Authorisation 89 New Active Substance Status 90 Page 4/90 List of abbreviations ACTH Adrenocorticotropic hormone AE Adverse Event b.i.d. bis in die/twice a day BMI Body mass index CI Confidence interval CRH Corticotropin-releasing hormone HRQL Health related quality of life IPSS Inferior petrosal sinus sampling ITT Intent (...) to treat LLN Lower limit of normal MRI Magnetic resonance imaging mUFC Mean urinary free cortisol PD Pharmacodynamics PK Pharmacokinetics PT Prothrombin time PTT Partial thromboplastin time s.c. Subcutaneous SD Standard deviation SE Standard error SOC System organ class SOM230 Pasireotide sst Somatostatin receptor t.i.d. ter in die/three times a day UFC Urinary free cortisol ULN Upper limit of normal Page 5/90 1. Background information on the procedure 1.1. Submission of the dossier The applicant
is required in patients with mild to moderate renal impairment according to the Sponsor. Volunteers with hepatic impairment were compared pharmacokinetically to healthy control volunteers who were matched for sex, age and body mass index (BMI). Following single dose administration of 100 mg mirabegron in volunteers with mild hepatic impairment (Child-Pugh Class A), mean mirabegron C max and AUC inf were increased by 9% and 19% relative to volunteers with normal hepatic function. In volunteers
function (3.1 ± 0.1 vs 3.5 ± 0.1 pg/dl, p <0.01). The free triiodothyronine level was significantly and negatively correlated with the relaxation time constant (p = 0.03) and brain natriuretic hormone (p <0.01) level and positively correlated with the cardiac index (p = 0.04). In conclusion, venous congestion in Fontan patients may cause thyroid dysfunction, which can be responsible for decreased ventricular function and cardiac output in Fontan patients. Thus, thyroid function should be routinely (...) Thyroid Function in Patients With a Fontan Circulation. In this study, we tested our hypothesis that thyroid function is impaired and contributes to perturbed hemodynamics in patients after Fontan operation. Cardiac catheterization and blood tests for thyroid function were performed in 37 patients who underwent a Fontan operation. Among them, 12 patients (33%) had subclinical thyroid dysfunction with an elevated thyroid-stimulating hormone level despite normal thyroxine levels. Thyroid
Impaired Sensitivity to Thyroid Hormones Is Associated With Diabetes and Metabolic Syndrome. Diabetes prevalence and incidence increase among individuals with hypothyroidism but also among those with hyperthyroxinemia, which seems contradictory. Both high freethyroxine (fT4) and high thyroid-stimulating hormone (TSH) are present in the resistance to thyroid hormone syndrome. A mild acquired resistance to thyroid hormone might occur in the general population and be associated with diabetes. We (...) aimed to analyze the association of resistance to thyroid hormone indices (the Thyroid Feedback Quantile-based Index [TFQI], proposed in this work, and the previously used Thyrotroph T4 Resistance Index and TSH Index) with diabetes.We calculated the aforementioned resistance to thyroid hormone indices based on a U.S. representative sample of 5,129 individuals ≥20 years of age participating in the 2007-2008 National Health and Nutrition Examination Survey (NHANES). Also, to approximate TFQI, a U.S
hormone supplements (x 3 months) prior to baseline visit and normal levels of freethyroxine, testosterone in males and normal adrenal function if not on replacement therapy. If female, a. Not pregnant (as evidenced by a negative serum pregnancy test) or lactating and b. If of childbearing potential, agrees to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the time of screening, for the duration of the study, and for at least one month after (...) adipose tissue biopsy. Adipose tissue parameters will be analyzed in each specimen and then compared to each patient over time as well as to body mass index (BMI)-matched control subjects. Study Design Go to Layout table for study information Study Type : Observational Estimated Enrollment : 60 participants Observational Model: Cohort Time Perspective: Prospective Official Title: Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency Estimated Study Start Date : May 2019 Estimated
. ] This outcome will be assessed via blood collection. Cytokine-based pharmacodynamic (PD) biomarkers of APX005M, in combination with nivolumab and cabiralizumab assessed by interferon-gamma levels . [ Time Frame: Change from baseline to 8 weeks. ] This outcome will be assessed via blood collection. Efficacy measured by progression-free survival (PFS) [ Time Frame: From study enrollment up to 6 years. ] PFS will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1. Efficacy (...) measured by overall survival (OS) [ Time Frame: From study enrollment up to 6 years. ] OS will be ascertained by review of the National Death Index, medical records and follow-up phone calls. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research
cholesterol [ Time Frame: day 1 ] blood analyses high-density lipoprotein cholesterol [ Time Frame: day 1 ] blood analyses low-density lipoprotein cholesterol [ Time Frame: day 1 ] blood analyses proteins [ Time Frame: day 1 ] blood analyses triglyceride concentrations [ Time Frame: day 1 ] blood analyses c-reactive proteine [ Time Frame: day 1 ] blood analyses thyroid-stimulating hormone [ Time Frame: day 1 ] blood analyses freethyroxine [ Time Frame: day 1 ] blood analyses cortisol and serum insulin (...) mass index cut-offs for thinness, overweight and obesity) Parental permission Exclusion Criteria: - Chronic cardiovascular, renal, pulmonary and orthopedic disease Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516721 Locations Layout table
), time to progression (TTP), progression free survival (PFS), overall survival (OS), and alpha-fetoprotein (AFP) response of study participants. II. To evaluate the safety profile of treated patients. OUTLINE: Patients receive TSR-022 and TSR-042 on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated (...) of treatment until the date of progression, assessed up to 36 months ] Time from treatment to progression of cancer Progression free survival [ Time Frame: From date of treatment until the date of progression or death, assessed up to 36 months ] Time from treatment to progression of cancer or death Overall survival [ Time Frame: From date of treatment until the date of death, assessed up to 36 months ] Time from treatment to death AFP response [ Time Frame: From treatment start to documentation of AFP
of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days ] Part A and B: Fluctuation Index of M3814 [ Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days ] Part A and B: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of M3814 [ Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days ] Part A and B: Area (...) -free Survival (PFS) Time According to RECIST v 1.1 Assessed by Investigator [ Time Frame: Part A: From baseline to planned final assessment at 305 days; Part B: From baseline to planned final assessment at 473 days ] Part A and B: Tumor size Based on Investigator Assessment According to RECIST v 1.1 [ Time Frame: From the first study intervention to planned final assessment at 508 days ] Part A and B: Overall Survival [ Time Frame: From the first study intervention to planned final assessment
: Progression-free survival [ Time Frame: 60 months ] Progression-free survival (PFS), as defined as the time between treatment initiation and disease progression or patient death from any cause, whichever came first Secondary Outcome Measures : Grade 3/4 adverse events (AEs) [ Time Frame: 60 months ] Incidence (%) Grade 3/4 adverse events (AEs) Treatment-related adverse events [ Time Frame: 60 months ] Incidence (%) of treatment-related adverse events Patient compliance to the experimental treatment [ Time (...) treatment on plasma fatty acids, measured through mass spectrometry analysis Effect of the experimental treatment on urinary ketones [ Time Frame: 40 months ] Effect of the experimental treatment on the concentration of urinary ketones Impact of plasma glucose modifications on progression free survival [ Time Frame: 40 months ] Impact of plasma glucose modifications during the treatment on progression free survival Impact of serum insulin modifications on progression free survival [ Time Frame: 40
Baseline in thyroxine stimulating hormone (TSH)-Part 1 [ Time Frame: Baseline and up to 2 years ] Blood samples will be collected to assess change from Baseline in TSH. Change from Baseline in free triiodothyronine (T3)-Part 1 [ Time Frame: Baseline and up to 2 years ] Blood samples will be collected to assess change from Baseline in free T3. Change from Baseline in freethyroxine (T4)-Part 1 [ Time Frame: Baseline and up to 2 years ] Blood samples will be collected to assess change from Baseline (...) in free T4. Overall survival-Part 2 [ Time Frame: Up to 4 years ] For subjects in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause. Secondary Outcome Measures : Overall response rate-Part 1 [ Time Frame: Up to 4 years ] Overall response rate is defined as percentage of subjects with confirmed complete response or partial response at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1. Overall response rate
cholesterol ratio) in mg/dl High sensitivity CRP [ Time Frame: 12 months ] High sensitivity CRP in mg/L Quality of Life ratings [ Time Frame: 12 months ] As assessed using IWQoL scale Blood pressure [ Time Frame: 12 months ] Blood pressure in mmHg Heart rate [ Time Frame: 12 months ] Heart rate in beats per minute Hip-waist ratio [ Time Frame: 12 months ] Hip-waist ratio Body Mass Index (BMI) in [ Time Frame: 12 months ] BMI in kg/m^2 Other Outcome Measures: Dose Response Analysis [ Time Frame: 12 months (...) Questionnaire Fat & saturated fat [ Time Frame: 6 & 12 months ] Fat & saturated fat (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire Carbohydrate; starchy carbohydrates, sugars, and free sugars [ Time Frame: 6 & 12 months ] Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire Fiber [ Time Frame: 6 & 12 months ] Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency
in breast cancer patients with bone metastases adversely increases the frequency and severity of radiotherapy toxicities including neurological and bone injury. III. To assess fatigue, quality of life, and depression before and after radiotherapy for bone metastases in metastatic breast cancer patients treated with palbociclib. IV. To determine progression free survival (PFS) and overall survival (OS) in breast cancer patients treated with palbociclib and concurrent radiotherapy to bone metastases. V (...) according to International Bone Consensus Guideline Criteria [ Time Frame: At 3 months post-radiation ] Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who fulfill the International Bone Consensus response criteria using the BPI item rating maximum pain over the last 3 days at the index site and analgesic usage for the treated site within the last 24
were elevated with low normal freethyroxine (T4) levels.
Levothyroxine treatment was initiated and the dose was gradually titrated to supraphysiologic doses. This led to the
normalisation of her TSH levels but her free T4 and triiodothyronine (T3) levels remained persistently elevated. This
prompted a serum prolactin check which returned elevated at 2495 μ/L, leading onto pituitary imaging. A MRI of the
pituitary gland revealed a pituitary macroadenoma measuring 2.4 × 2 × 1.6 cm. Despite starting (...) the
importance of further investigations with thyroid assay interferences, heterophile antibodies, alpha subunit testing and
anterior pituitary profile in cases of resistant and non-resolving primary hypothyroidism.
•• Levothyroxine treatment in primary hypothyroidism can potentially unmask the presence of a latent TSH-secreting
pituitary macroadenoma, which can make diagnosis very challenging.
•• A high index of suspicion should prompt clinicians to further investigate cases of primary
and SCHypo were classified by use of medication to treat thyroid disorders, thyrotropin levels respectively above and under the reference range, and normal freethyroxine levels. For HRV, the participants underwent 10 min in supine position and the R-R intervals of the final 5 min were selected for analysis. We first used linear regression models to report crude data and then, multivariate adjustment for sociodemographic (age, sex, and race) and cardiovascular risk factors (hypertension, dyslipidemia (...) , diabetes, smoking, body mass index, use of alcohol, and leisure physical activity) using the euthyroid group as reference. From 9270 subjects (median age, 50; interquartile range: 44-56), 8623 (93.0%) were classified as euthyroid, 136 (1.5%) as SCHyper, and 511 (5.5%) as SCHypo. Compared to euthyroid subjects, SCHyper participants presented significantly higher heart rate (68.8 vs 66.5 for euthyroidism, P=0.007) and shorter R-R intervals (871.4 vs 901.6, P=0.007). Although SCHyper was associated
, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides, thyroid stimulating hormone, free triiodothyronine, and the freethyroxine levels were evaluated.Mean platelet volume and PDW levels were significantly higher in the mild PV with MetS group compared to the mild PV without MetS group, MetS without PV patients and the healthy control group (p < 0.05, for all). There was no significant difference between the mild PV without MetS (...) group and the healthy control group in terms of MPV and PDW levels (p > 0.05, for all). There was no significant difference between the groups with MetS and without MetS in terms of the psoriasis area and severity index (PASI) (p > 0.05). The PASI was not correlated with MPV and PDW. In addition, metabolic parameters were not correlated with MPV and PDW in mild PV patients.Mean platelet volume and PDW levels showing platelet activation increase significantly in the presence of MetS in patients
subclinical hypothyroidism (SCH). Upon checking her biochemical thyroid panel when taking daily Aloe barbardensis Miller juice (ABMJ) for thyroid-unrelated reasons, she noticed a decrease in serum thyroperoxidase autoantibodies (TPOAb) and thyrotropin (TSH) and an increase in serum freethyroxine (FT4). Based on this observation, we enrolled 30 consecutive HT women with levothyroxine-untreated SCH and high TPOAb levels. All of them took ABMJ (50 ml daily) for nine months and were tested for serum TSH, FT4 (...) , free triiodothyronine (FT3) and TPOAb. Measurements were performed at baseline and at months 3 and 9. TSH, FT4 and TPOAb improved significantly already at month 3 and further (-61%, +23% and -56%) at month 9. However, FT3 decreased significantly at month 3 (-16%) with no further decrease at month 9, so that the FT4:FT3 ratio increased significantly (+33% and + 49%). At baseline, 100% of women had TSH > 4.0 mU/L and TPOAb > 400 U/ml, but frequencies fell to 0% and 37%, respectively, at month 9
(follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, and prolactin) and peptide hormones (insulin-like growth factor, glucagon, cortisol, growth hormone, freethyroxine, free triiodothyronine, insulin, and leptin). We also measured weight, abdominal circumference, neck circumference, and body length and then calculated the porcine obesity index. Data were analyzed by one-way ANOVA, and means were compared by least significance difference testing. Pearson correlation (...) between parameters and litter size was analyzed. Prepregnancy porcine obesity index and litter size were negatively correlated in primiparous minipigs. Litter size was influenced by luteinizing hormone, estradiol, progesterone, testosterone, prolactin, follicle-stimulating hormone, cortisol, insulin-like growth factor 1, growth hormone, freethyroxine, insulin, and leptin. In conclusion, prepregnancy obesity reduces litter size in primiparous minipigs.
integrity and nutrients influencing thyroid function and/or inflammation. Most remarkably, CFS patients exhibited similar thyrotropin, but lower free triiodothyronine (FT3) (difference of medians 0.1%), total thyroxine (TT4) (11.9%), total triiodothyronine (TT3) (12.5%), %TT3 (4.7%), sum activity of deiodinases (14.4%), secretory capacity of the thyroid gland (14.9%), 24-h urinary iodine (27.6%), and higher % reverse T3 (rT3) (13.3%). FT3 below the reference range, consistent with the "low T3 syndrome (...) ," was found in 16/98 CFS patients vs. 7/99 controls (OR 2.56; 95% confidence interval = 1.00-6.54). Most observations persisted in two sensitivity analyses with more stringent cutoff values for body mass index, high-sensitive C-reactive protein (hsCRP), and WBC. We found possible evidence of (chronic) low-grade metabolic inflammation (ferritin and HDL-C). FT3, TT3, TT4, and rT3 correlated positively with hsCRP in CFS patients and all subjects. TT3 and TT4 were positively related to hsCRP in controls. Low