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Adrenal Mass

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3481. The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

is considered appropriate according to the criteria of the participating centre Infertility for at least 1 year before randomisation (except for tubal infertility) A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy 25- 34 days of menstruation cycle Body mass index (BMI) < 29 kg/m2 Exclusion Criteria: Any clinically significant systemic disease (e.g., insulin dependent diabetes) Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas (...) vaginal bleeding Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus Pregnancy, lactation or contraindication to pregnancy – must be confirmed by negative urinary pregnancy test at randomisation 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

2006 Clinical Trials

3482. Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency

and decreased insulin sensitivity. To test this hypothesis, 10 healthy and 10 GHD children will be studied using the stable isotope [U-13C] glucose and Mass Isotopes Distribution Analysis (MIDA). The investigators will be specifically measuring the rate of glucose production, gluconeogenesis, glycogenolysis, insulin sensitivity and glucagon response after an overnight fast. In addition, the investigators will measure changes in protein oxidation, proteolysis and fat metabolism using the stable isotopes (...) with evidence of tumors or space occupying lesions will be excluded. GHD subjects with adrenal insufficiency and or hypothyroidism. will not be considered for the study. 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): NCT00362063 Locations Layout table

2006 Clinical Trials

3483. Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults

% of older adults fall once a year and, of those falls, 5% result in fractures. Preserving muscle mass and strength is an effective way to lower the risk of falling and to maintain independence among older people. Potassium bicarbonate is a base supplement that can neutralize acid. The purpose of this study is to determine the effectiveness of potassium and bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older adults. This study will last 3 months. Participants (...) the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 50 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Body mass idex less than 35 Not currently on a weight gain or weight loss diet Willing to maintain usual level of physical activity Willing to refrain from taking own calcium supplements, antacids, or salt substitutes Exclusion Criteria: Vegetarian Use

2006 Clinical Trials

3484. Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

resistance, the following is hypothesized: 1) an intensive lifestyle intervention with DE will improve the plasma lipid profile, decrease visceral fat mass, and improve hormonal, metabolic, and lipoprotein markers associated with insulin resistance; and 2) adding niacin, fenofibrate, or a combination of the two drugs to the intensive lifestyle intervention will result in further improvement in the cardiovascular risk profile. DESIGN NARRATIVE: This randomized, placebo-controlled study of 200 (...) ] Total cholesterol : HDL-C ratio: Fasting lipid levels Secondary Outcome Measures : Insulin Sensitivity [ Time Frame: Measured at 24 weeks ] Adiponectin (micrograms/ml) Body Composition [ Time Frame: Measured at 24 weeks ] Body cell mass (kg) Fat mass (kg) 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

2005 Clinical Trials

3485. Appetite stimulants in cystic fibrosis: a systematic review. Full Text available with Trip Pro

, including authors of identified published articles, and suppliers of appetite stimulants.Fifty-four articles were located. Fifteen studies were suitable for inclusion in the review: 10 studied, megesterol acetate (MA); 1, dronabinol; 2, mirtazapine; and 2, cyproheptadine. MA showed a beneficial effect on lung function, weight, appetite, fat free and fat mass. Adverse effects for MA included adrenal suppression, abnormalities of glycaemic control, mood changes and testicular failure

2007 Journal of human nutrition and dietetics : the official journal of the British Dietetic Association

3486. Effects of megestrol acetate on pituitary function and end-organ hormone secretion: a post hoc analysis of serum samples from a 12-week study in healthy older men. (Abstract)

as the end-organ hormones estradiol (E2), cortisol, free T4, and T, were measured in samples obtained at baseline (week 0) and after 12 weeks of MA treatment.Serum samples from 21 men (mean [SD]age, 67.0 [7.3]years; mean [SD] body mass index, 23.1 [10.4] kg/m2; mean [SD] percentage of body fat, 22.5% [8.8%]; RT + T, T, RT + P, and P groups, n = 4, 5, 6, and 6 subjects, respectively) were available from the original study. The mean percentage changes from baseline in serum pituitary hormone concentrations (...) not significantly changed.This analysis of serum samples from healthy older men suggests that MA administration significantly affected the secretion of several pituitary hormones and end-organ hormone synthesis. Most notably, ACTH secretion and serum cortisol levels were statistically significantly suppressed in 20 of 21 subjects, without the development of clinically significant adrenal suppression.

2005 The American journal of geriatric pharmacotherapy

3487. Levels of DHEA and DHEAS and responses to CRH stimulation and hydrocortisone treatment in chronic fatigue syndrome. (Abstract)

Levels of DHEA and DHEAS and responses to CRH stimulation and hydrocortisone treatment in chronic fatigue syndrome. An association between chronic fatigue syndrome (CFS) and abnormalities of the hypothalamo-pituitary-adrenal axis has been described, and other adrenal steroid abnormalities have been suggested. Dehydroepiandrostenedione (DHEA) and its sulphate (DHEA-S), apart from being a precursor of sex steroids, have other functions associated with memory, depression and sleep. It has been (...) and cortisol were measured in 16 patients with CFS without depression and in 16 controls matched for age, gender, weight, body mass index and menstrual history. CRH tests (1 g/kg i.v.) were carried out on all subjects and DHEA measured at 0, +30 and +90 min. In the patient group, CRH tests were repeated on two further occasions following treatment with hydrocortisone (5 or 10 mg, p.o.) or placebo for 1 month each in a double-blind cross over study protocol.Basal levels of DHEA were higher in the patient

2004 Psychoneuroendocrinology

3488. Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency

: Placebo No Intervention: AcroGHS No Intervention: Active Acromegaly Outcome Measures Go to Primary Outcome Measures : Change in High-sensitivity C-reactive Protein [ Time Frame: baseline and 6 months ] Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results. Secondary Outcome Measures : Change in Total Fat Mass (...) [ Time Frame: baseline and 6 months ] Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results. Change in Total Abdominal Adipose Tissue [ Time Frame: baseline and 6 months ] Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active

2005 Clinical Trials

3489. Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study. Full Text available with Trip Pro

, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass (...) index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly. Results and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05

2006 International journal of biomedical science : IJBS Controlled trial quality: uncertain

3490. Neutrophil count in small-for-gestational age children: contrasting effects of metformin and growth hormone therapy. Full Text available with Trip Pro

and reduced adiponectin levels. Metformin therapy in SGA-PP girls attenuates the hyperinsulinemia, the adrenal androgen excess, and the proinflammatory state. In contrast, GH therapy in SGA-SS children promotes height gain but may induce hyperinsulinemia. Both groups are associated with increased risk markers for future cardiovascular disease. Therefore, we studied markers of inflammation in both SGA subpopulations at baseline and after their respectively corrective therapies. SGA-PP girls (n = 33; mean (...) age, 8 yr; body mass index, 18.5 kg/m(2)) were randomized to remain untreated or to receive metformin (425 mg/d) for 6 months. SGA-SS children (n = 29; mean age, 7 yr; body mass index, 14.7 kg/m(2)) were randomly assigned to remain untreated or to receive GH (60 mug/kg/d). In SGA-PP girls, the mean neutrophil count (4.0 x 1000/mm(3)) was more than 2 sd above the mean reference level (2.8 x 1000/mm(3), P < 0.001); this remained stable over 6 months in untreated girls but dropped in metformin

2005 The Journal of clinical endocrinology and metabolism Controlled trial quality: uncertain

3491. Improved insulin sensitivity in 80 nondiabetic patients with MDD after clinical remission in a double-blind, randomized trial of amitriptyline and paroxetine. (Abstract)

-adrenal (HPA) system activity. Therefore, the aim of the present study was to examine whether insulin sensitivity improves during anti-depressive treatment in depressed patients with declining HPA system activity.Eighty inpatients with an episode of major depressive disorder (DSM-IV criteria) were treated in a double-blind, randomized protocol with either amitriptyline or paroxetine over a period of 5 weeks. After 6 drug-free days, an oral glucose tolerance test was performed on day 1 and again 35 (...) days after antidepressive treatment. For quantification of free cortisol levels, saliva was obtained daily at 8:00 a.m. during weeks -1 (washout) and 5. The study was conducted from May 2005 to December 2005.The insulin sensitivity index(Matsuda) increased in only those patients who remitted from major depressive disorder as a result of treatment with either antidepressant (F = 7.0, df = 1,74; p < .01), while correcting for body mass index. Further, cortisol concentrations declined in remitters

2006 Journal of Clinical Psychiatry Controlled trial quality: uncertain

3492. Combining growth hormone releasing hormone-arginine and synacthen testing diminishes the cortisol response. Full Text available with Trip Pro

Combining growth hormone releasing hormone-arginine and synacthen testing diminishes the cortisol response. The GHRH/arginine test and short synacthen test (SST) have been validated as safe alternatives to the insulin tolerance test for the assessment of the GH reserve and hypothalamic-pituitary-adrenal axis integrity, respectively. However, these two tests are usually performed separately. The objective was to see whether the synacthen and GHRH/arginine tests could be combined to save time (...) , patients had a lower peak cortisol response with a mean difference of 116 nmol/liter (95% confidence interval, 52.54 to 179.37; P < 0.001), and one patient with a normal response on the SST had a subnormal cortisol response in the combined test. Similar lower peak cortisol responses were observed in males and females with combined test. The difference between the peak cortisol responses showed no significant correlation with age (r = 0.123; P = 0.58) or with the body mass index (r = -0.376; P = 0.09

2007 The Journal of clinical endocrinology and metabolism Controlled trial quality: uncertain

3493. Use of the electrothermal bipolar vessel system (EBVS) in laparoscopic adrenalectomy: a prospective study. (Abstract)

Use of the electrothermal bipolar vessel system (EBVS) in laparoscopic adrenalectomy: a prospective study. Since laparoscopic adrenalectomy (LA) has been adopted as the gold standard for the treatment of adrenal diseases, the development of technology for vascular control and dissection manoeuvres, amongst other things, may play a pivotal role in its further improvement. We report our experience with the electrothermal bipolar vessel sealing (EBVS) device for LA.From January 2004 to January (...) 2006, 50 patients (pts) undergoing LA were selected and randomized for use of the EBVS (25 pts, group A) versus the UltraSonic Shears (USS) device (25 pts, group B). Age, sex, body mass index (BMI), previous surgery and associated diseases were similar between the two groups. The main surgical parameters collected for each patient (pt) concerned operative time, major and minor complications, conversion rate, blood loss, hospital stay and histology.There was no mortality in either group. The right

2008 Surgical endoscopy Controlled trial quality: uncertain

3494. Safety, tolerability, and exposure of ciclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis. (Abstract)

and its active metabolite, desisobutyryl-ciclesonide, were measured using high-performance liquid chromatography assay with tandem mass spectrometric detection, with lower limits of quantification of 25 and 10 pg/mL, respectively. Adrenal function was monitored by diurnal serum free and 24-hour urine cortisol concentrations. Despite the use of a sensitive assay and a high ciclesonide dose (800 microg/d), serum levels of ciclesonide and desisobutyryl-ciclesonide were below the lower limits

2006 Journal of clinical pharmacology Controlled trial quality: uncertain

3495. Effects of testosterone replacement in androgen-deficient women with hypopituitarism: a randomized, double-blind, placebo-controlled study. Full Text available with Trip Pro

Effects of testosterone replacement in androgen-deficient women with hypopituitarism: a randomized, double-blind, placebo-controlled study. Hypopituitarism in women is characterized by profound androgen deficiency due to a loss of adrenal and/or ovarian function. The effects of testosterone replacement in this population have not been reported.The objective of the study was to determine whether physiologic testosterone replacement improves bone density, body composition, and/or neurobehavioral (...) function in women with severe androgen deficiency secondary to hypopituitarism.This was a 12-month randomized, placebo-controlled study.The study was conducted at a general clinical research center.Fifty-one women of reproductive age with androgen deficiency due to hypopituitarism participated.Physiologic testosterone administration using a patch that delivers 300 microg daily or placebo was administered.Bone density, fat-free mass, and fat mass were measured by dual x-ray absorptiometry. Thigh muscle

2006 The Journal of clinical endocrinology and metabolism Controlled trial quality: predicted high

3496. Testosterone supplementation of megestrol therapy does not enhance lean tissue accrual in men with human immunodeficiency virus-associated weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Full Text available with Trip Pro

coadministration of testosterone with MA could enhance lean body mass (LBM) accrual and evaluate the effects of MA, alone or combined with testosterone, on sexual functioning and the hypothalamic-pituitary-adrenal axis.This was a randomized, double-blind, placebo-controlled, multicenter trial.Fourteen AIDS Clinical Trials Units in the United States participated in the study.Seventy-nine HIV-positive men with 5% or more weight loss or body mass index less than 20 kg/m2 took part in the study.Subjects were (...) randomized to receive MA (800 mg daily) plus testosterone enanthate (200 mg; MA/TE; n = 41) or placebo (MA/PL; n = 38) biweekly for 12 wk.Weight, body composition (bioelectric impedance analysis), adrenal and gonadal hormones, and sexual functioning (questionnaire) were measured.Both groups experienced robust increases in weight (median 5.3 and 7.3 kg in MA/TE and MA/PL, respectively), LBM (3.3 and 3.3 kg), and fat (3.0 and 3.8 kg). There were no significant differences between groups in the magnitude

2007 The Journal of clinical endocrinology and metabolism Controlled trial quality: predicted high

3497. Effects of dehydroepiandrosterone and alprazolam on hypothalamic-pituitary responses to exercise. Full Text available with Trip Pro

Effects of dehydroepiandrosterone and alprazolam on hypothalamic-pituitary responses to exercise. The hypothalamic-pituitary-adrenal axis (HPA) is restrained by activation of gamma-amino-butyric acid receptors. Alprazolam (APZ) and dehydroepiandrosterone (DHEA) are purported to be gamma-amino-butyric acid agonists and antagonists, respectively.Our objective was to examine the effects of APZ and DHEA alone and in combination on HPA axis activity.This was a double-blind, crossover, placebo (...) -controlled study.The study setting was the general community.Subjects consisted of 15 men (age, 20-45 yr) with a body mass index of 20-25 kg/m2.DHEA (100 mg/d) or placebo was given for 4 wk, followed by a 2-wk washout; participants ingested 0.5 mg APZ or placebo 10 and 2 h before high-intensity exercise.We measured basal and exercise-induced ACTH, arginine vasopressin (AVP), cortisol, DHEA, and GH responses. It was hypothesized that DHEA would enhance and APZ would blunt exercise-induced ACTH

2005 The Journal of clinical endocrinology and metabolism Controlled trial quality: uncertain

3498. Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy. (Abstract)

patient age greater than 80 years, body mass index greater than 40, bilateral adrenalectomy and significant prior abdominal surgery in the quadrant of interest. Mean followup was 5.96 years in the 2 groups.The groups were matched in regard to patient age (p = 0.84), body mass index (p = 0.43), American Society of Anesthesiologists class (p = 0.81) and laterality (p = 0.12). Median adrenal mass size was 2.7 cm (range 1 to 9) in the TLA group and 2.6 cm (range 0.5 to 6) in the RLA group (p = 0.83). TLA (...) Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy. We report a prospective, randomized comparison of transperitoneal laparoscopic adrenalectomy (TLA) vs retroperitoneal laparoscopic adrenalectomy (RLA) for adrenal lesions with long-term followup.Between December 1997 and November 1999, 57 consecutive eligible patients with surgical adrenal disease were prospectively randomized to undergo TLA (25) or RLA (32). Study exclusion criteria were

2005 The Journal of urology Controlled trial quality: uncertain

3499. Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency. Full Text available with Trip Pro

Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency. Treatment of adult GH deficiency (AGHD) with daily injections of GH results in decreased adipose mass, increased lean body mass (LBM), increased bone mineral density, and improved quality of life.This study seeks to determine whether a depot preparation of GH given every 14 d would lead to comparable decreases in trunk adipose tissue as daily GH.This open-label, randomized study compares subjects (...) absorptiometry.The percentage of the trunk region that is fat increased by 0.4 in the no treatment group, but decreased by 3.2 (P = 0.001 vs. untreated) in the GH depot group and by 2.5 (P < 0.004 vs. untreated) in the daily GH group. Visceral adipose tissue area decreased by 9.1% in the GH depot group and by 6.8% in the daily GH group. LBM and high-density lipoprotein increased in both treatment groups. Side effect profiles were similar. Three subjects receiving GH experienced serious episodes of adrenal

2005 The Journal of clinical endocrinology and metabolism Controlled trial quality: uncertain

3500. In boys with abnormal developmental tempo, maturation of the skeleton and the hypothalamic-pituitary-gonadal axis remains synchronous. Full Text available with Trip Pro

with congenital adrenal hyperplasia (n = 13) and familial male-limited precocious puberty (n = 22), two conditions that accelerate maturational tempo, and boys with idiopathic short stature (n = 18) in which maturational tempo is sometimes delayed. In all three conditions, the onset of central puberty generally occurred at an abnormal chronological age but a normal bone age. Boys with the greatest skeletal advancement began central puberty at the earliest age, whereas boys with the greatest skeletal delay (...) began puberty at the latest age. Furthermore, the magnitude of the skeletal advancement or delay matched the magnitude of the pubertal advancement or delay. This synchrony between skeletal maturation and hypothalamic-pituitary-gonadal axis maturation was observed among patients within each condition and also between conditions. In contrast, the maturation of the hypothalamic-pituitary-gonadal axis did not remain synchronous with other maturational processes including weight, height, or body mass

2004 The Journal of clinical endocrinology and metabolism

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