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Adrenal Mass

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3461. Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

to continue the same diet and exercise program during the study. Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study. Exclusion Criteria: Participants who meet any of the following criteria will be excluded: Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2. Consume > 14 (...) , including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (> 1 quart/day). Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day) Participants who are on over the counter lipid lowering agents such as fish oils, garlic and cholestin Participants who are on oral corticosteroids, unless used as replacement therapy for pituitary/adrenal

2006 Clinical Trials

3462. The Final Diagnosis and Treatment Result of Metastatic Cervical Carcinoma of Unknown Primary

or by physical examination were found most frequently in the lymph nodes (37.1%), followed by the liver, bone, lung, pleura/pleural space, brain, peritoneum, adrenal and skin. Of the lymph nodes of metastasis, the supraclavicular cervical area is the leading site (31.3%), followed by the mediastinum, axilla, retroperitonium, and inguina.5 The incidence of metastatic cervical CUP (MCCUP) varies between 2% and 9% of all head and neck cancers.6-8 The level of cervical metastatic involvement may give some clue (...) as to the likely primary site. A submandibular mass (level I) would most commonly be related to a primary in the oral cavity or skin. Level II nodes, including the jugulodigastric node, may point to a primary in the oral cavity, oropharynx, or supraglottic larynx. Tumours of the nasopharynx generally spread to level II or the posterior triangle, as well as retropharyngeal nodes. Middle and lower jugular nodes (levels III and IV) are more likely related to a laryngeal or hypopharyngeal cancer. Metastatic

2006 Clinical Trials

3463. Effect Of GW501516X On How The Heart Obtains And Uses Energy

members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 40 Years (Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion criteria: Non-smoking. Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist (...) circumference of greater than 95 cm (37.5 inches). Exclusion criteria: History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease). Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder. 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

2006 Clinical Trials

3464. Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women

species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given (...) Volunteers: Yes Criteria Inclusion Criteria: Healthy postmenopausal women with 50 or more moderate to severe hot flushes. Women between 40 to 70 years of age. Exclusion Criteria: Body mass index (BMI) of 35 kg/m2 or more. Significant metabolic and endocrine diseases. Diagnosis of cancer. Use of steroids or drugs that interfere with the metabolism of estrogen. Use of any systemic estrogen, progestin, or DHEA in the eight weeks prior to randomization. Use of alternative therapies or natural products

2006 Clinical Trials

3465. A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer

, we would like to determine what effect any improvement in weight has on body composition by DEXA scan. This includes whether the drug results in an increase in fat, fat-free mass, or both. If our patients gain weight we would like to know if it improves their quality of life. Finally, many children with cancer lose too much weight and require feeding to occur through a tube put down their nose into their stomach (NG feeding). The tube can be painful to put down and is uncomfortable when in. Some (...) of corticosteroids AND who are not at least 14 days from their last dose of corticosteroids. Subjects concurrently prescribed other appetite-stimulating medications. Subjects with hormone-sensitive tumors including meningiomas. Subjects with any of the following conditions: Adrenal insufficiency Defined as: A pre-study 8:00 AM serum cortisol lower than the defined limits of this study (see section 7.4) plus confirmation of adrenal insufficiency by an ACTH stimulation test. Diabetes Mellitus Defined as: A pre

2007 Clinical Trials

3466. Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma

response and evaluation will be performed using standardized lymphoma International Working Group recommendations. > > A Complete Response (CR) requires: Complete disappearance of all detectable clinical and radiographic evidence of > disease. All lymph nodes and nodal masses must have regressed to normal size. Partial Response (PR): greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions. No increase in size of other nodes no new sites (...) denileukin diftitox More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side effects of this therapy are resolved) More than 2 weeks since prior oral corticosteroids (unless being used to treat adrenal insufficiency) More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with ultraviolet A More than 1 week since prior biologic therapy No concurrent chemotherapy, other immunotherapy, or radiotherapy No other concurrent investigational agents Contacts

2007 Clinical Trials

3467. Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-

. HbA1c <5.8% Fasting blood glucose is defined as glucose concentrations in plasma samples taken between 5 a.m. and 12 noon after at least eight hours of fasting (including abstinence from snacks and calorie-containing juice, coffee, etc. ). All other blood glucose measurements of are counted random glucose. Patients who have no obvious family history (in parents or siblings) of diabetes mellitus at the time of commencement of study drug administration Patients whose body mass index (BMI) is less than (...) 25 kg/m2 in the current charts of the study site at the time of giving informed consent Body Mass Index (BMI) = Body weight in kg /(height in m)2 Exclusion Criteria: Patients who have been given aripiprazole after market launching Patients who clearly experienced symptoms of polydipsia, including so-called PET-bottle syndrome (hyperglycemia caused when the supply of insulin, which promotes glucose metabolism, becomes insufficient due to continuous soft drink consumption) and water intoxication

2006 Clinical Trials

3468. Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase (...) rheumatica, adrenal insufficiency, or asthma) Non-escalating doses of steroids at the lowest possible dosing level are allowed for CNS lymphoma No other concurrent investigational ancillary therapy No other concurrent chemotherapy, immunotherapy, or radiotherapy No concurrent participation in any other clinical trial involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intent Contacts and Locations Go to Information from the National

2007 Clinical Trials

3469. Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

inclusive), presumed to be ovulatory Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive) Willing to donate the retrieved oocytes Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit Exclusion Criteria Abnormal karyotype Any known clinically significant systemic disease (e.g., insulin dependent diabetes) Any known endocrine (...) or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV Diagnosed as "poor responder" History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy) Pregnancy or lactation Use of any investigational drug during 3 months prior to start of the current COH cycle Previous participation in the study Hypersensitivity to any

2007 Clinical Trials

3470. Influence of nCPAP on Metabolic Consequences Associated With OSAS

of inflammation and hypoadiponectinemia independent of the body mass index. Furthermore, hyperactivity of HPA axis and sympathetic nervous system are recovered by nCPAP. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 45 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science Official Title: Improvement in Hypothalamic-Pituitary-Adrenal Axis Function (...) Study Details Study Description Go to Brief Summary: Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity. Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic pituitary adrenal axis, insulin resistance, blood pressure values

2007 Clinical Trials

3471. Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than (...) Frame: 5 years ] Time to clinical local recurrence (The time from randomization to the first biopsy-proven recurrence in the prostatic bed or new mass.) [ Time Frame: Up to 15 years post-randomization ] Time to metastatic disease progression (The date of randomization to date of evidence of systemic disease on bone scan or cross sectional imaging.) [ Time Frame: Up to 15 years post-randomization ] Unacceptable toxicity (grade 3 or higher toxicity) [ Time Frame: Up to 15 years post-randomization

2007 Clinical Trials

3472. DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

Detailed Description: Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance (...) of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity, Women having a low maturation index and a vaginal pH above 5, Endometrial thickness of 4 mm or less at transvaginal ultrasonography, Body weight within 18.5 and 32.0 according to body mass index. Exclusion Criteria: Undiagnosed abnormal genital bleeding, Active or history of thromboembolic disease, Significant metabolic

2007 Clinical Trials

3473. Sunitinib in Refractory Adrenocortical Carcinoma

ulcer(s), or significant bone fracture(s). Prior radiation therapy to >25% of the bone marrow. Cachectic patients with a body mass index < 18 kg/m2 Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Contacts (...) 31, 2019 Last Verified: August 2018 Keywords provided by Martin Fassnacht, University of Wuerzburg: Adrenal cancer refractory to cytotoxic therapy Sunitinib Multitargeted tyrosine-kinase inhibitor Additional relevant MeSH terms: Layout table for MeSH terms Carcinoma Adrenocortical Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases

2007 Clinical Trials

3474. Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)

but not older than 50 years of age at the time of screening; Body mass index >=17 and <=35; Good physical and mental health; Willing to give informed consent in writing. Exclusion Criteria: Contraindications for contraceptive steroids In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia): Renal insufficiency; Hepatic dysfunction (...) ; Adrenal insufficiency. An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening; Clinically relevant abnormal laboratory result at screening as judged by the investigator; Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1

2006 Clinical Trials

3475. DHEA and Testosterone Replacement in Elderly

: July 1998 Actual Primary Completion Date : February 2007 Actual Study Completion Date : February 2007 Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension body composition (fat percent, fat free mass, abdominal visceral fat, and thigh muscle area) bone parameters (BMD of ultradistal radius, femur neck, femur total and anterior-posterior of L2-L4 (...) mellitus, malignancy, malabsorption, bone disorders, chronic obstructive pulmonary disease, or sleep apnea. Others exclusion criteria include abnormal serum calcium, phosphorus, alkaline phosphatase, asparate aminotransferase, creatinine, urinary calcium, thyroid stimulating hormone, and erythrocyte sedimentation rate. People taking medication that may affect outcome measures such as adrenal steroids, anticonvulsant therapy thiazide diuretics, and estrogen replacement were also excluded. People engaged

2005 Clinical Trials

3476. Effects of DHEA and Exercise in the Elderly

: DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to the levels found in young people. Anotehr (...) the effect of DHEA replacement on age-related changes in body composition, muscle function and metabolism, and bone mass in healthy older adults. The specific aims are to evaluate the effects of DHEA replacement (50 mg/d) alone, or in combination with resistance exercise training on: a) lean body mass, intraabdominal fat and thigh muscle volume, and muscle protein synthesis rate b) bone mineral density (BMD) of the total body, lumbar spine, and hip and biochemical markers of bone turnover and c) insulin

2005 Clinical Trials

3477. Insulin Glargine in Type 1 Diabetes Mellitus

C-Peptide <= 0,1nmol/L with FBG >126 mg/dl Body Mass Index (BMI) < 30 kg/m2 Willingness to accept intensive insulin therapy Ability and willingness to perform SMBG using plasma glucose meter Female subjects must be postmenopausal or under adequate contraception as judged by the investigator (it may be oral contraceptives, intra-uterine device or surgical treatment) and must have a negative serum pregnancy test Exclusion criteria: Diabetes other than type 1 diabetic mellitus Type 1 diabetic (...) hypoglycemia with seizure or coma during the past year Likelihood of requiring treatment during the study period with any anti-diabetic drug other than the study drugs Failure to use adequate contraception (women of current reproductive potential only) Known hypersensitivity to insulin glargine, or any of the excipients Malignancy except basal cell carcinoma within the last five years Long lasting (> 2 weeks) treatment with systemic glucocorticoid therapy Known adrenal insufficiency (interferes

2006 Clinical Trials

3478. Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults

, including use of: n) systemic corticosteroids, known to be associated with suppression of the hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids [15 mg/day of prednisone or its equivalent] or chronic use of inhaled high potency corticosteroids [budesonide 800 μg/day or fluticasone 750 μg/day]), both within the previous 60 days, o) receipt of immunostimulants within 60 days, p) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the 3 (...) entry; obese (e.g., with a body mass index [BMI] ≥35, where BMI reflects obesity and not high muscle mass); any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject. 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

2005 Clinical Trials

3479. Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

a period of 24 hours ] This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually. Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment] [ Time Frame: 10 minutes, over a period of 24 hours ] This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 (...) will require: the presence of oligo/amenorrhea; hyperandrogenemia, defined by a supranormal plasma free testosterone level (> 10 pg/ml); hyperandrogenism, as evidenced by infertility, hirsutism, acne, or androgenetic alopecia; and exclusion of nonclassic 21-hydroxylase deficiency congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, or significant elevations in serum prolactin. Thus, all subjects will meet the National Institutes of Health (NIH) consensus criteria for PCOS. Control subjects

2005 Clinical Trials

3480. Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)

(e.g., hysterectomy or tubal ligation). Subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations. Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on their current cholesterol-lowering diet and their current exercise regimen for the duration of the study. Exclusion Criteria: Subjects whose body mass index (BMI=weight [kg]/height2[m]) is >=30 (...) : niacin (>200 mg/day) and resins taken within 5 weeks, fibric acid derivatives taken within 8 weeks, and probucol taken within one year prior to Visit 3 (Baseline Visit). Over the counter lipid lowering agents such as fish oils, garlic and cholestin taken within 5 weeks prior to Visit 3 (Baseline Visit). Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks prior to Visit 3 (Baseline Visit). Subjects who

2005 Clinical Trials

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