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Adrenal Mass

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3341. TDSM- Testosterone Dose Response in Surgically Menopausal Women

a significant role. Fifty percent of a women's testosterone is made in her adrenal glands (glands that sit on top of the kidneys) and fifty percent is made in her ovaries. When a woman has her ovaries removed it is thought that her testosterone levels decrease rapidly and significantly. This study will be examining testosterone's role in sexual function, general well being, muscle performance, cognitive function, carbohydrate metabolism and muscle and fat distribution. The study is 14 months long (...) , and other health-related outcomes can be achieved at testosterone doses and concentrations that are substantially lower than those required to produce similar effects in men; however, these assumptions have not been tested rigorously. Therefore, the primary objective of this study is to establish testosterone dose-response relationships in surgically menopausal women with low testosterone concentrations for a range of androgen-dependent outcomes, including sexual function, fat-free mass, thigh muscle

2007 Clinical Trials

3342. Donor T Cells, Low-Dose Aldesleukin, and Low-Dose GM-CSF After Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

-dose sargramostim (GM-CSF) SC every other day for 3 doses beginning within 24 hours after each infusion of ATC-CD20Bi. Patients also receive tacrolimus and mycophenolate mofetil as standard graft-vs-host disease prophylaxis. Treatment continues in the absence of unacceptable toxicity. Some patients with well-defined or evaluable masses receive indium I 111 (^111I)-labeled ATC-CD20Bi IV and ^111I-labeled unarmed ATC and then undergo whole-body imaging for trafficking studies. After completion (...) No uncompensated major thyroid or adrenal dysfunction Not pregnant or nursing Persistently elevated systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg must be controlled with antihypertensive agents for at least 7 days prior to initiation of cell therapy Patients with essential hypertension that is controlled with medication are eligible PRIOR CONCURRENT THERAPY: Prior total dose of doxorubicin or daunorubicin must have been less than 450 mg/m^2 unless an endomyocardial biopsy shows less than

2007 Clinical Trials

3343. Safety Study of Oral BTA9881 to Treat RSV Infection

by the Investigator as clinically significant. Subjects known to have experienced elevated liver enzyme values in previous clinical studies will also be excluded. History or clinical evidence of adrenal disease (including Cushing's Syndrome or Addison's disease) or thyroid disease (including hyper or hypothyroidism), and/or previous clinically significant laboratory abnormalities of adrenal or thyroid function parameters. All subjects with thyroid function (TSH, FT4, FT3) outside the normal laboratory reference (...) range at baseline and regarded by the Investigator as clinically significant. Psychiatric or emotional problems that would invalidate the giving of Informed Consent or limit the ability of the subject to comply with clinical trial requirements. Body Mass Index (BMI) ≤18.5 kg/m2 or >=30.0 kg/m2. History of alcohol and/or drug abuse within 1 year prior to screening (verified by drug screening). Receipt of blood or blood products, or loss of 450 mL or more of blood, during the last three months prior

2007 Clinical Trials

3344. Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).] Secondary Outcome Measures : Response Rate [ Time Frame: 27 months ] The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable

2007 Clinical Trials

3345. Metformin Administration in Infertile Anovulatory PCOS Patients

Graecia Study Details Study Description Go to Brief Summary: In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line approach for infertile anovulatory patients with PCOS, we identified predictors for metformin efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data for insulin resistance, a trend in reduced effectiveness was observed (...) disorders or other concurrent medical illnesses Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs Previous use of ovulation induction agents Intention to start a diet or a specific program of physical activity Organic pelvic diseases Previous pelvic surgery Suspected peritoneal

2007 Clinical Trials

3346. Abiraterone Acetate in Treating Postmenopausal Women With Advanced or Metastatic Breast Cancer

weeks in these patients. (Phase II) Secondary To study the pharmacokinetics of this drug in these patients. (Phase I) To determine the endocrine impact of this drug on the pituitary-adrenal-gonad endocrine axis. (Phase I) To estimate the duration of objective tumor response in these patients. (Phase II) To correlate response rates and duration of response with the endocrine profile in these patients. (Phase II) To determine overall survival of these patients. (Phase II) Tertiary To enumerate (...) Outcome Measures : Plasma levels of abiraterone acetate as measured by liquid chromatography/tandem mass spectrometry assay (Phase I) Relationship between dose and endocrine response (Phase I) Duration of objective tumor response as measured by RECIST criteria (Phase II) Relationship between tumor response and endocrine response (Phase II) Median overall survival (Phase II) Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important

2008 Clinical Trials

3347. A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers

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 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Male or female healthy volunteers Body mass index (BMI) of 18-32 kg/m2 Female subjects must have a negative (...) , anorexia, nausea, abdominal pain, joint and muscle pain if considered to be a marker of adrenal insufficiency History of an allergic reaction to mifepristone or fluvastatin Positive serum test for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus Blood donation within 30 days of dosing 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

2008 Clinical Trials

3348. Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer

at the same gynecologic clinic; and, explore modification of the neuronal signals by candidate genes and serum biomarkers in the hypothalamic pituitary-adrenal axis, serotonergic and inflammatory pathways. OUTLINE: Patients are stratified according to body mass index (25.0-39.9 vs ≥ 40) and randomized to 1 of 2 intervention arms. Arm I: Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting (...) through obesity management. SECONDARY OBJECTIVES: To expand and refine a previous pilot study of a behavioral, lifestyle-change education intervention for use in overweight and obese patients in remission from endometrial carcinoma. To determine the potential effects and variation of each regimen in these patients. To explore potential mediators (self-efficacy, depression) and moderators (body mass index) of healthful dietary and exercise behaviors. To evaluate neuronal response to high-versus-low

2008 Clinical Trials

3349. Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?

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: This study will be conducted in subjects with body mass index < 38 kg/m2. Women must be at least 6 months since last menses. Subjects must be willing to maintain their usual exercise level and agree not to attempt to gain or lose weight or change their diets substantially (...) ) Hyperparathyroidism Untreated thyroid disease Significant immune disorder such as rheumatoid arthritis, SLE Current unstable heart disease Active malignancy or cancer therapy in the last year 24-hr urine calcium > 300 mg/d after 1 wk off of calcium supplements Subjects with arrythmias (surgically treated arrythmias acceptable), or myocardial infarction in last 12 months Total hip T score of < -3.0 Abnormal serum calcium; alkaline phosphatase >10% above the upper end of the reference range Adrenal insufficiency

2008 Clinical Trials

3350. Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

disease, defined as at least one of the following: A lymph node or tumor mass that is >= 2.0 cm in at least one dimension by positron emission tomography (PET)/computed tomography (CT), CT, magnetic resonance imaging (MRI), or plain radiograph imaging Splenic enlargement may be used as a measurable parameter if the spleen is palpable >= 3 cm below the left costal margin Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without (...) a discrete mass would constitute assessable, but not measurable, disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 Life expectancy >= 12 weeks Absolute neutrophil count (ANC) >= 1,500/mm³ Platelet count (PLT) >= 100,000/mm³ Serum creatinine =< 2.0 mg/dL Serum total bilirubin (or direct bilirubin if total is abnormal) =< institutional upper limit of normal (ULN) with or without secondary liver involvement Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x

2008 Clinical Trials

3351. Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

, Not previously treated with insulin, On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months HbA1c ≥ 7 and < 11 %, Body Mass Index (BMI) between 25 and 45 kg/m² inclusively, Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary, Signed informed consent obtained prior any study procedures, Willingness and ability to comply with the study protocol. Exclusion Criteria: Treatment with oral (...) (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry), Alcohol or drug abuse within the last year, Night shift worker, Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study, Treatment with weight loss

2008 Clinical Trials

3352. TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.

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 staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 55 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Body Mass Index of 18.0 to 30.0 kg (...) Criteria: A positive test for HIV-1, HIV-2, hepatitis A virus or hepatitis B virus female of child bearing potential evidence of current use of illicit drugs or opioids (with the exception of methadone) or abuse of alcohol impaired liver function as defined in the protocol other currently active or underlying disorders, including gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, adrenal, renal, hepatic, respiratory, inflammatory, or infectious disease

2008 Clinical Trials

3353. Menopur&#174; Versus Follistim&#174; in Polycystic Ovarian Syndrome (PCOS)

Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Pre-menopausal females between the ages of 18 and 42 years Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome]) Oligo- or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries Body mass (...) for assisted reproductive technology (ART) with respect to uterus and adnexa Signed informed consent Exclusion Criteria: Gestational or surrogate carrier, donor oocyte Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, uterine cancer) Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption

2008 Clinical Trials

3354. Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

autonomic failure in type 1 diabetic volunteers. Condition or disease Intervention/treatment Phase Type 1 Diabetes Drug: Dehydroepiandrosterone Drug: Placebo Early Phase 1 Detailed Description: DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. It is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA antagonizes the effects of corticosterone on hippocampal (...) Criteria Inclusion Criteria: 28 (14 males, 14 females) Healthy volunteers aged 18-45 yr. 28 (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr. HbA1c < 11.0% Has been diagnosed Type 1 DM No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) Body mass index < 40kg/m-2 Exclusion Criteria: - pregnancy Medical history- Hepatic Failure/Jaundice Renal Failure Acute Cerebrovascular/ Neurological deficit Physical Exam- Pneumonia Fever greater than 38.0

2008 Clinical Trials

3355. Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child. Body Mass Index (BMI) SDS [ Time Frame: Month 0, 3 and 6 ] Change From Baseline in Growth Velocity (GV) SDS at Month 6 [ Time Frame: Baseline and month 6 ] Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm. Growth velocity during the study was calculated using the two height (...) (stimulated LH ≥ 5 IU/l). Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) > 1 year. Testosterone level ≥ 0.5 ng/ml in boys. Exclusion Criteria: Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion. Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation. Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth

2007 Clinical Trials

3356. Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity

Information provided by: Federico II University Study Details Study Description Go to Brief Summary: Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss without inducing malabsorption (4-6). However, also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM) loss, and the relevance of the FFM (...) contribution to total energy expenditure is well-known (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic effects, are increased after the massive and sustainable weight loss induced by LASGB in severely obese premenopausal women and correlated with the higher post-operative FFM (9-10). It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced

2007 Clinical Trials

3357. Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically* confirmed follicular non-Hodgkin lymphoma (NHL) Previously untreated disease WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as the sole means (...) of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry Measurable disease by physical examination or imaging studies Any tumor mass > 1 cm is acceptable No nonmeasurable disease only, including any of the following: Bone lesions Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Bone marrow (involvement by NHL should

2007 Clinical Trials

3358. AS900672-Enriched in Ovulation Induction

Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Oligo-anovulation defined by a menstrual period of 35 days to 6 months Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months Age between 18 and 36 years, inclusive, at time of informed consent signature Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive No clinically significant (...) or requiring treatment Ovarian cyst with a mean diameter of >25 mm on the day of randomization History or suspicion of ovarian, uterine or mammary cancer Adrenal congenital hyperplasia, partial or complete enzymatic block Use of metformin or other insulin sensitizing agents related to infertility within the prior 2 months Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial Any

2007 Clinical Trials

3359. Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Leptomeningeal disease Ascites Pleural or pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months Patients with tumors (...) radiotherapy No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic No concurrent palliative radiotherapy 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

2007 Clinical Trials

3360. Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Secondary Outcome Measures : Objective Response Rate [ Time Frame: 2 years ] The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all (...) corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required. Safety of Study Treatment Regimen [ Time Frame: 2 years ] Number of participants experiencing a non

2008 Clinical Trials

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