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Adrenal Mass

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3361. 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

3362. Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

Measures : Response Rate [ Time Frame: 4 months ] The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. 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, and maintained

2008 Clinical Trials

3363. Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido

Exclusion Criteria: Female sexual dysfunction other than HSDD, arousal and orgasmic disorder, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia Hyperandrogenemic conditions, such as congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), Cushing's syndrome or signs of hyperandrogenism like severe hirsutism or severe acne Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial (...) to normal. Presence or history of liver tumors (benign or malignant). Known or suspected sex-steroid influenced malignancies (e.g., of the genital organs or the breasts) Undiagnosed vaginal bleeding. Known or suspected pregnancy. Hypersensitivity to the active substances or to any of the excipients. Body-mass index (BMI ) more than 30.0 kg/m² Hypersensitivity to any of the study drug ingredients Any disease or condition that can compromise the function of the body systems and could result in altered

2007 Clinical Trials

3364. Stress and Marijuana Cue-elicited Craving and Reactivity

not be taking any psychoactive medication, or medication that alters the hypothalamic pituitary adrenal (HPA) Axis functioning Must not be taking any medications that alter heart rate or skin conductance monitoring Cannot meet criteria for current major Axis I disorder (may alter response to stress) Cannot be morbidly obese (Body Mass Index >39) Cannot meet current abuse or dependence criteria of other substances in past 90 days Must not have a medical condition that impacts HPA functioning (Hypertension

2008 Clinical Trials

3365. Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

Period. Secondary Outcome Measures : Mean 24-hour Urinary Free Cortisol Excretion [ Time Frame: Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60) ] Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior (...) to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Mean Values for Urine Specific Gravity [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ] Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass

2007 Clinical Trials

3366. Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

scan Lesions that are not considered measurable include the following: Bone lesions 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, unless progression after radiotherapy is documented in these lesions No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks) ECOG (...) radiotherapy; or palliative radiotherapy initially or at relapse) At least 2 weeks since prior surgery and recovered At least 1 week since prior and no concurrent agents with proarrhythmic potential At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers At least 1 week since prior and no concurrent grapefruit concentrate No concurrent palliative radiotherapy No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related

2007 Clinical Trials

3367. Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)

(NASACORT® AQ placebo group) for 12-months. The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo: the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal [HPA] axis function) the rate of treatment-emergent-adverse-events (TEAE) global efficacy rated by the investigator and the participant separately the rate of use of rescue medication during the study Condition (...) History of hypersensitivity to the corticosteroids or to any excipient of the investigational product Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3 Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within

2007 Clinical Trials

3368. 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

3369. 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

3370. Treatment of Anovulatory Infertility in PCOS Patients

: Clomiphene citrate Drug: Metformin Phase 4 Detailed Description: Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups). Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients (...) adrenal hyperplasia Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. Organic pelvic diseases Previous pelvic surgery Suspected peritoneal factor infertility Tubal or male factor infertility or sub-fertility Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact

2007 Clinical Trials

3371. 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

3372. 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

3373. 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

3374. Insulin Resistance in Women With Prolactinoma

-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution. Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 2004 (...) : Yes Criteria Inclusion Criteria: Prolactinoma Female gender Premenopausal Exclusion Criteria: Obesity (BMI ≥ 30 kg/m²) Diabetes mellitus Hypertension GH deficiency Hypothyroidism Primary hypogonadism Adrenal insufficiency Pituitary surgery 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

2007 Clinical Trials

3375. Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma

. Partial Response (PR): MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma. Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline. Secondary Outcome Measures : Survival Time [ Time Frame (...) node biopsy within past 4 weeks allowed Prior everolimus allowed No concurrent immunosuppressant therapy Concurrent stable chronic doses of steroids (≤ 20 mg of prednisone per day) for disorders other than lymphoma (i.e., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, asthma) or for pruritus or fever associated with lymphoma allowed Concurrent corticosteroids at the lowest possible dose necessary to control symptoms in patients with CNS lymphoma allowed No concurrent CYP450

2007 Clinical Trials

3376. Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA

Mass Index (BMI) 20-28 kg/m2 early follicular phase FSH level < 9 IU/l. Exclusion Criteria: ascertained or presumptive hypersensitivity to the active principle and/or their ingredients primary ovarian failure ovarian cysts or enlargement not due to polycystic ovarian syndrome oocyte donation abnormal bleeding of undetermined origin patients who have exhibited poor response or requiring doses of more than 300 IU daily in previous treatment cycles or those who have received similar therapies (...) (previous treatment cycles) in the 30 days prior to the beginning of the present study uncontrolled thyroid or adrenal dysfunction neoplasia severe impairment of the renal and/or hepatic functions diabetes and active thrombophlebitis, cardiopathies and epilepsy presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term presence of any anatomical abnormality of the reproductive system being pregnant or breastfeeding menopause

2007 Clinical Trials

3377. 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

3378. Closed-loop Glucose Control for Automated Management of Type 1 Diabetes

Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria (type 1 diabetic subjects): Age 18 years or older Clinical type 1 diabetes for at least five years Otherwise healthy (mild chronic disease allowed if well controlled) Diabetes managed using an insulin infusion pump Body mass index (BMI) between 20 and 31 Total daily dose (TDD) of insulin ≤ 1 U/kg and ≤ 100 U/day Post-prandial C-peptide < 0.1 nmol/L at 90 minutes in a mixed meal (Sustacal) tolerance test by the DCCT method Hemoglobin A1c less (...) than or equal to 8.5% Prescription medication regimen stable for at least 1 month Inclusion Criteria (non-diabetic subjects): Age 18 years or older No personal history of diabetes, impaired fasting glucose, or impaired glucose tolerance No personal history of pancreatic disease Not taking medication that may affect glucose, insulin, or glucagon dynamics Otherwise healthy (mild chronic disease allowed if well controlled) Body mass index (BMI) between 20 and 31 Normal 75 g oral glucose tolerance test

2008 Clinical Trials

3379. Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

sterilization, no pregnancy test or contraception will be required. Willingness to attend all clinic visits and participate in two 28-hour studies or one 9-hour study. Hemoglobin A1C of 5.0-10%. (Values below 5.0 suggest a severe tendency towards hypoglycemia, and values above 10% suggest severely uncontrolled diabetes with risk for ketoacidosis.) Body mass index of 19-35. Exclusion Criteria: Pregnancy, lactation or refusal to use contraception. Use of any investigational drug during the 30 days prior (...) or a family history of Multiple Endocrine Neoplasia (MEN) 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease. Hypoglycemic unawareness or chronic hypoglycemia. A severe hypoglycemic event which required hospitalization within the past two years. Adrenal insufficiency. Insulinoma. Use of both acetaminophen and ascorbic acid. Impaired mentation or psychiatric diagnoses Uncontrolled candidiasis. Any known allergy to glucagon. Contacts and Locations Go to Information from the National Library

2008 Clinical Trials

3380. Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914

or sarcoma) Medically diagnosed severe depression currently or in the past Known or suspected alcoholism or drug abuse Abnormal serum fasting clinical chemistry values Women with known abnormal thyroid status Women with known impaired hypothalamic-pituitary-adrenal reserve Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest Body mass index(BMI) > 29.0 Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women < 35 years who smoke

2008 Clinical Trials

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