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Adrenal Mass

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3441. Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

. Body Mass Index (BMI) of >/= 17 and adrenal insufficiency). Breastfeeding. Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin

2007 Clinical Trials

3442. Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

cycles). At least 18 but not older than 50 years of age at the time of screening. Body mass index (BMI) of >/= 17 and 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

2007 Clinical Trials

3443. 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

3444. 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

3445. 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

3446. 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

3447. Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI Nonmeasurable disease includes any of the following: Small lesions with longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonitis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Irradiated lesions, unless progression is documented after (...) lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated More than 4 weeks since prior and no other concurrent anticancer therapy Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency) Topical and/or inhaled steroids allowed No concurrent full-dose oral or parenteral anticoagulation Low-dose warfarin (1 mg

2007 Clinical Trials

3448. 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

3449. 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

3450. 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

3451. 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

3452. 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

3453. 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

3454. Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

disease, unless more than 5 years between primary surgery and development of metastatic disease OR primary cancer was stage I Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Nonmeasurable lesions include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions UGT1A1*1 homozygous (...) as measurable lesion is outside irradiated field No concurrent palliative radiotherapy No other concurrent chemotherapy No concurrent steroids except those given for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic or for prevention of infusion reaction 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

2006 Clinical Trials

3455. Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area PATIENT CHARACTERISTICS: ECOG performance status 0-1 Granulocyte count ≥ 1,500/mm^3 Hemoglobin > 8.0 g/dL Platelet count ≥ 100,000/mm^3 Bilirubin < 1.5 mg/dL Creatinine < 1.5 times upper limit of normal (ULN) Meets 1 of the following criteria: AST and ALT < 2 times ULN AST and ALT ≤ 2.5 times ULN AND alkaline phosphatase (AP) normal AST (...) concurrent hormonal therapy or chemotherapy except for the following: Steroids for adrenal failure, allergic reactions, or septic shock Hormones for nondisease-related conditions (e.g., insulin for diabetes) Glucocorticosteroids as anti-emetics 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

2006 Clinical Trials

3456. Treatment of Adults With Growth Hormone Deficiency

provided by the National Library of Medicine related topics: related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: LB03002 Drug: growth hormone subcutaneous injection, once-weekly Placebo Comparator: Placebo Drug: growth hormone subcutaneous injection, once-weekly Outcome Measures Go to Primary Outcome Measures : Changes in Fat Mass at the end of 26-week treatment from baseline [ Time Frame: 26 weeks ] Secondary Outcome Measures : Changes (...) at screening No exposure to rhGH within the last 6 months Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing

2006 Clinical Trials

3457. Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Disease must be confined to the breast and axillary nodes without detected masses elsewhere No history of prior ipsilateral or contralateral invasive breast cancer Resected disease No more than 16 weeks since last surgery to remove the tumor No known clinical residual locoregional disease Margins must be negative for invasive breast cancer and ductal carcinoma in situ (...) estrogen receptor modulators (SERMs) No concurrent recombinant human epoetin alfa or pegfilgrastim No prior neoadjuvant or adjuvant therapy for breast cancer except radiotherapy Concurrent trastuzumab (Herceptin®) allowed No concurrent hormonal replacement therapy No other concurrent hormonal therapy (including estrogen, progesterone, androgens, tamoxifen citrate, SERMs, or aromatase inhibitors) except for the following: Steroids for adrenal failure Hormones for non-disease-related conditions (e.g

2006 Clinical Trials

3458. 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

3459. The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

and their exercise regimen for the duration of the study. Exclusion Criteria: Subjects whose body mass index (BMI = weight [kg]/height2 [m]) is >= 35 kg/m^2 at Visit 3 (Baseline Visit). Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits). Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study. Women who are pregnant or nursing. Exclusion Criteria (...) Visit 3, including amiodarone hydrochloride (6 months) and probucol (12 months). Subjects currently consuming large amounts of grapefruit juice (> 1 liter/day). 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 are currently using cardiovascular medication (e.g. antihypertensive, antiarrhythmic) and have not been on a stable regimen for at least 6 weeks

2007 Clinical Trials

3460. Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

evaluations. Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on their cholesterol-lowering diet and their exercise regimen for the duration of the study Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. Exclusion Criteria: Subjects whose body mass index (BMI = weight[kg]/height[m]**2) is >=35 kg/m**2 at Visit 3 (Baseline Visit). Subjects who consume >14 (...) . Subjects currently consuming large amounts of grapefruit juice (>1 liter/day). Oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at lest 6 weeks prior to Visit 3 (Baseline Visit). Subjects who are currently using cardiovascular medication (e.g., antihypertensive, antiarrhythmic) and have not been on a stable regimen for at least 6 weeks prior to Visit 3 (Baseline Visit) and it is expected to change during the study

2007 Clinical Trials

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